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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended June 30, 2023
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ___ to ___
Commission file number 001-35023
iBio, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or organization)
8800 HSC Parkway, Bryan, TX
(Address of principal executive offices)
26-2797813
(I.R.S. Employer Identification No.)
77807-1107
(Zip Code)
Registrant’s telephone number, including area code: (302) 355-0650
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock
Trading Symbol(s)
IBIO
Name of each exchange on which registered
NYSE American
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ◻ No ⌧
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ◻ No ⌧
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ⌧ No ◻
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during
the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ⌧ No ◻
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions
of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer
Non-accelerated filer
Emerging growth company
◻
⌧
☐
Accelerated filer
Smaller reporting company
◻
☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ◻
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ◻
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to
previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers
during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ⌧
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was $5,435,812 as of December 31, 2022, based upon the closing sale price on the
NYSE American of $0.44 per share reported for such date.
There were 27,586,499 shares of the registrant’s common stock issued and outstanding as of September 26, 2023.
DOCUMENTS INCORPORATED BY REFERENCE:
Certain portions of the Definitive Proxy Statement to be used in connection with the Registrant’s 2022 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report
on Form 10-K
Table of Contents
IBIO, INC.
ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
Item 15.
Item 16.
Exhibits and Financial Statement Schedules
Form 10-K Summary
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Unless the context requires otherwise, references in this Annual Report for the fiscal year ended June 30, 2023 (this “Annual Report”) to
“iBio,” the “Company,” “we,” “us,” “our” and similar terms mean iBio, Inc.
Certain statements in this Annual Report, including, without limitation, statements under the heading “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,” include forward-looking statements as defined in Section 27A of the Securities
Act of 1933 (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), the Private Securities
Litigation Reform Act of 1995 (the “PSLRA”) or in releases made by the Securities and Exchange Commission (the “SEC”), all as may be
amended from time to time. These cautionary statements are being made pursuant to the Securities Act, the Exchange Act and the PSLRA
with the intention of obtaining the benefits of the “safe harbor” provisions of such laws. All statements contained in this Annual Report,
other than statements that are purely historical, are forward-looking statements. Forward looking-statements can be identified by, among
other things, the use of forward-looking language, such as the words “plans,” “intends,” “believes,” “expects,” “anticipates,” “estimates,”
“projects,” “potential,” “may,” “will,” “would,” “could,” “should,” “seeks,” or “scheduled to,” or other similar words, the negative of these
terms, other variations of these terms or comparable language, or by discussion of strategy or intentions. Forward-looking statements are
based upon management’s present expectations, objectives, anticipations, plans, hopes, beliefs, intentions or strategies regarding the future
and are subject to known and unknown risks and uncertainties that could cause actual results, events or developments to be materially
different from those indicated in such forward-looking statements, including the risks and uncertainties set forth in Item 1A of this Annual
Report and in other securities filings by the Company. These risks and uncertainties should be considered carefully, and readers are
cautioned not to place undue reliance on such forward-looking statements. As such, no assurance can be given that the future results
covered by the forward-looking statements will be achieved. All information in this Annual Report is as of June 30, 2023, unless otherwise
indicated. The Company does not intend to update this information to reflect events after the date of this Annual Report.
Copies of this Annual Report, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and our other reports filed with the
SEC can be obtained free of charge as soon as reasonably practicable after such material is electronically filed with, or furnished to, the
SEC on our website at http://www.ibioinc.com/ or directly from the SEC’s website at http://www.sec.gov/. Our website and the information
contained therein or connected thereto are not intended to be incorporated into this Annual Report.
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Item 1. Business.
Overview
PART I
iBio, Inc. (also referred to as "we", "us", "our", "iBio", or the "Company") is a preclinical stage biotechnology company that leverages the
power of Artificial Intelligence (AI) for the development of precision antibodies. Our proprietary technology stack is designed to minimize
downstream development risks by employing AI-guided epitope-steering and monoclonal antibody (mAb) optimization.
In September 2022, iBio made a strategic pivot by acquiring substantially all of the assets of RubrYc Therapeutics, Inc. ("RubrYc"). This
acquisition commenced our transition to an AI-enabled biotech company and led to the divestiture of our Contract Development and
Manufacturing Organization (CDMO) business. This strategic decision allowed us to focus resources on the development of AI-powered
precision antibodies, positioning iBio at the forefront of this exciting field.
One of the key features of iBio’s technology stack is the patented epitope-steering AI-engine. This advanced technology allows us to target
specific regions of proteins with precision enabling the creation of antibodies highly specific to therapeutically relevant regions within large
target proteins, potentially improving their efficacy and safety profile. Another integral part of iBio’s technology stack is the machine
learning (ML) based antibody-optimizing StableHu™ technology. When coupled with our mammalian display technology, StableHu has
been shown to accelerate the Lead Optimization process and potentially reduces downstream risks, making the overall development process
faster, more efficient and cost-effective.
iBio also developed the EngageTx™ platform, which provides an optimized next-generation CD3 T-cell engager antibody panel. This panel
is characterized by a wide spectrum of potencies, Non-Human Primate (NHP) cross-reactivity, enhanced humanness of the antibodies, and
a maintained tumor cell killing capacity, all while reducing cytokine release. These attributes are meticulously designed to fine-tune the
efficacy, safety, and tolerability of our antibody products. By incorporating EngageTx into iBio’s own development initiatives, the
Company’s internal pre-clinical pipeline reaps the benefits of the same cutting-edge technology extended to our potential partners.
iBio’s scientific team, composed of experienced AI/ML scientists and biopharmaceutical scientists, located side-by-side in our San Diego
laboratory, possess the skills and capabilities to rapidly advance antibodies in house from concept to in vivo proof-of-concept (POC). This
multidisciplinary expertise allows us to quickly translate scientific discoveries into potential therapeutic applications.
Artificial Intelligence in Antibody Discovery and Development
The potential of AI in antibody discovery is immense and is being increasingly recognized in the biopharmaceutical industry. The mAbs
market has seen impressive growth in recent years, with mAbs increasingly the top-selling drugs in the United States. This success has
driven the industry to seek innovative methods for refining and improving their antibody pipelines. AI and deep learning, which have
already revolutionized small molecule drug design, are now making significant strides in the development and optimization of antibodies.
iBio is leveraging its AI-powered technology stack to enhance the success rate of identifying antibodies for challenging target proteins,
expedite the process of antibody optimization, improve developability, and engineer finely calibrated bi-specifics. By continually refining
the Company’s AI algorithms, incorporating new data sources, and developing robust experimental validation processes, iBio is paving the
way for groundbreaking advancements in antibody design and drug discovery.
Key Achievements in Fiscal Year 2023
Transformation to an AI-powered biotech
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● Completed construction of a state-of-the-art lab and commenced operations at San Diego research and development (R&D)
center.
● Acquired substantially all of RubrYc’s assets and integrated key RubrYc AI team members with iBio’s existing ML
biopharmaceutical scientists.
● Epitope steering AI platform patent issued with broad set of allowed claims.
● Filed five provisional patents for the Company’s PD-1 agonist antibodies, chemokine receptor 8 (CCR8) antibodies, epidermal
growth factor receptor variant III (EGFRvIII) antibodies, anti-MU16 antibodies, and TROP2 antibodies.
● Developed next gen T-cell engager antibody panel EngageTx.
Business Development
● Forged research collaboration with National Institute of Allergy and Infectious Diseases, a component of National Institutes of
Health
Pipeline
● Advanced IBIO-101 into IND enabling stage
● Expanded pre-clinical pipeline with MUC16 and TROP2 bispecific
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Strategy
iBio is a pioneering biotechnology company at the intersection of AI and biologics, committed to reshaping the landscape of discovery. Our
core mission is to harness the potential of AI and machine learning to unveil elusive biologics that stand out and have evaded other
scientists. Through iBio’s innovative platform, we champion a culture of innovation by swiftly identifying novel targets, forging strategic
collaborations with the goal of to enhancing efficiency, diversifying pipelines, and accelerating preclinical processes.
Additionally, iBio’s groundbreaking EngageTx technology enables us to precisely target bi-specific molecules. With the ability to navigate
sequence diversity and promote Human-Cyno cross reactivity while mitigating cytokine release, our goal is to enhance agility and bolster
preclinical safety assessments.
Our strategic approach to fulfilling iBio’s mission is outlined as follows:
● Elevate Epitope Discovery: iBio is one of the leaders in the field with our patented AI-engine uncovering "hard to develop"
molecules. Our unparalleled epitope engine stands out by allowing the ability to target select regions of a protein potentially
removing the lengthy trial and error out of mAb discovery. This capability can improve the probability of success of drug
discovery while at the same time, can reduce costs commonly caused by having an iterative process. iBio’s epitope engine, is
engineered to match its target, refined for stability and optimized for water solubility; allowing us to identify new drug candidates
that have failed or have been abandoned due to their complexity.
● Capital efficient business approach: iBio’s strategic business approach is structured around the following pillars of value
creation:
o
Strategic Collaborations: We have leveraged our platform and pipeline by forming strategic partnerships. We aim is to
become the preferred partner for major pharmaceutical and biotechnology companies seeking rapid and cost-effective
integration of complex molecules into their portfolios, de-risking their early-stage pre-clinical work. Additionally, rich
array of fast follower molecules within the Company’s pre-clinical pipeline holds the potential to drive substantial
partnerships, opening doors to innovative projects. By tapping into our, infrastructure, and expertise, partners have the
potential to streamline timelines, reduce costs tied to biologic drug discovery applications and cell line process
development, and expedite preclinical programs with efficiency.
o Developing and advancing our in-house programs cost effectively: Clinical advancement is crucial for drug
discovery. We are actively looking for opportunities to progress our internal preclinical programs, with a focal point on
oncology, steadily reinforcing our pre-clinical pipeline.
o Tech Licensing in Diverse Therapeutic Areas: In pursuit of adding value, iBio is exploring partnerships in diverse
therapeutic domains such as CNS or vaccines. Our intention is to license the AI tech stack, extending its benefits to our
partners and amplifying its biological impact and insights. This strategic approach enables us to capitalize on the value of
our meticulously curated data while empowering collaborations and innovations, while at the same time allowing iBio to
focus on both the platform and our core therapeutic area, oncology.
● Focused Investment in advancing the platform: iBio maintains a focused commitment to invest in our platform, continually
unlocking the potential of biology through AI and machine learning. The pinnacle of being on the forefront of Machine learning
advancing algorithms, and models in order to improve its predictive power and reduce the time it takes to find a viable molecule.
In essence, we believe that we are sculpting a future where cutting-edge AI-driven biotechnology propels the discovery of intricate
biologics, fostering partnerships, accelerating innovation, and propelling the advancement of science.
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AI-Technology Platform
Overview
iBio's technology stack is a multi-layered, AI-powered system designed to significantly enhance the probability of success to discover and
develop antibodies against hard-to-drug pathophysiologically relevant proteins. This platform comprises four key components, each
playing a crucial role in the discovery and optimization of precision antibodies.
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer
antibodies with high specificity and efficacy. The second layer involves the proprietary antibody library, which is built on clinically
validated frameworks and offers a rich diversity of human antibodies. The third layer of the technology stack is the antibody optimizing
StableHu AI technology, coupled with mammalian display technology. This combination speeds up the Lead Optimization process and
potentially minimizes downstream risks, with the goal of making the overall development process more efficient and cost-effective. Finally,
our EngageTx platform forms the fourth layer. It provides an optimized next-generation CD3 T-cell engager antibody panel characterized
by a wide range of potencies, Non-Human Primate (NHP) cross-reactivity, increased humanness of the antibodies, and retained tumor cell
killing capacity with reduced cytokine release. Each layer of the tech stack is designed to work synergistically, enabling us to rapidly
advance antibodies from concept to in vivo proof-of-concept (POC).
Figure 1: iBio’s Technology Stack
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AI Epitope Steering Technology
Epitopes, the small regions on large drug target proteins, play a crucial role in eliciting a desired biological function when targeted with
antibodies. However, traditional approaches to epitope-specific antibody discovery often face significant challenges. For instance,
dominant-epitope antibodies, which typically exhibit low or no efficacy, can overwhelm traditional discovery methods. This inundation can
make it difficult to identify and isolate the more effective antibodies targeting less dominant epitopes. Additionally, these traditional
methods often yield low or even zero discovery results when it comes to high-value, therapeutically challenging epitopes. These are the
epitopes that, despite their potential therapeutic value, are particularly difficult to target due to their complex structure or location on the
protein. Another challenge lies in the limited availability of epitope-stabilizing immunogen scaffolds suitable for epitope grafting. These
scaffolds are crucial for maintaining the structure of the epitope during the antibody discovery process, and their scarcity can further
complicate the discovery of effective antibodies.
iBio’s Epitope steering technology is designed to address these issues by guiding antibodies exclusively against the desired regions of the
target protein. By focusing on these specific regions, we believe we can overcome the limitations of traditional methods and significantly
improve the efficiency and effectiveness of our antibody discovery process. iBio’s AI engine creates engineered epitopes, which are small
embodiments of epitopes on the target protein. The engine is trained to match the epitope structure as closely as possible and refine the
designs for greater stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to
identify antibodies from naïve or immunized libraries.
The application of engineered epitopes extends to a wide array of complex and hard-to-drug protein structures (as depicted in Figure 2).
This broad applicability not only has the potential to unlock high-value targets in the field of immuno-oncology (I/O), but it could also be
transformative in various other disease areas such as immunology and pain
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management. Furthermore, the potential use of this approach in vaccine development could open up new avenues for disease prevention.
Naïve Human Antibody Library
Figure 2: iBio’s patented epitope steering technology
The fully human antibody library is built upon clinically validated, entirely human antibody frameworks. By leveraging public databases,
iBio has extracted a diverse array of Complementarity-Determining Region (CDR) sequences. Subsequently, iBio has meticulously
eliminated a range of sequence liabilities. Such careful curation process could potentially significantly reduce the development risk for
antibodies identified from our library.
StableHuTM AI Antibody-Optimizing Technology
Antibody optimization is a pivotal step in the development of therapeutic antibodies. It refines an antibody's properties to enhance its
efficacy, safety, and manufacturability. This process includes humanization, which alters non-human antibodies to mimic human antibodies,
thereby reducing the risk of immune reactions when used in therapy.
The proprietary StableHu technology is instrumental in this optimization process. StableHu is an AI-powered tool designed to predict a
library of antibodies with fully human CDR variants based on an input antibody. This input can range from an early, unoptimized molecule
to an approved drug. The model has been trained utilizing a set of over 1 billion human antibodies, progressively masking known amino
acids within CDRs until the algorithm could predict the correct human sequence.
While phage display libraries are often used in antibody optimization due to their vast diversity, they can increase developability risks such
as low expression, instability, or aggregation of antibodies. Mammalian display libraries, on the other hand, offer significantly improved
developability but reduced diversity due to the smaller library size they can handle. StableHu overcomes this limitation by utilizing a
machine learning algorithm generating focused library diversity within the capacity of mammalian display.
Mammalian display is a technology that presents antibodies on the surface of mammalian cells, allowing for the direct screening and
selection of antibodies in a mammalian cell environment. This approach is advantageous as antibodies that express well on the mammalian
cells used in the display are more likely to express well in the production cell line. Moreover, single-cell sorting of antibody-displaying
cells allows rapid selection of desired antibodies based on multiple dimensions, such as potency, selectivity, and cross-species selectivity.
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When paired with mammalian display technology, StableHu enables antibody optimization with fewer iterative optimization steps, lower
immunogenicity risk, and improved developability.
Figure 3: StableHuTM Antibody Optimization Technology
EngageTx CD3-Based T-Cell Engager Panel
CD3-based T-cell engagers potentially offer significant clinical benefits in cancer treatment. They have the potential to effectively target
and eliminate a wide range of tumor types, including those resistant to other therapies. By recruiting and activating the body's own T-cells
to specifically target cancer cells, they can overcome some mechanisms of immune evasion, potentially leading to improved patient
outcomes. However, first-generation T-cell engaging bispecific antibodies often face challenges related to safety and efficacy. They can
cause severe side effects, such as cytokine release syndrome due to overactivation of the immune system. Additionally, they may lack
specificity, which can lead to off-target effects and damage to healthy tissues. The lack of non-human primate (NHP) cross-reactivity also
prevents safety assessment in higher species.
To address these issues, iBio used antibodies from an epitope steering campaign as well as a first-generation T-cell engager as input and
utilized our StableHu technology to identify a next-generation CD3 antibody panel. The sequence diversity generated by StableHu led to an
antibody panel with a wide range of potencies, which allows us to pair the panel with a wide variety of tumor-targeting antibodies.
Importantly, iBio was able to retain T-cell activation and tumor cell killing capacity with significantly reduced cytokine release. This
reduction is believed to lower the risk of cytokine release syndrome. Additionally, the increased humanness of the predicted antibodies,
thanks to our StableHu technology, reduces the risk of immunogenicity.
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Furthermore, our StableHu technology enabled the Company to engineer NHP cross-reactivity into EngageTx. This allows for advanced
safety assessment in NHP ahead of clinical trials, providing another layer of safety assurance.
Figure 4: CD3-Based T-Cell Engager Panel EngageTxTM
Modalities
Epitope steering, a technology iBio is pioneering, has the potential to positively impact various areas of medicine. In the field of immuno-
oncology, it can be used to develop antibodies targeting specific cancer antigens, potentially enhancing the efficacy of treatments like
checkpoint inhibitors and CAR-T therapies.
The technology also holds promise in the realm of systemic secreted and cell-surface therapeutics. Here, epitope steering can be applied to
the development of antibodies, circulating immune modulation factors, secreted enzymes, and transmembrane proteins. This could be
particularly beneficial in treating diseases such as heart failure, infectious diseases, and rare genetic conditions. In the context of localized
regenerative therapeutics, epitope steering could potentially be used to develop treatments that target specific damaged or diseased tissues.
This approach could be particularly beneficial in the treatment of cardiovascular diseases. Intratumoral immuno-oncology is another area
where epitope steering could make a significant impact. It could potentially be used to develop treatments that alter the tumor
microenvironment to favor an immune response against tumors, potentially enhancing the efficacy of treatments that use immune-
stimulatory proteins. The potential of epitope steering extends to cancer vaccine development as well. The ability to target specific
epitopes could be beneficial in the development of vaccines, particularly those that aim to increase the number and antitumor activity of a
patient's T cells. Finally, epitope steering could be used to develop treatments for a wide range of diseases, including those in the immune-
oncology space, immunology, pain, and potentially in vaccine development. This is particularly relevant for complex and hard-to-drug
protein structures.
Pre-Clinical Pipeline
iBio is currently in the process of building and advancing its preclinical pipeline. The focus of this pipeline is primarily on immuno-
oncology, with one program also dedicated to the immunology space. By leveraging iBio’s technology stack, the pipeline is geared towards
hard-to-drug targets and molecules offering differentiation. To mitigate target risk and capitalize
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on the learnings of competitors, iBio's programs are primarily adopting a fast follower strategy. This approach allows iBio to focus on
targets that have to some extent been validated and learn from the advancements of those ahead in the field.
Figure 5: iBio’s Preclinical Therapeutics Pipeline
Therapeutics
Immuno-Oncology
There have been notable advances in the field of oncology in recent years, and arguably none more important than the advent of
immunotherapies. The Company has established its own AI drug discovery and drug development capabilities in San Diego, California, has
built a pipeline of nine immuno-oncology programs.
IBIO-101
In August 2021, the Company signed a worldwide exclusive licensing agreement with RubrYc to develop and commercialize RTX-003
(now referred to as IBIO-101), an anti-CD25 monoclonal antibody [mAb]. In September 2022, the Company acquired exclusive ownership
rights to IBIO-101. IBIO-101 is a second-generation anti-CD25 mAb that has demonstrated in preclinical models of disease the ability to
bind and deplete immunosuppressive regulatory T [Treg] cells to inhibit the growth of solid tumors.
Targeting depletion of Treg cells to control tumors emerged as an area of interest in oncology over the past several years. Since Treg cells
express interleukin-2 Rα (“IL-2Rα” or “CD25”), it was envisioned mAbs could be developed that bind CD25 and thereby trigger depletion
by Natural Killer cells, resulting in stimulation of anti-tumor immunity.
Unfortunately, while first-generation mAbs successfully bound CD25+ cells, they also interfered with interleukin-2 [IL-2] signaling to T
effector [Teff] cells to activate their cancer cell killing effects. The result was a failure of first-gen anti-CD25 mAbs as cancer
immunotherapies, since their favorable anti-Treg effects were negated by their unfavorable impact on Teff cells.
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Figure 6: Mechanism of action of first and 2nd generation Treg depleting antibodies
In vitro characterization of IBIO-101 demonstrated potent binding to recombinant CD25 while preserving IL-2 signaling. Further
assessment of IBIO-101 showed selective Treg depletion and sparing of Teffs.
Figure 7: In vitro characterization of IBIO-101
In a humanized mouse disease model, IBIO-101, when used as a monotherapy, effectively demonstrated its mechanism of action by
significantly enhancing the Treg/Teff ratio, resulting in the suppression of tumor growth. When paired with an anti-PD-1 checkpoint
inhibitor in the same model, the combined treatment of IBIO-101 and anti-PD-1 exhibited superior tumor inhibition compared to either
anti-PD-1 or IBIO-101 used independently.
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Figure 8: IBIO-101 monotherapy in a humanized mouse model leads to increased Treg/Teff ratio, resulting in the suppression of tumor
growth
Figure 9: Combination Therapy of IBIO-101 and anti-PD-1 exhibited superior tumor inhibition compared to anti-PD-1 or IBIO-101 alone
iBio has progressed IBIO-101 to the IND-enabling phase and entrusted its Chemistry, Manufacturing, and Controls (CMC) development to
a reputable Contract Research Organization (CRO). In the initial stages of this process, IBIO-101 has exhibited promising attributes for
CMC progression. Notably, we've pinpointed optimal cell lines for master cell bank creation and have set in place a CMC methodology to
produce IBIO-101 in compliance with cGMP standards.
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Figure 10: IBIO-101 has shown favorable characteristics for CMC development
The Company continues to advance our IL-2 sparing anti-CD25 antibody, IBIO-101, and anticipates moving the program from IND-
enabling stage to an IND filing during the calendar year 2025.
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TROP-2 x CD3 Bispecific
iBio has identified highly potent, fully human TROP-2 (Trophoblast Cell Surface Antigen 2) monoclonal antibodies, which have been
formatted into bispecific TROP-2 x CD3 molecules using the Company’s T-cell engager antibody panel, EngageTx. TROP-2 is highly
expressed in multiple solid tumors, including breast, lung, colorectal, and pancreatic cancers and is closely linked to metastasis and tumor
growth. TROP-2 antibody drug conjugates have been developed to deliver toxic payloads to these cancer cells but could risk harming
healthy cells and cause adverse effects. The Company’s bispecific approach has the potential to increase the therapeutic window, while
promoting a robust and long-lasting anti-tumor response. Combining the bispecific TROP-2 approach with immunotherapies like
checkpoint inhibitors can potentially lead to improved clinical outcomes.
Figure 11: Proposed mechanism of action of iBio’s TROP-2 x CD3 bispecific antibodies
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Using EngageTx, iBio’s lead TROP-2 x CD3 bispecific antibody was engineered to potently kill tumor cells while limiting the release of
cytokines, like Interferon Gamma (IFNg), Interleukin 2 (IL-2) and Tumor Necrosis Factor Alpha (TNFa), all of which have the potential to
cause cytokine release syndrome. When compared to a bispecific molecule engineered with iBio’s TROP-2 binding arm and a first
generation CD3 engager, SP34, the Company’s lead TROP-2 x CD3 bispecific antibody showed a markedly reduced cytokine release
profile, potentially indicating a decreased risk for cytokine release syndrome.
Figure 12: iBio’s TROP-2 x CD3 lead antibody shows reduced cytokine release while retaining tumor cell killing potential
When tested in a humanized mouse model of squamous cell carcinoma, iBio’s lead TROP-2 x CD3 bi-specific antibody demonstrated a
significant 36 percent reduction in tumor size within just 14 days after tumor implantation, and after only a single dose.
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Figure 13: iBio’s lead TROP-2 x CD3 molecule showed a 36% reduction in tumor size in an animal model engrafted with human
peripheral blood mononuclear immune cells (PBMC) and human tumor cells
MUC16
MUC16 is a well-known cancer target often overexpressed in several types of solid tumors, including ovarian, lung, and pancreas cancers.
Specifically, MUC16 is a large extracellular protein expressed on more than 80% of ovarian tumors. Tumor cells can evade immune attack
by shedding or glycosylating MUC16, making it difficult for traditional antibody therapies to effectively target and destroy the cancer cells.
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Figure 14: MUC16 structure and mechanisms to evade anti-cancer therapy
Using the Company’s patented epitope steering AI platform, iBio's innovative approach to this challenge allows its new mAbs to bind to a
specific region of MUC16 that is not shed or glycosylated, circumventing both tumor evasion mechanisms and potentially providing a
powerful tool in the fight against cancer.
Figure 15: iBio’s epitope steering approach and immunization strategy to target the non-shed MUC16 region
During its immunization and screening campaign, iBio identified several hits that specifically bound to the non-shed region of MUC16
while no binding to the shed fragment of MUC16 was observed.
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Figure 16: iBio’s hit molecules bind to the non-shed but not the shed region of MUC16
Establishing antibodies with the ability to bind to a recombinant version of their target protein represents a vital initial step in the validation
process. However, it's crucial to ensure such antibodies maintain their binding affinity in a whole cell context, specifically when the target
protein is expressed on a cell's surface. To best predict therapeutic efficacy, it's recommended to utilize tumor cells as a means to
demonstrate and confirm this cell binding capability. During pre-clinical studies, iBio’s MUC16 molecule has demonstrated binding to
MUC16 on OVCAR-3 ovarian cancer cells as shown below.
Figure 17: iBio’s MUC16 molecule shows binding to MUC16 on human ovarian cancer cells
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Another critical step in antibody optimization is the humanization of molecules originally raised in mice or other species. Humanization
efforts of antibodies carry the risk of, among other things, losing binding strength. After engineering the leading MUC16 molecule with a
fully human framework, the MUC16 molecule retained potent binding to the engineered epitope and maintained binding to human
OVCAR-3 ovarian cancer cells.
Figure 18: iBio’s humanized MUC16 molecule retains binding to the engineered epitope and human tumor cell lines
EGFRvIII
EGFRvIII is a specific variant of the EGFR protein, unique to tumor cells. Unlike the more common EGFR, EGFRvIII is not found in
healthy cells, making it an attractive target for therapeutic interventions. This variant is most prominently associated with glioblastoma, a
type of brain cancer and head and neck cancer, but can also be present in certain cases of breast, lung, and ovarian cancers, among others.
In our pursuit of innovative treatments, iBio is exploring antibody therapeutics that specifically target EGFRvIII, aiming to address these
cancer types without affecting healthy cells.
Leveraging our patented AI-enabled epitope steering engine, we've specifically directed antibodies to target a unique epitope found
exclusively on EGFRvIII, and not on the wildtype receptor, EGFR. Through this precision approach, iBio has designed tumor-specific
molecules aimed at selectively targeting cancer cells while preserving healthy ones, potentially offering patients a more focused and safer
therapeutic solution.
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Figure 19: Tumor epitope specific antibodies target tumor cells while sparing healthy cells
iBio's hit molecules have demonstrated strong binding to the tumor-specific EGFRvIII protein without targeting the wildtype EGFR.
Additionally, these molecules have effectively eliminated tumor cells, while sparing healthy ones, in in vitro cell killing tests.
Figure 20: In vitro characterization of iBio’s hit molecules demonstrates selective binding to EGFRvIII leading to tumor-specific cell
killing while sparing healthy cells
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iBio’s lead anti-EGFRvIII antibody was specially engineered to enhance its ability to attack cancer cells and has proven effective in a
mouse model for head and neck cancer. In preclinical studies, iBio’s anti-EGFRvIII antibody demonstrated a 43 percent reduction in tumor
growth compared to untreated animals.
Figure 21: iBio’s lead molecule demonstrates efficacy in a mouse model for head and neck cancer
CCR8
GPCRs are one of the most successful therapeutic target classes, with approximately one-third of all approved drugs targeting these
proteins. Compared to small molecule-based GPCR drugs, antibody-based GPCR therapeutics potentially offer several potential
advantages, including superior selectivity, extended mechanisms of action, and longer half-life. However, GPCRs are intricate, multi-
membrane spanning receptors, making clinically relevant regions difficult to identify and target.
The chemokine receptor CCR8 is a GPCR which is predominantly expressed on Tregs, which play a role in suppressing immune responses.
In the context of cancer, Tregs can inhibit the body's natural immune response against tumor cells, promoting cancer progression. Anti-
CCR8 antibodies are being explored as a therapeutic strategy to deplete these Tregs in the tumor environment. By targeting and reducing
Tregs using anti-CCR8 antibodies, the hope is to enhance the body's immune response against cancer cells, offering a promising avenue for
cancer treatment.
Aiming directly at CCR8 is believed to be a safer approach because it focuses on specific suppressive Treg cells in the tumor environment
without affecting other immune cells and functions. It's important to make sure antibodies are fine-tuned to CCR8 and don't mistakenly
target a similar receptor, CCR4. This is because CCR4 is found in many immune cells, and accidentally targeting it could potentially lead to
unwanted side effects.
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Figure 22: Proposed mechanism of action for selective anti-CCR8 antibodies
Using its unique AI-driven technology, iBio successfully identified molecules targeting CCR8, addressing some of the hurdles often faced
when creating therapies that target GPCR with antibodies. iBio's specialized anti-CCR8 antibody has shown strong attachment to cells
expressing CCR8 and effectively disrupted the CCR8 signaling process, resulting in the efficient elimination of Tregs derived from primary
human immune cells. Notably, iBio's CCR8-focused molecule did not attach to cells overproducing CCR4, highlighting its precision in
targeting only CCR8.
Figure 23: Selective binding to CCR8 and inhibition of the CCR8 signaling pathway by iBio’s lead molecule leads to potent killing of Tregs
derived from primary human immune cells
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iBio’s CCR8 antibody has proven effective in a mouse model for colon cancer. Preclinical studies show iBio’s anti-CCR8 molecule
inhibited tumor growth and achieved a 22 percent reduction in tumor size compared to its pre-treatment dimensions. iBio specifically
engineered the anti-CCR8 molecule as a high Antibody-Dependent Cellular Cytotoxicity (ADCC) antibody to enhance its ability to attack
cancer cells.
Figure 24: iBio’s lead CCR8 antibody inhibited tumor growth and achieved a 22 percent tumor regression in a humanized mouse model for
colon cancer
Autoimmune
PD-1 Agonist
Programmed cell death protein 1 (PD-1) is a pivotal player in the immune system, acting as a type of "off switch" that helps keep the cells
from attacking other cells in the body. By agonizing or enhancing the signaling of PD-1, it's possible to temper the immune response,
making it particularly valuable in the treatment of autoimmune diseases. In conditions where the immune system mistakenly wages war on
the body's own cells, such as in autoimmune diabetes or lupus, therapies that target PD-1 can potentially reduce the severity of these
autoimmune reactions. This approach offers a promising avenue for providing relief to patients suffering from these debilitating conditions.
The figures below depict the mechanism of action of antagonistic and agonistic PD-1 antibodies.
iBio purchased the global rights to a partnership-ready PD-1 agonistic mAb intended to treat serious autoimmune disorders. While the goal
in immuno-oncology is to remove immune tolerance towards cancer cells, in autoimmune diseases the opposite is the case, because
autoimmune diseases can result from deficits in peripheral and/or central tolerance mechanisms which presents an opportunity for
therapeutic intervention. Specifically, agonism or stimulation of inhibitory receptors like PD-1 or CTLA4, which mediate peripheral
tolerance is a promising approach to treat autoimmune diseases. Unlike PD-1 antagonists used in immuno-oncology, PD-1 agonists are
difficult to find. RubrYc used its AI Discovery Platform to discover PD-1. PD-1 is currently in the late-discovery stage, having undergone
extensive screening and in vitro characterization, and we anticipate it will be advanced into in vivo models as IBIO-102, in the near future.
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Figure 25: A PD-1 antagonist antibody worsens autoimmunity and increases systemic inflammation
Figure 26: A PD-1 agonist antibody improves autoimmunity, reduces inflammation in diseased tissue and maintains a low inflammatory
status in healthy tissue
iBio has harnessed the power of three core components of its technology stack to discover PD-1 agonists: the epitope steering engine, the
proprietary naive human antibody library, and the StableHu antibody optimizer. Engineering the resulting agonist antibodies into both
bivalent and tetravalent formats has led to potent PD-1 agonists.
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Figure 27: iBio’s bi- and tetravalent PD-1 antibodies potently agonize PD-1 in vitro
Furthermore, in preclinical studies, iBio's PD-1 agonists have been evaluated using a primary T-cell assay. Our top-performing molecules
showed a significant decrease in the proinflammatory cytokine IL-2 and reduced expression of the T-cell activation marker CD96. Both of
these outcomes are indicative of the desired dampening of T-cell activation.
Figure 28: iBio’s most promising PD-1 antibodies demonstrate suppression of T-cell activation in primary human cells
iBio’s PD-1 agonist is currently in the late-discovery stage and we anticipate it will be advanced into in vivo models as IBIO-102, in the
near future.
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Fibrosis
Fibrosis is a pathological disorder in which connective tissue replaces normal parenchymal tissue to the extent that it goes unchecked,
leading to considerable tissue remodeling and the formation of permanent scar tissue. Fibrosis can occur in many tissues within the body,
including the lungs (e.g., idiopathic pulmonary fibrosis [“IPF”] and skin (e.g., systemic scleroderma [“SSc’].
IBIO-100
Our preclinical anti-fibrotic program, IBIO-100, is design and based upon work by Dr. Carol Feghali-Bostwick, Professor of Medicine at
the Medical University of South Carolina and Vice-Chair of the Scleroderma Foundation. Her initial work was conducted at the University
of Pittsburgh, and we had a license to the patents relevant for the continued development of the molecule from the university. After careful
consideration, in February 2023, we terminated all efforts on IBIO-100 anti-fibrotic program and provided a six (6) month notice of
termination of the license agreement to the University of Pittsburgh, as required by the license agreement. Pursuant to the license
agreement with the University of Pittsburgh, our financial obligations for the management of the patents under the license ceased on
August 14, 2023, and at such time, transitioned back to the University of Pittsburgh and the Medical University of South Carolina.
As part of this decision, we completed the pre-clinical cancer studies we were conducting in collaboration with University of Texas
Southwestern using E4 endostatin peptide, which is derived from IBIO-100. After the conclusion of the pre-clinical studies, we determined
not to further pursue this oncology program.
Digital Infrastructure
iBio is a firm believer in the transformative power of digital technologies, including robotics, automation, artificial intelligence (AI),
machine learning (ML), and cloud computing. These technologies are integral to operationalizing our strategy, accelerating our learning
curve, and executing at scale. As such, the Company has made substantial investments in these areas. iBio’s aspiration is to digitize our
operations to the greatest extent possible, harnessing the potential of digital technology to maximize our impact on human health. As the
Company continues to grow, we remain committed to further investing in our digital infrastructure to support our ambitious goals.
Strategic Alliances, Collaborations, and Joint Ventures
iBio has formed collaborations and strategic alliances to gain access to funding, capabilities, technical resources and intellectual property to
further its development efforts, commercialize its technology and to generate revenues, including through the use of our patented epitope-
steering AI-engine and our EngageTX platform.
National Institute of Allergy and Infectious Diseases
On June 12, 2023, iBio entered into a research collaboration with the National Institute of Allergy and Infectious Diseases (“NIAID”), a
component of the National Institutes of Health (“NIH”), to investigate the potential of the patented AI-driven epitope steering platform for
the development of a vaccine for Lassa fever, which currently there is no vaccine available. Based on the viral epitopes identified by
researchers at NIAID’s Vaccine Research Center (“VRC”), the Company will work with the VRC to determine if using the platform to steer
immunity toward these epitopes offers advantages over other vaccine development approaches. Should the collaboration be successful,
researchers at the VRC may assess promising candidates in both in vitro and in vivo studies, and potentially advance a lead candidate to a
Phase 1 clinical trial.
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Several agreements with RubrYc Therapeutics, Inc.
On August 23, 2021, we entered into a series of agreements with RubrYc described in more detail below:
Collaboration and License Agreement: iBio entered into a collaboration and licensing agreement (the “RTX-003 License Agreement”)
with RubrYc to further develop RubrYc’s immune-oncology antibodies in its RTX-003 campaign. During the term of the RTX-003
License Agreement, RubrYc granted us an exclusive worldwide sublicensable royalty-bearing license under the patents controlled by
RubrYc that cover the RTX-003 antibodies. The RTX-003 License Agreement was terminated when the Company acquired substantially
all of the assets of RubrYc in September 2022, including RubrYc’s immune-oncology antibodies in its RTX-003 campaign.
Collaboration, Option and License Agreement: iBio entered into a collaboration agreement (the “Collaboration Agreement”) with RubrYc
to collaborate for up to five years to discover and develop novel antibody therapeutics using RubrYc’s artificial intelligence discovery
platform. In addition, RubrYc granted the Company an exclusive option to obtain a worldwide sublicensable commercial license with
respect to each of the lead product candidates resulting from such collaboration programs (the “Selected Compounds”). With the exception
of any obligations that survive the termination, the Collaboration, Option and License Agreement was terminated when the Company
acquired substantially all of the assets of RubrYc in September 2022.
Stock Purchase Agreement: In connection with the entry into the Collaboration Agreement and RTX-003 License Agreement, iBio also
entered into a Stock Purchase Agreement (“Stock Purchase Agreement”) with RubrYc whereby we purchased 1,909,563 shares of
RubrYc’s Series A-2 preferred stock “Series A-2 Preferred”) for $5,000,000 and acquired an additional 954,782 shares of RubrYc’s Series
A-2 Preferred. In connection with the Stock Purchase Agreement, iBio entered into the RubrYc Therapeutics, Inc. Second Amended and
Restated Investors’ Rights Agreement (the “Investors’ Rights Agreement”), RubrYc Therapeutics, Inc. Second Amended and Restated
Voting Agreement (the “Voting Agreement”) and the RubrYc Therapeutics, Inc. Second Amended and Restated Right of First Refusal and
Co-Sale Agreement (the “Right of First Refusal and Co-Sale Agreement”).
The rights, preferences of and privileges of the RubrYc Series A-2 Preferred Stock (“Series A-2 Preferred”) are set forth in the Third
Amended and Restated Certificate of Incorporation of RubrYc Therapeutics, Inc. (the “Amended RubrYc COI”), and include a preferential
eight percent (8%) dividend, senior rights on liquidation, the right to elect a Series A-2 Preferred director for as long as we hold at least
1,500,000 shares of RubrYc stock, the right to vote on an as-converted basis, certain anti-dilution and other protective provisions, the right
to convert the Series A-2 Preferred into shares of RubrYc common stock at our option, and mandatory conversion of the Series A-2
Preferred into shares of RubrYc common stock upon (a) the closing of a firm-commitment underwritten public offering to the public
pursuant to an effective registration statement under the Securities Act of 1933, as amended, for shares of RubrYc common stock at a per
share price of at least five (5) times the Series A-2 Original Issue Price (as defined in the Amended RubrYc COI) and resulting in at least
$30,000,000 of gross proceeds to RubrYc or (b) such other date, time or event, specified by vote or written consent of the majority of the
aggregate voting power, on an as-converted basis, of the RubrYc Series A preferred stock (“Series A Preferred” and together with the Series
A-2 Preferred, the “Senior Preferred Stock”) and Series A-2 Preferred. The Right of First Refusal and Co-Sale Agreement gives RubrYc the
right of first refusal on stock sales by key holders, generally defined as founders, and a second right of first refusal and a co-sale right to
specified other investors, including certain holders of Senior Preferred Stock and the Company.
The Investors’ Rights Agreement provides the holders of Senior Preferred Stock with, among things: (i) demand registration rights, under
specified circumstances; (ii) piggyback registration rights in the event of a company registered offering; (iii) lock-up and market-standoff
obligations following a registered underwritten public offering; (iv) preemptive rights on company offered securities; and (v) additional
protective covenants that require the approval at least two of the three directors elected by the holders of the Senior Preferred Stock.
Pursuant to the Voting Agreement, certain RubrYc stockholders are contractually obligated to, among other things, vote for and maintain
the authorized number of directors at five members, one of which the Company has the contractual right to elect subject to the conditions
set forth above.
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Purchase Agreement: On September 16, 2022, iBio entered into an asset purchase agreement (the “Purchase Agreement”) with RubrYc in
order to acquire substantially all of its assets, including the AI Drug Discovery Platform, RTX-003 (IBIO-101), all Selected Compounds,
three additional immune-oncology candidates, a PD-1 agonist, in addition to lab and technology equipment. On September 19, 2022, in
connection with the closing of the acquisition, the Company entered into a termination agreement (the “Termination Agreement”) with
RubrYc in order terminate the RTX-003 License Agreement and the Collaboration Agreement, which terminated any and all future
milestone payments or royalty obligations we had under those agreements. Under the terms of the Purchase Agreement, upon closing of
the acquisition, the Company made an upfront payment of approximately $1,000,000 by issuing 102,354 (post reverse split effected in
October 2022) shares of our common stock, par value $.001 per share (the “Common Stock”) to RubrYc. RubrYc is also eligible to receive
up to $5,000,000 in development milestone over the period of five years from the date of the Purchase Agreement, which can be paid in
shares of our Common Stock or cash, at our sole discretion. In addition, we had advanced RubrYc $484,000 to support their operation
costs during the negotiation period and incurred transaction costs totaling $208,000, which were also capitalized as part of the assets
acquired. The assets acquired include the patented AI drug discovery platform, all rights with no future milestone payments or royalty
obligations, to IBIO-101 (RTX-003), in addition to CCR8, EGFRvIII, MUC16, CD3 and one additional immuno-oncology candidate plus a
PD-1 agonist. The Purchase Agreement contained representations, warranties and covenants of RubrYc and the Company. The acquisition
closed on September 19, 2022 after receipt of approval of the NYSE American.
License with University of Pittsburgh (“Univ. of Pitt”)
On January 14, 2014 (the “Effective Date”), we entered into an exclusive worldwide License Agreement with Univ. of Pitt, which was
amended on August 11, 2016, December 2, 2020 and February 8, 2022 (the “Exclusive License Agreement”) covering all of the U.S. and
foreign patents and patent applications and related intellectual property owned by Univ. of Pitt pertinent to the use of endostatin peptides
for the treatment of human and veterinary fibrosis (the “Field”). We paid an initial license fee of $20,000 and we were required to pay all of
Univ. of Pitt’s patent prosecution costs that were incurred prior to, totaling $30,627, and subsequent to the Effective Date. On each
anniversary date through the fourth anniversary we were to pay license fees ranging from $25,000 and $100,000, and upon the execution of
the amendment in February, 2022, $10,000 starting on the eighth anniversary and on each subsequent anniversary date until the first
commercial sale of the licensed technology. On February 14, 2023, we provided notification to the Univ. of Pitt terminating the License
Agreement. Pursuant to the termination of the license agreement with the Univ. of Pitt, our financial obligations for the management of the
patents under the license ceased on August 14, 2023, and at or about such time, we transitioned back the management of the patents under
the license to the Univ. of Pitt.
Facility Purchase from Eastern Capital Limited
On November 1, 2021, we purchased the manufacturing facility (the “Facility”) previously operated under a lease from two affiliates of
Eastern Capital Limited (the “Eastern Affiliates”). We also acquired the approximate 30% equity interest (after conversion) in iBio CDMO
LLC (“iBio CDMO”) held by the Eastern Affiliates, who became the lessee under the ground lease agreement with the Board of Regents of
the Texas A&M University System (the “Ground Lease Agreement”) for the land upon which the Facility is located and terminated the
Sublease iBio had entered into with the Eastern Affiliates. As a result, iBio CDMO and its intellectual property are now wholly owned by
iBio. The total purchase price for the Facility, the termination of the Sublease and other agreements among the parties, and the equity
described below was $28,750,000, which was paid $28,000,000 in cash and by the issuance to Bryan Capital Investors LLC, an affiliate of
the Eastern Affiliates a five-year warrant to purchase 51,583 shares of our Common Stock at an exercise price of $33.25 per share.
In connection with the purchase of the Facility, iBio CDMO entered into a Credit Agreement, dated November 1, 2021 (the “Credit
Agreement”), with Woodforest National Bank (“Woodforest”) pursuant to which Woodforest provided iBio CDMO a $22,375,000 secured
term loan (the “Term Loan”) to purchase the Facility, which Term Loan is evidenced by a Term Note (the “Term Note”). The Term Loan
was advanced in full on the closing date. The Term Loan originally bared an interest at a rate of 3.25%, with higher interest rates upon an
event of default, which interest is payable monthly beginning November 5, 2021. Principal on the Term Loan was originally payable on
November 1, 2023, subject to early termination upon events of default. The Term Loan provides that it may be prepaid by iBio CDMO at
any time and provides
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for mandatory prepayment upon certain circumstances. The Term Loan is secured by a lien on all of the assets of iBio CDMO and we
guaranteed payments of the obligations owed under the Term Loan.
The Credit Agreement contains customary events of default (which are in some cases subject to certain exceptions, thresholds, notice
requirements and grace periods), including, but not limited to, nonpayment of principal or interest, failure to perform or observe covenants,
breaches of representations and warranties, cross-defaults with certain other indebtedness, certain bankruptcy-related events or
proceedings, final monetary judgments or orders and certain change of control events. The Credit Agreement also contains negative
covenants which included a prohibition on the incurrence of Debt (as defined in the Credit Agreement) except Permitted Debt (as defined
in the Credit Agreement) and Liens (as defined in the Credit Agreement), and termination of the Ground Lease Agreement and affirmative
covenants that have been amended and originally included delivery of audited financial statements within 120 days of the year end without
a “going concern” or like qualification. In addition, the Credit Agreement originally provided that the Company must maintain unrestricted
cash of no less than $10,000,000 (the “Liquidity Covenant”), which amount has been amended to $1,000,000.
On October 11, 2022, iBio CDMO and Woodforest amended the Credit Agreement (the “First Amendment”) to: (i) include a payment of
$5,500,000 of the outstanding principal balance owed under the Credit Agreement on the date of the First Amendment, (ii) include a
payment of $5,100,000 of the outstanding principal balance owed under the Credit Agreement within two (2) business days upon our
receipt of such amount owed to us by Fraunhofer USA, Inc. (“Fraunhofer”) as part of our legal settlement with them (the “Fraunhofer
Settlement Funds”) (see Note 19 – Fraunhofer Settlement for more information), (iii) include principal payments of $250,000 per month in
debt amortization for a six-month period commencing the date of the amendment through March 2023, (iv) include an amendment fee of
$22,375 and all costs and expenses, (v) require delivery of a report detailing cash flow expenditures every two (2) weeks for the period
prior to the delivery of the last report and a monthly 12-month forecast, (vi) reduce the liquidity covenant in the Guaranty (as defined in the
Credit Agreement) from $10 million to $7.5 million with the ability to lower the liquidity covenant to $5.0 million upon the occurrence of a
specific milestone in the Credit Agreement, and (vii) change the annual filing requirement solely for the fiscal year ended June 30, 2022,
such that the filing is acceptable with or without a “going concern” designation. In addition, Woodforest cancelled the irrevocable letter of
credit issued by JPMorgan Chase Bank upon closing of the First Amendment.
In January 2023, the Company’s unrestricted cash decreased below the required $7,500,000, did not comply with the Liquidity Covenant at
the time. As a result, on February 9, 2023, iBio CDMO and Woodforest entered into a second amendment to the Credit Agreement (the
“Second Amendment”), which as amended, among other things, added a milestone that had to be met by a specified date, the failure of
which would be an event of default. In addition, on February 9, 2023, the Company, as guarantor, entered into a second amendment to the
Guaranty, which as amended, among other things, allowed the Company to account for the Fraunhofer Settlement Funds in determining
whether the Company is in compliance with the Liquidity Covenant until a specified period dependent upon the occurrence of a specific
milestone in the Credit Agreement.
On February 20, 2023, iBio CDMO entered into a third amendment to the Credit Agreement (the “Third Amendment”), which removed the
added milestone specified in the Second Amendment, the failure of which would be an event of default. In addition, the Guaranty was
amended to allow the Company until February 28, 2023, to account for the Fraunhofer Settlement Funds in determining whether the
Company was in compliance with the Liquidity Covenant without being dependent upon a specified milestone. In addition, the Company
agreed that each time it consummates an at-the-market issuance of Equity Interests (as defined within the Credit Agreement), no later than
five (5) days following such issuance of Equity Interests, it will (i) pay to Woodforest in immediately available cash funds, without setoff or
counterclaim of any kind, forty percent (40%) of the Net Proceeds (as defined within the Credit Agreement) received by the Company for
such issuance of Equity Interests; provided, any such payment would cease upon payment obligations in full and (ii) provide Woodforest
with a detailed accounting of each such issuance of Equity Interests.
On March 24, 2023, iBio CDMO and Woodforest entered into a fourth amendment to the Credit Agreement (the “Fourth Amendment”),
which within the Fourth Amendment Woodforest agreed to (i) reduce the percentage of any payment to Woodforest the Company is
required to make from the proceeds of sales of its common stock under its at-the-market facility from 40% to 20%, (ii) reduce the
percentage of any payment to Woodforest the Company is required to make from
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the proceeds of sales of its equipment from 40% to 20%, and (iii) allowed the Company to retain $2,000,000 million of the $5,100,000
million that the Company received from the Fraunhofer Settlement Funds, with the remaining $3,000,000 million being held in a Company
account at Woodforest. In addition, the Company was obligated to (y) deliver to Woodforest an executed copy of a purchase agreement
(the “Purchase Agreement”) for the sale of the Facility, no later than April 14, 2023, and (z) pay to Woodforest a fee in the amount of
$75,000 on the earlier of the date of the closing of the Purchase Agreement, or the Maturity Date (as defined in the Credit Agreement). In
addition, on March 24, 2023, the Company, as guarantor, entered into a fourth amendment to the Guaranty, which reduced the Liquidity
Covenant from $7,500,000 to $1,000,000.
On May 10, 2023, iBio CDMO and Woodforest entered into a fifth amendment to the Credit Agreement (the “Fifth Amendment”), pursuant
to which Woodforest agreed to: (i) waive our obligation to deliver to Woodforest an executed copy of a Purchase Agreement for the sale of
the Facility no later than April 14, 2023 and, (ii) release $500,000 of the $3.0 million being held in a Company account at Woodforest when
the outstanding principal amount is reduced to $10.0 million and for each additional $2.5 million reduction of the outstanding principal
amount, an additional $750,00 will be released from the Company account at Woodforest. In addition, starting on the effective date of the
Fifth Amendment, the interest on the Term Loan increased to 5.25%, and the Term Loan shall further accrue interest, payable in kind and
added to the balance of the outstanding principal amount at a fixed rate per annum equal to (a) 1.00%, if the Facility is sold on or before
June 30, 2023, (b) 2.00% if the Facility is sold after June 2023, but on or before September 30, 2023, or (c) 3:00%, if the Facility is sold
after September 30, 2023, or not sold prior to the Maturity Date. The Company also agreed to pay Woodforest a fee in the amount of (x)
$75,000 if the Facility is sold on or before June 30, 2023, (y) $100,000 if the Facility is sold after June 2023, but on or before September
30, 2023, or (x) $125,000, if the Facility is sold after September 30, 2023, or not sold prior to the Maturity Date.
On September 15, 2023, iBio CDMO entered into a purchase and sale agreement, dated as of September 15, 2023 (the “Purchase and Sale
Agreement”) with Majestic Realty Co., a California corporation (“Majestic Realty”), pursuant to which iBio CDMO agreed to sell to
Majestic Realty for a purchase price of $17,250,000 its Facility located in Bryan, TX consisting of: (i) the ground leasehold estate and
interest held under the Ground Lease Agreement, dated March 8, 2010, as amended by an Estoppel Certificate and Amendment to Ground
Lease Agreement, dated as of December 22, 2015, between iBio CDMO (as assignee from College Station Investors LLC) and The Board
of Regents of the Texas A&M University System (together, the “Ground Lease”), related to 21.401 acres in Brazos County, Texas land (the
“Land”); (ii) the buildings, parking areas, improvements, and fixtures situated on the Land (the “Improvements”); (iii) all iBio CDMO’s
right, title, and interest in and to furniture, personal property, machinery, apparatus, and equipment owned and currently used in the
operation, repair and maintenance of the Land and Improvements and situated thereon (collectively, the “Personal Property”); (iii) all iBio
CDMO’s rights under the contracts and agreements relating to the operation or maintenance of the Land, Improvements or Personal
Property which extend beyond the closing date (the “Contracts”); and (iv) all iBio CDMO’s rights in intangible assets of any nature relating
to any or all of the Land, the Improvements and the Personal Property (the “Intangibles”; and together with the Ground Lease,
Improvements and Personal Property, collectively, the “Property”). The closing of the sale of the Property is to occur, with time being of
the essence, on December 1, 2023 or such other date as mutually agreed. Pursuant to the terms of the Purchase and Sale Agreement ,
Majestic Realty deposited with a title company (the “Escrow Agent”) $200,000 as an earnest money deposit. Majestic Realty will also be
afforded access to the Property to conduct a due diligence review of its condition. The closing is subject to certain closing conditions,
including: (i) Majestic Realty’s delivery to iBio CDMO and the Escrow Agent of written notice of its approval of the condition of the
Property on or before 5:00 p.m. Central time on October 16, 2023 (the “Due Diligence Deadline”); (ii) Majestic Realty obtaining the
approval of The Board of Regents of the Texas A&M University System of Majestic Realty’s purchase from it of the fee interest in the
Land on or before 5:00 p.m. Central time on November 13, 2023; and (iii) the delivery at closing by the title company of a title policy to
Majestic Realty in the amount of the Purchase Price.
On September 18, 2023, iBio CDMO and Woodforest entered into a sixth amendment to the Credit Agreement (the “Sixth Amendment”),
to amend the Credit Agreement to: (i) set the maturity date of the term loan to the earlier of (a) December 31, 2023, or (b) the acceleration
of maturity of the term loan in accordance with the Credit Agreement, (ii) provided that iBio CDMO will, immediately upon receipt of the
proceeds of the sale of the Property, apply the net proceeds to satisfy all outstanding obligations under the term loan, and to the extent such
net proceeds are sufficient, to pay off the term loan, and (iii) change the annual filing requirement solely for the fiscal year ending June 30,
2023, such that the filing is
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acceptable with or without a “going concern” designation; provided that (y) iBio CDMO shall deliver an executed copy of the Purchase and
Sale Agreement for the sale of the Facility within one business day after entry into the Sixth Amendment, and (z) if the Facility is not sold
on or before December 1, 2023, iBio CDMO will pay a fee in the amount of $20,000 upon the earlier of the date of the closing or the
maturity date.
The Facility is a life science building located on land owned by the Board of Regents of the Texas A&M University System (“Texas
A&M”) and is designed and equipped for the manufacture of plant-made biopharmaceuticals. As part of the transaction, iBio CDMO
became the tenant under the Ground Lease Agreement for the land until 2060 upon exercise of available extensions. The base rent payable
under the Ground Lease Agreement, which was $151,450 for the prior year, is 6.5% of the Fair Market Value (as defined in the Ground
Lease Agreement) of the land. The Ground Lease Agreement includes various covenants, indemnities, defaults, termination rights, and
other provisions customary for lease transactions of this nature. The Facility has been listed for sale since November 2022 and remarketed
starting July 2023.
Intellectual Property
We currently own 95 patents. Of the 95 patents, 24 are U.S. and 71 are international. Since July 1, 2022, we have primarily focused our
intellectual property estate on our preclinical assets filing 10 provisional patents in the U.S. and foreign countries, including for chemokine
receptor 8 (CCR8) antibodies, epidermal growth factor receptor variant III (EGFRvIII) antibodies, anti-MUC16 antibodies, TROP2
antibodies, CD3 antibodies, and recently filed a provisional patent for our high-efficiency, conditionally-activated antibodies. We now
have 18 U.S., 2 Patent Cooperation Treaty, and 32 international applications pending. International patents and applications include
numerous foreign countries including Australia, Brazil, Canada, China, Hong Kong, India, Japan, Korea, and several countries in Europe.
In the U.S. our patents expire between 2023 and 2036. Outside the U.S. these patents expire between 2023 and 2036. The 8 patents
expiring in 2023 in the U.S. and overseas are related to virus-induced gene silencing in plants.
Included in the 95 patents are 30 U.S. and foreign applications that we acquired from RubrYc for novel antibodies, scaffold technology,
and a machine learning apparatus for engineering meso-scale peptides, including 1 allowed application.
As part of the plant portfolio, we exclusively own the right to use certain intellectual property acquired by or developed at Fraunhofer for
human health and certain veterinary and diagnostic applications. We also own intellectual property developed or acquired independently of
Fraunhofer as part of the plant portfolio.
During the second quarter of Fiscal 2023, we re-evaluated our business strategy and reviewed our product portfolio. After such review, we
identified intellectual property, patent and licenses with a net book value of approximately $565 that will no longer be utilized and therefore
they were fully impaired.
In addition to patents and patent applications that we own, our plant focused patent estate relies on trade secrets and know-how, which we
are currently seeking a partner to out-license such proprietary technology and processes.
Our success will depend in part on our ability to obtain and maintain patent protection for our technologies and preclinical assets. Our
policy is to seek to protect our proprietary rights, by among other methods, filing patent applications in the U.S. and foreign jurisdictions to
cover certain aspects of our technology. We continue to prepare patent applications relating to our expanding technology in the U.S. and
abroad.
The technology and products covered by our issued and pending patent applications are summarized below:
Technology and Product Patents (U.S.)
● Virus-induced gene silencing in plants
● Transient expression of foreign genes in plants
● Production of foreign nucleic acids and polypeptides in sprout systems
● Production of pharmaceutically active proteins in sprouted seedlings
● Systems and method for clonal expression in plants
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● Recombinant carrier molecule for expression, delivery and purification of target polypeptides
● Influenza antigens, vaccine compositions, and related methods
● Plague antigens, vaccine compositions, and related methods
● Influenza therapeutic antibodies
● Trypanosomiasis vaccine
● Anthrax antigens, vaccine compositions, and related methods
● Use of endostatin peptides for the treatment of fibrosis
Pending Technology Patent Applications (U.S. and International)
● Activation of transgenes in plants by viral vectors
● Transient expression of proteins in plants
● Thermostable carrier molecule
● In vivo deglycosylation of recombinant proteins in plants
● Scaffold technology
● Machine learning apparatus for engineering meso-scale peptides
● Methods of making conditionally-activated antibodies
Pending Product Patent Applications (U.S. and International)
● Antibodies
● Influenza vaccines
● Influenza therapeutic antibodies
● Anthrax vaccines
● Plague vaccines
● HPV vaccines
● Trypanosomiasis vaccine
● Malaria vaccines
● COVID-19 vaccines
● Antibodies against chemokine receptor 8 (CCR8)
● Antibodies against epidermal growth factor receptor variant III (EGFRvIII)
● Antibodies against MUC16
● Antibodies against TROP2
● Antibodies against CD3
● High-efficiency, conditionally-activated antibodies
Competition
The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong
emphasis on proprietary products.
We face competition from many different sources, including commercial pharmaceutical and biotechnology enterprises, academic
institutions, government agencies, and private and public research institutions. Our commercial opportunities will be reduced or eliminated
if our competitors develop and commercialize products that are safer, more effective, have fewer side effects or are less expensive than any
products that we or our collaborators may develop based on the use of our technologies.
While we believe that the potential advantages of our new technologies will enable us to compete effectively against other providers of
technology for biologic product development and manufacturing, many of our competitors have significantly greater financial resources
and expertise in research and development, manufacturing, preclinical testing, clinical trials,
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regulatory approvals and marketing approved products than we do. Smaller or early-stage companies may also prove to be significant
competitors, particularly through arrangements with large and established companies, and this may reduce the value of our technologies for
the purposes of establishing license agreements. In addition, these third parties compete with us in recruiting and retaining qualified
scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring
technologies and technology licenses complementary to our programs or advantageous to our business.
We expect to rely upon licensees, collaborators or customers for support in advancing certain of our drug candidates and intend to rely on
additional work with our collaborators during our efforts to commercialize our product candidates. Our licensees, collaborators or
customers may be conducting multiple product development efforts within the same disease areas that are the subjects of their agreements
with us. Agreements with collaborators may not preclude them from pursuing development efforts using a different approach from that
which is the subject of our agreement with them. Any of our drug candidates, therefore, may be subject to competition with a drug
candidate under development by a customer.
There are currently approved vaccines and therapies for many of the diseases and conditions addressed by the product candidates our
partners and collaborators may be developing or manufacturing or in our own pipeline. Technological developments in our field of research
and development occur at a rapid rate and we expect competition to intensify as advances in this field are made. We will be required to
continue to devote substantial resources and efforts to our research and development activities.
As a biopharmaceutical company with a focus on cancer therapeutics, we compete with a broad range of companies. At the highest level,
our therapeutics can be seen as both a complement and a potential competitor to any oncology therapy, most notably chemotherapy,
radiotherapy, biologics and small molecule drugs. Not only do we compete with companies engaged in various cancer treatments including
radiotherapy and chemotherapy, but we also compete with various companies that have developed or are trying to develop immunology
vaccines for the treatment of cancer. Certain of our competitors have substantially greater capital resources, large customer bases, broader
product lines, sales forces, greater marketing and management resources, larger research and development staffs with extensive facilities
and equipment than we do and have more established reputations as well as global distribution channels. Our most significant competitors,
among others, are fully integrated pharmaceutical companies such as Eli Lilly and Company, Bristol-Myers Squibb Company, Merck &
Co., Inc., Novartis AG, MedImmune, LLC (a wholly owned subsidiary of AstraZeneca plc), Johnson & Johnson, Pfizer Inc., Merck KGaA
and Sanofi SA, and more established biotechnology companies such as Genentech, Inc. (a member of the Roche Group), Amgen Inc.,
Gilead Sciences, Inc. and its subsidiary Kite Pharma, Inc., and competing cancer immunotherapy companies such as, Bluebird Bio, Inc.,
Transgene SA, Bausch Health Companies, Lumos Pharma, Agenus Inc., Aduro Biotech, Inc., Advaxis, Inc., ImmunoCellular
Therapeutics, Ltd., IMV Inc., Oxford BioMedica plc, Bavarian Nordic A/S, Celldex Therapeutics, Inc., as well as tech enabled drug
discovery companies such as Recursion, Abcellera Biologics, Inc., Cellarity, BenevolentAI, and others, some of which have substantially
greater financial, technical, sales, marketing, and human resources than we do. These companies might succeed in obtaining regulatory
approval for competitive products more rapidly than we can for our products. In addition, competitors might develop technologies and
products that are less expensive, safer or more effective than those being developed by us or that would render our technology obsolete. In
addition, the pharmaceutical and biotechnology industry is characterized by rapid technological change. Because our research approach
integrates many technologies, it may be difficult for us to remain current with the rapid changes in each technology. If we fail to stay at the
forefront of technological change, we may be unable to compete effectively. Our competitors may render our technologies obsolete by
advancing their existing technological approaches or developing new or different approaches.
Research and Development
Our research and development functions are focused on the creation of new products and services, as well as enhancements to our existing
offerings, both of which are necessary to maintain our competitive position. Our research and development activities take place primarily at
our facilities in San Diego. iBio has leased lab and office space in San Diego for the purpose of conducting research. For the Fiscal year
2023, iBio spent $10.3 million in R&D related activities.
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Suppliers
We outsource certain functions and supplies to third parties such as Charles River Laboratories, Sartorius AG, Fisher Scientific, Lonza
Sales AG, and Twist Bioscience Corporation. While we rely on our outsourcing partners to perform their contracted functions, we are
continuing to build internal capabilities. Our suppliers are generally available to meet our demands and supply requirements, but our items
are long lead time items that have been exacerbated by the current macro environment due to increased demand. We continue to mitigate
the risks through inventory management, relationship management and evaluation of alternative sources when possible. Refer to Item 1A,
“Risk Factors,” for a description of risks associated with our reliance on suppliers and outsourcing partners.
Government Regulation and Product Approval
Government authorities in the United States at the federal, state and local level and in other countries extensively regulate, among other
things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion,
advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug products. Generally, before a
new drug can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format
specific to each regulatory authority, submitted for review and approved by the regulatory authority.
U.S. Drug Approval Process
All of the vaccine and therapeutic products developed from our technologies will require regulatory approval by governmental agencies
prior to commercialization. In particular, pharmaceutical drugs and vaccines are subject to rigorous preclinical testing and clinical trials and
other pre-marketing approval requirements by the FDA and regulatory authorities in other countries. In the U.S., various federal, and, in
some cases, state statutes and regulations, also govern or impact the manufacturing, safety, labeling, storage, record-keeping and marketing
of vaccines and pharmaceutical products. The lengthy process of seeking required approvals and the continuing need for compliance with
applicable statutes and regulations requires the expenditure of substantial resources. Regulatory approval, if and when obtained for any of
our product candidates, may be limited in scope, which may significantly limit the indicated uses for which our product candidates may be
marketed. Further, FDA approved vaccines and drugs are subject to ongoing oversight and discovery of previously unknown problems may
result in restrictions on their manufacture, sale or use, or in their withdrawal from the market.
The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the
following:
● completion of pre-clinical laboratory tests and animal studies according to good laboratory practices (“GLP”) and applicable
requirements for the humane use of laboratory animals or other applicable regulations;
● submission to the FDA of an Investigational New Drug (“IND”) application which must become effective before human clinical
trials may begin;
● performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as
good clinical practices (“GCPs”) and any additional requirements for the protection of human research subjects and their health
information, to establish the safety and efficacy of the proposed biological product for its intended use;
● submission to the FDA of a New Drug Application or NDA or Biologics License Application (“BLA”) for marketing approval
that meets applicable requirements to ensure the continued safety, purity, and potency of the product that is the subject of the
NDA or BLA based on results of pre-clinical testing and clinical trials;
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● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the product candidates
are produced, to assess compliance with cGMP, to assure that the facilities, methods and controls are adequate to preserve the
product’s identity, strength, quality and purity;
● potential FDA audit of the pre-clinical trial and clinical trial sites that generated the data in support of the NDA or BLA; and
● FDA review and approval of the NDA or licensure of the BLA.
Preclinical Tests
Before any product candidates with potential immunization or therapeutic value may be tested in human subjects, we must satisfy stringent
government requirements for preclinical studies. Preclinical testing includes both in vitro and in vivo laboratory evaluation and
characterization of the safety and efficacy of the product candidate. “In vitro” refers to tests conducted with cells in culture and “in vivo”
refers to tests conducted in animals. The conduct of the preclinical tests must comply with federal regulations and requirements including
GLP. Preclinical testing results obtained from studies in several animal species, as well as data from in vitro studies, are submitted to the
FDA as part of an IND application and are reviewed by the FDA prior to the commencement of human clinical trials. These preclinical data
must provide an adequate basis for evaluating both the safety and the scientific rationale for the initial clinical trials. In the case of vaccine
candidates, animal immunogenicity and immune protection tests must establish a sound scientific basis to believe that the product
candidate may be beneficial when administered to humans.
IND
An IND becomes effective automatically 30 days after receipt by the FDA unless the FDA raises concern or questions about the conduct of
the clinical trials as outlined in the IND prior to that time. In such an event, the IND sponsor and the FDA must resolve any outstanding
concerns before clinical trials may proceed. For additional information on the most recent FDA regulations and guidance on vaccine and
therapeutic product testing and approval, visit its website at http://www.fda.gov. The FDA may also impose clinical holds on a product
candidate at any time before or during clinical trials due to potential safety concerns or non-compliance. If the FDA imposes a clinical hold,
trials may not recommence without FDA authorization and then only under terms authorized by the FDA. Accordingly, we cannot be sure
that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or
terminate such trials.
Clinical Trails
Clinical trials involve the administration of the product candidate to healthy volunteers or patients under the supervision of qualified
investigators, generally physicians not employed by or under the trial sponsor’s control. Clinical trials are conducted under protocols
detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the
parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events
should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. Clinical trials must be
conducted and monitored in accordance with the FDA’s regulations composing the good clinical practice requirements, including the
requirement that all research subjects provide informed consent. Further, each clinical trial must be reviewed and approved by an
independent institutional review board (the “IRB”) at or servicing each institution at which the clinical trial will be conducted. An IRB is
charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating
in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the
informed consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until
completed. Human clinical trials involving biological products are typically conducted in three sequential phases that may overlap or be
combined:
● Phase 1. The biological product is initially introduced into a small number of closely monitored healthy human volunteers and
tested for safety. In the case of some products for severe or life-threatening diseases, especially
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when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often
conducted in patients with the targeted disease.
● Phase 2. The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to
preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage
and dosing schedule.
● Phase 3. Clinical trials generally enroll a large number of volunteers and are undertaken to further evaluate dosage, clinical
efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials
are intended to establish the overall risk to benefit ratio of the product and provide an adequate basis for product labeling.
During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical
data, and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written
IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events, any findings
from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human subjects, or any clinically
important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor
also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the
sponsor’s initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any
specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend or terminate a clinical trial at any time
on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can
suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s
requirements or if the biological product has been associated with unexpected serious harm to subjects.
Concurrently with clinical trials, companies usually complete additional studies and must also develop additional information about the
physical characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in
accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product
candidate and, among other criteria, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the
final biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted.
Many other countries in which we might choose to develop drugs or run clinical trials have similar rules and regulation. Although many of
the issues discussed above with respect to the United States apply similarly in the context of the European Union or other foreign countries,
the approval process varies between countries and jurisdictions and can involve additional product testing and additional administrative
review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required
to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or
delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.
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● NDA/BLA:
o Once clinical trials of a product candidate are completed, FDA approval of an NDA or BLA must be obtained before
commercial marketing of the product. The NDA or BLA must include results of product development, laboratory and
animal studies, human trials, information on the manufacture and composition of the product, proposed labeling and
other relevant information. The FDA may grant deferrals for submission of data, or full or partial waivers. The testing
and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the
NDA or BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.
Post-Approval Requirements:
o Any products for which we receive FDA approvals will be subject to continuing regulation by the FDA, including,
among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA
with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA
promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising,
restrictions on promoting products for uses or in patient populations that are not described in the product’s approved
uses, known as ‘off-label’ use, limitations on industry-sponsored scientific and educational activities, and requirements
for promotional activities involving the internet.
Other U.S. Healthcare Laws and Compliance Requirement:
o
In the United States, our activities are potentially subject to regulation by various federal, state and local authorities in
addition to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services, or CMS, other
divisions of the U.S. Department of Health and Human Services, for instance the Office of Inspector General, the U.S.
Department of Justice, or DOJ, and individual U.S. Attorney offices within the DOJ, and state and local governments.
For example, research, sales, marketing and scientific/educational grant programs must comply with the anti-fraud and
abuse provisions of the Social Security Act, the false claims laws, the physician payment transparency laws, the privacy
and security provisions of HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act
(“HITECH”), and similar state laws, each as amended. Once commercialized, we could be liable to ensure full
compliance with the law.
Coverage, Pricing and Reimbursement
o
Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain
regulatory approval. This is dictated by third-party payors’ coverage and establish adequate reimbursement levels for
such products. The marketability of any product candidate for which we receive regulatory approval for commercial sale
may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.
Foreign Regulation:
o
In order to market any product outside of the United States, we would need to comply with numerous and varying
regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among
other things, clinical trials, marketing authorization, commercial sales and distribution of our products. Whether or not
we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable foreign
regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and
jurisdictions. Although many of the issues discussed above with respect to the United States apply similarly in the
context of the European Union, the approval process varies between countries and jurisdictions and can involve
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Orphan Drug Act
additional product testing and additional administrative review periods. The time required to obtain approval in other
countries and jurisdictions might differ from and be longer than that required to obtain FDA approval. Regulatory
approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining
regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition,
which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, and for which there is no
reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will
be recovered from sales in the United States for that drug. Orphan drug designation must be requested before submitting an NDA or BLA.
After the FDA grants orphan drug designation, the name of the sponsor, identity of the drug or biologic and its potential orphan use are
disclosed publicly by the FDA. The orphan drug designation does not shorten the duration of the regulatory review or approval process, but
does provide certain advantages, such as a waiver of Prescription Drug User Fee Act, or PDUFA, fees, enhanced access to FDA staff and
potential waiver of pediatric research requirements.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation,
the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full
NDA, to market the same drug or biologic for the same indication for seven years, except in limited circumstances, such as a showing of
clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different
drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other
benefits of orphan drug designation are tax credits for certain research and a waiver of the application user fee. A designated orphan drug
may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan
designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for
designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of
patients with the rare disease or condition.
Accelerated Approval
There are a variety of pathways under which applicants may seek expedited approval from FDA, including fast track, breakthrough therapy,
priority review and accelerated approval. The FDA accelerated approval program provides for early approval of drugs based on a drug on a
clinical trial(s) showing that the drug meets a surrogate or an intermediate clinical endpoint rather than a clinical benefit endpoint.
Accelerated approval is possible for drugs for serious conditions that fill an unmet medical need.
A surrogate endpoint used for accelerated approval is a marker, such as a laboratory measurement, that is thought to predict clinical benefit,
but is not itself a measure of clinical benefit. Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is
considered reasonably likely to predict the clinical benefit of a drug, such as an effect on irreversible morbidity and mortality. Because it
sometimes can take many years for a drug trial to show a clinical benefit, the use of a surrogate endpoint or an intermediate clinical
endpoint can significantly shorten the time required to complete clinical trials and obtain FDA approval.
If a drug receives an accelerated approval, the company that sponsored the application must conduct a post-approval trial to confirm the
anticipated clinical benefit. These trials are known as Phase 4 or post-approval confirmatory trials. If the confirmatory trial shows that the
drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. Failure to conduct required post-approval
studies, or confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug from the market on an
expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the
FDA. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead
to removing the drug from the market.
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Healthcare Regulations and Healthcare Reform
Healthcare regulation and pricing (included drug pricing) is complex, extensive, and dynamic around the world. In the United States and
some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and regulatory changes and proposed
changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality of healthcare, and
containing or lowering the cost of healthcare. We expect that there will continue to be a number of federal and state proposals to implement
government pricing controls and limit the growth of healthcare costs.
We cannot predict what healthcare reform initiatives may be adopted in the future. Further federal, state and foreign legislative and
regulatory developments are likely, and we expect ongoing initiatives to increase pressure on drug pricing. Such reforms could have an
adverse effect on anticipated revenues from product candidates and may affect our overall financial condition and ability to develop
product candidates.
We anticipate that current and future U.S. legislative healthcare reforms may result in additional downward pressure on the price that we
receive for any approved product, if covered, and could seriously harm our business. Any reduction in reimbursement from Medicare and
other government programs may result in a similar reduction in payments from private payors.
U.S. Patent-Term Extension
Depending upon the timing, duration and specifics of FDA approval of our current product candidates or any future product candidate,
some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration
Act of 1984, commonly referred to as the Hatch Waxman Act. The Hatch Waxman Act permits extension of the patent term of up to five
years as compensation for patent term lost during FDA regulatory review process. Patent term extension, however, cannot extend the
remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term extension period is generally one
half the time between the effective date of an IND and the submission date of an NDA plus the time between the submission date of an
NDA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise
due diligence. Only one patent applicable to an approved drug is eligible for the extension (and only those patent claims covering the
approved drug, a method for using it or a method for manufacturing it may be extended), and the application for the extension must be
submitted prior to the expiration of the patent. A patent that covers multiple products for which approval is sought can only be extended in
connection with one of the approvals. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term
extension. In the future, we may apply for extension of a patent term for our currently owned patents to add patent life beyond its current
expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant NDA.
However, there can be no assurance that the USPTO will grant us any requested patent term extension, either for the length we request or at
all.
Human Capital/Employees
As of June 30, 2023, we had 23 employees in iBio and 3 employees in iBio CDMO that are maintaining the Facility until it is sold, all of
which are full time employees. Our employees are not represented by any union and are not the subject of a collective bargaining
agreement. We consider our relations with our employees to be good.
We believe that our success depends upon our ability to attract, develop, retain and motivate key personnel. Our management and scientific
teams possess considerable experience in drug discovery, research and development, manufacturing, clinical and regulatory affairs, and
iBio directly benefits from this experience and industry knowledge.
We anticipate that we will need to identify, attract, train and retain other highly skilled personnel to pursue our development program.
Hiring for such personnel is competitive, and there can be no assurance that we will be able to retain our key employees or attract,
assimilate or retain the qualified personnel necessary for the development of our business.
We have no collective bargaining agreements with our employees and have not experienced any work stoppages. We consider our relations
with our employees to be good. Management believes that it has sufficient human capital to operate
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its business successfully currently and will need to attract new talent to the organization in order to achieve its plans for growth.
Competitive Pay and Benefits. Our compensation programs are designed to align the compensation of our employees with our performance
and to provide the proper incentives to attract, retain and motivate employees to achieve superior results. The structure of our compensation
programs balances incentive earnings for both short-term and long-term performance. Specifically:
● we provide employee wages that are competitive and consistent with employee positions, skill levels, experience, knowledge and
geographic location;
● we engage nationally recognized outside compensation and benefits consulting firms to independently evaluate the effectiveness
of our executive compensation and benefit programs and to provide benchmarking against our peers within the industry;
● we align our executives’ long-term equity compensation with our shareholders’ interests by linking realizable pay with stock
performance;
● annual increases and incentive compensation are based on merit, which is communicated to employees at the time of hiring and
documented through our talent management process as part of our annual review procedures and upon internal transfer and/or
promotion; and
● commencing January 1, 2018, we established the iBio, Inc. 401(k) Plan. Eligible employees may participate in the 401(k) Plan,
whereby they may elect to make elective deferral contributions pursuant to a salary deduction agreement and receive matching
contributions upon meeting age and length-of-service requirements. We will make a 100% matching contribution that is not in
excess of 5% of an eligible employee’s compensation. In addition, we may make qualified non-elective contributions at our
discretion.
Corporate Information
We were incorporated under the laws of the State of Delaware on April 17, 2008, under the name iBioPharma, Inc. We engaged in a merger
with InB:Biotechnologies, Inc., a New Jersey corporation on July 25, 2008, and changed our name to iBio, Inc. on August 10, 2009.
Our principal executive offices are located at 8800 Health Science Center Parkway, Bryan, Texas and our telephone number is (979) 446-
0027. Our website address is www.ibioinc.com. The information contained on, or accessible through, our website does not constitute part
of this Annual Report. We have included our website address in this Annual Report solely as an inactive textual reference.
Reverse Stock Split
On October 7, 2022, we effected a reverse stock split at a ratio of one-for-twenty five (1:25) shares of our common stock. As a result of the
reverse stock split, every twenty five (25) shares of the Company's common stock either issued and outstanding or held by us in our
treasury immediately prior to the effective time was, automatically and without any action on the part of the respective holders thereof,
combined and converted into one (1) share of our common stock. The reverse split also applied to common stock issuable upon the exercise
of our outstanding stock options. The reverse stock split did not affect the par value of our common stock or the shares of our common
stock that we are authorized to issue under our Certificate of Incorporation, as amended. No fractional shares were issued in connection
with the reverse stock split. Stockholders who otherwise were entitled to receive a fractional share in connection with the reverse stock split
instead were eligible to receive a cash payment, which was not material in the aggregate, instead of shares. All share and per share amounts
of common stock presented in this Annual Report have been retroactively adjusted to reflect the one-for-twenty five reverse stock split.
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Available Information
Our website address is www.ibioinc.com. We file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K, proxy statements and other materials with the SEC. We are subject to the informational requirements of the Exchange Act and
file or furnish reports, proxy statements and other information with the SEC. Such reports and other information filed by the Company with
the SEC are available free of charge on our website at www.ibioinc.com. Information contained on, or that can be accessed through, our
website is not incorporated by reference into this Annual Report, and you should not consider information on our website to be part of this
Annual Report.
The SEC also maintains a website that contains reports, proxy and information statements and other information regarding issuers that file
electronically with the SEC at www.sec.gov.
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Item 1A. Risk Factors
Summary Risk Factors
Our business faces significant risks and uncertainties of which investors should be aware before making a decision to invest in our common
stock. If any of the following risks are realized, our business, financial condition and results of operations could be materially and adversely
affected. The following is a summary of the more significant risks relating to the Company. A more detailed description of our risk factors
is set forth below under the caption “Detailed Risk Factors.”
Risks Related to Our Financial Position and Need for Additional Capital
• We have a limited operating history developing vaccines and therapeutics.
• We are evaluating potential options to extend our cash runway that could impact our future operations and financial position.
• Substantial doubt exists related to our ability to operate as a going concern.
• We have incurred and expect to continue to incur significant losses.
• We anticipate that our expenses will increase in the future.
• We need additional funding to fully execute our business plan.
• The actual amount of funds we will need to operate is subject to many risk factors.
• Raising additional capital may cause dilution to our existing stockholders and/or restrict our operations or rights.
• There can be no assurance that the sale of the Property will be completed in a timely manner or at all.
• Failure to complete the sale of the Property is expected to negatively impact our stock price and our future business and financial results.
• If the sale of the Property is not complete, we will have incurred substantial expenses without realizing the expected benefits of the sale.
• The unaudited pro forma financial information included as an exhibit to our Current Report on Form 8-K filed with the SEC on
September 21, 2023 is for illustrative purposes and although we do not expect actual results to differ materially from the preliminary
estimates, our actual financial position or result of operations after the anticipated sale may differ from the estimates.
• A default under the terms of the Credit Agreement could result in action against our pledged assets.
• The Credit Agreement requires that we pay a significant amount of cash to the lender.
• Covenant restrictions in the Credit Agreement may limit our ability to operate our business.
• Potential use of government funding for R&D programs may impose conditions limiting our ability to take certain actions.
Risks Related to the Development and Commercialization of Our Technologies and Product Candidates
• We have a limited operating history developing precision antibodies and have no significant source of revenue.
• We are reliant on a limited number of product candidates that involve significant clinical testing before seeking regulatory approval.
• We may fail to capitalize on particular technology or product candidates that we expend our limited resources on.
• There can be no guarantee that we will be able to successfully develop and commercialize product candidates.
• We may not be successful in our efforts to use iBio technologies to build a pipeline of product candidates.
• Clinical trials are very expensive, time-consuming and difficult to design and implement.
• We or our clients, collaborators or licensees are dependent upon successful preclinical and clinical studies.
• If we, or our clients and collaborators, are not able to obtain required regulatory approvals, we, or our clients and collaborators, will not
be able to commercialize our, or third-party, product candidates.
• Alternative technologies may supersede our technologies or make them noncompetitive.
• Our clinical product candidates may exhibit undesirable side effects.
• Our failure to receive or maintain regulatory approval for product candidates could negatively impact our revenue and profitability.
• Product liability lawsuits could cause us to incur substantial liabilities and to limit product commercialization.
• Any manufacturing problems experienced by our only third-party contract manufacturer could result in a delay or interruption in the
supply of our clinical product candidate.
Risks Related to Dependence on Third Parties
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• If we are unable to establish new collaborations and maintain both new and existing collaborations, or if these collaborations are not
successful, our business could be adversely affected.
• If third parties on whom we or our licensees will rely for the conduct of preclinical and clinical studies do not perform as required, we
may not be able to obtain regulatory approval for or commercialize our product candidates.
• Our inability to obtain materials or supplies may adversely impact our business and results of operations.
• Any claims beyond our insurance coverage limits may result in substantial costs.
• We may be subject to various litigation claims and legal proceedings.
Risks Related to Intellectual Property
• If we or our licensors are unable to obtain and maintain sufficient patent protection for our technology and products, our ability to
successfully commercialize our technology and products may be impaired.
• We may become involved in lawsuits to protect or enforce our patents or other intellectual property.
• Patent terms may be inadequate to protect our competitive position for an adequate amount of time.
• If we are unable to protect our trade secrets, our business and competitive position would be harmed.
• We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.
• Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
• We may not be able to protect our intellectual property rights throughout the world.
• If we should fail to comply with various patents laws, our patent protection could be reduced or eliminated.
• Changes in patent law could increase the uncertainties and costs surrounding the prosecution of our patent applications and the
enforcement or defense of our issued patents.
Risks Related to iBio’s Operations
• We recently identified and remediated material weaknesses in our internal controls, and we cannot provide assurances that these
weaknesses will not occur in the future.
• The loss of one or more of our executive officers or key employees could adversely affect our business.
• A failure to have an appropriately skilled and adequate workforce could adversely impact the ability of our R&D facility to operate.
• A natural disaster, unfavorable weather conditions or other disruptions at laboratory would adversely affect our business and results of
operations.
• We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
• If we are unable to protect the confidentiality of our customers’ proprietary information, we may be subject to claims.
• We may face integration risks and additional costs if we acquire companies, products or technologies.
Risks Related to Our Common Stock
• Our stockholders will experience dilution from the issuance of the development milestone payments if paid in equity.
• We are subject to compliance under the NYSE American continued listing standards of the NYSE American Company Guide, the failure
of which can result in our delisting from the NYSE American.
• Provisions in our certificate of incorporation, bylaws and under Delaware law could discourage a takeover.
• Our bylaws provide that the Delaware Court of Chancery is the exclusive forum for certain disputes.
• We do not anticipate paying cash dividends for the foreseeable future.
• The issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock.
• Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors
beyond our control may adversely impact our business and operating results.
• We rely extensively on our information technology systems and are vulnerable to damage and interruptions.
• Holders of our warrants have no rights as common stockholders until they exercise their warrants.
• The market price of our common stock has been and may continue to be volatile.
• Reports published by securities or industry analysts, could adversely affect our common stock price and trading volume.
• We are subject to reduced disclosure requirements applicable to smaller reporting companies.
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Detailed Risk Factors
Our business faces many risks. Past experience may not be indicative of future performance, and as noted elsewhere in this Annual Report,
we have included forward-looking statements about our business, plans and prospects that are subject to change. Forward-looking
statements are particularly located in, but not limited to, the sections “Business” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations.” In addition to the other risks or uncertainties contained in this Annual Report, the risks described
below may affect our operating results, financial condition and cash flows. If any of these risks occur, either alone or in combination with
other factors, our business, financial condition or operating results could be adversely affected, and the trading price of our common stock
may decline. Moreover, readers should note this is not an exhaustive list of the risks we face; some risks are unknown or not quantifiable,
and other risks that we currently perceive as immaterial may ultimately prove more significant than expected. Statements about plans,
predictions or expectations should not be construed to be assurances of performance or promises to take a given course of action.
Risks Related to Our Financial Position and Need for Additional Capital
We have a limited operating history developing vaccines and therapeutics, which may limit the ability of investors to make an informed
investment decision.
We commenced independent operations in 2008, and our operations to date have included organizing and staffing our company, business
planning, raising capital, acquiring and developing our proprietary technologies, identifying potential product candidates and undertaking,
through third parties, preclinical trials and clinical trials of product candidates derived from our technologies. During the past year, we
shifted our focus away from generating revenue as a CDMO service provider to the development of vaccines and therapeutics for
commercialization. Our current focus is on immune-oncology therapeutics. The current vaccines and therapeutics being developed are all
in preclinical development. Certain vaccine candidates using iBio’s technologies have previously been evaluated by other organizations in
Phase 1 clinical trials; however, all of our vaccine and therapeutic protein product candidates are still in preclinical development. Neither
we nor our collaborators have completed any other clinical trials for any vaccine or therapeutic protein product candidate produced using
iBio technology. As a result, we have not yet demonstrated our ability to successfully complete any Phase 2 or pivotal clinical trials, obtain
regulatory approvals, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and
marketing activities necessary for successful product commercialization. Consequently, any conclusion you reach about our future success
or viability may not be as predictive as it might be if we had a longer operating history.
Even if we receive regulatory approval for the sale of any of our product candidates, we do not know when we will begin to generate
significant revenue from such product candidates, if at all. Our ability to generate revenue depends on a number of factors, including our
ability to:
● set an acceptable price for our products and obtain coverage and adequate reimbursement from third-party payors;
● establish sales, marketing, manufacturing and distribution systems; add operational, financial and management information
systems and personnel, including personnel to support our clinical, manufacturing and planned future clinical development and
commercialization efforts and operations as a public company;
● manufacture commercial quantities of product candidates at acceptable cost levels;
● achieve broad market acceptance of our product candidates in the medical community and with third-party payors and consumers;
● attract and retain an experienced management and advisory team;
● launch commercial sales of our products, whether alone or in collaboration with others; and
● maintain, expand and protect our intellectual property portfolio.
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Because of the numerous risks and uncertainties associated with development and manufacturing product candidates, we are unable to
predict if we will generate significant revenue. If we cannot successfully execute on any of the factors listed above, our business may not
succeed, and we may never generate significant revenue.
We are reviewing potential options to extend our cash runway. This review could impact our future operations and financial position.
We are currently evaluating a number of potential options to expand our cash runway, the implementation of which will impact our
liquidity. In an effort to improve liquidity and our runway, we have placed our CDMO business and Facility on the market for sale and
recently entered into an agreement for the sale of the CDMO Facility, reduced our work force and ceased operations of our CDMO, thereby
reducing annual spend on expenses by approximately 67% and generating cash savings of approximately 64% from first quarter Fiscal year
2023 compared to the fourth quarter Fiscal year 2023. Potential options being considered to further increase liquidity, focusing product
development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from the
capital markets, grant revenue or collaborations, or a combination thereof. However, we anticipate that our expenses will increase as we
continue our research and development activities and conduct clinical trials.
Our cash, cash equivalents and restricted cash of $7.6 million as of June 30, 2023, is not anticipated to be sufficient to support our
operations for at least 12 months from the date of the filing of this Annual Report unless we reduce our burn rate further, sell the CDMO
Facility for amounts above its term note payable, or raise additional capital. Regardless of whether we are able to reduce our burn rate or
sell or out-licensing certain assets or parts of the business, we will need to raise additional capital in order to fully execute our near and
long-term business plans. In fact, our current cash, cash equivalents and restricted cash as of June 30, 2023, is not anticipated to be
sufficient to support operations through the second quarter of Fiscal 2024.
There can be no assurance that all of the conditions set forth in the Purchase and Sale Agreement will be met and that we will be able to
close on the sale of the CDMO Facility or that if we are able to do so that we do so on favorable terms or that we will be able to do so
before the maturity date of the Term Loan or that the exploration of potential options will result in any agreements or transactions, or that,
if completed, any agreements or transactions will be successful or on attractive terms. If we determine to change our business strategy, our
future business, prospects, financial position and operating results could be significantly different than those in historical periods or
projected by our management. Because of the significant uncertainty regarding our future plans, we are not able to accurately predict the
impact of a potential change in our business strategy and future funding requirements.
Our historical operating results indicate substantial doubt exists related to our ability to operate as a going concern.
We have incurred net losses and used significant cash in operating activities since inception, and we expect to continue to generate
operating losses for the foreseeable future. As of June 30, 2023, we have an accumulated deficit of $288.9 million.
We held cash, cash equivalents and restricted cash of $7.6 million as of June 30, 2023. Based on current trends and activities, there is
significant doubt that we can continue as a going concern beyond the second quarter of Fiscal 2024. We are currently evaluating a number
of potential options to expand our cash runway, the implementation of which will impact our liquidity. Potential options being
considered to increase liquidity include focusing product development on a select number of product candidates, the sale of the CDMO
Facility, the sale or out-licensing of certain product candidates or parts of the business, raising money from capital markets, grant revenue
or collaborations, or a combination thereof. Regardless of whether we are able to reduce our burn rate or sell or out-licensing certain assets
or parts of the business, we will need to raise additional capital in order to fully execute our longer-term business plan. We believe based on
input from expert advisors, that it is likely we will be able to implement one or more options that will extend our cash runway for 12
months or more from the date of the filing of this Annual Report. However, there can be no assurance that we will be successful in
implementing any of the options that we are evaluating.
Our consolidated audited financial statements as of and for the year ended June 30, 2023 have been prepared under the assumption that we
will continue as a going concern for the next 12 months. Our management concluded that our recurring losses from operations and the fact
that we have not generated significant revenue or positive cash flows from operations raise substantial doubt about our ability to continue
as a going concern for the next 12 months after issuance of our financial
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statements. Our auditors also included an explanatory paragraph in its report on our financial statements as of and for the year ended June
30, 2023 with respect to this uncertainty. If we continue to experience operating losses, and we are not able to generate additional liquidity
through a capital raise or other cash infusion, we might need to secure additional sources of funds, which may or may not be available to
us. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to further scale back or
discontinue the development of our product candidates or other research and development initiatives or initiate steps to cease operations or
liquidate our assets.
We have incurred significant losses since our inception. We expect to incur losses during our next fiscal year, we do not anticipate
generating significant revenue for several years and may never achieve or maintain profitability.
Since our 2008 spinoff from Integrated BioPharma, we have incurred operating losses and negative cash flows from operations. Our
comprehensive net loss was approximately ($64.8) million and ($50.5) million for the years ended June 30, 2023 and 2022, respectively. As
of June 30, 2023, we had an accumulated deficit of approximately ($288.9) million.
To date, we have financed our operations primarily through the sale of common stock, preferred stock and warrants. We devoting
substantially all of our efforts to research and development, including the development and validation of our technologies, and the
development of a proprietary therapeutic products against oncology. We have not completed development of or commercialized any
vaccine or therapeutic product candidates. We expect to continue to incur significant expenses and may incur operating losses for at least
the next year. We anticipate that our expenses and losses will increase substantially if we:
● initiate clinical trials of our product candidates;
● continue the research and development of our product candidates;
● seek to discover or license in additional product candidates; and
● add operational, financial and management information systems and personnel, including personnel to support our product
development and manufacturing efforts.
Our future profitability and cash flow in large part depends on our research and development programs, including our AI platform, and our
ability to successfully develop, partner or commercialize our product candidates and to a lesser extent, which is not anticipated for several
years. Our cash position is expected to limit the number of product candidates that we seek to develop. This will require us, alone or with
our licensees and collaborators, to be successful in a range of challenging activities, including completing preclinical testing and clinical
trials of our product candidates, obtaining regulatory approval for these product candidates and manufacturing, marketing and selling those
products for which regulatory approval is obtained or establishing collaborations with parties willing and able to provide necessary capital
or other value. We may never succeed in these activities. We may never generate revenues that are significant or large enough to achieve
profitability.
All of our existing product candidates are in various stages of development and will require extensive additional clinical evaluation,
regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue. As
a result, even if we successfully develop, achieve regulatory approval and commercialize our products, we may be unable to generate
revenue for many years, if at all. We do not anticipate that we will generate revenue from product sales for at least several years, if at all. If
we are unable to generate revenue from product sales, we will not become profitable, and we may be unable to continue our operations.
Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would diminish the value of our company and could impair our ability to raise capital, expand our business,
diversify our product offerings or continue our operations. A decline in the value of our company could also cause you to lose all or part of
your investment.
We anticipate that our expenses will increase in the future.
Although we have recently reduced expenses, we expect our research and development expenses to increase significantly in light of the
acquisition of the assets of RubrYc as our product candidates advance in clinical development, and as we
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add more employees. As part of the regulatory process, we must conduct clinical trials for each product candidate to demonstrate safety and
efficacy to the satisfaction of the FDA and other regulatory authorities. The number and design of the clinical trials that will be required
varies depending upon product candidate, the condition being evaluated, and the trial results themselves. Therefore, it is difficult to
accurately estimate the cost of the clinical trials. Clinical trials are very expensive and difficult to design and implement, in part because
they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming. We estimate that clinical trials of our
product candidates will take at least several years to complete. Because of numerous risks and uncertainties involved in our business, the
timing or amount of increased development expenses cannot be accurately predicted, and our expenses could increase beyond expectations
if we are required by the FDA, or comparable non-U.S. regulatory authorities, to perform studies or clinical trials in addition to those we
currently anticipate. We anticipate that further product development is also expected to increase expenses, including but not limited to the
expected initiation of IND-enabling studies IBIO-101 and the additional studies that will be required to support development of our
immuno-oncology programs. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to
abandon or repeat clinical trials.
In addition, as we expand our business, we will need to retain additional employees with the necessary skills including employees for our
continued expansion of drug discovery capabilities in San Diego, California.
Even if any of our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with the
commercial launch of and the related commercial-scale manufacturing requirements for our product candidates. As a result, we expect to
continue to incur significant and increasing operating losses and negative cash flows for the foreseeable future. Because of the numerous
risks and uncertainties associated with biopharmaceutical product development and commercialization, we are unable to accurately predict
the timing or amount of future expenses or when, or if, we will be able to achieve or maintain profitability. These losses have had and will
continue to have an adverse effect on our financial position and working capital.
We need additional funding to fully execute our business plan, which funding may not be available on commercially acceptable terms
or at all. If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate the commercialization of our
development and manufacturing services and efforts for our product development programs.
Even if we are able to consummate the sale of the Facility, we will need additional capital to fully implement our near term and long-term
business, operating and development plans as we do not anticipate that any of our product candidates will generate revenue in the next few
years, if at all. To the extent that we initiate or continue clinical development without securing collaborator or licensee funding, our
research and development expenses could increase substantially.
When we elect to raise additional funds or additional funds are required, we may raise such funds from time to time through public or
private equity offerings, debt financings, corporate collaboration and licensing arrangements or other financing alternatives. Additional
equity or debt financing or corporate collaboration and licensing arrangements may not be available on acceptable terms, if at all. We
currently have no committed sources of funding. Our purchase agreement that we entered into on August 4, 2023 (the “Purchase
Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), allows us to sell shares of common stock to Lincoln Park only if
certain conditions are met and there can be no guarantee that we will meet such conditions. The Controlled Equity Offering SM Sales
Agreement (the “Sales Agreement”) that we entered into with Cantor Fitzgerald & Co. ("Cantor Fitzgerald") in November 25, 2020 also
has certain requirements that we must meet in order to sell securities pursuant to the Sales Agreement. There can be no assurance that we
will meet the requirements to be able to sell securities pursuant to the Purchase Agreement or the Sales Agreement, of if we meet the
requirements that we will be able to raise sufficient funds on favorable terms. In addition, we will not be eligible to sell securities pursuant
our registration statement on Form S-3, including pursuant to the Sales Agreement, from the date of the filing of this Annual Report until
March 1, 2024 due to our late filing of our Quarterly Report on Form 10-Q for the quarter ended December 31, 2022. There can be no
assurances that we will be able to raise the funds needed, especially in light of the fact that our ability to sell securities registered on our
registration statement on Form S-3 after we regain eligibility to use a registration statement on Form S-3 will be limited until such time the
market value of our voting securities held by non-affiliates is $75 million or more. If we are unable to raise capital in sufficient amounts
when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or
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commercialization efforts and our ability to generate revenues and achieve or sustain profitability will be substantially harmed.
If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a)
significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek
collaborators for our technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or
otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or
d) possibly liquidate assets or cease operations.
The actual amount of funds we will need to operate is subject to many risk factors, some of which are beyond our control.
The actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control therefore we are
unable to determine this amount with certainty. These factors include the following:
● the progress of our research activities;
● the number and scope of our research programs;
● the progress of our preclinical and clinical development activities;
● the progress of the development efforts of parties with whom we have entered into research and development agreements and
amount of funding received from partners and collaborators;
● our ability to maintain current research and development licensing arrangements and to establish new research and development
and licensing arrangements;
● our ability to achieve our milestones under licensing arrangements;
● the costs associated with manufacturing related services to produce materials for use in our clinical trials;
● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights;
● the costs incurred to screen and enroll patients; and
● the costs and timing of regulatory approvals.
We have based our estimate on assumptions that may prove to be wrong. We may need to obtain additional funds sooner or in greater
amounts than we currently anticipate. Potential sources of financing include strategic relationships, public or private sales of our shares or
debt and other sources. Additionally, we may seek to access the public or private equity markets when conditions are favorable due to our
long-term capital requirements. We do not have any committed sources of financing at this time, and it is uncertain whether additional
funding will be available when we need it on terms that will be acceptable to us, or at all.
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to
our technologies or product candidates.
Until such time as we can generate substantial development, manufacturing, license or product revenues, we expect to finance our cash
needs through a combination of equity offerings, collaborations, strategic alliances, service contracts, manufacturing contracts, facility
build-out and technology transfer contracts, licensing and other arrangements. Sources of funds may not be available or, if available, may
not be available on terms satisfactory to us.
If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, would result
in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific
actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that
we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our stockholders. If we raise
additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to
our technologies, future
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revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Should the
financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, our business,
operating results, financial condition and prospects could be materially and adversely affected, and we may be unable to continue our
operations.
To the extent that we raise additional capital through a public or private offering and sale of equity securities, your ownership interest will
be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.
Sales of our common stock offered through current or future equity offerings may result in substantial dilution to our stockholders. The sale
of a substantial number of shares of our common stock to investors, or anticipation of such sales, could make it more difficult for us to sell
equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
There can be no assurance that the sale of the Property will be completed in a timely manner or at all. If the sale is not completed by
December 31, 2023, it is unlikely iBio CDMO would have sufficient funding to pay the Term Loan with Woodforest for which we are a
guarantor.
Although we have entered into a Purchase and Sale Agreement for the sale of the Property, there can be no assurance that the sale of the
Property will be completed in a timely manner or at all. The closing of the sale is subject to many conditions
including: (i) Majestic Realty’s delivery to iBio CDMO and the Escrow Agent of written notice of its approval of the condition of the
Property (the “Property Approval Notice”) on or before 5:00 p.m. Central time on October 16, 2023 ; (ii) Majestic Realty obtaining the
approval of The Board of Regents of the Texas A&M University System of Majestic Realty’s purchase from it of the fee interest in the
Land on or before 5:00 p.m. Central time on November 13, 2023; and (iii) the delivery at closing by the title company of a title policy to
Majestic Realty in the amount of the purchase price. None of the mentioned closing conditions are within our control. We cannot guarantee
that these conditions will be satisfied. The conditions to the closing of the sale of the Property may not be fulfilled in a timely manner or at
all, and, accordingly, the sale may not be completed. If the closing is not consummated prior to the December 31, 2023 maturity date of the
Term Loan it is unlikely that we will have sufficient funds the repay the Term Loan on its maturity date, the outstanding balance of which
is $12,688,817 as of September 15, 2023. Our failure to make such payments when due could result in our loss of the Facility. Any action
to proceed against our assets would likely have a serious disruptive effect on our business operations, especially if the Facility or our other
assets were foreclosed upon or our guarantee were enforced.
Failure to complete the sale of the Property could negatively impact our stock price and our future business and financial results.
Majestic Realty’s obligation to complete the sale of the Property is subject to the satisfaction or waiver of a number of conditions set forth
in the Purchase and Sale Agreement. There can be no assurance that the conditions to complete the sale will be satisfied or waived or that
the sale will be completed. If the sale is not completed for any reason, our ongoing business may be materially and adversely affected and,
without realizing any of the benefits of having completed the sale, we would be subject to a number of risks, including the following:
● we may experience negative reactions from the financial markets, including negative impacts on the trading price of our common
stock, which could affect its ability to secure sufficient financing in the future on attractive terms (or at all);
● we will be required to pay our transaction-related expenses incurred in connection with the Purchase and Sale Agreement whether
or not the sale is completed; and
● matters related to the sale of the Property may require substantial commitments of time and resources by our management, which
could otherwise have been devoted to other opportunities that may have been beneficial to us.
In addition, we could be subject to litigation related to any failure to complete the sale.
If the sale of the Property is not completed, we cannot assure our stockholders that the risks described above will not materialize and will
not materially and adversely affect our business, financial condition, financial results and common stock prices.
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If the sale of the Property is not completed, we will have incurred substantial expenses without realizing the expected benefits of the
sale.
We have incurred substantial expenses in connection with the negotiation and completion of the transactions contemplated by the Purchase
and Sale Agreement. If the sale of the Property is not completed, we would have to recognize these expenses without realizing the expected
benefits of the sale.
The unaudited pro forma financial information included as an exhibit to this Current Report on Form 8-K is for illustrative purposes.
Our actual financial position or results of operations after the anticipated sale may differ materially.
The unaudited pro forma financial information included as an exhibit to our Current Report on Form 8-K filed with the SEC on September
21, 2023 and incorporated by reference herein is presented for illustrative purposes only and is not necessarily indicative of what our actual
financial position or results of operations would have been had the sale been completed on the dates indicated. The unaudited pro forma
financial information reflects adjustments, which are based upon estimates. The information upon which these adjustments and
assumptions have been made is preliminary, and these kinds of adjustments and assumptions are difficult to make with complete accuracy.
Moreover, the pro forma financial information does not reflect all costs that are expected to be incurred by us. Accordingly, the final
accounting adjustments may differ materially from such pro forma information.
The failure to comply with the terms of the Credit Agreement, as amended, could result in a default under the terms of the Credit
Agreement, as amended, and, if uncured, it could potentially result in action against our pledged assets.
There is no assurance that we will generate sufficient revenue or raise sufficient capital to be able to make the required principal payment
under the Term Loan that iBio CDMO entered into with Woodforest. The Term Loan with Woodforest is secured by (a) a leasehold deed of
trust on our Facility, and (b) a first lien on all assets of iBio CDMO including the Facility. We have also guaranteed the payment of all iBio
CDMO’s obligations under the Credit Agreement. The Term Loan matures the earlier of December 31, 2023, or the acceleration of
maturity of the Term Loan pursuant to the Credit Agreement. If we or iBio CDMO fail to comply with the terms of the Term Loan and/or
the related agreements, including the affirmative and negative covenants contained therein, Woodforest National Bank could declare a
default and if the default were to remain uncured, Woodforest National Bank would have the right to proceed against any or all of the
collateral securing their Term Loan. Our failure to make such payments when due could result in our loss of the Facility. Any action to
proceed against our assets would likely have a serious disruptive effect on our business operations, especially if the Facility or our other
assets were foreclosed upon.
The Credit Agreement, as amended, requires that we pay a significant amount of cash to the lender. Our ability to generate sufficient
cash to make all required payments under the Credit Agreement, as amended, depends on many factors beyond our control.
Our ability to make payments on and to refinance the Term Loan, to fund planned capital expenditures and to maintain sufficient working
capital depends on our ability to raise capital and generate cash in the future. This, to a certain extent, is subject to general economic,
financial, competitive, legislative, regulatory and other factors that are beyond our control. We cannot assure you that our business will
generate sufficient cash flow from operations or from other sources in an amount sufficient to enable us to service our debt or to fund our
other liquidity needs. To date, we have generated minimal revenue and have financed a significant portion our capital needs from sales of
our equity and most recently the Term Loan. There can be no assurance that financing options will be available to us when needed to
make payments under the Term Loan or if available, that they will be on favorable terms. If our cash flow and capital resources are
insufficient to allow us to make payments due under the Term Loan, we may need to seek additional capital or restructure or refinance all
or a portion of the Term Loan on or before the maturity thereof, any of which could have a material adverse effect on our business,
financial condition or results of operations. Although we plan to explore potential longer-term financing options for our Facility, including,
but not limited to, the sale of the Facility, we cannot assure you that we will be able to enter consummate the sale prior to the maturity date
of the Term Loan or refinance the Term Loan on commercially reasonable terms or at all. If we are unable to generate sufficient cash flow
to repay or refinance our debt on favorable terms, it could significantly adversely affect our financial condition. Our ability to restructure
or refinance the Term Loan will depend on the condition of the capital markets and our financial condition. Any refinancing of the Term
Loan could
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be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations.
There can be no assurance that we will be able to obtain any financing when needed.
Covenant restrictions in the Credit Agreement, as amended, may limit our ability to operate our business.
The Credit Agreement contains, and our future indebtedness agreements may contain covenants that restrict our ability to finance future
operations or capital needs or to engage in other business activities. The Credit Agreement, as amended, currently requires maintaining
$1,000,000 of unrestricted cash and cash equivalents and restricts our ability to:
● incur, assume or guarantee additional Debt (as defined in the Credit Agreement);
● repurchase capital stock;
● make other restricted payments including, without limitation, paying dividends and making investments;
● sell or otherwise dispose of assets.
As of the date of this filing, iBio is in compliance with this covenant in the Credit Agreement, as amended.
In order to develop certain of our product candidates we will rely upon government funding. Any government funding for our R&D
programs may impose requirements that limit our ability to take certain actions, and subject us to potential financial penalties, which
could materially and adversely affect our business, financial condition and results of operations.
We have applied for government grants to support some of our research and development activities for our product candidates. If we do
not obtain the grants we applied for or other grants, we currently do not anticipate developing certain of our product candidates. Even if we
obtain grant funding, the terms of the grant funding may be restrictive. Often government grants include provisions that reflect the
government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the
government to potentially require repayment of all or a portion of the grant award proceeds, in certain cases with interest, in the event we
violate certain covenants pertaining to various matters.
Risks Related to the Development and Commercialization of Our Technologies and Product Candidates
We currently have a limited operating history developing precision antibodies, no products approved for commercial sale, have no
significant source of revenue and may never generate significant revenue.
We are a pre-clinical-stage biopharmaceutical company that recently began to focus on leveraging the power of Artificial Intelligence (AI)
for the development of precision antibodies. Prior to August 23, 2021, when we entered into a series of agreements with RubrYc, we were
focused on our CDMO business. We have never generated any product revenue from the development of precision antibodies, do not
expect to generate revenue in the near future and do not have any products approved for sale. Our operations to date have been primarily
focused on developing our product candidates. We have not yet successfully conducted any clinical trials of any antibodies we have
developed. Consequently, predictions about our
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future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully
developing and commercializing product candidates.
All of our existing product candidates are in very early stages of development and will require extensive additional clinical evaluation,
regulatory review and approval, significant marketing efforts and substantial investment before they could provide us with any revenue.
We currently have a limited number of product candidates in early stages of pre-clinical development and are dependent on the success
of these product candidates, which requires significant clinical testing before seeking regulatory approval. If our product candidates do
not receive regulatory approval or are not successfully commercialized, our business may be harmed.
We are currently in preclinical development of multiple product candidates as potential treatments across multiple therapeutic areas;
however, we announced we are evaluating potential options to extend our cash runway and may change the focus of our resources. It is
possible that we may never be able to develop a marketable product candidate.
We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to our product candidates in the
immune-oncology field. Accordingly, our business currently depends heavily on the successful development, regulatory approval and
commercialization of these product candidates, which may not receive regulatory approval or be successfully commercialized even if
regulatory approval is received. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of product
candidates are and will remain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other
countries that each have differing regulations. We are not permitted to market any product in the United States unless and until we receive
approval from the FDA, or in any foreign countries unless and until we receive the requisite approval from regulatory authorities in such
countries. We have never submitted an NDA or BLA to the FDA or comparable applications to other regulatory authorities and do not
expect to be in a position to do so for the foreseeable future. Obtaining approval of an NDA or BLA is an extensive, lengthy, expensive, and
inherently uncertain process, and the FDA may delay, limit or deny approval of its product for many reasons.
Because we have limited financial and managerial resources, our focus is limited to the development of multiple product candidates. As a
result, we may forego or delay pursuit of opportunities with other technologies or product candidates that later prove to have greater
commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable
market opportunities. Our spending and the spending of our clients and collaborators may not yield any commercially viable products.
We have based our research and development efforts largely on our technologies and product candidates derived from such technologies.
Notwithstanding our large investment to date and anticipated future expenditures in these technologies, we have not yet developed, and
may never successfully develop, any marketed products using these technologies. As a result, we may fail to address or develop product
candidates based on other scientific approaches that may offer greater commercial potential or for which there is a greater likelihood of
success.
We also may not be successful in our efforts to identify or discover additional product candidates using our technologies. Research
programs to identify new product candidates require substantial technical, financial, and human resources. These research programs may
initially show promise in identifying potential product candidates yet fail to yield product candidates for clinical development.
We may expend our limited resources to pursue a particular technology or product candidate and fail to capitalize on technologies or
product candidates that may be more profitable or for which there is a greater likelihood of success.
Because we have limited financial and managerial resources, we focus on specific product candidates derived from or enhanced by our
technologies or that have been identified and partially developed by our clients or collaborators. As a result, we may forego or delay pursuit
of opportunities with other technologies or product candidates that later prove to have greater commercial potential. Our resource allocation
decisions may cause us to fail to capitalize on viable
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commercial products or profitable market opportunities. Our spending and the spending of our clients and collaborators may not yield any
commercially viable products.
We have based our research and development efforts largely on our technologies and product candidates derived from such technologies.
Notwithstanding our large investment to date and anticipated future expenditures in these technologies, we have not yet developed, and
may never successfully develop, any marketed products using these technologies. As a result, we may fail to address or develop product
candidates based on other scientific approaches that may offer greater commercial potential or for which there is a greater likelihood of
success.
We also may not be successful in our efforts to identify or discover additional product candidates using our technologies. Research
programs to identify new product candidates require substantial technical, financial, and human resources. These research programs may
initially show promise in identifying potential product candidates yet fail to yield product candidates for clinical development.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable
rights to that product candidate through collaboration, licensing or other royalty arrangements on terms less favorable to us than possible.
We, our clients and collaborators, are very early in our development efforts. If we or our clients and collaborators are unable to
successfully develop and commercialize product candidates or experience significant delays in doing so, our business will be materially
harmed.
All of our vaccine and therapeutic protein product candidates are still in preclinical development. Our ability to generate product sales
revenues for our own products, which we do not expect will occur for many years, will depend heavily on the successful development and
eventual commercialization of our product candidates. The success of our product candidates will depend on several factors, including the
following:
● completion of preclinical studies and clinical trials with positive results;
● receipt of marketing approvals from applicable regulatory authorities;
● obtaining and maintaining patent and trade secret protection and regulatory exclusivity, which may exceed patent exclusivity, for
our product candidates;
● making arrangements with third-party manufacturers for commercial manufacturing capabilities;
● launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;
● successfully maintaining existing collaborations and entering into new ones throughout the development process as appropriate,
from preclinical studies through to commercialization;
● acceptance of the products, if and when approved, by patients, the medical community and third-party payors;
● effectively competing with other products;
● obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for any
products we successfully develop;
● protecting our rights in our intellectual property portfolio; and
● maintaining a continued acceptable safety profile of the products following approval.
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If we or our collaborators do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or
an inability to successfully develop and commercialize our product candidates, which would materially harm our business.
We may not be successful in our efforts to use iBio technologies to build a pipeline of product candidates and develop marketable
products.
While we believe that data we and our collaborators have obtained from preclinical studies of iBio technology-derived and iBio
technology-enhanced product candidates has validated these technologies, our technologies have not yet, and may never lead to, approvable
or marketable products. Even if we are successful in further validating our technologies and continuing to build our pipeline, the potential
product candidates that we identify may not be suitable for clinical development for many possible reasons, including harmful side effects,
limited efficacy or other characteristics that indicate that such product candidates are unlikely to be products that will receive marketing
approval and achieve market acceptance. If we and our collaborators do not successfully develop and commercialize product candidates
based upon our technologies, we will not obtain product or collaboration revenues in future periods, which likely would result in significant
harm to our financial position and adversely affect our stock price.
Clinical trials are very expensive, time-consuming, and difficult to design and implement.
Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory
requirements. The clinical trial process is also time-consuming. We estimate that clinical trials for our product candidates would take at
least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to
abandon or repeat clinical trials. Commencement and completion of clinical trials may be delayed by several factors, including:
● obtaining an IND application with the FDA or foreign equivalent to commence clinical trials;
● identification of, and acceptable arrangements with, one or more clinical sites;
● obtaining IRB or EC approval to commence clinical trials;
● obtaining IBC approval for use of a genetically modified organism;
● unforeseen safety issues;
● determination of dosing;
● lack of effectiveness during clinical trials;
● slower than expected rates of patient recruitment;
● inability to monitor patients adequately during or after treatment;
● lower than expected rates of patient completion of clinical trials;
● inability to obtain supply of our drug candidate in a timely manner;
● inability or unwillingness of medical investigators to follow our clinical protocols; and
● unwillingness of the FDA or foreign equivalent, IRBs/ECs, or IBCs to permit the clinical trials to be initiated.
In addition, we, IRBs/ECs or the FDA or foreign equivalent may suspend our clinical trials at any time if it appears that we are exposing
participants to unacceptable health risks or if IRBs/ECs or the FDA or foreign equivalent finds deficiencies in our submissions or conduct
of our trials.
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Neither we nor our clients, collaborators or potential licensees will be able to commercialize product candidates based on our
technologies and services if preclinical studies do not produce successful results or clinical trials do not demonstrate safety and efficacy
in humans.
Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and has an uncertain
outcome. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and interim results
of a clinical trial do not necessarily predict final results. We and our licensees may experience numerous unforeseen events during, or as a
result of, preclinical testing and the clinical trial process that could delay or prevent the commercialization of product candidates based on
our iBio technologies, including the following:
● Preclinical or clinical trials may produce negative or inconclusive results, which may require additional preclinical testing,
additional clinical trials or the abandonment of projects that we expect to be promising. For example, promising animal data may
be obtained about the anticipated efficacy of a therapeutic protein product candidate and then human tests may not result in such
an effect. In addition, unexpected safety concerns may be encountered that would require further testing even if the therapeutic
protein product candidate produced an otherwise favorable response in human subjects.
● Initial clinical results may not be supported by further or more extensive clinical trials. For example, a licensee may obtain data
that suggest a desirable immune response from a product candidate in a small human study, but when tests are conducted on larger
numbers of people, the same extent of immune response may not occur. If the immune response generated by a product candidate
is too low or occurs in too few treated individuals, then the product candidate will have no commercial value.
● Enrollment in any clinical trials that we or our licensee’s conduct may be slower than projected, resulting in significant delays.
The cost of conducting a clinical trial increases as the time required to enroll adequate numbers of human subjects to obtain
meaningful results increases. Enrollment in a clinical trial can be a slower-than-anticipated process because of competition from
other clinical trials, because the study is not of interest to qualified subjects, or because the stringency of requirements for
enrollment limits the number of people who are eligible to participate in the clinical trial.
● We or our potential licensees might have to suspend or terminate clinical trials if the participating subjects are being exposed to
unacceptable health risks. Animal tests do not always adequately predict potential safety risks to human subjects. The risk of any
candidate product is unknown until it is tested in human subjects, and if subjects experience adverse events during the clinical
trial, the trial may have to be suspended and modified or terminated entirely.
● Regulators or institutional review boards may suspend or terminate clinical research for various reasons, including safety concerns
or noncompliance with regulatory requirements.
● Any regulatory approval ultimately obtained may be limited or subject to restrictions or post-approval commitments that render
the product not commercially viable.
● The effects of iBio technology-derived or iBio technology-enhanced product candidates may not be the desired effects or may
include undesirable side effects.
Significant clinical trial delays could allow our competitors to bring products to market before we or our licensees do and impair our ability
to commercialize our technologies and product candidates based on our technologies. Poor clinical trial results or delays may make it
impossible to license a product candidate, or reduce its attractiveness to prospective licensees, so that we will be unable to successfully
develop and commercialize such a product candidate.
Clinical trials are risky, lengthy, and expensive. We will incur substantial expense for, and devote significant time and resources to,
preclinical testing and clinical trials, yet we cannot be certain that these tests and trials will demonstrate that a product candidate is effective
and well-tolerated or will ever support its approval and commercial sale. For example,
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clinical trials require adequate supplies of clinical trial material and sufficient patient enrollment to power the trial. Delays in patient
enrollment can result in increased costs and longer development times. Even if we, or a licensee or collaborator, if applicable, successfully
complete clinical trials for our clinical product candidate, we or they might not file the required regulatory submissions in a timely manner
and may not receive marketing approval for the clinical product candidate. We cannot assure you that our clinical product candidate will
successfully progress further through the drug development process or will ultimately result in an approved and commercially viable
product.
If we, or our clients and collaborators, are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we, or
our clients and collaborators, will not be able to develop or commercialize our, or third-party, product candidates or will not be able to
do so as soon as anticipated, and our ability to generate revenue will be materially impaired.
Our product candidates and the activities associated with their development and commercialization, including their design, testing,
manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to
comprehensive regulation by the FDA and by similar regulatory authorities outside the United States. Failure to obtain marketing approval
for a product candidate will prevent us from commercializing the product candidate. We have not received approval to engage in any
clinical trials for any of our product candidates and there is no assurance that we will conduct successful clinical trials or obtain approval to
market any of our product candidates from regulatory authorities in any jurisdiction. We have only limited experience in filing and
supporting the applications necessary to gain marketing approvals and expect to rely on third parties to assist us in this process. Securing
marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities
for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the
submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory
authorities. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended
side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. If
any of our product candidates receives marketing approval, the accompanying label may limit the approved use in such a restrictive manner
that it is not possible to obtain commercial viability for such product.
The process of obtaining marketing approvals, both in the United States and abroad, is expensive and may take many years. If additional
clinical trials are required for certain jurisdictions, these trials can vary substantially based upon a variety of factors, including the type,
complexity and novelty of the product candidates involved, and may ultimately be unsuccessful. Changes in marketing approval policies
during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review process
for each submitted product application, may cause delays in the review and approval of an application. Regulatory authorities have
substantial discretion in the approval process and may refuse to accept a marketing application as deficient or may decide that our data is
insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained
from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we
ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not
commercially viable.
Although the FDA and other regulatory authorities have approved plant-based therapeutics in the past, consistent with the oversight of all
products, the FDA is monitoring whether these plant-based therapeutics pose any health and human safety risks. While they have not issued
any regulation to date that is averse to plant-based vaccines or therapeutics, it is possible that the FDA and other regulatory authorities
could issue regulations in the future that could adversely affect our product candidates.
If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our
product candidates may be harmed and our ability to generate revenues will be materially impaired.
Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data,
labeling, packaging, distribution, adverse event reporting, storage, recordkeeping, export, import, advertising and promotional activities for
such product candidate, among other things, will be subject to extensive and ongoing requirements of and review by the FDA and other
regulatory authorities. These requirements include submissions of safety,
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efficacy and other post-marketing information and reports, establishment registration and drug listing requirements, continued compliance
with current Good Manufacturing Practice, or cGMP, requirements relating to manufacturing, quality control, quality assurance and
corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping
and current GCP requirements for any clinical trials that we conduct post-approval. Even if marketing approval of a product candidate is
granted, the approval may be subject to limitations on the indicated uses for which the product candidate may be marketed or to the
conditions of approval. If our clinical product candidate receives marketing approval, the accompanying label may limit the approved use
of our product, which could limit sales.
Alternative technologies may supersede our technologies or make them noncompetitive, which would harm our ability to generate
future revenue.
The manufacture of precision antibodies and use of artificial intelligence to do so is intensely competitive. There are currently extensive
research efforts in this field, which result in rapid technological progress that can render existing technologies obsolete or economically
noncompetitive. If our competitors succeed in developing more effective technologies or render our technologies obsolete or
noncompetitive, our business will suffer. Many universities, public agencies and established pharmaceutical, biotechnology, and other life
sciences companies with substantially greater resources than we have are developing and using technologies and are actively engaging in
the development of products similar to or competitive with our technologies and products. To remain competitive, we must continue to
invest in new technologies and improve existing technologies. To make such renewing investment we will need to obtain additional
financing and/or collaborations. If we are unable to secure such financing, we will not have sufficient resources to continue such
investment. In addition, they also have significantly greater experience in the discovery and development of products, as well as in
obtaining regulatory approvals of those products in the United States and in foreign countries. Our current and potential future competitors
also have significantly more experience commercializing drugs that have been approved for marketing. Mergers and acquisitions in the
pharmaceutical and biotechnology industries could result in even more resources being concentrated among a small number of our
competitors.
Our competitors may devise methods and processes for protein expression that are faster, more efficient or less costly than that which can
be achieved using iBio technologies. There has been and continues to be substantial academic and commercial research effort devoted to
the development of such methods and processes. If successful competitive methods are developed, it may undermine the commercial basis
for iBio products and our technologies and related services.
For our cancer product candidates, not only will we compete with companies engaged in various cancer treatments including radiotherapy
and chemotherapy, but we will also compete with various companies that have developed or are trying to develop immunology vaccines for
the treatment of cancer. Certain of our competitors have substantially greater capital resources, large customer bases, broader product lines,
sales forces, greater marketing and management resources, larger research and development staffs with extensive facilities and equipment
than we do and have more established reputations as well as global distribution channels. Our most significant competitors, among others,
are fully integrated pharmaceutical companies such as Eli Lilly and Company, Bristol-Myers Squibb Company, Merck & Co., Inc.,
Novartis AG, MedImmune, LLC (a wholly owned subsidiary of AstraZeneca plc), Johnson & Johnson, Pfizer Inc., MerckKGaA and Sanofi
SA, and more established biotechnology companies such as Genentech, Inc. (a member of the Roche Group), Amgen Inc., Gilead
Sciences, Inc. and its subsidiary Kite Pharma, Inc., and competing cancer immunotherapy companies such as, Bluebird Bio, Inc., Transgene
SA, Bausch Health Companies, Lumos Pharma, Agenus Inc., Aduro Biotech, Inc., Advaxis, Inc., ImmunoCellular Therapeutics, Ltd.,
IMV Inc., Oxford BioMedica plc, Bavarian Nordic A/S, Celldex Therapeutics, Inc., as well as tech enabled drug discovery companies such
as Recursion, Abcellera Biologics, Inc., Cellarity, and BenevolentAI.
Our product candidates may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical
products, which may delay or preclude its development or regulatory approval or limit its use if ever approved.
Throughout the drug development process, we must continually demonstrate the activity, safety, and tolerability of our product candidates
in order to obtain regulatory approval to further advance our clinical development, or to eventually market it. Even if any of our product
candidates demonstrate adequate biologic activity and clear clinical benefit, any
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unacceptable side effects or adverse events, when administered alone or in the presence of other pharmaceutical products, may outweigh
these potential benefits. We may observe adverse or serious adverse events or drug-drug interactions in preclinical studies or clinical trials
of our clinical product candidate, which could result in the delay or termination of its development, prevent regulatory approval, or limit its
market acceptance if it is ultimately approved.
Adverse events caused by any of our product candidates or generally by plant-based therapeutics could cause reviewing entities, clinical
trial sites or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval. If an
unacceptable frequency or severity of adverse events are reported in any clinical trials we may conduct for our product candidates, our
ability to obtain regulatory approval for such clinical product candidate may be negatively impacted. In addition, adverse events caused by
any product candidate administered in combination with our product candidates could cause similar interruptions and delays, even though
not caused by our product candidates.
Furthermore, if any of our products are approved and then cause serious or unexpected side effects, a number of potentially significant
negative consequences could result, including:
● regulatory authorities may withdraw their approval of the clinical product candidate or impose restrictions on its distribution or
other risk management measures;
● regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
● we may be required to conduct additional clinical trials;
● we could be sued and held liable for injuries sustained by patients;
● we could elect to discontinue the sale of the clinical product candidate; and
● our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the affected clinical product candidate and could
substantially increase the costs of commercialization.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we
may develop.
We face the risk of product liability exposure in connection with the testing of our product candidates in human clinical trials and will face
an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims
that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome,
liability claims may result in:
● decreased demand for any product candidates or products that we may develop;
● injury to our reputation and significant negative media attention;
● withdrawal of clinical trial participants;
● significant costs to defend the related litigation;
● substantial monetary awards to trial participants or patients;
● loss of revenue;
● reduced resources of our management to pursue our business strategy; and
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● the inability to commercialize any products that we may develop.
Prior to commencing human clinical trials, we will seek to obtain product liability insurance coverage. Such insurance coverage is
expensive and may not be available in coverage amounts we seek or at all. If we obtain such coverage, we may in the future be unable to
maintain such coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Risks Related to Dependence on Third Parties
For our clinical product candidates, we currently rely on one third-party contract manufacturer. Any manufacturing problems
experienced by us could result in a delay or interruption in the supply of our clinical product candidate until the problem is cured or
until we locate and qualify an alternative source of manufacturing and supply.
We currently do not manufacture any of our clinical product candidates and currently rely upon one third-party manufacturer to
manufacture such product candidates. If we were to experience any prolonged disruption for our manufacturing, we could be forced to seek
additional third-party manufacturing contracts, thereby increasing our development costs and negatively impacting our timelines and any
commercialization costs. Although we believe there are other manufacturers that could manufacture our product candidates, they may not
do so on favorable term. In addition, if we change manufacturers at any point once we commence clinical trials or after approval of a
product candidate, we will be required to demonstrate comparability between the product manufactured by the old manufacturer and the
product manufactured by the new manufacturer. If we are unable to do so we may need to conduct additional clinical trials with product
manufactured by the new manufacturer.
If we or any outsourced manufacturer of our products are not able to manufacture sufficient quantities of our clinical product candidate, our
development activities would be impaired. In addition, any manufacturing facility where any of our clinical product candidates are
manufactured will be subject to ongoing, periodic inspection by the FDA or other comparable regulatory agencies to ensure compliance
with current Good Manufacturing Practice, or cGMP. Any failure to follow and document the manufacturer’s adherence to such cGMP
regulations or other regulatory requirements may lead to significant delays in the availability of clinical bulk drug substance and finished
product for clinical trials, which may result in the termination of or a hold on a clinical trial, or may delay or prevent filing or approval of
marketing applications for our clinical product candidate. We also may encounter problems with the following:
● achieving adequate or clinical-grade materials that meet FDA or other comparable regulatory agency standards or specifications
with consistent and acceptable production yield and costs;
● failing to develop an acceptable formulation to support late-stage clinical trials for, or the commercialization of, our clinical
product candidate;
● being unable to increase the scale of or the capacity for, or reformulate the form of our clinical product candidate, which may
cause us to experience a shortage in supply or cause the cost to manufacture our clinical product candidate to increase;
● we cannot assure you that we will be able to manufacture our clinical product candidate at a suitable commercial scale, or that we
will be able to find alternative manufacturers acceptable to us that can do so;
● our facility closing as a result of regulatory sanctions, pandemic or a natural disaster;
● shortages of qualified personnel, raw materials or key contractors;
● failing to obtain FDA approval for commercial scale manufacturing; and
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● ongoing compliance with cGMP regulations and other requirements of the FDA or other comparable regulatory agencies.
If we encounter any of these problems or are otherwise delayed, or if the cost of manufacturing is not economically feasible or we cannot
find another third-party manufacturer, we may not be able to produce our clinical product candidate in a sufficient quantity to meet future
demand.
These risks are likely to be exacerbated by our limited experience with our current products and manufacturing processes. If demand for
our products materializes, we may have to invest additional resources to purchase materials, hire and train employees, and enhance our
manufacturing processes or those of third-party manufacturers. It may not be possible for us to manufacture our clinical product candidate
at a cost or in quantities sufficient to make its clinical product candidate commercially viable. Any of these factors may affect our ability to
manufacture our products and could reduce gross margins and profitability.
Reliance on third-party manufacturers and suppliers entails risks to which we would not be subject if we manufacture our clinical product
candidate ourselves, including:
● reliance on the third parties for regulatory compliance and quality assurance;
● the possible breach of the manufacturing agreements by the third parties because of factors beyond our control or the insolvency
of any of these third parties or other financial difficulties, labor unrest, natural disasters or other factors adversely affecting their
ability to conduct their business; and
● possibility of termination or non-renewal of the agreements by the third parties, at a time that is costly or inconvenient for us,
because of our breach of the manufacturing agreement or based on their own business priorities.
If we rely on a third-party contract manufacturer or its suppliers fail to deliver the required commercial quantities of our clinical product
candidate required for our clinical trials and, if approved, for commercial sale, on a timely basis and at commercially reasonable prices, and
we are unable to find one or more replacement manufacturers or suppliers capable of production at a substantially equivalent cost, in
substantially equivalent volumes and quality, and on a timely basis, we would likely be unable to meet demand for our products and would
have to delay or terminate our pre-clinical or clinical trials, and we would lose potential revenue. It may also take significant time to
establish an alternative source of supply for our clinical product candidate and to have any such new source approved by the FDA or any
applicable foreign regulatory authorities. Furthermore, any of the above factors could cause the delay or suspension of initiation or
completion of clinical trials, regulatory submissions or required approvals of our clinical product candidate, cause it to incur higher costs
and could prevent us from commercializing our clinical product candidate successfully.
If we are unable to establish new collaborations and maintain both new and existing collaborations, or if these collaborations are not
successful, our business could be adversely affected.
Our current business plan contemplates that we will in the future derive revenues or payments from collaborators and licensees that
successfully utilize iBio technologies in connection with the production, development and commercialization of vaccines and therapeutic
protein product candidates. Our realization of these revenues and payments including dependence on existing collaborations, and any future
collaborations we enter into, is subject to a number of risks, including the following:
● collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations;
● collaborators may not perform their obligations as expected;
● collaborators may not pursue development and, if successful, commercialization of product candidates or may elect not to
continue or renew development or commercialization programs based on clinical trial results, changes
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in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, which divert resources or
create competing priorities;
● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a
product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our
products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed
or can be commercialized under terms that are more economically attractive than ours, which may cause collaborators to cease to
devote resources to the commercialization of our product candidates;
● collaborators with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval
may not commit sufficient resources to the marketing and distribution of such product or products; or commercialization of
product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation
or arbitration, any of which would be time-consuming and expensive;
● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such
a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to
potential litigation;
● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
● collaborations may be terminated for the convenience of the collaborator and, if terminated, we would potentially lose the right to
pursue further development or commercialization of the applicable product candidates;
● collaborators may learn about our technology and use this knowledge to compete with us in the future;
● results of collaborators’ preclinical or clinical studies could produce results that harm or impair other products using our
technology;
● there may be conflicts between different collaborators that could negatively affect those collaborations and others; and
● the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers.
If our collaborations do not result in the successful development and commercialization of products or if one or more of our collaborators
terminates its agreement with us, we may not receive any future research and development funding or milestone or royalty payments under
the collaboration. If we do not receive the funding we expect under these agreements, our continued development of our product candidates
could be delayed, and we may need additional resources to develop additional product candidates. There can be no assurance that our
collaborations will produce positive results or successful products on a timely basis or at all.
We seek to establish and collaborate with additional pharmaceutical and biotechnology companies for development and potential
commercialization of iBio technology-produced and iBio technology-enhanced product candidates. We face significant competition in
seeking appropriate collaborators. Our ability to reach a definitive agreement for a collaboration depends, among other things, upon our
assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed
collaborator’s evaluation of several factors. If we fail to reach agreements
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with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate,
reduce or delay its development or the development of one or more of our other product candidates, or increase our expenditures and
undertake additional development or commercialization activities at our own expense. If we elect to fund and undertake development or
commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to
us on acceptable terms or at all.
If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and
commercialization activities, we may not be able to further develop our product candidates or bring them to market or continue to develop
our product portfolio and our business may be materially and adversely affected.
If third parties on whom we or our licensees will rely for the conduct of preclinical studies and clinical trials do not perform as
contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our product candidates
and our business may suffer.
We have limited resources dedicated to designing, conducting, and managing our preclinical studies and clinical trials. We do not have the
ability to independently conduct the preclinical studies and clinical trials required to obtain regulatory approval for our product candidates.
We have not yet contracted with any third parties to conduct clinical trials of product candidates we develop independently of collaborators.
We will depend on licensees or on independent clinical investigators, contract research organizations and other third-party service providers
to conduct the clinical trials of our product candidates. We will rely on these vendors and individuals to perform many facets of the clinical
development process on our behalf, including conducting preclinical studies and will rely on them for the recruitment of sites and subjects
for participation in our clinical trials, maintenance of good relations with the clinical sites, and ensuring that these sites are conducting our
trials in compliance with the trial protocol and applicable regulations.
We will rely heavily on these parties for successful execution of our clinical trials but will not control many aspects of their activities. For
example, the investigators participating in our clinical trials will not be our employees. However, we will be responsible for ensuring that
each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Third parties may not
complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or our stated protocols.
The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of
our product candidates. If these third parties fail to perform satisfactorily, or do not adequately fulfill their obligations under the terms of
our agreements with them, we may not be able to enter into alternative arrangements without undue delay or additional expenditures, and
therefore the preclinical studies and clinical trials of our clinical product candidate may be delayed or prove unsuccessful.
Further, the FDA, the EMA, or similar regulatory authorities in other countries, may inspect some of the clinical sites participating in our
clinical trials or our third-party vendors’ sites to determine if our clinical trials are being conducted according to good clinical practices, or
GCPs, or similar regulations. If we or a regulatory authority determine that our third-party vendors are not in compliance with or have not
conducted our clinical trials according to applicable regulations, we may be forced to exclude certain data from the results of the trial, or
delay, repeat or terminate such clinical trials.
We rely on third parties to supply the raw materials needed to operate our research and development activities and do not have any
long-term commitments from such suppliers.
We currently rely on third parties for the raw materials needed to operate our research and development activities. We do not have any
long-term commitments from any raw material suppliers and therefore cannot guarantee that there will be adequate supply of our raw
materials. Natural disasters or other disruptions at any of our suppliers’ facilities may impair or delay the delivery of our products.
Influenza or other pandemics, such as the coronavirus, could disrupt production of our products, reduce demand for certain of our products,
or disrupt the marketplace in the food service or retail environment with consequent material adverse effects on our results of operations.
To the extent we are unable to, or cannot, financially mitigate the likelihood or potential impact of such events, or effectively manage such
events if they occur, particularly when a product is sourced from a single location, there could be a material adverse effect on our business
and results of operations, and additional resources could be required to restore our supply chain. Although we believe we have sufficient
supply of our other raw materials at this time, due to supply chain shortages, we may not be able to obtain such materials
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in the future is our current suppliers should be unable to satisfy our needs. Such suppliers may not be able to provide us with engines in a
timely manner due to supply chain shortages and even if other suppliers are able to fulfill our needs they may not be able to do so at the
same price as we currently pay for such materials, which could result in lower profit margins or us increasing the price of our services in
order to maintain profit margins which could adversely impact demand for our services.
Any claims beyond our insurance coverage limits, or that are otherwise not covered by our insurance, may result in substantial costs
and a reduction in our available capital resources.
We maintain property insurance, employer’s liability insurance, product liability insurance, general liability insurance, business interruption
insurance, and directors’ and officers’ liability insurance, among others. Although we maintain what we believe to be adequate insurance
coverage, potential claims may exceed the amount of insurance coverage or may be excluded under the terms of the policy, which could
cause an adverse effect on our business, financial condition and results from operations. Generally, we would be at risk for the loss of
inventory that is not within customer specifications. These amounts could be significant. In addition, in the future we may not be able to
obtain adequate insurance coverage, or we may be required to pay higher premiums and accept higher deductibles in order to secure
adequate insurance coverage.
We may be subject to various litigation claims and legal proceedings.
We, as well as certain of our directors and officers, may be subject to claims or lawsuits during the ordinary course of business. Regardless
of the outcome, these lawsuits may result in significant legal fees and expenses and could divert management’s time and other resources. If
the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages and be required to alter or cease
certain of our business practices. Any of these outcomes could cause our business, financial performance and cash position to be negatively
impacted.
Risks Related to Intellectual Property
If we or our licensors are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent
protection obtained is not sufficiently broad, competitors could develop and commercialize technology and products similar or identical
to ours, and our ability to successfully commercialize our technology and products may be impaired.
Our success depends in part on our ability to obtain and maintain patent and other intellectual property protection in the United States and
other countries with respect to our proprietary technology and products. We seek to protect our proprietary position by filing patent
applications in the United States and abroad related to our novel technologies and product candidates, and by maintenance of our trade
secrets through proper procedures.
The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable
patent applications at a reasonable cost, in a timely manner, or in all jurisdictions. It is also possible that we will fail to identify patentable
aspects of our research and development output before it is too late to obtain patent protection.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual
questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to
the same extent as the laws of the United States and we may fail to seek or obtain patent protection in all major markets. For example,
European patent law restricts the patentability of methods of treatment of the human body more than United States law does. Publications
of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other
jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty
whether we were the first to make the inventions claimed in our owned patents or pending patent applications, or that we were the first to
file for patent protection of such inventions, nor can we know whether those from whom we license patents were the first to make the
inventions claimed or were the first to file. As a result, the issuance, scope, validity, enforceability and commercial value of our patent
rights are highly uncertain. Our pending and future patent applications may not result in patents being issued
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which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive
technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries
may diminish the value of our patents or narrow the scope of our patent protection.
Moreover, we may be subject to a third-party pre-issuance submission of prior art to the U.S. PTO, or become involved in opposition,
derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent
rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our
patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result
in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength
of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to
license, develop or commercialize current or future product candidates.
Even if our pending or future patent applications issue as patents, they may not issue in a form that will provide us with any meaningful
protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be
able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the
courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent
claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or
commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such
candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us
with sufficient rights to exclude others from commercializing products similar or identical to ours.
We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-
consuming and ultimately unsuccessful.
Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our product
candidates and use our proprietary technologies without infringing the proprietary rights of third parties. There is considerable intellectual
property litigation in the biotechnology and pharmaceutical industries. Competitors may infringe our issued patents or other intellectual
property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-
consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that
we infringe their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or
unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue
on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or
more of our patents at risk of being invalidated or interpreted narrowly, which could adversely affect us and our collaborators.
While no such litigation has been brought against us and we have not been held by any court to have infringed a third party’s intellectual
property rights, we cannot guarantee that our technology, products or use of our products do not infringe third-party patents. It is also
possible that we have failed to identify relevant third-party patents or applications. For example, applications filed before November 29,
2000, and certain applications filed after that date that will not be filed outside the United States remain confidential until patents issue.
Patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing date, which is
referred to as the priority date. Therefore, patent applications covering our products or technology could have been filed by others without
our knowledge. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended
in a manner that could cover our technologies, our products or the use of our products.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect
to our products and technology, including interference or derivation proceedings before the U.S. PTO
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and similar bodies in other countries. Third parties may assert infringement claims against us based on existing intellectual property rights
and intellectual property rights that may be granted in the future.
If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to
continue developing and marketing our products and technology. However, we may not be able to obtain any required license on
commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors
access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing
technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are
found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates or
force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the
confidential information or trade secrets of third parties could have a similar negative impact on our business.
In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to
continue our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development
partnerships that would help us bring our product candidates to market. Furthermore, because of the substantial amount of discovery
required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised
by disclosure during this type of litigation.
In spite of our efforts, our licensors might allege that we have materially breached our obligations under such license agreements and might
therefore attempt to terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and
technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended
exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and to market, products identical to
ours and we may be required to cease our development and commercialization of our lead products or other product candidates that we may
identify. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of
operations, and prospects.
Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including:
● the scope of rights granted under the license agreement and other interpretation-related issues;
● the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not
subject to the licensing agreement;
● the sublicensing of patent and other rights under our collaborative development relationships;
● our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our
licensors and us and our partners; and
● the priority of invention of patented technology.
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In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain
provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement
that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase
what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect
on our business, financial condition, results of operations, and prospects. Moreover, if disputes over intellectual property that we have
licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable
to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business,
financial conditions, results of operations, and prospects.
Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it
affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to
competition from competitive products, including generics or biosimilars. Given the amount of time required for the development, testing
and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates
are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from
commercializing products similar or identical to ours.
If we are unable to protect our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for some of our technology and product candidates, we also rely on trade secrets, including unpatented know-
how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by
entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate
collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also seek to enter
into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these
parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain
adequate remedies for such breaches. Our trade secrets may also be obtained by third parties by other means, such as breaches of our
physical or computer security systems. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult,
expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less
willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a
competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to
compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position
would be harmed.
We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.
Many of our employees, including our senior management, were previously employed at other biotechnology or pharmaceutical
companies. These employees typically executed proprietary rights, non-disclosure and non-competition agreements in connection with their
previous employers. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their
work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including trade secrets or
other proprietary information, of any such employee’s former employer. We or our licensors may be subject to claims that former
employees, collaborators or other third parties have an interest in our owned or in-licensed patents, trade secrets, or other intellectual
property as an inventor or co-inventor. For example, we or our licensors may have inventorship disputes arise from conflicting obligations
of employees, consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against
these and other claims challenging inventorship or our or our licensors’ ownership of our owned or in-licensed patents, trade secrets or
other intellectual property. If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose
valuable intellectual property rights, such as exclusive ownership of,
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or right to use, intellectual property that is important to our product candidates. Even if we are successful in defending against such claims,
litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could have a
material adverse effect on our business, financial condition, results of operations and prospects. In addition, while we require our
employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning
such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or
develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the
assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring
against us, to determine the ownership of what we regard as our intellectual property.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations
and may not adequately protect our business or permit us to maintain our competitive advantage. The following examples are illustrative:
● others may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents
that we license;
● our licensors or collaborators might not have been the first to make the inventions covered by an issued patent or pending patent
application;
● our licensors or collaborators might not have been the first to file patent applications covering an invention;
● others may independently develop similar or alternative technologies or duplicate any of our or our licensors’ technologies
without infringing our intellectual property rights;
● pending patent applications may not lead to issued patents;
● issued patents may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal
challenges by our competitors;
● our competitors might conduct research and development activities in countries where we do not have patent rights and then use
the information learned from such activities to develop competitive products for sale in our major commercial markets;
● we may not develop or in-license additional proprietary technologies that are patentable;
● the patents of others may have an adverse effect on our business; and
● we may choose not to file a patent application for certain trade secrets or know-how, and a third party may subsequently obtain a
patent covering such intellectual property.
Should any of these events occur, they could significantly harm our business, results of operations and prospects.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive,
and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In
addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the
United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United
States, or from selling or importing products made
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using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we
have not obtained patent protection to develop their own products and may also export infringing products to territories where we have
patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our
patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have
encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of
certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual
property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of
our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in
foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of
our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and
could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other
remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around
the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
If we should fail to comply with various patent laws our patent protection could be reduced or eliminated.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be
paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents
and/or applications. We have systems in place to remind us to pay these fees, and we employ an outside firm and rely on our outside
counsel to pay these fees due to non-U.S. patent agencies. The USPTO and various non-U.S. governmental patent agencies require
compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We
employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of
a late fee or by other means in accordance with the applicable rules. However, there are situations in which non-compliance can result in
abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In
such an event, our competitors might be able to enter the market and this circumstance would have a material adverse effect on our
business.
Changes in patent law, including recent patent reform legislation, could increase the uncertainties and costs surrounding the
prosecution of our patent applications and the enforcement or defense of our issued patents.
Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs
surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Assuming that other requirements for
patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while
outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America
Invents Act, or the America Invents Act, enacted in September 2011, the United States transitioned to a first inventor to file system in
which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent
on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application
in the USPTO after March 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the
invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent
application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until
issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our product
candidates or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications. In addition, the patent
positions of companies in the development and commercialization of pharmaceuticals are particularly uncertain. Recent U.S. Supreme
Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in
certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once
obtained. Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents
could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and
enforce our intellectual property in the future.
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Risks Related to iBio’s Operations
We recently identified and remediated material weaknesses in our internal controls, and we cannot provide assurances additional
material weaknesses will not occur in the future.
Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate
disclosure controls and procedures, is designed to prevent fraud. During the preparation of the Quarterly Report for the quarter ended
March 31, 2023, we identified a material weakness in our controls relating to accounting for stock-based compensation expense relating to
the vesting of severed employees’ awards. If our internal control over financial reporting or our disclosure controls and procedures are not
effective, we may not be able to accurately report our financial results, prevent fraud, or file our periodic reports in a timely manner, which
may cause investors to lose confidence in our reported financial information and may lead to a decline in our stock price. In addition, a
material weakness will not be considered remediated until the applicable controls operate for a sufficient period of time and management
has concluded, through testing, that these controls are designed and operating effectively. As of June 30, 2023, management believes that
significant progress has been made in enhancing internal controls and has concluded that the enhanced controls are operating effectively.
Therefore, as of June 30, 2023, the material weakness described in Item 4 Controls and Procedures in our Quarterly Report on Form 10-Q
for quarter ended March 31, 2023 has been fully remediated. Although the material weakness has been remediated, there can be no
assurance that the internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the
future.
Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to
meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection with Section 404 of the
Sarbanes-Oxley Act, or Section 404, or any subsequent testing by our independent registered public accounting firm, as and when required,
may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require
prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. As a growing
company, implementing and maintaining effective controls may require more resources, and we may encounter internal control integration
difficulties. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have
a negative effect on the trading price of our common stock.
We have experienced turnover in our senior management team, and the loss of one or more of our executive officers or key employees
or an inability to attract and retain highly skilled employees could adversely affect our business.
Our success depends largely upon the continued services of our key executive officers. We have in the past and may in the future
experience changes in our executive management team resulting from the departure of executives, which may be disruptive to our business.
To continue to develop our pipeline and execute our strategy, we also must attract and retain highly skilled personnel in our industry.
A failure by iBio to hire and retain an appropriately skilled and adequate workforce could adversely impact the ability to operate and
function efficiently.
iBio’s operations will depend, in part, on our ability to attract and retain an appropriately skilled and sufficient workforce to operate our
R&D facility. These employees may voluntarily terminate their employment with us at any time. The R&D facility is located in San Diego,
California, a growing biotechnology hub and competition for skilled workers will continue to increase as the industry undergoes further
growth in the area. There can be no assurance that we will be able to retain key personnel, or to attract and retain additional qualified
employees especially in light of our cash position. Our inability to attract and retain key personnel as we grow in two locations may have a
material adverse effect on our business.
Use of our laboratory space in San Diego is critical to our success. A natural disaster or other disruptions at our laboratory would
adversely affect our business, financial condition, and results of operations.
We currently conduct all of our pre-clinical research at our laboratory in San Diego using specialized equipment that we have purchased.
Any natural disaster or other serious disruption to our facility due to fire, flood, earthquake, or any other unforeseen circumstance would
adversely affect our business, financial condition, and results of operations. Although we
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do believe that we could find alternative space in the case of a natural disaster, there can be no assurance that we will find suitable space
near the location of our employees or that our equipment will survive a natural disaster. The occurrence of any disruption at our laboratory,
even for a short period of time, may have an adverse effect on our research and development operations, during and after the period of the
disruption. Although we maintain property, casualty, and business interruption insurance of the types and in the amounts that we believe are
customary for the industry, we are not fully insured against all potential natural disasters or other disruptions to our laboratory.
We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
We intend to grow our business operations as demand increases and increase the number of our employees to accommodate such potential
growth, which may cause us to experience periods of rapid growth and expansion. This potential future growth could create a strain on our
organizational, administrative and operational infrastructure, including manufacturing operations, quality control, technical support and
other administrative functions. Our ability to manage our growth properly will require us to continue to improve our operational, financial
and management controls.
As our commercial operations and sales volume grow, we will need to continue to increase our capacity for manufacturing, customer
service, billing and general process improvements and expand our internal quality assurance program, among other things. We may also
need to purchase additional equipment, some of which can take several months or more to procure, set up and validate, and increase our
manufacturing, maintenance, software and computing capacity to meet increased demand. These increases in scale, expansion of personnel,
purchase of equipment or process enhancements may not be successfully implemented.
If we are unable to protect the confidentiality of our partners’ or collaborators’ proprietary information, we may be subject to claims.
The research and development processes developed by us or our partners’ or collaborators’ products are subject to trade secret protection,
patents or other intellectual property protections owned or licensed by such partners. While we make significant efforts to protect our
partners’ proprietary and confidential information, including requiring our employees to enter into agreements protecting such information,
if any of our employees breaches the non-disclosure provisions in such agreements, or if our partners make claims that their proprietary
information has been disclosed, our reputation may suffer damage and we may become subject to legal proceedings that could require us to
incur significant expenses and divert our management’s time, attention and resources.
If we acquire companies, products or technologies, we may face integration risks and costs associated with those acquisitions that could
negatively impact our business, results from operations and financial condition.
If we are presented with appropriate opportunities, we may acquire or make investments in complementary companies, products or
technologies. We may not realize the anticipated benefit of any acquisition or investment. If we acquire companies or technologies, we will
face risks, uncertainties and disruptions associated with the integration process, including difficulties in the integration of the operations of
an acquired company, integration of acquired technology with our products, diversion of our management’s attention from other business
concerns, the potential loss of key employees or customers of the acquired business, and impairment charges if future acquisitions are not
as successful as we originally anticipate. In addition, our operating results may suffer because of acquisition-related costs or amortization
expenses or charges relating to acquired intangible assets. Any failure to successfully integrate other companies, products, or technologies
that we may acquire may have a material adverse effect on our business and results of operations. Furthermore, we may have to incur debt
or issue equity securities to pay for any additional future acquisitions or investments, the issuance of which could be dilutive to our existing
stockholders.
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Risks Related to Our Common Stock
Our stockholders will experience substantial dilution from the issuance of the development milestone payments if paid in equity and
may not realize a benefit from the acquisition of substantially all of the assets RubrYc commensurate with the ownership dilution they
will experience in connection therewith.
We have the option to pay the contingent development milestone consideration owed to the RubrYc shareholders in shares of our common
stock. Our stockholders will experience substantial dilution from the issuance of shares of common stock to pay the contingent
development milestone consideration, should we elect to pay such development milestones in shares of common stock in lieu of cash.
iBio is subject to compliance under the NYSE American continued listing standards of the NYSE American Company Guide, the failure
of which can result in delisting from the NYSE American.
In order to maintain its listing with NYSE American, we must remain in compliance with the continued listing standards as set forth in the
NYSE American Company Guide (the “Company Guide”), including the listing standard set forth in Section 1003 of the Guide, which
applies if a listed company has stockholders’ equity below certain threshold amounts and has sustained losses from continuing operations
and/or net losses in its five most recent fiscal years. In the past, we have received notification of noncompliance with the continued listing
requirements, which to date have been remediated
There can be no assurance that we will continue to meet all of the Exchange’s continued listing standards, or exemptions therefrom, in the
future.
Provisions in our certificate of incorporation, bylaws and under Delaware law could discourage a takeover that stockholders may
consider favorable.
Provisions of our certificate of incorporation, bylaws and provisions of applicable Delaware law may discourage, delay or prevent a merger
or other change in control that a stockholder may consider favorable. Pursuant to our certificate of incorporation, our Board of Directors
may issue additional shares of common stock or preferred stock. Any additional issuance of common stock could have the effect of
impeding or discouraging the acquisition of control of us by means of a merger, tender offer, proxy contest or otherwise, including a
transaction in which our stockholders would receive a premium over the market price for their shares, and thereby protect the continuity of
our management. Specifically, if in the due exercise of its fiduciary obligations, the Board of Directors were to determine that a takeover
proposal was not in our best interest, shares could be issued by our Board of Directors without stockholder approval in one or more
transactions that might prevent or render more difficult or costly the completion of the takeover by:
● diluting the voting or other rights of the proposed acquirer or insurgent stockholder group,
● putting a substantial voting bloc in institutional or other hands that might undertake to support the incumbent Board of Directors,
or
● effecting an acquisition that might complicate or preclude the takeover.
Our certificate of incorporation also allows our Board of Directors to fix the number of directors in the by-laws. Our certificate of
incorporation does not contemplate cumulative voting in the election of directors and thus, under Delaware law, cumulative voting in the
election of directors is not permitted. Our Board of Directors is divided into three classes, each of which serves for a staggered term of
three years. This division of our Board of Directors could have the effect of impeding an attempt to take over our company or change or
remove management, since only one class will be elected annually. Thus, only approximately one-third of the existing Board of Directors
could be replaced at any election of directors.
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The effect of these provisions may be to delay or prevent a tender offer or takeover attempt that a stockholder may determine to be in his,
her or its best interest, including attempts that might result in a premium over the market price for the shares held by the stockholders.
Our Second Amended and Restated Bylaws provides that the Court of Chancery of the State of Delaware is the exclusive forum for
certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for
disputes with us or our directors, officers or employees.
Our Second Amended and Restated Bylaws provides that the Court of Chancery of the State of Delaware shall be the sole and exclusive
forum for any derivative action or proceeding brought on behalf of the Company, any action asserting a claim of breach of a fiduciary duty
owed by any director, officer or other employee of the Company to the Company or the Company’s stockholders, any action asserting a
claim arising pursuant to any provision of the Delaware General Corporation Law or any action asserting a claim governed by the internal
affairs doctrine. The federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and
exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended and the
forum selection provision does not apply to claims arising exclusively under the Exchange Act or the Investment Company Act, or any
other claim for which the federal courts have exclusive jurisdiction.
This forum selection provision may limit a stockholder’s ability to bring certain claims in a judicial forum that it finds favorable for
disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such
claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and
regulations thereunder. If a court were to find this forum selection provision to be inapplicable or unenforceable in an action, we may incur
additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business and financial
condition.
The issuance of preferred stock could adversely affect the rights of the holders of shares of our common stock.
Our Board of Directors is authorized to issue up to 1,000,000 shares of preferred stock without any further action on the part of our
stockholders. Our Board of Directors has the authority to fix and determine the voting rights, rights of redemption and other rights and
preferences of preferred stock. Our Board of Directors may, at any time, designate a new series of preferred stock that would grant to
holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the
holders of common stock, and the right to the redemption of the shares, together with a premium, before the redemption of our common
stock and authorize the issuance of such series of preferred stock, which may have a material adverse effect on the rights of the holders of
our common stock. In addition, our Board of Directors, without further stockholder approval, may, at any time, issue large blocks of
preferred stock. In addition, the ability of our Board of Directors to designate and issue shares of preferred stock without any further action
on the part of our stockholders may impede a takeover of our company and may prevent a transaction that is favorable to our stockholders.
We do not anticipate paying cash dividends for the foreseeable future, and therefore investors should not buy our stock if they wish to
receive cash dividends.
We have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings to
support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the
foreseeable future.
Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other
factors beyond our control may adversely impact our business and operating results.
The uncertain financial markets, disruptions in supply chains, mobility restraints, and changing priorities as well as volatile asset values
could impact our business in the future. We and our third-party contract manufacturers, contract research organizations, and any clinical
sites that may conduct our clinical trials in the future may also face disruptions in procuring items that are essential to our research and
development activities, including, for example, medical and laboratory supplies used in our clinical trials or preclinical studies, in each
case, that are sourced from abroad or for
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which there are shortages because of ongoing efforts to address the outbreak. These minor disruptions have had an immaterial effect on
business, which we have been able to address with minimal impact to our business operations to date. Further, although we have not
experienced any material adverse effects on our business due to increasing inflation, it has raised operating costs for many businesses
and, in the future, could impact demand or pricing manufacturing of our drug candidates or services providers, foreign exchange rates or
employee wages. We are actively monitoring the effects these disruptions and increasing inflation could have on our operations.
Our operations and performance depend on global, regional and U.S. economic and geopolitical conditions. Russia’s invasion and
military attacks on Ukraine have triggered significant sanctions from U.S. and European leaders. Resulting changes in U.S. trade policy
could trigger retaliatory actions by Russia, its allies and other affected countries, including China, resulting in a “trade war.”
The above factors, including a number of other economic and geopolitical factors both in the U.S. and abroad, could ultimately
have material adverse effects on our business, financial condition, results of operations or cash flows, including the following:
● effects of significant changes in economic, monetary and fiscal policies in the U.S. and abroad including currency fluctuations,
inflationary pressures and significant income tax changes;
● supply chain disruptions;
● a global or regional economic slowdown in any of our market segments;
● changes in government policies and regulations affecting the Company or its significant customers;
● industrial policies in various countries that favor domestic industries over multinationals or that restrict foreign companies
altogether;
● new or stricter trade policies and tariffs enacted by countries, such as China, in response to changes in U.S. trade policies and
tariffs;
● postponement of spending, in response to tighter credit, financial market volatility and other factors;
● rapid material escalation of the cost of regulatory compliance and litigation;
● difficulties protecting intellectual property;
● longer payment cycles;
● credit risks and other challenges in collecting accounts receivable; and
● the impact of each of the foregoing on outsourcing and procurement arrangements.
We rely extensively on our information technology systems and are vulnerable to damage and interruption
We rely on our information technology systems and infrastructure to process transactions, summarize results and manage our business,
including maintaining client and supplier information. Additionally, we utilize third parties, including cloud providers, to store, transfer and
process data. Our information technology systems, as well as the systems of our suppliers and other partners, whose systems we do not
control, are vulnerable to outages and an increasing risk of continually evolving deliberate intrusions to gain access to company sensitive
information. Likewise, data security incidents and breaches by employees and others with or without permitted access to our systems pose
a risk that sensitive data may be exposed to unauthorized persons or to the public. A cyber-attack or other significant disruption involving
our information technology systems, or those of our vendors, suppliers and other partners, could also result in disruptions in critical
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systems, corruption or loss of data and theft of data, funds or intellectual property. A security breach of any kind, including physical or
electronic break-ins, computer viruses and attacks by hackers, employees or others, could expose us to risks of data loss, litigation,
government enforcement actions, regulatory penalties and costly response measures, and could seriously disrupt our operations. We may be
unable to prevent outages or security breaches in our systems. We remain potentially vulnerable to additional known or yet unknown
threats as, in some instances, we, our suppliers and our other partners may be unaware of an incident or its magnitude and effects. We also
face the risk that we expose our vendors or partners to cybersecurity attacks. Any or all of the foregoing could harm our reputation and
adversely affect our results of operations and our business reputation.
Holders of our warrants issued in our offerings have no rights as common stockholders until they exercise their warrants and acquire
our common stock.
Until the holders of the warrants we issued in our offerings acquire shares of our common stock by exercising their warrants, the holders of
the warrants have no rights as a stockholder with respect to the shares of common stock underlying their securities. Upon exercise of the
warrants they will be entitled to the rights of a common stockholder only as to matters for which the record date occurs after the exercise
date.
Whether the outstanding warrants will have any value will depend on the market conditions for, and the price of, our common stock, which
conditions will depend on factors related and unrelated to the success of our clinical development program, and cannot be predicted at this
time. If our common stock price does not increase to an amount sufficiently above the exercise price of the warrants during the periods the
warrants are exercisable, holders of warrants will be unable to recover any of their investment in the warrants.
Because there is no established public trading market for any of our warrants we issued, the liquidity of each such security is limited. We
do not expect a market to develop, nor do we intend to apply to list the warrants on any securities exchange. Upon exercise of the warrants,
our stockholders will experience dilution.
The market price of our common stock has been and may continue to be volatile and adversely affected by various factors.
Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future. By way of example, on September
11, 2023, the price of our common stock closed at $0.28 per share while on April 19, 2023, our stock price closed at $1.30 per share. We
may incur rapid and substantial decreases in our stock price in the foreseeable future that are unrelated to our operating performance or
prospects. The stock market in general and the market for biotechnology and pharmaceutical companies in particular have experienced
extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors
may experience losses on their investment in our common stock. The market price of our common stock could fluctuate significantly in
response to various factors and events, including:
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investor reaction to our business strategy;
the success of competitive products or technologies;
our continued compliance with the listing standards of the NYSE American;
results of our preclinical and clinical trials;
actions taken by regulatory agencies with respect to our products, clinical studies, manufacturing process or sales and
marketing terms;
variations in our financial results or those of companies that are perceived to be similar to us;
developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our
ability to obtain patent protection for our products;
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our ability or inability to raise additional capital and the terms on which we raise it;
declines in the market prices of stocks generally;
trading volume of our common stock;
sales of our common stock by us or our stockholders;
announcements of licensing or other business development initiatives;
general economic, industry and market conditions; and
other events or factors, including those resulting from such events, or the prospect of such events, including war,
terrorism and other international conflicts, public health issues including health epidemics or pandemics, and natural
disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate conditions, whether
occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations of our suppliers or result
in political or economic instability.
These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating
performance. Since the stock price of our common stock has fluctuated in the past, has been recently volatile and may be volatile in the
future, investors in our common stock could incur substantial losses. In the past, following periods of volatility in the market, securities
class-action litigation has often been instituted against companies. Such litigation, if instituted against us, could result in substantial costs
and diversion of management’s attention and resources, which could materially and adversely affect our business, financial condition,
results of operations and growth prospects. There can be no guarantee that our stock price will remain at current prices or that future sales
of our common stock will not be at prices lower than those sold to investors.
Reports published by securities or industry analysts, including projections in those reports that exceed our actual results, could
adversely affect our common stock price and trading volume.
Securities research analysts, including those affiliated with our underwriters from prior offerings, establish and publish their own periodic
projections for our business. These projections may vary widely from one another and may not accurately predict the results we actually
achieve. Our stock price may decline if our actual results do not match securities research analysts’ projections. Similarly, if one or more of
the analysts who writes reports on us downgrades our stock or publishes inaccurate or unfavorable research about our business or if one or
more of these analysts ceases coverage of our company or fails to publish reports on us regularly, our stock price or trading volume could
decline. While we expect securities research analyst coverage to continue going forward, if no securities or industry analysts begin to cover
us, the trading price for our stock and the trading volume could be adversely affected.
We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make
our common stock less attractive to investors.
We are a "smaller reporting company" as defined in Rule 12b-2 promulgated under the Exchange Act. We may remain a smaller reporting
company until we have a non-affiliate public float in excess of $250 million or annual revenues in excess of $100 million and a non-
affiliate public float in excess of $700 million, each as determined on an annual basis. For so long as we remain smaller reporting company,
we are permitted and may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public
companies. These provisions include:
● an exemption from compliance with the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act of 2002, or
the Sarbanes-Oxley Act, on the design and effectiveness of our internal controls over financial reporting; and
● scaled reporting and disclosure requirements including about our executive compensation arrangements.
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We cannot predict whether investors will find our common stock less attractive if we rely on such exemptions. If some investors find our
common stock less attractive as a result, there may be a less active trading market for our common stock and the market price of our
common stock may be more volatile.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Facility
On November 1, 2021, the Company and its subsidiary, iBio CDMO LLC (“iBio CDMO”, and collectively with the Company, the
“Purchaser”) entered into a series of agreements (the “Transaction”) with College Station Investors LLC (“College Station”), and Bryan
Capital Investors LLC (“Bryan Capital” and, collectively with College Station, “Seller”), each affiliates of Eastern Capital Limited
(“Eastern,” a former significant stockholder of the Company) described in more detail below whereby in exchange for a certain cash
payment and a warrant the Company:
(i) acquired both the Facility where iBio CDMO at that time conducted business and also the rights as the tenant in the Facility’s
ground lease;
(ii) acquired all of the equity owned by one of the affiliates of Eastern in the Company and iBio CDMO; and
(iii) otherwise terminated all agreements between the Company and the affiliates of Eastern.
On September 15, 2023, iBio CDMO entered into a Purchase and Sale Agreement with Majestic Realty, pursuant to which iBio CDMO
agreed to sell the Property to Majestic Realty for a purchase price of $17,250,000. The closing of the sale of the Property is to occur, with
time being of the essence, on December 1, 2023 or such other date as mutually agreed. Pursuant to the terms of the Purchase and Sale
Agreement, Majestic Realty deposited with a title company $200,000 as an earnest money deposit. Majestic Realty will also be afforded
access to the Property to conduct a due diligence review of its condition. The closing is subject to certain closing conditions, including: (i)
Majestic Realty’s delivery to iBio CDMO and the Escrow Agent of written notice of its approval of the condition of the Property on or
before 5:00 p.m. Central time on October 16, 2023; (ii) Majestic Realty obtaining the approval of The Board of Regents of the Texas A&M
University System of Majestic Realty’s purchase from it of the fee interest in the Land on or before 5:00 p.m. Central time on November
13, 2023; and (iii) the delivery at closing by the title company of a title policy to Majestic Realty in the amount of the Purchase Price.
Biopharmaceutical R&D Facility
On September 11, 2021, iBio entered into a lease with SAN DIEGO INSPIRE 4, LLC for approximately 11,383 square feet of lab and
office space at 11750 Sorrento Valley Road in San Diego, CA. The lease recently commenced in September 2022. The lease is for seven
years and four months. The lease is triple net with Base Rent starting at $4.50 per month per square foot escalating approximately 3.0
percent per year during the lease term. iBio will use the facility primarily for R&D associated with its AI Drug Discovery Platform and our
biologic product portfolio.
Item 3. Legal Proceedings.
Lawsuits
We are not currently subject to any material legal proceedings. From time to time, we may be subject to various legal proceedings and
claims that arise in the ordinary course of its business activities. Litigation, regardless of the outcome, could have an adverse impact on us
because of defense and settlement costs, diversion of management resources and other factors.
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Item 4. Mine Safety Disclosures.
Not applicable.
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Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
PART II
Market Information
Our common stock is traded on the NYSE American under the trading symbol “IBIO.”
Holders
On September 12, 2023, there were 27 stockholders of record of our common stock, one of which was Cede & Co., a nominee for
Depository Trust Company, or DTC. All of the shares of our common stock held by brokerage firms, banks and other financial institutions
as nominees for beneficial owners are deposited into participant accounts at DTC and are therefore considered to be held of record by Cede
& Co. as one stock.
Dividends
We have never declared or paid any cash dividends on our common stock. Dividends on our common stock cannot be declared or paid or
set aside for payment or other distribution unless all accrued dividends on all outstanding shares of Preferred Tracking Stock are paid in
full.
Recent Sales of Unregistered Securities
There were no sales of unregistered securities other than as set forth in documents previously filed by the Company with the SEC.
Reverse Stock Split
As discussed above, the Company completed a reverse stock split at a ratio of one-for-twenty five (1:25) shares of the Company's common
stock. The effective date of the reverse stock split was October 7, 2022. All share and per share amounts of common stock presented have
been retroactively adjusted to reflect the one-for-twenty five reverse stock split.
Item 6. [Reserved]
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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion of our financial condition and results of operations should be read together with our financial statements and the
notes thereto and other information included elsewhere in this Annual Report. Unless the context requires otherwise, references in this
Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc.
Overview
We are a pioneering biotechnology company at the intersection of AI and biologics, committed to reshaping the landscape of discovery.
Our core mission is to harness the potential of AI and machine learning to unveil elusive biologics that stand out and have evaded other
scientists. Through our innovative platform, we champion a culture of innovation by identifying novel targets, forging strategic
collaborations to enhance efficiency, diversify pipelines, and with the goal of accelerating preclinical processes.
Additionally, our groundbreaking EngageTx technology enables us to target bi-specific molecules. With the ability to navigate sequence
diversity and promote Human-Cyno cross reactivity while mitigating cytokine release, our goal is to enhance agility and bolster preclinical
safety assessments.
Our strategic approach to fulfilling our mission is outlined as follows:
● Elevate Epitope Discovery: We believe we lead the field with our patented AI-engine uncovering "hard to develop" molecules.
Our unparalleled epitope engine stands out by allowing the ability to target select regions of a protein, potentially removing the
lengthy trial and error out of mAb discovery. This capability is expected to improve probability of success while at the same time,
reduces costs commonly caused by having an iterative process. Our epitope engine is engineered to match its target, refined for
stability and optimized for water solubility; allowing us to identify new drug candidates that have failed or have been abandoned
due to their complexity.
● Capital efficient business approach: Our strategic business approach is structured around the following pillars of value creation:
o
Strategic Collaborations: We are leveraging our platform and pipeline by forming strategic partnerships. Our aim is to
become the preferred partner for major pharmaceutical and biotechnology companies seeking rapid and cost-effective
integration of complex molecules into their portfolios, de-risking their early-stage pre-clinical work. Additionally, a rich
array of fast follower molecules within our pre-clinical pipeline holds the potential to drive substantial partnerships,
opening doors to innovative projects. By tapping into our platform, infrastructure, and expertise, partners have the
potential to streamline timelines, reduce costs tied to biologic drug discovery applications and cell line process
development, and expedite preclinical programs with efficiency.
o Developing and advancing our in-house programs cost effectively: Clinical advancement is crucial for drug
discovery. We are actively looking for opportunities to progress our internal pre-clinical programs, with a focal point on
oncology, steadily reinforcing our pre-clinical pipeline.
o Tech Licensing in Diverse Therapeutic Areas: In pursuit of adding value, we are exploring partnerships in diverse
therapeutic domains such as CNS or vaccines. Our intention is to license the AI tech stack, extending its benefits to our
partners and amplifying its biological impact and insights. This strategic approach enables us to capitalize on the value of
our meticulously curated data while empowering collaborations and innovations, while at the same time allowing us to
focus on both the platform and our core therapeutic area, oncology.
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● Unwavering Investment in advancing the platform: We maintain an unwavering commitment to invest in our platform,
continually unlocking the potential of biology through AI and machine learning. The pinnacle of being on the forefront of
machine learning advancing algorithms, and models in order to improve its predictive power and reduce the time it takes to find a
viable molecule.
In essence, we are sculpting a future where cutting-edge AI-driven biotechnology propels the discovery of intricate biologics, fostering
partnerships, accelerating innovation, and propelling the advancement of science.
AI-Technology Platform
Overview
Our platform comprises four key components, each playing a crucial role in the discovery and optimization of precision antibodies.
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer
antibodies with high specificity and efficacy. The second layer involves the proprietary antibody library, which is built on clinically
validated frameworks and offers a rich diversity of human antibodies. The third layer of the technology stack is the antibody optimizing
StableHu AI technology, coupled with mammalian display technology. Finally, our EngageTx platform forms the fourth layer. Each layer of
the tech stack is designed to work synergistically, enabling us to rapidly advance antibodies from concept to in vivo proof-of-concept
(POC).
AI Epitope Steering Technology
Our epitope steering technology is designed to address these issues by guiding antibodies exclusively against the desired regions of the
target protein. By focusing on these specific regions, we can overcome the limitations of traditional methods and significantly improve the
efficiency and effectiveness of our antibody discovery process. Our AI engine creates engineered epitopes, which are small embodiments
of epitopes on the target protein. The engine is trained to match the epitope structure as closely as possible and refine the designs for greater
stability and water solubility, which are critically important factors. The optimized engineered epitope is then used to identify antibodies
from naïve or immunized libraries.
Naïve Human Antibody Library
The fully human antibody library is built upon clinically validated, entirely human antibody frameworks. By leveraging public databases,
we have extracted a diverse array of Complementarity-Determining Region (CDR) sequences. Subsequently, we have meticulously
eliminated a range of sequence liabilities. Such careful curation process could potentially significantly reduce the development risk for
antibodies identified from our library.
StableHuTM AI Antibody-Optimizing Technology
Our proprietary StableHu technology is instrumental in the optimization process. StableHu is an AI-powered tool designed to predict a
library of antibodies with fully human CDR variants based on an input antibody. This input can range from an early, unoptimized molecule
to an approved drug. The model has been trained utilizing a set of over 1 billion human antibodies, progressively masking known amino
acids within CDRs until the algorithm could predict the correct human sequence.
While phage display libraries are often used in antibody optimization due to their vast diversity, they can increase developability risks such
as low expression, instability, or aggregation of antibodies. Mammalian display libraries, on the other hand, offer significantly improved
developability but reduced diversity due to the smaller library size they can handle. StableHu overcomes this limitation by utilizing a
machine learning algorithm generating focused library diversity within the capacity of mammalian display.
Mammalian display is a technology that presents antibodies on the surface of mammalian cells, allowing for the direct screening and
selection of antibodies in a mammalian cell environment. This approach is advantageous as antibodies that
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express well on the mammalian cells used in the display are more likely to express well in the production cell line. Moreover, single-cell
sorting of antibody-displaying cells allows rapid selection of desired antibodies based on multiple dimensions, such as potency, selectivity,
and cross-species selectivity.
When paired with mammalian display technology, StableHu enables antibody optimization with fewer iterative optimization steps, lower
immunogenicity risk, and improved developability.
EngageTx CD3-Based T-Cell Engager Panel
We have used antibodies from an epitope steering campaign as well as a first-generation T-cell engager as input and utilized our StableHu
technology to identify a next-generation CD3 antibody panel. The sequence diversity generated by StableHu led to an antibody panel with
a wide range of potencies, which allows us to pair the panel with a wide variety of tumor-targeting antibodies. Importantly, we were able to
retain T-cell activation and tumor cell killing capacity with significantly reduced cytokine release. This reduction is believed to lower the
risk of cytokine release syndrome. Additionally, the increased humanness of the predicted antibodies, thanks to our StableHu technology,
reduces the risk of immunogenicity.
Furthermore, our StableHu technology enabled us to engineer NHP cross-reactivity into EngageTx. This allows for advanced safety
assessment in NHP ahead of clinical trials, providing another layer of safety assurance.
Pre-Clinical Pipeline
We are currently in the process of building and advancing our preclinical pipeline. The focus of our pipeline is primarily on immuno-
oncology, with one program also dedicated to the immunology space. By leveraging our technology stack, the pipeline is geared towards
hard-to-drug targets and molecules offering differentiation. To mitigate target risk and capitalize on the learnings of competitors, our
programs are primarily adopting a fast follower strategy. This approach allows us to focus on targets that have to some extent been
validated and learn from the advancements of those ahead in the field.
Recent Developments
On September 15, 2023, iBio CDMO entered into the Purchase and Sale Agreement with Majestic Realty Co., pursuant to which iBio
CDMO agreed to sell to Majestic Realty for a purchase price of $17,250,000 its Facility located in Bryan, TX consisting of: (i) the ground
leasehold estate and interest held under the Ground Lease Agreement, dated March 8, 2010, as amended by an Estoppel Certificate and
Amendment to Ground Lease Agreement, dated as of December 22, 2015, between iBio CDMO (as assignee from College Station
Investors LLC) and The Board of Regents of the Texas A&M University System (together, the “Ground Lease”), related to 21.401 acres in
Brazos County, Texas land (the “Land”); (ii) the buildings, parking areas, improvements, and fixtures situated on the Land (the
“Improvements”); (iii) all iBio CDMO’s right, title, and interest in and to furniture, personal property, machinery, apparatus, and equipment
owned and currently
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used in the operation, repair and maintenance of the Land and Improvements and situated thereon (collectively, the “Personal Property”);
(iii) all iBio CDMO’s rights under the contracts and agreements relating to the operation or maintenance of the Land, Improvements or
Personal Property which extend beyond the closing date (the “Contracts”); and (iv) all iBio CDMO’s rights in intangible assets of any
nature relating to any or all of the Land, the Improvements and the Personal Property (the “Intangibles”; and together with the Ground
Lease, Improvements and Personal Property, collectively, the “Property”). The closing of the sale of the Property is to occur, with time
being of the essence, on December 1, 2023 or such other date as mutually agreed. Pursuant to the terms of the Purchase and Sale
Agreement, Majestic Realty deposited with a title company (the “Escrow Agent”) $200,000 as an earnest money deposit. Majestic Realty
will also be afforded access to the Property to conduct a due diligence review of its condition. The closing is subject to certain closing
conditions, including: (i) Majestic Realty’s delivery to iBio CDMO and the Escrow Agent of written notice of its approval of the condition
of the Property on or before 5:00 p.m. Central time on October 16, 2023; (ii) Majestic Realty obtaining the approval of The Board of
Regents of the Texas A&M University System of Majestic Realty’s purchase from it of the fee interest in the Land on or before 5:00 p.m.
Central time on November 13, 2023; and (iii) the delivery at closing by the title company of a title policy to Majestic Realty in the amount
of the Purchase Price.
Results of Operations
Revenue
Revenue from the CDMO operations is now included in discontinued operations and not broken out separately on the financial statements.
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all,
and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the
AI-driven discovery platform in the future. During the year ended June 30, 2023, we reported no revenue. Revenue for the year ended June
30, 2022 was mainly related to a licensing agreement.
Research and Development Expenses (“R&D”)
R&D expenses for Fiscal year ended June 30, 2023 and Fiscal year ended June 30, 2022 were approximately $10.3 million and $9.8
million, respectively, an increase of approximately $0.5 million or 5%. The increase primarily related to the increase in activities related to
our internal pipeline including IBIO-101, CCR8, and EGFRvIII, and the expansion of our AI-driven discovery platform to include an
increased spend of approximately $1.7 million on lab supplies, lab equipment/maintenance, and facility rent for the San Diego facility and
an increase of approximately $0.6 million in R&D personnel at the San Diego center. This increase was partially offset by a reduction of
approximately $1.8 million in spend on consultants and contracted services. iBio anticipates R&D expenses in Fiscal year ended June 30,
2024 will be close to those of Fiscal year ended June 30, 2023.
R&D expenses relating to CDMO operations are captured separately under discontinued operations.
General and Administrative Expenses (“G&A”)
G&A expenses for Fiscal year ended June 30 2023 and Fiscal year ended June 30 2022 were approximately $19.0 million and $21.8
million, respectively, a decrease of ($2.8) million or (13)%. G&A expenses principally include officer and employee salaries and benefits,
depreciation and amortization, professional fees, consulting services, operational costs and other costs associated with being a publicly
traded company. The decrease is primarily attributable to a reduction in intangible asset impairment charges and related amortization of
($1.5) million, a reduction of legal fees expense of ($0.8) million, a reduction in profession/consulting fees and outside services of ($0.8)
million, and reduced travel of ($0.2) million. The decrease was partially offset by an increase of ($0.5) million for IT security and related
costs. iBio expects G&A expenses to continue to decrease in Fiscal year ended June 30, 2024.
G&A expenses relating to CDMO operations are captured separately under discontinued operations.
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Total Operating Expenses
Total operating expenses, consisting primarily of R&D and G&A expenses, for Fiscal year ended June 30, 2023 were approximately $29.3
million, compared to approximately $31.6 million for Fiscal ended June 30, 2022.
Other Income (Expense)
Other income (expense) for Fiscal year ended June 30, 2023 and Fiscal year ended June 30, 2022 was approximately $0.03 million and
$0.2 million, a decrease of approximately ($0.2) million. The minimal increase in interest income was offset by interest expenses and loss
on sale of debt securities for a total other income (expense) of approximately $0.03 million.
Net Loss Available to iBio, Inc. Stockholders from Continuing Operations
Net loss available to iBio, Inc. stockholders from continuing operations for Fiscal year ended June 30, 2023 was approximately ($29.3)
million, or ($2.39) per share, compared to approximately ($29.6) million, or ($3.39) per share, in 2022.
Discontinued Operations
On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO, LLC) in
order to complete our transformation into an AI-driven, precision antibody drug discovery and development company. In conjunction with
the restructuring, we completed a workforce reduction of approximately 60% and discontinued the CDMO operations. CDMO operations
are reported as discontinued operations on our financial statements. Losses for Discontinued Operations for 2023 and 2022 were
approximately ($35.7) million and ($20.8) million, respectively, an increase of ($14.9) million, or 72%. This increase was primarily due to
the impairment of fixed assets ($17.9) million, impairment of consumable inventory of ($4.9) million, and ($3.1) million of personnel
restructuring related charges including severance, benefits and the acceleration of stock compensation awards. This increase in expense
was offset by the decrease of Facility related expenses of ($4.5) million, personnel costs of ($3.6) million, consultant/outside services of
($1.5) million, the gain on sale of fixed assets of ($0.8) million and the ($0.6) million forgiveness of the PPP loan in Fiscal year 2022,
which did not reoccur in Fiscal year 2023.
Total Net Loss Available to iBio, Inc. Stockholders
Net loss available to iBio, Inc. stockholders from both continuing and discontinued operations for Fiscal year ended June 30, 2023 was
approximately ($65.0) million, or ($5.31) per share, compared to approximately ($50.4) million, or ($5.78) per share, in Fiscal year ended
June 30, 2022.
Liquidity and Capital Resources
The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by the
Company on its ability to obtain additional financing to fund its operations after the current cash resources are exhausted raises substantial
doubt about the Company's ability to continue as a going concern. Our management concluded that our recurring losses from operations
and the fact that we have not generated significant revenue or positive cash flows from operations raise substantial doubt about our ability
to continue as a going concern for the next 12 months after issuance of our financial statements. Our auditors also included an explanatory
paragraph in its report on our consolidated financial statements as of and for the year ended June 30, 2023 with respect to this uncertainty.
In an effort to remain a going concern and increase cash reserves, we completed a public offering in December 2022, reduced our work
force by approximately 60% (a reduction of approximately 69 positions) in November 2022, and ceased operations of our CDMO Facility
thereby reducing annual spend on expenses by approximately 67% and generating cash savings of approximately 64% from first quarter
Fiscal year 2023 compared to fourth quarter Fiscal year 2023. Additionally, we have executed the Purchase and Sale Agreement for the sale
of the CDMO Facility, which sale if consummated will allow us to pay all outstanding amounts under the Term Loan; however, the
consummation of the sale
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is subject to closing conditions for which there can be no assurance that they will be met or the closing will occur in a timely manner, if at
all . If the closing is not consummated prior to the December 31, 2023 maturity date of the Term Loan it is unlikely that we will have
sufficient funds the repay the Term Loan on its maturity date, which Term Loan has an outstanding balance of which is $12.7 million as of
September 26, 2023.
During the first quarter of Fiscal 2023, we completed at-the-market offerings and sold 175,973 shares of our common stock, par value
$.001 per share (the “Common Stock”) for net proceeds of approximately $1.2 million. During the second quarter of Fiscal 2023, we
completed a public offering and raised gross proceeds of approximately $3.5 million selling an aggregate of 3,365,385 shares of its
Common Stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 3,870,192 shares of Common Stock and Series
B warrants to purchase up to 3,870,192 shares of Common Stock. Subsequently after the public offering, during the third quarter of Fiscal
2023, 341,300 Class A Warrants and 1,704,916 Class B Warrants were exercised for total proceeds of $2,128,000. Also, during the third
quarter of Fiscal 2023, we completed at-the-market offerings and sold 1,375,906 shares of Common Stock for which we received
approximately $2.0 million. In the fourth quarter of Fiscal 2023, an additional 76,300 Class B Warrants were exercised with total proceeds
of approximately $79,000. Also, during the fourth quarter of Fiscal 2023, we completed at-the-market offerings and sold 4,230,992 shares
of Common Stock of which we received approximately $3.3 million and holds a subscription receivable for $204,000 at June 30, 2023 for
proceeds received on July 6, 2023. (See Note 17 – Stockholder’s Equity for more information.)
Subsequent to June 30, 2023, we completed at-the-market offerings and sold 3,419,795 shares of Common Stock which we received
approximately $1.7 million. We also sold 3,622,834 shares of Common Stock under our Purchase Agreement with Lincoln Park and
received approximately $1.2 million in proceeds.
Our cash, cash equivalents and restricted cash of approximately $7.6 million as of June 30, 2023, is not anticipated to be sufficient to
support operations through the second quarter of Fiscal 2024, unless we further reduce our burn rate, consummate the sale of the Facility
for amounts above the debt on the Facility, or increase our capital as described above. Regardless of whether we are able to reduce our burn
rate or sell or out-license certain assets or parts of the business, we will need to raise additional capital in order to fully execute our longer-
term business plan. It is our goal to implement one or more potential options described herein to allow us to have a cash runway for at least
12 months from the date of the filing of this Annual Report. However, there can be no assurance that we will be successful in implementing
any of the options that we are evaluating.
Our liquidity and operations could also be impacted by our obligations under the Woodforest Credit Agreement. As described below and in
detail in Note 6 - Significant Transactions, to avoid violating the Liquidity Covenant associated with the parent guarantee of the debt, we
need to pay off the debt through the sale of the Facility or we need to raise additional capital.
Woodforest Debt
On October 11, 2022, we and Woodforest entered into the First Amendment to the Credit Agreement pursuant to which the Credit
Agreement was amended to: (i) include a payment of $5,500,000 of the outstanding principal balance owed under the Credit Agreement on
the date of the amendment, (ii) include a payment of $5,100,000 of the outstanding principal balance owed under the Credit Agreement
within two (2) business days upon our receipt of such amount owed to us by Fraunhofer as part of our legal settlement with them (see Item
3 – Legal Proceedings for more information), (iii) include principal payments of $250,000 per month in debt amortization for a six-month
period commencing the date of the amendment through March 2023, (iv) include an amendment fee of $22,375 and all costs and expenses,
(v) require delivery of a report detailing cash flow expenditures every two (2) weeks for the period prior to the delivery of the last report
and a monthly 12-month forecast (vi) reduce the liquidity covenant in the Guaranty (as defined in the Credit Agreement) from $10 million
to $7.5 million with the ability to lower the liquidity covenant to $5.0 million upon the occurrence of a specific milestone in the Credit
Agreement, and (vii) change the annual filing requirement solely for the fiscal year ending June 30, 2022, such that the filing is acceptable
with or without a “going concern” designation. In addition, Woodforest cancelled the irrevocable letter of credit issued by JPMorgan Chase
Bank upon closing of the amendment.
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In January 2023, iBio’s unrestricted cash decreased below the required $7,500,000, which created an event of default under the Credit
Agreement and Guaranty as a result of not complying with the Liquidity Covenant. As a result, on February 9, 2023, iBio CDMO and
Woodforest entered into a second amendment to the Credit Agreement (the “Second Amendment”), which amended, among other things,
added a milestone that had to be met by a specified date, the failure of which would be an event of default. In addition, on February 9,
2023, iBio, as guarantor, entered into a second amendment to the Guaranty, which amended, among other things, allowed iBio to account
for the Fraunhofer Settlement Funds in determining whether the Company is in compliance with the Liquidity Covenant until a specified
period dependent upon the occurrence of a specific milestone in the Credit Agreement.
On February 20, 2023, iBio CDMO entered into a third amendment to the Credit Agreement (the “Third Amendment”), which removed the
added milestone specified in the Second Amendment, the failure of which would be an event of default. In addition, the Guaranty was
amended to allow us until February 28, 2023, to account for the Fraunhofer Settlement Funds in determining whether we are in compliance
with the Liquidity Covenant without being dependent upon a specified milestone. In addition, we agreed that each time it consummates an
at-the-market issuance of Equity Interests (as defined within the Credit Agreement), no later than five (5) days following such issuance of
Equity Interests, it will (i) pay to Woodforest in immediately available cash funds, without setoff or counterclaim of any kind, forty percent
(40%) of the Net Proceeds (as defined within the Credit Agreement) received by us for such issuance of Equity Interests; provided, any
such payment would cease upon payment obligations in full and (ii) provide Woodforest with a detailed accounting of each such issuance
of Equity Interests.
On March 24, 2023, iBio CDMO and Woodforest entered into a fourth amendment to the Credit Agreement (the “Fourth Amendment”),
which within the Fourth Amendment Woodforest agreed to (i) reduce the percentage of any payment to Woodforest we are required to
make from the proceeds of sales of our common stock under its at-the-market facility from 40% to 20%, (ii) reduce the percentage of any
payment to Woodforest we are required to make from the proceeds of sales of its equipment from 40% to 20%, and (iii) allowed us to retain
$2,000,000 million of the $5,100,000 million that we received from the Fraunhofer Settlement Funds, with the remaining $3,000,000
million being held in our account at Woodforest. In addition, we are obligated to (y) deliver to Woodforest an executed copy of a purchase
agreement (the “Purchase Agreement”) for the sale of the Facility, no later than April 14, 2023, and (z) pay to Woodforest a fee in the
amount of $75,000 on the earlier of the date of the closing of the Purchase Agreement, or the Maturity Date (as defined in the Credit
Agreement). In addition, on March 24, 2023, iBio, as guarantor, entered into a fourth amendment to the Guaranty, which reduced the
Liquidity Covenant from $7,500,000 to $1,000,000.
On May 10, 2023, iBio CDMO and Woodforest entered into a fifth amendment to the Credit Agreement (the “Fifth Amendment”), which
within the Fifth Amendment Woodforest agreed to: (i) waive our obligation to deliver to Woodforest an executed copy of a Purchase
Agreement for the sale of the Facility no later than April 14, 2023 and, (ii) release $500,000 of the $3.0 million being held in our account at
Woodforest when the outstanding principal amount is reduced to $10.0 million and for each additional $2.5 million reduction of the
outstanding principal amount, an additional $750,00 will be released from our account at Woodforest. In addition, starting on the effective
date of the Fifth Amendment, the interest on the Term Loan increased to 5.25%, and the Term Loan shall further accrue interest, payable in
kind and added to the balance of the outstanding principal amount at a fixed rate per annum equal to (a) 1.00%, if the Facility is sold on or
before June 30, 2023, (b) 2.00% if the Facility is sold after June 2023, but on or before September 30, 2023, or (c) 3:00%, if the Facility is
sold after September 30, 2023, or not sold prior to the Maturity Date. We also agreed to pay Woodforest a fee in the amount of (x) $75,000
if the Facility is sold on or before June 30, 2023, (y) $100,000 if the Facility is sold after June 2023, but on or before September 30, 2023,
or (x) $125,000, if the Facility is sold after September 30, 2023, or not sold prior to the Maturity Date.
On September 18, 2023, iBio CDMO and Woodforest entered into a sixth amendment to the Credit Agreement (the “Sixth Amendment”),
to amend the Credit Agreement to: (i) set the maturity date of the term loan to the earlier of (a) December 31, 2023, or (b) the acceleration
of maturity of the term loan in accordance with the Credit Agreement, (ii) provided that iBio CDMO will, immediately upon receipt of the
proceeds of the sale of the Property, apply the net proceeds to satisfy all outstanding obligations under the term loan, and to the extent such
net proceeds are sufficient, to pay off the term loan, and (iii) change the annual filing requirement solely for the fiscal year ending June 30,
2023, such that the filing is acceptable with or without a “going concern” designation; provided that (y) iBio CDMO shall deliver an
executed copy of the Purchase and Sale Agreement for the sale of the Facility within one business day after entry into the Sixth
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Amendment, and (z) if the Facility is not sold on or before December 1, 2023, iBio CDMO will pay a fee in the amount of $20,000 upon
the earlier of the date of the closing or the maturity date.
Cantor Fitzgerald Underwriting
On November 25, 2020, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald
& Co. ("Cantor Fitzgerald") to sell shares of Common Stock, from time to time, through an “at the market offering” program having an
aggregate offering price of up to $100,000,000 through which Cantor Fitzgerald would act as sales agent. Between July 25, 2022, and June
30, 2023, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 5,782,871 shares of Common Stock. We received net
proceeds of approximately $6.4 million during the Fiscal year 2023 and hold a subscription receivable for $204,000 at June 30, 2023 for
proceeds received on July 6, 2023.
In Fiscal year 2022, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 175,973 shares of Common Stock. We received
net proceeds of approximately $1.2 million. (See Note 17 - Stockholders’ Equity for more detail.)
Wainwright Underwriting
On December 6, 2022, we entered into an underwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC
(“Wainwright”). Pursuant to the Underwriting Agreement, we agreed to sell to Wainwright, in a firm commitment underwritten offering
(the “Offering”) (i) 1,530,769 shares of the Company’s Common Stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase
up to 1,834,616 shares of Common Stock, (iii) Series A Common Stock purchase warrants (the “Series A Warrants”) to purchase up to
3,365,385 shares of Common Stock and (iv) Series B Common Stock purchase warrants (the “Series B Warrants” and together with the
Series A Warrants, the “Common Warrants”) to purchase up to 3,365,385 shares of Common Stock. The offering closed on December 9,
2022.
Wainwright acted as the sole book-running manager for the Offering. We paid Wainwright an underwriting discount equal to 7.0% of the
gross proceeds of the offering, and reimbursed Wainwright for the legal fees and certain expenses of the underwriter. Pursuant to the
Underwriting Agreement, we granted Wainwright a 30-day option to purchase up to an additional 504,807 shares of Common Stock and/or
Common Warrants to purchase up to an additional 1,009,614 shares of Common Stock at the public offering price, less the underwriting
discounts and commissions, solely to cover over-allotments. Wainwright elected to purchase 504,807 Series A Warrants and 504,807 Series
B Warrants.
We also agreed to issue to Wainwright, as the representative of the underwriters, warrants (the “Representative’s Warrants”) to purchase a
number of shares of Common Stock equal to 6.0% of the aggregate number of shares of Common Stock and Pre-Funded Warrants being
offered in the offering. Wainwright received warrants to purchase up to 201,923 shares of Common Stock.
We received net proceeds of approximately $2,864,000 after deducting underwriting discounts, commissions and other issuance costs.
During the year ended June 30, 2023, 341,300 Class A Warrants and 1,781,216 Class B Warrants were exercised. The total proceeds from
Class A and B Warrants exercised during the year ended June 30, 2023 was $2,207,000. (See Note 17 - Stockholders’ Equity for more
detail.)
Series 2022 Convertible Preferred Stock
On May 12, 2022, we entered into a securities purchase agreement with a certain accredited investor for the issuance and sale of 1,000
shares of Series 2022 Convertible Preferred Stock, $0.001 par value per share (the “Preferred Stock”), at a price of $0.27 per share. The
Preferred Stock permitted the holder to vote at the Special Meeting, on the Reverse Stock Split proposal, with the holders of the common
stock as a single class, with each share of Preferred Stock being entitled to 200,000 votes per share, provided that any votes cast by the
Preferred Stock with respect to the Proposal must be voted in the same proportion as the aggregate shares of common stock are voted on
the Proposal. Pursuant to the terms of the preferred stock, our Board of Directors converted the Preferred Stock to common stock at a
conversion ratio of 1:1 on July 19, 2022. (See Note 17 - Stockholders’ Equity for more detail.)
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Bryan Capital
On November 3, 2021, as part of consideration for the purchase of the Bryan site and other rights, iBio issued a warrant to purchase 51,583
shares of the Common Stock at an exercise price of $33.25 per share to affiliates of Eastern Capital Limited. The Warrant expires October
10, 2026, is exercisable immediately, provides for a cashless exercise at any time and automatic cashless exercise on the expiration date if
on such date the exercise price of the Warrant exceeds its fair market value as determined in accordance with the terms of the Warrant and
adjustments in the case of stock dividends and stock splits.
Also, as part of the consideration for the purchase of the Bryan site and other rights, iBio entered into a $22,375,000 Senior Secured Term
Loan with Woodforest National Bank. The loan bears interest at 5.25% plus a payment in kind adjustment dependent on when the Facility
is sold and original maturity date of November 1, 2023. See Note 14 – Debt for further details.
Lincoln Park Stock Purchase Agreement
On August 4, 2023, iBio entered into a purchase agreement, dated as of August 4, 2023 (the “Purchase Agreement”), with Lincoln Park
Capital Fund, LLC (“Lincoln Park”), pursuant to which, under the terms and subject to the satisfaction of specified conditions set forth
therein, we may sell to Lincoln Park up to $10.0 million (subject to certain limitations) of Common Stock, from time to time during the
term of the Purchase Agreement. Additionally, on August 4, 2023, we entered into a registration rights agreement, dated as of August 4,
2023 (the “Registration Rights Agreement”), with Lincoln Park, pursuant to which we agreed to file a registration statement with the SEC,
to register under the Securities Act of 1933, as amended (the “Securities Act”), the resale by Lincoln Park of shares of Common Stock that
have been or may be issued and sold by us to Lincoln Park under the Purchase Agreement. We cannot sell any shares of Common Stock to
Lincoln Park under the Purchase Agreement unless all of the conditions to Lincoln Park’s purchase obligation set forth in the Purchase
Agreement, including that the resale registration statement that we are required to file with the SEC under the Registration Rights
Agreement is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC (the date on which all of such
conditions are satisfied, the “Commencement Date”). The registration statement was declared effective on August 11, 2023.
Beginning on the Commencement Date and for a period of up to 24 months thereafter, under the terms and subject to the conditions of the
Purchase Agreement, from time to time, at our discretion, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln
Park is obligated to purchase, up to $10 million of shares of Common Stock, subject to certain limitations set forth in the Purchase
Agreement. Specifically, from time to time from and after the Commencement Date, we may, at our discretion, on any single business day
on which the closing price of the common stock on the NYSE American is equal to or greater than $0.15, by written notice delivered to
Lincoln Park, direct Lincoln Park to purchase up to 100,000 shares of Common Stock on such business day, at a purchase price per share
that will be determined and fixed in accordance with the Purchase Agreement at the time the Company delivers such written notice to
Lincoln Park (each, a “Regular Purchase”); provided, however, that the maximum number of shares we may sell to Lincoln Park in a
Regular Purchase may be increased to up to (i) 150,000 shares, if the closing sale price of the Common Stock on the NYSE American on
the applicable purchase date is not below $1.00, and (ii) 200,000 shares, if the closing sale price of the Common Stock on the applicable
purchase date is not below $2.00; provided, however, that Lincoln Park’s maximum purchase commitment in any single Regular Purchase
may not exceed $500,000. The foregoing share amounts and per share prices will be adjusted for any reorganization, recapitalization, non-
cash dividend, stock split, reverse stock split or other similar transaction occurring after the date of the Purchase Agreement with respect to
the Common Stock. The purchase price per share of Common Stock sold in each such Regular Purchase, if any, will be based on market
prices of the Common Stock immediately preceding the time of sale, calculated as set forth in the Purchase Agreement.
In addition, provided that we have directed Lincoln Park to purchase the maximum amount of shares that we are then able to sell to Lincoln
Park in a Regular Purchase on a particular business day on which the closing price of the common stock on the NYSE American is equal to
or greater than $0.20, then in addition to such Regular Purchase, we may, in our sole discretion, also direct Lincoln Park to purchase
additional shares of Common Stock in an “accelerated purchase,” and one or more “additional accelerated purchases” on the business day
immediately following the purchase date for such Regular Purchase, as provided in the Purchase Agreement. The purchase price per share
of Common Stock sold to Lincoln Park in
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each accelerated purchase and additional accelerated purchase, if any, will be based on market prices of the Common Stock at the time of
sale on the applicable purchase date for such accelerated purchase and such additional accelerated purchase(s), as applicable, calculated as
set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common
Stock in any purchase under the Purchase Agreement.
We will control the timing and amount of any sales of Common Stock to Lincoln Park pursuant to the Purchase Agreement. Lincoln Park
has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases
as we direct, subject to certain conditions.
Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by us from time to time,
including, among others, market conditions, market prices of the Common Stock from time to time during the term of the Purchase
Agreement and determinations by us as to the appropriate sources of funding for iBio and its operations. The net proceeds under the
Purchase Agreement to iBio will depend on the frequency and prices at which we sell shares of Common Stock to Lincoln Park. We expect
that any proceeds received by us from such sales to Lincoln Park will be used for working capital and general corporate purposes.
As consideration for Lincoln Park’s commitment to purchase shares of Common Stock at our direction pursuant to the Purchase
Agreement, we issued 211,473 shares of Common Stock to Lincoln Park as commitment shares (the “Initial Commitment Shares”) and
agreed to issue 211,474 additional shares of Common Stock to Lincoln Park as commitment shares (the “Additional Commitment Shares”
and, collectively with the Initial Commitment Shares, the “Commitment Shares”) at such time as we have received an aggregate of
$5,000,000 in cash proceeds from Lincoln Park from sales of Common Stock to Lincoln Park, if any, that we elect, in our sole discretion, to
make from time to time from and after the Commencement Date, pursuant to the Purchase Agreement. (See Note 17 - Stockholders’ Equity
for more detail.)
Between August 16, 2023 and September 15, 2023, Lincoln Park purchased pursuant to the Purchase Agreement 3,622,834 shares of
Common Stock. The Company received net proceeds of approximately $1.2 million during the first quarter of Fiscal 2024.
Net Cash Used in Operating Activities
In fiscal year 2023, net cash used in operating activities was ($30.4) million, compared to net cash used in operating activities of ($37.5)
million in 2022. The decrease in net cash was primarily used to support our ongoing operations.
Net Cash Provided by (Used in) Investing Activities
In fiscal year 2023, net cash provided by investing activities was $7.0 million, which primarily consisted of redemption and sales of debt
securities of $10.8 million and the sale of fixed asset of $2.6 million, partially offset by the purchase of ($5.7) million of fixed assets and
($0.7) million for certain assets acquired from RubrYc. Offset by proceeds from the sales of fixed assets. In fiscal year 2022, our net cash
used in investing activities was ($5.1) million, which primarily consisted of the purchase of RubrYc equity and acquisition of intangible
assets related to our license of IBIO-101, and purchases of fixed assets, offset by the net redemption of debt securities.
Net Cash Provided by (Used in) Financing Activities
In fiscal year 2023, net cash provided by financing activities was $2.3 million, compared to net cash used in financing activities of ($6.1)
million in 2022. Net cash generated from financing activities in 2023 primarily related to proceeds from sales of common stock offset by
payments made towards term note payable while the net cash spent in 2022 mainly related to the purchase of the Facility.
Funding Requirements
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008.
As of June 30, 2023, our accumulated deficit was approximately ($288.9) million, and we used approximately ($21.1) million of net cash in
fiscal year 2023.
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We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of
our technologies, through proceeds from the sale of the CDMO Facility, through potential proceeds from the sale or out-licensing of assets,
and through proceeds from the sale of additional equity or other securities. However, there can be no assurance that we will be successful in
implementing these plans, many of which will take several years before we realize proceeds. The Term Loan with Woodforest and the
Guaranty requires we maintain an unrestricted cash balance of $1.0 million, which limits our ability to use our funds for operations. If we
should default on the Credit Agreement and Woodforest does not waive the default, and if Woodforest makes a demand for the acceleration
of all payments due to this default, it could result in all obligations that are guaranteed being due and payable immediately without further
notice. We cannot be certain that such funding will be available on favorable terms or available at all. If we are unable to raise funds when
required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or
discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and
product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise dispose of rights to
technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly cease operations.
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured finance or special purpose entities (SPEs), which would have been established
for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes. As of June 30, 2023, we were not
involved in any SPE transactions.
Critical Accounting Estimates
A critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results of operations and
requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of
matters that are inherently uncertain.
Our consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of
America (“U.S. GAAP”). All applicable U.S. GAAP accounting standards effective as of June 30, 2023, have been taken into consideration
in preparing the consolidated financial statements. The preparation of consolidated financial statements requires estimates and assumptions
that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. Some of those estimates are subjective and
complex, and, consequently, actual results could differ from those estimates. We base our estimates, to the extent possible, on historical
experience. Historical information is modified as appropriate based on current business factors and various assumptions that we believe are
necessary to form a basis for making judgments about the carrying value of assets and liabilities. We evaluate our estimates on an ongoing
basis and make changes when necessary. Actual results could differ from our estimates.
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation
uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations of the
Company. The following accounting estimate had a material impact on the results of operations of the Company for the year ended June 30,
2023.
Impairment of Fixed Assets
We monitor fixed assets for impairment indicators throughout the year. When necessary, charges for impairments of long-lived assets are
recorded for the amount by which the fair value is less than the carrying value of these assets. Changes in the Company’s business strategy
or adverse changes in market conditions could impact impairment analyses and require the recognition of an impairment charge. Although
we base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances,
actual results could differ from these estimates.
On November 3, 2022, we announced we are seeking to divest our contract development and manufacturing organization (iBio CDMO) in
order to complete our transformation into an antibody discovery and development company. Through the process of seeking to divest its
contract development and manufacturing organization, we have entered into a Purchase
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and Sale Agreement for the Facility. The decision to divest triggered a quantitative impairment analysis of our CDMO fixed assets of the
Facility totaling $22.65 million and machinery and equipment totaling $13.4 million.
We utilized a market approach in the second quarter of Fiscal 2023, using independent third-party appraisals, including comparable assets,
in addition to bids received from prospective buyers, to estimate the fair value of the Facility, the machinery and equipment. We recorded
an impairment charge of $6.3 million for the facility and $11.3 million for the machinery and equipment in the quarter ended December 31,
2022. The key assumption in the valuation analysis is the expected sale price of $21.1 million for the Facility and the associated machinery
and equipment less approximate costs to sell of $2.7 million. In the first quarter of Fiscal 2024, we entered into an agreement for the sale of
the Facility for $17.25 million, and an additional impairment of $0.3 million was recorded in Fiscal 2023 to reflect the agreed upon sales
price less estimated costs to sell. The carrying amount of the CDMO fixed assets after impairment on June 30, 2023 was $16.1 million.
On February 10, 2021, the “Company, entered into an Auction Sale Agreement (the “Auction Sale Agreement”) with Holland Industrial
Group, together with Federal Equipment Company and Capital Recovery Group LLC (collectively, the “Auctioneers”) for the sale at public
auction of equipment and other tangible personal property (the “Equipment”) located at the Facility. The Auctioneer guaranteed an amount
of gross proceeds from the sale of the equipment of $2.1 million, which was paid to the Company on February 17, 2023. The auction,
which commenced on March 24, 2023 and concluded on March 30, 2023, resulted in total proceeds of approximately $2.9 million. In
accordance with the Auction Sale Agreement, the Company received 80% of the excess proceeds, after Holland was paid a fixed amount of
$0.2 million for expenses, which was approximately $0.5 million.
We may have to record a further, potentially material, impairment to the fair value of this asset group if we do not realize a sale transaction
for the expected amount of $17.25 million less costs to sell in the near term.
Impairment of Indefinite-Lived Intangible Assets
For indefinite life intangible assets, we perform an impairment test annually and whenever events or changes in circumstances indicate the
carrying value of an asset may not be recoverable.
Evaluating for impairment requires judgment, including the estimation of future cash flows, future growth rates and profitability and the
expected life over which cash flows will occur. Changes in our business strategy or adverse changes in market conditions could impact
impairment analyses and require the recognition of an impairment charge. Although we base our estimates on historical experience and
various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.
During the fourth quarter of Fiscal 2023, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”),
classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million at June 30, 2023. We engaged a third party to
perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-
Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM
determines the value of a specified asset by calculating the present value of future earnings attributed to the asset. Since IBIO-101 is
currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of
reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the
theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the
cash flows related to the subject asset.
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 13% discount rate, which was
based on iBio’s weighted average cost of capital. The sum of the discounted excess earnings and the present value of the tax benefit related
to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $7.1 million as of the April 1, 2023, valuation
date. Given that the carrying amount of the asset was $5 million at June 30, 2023, it was concluded that no impairment existed.
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We will continue to monitor the value of the IP, since we believe it is at risk for impairment. The primary impairment indicators that may
arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing
technologies that are applying for Phase 1 approval.
We continue to operate in a highly competitive environment, rising interest rates (and cost of capital) and experience liquidity challenges.
Accordingly, we may have to adjust our cash flow projections and valuation assumptions in the near future to account for market trends and
any changes to our research and development plans. Any such future adjustments may lead to material future impairments in the IP and
other related assets.
Our remaining critical accounting estimates remain consistent with the information disclosed in the same section in our last annual report
on Form 10-K for the year ended June 30, 2022.
In addition to the aforementioned critical accounting estimates, the following accounting policies and estimates have been highlighted as
significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial
statements:
● revenue recognition;
● legal and contractual contingencies;
● research and development expenses; and
● share-based compensation expenses.
We base our estimates, to the extent possible, on historical experience. Historical information is modified as appropriate based on current
business factors and various assumptions that we believe are necessary to form a basis for making judgments about the carrying value of
assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when necessary. Actual results could differ from our
estimates. See Note 4 – Summary of Significant Accounting Policies - for a complete discussion of our significant accounting policies and
estimates.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
The information under this Item is not required to be provided by smaller reporting companies.
Item 8. Financial Statements and Supplementary Data.
Financial statements and notes thereto appear on pages F-1 to F-44 of this Annual Report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, under the direction of our Chief Executive Officer (our Principal Executive Officer) and Chief Financial Officer (our
Principal Financial Officer) have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act, as amended), as of June 30, 2023. The term “disclosure controls and procedures,” as defined in
Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that
information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it
files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal
executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding
required disclosure. The Company’s disclosure controls and procedures are also designed to ensure that such
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information is accumulated and communicated to management to allow timely decisions regarding required disclosure. Management
recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
Based on our evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and
procedures were effective as of June 30, 2023.
Management’s Report on Internal Control over Financial Reporting
It is the responsibility of the management of iBio to establish and maintain effective internal control over financial reporting (as defined in
Rule 13a-15(f) under the Exchange Act). Internal control over financial reporting is designed to provide reasonable assurance to iBio’s
management and board of directors regarding the preparation of reliable financial statements for external purposes in accordance with
generally accepted accounting principles.
iBio’s internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of iBio; (ii) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of iBio are being made only in accordance with authorizations of management and directors
of iBio; and (iii) provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition
of iBio’s assets that could have a material effect on the financial statements of iBio.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those
systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
Management has performed an assessment of the effectiveness of iBio’s internal control over financial reporting as of June 30, 2023, based
upon criteria set forth in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (2013 COSO Framework).
Based on this assessment, management has concluded that our internal control over financial reporting was effective as of June 30, 2023.
Changes in Internal Control Over Financial Reporting
We remediated the material weakness relating to our internal controls over the accounting for stock-based compensation, as described
below. Except as otherwise described herein, there were no changes in our internal control over financial reporting, as such term is defined
in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the quarter ended June 30, 2023, that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Remediation of Material Weakness in Internal Controls over Accounting for Stock-Based Compensation
We strengthened our internal controls over accounting for stock-based compensation through designing and implementing additional
procedures and controls over stock-based compensation. Management believes that significant progress has been made in enhancing
internal controls as of June 30, 2023 and has concluded that the enhanced controls are operating effectively. The material weakness
described in in Item 4 Controls and Procedures in our Quarterly Report on Form 10-Q for the nine months ended March 31, 2023 has been
fully remediated.
Report of Independent Registered Public Accounting Firm
This Annual Report does not include an attestation report by CohnReznick LLP ("CohnReznick"), our independent registered public
accounting firm, regarding internal control over financial reporting. As a smaller reporting company, our internal control over financial
reporting was not subject to audit by our independent registered public accounting firm pursuant to rules of the SEC that permit us to
provide only management’s report.
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Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.
Not applicable
PART III
Certain information required by Part III is omitted from this Annual Report because we intend to file our definitive proxy
statement for our 2023 Annual Meeting of Stockholders, pursuant to regulation 14A of the Exchange Act, not later than 120 days
after the end of the fiscal year covered by this Annual Report and certain information to be included in the definitive proxy
statement is incorporated herein by reference.
Item 10. Directors, Executive Officers and Corporate Governance
Information required by this Item that will appear under the headings “Governance,” “Executive Officers,” and “Delinquent
Section 16(a) Reports” in the definitive proxy statement to be filed with the SEC relating to our 2023 Annual Meeting of Stockholders is
incorporated herein by reference.
Code of Ethics
We have adopted a written code of business conduct and ethics within the meaning of Item 406 of SEC Regulation S-K, which applies to
all of our employees, including our principal executive officer and our chief financial officer, a copy of which can be found on our website
at www.ibioinc.com. If we make any waivers or substantive amendments to the code of ethics that are applicable to our principal executive
officer or our chief financial officer, we will disclose the nature of such waiver or amendment in a Current Report on Form 8-K in a timely
manner. No waivers from any provision of our policy have been granted.
Item 11. Executive Compensation
Information required by this Item that will appear under the heading “Executive Compensation” and “Director Compensation” in the
definitive proxy statement to be filed with the SEC relating to our 2023 Annual Meeting of Stockholders is incorporated herein by
reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Information required by this Item that will appear under the headings “Security Ownership of Certain Beneficial Owners and Management”
and “Equity Compensation Plan Information” in the definitive proxy statement to be filed with the SEC relating to our 2023 Annual
Meeting of Stockholders is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Information required by this Item that will appear under the headings “Certain Relationships and Related Transactions” and “Independence
of Board” in the definitive proxy statement to be filed with the SEC relating to our 2023 Annual Meeting of Stockholders is incorporated
herein by reference.
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Item 14. Principal Accountant Fees and Services
Information required by this Item that will appear under the heading “Independent Auditor Fees and Other Matters” in the definitive proxy
statement to be filed with the SEC relating to our 2023 Annual Meeting of Stockholders is incorporated herein by reference.
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Item 15. Exhibits and Financial Statement Schedules.
(a) Exhibits and Index
PART IV
(1) A list of the financial statements filed as part of this Annual Report is set forth in the index to financial statements at page F-1
and is incorporated herein by reference.
(2) An exhibit index is incorporated by reference or filed with this Annual Report is provided below:
Item 16. Form 10-K Summary
Not Applicable
Exhibit No. Description
1.1
1.2
3.1
3.2
3.3
3.4
3.5
3.6
Controlled Equity OfferingSM Sales Agreement, dated as of November 25, 2020, by and between iBio, Inc. and Cantor
Fitzgerald & Co. (incorporated herein by reference to Exhibit Number 1.1 to the Company’s registration statement on
Form S-3 (File No. 333-250973) filed by the Company with the Securities and Exchange Commission on November 25,
2020 – Commission File No. 001-35023)
Underwriting Agreement, dated December 6, 2022, by and between iBio, Inc. and H.C. Wainwright & Co., LLC
(incorporated herein by reference to the Company’s Current Report on Form 8-K filed by the Company with the
Securities and Exchange Commission on December 8, 2022 – Commission File No. 001-35023)
Certificate of Incorporation of iBio, Inc., Certificate of Merger, Certificate of Ownership and Merger, Certificate of
Amendment of the Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Quarterly Report
on Form 10-Q filed by the Company with the Securities and Exchange Commission on May 11, 2018 – Commission File
No. 001-35023)
Certificate of Amendment of the Certificate of Incorporation of iBio, Inc. (incorporated herein by reference to Exhibit 3.2
to the Quarterly Report on Form 10-Q filed by the Company with the Securities and Exchange Commission on February
14, 2018 – Commission File No. 001-35023)
Certificate of Amendment of the Certificate of Incorporation of iBio, Inc. (incorporated herein by reference to the
Company’s Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission on June 8,
2018 – Commission File No. 001-35023)
Certificate of Designation, Preferences and Rights of the iBio CMO Preferred Tracking Stock of iBio, Inc. (incorporated
herein by reference to Exhibit 3.1 to the Current Report on Form 8-K filed by the Company with the Securities and
Exchange Commission on February 24, 2017 – Commission File No. 001-35023)
Certificate of Designation, Preferences and Rights of the Series A Convertible Preferred Stock of iBio, Inc. (incorporated
herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on June 27, 2018 – Commission File No. 001-35023)
Certificate of Designation, Preferences and Rights of the Series B Convertible Preferred Stock of iBio, Inc. (incorporated
herein by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on June 27, 2018 – Commission File No. 001-35023)
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3.7
3.8
3.9
3.10
3.11
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
Certificate of Designation, Preferences and Rights of the Series C Convertible Preferred Stock of iBio, Inc. (incorporated
herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on October 29, 2019 – Commission File No. 001-35023)
Second Amended and Restated Bylaws of iBio, Inc. (incorporated herein by reference to Exhibit 3.1 to the Company’s
Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission on August 14, 2009 –
Commission File No. 000-53125)
Certificate of Designation of Preferences, Rights and Limitations of Series 2022 Convertible Preferred Stock
(incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on May 12, 2022 – Commission File No. 001-35023)
Certificate of Designation of Preferences, Rights and Limitations of Series 2022 Convertible Preferred Stock
(incorporated herein by reference to the Company’s Current Report on Form 8-K filed by the Company with the
Securities and Exchange Commission on May 12, 2022 – Commission File No. 001-35023)
Certificate of Amendment of the Certificate of Incorporation of iBio, Inc. (incorporated herein by reference to the
Company’s Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission on
October 7, 2022 – Commission File No. 001-35023)
Form of Common Stock Certificate (incorporated herein by reference to Exhibit 4.1 to the Company’s Form 10-12G filed
with the Securities and Exchange Commission on July 11, 2008 – Commission File No. 000-53125)
Description of Securities of iBio, Inc. (incorporated by reference to Exhibit 4.10 to the Annual Report on Form 10-K for
the year ended June 30, 2021- Commission File No. 000-53125)
Term Note of IBIO CDMO LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on November 4, 2021 – Commission File No. 001-35023)
iBio, Inc. Warrant (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on November 4, 2021 – Commission File No. 001-35023)
Form of Pre-Funded Warrant (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on December 8, 2022 – Commission File No. 001-35023)
Form of Series A Warrants (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-
K filed with the Securities and Exchange Commission on December 8, 2022 – Commission File No. 001-35023)
Form of Series B Warrants (incorporated herein by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-
K filed with the Securities and Exchange Commission on December 8, 2022 – Commission File No. 001-35023)
Form of Representative’s Warrants (incorporated herein by reference to Exhibit 4.4 to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on December 8, 2022 – Commission File No. 001-35023)
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10.1
10.2+
10.3
10.4
10.7
10.8†
10.11†
10.12†
10.16†
10.17†
10.18†
10.19†
Technology Transfer Agreement, dated as of January 1, 2004, between the Company and Fraunhofer USA Center for
Molecular Biotechnology, Inc. as amended (incorporated herein by reference to Exhibit 10.6 to the Company’s Form 10-
12G filed with the Securities and Exchange Commission on June 18, 2008 – Commission File No. 000-53125)
Ratification dated September 6, 2013 of Terms of Settlement by and between the Company and Fraunhofer USA Center
for Molecular Biotechnology, Inc. (incorporated herein by reference to Exhibit 10.3 to the Company’s Annual Report on
Form 10-K for the fiscal year ended June 30, 2013, filed with the Securities and Exchange Commission on September 30,
2013 – Commission File No. 001-35023).
Amended and Restated Limited Liability Company Agreement of iBio CDMO LLC, dated January 13, 2016, between the
Company, Bryan Capital Investors LLC and iBio CDMO LLC (incorporated herein by reference to Exhibit 10.3 to the
Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on February 22, 2016 –
Commission File No. 001-35023)
License Agreement, dated January 13, 2016, between the Company and iBio CDMO LLC (incorporated herein by
reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission on February 22, 2016 – Commission File No. 001-35023)
Amendment No. 1 to the Amended and Restated Limited Liability Company Agreement of iBio CDMO LLC, dated
February 23, 2017 (incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on February 24, 2017 – Commission File No. 001-35023)
Form of Directors and Officer Indemnification Agreement (incorporated herein by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 1, 2019 –
Commission File No. 001-35023)
2018 Omnibus Equity Incentive Plan, effective December 18, 2018 (incorporated herein by reference to Exhibit 10.13 to
the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on August 26, 2019 –
Commission File No. 001-35023)
Amended and Restated 2018 Omnibus Equity Incentive Plan, effective December 18, 2018 (incorporated herein by
reference to Appendix B to the Company’s Definitive Proxy Statement filed with the Securities and Exchange
Commission on January 23, 2020 – Commission File No. 001-35023)
Employment Agreement dated January 18, 2021, by and between iBio, Inc. and Martin B. Brenner (incorporated by
reference to Exhibit 10.20 to the Annual Report on Form 10-K for the year ended June 30, 2021- Commission File No.
000-53125)
iBio, Inc. 2020 Omnibus Equity Incentive Plan (incorporated by reference to Appendix B to the Definitive Proxy
Statement on Schedule 14A filed with the Securities and Exchange Commission on November 3, 2020 – Commission
File No. 001-35023)
Form of Non-Qualified Stock Option Agreement for Employees under the iBio, Inc. 2020 Omnibus Incentive Plan
(incorporated herein by reference to Exhibit 10.2 to the Registration Statement on Form S-8 filed by the Company with
the Securities and Exchange Commission on January 11, 2021 – Commission File No. 333-252027)
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors (Initial Grant) under the iBio, Inc. 2020
Omnibus Incentive Plan (incorporated herein by reference to Exhibit 10.3 to the Registration Statement on Form S-8
filed by the Company with the Securities and Exchange Commission on January 11, 2021 – Commission File No. 333-
252027)
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10.20†
10.21†
10.22†
10.23†
10.24++
10.25++
10.26
10.27†
Form of Non-Qualified Stock Option Agreement for Non-Employee Directors (Annual Grant) under the iBio, Inc. 2020
Omnibus Incentive Plan (incorporated herein by reference to Exhibit 10.4 to the Registration Statement on Form S-8
filed by the Company with the Securities and Exchange Commission on January 11, 2021 – Commission File No. 333-
252027)
Form of Restricted Stock Unit Award Agreement for Employees under the iBio, Inc. 2020 Omnibus Incentive Plan
(incorporated herein by reference to Exhibit 10.5 to the Registration Statement on Form S-8 filed by the Company with
the Securities and Exchange Commission on January 11, 2021 – Commission File No. 333-252027)
Form of Restricted Stock Unit Award Agreement for Employees under the iBio, Inc. 2018 Omnibus Equity Incentive
Plan, as amended and restated (incorporated herein by reference to Exhibit 10.2 to the Registration Statement on Form S-
8 filed by the Company with the Securities and Exchange Commission on January 11, 2021 – Commission File No. 001-
35023)
Employment Agreement dated February 15, 2021, by and between iBio, Inc. and Robert Lutz, Effective March 4, 2021
(incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Company with the
Securities and Exchange Commission on February 16, 2021 – Commission File No. 001-35023)
Exclusive License Agreement between the Company and University of Pittsburgh dated January 14, 2014 (incorporated
herein by reference to Exhibit 10.6 to the Quarterly Report on Form 10-Q filed by the Company with the Securities and
Exchange Commission on February 16, 2021 – Commission File No. 001-35023)
First Amendment to Exclusive License Agreement between the Company and the University of Pittsburgh dated August
11, 2016 (incorporated herein by reference to Exhibit 10.7 to the Quarterly Report on Form 10-Q filed by the Company
with the Securities and Exchange Commission on February 16, 2021 – Commission File No. 001-35023)
Second Amendment to Exclusive License Agreement between the Company and the University of Pittsburgh dated
November 2, 2020 (incorporated herein by reference to Exhibit 10.8 to the Quarterly Report on Form 10-Q filed by the
Company with the Securities and Exchange Commission on February 16, 2021 – Commission File No. 001-35023)
Employment Agreement, dated as of April 30, 2021, by and between iBio, Inc. and Thomas F. Isett (incorporated herein
by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Company with the Securities and Exchange
Commission on May 6, 2021 – Commission File No. 001-35023)
10.28†
Director Offer Letter (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the
Company with the Securities and Exchange Commission on June 9, 2021 – Commission File No. 001-35023)
10.29++**
10.30++**
Collaboration, Option and License Agreement, dated August 23, 2021, by and between iBio, Inc. and RubrYc
Therapeutics, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on August 27, 2021– Commission File No. 001-35023).
Collaboration and License Agreement, dated August 23, 2021, by and between iBio, Inc. and RubrYc Therapeutics, Inc.
(incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on August 27, 2021– Commission File No. 001-35023).
97
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10.31++**
10.32++**
10.33++**
10.34++**
Stock Purchase Agreement, dated August 23, 2021, by and between iBio, Inc. and RubrYc Therapeutics, Inc.
(incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on August 27, 2021– Commission File No. 001-35023).
Second Amended and Restated Investor Rights Agreement, dated August 23, 2021, by and among RubrYc Therapeutics,
Inc. and certain investors (incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-
K filed with the Securities and Exchange Commission on August 27, 2021– Commission File No. 001-35023).
Second Amended and Restated Voting Agreement, dated August 23, 2021, by and among RubrYc Therapeutics, Inc. and
certain investors(incorporated herein by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on August 27, 2021– Commission File No. 001-35023).
Second Amended and Restated Right of First Refusal and Co-Sale Agreement, dated August 23, 2021, by and among
RubrYc Therapeutics, Inc. and certain investors(incorporated herein by reference to Exhibit 10.6 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on August 27, 2021– Commission File
No. 001-35023).
10.35++
Employment Agreement dated December 23, 2020 and effective as of January 18, 2021, by and between iBio, Inc. and
Martin B. Brenner (incorporated herein by reference to Exhibit 10.20 to the Annual Report on Form 10-K filed by the
Company with the Securities and Exchange Commission on September 28, 2021 – Commission File No. 001-35023)
10.36
10.37
10.38
10.39
10.40
10.41
Confidential Settlement and Mutual Release with Fraunhofer USA, Inc. dated May 4, 2021 (incorporated herein by
reference to Exhibit 10.31 to the Annual Report on Form 10-K filed by the Company with the Securities and Exchange
Commission on September 28, 2021 – Commission File No. 001-35023)
Purchase and Sale Agreement, dated November 1, 2021, by and among College Station Investors LLC, Bryan Capital
Investors LLC, iBio CDMO LLC and iBio, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on November 4, 2021 – Commission
File No. 001-35023)
Equity Purchase Agreement dated November 1, 2021 by and between Bryan Capital Investors LLC and iBio, Inc.
(incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on November 4, 2021 – Commission File No. 001-35023)
Credit Agreement, dated November 1, 2021 by and, between iBio CDMO LLC with Woodforest National Bank
(incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on November 4, 2021 – Commission File No. 001-35023)
Guaranty Agreement, dated November 1, 2021, by iBio, Inc. for the benefit of Woodforest National Bank
(incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on November 4, 2021 – Commission File No. 001-35023)
Leasehold Deed of Trust, Assignment of Leases and Rents, Security Agreement and UCC Financing Statement for
Fixture Filing by iBio CDMO LLC as grantor to the trustee for the benefit of Woodforest National Bank (incorporated
herein by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on November 4, 2021 – Commission File No. 001-35023)
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10.42
10.43
10.44
10.46
10.47
10.48
10.49
Security Agreement, dated November 1, 2021 by iBio CDMO LLC for the benefit of Woodforest National
Bank(incorporated herein by reference to Exhibit 10.6 to the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on November 4, 2021 – Commission File No. 001-35023)
Environmental Indemnity Agreement, dated November 1, 2021 by iBio CDMO LLC and iBio, Inc. in favor of
Woodforest National Bank (incorporated herein by reference to Exhibit 10.7 to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on November 4, 2021 – Commission File No. 001-35023)
Ground Lease Agreement (included as Exhibit A to The Purchase and Sale Agreement, dated November 1, 2021 by and
among College Station Investors LLC, Bryan Capital Investors LLC, iBio CDMO LLC and iBio, Inc. filed as Exhibit
10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on November 4, 2021 –
Commission File No. 001-35023)
Form of Stock Purchase Agreement (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed with the Securities and Exchange Commission on May 12, 2022 – File No. 001-35023)
Form of Irrevocable Proxy for Voting Control (incorporated herein by reference to Exhibit 10.2 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on May 12, 2022 – File No. 001-
35023)
Third Amendment to Exclusive License Agreement, dated February 3, 2022, by and between University of Pittsburgh and
iBio, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on May 12, 2022– Commission File No. 001-35023)
Asset Purchase Agreement dated September 16, 2022, by and between iBio, Inc. and RubrYc Therapeutics, Inc.
(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on September 21, 2022 – File No. 001-35023)
10.50*++
First Amendment to Credit Agreement entered into as of October 11, 2022, by and between iBio CDMO LLC with
Woodforest National Bank (incorporated herein by reference to Exhibit 10.51 to the Company’s Annual Report on Form
10-K filed with the Securities and Exchange Commission on October 11, 2022– Commission File No. 001-35023).
10.51
10.52
10.53†
10.54†
Termination Agreement and Release dated September 19, 2022, by and between iBio, Inc. and RubrYc Therapeutics, Inc.
(incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on November 14, 2022 – File No. 001-35023)
Lease dated September 10, 2021, by and between iBio, Inc., and San Diego Inspire 4, LLC (incorporated herein by
reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission on November 14, 2022 – File No. 001-35023)
Restricted Stock Unit Award Agreement dated November 10, 2022, by and between iBio, Inc. and Thomas Isett
(incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on November 14, 2022 – File No. 001-35023)
Separation Agreement and General Release, dated December 1, 2022, by and between iBio, Inc. and Thomas Isett
(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on December 2, 2022, –File No. 001-35023)
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10.55†
10.56
10.57†
10.58†
10.59
10.60
10.61
10.62
10.63
10.64
21.1*
23.1*
31.1*
Offer Letter by and between iBio, Inc. and Felipe Duran dated January 23, 2023 (incorporated herein by reference to
Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on
January 25, 2023 – File No. 001-35023)
Second Amendment to Credit Agreement dated February 9, 2023, by and between iBio, Inc. and Woodforest National
Bank (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on February 14, 2023 – File No. 001-35023)
Special Incentive Bonus Agreement dated January 26, 2023, by and between iBio, Inc. and Martin Brenner (incorporated
herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on February 14, 2023 – File No. 001-35023)
Special Incentive Bonus Agreement dated January 26, 2023, by and between iBio, Inc. and Felipe Duran (incorporated
herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on February 14, 2023 – File No. 001-35023)
Third Amendment to Credit Agreement dated February 21, 2023 between iBio CDMO LLC and Woodforest National
Bank and Third Amended Guaranty of iBio, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on February 21, 2023 – File No. 000
35023)
Fourth Amendment to Credit Agreement dated March 24, 2023, between iBio CDMO LLC and Woodforest National
Bank and Fourth Amended Guaranty of iBio, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on March 30, 2023 – File No. 000
35023)
Auction Sale Agreement between iBio, Inc. and Holland Industrial Group, Federal Equipment Company and Capital
Recovery Group LLC dated as of February 10, 2023 (incorporated herein by reference to Exhibit 10.7 to the Company’s
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2023 – File No. 001-
35023)
Fifth Amendment to the Credit Agreement dated May 10, 2023, between iBio CDMO LLC and Woodforest National
Bank and Fifth Amended Guaranty of iBio, Inc. (incorporated herein by reference to Exhibit 10.8 to the Company’s
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2023 – File No. 001-
35023)
Purchase Agreement by and between the Registrant and Lincoln Park Capital Fund, LLC, dated August 4, 2023
(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on August 4, 2023– Commission File No. 001-35023).
Registration Rights Agreement by and between the Registrant and Lincoln Park Capital Fund, LLC, dated August 4, 2023
(incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on August 4, 2023– Commission File No. 001-35023).
Subsidiaries of Registrant
Consent of the Independent Registered Public Accounting Firm
Certification of Periodic Report by Principal Financial Officer and Principal Accounting Officer Pursuant to Rule 13a-14
and 15d-14 of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
100
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32.1*
32.2*
Certification of Periodic Report by Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
Certification of Periodic Report by Principal Financial Officer and Principal Accounting Officer Pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS Inline XBRL Instance Document*
101.SCH Inline XBRL Taxonomy Extension Schema Document *
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document *
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document *
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document *
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document *
Filed herewith.
*
† Management contract or compensatory plan or arrangement required to be identified pursuant to Item 15(a)(3) of this Annual
Report.
Certain portions of this exhibit have been omitted subject to a confidential treatment request.
+
++ Certain portions of this exhibit indicated therein by [**] have been omitted in accordance with Item 601(b)(10) of Regulation S-
K. The Company agrees to furnish unredacted copies of these Exhibits to the SEC upon request.
* *Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish supplementally to the SEC
a copy of any omitted schedule upon request.
101
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Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
Dated: September 27, 2023
iBio, Inc.
(Registrant)
/s/ Martin Brenner
Martin Brenner
Chief Executive Officer
/s/ Felipe Duran
Felipe Duran
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf
of the registrant and in the capacities and on the dates indicated:
Name
Title
/s/ Martin Brenner
Martin Brenner
/s/ Felipe Duran
Felipe Duran
/s/Linda Armstrong
Linda Armstrong
/s/Alexandra Kropotova
Alexandra Kropotova
/s/William Clark
William Clark
/s/Evert Schimmelpennink
Evert Schimmelpennink
/s/James T. Hill
General James T. Hill, USA (Retired)
/s/Gary Sender
Gary Sender
Chief Executive
Officer and Chief Scientific Officer (Principal
Executive Officer)
Chief Financial Officer
Officer (Principal Financial Officer and
Principal Accounting Officer)
Director
Director
Date
September 27, 2023
September 27, 2023
September 27, 2023
September 27, 2023
Chairman of the Board
September 27, 2023
Director
Director
Director
102
September 27, 2023
September 27, 2023
September 27, 2023
Table of Contents
Annual Financial Statements
iBio, Inc.
Financial Statement Index
Report of Independent Registered Public Accounting Firm – PCAOB ID 596
Financial Statements:
Consolidated Balance Sheets – June 30, 2023 and 2022
Consolidated Statements of Operations and Comprehensive Loss – Fiscal years ended June 30, 2023 and 2022
Consolidated Statements of Stockholders’ Equity – Fiscal years ended June 30, 2023 and 2022
Consolidated Statements of Cash Flows – Fiscal years ended June 30, 2023 and 2022
Notes to Consolidated Financial Statements
Page
F-2
F-6
F-7
F-8
F-9
F-11
F-1
Table of Contents
The Board of Directors and
Stockholders of iBio, Inc.
Opinion on the Financial Statements
Report of Independent Registered Public Accounting Firm
We have audited the accompanying consolidated balance sheets of iBio, Inc. and Subsidiaries (the “Company”) as of June 30, 2023 and
2022, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the
years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the consolidated financial
statements present fairly, in all material respects, the financial position of the Company as of June 30, 2023 and 2022, and the results of its
operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United
States of America.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As
discussed in Note 2 to the consolidated financial statements, the Company has suffered recurring losses from operations and negative cash
flows from operating activities for the years ended June 30, 2023 and 2022 and has an accumulated deficit as of June 30, 2023. These
matters, among others, raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these
matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on
these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company
Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance
with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or
fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As
part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of
expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such
opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial
statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements
that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are
material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The
communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole,
and we are not, by communicating the critical audit
F-2
Table of Contents
matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Asset Purchase Agreement
Critical Audit Matter Description
As discussed in the notes to the consolidated financial statements, on September 16, 2022, the Company entered into an Asset Purchase
Agreement with RubrYc Therapeutics, Inc. (“RubrYc”). The Company accounted for this agreement as an asset purchase and allocated the
consideration to the various assets acquired.
The financial reporting for the terms of the Asset Purchase Agreement (the “Agreement”) involved significant estimation by management
in its determination of the fair value of the assets acquired and the related fair value allocation of the Agreement. Given these factors, the
related audit effort in evaluating management’s judgments of the fair value of the assets acquired and related fair value allocation related to
the Agreement was challenging, subjective, and complex and required a high degree of auditor judgment.
How the Critical Audit Matter was addressed in the Audit
Our principal audit procedures related to the Company’s financial reporting for the Agreement included, among others:
● We obtained an understanding of and evaluated the design and implementation of controls that address the risk of material
misstatement for the financial reporting for asset acquisitions.
● We evaluated management’s significant accounting policies related to asset acquisitions for reasonableness.
● We evaluated the reasonableness of the assets acquired included within the Agreement.
● We verified the total consideration included among the terms of the Agreement.
● We involved our valuation specialists to assist in testing the Company’s methodology and significant assumptions used to fair
value the assets acquired.
● We utilized our valuation specialists who performed sensitivity analyses of the significant assumptions to evaluate the change in
the fair value allocation of the assets acquired resulting from changes in the assumptions.
● We evaluated the Company’s allocation of total consideration to the assets acquired.
● We evaluated the Company’s relevant financial statement presentation and disclosures for consistency with our knowledge of the
terms of the Agreement and with accounting standards.
Acquired License Impairment Assessment
As disclosed in the notes to the consolidated financial statements, the Company acquired an indefinite-lived license of approximately
$5.003 million. This asset is assessed for impairment at least annually and upon the occurrence of a triggering event. The impairment test
for indefinite life licenses consists of comparing the fair value, which is estimated using the income approach, to its carrying value. If the
carrying value exceeds the fair value, an impairment loss is recognized in an amount equal to such excess. The determination of the fair
value is primarily based on discounted future cash flows projected to be generated from the license, including the estimates of future
revenue, future development costs, the probability of success in various phases of development programs, and potential post-launch cash
flows. Changes in these assumptions could have a significant impact on either the fair value, the amount of any impairment charges, or
both.
Significant judgment is exercised by management when developing the fair value measurement of the license. Given these factors, the
related audit effort in evaluating management’s judgments of the fair value of the acquired license was challenging, subjective, and
complex and required a high degree of auditor judgment.
F-3
Table of Contents
How the Critical Audit Matter was addressed in the Audit
Our principal audit procedures related to the Company’s financial reporting relating to potential impairment of the license included, among
others:
● We obtained an understanding and evaluated the design and implementation of internal controls over the Company’s process for
indefinite-lived intangible impairment assessments.
● We evaluated management’s significant accounting policies related to impairment of the acquired license intangible for
reasonableness.
● We tested management’s process for developing the fair value of the license.
● Through the use of internal valuation specialists, we assessed the appropriateness and consistency of the discounted cash flow
analyses model.
● We involved our valuation specialists to assist in testing the Company’s methodology and significant assumptions used amongst
the Company’s impairment assessment.
● We involved our valuation specialists to assist in testing the Company’s market capitalization reconciliation associated with the
Company’s impairment assessment.
● We utilized our valuation specialists who performed sensitivity analyses of the significant assumptions to evaluate the Company’s
impairment assessment resulting from changes in the assumptions.
● We evaluated the significant assumptions related to future revenue, future development costs, and the probability of success in
various phases of development programs as well as post launch cash flows.
● In evaluating management’s significant assumptions for reasonableness, we considered consistency with external market and
industry data and evidence obtained in other areas of the audit.
● We assessed the sensitivity of changes in estimating the fair value in comparison to the carrying value for reasonableness.
Assets Held for Sale
As disclosed in the notes to the consolidated financial statements, the Company has Assets Held for Sale of approximately $18.065 million.
Assets held for sale shall be measured at the lower of its carrying amount or fair value less costs to sell. A loss shall be recognized for any
initial or subsequent write-down to fair value less costs to sell. The determination of fair value less costs to sell is based on a combination
of appraisal of the respective building and associated land, discussions with the Company engaged brokers and estimated closing costs on
any potential sale of the assets held for sale. Changes in the assumptions could have a significant impact on either the fair value, the amount
of any impairment charges, or both.
Significant judgment is exercised by management when developing the fair value less costs to sell analysis related to the assets held for
sale. Given these factors, the related audit effort in evaluating management’s judgments of the fair value less costs to sell was challenging,
subjective and complex and required a high degree of auditor judgement.
How the Critical Audit Matter was addressed in the Audit
Our principal audit procedures related to the Company’s financial reporting relating to impairment of the assets held for sale included,
among others:
● We obtained an understanding and evaluated the design and implementation of internal controls over the Company’s process for
impairment assessments regarding assets held for sale.
● We evaluated management’s significant accounting policies related to impairment of the Company’s assets held for sale.
● We tested management’s process for developing the fair value estimates regarding the assets held for sale.
● We involved our valuation specialists to assist in testing the Company’s methodology and significant assumptions used to estimate
fair value of the assets held for sale.
● We tested management’s process for developing the estimated costs to sell the assets held for sale.
● In evaluating management’s significant assumptions for reasonableness, we considered consistency with external market data and
evidence obtained in other areas of the audit.
F-4
Table of Contents
/s/ CohnReznick LLP
We have served as the Company's auditor since 2010.
Holmdel, New Jersey
September 27, 2023
F-5
Table of Contents
iBio, Inc. and Subsidiaries
Consolidated Balance Sheets
(In Thousands, except share and per share amounts)
June 30, 2023
June 30, 2022
Assets
Current assets:
Cash and cash equivalents
Restricted cash
Investments in debt securities
Accounts receivable - trade
Subscription receivable
Settlement receivable - current portion
Prepaid expenses and other current assets
Current assets held for sale
Total Current Assets
Restricted cash
Promissory note receivable and accrued interest
Finance lease right-of-use assets, net of accumulated amortization
Operating lease right-of-use asset
Fixed assets, net of accumulated depreciation
Intangible assets, net of accumulated amortization
Security deposits
Prepaid expenses - noncurrent
Noncurrent assets held for sale
Total Assets
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
Accrued expenses
Finance lease obligations - current portion
Operating lease obligation - current portion
Equipment financing payable - current portion
Term note payable - net of deferred financing costs
Contract liabilities
Current liabilities related to assets held for sale
Total Current Liabilities
Finance lease obligations - net of current portion
Operating lease obligation - net of current portion
Equipment financing payable - net of current portion
Accrued expenses - noncurrent
Noncurrent liabilities related to assets held for sale
Total Liabilities
Stockholders' Equity
Series 2022 Convertible Preferred Stock - $0.001 par value; 1,000,000 shares authorized; 0 and 1,000
shares issued and outstanding as of June 30, 2023 and 2022
Common Stock - $0.001 par value; 275,000,000 shares authorized at June 30, 2023 and 2022;
20,310,077 and 8,727,158 shares issued and outstanding as of June 30, 2023 and June 30, 2022,
respectively
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total Stockholders’ Equity
Total Liabilities and Stockholders' Equity
$
$
$
$
$
4,301
3,025
—
—
204
—
664
18,065
26,259
$
$
253
1,706
610
2,722
4,219
5,388
50
—
—
41,207
1,849
4,034
272
389
160
12,937
—
1,941
21,582
351
3,125
241
527
—
25,826
—
20
304,301
—
(288,940)
15,381
41,207
$
22,676
—
10,845
1,000
—
5,100
1,549
3,900
45,070
5,996
1,631
—
3,068
1,373
4,851
29
74
37,314
99,406
4,264
3,764
—
91
—
22,161
100
56
30,436
—
3,514
—
—
1,971
35,921
—
9
287,619
(213)
(223,930)
63,485
99,406
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Table of Contents
Revenues
Operating expenses:
Research and development
General and administrative
Total operating expenses
Operating loss
Other income (expense):
Interest expense
Interest income
Loss on sale of debt securities
Royalty income
Total other income
iBio, Inc. and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In Thousands, except per share amounts)
Years Ended
June 30,
2023
2022
$
—
$
1,884
10,327
19,016
29,343
(29,343)
(83)
213
(98)
—
32
(29,311)
—
(29,311)
—
(29,311)
(35,699)
(65,010)
(65,010)
180
33
(64,797)
(2.39)
(2.92)
(5.31)
12,245
$
$
$
$
$
$
9,827
21,754
31,581
(29,697)
—
177
—
7
184
(29,513)
1
(29,512)
(88)
(29,600)
(20,791)
(50,391)
(50,304)
(150)
—
(50,454)
(3.39)
(2.39)
(5.78)
8,721
Consolidated net loss from continuing operations
Net loss attributable to noncontrolling interest
Net loss attributable to iBio, Inc. from continuing operations
Preferred stock dividends - iBio CDMO Tracking Stock
Net loss available to iBio, Inc. stockholders from continuing operations
Loss from discontinued operations
Net loss available to iBio, Inc. stockholders
Comprehensive loss:
Consolidated net loss
Other comprehensive income (loss) - unrealized gain (loss) on debt securities
Other comprehensive income - foreign currency adjustment
Comprehensive loss
Loss per common share attributable to iBio, Inc. stockholders - basic and diluted - continuing
operations
Loss per common share attributable to iBio, Inc. stockholders - basic and diluted - discontinued
operations
Loss per common share attributable to iBio, Inc. stockholders - basic and diluted - total
Weighted-average common shares outstanding - basic and diluted
$
$
$
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
F-7
Table of Contents
iBio, Inc. and Subsidiaries
Consolidated Statements of Stockholders’ Equity
Years Ended June 30, 2023 and 2022
(In Thousands)
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive Accumulated Noncontrolling
Deficit
Interest
Loss
Total
Balance as of July 1, 2021
— $
Sale of preferred stock
Vesting of RSUs
Warrant issued for Transaction
Acquisition of remaining portion of iBio
CDMO
Exercise of stock options
Share-based compensation
Unrealized loss on available-for-sale debt
securities
Net loss
Balance as of June 30, 2022
Capital raises
Costs to raise capital
Asset acquisition
Payments for fractional shares resulting
from reverse stock split
Vesting of RSUs
Conversion of preferred stock to common
stock
Share-based compensation
Foreign currency adjustment
Reclassification adjustment for loss on
available-for-sale debt securities realized in
net income
Unrealized gain on available-for-sale debt
securities
Net loss
Balance as of June 30, 2023
1
—
—
—
—
—
—
—
1
—
—
—
—
—
(1)
—
—
—
—
—
— $
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
8,715 $
9 $
282,266 $
(63) $
(173,627) $
(17) $ 108,568
—
9
—
—
3
—
—
—
8,727
11,271
—
102
(8)
218
—
—
—
—
—
—
20,310
$
—
—
—
—
—
—
—
—
9
11
—
—
—
—
—
—
—
—
—
—
20
—
—
967
(68)
77
4,377
—
—
287,619
12,316
(636)
650
(39)
—
—
4,391
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(150)
—
(213)
—
(50,303)
(223,930)
—
—
—
—
—
—
—
33
21
—
—
—
—
—
—
—
—
—
—
—
304,301
$
$
159
—
— $
—
(65,010)
(288,940) $
—
—
—
18
—
—
—
(1)
—
—
—
—
—
—
—
—
—
—
—
967
(50)
77
4,377
(150)
(50,304)
63,485
12,327
(636)
650
(39)
—
—
4,391
33
—
—
—
— $
21
159
(65,010)
15,381
The accompanying notes are an integral part of these consolidated financial statements.
F-8
Table of Contents
iBio, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In Thousands)
Cash flows from operating activities:
Consolidated net loss
Adjustments to reconcile consolidated net loss to net cash used in operating activities:
Years Ended
June 30,
2023
2022
$
(65,010)
$
(50,304)
Share-based compensation
Amortization of intangible assets
Amortization of finance lease right-of-use assets
Amortization of operating lease right-of-use assets
Depreciation of fixed assets
Gain on sale of fixed assets
Accrued interest receivable on promissory note receivable
Amortization of premiums on debt securities
Loss on sale of debt securities
Amortization of deferred financing costs
Inventory reserve
Impairment of fixed assets
Impairment of intangible assets
Gain on disposition of finance lease ROU assets
Forgiveness of note payable and accrued interest - SBA loan
Settlement of revenue contract
Impairment of investment in equity security
Changes in operating assets and liabilities:
Accounts receivable - trade
Settlement receivable
Inventory
Prepaid expenses and other current assets
Prepaid expenses - noncurrent
Security deposit
Accounts payable
Accrued expenses
Accrued expenses - noncurrent
Operating lease obligations
Contract liabilities
Net cash used in operating activities
Cash flows from investing activities:
Purchases of debt securities
Redemption of debt securities
Sale of debt securities
Purchase of equity security
Additions to intangible assets
Purchases of fixed assets
Sales proceeds for fixed assets
Payment for RubrYc asset acquisition
Net cash provided by (used in) investing activities
Cash flows from financing activities:
Proceeds from sales of common stock
Payments for fractional shares after reverse stock split
Acquisition of noncontrolling interest
Proceeds from equipment financing loan
Payment of equipment financing loan
Payment of term note payable
Proceeds from exercise of stock options
Costs to attain term note
Payment of finance lease obligation
Net cash provided by (used in) financing activities
Effect of exchange rate changes
Net decrease in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash - beginning
Cash, cash equivalents and restricted cash - end
4,391
126
224
356
674
(773)
(75)
67
98
242
4,915
17,900
565
(5)
—
—
—
1,000
5,100
(1,015)
885
74
(21)
(625)
145
527
(101)
(100)
(30,436)
—
4,100
6,739
—
—
(5,738)
2,600
(692)
7,009
11,487
(39)
—
500
(99)
(9,318)
—
(22)
(208)
2,301
33
(21,093)
28,672
7,579
$
4,377
401
599
516
2,275
—
(75)
312
—
107
—
—
—
—
(607)
(84)
1,760
(886)
5,100
(3,873)
307
(74)
(5)
1,239
1,443
—
(15)
7
(37,480)
(5,355)
13,618
—
(1,760)
(4,300)
(7,330)
—
—
(5,127)
—
—
(50)
—
—
—
77
(322)
(5,830)
(6,125)
—
(48,732)
77,404
28,672
$
The accompanying notes are an integral part of these consolidated financial statements.
F-9
Table of Contents
iBio, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In Thousands)
Schedule of non-cash activities:
Fixed assets included in accounts payable in prior period, paid in current period
Increase in finance lease ROU assets for new leases
Increase in finance lease obligation for new leases
RubrYc asset acquisition by issuance of common stock
Costs to raise capital paid directly from gross proceeds
Subscription receivable
Cost accrued to amend term note payable
Unpaid fixed assets included in accounts payable
Termination of finance ROU assets including issuance of warrant
Note payable to acquire Facility
Increase in operating lease ROU assets for new lease - net of lease incentive
Settlement of revenue contract
Issuance of warrant for final finance lease obligation payment
Lease incentive for construction in progress
Acquisition of noncontrolling interest
Unrealized (gain) loss on available-for-sale debt securities
Supplemental cash flow information:
Cash paid during the period for interest
Years Ended
June 30,
2023
2022
1,769
814
814
650
636
204
125
—
—
—
—
—
—
—
—
(159)
687
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
791
—
—
—
—
—
—
1,769
25,386
22,375
5,570
580
217
82
18
150
1,045
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
F-10
Table of Contents
1. Nature of Business
iBio, Inc. (also referred to as "we", "us", "our", "iBio", or the "Company") is a preclinical stage biotechnology company that leverages the
power of Artificial Intelligence (AI) for the development of precision antibodies. Our proprietary technology stack is designed to minimize
downstream development risks by employing AI-guided epitope-steering and monoclonal antibody (mAb) optimization.
In September 2022, iBio made a strategic pivot by acquiring substantially all of the assets of RubrYc Therapeutics, Inc. ("RubrYc"). This
acquisition commenced our transition to an AI-enabled biotech company and led to the divestiture of our Contract Development and
Manufacturing Organization (CDMO) business. This strategic decision allowed us focus resources on the development of AI-powered
precision antibodies, positioning iBio at the forefront of this exciting field.
One of the key features of iBio’s technology stack is the patented epitope-steering AI-engine. This advanced technology allows us to target
specific regions of proteins with unprecedented precision enabling the creation of antibodies highly specific to therapeutically relevant
regions within large target proteins, potentially improving their efficacy and safety profile. Another integral part of iBio’s technology stack
is the machine learning (ML) based antibody-optimizing StableHu™ technology. When coupled with our mammalian display technology,
StableHu has been shown to accelerate the Lead Optimization process and potentially reduces downstream risks, making the overall
development process faster, more efficient and cost-effective.
iBio also developed the EngageTx™ platform, which provides an optimized next-generation CD3 T-cell engager antibody panel. This panel
is characterized by a wide spectrum of potencies, Non-Human Primate (NHP) cross-reactivity, enhanced humanness of the antibodies, and
a maintained tumor cell killing capacity, all while reducing cytokine release. These attributes are meticulously designed to fine-tune the
efficacy, safety, and tolerability of our antibody products. By incorporating EngageTx into iBio’s own development initiatives, the
Company’s internal pre-clinical pipeline reaps the benefits of the same cutting-edge technology extended to our potential partners.
iBio’s scientific team, composed of experienced AI/ML scientists and drug hunters located side-by-side in our San Diego laboratory,
possess the skills and capabilities to rapidly advance antibodies in house from concept to in vivo proof-of-concept (POC). This
multidisciplinary expertise allows us to quickly translate scientific discoveries into potential therapeutic applications.
Artificial Intelligence in Antibody Discovery and Development
The potential of AI in antibody discovery is immense and is being increasingly recognized in the biopharmaceutical industry. The mAbs
market has seen impressive growth in recent years, with mAbs increasingly the top-selling drugs in the United States. This success has
driven the industry to seek innovative methods for refining and improving their antibody pipelines. AI and deep learning, which have
already revolutionized small molecule drug design, are now making significant strides in the development and optimization of antibodies.
iBio is leveraging its AI-powered technology stack to enhance the success rate of identifying antibodies for challenging target proteins,
expedite the process of antibody optimization, improve developability, and engineer finely calibrated bi-specifics. By continually refining
the Company’s AI algorithms, incorporating new data sources, and developing robust experimental validation processes, iBio is paving the
way for groundbreaking advancements in antibody design and drug discovery.
Pre-Clinical Pipeline
iBio is currently in the process of building and advancing its preclinical pipeline. The focus of this pipeline is primarily on immuno-
oncology, with one program also dedicated to the immunology space. By leveraging iBio’s technology stack, the pipeline is geared towards
hard-to-drug targets and molecules offering differentiation. To mitigate target risk and capitalize
F-11
Table of Contents
on the learnings of competitors, iBio's programs are primarily adopting a fast follower strategy. This approach allows iBio to focus on
targets that have to some extent been validated and learn from the advancements of those ahead in the field.
Digital Infrastructure
iBio is a firm believer in the transformative power of digital technologies, including robotics, automation, artificial intelligence (AI),
machine learning (ML), and cloud computing. These technologies are integral to operationalizing our strategy, accelerating our learning
curve, and executing at scale. As such, the Company has made substantial investments in these areas. iBio’s aspiration is to digitize our
operations to the greatest extent possible, harnessing the potential of digital technology to maximize our impact on human health. As the
Company continues to grow, we remain committed to further investing in our digital infrastructure to support our ambitious goals.
Strategic Alliances, Collaborations, and Joint Ventures
iBio has formed collaborations and strategic alliances to gain access to funding, capabilities, technical resources and intellectual property to
further its development efforts, commercialize its technology and to generate revenues, including through the use of our patented epitope-
steering AI-engine and our EngageTX platform.
2. Basis of Presentation
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and include the accounts of iBio Inc. and its subsidiaries. All significant intercompany transactions and
accounts have been eliminated in consolidation. Non-controlling interest in the consolidated financial statements represented the share of
the loss in iBio CDMO, LLC (“iBio CDMO”) for an affiliate of Eastern Capital Limited (“Eastern Capital”) through November 1, 2021,
the date the Company acquired the remaining interest in iBio CDMO. See Note 6 – Significant Transactions.
Going Concern
The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by the
Company on its ability to obtain additional financing to fund its operations after the current cash resources are exhausted raise substantial
doubt about the Company's ability to continue as a going concern. In an effort to remain a going concern and increase cash reserves, the
Company completed a public equity offering and at-the-market offerings, reduced its work force by approximately 60% (a reduction of
approximately 69 positions) in November 2022, and ceased operations of its CDMO Facility thereby reducing annual spend on expenses.
Additionally, the Company has executed the Purchase and Sale Agreement for the sale of the CDMO Facility, which sale if consummated
will allow us to pay all outstanding amounts under the Term Loan; however, the consummation of the sale is subject to closing conditions
F-12
Table of Contents
for which there can be no assurance that they will be met or the closing will occur in a timely manner, if at all. If the closing is not
consummated prior to the December 31, 2023 maturity date of the Term Loan it is unlikely that the Company will have sufficient funds the
repay the Term Loan on its maturity date, which Term Loan has an outstanding balance of $12.7 million as of September 26, 2023.
Additionally, in July 2022, the Company initiated the selling of the CDMO assets and facility, and since then has sold a substantial portion
of the CDMO assets. (See Note 3 – Discontinued Operations for more information.)
The Company’s cash, cash equivalents and restricted cash of approximately $7.6 million as of June 30, 2023, is not anticipated to be
sufficient to support operations through the second quarter of Fiscal 2024 unless the Company reduces its burn rate further, sells the CDMO
Facility for amounts above its term note payable or increases its capital as described above. Regardless of whether the Company is able to
reduce its burn rate or sell or out-license certain assets or parts of the business, the Company will need to raise additional capital in order to
fully execute its longer-term business plan. It is the Company’s goal to implement one or more potential options described above to allow
the Company to have a cash runway for at least 12 months from the date of the filing of this Annual Report. However, there can be no
assurance that the Company will be successful in implementing any of the options that it is evaluating.
The accompanying consolidated financial statements do not include any adjustments related to the recoverability and classification of
assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going
concern.
Reverse Stock Split
On September 22, 2022, the Company's Board of Directors approved the implementation of a reverse stock split at a ratio of one-for-twenty
five (1 : 25) shares of the Company's Common Stock. The reverse stock split was effective as of October 7, 2022. All share and per share
amounts of our common stock presented have been retroactively adjusted to reflect the one-for-twenty five reverse stock split. See Note 17
– Stockholders’ Equity for more information.
F-13
Table of Contents
3. Discontinued Operations
On November 3, 2022, the Company announced it is seeking to divest its contract development and manufacturing organization (iBio
CDMO, LLC) in order to complete its transformation into an antibody discovery and development company. In conjunction with the
divestment, the Company commenced a workforce reduction of approximately 60% of the current Company staffing levels (a reduction of
approximately 69 positions). The Company substantially completed the employee reduction by January 2, 2023. Through the process of
seeking to divest its contract development and manufacturing organization, the Company continues to market for sale the 130,000 square
foot cGMP facility location in Bryan, Texas (the “Facility”). Additionally, on February 10, 2023, the Company entered into an Auction Sale
Agreement (the “Auction Sale Agreement”) with Holland Industrial Group, together with Federal Equipment Company and Capital
Recovery Group LLC (collectively, the “Auctioneers”) for the sale at public auction of equipment and other tangible personal property (the
“Equipment”) located at the Facility. The Auctioneers guaranteed an amount of gross proceeds from the sale of the equipment of $2.1
million, which was paid to the Company on February 17, 2023. The auction, which commenced on March 24, 2023 and concluded on
March 30, 2023, resulted in total proceeds of approximately $2.9 million. In accordance with the Auction Sale Agreement, the Company
received 80% of the excess proceeds, after Holland Industrial Group’s $0.2 million fee. Total proceeds received in Fiscal 2023 were
approximately $2.6 million.
The Company incurred pre-tax charges of approximately $1.9 million for the employee reduction which consisted of severance obligations,
continuation of salaries and benefits over a 60-day transitional period during which impacted employees remained employed but were not
expected to provide active service, and other customary employee benefit payments in connection with an employee reduction. The
Company recorded a charge in discontinued operations for approximately $35.7 million in Fiscal 2023, of which approximately $17.9
million was the result of a fixed asset impairment charge (see Note 11 – Fixed Assets for more information), approximately $4.9 million to
write down inventory to its net realizable value, approximately $7.5 million of personnel costs including severance and the balance related
to operational costs related to winding down the CDMO business.
As such, the results of iBio CDMO's operations are reported as discontinued operations for the year ended June 30, 2023. The Company
has retrospectively recast its consolidated statement of operations for the year ended June 30, 2022 presented. In addition, those assets and
liabilities associated with the discontinued operations of the CDMO that the Company intends to sell have been classified as “held for sale”
as of June 30, 2023. The Company has retrospectively recast its consolidated balance sheet as of June 30, 2022 for assets and liabilities
held for sale. The Company has chosen not to segregate the cash flows of iBio CDMO in the consolidated statements of cash flows.
Supplemental disclosures related to discontinued operations for the statements of cash flows have been provided below. Unless noted
otherwise, discussion in the Notes to the Consolidated Financial Statements refers to the Company's continuing operations.
The following table presents a reconciliation of the major financial lines constituting the results of operations for discontinued operations to
the loss from discontinued operations presented separately in the consolidated statements of operations (in thousands):
F-14
Table of Contents
Revenues
Cost of goods sold
Gross profit
Operating expenses:
Research and development
General and administrative
Fixed asset impairments
Gain on sale of fixed assets
Inventory reserve
Total operating expenses
Other income (expenses):
Interest expense - term note payable
Interest expense - related party
Forgiveness of note payable and accrued interest - SBA loan
Other
Total other expenses
Years Ended June 30,
2023
2022
$
$
391
52
339
6,344
6,751
17,900
(773)
4,915
35,137
(900)
—
—
(1)
(901)
499
216
283
7,902
12,373
—
—
—
20,275
(602)
(810)
607
6
(799)
Loss from discontinued operations
$
(35,699)
$
(20,791)
The following table presents net carrying values related to the major classes of assets that were classified as held for sale at June 30, 2023
and 2022 (in thousands):
Current assets:
Inventory
Operating lease right-of-use assets
Property and equipment, net
Total current assets
Other assets:
Property and equipment, net
Finance lease right-of-use assets
Operating lease right-of-use assets
Total other assets
Current liabilities:
Finance lease obligation
Operating lease obligation
Total current liabilities
Long-term liabilities:
Finance lease obligation
Operating lease obligation
Total long-term liabilities
June 30,
2023
June 30,
2022
$
$
$
$
$
$
$
$
—
1,941
16,124
18,065
—
—
—
—
—
1,941
1,941
—
—
—
$
$
$
$
$
$
$
$
3,900
—
—
3,900
35,289
74
1,951
37,314
46
10
56
30
1,941
1,971
F-15
Table of Contents
The following table presents the supplemental disclosures related to discontinued operations for the cash flows (in thousands):
$
Depreciation expense
Amortization of finance lease right-of-use assets
Purchase of fixed assets
Fixed asset impairments
Inventory reserve
Sales proceeds of fixed assets
Investing non-cash transactions:
Increase in ROU operating assets and liabilities for new leases
Fixed assets included in accounts payable in prior period, paid in current period
Unpaid fixed assets included in accounts payable
Termination of finance ROU assets including issuance of warrant
Note payable to acquire Facility
Issuance of warrant for final lease obligation payment
Supplemental cash flow information:
Cash paid during the period for interest
4. Summary of Significant Accounting Policies
Use of Estimates
Years Ended June 30,
2023
2022
$
273
20
1,542
17,900
4,915
2,600
—
1,542
—
—
—
—
603
2,275
599
5,809
—
—
—
1,952
791
1,542
25,386
22,375
217
1,045
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and
assumptions that affect reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the
consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. These estimates include
liquidity assertions, the valuation of intellectual property and fixed assets held for sale, the incremental borrowing rate utilized in the
finance and operating lease calculations, legal and contractual contingencies and share-based compensation. Although management bases
its estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, actual
results could differ from these estimates.
Accounts Receivable
Accounts receivable are reported at their outstanding unpaid principal balances net of allowances for uncollectible accounts. The Company
provides for allowances for uncollectible receivables based on its estimate of uncollectible amounts considering age, collection history, and
any other factors considered appropriate. Management’s policy is to write off accounts receivable against the allowance for doubtful
accounts when a balance is determined to be uncollectible. At June 30, 2023 and 2022, the Company determined that an allowance for
doubtful accounts was not needed.
Revenue Recognition
The Company accounts for its revenue recognition under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with
Customers. Under this standard, the Company recognizes revenue when a customer obtains control of promised services or goods in an
amount that reflects the consideration to which the Company expects to receive in exchange for those goods or services. In addition, the
standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from customer contracts.
F-16
Table of Contents
The Company’s contract revenue consists primarily of amounts earned under contracts with third-party customers and reimbursed expenses
under such contracts. The Company analyzes its agreements to determine whether the elements can be separated and accounted for
individually or as a single unit of accounting. Allocation of revenue to individual elements that qualify for separate accounting is based on
the separate selling prices determined for each component, and total contract consideration is then allocated pro rata across the components
of the arrangement. If separate selling prices are not available, the Company will use its best estimate of such selling prices, consistent with
the overall pricing strategy and after consideration of relevant market factors.
In general, the Company applies the following steps when recognizing revenue from contracts with customers: (i) identify the contract, (ii)
identify the performance obligations, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations
and (v) recognize revenue when a performance obligation is satisfied.
Recognition of revenue is driven by satisfaction of the performance obligations using one of two methods: revenue is either recognized
over time or at a point in time. Contracts containing multiple performance obligations classify those performance obligations into separate
units of accounting either as standalone or combined units of accounting. For those performance obligations treated as a standalone unit of
accounting, revenue is generally recognized based on the method appropriate for each standalone unit. For those performance obligations
treated as a combined unit of accounting, revenue is generally recognized as the performance obligations are satisfied, which generally
occurs when control of the goods or services have been transferred to the customer or client or once the client or customer is able to direct
the use of those goods and / or services as well as obtaining substantially all of its benefits. As such, revenue for a combined unit of
accounting is generally recognized based on the method appropriate for the last delivered item but due to the specific nature of certain
project and contract items, management may determine an alternative revenue recognition method as appropriate, such as a contract
whereby one deliverable in the arrangement clearly comprises the overwhelming majority of the value of the overall combined unit of
accounting. Under this circumstance, management may determine revenue recognition for the combined unit of accounting based on the
revenue recognition guidance otherwise applicable to the predominant deliverable.
If a loss on a contract is anticipated, such loss is recognized in its entirety when the loss becomes evident. When the current estimates of the
amount of consideration that is expected to be received in exchange for transferring promised goods or services to the customer indicates a
loss will be incurred, a provision for the entire loss on the contract is made. At June 30, 2023 and 2022, the Company had no contract loss
provisions.
The Company generates (or may generate in the future) contract revenue under the following types of contracts:
Fixed-Fee
Under a fixed-fee contract, the Company charges a fixed agreed upon amount for a deliverable. Fixed-fee contracts have fixed deliverables
upon completion of the project. Typically, the Company recognizes revenue for fixed-fee contracts after projects are completed, delivery is
made and title transfers to the customer, and collection is reasonably assured.
Revenue can be recognized either 1) over time or 2) at a point in time and is summarized below (in thousands). All revenue was
recognized at a point in time for all periods presented.
No revenue was recognized in the year ended June 30, 2023. Revenue was recognized from a license agreement and the settlement of a
revenue contract in the year ended June 30, 2022.
Time and Materials
Under a time and materials contract, the Company charges customers an hourly rate plus reimbursement for other project specific costs.
The Company recognizes revenue for time and material contracts based on the number of hours devoted to the project multiplied by the
customer’s billing rate plus other project specific costs incurred.
F-17
Table of Contents
Contract Assets
A contract asset is an entity's right to payment for goods and services already transferred to a customer if that right to payment is
conditional on something other than the passage of time. Generally, an entity will recognize a contract asset when it has fulfilled a contract
obligation but must perform other obligations before being entitled to payment.
Contract assets consist primarily of the cost of project contract work performed by third parties whereby the Company expects to recognize
any related revenue at a later date, upon satisfaction of the contract obligations. At both June 30, 2023 and 2022, contract assets were $0.
Contract Liabilities
A contract liability is an entity’s obligation to transfer goods or services to a customer at the earlier of (1) when the customer prepays
consideration or (2) the time that the customer’s consideration is due for goods and services the entity will yet provide. Generally, an entity
will recognize a contract liability when it receives a prepayment.
Contract liabilities consist primarily of consideration received, usually in the form of payment, on project work to be performed whereby
the Company expects to recognize any related revenue at a later date, upon satisfaction of the contract obligations. At June 30, 2023 and
2022, contract liabilities were $0 and $100,000, respectively. The Company recognized revenue of $100 in 2023 that was included in the
contract liabilities balance as of June 30, 2022 and $178,000 in 2022 that was included in the contract liabilities balance as of June 30, 2021
and was reported in discontinued operations.
Leases
The Company accounts for leases under the guidance of ASC 842, Leases. The standard established a right-of-use (“ROU”) model
requiring a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months and
classified as either an operating or finance lease.
In accordance with ASC 842, at the inception of an arrangement, the Company determines whether the arrangement is or contains a lease
based on the unique facts and circumstances present and the classification of the lease including whether the contract involves the use of a
distinct identified asset, whether the Company obtains the right to substantially all the economic benefit from the use of the asset, and
whether the Company has the right to direct the use of the asset. Leases with a term greater than one year are recognized on the balance
sheet as ROU assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance
sheet leases with terms of one year or less under practical expedient in paragraph ASC 842-20-25-2. For contracts with lease and non-lease
components, the Company has elected not to allocate the contract consideration and to account for the lease and non-lease components as a
single lease component.
The lease liability and the corresponding ROU assets are recorded based on the present value of lease payments over the expected
remaining lease term. The implicit rate within the Company’s existing finance (capital) lease was determinable and, therefore, used at the
adoption date of ASC 842 to determine the present value of lease payments under the finance lease. The implicit rate within the Company’s
operating lease was not determinable and, therefore, the Company used the incremental borrowing rate at the lease commencement date to
determine the present value of lease payments. The determination of the Company’s incremental borrowing rate requires judgement. The
Company will determine the incremental borrowing rate for each new lease using its estimated borrowing rate.
An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain
we will exercise that option. An option to terminate is considered unless it is reasonably certain the Company will not exercise the option.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents.
Cash equivalents at June 30, 2023 and 2022 consisted of money market accounts. Restricted cash consists
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of approximately $3.0 million held within a Company account at Woodforest Bank for the Term Note payable (see Note 6 – Significant
Transactions and Note 14 – Debt) collateral, a letter of credit obtained related to the San Diego operating lease (see Note 16 – Operating
Lease Obligations) and a Company purchasing card. The Company’s bank requires an additional 5% collateral held above the actual letters
of credit issued for the San Diego lease and Company purchasing card. Restricted cash was $3,278,000 and $5,996,000 June 30, 2023 and
2022, respectively.
The following table summarizes the components of total cash, cash equivalents and restricted cash in the consolidated statements of cash
flows (in thousands):
Cash and equivalents
Collateral held for letter of credit - term note payable
Collateral held for letter of credit - San Diego lease
Collateral held for Company purchasing card
Total cash, cash equivalents and restricted cash
Investments in Debt Securities
June 30,
2023
June 30,
2022
4,301
3,025
198
55
7,579
$
$
22,676
5,743
198
55
28,672
$
$
Debt investments are classified as available-for-sale. Changes in fair value are recorded in other comprehensive income (loss). Fair value is
calculated based on publicly available market information. Discounts and/or premiums paid when the debt securities are acquired are
amortized to interest income over the terms of the debt securities. See Note 6 - Significant Transactions.
Inventory
Inventory is stated at the lower of cost or net realizable value on the first-in, first-out basis. Inventory held is related to the CDMO business
ad has been classified as held for sale. See Note 3 – Discontinued Operations for more information on the inventory reserved reflected in
the year ended June 30, 2023. The Company periodically evaluates inventory items and establishes reserves for obsolescence accordingly.
Inventory consists of the following (table in thousands):
Raw materials
Work in process
Research and Development
June 30,
2023
June 30,
2022
$
$
—
—
—
$
$
3,896
4
3,900
The Company accounts for research and development costs in accordance with the Financial Accounting Standards Board (“FASB”) ASC
730-10, “Research and Development” (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense
as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are
expensed when the contracted work has been performed or as milestone results have been achieved. For the years ended June 30, 2023 and
2022, research and development expense was reported in both continuing and discontinuing operations.
Right-of-Use Assets
Assets held under the terms of finance (capital) leases are amortized on a straight-line basis over the terms of the leases or the economic
lives of the assets. Obligations for future lease payments under finance (capital) leases are shown within
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liabilities and are analyzed between amounts falling due within and after one year. See Note 9 - Finance Lease ROU Assets and Note 15 -
Finance Lease Obligations for additional information.
Fixed Assets
Fixed assets are stated at cost net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated
useful lives of the assets ranging from three to thirty-nine years.
The Company monitors fixed assets for impairment indicators throughout the year. When necessary, charges for impairments of long-lived
assets are recorded for the amount by which the fair value is less than the carrying value of these assets. Changes in the Company’s
business strategy or adverse changes in market conditions could impact impairment analyses and require the recognition of an impairment
charge. Although management bases its estimates on historical experience and various other assumptions that are believed to be reasonable
under the circumstances, actual results could differ from these estimates.
See Note 11 – Fixed Assets for additional information.
Intangible Assets
Identifiable intangible assets are comprised of definite life intangible assets and indefinite life intangible assets.
The Company accounts for definite life intangible assets at either their historical cost or allocated purchase price at asset acquisition and
records amortization utilizing the straight-line method based upon their estimated useful lives. Intellectual property is amortized over 20
years. The Company reviews the carrying value of its definite life intangible assets for impairment whenever events or changes in business
circumstances indicate the carrying amount of such assets may not be fully recoverable. The carrying value is not recoverable if it exceeds
the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset. An impairment loss is
measured as the amount by which the carrying amount exceeds it fair value.
For indefinite life intangible assets, the Company performs an impairment test annually and whenever events or changes in circumstances
indicate the carrying value of an asset may not be recoverable. The Company determines the fair value of the asset quarterly or when
triggering events are present, based on discounted cash flows and records an impairment loss if book value exceeds fair value.
Evaluating for impairment requires judgment, including the estimation of future cash flows, future growth rates and profitability and the
expected life over which cash flows will occur. Changes in the Company’s business strategy or adverse changes in market conditions could
impact impairment analyses and require the recognition of an impairment charge. Although management bases its estimates on historical
experience and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these
estimates.
See Note 12 – Intangible Assets for additional information.
Share-based Compensation
The Company recognizes the cost of all share-based payment transactions at fair value. Compensation cost, measured by the fair value of
the equity instruments issued, adjusted for estimated forfeitures, is recognized in the financial statements as the respective awards are
earned over the performance period. The Company uses historical data to estimate forfeiture rates.
The impact that share-based payment awards will have on the Company’s results of operations is a function of the number of shares
awarded, the trading price of the Company’s stock at the date of grant or modification, the vesting schedule and forfeitures. Furthermore,
the application of the Black-Scholes option pricing model employs weighted-average assumptions for expected volatility of the Company’s
stock, expected term until exercise of the options, the risk-free interest rate, and dividends, if any, to determine fair value.
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Expected volatility is based on historical volatility of the Company’s common stock (the “Common Stock”); the expected term until
exercise represents the weighted-average period of time that options granted are expected to be outstanding giving consideration to vesting
schedules and the Company’s historical exercise patterns; and the risk-free interest rate is based on the U.S. Treasury yield curve in effect at
the time of grant for periods corresponding with the expected life of the option. The Company has not paid any dividends since its
inception and does not anticipate paying any dividends for the foreseeable future, so the dividend yield is assumed to be zero. In addition,
the Company estimates forfeitures at each reporting period rather than electing to record the impact of such forfeitures as they occur. See
Note 19 – Share-Based Compensation for additional information.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated
future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax
rates expected to apply to taxable income in the years in which those temporary differences are expected to be realized. The effect of a
change in tax rates or laws on deferred tax assets and liabilities is recognized in operations in the period that includes the enactment date of
the rate change. A valuation allowance is established to reduce the deferred tax assets to the amounts that are more likely than not to be
realized from operations.
Tax benefits of uncertain tax positions are recognized only if it is more likely than not that the Company will be able to sustain a position
taken on an income tax return. The Company has no liability for uncertain tax positions as of June 30, 2023 and 2022. Interest and
penalties, if any, related to unrecognized tax benefits would be recognized as income tax expense. The Company does not have any accrued
interest or penalties associated with unrecognized tax benefits, nor was any significant interest expense recognized during the years ended
June 30, 2023 and 2022.
Concentrations of Credit Risk
Cash
The Company maintains principally all cash balances in two financial institutions which, at times, may exceed the amount insured by the
Federal Deposit Insurance Corporation. The exposure to the Company is solely dependent upon daily bank balances and the strength of the
financial institution. The Company has not incurred any losses on these accounts. At June 30, 2023 and 2022, amounts in excess of insured
limits were approximately $6,900,000 and $18,200,000, respectively.
Revenue
During the Fiscal year ended June 30, 2023, the Company reported no revenue from continuing operations and generated $391,000 of its
revenue reported in discontinued operations from four customers. During the Fiscal year ended June 30, 2022, the Company reported
revenue from continuing operations related to a license agreement and a settlement of a revenue contract and generated $499,000 of
revenue reported in discontinued operations from eight customers.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on
Financial Instruments (“ASU 2016-13”), which requires an entity to assess impairment of its financial instruments based on its estimate of
expected credit losses. Since the issuance of ASU 2016-13, the FASB released several amendments to improve and clarify the
implementation guidance. In November 2019, the FASB issued ASU2019-10, Financial Instruments - Credit Losses (Topic 326),
Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates, which amended the effective date of the various topics. As
the Company is a smaller reporting company, the provisions of ASU 2016-13 and the related amendments are effective for fiscal years, and
interim periods within those fiscal years, beginning after December 15, 2022 (quarter ending September 30, 2023, for the Company).
Entities are
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required to apply these changes through a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period
in which the guidance is effective. The Company does not expect the adoption of ASU 2016-13 to have a significant impact on the
Company’s consolidated financial statements.
Management does not believe that any other recently issued, but not yet effective, accounting standard if currently adopted would
have a material effect on the accompanying consolidated financial statements. Most of the newer standards issued represent technical
corrections to the accounting literature or application to specific industries which have no effect on the Company’s consolidated financial
statements.
5. Financial Instruments and Fair Value Measurement
The carrying values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable and term note payable in the
Company’s consolidated balance sheets approximated their fair values as of June 30, 2023 and 2022 due to their short-term nature. The
carrying value of the convertible promissory note receivable, term note payable and finance lease obligations approximated fair value as of
June 30, 2023 and 2022 as the interest rates related to the financial instruments approximated market.
The Company accounts for its investments in debt securities at fair value. The following provides a description of the three levels of inputs
that may be used to measure fair value under the standard, the types of plan investments that fall under each category, and the valuation
methodologies used to measure these investments at fair value:
•
•
•
Level 1 – Inputs are based upon unadjusted quoted prices for identical instruments in active markets.
Level 2 – Inputs to the valuation include quoted prices for similar assets and liabilities in active markets, quoted prices
for identical or similar assets or liabilities in inactive markets, inputs other than quoted prices that are observable for the
asset or liability, and inputs that are derived principally from or corroborated by observable market data by correlation or
other means. If the asset or liability has a specified (contractual) term, the Level 2 input must be observable for
substantially the full term of the asset or liability. All debt securities were valued using Level 2 inputs.
Level 3 – Inputs to the valuation methodology are unobservable and significant to the fair value measurement.
The Company’s fixed assets and amortizable intangible assets are measured at fair value on a nonrecurring basis; that is, these assets are
not measured at fair value on an ongoing basis, but are subject to fair value adjustments in certain circumstances, such as when there is
evidence of impairment.
The Company initially marketed the CDMO business and during the second quarter of Fiscal year 2023, changed its strategy to selling the
stand-alone CDMO assets. These assets were assessed for impairment and the analysis resulted in the expected future cash flows from the
sale of the Facility and equipment falling below its current carrying value. The Company utilized a market approach, using independent
third-party appraisals, including comparable assets, in addition to bids received from prospective buyers, to estimate the fair value of the
Facility and equipment. As a result, the carrying value of the Facility and equipment was reduced to their estimated fair values of
$16,350,000 and $2,100,000, respectively. In the second quarter of Fiscal year 2023, impairment charges were recorded in discontinued
operations under general and administrative expense of $6,300,000 and $11,300,000 for the Facility and equipment, respectively. In the
first quarter of Fiscal 2024, the Company entered into an agreement for the building for $17.25 million, and an additional impairment of
$0.3 million was recorded in the fourth quarter of Fiscal 2023 to reflect the agreed upon sales price less estimated costs to sell. The
carrying amount of the CDMO fixed assets after impairment on June 30, 2023 was $16.1 million. The machinery and equipment were sold
during the third quarter of Fiscal year 2023.
The following table shows the fair value of the Company's fixed assets included in Current Assets Held For Sale measured at fair value on
a non-recurring basis as of June 30, 2023 (amounts in thousands):
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June 30, 2023
Fair Value Hierarchy
Building in Bryan, Texas
$
Quoted Prices in
Active Markets
for Identical
Assets (Level 1)
—
Significant Other
Observable Inputs
(Level 2)
—
$
Significant
Unobservable
Inputs (Level 3)
$
16,064
$
Total Fair
Value
16,064
Total
Impairments
6,600
$
During the second quarter of Fiscal year 2023, the Company re-evaluated its business strategy and reviewed its product portfolio.
After such review, the Company identified intellectual property, patent and licenses that would no longer be utilized and therefore were
fully impaired (Level 3). See Note 12 – Intangible Assets for additional information.
6. Significant Transactions
Affiliates of Eastern Capital Limited
On November 1, 2021, the Company and its subsidiary, iBio CDMO LLC (“iBio CDMO”, and collectively with the Company, the
“Purchaser”) entered into a series of agreements (the “Transaction”) with College Station Investors LLC (“College Station”), and Bryan
Capital Investors LLC (“Bryan Capital” and, collectively with College Station, “Seller”), each affiliates of Eastern Capital Limited
(“Eastern,” a former significant stockholder of the Company) described in more detail below whereby in exchange for a certain cash
payment and a warrant the Company:
(i) acquired both the Facility where iBio CDMO at that time and currently conducts business and also the rights as the tenant in the
Facility’s ground lease;
(ii) acquired all of the equity owned by one of the affiliates of Eastern in the Company and iBio CDMO; and
(iii) otherwise terminated all agreements between the Company and the affiliates of Eastern.
The Facility is a life sciences building located on land owned by the Board of Regents of the Texas A&M University System (“Texas
A&M”) and is designed and equipped for the manufacture of plant-made biopharmaceuticals. iBio CDMO had held a sublease for the
Facility through 2050, subject to extension until 2060 (the “Sublease”) until the purchase of the Facility described below.
The Purchase and Sale Agreement
On November 1, 2021, the Purchaser entered into a purchase and sale agreement (the “PSA”) with the Seller pursuant to which: (i) the
Seller sold to Purchaser all of its rights, title and interest as the tenant in the Ground Lease Agreement (the “Ground Lease Agreement”)
that it entered into with Texas A&M (the “Landlord’’) related to the land at which the Facility is located together with all improvements
pertaining thereto (the “Ground Lease Property”), which previously had been the subject of the Sublease; (ii) the Seller sold to Purchaser
all of its rights, title and interest to any tangible personal property owned by Seller and located on the Ground Lease Property including the
Facility; (iii) the Seller sold to Purchaser all of its rights, title and interest to all licensed, permits and authorization for use of the Ground
Lease Property; and (iv) College Station and iBio CDMO terminated the Sublease. The total purchase price for the Ground Lease Property,
the termination of the Sublease and other agreements among the parties, and the equity described below is $28,750,000, which was paid
$28,000,000 in cash and by the issuance to Seller of warrants (the “Warrant”) described below. As part of the transaction, iBio CDMO
became the tenant under the Ground Lease Agreement for the Ground Lease Property until 2060 upon exercise of available extensions. The
base rent payable under the Ground Lease Agreement, which was $151,450 for the prior year, is 6.5% of the Fair Market Value (as defined
in the Ground Lease Agreement) of the land. The Ground
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Lease Agreement includes various covenants, indemnities, defaults, termination rights, and other provisions customary for lease
transactions of this nature.
As discussed above, iBio CDMO is being accounted for as a discontinued operation. As such, the assets acquired and/or leased are now
classified as assets held for sale on the June 30, 2023 and 2022 consolidated balance sheets.
The Equity Purchase Agreement
The Company also entered into an Equity Purchase Agreement with Bryan Capital on November 1, 2021 (the “Equity Purchase
Agreement”) pursuant to which the Company acquired for $50,000 cash, plus the Warrant, the one (1) share of iBio CMO Preferred
Tracking Stock and the 0.01% interest in iBio CDMO owned by Bryan Capital. iBio CDMO is now a wholly owned subsidiary of the
Company.
The Credit Agreement
In connection with the PSA, iBio CDMO entered into a Credit Agreement, dated November 1, 2021, with Woodforest pursuant to which
Woodforest provided iBio CDMO a $22,375,000 secured term loan to purchase the Facility, which Term Loan is evidenced by a term note.
The term loan was advanced in full on the closing date.
See Note 14 – Debt for further information of the Term Loan.
The Warrant
As part of the consideration for the purchase and sale of the rights set forth above, the Company issued to Bryan Capital a Warrant to
purchase 51,583 shares of the Common Stock at an exercise price of $33.25 per share. The Warrant expires on October 10, 2026, is
exercisable immediately, provides for a cashless exercise at any time and automatic cashless exercise on the expiration date if on such date
the exercise price of the Warrant exceeds its fair market value as determined in accordance with the terms of the Warrant and adjustments in
the case of stock dividends and stock splits. Of the total shares that can be exercised under the Warrant, 11,583 of such shares were valued
at $217,255 to reflect the final payment of rent due under the Sublease. The Warrant, as shown on the consolidated statements of equity,
was recorded in additional paid-in capital with the corresponding activity included in the basis of the purchase price allocation of the
Ground Lease Property acquired. See Note 17 – Stockholders’ Equity for additional information.
RubrYc
On August 23, 2021, the Company entered into a series of agreements with RubrYc Therapeutics, Inc. (“RubrYc”) described in more detail
below:
Collaboration and License Agreement
The Company entered into a collaboration and licensing agreement (the “RTX-003 License Agreement”) with RubrYc to further develop
RubrYc’s immune-oncology antibodies in its RTX-003 campaign. Under the terms of the agreement, the Company is solely responsible for
worldwide research and development activities for development of the RTX-003 antibodies for use in pharmaceutical products in all
fields. RubrYc was also entitled to receive royalties in the mid-single digits on net sales of RTX-003 antibodies, subject to adjustment
under certain circumstances. The RTX-003 License Agreement was terminated when the Company acquired substantially all of the assets
of RubrYc in September 2022.
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Collaboration, Option and License Agreement
The Company entered into an agreement with RubrYc (the “Collaboration, Option and License Agreement”) to collaborate for up to five
years to discover and develop novel antibody therapeutics using RubrYc’s artificial intelligence discovery platform. The Company agreed
to pay RubrYc for each Selected Compound as it achieves various milestones in addition to royalties if the Selected Compounds are
commercialized. RubrYc was also entitled to receive tiered royalties ranging from low- to mid-single digits on net sales of Collaboration
Products, subject to adjustment under certain circumstances. Royalties are payable on a country-by-country and collaboration product-by-
collaboration product basis until the latest to occur of: (i) the last-to-expire of specified patent rights in such country; (ii) expiration of
marketing or regulatory exclusivity in such country; or (iii) ten (10) years after the first commercial sale of a product in such country,
provided that no biosimilar product has been approved in such country. With the exception of any obligations that survive the termination,
the Collaboration, Option and License Agreement was terminated when the Company acquired substantially all of the assets of RubrYc in
September 2022.
Stock Purchase Agreement
In connection with the entry into the Collaboration, Option and License Agreement and RTX-003 License Agreement, the Company also
entered into a Stock Purchase Agreement (“Stock Purchase Agreement”) with RubrYc whereby the Company purchased a total of
2,864,345 shares of RubrYc’s Series A-2 preferred stock (“Series A-2 Preferred”) for $7,500,000.
The Company accounted for the agreements as an asset purchase and allocated the purchase price of $7,500,000 as follows:
Preferred stock
Intangible assets
Prepaid expenses
$
$
1,760,000
4,300,000
1,440,000
7,500,000
Subsequently after the Company acquired substantially all of the assets of RubrYc in September 2022, RubrYc ceased its operations and
completed bankruptcy proceedings in June 2023. The Company recorded an impairment of the investment in the amount of $1,760,000
during the year ended June 30, 2022 which was recorded in the consolidated statement of operations and comprehensive loss under general
and administrative expense. The Company also recorded an impairment of current and non-current prepaid expense of $288,000 and
$864,000, respectively, during the year ended June 30, 2022. The amount was recorded in the consolidated statement of operations and
comprehensive loss under research and development expense.
On September 16, 2022, the Company entered an Asset Purchase Agreement with RubrYc pursuant to which it acquired substantially all of
the assets of RubrYc. The Company issued 102,354 shares of the Common Stock to RubrYc with an approximate market value of
$1,000,000 (the “Closing Shares”). Pursuant to the Asset Purchase Agreement, the shares are subject to an initial lockup period and the
estimated fair value was calculated as $650,000. The Company also agreed to make potential additional payments of up to $5,000,000 upon
the achievement of specified developmental milestones on or before the fifth anniversary of the closing date, payable in cash or shares of
the Common Stock, at the Company’s option. In addition, the Company had advanced RubrYc $484,000 to support their operation costs
during the negotiation period and incurred transaction costs totaling $208,000, which were also capitalized as part of the assets acquired.
The assets acquired include the patented AI drug discovery platform, all rights with no future milestone payments or royalty obligations, to
IBIO-101, in addition to CCR8, EGFRvIII, MUC16, CD3 and one additional immuno-oncology candidate plus a PD-1 agonist. The
Purchase Agreement contained representations, warranties and covenants of RubrYc and the Company. The acquisition closed on
September 19, 2022 after receipt of approval of the NYSE American.
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The Company accounted for the agreements as an asset purchase and allocated the purchase price of approximately $1,342,000 as follows:
Intangible assets
Fixed assets
$
$
1,228,000
114,000
1,342,000
In addition, the Company assumed three equipment leases that were accounted for as finance leases totaling approximately $814,000. See
Note 9 – Finance Lease ROU Assets and Note 15 – Finance Lease Obligations.
Former CEO Departure
Effective December 1, 2022, the Company and Mr. Thomas F. Isett, the former Chief Executive Officer (the “CEO) and former Chairman
of the Board of Directors (the “Board”), agreed for Mr. Isett to resign as a member of the Board and relinquish his duties, rights and
obligations as the CEO of the Company.
Separation Agreement and General Release
In connection with Mr. Isett’s resignation, the Company entered into a separation agreement and general release with Mr. Isett effective
December 1, 2022 (the “Agreement”). Pursuant to the Agreement, Mr. Isett resigned as CEO of the Company effective December 1, 2022,
and will remain an employee of the Company until December 31, 2022, on which date his employment with the Company will
automatically terminate. Following Mr. Isett’s termination of employment with the Company, pursuant to the Agreement, Mr. Isett will
receive the severance benefits set forth in his employment agreement, as previously disclosed by the Company, including (i) an amount
equal to his current base salary in equal bi-monthly installments for twenty-four (24) months; (ii) an amount equal to a pro rata share of his
target bonus for the current fiscal year; (iii) an amount equal to the target bonus in equal bi-monthly installments for the twenty-four (24)
month severance period and (iv) provided that he elects continuation coverage for health insurance under the Consolidated Omnibus
Budget Reconciliation Act of 1985 (“COBRA”), the Company will pay the full cost of this benefit for up to eighteen (18) months, or if he
has not obtained alternative employer-provided health coverage by the end of the eighteen (18) month COBRA subsidy period, the
Company will provide him with a lump-sum cash payment equal to six (6) times the monthly amount paid by the Company for the COBRA
subsidy. The Agreement includes a general release of claims by Mr. Isett. The Company accrued approximately $2.13 million to general
and administrative expenses in the second quarter of Fiscal 2023. As of June 30, 2023, approximately $1.1 million is recorded in accrued
expenses and $527,000 in accrued expenses – noncurrent.
7. Promissory Note Receivable
On June 19, 2023, the Company issued a promissory note (the “Note”) with Safi Biosolutions, Inc. (“Safi”) in the principal amount of
$1,500,000, which was issued in exchange for the convertible promissory note (the “Convertible Note”) issued by the Company to Safi on
October 1, 2020. The Note has a maturity date of two (2) years from the date of issuance and can be extended by the mutual consent of the
Company and Safi for two (2) additional one (1) year terms upon the payment of all accrued interest accrued through the date of such
extension. In addition, the outstanding balance under the Note, or portions thereof, is due within a specified number of days after the receipt
by Safi in a closing of specified financing milestones as more detailed in the Note. The Note will bear interest at the rate of 5% per annum
and will increase to 7% for the first one (1) year extension and 9% for the second one (1) year extension. Upon the issuance of the Note, the
Convertible Note, which bore interest at the rate of 5% per annum and had a maturity date of October 1, 2023, was voided.
For the Fiscal years ended June 30, 2023 and 2022, interest income amounted to $75,000 and $75,000, respectively. As of June 30,
2023 and 2022, the Note balance and accrued interest, which have been classified as long term, totaled $1,706,000 and $1,631,000,
respectively.
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8. Investments in Debt Securities
The Company did not hold any investments in debt securities at March 31, 2023. The components of investments in debt securities are as
follows (in thousands):
June 30,
2023
June 30,
2022
Adjusted cost
Gross unrealized losses
Fair value
$
$
The fair value of available-for-sale debt securities, by contractual maturity was as follows (in thousands):
Fiscal period ending:
2023
2024
June 30,
2023
$
$
—
—
—
—
—
—
$
$
$
$
11,029
(184)
10,845
8,054
2,791
10,845
June 30,
2022
Amortization of premiums paid on the debt securities amounted to $67,000 and $312,000 for the years ended June 30, 2023 and 2022,
respectively.
Realized losses on available-for-sale debt securities are as follows (in thousands):
Proceeds from sale of debt securities
Cost of debt securities
Realized loss on sale of debt securities
9. Finance Lease ROU Assets
Years Ended June 30,
2023
$
$
6,739
6,837
(98)
$
$
2022
—
—
—
As discussed above, the Company assumed three equipment leases as part of the RubrYc asset acquisition. In addition, the Company leased
a mobile office trailer which is classified as part of assets held for sale. The lease for the mobile office trailer was terminated in December
2022.
See Note 15 – Finance Lease Obligations for more details of the terms of the leases.
The following table summarizes by category the gross carrying value and accumulated amortization of finance lease ROU (in thousands):
ROU - Equipment
Accumulated amortization
Net finance lease ROU
June 30,
2023
June 30,
2022
$
$
814
(204)
610
$
$
—
—
—
Amortization expense of finance lease ROU assets was approximately $204,000 and $0 for the years ended June 30, 2023 and 2022,
respectively.
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10. Operating Lease ROU Assets
San Diego, California
On September 10, 2021, the Company entered into a lease for approximately 11,383 square feet of space in San Diego, California. Based
on the terms of the lease payments, the Company recorded an operating lease ROU asset of $3,603,000. The net carrying amount of this
ROU operating lease asset was $2,722,000 and $3,068,000 at June 30, 2023 and 2022, respectively.
Bryan, Texas
On November 1, 2021, as discussed above, iBio CDMO acquired the Facility and became the tenant under the Ground Lease Agreement
upon which the Facility is located. Based on the terms of the lease payments, the Company recorded an operating lease ROU asset of
$1,967,000. The net amount of this ROU operating lease asset is included in assets held for sale.
See Note 16 - Operating Lease Obligations for additional information.
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Table of Contents
11. Fixed Assets
The following table summarizes by category the gross carrying value and accumulated depreciation of fixed assets (in thousands):
Building and improvements
Machinery and equipment
Office equipment and software
Construction in progress
Accumulated depreciation
Net fixed assets
June 30,
2023
June 30,
2022
$
$
695
3,521
403
—
4,619
(400)
4,219
$
$
—
—
—
1,373
1,373
—
1,373
Depreciation expense was approximately $400,000 and $0 for the years ended June 30, 2023 and 2022, respectively.
Fixed assets held for sale at June 30, 2023 and 2022 in the amount of $16,124,000 and $35,289,000, respectively, are included in assets
held for sale. The depreciation expense for the years ended June 30, 2023 and 2022 is classified as part of loss from discontinued
operations.
During the Fiscal year ended June 30, 2023, the Company re-evaluated its business strategy and reviewed its product portfolio. After such
review, the Company recorded an impairment charge of approximately $17.9 million.
See Note 5 - Financial Instruments and Fair Value Measurement for more information.
12. Intangible Assets
The Company has two categories of intangible assets – intellectual property and patents. Intellectual property consists of all technology,
know-how, data, and protocols for producing targeted proteins in plants and related to any products and product formulations for
pharmaceutical uses and for other applications. Intellectual property includes, but is not limited to, certain technology for the development
and manufacture of novel vaccines and therapeutics for humans and certain veterinary applications acquired in December 2003 from
Fraunhofer USA Inc., acting through its Center for Molecular Biotechnology ("Fraunhofer"), pursuant to a Technology Transfer
Agreement, as amended (the "TTA"). The Company designates such technology further developed and acquired from Fraunhofer as
iBioLaunch™ or LicKM™ or FastPharming technology. The value on the Company’s books attributed to patents owned or controlled by
the Company is based only on payments for services and fees related to the protection of the Company’s patent portfolio. The intellectual
property also includes certain trademarks.
On August 23, 2021, the Company entered into a series of agreements with RubrYc described in more detail above (see Note 6 –
Significant Transactions) whereby in exchange for a $7.5 million investment in RubrYc, the Company acquired a worldwide exclusive
license to certain antibodies that RubrYc develops under what it calls its RTX-003 campaign, which are promising immuno-oncology
antibodies that bind to the CD25 protein without interfering with the IL-2 signaling pathway thereby potentially depleting T regulatory (T
reg) cells while enhancing T effector (T eff) cells and encouraging the immune system to attack cancer cells. The Company accounted for
this license as an indefinite-lived intangible asset until the completion or abandonment of the associated research and development efforts.
In addition, the Company also received preferred shares and an option for future collaboration licenses.
On September 16, 2022, the Company entered into an Asset Purchase Agreement with RubrYc described in more detail above (see Note 6 –
Significant Transactions) pursuant to which it acquired substantially all of the assets of RubrYc. The assets acquired include the patented
AI drug discovery platform, all rights with no future milestone payments or royalty
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Table of Contents
obligations, to IBIO-101, in addition to CCR8, EGFRvIII, MUC16, CD3, and one additional immuno-oncology candidate, plus a PD-1
agonist.
In January 2014, the Company entered into a license agreement with the University of Pittsburgh whereby the Company acquired exclusive
worldwide rights to certain issued and pending patents covering specific candidate products for the treatment of fibrosis (the "Licensed
Technology") which license agreement was amended in August 2016 and again in December 2020 and February 2022. The license
agreement provides for payment by the Company of a license issue fee, annual license maintenance fees, reimbursement of prior patent
costs incurred by the university, payment of a milestone payment upon regulatory approval for sale of a first product, and annual royalties
on product sales. In addition, the Company has agreed to meet certain diligence milestones related to product development benchmarks. As
part of its commitment to the diligence milestones, the Company successfully commenced production of a plant-made peptide comprising
the Licensed Technology before March 31, 2014. The next milestone – filing an Investigational New Drug Application with the FDA or
foreign equivalent covering the Licensed Technology ("IND") – initially was required to be met by December 1, 2015, and on November 2,
2020, was extended to be required to be met by December 31, 2021 and on February 8, 2022, was further extended to December 31, 2023.
In addition, the amounts of the annual license maintenance fee and payment upon completion of various regulatory milestones were
amended. On February 14, 2023, the Company provided notification to the University of Pittsburgh terminating the license agreement.
Pursuant to the termination of the license agreement with the University of Pittsburgh, the Company’s financial obligations for the
management of the patents under the license agreement ceased on August 14, 2023, and at such time, transitioned back to the University of
Pittsburgh and the Medical University of South Carolina. As a result of the termination of the license agreement, the Company recorded a
full impairment of the related intangible asset associated with IBIO-100 in the amount of $25,000.
During the second quarter of Fiscal year 2023, the Company re-evaluated its business strategy and reviewed its product portfolio. After
such review, the Company identified intellectual property, patent and licenses that will no longer be utilized and therefore were fully
impaired. The Company recorded an impairment charge in general and administrative expenses of approximately $565,000 for the year
ended June 30, 2023. No impairments were recorded in Fiscal year 2022.
The following table summarizes by category the gross carrying value and accumulated amortization of intangible assets (in thousands):
Intellectual property – gross carrying value
Patents and licenses – gross carrying value
$
Intellectual property – accumulated amortization
Patents and licenses – accumulated amortization
Total definite lived intangible assets
License - indefinite lived
Total net intangible
June 30,
2022
3,100
2,846
5,946
(2,867)
(2,403)
(5,270)
676
4,175
$
Amortization
$
Additions
400
400
Impairments
(3,100)
$
(2,846)
—
(5,946)
2,931
2,450
5,381
(565)
—
—
—
$
400
$
June 30,
2023
400
—
400
(15)
—
(15)
385
— $
—
—
(79)
(47)
(126)
(126)
—
828
—
5,003
$
4,851
$
1,228
$
5,388
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Table of Contents
Amortization expense was approximately $126,000 and $401,000 for the years ended June 30, 2023 and 2022, respectively. The weighted-
average remaining life for intellectual property and patents on June 30, 2023 was approximately 19.3 years and 1.5 years, respectively. The
estimated annual amortization expense for the next five years and thereafter is as follows (in thousands):
For the Year Ended June 30,
2024
2025
2026
2027
2028
Thereafter
Total
$
$
20
20
20
20
20
285
385
13. Accrued Expenses
Accrued expenses consist of the following (in thousands):
Personnel related costs
Real estate taxes
Interest and fees related to term note payable
Professional fees
Other accrued expenses
Total accrued expenses
14. Debt
The Credit Agreement
June 30,
2023
June 30,
2022
$
$
3,352
268
183
31
200
4,034
$
$
3,066
284
59
126
229
3,764
In connection with the PSA, iBio CDMO entered into a Credit Agreement, dated November 1, 2021, with Woodforest pursuant to which
Woodforest provided iBio CDMO a $22,375,000 secured term loan (the “Term Loan”) to purchase the Facility, which Term Loan is
evidenced by a term note (the “Term Note”) (for a complete description of the Transaction please see Note 6 – Significant Transactions).
The Term Loan was advanced in full on the closing date. The Term Loan bore interest at a rate of 3.25%, with higher interest rates upon an
event of default, which interest was payable monthly beginning November 5, 2021. Principal on the Term Loan was originally payable on
November 1, 2023, subject to early termination upon events of default. The Term Loan provides that it may be prepaid by iBio CDMO at
any time and provides for mandatory prepayment upon certain circumstances.
On October 11, 2022, iBio CDMO and Woodforest amended the Credit Agreement to: (i) include a payment of $5,500,000 of the
outstanding principal balance owed under the Credit Agreement on the date of the amendment, (ii) include a payment of $5,100,000 of the
outstanding principal balance owed under the Credit Agreement within two (2) business days upon our receipt of such amount owed to us
by Fraunhofer as part of our legal settlement with them (the “Fraunhofer Settlement Funds”) (see Note 20 – Fraunhofer Settlement for
more information), (iii) include principal payments of $250,000 per month in debt amortization for a six-month period commencing the
date of the amendment through March 2023, (iv) include an amendment fee of $22,375 and all costs and expenses, (v) require delivery of a
report detailing cash flow expenditures every two (2) weeks for the period prior to the delivery of the last report and a monthly 12-month
forecast, (vi) reduce the liquidity covenant (the “Liquidity Covenant”) in the Guaranty (as defined in the Credit Agreement) from
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$10,000,000 to $7,500,000 with the ability to lower the liquidity covenant to $5,000,000 upon the occurrence of a specific milestone in the
Credit Agreement, and (vii) change the annual filing requirement solely for the fiscal year ended June 30, 2022, such that the filing is
acceptable with or without a “going concern” designation. In addition, Woodforest cancelled the irrevocable letter of credit issued by
JPMorgan Chase Bank upon closing of the amendment.
In January 2023, the Company’s unrestricted cash decreased below the required $7,500,000, which created an event of default under the
Credit Agreement and Guaranty as a result of not complying with the Liquidity Covenant. As a result, on February 9, 2023, iBio CDMO
and Woodforest entered into a second amendment to the Credit Agreement (the “Second Amendment”), which amended, among other
things, added a milestone that had to be met by a specified date, the failure of which would be an event of default. In addition, on February
9, 2023, the Company, as guarantor, entered into a second amendment to the Guaranty, which amended, among other things, allowed the
Company to account for the Fraunhofer Settlement Funds in determining whether the Company is in compliance with the Liquidity
Covenant until a specified period dependent upon the occurrence of a specific milestone in the Credit Agreement.
On February 20, 2023, iBio CDMO entered into a third amendment to the Credit Agreement (the “Third Amendment”), which removed the
added milestone specified in the Second Amendment, the failure of which would be an event of default. In addition, the Guaranty was
amended to allow the Company until February 28, 2023, to account for the Fraunhofer Settlement Funds in determining whether the
Company is in compliance with the Liquidity Covenant without being dependent upon a specified milestone. In addition, the Company
agreed that each time it consummates an at-the-market issuance of Equity Interests (as defined within the Credit Agreement), no later than
five (5) days following such issuance of Equity Interests, it will (i) pay to Woodforest in immediately available cash funds, without setoff or
counterclaim of any kind, forty percent (40%) of the Net Proceeds (as defined within the Credit Agreement) received by the Company for
such issuance of Equity Interests; provided, any such payment would cease upon payment obligations in full and (ii) provide Woodforest
with a detailed accounting of each such issuance of Equity Interests.
On March 24, 2023, iBio CDMO and Woodforest entered into a fourth amendment to the Credit Agreement (the “Fourth Amendment”),
which within the Fourth Amendment Woodforest agreed to (i) reduce the percentage of any payment to Woodforest the Company is
required to make from the proceeds of sales of its common stock under its at-the-market facility from 40% to 20%, (ii) reduce the
percentage of any payment to Woodforest the Company is required to make from the proceeds of sales of its equipment from 40% to 20%,
and (iii) allowed the Company to retain $2,000,000 of the $5,100,000 that the Company received from the Fraunhofer Settlement Funds,
with the remaining $3,000,000 being held in a Company account at Woodforest. In addition, the Company is obligated to (y) deliver to
Woodforest an executed copy of a purchase agreement (the “Purchase Agreement”) for the sale of the Facility, no later than April 14, 2023,
and (z) pay to Woodforest a fee in the amount of $75,000 on the earlier of the date of the closing of the Purchase Agreement, or the
Maturity Date (as defined in the Credit Agreement). In addition, on March 24, 2023, the Company, as guarantor, entered into a fourth
amendment to the Guaranty, which reduced the Liquidity Covenant from $7,500,000 to $1,000,000.
On May 10, 2023, iBio CDMO and Woodforest entered into a fifth amendment to the Credit Agreement (the “Fifth Amendment”), which
within the Fifth Amendment Woodforest agreed to: (i) waive our obligation to deliver to Woodforest an executed copy of a Purchase
Agreement for the sale of the Facility no later than April 14, 2023 and, (ii) release $500,000 of the $3,000,000 being held in a Company
account at Woodforest when the outstanding principal amount is reduced to $10,000,000 and for each additional $2,500,000 reduction of
the outstanding principal amount, an additional $750,000 will be released from the Company account at Woodforest. In addition, starting
on the effective date of the Fifth Amendment, the interest on the Term Loan increased to 5.25%, and the Term Loan shall further accrue
interest, payable in-kind and added to the balance of the outstanding principal amount at a fixed rate per annum equal to (a) 1.00%, if the
Facility is sold on or before June 30, 2023, (b) 2.00% if the Facility is sold after June 2023, but on or before September 30, 2023, or (c)
3:00%, if the Facility is sold after September 30, 2023, or not sold prior to the maturity date. The Company also agreed to pay Woodforest
a fee in the amount of (x) $75,000 if the Facility is sold on or before June 30, 2023, (y) $100,000 if the Facility is sold after June 2023, but
on or before September 30, 2023, or (x) $125,000, if the Facility is sold after September 30, 2023, or not sold prior to the maturity date. As
of the date of the filing of this Quarterly Report on Form 10-Q, the Company is not in negotiations on a Purchase Agreement with a
potential buyer of the Facility.
On September 18, 2023, iBio CDMO and Woodforest entered into a sixth amendment to the Credit Agreement (the “Sixth Amendment”),
pursuant to which Woodforest agreed to modify the Maturity Date to the earlier of December 31, 2023, or
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the acceleration of maturity of the Term Loan pursuant to the Credit Agreement, provided that (i) iBio CDMO shall deliver an executed
copy of a Purchase Agreement for the sale of the Facility within one business day after entry into the Sixth Amendment, and (ii) if the
Facility is not sell on or before December 1, 2023, iBio CDMO will pay a fee in the amount of $20,000 upon the earlier of the date of the
closing or the Maturity Date. In addition, if the closing and funding of the Purchase Agreement does not occur on or before December 1,
2023, iBio CDMO will permit Woodforest to obtain an appraisal of iBio CDMO’s real estate, including the Facility, at the cost of iBio
CDMO.
At June 30, 2023, the balance of the Term Loan was $12,937,000 which consisted of the Term Note of $13,057,000, net of approximately
$120,000 of deferred finance costs. At June 30, 2022, the balance was $22,161,000 which consisted of the Term Note of $22,375,000, net
of approximately $214,000 of deferred finance costs.
Equipment Financing
On October 12, 2022, the Company entered into an equipment financing master lease agreement and a lease supplement whereby $500,000
was borrowed over 36 months at an imputed interest rate of 10.62% and securitized by certain assets purchased for the San Diego research
site. The financing is payable in monthly installments of $16,230 through October 2025. At June 30, 2023, the balance owed under the
financing was $401,000. Interest incurred under the financing for the year ended June 30, 2023 totaled approximately $31,000.
Future minimum payments under the finance lease obligation are due as follows (in thousands):
Fiscal period ending on March 31:
2024
2025
2026
Total minimum equipment financing payments
Less: current portion
Long-term portion of minimum equipment financing obligation
Note Payable – PPP Loan
Principal
Interest
Total
$
$
$
$
160
177
64
401
(160)
241
$
35
17
1
53
$
195
194
65
454
On April 16, 2020, the Company received $600,000 related to its filing under the Paycheck Protection Program and Coronavirus Aid,
Relief, and Economic Security Act (the “CARES Act”). The Company elected to treat the Small Business Administration (“SBA”) Loan as
debt under ASC 470, Debt. At June 30, 2021, the Company owed $600,000.
On July 21, 2021, iBio was granted forgiveness in repaying the loan. In accordance with ASC 405-20-40, Liabilities - Extinguishments of
Liabilities – Derecognition, the Company derecognized the liability and accrued interest in the first quarter of Fiscal 2022. The forgiveness
is included in loss from discontinued operations.
15. Finance Lease Obligations
Sublease
As discussed above, until November 1, 2021, iBio CDMO leased the Facility as well as certain equipment from College Station under the
Sublease.
The Sublease was terminated on November 1, 2021, when iBio CDMO acquired the Facility and became the tenant under the Ground
Lease Agreement upon which the Facility is located. See Note 16 – Operating Lease Obligations for additional information related to the
ground lease.
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Table of Contents
General and administrative expenses related to College Station, including rent related to the increases in the Consumer Price Index (“CPI”)
and real estate taxes, were approximately $250,000 for the year ended June 30, 2022. Interest expense related to College Station was
approximately $810,000 for the year ended June 30, 2022. Such expenses were classified as part of loss from discontinued operations.
Equipment
As discussed above, the Company assumed three equipment leases that were accounted for as finance leases totaling $814,000 as part of
the RubrYc Asset Purchase Agreement. The monthly rental for the three leases is approximately $14,000 per month and all three expire on
August 1, 2025.
Mobile Office Trailer
Commencing April 1, 2021, the Company leased a mobile office trailer that was located at the Facility in Bryan, Texas, at a monthly rental
of $3,819 through March 31, 2024. In December 2022, the Company terminated the lease and returned the mobile office trailer. Expenses
related to the lease prior to its termination are included in discontinued operations.
The following tables present the components of lease expense and supplemental balance sheet information related to the finance lease
obligation (in thousands):
Year Ended
June 30,
2023
Year Ended
June 30,
2022
Finance lease cost:
Amortization of ROU assets
Interest on lease liabilities
Total lease cost
Other information:
Cash paid for amounts included in the measurement lease liabilities:
Financing cash flows from finance lease obligations
$
$
$
224
49
273
$
$
208
$
June 30,
2023
June 30,
2023
Finance lease ROU assets
Finance lease obligation - current portion
Finance lease obligation - noncurrent portion
Weighted average remaining lease term - finance lease
Weighted average discount rate - finance lease obligation
$
$
$
610
272
351
2.17 years
9.50 %
Future minimum payments under the capitalized lease obligations are due as follows:
Fiscal year ending on June 30:
2024
2025
2026
Total minimum lease payments
Less: current portion
Long-term portion of minimum lease obligations
Principal
272
299
$
52
623
(272)
351
$
$
$
$
$
$
F-34
—
—
—
—
—
—
—
— years
— %
Interest
Total
$
47
20
1
68
$
319
319
53
691
Table of Contents
16. Operating Lease Obligations
Texas Ground Lease
As discussed above, as part of the Transaction, iBio CDMO became the tenant under the Ground Lease Agreement for the Ground Lease
Property until 2060 upon exercise of available extensions. The base rent payable under the Ground Lease Agreement, which was $151,450
for the prior year, is 6.5% of the Fair Market Value (as defined in the Ground Lease Agreement) of the land. The Ground Lease Agreement
includes various covenants, indemnities, defaults, termination rights, and other provisions customary for lease transactions of this nature.
San Diego
On September 10, 2021, the Company entered into a lease for 11,383 square feet of space in San Diego, California. Terms of the lease
include the following:
● The length of term of the lease is 88 months from the lease commencement date (as defined).
● The lease commencement date is September 16, 2022.
● The monthly rent for the first year of the lease is $51,223 and increases approximately 3% per year.
● The lease provides for a base rent abatement for months two through five in the first year of the lease.
● The landlord is providing a tenant improvement allowance of $81,860 to be used for improvements as specified in the lease.
● The Company is responsible for other expenses such as electric, janitorial, etc.
● The Company opened an irrevocable letter of credit in the amount of $188,844 in favor of the landlord. The letter of credit
expires on October 8, 2022 and renews annually as required.
As discussed above, the lease provides for scheduled increases in base rent and scheduled rent abatements. Rent expense is charged to
operations using the straight-line method over the term of the lease which results in rent expense being charged to operations at inception of
the lease in excess of required lease payments. This excess (formerly classified as deferred rent) is shown as a reduction of the operating
lease right-of-use asset in the accompanying balance sheet. Rent expense for the San Diego facility commenced in Fiscal 2022, when the
Company began making improvements to the facility.
The following tables present the components of lease expense and supplemental balance sheet information related to the operating lease
obligation (in thousands):
Operating lease cost:
Total lease cost
Other information:
Cash paid for amounts included in the measurement lease liability:
Operating cash flows from operating lease
Operating cash flows from operating lease obligation
Operating lease ROU assets
Operating lease obligations - current portion
Operating lease obligations - noncurrent portion
Weighted average remaining lease term - operating leases
Weighted average discount rate - operating lease obligations
F-35
—
—
—
—
Years Ended June 30,
2023
2022
$
$
$
$
$
$
$
563
563
563
307
$
$
$
$
June 30,
2023
2,722
389
3,125
6.50 years
7.25 %
Table of Contents
Future minimum payments under the operating lease obligation are due as follows (in thousands):
Fiscal year ending on June 30:
2024
2025
2026
2027
2028
Thereafter
Total minimum lease payments
Less: current portion
Long-term portion of minimum lease obligation
17. Stockholders’ Equity
Preferred Stock
$
$
Principal
$
Imputed Interest
242
212
179
142
100
61
389
436
490
546
610
1,043
$
$
3,514
(389)
3,125
936
$
Total
631
648
669
688
710
1,104
4,450
The Company’s Board of Directors is authorized to issue, at any time, without further stockholder approval, up to 1 million shares of
preferred stock. The Board of Directors has the authority to fix and determine the voting rights, rights of redemption and other rights and
preferences of preferred stock.
Series 2022 Convertible Preferred Stock (“Series 2022 Preferred”)
On May 9, 2022, the Board of Directors of the Company created the Series 2022 Preferred, par value $0.001 per share, out of the
Company’s 1 million authorized shares of preferred stock. Each share of Series 2022 Preferred was convertible at a ratio of one-for-one
(1:1) shares of the Common Stock on a pre-split basis.
The Company issued 1,000 shares of Series 2022 Preferred and received proceeds of $270. Pursuant to the terms of the preferred stock, the
Company’s Board converted the Preferred Stock to 40 shares of Common Stock on July 19, 2022.
iBio CMO Preferred Tracking Stock
On February 23, 2017, the Company entered into an exchange agreement with Bryan Capital pursuant to which the Company acquired
substantially all of the interest in iBio CDMO held by Bryan Capital and issued one share of a newly created Preferred Tracking Stock, in
exchange for 29,990,000 units of limited liability company interests of iBio CDMO held by Bryan Capital at an original issue price of $13
million. After giving effect to the transaction, the Company owned 99.99% and Bryan Capital owned 0.01% of iBio CDMO.
On February 23, 2017, the Board of Directors of the Company created the Preferred Tracking Stock out of the Company’s 1 million
authorized shares of preferred stock. The Preferred Tracking Stock accrued dividends at the rate of 2% per annum on the original issue
price. Accrued dividends were cumulative and were payable if and when declared by the Board of Directors, upon an exchange of the
shares of Preferred Tracking Stock and upon a liquidation, winding up or deemed liquidation (such as a merger) of the Company. No
dividends were declared through October 31, 2021.
On November 1, 2021, iBio purchased the iBio CMO Preferred Tracking Stock held by Bryan Capital. No iBio CMO Preferred Tracking
Stock remains outstanding. As a result, the iBio CDMO subsidiary and its intellectual property are now wholly owned by iBio.
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Table of Contents
Common Stock
The number of authorized shares of the Company’s common stock is 275 million. In addition, the Company has reserved 1,280,000 shares
of Common Stock for issuance pursuant to the grant of new awards under the Company’s 2020 Omnibus Incentive Plan (the “2020 Plan”).
Reverse Stock Split
On June 30, 2022, the Company held a special meeting of its stockholders at which the stockholders approved a proposal to affect an
amendment to the Company's certificate of incorporation, as amended, to implement a reverse stock split at a ratio of one-for-twenty-five
(1:25). On September 22, 2022, the Company's Board approved the implementation of the reverse stock split of the Common Stock. As a
result of the reverse stock split, every twenty-five (25) shares of the Common Stock either issued and outstanding or held by the Company
in its treasury immediately prior to the effective time was, automatically and without any action on the part of the respective holders
thereof, combined and converted into one (1) share of the Common Stock. No fractional shares were issued in connection with the reverse
stock split. Stockholders who otherwise were entitled to receive a fractional share in connection with the reverse stock split instead were
eligible to receive a cash payment, which was not material in the aggregate, instead of shares. On October 7, 2022, the Company filed a
Certificate of Amendment of its Certificate of Incorporation, as amended with the Secretary of State of Delaware effecting a one-for-twenty
five (1:25) reverse stock split of the shares of the Common Stock, either issued and outstanding, effective October 7, 2022. The Company’s
common stock began trading on a reverse split adjusted basis when the market opened Monday, October 10, 2022.
Issuances of Common Stock for the years ended June 30, 2023 and 2022 include the following:
Cantor Fitzgerald Underwriting
On November 25, 2020, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor
Fitzgerald & Co. ("Cantor Fitzgerald") to sell shares of Common Stock, from time to time, through an “at the market offering” program
having an aggregate offering price of up to $100,000,000 through which Cantor Fitzgerald would act as sales agent. Between July 25, 2022
and June 30, 2023, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 5,782,871 shares of Common Stock. The
Company received net proceeds of approximately $6.4 million during the Fiscal year ended June 30, 2023 and holds a subscription
receivable for $204,000 at June 30, 2023 for proceeds received on July 6, 2023.
In Fiscal year ended June 30, 2022, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 175,973 shares of Common
Stock. The Company received net proceeds of approximately $1.2 million.
RubrYc Transaction
On September 19, 2022, the Company issued 102,354 shares valued at approximately $1,000,000 to RubrYc as part of the payment for
purchasing the assets of RubrYc.
Wainwright Underwriting
On December 6, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with H.C. Wainwright &
Co., LLC (“Wainwright”). Pursuant to the Underwriting Agreement, the Company agreed to sell to Wainwright, in a firm commitment
underwritten offering (the “Offering”) (i) 1,530,769 shares of the Company’s Common Stock, (ii) pre-funded warrants (the “Pre-Funded
Warrants”) to purchase up to 1,834,616 shares of Common Stock, (iii) Series A Common Stock purchase warrants (the “Series A
Warrants”) to purchase up to 3,365,385 shares of Common Stock and (iv) Series B Common Stock purchase warrants (the “Series B
Warrants” and together with the Series A Warrants, the “Common Warrants”) to purchase up to 3,365,385 shares of Common Stock. The
offering closed on December 9, 2022.
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Wainwright acted as the sole book-running manager for the Offering. The Company paid Wainwright an underwriting discount equal to
7.0% of the gross proceeds of the offering, and reimbursed Wainwright for the legal fees and certain expenses of the underwriter. Pursuant
to the Underwriting Agreement, the Company has granted Wainwright a 30-day option to purchase up to an additional 504,807 shares of
Common Stock and/or Common Warrants to purchase up to an additional 1,009,614 shares of Common Stock at the public offering price,
less the underwriting discounts and commissions, solely to cover over-allotments. Wainwright elected to purchase 504,807 Series A
Warrants and 504,807 Series B Warrants.
The Company has also agreed to issue to Wainwright, as the representative of the underwriters, warrants (the “Representative’s Warrants”)
to purchase a number of shares of Common Stock equal to 6.0% of the aggregate number of shares of Common Stock and Pre-Funded
Warrants being offered in the offering. Wainwright received warrants to purchase up to 201,923 shares of Common Stock.
The Company received net proceeds of approximately $2,864,000 after deducting underwriting discounts, commissions and other issuance
costs.
Vesting of Restricted Stock Units “RSUs”
RSUs for 217,553 of Common Stock vested during the year ended June 30, 2023. RSUs for 8,854 of Common Stock vested during the year
ended June 30, 2022.
Exercise of Stock Options
No stock options were exercised in the year ended June 30, 2023. In the year ended June 30, 2022, options for 3,380 shares of Common
Stock were exercised.
Warrants
Bryan Capital
As discussed above, the Company issued to Bryan Capital a Warrant to purchase 51,583 shares of the Common Stock of the Company at an
exercise price of $33.25 per share. The Warrant expires October 10, 2026, is exercisable immediately, provides for a cashless exercise at
any time and automatic cashless exercise on the expiration date if on such date the exercise price of the Warrant exceeds its fair market
value as determined in accordance with the terms of the Warrant and adjustments in the case of stock dividends and stock splits.
The Company estimated the fair value of the Warrant using the Black-Scholes model with the following assumptions:
Weighted average risk-free interest rate
Dividend yield
Volatility
Expected term (in years)
Wainwright
0.23 %
0 %
136.9 %
4.95
As discussed above, the Company issued various warrants with the following terms:
1. Pre-Funded Warrants – Immediately exercisable at an exercise price of $0.001 per share. All of the Pre-Funded Warrants were
exercised in December 2022.
2. Class A Warrants – Immediately exercisable at an exercise price of $1.04 per share for a term of five years.
3. Class B Warrants – Immediately exercisable at an exercise price of $1.04 per share for a term of two years.
4. Representative Warrants – Immediately exercisable at an exercise price of $1.30 per share for a term of five years.
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During the year ended June 30, 2023, 341,300 Class A Warrants and 1,781,216 Class B Warrants were exercised. The total proceeds from
Class A and B Warrants exercised during the year ended June 30, 2023 was $2,207,000.
On August 4, 2023, the Company agreed to amend the exercise price with certain holders of the Series A Warrants and Series B Warrants
that were acquired from the Company in the underwritten public offering that was completed in December 2022. Under the amended
warrants, the Company agreed to amend existing Series A Warrants to purchase up to 3,475,916 shares of common stock and existing
Series B Warrants to purchase up to 2,058,000 shares of common stock that were previously issued in December 2022 to the certain
investors in the public offering, with exercise prices of $1.04 per share (the “Existing Warrants”), to lower the exercise price of the Existing
Warrants to $0.50 per share.
18. Earnings (Loss) Per Common Share
Basic earnings (loss) per common share is computed by dividing the net income (loss) allocated to common stockholders by the weighted-
average number of shares of common stock outstanding during the period. For purposes of calculating diluted earnings per common share,
the denominator includes both the weighted-average number of shares of common stock outstanding during the period and the number of
common stock equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock equivalents potentially
include stock options and warrants using the treasury stock method. The following table summarizes the components of the earnings (loss)
per common share calculation (in thousands, except per share amounts):
Basic and diluted numerator:
Net loss attributable to iBio, Inc. from continuing operations
Preferred stock dividends – iBio CMO Preferred Tracking Stock
Net loss available to iBio, Inc. stockholders from continuing operations
Net loss available to iBio, Inc. stockholders from discontinued operations
Net loss available to iBio, Inc. stockholders - total
Basic and diluted denominator:
Weighted-average common shares outstanding
Per share amount - continuing operations
Per share amount - discontinued operations
Per share amount - total
Year Ended
June 30,
2023
2022
$
$
$
$
$
$
$
(29,311) $
—
$
(29,311)
(35,699)
(65,010)
12,245
(2.39)
(2.92)
(5.31)
$
$
$
$
$
(29,512)
(88)
(29,600)
(20,791)
(50,391)
8,721
(3.39)
(2.39)
(5.78)
In Fiscal Years 2023 and 2022, the Company incurred net losses which cannot be diluted; therefore, basic and diluted loss per common
share is the same. As of June 30, 2023 and 2022, shares issuable which could potentially dilute future earnings included were as follows:
Stock options
Restricted stock units
Warrants
Series 2022 Preferred
Shares excluded from the calculation of diluted loss per share
* Less than 1,000
F-39
June 30,
2023
2022
(in thousands)
292
248
5,871
—
6,411
622
51
21
*
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19. Share-Based Compensation
The following table summarizes the components of share-based compensation expense in the Consolidated Statements of Operations (in
thousands):
Research and development
General and administrative
Total
Year Ended
June 30,
2023
2022
$
$
149
2,714
2,863
$
$
182
3,776
3,958
In addition, share-based compensation expense included in loss from discontinued operations totaled approximately $1,528,000 and
$419,000 for the years ended June 30, 2023 and 2022, respectively.
Stock Options
iBio, Inc. 2020 Omnibus Equity Incentive Plan (the “2020 Plan”)
On December 9, 2020, the Company adopted the 2020 Plan for employees, officers, directors and external service providers. The total
number of shares of Common Stock reserved under the 2020 Plan is 1,280,000 shares of Common Stock for issuance pursuant to the grant
of new awards under the 2020 Plan. The 2020 Plan allows for the award of stock options, stock appreciation rights, restricted stock,
restricted stock units, unrestricted stock, cash-based awards, and dividend equivalent rights. The value of all awards awarded under the
2020 Plan and all other cash compensation paid by the Company to any non-employee director in any calendar year may not exceed
$500,000; provided, however, that such amount shall be $750,000 for the calendar year in which the applicable non-employee director is
initially elected or appointed to the Board of Directors and $1,500,000 for any non-executive chair of our Board of Directors should one be
appointed. Notwithstanding the foregoing, the independent members of the Board of Directors may make exceptions to such limits in
extraordinary circumstances. The term of the 2020 Plan will expire on the tenth anniversary of the date the Plan is approved by the
stockholders.
Vesting of service awards is determined by the Board of Directors and stated in the award agreements. In general, vesting occurs ratably on
the anniversary of the grant date over the service period, generally three or five years, as determined at the time of grant. Vesting of
performance awards occurs when the performance criteria is satisfied. The Company uses historical data to estimate forfeiture rates.
Issuances of stock options during the year ended June 30, 2023 were as follows:
During the first quarter of Fiscal year 2023, the Company granted stock option agreements to various employees to purchase 303,869
shares of the Common Stock at exercise prices between $6.75 and $9.50 per share. The options vest 25% after one year and then in equal
quarterly installments over a 36-month period and expire on the tenth anniversary of the grant date.
During the first quarter of Fiscal year 2023, the Company granted a stock option agreement to a consultant to purchase 4,000 shares of the
Common Stock at an exercise price of $6.75 per share. The option vests in equal monthly installments, over a period of 12 months, starting
after the second month and expire on the tenth anniversary of the grant date. During the third quarter of Fiscal year 2023, the Company
terminated the consultant’s services. As a result, none of the 4,000 shares pursuant to the stock option agreement were exercised and as
such, all 4,000 shares will be forfeited.
Issuances of stock options during the year ended June 30, 2022 were as follows:
During the first quarter of Fiscal Year 2022, the Company granted stock option agreements to various employees to purchase 165,488
shares of the Common Stock at exercise prices between $26.50 and $33.75 per share. The options vest
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25% after one year and then in equal quarterly installments over a 36-month period and expire on the tenth anniversary of the grant date.
During the first quarter of Fiscal year 2022, the Company granted a stock option agreement to a new member of its Board of Directors to
purchase 4,000 shares of Common Stock at an exercise price of $31.50 per share. The option vests monthly over a period of three years and
expires on the tenth anniversary of the grant date.
During the first quarter of Fiscal year 2022, the Board of Directors approved an option grant award to Mr. Isett to purchase 80,000 shares of
Common Stock with an exercise price of $29.25, which vests in equal monthly installments over a 36-month period following the grant
date.
During the second quarter of Fiscal year 2022, the Company granted a stock option agreement to a consultant to purchase 4,000 shares of
Common Stock at an exercise price of $21.25 per share. The option vests over a period of eight months commencing in April 2022 and
expires on the tenth anniversary of the grant date.
During the second quarter of Fiscal year 2022, the Company granted stock option agreements to various directors to purchase an aggregate
of 34,880 shares of Common Stock at an exercise price of $17.25 per share. The options vest over a period of one year commencing in
January 2022 and expire on the tenth anniversary of the grant date.
During the third quarter of Fiscal year 2022, the Company granted stock option agreements to two consultants to purchase an aggregate of
1,200 shares of Common Stock at an exercise price of $13.00 per share. The options vest over a period of 12 months and expire on the
tenth anniversary of the grant date.
During the third quarter of Fiscal year 2022, the Company granted a stock option agreement to various employees to purchase 24,000
shares of Common Stock at exercise prices between $8.50 and $11.50 per share. The options vest 25% after one year and then in equal
quarterly installments over a 36-month period and expire on the tenth anniversary of the grant date.
The following table summarizes all stock option activity during the years ended June 30, 2023 and 2022:
Outstanding as of July 1, 2021
Granted
Exercised
Forfeited/expired
Outstanding as of June 30, 2022
As of June 30, 2022, vested and expected to vest
Exercisable as of June 30, 2022
Outstanding as of June 30, 2022
Granted
Exercised
Forfeited/expired
Outstanding as of June 30, 2023
As of June 30, 2023, vested and expected to vest
Exercisable as of June 30, 2023
Weighted-
average
Remaining
Contractual
Term (in years)
8.8
$
—
—
—
$
8.3
$
8.3
6.7
$
8.3
$
—
—
—
$
8.5
$
8.5
7.9
$
Aggregate
Intrinsic Value
(in thousands)
1,995
—
—
—
—
—
—
—
—
—
—
—
—
—
Weighted-
average
Exercise
Price
32.75
27.50
22.75
35.00
30.00
30.00
29.25
30.00
7.06
—
23.96
19.18
19.18
29.17
Stock
Options
341,686
313,568
(3,380)
(30,068)
621,806
620,810
197,404
621,806
307,863
—
(637,191)
292,478
292,431
96,050
$
$
$
$
$
$
$
$
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Table of Contents
The following table summarizes information about options outstanding and exercisable at June 30, 2023:
Exercise prices:
$7.00 - $11.50
$17.35 - $26.03
$26.50 - $39.75
$41.25 - $61.88
Number
Outstanding
151,309
29,674
95,495
16,000
292,478
Options Outstanding and Exercisable
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining Life
In Years
9.1
7.9
7.9
7.4
8.3
$
$
$
$
$
7.51
18.00
33.08
48.75
28.31
Number
Exercisable
6,250
29,652
47,483
12,665
96,050
The total fair value of stock options that vested during 2023 and 2022 was approximately $4,828,000 and $3,334,000, respectively. The
total cash received for stock options that were exercised during 2023 and 2022 was approximately $0 and $77,000, respectively. The total
intrinsic value of stock options that were exercised during 2023 and 2022 was approximately $0 and $19,000, respectively. As of June 30,
2023, there was approximately $2,193,000 of total unrecognized compensation cost related to non-vested stock options that the Company
expects to recognize over a weighted-average period of 2.3 years.
The weighted-average grant date fair value of stock options granted during 2023 and 2022 was $6.30 and $23.25 per share,
respectively. The Company estimated the fair value of options granted using the Black-Scholes option pricing model with the following
assumptions:
Weighted average risk-free interest rate
Dividend yield
Volatility
Expected term (in years)
2023
3.21% - 3.61 %
0 %
115.52 - 116.93 %
7
2022
0.80 - 2.52 %
0 %
119.16 - 120.34 %
6
The aggregate intrinsic value in the table above represents the total intrinsic value, based on the Company’s closing stock price of $0.61 as
of June 30, 2023 and $6.50 as of June 30, 2022, which would have been received by the option holders had all option holders exercised
their options as of that date.
Restricted Stock Units (“RSUs”):
Issuances of RSUs during the year ended June 30, 2023 were as follows:
On August 29, 2022, the Company issued RSUs to acquire 6,954 shares of common stock to various employees at a market value of $7.06
per share. The RSUs vest over a four-year period. The grant date fair value of the RSUs totaled approximately $49,000.
On November 10, 2022, as previously disclosed in relation to the Employment Agreement with Mr. Isett, the Company’s former CEO,
dated April 30, 2021, the Company granted Mr. Isett RSUs to acquire 200,000 shares of Common Stock. The RSUs vest over a three-year
period commencing April 30, 2021 provided the vesting is subject to the following performance conditions: (i) submission to the U.S. Food
and Drug Administration (FDA) of an Investigational New Drug (IND) application, or alternatively, if the Board approves not to file an
IND, (ii) consummation of a disposition of iBio CDMO, LLC, or (iii) out-licensing, with full global rights, any of its investigational
product candidates prior to the submission to the FDA an IND application. The grant-date fair value of the RSUs totaled approximately
$296,000. The performance conditions were not met and the RSUs did not vest.
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On November 11, 2022, the Board of the Company granted Mr. Robert Lutz, the Company’s Chief Financial and Business Officer at the
time, RSUs to acquire 100,057 shares of the Company’s Common Stock in exchange for Mr. Lutz’s agreement to continue employment
with the Company through July 1, 2023. The RSUs vest the earlier of: (i) July 1, 2023, or (ii) the successful achievement of the Company’s
2023 objectives, as defined by the Board. The grant-date fair value of the RSUs totaled approximately $175,100. Mr. Lutz resigned from
the Company and was no longer an employee of the Company effective February 10, 2023; accordingly, the RSUs did not vest.
On November 11, 2022, the Board of the Company granted Dr. Martin Brenner, the Company’s Chief Scientific Officer, RSUs to acquire
95,348 shares of the Company’s Common Stock in exchange for Mr. Brenner’s agreement to continue employment with the Company
through July 1, 2023. The RSUs vest the earlier of: (i) July 1, 2023, or (ii) the successful achievement of the Company’s 2023 objectives,
as defined by the Board. The grant-date fair value of the RSUs totaled approximately $167,000.
On January 20, 2023, the Board of the Company appointed Dr. Brenner to the position of Interim Chief Executive Officer, effective
immediately. Dr. Brenner was granted RSUs to acquire 130,000 shares of the Company’s Common Stock, which RSUs shall vest pro rata
over a 12-month period, such vesting to terminate if Dr. Brenner is no longer the Company’s Interim Chief Executive Officer. The grant-
date fair value of the RSUs totaled approximately $91,000. Upon appointment of Dr. Brenner to permanent Chief Executive Officer on
June 22, 2023, 75,833 of the RSUs terminated and did not vest.
On March 31, 2023, the Compensation Committee (the “Committee”) of the Board of the Company approved a special equity award
program pursuant to which it awarded to its employees an aggregate of 225,000 RSUs under the Company’s 2020 Omnibus Equity
Incentive Plan, as amended (the “Plan”), which awards included a grant of 50,000 and 37,500 restricted stock units to each of Dr. Brenner,
and Felipe Duran, the Company’s Interim, Chief Financial Officer, respectively, vesting quarterly over 12 months commencing April 1,
2023. The grant-date fair value of the RSUs totaled approximately $468,000.
On June 26, 2023, the Board of the Company granted Dr. Brenner RSUs to acquire 75,833 shares of the Company’s Common Stock, which
RSUs shall vest pro rata over a seven-month period. The grant-date fair value of the RSUs totaled approximately $52,000.
Issuances of RSUs during the year ended June 30, 2022 were as follows:
On August 23, 2021, the Company issued RSUs to acquire 4,229 shares of Common Stock to various employees at a market value of
$31.50 per share. The RSUs vest over a four-year period. The grant-date fair value of the RSUs totaled approximately $133,000.
As of June 30, 2023, there was approximately $445,000 of total unrecognized compensation cost related to non-vested RSUs that the
Company expects to recognize over a weighted-average period of 0.8 years.
20. Fraunhofer Settlement
Fraunhofer Settlement
On May 4, 2021, iBio, Inc. (the “Company”) and Fraunhofer USA, Inc. (“FhUSA”) entered into a Confidential Settlement Agreement and
Mutual Release (the “Settlement Agreement”) to settle all claims and counterclaims in the litigation captioned iBio, Inc. v. Fraunhofer
USA, Inc. (Case No. 10256-VCF) in Delaware Chancery Court (the “Lawsuit”). The Settlement Agreement, among other things, resolves
the Company’s claims to ownership of certain plant-based technology developed by FhUSA from 2003 through 2014, and sets forth the
terms of a license of intellectual property. The Lawsuit was commenced against FhUSA by the Company in March 2015 in the Court of
Chancery of the State of Delaware and is described in more detail in the Company’s Quarterly Report on Form 10-Q for the quarter ended
December 31, 2020. The Settlement Agreement is not an admission of liability or fault of the parties.
The terms of the Settlement Agreement provided for cash payments to the Company of $28,000,000 as follows: (i) $16,000,000 paid no
later than May 14, 2021 (which was paid 100% to cover legal fees and expenses); (ii) two payments
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of $5,100,000 paid by March 31, 2022 and 2023 and (iii) as additional consideration for a license agreement, two payments of $900,000
paid by March 1, 2022 and 2023. The license provides for a nonexclusive, nontransferable, worldwide, fully paid-up license to all
intellectual property rights in and to certain plant-based technology developed by FhUSA from 2003 through 2014 that were the subject of
the Lawsuit. After payment of the fees and expenses of its attorneys and others retained by the Company, including the litigation funding
company, the Company’s aggregate net cash recovery as a result of the Settlement Agreement was approximately $10,200,000.
As of June 30, 2021, the Company held receivables related to the settlement in the amount of $10,200,000. This amount was recorded in
the consolidated statement of operations and comprehensive loss as settlement income in Fiscal 2021. During the quarter ended March 31,
2022, the Company received the first payment of $5,100,000.
On March 17, 2023, the Company received a payment of $5,100,000 from Fraunhofer related to the Fraunhofer Settlement Funds and in
accordance with the Fourth Amendment to the Credit Agreement with Woodforest, transferred $3,000,000 to a Company account at
Woodforest on March 24, 2023.
The Company would recognize the $1.8 million of license revenue when it determines the collection of the license fees was reasonably
assured in accordance with ASC 606. On February 9, 2022, the Company received the first $900,000 payment under the license agreement.
As such, the Company determined that the collection of the license fees was reasonably assured, and the Company recognized license
revenue related to the license fees and recorded a receivable for the second payment in the third quarter of 2022. The second $900,000
payment was received on February 17, 2023.
21. Income Taxes
The components of the provision (benefit) for income taxes consist of the following (in thousands):
Current – Federal and state
Deferred – Federal
Deferred – State
Total
Change in valuation allowance
Income tax expense
For the Years Ended
June 30,
2023
2022
$
$
— $
(12,153)
(637)
(12,790)
12,790
— $
—
(9,051)
—
(9,051)
9,051
—
The Company has deferred income taxes due to income tax credits, net operating loss carryforwards, and the effect of temporary
differences between the carrying values of certain assets and liabilities for financial reporting and income tax purposes.
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The components of the Company’s deferred tax assets and liabilities are as follows (in thousands):
Deferred tax assets (liabilities):
Net operating loss
Share-based compensation
Capitalized research and development costs
Research and development tax credits
Investment in equity security
Property, plant and equipment
Intangible assets
Operating and finance lease liabilities
Operating and finance lease ROU assets
Accrued expenses
Valuation allowance
Total
As of June 30,
2023
2022
$
$
42,951
883
2,775
1,764
395
121
(42)
1,363
(1,184)
529
(49,555)
$
— $
35,829
1,248
—
1,764
370
(2,520)
(71)
—
—
145
(36,765)
—
The Company has a valuation allowance against the full amount of its net deferred tax assets due to the uncertainty of realization of the
deferred tax assets due to the operating loss history of the Company. The Company currently provides a valuation allowance against
deferred taxes when it is more likely than not that some portion, or all of its deferred tax assets will not be realized. The valuation
allowance could be reduced or eliminated based on future earnings and future estimates of taxable income.
Federal net operating losses of approximately $5.5 million were used by the Former Parent prior to June 30, 2008 and are not available to
the Company. The Former Parent allocated the use of the Federal net operating losses available for use on its consolidated Federal tax
return on a pro rata basis based on all of the available net operating losses from all the entities included in its control group.
U.S. federal net operating losses of approximately $202.1 million are available to the Company as of June 30, 2023, of which $63.9 million
will expire at various dates through 2039 and $138.2 million with no expiration date. These carryforwards could be subject to certain
limitations in the event there is a change in control of the Company pursuant to Internal Revenue Code Section 382, though the Company
has not performed a study to determine if the loss carryforwards are subject to these Section 382 limitations. The Company has a research
and development credit carryforward of approximately $1.76 million at June 30, 2023. In addition, the Company has net operating loss
carry forwards from various states of approximately $35.2 million which expire from 2029 through 2042.
A reconciliation of the statutory tax rate to the effective tax rate is as follows:
Statutory federal income tax rate
State taxes, net of federal benefit
Expiration and forfeiture of stock options
Change related to iBio CDMO
Change in valuation allowance
Effective income tax rate
Years Ended
June 30,
2023
2022
21 %
1 %
(2)%
— %
(20)%
— %
21 %
— %
— %
(3)%
(18)%
— %
The Company has not been audited in connection with income taxes. iBio files U.S. Federal and state income tax returns subject to
varying statutes of limitations. The 2019 through 2022 tax returns generally remain open to examination by U.S. Federal authorities and by
state tax authorities.
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22. Commitments and Contingencies
CRO Agreement
On October 10, 2022, the Company entered into an agreement with a CRO for cell line development and master cell banking to produce
IBIO-101 in addition to process development and GMP manufacturing of IBIO-101 drug substance and drug product to support GLP
toxicology and Phase 1 clinical studies. The Company has incurred costs totaling approximately $1,209,000 through June 30, 2023. The
Company is committed to additional costs totaling approximately $171,000 as of the date of the filing of this Annual Report.
Inflation
Although the Company has not experienced any material adverse effects on our business due to increasing inflation, it has raised operating
costs for many businesses and, in the future, could impact demand or pricing of manufacturing services, foreign exchange rates or
employee wages. We are actively monitoring the effects these disruptions and increasing inflation could have on the Company’s operations.
23. Employee 401(K) Plan
Commencing January 1, 2018, the Company established the iBio, Inc. 401(K) Plan (the “Plan”). Eligible employees of the Company may
participate in the Plan, whereby they may elect to make elective deferral contributions pursuant to a salary deduction agreement and receive
matching contributions upon meeting age and length-of-service requirements. The Company will make a 100% matching contribution that
is not in excess of 5% of an eligible employee’s compensation. In addition, the Company may make qualified non-elective contributions at
its discretion. Employer contributions made to the Plan totaled approximately $263,000 and $169,000 for the years ended June 30, 2023
and 2022, respectively. In addition, employer contributions included in loss from discontinued operations totaled approximately $135,000
and $150,000 for the years ended June 30, 2023 and 2022, respectively,
24. Subsequent Events
Purchase and Sale Agreement with Majestic Realty Co.
On September 15, 2023, iBio CDMO entered into the Purchase and Sale Agreement with Majestic Realty Co., pursuant to which iBio
CDMO agreed to sell to Majestic Realty for a purchase price of $17,250,000 its Facility located in Bryan, TX consisting of: (i) the ground
leasehold estate and interest held under the Ground Lease Agreement, dated March 8, 2010, as amended by an Estoppel Certificate and
Amendment to Ground Lease Agreement, dated as of December 22, 2015, between iBio CDMO (as assignee from College Station
Investors LLC) and The Board of Regents of the Texas A&M University System (together, the “Ground Lease”), related to 21.401 acres in
Brazos County, Texas land (the “Land”); (ii) the buildings, parking areas, improvements, and fixtures situated on the Land (the
“Improvements”); (iii) all iBio CDMO’s right, title, and interest in and to furniture, personal property, machinery, apparatus, and equipment
owned and currently used in the operation, repair and maintenance of the Land and Improvements and situated thereon (collectively, the
“Personal Property”); (iii) all iBio CDMO’s rights under the contracts and agreements relating to the operation or maintenance of the Land,
Improvements or Personal Property which extend beyond the closing date (the “Contracts”); and (iv) all iBio CDMO’s rights in intangible
assets of any nature relating to any or all of the Land, the Improvements and the Personal Property (the “Intangibles”; and together with the
Ground Lease, Improvements and Personal Property, collectively, the “Property”). The closing of the sale of the Property is to occur, with
time being of the essence, on December 1, 2023 or such other date as mutually agreed. Pursuant to the terms of the Purchase and Sale
Agreement , Majestic Realty deposited with a title company (the “Escrow Agent”) $200,000 as an earnest money deposit. Majestic Realty
will also be afforded access to the Property to conduct a due diligence review of its condition. The closing is subject to certain closing
conditions, including: (i) Majestic Realty’s delivery to iBio CDMO and the Escrow Agent of written notice of its approval of the condition
of the Property on or before 5:00 p.m. Central time on October 16, 2023; (ii) Majestic
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Realty obtaining the approval of The Board of Regents of the Texas A&M University System of Majestic Realty’s purchase from it of the
fee interest in the Land on or before 5:00 p.m. Central time on November 13, 2023; and (iii) the delivery at closing by the title company of
a title policy to Majestic Realty in the amount of the Purchase Price.
Credit Agreement with Woodforest National Bank
On September 18, 2023, iBio CDMO and Woodforest entered into a sixth amendment to the Credit Agreement (the “Sixth Amendment”),
to amend the Credit Agreement to: (i) set the maturity date of the term loan to the earlier of (a) December 31, 2023, or (b) the acceleration
of maturity of the term loan in accordance with the Credit Agreement, (ii) provided that iBio CDMO will, immediately upon receipt of the
proceeds of the sale of the Property, apply the net proceeds to satisfy all outstanding obligations under the term loan, and to the extent such
net proceeds are sufficient, to pay off the term loan, and (iii) change the annual filing requirement solely for the fiscal year ending June 30,
2023, such that the filing is acceptable with or without a “going concern” designation; provided that (y) iBio CDMO shall deliver an
executed copy of the Purchase and Sale Agreement for the sale of the Facility within one business day after entry into the Sixth
Amendment, and (z) if the Facility is not sold on or before December 1, 2023, iBio CDMO will pay a fee in the amount of $20,000 upon
the earlier of the date of the closing or the maturity date.
Repriced Existing Warrants issued pursuant to Wainwright Underwriting
On August 4, 2023, iBio, Inc. (the “Company”) agreed to amend the exercise price with certain holders of the Series A Warrants and Series
B Warrants that were acquired from the Company in the underwritten public offering that was completed in December 2022. Under the
amended warrants, the Company agreed to amend existing Series A warrants to purchase up to 3,475,916 shares of common stock and
existing Series B warrants to purchase up to 2,058,000 shares of common stock that were previously issued in December 2022 to the
certain investors in the public offering, with exercise prices of $1.04 per share (the “Existing Warrants”), to lower the exercise price of the
Existing Warrants to $0.50 per share.
Lincoln Park Stock Purchase Agreement
On August 4, 2023, iBio, Inc. (the “Company”) entered into a purchase agreement, dated as of August 4, 2023 (the “Purchase Agreement”),
with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which, under the terms and subject to the satisfaction of specified
conditions set forth therein, the Company may sell to Lincoln Park up to $10.0 million (subject to certain limitations) of the Company’s
Common Stock, from time to time during the term of the Purchase Agreement. Additionally, on August 4, 2023, the Company entered into
a registration rights agreement, dated as of August 4, 2023 (the “Registration Rights Agreement”), with Lincoln Park, pursuant to which the
Company agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”), to register under the Securities
Act of 1933, as amended (the “Securities Act”), the resale by Lincoln Park of shares of Common Stock that have been or may be issued and
sold by the Company to Lincoln Park under the Purchase Agreement. The Company cannot sell any shares of Common Stock to Lincoln
Park under the Purchase Agreement until such time that all of the conditions to Lincoln Park’s purchase obligation set forth in the Purchase
Agreement, including that the resale registration statement that the Company is required to file with the SEC under the Registration Rights
Agreement is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC (the date on which all of such
conditions are satisfied, the “Commencement Date”).
Beginning on the Commencement Date and for a period of up to 24 months thereafter, under the terms and subject to the conditions of the
Purchase Agreement, from time to time, at the Company’s discretion, the Company has the right, but not the obligation, to sell to Lincoln
Park, and Lincoln Park is obligated to purchase, up to $10 million of shares of Common Stock, subject to certain limitations set forth in the
Purchase Agreement. Specifically, from time to time from and after the Commencement Date, the Company may, at its discretion, on any
single business day on which the closing price of the common stock on the NYSE American is equal to or greater than $0.15, by written
notice delivered to Lincoln Park, direct Lincoln Park to purchase up to 100,000 shares of Common Stock on such business day, at a
purchase price per share that will be determined and fixed in accordance with the Purchase Agreement at the time the Company delivers
such written notice to Lincoln Park (each, a “Regular Purchase”); provided, however, that the maximum number of shares the Company
may sell to Lincoln Park in a Regular Purchase may be increased to up to (i) 150,000 shares, if the closing sale price of the Common Stock
on the NYSE American on the applicable purchase date is not below $1.00, and (ii) 200,000 shares, if
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the closing sale price of the Common Stock on the applicable purchase date is not below $2.00; provided, however, that Lincoln Park’s
maximum purchase commitment in any single Regular Purchase may not exceed $500,000. The foregoing share amounts and per share
prices will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction
occurring after the date of the Purchase Agreement with respect to the Common Stock. The purchase price per share of Common Stock sold
in each such Regular Purchase, if any, will be based on market prices of the Common Stock immediately preceding the time of sale,
calculated as set forth in the Purchase Agreement.
In addition, provided that the Company has directed Lincoln Park to purchase the maximum amount of shares that the Company is then
able to sell to Lincoln Park in a Regular Purchase on a particular business day on which the closing price of the common stock on the
NYSE American is equal to or greater than $0.20, then in addition to such Regular Purchase, the Company may, in its sole discretion, also
direct Lincoln Park to purchase additional shares of Common Stock in an “accelerated purchase,” and one or more “additional accelerated
purchases” on the business day immediately following the purchase date for such Regular Purchase, as provided in the Purchase
Agreement. The purchase price per share of Common Stock sold to Lincoln Park in each accelerated purchase and additional accelerated
purchase, if any, will be based on market prices of the Common Stock at the time of sale on the applicable purchase date for such
accelerated purchase and such additional accelerated purchase(s), as applicable, calculated as set forth in the Purchase Agreement. There
are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock in any purchase under the Purchase
Agreement.
The Company will control the timing and amount of any sales of Common Stock to Lincoln Park pursuant to the Purchase Agreement.
Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to
make purchases as the Company directs, subject to certain conditions.
Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to
time, including, among others, market conditions, market prices of the Common Stock from time to time during the term of the Purchase
Agreement and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net
proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of
Common Stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be
used for working capital and general corporate purposes.
As consideration for Lincoln Park’s commitment to purchase shares of Common Stock at the Company’s direction pursuant to the Purchase
Agreement, the Company issued 211,473 shares of Common Stock to Lincoln Park as commitment shares (the “Initial Commitment
Shares”) and agreed to issue 211,474 additional shares of Common Stock to Lincoln Park as commitment shares (the “Additional
Commitment Shares” and, collectively with the Initial Commitment Shares, the “Commitment Shares”) at such time as the Company has
received an aggregate of $5,000,000 in cash proceeds from Lincoln Park from sales of Common Stock to Lincoln Park, if any, that the
Company elects, in its sole discretion, to make from time to time from and after the Commencement Date, pursuant to the Purchase
Agreement.
Under applicable rules of the NYSE American, the Company may not issue or sell to Lincoln Park under the Purchase Agreement more
than 4,474,945 shares (inclusive of the Commitment Shares), subject to adjustment as described above, of Common Stock (which is equal
to approximately 19.99% of the shares of Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the
“Exchange Cap”), unless stockholder approval is obtained to issue shares of Common Stock in excess of the Exchange Cap in accordance
with the applicable rules of the NYSE American. In any event, the Company may not issue or sell any shares of Common Stock under the
Purchase Agreement if such issuance or sale would breach any applicable rules or regulations of the NYSE American.
The Purchase Agreement also prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares,
when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park (as calculated pursuant to Section 13(d)
of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder), would result in Lincoln Park beneficially owning more
than 4.99% of the outstanding shares of Common Stock.
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There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase
Agreement or Registration Rights Agreement, other than a prohibition (with certain limited exceptions) on entering into specified “Variable
Rate Transactions” (as such term is defined in the Purchase Agreement) for a period specified in the Purchase Agreement. Such transactions
include, among others, any sale of debt or equity securities that are convertible into or exercisable for shares of Common Stock at a
conversion price or exercise price that is based upon and/or varies with the trading prices of the Common Stock after the initial issuance of
such securities, or effecting or entering into an agreement to effect an “equity line of credit” or other substantially similar continuous
offering with a third party, in which we may offer, issue or sell Common Stock or any securities exercisable, exchangeable or convertible
into Common Stock at a future determined price. During any “suspension event” under the Purchase Agreement, the Company may not
initiate any Regular Purchase, accelerated purchase or additional accelerated purchase of Common Stock by Lincoln Park, until such
suspension event is cured.
Lincoln Park has agreed not to engage in or effect, directly or indirectly, for its own principal account or for the principal account of any of
its affiliates, any short sales of the Common Stock or hedging transaction that establishes a net short position in the Common Stock during
the term of the Purchase Agreement. The Company has the right to terminate the Purchase Agreement at any time with one business days’
notice, at no cost or penalty.
The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and
indemnification obligations of the parties. The representations, warranties and covenants contained in such agreements were made only for
purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to
limitations agreed upon by the contracting parties.
The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to
the full text of such agreements, copies of which are attached hereto as Exhibits 10.1 and 10.2, respectively, and each of which is
incorporated herein in its entirety by reference.
Between August 16, 2023 and September 15, 2023, Lincoln Park purchased pursuant to the Purchase Agreement 3,622,834 shares of
Common Stock. The Company received net proceeds of approximately $1.2 million during the first quarter of Fiscal 2024.
Cantor Fitzgerald Underwriting
Between July 3 and September 26, 2023, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 3,419,795 shares of
Common Stock. The Company received net proceeds of approximately $1.7 million during the first quarter of Fiscal 2024.
Issuances of stock options during Fiscal 2024 were as follows:
In Fiscal 2024, the Company granted stock option agreements to certain officers and employees to purchase an aggregate of 473,000 shares
of Common Stock at an exercise price of $0.35 per share. The options vest 25% after one year and then in equal quarterly installments over
a 36-month period and expire on the tenth anniversary of the grant date.
Vesting of RSUs during Fiscal 2024 were as follows:
During the first quarter of Fiscal 2024, RSUs for 33,153 shares of Common Stock were vested.
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Subsidiaries of Registrant
Exhibit 21.1
iBio Manufacturing LLC (“iBio Manufacturing”) is wholly-owned and incorporated in Delaware
iBio CDMO LLC (“iBio CDMO”) is wholly-owned and incorporated in Delaware. Name was changed effective July 1, 2017.
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the following Registration Statements:
● Form S-1 (File No. 333-233504, File No. 333-224620 and File No. 333-273749),
● Form S-3 (File No. 333-171315, File No. 333-175420, File No. 333-200410, File No. 333-236735, and File No. 333-250973) and on
● Form S-8 (File No. 333-181729, File No. 333-229261, File No. 333-25027 and File No. 333-252028)
of iBio, Inc. and Subsidiaries of our report, which includes an explanatory paragraph relating to the Company’s ability to continue as a going concern,
dated September 27, 2023, on our audits of the consolidated financial statements of iBio, Inc. and Subsidiaries as of June 30, 2023 and 2022 and for the
years then ended, included in this Annual Report on Form 10-K of iBio, Inc. for the year ended June 30, 2023.
Exhibit 23.1
/s/ CohnReznick LLP
Holmdel, New Jersey
September 27, 2023
CERTIFICATION PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
Exhibit 31.1
I, Martin Brenner, certify that:
1.
I have reviewed this Annual Report on Form 10-K of iBio, Inc. for the fiscal year ended June 30, 2023;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: September 27, 2023
By:
/s/ Martin Brenner
Martin Brenner
Chief Executive Officer and Chief Scientific
Officer
(Principal Executive Officer)
CERTIFICATION PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Felipe Duran, certify that:
1.
I have reviewed this Annual Report on Form 10-K of iBio, Inc. for the fiscal year ended June 30, 2023;
Exhibit 31.2
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: September 27, 2023
By:
/s/ Felipe Duran
Felipe Duran
Chief Financial Officer
(Principal Financial Officer and Principal
Accounting Officer)
CERTIFICATION PURSUANT TO
18 U.S.C. §1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of iBio, Inc. (the Company) on Form 10-K for the fiscal year ended June 30, 2023 as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), I, Martin Brenner, Chief Executive Officer and Chief Scientific
Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, that to my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
September 27, 2023
/s/ Martin Brenner
Martin Brenner
Chief Executive Officer and Chief Scientific Officer
(Principal Executive Officer)
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to iBio, Inc. and
will be furnished to the Securities and Exchange Commission or its staff upon request.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report of iBio, Inc. (the Company) on Form 10-K for the fiscal year ended June 30, 2023 as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), I, Felipe Duran, Chief Financial Officer of the Company, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
September 27, 2023
/s/ Felipe Duran
Felipe Duran
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to iBio, Inc. and
will be furnished to the Securities and Exchange Commission or its staff upon request.