Celldex Therapeutics Inc.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark one)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT
OF 1934
Commission File Number 000-15006
CELLDEX THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
13-3191702
State or other jurisdiction of

incorporation or organization
(I.R.S. Employer

Identification No.)
Perryville III Building, 53 Frontage Road, Suite 220, Hampton, New Jersey 08827
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (908) 200-7500
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class:
    
Trading Symbol(s)
    
Name of Each Exchange Where Registered:
Common Stock, par value $.001
CLDX
NASDAQ Capital Market
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 and post such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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. (Check one):
Large accelerated filer ☒
Accelerated filer ☐
Non-accelerated filer ☐
Smaller reporting company ☐
Emerging growth 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 Act). Yes ☐ No ☒
The aggregate market value of the registrant’s common stock held by non-affiliates as of June 30, 2024 was $2.4 billion. Exclusion of shares held by any person
should not be construed to indicate that such person possesses the power, direct or indirect, to direct or cause the actions of the management or policies of the registrant, or
that such person is controlled by or under common control with the registrant.
The number of shares of common stock outstanding at February 14, 2025 was 66,383,811 shares.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the definitive Proxy Statement for our 2025 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report.
Auditor Firm ID: 238
Auditor Name: PricewaterhouseCoopers LLP
Auditor Location: Boston, Massachusetts

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i
CELLDEX THERAPEUTICS, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2024
TABLE OF CONTENTS
    
    
Page
Part I
Item 1.
Business
1
Item 1A.
Risk Factors
24
Item 1B.
Unresolved Staff Comments
53
Item 1C.
Cybersecurity
53
Item 2.
Properties
54
Item 3.
Legal Proceedings
54
Item 4.
Mine Safety Disclosures
54
Part II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
55
Item 6.
[Reserved]
55
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
56
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
75
Item 8.
Financial Statements and Supplementary Data
76
Item 9.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
98
Item 9A.
Controls and Procedures
98
Item 9B.
Other Information
99
Item 9C.
Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
99
Part III
Item 10.
Directors, Executive Officers and Corporate Governance
99
Item 11.
Executive Compensation
99
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
99
Item 13.
Certain Relationships and Related Transactions, and Director Independence
99
Item 14.
Principal Accountant Fees and Services
99
Part IV
Item 15.
Exhibits, Financial Statement Schedules
100
Item 16.
Form 10-K Summary
103
Signatures
104

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ii
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This Annual Report on Form 10-K contains
forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-
looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions,
estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be
beyond our control and which may cause our actual results, performance or achievements to be materially different from future results,
performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical
fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of
words such as “may,” “will,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,”
“estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and
expressions of the future.
There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-
looking statement made by us. These factors include, but are not limited to:
●
our dependence on product candidates that are still in development stages;
●
our ability to successfully complete research and further development, including preclinical and clinical studies;
●
our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials
and product approvals;
●
our ability to negotiate strategic partnerships, where appropriate, for our drug candidates;
●
our ability to manage multiple clinical trials for a variety of drug candidates at different stages of development;
●
the cost, timing, scope and results of ongoing preclinical and clinical testing;
●
our expectations of the attributes of our product and development candidates, including pharmaceutical properties, efficacy,
safety and dosing regimens;
●
the cost, timing and uncertainty of obtaining regulatory approvals for our drug candidates;
●
the availability, cost, delivery and quality of clinical management services provided by our clinical research organization
partners;
●
the availability, cost, delivery and quality of clinical and commercial-grade materials produced by our own manufacturing
facility or supplied by contract manufacturers, suppliers and partners;
●
our ability to commercialize our drug candidates and the growth of the markets for those drug candidates;
●
our ability to develop and commercialize products before competitors that are superior to the alternatives developed by such
competitors;
●
our ability to develop technological capabilities, including identification of novel and clinically important targets, exploiting our
existing technology platforms to develop new drug candidates and expand our focus to broader markets for our existing targeted
therapeutics;
●
the cost of paying the regulatory approval milestone under the merger agreement by which we acquired Kolltan
Pharmaceuticals, Inc. (“Kolltan”) and our related settlement agreement with Kolltan;

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iii
●
our ability to raise sufficient capital to fund our preclinical and clinical studies and to meet our long-term liquidity needs, on
terms acceptable to us, or at all. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may
have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical
trials, discontinue or delay our commercial manufacturing efforts, discontinue or delay our efforts to expand into additional
indications for our drug product candidates, license out programs earlier than expected, raise funds at significant discount or on
other unfavorable terms, if at all, or sell all or part of our business;
●
our ability to protect our intellectual property rights and our ability to avoid intellectual property litigation, which can be costly
and divert management time and attention;
●
our ability to develop and commercialize products without infringing the intellectual property rights of third parties; and
●
the factors listed under “Risk Factors” in this Annual Report on Form 10-K.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place
undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated
by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the
forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations,
beliefs and projections in good faith, and we believe they have a reasonable basis. However, we cannot assure you that our expectations,
beliefs or projections will result or be achieved or accomplished.

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1
PART I
Item 1. BUSINESS
Overview
Celldex Therapeutics, Inc., which we refer to as “Celldex,” “we,” “us,” “our” or the “Company,” is a biopharmaceutical company
dedicated to exploring the science of mast cell biology and developing therapeutic antibodies which have the ability to engage the human
immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune
and other devastating diseases. Our drug candidates include monoclonal and bispecific antibodies designed to address mast cell mediated
diseases for which available treatments are inadequate.
We are focusing our efforts and resources on the continued research and development of
●
Barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that specifically binds the KIT receptor and potently
inhibits its activity, which is currently being studied across multiple mast cell driven diseases including
-
Chronic Urticarias: We initiated Phase 3 studies in chronic spontaneous urticaria (CSU) in July 2024. In November
2023, we announced that our Phase 2 study in CSU achieved the primary efficacy endpoint (statistically significant
mean change from baseline to week 12 of urticaria activity score compared to placebo) and was well tolerated. Patients
on study continued to receive barzolvolimab and, in September 2024, we reported data from 52 weeks of treatment—
demonstrating sustained and deepening disease efficacy and a well tolerated long term safety profile. In July 2024, we
announced that our Phase 2 study in chronic inducible urticaria (CIndU) achieved the primary efficacy endpoint,
(statistically significant difference between the percent of patients with a negative provocation test compared to
placebo at week 12) and was well tolerated. 12 week data from the CIndU study were presented in October of 2024
and all secondary endpoints across the study were also met and were highly statistically significant and clinically
meaningful. Patients on study continued to receive barzolvolimab for 20 weeks of treatment;
-
Prurigo Nodularis (PN): In April 2024, we initiated a Phase 2 study in PN and enrollment is ongoing; positive data
from a Phase 1b study in PN was reported in November 2023;
-
Eosinophilic Esophagitis (EoE): A Phase 2 study in EoE was initiated in June 2023 and is fully accrued; and
-
Atopic Dermatitis (AD): A Phase 2 study in AD was initiated in December 2024 and enrollment is ongoing.
●
Our next generation bispecific antibody platform to support pipeline expansion with additional candidates for inflammatory
diseases. Targets are being selected based on new science as well as their compatibility to be used in bispecific antibody formats
with our existing antibody programs. Development is focused on emerging, important pathways controlling inflammatory
diseases.
-
CDX-622 (TSLP & SCF): Our first bispecific candidate for inflammatory diseases is CDX-622 which targets two
complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal
lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. In November 2024, a Phase 1a
dose-escalation study in healthy volunteers was initiated and enrollment is ongoing.
More detail on these programs is provided in the Clinical Development Programs section.
Our goal is to build a fully integrated, commercial-stage biopharmaceutical company that develops important therapies for patients
with unmet medical needs. We believe our program assets provide us with the strategic options to either retain full economic rights to our
innovative therapies or seek favorable economic terms through advantageous commercial partnerships. This approach allows us to
maximize the overall value of our technology and product portfolio while best ensuring the expeditious development of each individual
product.

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2
Our future success depends upon many factors, including our ability, and that of any licensees and collaborators that we may have,
to successfully develop, obtain regulatory approval for and commercialize our drug candidates. We have had no commercial revenues
from sales of our drug candidates, and we have had a history of operating losses. It is possible that we may not be able to successfully
develop, obtain regulatory approval for, or commercialize, our drug candidates, and we are subject to a number of risks that you should
be aware of before investing in us. These risks are described more fully in “Item 1A. Risk Factors.”
Clinical Development Programs
Barzolvolimab (also referred to as CDX-0159)
Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT and potently inhibits its
activity. KIT is expressed in a variety of cells, including mast cells, and its activation by its ligand SCF regulates mast cell growth,
differentiation, survival, chemotaxis and degranulation. Barzolvolimab is designed to block KIT activation by disrupting both SCF
binding and KIT dimerization. By targeting KIT, barzolvolimab has been shown to inhibit mast cell activity and decrease mast cell
numbers, which we believe could provide potential clinical benefit in mast cell related diseases.
Barzolvolimab was initially studied in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), diseases where
mast cell degranulation plays a central role in the onset and progression of the disease. In July 2024, we initiated two Phase 3 studies in
CSU. Phase 1 studies in CSU and CIndU were successfully completed and Phase 2 studies are ongoing. In July 2023, we announced that
enrollment was complete in the ongoing Phase 2 CSU study. In November 2023, we reported that barzolvolimab achieved the primary
efficacy endpoint in this study, with a statistically significant mean change from baseline to week 12 of UAS7 (weekly urticaria activity
score) compared to placebo and was well tolerated. In September 2024, we presented 52 week treatment data from the CSU study,
demonstrating sustained and deepening disease efficacy and a well tolerated long term safety profile. We plan to present follow up data
from this study through week 76 in 2025. In April 2024, we announced enrollment was complete in the ongoing Phase 2 CIndU study. In
July 2024, we announced that our Phase 2 study in chronic inducible urticaria (CIndU) achieved the primary efficacy endpoint,
(statistically significant difference between the percent of patients with a negative provocation test compared to placebo at week 12) and
was well tolerated.12 week data from the CIndU study were presented in October of 2024 and all secondary endpoints across the study
were also met and were highly statistically significant and clinically meaningful. Patients on study continued to receive barzolvolimab
for 20 weeks of treatment and were then followed for up to 24 additional weeks without treatment. We plan to present data from this
study through week 44 in 2025. Patients with resumption of symptoms were eligible to enroll into an open label extension.
Based on the positive results reported in urticaria, we expanded development of barzolvolimab into additional indications where
mast cells are believed to play an important role. We are conducting ongoing Phase 2 studies in eosinophilic esophagitis (EoE), prurigo
nodularis (PN) and atopic dermatitis (AD). We continue to assess potential opportunities for barzolvolimab in other diseases where mast
cells play an important role, such as dermatologic, respiratory, allergic, gastrointestinal and ophthalmic conditions.
Chronic Spontaneous Urticaria (CSU) Summary of Phase 1 and Phase 2 Data Presented to Date; 76 week Phase 2 follow up data to be
presented in 2025.
CSU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over
years or even decades. It is one of the most frequent dermatologic diseases with a prevalence of 0.5-1.0% of the total population or up to
approximately 1 to 3 million patients in the United States (Weller et al. 2010. Hautarzt. 61(8), Bartlett et al. 2018. DermNet.Org).
Approximately 50% of patients with CSU achieve symptomatic control with antihistamines. Omalizumab, an IgE inhibitor, provides
relief for roughly half of the remaining antihistamine refractory patients. Consequently, there is a need for additional therapies.
We have completed a Phase 1b randomized, double-blind, placebo-controlled multi-center study of barzolvolimab in CSU. The
study was designed to assess the safety of multiple ascending doses of barzolvolimab in patients with CSU who remain symptomatic
despite treatment with antihistamines. Secondary and exploratory objectives included pharmacokinetic and pharmacodynamic
assessments, clinical activity outcomes and quality of life assessments. Barzolvolimab was administered intravenously as add on
treatment to H1-antihistamines, either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists. 45 patients
with moderate to severe CSU refractory to antihistamines were enrolled and treated [35 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5
mg/kg; n=9 in 3.0 mg/kg; n=9 in 4.5 mg/kg) and 10 placebo].

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At saturating doses (1.5 mg/kg and higher), barzolvolimab resulted in rapid, marked and durable responses in patients with moderate
to severe CSU refractory to antihistamines. The 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups showed similar markedly improved
urticaria symptoms, including rapid onset of responses (as early as 1 week after the first dose) and prolonged disease control with
sustained durability up to 24 weeks. Patients with prior omalizumab therapy also had similar symptom improvement as all patients.
Phase 1 CSU: Summary of Clinical Activity Assessments at Week 12 & 24
4.5 mg/kg Q8
3.0 mg/kg Q8
1.5 mg/kg Q4
Mean Reduction Baseline UAS7; % at Week 12
82% (n=9)
67% (n=9)
67% (n=8)
Mean Reduction Baseline UAS7; % at Week 24
77% (n=7)
70% (n=6)
80% (n=7)
UAS7=0 (Complete Control); % at Week 12
67%
44%
57%
UAS7=0 (Complete Control); % at Week 24
43%
67%
57%
UAS7≤6 (Well-controlled); % at Week 12
67%
67%
57%
UAS7≤6 (Well-controlled); % at Week 24
57%
67%
57%
UCT ≥ 12 (Well-controlled); % at Week 12
89%
63%
75%
UCT ≥ 12 (Well-controlled); % at Week 24
67%
67%
75%
During post-treatment follow up, 71% (10 of 14) of patients who had been treated with doses greater than or equal to 1.5 mg/kg and
had a complete response (UAS7=0) at week 12, remained urticaria free at week 24 (patients received last dose of barzolvolimab at week
8). Profound and durable improvement in angioedema symptoms as measured through the weekly angioedema activity score (AAS7)
was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels. Patients also
reported improvements in quality of life outcomes as assessed by the Dermatology Life Quality Index (DLQI) which surveys patients’
perceptions of symptoms and feelings, daily activities, leisure, work and school performance, personal relationships and treatment.
Tryptase suppression, indicative of mast cell depletion, paralleled symptom improvement, demonstrating the impact of mast cell
depletion on CSU disease activity.
Barzolvolimab was well tolerated. Most adverse events were mild or moderate in severity and resolved while on study. The most
common treatment emergent adverse events were hair color changes, COVID-19, headache, neutropenia and urinary tract infections
(UTIs). UTIs and COVID-19 were reported as unrelated to treatment. Generally transient, asymptomatic and mild changes in
hematologic parameters were observed, consistent with observations from prior studies. No pattern of further decrease was observed with
multiple dose administration.
Data from this study were reported across multiple medical meetings, including the American Academy of Allergy, Asthma &
Immunology (AAAAI) Annual Meeting in February 2023, the European Academy of Allergy and Clinical Immunology (EAACI)
Annual Congress in June 2023 and the European Academy of Dermatology & Venereology (EADV) Congress in October 2023.
In June 2022, we initiated dosing in a Phase 2 study in patients with CSU who remained symptomatic despite antihistamine therapy;
in July 2023, we announced that enrollment was complete. The study is being conducted at approximately 75 sites across 9 countries.
The study is a randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluating the efficacy and safety profile of
multiple dose regimens of barzolvolimab to determine the optimal dosing strategy. 208 patients have been randomly assigned on a
1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks
or placebo during a 16-week placebo-controlled treatment phase. After 16 weeks, patients then enter a 36-week active treatment period,
in which patients receiving placebo or the 75 mg dose are randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8
weeks; patients already randomized to the 150 mg and 300 mg treatment arms remain on the same regimen as during the placebo-
controlled treatment period. After 52 weeks, patients then enter a follow-up period for an additional 24 weeks. The primary endpoint of
the study is mean change in baseline to week 12 in UAS7 (weekly urticaria activity score). Secondary endpoints include safety and other
assessments of clinical activity including ISS7 (weekly itch severity score), HSS7 (weekly hive severity score) and AAS7 (weekly
angioedema activity score).

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Topline data from this study were presented in November of 2023 and 12 week treatment results were presented at the American
Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in February 2024. Data from the 208 patients randomized in the
study showed that barzolvolimab achieved the primary efficacy endpoint, with a statistically significant mean change from baseline to
week 12 in UAS7 compared to placebo at all dose levels. Secondary and exploratory endpoints in the study were also achieved at week
12 and strongly support the primary endpoint results, including changes in ISS7 and HSS7 and responder analyses. Importantly,
barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to
antihistamines, including patients with prior omalizumab treatment. Demographics and baseline disease characteristics were well
balanced across treatment groups. The majority of patients on study had severe disease (UAS7≥28).
Phase 2 CSU: Summary of Clinical Activity Assessments at Week 12
300 mg Q8W
(n=51)
150 mg Q4W
(n=52)
75 mg Q4W
(n=53)
Placebo
(n=51)
UAS7 Changes
Baseline UAS7 (mean)
31.33
30.75
30.30
30.09
LS Mean change at Week 12
-23.87
-23.02
-17.06
-10.47
LS Mean difference from placebo
(Confidence Interval, p value)
-13.41
(CI: -17.47, -9.34)
p<0.0001
-12.55
(CI:-16.56, -8.55)
p<0.0001
-6.60
(CI:-10.71, -2.49)
p=0.0017
HSS7 Changes
Baseline HSS7 (mean)
14.92
15.05
14.86
14.47
LS Mean change at Week 12
-12.19
-11.19
-8.25
-4.95
LS Mean difference from placebo
(Confidence Interval, p value)
-7.24
(CI:-9.36, -5.12)
p<0.0001
-6.24
(CI:-8.33, -4.16),
p<0.0001
-3.31
(CI:-5.40, -1.22),
p=0.0020
ISS7 Changes
Baseline ISS7 (mean)
16.42
15.70
15.44
15.61
LS Mean change at Week 12
-11.79
-11.68
-8.62
-5.47
LS Mean difference from placebo
(Confidence Interval, p value)
-6.32
(CI: -8.50, -4.13),
p<0.0001
-6.21
(CI: -8.38, -4.04),
p<0.0001
-3.16
(CI: -5.41, -0.91),
p=0.0061
Responder Analyses/Clinical Responses
UAS7=0 (Complete Control)
37.5%
51.1%
22.9%
6.4%
UAS7≤6 (Well-controlled)
62.5%
59.6%
41.7%
12.8%
UAS7, HSS7 and ISS7 data were analyzed using ANCOVA model and multiple imputation.
Barzolvolimab demonstrated strong improvement in UAS7 independent of omalizumab status at week 12. Approximately 20%
(n=41) of enrolled patients received prior treatment with omalizumab and more than half of these patients had omalizumab-refractory
disease. These patients experienced a similar clinical benefit as the overall treated population within their individual dosing groups
consistent with the barzolvolimab mechanism of action.
Barzolvolimab was well tolerated with a favorable safety profile. Most adverse events were mild to moderate in severity; through 12
weeks, the most common treatment emergent adverse events in barzolvolimab treated patients were urticaria/CSU (10%), hair color
changes (9%), and neutropenia/ANC decrease (8%). The rate of infections was similar between barzolvolimab treated patients and
placebo with no association between neutropenia and infections.
In June 2024, data on a secondary endpoint from the study, angioedema activity, and additional measures of angioedema control,
were presented at the EAACI 2024 Congress. Approximately 72% of patients on study had angioedema at baseline. Barzolvolimab
demonstrated significant improvements in AAS7 in patients with angioedema across all doses at week 12. This improvement was rapid
(within 2 weeks) and durable (continued through 12 weeks). Barzolvolimab demonstrated strong improvement in AAS7 independent of
omalizumab status at Week 12. Patients on barzolvolimab experienced a > 8 point improvement in AAS7 (considered a clinically
meaningful result) across all doses compared to placebo (p<0.05). Barzolvolimab increased angioedema free days compared to placebo
through 12 weeks. Patients in the 300 mg cohort were angioedema free 77% of the time over the 12 week period.

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5
Patients on study continued to receive barzolvolimab for up to 52 weeks and these long term treatment data were presented in
September at the European Academy of Dermatology & Venereology (EADV) Congress 2024. The data demonstrated a sustained and
deepening disease efficacy and a well tolerated safety profile over a 52 week treatment period. Key highlighted included:
●
Improvements in UAS7 (weekly urticaria activity score), previously shown to be statistically significantly vs placebo at
Week 12, were noted as early as week 1 and were sustained or deepened at Week 52.
●
At Week 16, patients receiving low dose barzolvolimab (75 mg) or placebo were transitioned to barzolvolimab 150 mg or
300 mg; after crossover, these patients experienced similar clinically meaningful disease response as the rest of the study
population.
●
71% of patients treated with barzolvolimab 150 mg Q4W and 52% of patients treated with 300 mg Q8W had a complete
response (no itch/hives; UAS7=0) at Week 52. These responses were observed early and sustained through 52 weeks.
●
74% of patients treated with barzolvolimab 150 mg Q4W and 68% of patients treated with 300 mg Q8W had well
controlled (UAS7<6) disease at Week 52.
●
These robust responses were observed regardless of prior omalizumab experience.
●
Barzolvolimab was well tolerated with a favorable safety profile through 52 weeks of treatment. Most adverse events were
grade 1 (mild), mechanism related (KIT) and expected to be reversible. The most common treatment emergent adverse
events occurring in greater than 10% of barzolvolimab treated patients were hair color changes, neutropenia, urticaria, skin
hypopigmentation (areas of skin lightening) and nasopharyngitis (common cold). Neutrophil counts did not decline further
with continued dosing and there was no association between infections and neutropenia. The hypopigmentation was
observed with longer term exposure and did not lead to treatment discontinuation. Adverse events were not dose
dependent.
We believe these results strongly support the further development of barzolvolimab in CSU. In July 2024, we initiated two Phase 3
studies of barzolvolimab in CSU. The studies, EMBARQ-CSU1 and EMBARQ-CSU2, are designed to establish the efficacy and safety
of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. Both Phase 3 trials are
randomized, double-blind, placebo-controlled, parallel group, global studies (approximately 40 countries; 250 sites per study) where
approximately 915 patients per trial will be randomized evenly to barzolvolimab 150 mg every 4 weeks (following 300 mg loading
dose), barzolvolimab 300 mg every 8 weeks (following 450 mg loading dose) or placebo for 52 weeks. At 24 weeks, patients on placebo
will be re-randomized to active treatment across both dosing groups. The primary endpoint of the studies will evaluate the clinical effect
of barzolvolimab in reducing urticaria activity (weekly urticaria activity score; UAS7) at week 12. The studies are designed to detect a
clinically meaningful difference between each of the active arms versus placebo in the overall population as well as in the subpopulation
of omalizumab refractory participants. Enrollment is ongoing.
Chronic Inducible Urticaria (CIndU) Summary of Phase 1 and Phase 2 Data Presented to Date; 44 week Phase 2 follow up data to be
presented in 2025.
CIndUs are forms of urticaria that have an attributable cause or trigger associated with them, typically resulting in hives or wheals.
The prevalence of CIndU is estimated at 0.5% of the total population and is reported to overlap in up to 36% of CSU patients (Weller et
al. 2010. Hautarzt. 61(8), Bartlett et al. 2018. DermNet.Org). There are currently no approved therapies for chronic inducible urticarias
other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers. We are
currently exploring cold-induced and dermographism (scratch-induced) urticarias in an ongoing Phase 2 study.
We completed a Phase 1b open label clinical trial in patients with CIndU refractory to antihistamines, conducted in Germany. This
study was designed to evaluate the safety of a single intravenous dose (3 mg/kg) of barzolvolimab in patients with cold urticaria (ColdU)
or symptomatic dermographism (SD). The study was expanded to include a cohort (single dose, 3 mg/kg) in patients with cholinergic
urticaria (“CholU”) and a cohort at a lower dose (single dose, 1.5 mg/kg) in ColdU. Patient’s symptoms were induced via provocation
testing that resembles real life triggering situations. Secondary and exploratory objectives included pharmacokinetic and
pharmacodynamic assessments, including changes from baseline provocation thresholds, measurement of tryptase and stem cell factor
levels, clinical activity outcomes, quality of life assessments and measurement of tissue mast cells through skin biopsies.

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6
Generally patients on study had high disease activity at baseline that was poorly controlled and marked impairment in quality of life.
At 3 mg/kg in the ColdU and SD cohorts, safety results were reported for 21 patients and activity results were reported for the 20 patients
who received a full dose of barzolvolimab. At 1.5 mg/kg in the ColdU cohort, safety results were reported for 10 patients and activity
results were reported for the 9 patients who received a full dose of barzolvolimab. At 3 mg/kg in the cholinergic cohort, safety results
were reported for 21 patients and activity results were reported for the 20 patients who received a full dose of barzolvolimab.
Rapid (as early as 1 week) and durable responses were observed in patients as assessed by provocation testing.
●
A complete response was achieved in 95% (n=19/20) of patients with ColdU and SD treated with a single dose at 3 mg/kg
(n=10/10 ColdU; n=9/10 SD), including 3 patients who experienced insufficient response to prior omalizumab treatment.
The median duration (range) of complete response through the 12-week observation period was 77+ days (29–86; n=10)
for patients with ColdU and 57+ days (16–70; n=9) for patients with SD. A UCT score of ≥12 (well controlled) was
achieved by 80% (n=16/20) of the patients within week 4 post-treatment. By week 8, all patients (100%; n=20/20)
achieved well-controlled urticaria, which was sustained to week 12 post-dose by 80% (n=16/20) of patients. Complete
urticaria control (UCT=16) was achieved by 35% (n=7/20), 65% (n=13/20), and 40% (n=8/20) at weeks 4, 8, and 12,
respectively.
●
A complete response was achieved in 100% (n=9 of 9) patients with ColdU treated with a single dose at 1.5 mg/kg,
including 4 patients with disease refractory to omalizumab. The median duration of complete response through the 12-
week observation period was 51+ days (7+ weeks). Following barzolvolimab administration, all patients achieved well
controlled disease (UCT>12) with 7 of 9 achieving complete control (UCT=16).
●
A complete response was achieved in 56% (n=5 of 9) patients with cholinergic urticaria treated with a single dose at 3
mg/kg. Most responses remained durable through to week 12. 63% (5/8) patients reported well controlled disease (UCT
≥12) at week 8 and 50% (4/8) at week 12, respectively.
●
Patients also reported improvements in quality of life outcomes as assessed by the Dermatology Life Quality Index (DLQI)
which surveys patients’ perceptions of symptoms and feelings, daily activities, leisure, work and school performance,
personal relationships and treatment.
●
A single dose of barzolvolimab led to marked decreases in tryptase and in skin mast cells. The kinetics correlated with
improvements in provocation testing and clinical activity, consistent with a central role for mast cells in the pathogenesis of
ColdU and SD. This confirmed that serum tryptase level is a robust pharmacodynamic biomarker for assessing mast cell
burden and clinical activity in inducible urticaria and potentially in other diseases with mast cell driven involvement.

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7
●
Barzolvolimab was well tolerated across all cohorts. In the 3 mg/kg ColdU and SD cohorts, most adverse events were mild,
and the most common (≥3 patients) were hair color changes (76%; n=16/21), infusion reactions (43%; n=9/21), taste
changes (38%; n=8/21), nasopharyngitis (24%; n=5/21), malaise (24%; n=5/21), and headache (19%; n=4/21). Hair color
changes (generally small areas of hair color lightening) and taste disorders (generally partial changes of ability to taste salt
or umami) are consistent with inhibiting KIT signaling in other cell types and completely resolved over time during follow-
up. One patient with a history of fainting experienced loss of consciousness during infusion. The patient rapidly recovered.
Importantly, no evidence of mast cell activation as measured by serum tryptase monitoring was observed in this patient.
Barzolvolimab was also generally well tolerated by patients in the 1.5 mg/kg ColdU cohort and the 3.0 mg/kg cholinergic
cohort with a similar safety profile to that reported previously. Across the Phase 1b inducible urticaria study, mean
hematology parameters generally remained within the normal ranges—an important finding for a KIT inhibitor. Mild,
transient, and asymptomatic decreases in hemoglobin and white blood cell parameters occurred for some patients.
●
Long term follow up data was collected from the 3.0 mg/kg cohorts in cold urticaria and symptomatic dermographism. 14
patients consented to the optional evaluation (6 cold, 8 symptomatic dermographism); 10 of the 14 still had complete
control of their disease as assessed by provocation testing at week 12. Data were collected at one or more timepoints
beyond week 12 through week 36. Most patients had return of symptoms and/or loss of urticaria control between 12 and 36
weeks. Remarkably, two patients remained provocation negative at 36 weeks, and four had well controlled disease (UCT
≥12) 36 weeks post dosing. Serum tryptase exhibits a similar rate of recovery as clinical symptoms, while skin mast cells
return at a slower rate. Tissue KIT signaling, as approximated by SCF levels, was rapidly inhibited after dose
administration and fully reactivated approximately 18 weeks after dosing. Tryptase levels return to pretreatment levels
during follow up, while mast cells continue to recover. Drug related adverse events noted during the study all resolved.
Data from this study were reported in Allergy (Nov 2022) and across multiple medical meetings, including the GA²LEN Global
Urticaria Forum (GUF) in December and the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in
June 2022.
In July 2022, we announced that the first patient had been dosed in a Phase 2 study in patients with CIndU who remain symptomatic
despite antihistamine therapy; in April 2024, we announced that enrollment was complete. The study is being conducted at
approximately 85 sites across approximately 12 countries. The randomized, double-blind, placebo-controlled, parallel group Phase 2
study is evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CIndU to determine the
optimal dosing strategy. 196 patients in 2 cohorts (differentiated by CIndU subtype) including 97 patients with cold urticaria and 99
patients with symptomatic dermographism were randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab
at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase. Patients then enter a follow-up phase for
an additional 24 weeks. In addition, the study includes the option for patients who have symptoms following the treatment phase,
including patients who were on placebo, to enroll in an open label extension where all patients receive 300 mg of barzolvolimab every 8
weeks. The primary endpoint of the study is the percentage of patients with a negative provocation test at week 12. Secondary endpoints
include safety and other assessments of clinical activity including CTT (Critical Temperature Threshold), CFT (Critical Friction
Threshold) and WI-NRS (Worst itch numeric rating scale).

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8
Topline primary endpoint data from this study were reported in July 2024 and 12 week treatment results were presented at the
American College of Allergy, Asthma & Immunology’s Annual Scientific Meeting. Data from the 193 patients randomized and treated in
the study showed that barzolvolimab achieved the primary efficacy endpoint, a statistically significant difference between the percent of
patients with a negative provocation test compared to placebo at week 12 as assessed by the TempTest® in ColdU and the FricTest® in
SD. Secondary and exploratory endpoints in the study were also achieved at week 12 and strongly support the primary endpoint results,
including responder analyses, improvements in Critical Temperature and Critical Friction Thresholds (CFT and CFT), changes in WI-
NRSprovo (itch associated with provocation test) and Urticaria Control Test. Demographics and baseline disease characteristics were
well balanced across treatment groups. In cold urticaria, patients presented with a mean baseline critical temperature threshold of
approximately 19°C or 66°F on the TempTest on initial provocation testing. In patients with symptomatic dermographism baseline
FricTest thresholds were an average of 3.6 out of 4 pins. UCT scores at baseline reflect poorly controlled disease.
Summary of Clinical Assessments at Week 12
Cold Urticaria
    
Symptomatic Dermographism
All measurements at
Week 12
150 mg
q4w

(n=32)
300 mg
q8w

(n=32)
Placebo
(n=32)
150 mg
q4w 

(n=33)
300 mg
q8w

(n=33)
Placebo
(n=31)
Primary endpoint: % of
patients with negative
provocation test (complete
response)
46.9%
p=0.0023
53.1%
p=0.0011
12.5%
57.6%
p<0.0001
42.4%
p=0.0003
3.2%
% of patients with complete
or partial response per
provocation test
62.5%
p=0.0118
75%
p=0.0006
31.3%
66.6%
p<0.0001
57.5%
p=0.0002
12.9%
Improvement in Critical
Temperature (CTT) and
Critical Friction (CFT)
Thresholds
-8.82°C
p<0.0001
-9.61°C
p<0.0001
-0.30°C
-2.46 pins
p<0.0001
-2.27 pins
p=0.0002
-0.82 pins
% of patients with Urticaria
Control Test >12
58.6%
p=0.0048
68.8%
p<0.0001
31.0%
54.8%
p=0.0015
65.5%
p<0.0001
32.0%
Patients experienced rapid disease improvement as early as two weeks (the first assessment) after receiving the initial dose of
barzolvolimab as demonstrated by reductions in critical temperature and friction thresholds resulting in hives and rapid reduction in itch
at the time of provocation testing (WI-NRSprovo).
Barzolvolimab was well tolerated with a favorable safety profile consistent with prior studies. Most adverse events were grade 1
(mild). Through 12 weeks, the most common treatment emergent adverse events in barzolvolimab treated patients were hair color
changes (13%; Grade 1, n=15 / Grade 2, n=2) and neutropenia (10%; Grade 1, n=7 / Grade 2, n=6), which are mechanism related (KIT)
and expected to be reversible. The rate of infections was similar between barzolvolimab-treated patients and placebo with no association
between neutropenia and infections.
We believe these results strongly support the further development of barzolvolimab in CIndU and plan to advance CIndU into Phase
3 registrational development.
Prurigo Nodularis (PN)
We have expanded clinical development of barzolvolimab into prurigo nodularis (PN). PN is a chronic skin disease characterized by
the development of hard, intensely itchy (pruritic) nodules on the skin. Mast cells through their interactions with sensory neurons and
other immune cells are believed to play an important role in amplifying chronic itch and neuroinflammation, both of which are a
hallmark of PN. There is currently only one FDA approved therapy for PN, representing an area of significant unmet need. Industry
sources estimate there are approximately 154,000 patients in the United States with PN who have undergone treatment within the last 12
months and, of these, approximately 75,000 would be biologic-eligible.
We have completed a Phase 1b multi-center, randomized, double-blind, placebo-controlled intravenous study in PN. Data from the
study, including 24 weeks of follow-up, were presented at the 12th World Congress on Itch (WCI) held in November 2023. 24 adults
(evaluable: n=23 safety; n=22 efficacy) with moderate to severe PN were randomized across three arms: (1) barzolvolimab 3.0 mg/kg
(n=9), barzolvolimab 1.5 mg/kg (n=7) and placebo (n=8). The primary endpoint of the study was safety; key secondary

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9
endpoints include changes from baseline in Worst Itch-Numerical Rating Scale (WI-NRS) & Investigator Global Assessment (IGA). The
primary timepoint for evaluation of clinical activity was 8 weeks; patients were followed for safety and efficacy endpoints to 24 weeks.
Patients on study generally had moderate to severe disease with mean baselines scores across all arms of 8.6 for WI-NRS and 3.3 for
IGA.
A single IV dose of 3.0 mg/kg barzolvolimab resulted in rapid and durable reductions in itch and healing of skin lesions in patients
with moderate to severe PN and that barzolvolimab was generally well tolerated.
●
At week 8, the percentage of patients with ≥4-point decrease in WI-NRS was 57% and 43% for the single dose 3.0 or 1.5
mg/kg barzolvolimab arms, respectively, and 25% for the placebo arm; this level of response generally persisted out to
week 16. In the 3.0 mg/kg arm, a ≥4-point decrease in WI-NRS reduction was seen as early as the first week and reached a
high of 71% of patients at week six which was distinct from both the 1.5 mg/kg barzolvolimab and placebo arms.
% of Subjects with ≥4-point decrease in WI-NRS
Dose
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Week 8
1.5 mg/kg
0
14
29
14
29
29
29
43
3.0 mg/kg
14
29
29
29
57
71
57
57
placebo
0
0
13
13
25
38
38
25
●
At week 8, 29% of patients achieved clear or almost clear skin according to IGA following a single dose of barzolvolimab
3.0 mg/kg. This effect was noted as early as week 2 (the first clinic visit) and was maintained out to week 12/16. No
patients treated at 1.5 mg/kg barzolvolimab or placebo achieved clear or almost clear skin according to IGA through week
8. 2 additional patients in the 1.5 mg/kg arm, 2 additional patients in the 3.0 mg/kg arm and 1 patient on placebo had IGA
0/1 at timepoints between weeks 8 and 24.
% of Subjects with IGA 0/1
Dose
Baseline
Week 2
Week 4
Week 8
1.5 mg/kg
0
0
0
0
3.0 mg/kg
0
14
14
29
Placebo
0
0
0
0
●
Clinical activity was associated with profound serum tryptase reduction. At the 3.0 mg/kg dose, tryptase was profoundly
reduced to, or below, the level of quantification and this level of reduction was maintained at least through 8 weeks.
Tryptase reduction was observed in the 1.5 mg/kg arm but to a lesser extent.
●
Adverse Events were generally mild to moderate in intensity and considered unrelated to treatment. During the initial 8
week observation period in the 3.0 mg/kg dosing arm, an anaphylactic reaction occurred in a complicated patient with
multiple comorbidities; the event fully resolved without sequelae. Generally, adverse events seen during the 24-week
follow-up period were consistent with comorbidities commonly observed in the PN population.
In April 2024, we initiated a Phase 2 subcutaneous study in PN. This randomized, double-blind, placebo-controlled, parallel group
study is evaluating the efficacy and safety profile of 2 dose levels of barzolvolimab compared to placebo in approximately 120 patients
with moderate to severe PN who had inadequate response to prescription topical medications, or for whom topical medications are
medically inadvisable (such as concerns for safety). Patients are randomly assigned on a 1:1:1 ratio to receive barzolvolimab injections
of 150 mg Q4W after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo during a
24‑week Treatment Phase. Participants then enter a follow-up phase with no study treatment for an additional 16 weeks through week 40.
The primary objective of this study is to evaluate the clinical effect of barzolvolimab, compared to placebo, on itch response as measured
by the proportion of participants with ≥ 4-point improvement in the worst intensity itch per a numeric rating scale (WI-NRS). Secondary
objectives include but are not limited to additional measures of itch response from baseline compared to different timepoints, the
assessment of skin lesions as measured by the Investigator Global Assessment (IGA), QoL outcomes and safety. The study will include
approximately 50 clinical trial centers worldwide, including the United States. Enrollment is ongoing.

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10
Eosinophilic Esophagitis (EoE)
In July of 2023, we announced that the first patient had been dosed in a Phase 2 study of eosinophilic esophagitis (EoE). EoE, the
most common type of eosinophilic gastrointestinal disease, is a chronic inflammatory disease of the esophagus characterized by the
infiltration of eosinophils. This chronic inflammation can result in trouble swallowing, chest pain, vomiting and impaction of food in the
esophagus, a medical emergency. Several studies have suggested that mast cells may be an important driver in the disease, demonstrating
that the number and activation state of mast cells are greatly increased in EoE biopsies and that mast cell signatures correlate with
markers of inflammation, fibrosis, pain and disease severity. Currently, there is only one FDA approved therapy for EoE, representing an
area of significant unmet need. Industry sources estimate there are approximately 160,000 patients in the United States with EoE who
have undergone treatment within the last 12 months and, of these, approximately 48,000 would be biologic-eligible. Given the lack of
effective therapies for EoE and barzolvolimab’s potential as a mast cell depleting agent, we believe EoE is an important indication for
future study.
The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of
subcutaneous barzolvolimab in patients with active EoE. To optimize potential efficacy signal in this difficult to treat indication, we have
recently amended the protocol to dose 300 mg every 4 weeks rather than 8 weeks. Approximately 75 patients will be enrolled in total. In
the revised protocol, patients will be randomly assigned on a 1:1 ratio to receive subcutaneous injections of barzolvolimab at 300 mg
every 4 weeks or placebo during a 16-week placebo-controlled treatment phase. Patients then enter a 12-week active treatment phase, in
which all patients will receive barzolvolimab 300 mg every 4 weeks. Patients then enter a follow-up phase for an additional 16 weeks.
The primary endpoint of the study is reducing esophageal intraepithelial infiltration of mast cells as assessed by peak esophageal
intraepithelial mast cell count. Secondary endpoints include the reduction of symptoms of dysphagia and esophageal intraepithelial
infiltration of eosinophils and safety. The study includes approximately 60 clinical trial centers across 8 countries, including the United
States. The study is fully accrued and we plan to present data from the study in the second half of 2025.
Atopic Dermatitis (AD)
In December of 2024, we announced the initiation of a Phase 2 study in atopic dermatitis (AD). AD is one of the most common
chronic inflammatory skin diseases, with a lifetime prevalence of up to 20% of the US population and a substantial impact on quality of
life (Kawakami, et al. 2009). Mast cells are strongly implicated in all facets of AD pathophysiology and the fundamental processes that
characterize AD, including epithelial barrier dysfunction, immune cell recruitment, neuroinflammation (Keith, et al. 2023) and multiple
other mast cell-associated factors that correlate with disease severity. Activated mast cells are also found in increased numbers in lesional
biopsies. Two-thirds of patients treated with first line systemic therapy (1.7 million patienst in the US) do not achieve complete control of
their atopic dermatitis (Simpson, Bieber, Guttman-Yassky, et al. 2016) and new therapies that offer rapid, meaningful relief from the
severe itching and breakdown of the skin associated with AD are needed. Given barzolvolimab’s potential as a mast cell depleting agent,
we believe AD is an important indication for future study.
The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of
subcutaneous barzolvolimab in patients with moderate to severe AD. Approximately 120 patients will be randomly assigned on a 1:1:1
ratio to receive subcutaneous injections of barzolvolimab at either 150 or 300 mg or placebo every 4 weeks after an initial loading dose
of 450 mg or placebo during a 16-week placebo-controlled treatment phase. Participants randomized into the placebo arm will be re-
randomized at Week 16 into 1 of the 2 active treatment arms. Patients then enter a 16-week active treatment phase, in which all patients
will receive barzolvolimab every 4 weeks. The primary endpoint of the study is to evaluate the clinical efficacy of the two dose levels
compared to placebo using the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16, a well‐defined, reliable, sensitive and valid
scale for evaluating worst itch intensity in adults with moderate‐to‐severe AD. Secondary endpoints include the evaluation of the clinical
efficacy of barzolvolimab, compared to placebo across multiple patient-reported outcomes, including assessing impressions of disease
change and severity and improvements in quality of life. When all clinical trial sites are open, the study will include up to 50 clinical trial
centers in the United States. Enrollment is ongoing.
Additional Barzolvolimab Development Activities
In 2023, we completed the transfer of our current barzolvolimab manufacturing process to a Contract Development &
Manufacturing Organizations (“CDMO”) and successfully scaled up the drug substance manufacturing process to produce larger cGMP
batches in support of late-stage trials and to prepare for potential commercialization. Drug product manufacturing into 1 mL pre-filled
syringes has been completed and are actively being used in the ongoing Phase 3 CSU trials.

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11
In February 2022, we reported interim data after completing the in-life dosing portion of our six-month chronic toxicology study in
non-human primates. The only clinically adverse finding at the completion of dosing was a profound impact on spermatogenesis, an
expected and well understood effect of KIT inhibition. As a standard part of toxicology studies, some animals from each group continued
to be observed through a recovery period to understand the reversibility of any adverse findings. Due to the very high concentrations of
barzolvolimab at the end of dosing, the recovery period was approximately one year. As we expected, and consistent with previous
findings with KIT blocking antibodies, we were pleased to report in December 2022, that during this recovery period spermatogenesis
fully recovered in all male animals as measured by both sperm count and motility. The final histologic analysis and study report were
completed in early 2023 and were consistent with previously reported results. We are encouraged with these findings and believe these
data strongly support continued development of barzolvolimab.
Bispecific Platform
Our next generation bispecific antibody platform is supporting the expansion of our pipeline with additional candidates for
inflammatory diseases. Targets are being selected based on new science as well as their compatibility to be used in bispecific antibody
formats with our existing antibody programs. Development is focused on emerging, important pathways controlling inflammatory
diseases.
CDX-622
CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing
the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. TSLP has been directly
implicated in several respiratory and dermatological disorders, such as asthma, chronic obstructive pulmonary disease (COPD),
eosinophilic esophagitis, atopic dermatitis and chronic spontaneous urticaria, and in fibrotic diseases such as systemic sclerosis and
idiopathic pulmonary fibrosis. In these disorders, TSLP is often upregulated and associated with disease severity. Similarly, mast cells
drive or contribute to the pathophysiology of allergic, inflammatory, autoimmune and fibrotic disorders and CDX-622 contains a unique
SCF neutralizing function that is expected to inhibit and deplete mast cells. Combined neutralization of SCF and TSLP with CDX-622 is
expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic
benefit in inflammatory and fibrotic disorders. In preclinical studies, CDX-622 inhibits TSLP and SCF with similar potency to both its
respective parental mAbs and comparator mAbs in vitro. CDX-622 was well tolerated in a multi-dose 8 week toxicology study in non-
human primates. The No Adverse Event Level (NOAEL) was established to be 75 mg/kg, the highest dose level tested.
In November 2024, we initiated a Phase 1 study of CDX-622 in healthy volunteers. The Phase 1a clinical trial is a two-part,
randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and
pharmacodynamics of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants.
A single dose of CDX-622 or placebo will be administered intravenously once during Part 1. In Part 2, CDX-622 or placebo will be
administered every 3 weeks (Q3W) for up to 6 weeks following the first dose, for a total of 3 doses. Participants will be followed for 12
weeks in both Parts 1 and 2 following the last dose of study drug. The pharmacodynamic biomarkers from blood and skin will be highly
informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. A subcutaneous formulation is currently being
manufactured and will be added to this study in 2025.
CDX-585 (development discontinued)
CDX-585 combined PD-1 blockade and anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells,
respectively. We initiated a Phase 1 open-label, multi-center, multi-dose study in patients with advanced or metastatic solid tumors that
had progressed during or after standard of care therapy. The dose-escalation phase of the study was completed and we announced in Q4
2024 that we would not advance CDX-585 given our expanding clinical development program in the inflammatory space.
Partnerships
We may enter into co-development and commercialization partnerships for any of our programs where appropriate. In the past, we
have entered into collaborative partnership agreements with pharmaceutical and other companies and organizations that provided
financial and other resources, including capabilities in research, development, manufacturing, and sales and marketing, to support our
research and development programs and may enter into more of them in the future.

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12
Partnership agreements may terminate without benefit to us if the underlying products are not fully developed. If we fail to meet our
obligations under these agreements, they could terminate, and we might need to enter into relationships with other collaborators and to
spend additional time, money and other valuable resources in the process. We cannot predict whether our collaborators will continue
their development efforts or, if they do, whether their efforts will achieve success. Many of our collaborators face the same kinds of risks
and uncertainties in their businesses that we face. A delay or setback to a partner will, at a minimum, delay the commercialization of any
affected drug candidates, and may ultimately prevent it. Moreover, any partner could breach its agreement with us or otherwise not use
best efforts to promote our products. A partner may choose to pursue alternative technologies or products that compete with our
technologies or drug candidates. In either case, if a partner failed to successfully develop one of our drug candidates, we would need to
find another partner. Our ability to do so would depend upon our legal right to do so at the time and whether the product remained
commercially viable.
Research Collaboration and License Agreements
We have entered into license agreements whereby we have received licenses or options to license technology, specified patents
and/or patent applications. These license and collaboration agreements generally provide for royalty payments equal to specified
percentages of product sales, annual license maintenance fees, continuing patent prosecution costs and potential future milestone
payments to third parties upon the achievement of certain development, regulatory and/or commercial milestones. Summarized below is
our significant research collaboration and license agreement for our current clinical drug candidates.
Yale University (Yale)
Under a license agreement with Yale, we may be required to make a one-time payment to Yale of $3.0 million with respect to
barzolvolimab upon achievement of a specified commercial milestone. In addition, we may be required to pay a low single-digit royalty
on annual worldwide net sales of barzolvolimab. Unless earlier terminated by us or Yale, the Yale license agreement is due to expire no
later than May 2038 but may expire earlier on a country-by-country basis under specified circumstances.
Competition
The biotechnology and pharmaceutical industry is intensely competitive and subject to rapid and significant technological change.
Many of the products that we are attempting to develop and commercialize will be competing with existing therapies. Other companies
are pursuing the development of new therapies that target the same diseases and conditions that we are targeting and may compete
directly with our drug candidates. We face competition from companies, major universities and research institutions in the United States
and abroad, including a number of large pharmaceutical companies, as well as firms specialized in the development and production of
targeted therapies and immune modulators. Some of our competitors possess substantially greater financial, technical and human
resources than we do.
The following table is a summary of the competitors of which we are aware that have initiated a Phase 3 study or have obtained
marketing approval for a potentially competitive drug to barzolvolimab for treatment of CSU, CIndU, PN, EoE and AD.

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13
Competitor
Competitor Product
Indication(s)
Abbvie
Rinvoq
AD
Amgen
Tezpire
EoE
Amgen/Kiowa Kirin
Rocatinlimab
AD and PN
Celltrion
CT-P39, omalizumab biosimilar
CSU
Eli Lilly
Olumiant and Ebglyss
AD
Galderma/Chugai
Nemluvio
PN and AD
Incyte
Povorcitinib
PN
Kashiv Biosciences
ADL-018 omalizumab biosimilar
CSU
Leo Pharma
Adbry
AD
Medimetriks
Difamilast
AD
Novartis
Remibrutinib
CSU and CIndU
Pfizer
Cibinqo
AD
Regeneron/Sanofi
Dupixent
CSU, PN, EoE and AD
Regeneron/Sanofi
Amlitelimab
AD
Teva
Tev-45779, omalizumab biosimilar
CSU
Vanda Pharmaceuticals
Tradipitant
AD
Our competitors may utilize discovery technologies and techniques or partner with collaborators in order to develop products more
rapidly or successfully than us or our collaborators are able to. In addition, some competitors have significantly greater experience than
we have in conducting preclinical and nonclinical testing and human clinical trials of drug candidates, scaling up manufacturing
operations and obtaining regulatory approvals of drugs and manufacturing facilities. Accordingly, our competitors may succeed in
obtaining regulatory approval for drugs more rapidly than we do. If we obtain regulatory approval and commence commercial sales of
our drug candidates, we also will compete with respect to manufacturing efficiency and sales and marketing capabilities, areas in which
we currently have limited experience.
In addition, academic institutions, government agencies and other public and private organizations conducting research may seek
patent protection with respect to potentially competitive products or technologies and may establish exclusive collaborative or licensing
relationships with our competitors. Moreover, technology controlled by third parties that may be advantageous to our business may be
acquired or licensed by our competitors, thereby preventing us from obtaining technology on commercially reasonable terms, if at all. We
will also compete for the services of third parties that may have already developed or acquired internal biotechnology capabilities or
made commercial arrangements with other biopharmaceutical companies to target the diseases on which we have focused both in the
U.S. and outside of the U.S.
We also face competition in recruiting and retaining highly qualified scientific personnel and consultants and in the development and
acquisition of technologies.
Our competitive position will depend upon our ability to attract and retain qualified personnel, obtain patent protection or otherwise
develop proprietary products or processes and secure sufficient capital resources for the often lengthy period between technological
conception and commercial sales. We will require substantial capital resources to complete development of some or all of our drug
candidates, obtain the necessary regulatory approvals and successfully manufacture and market our drug candidates. In order to secure
capital resources, we anticipate having to sell additional capital stock, which would dilute existing stockholders. We may also attempt to
obtain funds through research grants and agreements with commercial collaborators. However, these types of funding are uncertain
because they are at the discretion of the organizations and companies that control the funds. As a result, we may not receive any funds
from grants or collaborations. Alternatively, we may borrow funds from commercial lenders, likely at high interest rates, which would
increase the risk of any investment in us.
Manufacturing
We are a research and development company and have limited experience in commercial manufacturing. To conduct late-stage
clinical trials, as well as manufacture and commercialize our drug candidates, we engage CDMOs in the U.S and outside the U.S. to
manufacture our drug candidates on a large scale at a competitive cost and in accordance with current Good Manufacturing Practices
(cGMP) and U.S. and foreign regulatory requirements, as applicable. We also rely on CDMOs for filling, labeling and storage for studies
inside and outside the U.S. Any manufacturing failures or compliance issues at our CDMOs could cause delays in our clinical studies or
commercialization of our drug candidates.

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We currently operate our own cGMP manufacturing facility in Fall River, Massachusetts, to produce drug substance for our current
and planned early-stage clinical trials. Our Fall River manufacturing facility has 250L and 1000L bioreactor capacity and is able to
manufacture in compliance with FDA and EU regulations, allowing us to distribute drug candidates to clinical sites in the U.S., EU and
ROW for early-stage clinical trials. We have manufactured barzolvolimab and CDX-622 drug substance in our Fall River facility for our
current and planned Phase 1 and Phase 2 clinical trials.
Our barzolvolimab drug product is currently administered subcutaneously. The subcutaneous formulation will allow for potential
self-administration at home setting versus the need for intravenous dosing in a hospital or clinic setting. The subcutaneous form could
improve the patient experience if the product becomes available commercially. In 2023, we completed the transfer of our current
barzolvolimab manufacturing process to a CDMO and successfully scaled up the drug substance manufacturing process to produce larger
cGMP batches in support of late-stage trials and to prepare for potential commercialization. Drug product manufacturing into 1 mL pre-
filled syringes has been completed and are actively being used in the ongoing Phase 3 CSU trials. We are in the process of scaling up our
drug product manufacturing. We believe that barzolvolimab can be scaled up to permit drug product manufacturing in commercial
quantities.
Commercial Organization
We have limited commercial experience in marketing, sales, distribution and product reimbursement. We have the capability to
provide current and future market insights to our research and development organization regarding our potential drug candidates. In the
future, we may choose to expand our commercial team and build a full-scale commercial organization which we believe could provide us
the opportunity to retain marketing rights to our drug candidates and commercialize such products ourselves where we deem appropriate
or pursue strategic partnerships to develop, sell, market and distribute our drug candidates where we deem appropriate.
Patents, Licenses and Proprietary Rights
In general, our intellectual property strategy is to protect our technology by filing patent applications and obtaining patent rights
covering our own technology, both in the United States and in foreign countries that we consider important to our business. In addition,
we have acquired and will seek to acquire as needed or desired, exclusive rights of others through assignment or license to complement
our portfolio of patent rights. We also rely on trade secrets, unpatented know-how and technological expertise and innovation to develop
and maintain our competitive position.
Patents
The successful development and marketing of products by us will depend in part on our ability to create and maintain intellectual
property, including patent rights. We are the owner or exclusive licensee to proprietary patent positions in the areas of immunotherapy
technologies and antibody technologies. Although we continue to pursue patent protection for our products, no assurance can be given
that any pending application will issue as a patent, that any issued patent will have a scope that will be of commercial benefit or that we
will be able to successfully enforce our patent position against infringers. We routinely review our patent portfolio and adjust our
strategies for prosecution and maintenance of individual cases according to a number of factors, including program priorities, stage of
development and patent term.
The key patents and patent applications owned by us or licensed to us that we consider important to our current clinical programs
include the following (except where stated otherwise, the indicated and estimated patent expiry dates are the estimated normal
expirations if all maintenance fees and annuities are paid when due, and do not include any possible additional terms for Patent Term
Adjustments (PTAs), Patent Term Extensions (PTEs), other term extensions or Supplementary Protection Certificates (SPCs), if these
may be secured in due course):
●
We own a portfolio of patents and patent applications directed to barzolvolimab and other anti-KIT receptor antibodies. These
patents and patent applications include claims directed to particular anti-KIT antibody compositions of matter, including
barzolvolimab compositions of matter, and methods of using such antibodies. A composition of matter patent has been issued in
the U.S. which would have an estimated patent expiry date in 2034 (this includes additional term due to PTA, but does not
include any PTE if this may be secured in due course) and further U.S. patent applications are pending. Patents have also been
issued in Europe, Japan, Canada, China, Australia, New Zealand, Israel, India, the Republic of Korea, the Russian Federation,
Singapore, Brazil, Mexico, South Africa and certain other countries. Where issued the foregoing would

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have estimated normal patent expiry dates ranging from 2032 to 2033. Further (later filed) patent applications (relating to Fc
sequences used in barzolvolimab and certain uses of barzolvolimab) are pending in the U.S., the European Patent Office, Japan,
Canada, China, Australia, New Zealand, Israel, India, the Republic of Korea, the Eurasian Patent Office, Singapore, Brazil,
Mexico and South Africa. If, when and where issued the latter would have estimated normal patent expiry dates in 2042.
●
We own a pending international patent application directed to anti-SCF and anti-TSLP antibody sequences used in CDX-622 as
compositions of matter. If, when and where issued any applications in the national and regional phases of this application would
have estimated normal patent expiry dates in 2044.
There can be no assurance that patent applications owned by or licensed to us will result in granted patents or that, if granted, the
resultant patents will afford protection against competitors with similar technology. It is also possible that third parties may obtain patents
or other proprietary rights that may be necessary or useful to us. In cases where third parties are first to invent a particular product or
technology, it is possible that those parties will obtain patents that will be sufficiently broad to prevent us from using important
technology or from further developing or commercializing important drug candidates and immunotherapeutic systems. If licenses from
third parties are necessary but cannot be obtained, commercialization of the covered products might be delayed or prevented. Even if
these licenses can be obtained, they would probably require us to pay ongoing royalties and other costs, which could be substantial.
Although a patent has a statutory presumption of validity in the United States, the issuance of a patent is not conclusive as to validity
or as to the enforceable scope of the patent claims. The validity or enforceability of a patent after its issuance by the Patent and
Trademark Office can be challenged in litigation. As a business that uses a substantial amount of intellectual property, we face a
heightened risk of intellectual property litigation. If the outcome of the litigation is adverse to the owner of the patent, third parties may
then be able to use the invention covered by the patent without authorization or payment. There can be no assurance that our issued
patents or any patents subsequently issued to or licensed by us will not be successfully challenged in the future. In addition, there can be
no assurance that our patents will not be infringed or that the coverage of our patents will not be successfully avoided by competitors
through design innovation.
We are aware that others, including universities and companies, have filed patent applications and have been granted patents in the
United States and other countries which claim subject matter potentially useful or necessary to the commercialization of our products.
The ultimate scope and validity of existing or future patents which have been or may be granted to third parties, and the availability and
cost of acquiring rights in those patents necessary to the manufacture, use or sale of our products presently cannot be determined by us.
Third parties may have or may obtain valid and enforceable patents or proprietary rights that could block us from developing
products using our technology, including:
●
certain patents and pending patent applications in the United States and foreign countries relating to particular receptors,
antigens and antigenic fragments targeted by our current drug candidates; and
●
certain patents and pending patent applications in the United States and foreign countries relating to antibodies targeting certain
receptors and other targets including anti- SCF antibodies, anti-TSLP antibodies and certain other antibodies and their
sequences and uses.
In addition to the patents referred to in the previous paragraphs, there may be other patent applications and issued patents belonging
to competitors that may require us to alter our drug candidates and immunotherapeutic delivery systems, pay licensing fees or cease some
of our activities. If our drug candidates conflict with patents that have been or may be granted to competitors, universities or others, the
patent owners could bring legal action against us claiming damages and seeking to enjoin manufacturing and marketing of the patented
products. If any of these actions is successful, in addition to any potential liability for damages, we could be required to obtain a license
in order to continue to manufacture or market the affected products. There can be no assurance that we would prevail in any such action
or that any license required under any such third-party patent would be made available on acceptable terms or at all. We believe that there
may be significant litigation in the biotechnology industry regarding patent and other intellectual property rights. If we become involved
in that litigation, we could consume substantial resources.

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Licenses
We have entered into significant license agreements relating to technologies that are being developed by us. Typically, institutions
have granted us an exclusive worldwide license (with right to sublicense) to make, use and sell products embodying the licensed
technology, subject to the reservation by the licensor of a non-exclusive right to use the technologies for non-commercial research
purposes. Generally, the term of each license is through the expiration of the last of the patents issued with respect to the technologies
covered by the license and/or a specified period from first commercial sale on a territory-by- territory basis. We have generally agreed to
use reasonable efforts to develop and commercialize licensed products and to achieve specified milestones and pay license fees,
milestone payments and royalties based on the net sales of the licensed products or to pay a percentage of sublicense income. If we
breach our obligations, the licensor has the right to terminate the license, and, in some cases, convert the license to a non-exclusive
license. Generally, we control and are responsible for the cost of defending the patent rights of the technologies that we license.
Proprietary Rights
We also rely on unpatented technology, trade secrets and confidential information, and no assurance can be given that others will not
independently develop substantially equivalent information and techniques or otherwise gain access to our know-how and information,
or that we can meaningfully protect our rights in such unpatented technology, trade secrets and information. We require each of our
employees, consultants and advisors to execute a confidentiality agreement at the commencement of an employment or consulting
relationship with us. The agreements generally provide that all inventions conceived by the individual in the course of employment or in
providing services to us and all confidential information developed by, or made known to, the individual during the term of the
relationship shall be the exclusive property of us and shall be kept confidential and not disclosed to third parties except in limited
specified circumstances. There can be no assurance, however, that these agreements will provide meaningful protection for our
information in the event of unauthorized use or disclosure of such confidential information.
Government Regulation
Our activities and products are significantly regulated by a number of governmental entities, including the U.S. Food and Drug
Administration, or FDA, in the United States and by comparable authorities in other countries. These entities regulate, among other
things, the manufacture, testing, safety, effectiveness, labeling, documentation, advertising and sale of our products. We must obtain
regulatory approval from the FDA and comparable authorities in other countries, as applicable, for our drug candidates before we can
commercialize such drugs in the U.S. and foreign jurisdictions. Product development within this regulatory framework takes a number of
years and involves the expenditure of substantial resources. Many drug candidates that initially appear promising ultimately do not reach
the market because they are found to be unsafe or ineffective when tested. Our inability to commercialize a product would impair our
ability to earn future revenues.
FDA Approval Process
In the United States, the FDA regulates drugs and biological products under the Federal Food, Drug, and Cosmetic Act, or FDCA,
the Public Health Service Act, or PHSA, and implementing regulations. The process of obtaining regulatory approvals and the
subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial
time and financial resources. Failure to comply with the applicable United States requirements at any time during the product
development process, approval process or after approval may subject an applicant to a variety of administrative or judicial sanctions,
such as the FDA’s refusal to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of untitled
or warning letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of
government contracts, restitution, disgorgement of profits, civil penalties and criminal prosecution.
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 preclinical studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP,
regulations;
●
submission to the FDA of an investigational new drug, or IND, application which must become effective before human clinical
trials may begin;

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●
approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated;
●
performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, to
establish the safety and efficacy of the proposed drug or biological product for each indication;
●
submission to the FDA of a new drug application, or NDA, or a biologics license application, or BLA, as applicable;
●
satisfactory completion of an FDA advisory committee review, if applicable;
●
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to
assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the
drug’s identity, strength, quality and purity; and
●
FDA review and approval of the NDA or BLA.
We expect that all of our clinical drug candidates will be subject to review as biological products under BLA standards.
Data obtained at any stage of testing is susceptible to varying interpretations, which could delay, limit or prevent regulatory
approval. Moreover, during the regulatory process, new or changed drug approval policies may cause unanticipated delays or rejection of
our product. We may not obtain necessary regulatory approvals within a reasonable period of time, if at all, or avoid delays or other
problems in testing our products. Moreover, even if we received regulatory approval for a product, the approval may require limitations
on use, which could restrict the size of the potential market for the product.
Clinical Trials
The FDA provides that human clinical trials may begin 30 days after receipt and review of an IND application, unless the FDA
requests additional information or changes to the study protocol within that period. An IND must be sponsored and filed for each of our
proposed drug candidates. Authorization to conduct clinical trials in no way assures that the FDA will ultimately approve the product.
Clinical trials are generally conducted in three sequential phases. In a Phase 1 trial, the product is given to a small number of patients to
test for safety (adverse effects), determine a recommended Phase 2 dose(s) and evaluate any signals of efficacy. Phase 2 trials are
conducted on a limited group of the target patient population; safety, optimal dosage and efficacy are studied. A Phase 3 trial is
performed in a large patient population, generally over a wide geographic area to provide evidence for the safety and efficacy of the
product. The FDA maintains and exercises oversight authority throughout the clinical trial. Studies that are conducted in multiple
countries are reviewed and authorized by additional regional or country specific health authorities in addition to the FDA. The additional
international review often is slower than that of the FDA and may result in regulatory opinions that are different than the decisions
provided by the FDA.
A product’s safety and effectiveness in one clinical trial is not necessarily indicative of its safety and effectiveness in another clinical
trial. Moreover, we may not discover all potential problems with a product even after completing clinical trials on it. Some of our
products and technologies have undergone only preclinical testing. As a result, we do not know whether they are safe or effective for
humans. Also, regulatory authorities may decide, contrary to our findings, that a product is unsafe or not as effective in actual use as its
clinical trial results indicated. This could prevent the product’s widespread use, require its withdrawal from the market or expose us to
liability. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the
patients 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 drug has been associated with
unexpected serious harm to patients. Any such action could materially harm us. Clinical trials are critical to the success of our products
but are subject to unforeseen and uncontrollable delay, including delay in enrollment of patients. Any delay in clinical trials could delay
our commercialization of a product.
Disclosure of Clinical Trial Information
Sponsors of clinical trials of FDA-regulated products, including biological products, are required to register and disclose certain
clinical trial information on the website www.clinicaltrials.gov. Information related to the product, patient population, phase of
investigation, trial sites and investigators, and other aspects of a clinical trial are then made public as part of the registration. Sponsors are
also obligated to disclose the results of their clinical trials after completion. Disclosure of the results of clinical trials can be

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delayed in certain circumstances for up to two years after the date of completion of the trial. Competitors may use this publicly available
information to gain knowledge regarding the progress of clinical development programs as well as clinical trial design.
Marketing Approval
Assuming successful completion of the required clinical testing, the results of the preclinical and clinical studies, together with
detailed information relating to the product’s pharmacology, chemistry, manufacture, controls and proposed labeling, among other things,
are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications. FDA
approval of the NDA or BLA is required before marketing of the product may begin in the United States. Under federal law, the
submission of most NDAs and BLAs is additionally subject to a substantial application user fee and the sponsor of an approved NDA or
BLA is also subject to annual prescription drug program fees.
The FDA conducts a preliminary review of all NDAs and BLAs within the first 60 days after receipt before accepting them for filing
based on the agency’s threshold determination that they are sufficiently complete to permit substantive review. The FDA may request
additional information rather than accept an NDA or BLA for filing. In this event, the application must be resubmitted with the additional
information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted
for filing, the FDA begins an in-depth substantive review. The FDA has agreed to specified performance goals in the review of NDAs
and BLAs. Most such applications for non-priority products are reviewed within ten to twelve months after filing, and most applications
for priority review products, that is, drugs and biologics that the FDA determines represent a significant improvement over existing
therapy, are reviewed in six to eight months after filing. The review process may be extended by the FDA for three additional months to
consider certain late-submitted information or clarification regarding information already provided in the submission. The FDA may also
refer applications for novel drugs or biological products or products that present difficult questions of safety or efficacy to an advisory
committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the
application should be approved. The FDA is not bound by the recommendations of an advisory committee, but it considers such
recommendations carefully when making decisions.
Before approving an NDA or BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The
FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP
requirements and adequate to assure consistent production of the product within required specifications. In addition, before approving an
NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP and integrity of the clinical data
submitted.
The testing and approval processes require substantial time, effort and financial resources, and each may take many years to
complete. Data obtained from clinical activities are not always conclusive and may be susceptible to varying interpretations that could
delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis, or at all. We may encounter difficulties or
unanticipated costs in our efforts to develop our drug candidates and secure necessary governmental approvals, which could delay or
preclude us from marketing our products.
After the FDA’s evaluation of the NDA or BLA and inspection of the manufacturing facilities, the FDA may issue an approval letter
or a complete response letter. An approval letter authorizes commercial marketing of the drug or biological product with specific
prescribing information for specific indications. A complete response letter generally outlines the deficiencies in the submission and may
require substantial additional testing or information in order for the FDA to reconsider the application. If and when those deficiencies
have been addressed to the FDA’s satisfaction in a resubmission of the NDA or BLA, the FDA will resume review and may subsequently
issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of
information included. Even with submission of this additional information, the FDA ultimately may decide that the application does not
satisfy the regulatory criteria for approval.
Even if the FDA approves a product, it may limit the approved indications for use for the product, require that contraindications,
warnings or precautions be included in the product labeling, require that post- approval studies, including Phase 4 clinical trials, be
conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after
commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms, which can
materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based
on the results of post-market studies or surveillance programs. After approval, many types of changes to the approved product, such as
changes in indications, manufacturing changes and labeling, are subject to further testing requirements and FDA review and approval.

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Special Regulatory Procedures
Fast track designation — The FDA is required to facilitate the development and expedite the review of drugs and biologics that are
intended for the treatment of a serious or life-threatening disease or condition and that demonstrate the potential to address unmet
medical needs. Under the fast track program, the sponsor of a new drug or biologic candidate may request the FDA to designate the
product for a specific indication as a fast track product, concurrent with or after the filing of the IND for the drug candidate. A drug that
receives fast track designation is eligible for some or all of the following: (i) more frequent meetings with the FDA to discuss the drug’s
development plan and ensure collection of appropriate data needed to support drug approval; (ii) more frequent written communication
from the FDA about such things as the design of the proposed clinical trials and use of biomarkers; (iii) eligibility for accelerated
approval and priority review, if relevant criteria are met; and (iv) “Rolling Review,” which means that a drug company can submit
completed sections of its BLA or NDA for review by the FDA, rather than waiting until every section of the NDA or BLA is completed
before the entire application can be reviewed. This rolling review is available if the applicant provides and the FDA approves a schedule
for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s time period goal for
reviewing a fast track application does not begin until the last section of the NDA or BLA is submitted. In addition, the fast track
designation may be withdrawn by the FDA if it believes that the designation is no longer supported by data emerging in the clinical trial
process.
Priority review — Under FDA policies, a drug candidate may be eligible for priority review. The priority review program provides
for expedited review or an NDA or BLA, typically within a six to eight month time frame from the time a complete application is
accepted for filing. Products regulated by the FDA’s Center for Drug Evaluation and Research, or CDER, are eligible for priority review
if they provide a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. Products
regulated by the FDA’s Center for Biologics Evaluation and Research, or CBER, are eligible for priority review if they provide a
significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. A
fast track designated drug candidate could be eligible for priority review if supported by clinical data at the time of the BLA or NDA
submission.
Accelerated approval — Under the law and the FDA’s accelerated approval regulations, the FDA may approve a drug or biologic for
a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based on a surrogate
endpoint that is reasonably likely to predict clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than
clinical endpoints. A drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the
completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-
approval studies, or confirm a clinical benefit during post-marketing studies, would 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.
Breakthrough therapy designation — The FDA is also required to expedite the development and review of the application for
approval of drugs that are intended to treat a serious or life-threatening disease or condition where preliminary clinical evidence indicates
that the drug candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Under the breakthrough therapy program, the sponsor of a new drug candidate may request that the FDA designate the drug candidate for
a specific indication as a breakthrough therapy concurrent with, or after, the filing of the IND for the drug candidate.
Orphan drug designation — Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biologic intended
to treat a rare disease or condition, which is generally defined as a disease or condition that affects fewer than 200,000 individuals in the
United States. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval
process. The first NDA or BLA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with
FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the United States for that product, for that
indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug or
biologic for the same orphan indication, except in limited circumstances. Among the other benefits of orphan drug designation are tax
credits for certain research and a waiver of the NDA or BLA application user fee.
Pediatric Information
Under the Pediatric Research Equity Act of 2003, an NDA, BLA or supplement to an NDA or BLA must contain data that are
adequate to assess the safety and effectiveness of the drug or biological product for the claimed indications in all relevant pediatric

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subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until
after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Under the Food and Drug
Administration Safety and Innovation Act, or FDASIA, the FDA has additional authority to take action against manufacturers not
adhering to pediatric study requirements. Unless otherwise required by regulation, the pediatric data requirements do not apply to
products with orphan drug designation.
Post Approval
Any drug or biological products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and
continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product
sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most
changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval.
The FDA may impose a number of post-approval requirements as a condition of approval of an NDA or BLA. For example, the
FDA may require post-marketing testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s
safety and effectiveness after commercialization. Regulatory approval of oncology products often requires that patients in clinical trials
be followed for long periods to determine the overall survival benefit of the drug or biologic.
In addition, drug and biologic manufacturers and other entities involved in the manufacture and distribution of approved drugs and
biological products are required to register their establishments with the FDA and state agencies and are subject to periodic unannounced
inspections by the FDA and these state agencies for compliance with cGMP requirements. The FDA was also granted new inspection
authorities under FDASIA. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before
being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and
documentation requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must
continue to expend time, money and effort in the areas of production and quality control to maintain cGMP compliance.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not
maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product,
including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory
requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or
clinical trials to assess new safety risks or imposition of distribution or other restrictions under a Risk Evaluation and Mitigation Strategy
program. Other potential consequences include, among other things:
●
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product
recalls;
●
fines, untitled and warning letters or holds on post-approval clinical trials;
●
refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of
product license approvals;
●
product seizure or detention, or refusal to permit the import or export of products; or
●
consent decrees, injunctions or the imposition of civil or criminal prosecution.

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The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs and
biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label. The FDA, the
Office of the Inspector General of Health and Human Services and other agencies actively enforce the laws and regulations prohibiting
the promotion of off label uses, and a company that is found to have improperly promoted off label uses may be subject to significant
liability.
Biosimilars and Exclusivity
The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) created an abbreviated approval pathway for biological
products shown to be highly similar to, or interchangeable with, an FDA-licensed reference biological product. The FDA has issued
several guidance documents outlining an approach to review and approval of biosimilars.
Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference
product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies.
Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected
to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to
an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without
increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
The BPCIA includes, among other provisions, a 12-year exclusivity period from the date of first licensure, or BLA approval, of the
reference product, during which approval of a 351(k) application referencing that product may not be made effective; a four-year
exclusivity period from the date of first licensure of the reference product, during which a 351(k) application referencing that product
may not be submitted; and an exclusivity period for certain biological products that have been approved through the 351(k) pathway as
interchangeable biosimilars.
The BPCIA also establishes procedures for identifying and resolving patent disputes involving applications submitted under section
351(k) of the PHSA.
The BPCIA is complex and its interpretation and implementation by the FDA remains unpredictable. In addition, government
proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may
impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate effect, implementation,
and meaning of the BPCIA is subject to uncertainty.
Federal and State Fraud and Abuse, Data Privacy and Security and Transparency Laws
In addition to FDA restrictions on marketing and promotion of pharmaceutical products, several other types of federal and state laws
have been applied to restrict certain marketing business practices in the biopharmaceutical and medical device industries in recent years.
These laws include, without limitation, state and federal anti-kickback statutes and false claims statutes and false claims laws, data
privacy and security laws, as well as transparency laws regarding payments or other items of value provided to health care providers.
Applicable state law may be broader in scope than federal law and may apply regardless of payor, in addition to items and services
reimbursed under Medicaid and other state programs. If our operations are found to be in violation of any of the health regulatory laws
described above or any other laws that apply to us, we may be subject to penalties, including potentially significant criminal and civil
and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government health care
programs, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or
restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To
the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws, which may include, for
instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of
corporate compliance programs and reporting of payments or transfers of value to health care professionals.
In addition, the United States Foreign Corrupt Practices Act, or FCPA, prohibits corporations and individuals from engaging in
certain activities to obtain or retain business or to influence a person working in an official capacity. It is illegal to pay, offer to pay or
authorize the payment of anything of value to any official of another country, government staff member, political party or political
candidate in an attempt to obtain or retain business or to otherwise influence a person working in that capacity. In many countries, the
health care professionals we may interact with may meet the FCPA’s definition of a foreign government official.

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Foreign Regulation
In order to market any therapeutic or diagnostic product outside of the United States, we need to comply with numerous and varying
regulatory requirements of other countries regarding 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 need to
obtain the necessary approvals by the comparable regulatory authorities of foreign countries before we can commence clinical trials or
marketing of the product in those countries. The approval process varies from country to country and can involve additional product
testing and additional administrative review periods. The time required to obtain approval in other countries might differ from and be
longer than that required to obtain FDA approval. Regulatory approval in one country does not ensure regulatory approval in another, but
a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others.
Under the EU regulatory system, we will submit all of our marketing authorization applications under the centralized procedure. The
centralized procedure is compulsory for medicines produced by biotechnology, or are for the treatment of cancer, or officially designated
as ‘orphan medicines.’ The centralized procedure provides for the grant of a single marketing authorization that is valid for all EU
member states. As in the United States, we may apply for designation of a drug candidate as an orphan drug for the treatment of a
specific indication in the EU before the application for marketing authorization is made. The European Medicines Agency (“EMA”)
grants orphan medicinal product designation to promote the development of products that may offer therapeutic benefits for life-
threatening or chronically debilitating conditions affecting not more than five in 10,000 people in the EU. Orphan drugs in Europe enjoy
economic and marketing benefits, including a 10-year market exclusivity period for the approved indication, but not for the same
product, unless another applicant can show that its product is safer, more effective or otherwise clinically superior to the orphan-
designated product.
Other Regulatory Processes
From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions
governing the testing, approval, manufacturing and marketing of products regulated by the FDA.
In addition to new legislation, FDA regulations and policies are often revised or interpreted by the agency in ways that may
significantly affect our business and our products. It is impossible to predict whether further legislative changes will be enacted or
whether FDA regulations, guidance, policies or interpretations will change or what the effect of such changes, if any, may be.
Third-Party Payor Coverage and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any drug products for which we obtain regulatory
approval. Sales of any of our drug candidates, if approved, will depend, in part, on the extent to which the acquisition costs of the drugs
will be covered by third-party payors, including government health programs such as Medicare and Medicaid, as well as commercial
health insurers, such as managed care organizations. The process for determining reimbursement rates is separate from the payor
coverage decision. Therefore, despite obtaining coverage, reimbursement rates may be lower than expected, which can result in
significant out-of-pocket payments for the patient.
In order to secure coverage and reimbursement for any drug that might be approved for sale, we need to conduct analyses and
pharmaco-economic studies in order to demonstrate the incremental value over and above the currently available treatment options. Our
drug candidates may not be considered medically necessary, provide insufficient incremental value, or may not be deemed cost-effective
per payor criteria. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be
approved.
The containment of health care costs has become a priority of federal, state and foreign governments, and the prices of drugs have
been a focus in this effort. Given that the Inflation Reduction Act is now in place, potential implications for the biopharma industry are
still being assessed. In the meantime, third-party payors are increasingly challenging the prices charged for medical products and services
and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. If
these third-party payors do not consider our drugs to be cost-effective compared to other available therapies, they may not cover our
drugs after approval as a benefit under their plans or, if they do, the level of reimbursement and/or restrictions in formulary placement
may be such that they would significantly limit projected sales volumes. In addition to third-party payors, we will also need to negotiate
formulary placement with hospitals, health systems and certain independent delivery networks. Such negotiations may be

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more protracted than anticipated and may be compromised because of similar considerations, relating to insufficient incremental value
and/or cost-effectiveness.
Pricing and reimbursement schemes vary widely from country to country. For example, certain EU member states may approve a
specific price and volume for a drug product after which incremental revenues or profits need to be paid back by way of rebates. They
may also institutionalize utilization restrictions, curb physicians’ drug budgets, provide conditional reimbursement schemes that require
additional evidence to be generated post-marketing authorization, etc. The downward pressure on health care costs in general, including
prescription drugs, has been evident in EU markets for some time and is now a major focus of federal and state governments in the U.S.
As a result, increasingly high barriers are being erected to the pricing and reimbursement of new drugs, despite regulatory efforts to bring
drugs to market sooner. Cross- border trade has existed for some time in the EU, allowing pharmacies in one country to import, at a
lower price, drug from another country, further exerting pricing pressures across the EU. There is U.S. legislation that establishes a
process for states to import less expensive drugs from Canada to the U.S. In January 2024, the FDA authorized the state of Florida to
establish such a program, although Florida must take several other steps before drugs begin to be imported. There can be no assurance
that any country that has price controls or reimbursement limitations for drug products will allow favorable reimbursement and pricing
arrangements for any of our drugs.
The marketability of any drugs for which we receive regulatory approval for commercial sale may suffer if third-party payors and/or
hospital administrators fail to provide adequate coverage, reimbursement or formulary placement. Coverage policies, third-party
reimbursement rates and drug pricing regulations may change in the future. In addition, the States may continue to consider legislation of
their own (e.g. Prescription Drug Afforability Boards) which could further restrict the ability to freely price drugs and/or curb utilization
in the U.S. Even if favorable coverage and reimbursement status is attained for one or more drugs for which we receive regulatory
approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Employees
As a mission driven organization, we believe the engagement and dedication of our employees is central to our success and employ
talented individuals who have the skills and expertise to help us achieve our goals.
As of December 31, 2024, we had 186 full-time employees, 29 of whom have Ph.D. and/or M.D. degrees. Of these employees, 157
were engaged in or directly support research and development activities. We consider our relationship with our employees to be good.
We believe that our success depends in large part on our ability to attract and retain experienced and skilled employees. We endeavor
to provide competitive compensation and benefits packages designed to attract, retain and reward talented individuals who possess the
skills necessary to support our business objectives, assist in the achievement of our strategic goals and increase stockholder value. We
employ a pay for performance philosophy. Annual salary increases, incentive bonuses and stock option grants are available to all
employees and are based on merit and include individual and corporate performance factors.
Much of our success is rooted in the diversity of our teams and our commitment to inclusion. We value diversity at all levels and
continue to focus on extending our diversity and inclusion initiatives across our entire workforce. We believe that our business benefits
from the different perspectives that a diverse workforce brings.
We are committed to the health, safety and well-being of our employees at all times. We follow federal, state and local rules and
guidelines to ensure the safety of our workforce and provide resources to assist our employees in managing their overall physical and
mental health.
Research and Development
We have dedicated a significant portion of our resources to our efforts to develop our drug candidates. We incurred research and
development expenses of $163.6 million, $118.0 million and $82.3 million during the years ended December 31, 2024, 2023 and 2022,
respectively. We anticipate that a significant portion of our operating expenses will continue to be related to research and development in
2025 as we continue to advance our drug candidates through clinical development.

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Corporate and Available Information
We are incorporated in Delaware. Our website is located at http://www.celldex.com. On our website, investors can obtain, free of
charge, a copy of our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, our Code of
Business Conduct and Ethics, including disclosure related to any amendments or waivers thereto, other reports and any amendments
thereto filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act of 1934, as amended, as soon as reasonably practicable
after we file such material electronically with, or furnish it to, the Securities and Exchange Commission, or the SEC. None of the
information posted on our website is incorporated by reference into this Annual Report. The SEC also maintains a website at
http://www.sec.gov that contains reports, proxy and information statements and other information regarding us and other companies that
file materials with the SEC electronically.
Item 1A. RISK FACTORS
You should consider carefully these risk factors together with all of the information included or incorporated by reference in this
Annual Report in addition to our financial statements and the notes to our financial statements. This section includes forward-looking
statements.
The following is a discussion of the risk factors that we believe are material to us at this time. These risks and uncertainties are not
the only ones facing us, and there may be additional matters that we are unaware of or that we currently consider immaterial. All of these
could adversely affect our business, results of operations, financial condition and cash flows.
Summary of Risk Factors
Risks Related to Our Financial Condition and Capital Requirements
●
Risks related to our need for additional capital to fund our operations.
●
Risks related to the Merger Agreement and related Settlement Agreement with Kolltan.
Risks Related to Development and Regulatory Approval of Drug Candidates
●
Risks related to our ability to fund and complete the research and development activities and obtain regulatory approval for our
program assets.
●
Risks related to the extensive and lengthy regulatory scrutiny to which we are subject.
●
Risks related to our ability to commence, enroll, manage and complete our clinical trials.
●
Risk of serious adverse or unacceptable side effects identified related to our drug candidates.
●
Risk related to showing that our drug candidates are effective and competitive with other therapies and approved products.
●
We may enter into collaboration agreements for our lead drug candidates that may not meet our expectations.
Risks Related to Commercialization of Our Drug Candidates
●
Risks related to delays, difficulties or unanticipated costs in establishing sales, marketing and distribution capabilities.
●
Risks related to the acceptance of our drug candidates by physicians, patients and third-party payors.
●
Risks related to reimbursement decisions by third-party payors.
●
Risks, including the terms of FDA approval, that could affect the demand for and sales and profitability of any of our drug
candidates.

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●
Risks related to the failure to obtain regulatory approvals in foreign jurisdictions and risks related to international operations if
we do obtain regulatory approval in foreign jurisdictions.
Risks Related to Reliance on Third Parties
●
Risks related to our reliance on third parties.
Risks Related to Business Operations
●
Risks related to strategic transactions.
●
Risks related to managing our growth.
●
Risks related to our ability to integrate and modify our technologies to create new drugs.
●
Risks related to computer systems that we and third parties use and potential security breaches.
●
Risks related to hazardous materials.
●
Risks related to product liability claims.
Risks Related to Intellectual Property
●
Risks related to intellectual property.
Regulatory Risks
●
Risks related to the regulatory approval process for our drugs.
●
Risks related to changes in product candidate manufacturing or formulation.
●
Risks related to our compliance with laws and regulations.
Risks Related to Our Capital Stock
●
Risks related to our history of losses and uncertainty of future profitability.
●
Risks relates to the volatility of our common stock.
●
Risks related to our use of our net operating loss carryforwards.
General Risk Factors
●
Risks related to internal controls over financial reporting.
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Risks that our competitors may develop technologies that make ours obsolete.
●
Risks related to health epidemics and outbreaks.
●
Risks related to the global economy and supply chain disruptions.
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Risks related to the loss of our key executives and scientists.

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●
Risks that our employees may engage in misconduct or other improper activities.
●
Risks related to our compliance with the Nasdaq Listing Rules.
Risks Related to Our Financial Condition and Capital Requirements
We currently have no product revenue and will need to raise capital to operate our business.
To date, we have generated no product revenue and cannot predict when and if we will generate product revenue. We had an
accumulated deficit of $1.6 billion as of December 31, 2024. Until, and unless, we complete clinical trials and other development
activity, and receive approval from the FDA and other regulatory authorities, for our drug candidates, we cannot sell our drugs and will
not have product revenue. We expect to spend substantial funds to continue the research, development and testing of our products that are
in the preclinical and clinical testing stages of development and to prepare to commercialize products in anticipation of FDA approval.
Therefore, for the foreseeable future, we will have to fund all of our operations and development expenditures from cash on hand, equity
or debt financings, licensing fees and grants. Additional financing will be required to meet our liquidity needs. If we do not succeed in
raising additional funds on acceptable terms, we might not be able to complete planned preclinical and clinical trials or obtain approval
of any drug candidates from the FDA and other regulatory authorities. In addition, we could be forced to discontinue product
development, reduce or forego sales and marketing efforts, forego attractive business opportunities or curtail operations. Any additional
sources of financing could involve the issuance of our equity securities, which would have a dilutive effect on our stockholders. No
assurance can be given that additional financing will be available to us when needed on acceptable terms, or at all.
We cannot be certain that we will achieve or sustain profitability in the future. Failure to achieve profitability could diminish our
ability to sustain operations, pay dividends on our common stock, obtain additional required funds and make required payments on our
present or future indebtedness.
We expect to incur future losses and we may never become profitable.
We have incurred operating losses of $195.1 million, $154.5 million and $115.2 million during 2024, 2023 and 2022, respectively,
and expect to incur an operating loss in 2025 and beyond. We believe that operating losses will continue in 2025 and beyond because we
are planning to incur significant costs associated with the development of our drug candidates. During the years ended December 31,
2024, 2023 and 2022, we incurred $73.0 million, $32.4 million and $23.8 million in clinical trial expense and $16.4 million, $24.1
million and $4.5 million in contract manufacturing expense. Our net losses have had and will continue to have an adverse effect on,
among other things, our stockholders’ equity, total assets and working capital. We expect that losses will fluctuate from quarter to quarter
and year to year, and that such fluctuations may be substantial. We cannot predict when we will become profitable, if at all.
We will need additional capital to fund our operations, including the development, manufacture and potential commercialization of
our drug candidates. If we do not have or cannot raise additional capital when needed, we may be unable to develop and ultimately
commercialize our drug candidates successfully.
We expect to incur significant costs as we develop our drug candidates. The continuing development and commercialization of our
drug candidates requires additional capital beyond our current resources. As of December 31, 2024, we had cash, cash equivalents and
marketable securities of $725.3 million. During the next twelve months and beyond, we will take further steps to raise additional capital
to fund our long-term liquidity needs. Our capital raising activities may include, but may not be limited to, one or more of the following:
●
licensing of drug candidates with existing or new collaborative partners;
●
possible business combinations;
●
issuance of debt; or
●
issuance of common stock or other securities via private placements or public offerings.

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While we may seek capital through a number of means, there can be no assurance that additional financing will be available on
acceptable terms, if at all, and our negotiating position in capital-raising efforts may worsen as existing resources are used. There is also
no assurance that we will be able to enter into further collaborative relationships. Additional equity financing may be dilutive to our
stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict our ability to
operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce our economic potential
from drug candidates under development. If we are unable to raise the funds necessary to meet our liquidity needs, we may have to delay
or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, discontinue or delay
our commercial manufacturing efforts, discontinue or delay our efforts to expand into additional indications for our drug product
candidates, license out programs earlier than expected, raise funds at significant discount or on other unfavorable terms, if at all, or sell
all or part of our business.
Our stockholders may be subject to substantial dilution if we elect to pay future milestone consideration to the former Kolltan
stockholders in shares of common stock. If we elect to pay future milestone consideration in cash, we would likely need to raise
additional capital.
In connection with the agreement pursuant to which we acquired Kolltan in 2016 (the “Merger Agreement”) as modified by the
definitive settlement agreement (the “Settlement Agreement”) we entered on July 15, 2022 related to litigation arising from the Kolltan
merger, in the event that regulatory approval by the United States Food and Drug Administration or European Medicines Agency of
certain drug candidates are achieved, we will be required to pay to the former stockholders of Kolltan a milestone payment of
$52,500,000, which milestone payment may be made, at our sole election, in cash, in shares of our common stock or a combination of
both, subject to provisions of the Merger Agreement.
We may require additional capital to fund the milestone payment in cash, depending on the facts and circumstances at the time such
payment becomes due. The number of shares of our common stock issuable in connection with a milestone payment, if any, will be
determined based on the average closing price per share of our common stock for the five trading day period ending three calendar days
prior to the achievement of such milestone. If we elect to pay the milestone payment in shares of our common stock, our stockholders
would experience substantial dilution.
Risks Related to Development and Regulatory Approval of Drug Candidates
Our long-term success depends heavily on our ability to fund and complete the research and development activities and obtain
regulatory approval for our program assets.
Only a small minority of all research and development programs ultimately result in commercially successful drugs. Clinical failure
can occur at any stage of clinical development. Clinical and preclinical trials may produce negative or inconclusive results, and we may
decide, or regulators may require us, to conduct additional clinical or preclinical trials. In addition, data obtained from trials are
susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent
regulatory approval. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same
results or otherwise provide adequate data to demonstrate the efficacy and safety of a drug candidate. As part of development, we also
must show that we can formulate and manufacture our product candidates in compliance with regulatory requirements.
We will need substantial additional financing to complete the development of our drug candidates and comply with the regulatory
requirements governing this process. Further, even if we complete the development of our drug candidates and gain marketing approvals
from the FDA and comparable foreign regulatory authorities in a timely manner, we cannot be sure that such drug candidates will be
commercially successful in the pharmaceutical market. If the results of clinical trials, the anticipated or actual timing of marketing
approvals, or the market acceptance of any of our drug candidates, if approved, do not meet the expectations of investors or public
market analysts, the market price of our common stock would likely decline.
Our drug candidates are subject to extensive regulatory scrutiny.
All of our drug candidates are at various stages of development, and our activities and drug candidates are significantly regulated by
a number of governmental entities, including the FDA in the United States and by comparable authorities in other countries. These
entities regulate, among other things, the manufacture, testing, safety, effectiveness, labeling, documentation, advertising and sale of
drugs and drug candidates. We or our partners must obtain regulatory approval for a drug candidate in all of these areas before we can

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commercialize any of our drug candidates. Product development within this regulatory framework takes a number of years and involves
the expenditure of substantial resources. This process typically requires extensive preclinical and clinical testing, which may take longer
or cost more than we anticipate, and may prove unsuccessful due to numerous factors. Many drug candidates that initially appear
promising ultimately do not reach the market because they are found to be unsafe or ineffective when tested. Companies in the
pharmaceutical, biotechnology and immunotherapeutic drug industries have suffered significant setbacks in advanced clinical trials, even
after obtaining promising results in earlier trials. Our inability to commercialize a drug candidate would impair our ability to earn future
revenues.
Premarket review of our product candidates by the FDA and/or other regulatory authorities is a lengthy and uncertain process and
approval may be delayed, limited or denied, any of which would adversely affect our ability to generate operating revenues.
We are not permitted to market our drug product candidates in the United States until we receive approval of an application by the
FDA. The time required to obtain approval by the FDA is unpredictable, but typically takes multiple years following the commencement
of clinical trials, and depends upon numerous factors, including the substantial discretion of the FDA and the type, complexity and
novelty of the product candidates involved. Similar processes are used in countries outside of the U.S. We have not submitted a
marketing application such as BLA or NDA to the FDA or any similar application to any other regulatory authority in any jurisdiction.
The FDA has substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of a product
candidate for many reasons. For example, the FDA:
●
could determine that the information provided by us as part of an IND or BLA/NDA is inadequate, contains clinical
deficiencies or otherwise fails to demonstrate safety and effectiveness of any of our product candidates for any indication;
●
may not find the data from pre-clinical and clinical trials sufficient to support the submission of a marketing application or to
obtain marketing approval, including any findings that the safety risks outweigh clinical and other benefits of our product
candidates;
●
may require us to perform additional studies to demonstrate the safety, efficacy, pharmacokinetics, or other properties of our
product candidates prior to approval, or require such studies as a condition of approval;
●
may disagree with our clinical trial designs or our interpretation of data from product development manufacturing data,
bioequivalence studies and/or clinical trials, or may change the requirements for approval even after it has reviewed and
commented on the design for our trials;
●
may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into
agreements for the supply of the API used in our product candidates;
●
may identify deficiencies in our own manufacturing processes or our proposed scale-up of the manufacturing processes or
facilities for the production of our product candidates;
●
may approve our product candidates for fewer or more limited indications than we request, or may grant approval contingent on
the performance of costly post-approval clinical trials;
●
may change its approval policies or adopt new regulations; or
●
may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our
product candidates.
The time and expense of the approval process, as well as the unpredictability of future clinical trial results and other contributing
factors, may result in our failure to obtain regulatory approval to market, in the United States or other jurisdictions, barzolvolimab and
other drug candidates that we are developing or may seek to develop in the future, which would significantly harm our business, results
of operations and prospects. In such case, we may also not have the resources to conduct new clinical trials and/or we may determine that
further clinical development of any such drug candidate is not justified and may discontinue any such programs.

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If our drug candidates do not pass required tests for safety and effectiveness, we will not be able to obtain regulatory approval and
derive commercial revenue from them.
In order to succeed, we will need to obtain regulatory approval for our drug candidates. The FDA has not approved any of our drug
candidates for sale to date. Our drug candidates are in various stages of preclinical and clinical testing. Preclinical tests are performed at
an early stage of a product’s development and provide information about a drug candidate’s safety and effectiveness before initiating
human clinical trials. Preclinical tests can last years. If a product passes its preclinical tests satisfactorily and we determine that further
development is warranted, we would file an IND application for the product with the FDA, and, if the FDA gives its approval, we would
begin Phase 1 clinical tests. Phase 1 testing generally lasts between 6 and 24 months. If Phase 1 test results are satisfactory and the FDA
gives its approval, we can begin Phase 2 clinical tests. Phase 2 testing generally lasts between 6 and 36 months. If Phase 2 test results are
satisfactory and the FDA gives its approval, we can begin Phase 3 pivotal studies. Phase 3 studies generally last between 12 and 48
months. Once clinical testing is completed and a BLA or NDA is filed with the FDA, it may take more than a year to receive FDA
approval.
In all cases we must show that a drug candidate is both safe and effective before the FDA, or drug approval agencies of other
countries where we intend to sell the product, will approve it for sale. Our research and testing programs must comply with drug
approval requirements both in the United States and in other countries, since we are developing our drug candidates with the intention to,
or could later decide to, commercialize them both in the U.S. and abroad. A product may fail for safety or effectiveness at any stage of
the testing process. A major risk we face is the possibility that none of our products under development will come through the testing
process to final approval for sale, with the result that we cannot derive any commercial revenue from them after investing significant
amounts of capital in multiple stages of preclinical and clinical testing.
Success in early clinical trials does not ensure that later clinical trials will be successful, and we cannot assure you that any of the
clinical trials that we may conduct will demonstrate consistent or adequate efficacy and safety to obtain regulatory approval.
The results of preclinical studies and early clinical trials may not be predictive of the results of later- stage clinical trials, and interim
results of a clinical trial do not necessarily predict final results. Preclinical and clinical data are susceptible to various interpretations and
analyses, and many companies that have believed their drug candidates performed satisfactorily in preclinical studies and early-stage
clinical trials have nonetheless failed to replicate such results in later-stage clinical trials and subsequently failed to obtain marketing
approval. Drug candidates in later-stage clinical trials may fail to show the desired safety and efficacy despite having progressed through
preclinical and initial clinical trials, even if certain analyses of primary or secondary endpoints in those early trials showed trends
towards efficacy. Later-stage clinical trials with larger numbers of patients or longer durations of therapy may also reveal safety concerns
that were not identified in earlier smaller or shorter trials. Our failure to demonstrate efficacy and safety data sufficient to support
marketing approval for any of our other drug candidates would substantially harm our business, prospectus, financial condition and
results of operations.
Product testing is critical to the success of our drug candidates but subject to delay or cancellation if we have difficulty enrolling
patients.
As our portfolio of drug candidates moves from preclinical testing to clinical testing, and then through progressively larger and more
complex clinical trials, we will need to enroll an increasing number of patients with the appropriate characteristics. At times we have
experienced difficulty enrolling patients, and we may experience more difficulty as the scale of our clinical testing program increases.
The factors that affect our ability to enroll patients are largely uncontrollable and include principally the following:
●
the nature of the clinical test;
●
the size of the patient population;
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patients’ willingness to receive a placebo or less effective treatment on the control arm of a clinical study;
●
the distance between patients and clinical test sites; and
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the eligibility criteria for the trial.
If we cannot enroll patients as needed, our costs may increase, or we may be forced to delay or terminate testing for a product.

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We may have delays in commencing, enrolling and completing our clinical trials, and we may not complete them at all.
We have not completed the clinical trials necessary to obtain FDA approval to market any of our drug candidates in development.
Clinical trials for our products in development may be delayed or terminated as a result of many factors, including the following:
●
inability to reach agreements on acceptable terms with prospective contract research organizations (CROs) and trial sites, the
terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
●
difficulty in enrolling patients in our clinical trials;
●
inability to maintain necessary supplies of study drug and comparator to maintain predicted enrollment rates at clinical trial
sites;
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patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or other reasons;
●
failure by regulators to authorize us to commence a clinical trial;
●
suspension or termination by regulators of clinical research for many reasons, including concerns about patient safety, bias or
failure of our contract manufacturers to comply with cGMP requirements;
●
delays or failure to obtain clinical supply for our products necessary to conduct clinical trials from contract manufacturers,
including commercial grade-clinical supply for our Phase 3 clinical trials;
●
inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial
programs, including some that may be for the same indication as our product candidates;
●
drug candidates demonstrating a lack of efficacy during clinical trials;
●
inability to continue to fund clinical trials or to find a partner to fund the clinical trials;
●
competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and
●
delays in completing data collection and analysis for clinical trials.
Any delay or failure to commence, enroll or complete clinical trials, fulfill regulatory requirements and obtain FDA approval for our
drug candidates could have a material adverse effect on our cost to develop and commercialize, and our ability to generate revenue from,
a particular drug candidate.
If serious adverse or unacceptable side effects are identified during the development of our drug candidates, such events could
prevent us from obtaining regulatory approval or achieving market acceptance of our drug candidates, and we may need to abandon
or limit our development of some of our drug candidates.
If our drug candidates are associated with serious adverse events or undesirable side effects in clinical trials or have characteristics
that are unexpected, such events could prevent us from obtaining regulatory approval or achieving market acceptance of our drug
candidates, and we may need to abandon their development or limit development to more narrow uses or subpopulations in which the
serious adverse events, undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-
benefit perspective. In pharmaceutical development, many drugs that initially show promise in early-stage testing are later found to cause
side effects that prevent further development of the drug. Currently marketed therapies for the treatment of inflammatory diseases are
generally limited to some extent by their toxicity. In addition, some of our drug candidates would be chronic therapies or be used in
pediatric populations, for which safety concerns may be particularly important. Use of our drug candidates as monotherapies may also
result in adverse events consistent in nature with those associated with other marketed therapies. In addition, when used in combination
with other marketed therapies, our drug candidates may exacerbate adverse events associated with the marketed therapy.

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Our drug candidates, including barzolvolimab, are monoclonal antibodies, which are biologics. Side effects from biologics may
include but are not limited to hypersensitivity; severe reactions such as anaphylaxis or cytokine release syndrome; immune-mediated
adverse reactions that may occur in any organ system or tissue, such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and
dermatologic reactions; as well as infusion-related reactions, cellulitis, sepsis, pneumonia, urinary tract infection, fatigue, rash, and
diarrhea.
Most biologics, including our drug candidates, are injected, either subcutaneously or intravenously. There are risks inherent in
subcutaneous injections, such as injection-site reactions (including redness, itching, swelling, pain, and tenderness) and other side effects.
In addition, there are risks inherent in intravenous administration such as infusion-related reactions (including nausea, pyrexia, rash, and
dyspnea). These and other complications or side effects could harm further development and/or commercialization of our antibody-based
products and product candidates utilizing this method of administration.
In addition to the safety, efficacy, manufacturing, and regulatory hurdles faced by our product candidates, the administration of
biologics frequently causes an immune response, sometimes resulting in the creation of antibodies against the drug candidate which can
impact the safety and/or efficacy associated with the treatment.
We may expend our resources to pursue a particular drug candidate or indication and forgo the opportunity to capitalize on drug
candidates or indications that may ultimately be more profitable or for which there is a greater likelihood of success.
Because we have limited financial and managerial resources, we intend to focus on developing drug candidates for specific
indications that we identify as most likely to succeed, in terms of both their potential for regulatory approval and commercialization. As a
result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that may prove to have greater
commercial potential.
Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities.
Our spending on current and future research and development programs and drug candidates for specific indications may not yield any
commercially viable drug candidates. If we do not accurately evaluate the commercial potential or target market for a particular drug
candidate, we may relinquish valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in
cases in which it would have been more advantageous for us to retain sole development and commercialization rights to the drug
candidate.
We may be unable to manage multiple late-stage clinical trials for a variety of drug candidates simultaneously.
As our current clinical trials progress, we may need to manage multiple late-stage clinical trials simultaneously in order to continue
developing all of our current products. The management of late-stage clinical trials is more complex and time consuming than early-stage
trials. Typically, early-stage trials involve several hundred patients in no more than 10 to 30 clinical sites. Late-stage (Phase 3) trials may
involve up to several thousand patients in up to several hundred clinical sites and may require facilities in several countries. Therefore,
the project management required to supervise and control such an extensive program in a compliant manner is substantially larger than
early-stage programs. As the need for these resources is not known until some months before the trials begin, it is necessary to recruit
large numbers of experienced and talented individuals very quickly. If the labor market does not allow this team to be recruited quickly,
we could be faced with a decision to delay the program or to initiate it with inadequate management resources. This may result in
recruitment of inappropriate patients, inadequate monitoring of clinical investigators and inappropriate handling of data or data analysis.
Consequently, it is possible that conclusions of efficacy or safety may not be acceptable to permit filing of a BLA or NDA for any one of
the above reasons or a combination of several.
Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics for our drug candidates, if
needed, could harm our drug development strategy and operational results.
As an element of our clinical development approach, we may seek to screen and identify subsets of patients that express a certain
biomarker or that have a certain genetic alteration who may derive meaningful benefit from our development drug candidates. To achieve
this, one or more of our drug development programs may be dependent on the development and commercialization of a companion
diagnostic by us or by third-party collaborators. Companion diagnostics are developed in conjunction with clinical programs for the
associated drug candidate. Companion diagnostics are subject to regulation as medical devices and must themselves be approved for
marketing by the FDA or certain other foreign regulatory agencies before the related drug candidate may be commercialized. The
approval of a companion diagnostic as part of the product label will limit the use of the drug candidate to only

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those patients who express the specific biomarker it was developed to detect. We or our third-party collaborators may also experience
delays in developing a sustainable, reproducible and scalable manufacturing process or transferring that process to commercial partners
or negotiating insurance reimbursement for such companion diagnostic, all of which may prevent us from completing our clinical trials
or commercializing our drugs on a timely or profitable basis, if at all.
We and our third-party collaborators may encounter difficulties in developing and obtaining approval for these companion
diagnostics. Any delay or failure by us or third-party collaborators to develop or obtain regulatory approval of a companion diagnostic
could delay or prevent approval of our related drug candidates or, if regulatory approval is obtained, delay or limit our ability to
commercialize our related drug candidates.
Any delay in obtaining regulatory approval would have an adverse impact on our ability to earn future revenues.
It is possible that none of the drug candidates that we develop will obtain the regulatory approvals necessary for us to begin
commercializing them. The time required to obtain FDA and other approvals is unpredictable but in general takes years following the
commencement of clinical trials, depending upon the nature of the drug candidate. Any analysis we perform of data from clinical
activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.
Any delay or failure in obtaining required approvals could have a material adverse effect on our ability to generate revenues from the
particular drug candidate including, but not limited to, loss of patent term during the approval period. Furthermore, if we, or our partners,
do not reach the market with our products before our competitors offer products for the same or similar uses, or if we, or our partners, are
not effective in marketing our products, our revenues from product sales, if any, will be reduced.
We face intense competition in our development activities. We face competition from many companies in the United States and
abroad, including a number of large pharmaceutical companies. Most of our competitors have substantially greater resources, more
extensive experience in conducting preclinical studies and clinical testing and obtaining regulatory approvals for their products, greater
operating experience, greater research and development and marketing capabilities and greater production capabilities than those of ours.
These companies might succeed in obtaining regulatory approval for competitive products more rapidly than we can for our products,
especially if we experience any delay in obtaining required regulatory approvals.
We may enter into collaboration agreements for the licensing, development and ultimate commercialization of some of our drug
candidates including, where appropriate, for our lead drug candidates. In such cases, we will depend greatly on our third-party
collaborators to license, develop and commercialize such drug candidates, and they may not meet our expectations.
We may enter into co-development and commercialization partnerships for our drug candidates where appropriate. The process of
identifying collaborators and negotiating collaboration agreements for the licensing, development and ultimate commercialization of
some of our drug candidates may cause delays and increased costs. We may not be able to enter into collaboration agreements on terms
favorable to us or at all. Furthermore, some of those agreements may give substantial responsibility over our drug candidates to the
collaborator. Some collaborators may be unable or unwilling to devote sufficient resources to develop our drug candidates as their
agreements require. They often face business risks similar to ours, and this could interfere with their efforts. Also, collaborators may
choose to devote their resources to products that compete with ours. If a collaborator does not successfully develop any one of our
products, we will need to find another collaborator to do so. The success of our search for a new collaborator will depend on our legal
right to do so at the time and whether the product remains commercially viable.
If we enter into collaboration agreements for one or more of our lead drug candidates, the success of such drug candidates will
depend in great part upon our and our collaborators’ success in promoting them as superior to other treatment alternatives. We believe
that our drug candidates can be proven to offer disease treatment with notable advantages over drugs in terms of patient compliance and
effectiveness. However, there can be no assurance that we will be able to prove these advantages or that the advantages will be sufficient
to support the successful commercialization of our drug candidates.

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Risks Related to Commercialization of Our Drug Candidates
We may face delays, difficulties or unanticipated costs in establishing sales, marketing and distribution capabilities or seeking a
partnership for the commercialization of our drug candidates, even if regulatory approval is obtained.
We may retain full economic rights to our drug candidates or seek favorable economic terms through advantageous commercial
partnerships. As a result, we may have full responsibility for commercialization of one or more of our drug candidates if and when they
are approved for sale. We currently lack sufficient marketing, sales and distribution capabilities to carry out this strategy. If any of our
drug candidates are approved by the FDA, we will need a drug sales force with technical expertise prior to the commercialization of any
of our drug candidates. We may not succeed in developing such sales and distribution capabilities, the cost of establishing such sales and
distribution capabilities may exceed any product revenue, or our direct marketing and sales efforts may be unsuccessful. We may find it
necessary to enter into strategic partnerships, co-promotion or other licensing arrangements. To the extent we enter into such strategic
partnerships, co- promotion or other licensing arrangements, our product revenues are likely to be lower than if we directly marketed and
sold such drugs, and some or all of the revenues we receive will depend upon the efforts of third parties, which may not be successful
and may not be within our control. If we are unable to enter into such strategic partnerships, co-promotion or other licensing
arrangements on acceptable terms or at all, we may not be able to successfully commercialize our existing and future drug candidates. If
we are not successful in commercializing any drug candidates for which we obtain regulatory approval, either on our own or through
collaborations with one or more third parties, our future product revenue will suffer, and we may never achieve profitability or become
unable to continue the operation of our business.
If our drug candidates for which we obtain regulatory approval do not achieve broad acceptance from physicians, patients and third-
party payors, we may be unable to generate significant revenues, if any.
Even if we obtain regulatory approval for our drug candidates, our approved drugs may not gain market acceptance among
physicians and patients. We believe that effectively marketing our drug candidates, if any of them are approved, will require substantial
efforts, both prior to commercial launch and after approval. Physicians may elect not to prescribe our drugs, and patients may elect not to
request or take them, for a variety of reasons, including:
●
limitations or warnings contained in a drug’s FDA-approved labeling;
●
changes in the standard of care or the availability of alternative drugs for the targeted indications for any of our drug candidates;
●
limitations in the approved indications for our drug candidates;
●
the approval, availability, market acceptance and reimbursement for the companion diagnostic, where applicable;
●
demonstrated clinical safety and efficacy compared to other drugs;
●
significant adverse side effects;
●
effectiveness of education, sales, marketing and distribution support;
●
timing of market introduction and perceived effectiveness of competitive drugs;
●
price and cost-effectiveness;
●
adverse publicity about our drug candidates or favorable publicity about competitive drugs;
●
convenience and ease of administration of our drug candidates; and
●
willingness of third-party payors to reimburse for the cost of our drug candidates.
If our future drugs fail to achieve market acceptance, we will not be able to generate significant revenues and may never achieve
profitability.

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Even if any of our drug candidates receive FDA approval, the terms of the approval may limit such drug’s commercial potential.
Additionally, even after receipt of FDA approval, such drug would be subject to substantial, ongoing regulatory requirements.
The FDA has complete discretion over the approval of our drug candidates. If the FDA grants approval, the scope of the approval
may limit our ability to commercialize such drug, and in turn, limit our ability to generate substantial product revenue. For example, the
FDA may grant approval contingent on the performance of costly post-approval clinical trials or subject to warnings or contraindications
or under a Risk Evaluation and Mitigation Strategy (REMS) drug safety program. Additionally, after approval, the manufacturing
processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for such drug
will be subject to extensive and ongoing regulatory requirements. In addition, manufacturers of our drug candidates are required to
comply with cGMP regulations, which include requirements related to quality control and quality assurance as well as the corresponding
maintenance of records and documentation. Further, regulatory authorities must inspect and approve these manufacturing facilities before
they can be used to manufacture our drug candidates, and these facilities are subject to continual review and periodic inspections by the
FDA and other regulatory authorities for compliance with cGMP regulations. If we or a third party discover previously unknown
problems with a drug, such as adverse events of unanticipated severity or frequency, or problems with the facility where the drug is
manufactured, a regulatory authority may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of
the drug from the market or suspension of manufacturing. If we, our drug candidates or the manufacturing facilities for our drug
candidates fail to comply with regulatory requirements of the FDA and/or other non-U.S. regulatory authorities, we could be subject to
administrative or judicially imposed sanctions, including the following:
●
warning letters;
●
civil or criminal penalties and fines;
●
injunctions;
●
consent decrees;
●
suspension or withdrawal of regulatory approval;
●
suspension of any ongoing clinical studies;
●
voluntary or mandatory product recalls and publicity requirements;
●
refusal to accept or approve applications for marketing approval of new drugs;
●
restrictions on operations, including costly new manufacturing requirements; or
●
seizure or detention of drugs or import bans.
The regulatory requirements and policies may change, and additional government regulations may be enacted with which we may
also be required to comply. We cannot predict the likelihood, nature or extent of government regulation that may arise from future
legislation or administrative action, either in the United States or in other countries. If we are not able to maintain regulatory compliance,
we may not be permitted to market our future products and our business may suffer.

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Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance of any of our drug
candidates. If there is not sufficient reimbursement for our future drugs, it is less likely that such drugs will be widely used.
Market acceptance and sales of any of our drug candidates for which we obtain regulatory approval will depend on reimbursement
policies and may be affected by future health care reform measures in both the United States and foreign jurisdictions. Government
authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will
cover and establish payment levels. In addition, government authorities and these third-party payors are increasingly attempting to
contain health care costs by demanding price discounts or rebates and limiting both the types and variety of drugs that they will cover
and the amounts that they will pay for these drugs. In addition, we might need to conduct post-marketing studies in order to demonstrate
the cost-effectiveness of any future drugs to such payors’ satisfaction. Such studies might require us to commit a significant amount of
management time and financial and other resources.
Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on
payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or
services and may reflect budgetary constraints and/or imperfections in Medicare or Medicaid data used to calculate these rates. Net
prices for drugs may be reduced by mandatory discounts or rebates required by government health care programs. Such programs, or
regulatory changes or relaxation of laws that restrict imports of drugs from other countries, could reduce the net price we receive for any
future marketed drugs. In addition, our future drugs might not ultimately be considered cost-effective.
We cannot be certain that reimbursement will be available for any drug candidates that we develop. Also, we cannot be certain that
reimbursement policies will not reduce the demand for, or the price paid for, any future drugs. If reimbursement is not available or is
available on a limited basis, we may not be able to successfully commercialize any drug candidates that we develop.
Other factors could affect the demand for and sales and profitability of any drug candidates that we may commercialize in the future.
In general, other factors that could affect the demand for and sales and profitability of our future drugs include, but are not limited
to:
●
the timing of regulatory approval, if any, of competitive drugs;
●
our or any other of our partners’ pricing decisions, as applicable, including a decision to increase or decrease the price of a
drug, and the pricing decisions of our competitors;
●
government and third-party payor reimbursement and coverage decisions that affect the utilization of our future drugs and
competing drugs;
●
negative safety or efficacy data from new clinical studies conducted either in the U.S. or internationally by any party, which
could cause the sales of our future drugs to decrease or a future drug to be recalled;
●
the degree of patent protection afforded our future drugs by patents granted to or licensed by us and by the outcome of litigation
involving our or any of our licensor’s patents;
●
marketing exclusivity, if any, awarded by the FDA to our drugs;
●
the outcome of litigation involving patents of other companies concerning our future drugs or processes related to production
and formulation of those drugs or uses of those drugs;
●
the increasing use and development of alternate therapies;
●
the rate of market penetration by competing drugs; and
●
the termination of, or change in, existing arrangements with our partners.
Any of these factors could have a material adverse effect on the sales of any drug candidates that we may commercialize in the
future.

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Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.
We may seek approval for our drug candidates outside the United States and may market future products in international markets. In
order to market our future products in the European Economic Area, or EEA, and many other foreign jurisdictions, we must obtain
separate regulatory approvals. Specifically, in the EEA, medicinal products can only be commercialized after obtaining a Marketing
Authorization, or MA.
Before granting the MA, the European Medicines Agency or the competent authorities of the member states of the EEA make an
assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
The approval procedures vary among countries and can involve additional clinical testing, and the time required to obtain approval
may differ from that required to obtain FDA approval. Clinical studies conducted in one country may not be accepted by regulatory
authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval
by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries or by the FDA.
However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in
others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We may not obtain
foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals, and even if we file, we may
not receive necessary approvals to commercialize our products in any market.
If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with
international operations could materially adversely affect our business.
If our drug candidates are approved for commercialization outside of the United States, we expect that we will be subject to
additional risks related to international operations and entering into international business relationships, including:
●
different regulatory requirements for drug approvals;
●
reduced protection for intellectual property rights, including trade secret and patent rights;
●
unexpected changes in tariffs, trade barriers and regulatory requirements;
●
economic weakness, including inflation, uncertain interest rate environments or political instability in particular foreign
economies and markets;
●
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
●
foreign taxes, including withholding of payroll taxes;
●
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations
incident to doing business in another country;
●
workforce uncertainty in countries where employment regulations are different than, and labor unrest is more common than, in
the United States;
●
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
●
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including
earthquakes, hurricanes, floods and fires; and
●
difficulty in importing and exporting clinical trial materials and study samples.

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The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to change, including
due to judicial challenges.
The U.S. biopharmaceutical industry is highly regulated and subject to frequent and substantial changes, including as a result of new
judicial or government actions. Legislative and regulatory agendas as they relate to the biopharmaceutical industry are currently
uncertain. Changes in the regulatory approval process, or substantial reductions in the personnel who oversee that process, could affect
our ability to obtain regulatory approval for our product candidates or the timeline in which we can obtain that approval. We and our
current and future third party collaborators may rely on government programs or agencies, such as the National Institutes for Health
(“NIH”), as a source of grant funding for scientific research relevant to our product candidates. Funding from government agencies such
as the NIH can fluctuate and is subject to the political process, which is often unpredictable. Reductions in NIH grants to us or our third-
party collaborators may adversely impact our ability to develop our existing product candidates and our ability to identify new product
candidates. In addition, on June 28, 2024, the U.S. Supreme Court issued an opinion holding that courts reviewing agency action
pursuant to the Administrative Procedure Act (“APA”) “must exercise their independent judgment” and “may not defer to an agency
interpretation of the law simply because a statute is ambiguous.” The decision could have a significant impact on how lower courts
evaluate challenges to agency interpretations of law, including those by the FDA and other agencies with significant oversight of the
biopharmaceutical industry. The new framework may increase both the frequency of such challenges and their odds of success by
eliminating one way in which the government previously prevailed in such cases. As a result, significant regulatory policies could be
subject to increased litigation and judicial scrutiny. We cannot predict how other future federal or state legislative or administrative
changes relating to healthcare reform or the biopharmaceutical industry, or the regulatory agencies that oversee the biopharmaceutical
industry, will affect our business.
Risks Related to Reliance on Third Parties
We rely on third parties to plan, conduct and monitor our clinical tests, and their failure to perform as required would interfere with
our product development.
We rely on third parties to conduct a significant portion of our clinical development activities. These activities include clinical
patient recruitment and observation, clinical trial monitoring, clinical data management and analysis, safety monitoring and project
management. We conduct project management and medical and safety monitoring in-house for some of our programs and rely on third
parties for the remainder of our clinical development activities. If any of these third parties is unable to perform in a quality and timely
manner, and at a feasible cost, our clinical studies will face delays. Further, if any of these third parties fails to perform as we expect or if
their work fails to meet regulatory standards, our testing could be delayed, cancelled or rendered ineffective.
We rely on CDMOs over whom we have limited control. Should the cost, delivery and quality of clinical materials manufactured by us
in our Fall River facility or supplied by CDMOs vary to our disadvantage, our business operations could suffer significant harm.
We are a research and development company and have limited experience in commercial manufacturing. To conduct late-stage
clinical trials, as well as manufacture and commercialize our drug candidates, we engage CDMOs in the U.S and outside the U.S. to
manufacture our drug candidates on a large scale at a competitive cost and in accordance with cGMP and U.S. and foreign regulatory
requirements, as applicable. We also rely on CDMOs for filling, labeling and storage for studies inside and outside the U.S. Any
manufacturing failures or compliance issues at our CDMOs could cause delays in our clinical studies or commercialization of our drug
candidates.
In order for us to establish our own commercial manufacturing facility, we would require substantial additional funds and would
need to make facility modifications, hire and retain significant additional personnel and comply with extensive cGMP regulations
applicable to such a facility. The commercial manufacturing facility would also need to be licensed for the production of our drug
candidates by the FDA and meet other regulatory standards. We therefore work with CDMOs under established manufacturing
arrangements that comply with the FDA’s requirements and other regulatory standards, although there is no assurance that the
manufacturing will be successful.
Prior to approval of any drug candidate, the FDA must review and approve validation studies for both drug substance and drug
product. The manufacturing processes for our drug candidates and device delivery systems utilize known technologies. We believe that
the products we currently have under development can be scaled up to permit manufacture in commercial quantities. However, there can
be no assurance that we will not encounter difficulties in scaling up the manufacturing processes. Significant scale-up of

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manufacturing may result in unanticipated technical challenges and may require additional validation studies that the FDA must review
and approve. CDMOs may encounter difficulties in scaling up production, including problems involving supply chain, raw material
suppliers, production yields, technical difficulties, scaled-up product characteristics, quality control and assurance, shortage of qualified
personnel, capacity constraints, changing priorities within the CDMOs, compliance with FDA and foreign regulations, environmental
compliance, production costs and development of advanced manufacturing techniques and process controls. Any of these difficulties, if
they occur and are not overcome to the satisfaction of the FDA or other regulatory agency, could lead to significant delays and possibly
the termination of the development program for such drug candidate. These risks become more acute as we scale up for commercial
quantities, where reliable sources of drug substance and drug product become critical to commercial success. The commercial viability of
any of our drug candidates, if approved, will depend on the ability of our CDMOs to produce drug substance and drug product on a large
scale. Failure to achieve this level of supply can jeopardize and prevent the successful commercialization of the drug.
Our leading drug candidates require specialized manufacturing capabilities and processes. We may face difficulty in securing
commitments from U.S. and foreign CDMOs as these manufacturers could be unwilling or unable to accommodate our needs. Relying
on foreign manufacturers involves peculiar and increased risks, including the risk relating to the difficulty foreign manufacturers may
face in complying with cGMP requirements as a result of language barriers, lack of familiarity with cGMP or the FDA regulatory
process, supply chain issues or other causes, economic or political instability in or affecting the home countries of our foreign
manufacturers, shipping delays, potential changes in foreign regulatory laws governing the sales of our product supplies, fluctuations in
foreign currency exchange rates and the imposition or application of trade restrictions.
There can be no assurances that CDMOs will be able to meet our timetable and requirements. While we believe that there is
currently sufficient capacity worldwide for the production of our potential products through CDMOs, establishing long-term
relationships with CDMOs and securing multiple sources for the necessary quantities of clinical and commercial materials required can
be a challenge due to increasing industry demand for CDMO services. Qualifying the initial source of clinical and ultimately commercial
material is a time consuming and expensive process due to the highly regulated nature of the pharmaceutical/biotech industry. The key
difficulty in qualifying more than one source for each product is the duplicated time and expense in doing so without the potential to
mitigate these costs if the secondary source is never utilized. Further, CDMOs must operate in compliance with cGMP and failure to do
so could result in, among other things, the disruption of product supplies.
Use of CDMOs also limits our control over and ability to monitor the manufacturing process. As a result, we may not be able to
detect a variety of problems that may arise and may face additional costs in the process of interfacing with and monitoring the progress
of our CDMOs. If CDMOs fail to meet our manufacturing needs in an acceptable manner or fail to comply with regulatory requirements,
we would face delays and additional costs while we develop internal manufacturing capabilities or find alternate CDMOs. It may not be
possible to have multiple CDMOs ready to supply us with needed material at all or without incurring significant costs. Our dependence
upon CDMOs for the manufacture of our products may adversely affect our profit margins and our ability to develop, manufacture, sell
and deliver products on a timely and competitive basis. Any manufacturing failures, supply chain delays or compliance issues at our Fall
River facility or at our CDMOs could cause delays in our clinical studies for our drug candidates.
We may need to rely on third-party collaborators to develop and commercialize companion diagnostic tests for our drug candidates.
We do not have experience or capabilities in developing, administering, obtaining regulatory approval for, or commercializing
companion diagnostic tests and will need to rely in large part on third-party collaborators to perform these functions. Companion
diagnostic tests are subject to regulation by the FDA and similar regulatory authorities outside of the United States as medical devices
and require separate regulatory approval prior to commercialization. We may need to rely on such third-party collaborators to obtain
regulatory approval and commercialize such companion diagnostic tests. Such third-party collaborators:
●
may not perform their obligations as expected or as required under our collaboration agreement;
●
may encounter production difficulties that could constrain the supply of the companion diagnostic test;
●
may have difficulties gaining acceptance of the use of the companion diagnostic test in the clinical community;
●
may not pursue commercialization of the companion diagnostic test even if they receive any required regulatory approvals;

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●
may elect not to continue the development or commercialization of the companion diagnostic test based on changes in the third
parties’ strategic focus or available funding, or external factors such as an acquisition, that divert resources or create competing
priorities;
●
may be susceptible to third party cyber-attacks on our and their information security systems;
●
may not commit sufficient resources to the marketing and distribution of the companion diagnostic test; and
●
may terminate their relationship with us.
If such third-party collaborators fail to develop, obtain regulatory approval or commercialize the companion diagnostic test, we may
not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for use in
connection with the development and commercialization of our drug candidates or do so on commercially reasonable terms, which could
adversely affect and/or delay the development or commercialization of our drug candidates.
Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover
them.
Because we rely on third parties to develop our drug candidates, we must share trade secrets with them. We seek to protect our
proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative
research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants
prior to beginning research or disclosing proprietary information. These agreements typically restrict the ability of our collaborators,
advisors, employees and consultants to publish data potentially relating to our trade secrets. Our academic collaborators typically have
rights to publish data, provided that we are notified in advance and may delay publication for a specified time in order to secure our
intellectual property rights arising from the collaboration. In other cases, publication rights are controlled exclusively by us, although in
some cases we may share these rights with other parties. We also conduct joint research and development programs which may require us
to share trade secrets under the terms of research and development partnership or similar agreements. Despite our efforts to protect our
trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or
publication of information including our trade secrets in cases where we do not have proprietary or otherwise protected rights at the time
of publication. A competitor’s discovery of our trade secrets would impair our competitive position.
Risks Related to Business Operations
We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to
our management.
From time to time we may consider strategic transactions, including acquisitions of companies, asset purchases and out-licensing or
in-licensing of products, drug candidates or technologies. Additional potential transactions that we may consider include a variety of
different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business
combinations, acquisitions of assets and investments. Any such transaction may require us to incur non-recurring or other charges, may
increase our near and long-term expenditures and may pose significant integration challenges or disrupt our management or business,
which could adversely affect our operations and financial results. For example, these transactions may entail numerous operational and
financial risks, including:
●
exposure to unknown liabilities;
●
disruption of our business and diversion of our management’s time and attention in order to develop acquired products, drug
candidates or technologies;
●
incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions;
●
higher than expected acquisition and integration costs;

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●
write-downs of assets or impairment charges;
●
increased amortization expenses;
●
difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
●
impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and
ownership; and
●
inability to retain key employees of any acquired businesses.
Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature
described above, any transactions that we do complete could have a material adverse effect on our business, results of operations,
financial condition and prospects.
We may expand our clinical development, regulatory and sales and marketing capabilities, and as a result, we may encounter
difficulties in managing our growth, which could disrupt our operations.
We expect that if our drug candidates continue to progress in development, we may require significant additional investment in
personnel, management systems and resources, particularly in the build out of our commercial capabilities. To date we have hired a core
commercial team to plan for potential commercial launches if any of our drug candidates are approved. Over the next several years, we
may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug
development, regulatory affairs and sales and marketing. To manage this potential future growth, we may continue to implement and
improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified
personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such
anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified
personnel. The physical expansion of our operations may lead to significant costs and may divert our management and business
development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
We may not be able to successfully integrate our existing technology or to modify our technologies to create new immunotherapeutic
drugs.
If we are able to integrate our acquired assets and licensed assets with our immunotherapy technologies, we believe these assets will
give our immunotherapeutic drugs a competitive advantage. However, if we are unable to successfully integrate licensed assets, or other
technologies which we have acquired or may acquire in the future, with our existing technologies and potential products currently under
development, we may be unable to realize any benefit from our acquisition of these assets, or other technologies which we have acquired
or may acquire in the future, and we may face the loss of our investment of financial resources and time in the integration process.
We believe that our immunotherapy technology portfolio may offer opportunities to develop immunotherapeutic drugs that treat a
variety of inflammatory and infectious diseases by stimulating a patient’s immune system against those diseases. If our immunotherapy
technology portfolio cannot be used to create effective immunotherapeutic drugs against a variety of diseases, we may lose all or portions
of our investment in development efforts for new drug candidates.
Our internal computer systems, or those of our CROs, CDMOs, or other contractors or consultants, may fail or suffer security
breaches, which could result in a material disruption of our drug development programs.
Our computer systems and those of our CROs, CDMOs, and other contractors and consultants are vulnerable to damage from
cyberattacks, malicious intrusion, computer viruses, unauthorized access, data breaches, phishing attacks, cybercriminals, natural
disasters, terrorism, war and telecommunication, electrical failures or other significant disruption even with a cybersecurity risk
mitigation program developed by our enterprise. Such information technology systems are additionally vulnerable to security breaches
from inadvertent or intentional actions by our employees, third-party vendors, contractors, consultants, business partners, and/or other
third parties. The risks of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by traditional
computer “hackers,” threat actors, personnel (such as through theft, inadvertent mistake or misuse), sophisticated nation-state and

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nation-state-supported actors, sovereign governments and cyber terrorists, have generally increased over time, including for geopolitical
reasons and in conjunction with military conflicts and defense activities, along with the number, intensity and sophistication of attempted
attacks and intrusions from around the world. During times of war and other major conflicts, we and the third parties upon which we rely
may be vulnerable to a heightened risk of these attacks, including cyber-attacks that could materially disrupt our systems and operations,
supply chain and ability to produce and distribute our products and product candidates. If any such events were to occur and cause
interruptions in our operations, it could result in a material disruption of our drug development programs and commercialization efforts.
For example, the loss of clinical study data from completed or ongoing clinical studies for any of our drug candidates could result in
delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Further, the risk of cyber-
attacks or other privacy or data security incidents may be heightened due to common, external attempts to attack our information
technology systems and data using means such as phishing, other social engineering and vulnerability exploitation. To the extent that any
disruption or security breach were to result in a loss of or damage to our data or applications or inappropriate disclosure of confidential or
proprietary information, we could incur liability and the further development or commercialization of our drug candidates could be
delayed.
While we have not experienced any material disruptions to our business, systems or operations as a result of a cybersecurity incident
to date, if such an event were to occur and cause material interruptions in our operations, it could result in a material disruption of our
independent drug development programs and our business overall. For example, the loss of clinical trial data from ongoing or future
clinical trials for any of our product candidates could result in delays in regulatory approval efforts and significantly increase costs to
recover or reproduce the data. Our information security systems are also subject to laws and regulations requiring that we take measures
to protect the privacy and security of certain information we gather and use in our business. For example, HIPAA and its implementing
regulations impose, among other requirements, certain regulatory and contractual requirements regarding the privacy and security of
personal health information. In the European Union, the General Data Protection Regulation, or GDPR, further restricts all applicable
personal data, including information masked by a coding system that is not considered deidentified data under applicable law. In addition
to HIPAA and GDPR, numerous other federal and state laws, including, without limitation, state security breach notification laws, state
health information privacy laws and federal and state consumer protection laws, govern the collection, use, disclosure, protection and
storage of personal information. To the extent that any disruption or security breach of our information technology systems were to result
in a loss of or damage to data or applications, or inappropriate disclosure of third-party notifiable confidential or proprietary information,
personal health information, personal information or personal data, we could incur substantial liability under laws that protect the privacy
of personal information, our reputation would be damaged, and the further development of our product candidates could be delayed, any
of which could adversely affect our business. The costs related to significant security breaches or disruptions could be material and
exceed the limits of the cybersecurity insurance we maintain against such risks.
We cannot anticipate all possible types of security threats and we cannot guarantee that our data protection efforts and our
investments in information technology will prevent significant breakdowns, data leakages, security breaches in our systems, or those of
our third-party vendors and other contractors and consultants, or other cyber incidents that could have a material adverse effect upon our
reputation, business, operations, or financial condition.
Our business requires us to use hazardous materials, which increases our exposure to dangerous and costly accidents.
Our research and development activities involve the use of biological materials and small amounts of hazardous chemicals. The
company has internal policies and procedures for the safe handling and disposal of these materials, in full compliance with applicable
laws and regulations, including applicable OSHA, EPA, state and local regulations, and utilizing EPA licensed disposal companies and
facilities. Although we believe we have reduced our risk and impacts from these materials through our safety procedures, we cannot
completely eliminate the risk of accidental contamination or injury from these materials. The ongoing cost of complying with
environmental laws and regulations is significant and may increase in the future. All risks of environmental damage inherent to our
operations cannot be mitigated and failure to comply with applicable government regulations could result in the imposition of fines,
restrictions, or increased operational costs, which could impact our ability to carry on with our operations.
We face the risk of product liability claims, which could exceed our insurance coverage, and product recalls, each of which could
deplete our cash resources.
As a participant in the pharmaceutical, biotechnology and immunotherapeutic drug industries, we are exposed to the risk of product
liability claims alleging that use of our drug candidates caused an injury or harm. These claims can arise at any point in the development,
testing, manufacture, marketing or sale of our drug candidates and may be made directly by patients involved in clinical trials of our
products, by consumers or health care providers or by individuals, organizations or companies selling our products.

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Product liability claims can be expensive to defend, even if the drug or drug candidate did not actually cause the alleged injury or harm.
Insurance covering product liability claims becomes increasingly expensive as a drug candidate moves through the development
pipeline to commercialization. However, there can be no assurance that such insurance coverage is or will continue to be adequate or
available to us at a cost acceptable to us or at all. We may choose or find it necessary under our collaborative agreements to increase our
insurance coverage in the future. We may not be able to secure greater or broader product liability insurance coverage on acceptable
terms or at reasonable costs when needed. Any liability for damages resulting from a product liability claim could exceed the amount of
our coverage, require us to pay a substantial monetary award from our own cash resources and have a material adverse effect on our
business, financial condition and results of operations. Moreover, a product recall, if required, could generate substantial negative
publicity about our products and business and inhibit or prevent development of our drug candidates and, if approval is obtained,
commercialization of our future drugs.
Risks Related to Intellectual Property
We license technology from other companies to develop products, and those companies could influence research and development or
restrict our use of it. In addition, if we fail to comply with our obligations in our intellectual property licenses with third parties, we
could lose license rights that are important to our business.
Companies that license technologies to us that we use in our research and development programs may require us to achieve
milestones or devote minimum amounts of resources to develop products using those technologies. They may also require us to make
significant royalty and milestone payments, including a percentage of any sublicensing income, as well as payments to reimburse them
for patent costs. The number and variety of our research and development programs require us to establish priorities and to allocate
available resources among competing programs. From time to time, we may choose to slow down or cease our efforts on particular
products. If in doing so we fail to fully perform our obligations under a license, the licensor can terminate the license or permit our
competitors to use the technology. Termination of these licenses or reduction or elimination of our licensed rights may result in our
having to negotiate new or reinstated licenses with less favorable terms. Moreover, we may lose our right to market and sell any products
based on the licensed technology. The occurrence of such events could materially harm our business.
Our ability to successfully develop and, if regulatory approval is obtained, commercialize our drug candidates may be materially
adversely affected if we are unable to obtain and maintain effective intellectual property rights for our drug candidates and
technologies.
Our success depends in part on our ability to obtain and maintain patent protection and other intellectual property protection for our
drug candidates and proprietary technology. We have sought to protect our proprietary position by filing patent applications in the United
States and abroad related to our drug candidates and technology that are important to our business. This 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 or in a timely
manner. 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. Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from using
our technologies or from developing competing drugs and technologies. We may also be unable to obtain patent term adjustments or
extensions (or similar rights, such as Supplementary Protection Certificates, in foreign countries) at the relevant times, or the duration of
any such adjustments, extensions or the like may be less than requested.
Biotechnology patents involve complex legal, scientific and factual questions and are highly uncertain and may also result in
different outcomes in different territories. To date, there is no consistent policy regarding the breadth of claims allowed in biotechnology
patents, particularly in regard to patents for technologies for human uses like those we use in our business. We cannot predict whether the
patents we or our licensors seek will issue. If such patents are issued, a competitor may challenge them and may potentially have them
revoked or limit their scope, for example based on existing or newly identified prior art or other issues of validity. Moreover, our patents
may not afford effective protection against competitors with similar technology. A successful challenge to any one of our patents could
result in a third party’s ability to use the technology covered by the patent. We also face the risk that others will infringe, avoid or
circumvent our patents. Technology that we license from others is subject to similar risks and this could harm our ability to use that
technology. If we, or a company that licenses technology to us, were not the first creator of an invention that we use, and/or if
inventorship were to be decided against us (or our licensor) in any relevant litigation, our use of the underlying product or technology
will face restrictions, including elimination, and our ability to defend and/or enforce any affected patent rights could also be materially
harmed.

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If we must defend against suits brought against us or prosecute suits against others involving intellectual property rights, we will
incur substantial costs. In addition to any potential liability for significant monetary damages, a decision against us may require us to
obtain licenses to patents or other intellectual property rights of others on potentially unfavorable terms. If those licenses from third
parties are necessary but we cannot acquire them, we would attempt to design around the relevant technology, which would cause higher
development costs and delays and may ultimately prove impracticable.
We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on
commercially reasonable terms.
A third party may hold intellectual property, including patent rights, that are important or necessary to the development of our drug
candidates. It may be necessary for us to use the patented or proprietary technology of a third party to commercialize our own technology
or drug candidates, in which case we would be required to obtain a license from such third party. A license to such intellectual property
may not be available or may not be available on commercially reasonable terms, which could have a material adverse effect on our
business and financial condition.
We may be unable to protect the confidentiality of our trade secrets, thus harming our business and competitive position.
We rely upon trade secrets, including unpatented know-how, technology and other proprietary information to develop and maintain
our competitive position, which we seek to protect, in part, by confidentiality agreements with our employees and our collaborators and
consultants. We also have agreements with our employees that obligate them to assign their inventions to us. However, it is possible that
technology relevant to our business will be independently developed by a person that is not a party to such an agreement. Furthermore, if
the employees, consultants or collaborators that are parties to these agreements breach or violate the terms of these agreements, we may
not have adequate remedies for any such breach or violation, and we could lose our trade secrets through such breaches or violations.
Further, our trade secrets could be disclosed, misappropriated or otherwise become known or be independently discovered by our
competitors. In addition, intellectual property laws in foreign countries may not protect our intellectual property to the same extent as the
laws of the United States. If our trade secrets are disclosed or misappropriated, it would harm our ability to protect our rights and have a
material adverse effect on our business.
We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time- consuming and unsuccessful.
Competitors may infringe our patents. To counter infringement or unauthorized use, we may be required to file infringement claims,
which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is
invalid or unenforceable or may 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. 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.
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which
would be uncertain and could have a material adverse effect on the success of our business.
Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our
drug candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the proprietary rights or
intellectual property of third parties. We may become party to, or be threatened with, future adversarial proceedings or litigation
regarding intellectual property rights with respect to our drug candidates and technology. Third parties may assert infringement claims
against us based on existing patents or patents 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 our drug candidates 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 developing the infringing technology or product. In addition, we could be found liable
for monetary damages. Claims that we have misappropriated the confidential information or trade secrets of third parties can have a
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Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or
misappropriated trade secrets.
We employ individuals who were previously employed at universities or other diagnostic or biopharmaceutical companies, including
our competitors or potential competitors. Although we try to ensure that our employees and consultants 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 our employees, consultants or
independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other
proprietary information, of a former employer or other third parties. Litigation may be necessary to defend against these claims. If we fail
in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
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.
Regulatory Risks
We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
We may seek orphan drug designation for some of our product candidates in the United States. Regulatory authorities in some
jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or
condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States.
Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for
which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from
approving another marketing application for the same indication for that drug during that time period. The applicable period is seven
years in the United States and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets
the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan
drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the
manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
We cannot assure you that any future application for orphan drug designation with respect to any product candidate will be granted.
If we are unable to obtain orphan drug designation in the United States, we will not be eligible to obtain the period of market exclusivity
that could result from orphan drug designation or be afforded the financial incentives associated with orphan drug designation. Even if
we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because
different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the
same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more
effective or makes a major contribution to patient care.
Any fast track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory
review or approval process, nor will it assure FDA approval of our product candidates. Additionally, our product candidates may treat
indications that do not qualify for priority review vouchers.
We may seek fast track designation for some of our product candidates or priority review of applications for approval of our product
candidates. If a drug is intended for the treatment of a serious or life- threatening condition and the drug demonstrates the potential to
address unmet medical needs for this condition, the drug sponsor may apply for FDA fast track designation. If a product candidate offers
major advances in treatment, the FDA may designate it eligible for priority review. The FDA has broad discretion whether or not to grant
these designations, so even if we believe a particular product candidate is eligible for these designations, we cannot assure you that the
FDA would decide to grant them. Even if we do receive fast track designation or priority review, we may not experience a faster
development process, review or approval compared to conventional FDA procedures. The FDA may withdraw fast track designation if it
believes that the designation is no longer supported by data from our clinical development program.

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Any breakthrough therapy designation granted by the FDA for our product candidates may not lead to a faster development or
regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing
approval.
We may seek a breakthrough therapy designation for some of our product candidates. A breakthrough therapy is defined as a drug
that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and
preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more
clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs and biologics that
have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to
identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.
Drugs designated as breakthrough therapies by the FDA may also be eligible for accelerated approval if the relevant criteria are met.
Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our product
candidates meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such
designation. In any event, the receipt of a breakthrough therapy designation for a product candidate may not result in a faster
development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not
assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualify as breakthrough therapies, the
FDA may later decide that the products no longer meet the conditions for qualification or decide that the time period for FDA review or
approval will not be shortened.
If our processes and systems are not compliant with regulatory requirements, we could be subject to delays in submitting BLAs,
NDAs or restrictions on marketing of drugs after they have been approved.
We currently are developing drug candidates for regulatory approval and are in the process of implementing regulated processes and
systems required to obtain and maintain regulatory approval for our drug candidates. Certain of these processes and systems for
conducting clinical trials and manufacturing material must be compliant with regulatory requirements before we can apply for regulatory
approval for our drug candidates. These processes and systems will be subject to continual review and periodic inspection by the FDA
and other regulatory bodies. If we are unable to achieve compliance in a timely fashion or if compliance issues are identified at any point
in the development and approval process, we may experience delays in filing for regulatory approval for our drug candidates or delays in
obtaining regulatory approval after filing. In addition, any later discovery of previously unknown problems or safety issues with
approved drugs or manufacturing processes, or failure to comply with regulatory requirements may result in restrictions on such drugs or
manufacturing processes, withdrawal of drugs from the market, the imposition of civil or criminal penalties or a refusal by the FDA
and/or other regulatory bodies to approve pending applications for marketing approval of new drugs or supplements to approved
applications, any of which could have a material adverse effect on our business. In addition, we are a party to agreements that transfer
responsibility for complying with specified regulatory requirements, such as filing and maintenance of marketing authorizations and
safety reporting or compliance with manufacturing requirements, to our collaborators and third-party manufacturers. If our collaborators
or third-party manufacturers do not fulfill these regulatory obligations, any drugs for which we or they obtain approval may be subject to
later restrictions on manufacturing or sale or may even risk withdrawal, which could have a material adverse effect on our business.
We have conducted and are conducting clinical trials outside the United States and anticipate conducting additional clinical trials
outside the United States, and the FDA may not accept data from such trials.
We are currently conducting clinical trials for our product candidates in countries outside of the United States and we anticipate that
we will conduct additional clinical trials in countries outside the United States. Although the FDA may accept data from clinical trials
conducted outside the United States, acceptance of such study data by the FDA is subject to certain conditions. For example, the clinical
trial must be conducted in accordance with GCP requirements and the FDA must be able to validate the data from the clinical trial
through an onsite inspection if it deems such inspection necessary. Where data from foreign clinical trials are intended to serve as the
sole basis for marketing approval in the United States, the FDA will not approve the application on the basis of foreign data alone unless
those data are considered applicable to the U.S. patient population and U.S. medical practice, the clinical trials were performed by
clinical investigators of recognized competence, and the data is considered valid without the need for an on-site inspection by the FDA
or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other
appropriate means. In addition, such clinical trials would be subject to the applicable local laws of the foreign jurisdictions where the
clinical trials are conducted. A description of any studies related to overdosage is also required, including information on

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dialysis, antidotes, or other treatments, if known. There can be no assurance the FDA will accept data from clinical trials conducted
outside of the United States. If the FDA does not accept any such data, it would likely result in the need for additional clinical trials,
which would be costly and time-consuming and delay aspects of our development plan.
Risks inherent in conducting international clinical trials include, but are not limited to:
●
foreign regulatory requirements that could burden or limit our ability to conduct our clinical trials;
●
administrative burdens of conducting clinical trials under multiple foreign regulatory schema;
●
foreign currency fluctuations which could negatively impact our financial condition since certain payments are paid in local
currencies;
●
manufacturing, customs, shipment and storage requirements;
●
cultural differences in medical practice and clinical research; and
●
diminished protection of intellectual property in some countries.
Changes in product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates are developed through preclinical studies to late-stage clinical trials towards approval and commercialization,
it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the
way in an effort to optimize processes and results. During the course of a development program, sponsors may also change the contract
manufacturers used to produce the product candidates. Such changes carry the risk that they will not achieve these intended objectives.
Any of these changes could cause our product candidates to perform differently and affect the results of clinical trials. Such changes may
also require additional testing, notification or approval by the FDA, EMA or other regulatory authorities. This could delay completion of
clinical trials; require the conduct of bridging clinical trials or studies, or the repetition of one or more clinical trials; increase clinical trial
costs; delay or prevent approval of our product candidates and jeopardize our ability to commence product sales and generate revenue.
Even if we receive regulatory approval for a drug candidate, we will be subject to ongoing regulatory obligations and continued
regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable
regulatory requirements.
Once regulatory approval has been granted, the approved product and its manufacturer are subject to continual review by the FDA
and/or non-U.S. regulatory authorities. Any regulatory approval that we or our collaboration partners receive for our drug candidates may
be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for potentially costly post-
marketing follow-up studies to monitor the safety and efficacy of the product. In addition, if the FDA and/or non-U.S. regulatory
authorities approve any of our drug candidates, we will be subject to extensive and ongoing regulatory requirements by the FDA and
other regulatory authorities with regard to the labeling, packaging, adverse event reporting, storage, advertising, promotion and
recordkeeping for our products. In addition, manufacturers of our drug products are required to comply with cGMP regulations, which
include requirements related to quality control and quality assurance as well as the corresponding maintenance of records and
documentation. Further, regulatory authorities must inspect and approve these manufacturing facilities before they can be used to
manufacture our drug products, and these facilities are subject to continual review and periodic inspections by the FDA and other
regulatory authorities for compliance with cGMP regulations. If we or a third party discover previously unknown problems with a
product, such as adverse events of unanticipated severity or frequency or problems with the facility where the product is manufactured, a
regulatory authority may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from
the market or suspension of manufacturing. If we, our drug candidates or the manufacturing facilities for our drug candidates fail to
comply with regulatory requirements of the FDA and/or other non-U.S. regulatory authorities, we could be subject to administrative or
judicially imposed sanctions, including the following:
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●
civil or criminal penalties and fines;
●
injunctions;
●
consent decrees;
●
suspension or withdrawal of regulatory approval;
●
suspension of any ongoing clinical studies;
●
voluntary or mandatory product recalls and publicity requirements;
●
refusal to accept or approve applications for marketing approval of new drugs;
●
restrictions on operations, including costly new manufacturing requirements; or
●
seizure or detention of drugs or import bans.
The regulatory requirements and policies may change and additional government regulations may be enacted with which we may
also be required to comply. We cannot predict the likelihood, nature or extent of government regulation that may arise from future
legislation or administrative action, either in the United States or in other countries. If we are not able to maintain regulatory compliance,
we may not be permitted to market our future products, and our business may suffer.
We may be subject, directly or indirectly, to federal and state health care fraud and abuse laws, false claims laws, transparency and
pricing laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws,
we could face substantial penalties.
If we obtain FDA approval for any of our drug candidates and begin commercializing those products in the United States, our
operations will be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including,
without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. These laws may affect, among other things, our
proposed sales, marketing and education programs. In addition, we may be subject to patient privacy regulation by both the federal
government and the states in which we conduct our business. The laws that may affect our ability to operate include:
●
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting,
receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of
an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs;
●
federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or
entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-
party payors that are false or fraudulent;
●
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information
Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which impose
certain requirements relating to the privacy, security and transmission of individually identifiable health information;
●
the federal transparency requirements under the Patient Protection and Affordable Care Act of 2010 (“ACA”) requires
manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services
information related to physician payments and other transfers of value and physician ownership and investment interests;
●
state law and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may
apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the
privacy and security of health information in certain circumstances, many of which differ from each other in significant ways
and may not have the same effect, thus complicating compliance efforts; and

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●
state and federal laws, such as the Physician Sunshine Act, directed at generating transparency on financial issues, including
drug prices and payments made by drug companies to various entities and individuals involved in healthcare.
Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be
entirely eliminated. If our operations are found to be in violation of any of the laws described above or any other governmental
regulations that apply to us, we may be subject to penalties, including exclusion from payment by federal health care programs, civil and
criminal penalties, damages, fines and the curtailment or restructuring of our operations, any of which could adversely affect our ability
to operate our business and our results of operations. Moreover, achieving and sustaining compliance with applicable federal and state
privacy, security and fraud laws may prove costly.
Compliance with laws and regulations pertaining to the privacy and security of health information may be time consuming, difficult
and costly, particularly in light of increased focus on privacy issues in countries around the world, including the U.S. and the EU.
We are subject to various domestic and international privacy and security regulations related to personal information, including
health information, that are appliable to our business and associated data processing activities. The confidentiality, collection, use and
disclosure of personal data, including clinical trial patient-specific information, are subject to governmental regulation generally in the
country that the personal data was collected or used. In the United States, we are subject to various state and federal privacy and data
security regulations, including but not limited to HIPAA and as amended by the HITECH Act. HIPAA imposes specified requirements
relating to the privacy, security and transmission of individually identifiable health information, and mandates, among other things, the
adoption of uniform standards for the electronic exchange of information in common health care transactions, as well as standards
relating to the privacy and security of individually identifiable health information, which require the adoption of administrative, physical
and technical safeguards to protect such information. We may also be subject to state security breach notification laws, state laws
protecting the privacy and security of health and personal information, and federal and state consumer protections laws which regulate
the collection, use, disclosure and transmission of personal information. These laws may overlap and conflict with each other, and each
of these laws is subject to varying interpretations by courts and government agencies, creating complex compliance issues for us. In the
EU, personal data includes any information that relates to an identified or identifiable natural person with health information carrying
additional obligations, including obtaining the explicit consent from the individual for collection, use or disclosure of the information.
We are also subject to the EU General Data Protection Regulation 2016/679 (“GDPR”). Violations of the GDPR can carry hefty fines. In
addition, we may be subject to additional national laws and regulations that govern the privacy and security of health information in
certain circumstances, many of which differ from each other in significant ways, thus complicating compliance efforts. If we fail to
comply with applicable data protection laws and regulations, we could be subject to penalties or sanctions, including criminal penalties.
Furthermore, the legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an
increasing amount of focus on privacy and data protection issues.
Compliance with these laws may be time-consuming, difficult and costly. If we fail to comply with applicable laws, regulations or
duties relating to the use, privacy or security of personal data we could be subject to the imposition of significant civil and criminal
penalties, be forced to alter our business practices and suffer reputational harm.
Changes in health care law and implementing regulations, including government restrictions on pricing and reimbursement, as well
as health care policy and other health care payor cost-containment initiatives, may have a material adverse effect on us.
In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed
changes regarding the regulatory system, health care system and efforts to control health care costs, including drug prices, that could
have a significant negative impact on our business, including preventing, limiting or delay regulatory approval of our drug candidates
and reducing the sales and profits derived from our products once they are approved. For example, in the United States, the ACA
substantially changed the way health care is financed by both governmental and private insurers and significantly affects the
pharmaceutical industry. Many provisions of ACA impact the biopharmaceutical industry, including that in order for a biopharmaceutical
product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U.S. government
agencies, the manufacturer must extend discounts to entities eligible to participate in the drug pricing program under the Public Health
Services Act, or PHS. Since its enactment, there have been judicial and Congressional challenges and amendments to certain aspects of
ACA. There is continued uncertainty about the implementation of ACA, including the potential for further amendments to the ACA and
legal challenges to or efforts to repeal the ACA.

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In addition, the Inflation Reduction Act of 2022, enacted in August 2022, empowers the Centers for Medicare and Medicaid
Services to negotiate directly with pharmaceutical companies to set the prices for a limited set of high-cost drugs covered by Medicare,
and puts penalties in place for drug manufacturers who increase their Medicare prices by more than the rate of inflation.
Other examples of proposed changes include, but are not limited to, expanding post-approval requirements, changing the Orphan
Drug Act, and restricting sales and promotional activities for pharmaceutical products.
We cannot be sure whether additional legislative changes will be enacted, or whether government regulations, guidance or
interpretations will be changed, or what the impact of such changes would be on the marketing approvals, sales, pricing, or
reimbursement of our drug candidates or products, if any, may be.
Risks Related to Our Capital Stock
Our history of losses and uncertainty of future profitability make our common stock a highly speculative investment.
We have had no commercial revenue to date from sales of our drug candidates. We had an accumulated deficit of $1.6 billion as of
December 31, 2024. We expect to spend substantial funds to continue the research and development testing of our drug candidates.
In anticipation of FDA approval of these products, we will need to make substantial investments to establish sales, marketing,
quality control, regulatory compliance capabilities and commercial manufacturing alliances. These investments will increase if and when
any of these drug candidates receive FDA approval. We cannot predict how quickly our lead drug candidates will progress through the
regulatory approval process. As a result, we may continue to lose money for several years.
We cannot be certain that we will achieve or sustain profitability in the future. Failure to achieve profitability could diminish our
ability to sustain operations, pay dividends on our common stock, obtain additional required funds and make required payments on our
present or future indebtedness.
Our share price has been and could remain volatile.
The market price of our common stock has historically experienced and may continue to experience significant volatility. From
January 2023 through December 2024, the market price of our common stock has fluctuated from a high of $53.18 per share in the first
quarter of 2024, to a low of $22.11 per share in the fourth quarter of 2023. Our progress in developing and commercializing our products,
the impact of government regulations on our products and industry, the potential sale of a large volume of our common stock by
stockholders, our quarterly operating results, changes in general conditions in the economy or the financial markets and other
developments affecting us or our competitors could cause the market price of our common stock to fluctuate substantially with
significant market losses. If our stockholders sell a substantial number of shares of common stock, especially if those sales are made
during a short period of time, those sales could adversely affect the market price of our common stock and could impair our ability to
raise capital. In addition, in recent years, the stock market has experienced significant price and volume fluctuations. This volatility has
affected the market prices of securities issued by many companies for reasons unrelated to their operating performance and may
adversely affect the price of our common stock. In addition, we could be subject to a securities class action litigation as a result of
volatility in the price of our stock, which could result in substantial costs and diversion of management’s attention and resources and
could harm our stock price, business, prospects, results of operations and financial condition.
Our ability to use our net operating loss carryforwards will be subject to limitation and, under certain circumstances, may be
eliminated.
As of December 31, 2024, we had net operating loss carryforwards, or NOLs, of approximately $566.0 million for federal income
tax purposes, and $888.8 million for state income tax purposes. Utilization of these NOLs depends on many factors, including our future
income, which cannot be assured. In addition, utilization of our net operating loss and research and development credit carryforwards
may be subject to substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in
the future provided by Section 382 of the Internal Revenue Code of 1986, or Section 382, as well as similar state provisions. In general,
an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public
groups in the stock of a corporation by more than 50 percentage points over a three-year period.

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In October 2007, June 2009, December 2009, December 2013, November 2016 and June 2020, we experienced a change in
ownership as defined by Section 382. Historically, we have raised capital through the issuance of capital stock on several occasions
which, combined with shareholders’ subsequent disposition of those shares, has resulted in changes of control, as defined by Section 382.
As a result of these ownership changes, utilization of at least some of our federal NOL carryforwards is subject to an annual limitation.
We have not undertaken a study to assess whether an ownership change or multiple ownership changes have occurred for (i) acquired
businesses with NOLs prior to being acquired by the Company, (ii) the Company on the state level, (iii) the Company since June 2024 or
(iv) research and development credits. If, based on such a study, we were to determine that there has been an ownership change at any
time, utilization of net operating loss or tax credit carryforwards would be subject to an annual limitation under Section 382 (or similar
state provisions).
Any unused annual limitation may be carried over to later years, and the amount of the limitation may, under certain circumstances,
be subject to adjustment if the fair value of our net assets is determined to be below or in excess of the tax basis of such assets at the time
of the ownership change, and such unrealized loss or gain is recognized during the five-year period after the ownership change.
Subsequent ownership changes, as defined in Section 382, could further limit the amount of net operating loss carryforwards and
research and development credits that can be utilized annually to offset future taxable income.
Refer to Note 16, “Income Taxes,” in the accompanying notes to the financial statements for additional discussion on income taxes.
General Risk Factors
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our
financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which
would harm our business and the trading price of our common stock.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with
adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required or improved controls, or
difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations. We have designed, implemented
and tested the internal control over financial reporting required to comply with this obligation, which was and is time consuming, costly,
and complicated. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that
the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be
detected. Any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act of 2002, or any subsequent testing by
our independent registered public accounting firm, may reveal deficiencies in our internal controls 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. 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.

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We have many competitors in our field, and they may develop technologies that make ours obsolete.
Biotechnology, pharmaceuticals and therapeutics are rapidly evolving fields in which scientific and technological developments are
expected to continue at a rapid pace. We have many competitors in the U.S. and abroad. The following table is a summary of the
competitors of which we are aware that have initiated a Phase 3 study or have obtained marketing approval for a potentially competitive
drug to barzolvolimab for treatment of CSU, CIndU, PN, EoE and AD.
Competitor
Competitor Product
Indication(s)
Abbvie
Rinvoq
AD
Amgen
Tezpire
EoE
Amgen/Kiowa Kirin
Rocatinlimab
AD and PN
Celltrion
CT-P39, omalizumab biosimilar
CSU
Eli Lilly
Olumiant and Ebglyss
AD
Galderma/Chugai
Nemluvio
PN and AD
Incyte
Povorcitinib
PN
Kashiv Biosciences
ADL-018 omalizumab biosimilar
CSU
Leo Pharma
Adbry
AD
Medimetriks
Difamilast
AD
Novartis
Remibrutinib
CSU and CIndU
Pfizer
Cibinqo
AD
Regeneron/Sanofi
Dupixent
CSU, PN, EoE and AD
Regeneron/Sanofi
Amlitelimab
AD
Teva
Tev-45779, omalizumab biosimilar
CSU
Vanda Pharmaceuticals
Tradipitant
AD
Our success depends upon our ability to develop and maintain a competitive position in the product categories and technologies on
which we focus. Many of our competitors have greater capabilities, experience and financial resources than we do. Competition is
intense and is expected to increase as new products enter the market and new technologies become available. Our competitors may:
●
develop technologies and products that are more effective than ours, making ours obsolete or otherwise noncompetitive;
●
obtain regulatory approval for products more rapidly or effectively than us; and
●
obtain patent protection or other intellectual property rights that would block our ability to develop competitive products.
We or the third parties upon whom we depend may be adversely affected by natural disasters or other unforeseen events and our
business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Any unplanned event, such as flood, fire, explosion, earthquake, extreme weather condition, power shortage, telecommunication
failure or other natural or manmade accidents or incidents that result in us being unable to fully utilize our facilities, or the manufacturing
facilities of our third-party CDMOs, could severely disrupt our operations and have a material adverse effect on our business, results of
operations, financial condition and prospects. For example, our operations are located primarily on the east coast of the United States,
and any adverse weather event or natural disaster, such as a hurricane or heavy snowstorm, could have a material adverse effect on a
substantial portion of our operations. If any event occurred that prevented us from using all or a significant portion of our manufacturing
and lab facilities, damaged critical infrastructure, such as third-party manufacturing facilities, or otherwise disrupted operations and
travel, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster
recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. We may
incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a
material adverse effect on our business.
We face risks related to health epidemics and outbreaks, which could significantly disrupt our preclinical studies and clinical trials.
Disease outbreaks, epidemics and pandemics in regions where we have concentrations of clinical trial sites and other business
operations, could adversely affect our business, including by causing significant disruptions in our operations and/or in the operations

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of manufacturers and CROs upon whom we rely. Disease outbreaks, epidemics and pandemics may have negative impacts on our ability
to initiate new clinical trial sites, enroll new patients and maintain existing patients who are participating in clinical trials, which may
result in increased clinical trial costs, longer timelines and delay in our ability to obtain regulatory approvals of our product candidates, if
at all. For example, patient enrollment and recruitment could be delayed due to local clinical trial site protocols designed to protect staff
and patients from certain outbreaks, which could delay the expected timelines for data readouts of our preclinical studies and clinical
trials. Additionally, general supply chain issues may be exacerbated during disease outbreaks, epidemics or pandemics and may also
impact the ability of our clinical trial sites to obtain basic medical supplies used in our trials in a timely fashion, if at all. Moreover, the
extent to which disease outbreaks, epidemics and pandemics may impact our business, results of operations and financial position will
depend on future developments, which are highly uncertain and cannot be predicted with confidence. New health epidemics or
pandemics may emerge that result in similar or more severe disruptions to our business. A future disease outbreak, epidemic or pandemic
adversely affects our business, financial condition, results of operations and growth prospects.
The progression of an epidemic and the related effects on our business and operations are uncertain. A potential resurgence of an
epidemic could pose the risk that we or our employees, suppliers, customers and others may be restricted or prevented from conducting
business activities for indefinite or intermittent periods of time, including as a result of employee health and safety concerns, shutdowns,
shelter in place orders, travel restrictions and other actions and restrictions that may be prudent or required by governmental authorities.
This could disrupt our ability to operate our business, including producing drug product and administering our preclinical and clinical
studies. In addition, fluctuations in demand and other implications associated with an epidemic could result in supply chain constraints
and challenges.
Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and
results of operations.
The disruptions to the global economy due to geopolitical events have impeded, and may continue to impede in the future, global
supply chains, resulting in longer lead times and also increased critical component costs and freight expenses. We have taken steps to
minimize the impact of these increased costs by working closely with our suppliers. Despite the actions we have undertaken to minimize
the impacts from disruptions to the global economy, there can be no assurances that unforeseen future events in the global supply chain,
and inflationary pressures, will not have a material adverse effect on our business, financial condition and results of operations.
We depend greatly on the intellectual capabilities and experience of our key executives and scientists, and the loss of any of them
could affect our ability to develop our products.
The loss of any of our executive officers could harm us. We entered into employment agreements with each of our executive
officers, although an employment agreement as a practical matter does not guarantee retention of an employee. We also depend on our
scientific and clinical collaborators and advisors, all of whom have outside commitments that may limit their availability to us. In
addition, we believe that our future success will depend in large part upon our ability to attract and retain highly skilled scientific,
managerial and marketing personnel, particularly as we expand our activities in clinical trials, the regulatory approval process and sales
and manufacturing. We routinely enter into consulting agreements with our scientific and clinical collaborators and advisors, key opinion
leaders and heads of academic departments in the ordinary course of our business. We also enter into contractual agreements with
physicians and institutions who recruit patients into our clinical trials on our behalf in the ordinary course of our business.
Notwithstanding these arrangements, we face significant competition for this type of personnel from other companies, research and
academic institutions, government entities and other organizations. We cannot predict our success in hiring or retaining the personnel we
require for continued growth.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and
requirements, which could have a material adverse effect on our business.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to
comply with FDA regulations, provide accurate information to the FDA, comply with applicable privacy laws, comply with
manufacturing standards we have established, comply with federal and state health care fraud and abuse laws and regulations, report
financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business
arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing
and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and
promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct

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could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and
serious harm to our reputation. We have adopted a Code of Business Conduct and Ethics and launched a Health Care Compliance
program, but it is not always possible to identify and deter employee misconduct. The precautions we take and the investments we make
to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from
governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If
any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could
have a significant effect on our business and results of operations, including the imposition of significant fines or other sanctions.
We may not be able to maintain compliance with the Listing Rules of the NASDAQ Stock Exchange.
There can be no assurance that in the future we will be able to maintain compliance with the Nasdaq Listing Rules, including the
minimum bid price requirement and other applicable corporate governance requirements. If we fail to maintain compliance with the
minimum bid requirement or to meet the other applicable continued listing requirements for the NASDAQ Capital Market in the future
and NASDAQ determines to delist our common stock, the delisting could adversely affect the market price and liquidity of our common
stock and reduce our ability to raise additional capital. In addition, if our common stock is delisted from NASDAQ and the trading price
remains below $5.00 per share, trading in our common stock might also become subject to the requirements of certain rules promulgated
under the Exchange Act, which require additional disclosure by broker-dealers in connection with any trade involving a stock defined as
a “penny stock” (generally, any equity security not listed on a national securities exchange or quoted on NASDAQ that has a market
price of less than $5.00 per share, subject to certain exceptions).
Item 1B. UNRESOLVED STAFF COMMENTS
None.
Item 1C. CYBERSECURITY
Cybersecurity Risk Management and Strategy
To effectively prevent, detect and respond to cybersecurity threats, we maintain a cyber risk management program under the
responsibility of the head of the Information Technology (“IT”) function. Our IT head has more than 25 years of IT experience in the
biopharmaceutical industry where she has been responsible for technology leadership and digital transformation across core operations.
Management and administration of cybersecurity systems and activities are primarily outsourced to consultants who have cross-
functional expertise in cyber security and who perform the work under the supervision of the IT head. Our IT head, in turn reports to the
Senior Vice-President and General Counsel who is responsible for and knowledgeable of legal and contractual cybersecurity risk for the
organization. The program is comprised of policies, standards, architecture, and processes, which are reviewed and updated on a periodic
basis. The program leverages a multilayered approach of utilizing different practices, technologies, vendors or techniques without an
overreliance on a single vendor. We engage with consultants to help develop and evidence the policies, standards, and processes in a
manner consistent with applicable legal requirements, and also evaluate and adopt cybersecurity software from reputable vendors in
cybersecurity, some that provide software as a service solutions backed by a Security Operations Center. We also engage separate third
parties to provide penetration testing, risk consulting, cybersecurity incident assessment and forensics, as necessary and in addition to
IT’s internal risk assessment processes. We work with many companies that provide hosted software or support for software systems. It is
important for these companies to also have effective cybersecurity measures to protect data and systems. We have a self-attestation form
to assess cybersecurity readiness that is sent to select vendors based on a risk assessment. For certain vendors, we request System and
Organization Controls (SOC) reports or similar documents to provide assurance that the vendors have audited practices or practices in
keeping with our legal requirements even if SOC audit documentation does not exist. We have also engaged legal counsel to advise on
cybersecurity matters and we have developed an escalation protocol to report cybersecurity incidents as legally required. No material
cybersecurity incidents have occurred to date.
The program also includes training that reinforces our policies, standards, and practices, as well as the expectation that employees
comply with these policies. The training engages personnel on how to identify potential cybersecurity risks and protect our resources and
information. This training is mandatory for all employees on a periodic basis, and it is supplemented by testing initiatives, including
periodic phishing tests. We maintain a cybersecurity risk insurance policy.

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54
Governance; Board Oversight
Our Audit Committee is responsible for reviewing our information security programs, including cybersecurity. Our IT team provides
regular updates to the Audit Committee on our IT security strategy, secure score assessments, penetration testing results, and status of
risk mitigation activities, where applicable. Our IT team also notifies the Audit Committee and Executive Committee of any
cybersecurity incidents (suspected or actual) and provides updates on the incidents as well as cybersecurity risk mitigation activities, as
appropriate.
Item 2. PROPERTIES
As of December 31, 2024, our significant leased properties are described below.
    Approximate    
    
Property Location
     Square Feet     
Use
    Lease Expiration Date
Hampton, New Jersey
 
 33,400   Headquarters, Office and Laboratory
  July 2027(1)
Fall River, Massachusetts
 
 36,300   Manufacturing, Office and Laboratory   July 2027(2)
New Haven, Connecticut
 
 17,700   Office and Laboratory
  October 2026
(1) Lease includes two renewal options of two years.
(2) Lease includes one renewal option of three years.
Item 3. LEGAL PROCEEDINGS
We are not currently a party to any material legal proceedings.
Item 4. MINE SAFETY DISCLOSURES
Not applicable.

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PART II
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
Our common stock currently trades on the Nasdaq Capital Market (NASDAQ) under the symbol “CLDX.” As of February 14, 2025,
there were approximately 136 shareholders of record of our common stock. On February 14, 2025 the closing price of our common
stock, as reported by NASDAQ, was $22.70 per share. We have not paid any dividends on our common stock since our inception and do
not intend to pay any dividends in the foreseeable future.
CELLDEX THERAPEUTICS, INC., NASDAQ MARKET INDEX — U.S. AND PEER GROUP INDICES
The graph below compares the cumulative total stockholder return on the common stock for the period from December 31, 2019
through December 31, 2024, with the cumulative return on (i) NASDAQ U.S. Benchmark TR Index and (ii) NASDAQ Pharmaceutical
(Subsector) Index. The comparison assumes investment of $100 on December 31, 2019 in our common stock and in each of the indices
and, in each case, assumes reinvestment of all dividends. The points on the graph are as of December 31 of the year indicated.
    
2019
    
2020
    
2021
    
2022
    
2023
    
2024
Celldex Therapeutics, Inc.
$
 100
$
 786
$  1,733
$  1,999
$  1,778
$  1,133
NASDAQ U.S. Benchmark TR Index
$
 100
$
 121
$
 153
$
 123
$
 155
$
 193
NASDAQ Pharmaceutical (Subsector) Index
$
 100
$
 111
$
 137
$
 153
$
 159
$
 173
Item 6. [Reserved]

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Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
We are a biopharmaceutical company dedicated to exploring the science of mast cell biology and developing therapeutic antibodies
which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with
severe inflammatory, allergic, autoimmune and other devastating diseases. Our drug candidates include monoclonal and bispecific
antibodies designed to address mast cell mediated diseases for which available treatments are inadequate.
We are focusing our efforts and resources on the continued research and development of
●
Barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that specifically binds the KIT receptor and potently
inhibits its activity, which is currently being studied across multiple mast cell driven diseases including
-
Chronic Urticarias: We initiated Phase 3 studies in chronic spontaneous urticaria (CSU) in July 2024. In November
2023, we announced that our Phase 2 study in CSU achieved the primary efficacy endpoint (statistically significant
mean change from baseline to week 12 of urticaria activity score compared to placebo) and was well tolerated. Patients
on study continued to receive barzolvolimab and, in September 2024, we reported data from 52 weeks of treatment—
demonstrating sustained and deepening disease efficacy and a well tolerated long term safety profile. In July 2024, we
announced that our Phase 2 study in chronic inducible urticaria (CIndU) achieved the primary efficacy endpoint,
(statistically significant difference between the percent of patients with a negative provocation test compared to
placebo at week 12) and was well tolerated. 12 week data from the CIndU study were presented in October of 2024
and all secondary endpoints across the study were also met and were highly statistically significant and clinically
meaningful. Patients on study continued to receive barzolvolimab for 20 weeks of treatment;
-
Prurigo Nodularis (PN): In April 2024, we initiated a Phase 2 study in PN and enrollment is ongoing; positive data
from a Phase 1b study in PN was reported in November 2023;
-
Eosinophilic Esophagitis (EoE): A Phase 2 study in EoE was initiated in June 2023 and is fully accrued; and
-
Atopic Dermatitis (AD): A Phase 2 study in AD was initiated in December 2024 and enrollment is ongoing.
●
Our next generation bispecific antibody platform to support pipeline expansion with additional candidates for inflammatory
diseases. Targets are being selected based on new science as well as their compatibility to be used in bispecific antibody formats
with our existing antibody programs. Development is focused on emerging, important pathways controlling inflammatory
diseases.
-
CDX-622 (TSLP & SCF): Our first bispecific candidate for inflammatory diseases is CDX-622 which targets two
complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal
lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. In November 2024, a Phase 1a
dose-escalation study in healthy volunteers was initiated and enrollment is ongoing.
More detail on these programs is provided in the Clinical Development Programs section.
Our goal is to build a fully integrated, commercial-stage biopharmaceutical company that develops important therapies for patients
with unmet medical needs. We believe our program assets provide us with the strategic options to either retain full economic rights to our
innovative therapies or seek favorable economic terms through advantageous commercial partnerships. This approach allows us to
maximize the overall value of our technology and product portfolio while best ensuring the expeditious development of each individual
product.

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The expenditures that will be necessary to execute our business plan are subject to numerous uncertainties. Completion of clinical
trials may take several years or more, and the length of time generally varies substantially according to the type, complexity, novelty and
intended use of a drug candidate. It is not unusual for the clinical development of these types of drug candidates to each take five years or
more, and total development costs could exceed hundreds of millions of dollars for each drug candidate. We estimate that clinical trials
of the type we generally conduct are typically completed over the following timelines:
Estimated
Completion
Clinical Phase
    
Period
Phase 1
 
1 – 2 Years
Phase 2
 
1 – 5 Years
Phase 3
 
1 – 5 Years
The duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during the
clinical trial protocol, including, among others, the following:
●
the number of patients that ultimately participate in the trial;
●
the duration of patient follow-up that seems appropriate in view of results;
●
the number of clinical sites included in the trials;
●
the length of time required to enroll suitable patient subjects; and
●
the efficacy and safety profile of the drug candidate.
We test potential drug candidates in numerous preclinical studies for safety, toxicology and immunogenicity. We may then conduct
multiple clinical trials for each drug candidate. As we obtain results from trials, we may elect to discontinue or delay clinical trials for
certain drug candidates in order to focus our resources on more promising drug candidates.
An element of our business strategy is to pursue the discovery, research and development of a broad portfolio of drug candidates.
This is intended to allow us to diversify the risks associated with our research and development expenditures. To the extent we are unable
to maintain a broad range of drug candidates, our dependence on the success of one or a few drug candidates increases.
Regulatory approval is required before we can market our drug candidates as therapeutic products. In order to proceed to subsequent
clinical trial stages and to ultimately achieve regulatory approval, the regulatory agencies must conclude that our clinical data
demonstrate that our product candidates are safe and effective. Historically, the results from preclinical testing and early clinical trials
(through Phase 2) have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have
shown promising results in early clinical trials but subsequently failed to establish sufficient safety and efficacy data to obtain necessary
regulatory approvals.
Furthermore, our business strategy includes the option of entering into collaborative arrangements with third parties to complete the
development and commercialization of our drug candidates. In the event that third parties take over the clinical trial process for one of
our drug candidates, the estimated completion date would largely be under control of that third party rather than us. We cannot forecast
with any degree of certainty which proprietary products, if any, will be subject to future collaborative arrangements, in whole or in part,
and how such arrangements would affect our development plan or capital requirements. Our programs may also benefit from subsidies,
grants, contracts or government or agency-sponsored studies that could reduce our development costs.
As a result of the uncertainties discussed above, among others, it is difficult to accurately estimate the duration and completion costs
of our research and development projects or when, if ever, and to what extent we will receive cash inflows from the commercialization
and sale of a product. Our inability to complete our research and development projects in a timely manner or our failure to enter into
collaborative agreements, when appropriate, could significantly increase our capital requirements and could adversely impact our
liquidity. These uncertainties could force us to seek additional, external sources of financing from time to time in order to continue with
our business strategy. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the
future success of our business.

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58
During the past five years through December 31, 2024, we incurred an aggregate of $459.7 million in research and development
expenses. The following table indicates the amount incurred for each of our significant research programs and for other identified
research and development activities during the years ended December 31, 2024, 2023 and 2022. The amounts disclosed in the following
table reflect direct research and development costs and an allocation of indirect research and development costs to each program.
Year Ended
    
Year Ended
    
Year Ended
    December 31, 2024    December 31, 2023    December 31, 2022
(In thousands)
Barzolvolimab/Anti-KIT Program
$
 123,750
$
 79,913
$
 51,220
CDX-622
 
 17,341
 16,299
 5,613
CDX-585
 2,813
 6,357
 9,793
Other Programs
 
 19,646
 15,442
 15,632
Total R&D Expense
$
 163,550
$
 118,011
$
 82,258
Clinical Development Programs
Barzolvolimab (also referred to as CDX-0159)
Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT and potently inhibits its
activity. KIT is expressed in a variety of cells, including mast cells, and its activation by its ligand SCF regulates mast cell growth,
differentiation, survival, chemotaxis and degranulation. Barzolvolimab is designed to block KIT activation by disrupting both SCF
binding and KIT dimerization. By targeting KIT, barzolvolimab has been shown to inhibit mast cell activity and decrease mast cell
numbers, which we believe could provide potential clinical benefit in mast cell related diseases.
Barzolvolimab was initially studied in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), diseases where
mast cell degranulation plays a central role in the onset and progression of the disease. In July 2024, we initiated two Phase 3 studies in
CSU. Phase 1 studies in CSU and CIndU were successfully completed and Phase 2 studies are ongoing. In July 2023, we announced that
enrollment was complete in the ongoing Phase 2 CSU study. In November 2023, we reported that barzolvolimab achieved the primary
efficacy endpoint in this study, with a statistically significant mean change from baseline to week 12 of UAS7 (weekly urticaria activity
score) compared to placebo and was well tolerated. In September 2024, we presented 52 week treatment data from the CSU study,
demonstrating sustained and deepening disease efficacy and a well tolerated long term safety profile. We plan to present follow up data
from this study through week 76 in 2025. In April 2024, we announced enrollment was complete in the ongoing Phase 2 CIndU study. In
July 2024, we announced that our Phase 2 study in chronic inducible urticaria (CIndU) achieved the primary efficacy endpoint,
(statistically significant difference between the percent of patients with a negative provocation test compared to placebo at week 12) and
was well tolerated. 12 week data from the CIndU study were presented in October of 2024 and all secondary endpoints across the study
were also met and were highly statistically significant and clinically meaningful. Patients on study continued to receive barzolvolimab
for 20 weeks of treatment and were then followed for up to 24 additional weeks without treatment. We plan to present data from this
study through week 44 in 2025. Patients with resumption of symptoms were eligible to enroll into an open label extension.
Based on the positive results reported in urticaria, we expanded development of barzolvolimab into additional indications where
mast cells are believed to play an important role. We are conducting ongoing Phase 2 studies in eosinophilic esophagitis (EoE), prurigo
nodularis (PN) and atopic dermatitis (AD). We continue to assess potential opportunities for barzolvolimab in other diseases where mast
cells play an important role, such as dermatologic, respiratory, allergic, gastrointestinal and ophthalmic conditions.
Chronic Spontaneous Urticaria (CSU) Summary of Phase 1 and Phase 2 Data Presented to Date; 76 week Phase 2 follow up data to be
presented in 2025.
CSU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over
years or even decades. It is one of the most frequent dermatologic diseases with a prevalence of 0.5-1.0% of the total population or up to
approximately 1 to 3 million patients in the United States (Weller et al. 2010. Hautarzt. 61(8), Bartlett et al. 2018. DermNet.Org).
Approximately 50% of patients with CSU achieve symptomatic control with antihistamines. Omalizumab, an IgE inhibitor, provides
relief for roughly half of the remaining antihistamine refractory patients. Consequently, there is a need for additional therapies.

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We have completed a Phase 1b randomized, double-blind, placebo-controlled multi-center study of barzolvolimab in CSU. The
study was designed to assess the safety of multiple ascending doses of barzolvolimab in patients with CSU who remain symptomatic
despite treatment with antihistamines. Secondary and exploratory objectives included pharmacokinetic and pharmacodynamic
assessments, clinical activity outcomes and quality of life assessments. Barzolvolimab was administered intravenously as add on
treatment to H1-antihistamines, either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists. 45 patients
with moderate to severe CSU refractory to antihistamines were enrolled and treated [35 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5
mg/kg; n=9 in 3.0 mg/kg; n=9 in 4.5 mg/kg) and 10 placebo].
At saturating doses (1.5 mg/kg and higher), barzolvolimab resulted in rapid, marked and durable responses in patients with moderate
to severe CSU refractory to antihistamines. The 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups showed similar markedly improved
urticaria symptoms, including rapid onset of responses (as early as 1 week after the first dose) and prolonged disease control with
sustained durability up to 24 weeks. Patients with prior omalizumab therapy also had similar symptom improvement as all patients.
Phase 1 CSU: Summary of Clinical Activity Assessments at Week 12 & 24
4.5 mg/kg Q8
3.0 mg/kg Q8
1.5 mg/kg Q4
Mean Reduction Baseline UAS7; % at Week 12
82% (n=9)
67% (n=9)
67% (n=8)
Mean Reduction Baseline UAS7; % at Week 24
77% (n=7)
70% (n=6)
80% (n=7)
UAS7=0 (Complete Control); % at Week 12
67%
44%
57%
UAS7=0 (Complete Control); % at Week 24
43%
67%
57%
UAS7≤6 (Well-controlled); % at Week 12
67%
67%
57%
UAS7≤6 (Well-controlled); % at Week 24
57%
67%
57%
UCT ≥ 12 (Well-controlled); % at Week 12
89%
63%
75%
UCT ≥ 12 (Well-controlled); % at Week 24
67%
67%
75%
During post-treatment follow up, 71% (10 of 14) of patients who had been treated with doses greater than or equal to 1.5 mg/kg and
had a complete response (UAS7=0) at week 12, remained urticaria free at week 24 (patients received last dose of barzolvolimab at week
8). Profound and durable improvement in angioedema symptoms as measured through the weekly angioedema activity score (AAS7)
was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels. Patients also
reported improvements in quality of life outcomes as assessed by the Dermatology Life Quality Index (DLQI) which surveys patients’
perceptions of symptoms and feelings, daily activities, leisure, work and school performance, personal relationships and treatment.
Tryptase suppression, indicative of mast cell depletion, paralleled symptom improvement, demonstrating the impact of mast cell
depletion on CSU disease activity.
Barzolvolimab was well tolerated. Most adverse events were mild or moderate in severity and resolved while on study. The most
common treatment emergent adverse events were hair color changes, COVID-19, headache, neutropenia and urinary tract infections
(UTIs). UTIs and COVID-19 were reported as unrelated to treatment. Generally transient, asymptomatic and mild changes in
hematologic parameters were observed, consistent with observations from prior studies. No pattern of further decrease was observed with
multiple dose administration.
Data from this study were reported across multiple medical meetings, including the American Academy of Allergy, Asthma &
Immunology (AAAAI) Annual Meeting in February 2023, the European Academy of Allergy and Clinical Immunology (EAACI)
Annual Congress in June 2023 and the European Academy of Dermatology & Venereology (EADV) Congress in October 2023.

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60
In June 2022, we initiated dosing in a Phase 2 study in patients with CSU who remained symptomatic despite antihistamine therapy;
in July 2023, we announced that enrollment was complete. The study is being conducted at approximately 75 sites across 9 countries.
The study is a randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluating the efficacy and safety profile of
multiple dose regimens of barzolvolimab to determine the optimal dosing strategy. 208 patients have been randomly assigned on a
1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks
or placebo during a 16-week placebo-controlled treatment phase. After 16 weeks, patients then enter a 36-week active treatment period,
in which patients receiving placebo or the 75 mg dose are randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8
weeks; patients already randomized to the 150 mg and 300 mg treatment arms remain on the same regimen as during the placebo-
controlled treatment period. After 52 weeks, patients then enter a follow-up period for an additional 24 weeks. The primary endpoint of
the study is mean change in baseline to week 12 in UAS7 (weekly urticaria activity score). Secondary endpoints include safety and other
assessments of clinical activity including ISS7 (weekly itch severity score), HSS7 (weekly hive severity score) and AAS7 (weekly
angioedema activity score).
Topline data from this study were presented in November of 2023 and 12 week treatment results were presented at the American
Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in February 2024. Data from the 208 patients randomized in the
study showed that barzolvolimab achieved the primary efficacy endpoint, with a statistically significant mean change from baseline to
week 12 in UAS7 compared to placebo at all dose levels. Secondary and exploratory endpoints in the study were also achieved at week
12 and strongly support the primary endpoint results, including changes in ISS7 and HSS7 and responder analyses. Importantly,
barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to
antihistamines, including patients with prior omalizumab treatment. Demographics and baseline disease characteristics were well
balanced across treatment groups. The majority of patients on study had severe disease (UAS7≥28).
Phase 2 CSU: Summary of Clinical Activity Assessments at Week 12
300 mg Q8W
(n=51)
150 mg Q4W
(n=52)
75 mg Q4W
(n=53)
Placebo
(n=51)
UAS7 Changes
Baseline UAS7 (mean)
31.33
30.75
30.30
30.09
LS Mean change at Week 12
-23.87
-23.02
-17.06
-10.47
LS Mean difference from placebo
(Confidence Interval, p value)
-13.41
(CI: -17.47, -9.34)
p<0.0001
-12.55
(CI:-16.56, -8.55)
p<0.0001
-6.60
(CI:-10.71, -2.49)
p=0.0017
HSS7 Changes
Baseline HSS7 (mean)
14.92
15.05
14.86
14.47
LS Mean change at Week 12
-12.19
-11.19
-8.25
-4.95
LS Mean difference from placebo
(Confidence Interval, p value)
-7.24
(CI:-9.36, -5.12)
p<0.0001
-6.24
(CI:-8.33, -4.16),
p<0.0001
-3.31
(CI:-5.40, -1.22),
p=0.0020
ISS7 Changes
Baseline ISS7 (mean)
16.42
15.70
15.44
15.61
LS Mean change at Week 12
-11.79
-11.68
-8.62
-5.47
LS Mean difference from placebo
(Confidence Interval, p value)
-6.32
(CI: -8.50, -4.13),
p<0.0001
-6.21
(CI: -8.38, -4.04),
p<0.0001
-3.16
(CI: -5.41, -0.91),
p=0.0061
Responder Analyses/Clinical Responses
UAS7=0 (Complete Control)
37.5%
51.1%
22.9%
6.4%
UAS7≤6 (Well-controlled)
62.5%
59.6%
41.7%
12.8%
UAS7, HSS7 and ISS7 data were analyzed using ANCOVA model and multiple imputation.
Barzolvolimab demonstrated strong improvement in UAS7 independent of omalizumab status at week 12. Approximately 20%
(n=41) of enrolled patients received prior treatment with omalizumab and more than half of these patients had omalizumab-refractory
disease. These patients experienced a similar clinical benefit as the overall treated population within their individual dosing groups
consistent with the barzolvolimab mechanism of action.

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Barzolvolimab was well tolerated with a favorable safety profile. Most adverse events were mild to moderate in severity; through 12
weeks, the most common treatment emergent adverse events in barzolvolimab treated patients were urticaria/CSU (10%), hair color
changes (9%), and neutropenia/ANC decrease (8%). The rate of infections was similar between barzolvolimab treated patients and
placebo with no association between neutropenia and infections.
In June 2024, data on a secondary endpoint from the study, angioedema activity, and additional measures of angioedema control,
were presented at the EAACI 2024 Congress. Approximately 72% of patients on study had angioedema at baseline. Barzolvolimab
demonstrated significant improvements in AAS7 in patients with angioedema across all doses at week 12. This improvement was rapid
(within 2 weeks) and durable (continued through 12 weeks). Barzolvolimab demonstrated strong improvement in AAS7 independent of
omalizumab status at Week 12. Patients on barzolvolimab experienced a > 8 point improvement in AAS7 (considered a clinically
meaningful result) across all doses compared to placebo (p<0.05). Barzolvolimab increased angioedema free days compared to placebo
through 12 weeks. Patients in the 300 mg cohort were angioedema free 77% of the time over the 12 week period.
Patients on study continued to receive barzolvolimab for up to 52 weeks and these long term treatment data were presented in
September at the European Academy of Dermatology & Venereology (EADV) Congress 2024. The data demonstrated a sustained and
deepening disease efficacy and a well tolerated safety profile over a 52 week treatment period. Key highlighted included:
●
Improvements in UAS7 (weekly urticaria activity score), previously shown to be statistically significantly vs placebo at
Week 12, were noted as early as week 1 and were sustained or deepened at Week 52.
●
At Week 16, patients receiving low dose barzolvolimab (75 mg) or placebo were transitioned to barzolvolimab 150 mg or
300 mg; after crossover, these patients experienced similar clinically meaningful disease response as the rest of the study
population.
●
71% of patients treated with barzolvolimab 150 mg Q4W and 52% of patients treated with 300 mg Q8W had a complete
response (no itch/hives; UAS7=0) at Week 52. These responses were observed early and sustained through 52 weeks.
●
74% of patients treated with barzolvolimab 150 mg Q4W and 68% of patients treated with 300 mg Q8W had well
controlled (UAS7<6) disease at Week 52.
●
These robust responses were observed regardless of prior omalizumab experience.
●
Barzolvolimab was well tolerated with a favorable safety profile through 52 weeks of treatment. Most adverse events were
grade 1 (mild), mechanism related (KIT) and expected to be reversible. The most common treatment emergent adverse
events occurring in greater than 10% of barzolvolimab treated patients were hair color changes, neutropenia, urticaria, skin
hypopigmentation (areas of skin lightening) and nasopharyngitis (common cold). Neutrophil counts did not decline further
with continued dosing and there was no association between infections and neutropenia. The hypopigmentation was
observed with longer term exposure and did not lead to treatment discontinuation. Adverse events were not dose
dependent.
We believe these results strongly support the further development of barzolvolimab in CSU. In July 2024, we initiated two Phase 3
studies of barzolvolimab in CSU. The studies, EMBARQ-CSU1 and EMBARQ-CSU2, are designed to establish the efficacy and safety
of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. Both Phase 3 trials are
randomized, double-blind, placebo-controlled, parallel group, global studies (approximately 40 countries; 250 sites per study) where
approximately 915 patients per trial will be randomized evenly to barzolvolimab 150 mg every 4 weeks (following 300 mg loading
dose), barzolvolimab 300 mg every 8 weeks (following 450 mg loading dose) or placebo for 52 weeks. At 24 weeks, patients on placebo
will be re-randomized to active treatment across both dosing groups. The primary endpoint of the studies will evaluate the clinical effect
of barzolvolimab in reducing urticaria activity (weekly urticaria activity score; UAS7) at week 12. The studies are designed to detect a
clinically meaningful difference between each of the active arms versus placebo in the overall population as well as in the subpopulation
of omalizumab refractory participants. Enrollment is ongoing.

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62
Chronic Inducible Urticaria (CIndU) Summary of Phase 1 and Phase 2 Data Presented to Date; 44 week Phase 2 follow up data to be
presented in 2025.
CIndUs are forms of urticaria that have an attributable cause or trigger associated with them, typically resulting in hives or wheals.
The prevalence of CIndU is estimated at 0.5% of the total population and is reported to overlap in up to 36% of CSU patients (Weller et
al. 2010. Hautarzt. 61(8), Bartlett et al. 2018. DermNet.Org). There are currently no approved therapies for chronic inducible urticarias
other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers. We are
currently exploring cold-induced and dermographism (scratch-induced) urticarias in an ongoing Phase 2 study.
We completed a Phase 1b open label clinical trial in patients with CIndU refractory to antihistamines, conducted in Germany. This
study was designed to evaluate the safety of a single intravenous dose (3 mg/kg) of barzolvolimab in patients with cold urticaria (ColdU)
or symptomatic dermographism (SD). The study was expanded to include a cohort (single dose, 3 mg/kg) in patients with cholinergic
urticaria (“CholU”) and a cohort at a lower dose (single dose, 1.5 mg/kg) in ColdU. Patient’s symptoms were induced via provocation
testing that resembles real life triggering situations. Secondary and exploratory objectives included pharmacokinetic and
pharmacodynamic assessments, including changes from baseline provocation thresholds, measurement of tryptase and stem cell factor
levels, clinical activity outcomes, quality of life assessments and measurement of tissue mast cells through skin biopsies.
Generally patients on study had high disease activity at baseline that was poorly controlled and marked impairment in quality of life.
At 3 mg/kg in the ColdU and SD cohorts, safety results were reported for 21 patients and activity results were reported for the 20 patients
who received a full dose of barzolvolimab. At 1.5 mg/kg in the ColdU cohort, safety results were reported for 10 patients and activity
results were reported for the 9 patients who received a full dose of barzolvolimab. At 3 mg/kg in the cholinergic cohort, safety results
were reported for 21 patients and activity results were reported for the 20 patients who received a full dose of barzolvolimab.
Rapid (as early as 1 week) and durable responses were observed in patients as assessed by provocation testing.
●
A complete response was achieved in 95% (n=19/20) of patients with ColdU and SD treated with a single dose at 3 mg/kg
(n=10/10 ColdU; n=9/10 SD), including 3 patients who experienced insufficient response to prior omalizumab treatment.
The median duration (range) of complete response through the 12-week observation period was 77+ days (29–86; n=10)
for patients with ColdU and 57+ days (16–70; n=9) for patients with SD. A UCT score of ≥12 (well controlled) was
achieved by 80% (n=16/20) of the patients within week 4 post-treatment. By week 8, all patients (100%; n=20/20)
achieved well-controlled urticaria, which was sustained to week 12 post-dose by 80% (n=16/20) of patients. Complete
urticaria control (UCT=16) was achieved by 35% (n=7/20), 65% (n=13/20), and 40% (n=8/20) at weeks 4, 8, and 12,
respectively.
●
A complete response was achieved in 100% (n=9 of 9) patients with ColdU treated with a single dose at 1.5 mg/kg,
including 4 patients with disease refractory to omalizumab. The median duration of complete response through the 12-
week observation period was 51+ days (7+ weeks). Following barzolvolimab administration, all patients achieved well
controlled disease (UCT>12) with 7 of 9 achieving complete control (UCT=16).
●
A complete response was achieved in 56% (n=5 of 9) patients with cholinergic urticaria treated with a single dose at 3
mg/kg. Most responses remained durable through to week 12. 63% (5/8) patients reported well controlled disease (UCT
≥12) at week 8 and 50% (4/8) at week 12, respectively.
●
Patients also reported improvements in quality of life outcomes as assessed by the Dermatology Life Quality Index (DLQI)
which surveys patients’ perceptions of symptoms and feelings, daily activities, leisure, work and school performance,
personal relationships and treatment.

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63
●
A single dose of barzolvolimab led to marked decreases in tryptase and in skin mast cells. The kinetics correlated with
improvements in provocation testing and clinical activity, consistent with a central role for mast cells in the pathogenesis of
ColdU and SD. This confirmed that serum tryptase level is a robust pharmacodynamic biomarker for assessing mast cell
burden and clinical activity in inducible urticaria and potentially in other diseases with mast cell driven involvement.
●
Barzolvolimab was well tolerated across all cohorts. In the 3 mg/kg ColdU and SD cohorts, most adverse events were mild,
and the most common (≥3 patients) were hair color changes (76%; n=16/21), infusion reactions (43%; n=9/21), taste
changes (38%; n=8/21), nasopharyngitis (24%; n=5/21), malaise (24%; n=5/21), and headache (19%; n=4/21). Hair color
changes (generally small areas of hair color lightening) and taste disorders (generally partial changes of ability to taste salt
or umami) are consistent with inhibiting KIT signaling in other cell types and completely resolved over time during follow-
up. One patient with a history of fainting experienced loss of consciousness during infusion. The patient rapidly recovered.
Importantly, no evidence of mast cell activation as measured by serum tryptase monitoring was observed in this patient.
Barzolvolimab was also generally well tolerated by patients in the 1.5 mg/kg ColdU cohort and the 3.0 mg/kg cholinergic
cohort with a similar safety profile to that reported previously. Across the Phase 1b inducible urticaria study, mean
hematology parameters generally remained within the normal ranges—an important finding for a KIT inhibitor. Mild,
transient, and asymptomatic decreases in hemoglobin and white blood cell parameters occurred for some patients.
●
Long term follow up data was collected from the 3.0 mg/kg cohorts in cold urticaria and symptomatic dermographism. 14
patients consented to the optional evaluation (6 cold, 8 symptomatic dermographism); 10 of the 14 still had complete
control of their disease as assessed by provocation testing at week 12. Data were collected at one or more timepoints
beyond week 12 through week 36. Most patients had return of symptoms and/or loss of urticaria control between 12 and 36
weeks. Remarkably, two patients remained provocation negative at 36 weeks, and four had well controlled disease (UCT
≥12) 36 weeks post dosing. Serum tryptase exhibits a similar rate of recovery as clinical symptoms, while skin mast cells
return at a slower rate. Tissue KIT signaling, as approximated by SCF levels, was rapidly inhibited after dose
administration and fully reactivated approximately 18 weeks after dosing. Tryptase levels return to pretreatment levels
during follow up, while mast cells continue to recover. Drug related adverse events noted during the study all resolved.
Data from this study were reported in Allergy (Nov 2022) and across multiple medical meetings, including the GA²LEN Global
Urticaria Forum (GUF) in December and the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in
June 2022.
In July 2022, we announced that the first patient had been dosed in a Phase 2 study in patients with CIndU who remain symptomatic
despite antihistamine therapy; in April 2024, we announced that enrollment was complete. The study is being conducted at
approximately 85 sites across approximately 12 countries. The randomized, double-blind, placebo-controlled, parallel group Phase 2
study is evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CIndU to determine the
optimal dosing strategy. 196 patients in 2 cohorts (differentiated by CIndU subtype) including 97 patients with cold urticaria and 99
patients with symptomatic dermographism were randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab
at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase. Patients then enter a follow-up phase for
an additional 24 weeks. In addition, the study includes the option for patients who have symptoms following the treatment phase,
including patients who were on placebo, to enroll in an open label extension where all patients receive 300 mg of barzolvolimab every 8
weeks. The primary endpoint of the study is the percentage of patients with a negative provocation test at week 12. Secondary endpoints
include safety and other assessments of clinical activity including CTT (Critical Temperature Threshold), CFT (Critical Friction
Threshold) and WI-NRS (Worst itch numeric rating scale).

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Topline primary endpoint data from this study were reported in July 2024 and 12 week treatment results were presented at the
American College of Allergy, Asthma & Immunology’s Annual Scientific Meeting. Data from the 193 patients randomized and treated in
the study showed that barzolvolimab achieved the primary efficacy endpoint, a statistically significant difference between the percent of
patients with a negative provocation test compared to placebo at week 12 as assessed by the TempTest® in ColdU and the FricTest® in
SD. Secondary and exploratory endpoints in the study were also achieved at week 12 and strongly support the primary endpoint results,
including responder analyses, improvements in Critical Temperature and Critical Friction Thresholds (CFT and CFT), changes in WI-
NRSprovo (itch associated with provocation test) and Urticaria Control Test. Demographics and baseline disease characteristics were
well balanced across treatment groups. In cold urticaria, patients presented with a mean baseline critical temperature threshold of
approximately 19°C or 66°F on the TempTest on initial provocation testing. In patients with symptomatic dermographism baseline
FricTest thresholds were an average of 3.6 out of 4 pins. UCT scores at baseline reflect poorly controlled disease.
Summary of Clinical Assessments at Week 12
Cold Urticaria
    
Symptomatic Dermographism
All measurements at
Week 12
150 mg
q4w

(n=32)
300 mg
q8w

(n=32)
Placebo
(n=32)
150 mg
q4w 
(n=33)
300 mg
q8w

(n=33)
Placebo
(n=31)
Primary endpoint: % of
patients with negative
provocation test (complete
response)
46.9%
p=0.0023
53.1%
p=0.0011
12.5%
57.6%
p<0.0001
42.4%
p=0.0003
3.2%
% of patients with complete or
partial response per
provocation test
62.5%
p=0.0118
75%
p=0.0006
31.3%
66.6%
p<0.0001
57.5%
p=0.0002
12.9%
Improvement in Critical
Temperature (CTT) and
Critical Friction (CFT)
Thresholds
-8.82°C
p<0.0001
-9.61°C
p<0.0001
-0.30°C
-2.46 pins
p<0.0001
-2.27 pins
p=0.0002
-0.82 pins
% of patients with Urticaria
Control Test >12
58.6%
p=0.0048
68.8%
p<0.0001
31.0%
54.8%
p=0.0015
65.5%
p<0.0001
32.0%
Patients experienced rapid disease improvement as early as two weeks (the first assessment) after receiving the initial dose of
barzolvolimab as demonstrated by reductions in critical temperature and friction thresholds resulting in hives and rapid reduction in itch
at the time of provocation testing (WI-NRSprovo).
Barzolvolimab was well tolerated with a favorable safety profile consistent with prior studies. Most adverse events were grade 1
(mild). Through 12 weeks, the most common treatment emergent adverse events in barzolvolimab treated patients were hair color
changes (13%; Grade 1, n=15 / Grade 2, n=2) and neutropenia (10%; Grade 1, n=7 / Grade 2, n=6), which are mechanism related (KIT)
and expected to be reversible. The rate of infections was similar between barzolvolimab-treated patients and placebo with no association
between neutropenia and infections.
We believe these results strongly support the further development of barzolvolimab in CIndU and plan to advance CIndU into Phase
3 registrational development.
Prurigo Nodularis (PN)
We have expanded clinical development of barzolvolimab into prurigo nodularis (PN). PN is a chronic skin disease characterized by
the development of hard, intensely itchy (pruritic) nodules on the skin. Mast cells through their interactions with sensory neurons and
other immune cells are believed to play an important role in amplifying chronic itch and neuroinflammation, both of which are a
hallmark of PN. There is currently only one FDA approved therapy for PN, representing an area of significant unmet need. Industry
sources estimate there are approximately 154,000 patients in the United States with PN who have undergone treatment within the last 12
months and, of these, approximately 75,000 would be biologic-eligible.
We have completed a Phase 1b multi-center, randomized, double-blind, placebo-controlled intravenous study in PN. Data from the
study, including 24 weeks of follow-up, were presented at the 12th World Congress on Itch (WCI) held in November 2023. 24 adults
(evaluable: n=23 safety; n=22 efficacy) with moderate to severe PN were randomized across three arms: (1) barzolvolimab 3.0 mg/kg
(n=9), barzolvolimab 1.5 mg/kg (n=7) and placebo (n=8). The primary endpoint of the study was safety; key secondary

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65
endpoints include changes from baseline in Worst Itch-Numerical Rating Scale (WI-NRS) & Investigator Global Assessment (IGA). The
primary timepoint for evaluation of clinical activity was 8 weeks; patients were followed for safety and efficacy endpoints to 24 weeks.
Patients on study generally had moderate to severe disease with mean baselines scores across all arms of 8.6 for WI-NRS and 3.3 for
IGA.
A single IV dose of 3.0 mg/kg barzolvolimab resulted in rapid and durable reductions in itch and healing of skin lesions in patients
with moderate to severe PN and that barzolvolimab was generally well tolerated.
●
At week 8, the percentage of patients with ≥4-point decrease in WI-NRS was 57% and 43% for the single dose 3.0 or 1.5
mg/kg barzolvolimab arms, respectively, and 25% for the placebo arm; this level of response generally persisted out to
week 16. In the 3.0 mg/kg arm, a ≥4-point decrease in WI-NRS reduction was seen as early as the first week and reached a
high of 71% of patients at week six which was distinct from both the 1.5 mg/kg barzolvolimab and placebo arms.
% of Subjects with ≥4-point decrease in WI-NRS
Dose
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Week 8
1.5 mg/kg
0
14
29
14
29
29
29
43
3.0 mg/kg
14
29
29
29
57
71
57
57
placebo
0
0
13
13
25
38
38
25
●
At week 8, 29% of patients achieved clear or almost clear skin according to IGA following a single dose of barzolvolimab
3.0 mg/kg. This effect was noted as early as week 2 (the first clinic visit) and was maintained out to week 12/16. No
patients treated at 1.5 mg/kg barzolvolimab or placebo achieved clear or almost clear skin according to IGA through week
8. 2 additional patients in the 1.5 mg/kg arm, 2 additional patients in the 3.0 mg/kg arm and 1 patient on placebo had IGA
0/1 at timepoints between weeks 8 and 24.
% of Subjects with IGA 0/1
Dose
Baseline
Week 2
Week 4
Week 8
1.5 mg/kg
0
0
0
0
3.0 mg/kg
0
14
14
29
Placebo
0
0
0
0
●
Clinical activity was associated with profound serum tryptase reduction. At the 3.0 mg/kg dose, tryptase was profoundly
reduced to, or below, the level of quantification and this level of reduction was maintained at least through 8 weeks.
Tryptase reduction was observed in the 1.5 mg/kg arm but to a lesser extent.
●
Adverse Events were generally mild to moderate in intensity and considered unrelated to treatment. During the initial 8
week observation period in the 3.0 mg/kg dosing arm, an anaphylactic reaction occurred in a complicated patient with
multiple comorbidities; the event fully resolved without sequelae. Generally, adverse events seen during the 24-week
follow-up period were consistent with comorbidities commonly observed in the PN population.
In April 2024, we initiated a Phase 2 subcutaneous study in PN. This randomized, double-blind, placebo-controlled, parallel group
study is evaluating the efficacy and safety profile of 2 dose levels of barzolvolimab compared to placebo in approximately 120 patients
with moderate to severe PN who had inadequate response to prescription topical medications, or for whom topical medications are
medically inadvisable (such as concerns for safety). Patients are randomly assigned on a 1:1:1 ratio to receive barzolvolimab injections
of 150 mg Q4W after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo during a
24‑week Treatment Phase. Participants then enter a follow-up phase with no study treatment for an additional 16 weeks through week 40.
The primary objective of this study is to evaluate the clinical effect of barzolvolimab, compared to placebo, on itch response as measured
by the proportion of participants with ≥ 4-point improvement in the worst intensity itch per a numeric rating scale (WI-NRS). Secondary
objectives include but are not limited to additional measures of itch response from baseline compared to different timepoints, the
assessment of skin lesions as measured by the Investigator Global Assessment (IGA), QoL outcomes and safety. The study will include
approximately 50 clinical trial centers worldwide, including the United States. Enrollment is ongoing.

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Eosinophilic Esophagitis (EoE)
In July of 2023, we announced that the first patient had been dosed in a Phase 2 study of eosinophilic esophagitis (EoE). EoE, the
most common type of eosinophilic gastrointestinal disease, is a chronic inflammatory disease of the esophagus characterized by the
infiltration of eosinophils. This chronic inflammation can result in trouble swallowing, chest pain, vomiting and impaction of food in the
esophagus, a medical emergency. Several studies have suggested that mast cells may be an important driver in the disease, demonstrating
that the number and activation state of mast cells are greatly increased in EoE biopsies and that mast cell signatures correlate with
markers of inflammation, fibrosis, pain and disease severity. Currently, there is only one FDA approved therapy for EoE, representing an
area of significant unmet need. Industry sources estimate there are approximately 160,000 patients in the United States with EoE who
have undergone treatment within the last 12 months and, of these, approximately 48,000 would be biologic-eligible. Given the lack of
effective therapies for EoE and barzolvolimab’s potential as a mast cell depleting agent, we believe EoE is an important indication for
future study.
The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of
subcutaneous barzolvolimab in patients with active EoE. To optimize potential efficacy signal in this difficult to treat indication, we have
recently amended the protocol to dose 300 mg every 4 weeks rather than 8 weeks. Approximately 75 patients will be enrolled in total. In
the revised protocol, patients will be randomly assigned on a 1:1 ratio to receive subcutaneous injections of barzolvolimab at 300 mg
every 4 weeks or placebo during a 16-week placebo-controlled treatment phase. Patients then enter a 12-week active treatment phase, in
which all patients will receive barzolvolimab 300 mg every 4 weeks. Patients then enter a follow-up phase for an additional 16 weeks.
The primary endpoint of the study is reducing esophageal intraepithelial infiltration of mast cells as assessed by peak esophageal
intraepithelial mast cell count. Secondary endpoints include the reduction of symptoms of dysphagia and esophageal intraepithelial
infiltration of eosinophils and safety. The study includes approximately 60 clinical trial centers across 8 countries, including the United
States. The study is fully accrued and we plan to present data from the study in the second half of 2025.
Atopic Dermatitis (AD)
In December of 2024, we announced the initiation of a Phase 2 study in atopic dermatitis (AD). AD is one of the most common
chronic inflammatory skin diseases, with a lifetime prevalence of up to 20% of the US population and a substantial impact on quality of
life (Kawakami, et al. 2009). Mast cells are strongly implicated in all facets of AD pathophysiology and the fundamental processes that
characterize AD, including epithelial barrier dysfunction, immune cell recruitment, neuroinflammation (Keith, et al. 2023) and multiple
other mast cell-associated factors that correlate with disease severity. Activated mast cells are also found in increased numbers in lesional
biopsies. Two-thirds of patients treated with first line systemic therapy (1.7 million patienst in the US) do not achieve complete control of
their atopic dermatitis (Simpson, Bieber, Guttman-Yassky, et al. 2016) and new therapies that offer rapid, meaningful relief from the
severe itching and breakdown of the skin associated with AD are needed. Given barzolvolimab’s potential as a mast cell depleting agent,
we believe AD is an important indication for future study.
The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of
subcutaneous barzolvolimab in patients with moderate to severe AD. Approximately 120 patients will be randomly assigned on a 1:1:1
ratio to receive subcutaneous injections of barzolvolimab at either 150 or 300 mg or placebo every 4 weeks after an initial loading dose
of 450 mg or placebo during a 16-week placebo-controlled treatment phase. Participants randomized into the placebo arm will be re-
randomized at Week 16 into 1 of the 2 active treatment arms. Patients then enter a 16-week active treatment phase, in which all patients
will receive barzolvolimab every 4 weeks. The primary endpoint of the study is to evaluate the clinical efficacy of the two dose levels
compared to placebo using the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16, a well‐defined, reliable, sensitive and valid
scale for evaluating worst itch intensity in adults with moderate‐to‐severe AD. Secondary endpoints include the evaluation of the clinical
efficacy of barzolvolimab, compared to placebo across multiple patient-reported outcomes, including assessing impressions of disease
change and severity and improvements in quality of life. When all clinical trial sites are open, the study will include up to 50 clinical trial
centers in the United States. Enrollment is ongoing.

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67
Additional Barzolvolimab Development Activities
In 2023, we completed the transfer of our current barzolvolimab manufacturing process to a CDMO and successfully scaled up the
drug substance manufacturing process to produce larger cGMP batches in support of late-stage trials and to prepare for potential
commercialization. Drug product manufacturing into 1 mL pre-filled syringes has been completed and are actively being used in the
ongoing Phase 3 CSU trials.
In February 2022, we reported interim data after completing the in-life dosing portion of our six-month chronic toxicology study in
non-human primates. The only clinically adverse finding at the completion of dosing was a profound impact on spermatogenesis, an
expected and well understood effect of KIT inhibition. As a standard part of toxicology studies, some animals from each group continued
to be observed through a recovery period to understand the reversibility of any adverse findings. Due to the very high concentrations of
barzolvolimab at the end of dosing, the recovery period was approximately one year. As we expected, and consistent with previous
findings with KIT blocking antibodies, we were pleased to report in December 2022, that during this recovery period spermatogenesis
fully recovered in all male animals as measured by both sperm count and motility. The final histologic analysis and study report were
completed in early 2023 and were consistent with previously reported results. We are encouraged with these findings and believe these
data strongly support continued development of barzolvolimab.
Bispecific Platform
Our next generation bispecific antibody platform is supporting the expansion of our pipeline with additional candidates for
inflammatory diseases. Targets are being selected based on new science as well as their compatibility to be used in bispecific antibody
formats with our existing antibody programs. Development is focused on emerging, important pathways controlling inflammatory
diseases.
CDX-622
CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing
the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. TSLP has been directly
implicated in several respiratory and dermatological disorders, such as asthma, chronic obstructive pulmonary disease (COPD),
eosinophilic esophagitis, atopic dermatitis and chronic spontaneous urticaria, and in fibrotic diseases such as systemic sclerosis and
idiopathic pulmonary fibrosis. In these disorders, TSLP is often upregulated and associated with disease severity. Similarly, mast cells
drive or contribute to the pathophysiology of allergic, inflammatory, autoimmune and fibrotic disorders and CDX-622 contains a unique
SCF neutralizing function that is expected to inhibit and deplete mast cells. Combined neutralization of SCF and TSLP with CDX-622 is
expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic
benefit in inflammatory and fibrotic disorders. In preclinical studies, CDX-622 inhibits TSLP and SCF with similar potency to both its
respective parental mAbs and comparator mAbs in vitro. CDX-622 was well tolerated in a multi-dose 8 week toxicology study in non-
human primates. The No Adverse Event Level (NOAEL) was established to be 75 mg/kg, the highest dose level tested.
In November 2024, we initiated a Phase 1 study of CDX-622 in healthy volunteers. The Phase 1a clinical trial is a two-part,
randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and
pharmacodynamics of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants.
A single dose of CDX-622 or placebo will be administered intravenously once during Part 1. In Part 2, CDX-622 or placebo will be
administered every 3 weeks (Q3W) for up to 6 weeks following the first dose, for a total of 3 doses. Participants will be followed for 12
weeks in both Parts 1 and 2 following the last dose of study drug. The pharmacodynamic biomarkers from blood and skin will be highly
informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. A subcutaneous formulation is currently being
manufactured and will be added to this study in 2025
CDX-585 (development discontinued)
CDX-585 combined PD-1 blockade and anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells,
respectively. We initiated a Phase 1 open-label, multi-center, multi-dose study in patients with advanced or metastatic solid tumors that
had progressed during or after standard of care therapy. The dose-escalation phase of the study was completed and we announced in Q4
2024 that we would not advance CDX-585 given our expanding clinical development program in the inflammatory space.

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68
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our significant accounting policies are described in Note 2 to the financial statements included in Item 8 of this Form 10-K. We
believe our most critical accounting policies include accounting for contingent consideration, revenue recognition, intangible and long-
lived assets, research and development expenses and stock-based compensation expense.
The methods, estimates and judgments we use in applying our most critical accounting policies have a significant impact on the
results we report in our financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on
historical experience and on assumptions that we believe to be reasonable under the circumstances. Our experience and assumptions
form the basis for our judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual
results may vary from what we anticipate and different assumptions or estimates about the future could materially change our reported
results. We believe the following accounting policies are the most critical to us in that they are important to the portrayal of our financial
statements and they require our most difficult, subjective or complex judgments in the preparation of our financial statements:
Contingent Consideration
We record contingent consideration resulting from a business combination at its fair value on the acquisition date. We determine the
fair value of the contingent consideration based primarily on the following factors:
●
timing and probability of success of clinical events or regulatory approvals;
●
timing and probability of success of meeting clinical and commercial milestones; and
●
discount rates.
Our contingent consideration arose in connection with our acquisition of Kolltan. On a quarterly basis, we revalue these obligations
and record increases or decreases in their fair value as an adjustment to operating earnings. As of December 31, 2024, the fair value of
our contingent consideration was $0.0 million. Changes to contingent consideration obligations can result from adjustments to discount
rates, accretion of the discount rates due to the passage of time, changes in our estimates of the likelihood or timing of achieving
development or commercial milestones, changes in the probability of certain clinical events or changes in the assumed probability
associated with regulatory approval.
The assumptions related to determining the value of contingent consideration include a significant amount of judgment, and any
changes in the underlying estimates could have a material impact on the amount of contingent consideration adjustment recorded in any
given period.
Revenue Recognition
Revenues are recognized when performance obligations under agreements or contracts are satisfied, in an amount that reflects the
consideration the Company expects to be entitled to in exchange for those services.
The Company determines revenue recognition through the following steps:
●
Identification of the contract, or contracts, with a customer;
●
Identification of the performance obligations in the contract;
●
Determination of the transaction price;
●
Allocation of the transaction price to the performance obligations in the contract; and
●
Recognition of revenue when, or as, the Company satisfies a performance obligation.

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Revenue for the Company is derived from product development agreements with collaborative partners for the research and
development of therapeutic drug candidates. The terms of the agreements may include nonrefundable signing and licensing fees, funding
for research, development and manufacturing, milestone payments and royalties on any product sales derived from collaborations. The
Company assesses the multiple obligations typically within product development contracts to determine the distinct performance
obligations and how to allocate the arrangement consideration to each distinct performance obligation. Under product development
agreements, revenue is generally recognized using a cost-to-cost measure of progress. Revenue is recognized based on the costs incurred
to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds
with, and thereby best depicts, the transfer of control to the customer. Due to the nature of the work performed in these arrangements, the
estimation of cost at completion is complex, subject to many variables, such as expected clinical trial costs, and requires significant
judgements. Circumstances can arise that change original estimates of costs or progress toward completion. Any revisions to estimates
are reflected in revenue on a cumulative catch-up basis in the period in which the change in circumstances became known.
Revenue for the Company is also derived from manufacturing and research and development arrangements. The Company operates
a cGMP manufacturing facility in Fall River, Massachusetts, to produce drug substance for its current and planned early-stage clinical
trials. In order to utilize excess capacity, the Company has, from time to time, entered into contract manufacturing and research and
development arrangements in which services are provided on a time-and-material basis or at a negotiated fixed- price. Revenue from
time-and-material contracts is generally recognized on an output basis as labor hours and/or direct expenses are incurred. Under fixed-
price contracts, revenue is generally recognized on an output basis as progress is made toward completion of the performance obligations
using surveys of performance completed to date.
Intangible and Long-Lived Assets
We evaluate the recoverability of our long-lived assets, including property and equipment when circumstances indicate that an event
of impairment may have occurred. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting
from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the
carrying amount of the assets, the assets are written down to their estimated fair values.
IPR&D assets acquired in a business combination initially are recorded at fair value and accounted for as indefinite-lived intangible
assets. These assets are capitalized on our balance sheets until either the project underlying them is completed or the assets become
impaired. If a project is completed, the carrying value of the related intangible asset is amortized over the remaining estimated life of the
asset beginning in the period in which the project is completed. If a project becomes impaired or is abandoned, the carrying value of the
related intangible asset is written down to its fair value and an impairment charge is taken in the period in which the impairment occurs.
Discounted cash flow models are typically used in these tests, and the models require the use of significant estimates and assumptions
including but not limited to:
●
timing and costs to complete the in-process projects;
●
timing and probability of success of clinical events or regulatory approvals;
●
estimated future cash flows from product sales resulting from completed products and in-process projects; and
●
discount rates
Each IPR&D asset is assessed for impairment at least annually or when impairment indicators are present. The Company has the
option to assess qualitative factors to determine if it is more likely than not that the IPR&D asset is impaired and whether it is necessary
to perform a quantitative impairment test.
Research and Development Expenses
Research and development costs, including internal and contract research costs, are expensed as incurred. Research and development
expenses consist mainly of clinical trial costs, manufacturing of clinical material, toxicology and other preclinical studies, personnel
costs, depreciation, license fees and funding of outside contracted research.

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70
Clinical trial expenses include expenses associated with clinical research organization, or CRO, services. Contract manufacturing
expenses include expenses associated with contract development & manufacturing organization, or CDMO, services. The invoicing from
CROs and CDMOs for services rendered can lag several months. We accrue the cost of services rendered in connection with CRO and
CDMO activities based on our estimate of costs incurred. We maintain regular communication with our CROs and CDMOs to assess the
reasonableness of our estimates. Differences between actual expenses and estimated expenses recorded have not been material and are
adjusted for in the period in which they become known.
Stock-Based Compensation Expense
We record stock-based compensation expense for all stock-based awards made to employees, consultants and non-employee
directors based on the estimated fair values of the stock-based awards expected to vest at the grant date and adjust, if necessary, to reflect
actual forfeitures. Our estimates of employee, consultant and non-employ director stock option values rely on estimates of future
uncertain events. Significant assumptions include the use of historical volatility to estimate the expected stock price volatility. We also
estimate expected term based on historical exercise patterns. For consultant and non-employee director grants, we may elect to use the
contractual term as the expected term in the option-pricing model. Actual volatility and lives of options may be significantly different
from our estimates. Compensation expense for all stock-based awards is recognized using the straight-line method over the term of
vesting or performance.
RESULTS OF OPERATIONS
Year Ended December 31, 2024 compared with Year Ended December 31, 2023
Year Ended
Increase/
Increase/
 
December 31,
(Decrease)
(Decrease)  
    
2024
    
2023
    
$
    
%
 
(In thousands)
 
Revenues:
Product development and licensing agreements
$
 13
$
 278
$
 (265)
 (95)%
Contracts and grants
 
 7,007
 6,605
 402
 6 %
Total revenues
$
 7,020
$
 6,883
$
 137
 2 %
Operating expenses:
 
Research and development
   163,550
 118,011
 45,539
 39 %
General and administrative
 
 38,548
 30,914
 7,634
 25 %
Litigation settlement related loss
 —
 12,500
 (12,500)
 (100)%
Total operating expenses
   202,098
 161,425
 40,673
 25 %
Operating loss
   (195,078)
 (154,542)
 40,536
 26 %
Investment and other income, net
 
 37,215
 13,113
 24,102
 184 %
Net loss
$ (157,863)
$ (141,429)
$  16,434
 12 %
Net Loss
The $16.4 million increase in net loss for the year ended December 31, 2024, as compared to the year ended December 31, 2023,
was primarily due to increases in research and development and general and administrative expenses, partially offset by the $12.5 million
litigation settlement related loss recorded in 2023 and an increase in investment and other income, net.
Revenue
The $0.4 million increase in contracts and grants revenue for the year ended December 31, 2024, as compared to the year ended
December 31, 2023, was primarily due to an increase in services performed under our manufacturing and research and development
agreements with Rockefeller University. We expect revenue to decrease over the next twelve months as a result of a decrease in services
expected to be performed under our contract manufacturing and research and development agreements with Rockefeller University,
although there may be fluctuations on a quarterly basis.

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71
Research and Development Expense
Research and development expenses consist primarily of (i) personnel expenses, (ii) laboratory supply expenses relating to the
development of our technology, (iii) facility expenses and (iv) product development expenses associated with our drug candidates as
follows:
Year Ended
Increase/
 
December 31,
(Decrease)
 
    
2024
    
2023
    
$
    
%
 
(In thousands)
 
Personnel
$ 51,906
$ 40,121
$ 11,785
 29 %
Laboratory supplies
 
 5,611
 5,358
 253
 5 %
Facility
   5,094
 4,970
 124
 2 %
Product development
   90,604
 59,319
 31,285
 53 %
Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $11.8 million increase in
personnel expenses for the year ended December 31, 2024, as compared to the year ended December 31, 2023, was primarily due to
higher stock-based compensation expense and an increase in employee headcount. We expect personnel expenses to increase over the
next twelve months as a result of additional headcount to support the expanded development of barzolvolimab.
Laboratory supplies expenses include laboratory materials and supplies, services and other related expenses incurred in the
development of our technology. The $0.3 million increase in laboratory supply expenses for the year ended December 31, 2024, as
compared to the year ended December 31, 2023, was primarily due to higher laboratory services, materials and supplies purchases. We
expect laboratory supplies expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a
quarterly basis.
Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities.
Facility expenses for the year ended December 31, 2024 were relatively consistent with the year ended December 31, 2023. We expect
facility expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.
Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs,
contracted research and outside clinical drug product manufacturing. The $31.3 million increase in product development expenses for the
year ended December 31, 2024, as compared to the year ended December 31, 2023, was primarily due to an increase in barzolvolimab
clinical trial expenses, partially offset by a decrease in barzolvolimab contract manufacturing expenses. We expect product development
expenses to increase over the next twelve months as a result of the expanded development of barzolvolimab, although there may be
fluctuations on a quarterly basis.
General and Administrative Expense
The $7.6 million increase in general and administrative expenses for the year ended December 31, 2024, as compared to the year
ended December 31, 2023, was primarily due to higher stock-based compensation and barzolvolimab commercial planning expenses. We
expect general and administrative expenses to increase over the next twelve months as a result of the expanded development of
barzolvolimab and an increase in commercial planning efforts, although there may be fluctuations on a quarterly basis.
Litigation Settlement Related Loss
During the fourth quarter of 2023, we announced positive topline results from our Phase 2 clinical trial of barzolvolimab in patients
with moderate to severe CSU, which satisfied the requirement of “successful completion” of a Phase 2 Clinical Trial of barzolvolimab
such that we were obligated to make the applicable milestone payment under the Settlement Agreement with SRS in the amount of $12.5
million. During the fourth quarter of 2023, we paid the $12.5 million milestone in cash and recorded a litigation settlement related loss of
$12.5 million.

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72
Investment and Other Income, Net
The $24.1 million increase in investment and other income, net for the year ended December 31, 2024, as compared to the year
ended December 31, 2023, was primarily due to higher levels of cash as a result of our November 2023 and March 2024 underwritten
public offerings. We expect investment and other income to decrease over the next twelve months due to lower levels of cash and
investment balances, although there may be fluctuations on a quarterly basis.
Year Ended December 31, 2023 compared with Year Ended December 31, 2022
Year Ended
Increase/
Increase/
December 31,
(Decrease)
(Decrease)
    
2023
    
2022
    
$
    
%
(In thousands)
Revenues:
Product development and licensing agreements
$
 278
$
 56
$
 222
 396 %
Contracts and grants
 6,605
 2,301
 4,304
 187 %
Total revenues
$
 6,883
$
 2,357
$
 4,526
 192 %
Operating expenses:
  
  
  
 
Research and development
 
 118,011  
 82,258  
 35,753  
 43 %
General and administrative
 
 30,914  
 27,195  
 3,719  
 14 %
Gain on fair value remeasurement of contingent consideration
 
 —  
 (6,862) 
 (6,862) 
 (100)%
Litigation settlement related loss
 12,500
 15,000
 (2,500)
 (17)%
Total operating expenses
 
 161,425  
 117,591  
 43,834  
 37 %
Operating loss
 
 (154,542) 
 (115,234) 
 39,308  
 34 %
Investment and other income, net
 
 13,113  
 2,909  
 10,204  
 351 %
Net loss
$  (141,429)
$  (112,325)
$
 29,104  
 26 %
Net Loss
The $29.1 million increase in net loss for the year ended December 31, 2023, as compared to the year ended December 31, 2022,
was primarily due to an increase in research and development expenses and a decrease in the gain on fair value remeasurement of
contingent consideration, partially offset by increases in contracts and grants revenue and investment and other income, net.
Revenue
The $4.3 million increase in contracts and grants revenue for the year ended December 31, 2023, as compared to the year ended
December 31, 2022, was primarily related to an increase in services performed under our manufacturing and research and development
agreements with Rockefeller University.
Research and Development Expense
Research and development expenses consist primarily of (i) personnel expenses, (ii) laboratory supply expenses relating to the
development of our technology, (iii) facility expenses and (iv) product development expenses associated with our drug candidates as
follows:
Year Ended
Increase/
December 31,
(Decrease)
    
2023
    
2022
    
$
    
%
(In thousands)
Personnel
$  40,121
$  32,674
$  7,447
 23 %
Laboratory supplies
 
 5,358
 
 6,310
 
 (952) 
 (15)%
Facility
 
 4,970
 
 4,764
 
 206  
 4 %
Product development
   59,319
   32,156
   27,163  
 84 %

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Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $7.4 million increase in
personnel expenses for the year ended December 31, 2023, as compared to the year ended December 31, 2022, was primarily due to
higher stock-based compensation expense and an increase in employee headcount.
Laboratory supplies expenses include laboratory materials and supplies, services and other related expenses incurred in the
development of our technology. The $1.0 million decrease in laboratory supply expenses for the year ended December 31, 2023, as
compared to the year ended December 31, 2022, was primarily due to lower laboratory services, materials and supplies purchases.
Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities.
The $0.2 million increase in facility expenses for the year ended December 31, 2023, as compared to the year ended December 31, 2022,
was primarily due to higher repairs and depreciation expense.
Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs,
contracted research and outside clinical drug product manufacturing. The $27.2 million increase in product development expenses for the
year ended December 31, 2023, as compared to the year ended December 31, 2022, was primarily due to an increase in barzolvolimab
clinical trial and contract manufacturing expenses.
General and Administrative Expense
The $3.7 million increase in general and administrative expenses for the year ended December 31, 2023, as compared to the year
ended December 31, 2022, was primarily due to higher stock-based compensation, recruiting and barzolvolimab commercial planning
expenses, partially offset by a decrease in legal expenses.
Gain on Fair Value Remeasurement of Contingent Consideration
The $6.9 million gain on fair value remeasurement of contingent consideration for the year ended December 31, 2022 was primarily
due to our decision to deprioritize the CDX-1140 program.
Litigation Settlement Related Loss
We recorded a loss of $15.0 million in the second quarter of 2022 related to the Initial Payment due under the Settlement Agreement
with SRS. During the fourth quarter of 2023, we announced positive topline results from our Phase 2 clinical trial of barzolvolimab in
patients with moderate to severe CSU, which satisfied the requirement of “successful completion” of a Phase 2 Clinical Trial of
barzolvolimab such that we were obligated to make the applicable milestone payment under the Settlement Agreement in the amount of
$12.5 million. During the fourth quarter of 2023, we paid the $12.5 million milestone in cash and recorded a litigation settlement related
loss of $12.5 million.
Investment and Other Income, Net
The $10.2 million increase in investment and other income, net for the year ended December 31, 2023, as compared to the year
ended December 31, 2022, was primarily due to higher interest rates on fixed income investments and higher other income related to our
sale of New Jersey tax benefits.
LIQUIDITY AND CAPITAL RESOURCES
Our cash equivalents are highly liquid investments with a maturity of three months or less at the date of purchase and consist
primarily of investments in money market mutual funds with commercial banks and financial institutions. We maintain cash balances
with financial institutions in excess of insured limits. We do not anticipate any losses with respect to such cash balances. We invest our
excess cash balances in marketable securities, including municipal bond securities, U.S. government agency securities and high- grade
corporate bonds that meet high credit quality standards, as specified in our investment policy. Our investment policy seeks to manage
these assets to achieve our goals of preserving principal and maintaining adequate liquidity.
The use of our cash flows for operations has primarily consisted of salaries and wages for our employees; facility and facility-related
costs for our offices, laboratories and manufacturing facility; fees paid in connection with preclinical studies, clinical studies, contract
manufacturing, laboratory supplies and services; and consulting, legal and other professional fees. We anticipate that our cash

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flows from operations will continue to be focused in these areas as we progress our current drug candidates through the clinical trial
process and develop additional drug candidates. To date, the primary sources of cash flows from operations have been payments received
from our collaborative partners and from government entities and payments received for contract manufacturing and research and
development services provided by us. The timing of any new contract manufacturing and research and development agreements,
collaboration agreements, government contracts or grants and any payments under these agreements, contracts or grants cannot be easily
predicted and may vary significantly from quarter to quarter.
At December 31, 2024, our principal sources of liquidity consisted of cash, cash equivalents and marketable securities of $725.3
million. We have had recurring losses and incurred a loss of $157.9 million for the year ended December 31, 2024. Net cash used in
operations for the year ended December 31, 2024 was $157.8 million. We believe that the cash, cash equivalents and marketable
securities at December 31, 2024 are sufficient to meet estimated working capital requirements and fund current planned operations
through 2027. This could be impacted if we elect to pay the future milestone under the Settlement Agreement with SRS in cash, in the
event that we achieve the milestone related to that payment.
During the next twelve months, we may take further steps to raise additional capital to meet our long-term liquidity needs including,
but not limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible
business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings.
Although we have been successful in raising capital in the past, there can be no assurance that additional financing will be available on
acceptable terms, if at all, and our negotiating position in capital raising efforts may worsen as existing resources are used. There is also
no assurance that we will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to our
stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict our ability to
operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce our economic potential
from products under development. Our ability to continue funding our planned operations into and beyond twelve months from the
issuance date is also dependent on the timing and manner of payment of the future milestone under the Settlement Agreement with SRS,
in the event that we achieve the milestone related to that payment. We may decide to pay that milestone payment in cash, shares of our
common stock or a combination thereof. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may
have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials,
discontinue or delay our commercial manufacturing efforts, discontinue or delay our efforts to expand into additional indications for our
drug product candidates, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if
at all, or sell all or a part of our business.
Operating Activities
Net cash used in operating activities was $157.8 million for the year ended December 31, 2024 compared to $107.3 million for the
year ended December 31, 2023. The increase in net cash used in operating activities was primarily due to increases in research and
development and general and administrative expenses and an increase in advance payments to clinical research and contract
manufacturing organizations, partially offset by an increase in investment income as a result of higher levels of cash and a decrease in
payments made under the Settlement Agreement with SRS. We expect that cash used in operating activities will increase over the next
twelve months as a result of the expanded development of barzolvolimab.
Net cash used in operating activities was $107.3 million for the year ended December 31, 2023 compared to $103.7 million for the
year ended December 31, 2022. The increase in net cash used in operating activities was primarily due to increases in research and
development and general and administrative expenses, partially offset by an increase in revenue and a decrease in payments made under
the Settlement Agreement with SRS.
We have incurred and will continue to incur significant costs in the area of research and development, including preclinical and
clinical trials and clinical drug product manufacturing as our drug candidates are developed. We plan to spend significant amounts to
progress our current drug candidates through the clinical trial processes as well as to develop additional drug candidates. As our drug
candidates progress through the clinical trial process, we may be obligated to make significant milestone payments, pursuant to our
existing arrangements and arrangements we may enter in the future.
Investing Activities
Net cash used in investing activities was $290.1 million for the year ended December 31, 2024 compared to $105.8 million for the
year ended December 31, 2023. The increase in net cash used in investing activities was primarily due to net purchases of marketable

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securities of $288.2 million for the year ended December 31, 2024 as compared to $104.0 million for the year ended December 31, 2023.
We expect that cash provided by investing activities will increase over the next twelve months as we fund our operations through the
combination of net proceeds from the sales and maturities of marketable securities, cash provided by financing activities and/or new
partnerships, although there may be significant fluctuations on a quarterly basis based on the amount of cash provided by financing
activities and/or new partnerships.
Net cash used in investing activities was $105.8 million for the year ended December 31, 2023 compared to net cash provided by
investing activities of $89.9 million for the year ended December 31, 2022. The increase in net cash used in investing activities was
primarily due to net purchases of marketable securities of $104.0 million for the year ended December 31, 2023 as compared to net sales
and maturities of marketable securities of $91.7 million for the year ended December 31, 2022.
Financing Activities
Net cash provided by financing activities was $441.4 million for the year ended December 31, 2024 compared to $218.5 million for
the year ended December 31, 2023. The increase in net cash provided by financing activities was primarily due to an increase in net
proceeds from stock issuances.
Net cash provided by financing activities was $218.5 million for the year ended December 31, 2023 compared to $4.1 million for the
year ended December 31, 2022. The increase in net cash provided by financing activities was primarily due to an increase in net proceeds
from stock issuances.
Equity Offerings
In November 2023, we filed an automatic shelf registration statement with the SEC to register for sale any combination of the types
of securities described in the shelf registration statement, including shares of our common stock. Also in November 2023, we issued
8,538,750 shares of our common stock in an underwritten public offering resulting in net proceeds of $216.2 million, after deducting
underwriting fees and offering expenses.
On February 26, 2024, we entered into a controlled equity offering sales agreement (“ATM Agreement”) with Cantor Fitzgerald &
Co. (“Cantor”) to allow us to issue and sell shares of our common stock from time to time through Cantor, acting as agent. At December
31, 2024, we had registered $300.0 million of our common stock to be sold pursuant to the ATM Agreement, all of which remained
unsold as of that date.
In March 2024, we issued 9,798,000 shares of our common stock in an underwritten public offering resulting in net proceeds of
$432.3 million, after deducting underwriting fees and offering expenses.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We own financial instruments that are sensitive to market risk as part of our investment portfolio. Our investment portfolio is used to
preserve our capital until it is used to fund operations, including our research and development activities. None of these market-risk
sensitive instruments are held for trading purposes. We invest our cash primarily in money market mutual funds. These investments are
evaluated quarterly to determine the fair value of the portfolio. From time to time, we invest our excess cash balances in marketable
securities, including municipal bond securities, U.S. government agency securities, and high-grade corporate bonds that meet high credit
quality standards, as specified in our investment policy. Our investment policy seeks to manage these assets to achieve our goals of
preserving principal and maintaining adequate liquidity. Because of the short-term nature of these investments, we do not believe we
have material exposure due to market risk. The impact to our financial position and results of operations from changes in interest rates is
not material.
We do not utilize derivative financial instruments. The carrying amounts reflected in the balance sheet of cash and cash equivalents,
accounts receivables and accounts payable approximates fair value at December 31, 2024 due to the short-term maturities of these
instruments.

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Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Celldex Therapeutics, Inc.
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of Celldex Therapeutics, Inc. and its subsidiary (the “Company”) as
of December 31, 2024 and 2023, and the related consolidated statements of operations and comprehensive loss, of stockholders’ equity
and of cash flows for each of the three years in the period ended December 31, 2024, including the related notes (collectively referred to
as the “consolidated financial statements”). We also have audited the Company’s internal control over financial reporting as of December
31, 2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of
the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the
period ended December 31, 2024 in conformity with accounting principles generally accepted in the United States of America. Also in
our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31,
2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control
over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s
Annual Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the
Company’s consolidated financial statements and on the Company’s internal control over financial reporting 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
audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due
to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements 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. Our audit of internal control over financial reporting included obtaining
an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating
the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other
procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed 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. A company’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 the
company; (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 the company are being made only in
accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance

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regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a
material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial
statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures
that are material to the consolidated financial statements and (ii) 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 matter below, providing a separate opinion on the critical audit matter or on
the accounts or disclosures to which it relates.
Research and Development Expenses and Accruals Related to Clinical Research Organization and Contract Development and
Manufacturing Organization Activities
As described in Notes 2 and 10 to the consolidated financial statements, research and development costs, including internal and
contract research costs, are expensed as incurred. Research and development expenses consist mainly of clinical trial costs,
manufacturing of clinical material, toxicology and other preclinical studies, personnel costs, depreciation, license fees and funding of
outside contracted research. Clinical trial expenses include expenses associated with clinical research organization, or CRO, services.
Contract manufacturing expenses include expenses associated with contract development & manufacturing organization, or CDMO,
services. The invoicing from CROs and CDMOs for services rendered can lag several months. Management accrues the cost of services
rendered in connection with CRO and CDMO activities based on their estimate of costs incurred. Management maintains regular
communication with their CROs and CDMOs to assess the reasonableness of its estimates. Research and development expenses for the
year ended December 31, 2024 were $163.6 million, the majority of which related to CRO and CDMO activities. Within accrued
expenses, total accrued research and development contract costs as of December 31, 2024 amounted to $20.5 million, a majority of
which related to CRO and CDMO activities.
The principal consideration for our determination that performing procedures relating to research and development expenses and
accruals related to CRO and CDMO activities is a critical audit matter is a high degree of auditor effort in performing procedures related
to the Company’s research and development expenses and accruals.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion
on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s
estimated research and development accruals, including those related to CRO and CDMO activities. These procedures also included,
among others, (i) testing management’s process for developing the estimate of research and development accruals related to CROs and
CDMOs, (ii) evaluating the appropriateness of the methods used by management to develop the estimate, (iii) testing, on a sample basis,
the completeness and accuracy of costs incurred for services that have been performed and for which the Company has been invoiced by
comparing amounts to CRO and CDMO contracts and invoices, and evaluating the reasonableness of the cost incurred for the services
for which the Company has not yet been invoiced by comparing estimated amounts to information received from the CROs and CDMOs,
and (iv) testing, on a sample basis, classification of research and development expenses.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 27, 2025
We have served as the Company’s auditor since 2008.

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78
CELLDEX THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
    
December 31, 2024
    
December 31, 2023
Assets
Current assets:
Cash and cash equivalents
$
28,356
$
34,814
Marketable securities
696,925
388,784
Accounts and other receivables
700
2,628
Prepaid and other current assets
21,178
5,467
Total current assets
747,159
431,693
Property and equipment, net
4,346
4,060
Operating lease right-of-use assets, net
3,898
2,577
Intangible assets
27,190
27,190
Other assets
9,747
107
Total assets
$
792,340
$
465,627
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
3,265
$
3,494
Accrued expenses
33,842
22,029
Current portion of operating lease liabilities
1,452
1,614
Current portion of long-term liabilities
942
3,988
Total current liabilities
39,501
31,125
Long-term portion of operating lease liabilities
2,361
928
Other long-term liabilities
3,473
4,403
Total liabilities
45,335
36,456
Commitments and contingent liabilities (Note 15)
Stockholders’ equity:
Convertible preferred stock, $.01 par value; 3,000,000 shares authorized; no shares
issued and outstanding at December 31, 2024 and 2023
—
—
Common stock, $.001 par value; 297,000,000 shares authorized; 66,374,549 and
55,883,377 shares issued and outstanding at December 31, 2024 and 2023, respectively
66
56
Additional paid-in capital
2,298,849
1,823,168
Accumulated other comprehensive income
3,314
3,308
Accumulated deficit
(1,555,224)
(1,397,361)
Total stockholders’ equity
747,005
429,171
Total liabilities and stockholders’ equity
$
792,340
$
465,627
The accompanying notes are an integral part of the consolidated financial statements.

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CELLDEX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except per share amounts)
Year Ended
Year Ended
    
Year Ended
    December 31, 2024    December 31, 2023    December 31, 2022
Revenues:
Product development and licensing agreements
$
13
$
278
$
56
Contracts and grants
7,007
6,605
2,301
Total revenues
7,020
6,883
2,357
Operating expenses:
Research and development
163,550
118,011
82,258
General and administrative
38,548
30,914
27,195
Gain on fair value remeasurement of contingent consideration
—
—
(6,862)
Litigation settlement related loss
—
12,500
15,000
Total operating expenses
202,098
161,425
117,591
Operating loss
(195,078)
(154,542)
(115,234)
Investment and other income, net
37,215
13,113
2,909
Net loss
$
(157,863)
$
(141,429)
$
(112,325)
Basic and diluted net loss per common share
$
(2.45)
$
(2.92)
$
(2.40)
Shares used in calculating basic and diluted net loss per share
64,395
48,449
46,888
Comprehensive loss:
Net loss
$
(157,863)
$
(141,429)
$
(112,325)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities
6
2,048
(634)
Comprehensive loss
$
(157,857)
$
(139,381)
$
(112,959)
The accompanying notes are an integral part of the consolidated financial statements.

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CELLDEX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands, except share amounts)
Accumulated
Common
Common
Additional
Other
Total
Stock
Stock Par
Paid-In
Comprehensive
Accumulated
Stockholders’
    
Shares
    
Value
    
Capital
    
Income
    
Deficit
    
Equity
Balance at December 31, 2021
 
46,730,198
$
47
$
1,561,142
$
1,894
$
(1,143,607)
$
419,476
Shares issued under stock option and employee stock purchase plans
470,497
—
4,076
—
—
4,076
Stock-based compensation
 
—
—
15,611
—
—
15,611
Unrealized loss on marketable securities
 
—
—
—
(634)
—
(634)
Net loss
 
—
—
—
—
(112,325)
(112,325)
Balance at December 31, 2022
 
47,200,695
$
47
$
1,580,829
$
1,260
$
(1,255,932)
$
326,204
Shares issued under stock option and employee stock purchase plans
143,932
—
2,236
—
—
2,236
Shares issued in underwritten offering, net
8,538,750
9
216,213
—
—
216,222
Stock-based compensation
—
—
23,890
—
—
23,890
Unrealized gain on marketable securities
—
—
—
2,048
—
2,048
Net loss
—
—
—
—
(141,429)
(141,429)
Balance at December 31, 2023
55,883,377
$
56
$
1,823,168
$
3,308
$
(1,397,361)
$
429,171
Shares issued under stock option and employee stock purchase plans
693,172
—
9,151
—
—
9,151
Shares issued in underwritten offering, net
9,798,000
10
432,288
—
—
432,298
Stock-based compensation
—
—
34,242
—
—
34,242
Unrealized gain on marketable securities
—
—
—
6
—
6
Net loss
—
—
—
—
(157,863)
(157,863)
Balance at December 31, 2024
66,374,549
$
66
$
2,298,849
$
3,314
$
(1,555,224)
$
747,005
The accompanying notes are an integral part of the consolidated financial statements.

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81
CELLDEX THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended
Year Ended
Year Ended
     December 31, 2024     December 31, 2023     
December 31, 2022
Cash flows from operating activities:
Net loss
$
(157,863)
$
(141,429)
$
(112,325)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
3,177
3,008
2,896
Amortization and premium of marketable securities, net
(15,749)
(6,222)
844
Loss on sale or disposal of assets
16
—
2
Gain on fair value remeasurement of contingent consideration
—
—
(6,862)
Stock-based compensation expense
34,242
23,890
15,611
Changes in operating assets and liabilities:
Accounts and other receivables
1,928
(2,281)
(175)
Prepaid and other current assets
(19,887)
5,900
(9,572)
Other assets
(9,640)
(3)
—
Accounts payable and accrued expenses
11,634
9,384
3,123
Other liabilities
(5,636)
462
2,726
Net cash used in operating activities
(157,778)
(107,291)
(103,732)
Cash flows from investing activities:
Sales and maturities of marketable securities
501,714
320,597
280,666
Purchases of marketable securities
(789,924)
(424,561)
(188,965)
Acquisition of property and equipment
(1,919)
(1,818)
(1,828)
Proceeds from sale or disposal of assets
—
—
69
Net cash (used in) provided by investing activities
(290,129)
(105,782)
89,942
Cash flows from financing activities:
Net proceeds from stock issuances
432,298
216,222
—
Proceeds from issuance of stock from employee benefit plans
9,151
2,236
4,076
Net cash provided by financing activities
441,449
218,458
4,076
Net (decrease) increase in cash and cash equivalents
(6,458)
5,385
(9,714)
Cash and cash equivalents at beginning of period
34,814
29,429
39,143
Cash and cash equivalents at end of period
$
28,356
$
34,814
$
29,429
Non-cash investing activities
Accrued construction in progress
$
27
$
77
$
113
The accompanying notes are an integral part of the consolidated financial statements.

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CELLDEX THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
(1) Nature of Business and Overview
Celldex Therapeutics, Inc. (the “Company” or “Celldex”) is a biopharmaceutical company dedicated to exploring the science of mast
cell biology and developing therapeutic antibodies which have the ability to engage the human immune system and/or directly affect
critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Our
drug candidates include monoclonal and bispecific antibodies designed to address mast cell mediated diseases for which available
treatments are inadequate. The Company is primarily focusing its efforts and resources on the continued research and development of
barzolvolimab (also referred to as CDX-0159) and CDX-622.
At December 31, 2024, the Company had cash, cash equivalents and marketable securities of $725.3 million. The Company has had
recurring losses and incurred a loss of $157.9 million for the year ended December 31, 2024. Net cash used in operations for the year
ended December 31, 2024 was $157.8 million. The Company believes that the cash, cash equivalents and marketable securities at the
filing date of this Form 10-K will be sufficient to meet estimated working capital requirements and fund planned operations for at least
the next twelve months from the date of issuance of these financial statements.
During the next twelve months and beyond, the Company may take further steps to raise additional capital to meet its long-term
liquidity needs including, but not limited to, one or more of the following: the licensing of drug candidates with existing or new
collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private
placements or public offerings. Although the Company has been successful in raising capital in the past, there can be no assurance that
additional financing will be available on acceptable terms, if at all, and the Company’s negotiating position in capital-raising efforts may
worsen as existing resources are used. There is also no assurance that the Company will be able to enter into further collaborative
relationships. Additional equity financings may be dilutive to the Company’s stockholders; debt financing, if available, may involve
significant cash payment obligations and covenants that restrict the Company’s ability to operate as a business; and licensing or strategic
collaborations may result in royalties or other terms which reduce the Company’s economic potential from products under development.
The Company’s ability to continue funding its planned operations beyond twelve months from the issuance date is also dependent on the
timing and manner of payment of amounts due under the Settlement Agreement with Shareholder Representative Services LLC (“SRS”)
(refer to Note 18), in the event that the Company achieves the milestone related to that payment. The Company, at its option, may decide
to pay that milestone payment in cash, shares of its common stock or a combination thereof. If the Company is unable to raise the funds
necessary to meet its long-term liquidity needs, it may have to delay or discontinue the development of one or more programs,
discontinue or delay ongoing or anticipated clinical trials, discontinue or delay our commercial manufacturing efforts, discontinue or
delay our efforts to expand into additional indications for our drug product candidates, license out programs earlier than expected, raise
funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company.
(2) Summary of Significant Accounting Policies
Basis of Presentation
The balance sheets and statements of operations and comprehensive loss, stockholders’ equity, and cash flows, are consolidated for
the years ended December 31, 2024, 2023 and 2022. These consolidated financial statements reflect the operations of the Company and
its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.
Segment Information
The Company is managed as a single operating and reportable segment that operates in the business of development, manufacturing
and commercialization of novel therapeutics for human health care. Our chief operating decision maker (“CODM”), the Chief Executive
Officer, evaluates performance based on consolidated net loss. Other than general and administrative expenses as presented on the
consolidated statement of operations, research and development expense disaggregated by program and by nature are considered to be
the Company’s significant segment expenses. These results are used, in part, by our CODM in evaluating the performance of the
Company by comparing budget to actual results, and to allocate resources. All revenue is derived in and long-lived

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assets are located in the United States. The CODM does not receive asset information other than what is presented on the consolidated
balance sheets.
The following table is a summary of the Company’s research and development expenses disaggregated by program. The amounts
disclosed reflect direct research and development costs and an allocation of indirect research and development costs to each program.
Year Ended
Year Ended
Year Ended
     December 31, 2024     December 31, 2023    December 31, 2022
(In thousands)
Barzolvolimab/Anti-KIT Program
    $
123,750     $
79,913
$
51,220
CDX-622
 
17,341
 
16,299
 
5,613
CDX-585
 
2,813
 
6,357
 
9,793
Other Programs (a)
 
19,646
 
15,442
 
15,632
Total R&D Expense
$
163,550
$
118,011
$
82,258
(a) Other program expenses primarily include research and development expenses related to early-stage programs, revenue-
generating programs and discontinued programs.
The following table is a summary of the Company’s research and development expenses disaggregated by nature.
Year Ended
Year Ended
Year Ended
     December 31, 2024     December 31, 2023     December 31, 2022
(In thousands)
Personnel
    $
51,906     $
40,121     $
32,674
Laboratory Supplies
 
5,611
 
5,358
 
6,310
Facility
 
5,094
 
4,970
 
4,764
Product Development (b)
 
90,604
 
59,319
 
32,156
Other Expenses (c)
 
10,335
 
8,243
 
6,354
Total R&D Expense
$
163,550
$
118,011
$
82,258
(b) Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs,
contracted research and outside clinical drug product manufacturing.
(c) Other expenses primarily include research and development consulting, insurance, licensing and software expenses.
Use of Estimates
The preparation of the financial statements in conformity with accounting principles generally accepted in the United States of
America (U.S. GAAP) requires management to make estimates and use assumptions that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with a maturity date of 90 days or less at the date of purchase to be
cash equivalents. Cash equivalents consist principally of money market funds and debt securities.
Marketable Securities
The Company invests its excess cash balances in marketable securities, including municipal bond securities, U.S. government
agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the
balance sheets because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value
with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate
component of stockholders’ equity. Each reporting period, the Company evaluates its investment portfolio to determine if any security is
impaired and if an allowance for credit losses should be recorded. As part of this evaluation, the Company considers whether it has the
ability and intent to hold the investment until recovery of its amortized cost basis and whether the decline in fair

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value is due to any credit related factors. If an impairment is the result of a credit loss, the Company recognizes an allowance for credit
losses. Realized gains and losses are determined on the specific identification method and are included in investment and other income,
net.
Concentration of Credit Risk and of Significant Customers and Suppliers
Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash
equivalents, marketable securities and accounts receivable. The Company invests its cash, cash equivalents and marketable securities in
debt instruments and interest-bearing accounts at major financial institutions in excess of insured limits. The Company mitigates credit
risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. The
Company has not historically experienced credit losses from its accounts receivable and therefore has not established an allowance for
doubtful accounts.
Revenue from Rockefeller University represented 100%, 95% and 75% of total Company revenue for the years ended December 31,
2024, 2023 and 2022, respectively.
The Company relies on contract development & manufacturing organizations (CDMOs) to manufacture drug substance and drug
product as well as for future commercial supplies. The Company also relies on CDMOs for supply of raw materials as well as filling,
packaging, storing and shipping our drug products.
Fair Value Measurements
The Company has certain assets and liabilities that are measured at fair value in the financial statements. The Company seeks to
maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of
unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities) when measuring the
fair value of its assets and liabilities. These assets and liabilities are classified into one of three levels of the following fair value
hierarchy as defined by U.S. GAAP:
Level 1: Observable inputs such as quoted prices in active markets for identical assets or liabilities. An active market for an asset or
liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing
information on an ongoing basis.
Level 2: Observable inputs other than Level 1 prices, such as quoted prices in active markets for similar assets or liabilities and
quoted prices for identical assets or liabilities in markets that are not active.
Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing
the asset or liability.
Property and Equipment
Property and equipment are stated at cost and depreciated over the estimated useful lives of the related assets using the straight-line
method. Laboratory equipment and office furniture and equipment are depreciated over five years, and computer equipment is
depreciated over three years. Manufacturing equipment is depreciated over seven to ten years. Leasehold improvements are amortized
over the shorter of the estimated useful life or the non-cancelable term of the related lease, including any renewals that are reasonably
assured of occurring. Property and equipment under construction is classified as construction in progress and is depreciated or amortized
only after the asset is placed in service. Expenditures for maintenance and repairs are charged to expense whereas the costs of significant
improvements which extend the life of the underlying asset are capitalized. Upon retirement or sale, the cost of assets disposed of and the
related accumulated depreciation are eliminated and any resulting gain or loss is reflected in the Company’s statements of operations and
comprehensive loss.
The treatment of costs to construct property and equipment depends on the nature of the costs and the stage of construction. Costs
incurred in the project planning, design, construction and installation phases are capitalized as part of the cost of the asset. The Company
stops capitalizing these costs when the asset is substantially complete and ready for its intended use. For manufacturing property and
equipment, the Company also capitalizes the cost of validating these assets for the underlying manufacturing process. The Company
completes the capitalization of validation costs when the asset is substantially complete and ready for its intended use. Costs capitalized
include incremental labor and fringe benefits, and direct consultancy services.

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Leases
The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms of one to three
years and may include one or more options to renew or terminate early.
The Company determines if an arrangement contains a lease at inception. Operating lease right-of-use assets and lease liabilities are
recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Certain
adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments, initial direct costs paid or
incentives received. The Company’s leases do not contain an implicit rate, and therefore the Company uses an estimated incremental
borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments.
Options to extend or terminate the lease are reflected in the calculation when it is reasonably certain that the option will be exercised.
The Company has elected to account for lease and non-lease components as a single lease component, however non-lease components
that are variable, such as common area maintenance and utilities, are generally paid separately from rent based on actual costs incurred
and therefore are not included in the right-of-use asset and operating lease liability and are reflected as an expense in the period incurred.
Leases with an initial term of 12 months or less are not recorded on the balance sheet.
Contingent Consideration
The Company records contingent consideration resulting from a business combination at its fair value on the acquisition date. The
Company determines the fair value of the contingent consideration based primarily on the (i) timing and probability of success of clinical
events or regulatory approvals; (ii) timing and probability of success of meeting clinical and commercial milestones; and (iii) discount
rates. The Company’s contingent consideration liabilities arose in connection with its acquisition of Kolltan. On a quarterly basis, the
Company revalues these obligations and records increases or decreases in their fair value as an adjustment to operating earnings.
Changes to contingent consideration obligations can result from adjustments to discount rates, accretion of the discount rates due to the
passage of time, changes in the Company’s estimates of the likelihood or timing of achieving development or commercial milestones,
changes in the probability of certain clinical events or changes in the assumed probability associated with regulatory approval. The
assumptions related to determining the value of contingent consideration include a significant amount of judgment, and any changes in
the underlying estimates could have a material impact on the amount of contingent consideration adjustment recorded in any given
period.
Intangible Assets
IPR&D assets acquired in a business combination initially are recorded at fair value and accounted for as indefinite-lived intangible
assets. The valuation model used to measure the fair value of the Company’s IPR&D assets was primarily a discounted cash flow
approach. The assumptions used in determining the fair value of the Company’s IPR&D assets include (i) probability of success; (ii)
probability of partnership; (iii) partnership milestones; and (iv) discount rate. These assets are capitalized on the Company’s balance
sheets until either the project underlying them is completed or the assets become impaired. If a project is completed, the carrying value of
the related intangible asset is amortized over the remaining estimated life of the asset beginning in the period in which the project is
completed. If a project becomes impaired or is abandoned, the carrying value of the related intangible asset is written down to its fair
value and an impairment charge is taken in the period in which the impairment occurs.
Each IPR&D asset is assessed for impairment at least annually or when impairment indicators are present. The Company has the
option to assess qualitative factors to determine if it is more likely than not that the IPR&D asset is impaired and whether it is necessary
to perform a quantitative impairment test.
Impairment of Intangible and Long-Lived Assets
The Company evaluates the recoverability of its long-lived assets, including property and equipment, right-of-use assets, and
intangible assets when circumstances indicate that an event of impairment may have occurred. Determination of recoverability is based
on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such
cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated
fair values.

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86
Revenue Recognition
Revenues are recognized when performance obligations under agreements or contracts are satisfied, in an amount that reflects the
consideration the Company expects to be entitled to in exchange for those services.
The Company determines revenue recognition through the following steps:
●
Identification of the contract, or contracts, with a customer;
●
Identification of the performance obligations in the contract;
●
Determination of the transaction price;
●
Allocation of the transaction price to the performance obligations in the contract; and
●
Recognition of revenue when, or as, the Company satisfies a performance obligation.
Revenue for the Company is derived from product development agreements with collaborative partners for the research and
development of therapeutic drug candidates. The terms of the agreements may include nonrefundable signing and licensing fees, funding
for research, development and manufacturing, milestone payments and royalties on any product sales derived from collaborations. The
Company assesses the multiple obligations typically within product development contracts to determine the distinct performance
obligations and how to allocate the arrangement consideration to each distinct performance obligation. Under product development
agreements, revenue is generally recognized using a cost-to-cost measure of progress. Revenue is recognized based on the costs incurred
to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds
with, and thereby best depicts, the transfer of control to the customer. Due to the nature of the work performed in these arrangements, the
estimation of cost at completion is complex, subject to many variables, such as expected clinical trial costs, and requires significant
judgements. Circumstances can arise that change original estimates of costs or progress toward completion. Any revisions to estimates
are reflected in revenue on a cumulative catch-up basis in the period in which the change in circumstances became known.
Revenue for the Company is also derived from manufacturing and research and development arrangements. The Company operates
a cGMP manufacturing facility in Fall River, Massachusetts, to produce drug substance for its current and planned early-stage clinical
trials. In order to utilize excess capacity, the Company has, from time to time, entered into contract manufacturing and research and
development arrangements in which services are provided on a time-and-material basis or at a negotiated fixed price. Revenue from
time-and-material contracts is generally recognized on an output basis as labor hours and/or direct expenses are incurred. Under fixed-
price contracts, revenue is generally recognized on an output basis as progress is made toward completion of the performance obligations
using surveys of performance completed to date.
Contract Assets and Liabilities
The Company classifies the right to consideration in exchange for products or services transferred to a client as either a receivable or
a contract asset. A receivable is a right to consideration that is unconditional as compared to a contract asset which is a right to
consideration that is conditional upon factors other than the passage of time.
The Company’s contract liabilities result from arrangements where the Company has received payment in advance of performance
under the contract. These amounts are included as deferred revenue within current portion of long-term liabilities on the consolidated
balance sheets.
Research and Development Expenses
Research and development costs, including internal and contract research costs, are expensed as incurred. Research and development
expenses consist mainly of clinical trial costs, manufacturing of clinical material, toxicology and other preclinical studies, personnel
costs, depreciation, license fees and funding of outside contracted research.

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Clinical trial expenses include expenses associated with clinical research organization, or CRO, services. Contract manufacturing
expenses include expenses associated with contract development & manufacturing organization, or CDMO, services. The invoicing from
CROs and CDMOs for services rendered can lag several months. The Company accrues the cost of services rendered in connection with
CRO and CDMO activities based on our estimate of costs incurred. The Company maintains regular communication with our CROs and
CDMOs to assess the reasonableness of its estimates. Differences between actual expenses and estimated expenses recorded have not
been material and are adjusted for in the period in which they become known.
Patent Costs
Patent costs are expensed to general and administrative expense as incurred. Certain patent costs are reimbursed by the Company’s
product development and licensing partners. Any reimbursed patent costs are recorded as product development and licensing agreement
revenues in the Company’s consolidated financial statements.
Stock-Based Compensation
The Company records stock-based compensation expense for all stock-based awards made to employees, consultants and non-
employee directors based on the estimated fair values of the stock-based awards expected to vest at the grant date and adjusts, if
necessary, to reflect actual forfeitures. Compensation expense for all stock-based awards is recognized using the straight-line method
over the term of vesting or performance.
Foreign Currency Translation
Net unrealized gains and losses resulting from foreign currency translation are included in accumulated other comprehensive
income. At December 31, 2024 and 2023, accumulated other comprehensive income includes a net unrealized gain related to foreign
currency translation of $2.6 million.
Income Taxes
The Company uses the asset and liability method to account for income taxes, including the recognition of deferred tax assets and
deferred tax liabilities for the anticipated future tax consequences attributable to differences between financial statement amounts and
their respective tax basis. Quarterly, the Company reviews its deferred tax assets for recovery. A valuation allowance is established when
the Company believes that it is more likely than not that its deferred tax assets will not be realized. Changes in valuation allowances from
period to period are included in the Company’s tax provision in the period of change.
The Company records uncertain tax positions in the financial statements only if it is more likely than not that the uncertain tax
position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain
tax positions in income tax expense.
Comprehensive Loss
Comprehensive loss is comprised of net loss and certain changes in stockholders’ equity that are excluded from net loss. The
Company includes foreign currency translation adjustments and unrealized gains and losses on marketable securities in other
comprehensive loss. The statements of operations and comprehensive loss reflect total comprehensive loss for the years ended December
31, 2024, 2023 and 2022.

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Net Loss Per Share
Basic net loss per common share is based upon the weighted-average number of common shares outstanding during the period,
excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is based upon the weighted-
average number of common shares outstanding during the period plus additional weighted-average potentially dilutive common shares
outstanding during the period when the effect is dilutive. In periods in which the Company reports a net loss, there is no difference
between basic and diluted net loss per share because dilutive shares of common stock are not assumed to have been issued as their effect
is anti-dilutive. The potentially dilutive common shares that have not been included in the net loss per common share calculations
because the effect would have been anti-dilutive are as follows:
Year Ended December 31, 
    
2024
    
2023
    
2022
Stock options
7,540,109
6,378,924
5,085,662
Newly-Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07 Segment Reporting - Improvements to Reportable Segment Disclosures, which
improves reportable segment disclosure requirements, primarily through enhanced disclosure of significant segment expenses. The
amendments in ASU 2023-07 apply to public entities, including those with a single reportable segment. The Company retrospectively
adopted this ASU for its fiscal year ended December 31, 2024.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other
standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company
believes that the adoption of recently issued standards that are not yet effective will not have a material impact on the Company’s
consolidated financial statements or disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which
requires public entities to disclose specific categories in the effective tax rate reconciliation, as well as additional information for
reconciling items that exceed a quantitative threshold. ASU 2023-09 also requires all entities to disclose income taxes paid disaggregated
by federal, state and foreign taxes, and further disaggregated for specific jurisdictions that exceed 5% of total income taxes paid, among
other expanded disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted.
The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its consolidated financial statements and
related disclosures.
In March 2024, the SEC adopted final rules requiring public entities to provide certain climate-related information in their
registration statements and annual reports. The rules require disclosure of, among other things: material climate-related risks; activities to
mitigate or adapt to such risks; governance and management of such risks; and material greenhouse gas (GHG) emissions from
operations owned or controlled (Scope 1) and/or indirect emissions from purchased energy consumed in operations (Scope 2).
Additionally, the rules require disclosure in the notes to the financial statements of the effects of severe weather events and other natural
conditions, subject to certain materiality thresholds. In April 2024, the SEC voluntarily stayed the new rules as a result of pending legal
challenges. Absent the result of pending legal challenges, and the removal of the stay, the rules were to become effective on a phased-in
timeline, with the first requirements to be adopted for the Company’s fiscal year beginning in 2025. The Company is assessing the effect
of the new rules on its consolidated financial statements and related disclosures.

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89
(3) Accumulated Other Comprehensive Income
The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the year
ended December 31, 2024 are summarized below:
    
Unrealized 
    
    
Gain (Loss) on
Marketable
Foreign
Securities
Currency Items
Total
(In thousands)
Balance at December 31, 2023
$
712
$
2,596
$
3,308
Other comprehensive gain
6
—
6
Balance at December 31, 2024
$
718
$
2,596
$
3,314
No amounts were reclassified out of accumulated other comprehensive income during the years ended December 31, 2024, 2023 and
2022.
(4) Fair Value Measurements
The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements:
    
As of
    
    
    
December 31, 2024
Level 1
Level 2
Level 3
(In thousands)
Assets:
Money market funds and cash equivalents
$
9,927  
—
$
9,927
 
—
Marketable securities
696,925  
—
696,925
 
—
$
706,852
—
$
706,852
—
    
As of
    
    
    
December 31, 2023
Level 1
Level 2
Level 3
(In thousands)
Assets:
Money market funds and cash equivalents
$
19,803  
—
$
19,803
 
—
Marketable securities
388,784  
—
388,784
 
—
$
408,587
—
$
408,587
—
The Company’s financial assets consist mainly of cash equivalents and marketable securities and are classified as Level 2 within the
valuation hierarchy. The Company values its marketable securities utilizing independent pricing services which normally derive security
prices from recently reported trades for identical or similar securities, making adjustments based on significant observable transactions.
At each balance sheet date, observable market inputs may include trade information, broker or dealer quotes, bids, offers or a
combination of these data sources.
Contingent consideration liabilities measured at fair value using Level 3 inputs were $0.0 million as of December 31, 2024 and
December 31, 2023. The valuation technique used to measure fair value of the Company’s Level 3 liabilities, which consist of contingent
consideration related to the acquisition of Kolltan Pharmaceuticals, Inc. (“Kolltan”) in 2016, is primarily an income approach. The
significant unobservable inputs used in the fair value measurement of the contingent consideration are estimates including probability of
success, discount rates and amount of time until the conditions of the milestone payment are met.
During the year ended December 31, 2022, the Company recorded a $6.9 million gain on fair value remeasurement of contingent
consideration primarily due to the Company’s decision to deprioritize the CDX-1140 program. The assumptions related to determining
the value of contingent consideration include a significant amount of judgment, and any changes in the underlying estimates could have a
material impact on the amount of contingent consideration adjustment recorded in any given period.
The Company did not have any transfers of assets or liabilities between the fair value measurement classifications during the years
ended December 31, 2024 and 2023.

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90
(5) Marketable Securities
The following is a summary of marketable debt securities, classified as available-for-sale:
    
    
Gross
    
Gross
    
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
(In thousands)
December 31, 2024
Marketable securities
U.S. government and municipal obligations
Maturing in one year or less
$ 185,388
$
467
$
—
$ 185,855
Maturing after one year through three years
102,331
316
(144)
102,503
Total U.S. government and municipal obligations
$ 287,719
$
783
$
(144)
$ 288,358
Corporate debt securities
Maturing in one year or less
$ 336,350
$
350
$
(54)
$ 336,646
Maturing after one year through three years
72,139
36
(254)
71,921
Total corporate debt securities
$ 408,489
$
386
$
(308)
$ 408,567
Total marketable securities
$ 696,208
$
1,169
$
(452)
$ 696,925
December 31, 2023
Marketable securities
U.S. government and municipal obligations
Maturing in one year or less
$ 132,459
$
143
$
(53)
$ 132,549
Maturing after one year through three years
26,009
77
—
26,086
Total U.S. government and municipal obligations
$ 158,468
$
220
$
(53)
$ 158,635
Corporate debt securities
Maturing in one year or less
$ 183,625
$
300
$
(10)
$ 183,915
Maturing after one year through three years
45,977
257
—
46,234
Total corporate debt securities
$ 229,602
$
557
$
(10)
$ 230,149
Total marketable securities
$ 388,070
$
777
$
(63)
$ 388,784
The Company holds investment grade marketable securities. Unrealized losses are generally attributable to changes in interest rates.
The aggregate fair value of marketable securities held by the Company in an unrealized loss position as of December 31, 2024 and
December 31, 2023 was $142.5 million and $80.4 million, respectively. The Company has the intent and ability to hold its marketable
securities until recovery and has determined that there has been no material change to the Company’s credit risk. As a result, the
Company determined it did not hold any investments with a credit loss at December 31, 2024.
Marketable securities include $6.1 million and $1.9 million in accrued interest at December 31, 2024 and 2023, respectively.
(6) Property and Equipment, Net
Property and Equipment, net includes the following:
     December 31,       December 31, 
2024
2023
(In thousands)
Laboratory equipment
$
10,411
$
9,848
Manufacturing equipment
 
3,010  
2,419
Office furniture and equipment
 
3,965  
3,738
Leasehold improvements
 
10,285  
9,653
Construction in progress
 
139  
787
Total property and equipment
 
27,810  
26,445
Less: accumulated depreciation and amortization
 
(23,464) 
(22,385)
Property and equipment, net
$
4,346
$
4,060

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91
Depreciation and amortization expense related to property and equipment was $1.6 million, $1.5 million and $1.4 million for the
years ended December 31, 2024, 2023 and 2022, respectively.
(7) Leases
The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms of one to three
years and may include one or more options to renew.
During the years ended December 31, 2024, 2023 and 2022, the Company recorded right of use assets and lease liabilities of $2.9
million, $0.1 million and $2.5 million related to new leases and lease extensions, respectively.
Operating lease expense was $2.0 million, $1.9 million and $1.9 million for years ended December 31, 2024, 2023 and 2022,
respectively. Variable lease expense was $0.8 million, $0.8 million and $0.8 million for years ended December 31, 2024, 2023 and 2022,
respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $2.0 million, $2.0 million and $1.9
million for the years ended December 31, 2024, 2023 and 2022, respectively. As of December 31, 2024, the weighted-average remaining
lease term was 2 years and the weighted-average discount rate was 10.0%, compared to a weighted-average remaining lease term of 2
years and weighted average discount rate of 10.0% as of December 31, 2023.
Future minimum lease payments under non-cancellable leases as of December 31, 2024 were as follows:
2025
     $
1,761
2026
1,779
2027
 
742
Total lease payments
 
4,282
Less imputed interest
 
(469)
Present value of operating lease liabilities
$
3,813
(8) Intangible Assets
At December 31, 2024 and 2023, the carrying value of the Company’s indefinite-lived intangible assets was $27.2 million.
Indefinite-lived intangible assets consist of acquired in-process research and development (“IPR&D”) related to the development of the
anti-KIT program (including barzolvolimab). Barzolvolimab is in Phase 3 development. As of December 31, 2024, the IPR&D asset
related to the anti-KIT program had not reached technological feasibility nor did the asset have alternative future uses.
The Company performs an impairment test on IPR&D assets at least annually, or more frequently if events or changes in
circumstances indicate that IPR&D assets may be impaired.
The Company performed its annual impairment test of the IPR&D asset related to the development of the anti-KIT program
(including barzolvolimab) during the fourth quarter of 2024 and concluded that the IPR&D asset was not impaired. Due to the nature of
IPR&D projects, the Company may experience future delays or failures to obtain regulatory approvals to conduct clinical trials, failures
of such clinical trials or other failures to achieve a commercially viable product, and as a result, may recognize further impairment losses
in the future.
(9) Other Assets
The Company records advance payments for services that will not be performed within one year of the balance sheet date as other
assets. Such amounts will be recognized as expense in the period in which the related services are performed. Advance payments
reflected within other assets in our consolidated balance sheets were $9.6 million and $0.0 million at December 31, 2024 and December
31, 2023, respectively.

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92
(10) Accrued Expenses
Accrued expenses include the following:
    
December 31,
    
December 31,
2024
2023
(In thousands)
Accrued payroll and employee benefits
$
11,568
$
9,348
Accrued research and development contract costs
20,544
10,864
Accrued professional fees
1,392
1,439
Other accrued expenses
338
378
$
33,842
$
22,029
(11) Other Long-Term Liabilities
Other long-term liabilities include the following:
    
December 31,      
December 31, 
2024
2023
(In thousands)
Net deferred tax liabilities related to IPR&D (Note 16)
$
1,613
$
1,613
Deferred income from sale of tax benefits
2,790
3,720
Deferred revenue (Note 14)
12
3,058
Total
4,415
8,391
Less current portion
(942)
(3,988)
Long-term portion
$
3,473
$
4,403
In March 2022, the Company received approval from the New Jersey Economic Development Authority and agreed to sell New
Jersey tax benefits of $5.0 million to an independent third party for $4.7 million. Under the agreement, the Company must maintain a
base of operations in New Jersey for five years or the tax benefits must be paid back on a pro-rata basis based on the number of years
completed. The Company recognized $0.9 million in other income related to the sale of these tax benefits during the years ended
December 31, 2024 and 2023.
(12) Stockholders’ Equity
Common Stock
In November 2023, the Company filed an automatic shelf registration statement with the SEC to register for sale any combination of
the types of securities described in the shelf registration statement, including shares of its common stock. Also in November 2023, the
Company issued 8,538,750 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of
$216.2 million, after deducting underwriting fees and offering expenses.
On February 26, 2024, the Company entered into a controlled equity offering sales agreement (“ATM Agreement”) with Cantor
Fitzgerald & Co. (“Cantor”) to allow the Company to issue and sell shares of its common stock from time to time through Cantor, acting
as agent. At December 31, 2024, the Company had registered $300.0 million of its common stock to be sold pursuant to the Company’s
ATM Agreement, all of which remained unsold as of that date.
In March 2024, the Company issued 9,798,000 shares of its common stock in an underwritten public offering resulting in net
proceeds to the Company of $432.3 million, after deducting underwriting fees and offering expenses.
Convertible Preferred Stock
At December 31, 2024, the Company had authorized 3,000,000 shares of preferred stock all of which have been designated Class C
Preferred Stock including 350,000 shares which have been designated Series C-1 Junior Participating Cumulative Preferred Stock (the
“Series C-1 Preferred Stock”). No shares of Series C-1 Preferred Stock were outstanding at December 31, 2024 or 2023.

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93
(13) Stock-Based Compensation
The Company has the following stock-based compensation plans: the 2004 Employee Stock Purchase Plan (the “2004 ESPP Plan”),
the 2008 Stock Option and Incentive Plan (the “2008 Plan”) and the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). There are
no shares available for future grant under the 2008 Plan. Outstanding options under the 2008 Plan will be rolled into the 2021 Plan if
canceled.
Employee Stock Purchase Plan
At December 31, 2024, a total of 276,666 shares of common stock are reserved for issuance under the 2004 ESPP Plan. Under the
2004 ESPP Plan, each participating employee may purchase shares of common stock through payroll deductions at a purchase price
equal to 85% of the lower of the fair market value of the common stock at either the beginning of the offering period or the applicable
exercise date. During the years ended December 31, 2024, 2023 and 2022, the Company issued 13,187, 12,729 and 12,243 shares under
the 2004 ESPP Plan, respectively. At December 31, 2024, 150,316 shares were available for issuance under the 2004 ESPP Plan.
Employee Stock Option Plan
The 2021 Plan permits the granting of incentive stock options (intended to qualify as such under Section 422A of the Internal
Revenue Code of 1986, as amended), non-qualified stock options, stock appreciation rights, performance share units, restricted stock and
other awards of restricted stock to employees, consultants and non-employee directors.
The 2021 Plan allows for grants of new awards until April 19, 2031. As of December 31, 2024, there were 1,513,850 shares
outstanding under the 2008 Plan that will be rolled into the 2021 Plan if canceled. The Company’s Board of Directors determines the
term of each option, option price, and number of shares for which each option is granted and the rate at which each option vests. Options
generally vest over a period not to exceed four years. The term of each option cannot exceed ten years (five years for options granted to
holders of more than 10% of the voting stock of the Company), and the exercise price of stock options cannot be less than the fair market
value of the common stock at the date of grant (110% of fair market value for incentive stock options granted to holders of more than
10% of the voting stock of the Company). Vesting of all employee and non-employee director stock option awards may accelerate upon a
change in control as defined in the 2021 Plan.
A summary of stock option activity for the year ended December 31, 2024 is as follows:
    
    
Weighted
    
Weighted
Average
Average
Exercise
Remaining
Price
Contractual
Shares
Per Share
Term (In Years)
Options outstanding at December 31, 2023
6,378,924
$
29.69
7.5
Granted
1,959,320
$
36.22
—
Exercised
(679,985)
$
12.98
—
Canceled
(118,150)
$
120.67
—
Options outstanding at December 31, 2024
7,540,109
$
31.47
7.5
Options vested and expected to vest at December 31, 2024
7,416,025
$
31.41
7.4
Options exercisable at December 31, 2024
3,980,565
$
29.17
6.3
Shares available for grant under the Celldex Therapeutics, Inc. 2021 Omnibus Equity
Incentive Plan (as amended, effective as of June 13, 2024) at December 31, 2024
2,372,333
—
—
The total intrinsic value of stock options exercised during the years ended December 31, 2024, 2023 and 2022 was $17.2 million,
$2.7 million and $12.8 million, respectively. The weighted average grant-date fair value of stock options granted during the years ended
December 31, 2024, 2023 and 2022 was $26.21, $28.15 and $17.60, respectively. The total fair value of stock options vested during the
years ended December 31, 2024, 2023 and 2022 was $32.4 million, $20.4 million and $15.6 million, respectively.

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94
The aggregate intrinsic value of stock options outstanding at December 31, 2024 was $24.4 million. The aggregate intrinsic value of
stock options vested and expected to vest at December 31, 2024 was $24.4 million. The aggregate intrinsic value of stock options
exercisable at December 31, 2024 was $23.0 million. As of December 31, 2024, total compensation cost related to non-vested employee
and non-employee director stock options not yet recognized was approximately $77.1 million, net of estimated forfeitures, which is
expected to be recognized as expense over a weighted average period of 2.6 years.
Valuation and Expenses Information
Stock-based compensation expense for the years ended December 31, 2024, 2023 and 2022 was recorded as follows:
    
2024
    
2023
    
2022
(In thousands)
Research and development
$
17,442
$
11,948
$
8,082
General and administrative
16,800
11,942
7,529
Total stock-based compensation expense
$
34,242
$
23,890
$
15,611
The fair values of employee and director stock options granted during the years ended December 31, 2024, 2023 and 2022 were
valued using the Black-Scholes option pricing model with the following assumptions:
    
2024
    
2023
    
2022
Expected stock price volatility
82 -93%
92%
90 - 97%
Expected option term
6.0 Years
6.0 Years
6.0 Years
Risk-free interest rate
3.5 - 4.5%
3.5 - 4.7%
1.7 - 4.2%
Expected dividend yield
None
None
None
The Company estimates expected term based on historical exercise patterns. The Company uses its historical stock price volatility
consistent with the expected term of grant as the basis for its expected volatility assumption. The risk-free interest rate is based upon the
yield of U.S. Treasury securities consistent with the expected term of the option. The dividend yield assumption is based on the
Company’s history of zero dividend payouts and expectation that no dividends will be paid in the foreseeable future.
(14) Revenue
Contract and Grants Revenue
The Company has entered into agreements with Rockefeller University (“Rockefeller”) pursuant to which the Company performs
manufacturing and research and development services on a time-and-materials basis or at a negotiated fixed price. The Company
recognized $7.0 million, $6.6 million and $1.8 million in revenue under the agreements with Rockefeller during the years ended
December 31, 2024, 2023 and 2022, respectively.
Contract Assets and Liabilities
At December 31, 2024 and 2023, the Company’s right to consideration under all contracts was considered unconditional, and as
such, there were no recorded contract assets. At December 31, 2024, the Company had no material contract liabilities recorded. At
December 31, 2023, the Company had $3.1 million in contract liabilities recorded. Revenue recognized from contract liabilities as of
December 31, 2023 during the year ended December 31, 2024 was $3.1 million.
(15) Collaboration Agreements
The Company has entered into license agreements whereby the Company has received licenses or options to license technology,
specified patents and/or patent applications. These license and collaboration agreements generally provide for royalty payments equal to
specified percentages of product sales, annual license maintenance fees, continuing patent prosecution costs and potential future
milestone payments to third parties upon the achievement of certain development, regulatory and/or commercial milestones.
Nonrefundable license fee expense of $0.2 million, $0.3 million and $0.1 million was recorded to research and development expense for
the years ended December 31, 2024, 2023 and 2022, respectively.

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95
Yale University (Yale)
Under a license agreement with Yale, the Company may be required to make a one-time payment to Yale of $3.0 million with
respect to barzolvolimab upon achievement of a specified commercial milestone. In addition, the Company may be required to pay a low
single-digit royalty on annual worldwide net sales of barzolvolimab. Unless earlier terminated by us or Yale, the Yale license agreement
is due to expire no later than May 2038 but may expire earlier on a country-by-country basis under specified circumstances.
(16) Income Taxes
The components of income tax benefit (provision) are as follows:
Year Ended December 31, 
    
2024
    
2023
    
2022
(In thousands)
Income tax benefit (provision):
Federal
$ 39,821
$ 36,067
$ 17,484
State
15,375
13,691
9,606
Expiration of NOLs and R&D credit
(82,825)
(15,141)
(16,862)
(27,629)
34,617
10,228
Deferred tax valuation allowance
27,629
(34,617)
(10,228)
$
—
$
—
$
—
A reconciliation between the amount of reported income tax and the amount computed using the U.S. statutory rate is as follows:
    
2024
    
2023
    
2022
(In thousands)
Pre-tax loss
$ (157,863)
$ (141,429)
$ (112,325)
Loss at statutory rates
(33,151)
(29,700)
(23,588)
Research and development credits
(7,332)
(5,237)
(3,876)
State taxes
(15,375)
(13,691)
(9,606)
Other
662
(1,130)
11,421
Change in fair value remeasurement of contingent consideration
—
—
(1,441)
Expiration of Federal and State NOLs and R&D credits
82,825
15,141
16,862
Change in valuation allowance
(27,629)
34,617
10,228
Income tax (benefit) provision
$
—
$
—
$
—

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96
Deferred tax assets and liabilities are recognized based on temporary differences between the financial reporting and tax basis of
assets and liabilities using future expected enacted rates. The principal components of the deferred tax assets and liabilities at December
31, 2024 and 2023 are as follows:
     December 31,       December 31, 
2024
2023
(In thousands)
Gross deferred tax assets
Net operating loss carryforwards
$
176,816
$
197,618
Tax credit carryforwards
24,718
56,830
Deferred research and development expenses
101,047
82,077
Stock-based compensation
20,940
14,671
Fixed assets
1,033
1,019
Accrued expenses and other
429
398
324,983
352,613
Gross deferred tax liabilities
IPR&D intangibles
(6,840)
(6,840)
Total deferred tax assets and liabilities
318,143
345,773
Valuation allowance
(319,756)
(347,386)
Net deferred tax liability
$
(1,613)
$
(1,613)
The Company has evaluated the positive and negative evidence bearing upon the realizability of its net deferred tax assets and
considered its history of losses, ultimately concluding that it is “more likely than not” that the Company will not recognize the benefits of
federal, state and foreign deferred tax assets and, as such, has maintained a full valuation allowance on its deferred tax assets.
The net deferred tax liability of $1.6 million at December 31, 2024 and 2023, relates to the temporary differences associated with the
IPR&D intangible assets acquired in previous business combinations and are not deductible for tax purposes.
As of December 31, 2024, the Company had federal and state net operating loss carryforwards of $566.0 million and $888.8 million,
respectively, which may be available to offset certain future income tax liabilities. State net operating loss carryforwards begin to expire
in 2024. The federal net operating loss carryforwards of $566.0 million are from 2005 through 2024 and begin to expire in 2024. As of
December 31, 2024, the Company also had federal and state research and development tax credit carryforwards of $19.8 million and $6.3
million, respectively, which may be available to offset future income tax liabilities and begin to expire in 2040 and 2029, respectively.
Utilization of the net operating loss carryforwards and research and credit carryforwards may be subject to a substantial annual
limitation under Section 382 of the Internal Revenue Code of 1986, or Section 382, due to ownership changes that occurred previously or
that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset
future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of
certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has
performed a study under Internal Revenue Code Section 382 as of June 30, 2024, and concluded that a change in ownership following
stock issuances in 2016 and 2020 triggered Section 382 limitations and approximately $758.7 million of federal NOL carryforwards and
$48.7 million of federal tax credit carryforwards that were generated through June 30, 2020 will expire unutilized due to Section 382 and
383 limitations. The Company also estimated the amounts of State net operating loss and research and development tax credit
carryforwards which will expire unutilized as a result of its annual limitations under Section 382 and has excluded those amounts from
the carryforward amounts disclosed above and in the deferred tax assets and liabilities table included in this footnote.
As of December 31, 2024 and 2023, the Company did not have any unrecognized tax benefits.
Massachusetts, New Jersey, New York and Connecticut are the jurisdictions in which the Company primarily operates or has
operated and has income tax nexus. The Company is not currently under examination by these or any other jurisdictions for any tax year.
Generally, in U.S. federal and state taxing jurisdictions, all years which generated net operating losses and/or tax credit carryforwards
remain subject to examination to the extent those carryforwards are utilized in a subsequent period.

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97
(17) Retirement Savings Plan
The Company maintains a 401(k) Plan which is available to substantially all employees. Under the terms of the 401(k) Plan,
participants may elect to contribute up to 60% of their compensation or the statutory prescribed limits. The Company may make 50%
matching contributions on up to 4% of a participant’s annual salary. Benefit expense for the 401(k) Plan was $0.5 million, $0.5 million
and $0.4 million for the years ended December 31, 2024, 2023 and 2022, respectively.
(18) Kolltan Acquisition
On November 29, 2016, the Company acquired all of the share and debt interests of Kolltan, a clinical-stage biopharmaceutical
company, in exchange for 1,217,200 shares of the Company’s common stock plus contingent consideration in the form of development,
regulatory approval and sales-based milestones (“Kolltan Milestones”) of up to $172.5 million payable in cash, in shares of Celldex’s
common stock or a combination of both, in the sole discretion of Celldex and subject to provisions of the Agreement and Plan of Merger,
dated November 1, 2016 (the “Merger Agreement”).
In October 2019, the Company received a letter from SRS, the hired representative of the former stockholders of Kolltan, notifying
the Company that it objected to the Company’s characterization of the development, regulatory approval and sales-based Kolltan
Milestones relating to CDX-0158 as having been abandoned and contending instead that the related milestone payments are due from
Celldex to the Kolltan stockholder.
On August 18, 2020, Celldex filed a Verified Complaint in the Court of Chancery of the State of Delaware against SRS (acting in its
capacity as the representative of the former stockholders of Kolltan pursuant to the Merger Agreement) seeking declaratory relief with
respect to the rights and obligations of the parties relating to certain contingent milestone payments under the Merger Agreement relating
to the discontinued CDX-0158 program (the “Litigation”).
On July 15, 2022, the Company entered into a definitive settlement agreement between the Company and SRS (the “Settlement
Agreement”) and the Company and SRS jointly filed a Stipulation of Dismissal with prejudice relating to the Litigation on July 19, 2022.
Pursuant to the terms of the Settlement Agreement, all milestone payments provided for by the Merger Agreement were replaced in
their entirety with the following payments, each of which is payable only once:
(i)
The Company paid $15.0 million upon execution of the Settlement Agreement (the “Initial Payment”).
(ii) The Company paid $12.5 million upon the Successful Completion (as defined in the Settlement Agreement) of a Phase 2
Clinical Trial (as defined in the Merger Agreement) of barzolvolimab.
(iii) The Company shall pay $52.5 million upon the first United States Food and Drug Administration or European Medicines
Agency, or, in each case, any successor organization, regulatory approval of a Surviving Company Product (as defined in the
Settlement Agreement).
The above payment obligations replace, in their entirety, the contingent consideration in the form of development, regulatory
approval and sales-based milestones of up to $172.5 million contained in the Merger Agreement.
Under the Settlement Agreement, each of the Company and SRS provided broad mutual releases of all claims relating to or arising
out of the Merger Agreement, including without limitation, all claims brought in the Litigation or that could have been brought in the
Litigation.
The Company paid the Initial Payment in cash in July 2022. The Company paid the second milestone for “successful completion” of
a Phase 2 Clinical Trial of barzolvolimab in cash in November 2023.
A future milestone payment related to the barzolvolimab program, which was subject to the Litigation, will be recorded when and if
payment becomes probable and reasonably estimable in accordance with the loss contingency model under ASC 450. A future milestone
payment related to the remaining Surviving Company Products is measured at fair value (refer to Note 4). When and if the remaining
payment described above becomes due, it shall be payable, at the Company’s sole election, in either cash or stock (as set forth in the
Merger Agreement) or a combination thereof.

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98
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
As of December 31, 2024, our management evaluated, with the participation of our Chief Executive Officer and Chief Financial
Officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a- 15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”)). Based on that evaluation, our Chief Executive Officer and Chief Financial
Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2024.
Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the
reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within time periods specified by
the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief
Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal
control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under
the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our Board of Directors, management and
other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial
statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures
that:
●
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of
assets;
●
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 are being made only in
accordance with the authorizations of management and directors; and
●
provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of
assets that could have a material effect on our financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework provided
in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of
December 31, 2024.
The effectiveness of the Company’s internal control over financial reporting as of December 31, 2024, has been audited by
PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears in Item 8 above.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended December 31, 2024 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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99
Item 9B. OTHER INFORMATION
(a) None.
(b) During the three months ended December 31, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5 -
1 trading agreement” or “non - Rule 10b5 - 1 trading agreement,” as each term is defined in Item 408 (a) of Regulation S - K.
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
PART III
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this Item 10 will be included in the definitive Proxy Statement for our 2025 Annual Meeting of
Stockholders, or the 2025 Proxy Statement, under “Information Regarding Our Current Directors and Executive Officers,” “Delinquent
Section 16(a) Reports,” “Code of Business Conduct and Ethics,” “Insider Trading Policy” and “The Board of Directors and Its
Committees” and is incorporated herein by reference. If the 2025 Proxy Statement is not filed with the SEC within 120 days after the end
of our most recent fiscal year, we will provide such information by means of an amendment to this Annual Report on Form 10-K.
Item 11. EXECUTIVE COMPENSATION
The information required by this Item 11 will be included in the 2025 Proxy Statement under “Executive Compensation,” and
“Compensation Committee Interlocks and Insider Participation,” and is incorporated herein by reference. If the 2025 Proxy Statement is
not filed with the SEC within 120 days after the end of our most recent fiscal year, we will provide such information by means of an
amendment to this Annual Report on Form 10-K.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
The information required by this Item 12 will be included in the 2025 Proxy Statement under “Security Ownership of Certain
Beneficial Owners and Management” and “Equity Compensation Plan Information” and is incorporated herein by reference. If the 2025
Proxy Statement is not filed with the SEC within 120 days after the end of our most recent fiscal year, we will provide such information
by means of an amendment to this Annual Report on Form 10-K.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item 13 will be included in the 2025 Proxy Statement under “Election of Directors” and “Approval
of Related Person Transactions and Transactions with Related Persons” and is incorporated herein by reference. If the 2025 Proxy
Statement is not filed with the SEC within 120 days after the end of our most recent fiscal year, we will provide such information by
means of an amendment to this Annual Report on Form 10-K.
Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this Item 14 will be included in the 2025 Proxy Statement under “Independent Registered Public
Accounting Firm” and is incorporated herein by reference. If the 2025 Proxy Statement is not filed with the SEC within 120 days after
the end of our most recent fiscal year, we will provide such information by means of an amendment to this Annual Report on Form 10-K.

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100
PART IV
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(A)
The following documents are filed as part of this Form 10-K:
(1) Financial Statements:
The Financial Statements and Supplementary Data are included in Part II Item 8 of this report.
(2) Financial Statement Schedules:
Schedules are omitted since the required information is not applicable or is not present in amounts sufficient to require
submission of the schedule, or because the information required is included in the Financial Statements or Notes thereto.
(3) Exhibits:
Incorporated by Reference to
Form and
Exhibit
SEC
No.
    
Description
    
SEC File No.
    
No.
    
Filing Date
Plan of Acquisition, Reorganization, Arrangement, Liquidation or Succession
1.1
Sales Agreement, dated February 26, 2024, by and
between Celldex Therapeutics, Inc. and Cantor
Fitzgerald & Co.
10 – K

(000 - 15006)
1.1
2/26/24
2.1
Agreement and Plan of Merger, dated as of
November 1, 2016, by and among Kolltan
Pharmaceuticals, Inc., Celldex Therapeutics, Inc.,
Connemara Merger Sub 1 Inc. and Connemara Merger
Sub 2 LLC.
8-K

(000-15006)
2.1
11/1/16
Articles of Incorporation and By-Laws
3.1
Third Restated Certificate of Incorporation
S-4

(333-59215)
3.1
7/16/98
3.2
Certificate of Amendment of Third Restated
Certificate of Incorporation
S-4

(333-59215)
3.1
7/16/98
3.3
Second Certificate of Amendment of Third Restated
Certificate of Incorporation
S-4

(333-59215)
3.2
7/16/98
3.4
Third Certificate of Amendment of Third Restated
Certificate of Incorporation
10-Q

(000-15006)
3.1
5/10/02
3.5
Fourth Certificate of Amendment of Third Restated
Certificate of Incorporation
8-K

(000-15006)
3.1
3/11/08
3.6
Fifth Certificate of Amendment of Third Restated
Certificate of Incorporation
8-K

(000-15006)
3.2
3/11/08
3.7
Sixth Certificate of Amendment of Third Restated
Certificate of Incorporation
10-Q

(000-15006)
3.7
11/10/08
3.8
Seventh Certificate of Amendment of Third Restated
Certificate of Incorporation
8-K

(000-15006)
3.1
2/8/19
3.9
Second Amended and Restated By-Laws of Celldex
Therapeutics, Inc., dated November 3, 2022
10-Q

(000-15006)
3.1
11/9/22
Instruments Defining the Rights of Security Holders
4.1
Specimen of Common Stock Certificate
8-K

(000-15006)
4.1
2/8/19
4.2
Certificate of Designations, Preferences and Rights of
a Series of Preferred Stock classifying and designating
the
8-A

(000-15006)
3.1
11/8/04

Table of Contents
101
Series C-1 Junior Participating Cumulative Preferred
Stock
4.3
Description of Securities
10-K
(000-15006)
4.3
2/28/23
Material Contracts-Leases
*10.1
Lease Agreement, by and between the Company and the
Massachusetts Development Finance Agency, dated as of
December 22, 2003
10-Q
(000-15006)
10.1
4/30/04
10.2
First Amendment to Lease between Massachusetts
Development Finance Agency and the Company dated
March 17, 2005
10-K/A
(000-15006)
10.6
12/23/10
10.3
Second Amendment to Lease by and between the
Company and the Massachusetts Development Finance
Agency dated as of November 4, 2005
10-K
(000-15006)
10.41
3/16/06
10.4
Third Amendment to Lease between Massachusetts
Development Finance Agency and the Company dated
December 20, 2006
10-K/A
(000-15006)
10.7
12/23/10
10.5
Fifth Amendment to Lease between Massachusetts
Development Finance Agency and the Company dated
October 3, 2008
10-K/A
(000-15006)
10.8
12/23/10
10.6
Sixth Amendment to Lease between Massachusetts
Development Finance Agency and the Company dated
August 20, 2009
10-K/A
(000-15006)
10.9
12/23/10
10.7
Seventh Amendment to Lease by and between the
Company and the Massachusetts Development Finance
Agency dated as of June 22, 2010
10-Q
(000-15006)
10.1
8/5/10
10.8
Eighth Amendment to Lease by and between the
Company and University of Massachusetts Dartmouth
dated as of November 1, 2015
10-K/A
(000-15006)
10.12
2/25/16
10.9
Ninth Amendment to Lease by and between the Company
and University of Massachusetts Dartmouth dated as of
October 1, 2019
10-K
(000-15006)
10.13
3/26/20
10.10
Extension of Lease Agreement between the Company and
University of Massachusetts Dartmouth dated as of July 1,
2020
10-Q
(000-15006)
10.1
8/6/20
10.11
Tenth Amendment to Lease by and between the Company
and University of Massachusetts Dartmouth dated as of
August 1, 2022
10-Q
(000-15006)
10.2
11/9/22
10.12
Eleventh Amendment to Lease by and between the
Company and University of Massachusetts Dartmouth
dated as of December 1, 2024
Filed herewith
10.13
Lease Agreement dated as of May 1, 2013 by and between
Crown Perryville, LLC and the Company.
10-Q
(000-15006)
10.1
5/03/13
10.14
First Amendment to Lease between Company and Crown
Perryville, LLC dated as of June 17, 2015
10-Q
(000-15006)
10.2
8/10/15
10.15
Second Amendment to Lease Agreement between the
Company and Crown Perryville, LLC dated as of
March 8, 2019
10-Q
(000-15006)
10.1
5/7/19
10.16
Third Amendment to Lease Agreement between the
Company and Perryville SPE LLC (successor-in-interest)
to Crown Perryville, LLC dated as of May 23, 2022
10-Q
(000-15006)
10.3
8/8/22
10.17
Fourth Amendment to Lease Agreement between the
Company and Perryville SPE LLC (successor-in-interest)
to Crown Perryville, LLC dated as of October 30, 2024
Filed herewith

Table of Contents
102
Material Contracts-License, Collaboration, Supply and Distribution Agreements
*10.18
Amended and Restated License Agreement by and
between the Company and Yale University dated as of
July 26, 2022
10-Q
(000-15006)
10.1
11/9/22
Material Contracts-Other
10.19
Confidential Settlement Agreement and Mutual Release,
dated July 15, 2022, by and between Shareholder
Representatives Services LLC, solely in its capacity as
Stockholders Representative, and Celldex Therapeutics,
Inc.
8-K
(000-15006)
10.1
7/18/22
Material Contracts- Management Contracts and Compensatory Plans
†10.20
Amendment No. 2 to Celldex Therapeutics, Inc. 2021
Omnibus Equity Incentive Plan
8-K
(000-15006)
10.1
6/14/24
†10.21
Celldex Therapeutics, Inc. 2021 Omnibus Equity Incentive
Plan (as amended June 15, 2023)
8-K
(000-15006)
10.1
6/15/23
†10.22
Celldex Therapeutics, Inc. 2021 Omnibus Equity Incentive
Plan
8-K
(000-15006)
10.1
6/17/21
†10.23
Celldex Therapeutics, Inc. Amended and Restated 2008
Stock Option and Incentive Plan (as amended, effective
June 18, 2020).
8-K
(000-15006)
10.1
6/18/20
†10.24
Celldex Therapeutics, Inc. Amended and Restated 2004
Employee Stock Purchase Plan (effective as of June 19,
2019)
8-K
(000-15006)
10.2
6/19/19
†10.25
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Anthony S. Marucci
8-K
(000-15006)
10.1
7/1/21
†10.26
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Sam Martin
8-K
(000-15006)
10.2
7/1/21
†10.27
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Tibor Keler, Ph.D.
8-K
(000-15006)
10.3
7/1/21
†10.28
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Ronald Pepin, Ph.D.
8-K
(000-15006)
10.4
7/1/21
†10.29
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Sarah Cavanaugh
8-K
(000-15006)
10.5
7/1/21
†10.30
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Margo Heath-Chiozzi, M.D.
8-K
(000-15006)
10.6
7/1/21
†10.31
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Elizabeth Crowley
8-K
(000-15006)
10.7
7/1/21
†10.32
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Richard Wright, Ph.D.
8-K
(000-15006)
10.8
7/1/21
†10.33
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Diane Young, M.D.
8-K
(000-15006)
10.9
7/1/21
†10.34
Amended and Restated Employment Agreement, dated as
of July 1, 2021, by and between Celldex Therapeutics, Inc.
and Freddy Jimenez
8-K
(000-15006)
10.10
7/1/21

Table of Contents
103
†10.35
Celldex Therapeutics, Inc. 2021 Plan Form of Restricted
Stock Award Agreement
8-K
(000-15006)
10.2
6/17/21
†10.36
Celldex Therapeutics, Inc. 2021 Plan Form of Incentive
Stock Option Grant Agreement
8-K
(000-15006)
10.3
6/17/21
†10.37
Celldex Therapeutics, Inc. 2021 Plan Form of
Nonqualified Stock Option Grant Agreement
8-K
(000-15006)
10.4
6/17/21
†10.38
Celldex Therapeutics, Inc. 2021 Plan Form of Restricted
Stock Unit Award Agreement
8-K
(000-15006)
10.5
6/17/21
†10.39
2008 Plan Form of Stock Option Agreement
10-Q
(000-15006)
10.1
8/08/18
†10.40
2008 Plan Form of Restricted Stock Award
10-K
(000-15006)
10.42
3/12/10
19.1
Celldex Therapeutics, Inc. Insider Trading Policy
Filed herewith
21.1
Subsidiaries of Celldex Therapeutics, Inc.
Filed herewith
23.1
Consent of PricewaterhouseCoopers LLP, an Independent
Registered Public Accounting Firm
Filed herewith
31.1
Certification of President and Chief Executive Officer
Filed herewith
31.2
Certification of Senior Vice President and Chief Financial
Officer
Filed herewith
32
Section 1350 Certifications
Furnished herewith
†97
Celldex Therapeutics, Inc. Compensation Recovery Policy
10-K
(000-15006)
97
2/26/24
101.INS
Inline XBRL Instance Document - the instance document
does not appear in the Interactive Data File because its
XBRL tags are embedded within the Inline XBRL
document
Filed herewith
101.SCH
Inline XBRL Taxonomy Extension Schema Document
Filed herewith
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase
Document
Filed herewith
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase
Document
Filed herewith
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase
Document
Filed herewith
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase
Document
Filed herewith
104
Cover Page Interactive Data File (formatted as Inline
XBRL and contained in Exhibit 101)
*
Certain confidential portions of this exhibit were redacted. Celldex Therapeutics, Inc. agrees to furnish supplementally to the U.S.
Securities and Exchange Commission a copy of any omitted schedule and/or exhibit upon request. The confidential portions of this
exhibit were omitted by means of marking such portions with asterisks because the identified confidential portions (i) are not
material, (ii) would be competitively harmful if publicly disclosed and (iii) contain information that Celldex Therapeutics, Inc,
customarily and actually treats as private or confidential.
†
Indicates a management contract or compensation plan, contract or arrangement.
Item 16. FORM 10-K SUMMARY
None.

Table of Contents
104
SIGNATURES
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.
CELLDEX THERAPEUTICS, INC.
By:
/s/ ANTHONY S. MARUCCI
Date
February 27, 2025
Anthony S. Marucci
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf
of the registrant and in the capacities and on the dates indicated.
Signature
    
Title
    
Date
/s/ ANTHONY S. MARUCCI
President, Chief Executive Officer, and Director
February 27, 2025
Anthony S. Marucci
(Principal Executive Officer)
/s/ SAM MARTIN
Senior Vice President,
February 27, 2025
Sam Martin
Chief Financial Officer and Treasurer 
(Principal Financial and Accounting Officer)
/s/ KAREN L. SHOOS
Director, Chair of the Board of Directors
February 27, 2025
Karen L. Shoos
/s/ KEITH L. BROWNLIE
Director
February 27, 2025
Keith L. Brownlie
/s/ CHERYL L. COHEN
Director
February 27, 2025
Cheryl L. Cohen
/s/ HERBERT J. CONRAD
Director
February 27, 2025
Herbert J. Conrad
/s/ RITA I. JAIN, M.D,
Director
February 27, 2025
Rita I. Jain, M.D.
/s/ JAMES J. MARINO
Director
February 27, 2025
James J. Marino
/s/ GARRY A. NEIL, M.D.
Director
February 27, 2025
Garry A. Neil, M.D.
/s/ HARRY H. PENNER, JR.
Director
February 27, 2025
Harry H. Penner, Jr.

Page 1 of 7
Exhibit 10.12
ELEVENTH AMENDMENT TO LEASE
This ELEVENTH AMENDMENT TO LEASE (this “Amendment”) is made as of the 1st day of December, 2024, (the
“Effective Date”) by and between UNIVERSITY OF MASSACHUSETTS DARTMOUTH, an institution of Higher Education of the
Commonwealth of Massachusetts, with an address of 285 Old Westport Rd. North Dartmouth Massachusetts 02747 (“Landlord”) and
CELLDEX THERAPEUTICS, INC. (formerly AVANT Immunotherapeutic, Inc.), a Delaware corporation, with an address of 53
Frontage Road, Hampton NJ 08827 (“Tenant”).
RECITALS
WHEREAS, Tenant and the Massachusetts Development Finance Agency (“MDFA”) entered into a certain Lease dated
effective December 22, 2003 ( the “Lease), as amended by that certain First Amendment to Lease dated as of March 17, 2005 (the “First
Amendment”), that certain Second Amendment to Lease dated as of November 4, 2005 (the “Second Amendment”), that certain Third
Amendment To Lease dated as of December 20, 2006 (the “Third Amendment”), that certain Fourth Amendment to Lease dated as of
July 18, 2008 (the “Fourth Amendment”), that certain Fifth Amendment to Lease dated as of October 3, 2008 (the “Fifth
Amendment”), that certain Sixth Amendment to Lease dated as of August 20, 2009 (the “Sixth Amendment”), that certain Seventh
Amendment to Lease dated June 22, 2010 (the “Seventh Amendment”), that certain Eight Amendment to lease dated November 15,
2015 (the “Eight Amendment”), that certain Ninth Amendment to lease dated, October 1, 2019 (the “Ninth Amendment”), and that
certain Tenth Amendment to the lease dated August 1, 2022 (the “Tenth Amendment”) of certain premises consisting of approximately
33,931 rentable square feet of space (the “Premises”) in the building (the “Building”) located at 151 Martine Street,

Page 2 of 7
Fall River, Massachusetts (the “Property”) in the South Coast Research & Technology Park (the “Park”); and
WHEREAS, on June 24, 2014, MDFA conveyed all of its rights, title and interest in the Building and assigned the Lease to
Landlord; and
WHEREAS, the Premises is comprised of: (i) the original premises demised by the Lease, as amended through the Third
Amendment, being 11,756 rentable square feet on the second (2nd) floor of the Building, (ii) the Additional Space (as defined in the First
Amendment) demised by the First Amendment, being 71 rentable square feet on the first (1st) floor of the Building, (iii) the Expansion
Premises (as defined in the Second Amendment), being 2,487 rentable square feet on the second (2nd) floor of the Building; (iv) the
Second Expansion Premises (as defined in the Third Amendment), being 1,853 rentable square feet on the second (2nd) floor of the
Building; (v) the Substitute Third Expansion Premises (as defined in the Fifth Amendment), being 4,864 rentable square feet of space on
the second floor of the Building (referred to therein as the “Third Expansion Premises”); (vi) the Fourth Expansion Premises (as defined
in the Sixth Amendment), being 2,382 rentable square feet on the second (2nd) floor of the Building; (vii) the Fifth Expansion Premises
(as defined in the Eight Amendment), being 5,511 rentable square feet on the second (2nd) floor of the Building, and (viii) the Sixth
Expansion Premises ( as defined in the Ninth Amendment), being 5,007 rentable square feet - 4,686 rentable square feet on the first (1st)
floor of the building and 321 rentable square feet on the second (2nd) floor of the Building such that the “Premises Square Footage” (as
stated in the Ninth Amendment) is defined to be 33,931 rentable square feet; and
WHEREAS, Landlord and Tenant agree to enter into this Eleventh Amendment to the Lease to extend the term of the lease and
to amend certain additional provisions of the Lease,

Page 3 of 7
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby mutually
acknowledged, Landlord and Tenant agree as follows:
1.
Capitalized Terms. Unless otherwise defined herein, all capitalized terms used in this Amendment shall have the meanings
ascribed to them in the Lease, and all references in the Lease to the “Lease” or “this Lease” or “herein” or “hereunder” or similar terms
or to any Section thereof shall, after the Effective Date, mean the Lease, or such Section thereof, as amended by this Amendment.
2.
Section 2.2. Term. Section 2.2 of the Lease shall be amended as of December 1, 2024 to read as follows:”Section 2.2 Term.
TO HAVE AND TO HOLD for a term (the “Term”) beginning on the Term Commencement Date which shall be August 1, 2022 and
expiring on July 31, 2027 (the “Term Expiration Date”), unless earlier terminated as provided for in section 2.4”
3.
Annual Fixed Rental Rate. Section 1.1 as of December 1, 2024 the Lease is amended by deleting the provisions regarding
the “Annual Fixed Rental Rate” and inserting, the following language:
Annual Fixed Rental Rate:
As of December 1, 2024 and through July 31, 2025: 19.91 per square foot.
As of August 1, 2025 and through July 31, 2026: $21.00 per rentable square
foot.
As of August 1, 2026 through July 31, 2027: $21.50 per rentable square foot.

Page 4 of 7
4.
Demise of Seventh Expansion Premises. Commencing on December 1, 2024 (“The Seventh Expansion Premise
Commencement Date”), Landlord does hereby lease to Tenant and Tenant does lease from Landlord the approximately 2418 rentable
square feet - 1,333 rentable square feet on the first (1st) floor of the building and 1,085 rentable square feet on the second (2nd) floor of
the Building, as shown on the floor plan attached hereto as Exhibit A-10 (the “Seventh Expansion Premises”) to have and to hold for the
remainder of the Lease Term as set forth in the Lease. Tenant shall have access to the Seventh Expansion Premises as of December 1,
2024. Rental fee shall commence on December 1, 2024. Any delay in access to all Seventh Expansion Premises will result in similar
delay in rent commencement. Except as otherwise expressly provided herein, Tenant’s lease of the Seventh Expansion Premises shall be
on all of the terms and conditions of the Lease (including, without limitation, extension rights of Tenant for Extension Terms) and the
term of the Lease with respect to the Seventh Expansion Premises shall be coterminous with the Term (and, if exercised, Extension
Terms) of the Lease for the Existing Premises. As of the Seventh Expansion Premises Commencement Date, all references in the Lease
to (i) the “Premises” and/or premises demised by the Lease shall mean the Existing Premises and the Seventh Expansion Premises
collectively as shown on Exhibit A to the Lease, Exhibit A-1, attached to the First Amendment , Exhibit A-2, attached to the Second
Amendment, Exhibit A-3, attached to the Third Amendment, and on Exhibit A-5, attachead to the Fifth Amendment, Exhibit A-6,
attached to the Sixth Amendment, Exhibit A-7, attached to the Seventh Amendment, Exhibit A-8 attached to the Eight Amendment,
Exhibit A-9 attached to 9th Amendment and Exhibit A-10 attached to this amendment; (ii) the “Tenant’s Proportionate Fraction” as set
forth in Section 1.1, “Reference Information”, of the Lease shall mean 63.24% which is calculated by adding the Premises Square
Footage as set forth in the

Page 5 of 7
Eight Amendment and the Seventh Expansion Premises and dividing the Building’s rentable square foot into that sum; and (iii) the
“Premises Square Footage shall mean 36,349 rentable square feet.
5.
The parties agree that License agreement dated July 13, 2020 is terminated as of December 1, 2024.
6.
Landlord Representation Regarding Environmental Hazards. To its knowledge, Landlord represents that there are no
environmental hazards or violations of any environmental laws, regulations or ordinances in or around the Building which violations
might pose a present danger to health, life or safety.
7.
Non-disturbance of Tenancy. Landlord represents that it has no financing on the Building whereby Landlord’s lender would
be entitled to disturb the tenancy of Tenant upon a default therein Landlord. Landlord further represents that it shall not enter into any
such financing, but rather shall negotiate with any such lender so as to permit Tenant to remain in possession of the Premises on a direct
rental relationship with such lender so long as Tenant is not in default of its obligations under this Lease.
8.
Ratification. Except as expressly modified by this Amendment, the Lease shall remain in full force and effect, and as
further modified by this Amendment, is expressly ratified and confirmed by the parties hereto. This Amendment shall be binding upon
and inure to the benefit of the parties hereto and their respective successors and assigns, subject to the provisions of the Lease regarding
assignment and subletting.
9.
Governing Law; Interpretation; and Partial Invalidity. This Amendment shall be governed and construed in accordance with
the laws of the Commonwealth of Massachusetts. If any term of this Amendment, or the application thereof to any person or
circumstances, shall

Page 6 of 7
to any extent be invalid or unenforceable, the remainder of this Amendment, or the application of such term to persons or circumstances
other than those as to which it is invalid or unenforceable, shall not be affected thereby, and each term of this Amendment shall be valid
and enforceable to the fullest extent permitted by law. The titles for the paragraphs are for convenience only and not to be considered in
construing this Amendment. This Amendment contains all of the agreements of the parties with respect to the subject matter hereof, and
supersedes all prior dealings between them with respect to such subject matter. No delay or omission on the part of either party to this
Amendment in requiring performance by the other party or exercising any right hereunder shall operate as a waiver of any provision
hereof or any rights hereunder, and no waiver, omission or delay in requiring performance or exercising any right hereunder on any one
occasion shall be construed as a bar to or waiver of such performance or right on any future occasion.
10. Counterparts and Authority, This Amendment may be executed in multiple counterparts, each of which shall be deemed an
original and all of which together shall constitute one and the same document. Landlord and Tenant each warrant to the other that the
person or persons executing this Amendment on its behalf has or have authority to do so and that such execution has fully obligated and
bound such party to all terms and provisions of this Amendment.

Page 7 of 7
IN WITNESS WHEREOF, the undersigned executed this Amendment as of the date and year first written above.
LANDLORD:
University Of Massachusetts Dartmouth
By: /s/ Mark Fuller
Name: Mark Fuller
Title: Chancellor
TENANT:
CELLDEX THERAPEUTICS, INC.,
By: /s/ Anthony S. Marucci
Name: Anthony S. Marucci
Title: President and CEO

Exhibit 10.17
FOURTH AMENDMENT TO LEASE AGREEMENT
This Fourth Amendment to Lease Agreement (this “Amendment”) is made and entered into as of October 30, 2024 (“Effective Date”),
by and between PERRYVILLE SPE, LLC, a limited liability company (“Landlord”), and CELLDEX THERAPEUTICS, INC.
(“Tenant”).
W I T N E S S E T H:
WHEREAS, Landlord’s predecessor-in-interest, Crown Perryville, LLC., and Tenant entered into that certain Lease dated as of May 1,
2013 (the “Original Lease”) in the building known as Perryville Ill at Perryville Corporate Park located at 53 Frontage Road, Hampton,
New Jersey 08827 (the “Building) , as amended by a First Amendment of Lease, dated as of June 17, 2015 (the “First Amendment”), and
as further amended by a Second Amendment of Lease, dated as of March 8, 2019 (the “Second Amendment”), and as further amended
by a Third Amendment of Lease, dated as of May 22, 2022 (the “Third Amendment”), pursuant to which Tenant is currently leasing
premises (the “Premises”) consisting of approximately 3,539 rentable square feet located on a portion of the first (1st) floor and
approximately 29,824 rentable square feet located on a portion of the second (2nd) floor (the Original Lease, as amended by the First
Amendment, Second Amendment, and Third Amendment is hereinafter collectively referred to as the “Lease”); and
WHEREAS, Landlord and Tenant desire to further amend the Lease on the terms and conditions set forth herein, all as provided in this
Fourth Amendment;
NOW, THEREFORE, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Landlord and Tenant
agree to amend the Lease as follows:
1.
Incorporation of Recitals: The above Recitals are hereby incorporated into this Amendment as if fully set forth herein. Except
as otherwise defined herein, the capitalized terms used in this Amendment shall have the definitions as set forth in the Lease.
2.
Extension Term and Renewal Option:
A.
Extension Term: As of the Effective Date, the New Extension Term of the Lease commencing on August 1, 2020, and
ending on July 31, 2025, shall be extended by two years to end on July 31, 2027.
B.
Base Rent:
§
Year 1 (August 1, 2025 - July 31, 2026): $17.42 per Rentable Square Foot (RSF) plus Tenant Electric
(hereinafter defined).

§
Year 2 (August 1, 2026 - July 31, 2027): $17.86 per RSF plus Tenant Electric (hereinafter defined).
C.
Tenant Electric: Due to increased utility rates, Tenant Electric shall be $2.25 per RSF during the Extension Term.
D.
Additional Renewal Options: Tenant shall have two (2) additional two-year renewal options under the same terms as
Section 4.B. of the Third Amendment, except that the first Renewal Term shall be for the period commencing August
1, 2027 through July 31, 2029 and the second Renewal Term shall be for the period commencing August 1, 2029
through July 31, 2031. The rent shall be increased by 102.5% of the Base Rent for the last year of the prior term and
will increase 2.5% annually thereafter.
3.
Right of First Refusal (ROFR):
A.
As long as Tenant is not in default under the Lease (subject to applicable notice and cure periods), if Landlord receives
or issues a proposal for leasing any space on the third (3rd) floor of the Building (the “ROFR Space”), which Landlord
is willing to accept, Landlord will notify Tenant within seven (7) business days of the receipt of the offer.
B.
Tenant will have seven (7) business days to respond to Landlord if they wish to accept the ROFR Space at the terms
contained in the offer.
C.
If Tenant accepts the ROFR Space offer, the parties shall execute a lease amendment within thirty (30) days of
receiving the draft amendment from Landlord. Failure, on the part of Tenant, to execute the draft amendment within 30
days of receipt shall a rejection of the ROFR Space.
D.
If not specified in the offer, the commencement date for the ROFR Space shall be 180 days following the date the
ROFR Space is delivered to Tenant vacant and in broom-clean condition.
4.
Right of First Offer (ROFO):
Tenant retains a Right of First Offer, consistent with Section 19.29 of the Lease.
5.
Brokerage Representation:
A.
Tenant represents and warrants that they have dealt solely with Rv3 Solutions as their exclusive broker.
B.
Landlord has engaged Jones Lang LaSalle (JLL) as its broker.

C.
If a lease amendment is executed, a market commission based on the aggregate Base Rent will be paid by Landlord to
Rv3 Solutions and JLL pursuant to separate written agreements.
6.
No Further Modification: Except as specifically amended hereby, the Lease shall remain in full force and effect in accordance
with its terms. In the event of any conflict between this Amendment and the Lease, the terms of this Amendment shall prevail.
7.
Counterparts: This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
8.
Non-Binding Until Execution: Submission by Landlord of the within Amendment for execution by Tenant shall confer no
rights nor impose any obligation on Landlord unless and until both Landlord and Tenant shall have executed this Amendment
and duplicate originals thereof shall have been delivered by Landlord and Tenant to each other.
9.
Binding Effect: This Amendment shall be binding upon and shall inure to the benefit of the parties hereto and their respective
successors and assigns.
10. Miscellaneous: Except as expressly amended hereby, all of the terms, covenants, conditions and provisions of the Lease shall
remain and continue unmodified, in full force and effect. This Amendment sets forth the entire agreement between the parties
regarding the subject matter hereof, superseding all prior agreements and understandings, written and oral, and may not be
altered or modified except by a writing signed by both parties. Landlord and Tenant each represent and warrant to the other that
it has not relied upon any representation or warranty, express or implied, in entering into this Amendment, except those which
are set forth herein
[Signature on following page]

IN WITNESS WHEREOF, the parties hereto have executed this Fourth Amendment to Lease Agreement as of the date first above
written.
LANDLORD:
Shelbourne Spring, LLC
By:/s/ BERNARD S. BERTRAM
Name: Bernard Bertram
Title: Managing Member
TENANT:
Celldex Therapeutics, Inc.
By:/s/ ANTHONY S. MARUCCI

Exhibit 19.1
INSIDER TRADING POLICY (Revised February 12, 2025 )
This Insider Trading Policy (this “Policy”) of Celldex Therapeutics, Inc. (the “Company” or “Celldex”) is designed to prevent insider
trading or allegations of insider trading, protect the Company’s reputation for integrity and ethical conduct and to assist Insiders (as
defined below) in complying with their obligations under the federal securities laws. You must read, sign and retain a copy of this Policy
and, upon request by the Company, re-acknowledge it. Please address questions to the Company’s Chief Financial Officer, who has
initially been designated as the “Compliance Officer” for this Policy, or such other person who is designated by the Board of Directors of
the Company.
WHO IS SUBJECT TO THIS POLICY?
This Policy  applies to employees and directors of Celldex, their family members1 who reside with them, any other individuals who
reside with them, any Family Members who do not reside with them but whose transactions in the Company’s Securities (as defined
herein) would be directed by or are subject to the influence of the employee or director, any entity controlled by the employee or director
or any of the related individuals listed above (“Controlled Entities”), any nonemployees whom the Compliance Officer may designate as
“Insiders” because they have access to material non-public information concerning the Company, and any other persons to whom any of
the foregoing have communicated material nonpublic information. All such persons are referred to herein as “Insiders”. The use of “you”
and “your” throughout this Policy speaks directly to Insiders.
Compliance Officer
The Company has designated the Chief Financial Officer as its Compliance Officer. The Compliance Officer is responsible for
administering this Policy and monitoring and enforcing compliance. Any Insider who violates this Policy or knows of any such violation
by any other Insiders, must report the violation immediately to the Compliance Officer. The Compliance Officer will maintain as
Company records all documents required by the provisions of this Policy and all required Securities and Exchange Commission (“SEC”)
reports related to insider trading including Forms 3, 4, 5 and 144 and Schedules 13D and 13G. As described more fully in the “Pre-
Clearance” section below, the Compliance Officer will designate and announce Special Blackout Periods (as defined herein) during
which no Insider may Trade (as defined herein) in Company Securities. The Compliance Officer will review and either approve or
prohibit in his or her sole discretion all proposed Trades by the Insiders specified in this Policy with advice from the Company's outside
legal counsel, if needed. In the event the Compliance Officer is unavailable, all proposed Trades shall be approved by the President and
Chief Executive Officer. The Compliance Officer may not Trade in Company Securities unless the President and Chief Executive Officer
with advice from the Company's outside legal counsel, if needed, has previously approved the Trade.
WHAT TRANSACTIONS ARE SUBJECT TO THIS POLICY?
The policy applies to any and all transactions in (including gifts of) the Company's securities (“Trades”). Company securities include
common stock and options to purchase common stock, securities that are convertible into common stock and any other type of securities
that the Company may issue, such as preferred stock, securities that are convertible into preferred stock, convertible debentures, warrants
and exchange-traded options or other derivative securities, and any other
1
Family members include any relatives, such as a child, stepchild, grandchild, parent, stepparent, aunt, uncle, niece, nephew,
grandparent, spouse, sibling and in-law, and any other person typically considered a relative (“Family Members”).

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“security” defined under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder (collectively
referred to herein as “Securities”).
Gifts
For purposes of this Policy, gifts or other transfers to Family Members, whether for estate planning or otherwise, or to charities or other
third parties, are considered “Trades” within the meaning of this Policy.  Gifts are subject to the requirements and restrictions outlined in
this Policy and require pre-clearance in accordance with the “Pre-Clearance” section of this Policy.
WHAT IS ILLEGAL AND PROHIBITED INSIDER TRADING?
Generally, illegal and prohibited insider trading occurs when a person who is aware of material nonpublic information about a
company buys or sells, or engages in transactions with (e.g. buying, selling, hedging, shorting, swaps, etc.), that company’s securities or
provides material nonpublic information to another person who may trade on the basis of that information.
Material Information
Information about the Company is “material” if it would be expected to affect the investment decision (i.e., a decision to buy, hold, or
sell securities) of the reasonable shareholder or investor, or if the disclosure of the information would be expected to significantly alter
the total mix of the information in the marketplace about the Company. In simple terms, material information is any type of information,
positive or negative, which could reasonably be expected to affect the price of Company Securities. Material information is not limited to
information of a financial nature; rather, material information can relate to virtually any aspect of the Company's business. Material
information is also not limited to historical facts. Insiders can be in possession of material information with respect to a future event,
such as a merger, acquisition or introduction of a new product.
There is no bright-line standard for assessing materiality; rather, materiality is based on an assessment of all of the facts and
circumstances, and is often evaluated by enforcement authorities with the benefit of hindsight. While it is not possible to identify all
information that would be “material”, some examples of information that ordinarily would be regarded as material are: information about
the status of FDA filings, status and results of clinical trials, financing efforts, new business deals or collaborations, potential mergers
and acquisitions, status of product development, product launches, ability to commercialize products, actual or threatened major
litigation, or the resolution of such litigation, significant changes in senior management, cybersecurity incidents or quarterly and year-end
earnings.
Nonpublic Information
Material information is “non-public” if it has not been widely disseminated to the public through major newswire services, national news
services and financial news services; through a broadcast on widely available internet, radio or television programs; or through public
disclosure documents filed with the SEC. By contrast, information would likely not be considered widely disseminated if it is available
only to the Company’s employees, or if it is only available to a select group of analysts, brokers, institutional investors or industry
participants.
For purposes of this policy, information will be considered public, i.e., no longer “non-public”, after the close of trading on the second
full trading day following the Company's widespread release of the information. If, for example, the Company were to make an
announcement before market hours on a Monday morning, the information typically would not be considered digested until pre-market
on

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Wednesday morning. As a general rule, no Trade should take place prior to the completion of this two full trading-day period.
PRE-CLEARANCE
Before engaging in any Trades involving the Company's Securities, all employees and directors must obtain prior written approval
(including email) from the Compliance Officer. This will enable you to consult with the Compliance Officer for guidance as to whether
you are in possession of any material non-public information about the Company.  Note that while pre-clearance is not required for
trading in securities issued by other companies, you are cautioned to comply with our policy as well as applicable law when making
trades in other securities issued by other companies.
PROHIBITION ON ILLEGAL INSIDER TRADING
No Trading on Material Nonpublic Information
If you are aware of material nonpublic information about the Company or Company Securities, you may not Trade Company Securities,
except as otherwise specified in this Policy (see “Exempt Transactions” below). In addition, it is the policy of Celldex that no Insider
who, in the course of working for Celldex, learns of material nonpublic information about a company, (including, but not limited to, a
customer or supplier of Celldex) may trade in that company’s securities until the information becomes public or is no longer material.
No Tipping
If you are aware of material nonpublic information about the Company, or if you are aware of material nonpublic information about
another company learned in the course of performing your work duties for the Company, you may not communicate or pass (“Tip”) that
information on to persons within the Company whose jobs do not require them to have that information, or to persons outside the
Company, including Family Members, Controlled Entities, friends or anyone else. The federal securities laws impose liability on any
person who Tips or communicates (the “Tipper”) material nonpublic information to another person or entity (the “Tippee”) who then
Trades on the basis of the information. Penalties may apply regardless of whether or not the Tipper Trades or derives any benefits from
the Tippee’s Trading activities.
Blackout Periods
From time to time, the Compliance Officer will notify Insiders in writing (including by email) of a commencement of a quarterly
Blackout Period. Trading is prohibited during Blackout Periods or Special Blackout Periods, as described in more detail in the “Quarterly
Trading Windows for All Insiders” and “Special Blackout Periods” sections below.
BLACKOUT PERIODS
Quarterly Trading Windows for All Insiders
All Insiders who are NOT in possession of material non-public information concerning the Company may Trade in Company Securities
only during the quarterly Trading Window (as defined herein). Each quarter, the window opens beginning at the close of trading on the
second full trading day following the Company's widespread public release of quarterly or year-end earnings and ends on the fifteenth
day of the last month of the quarter (the “Trading Window”). All other times are considered “Blackout Periods”. Even if there is a
Trading Window open, persons who are in possession of material non-

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public information may not Trade in Company Securities. No Insider may Trade in Company Securities outside of the applicable trading
windows or during any Special Blackout Periods that the Compliance Officer may designate, as described in more detail in the “Special
Blackout Periods” section below. No Insider may disclose to any outside third party that a Special Blackout Period has been designated.
Special Blackout Periods
From time to time, an event may occur that is material to the Company. So long as the event remains material and nonpublic, certain
Insiders, in the discretion of the Compliance Office, may be restricted from Trading in Company Securities (a “Special Blackout
Period”).  In that situation, the Compliance Officer will notify those Insiders in writing (including by email) of the commencement of the
Special Blackout Period and that they are   prohibited from Trading in Company Securities, whether or not the Compliance Officer
discloses the reason for the restriction.  The Compliance Officer will also notify those Insiders in writing (including by email) of the
termination of the Special Blackout Period.  Until the Compliance Officer has notified those Insiders of the termination of the Special
Blackout Period, they may not Trade in Company Securities. The existence of a Special Blackout Period or extension of a Blackout
Period should not be communicated to any other person. Even if the Compliance Officer has not designated a Special Blackout Period,
an Insider should not Trade in Company Securities while aware of material nonpublic information. Exceptions will not be granted during
a Special Blackout Period.
ADDITIONAL RESTRICTIONS
Stock Option Exercises
The Trading prohibitions and restrictions of this Policy apply to all sales of Securities acquired through the exercise of stock options
granted by the Company – including, but not limited to, sales made in order to effectuate broker-assisted “cashless” exercise
arrangements.  The Trading prohibitions and restrictions of this Policy do not, however, apply to acquisitions of Securities pursuant to the
exercise of such options so long as cash proceeds are used.
Short Sales
Insiders may not sell any Company Securities that are not owned by such person at the time of the sale (a “short sale”), including a sale
with delayed delivery (a “sale or short against the box”).
Hedging Transactions
Certain forms of hedging or monetization transactions, such as zero-cost collars and forward sale contracts, allow investors to lock in
much of the value of their stock holdings, often in exchange for all or part of the potential for upside appreciation in the stock. These
transactions allow an investor to continue to own the covered securities, but without the full risks and rewards of ownership. When that
occurs, the investor may no longer have the same objectives as the Company’s other stockholders. Therefore, Insiders may not engage in
any such transactions.
Margin Accounts and Pledges
Securities held in a margin account may be sold by the broker without the customer's consent if the customer fails to meet a margin call.
Similarly, securities pledged (or hypothecated) as collateral for a loan may be sold in foreclosure if the borrower defaults on the loan. A
margin sale or foreclosure sale may occur at a time when the pledgor is aware of material non-public information or otherwise is not
permitted to trade in Company Securities.

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Consequently, Insiders of the Company are prohibited from holding Company Securities in a margin account or pledging Company
Securities as collateral for a loan.
EXEMPT TRANSACTIONS
Employee Stock Purchase Plan
The trading prohibitions and restrictions of this Policy do not apply to periodic contributions by the Company or employees to employee
benefit plans (e.g., ESPP, pension or 401(k) plans) which are used to purchase Company Securities pursuant to the employees’ advance
instructions. However, no employee may alter their instructions regarding the purchase or sale of Company Securities in such plans when
in possession of material non-public information.
Restricted Stock Awards.
This Policy does not apply to the vesting of restricted stock (if, as and when issued by the Company), or of a tax withholding right
pursuant to which you elect to have the Company withhold shares of stock to satisfy tax withholding requirements upon the vesting of
any restricted stock. This Policy, however, would apply to any market sale of restricted stock (if any becomes issued).
Rule 10b5-1 Trading Plans
A Rule 10b5-1 trading plan is a trading plan adopted pursuant to Rule 10b5-1 (“Rule 10b5-1”) promulgated under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”).  Trades in the Company’s Securities that are executed pursuant to a Rule
10b5-1 trading plan are not subject to the prohibition on Trading while in possession of material non-public information (i.e. pre-
clearance procedures and Trading Windows) contained in this Policy.
Insiders are prohibited from entering into a 10b5-1 Plan during (i) a Blackout Period, (ii) during a Special Blackout Period, or (iii) at any
time when they are aware of material, nonpublic information about the Company. Pre-clearance is required prior to entry into a 10b5-1
Plan, termination of a 10b5-1 Plan, or a modification of a 10b5-1 Plan.  A copy of a 10b5-1 Plan must be submitted to the Compliance
Officer for review and pre-­clearance at least three (3) business days prior to the anticipated entry into a 10b5-1 Plan.  The 10b5-1 Plan
document must be reviewed and pre-cleared by the Compliance Officer prior to being signed by the Insider.  The Company has discretion
to refuse approval of any 10b5-1 Plan document for any reason and need not provide any reason for such refusal to the Insider.  Once a
10b5-1 Plan is adopted, the Insider must not exercise any influence over the amount, price or the date of any Trade.  The 10b5-1 Plan
must include a cooling-off period consistent with applicable SEC rules before Trades can commence.

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In addition, the Rule 10b5-1 trading plan must be  in full compliance with the Company’s Rule 10b5-1 trading plan guidelines and
policies, as in effect from time to time.
POST-TRADE REPORTING
If you are required to file reports under Section 16 of the Exchange Act, including Forms 3, 4 and 5, you are required to report to the
Compliance Officer any Trade in Company Securities by you, your Family Members and Controlled Entities no later than the end of
business day in which you made the Trade. Each report made should include the date of the Trade, quantity, price, and broker through
which the Trade was effected. This reporting requirement may be satisfied by sending (or having your broker send) duplicate
confirmations of Trades to the Compliance Officer if such information is received by the required date.
The foregoing reporting requirement is designed to help monitor compliance with these procedures and to enable the Company to help
those persons who are subject to reporting obligations under Section 16 of the Exchange Act to comply with such reporting obligations.
Each officer and director, however, and not the Company, is personally responsible for ensuring that his or her Trades do not give rise to
“short swing” liability under Section 16 and for filing timely reports of Trades with the SEC.
THE CONSEQUENCES OF VIOLATING THIS POLICY
Trading of Company Securities while aware of material nonpublic information, or the disclosure of material nonpublic information to
others who then Trade in Company Securities, is prohibited by the federal and state laws. Insider trading violations are pursued
vigorously by the SEC, U.S. Attorneys, and state enforcement authorities as well as the laws of foreign jurisdictions. Punishment for
insider trading violations is severe, and could include significant fines and imprisonment. While the regulatory authorities concentrate
their efforts on the individuals who Trade, or who Tip information to others who Trade, the federal securities laws also impose potential
liability on companies and other “controlling persons” (such as directors, officers and other supervisory personnel) if they fail to take
reasonable steps to prevent insider trading by company personnel.
In addition, you would also be in violation of Company policy and subject to termination for cause, whether or not your failure to comply
results in a violation of law. Needless to say, a violation of law, or even an SEC investigation that does not result in prosecution, can
tarnish your reputation and irreparably damage a career.
POST-TERMINATION TRADES
This Policy continues to apply to Insiders even after the Insider ceases to be an Insider. If an Insider is aware of material, nonpublic
information when their employment or service relationship terminates, they may not Trade in Company Securities until that information
has become public or is no longer material.
REPORTING OF VIOLATIONS
If any person knows or has reason to believe that this Policy has been or may be violated, the person should bring the actual or potential
violation to the attention of the Compliance Officer.
MODIFICATIONS AND WAIVERS
The Company reserves the right to amend or modify the procedures set forth herein at any time. Waiver

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of any provision of this Policy in a specific instance may be authorized in writing by the Compliance Officer.
This document states a policy of the Company and is not intended to be regarded as the rendering of legal advice. This Policy is
intended to promote compliance with existing law and is not intended to create or impose liability that would not exist in the
absence of this Policy.
If you have any questions about this Policy, or about matters relating to the Company's Securities, please contact the Compliance Officer.

-8-
ACKNOWLEDGMENT AND CERTIFICATION
The undersigned does hereby acknowledge receipt of this Policy. The undersigned has read and understands (or has had explained) this
Policy and agrees to be governed by this Policy at all times and the confidentiality of nonpublic information.
    
(Signature)
(Please print name)
Date:

Exhibit 21.1
SUBSIDIARIES OF CELLDEX THERAPEUTICS, INC.
Name
    
Jurisdiction of
Organization
    
Ownership
Percentage
Celldex Therapeutics Switzerland GmbH
Switzerland
100%

Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-280207, 333-272804,
333-257137, 333-239463, 333-232253, 333-232255, 333-219867, 333-219869, 333-205694, 333-189336, 333-182142, 333-151728 and
333-117602) and on Form S-3 (Nos. 333-275300 and 333-215747) of Celldex Therapeutics, Inc. of our report dated February 27, 2025
relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in this Form 10-K.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 27, 2025

Exhibit 31.1
CERTIFICATION
I, Anthony S. Marucci, certify that:
1.
I have reviewed this annual report on Form 10-K of Celldex Therapeutics, Inc.;
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 the 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: February 27, 2025
By /s/ ANTHONY S. MARUCCI
Name: Anthony S. Marucci
Title: President and Chief Executive Officer

Exhibit 31.2
CERTIFICATION
I, Sam Martin, certify that:
1.
I have reviewed this annual report on Form 10-K of Celldex Therapeutics, Inc.;
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 the 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: February 27, 2025
By /s/ SAM MARTIN
Name: Sam Martin
Title: Senior Vice President and Chief Financial Officer

Exhibit 32
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
AND CHIEF FINANCIAL OFFICER PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Each of the undersigned hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002, in his capacity as an officer of Celldex Therapeutics, Inc. (the “Company”), that, to his knowledge, the Annual
Report of the Company on Form 10-K for the period ended December 31, 2024 (the “Form 10-K”), fully complies with the requirements
of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. §78m or 78o(d)) and that the information contained in such
report fairly presents, in all material respects, the financial condition and results of operations of the Company. This written statement is
being furnished to the Securities and Exchange Commission as an exhibit to the Form 10-K. A signed original of this statement has been
provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff
upon request.
Date: February 27, 2025
By: /s/ ANTHONY S. MARUCCI
Name: Anthony S. Marucci
Title: President and Chief Executive Officer
Date: February 27, 2025
By: /s/ SAM MARTIN
Name: Sam Martin
Title: Senior Vice President and Chief Financial Officer
This certification shall not be deemed “filed” for any purpose, nor shall it be deemed to be incorporated by reference into any filing
under the Securities Act of 1933 or the Exchange Act.