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Xenetic Biosciences, Inc.

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FY2015 Annual Report · Xenetic Biosciences, Inc.
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

Form 10-K

xx

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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the fiscal year ended December 31, 2015

TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the transition period from to

Commission File Number: 333-178082
XENETIC BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)

Nevada
(State or other jurisdiction of
incorporation or organization)

45-2952962
(IRS Employer
Identification No.)

99 Hayden Ave, Suite 230
Lexington, Massachusetts 02421
(Address of principal executive offices and zip code)
781-778-7720
(Registrant’s telephone number, including area code)

Title of Each Class
None

Name of Each Exchange
on Which Registered
None

Securities registered pursuant to Section 12(b) of the Act:
None
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  o No x
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 o No x
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 x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted 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 x No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405) is not contained herein, and
will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part
III of this Form 10-K or any amendment to this Form 10-K: Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
company.  See  the  definitions  of  “large  accelerated  filer,”  “accelerated  filer”  and  “smaller  reporting  company”  in  Rule  12b-2  of  the
Exchange Act. (Check one):
Large accelerated filer
Non-accelerated filer
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2): Yes o No x

Accelerated filer
Smaller reporting company

o
x

o
o

The approximate aggregate market value of voting common stock held by non-affiliates of the registrant, based upon the last sale price of
the  registrant’s  common  stock  on  the  last  business  day  of  the  registrant’s  most  recently  completed  second  fiscal  quarter  June  30,  2015
(based upon the shares of common stock at the closing sale price of the registrant’s common stock listed as reported on the OTCQB), was
approximately $9,500,000.

As of March 30, 2016 the number of outstanding shares of the registrant’s common stock was 151,980,084.

DOCUMENTS INCORPORATED BY REFERENCE

The registrant intends to file a proxy statement pursuant to Regulation 14A or a Form 10-K/A, not later than 120 days after the close of the
fiscal year ended December 31, 2015. Portions of such proxy statement or Form 10-K/A are incorporated by reference into Part III of this
Annual Report on Form 10-K.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XENETIC BIOSCIENCES, INC.
2015 ANNUAL REPORT ON FORM 10-K

TABLE OF CONTENTS

Business

Risk Factors

Unresolved Staff Comments

Properties

Legal Proceedings

Mine Safety Disclosures

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Selected Financial Data

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Quantitative and Qualitative Disclosures About Market Risk

Financial Statements and Supplementary Data

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures

Other Information

Directors, Executive Officers and Corporate Governance

Executive Compensation

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Certain Relationships and Related Transactions, and Director Independence

Principal Accounting Fees and Services

Exhibits, Financial Statement Schedules

2

PART I

Item 1

Item 1A

Item 1B

Item 2

Item 3

Item 4

PART II

Item 5

Item 6

Item 7

Item 7A

Item 8

Item 9
Item 9A

Item 9B

PART III

Item 10

Item 11

Item 12

Item 13

Item 14
PART IV

Item 15

Signatures
Exhibit Index

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30

30

30

30

30

31

34

35

45

46

49
49

50

51

51
51

51

51

51
51

52

53
54

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This  report  contains  both  historical  and  forward-looking  statements.  The  forward-looking  statements  in  this  annual  report  are  not
based on historical facts, but rather reflect the current expectations of our management concerning future results and events. These forward-
looking  statements  include,  but  are  not  limited  to,  statements  concerning  our  plans  to  continue  the  development  of  our  proposed  drug
candidates; our expectations regarding the nature, timing and extent of clinical trials and proposed clinical trials; our expectations regarding
the timing for proposed submissions of regulatory filings, including but not limited to any Investigational New Drug (“IND”) filing or any
New Drug Application (“NDA”); the nature, timing and extent of collaboration arrangements; the expected results pursuant to collaboration
arrangements including the receipts of future payments that may arise pursuant to collaboration arrangements; the outcome of our plans to
obtain regulatory approval of our drug candidates; the outcome of our plans for the commercialization of our drug candidates; our plans to
address  certain  markets,  engage  third  party  manufacturers,  and  evaluate  additional  drug  candidates  for  subsequent  commercial
development, and the likelihood and extent of competition to our drug candidates.

In  some  cases,  these  statements  may  be  identified  by  terminology  such  as  “may”,  “will”,  “should”,  “expect”,  “plan”,  “anticipate”,
“believe”, “estimate”, “predict”, “potential”, or “continue”, or the negative of such terms and other comparable terminology. Although we
believe  that  the  expectations  reflected  in  the  forward-looking  statements  contained  herein  are  reasonable,  we  cannot  guarantee  future
results, the levels of activity, performance or achievements. These statements involve known and unknown risks and uncertainties that may
cause  our  or  our  industry's  results,  levels  of  activity,  performance  or  achievements  to  be  materially  different  from  those  expressed  or
implied by forward-looking statements.

The Management's Discussion and Analysis of Financial Condition and Results of Operations (the “MD&A”) should be read together
with our financial statements and related notes included elsewhere in this annual report. This annual report, including the MD&A, contains
trend  analysis  and  other  forward-looking  statements. Any  statements  in  this  annual  report  that  are  not  statements  of  historical  facts  are
forward-looking  statements.  These  forward-looking  statements  made  herein  are  based  on  our  current  expectations,  involve  a  number  of
risks and uncertainties and should not be considered as guarantees of future performance.

The  single  most  pressing  factor  that  could  cause  actual  results  to  differ  materially  and  adversely  is  our  need  to  raise  additional

working capital for the purpose of further developing our various drug candidates.

Other factors that could cause actual results to differ materially include without limitation:

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our ability to continue to finance our business, including our plans to complete a capital raise during 2016;
our ability to successfully close on the transactions contemplated in the Asset Purchase Agreement (the ”APA”) entered into on
November 13, 2015;
our ability to complete a planned up-list to a national securities exchange;
our  ability  to  achieve  milestone  and  other  payments  associated  with  our  co-development  collaborations  and  strategic
arrangements;
the impact of new technologies on our drug candidates and our competition;
changes in laws or regulations of governmental agencies;
interruptions or cancellation of existing contracts;
impact of competitive products and pricing;
product demand and market acceptance and risks;
the presence of competitors with greater financial resources;
product development and commercialization risks;
continued availability of supplies or materials used in manufacturing at the current prices;
the ability of management to execute plans and motivate personnel in the execution of those plans;
adverse publicity related to our products or the Company (as defined below) itself;
adverse claims relating to our Intellectual Property (“IP”);
the adoption of new, or changes in, accounting principles;
the  costs  inherent  with  complying  with  new  statutes  and  regulations  applicable  to  public  reporting  companies,  such  as  the
Sarbanes-Oxley Act of 2002; and
other new lines of business that the Company may enter in the future.

These factors are not necessarily all of the important factors that could cause actual results to differ materially from those expressed
in the forward-looking statements in this annual report. Other unknown or unpredictable factors also could have material adverse effects on
our future results. The forward-looking statements in this annual report are made only as of the date of this annual report, and we do not
have any obligation to publicly update any forward-looking statements to reflect subsequent events or circumstances. Please also refer to
Item 1A - Risk Factors in this Annual Report on Form 10-K.

3

 
 
 
 
 
 
 
 
 
 
 
 
ITEM 1 – BUSINESS

Trademarks

PART I

Xenetic Biosciences, Inc.’s brand and product names, including but not limited to PolyXen™, Virexxa ®, OncoHist™ and ImuXen™
contained in this document are trademarks, registered trademarks or service marks of Xenetic Biosciences, Inc. and or its subsidiaries in the
United  States  of America  (“USA”  or  “U.S.”)  and  certain  other  countries.  This  document  contains  references  to  trademarks  and  service
marks  of  other  companies  that  are  the  property  of  their  respective  owners. As  used  in  this  annual  report,  unless  otherwise  indicated,  all
references herein to “Xenetic”, the “Company”, “we” or “us” refer to Xenetic Biosciences, Inc. and its wholly owned subsidiaries.

Significant Transactions and Recent Developments

Financing

On November 13, 2015, the Company entered into an Asset Purchase Agreement (the “APA”) with AS Kevelt, an Estonian biotech
company (“Kevelt”) and OJSC Pharmsynthez (“Pharmsynthez”, and together with Kevelt, “Sellers”). Pursuant to the APA, the Sellers will
transfer to the Company certain intellectual property rights held by the Sellers with respect to Virexxa ®, and the Company will receive the
worldwide  rights  to  develop,  market  and  license  Virexxa®  for  certain  uses,  except  for  excluded  uses  within  the  Commonwealth  of
Independent  States  (the  “CIS”),  in  exchange  for  111.5  million  shares  of  Company  common  stock  and  certain  other  consideration. 
Virexxa® is a Phase II oncology drug candidate which is under investigation for the treatment of certain endometrial cancers.  As part of
this total consideration, the Company will also acquire Kevelt's U.S. Orphan Drug designation for the use of Virexxa ® in the treatment of
progesterone receptor negative endometrial cancer in conjunction with progesterone therapy.

The APA  also  contains  a  financing  component  wherein  the  Company  received  from  Pharmsynthez  up  to  $3.5  million  in  bridge
financing  commitments  and  a  commitment  of  an  additional  $6.5  million  in  financing  as  part  of  a  planned  capital  raise  and  up-list  to  a
national securities exchange.

As of March 30, 2016, the Company has received $3.5 million of the $3.5 million bridge financing. In addition, the Company issued
11 million shares in November 2015 as a prepayment toward completing the APA transaction. However, transfer of all of the Virexxa ®
intellectual  property  and  development  rights  and  issuance  of  100.5  million  shares  of  the  total  111.5  million  shares  of  the  Company’s
common stock was not completed as of March 30, 2016. The Company expects these transfers, along with the balance of the transactions
contemplated in the APA, to be consummated during the second quarter of 2016.

This is not intended to be a full description of the APA. Please refer to the SEC Form 8-K filed on November 16, 2015 for a more

complete description of this transaction.

On  July  1,  2015,  the  Company  entered  into  a  Securities  Purchase Agreement  (the  “SPA”)  with  Pharmsynthez  providing  for  the
issuance of a minimum of a $3 million, 10% Senior Secured Collateralized Convertible Promissory Note (the “SPA Note”). The SPA also
provides for the issuance of certain warrants up to the amount of the SPA Note. In July 2015, the Company issued the SPA Note for $3
million plus a warrant to purchase 10 million shares of common stock (the “Warrant”) in accordance with the terms of the SPA. The SPA
Note carries a term of one year and is convertible, in whole or in part, at the option of Pharmsynthez into shares of common stock at a
conversion  price  of  $0.15.  In  the  event  that  the  SPA  Note  remains  outstanding  at  April  1,  2016,  Pharmsynthez  shall  be  granted  an
additional  warrant  to  purchase  an  additional  number  of  shares  of  the  Company’s  common  stock  equal  to  50%  of  the  number  of  shares
issuable under the SPA Note. The Warrant has a five-year term and is exercisable commencing January 1, 2016. The SPA was amended in
November concurrent with the execution of the APA.

This is not intended to be a full description of the SPA. Please refer to the SEC Form 8-K filed on July 3, 2015 for a more complete

description of this transaction.

4

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Acquisition

On January 23, 2014, the Company consummated an acquisition pursuant to a written plan of reorganization, in which we merged
with Xenetic Biosciences (UK) Limited (formerly Xenetic Biosciences plc) (“Xenetic UK”), a company incorporated in England and Wales
under the Companies Act of 1985, such that Xenetic UK became a wholly owned subsidiary of the Company (the “Acquisition”). Upon
completion  of  the Acquisition,  we  acquired  all  issued  and  outstanding  shares  of  capital  stock  of  Xenetic  UK. As  a  result,  132,545,504
shares  of  our  common  stock  were  newly  issued  and,  immediately  following  the Acquisition,  there  were  136,045,504  shares  of  common
stock issued and outstanding. At that time, because former Xenetic UK shareholders owned approximately 97% of the combined company
on  a  fully  diluted  basis  and  all  members  of  the  combined  company’s  executive  management  were  from  Xenetic  UK,  Xenetic  UK  was
deemed to be the acquiring company for accounting purposes and the transaction was accounted for as a reverse acquisition in accordance
with accounting principles generally accepted in the United States (“U.S. GAAP”).

Prior to the Acquisition, the Company changed its name from General Sales and Leasing, Inc. to Xenetic Biosciences, Inc.

Stock Purchase Agreement

On January 29, 2014 the Company entered into a stock purchase agreement (the “Purchase Agreement”) with Baxter Healthcare SA
(“Baxter SA”), pursuant to which the Company sold to Baxter SA 10,695,187 shares of the Company’s common stock, par value $0.01 per
share, (the “Shares”) for $10 million (the “Purchase Price”)  at  a  price  of  $0.935  per  share  yielding  a  market  cap  of  approximately  $140
million. During June 2015, in connection with the separation of its biopharmaceuticals business to form Baxalta Incorporated (“Baxalta”),
Baxter assigned the Shares to Baxalta.

The Shares were sold in a private placement and were not registered under the Securities Act, or the securities laws of any state, and
were offered and sold in reliance on the exemption from registration afforded by Section 4(a)(2) and Regulation D (Rule 506) under the
Securities Act  and  corresponding  provisions  of  state  securities  laws,  which  exempt  transactions  by  an  issuer  not  involving  any  public
offering. Baxter SA is an “Accredited Investor” as such term is defined in Regulation D promulgated under the Securities Act. For a further
discussion of the Purchase Agreement please refer to “Market for Registrant’s Common Equity,  Related  Stockholder  Matters  and  Issuer
Purchases of Equity Securities – Recent Sales of Unregistered Securities” in this Annual Report filed on Form 10-K.

5

 
 
 
 
 
 
 
 
 
 
Overview of Business

Xenetic Biosciences, Inc. is a clinical stage biopharmaceutical company that is focused on the research and development of certain
pharmaceutical products for use in humans that incorporate the use of its patented and proprietary platform technologies that we believe
will  enable  the  creation  of  next-generation  biologic  drugs  and  novel  oncology  therapeutics  with  an  emphasis  primarily  on  orphan
indications.

We  hold  more  than  201  United  States  (“U.S.”)  and  international  patents  in  addition  to  certain  proprietary  rights  to  four  core
technologies that are designed to treat a variety of indications with potential use advantages over competing products, in addition we have
approximately  90  pending  patents.  In  June  2014,  the  U.S.  Patent  and  Trademark  Office  (the  “USPTO”)  has  granted  the  Company  U.S.
Patent No. 8,735,557, entitled "Activated Sialic Acid Derivatives for Protein Derivatization and Conjugation," which contains claims that
cover lead compound, ErepoXen™, and Xenetic's broader polysialic acid technologies.

The Company’s core technologies are summarized below:

PolyXen™

Virexxa®

OncoHist™

ImuXen™

An enabling technology that utilizes Polysialic Acid (“PSA”), a biopolymer, consisting of a chain of sialic acids,  which is
a natural constituent of the human body. PSA is designed to extend the half-life in circulation in the human body  for  a
variety of existing drug molecules and, thereby, to create potentially superior next generation drug candidates.
Virexxa®, sodium cridanimod, belongs to a class of low-molecular weight synthetic interferon inducers. In addition to its
immunomodulatory properties, Virexxa® has been shown to increase levels of  progesterone receptor expression in tumor
tissue of patients who are progesterone receptor deficient, and thus may restore sensitivity of non-responsive endometrial
cancers  to  hormonal (e.g.  progestin)  therapy.  Based  on  preclinical  observations,  Virexxa®  may  also  be  therapeutically
relevant in other hormone-resistant cancers, such as triple-negative breast cancer.  Virexxa® has been granted an Orphan
Drug  Designation  by  the USFDA  for  use  in  conjunction  with  medroxyprogesterone  in  progesterone  receptor  negative
endometrial cancer.
A novel therapeutic platform that utilizes the properties of the human histone H1.3 (“H1.3”) for the development of drug
candidates  for  the  treatment  of  a  broad  range  of  cancer  indications.  OncoHist™,  unlike  many  competing  oncology
therapies, is based on a molecule occurring naturally in the human body, in the cell nucleus, and is therefore expected to be
less toxic and immunogenic than other oncology therapies.
A  novel  liposomal  co-entrapment  encapsulation  technology  designed  to  create  new  vaccines  and  improve  the  use  and
efficacy  of certain  existing  vaccines  for  use  in  the  human  body.  The  technology  is  based  on  the  co-entrapment  of  the
nominated antigen(s) in a liposomal vesicle, a design that is intended to maximize both cell and immune system mediated
responses.

All  of  the  Company’s  current  drug  candidates  are  in  the  development  stage  and  none  has  yet  received  regulatory  approval  for

marketing in the U.S. by the U.S. Food and Drug Administration (the “FDA”) or by any applicable agencies in other countries.

6

 
 
 
 
 
 
 
 
 
 
 
Our Business Strategy

Our strategy is to develop our orphan oncology drug candidates through to market launch. We plan to bring our orphan candidates to
full  and  final  regulatory  approval  and  commercialization  primarily  in  the  U.S.  and  Europe.  For  the  Company’s  PolyXen ®  based  next
generation biologics vested in our pipeline via its various collaborations, e.g. ErepoXen™, we will develop to a stage that will enable us to
seek profitable out-licensing arrangements with major pharmaceutical companies for further development and eventual commercialization,
in exchange for milestone payments and royalties from product sales. We are also pursuing outlicensing PolyXen ® for use with a partner’s
proprietary molecule, e.g. Baxalta, in exchange for upfront payments, clinical milestones and royalties linked to sales. Our collaborative
out-licensing agreements relating to the platforms are an integral part of our early-stage monetization strategy.

We advance our drug candidates through a combination of conducting our own in-house research and through the use of the outside
services  of  contract  manufacturing  and  research  organizations  in  order  to  efficiently  manage  the  Company’s  overheads.  Continuous
pipeline growth and advancement of outlicensed drug candidates is dependent, in part, on several important co-development collaborations
and  strategic  arrangements.  Together  with  our  collaborative  associates,  Baxalta  (formerly  Baxter  Healthcare  Corporation),  SynBio  LLC
(“SynBio”),  a  Russian  pharmaceutical  company  and  significant  shareholder  in  the  Company,  OJSC  (“Open  Joint  Stock  Company”)
Pharmsynthez  (“Pharmsynthez”),  a  Russian  pharmaceutical  company  and  Serum  Institute  of  India  Limited  (“Serum  Institute”),  one  of
India’s largest biotech companies and a shareholder in the Company, we are focused on developing our pipeline of next generation bio-
therapeutics and novel orphan drugs in oncology based on the Company’s PolyXen™, OncoHist™ and Virexxa® proprietary technologies.

Even  with  regard  to  our  strategy  of  current  and  planned  future  co-development  collaborations  and  out-licensing,  we  must  raise
significant additional capital in order to develop our drug candidates to the point of commercialization. Although we are optimistic, there
can  be  no  assurance  that  we  will  be  successful  in  raising  additional  working  capital.  If  not  successful,  our  business  could  be  adversely
affected.

Reliance on Principal Customer

Since August 2005, Baxalta (formerly Baxter Healthcare Corporation) has been a principal customer of the Company, accounting for
the substantial portion of the Company’s revenue in years prior to 2014, through up-front payments and fee for services. Please refer to the
agreement  with  Baxalta  under  the  caption  “Significant  Co-Development  Collaborations  and  Strategic Arrangements”  below  for  further
information regarding the importance of the Company’s relationship with Baxalta.

7

 
 
 
 
 
 
 
 
 
 
Our Technologies

PolyXen™

PolyXen™ is a platform technology based on the concept of polysialylation. PSA is a polymer chain composed of sialic acids linked
together.  Sialic  acid  is  found  on  the  external  membrane  of  a  number  of  cell  types  in  the  body.  In  addition,  it  is  a  natural  component
expressed on the external membrane on a number of bacterial types. The chain of sialic acid molecules can be anywhere from four to over
200 individual sialic acid molecules in length. The Company uses the linear form of PSA called colominic acid. It is a natural, hydrophilic
polymer isolated from a bacterial strain of E. coli K1. This natural glycan is negatively charged, non-toxic and is biodegradable. The PSA
chain  is  extensively  purified  from  large-scale  bacterial  cultures  under  Current  Good  Manufacturing  Practices  conditions,  modified  to
specified  sizes  and  then  attached  to  defined  sites  on  the  therapeutic.  Both  the  site  of  attachment  and  the  length  of  the  PSA  chain  can
enhance the properties of the therapeutic.

The  major  effect  of  PSA  addition  to  a  therapeutic  is  to  change  the  apparent  hydrodynamic  radius  of  the  molecule.  This  physical
alteration then changes a number of the biological characteristics of the therapeutic. The most noticeable, and perhaps the most relevant, is
an extension of the lifetime of the therapeutic in blood circulation. This is due to the increase in the size of the drug, which results in a
decrease  in  the  clearance  rate  of  the  molecule  in  the  kidney  by  glomerular  filtration.  In  addition,  studies  have  shown  changes  in  other
biological characteristics such as protease sensitivity and temperature sensitivity. An added benefit is that the conjugated molecules are less
viscous  in  solution  than  comparable  other  technologies,  providing  the  potential  for  easier  injections  and  fewer  injection  site  reactions.
Furthermore,  we  believe  that  adding  PSA  to  an  existing  marketed  drug  may  allow  for  patent  extension,  thereby  potentially  creating  a
patent-protected next generation candidate.

The current standard for certain biologic delivery agents is Polyethylene Glycol (“PEG”) which is attached similarly to therapeutics.
The mode of action between PSA and PEG is similar, increasing the apparent size of the molecule and thereby increasing the circulating
time  of  the  drug  in  the  blood.  PEGylation  is  a  proven  technology  that  can  offer  advantages  in  terms  of  pharmacokinetics  and
pharmacodynamics for therapeutics over non-modified, first generation molecules. There are a number of PEG-modified molecules on the
market, in clinical trials and under development. However, PEGylation is considered to have limitations, such as non-biodegradability and,
at high doses, may thereby result in intra-cellular accumulation, potentially leading to vacuole formation in the cells. In contrast, because
PSA  is  a  chain  of  sialic  acids,  which  are  natural  constituents  of  the  human  body,  it  is  biodegradable  into  individual  sialic  acid  units.  In
addition, PEG in many cases has been shown to be immunogenic when coupled to proteins and can activate the complement system. PEG
has also demonstrated limitations on a few select molecules. PSA has to date been shown to be non-immunogenic. We believe PSA may
provide the advantages of PEG without many of its disadvantages, offering a potential advance over PEG molecules.

Virexxa®

Virexxa® (sodium cridanimod) belongs to a class of low-molecular weight immunomodulators, which have been relevant in a wide
range of therapeutic areas (antiviral, antibacterial, antitumor, and anti-inflammatory). Sodium cridanimod is approved for marketing in the
Russian Federation, and numerous CIS countries for the treatment of certain infectious diseases. Sodium cridanimod has been authorized
and marketed in the Russian Federation and CIS states for more than 17 years and approximately 11,000,000 doses have been sold for non-
cancer indications under certain brand names Neovir® and Primavir®. In addition there are 22 completed clinical trials conducted by others
outside the U. S. that assessed the efficiency and safety of sodium cridanimod in certain non-cancer indications.

8

 
 
 
 
 
 
 
 
 
 
 
Our decision to investigate Virexxa® for the treatment of endometrial cancer was based in part on the history of sodium cridanimod

in preclinical and clinical research conducted by others, as summarized below.

In  addition  to  its  immunomodulatory  properties,  Virexxa®  has  been  shown  to  increase  the  levels  of  progesterone  receptor  (“PR”)
expression in the endometrial tumor tissue of patients who are PR deficient, and thus may have the potential to restore the sensitivity of
non-responsive  endometrial  cancers  to  hormonal  (e.g.  progestin)  therapy.  At  present,  the  clinical  development  program  for  Virexxa®
includes an ongoing FDA IND-enabled Phase II study for Virexxa® in conjunction with progestin therapy in a population of patients with
recurrent  or  persistent  progesterone  receptor  negative  (“PrR-“)  endometrial  cancer.  Virexxa®  has  been  granted  an  Orphan  Drug
Designation by the FDA for use in conjunction with medroxyprogesterone in PrR- endometrial cancer.

Preclinical studies have shown that sodium cridanimod can increase interferon-alpha production by human immune cells and increase
PR levels in endometrium. Furthermore, a Phase II clinical study conducted in patients with endometrial carcinoma has shown that sodium
cridanimod significantly increases levels of PR expression in tumor tissue of patients who are PR deficient.

Virexxa® may also represent therapeutic opportunities in other hormone-resistant tumor types, such as triple-negative breast cancer.

OncoHist™

OncoHist™ is based on research covered under our patent portfolio related to novel functions of histones. Histone H1 has strong anti-
proliferative  properties  against  cancer  cells  of  different  histological  origin.  This  has  been  demonstrated  extensively  for  hematologic
malignancies,  such  as  leukemias,  lymphomas,  and  myelomas,  and  for  tumors  from  other  tissues.  Susceptibility  of  cells  to  the  cytotoxic
effect of histones is determined by the ability of histone H1 to selectively destabilize the tumor cell membrane, which results in cell death.

A novel form of the molecule was developed by the Company and a patent filed for the protection of the new chemical entity, N-bis-
met-histone 1.3 (OncoHist™) in use against cancer, providing patent protection at least until 2027. The activity of the new molecule was
tested on 58 tumor cell lines derived from various tissues. Hematopoietic tumor cell lines were found to be among the most sensitive cell
lines.  The  mechanism  of  action  appears  to  be  novel,  involving  the  binding  of  OncoHist™  to  the  cell  membrane,  which  is  completely
different  from  that  of  other  therapeutic  agents  on  the  market  for  hematopoietic  cancers.  Confirmatory  work  on  this  mode  of  action  with
more detailed analyses is being completed by Dana-Farber Cancer Institute (“Dana-Farber”). Hematopoietic tumor lines resistant to current
chemotherapeutic agents have shown sensitivity to OncoHist™.

OncoHist’s™ potency and potential to inhibit growth of cells from various histological origins were indicated through in-vitro testing
against the U.S. National Cancer Institute 60 (“NCI-60”). OncoHist™ was awarded orphan drug designation (Orphan Medicinal Product
Designation  (“OMPD”))  for  treatment  of  AML  by  the  European  Commission  in  December  2007  and  by  the  FDA  in  October  2008.
OncoHist™ was awarded an additional OMPD status for Acute Lymphocytic Leukemia (“ALL”) by the EMA.

9

 
 
 
 
 
 
 
 
 
 
 
 
A  Phase  I-II  trial  to  evaluate  the  safety  and  tolerability  of  OncoHist™  was  conducted  in  2008  at  Saarland  University  in  Germany
with  22 AML  patients.  Clinical  effects  were  noted  in  seven  patients  with  three  partial  remissions.  Most  notably,  two  patients  who  had
received two treatment cycles each experienced stabilization of their disease for seven and 17 months, respectively.

A clinical safety trial with a planned 120 AML  patients  was  in  progress  and  being  performed  by  SynBio  in  clinical  centers  in  the
Russian  Federation.  The  aim  of  this  trial  was  to  examine  the  potential  benefits  of  OncoHist™  in  combination  with  standard  HAM
chemotherapy: high dose cytarabine with mitoxantrone. During execution of the SynBio AML trial, the Russian Ministry of Health issued
changes  in  their  standard  of  care  for  treating AML  patients.  High  dose  cytarabine  chemotherapy  was  determined  to  offer  no  benefits  in
terms of efficacy as compared to lower dose therapy and was discontinued.

We  have  completed  preclinical  toxicity  studies  using  clinical  material  supplied  to  us  by  SynBio.  We  have  had  a  pre-IND  meeting
with the FDA and came to agreement with the FDA on characterization, clinical criteria and the inclusion of an additional disease indication
in the Phase I study. In addition, we are planning to establish a second source supplier of OncoHist™ material suitable for humans in Phase
I/II(a) clinical trials under cGMP. We intend to commence clinical trials in the U.S. during the second half of 2017. Sponsored research at
Dana Farber Cancer Institute is helping to elucidate the mechanism of action of OncoHist™ as well as characterize the response of AML
tumor lines to OncoHist™. Interim data has been presented at the American Society of Hematology meeting and publications are expected
during  second  half  2016.  Certain  OncoHist™  clinical  data,  generated  by  SynBio,  that  is  available  to  us  for  analysis  has  advanced  our
understanding of this drug candidate in a capital efficient manner.

Other Technologies

ImuXen™

ImuXen™  is  a  patented  platform  technology  based  on  the  concept  of  simultaneous  delivery  of  multiple  Active  Pharmaceutical
Ingredients (“APIs”) as antigens within the same liposome. The liposomes are composed of lipids that encapsulate an aqueous core. The
APIs  can  be  trapped  in  the  core,  be  associated  with  the  lipids,  or  both.  Proteins,  peptides,  nucleic  acids,  polysaccharides  and  live  or
inactivated infectious agents can all be used as an API with the same liposome. Both the size and the lipid composition can be controlled
which  affects  the  biological  properties  of  the  liposome.  Manufacturing  involves  the  passive  entrapment  of  the  vaccine APIs  by  freeze
drying commercially available liposomes with the antigens of interest.

Having  multiple  APIs  formulated  with  the  same  liposome  allows  simultaneous  delivery  of  the  antigens  to  the  same  antigen-
presenting  cell.  This  may  allow  a  more  efficient  immune  response  to  all  the  agents  presented.  In  addition,  it  is  possible  that  multiple
vaccines can be delivered with a single injection. Relevant pre-clinical studies have indicated a reduction in the dose required, a reduction in
the number of doses required and a faster immune response time. This efficient immune response also may allow for use of antigens that
traditionally give a poor antibody response.

This  technology  is  not  currently  the  focus  of  clinical  development  for  the  Company.  However,  through  a  license  agreement  with

Pharmsynthez, there is a novel multiple sclerosis vaccine that is in clinical development in Russia.

A Phase I clinical trial to treat relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis was completed by
SynBio in the Russian Federation. Peptides corresponding to antigenic sections of basic myelin protein were encapsulated within liposomes
to  be  used  as  the  therapeutic  agent  (MyeloXen™). As  an  integral  part  of  the  Company’s  strategy,  we  await  later  stage  clinical  data  on
MyeloXen™ to determine whether to pursue this candidate in U. S. clinical trials for potential out-licensing.

10

 
 
 
 
 
 
 
 
 
 
 
 
 
Significant Co-Development Collaborations and Strategic Arrangements:

Baxalta Incorporated

In August 2005, the Company entered into an exclusive research, development, license and supply agreement with Baxter Healthcare
SA (“Baxter SA”) and Baxter Healthcare Corporation (together referred to as “Baxter”) to develop products with an extended half-life of
certain proteins and molecules using the Company’s patent protected PolyXen™ technology whereby polysialic acid (“PSA” – a chain of
polysialic acids) is conjugated with Baxter’s proprietary molecule(s) designed to create a longer-acting haemophilia drug, a polysialylated
recombinant Factor VIII (“rFVIII”) protein than what is currently available on the market. Baxter also has rights that extend to treatments
of the failure of blood to coagulate. Baxter commenced human clinical trials on this novel drug candidate during the first quarter of 2016.

During June 2015, in connection with the separation of its biopharmaceuticals business to form Baxalta Incorporated, Baxter assigned

all of its rights and obligations under its existing agreement with the Company to Baxalta.

This agreement has been amended several times since 2005, most recently in January 2014. The January 2014 amendment provides
for  increased  future  development,  regulatory,  sales  and  deadline  extension  receipts,  restructured  target  deadlines  and  royalty  receipts  on
potential  net  sales.  The  Company  is  entitled  to  up  to  $100  million  in  potential  development,  regulatory,  sales  and  deadline  extension
receipts,  which  are  contingent  on  the  performance  of  Baxter  achieving  certain  milestones.  The  Company  is  also  entitled  to  royalties  on
potential net sales.

In connection with this amendment, Baxter SA also made a $10 million equity investment at a price of $0.935 per share, which is a
post money market cap of approximately $140 million in the Company in exchange for 10,695,187 shares of the Company’s common stock
during January 2014.

Through December 31, 2015, the Company and Baxter continued to engage in research and development activities. No amounts were
recognized as revenue during the years ended December 31, 2015 and 2014. Since August 2005, the Company has received approximately
$19 million from Baxter that includes milestone receipts, fees for services and a $10 million purchase of common stock of the Company in
January 2014. The Company received a non-refundable $2 million payment from Baxter in 2010 and granted Baxter warrants to purchase
approximately 4.6 million new shares of common stock of the Company in connection with the 2010 amendment to the Baxter Agreement.

Baxter has agreed to meet a number of clinical milestones with strict timelines under the 2014 amendment relating to: Clinical Trial
Authorization (“CTA”) submission, Final Clinical Study Report and Biologics License Application (“BLA”) submission. Baxter submitted
a CTA application to the UK Medicines and Healthcare Products Regulatory Agency in late 2015 and commenced human clinical trials
during  the  first  quarter  of  2016  in  connection  with  this  collaboration.  There  are  very  limited  provisions  to  further  modify  the  Baxter
Agreement. There can be no assurance if or when Baxter will actually achieve any of the remaining due diligence milestones.

Baxter  is  a  related  party  of  the  Company,  with  a  share  ownership  of  approximately  8.0%  of  the  total  issued  common  stock  as  of

December 31, 2015.

SynBio LLC

In August  2011  the  Company  entered  into  a  stock  subscription  and  collaborative  development  agreement  with  SynBio  (the  “Co-
Development Agreement”)  pursuant  to  which  the  Company  granted  SynBio  an  exclusive  license  to  develop,  market  and  commercialize
certain drug candidates utilizing molecules based on the Company’s PolyXen™ and OncoHist™ technologies in the Russian market and
the  Commonwealth  of  Independent  States  (the  “CIS”)  (including Armenia, Azerbaijan,  Belarus,  Kazakhstan,  Kyrgyzstan,  Republic  of
Moldova, Tajikistan, Turkmenistan and Uzbekistan), collectively the “SynBio Market”. In exchange for the Company granting to SynBio
those certain license rights, SynBio granted an exclusive license to the Company to use any SynBio pre-clinical and clinical data generated
by SynBio, at its own expense, in connection with those development efforts and to engage in the development and commercialization of
drug  candidates  that  may  arise  from  the  collaboration  in  any  territory  outside  of  Russia  and  the  CIS  based  upon  the  Co-Development
Agreement.

11

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Company hopes and expects to mitigate certain risks of drug development by reviewing human clinical data arising out of this
collaboration  with  SynBio  before  the  Company  considers  taking  the  particular  drug  candidate  into  FDA  and  EMA  trials.  Under  the  Co-
Development Agreement,  SynBio  is  responsible  for  progressing  six  new  product  candidates  through  human  proof  of  concept  trials  in
Russia  as  primary  validation  for  the  initiation  of  EMA/FDA  clinical  trials  by  the  Company.  The  primary  goal  of  the  Co-Development
Agreement  is  to  research  and  develop  drug  candidates  for  planned  commercialization  using  SynBio  and  the  Company’s  combined
respective expertise and technologies. Drug candidates must meet the success criteria as decided upon by a joint steering committee, which
includes representation from both SynBio and the Company, where the Company has the right to appoint the Chair who has the casting
vote. Once a potential drug candidate is selected, clinical trials will be separately conducted by each company in their respective territories
with the goal to achieve regulatory approval of the products for commercial sale.

SynBio  is  wholly  responsible  for  funding  and  conducting  their  own  research  and  clinical  development  activities  in  Russia  as  the
Company is wholly responsible for funding and conducting their own research and clinical development activities in the US, Europe and
elsewhere  ex-Russia  and  the  ex-CIS  regions.  There  are  no  milestones  or  other  research  related  payments  provided  for  under  the  Co-
Development Agreement  other  than  fees  for  the  provision  of  each  party’s  respective  research  supplies  based  on  their  technology  and
royalties payable to the Company based on SynBio sales. For the years ended December 31, 2015 and 2014, the Company recognized no
supply service revenues in connection with the Co-Development Agreement.

Concurrent  with  entering  into  the  Co-Development  Agreement,  the  Company  entered  into  a  stock  subscription  agreement  with
SynBio  pursuant  to  which  the  Company  sold  SynBio  approximately  35.5  million  shares  of  newly  issued  common  stock  for  cash  of
approximately $18.6 million.

In  furtherance  of  our  co-development  clinical  objectives,  on  December  31,  2014  the  Company  granted  to  SynBio  certain  warrants
that  contain  vesting  triggers  based  on  the  achievement  by  SynBio  of  certain  clinical  development  objectives  within  specific  timeframes.
This grant consisted of a warrant to purchase 6,745,000 new shares of common stock at an exercise price of $0.77 per share (“SynBio 2014
Warrant”). Simultaneously with the SynBio 2014 Warrant grant, the Company granted additional warrants to purchase 320,000 aggregate
new shares of common stock to SynBio and Pharmsynthez non-director designees under the same terms and conditions of the SynBio 2014
Warrant. Pharmsynthez is a related party of SynBio and a collaboration partner of the Company. As part of this transaction, the warrant
granted to SynBio in 2011 was canceled and of no further force and effect. The SynBio 2014 Warrant expires on December 30, 2019 and
no warrants were exercised during the years ended December 31, 2015 and 2014.

Pursuant  to  the  Relationship  Deed  signed  concurrent  with  the  2011  Co-Development Agreement  and  subscription,  the  Company
granted SynBio (as Controlling Shareholder) the right to appoint two directors to the extent their shareholding is greater than 40% in the
Company.  The  Relationship  Deed  of  2011  was  replaced  in  January  2014  with  a  Director Appointment Agreement  containing  that  same
provision. Further undertakings therein state that, as long as the Controlling Shareholder holds more than 25% of the Company’s common
stock, all transactions and relationships between it and the Company will, (a) be at arm’s length and on a normal commercial basis; (b) it
will not seek to exercise any day-to-day operational or managerial control over the business of the Company, nor, (c) influence any director
or  non-executive  director  in  any  way  in  regard  to  the  conduct  of  the  Company’s  business.  The  agreement  contains  further  provisions
relating, inter alia, to: nominee board appointments, conflicts of interest, acting in good faith and terms of confidentiality.

SynBio is a related party of the Company, with a share ownership of approximately 39.0% of the total issued common stock as of

December 31, 2015.

12

 
 
 
 
 
 
 
 
 
 
Serum Institute of India Limited

In the period from 2004 through 2011, the Company entered into and amended certain license and supply agreements with Serum
Institute. The original license agreement with Serum Institute was a collaborative Development and Manufacturing Arrangement (“DMA”)
to  develop  agreed  upon  potential  commercial  product  candidates  using  the  Company’s  PolyXen™  technology.  Serum  Institute  then
endeavored  to  further  develop  the  potential  commercial  product  candidates  and  eventually  initiate  pre-clinical  and  clinical  trials  at  their
own  cost.  The  agreement  was  amended  in  2011,  resulting  in  the  surrender  of  development  rights  for  14  potential  commercial  product
candidates in 2012, which were vested to Serum Institute under the terms of the previous agreements, back to the Company.

Following  the  2011  amendment,  Serum  Institute  retained  an  exclusive  license  to  use  the  Company’s  PolyXen™  technology  to
research and develop one potential commercial product, Polysialylated Erythropoietin (“PSA-EPO”). Serum Institute will be responsible
for conducting all pre-clinical and clinical trials required to achieve regulatory approvals within territories outside of certain predetermined
territories  assigned  to  the  Company,  which  include  the  US,  the  European  Economic Area,  and  Japan,  among  other  territories,  at  Serum
Institute’s own expense. The royalty payment schedule based on net revenues on the future commercial sales of PSA-EPO under the DMA
was also modified as a result of the 2011 amendment. Royalty payments are payable by Serum Institute to the Company for net sales to
certain  customers  in  the  Serum  Institute  sales  territory.  Royalty  payments  are  payable  by  the  Company  to  Serum  Institute  for  net  sales
received  by  the  Company  over  the  term  of  the  license.  No  royalty  revenue  or  expense  was  recognized  by  the  Company  related  to  the
Serum  Institute  arrangement  during  the  years  ended  December  31,  2015  and  2014.  There  are  no  milestone  or  other  research-related
payments  due  under  the  DMA.  Through  December  31,  2015,  the  Company  and  Serum  Institute  continued  to  engage  in  research  and
development activities with no resultant commercial products.

In  furtherance  of  our  co-development  clinical  objectives,  on  December  31,  2014  the  Company  granted  to  Serum  Institute  certain
warrants  that  contain  vesting  triggers  based  on  the  achievement  by  Serum  Institute  of  certain  clinical  development  objectives  within
specific timeframes. This grant consisted of a warrant to purchase 3,200,000 new shares of common stock at an exercise price of $0.77 per
share (“Serum 2014 Warrant”). Simultaneously with the Serum 2014 Warrant grant, the Company granted additional warrants to purchase
160,000  aggregate  new  shares  of  common  stock  to  Serum  Institute  non-director  designees  under  the  same  terms  and  conditions  of  the
Serum  2014  Warrant.  The  Serum  2014  Warrant  expires  on  December  30,  2019  and  no  warrants  were  exercised  during  the  years  ended
December 31, 2015 and 2014.

In addition, the DMA allows for Serum Institute to nominate a non-executive director to the Board of Directors of the Company as
long  as  Serum  Institute  or  its  subsidiaries  holds  at  least  6%  of  the  Company’s  common  stock.  Serum  Institute  is  a  related  party  of  the
Company, with a share ownership of approximately 8.5% of the total issued common stock as of December 31, 2015.

OJSC Pharmsynthez

In November 2011, the Company entered into a collaborative research and development license agreement with OJSC Pharmsynthez
(the  “Pharmsynthez  Arrangement”)  pursuant  to  which  the  Company  granted  an  exclusive  license  to  Pharmsynthez  to  develop,
commercialize and market six product candidates based on the Company’s PolyXen™ and ImuXen™ technology anywhere within Russia
and the CIS. In exchange, Pharmsynthez granted an exclusive license to the Company to use any pre-clinical and clinical data developed by
Pharmsynthez, within the scope of the Pharmsynthez Arrangement, and to engage in further research, development and commercialization
of drug candidates in any territory outside of Russia and the CIS at the Company’s own expense.

In accordance with the terms of the Pharmsynthez Arrangement, the Company licensed certain PolyXen™ and ImuXen™ technology
rights for use in Russia and the CIS as well as certain clinical and research data developed by the Company on the six product candidates to
Pharmsynthez.

13

 
 
 
 
 
 
 
 
 
 
 
 
The Company hopes and expects to mitigate certain risks of drug development by reviewing human clinical data arising out of this
collaboration with Pharmsynthez before the Company takes the particular drug candidate into FDA and EMA trials, a strategy designed to
mitigate  drug  development  risks.  Under  the  agreement,  Pharmsynthez  is  responsible  for  progressing  six  new  drug  candidates  through
human proof of concept trials in Russia as primary validation prior to the initiation of EMA/FDA clinical trials by the Company outside of
Russia. The license agreement will operate alongside the current arrangements which the Company has entered into with SynBio, discussed
above.

A  joint  steering  committee  where  the  Company  has  the  right  to  appoint  the  Chair  who  has  the  casting  vote  was  established  to
facilitate  the  communication  of  scientific  data  and  to  assist  generally  with  each  party’s  research  decisions  and  to  monitor  research  and
development progress under the Pharmsynthez Arrangement.

Pharmsynthez is wholly responsible for funding and conducting their own research and clinical development activities in Russia. The
Company is wholly responsible for funding and conducting its own research and clinical development activities in the US, Europe and the
rest of the world outside of Russia and the ex-CIS regions. There are no milestones or other research related payments provided for under
the Co-Development Agreement other than royalties.

On July 1, 2015, the Company entered into a SPA with Pharmsynthez providing for the issuance of a minimum of a $3 million SPA
Note. The SPA also provides for the issuance of certain warrants up to the amount of the SPA Note. In July 2015, the Company issued the
SPA  Note  for  $3  million  plus  a  Warrant  in  accordance  with  the  terms  of  the  SPA.  The  SPA  Note  carries  a  term  of  one  year  and  is
convertible, in whole or in part, at the option of Pharmsynthez into shares of common stock at a conversion price of $0.15. In the event that
the SPA Note remains outstanding at May 11, 2016, Pharmsynthez shall be granted an additional warrant to purchase an additional number
of shares of the Company’s common stock equal to 50% of the number of shares issuable under the SPA Note. The Warrant has a five-year
term and is exercisable commencing January 1, 2016.

On  November  13,  2015,  the  Company  entered  into  an APA  with  Kevelt  and  Pharmsynthez.  Pursuant  to  the APA,  the  Sellers  will
transfer to the Company certain intellectual property rights held by the Sellers with respect to Virexxa®, and the Company will receive the
worldwide rights to develop, market and license Virexxa® for certain uses, except for excluded uses within the CIS, in exchange for 111.5
million shares of Company common stock and certain other consideration.  Virexxa® is a Phase II oncology drug candidate which is under
investigation for the treatment of certain endometrial cancers.  As part of this total consideration, the Company will also acquire Kevelt's
U.S. Orphan Drug designation for the use of Virexxa® in the treatment of progesterone receptor negative endometrial cancer in conjunction
with progesterone therapy.

The APA  also  contains  a  financing  component  wherein  the  Company  received  from  Pharmsynthez  up  to  $3.5  million  in  bridge
financing  commitments  and  a  commitment  of  an  additional  $6.5  million  in  financing  as  part  of  a  planned  capital  raise  and  up-list  to  a
national securities exchange.

As of March 30, 2016, the Company has received $3.5 million of the $3.5 million bridge financing. However, transfer of all of the
Virexxa®  intellectual  property  and  development  rights  and  issuance  of  100.5  million  shares  of  the  total  111.5  million  shares  of  the
Company’s common stock was not completed as of March 30, 2016. The Company expects these transfers, along with the balance of the
transactions contemplated in the APA, to be consummated during the second quarter of 2016.

The SPA was amended in November 2015 concurrent with the execution of the APA in order to provide for the New Notes and the

New Warrant.

Pharmsynthez is a related party of SynBio, which is related party of the Company. In addition, one of the Company’s directors is also

a director of SynBio and Pharmsynthez.

14

 
 
 
 
 
 
 
 
 
 
 
 
 
Tabular Summary of Drug Candidate Programs

Xenetic Corporate Programs

Product Candidate

Virexxa®

ErepoXen™

Indication
Endometrial
Cancer
Anemia

OncoHist™ AML

Acute Myeloid
Leukemia

Xenetic

Clinical Developer Headquarters
Xenetic

U.S.

Xenetic

U.S.

U.S.

Xenetic Collaborative Partner Programs
(alphabetical by clinical developer)

Product Candidate

Indication

Factor VIII

Hemophilia

Clinical Developer Headquarters
Baxter

US

PulmoXen™

Cystic Fibrosis

Pharmsynthez

Russia

MyeloXen™

Multiple Sclerosis Pharmsynthez

Russia

ErepoXen™

Anemia

Serum Institute

India

ErepoXen™
OncoHist™ AML

OncoHist™ NHL

Anemia
Acute Myeloid
Leukemia

Non-Hodgkins
Lymphoma

SynBio
SynBio

Russia
Russia

SynBio

Russia

15

Program Name/Developmental Stage
VIR-EC-01: US FDA IND-enabled Phase II trial in
progress
PSA-EPO-06: ICH Compliant Phase II in-process
being conducted in Australia, South Africa and New
Zealand. Cohort III in progress
Onc-AML-01: Pre-clinical studies and pre-IND
meeting with the FDA is complete. Negotiations
with contract manufacture and clinical research
organizations are in progress

Program Name/Developmental Stage
PSA-FVIII: CTA for a Phase I/II clinical trial was
approved.  Clinical trial commenced in Q1 2016
PMO-CF-01: Phase I completed. A Phase II
clinical trial is expected to start Q4 2016
IMU-MS-01: Phase I dose ranging study is
complete
PSA-EPO-03: Phase II(a) intravenous and
subcutaneous human clinical trials conducted in
India are complete. The study report is expected in
Q2 2016
PSA-EPO-05: Russian Phase II(b)/III in progress
Onc-AML-02: Russian Phase II is on hold pending
protocol revision due to a change in Russian
Standard of Care requirements
Onc-NHL-01: Russian Phase II dose ranging
studies are completed in Russia

 
 
 
 
 
 
 
 
 
Most advanced product candidate in the Company pipeline: Virexxa®

Virexxa®

Virexxa® (sodium cridanimod) belongs to a class of low-molecular weight immunomodulators, which have been relevant in a wide
range of therapeutic areas (antiviral, antibacterial, antitumor, and anti-inflammatory). Sodium cridanimod is approved for marketing in the
Russian Federation, and numerous CIS countries for the treatment of certain infectious diseases. Sodium cridanimod has been authorized
and marketed in the Russian Federation and CIS states for more than 17 years and approximately 11,000,000 doses have been sold for non-
cancer indications under certain brand names Neovir® and Primavir®. In addition there are 22 completed clinical trials conducted by others
outside the U. S. that assessed the efficiency and safety of sodium cridanimod in certain non-cancer indications.

Our decision to investigate Virexxa® for the treatment of endometrial cancer was based in part on the history of sodium cridanimod

in preclinical and clinical research conducted by others, as summarized below.

In  addition  to  its  immunomodulatory  properties,  Virexxa®  has  been  shown  to  increase  the  levels  of  progesterone  receptor  (“PR”)
expression in the endometrial tumor tissue of patients who are PR deficient, and thus may have the potential to restore the sensitivity of
non-responsive  endometrial  cancers  to  hormonal  (e.g.  progestin)  therapy.  At  present,  the  clinical  development  program  for  Virexxa®
includes an ongoing FDA IND-enabled Phase II study for Virexxa® in conjunction with progestin therapy in a population of patients with
recurrent  or  persistent  progesterone  receptor  negative  (“PrR-”)  endometrial  cancer.  Virexxa®  has  been  granted  an  Orphan  Drug
Designation by the FDA for use in conjunction with medroxyprogesterone in PrR- endometrial cancer.

Preclinical studies have shown that sodium cridanimod can increase interferon-alpha production by human immune cells and increase
PR levels in endometrium. Furthermore, a Phase II clinical study conducted in patients with endometrial carcinoma has shown that sodium
cridanimod significantly increases levels of PR expression in tumor tissue of patients who are PR deficient.

Virexxa® may also represent therapeutic opportunities in other hormone-resistant tumor types, such as triple-negative breast cancer.

Second most advanced product candidate in the Company pipeline: ErepoXen™

The  Company’s  drug  candidate  that  is  currently  the  second  most  advanced  in  its  clinical  pipeline  is  ErepoXen™  (polysialylated
erythropoietin  (“PSA-EPO”))  which  uses  the  Company’s  PolyXen™  technology  for  the  treatment  of  anemia  in  Chronic  Kidney  Disease
(“CKD”)  patients.  ErepoXen™  is  in  a  Company-sponsored  Phase  II  escalating  repeat  subcutaneous  dose-ranging  study  in Australia  and
New Zealand for pre-dialysis CKD patients. This trial is designed to be compliant with the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”). ErepoXen™ has also been a co-development project
with  our  long-established  strategic  partner,  Serum  Institute,  and  has  finished  a  Phase  II(a)  clinical  trial  in  India  for  intravenous
administration  to  patients  on  dialysis.  In  addition,  ErepoXen™  is  also  in  a  150  patient  Phase  II(b)/III  clinical  trial  in  Russia  to  directly
compare ErepoXen™ to Aranesp. The Company expects SynBio to enter the commercialization and marketing stage of ErepoXen™ in the
Russian and CIS markets, as the first market launch for a PSA candidate.

16

 
 
 
 
 
 
 
 
 
 
 
 
 
The  Company’s  commercialization  strategy  for  ErepoXen™,  being  a  potentially  mainstream  drug  addressing  a  substantial  global
market,  includes  seeking  an  out-license  arrangement  for  the  continuing  development  of  ErepoXen™  as  either  a  Phase  II(b)  or  Phase  III
candidate  with  a  well-capitalized  license  partner  more  experienced  at  taking  drug  candidates  through  the  latter  stages  of  human  clinical
trials and better able to execute a global market launch. If successful, this strategy could:

(a)

(b)

be  the  beginning  of  the  monetization of  the  Company’s  IP  investment  to  date  in  ErepoXen™  by  way  of  an  upfront
license payment plus milestone payments as the product is advanced through the clinic; and
potentially reduce the timeline for incoming royalty revenues if ErepoXen™ is taken to market by an already leading
provider with an established market presence.

The ErepoXen™ strategy, when implemented, should have the effect of decreasing demands on the Company’s own financial and
working capital resources, allowing those resources to be applied towards the in-house development and marketing of new orphan and rare
disease  candidates  where  the  Company  is  better  able  to  maintain  financial  and  clinical  control  throughout  the  process  from  pre-clinical
development, through IND filing, human clinical trials, and potentially market approval and product launch.

Next most advanced product candidate in the Company pipeline: OncoHist™

The  Company’s  next  most  advanced  drug  candidate  is  OncoHist™ AML.  We  have  completed  preclinical  toxicity  studies  using
clinical  material  supplied  to  us  by  SynBio.  We  have  had  a  pre-IND  meeting  with  the  FDA  and  came  to  agreement  with  the  FDA  on
characterization, clinical criteria and the inclusion of an additional disease indication in the Phase I study. In addition, we are planning to
establish  a  second  source  supplier  of  OncoHist™  material  suitable  for  humans  in  Phase  I/II(a)  clinical  trials  under  cGMP.  We  hope  to
commence  clinical  trials  in  the  U.S.  during  the  second  half  of  2017.  Sponsored  research  at  Dana  Farber  Cancer  Institute  is  helping  to
elucidate the mechanism of action of OncoHist™ as well as characterize the response of AML tumor lines to OncoHist™. Interim data has
been  presented  at  the American  Society  of  Hematology  meeting  and  publications  are  expected  during  the  second  half  of  2016.  Certain
OncoHist™ clinical data, generated by SynBio, that is available to us for analysis has advanced our understanding of this drug candidate in
a capital efficient manner.

Plans to commence clinical trials in the U.S. have been delayed due to insufficient working capital necessary to establish a source of

cGMP material suitable for these trials.

Other product candidates in the Company pipeline

The Company believes certain additional orphan and non-orphan oncology drug candidates may be developed utilizing certain of our
existing and future pre-clinical and clinical data. Specifically, we expect to be able to utilize the results from substantially all of our pre-
clinical  toxicity  and  certain  other  pre-clinical  data  generated  in  the  development  of  OncoHist™ AML  for  several  other  blood  cancer
indications focused on orphan indications.

We  also  believe  that  the  platform  nature  of  our  technologies  should  allow  us  to  pursue  additional  drug  candidates  by  leveraging

certain existing and future scientific data to be developed under our PolyXen™, OncoHist™ and Virexxa® technology programs.

17

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xenetic Corporate Programs

VIR-EC-01: Xenetic Virexxa® Clinical Trial

At  present,  the  clinical  development  program  for  Virexxa®  (sodium  cridanimod)  includes  an  ongoing  FDA  IND-enabled  Phase  II
study  for  Virexxa®  in  conjunction  with  progestin  therapy  in  a  population  of  subjects  with  recurrent  or  persistent  progesterone  receptor
negative (“PrR-“) recurrent or persistent endometrial cancer. This study is also active under the same IND in ex-U.S. sites in Belarus and
Ukraine.

The study is an open-label, multicenter, single-arm Phase II study calling for a total of 58 subjects with documented evidence of PrR-

endometrial cancer as determined by immunohistochemistry.

The primary objective of this study is to assess the antitumor activity of Virexxa® in conjunction with progestin therapy as measured
by objective response rate (partial/complete) in women with progesterone receptor negative recurrent or persistent endometrial carcinoma
not amenable to surgical treatment, radiotherapy, or chemotherapy.

Secondary objectives of the study include (a) to assess progression free survival, time to response , time to progression, duration of
overall survival and Overall Disease Control Rate for subjects receiving Virexxa® and progestin therapy and (b) to evaluate the safety and
tolerability of Virexxa® in conjunction with progestin therapy, as measured by adverse events, laboratory safety parameters, and cardiac
safety assessments.

Additional  translational  objectives  include  to  determine  the  efficacy  of  Virexxa®  in  combination  with  progestin  on  PrR  levels  in
tumor tissue, to correlate changes of PrR- levels with efficacy parameters and to assess pharmacokinetic data for Virexxa® and progestins
after a single-dose and multiple-dose administration.

PSA-EPO-06: Xenetic ErepoXen™ Clinical Trial

This  is  designed  to  be  an  ICH  compliant  Phase  II  open  label  clinical,  sequential  multiple  dose  finding  study  for  subcutaneously
administered  PSA-EPO  in  CKD  patients  not  on  dialysis  and  not  receiving  erythropoiesis  stimulating  agents.  It  is  being  conducted  in
Australia, South Africa and New Zealand. Patients with hemoglobin levels between 8 and 10 grams per deciliter (“g/dL”) were given the
drug candidate once every two weeks. If the hemoglobin level increases to between 10 and 12 g/dL, the patient is moved to once every four
weeks administration. The patient’s pharmacodynamic, pharmacokinetic and immunogenic parameters are followed for the duration of the
trial. Dose levels in an escalating form will then be administered. Safety and other parameters will be examined at the end of each dosing
cohort  before  moving  onto  the  next  dose  level.  The  first  two  cohorts  of  patients  have  been  completed.  There  were  no  Serious Adverse
Events (“SAEs”) attributable to PSA-EPO reported thus far. The third cohort of patients at a higher dose level is in progress. The endpoint
is to determine a dose of PSA-EPO that is safe and will move the patient’s hemoglobin level into the 10 to 12 g/dL range.

The  costs  for  this  trial  are  being  borne  by  the  Company.  Costs  will  be  dependent  on  how  many  cohorts  will  be  treated.  The  final
results  from  the  second  cohort  are  expected  to  be  reported  during  the  first  half  of  2016.  Clinical  material  was  manufactured  for  the
Company by Serum Institute. The trial is being run by Novotech Pty Limited (“Novotech”) of Australia.

18

 
 
 
 
 
 
 
 
 
 
 
 
 
 
ONC-AML-01: Xenetic OncoHist™ Clinical Trial

The Company expects to submit an IND filing for Phase I/II(a) clinical trials for AML to the FDA and commence clinical trials, but
not before the end of 2017. We expect this to be an open label increasing dose ranging study to assess the safety, tolerability and efficacy of
OncoHist™ for adult patients with refractory or relapsed AML. This trial will be conducted in the US. Data from the previously completed
work by Saarland University’s Phase I clinical trial and the SynBio clinical trials will be used to aid in the design of the clinical protocol.
We expect the Phase I/II(a) clinical trial material to be produced by a cGMP compliant manufacturing facility. Selection of the Clinical
Research Organization (“CRO”) to run the trial is in progress.

The  costs  for  the  clinical  trial  are  being  borne  by  the  Company.  The  Company  will  need  to  raise  additional  capital  prior  to
commencing  Phase  I/II(a)  clinical  trials.  The  OncoHist™  technology  was  acquired  as  part  of  the  Company’s  acquisition  of  SymbioTec
GmbH (“SymbioTec”) in January 2012 and was valued at $9.6 million as of the acquisition date.

Xenetic Collaborative Partner Programs

Under  the  terms  of  the  relevant  license  agreements  with  the  various  parties,  the  Company  provides  neither  capital  nor  human
resources to the clinical developments of the various product candidates thus licensed for development by our collaborative partners whose
sole responsibility is to meet the timelines associated with each program.   We use the data generated from these jurisdictions as a means of
understanding the clinical validity-human response of the drug before pursuing FDA and EMA trials, this having been a long-established
development  strategy  for  the  Company  as  a  means  of  maximizing  the  development  potential  of  the  Company’s  product  pipeline  while
minimizing the capital exposure associated with such objective.

Notwithstanding  that  there  has  been  a  history  of  delays  in  the  clinical  programs  being  pursued  by  our  partners  in  both  Russia  and
India, based on the data that has been available to us, we have accomplished this objective with both OncoHist™ and ErepoXen™, the two
product  candidates  which  are  currently  the  primary  focus  of  our  efforts  and  upon  which  we  are  now  devoting  our  capital  and  human
resources.  Accordingly, any program delays on these candidates outside the purview of the FDA or EMA will not have a negative impact
on the Company pipeline.

PSA-FVIII: Baxter Factor VIII Pre-Clinical Program

PSA-recombinant Factor VIII has been developed as a long acting therapeutic to treat hemophilia A. Baxter is running this program,
which is in the Clinical Trial phase. Baxter has agreed to meet strict due diligence time milestones based on: Clinical Trial Authorization
submission  in  respect  of  Phase  I/II  clinical  trials,  Final  Clinical  Study  Report Phase  I/II  and  BLA  submission  all  by  fixed  dates  per  the
contract. The total cost of this program is being borne by Baxter. There can be no assurance if or when Baxter will actually achieve any of
these  due  diligence  milestones.  Baxter  filed  a  CTA  for  the  program  in  Q4  2015  and  commenced  human  clinical  trials  during  the  first
quarter  of  2016.  The  stated  goal  of  Baxter  is  to  have  a  significantly  longer-acting  FVIII  to  remain  the  world’s  leader  in  Hemophilia
therapies.

PMO-CF-01: Pharmsynthez PulmoXen™ Clinical Trial

This is a Phase I(a) open label two dose safety study for inhaled PSA-DNase 1 in healthy volunteers and has been completed and
reported on April 7, 2014. The study is being conducted in Russia. No adverse events were reported so far and lung function was reported
to  be  normal. A  clinical  trial  with  CF  patients  is  in  start-up  stage  (regulatory  applications).  The  total  cost  of  the  trial  is  being  borne  by
Pharmsynthez. The trial is being run by a partner-sponsored CRO in Russia, Belarus and Ukraine.

If and when satisfactory human clinical data comes out of this collaboration, and provided that the Company is sufficiently confident
that the drug candidate is well-tolerated and effective for this indication, the Company plans to pursue its own development program for
this candidate. However, the Company would have to raise additional capital to pursue its own development of this drug candidate.

19

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IMU-MS-01: Pharmsynthez MyeloXen™ Clinical Trial (Multiple Sclerosis)

This  was  a  Phase  I  open  label  clinical  sequential  dose  finding  study  for  subcutaneously  administered  MyeloXen™  (liposomes
containing peptides for basic myelin protein) in healthy volunteers and patients. This was a proof-of-concept study to show the influence of
MyeloXen™ on catalytic anti-MBP levels and activities. The study was conducted in Russia and is complete. The study report is under
final review to be submitted to the Russian MoH. The total cost for the clinical trial was borne by Pharmsynthez. The clinical material was
manufactured by Pharmsynthez. The clinical trial was run by a partner-sponsored CRO in Russia.

If and when satisfactory clinical patient data comes out of this collaboration that provides the Company a level of comfort that the
drug candidate is well-tolerated and effective, the Company plans to pursue its own development program for this candidate. However, the
Company would have to raise additional capital to pursue its own development of this drug candidate.

PSA-EPO-03: Serum Institute ErepoXen™ Clinical Trial

This  is  a  Phase  II(a)  open  label  clinical,  sequential  single  dose  finding  study  for  intravenously  administered  PSA-EPO  for  CKD
patients who are on dialysis. This trial follows the successful completion of two subcutaneous PSA-EPO clinical trials in India. The first
was a Phase I single dose range finding study for subcutaneously administered PSA-EPO in healthy volunteers. The second was a Phase II
single dose range finding study for subcutaneously administered PSA-EPO in CKD patients not on dialysis. All trials are being conducted
in  India. All  three  cohorts  of  patients  have  been  completed.  There  were  no  Serious Adverse  Events  (“SAEs”)  attributable  to  PSA-EPO
reported  thus  far.  The  final  report  on  the  trail  is  expected  in  Q1  2016.  The  endpoint  of  the  trial  is  to  determine  the  maximum  tolerated
single dose of PSA-EPO. The total cost of the clinical trial is being borne by Serum Institute and the clinical material was manufactured by
Serum Institute. The clinical trial is being run by a partner-sponsored CRO in India.

PSA-EPO-05: SynBio ErepoXen™ (Epolong) Clinical Trial

This  is  a  Phase  II(b)/III  open  label  clinical,  randomized,  comparative,  multiple  dose  study  for  subcutaneously  administered
ErepoXen™ in CKD patients not on dialysis and not receiving erythropoiesis stimulating agents. Patients are compared to a control arm
with Aranesp® (darbepoetin alfa). The study is being conducted in the Russian Federation by SynBio and is currently in progress. The total
cost for this clinical trial is being borne by SynBio. The clinical material was manufactured by Serum Institute. The clinical trial is being
run by a partner-sponsored CRO in Russia.

ONC-AML-02: SynBio Arahist-09 Clinical Trial

This  was  a  Phase  II  open  label  two  dose  level,  randomized  comparative  study  to  assess  the  safety,  tolerability  and  efficacy  of
OncoHist™ in combination with HAM (high dose cytarabine chemotherapy) in adult patients with refractory or early relapsed AML. This
study was conducted in Russia. Patients received one cycle of HAM regimen (one week) and one cycle of OncoHist™ regimen (three times
per week for three weeks). The HAM regimen was based on the then current standard of care in Russia. This standard of care was changed
by the Russian Ministry of Health and the study is on hold. The total cost of the trial was borne by SynBio. The clinical material for this
OncoHist™ trial was manufactured at the Shemyakin Institute in Moscow for SynBio. The trial was run by a partner-sponsored CRO in
Russia.

20

 
 
 
 
 
 
 
 
 
 
 
 
 
ONC-NHL-01: SynBio Anahoret Clinical Trial

This was a Phase II open label increasing dose ranging study to assess the safety, tolerability and efficacy of OncoHist™ as a single
agent  in  treating  NHL.  This  study  was  conducted  in  Russia.  The  trial  is  complete  and  the  report  submitted  to  the  Russian  MoH.  It  was
shown  that  OncoHist™  was  well  tolerated  in  this  trial.  The  total  cost  of  the  trial  was  borne  by  SynBio.  The  clinical  OncoHist™  drug
product was manufactured at the Shemyakin Institute in Moscow for SynBio. The trial was run by a partner-sponsored CRO in Russia.

If and when satisfactory clinical patient data comes out of this collaboration that provides the Company a level of comfort that the
drug candidate is well-tolerated and effective, the Company plans pursue its own development program for this candidate. However, the
Company would have to raise additional capital to pursue its own development of this drug candidate.

Patents and Proprietary Rights

The Company has several drug product candidates under development, each protected by patent and pending patent applications in

the United States and the rest of the world. 

Xenetic  has  received  patent  protection  for  several  therapeutics  that  have  been  linked  to  a  polysialic  acid.    These  include  PSA-
erythropoietin, PSA-insulin and PSA-insulin like protein, PSA-Factor VIII, PSA-DNAse I and PSA-granulocyte colony stimulating factor. 
Further Xenetic’s portfolio includes patents cover methods to prepare proteins that are linked to a polysialic acid.  These patents include
coverage for linking a PSA to a protein in a high pH solution and through a process for producing an aldehyde derivative of a sialic acid
through the opening and oxidation of a sialic acid unit.  The linkage can be at the N-terminus. 

Xenetic has received patent protection for the production of PSA and the removal of endotoxin during the purification process.  The
removal  of  endotoxin  occurs  through,  for  instance,  the  addition  of  a  high  pH  solution  to  the  PSA  and  through  a  process  to  separate  a
polydisperse  ionically  charged  polysaccharide,  such  as  PSA,  into  fractions  of  different  average  molecular  weight  through  the  use,  for
instance, of a column and elution buffers with different and constant ionic strength and/or pH, resulting in a fractionated polysaccharide that
has a molecular weight polydispersity of 1.1 or lower.

Xenetic  also  has  patents  that  cover  its  OncoHist™  product.    These  include  recently  allowed  patents  covering  the  OncoHist™
composition and claims for the use of OncoHist™ to treat cancer, including leukemia.  The OncoHist™ portfolio also includes patents that
cover the use of a histone protein as an antibiotic and to threat thrombocytopenia and further as an antimicrobial component of a personal
care product.

The  Company’s  portfolio  also  includes  in-licensed  patents  from  Ploughshare  Innovations,  a  licensing  arm  of  the  United  Kingdom
Department of Defense, in connection with MyeloXen™ technology. The Company has no current clinical development efforts ongoing at
this time that fall within the bounds of the Ploughshare Innovations in-license. To the extent that such efforts are ongoing, such efforts are
being  undertaken  by  a  collaborative  partner,  though  the  rights  under  the  in-license  (e.g.  for  the  patents)  lie  with  the  Company  and  are
subject to a sublicense provided to the collaborative partner. This includes a method used to entrap a water soluble drug within a liposome
when the drug is mixed with a mono or disaccharide.  This patent portfolio fits well with the Company’s liposome patents and pending
applications that include those that cover using liposomes with an entrapped complex of a DNA operatively encoding antigen to induce an
immune response in a human or animal and methods to form liposomes.

21

 
 
 
 
 
 
 
 
 
 
 
 
 
The Company currently owns 201 US and international patents and over 90 pending patent applications that cover various aspects of
our  technologies.  We  have  filed  patent  applications,  and  plan  to  file  additional  patent  applications,  covering  various  aspects  of  our
PolyXen™  technology  platform  covering  polysialylation  and  advanced  polymer  conjugate  technologies,  as  well  as  proprietary  product
candidates  including  ErepoXen™  and  PulmoXen™. Additionally,  our  patents  and  patent  applications  cover  polymer  architecture,  drug
conjugates, formulations, methods of manufacturing polymers and polymer conjugates and methods of administering polymer conjugates.
In addition, our patent portfolio contains patents and patent applications that encompass our OncoHist™ technology platform including use
of histones for the treatment of different cancers. The OncoHist™ patent portfolio, acquired as part of our acquisition of SymbioTec GmbH
in January 2012, includes OncoHist™, a bis-Met histone. Our patent strategy is to file patent applications on innovations and improvements
to  cover  a  significant  majority  of  the  major  pharmaceutical  markets  in  the  world.  Generally,  patents  have  a  term  of  20  years  from  the
earliest priority date (assuming all maintenance fees are paid). In some instances, patent terms can be increased or decreased, depending on
the laws and regulations of the country or jurisdiction that issued the patent.

We  also  rely  on  trade  secret  protection  for  our  confidential  and  proprietary  information.  No  assurance  can  be  given  that  we  can
meaningfully protect our trade secrets. Others may independently develop substantially equivalent confidential and proprietary information
or otherwise gain access to, or disclose, our trade secrets. Thus, while we rely on trade secret protection and other unpatented proprietary
rights for important proprietary technologies, any loss of such rights could harm our business, results of operations and financial condition.

In  certain  situations  where  we  work  with  drugs  covered  by  one  or  more  patents,  our  ability  to  develop  and  commercialize  our
technologies  may  be  affected  by  limitations  in  our  access  to  these  proprietary  drugs.  Even  if  we  believe  we  are  free  to  work  with  a
proprietary  drug,  we  cannot  guarantee  that  we  will  not  be  accused  of,  or  be  determined  to  be,  infringing  a  third  party’s  rights  and  be
prohibited from working with the drug or found liable for damages. Any such restriction on access or liability for damages would have a
material adverse effect on our business, results of operations and financial condition.

The  patent  positions  of  pharmaceutical  and  biotechnology  companies,  such  as  ours,  are  uncertain  and  involve  complex  legal  and
factual issues. There can be no assurance that patents that have issued will be held valid and enforceable in a court of law. Even for patents
that are held valid and enforceable, the legal process associated with obtaining such a judgment is time consuming and costly. Additionally,
issued patents can be subject to opposition or other proceedings that can result in the revocation of the patent or maintenance of the patent
in  amended  form  (and  potentially  in  a  form  that  renders  the  patent  without  commercially  relevant  and/or  broad  coverage).  Further,  our
competitors  may  be  able  to  circumvent  and  otherwise  design  around  our  patents.  Even  if  a  patent  is  issued  and  enforceable,  because
development and commercialization of pharmaceutical products can be subject to substantial delays, patents may expire early and provide
only  a  short  period  of  protection,  if  any,  following  the  commercialization  of  a  products  encompassed  by  our  patent(s).  We  may  have  to
participate in interference proceedings declared by the U.S. Patent and Trademark Office, which could result in a loss of the patent and/or
substantial cost to us. Further, we understand that if any of our pending patent applications do not issue, or are deemed invalid following
issuance, we may lose valuable IP protection.

US  and  foreign  patent  rights  and  other  proprietary  rights  exist  that  are  owned  by  third  parties  and  relate  to  pharmaceutical
compositions  and  reagents,  medical  devices  and  equipment  and  methods  for  preparation,  packaging  and  delivery  of  pharmaceutical
compositions.  We  cannot  predict  with  any  certainty  which,  if  any,  of  these  rights  will  be  considered  relevant  to  our  technology  by
authorities in the various jurisdictions where such rights exist, nor can we predict with certainty which, if any, of these rights will or may be
asserted  against  us  by  third  parties.  We  could  incur  substantial  costs  in  defending  ourselves  and  our  partners  against  any  such  claims.
Furthermore, parties making such claims may be able to obtain injunctive or other equitable relief, which could effectively block our ability
to  develop  or  commercialize  some  or  all  of  our  products  in  the  US  and  in  other  countries  and  could  result  in  the  award  of  substantial
damages. In the event of a claim of infringement, we or our partners may be required to obtain one or more licenses from third parties.
There can be no assurance that we can obtain a license to any technology that we determine we require on reasonable terms, if at all, or that
we could develop or otherwise obtain alternative technology. The failure to obtain licenses, if required, may have a material adverse effect
on our business, results of operations and financial condition. Further, we may not be able to obtain IP licenses related to the development
of our drug candidates on a commercially reasonable basis, if at all.

22

 
 
 
 
 
 
 
 
 
It is our policy to require our employees and consultants, outside scientific collaborators, sponsored researchers and other advisors
who receive confidential information from us to execute confidentiality agreements upon the commencement of employment or consulting
relationships  with  us.  These  agreements  provide  that  all  confidential  information  developed  or  made  known  to  the  individual  during  the
course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances.
The agreements provide that all inventions conceived by an employee shall be our property. There can be no assurance, however, that these
agreements will provide meaningful protection or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of
such information.

Manufacturing and Supply

The Company does not maintain the capability to manufacture its own material necessary to support its drug candidate development
programs nor does it intend to acquire such capability as part of its present business strategy. The Company currently has agreements in
place with Serum Institute whereby Serum Institute produces clinical materials for use in the development of drug candidates involving our
PolyXen™ technology. The Company is currently dependent on SynBio for clinical materials with respect to its OncoHist™ AML research
programs. The Company is investigating second source alternative suppliers for its clinical materials. There can be no assurance that it will
be successful or that if a second source is secured that it would be available on commercially reasonable terms or in a timely fashion should
any disruption in supply from Serum Institute or SynBio occur.

Government Regulation

General

The  development,  testing,  manufacture,  labeling,  marketing,  and  promotion  of  any  drug,  including  all  of  our  drug  candidates,  are
subject to extensive regulation in the US by the FDA under the Federal Food, Drug and Cosmetic Act and by other federal, state, local and
foreign government laws and regulations including in the UK, Germany, Russia and other countries in which we conduct business.

The NDA Review Process

The steps ordinarily required before a new drug, that is subject to NDA approval, may be marketed in the US include pre-clinical
laboratory tests, further relevant testing, formulation studies, the submission to the FDA of an IND filing (which must become effective
before  clinical  testing  may  commence)  and  adequate  and  well  controlled  clinical  trials  on  human  subjects  to  establish  the  safety  and
effectiveness  of  the  drug  for  each  indication  for  which  FDA  approval  is  sought.  Satisfaction  of  FDA  pre-market  approval  requirements
typically  takes  several  years  and  the  actual  time  required  may  vary  substantially  based  upon  the  type,  complexity  and  novelty  of  the
product, disease or condition for which the new drug is indicated.

Government  regulation  may  delay  or  prevent  marketing  of  potential  products  for  a  considerable  period  of  time  and  requires
substantial time, effort and financial resources on the part of a manufacturer. Success in early stage clinical trials does not assure success in
later stage clinical trials. Data obtained from clinical activities is not always conclusive and may be susceptible to varying interpretations
that  could  delay,  limit,  or  prevent  regulatory  approval.  Even  if  a  product  receives  regulatory  approval,  later  discovery  of  previously
unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

Pre-clinical tests include laboratory evaluation of product chemistry and formulation, as well as additional relevant trials to assess the
potential safety and efficacy of the product. The conduct of the pre-clinical tests and formulation of compounds for testing must comply
with federal regulations and requirements. The results of pre-clinical testing are submitted to the FDA as part of an IND.

A 30 day waiting period after the filing of each IND is required prior to the commencement of clinical testing in humans. If the FDA
has not commented on or questioned the IND within this 30 day period, clinical trials may begin. If the FDA has comments or questions,
the questions must be answered to the satisfaction of the FDA before initial clinical testing can begin. In addition the FDA  may,  at  any
time, impose a clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot commence or recommence
without FDA authorization and then only under terms authorized by the FDA. In some instances, the IND process can result in substantial
delay and expense.

23

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical  trials  typically  involve  the  administration  of  the  IND  to  volunteers  or  patients  under  the  supervision  of  a  qualified
investigator.  Clinical  trials  must  be  conducted  in  compliance  with  federal  regulations  and  requirements,  under  protocols  detailing  the
objectives of the trial and the parameters to be used in monitoring safety and effectiveness. Each protocol involving testing on US subjects
must be submitted to the FDA as part of the IND. The study protocol and informed consent information for patients in clinical trials must
also be approved by the Institutional Review Board at each institution where the trials will be conducted.

Clinical  trials  to  support  NDAs  for  marketing  approval  are  typically  conducted  in  three  sequential  phases,  but  the  phases  may
overlap.  In  Phase  I,  the  initial  introduction  of  the  drug  into  healthy  human  subjects  or  patients,  the  drug  is  tested  to  assess  metabolism,
pharmacokinetics and pharmacological actions and safety, including side effects associated with increasing doses. Phase II usually involves
trials in limited patient populations to determine dosage tolerance and optimum dosage, identify possible adverse effects and safety risks,
and  provide  preliminary  support  for  the  efficacy  of  the  drug  in  the  indication  being  studied.  If  a  compound  demonstrates  evidence  of
effectiveness and an acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to further evaluate clinical efficacy and
to further test for safety within an expanded patient population, typically at geographically dispersed clinical trial sites. It is possible that
Phase I, Phase II, or Phase III testing of product candidates may not be completed successfully within any specified time period, if at all.

After successful completion of the required clinical testing, generally an NDA is prepared and submitted to the FDA. FDA approval
of the NDA is required before marketing of the product may begin in the US. The NDA must include the results of extensive clinical and
other testing and a compilation of data relating to the product's pharmacology, chemistry, manufacture, and controls. The cost of preparing
and submitting an NDA is substantial. Under federal law, the submission of an NDA is additionally subject to a substantial application user
fee (unless eligible for a waiver or reduction), which currently range from $1,084,550 to $2,169,100, and the manufacturer and/or sponsor
under  an  approved  NDA  are  also  subject  to  annual  product  and  establishment  user  fees,  currently  exceeding  $104,000  per  product  and
$554,000 per establishment. These fees are typically increased annually.

The  FDA  has  60  days  from  its  receipt  of  an  NDA  to  determine  whether  the  application  will  be  accepted  for  filing  based  on  the
agency's threshold determination that the NDA is sufficiently complete to permit substantive review. Once the submission is accepted for
filing, the FDA begins an in-depth review of the NDA. Under federal law, the FDA has agreed to certain performance goals in the review
of NDAs. The user fee goal for review of most non-priority applications is ten months. However, the review process is often significantly
extended by FDA requests for additional information or clarification of information already provided in the submission. The FDA may also
refer applications for novel drug products or drug products which 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 recommendation of an advisory committee.

If FDA evaluations of the NDA and the manufacturing facilities and procedures, which typically involves an FDA on-site inspection,
are favorable, the FDA may issue an approval letter or, in some cases, an approvable letter followed by an approval letter. An approvable
letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA. If and when those
conditions  have  been  met  to  the  FDA's  satisfaction,  the  FDA  will  typically  issue  an  approval  letter.  An  approval  letter  authorizes
commercial  marketing  of  the  drug  with  specific  prescribing  information  for  specific  indications  in  an  approved  label.  If  the  FDA's
evaluation  of  the  NDA  submission  or  manufacturing  facilities  is  not  favorable,  the  FDA  may  refuse  to  approve  the  NDA  or  issue  a  not
approvable letter. The not approvable letter outlines the deficiencies in the submission and often requires additional testing or information
in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide
that  the  application  does  not  satisfy  the  regulatory  criteria  for  approval.  With  limited  exceptions,  the  FDA  may  withhold  approval  of  an
NDA regardless of prior advice it may have provided or commitments it may have made to the sponsor. As a condition of NDA approval,
the  FDA  may  require  post-approval  testing  and  surveillance  to  monitor  the  drug's  safety  or  efficacy  and  may  impose  other  conditions,
including  labeling  restrictions.  Such  labeling  restrictions  can  materially  impact  the  potential  market  and  profitability  of  the  drug.  Once
granted,  product  approvals  can  still  be  withdrawn  if  compliance  with  regulatory  standards  is  not  maintained  or  problems  are  identified
following initial marketing.

24

 
 
 
 
 
 
 
 
 
Once the NDA is approved, a product will be subject to certain post-approval requirements, including requirements for adverse event
reporting and submission of periodic reports. Persons responsible for manufacture or distribution are subject to FDA inspections to assess
compliance  with  applicable  statutory  and  regulatory  requirements.  The  Food  and  Drug Administration Amendments Act  of  2007  also
provides the FDA enhanced post-marketing authority, including the authority to require post-marketing studies and clinical trials, labeling
changes based on new safety information, and compliance with risk evaluations and mitigation strategies approved by the FDA.

Additionally,  the  FDA  also  strictly  regulates  the  promotional  claims  that  may  be  made  about  drug  products.  The  FDA  requires
substantiation of any claims of superiority of one product over another including, in many cases, requirements that such claims be proven
by adequate and well controlled head-to-head clinical trials. To the extent that market acceptance of the Company’s products may depend
on their superiority over existing therapies, any restriction imposed by FDA on the Company’s ability to advertise or otherwise promote
claims of superiority, or requirements to conduct additional expensive clinical trials to provide proof of such claims, could negatively affect
the sales of the Company's products and/or its costs.

Orphan Drug Act

The Orphan Drug Act provides incentives to manufacturers to develop and market drugs for rare diseases and conditions affecting
fewer  than  200,000  persons  in  the  US  at  the  time  of  application  for  Orphan  Drug  Designation.  The  first  developer  to  receive  FDA
marketing approval for an orphan drug is entitled to a seven year exclusive marketing period in the US for that product. However, a drug
that the FDA considers to be clinically superior to, or different from, another approved orphan drug, even though for the same indication,
may also obtain approval in the US during the seven year exclusive marketing period. In addition, holders of exclusivity for orphan drugs
are expected to assure the availability of sufficient quantities of their orphan drugs to meet the needs of patients. Failure to  do  so  could
result in the withdrawal of marketing exclusivity for the drug.

Legislation  similar  to  the  Orphan  Drug Act  has  been  enacted  in  other  countries  outside  the  US,  including  the  European  Union
(“EU”). The orphan legislation in the EU is available for therapies addressing chronic debilitating or life threatening conditions that affect
five or fewer out of 10,000 persons or are financially not viable to develop. The market exclusivity period is for ten years, although that
period can be reduced to six years if, at the end of the fifth year, available evidence establishes that the product is sufficiently profitable not
to  justify  maintenance  of  market  exclusivity.  The  market  exclusivity  may  be  extended  to  12  years  if  sponsors  complete  a  pediatric
investigation plan agreed upon with the relevant committee of the EMA.

Pediatric Information

Under the Pediatric Research Equity Act of 2007 (“PREA”), NDAs or BLAs or supplements to NDAs or BLAs must contain data to
assess the safety and effectiveness of the drug for the claimed indication(s) in all relevant pediatric sub-populations and to support dosing
and administration for each pediatric sub-population for which the drug is safe and effective. The FDA may grant deferrals for submission
of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which
orphan  drug  designation  has  been  granted.  The  Best  Pharmaceuticals  for  Children Act  (“BPCA”),  provides  sponsors  of  NDAs  with  an
additional six month period of market exclusivity for all unexpired patent or non-patent exclusivity on all forms of the drug containing the
active moiety if the sponsor submits results of pediatric studies specifically requested by the FDA under BPCA within required timeframes.
The Biologics Price Competition and Innovation Act provides sponsors of BLAs an additional six month extension for all unexpired non-
patent market exclusivity on all forms of the biologic containing the active moiety pursuant to the BPCA if the conditions under the BPCA
are met.

25

 
 
 
 
 
 
 
 
 
 
 
Foreign Regulation

In addition to regulations in the U.S., we are subject to a variety of foreign regulatory requirements governing human clinical trials
and marketing approval for drugs. The foreign regulatory approval process includes all of the risks associated with FDA approval set forth
above, as well as additional country specific regulations. Whether or not we obtain FDA approval for a product, we must obtain approval of
a product 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 the time may be longer or shorter than that required for FDA
approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country
to country.

Environmental Regulation

In  addition  to  being  subject  to  extensive  regulation  by  the  FDA,  the  Company  must  also  comply  with  environmental  regulation
insofar as such regulation applies to the Company or its drug candidates. Our costs of compliance with environmental regulation as applied
to similar pharmaceutical companies are minimal, since we do not currently, nor do we intend to, engage in the production of any of our
drug  candidates.  The  Company  currently  uses  unaffiliated  manufacturers  to  produce  all  of  its  drug  candidate  material  and  receive  final
material from such manufacturer, without any involvement on our part in the manufacturing process at any stage of the process.

Although we believe that our safety procedures for using, handling, storing and disposing of our product candidate materials comply
with the environmental standards required by state and federal laws and regulations, we cannot completely eliminate the risk of accidental
contamination or injury from these materials. We do not carry a specific insurance policy to mitigate this risk to us or to the environment.

Employees & Consultants

At March 30, 2016 the Company employed seven full time and three part time persons. The Company is not a party to any collective
bargaining agreement with its employees; nor are any of its employees a member of any labor unions. The Company is subject to certain
statutory  and  contractual  obligations  in  instances  where  it  terminates  U.K.  based  employees.  These  obligations,  which  are  ordinary  and
customary in the U.K., generally range from one to six months wages for terminated employees and would not be expected to represent a
material adverse effect to the Company.

To complement our own expert professional staff, we utilize specialists in regulatory affairs, pharmacovigilance, process engineering,
manufacturing, quality assurance, clinical development and business development. These individuals include scientific advisors as well as
independent consultants.

Competition

We are engaged in a rapidly evolving field. If our drug candidate development reaches the level of commercialization and marketing,
we  expect  to  compete  primarily  with  established  pharmaceutical  companies  such  as  Amgen  Inc.,  Bristol-Myers  Squibb  Company,  F.
Hoffmann-La Roche Ltd, Nektar Therapeutics and others. We also expect to compete with established pharmaceutical companies as well as
academic  institutions  and  other  smaller  pharmaceutical  companies  during  the  drug  development  stage  of  our  progress.  Competition  is
intense and expected to increase.

26

 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  large  and  rapidly  growing  market  for  new  drug  therapies  for  use  in  humans  is  likely  to  attract  new  entrants.  Numerous
biotechnology  and  pharmaceutical  companies  are  focused  on  developing  new  drug  therapies  and  many  of  these  companies  have  greater
financial  and  other  resources  and  development  capabilities  than  we  do.  Our  competitors  also  have  greater  collective  experience  in
undertaking  pre-clinical  and  clinical  testing  of  products,  obtaining  regulatory  approvals  and  manufacturing  and  marketing  prescription
pharmaceutical  products. Accordingly,  certain  of  these  competitors  may  succeed  in  obtaining  approval  for  drug  products  and  therapies
more rapidly than us.

In addition to competing with universities and other research institutions in the development of drug products, therapies, technologies
and processes, we may compete with other companies in acquiring rights to products or technologies from universities. There can be no
assurance that our products or product candidates will be more effective or achieve greater market acceptance than competitive products, or
that these companies will not succeed in developing products and technologies that are more effective than those being developed for us or
that would render our products and technologies less competitive or obsolete.

Available Information

Our  website  address  is  www.xeneticbio.com.  The  information  in,  or  that  can  be  accessed  through,  our  website  is  not  part  of  this
Annual Report on Form 10-K. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and
amendments to those reports are available, free of charge, on or through our website as soon as practicable after we electronically file such
forms, or furnish them to, the SEC. The public may read and copy any materials we file with the SEC at the SEC’s Public Reference Room
at 100 F Street, NE, Washington, D.C. 20549. Information on the operations of the Public Reference Room can be obtained by calling 1-
800-SEC-0330. The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding
our filings at www.sec.gov.

In addition to disclosing current information pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 and for reports of
information required to be disclosed by Regulation FD through our SEC filings, we also intend to disclose such current information through
our  investor  relations  website,  press  releases,  public  conference  calls,  webcasts  and  through  various  social  media  channels,  including
Facebook, Twitter, LinkedIn, Google+ and Chairman’s Blog Profile.

Directors and Executive Officers

Set forth below is the name, age, position and brief account of the business experience of each of our executive officers and directors

as of March 30, 2016:

Name
Michael Scott Maguire
Dr. Dmitry Genkin
Firdaus Jal Dastoor FCS
Darlene Deptula-Hicks
Roman Knyazev
Dr. Roger Kornberg

Age
52
47
63
58
35
68

Position
President, Chief Executive Officer and Director
Director
Director
Director
Director
Director

27

 
 
 
 
 
 
 
 
 
 
 
 
Michael Scott Maguire

Mr.  Maguire  has  been  President,  Chief  Executive  Officer  and  Director  of  the  Company  since  his  appointment  in  2004.  His
background is in life science and healthcare investment banking and he has advised many US and European companies on capital raisings
and commercial development over his 26 year career. Mr. Maguire began his banking career with Merrill Lynch in 1987 in New York, and
after receiving his MBA from the Babson Graduate School in 1993, he joined the healthcare division of W.R. Grace National Medical Care
(“NMC”) where he helped develop the international healthcare division. During his time in charge of international business development,
he  helped  double  NMC’s  international  revenues  through  Mergers  and Acquisitions.  In  1996  he  co-founded  the Arthur Andersen  global
healthcare corporate finance practice based in London, a practice that he built to include a staff of 36 across the US and Europe, elevating to
the role of managing director. Mr. Maguire is currently a director of Healthcare Capital Partners Limited, a healthcare corporate finance and
proprietary investment boutique he co-founded in 2002 and a non-executive director of Renal Services (UK) Limited, a company focused
on dialysis service provision in the U.K. Based on Mr. Maguire’s experience within the biotechnology sector and his executive experience,
specifically his experience as an executive officer at other companies, as well as his service on other boards of directors, the Board believes
Mr. Maguire has the appropriate set of skills to serve as a member of our Board.

Dr. Dmitry Genkin

Dr.  Genkin  was  appointed  as  a  Director  of  the  Company  in  September  2015.  Dr.  Genkin  has  the  Russian  equivalent  of  an  MD  in
Internal Therapy and studied drug delivery under Professor Gregoriadis at The School of Pharmacy, University of London in 1992 and the
Department  of  Clinical  Pharmacology  at  Karolinska  Hospital,  Stockholm  from  1992  until  1993.  Since  1993,  Dr.  Genkin  has  headed  a
number of Russia's largest pharmaceutical companies including Pharmavit, which had 27% of the Russian pharmaceutical market. In 1998,
he was awarded the silver medal by the Russian Natural Science Academy. Dr. Genkin is currently a partner and director of FDS Pharma
and  Chairman  of  Pharmsynthez,  which  is  listed  on  the  Moscow  stock  exchange.  Based  on  Dr.  Genkin’s  experience  in  the  field  of  life
sciences and biotechnology, the Board believes Dr. Genkin has the appropriate set of skills to serve as a member of our Board.

Firdaus Jal Dastoor, FCS

Mr. Dastoor was appointed as a Director of the Company in January 2014 pursuant to terms included in the Company’s acquisition of
Xenetic  UK.  Mr.  Dastoor  was  appointed  non-executive  Director  of  Xenetic  UK  in  July  2007.  He  has  been  a  Fellow  Member  of  The
Institute  of  Company  Secretaries  of  India  since  2008  and  began  his  career  as  a  company  secretary.  He  was  Company  Secretary  of  the
Poonawalla Group until 1994. He then took on assignments involved in business development strategies and operations. Mr. Dastoor is on
the  board  of  several  companies  operating  in  the  field  of  engineering  products,  life  sciences  and  biotech,  international  trade,  financial
services and quality standards certifications. Currently, he is a Group Director of the Poonawalla Group of Companies in charge of Finance
and  Corporate  Affairs.  Based  on  Mr.  Dastoor’s  experience  in  the  field  of  life  sciences  and  biotechnology,  finance  and  business
development, the Board believes Mr. Dastoor has the appropriate set of skills to serve as a member of our Board.

28

 
 
 
 
 
 
 
 
 
 
Darlene Deptula-Hicks

Ms. Deptula-Hicks was appointed to the Board of Directors of the Company in April 2014. Ms. Deptula-Hicks is a strategic senior
financial  executive  with  extensive  experience  in  both  public  and  private  companies,  including  experience  in  fund  raising,  mergers  and
acquisitions, public and private offerings and with operational management focused in life sciences. Since September 2015, Ms. Deptula-
Hicks is the Senior Vice President and Chief Financial Officer of Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS).  In November 2014, Ms.
Deptula-Hicks was engaged as a financial consultant at Pieris Pharmaceuticals, Inc. pursuant to a consulting agreement with the financial
advisory firm of Danforth Advisors, LLC.   Prior to that and since June 2012, Ms. Deptula-Hicks served as Executive Vice President and
Chief  Financial  Officer  of  Microline  Surgical,  Inc.  From  2006  to  2011,  Ms.  Deptula-Hicks  was  the  Executive  Vice  President,  Chief
Financial  Officer,  Treasurer  and  Secretary  of  ICAD,  Inc.    She  received  her  Bachelor  of  Science  in  Accounting  from  Southern  New
Hampshire  University  and  her  MBA  from  Rivier  College.  Based  upon  her  extensive  financial  experience  including  experience  in  fund
raising, mergers, public companies and life sciences, the Board believes Ms. Deptula-Hicks has the appropriate set of skills to serve as a
member of our Board.

Roman Knyazev

Mr. Knyazev was appointed to the Board of Directors of the Company in April 2014.  Mr. Knyazev has been an Investment director
for  Rusnano  Moscow  since  2009  and  is  currently  on  the  board  of  several  biotechnology  companies.  In  his  current  role,  he  provides
technical expertise, asset valuation, financial modelling and business valuation as well as develops and presents investment strategies and
project  financing  to  clients.  In  2003,  he  began  his  career  as  the  Chief  Financial  Officer  of  Biotech  Pharma  Moscow  where  he  gained
experience in both the financial and management sector. Mr. Knyazev led the development and implementation of management accounting
and budgeting processes as well as facilitated internal audits of regional branches. Mr. Knyazev is a Kauffman Fellow, Class 17, which is a
Silicon Valley-based two year leadership program for venture capitalists and innovators of all kinds. Based on Mr. Knyazev’s experience in
clinical stage biotechnology companies, the Board believes Mr. Knyazev has the appropriate set of skills to serve as a member of our Board.

Dr. Roger Kornberg

Dr.  Kornberg  was  appointed  to  the  Board  of  Directors  of  the  Company  in  February  2016.  Dr.  Kornberg  is  a  member  of  the  U.S.
National Academy of Sciences and the Winzer Professor of Medicine in the Department of Structural Biology at Stanford University. He
earned his bachelor's degree in chemistry from Harvard University in 1967 and his Ph.D. in chemical physics from Stanford in 1972. He
became a postdoctoral fellow at the Laboratory of Molecular Biology in Cambridge, England and then an assistant professor of biological
chemistry at Harvard Medical School in 1976, before moving to his present position as professor of structural biology at Stanford Medical
School in 1978. In 2006, Dr. Kornberg was awarded the Nobel Prize in Chemistry in recognition for his studies of the molecular basis of
Eukaryotic Transcription, the process by which DNA is copied to RNA. Dr. Kornberg is also the recipient of several awards, including the
2001 Welch Prize, the highest award granted in the field of chemistry in the United States, and the 2002 Leopald Mayer Prize, the highest
award granted in the field of biomedical sciences from the French Academy of Sciences. Based on Dr. Kornberg’s experience in the field of
molecular biology, the Board believes Dr. Kornberg has the appropriate set of skills to serve as a member of our Board.

29

 
 
 
 
 
 
 
 
 
 
ITEM 1A – RISK FACTORS

We are not required to provide the information required by this Item because we are a smaller reporting company.

ITEM 1B – UNRESOLVED STAFF COMMENTS

None.

ITEM 2 – PROPERTIES

The Company occupies a facility consisting of approximately 4,000 square feet in the Ledgemont Technology Center in Lexington,
Massachusetts.  The  premises  are  divided  into  approximately  50%  laboratory  and  50%  office  space  and  are  leased  by  the  Company’s
subsidiary, Xenetic Bioscience, Incorporated. The lease provides for an initial term of 61 months which commenced in January 2014 with
an extension option of one additional five-year term. We believe that this space is adequate for the Company’s current needs and that, if
additional  space  is  required,  it  can  be  obtained  at  commercially  reasonable  terms  either  within  the  Ledgemont  Technology  Center  or
nearby.

ITEM 3 – LEGAL PROCEEDINGS

None.

ITEM 4 – MINE SAFETY DISCLOSURES

Not applicable.

30

 
 
 
 
 
 
 
 
 
 
 
 
 
 
PART II

ITEM  5  –  MARKET  FOR  REGISTRANT’S  COMMON  EQUITY,  RELATED  STOCKHOLDER  MATTERS  AND  ISSUER
PURCHASES OF EQUITY SECURITIES

Our common stock is quoted under the symbol “XBIO” on the OTCQB operated by the OTC Markets Group, Inc. The criteria for
listing on the OTCQB include that we remain current in our SEC reporting. Our reporting is presently current, and since inception, we have
filed our SEC reports on time.

Only a limited market exists for our securities. There is no assurance that a regular trading market will develop, or if developed, that it

will be sustained. Therefore, a shareholder may be unable to resell his securities in our company.

The following table sets forth the range of high and low prices for our common stock for each of the periods indicated as reported by
the  OTCQB.  These  quotations  reflect  inter-dealer  prices,  without  retail  mark-up,  mark-down  or  commission  and  may  not  necessarily
represent actual transactions.

Year ended December 31, 2014

High Price

Low Price

1st Quarter ended March 31, 2014
2nd Quarter ended June 30, 2014
3rd Quarter ended September 30, 2014
4th Quarter ended December 31, 2014

Year Ended December 31, 2015

1st Quarter Ended March 31, 2015
2nd Quarter Ended June 30, 2015
3rd Quarter Ended September 30, 2015
4th Quarter Ended December 31, 2015

On March 15, 2016 the last sales price per share of our common stock was $0.29.

Penny Stock

$

$

9.50$
1.00  
0.99  
0.68  

0.25$
0.24  
0.47  
0.92  

0.31
0.30
0.51
0.18

0.20
0.18
0.20
0.33

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are
generally equity securities with a market price of less than $5.00, other than securities registered on certain national securities exchanges or
quoted on the NASDAQ system, provided that the current price and volume information with respect to transactions in such securities is
provided  by  the  exchange  or  system.  The  penny  stock  rules  require  a  broker-dealer,  prior  to  a  transaction  in  a  penny  stock,  to  deliver  a
standardized risk disclosure document prepared by the SEC, that: (a) contains a description of the nature and level of risk in the market for
penny stocks in both public offerings and secondary trading; (b) contains a description of the broker’s or dealer’s duties to the customer and
of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws;
(c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the
spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant
terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form,
including language, type size and format, as the SEC shall require by rule or regulation.

31

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations
for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; and (c) the number of shares to which
such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a
monthly account statement showing the market value of each penny stock held in the customer’s account.

In  addition,  the  penny  stock  rules  require  that  prior  to  a  transaction  in  a  penny  stock  not  otherwise  exempt  from  those  rules,  the
broker-dealer  must  make  a  special  written  determination  that  the  penny  stock  is  a  suitable  investment  for  the  purchaser  and  receive  the
purchaser’s written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny
stocks, and a signed and dated copy of a written suitability statement.

These disclosure requirements may have the effect of reducing the trading activity for  our  common  stock.  Therefore,  stockholders

may have difficulty selling our securities.

Holders of Record

As of March 15, 2016 there were 426 holders of common stock of the Company of record.

Dividends

There  are  no  restrictions  in  our  articles  of  incorporation  or  bylaws  that  prevent  us  from  declaring  dividends.  The  Nevada  Revised

Statutes, however, do prohibit us from declaring dividends where after giving effect to the distribution of the dividend:

· We would not be able to pay our debts as they become due in the usual course of business; or
· Our total assets would be less than the sum of our total liabilities plus the amount that would be needed to satisfy the rights of

shareholders who have preferential rights superior to those receiving the distribution.

The Company has never previously declared or paid any cash dividends on its common stock. We currently intend to retain earnings
and profits, if any, to support our business strategy and do not intend to pay any cash dividends within the foreseeable future. Any future
determination to pay cash dividends will be at the sole discretion of the Company’s Board of Directors and will depend upon the financial
condition of the Company, its operating results, capital requirements, general business conditions and any other factors that the Board of
Directors deems relevant.

Recent Sales of Unregistered Securities

Issuances of Unregistered Shares of Common Stock

December 2015

In December 2015, the Company issued 500,000 shares of the Company’s common stock to non-employee consultants in exchange
for  services  provided  to  the  Company.  The  Company  recorded  $221,000  as  the  aggregate  amount  of  consideration  received  by  the
Company for the associated services.

The shares were not registered under the Securities Act, or the securities laws of any state, and were offered and sold in reliance on
the  exemption  from  registration  afforded  by  Section  4(a)(2)  and  Regulation  D  (Rule  506)  under  the  Securities Act  and  corresponding
provisions of state securities laws, which exempt transactions by an issuer not involving any public offering.

32

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
November 2015

In  November  2015,  in  consideration  of  the  assignment  of  certain  intellectual  property  rights  by  Dr.  Dmitry  Genkin  and  Kirill
Surkhov (together “the Assignors”) to Lipoxen Technologies Limited, the Company issued 11,000,000 shares of the Company’s common
stock to the Assignors pursuant to the terms of the APA. The Company recorded $3.74 million as the aggregate amount of consideration
received by the Company for these certain intellectual property rights.

This issuance was made by the Company pursuant to an exemption from the registration either (a) under the Securities Act generally,
in  that  the  transactions  are  between  an  issuer  and  sophisticated  investors  and  do  not  involve  any  public  offering  within  the  meaning  of
Section 4(a)(2) or (b) under Regulation S promulgated under the Securities Act in that offers, sales and issuances are not made to persons in
the United States and no directed selling efforts are made in the United States.

August 2015

In August 2015, the Company issued 527,535 shares of the Company’s common stock to non-employee consultants in exchange for
services provided to the Company. The Company recorded $196,341 as the aggregate amount of consideration received by the Company
for the associated services.

The shares were not registered under the Securities Act, or the securities laws of any state, and were offered and sold in reliance on
the  exemption  from  registration  afforded  by  Section  4(a)(2)  and  Regulation  D  (Rule  506)  under  the  Securities Act  and  corresponding
provisions of state securities laws, which exempt transactions by an issuer not involving any public offering.

Issuances of Common Stock Warrants

Pharmsynthez Common Stock Warrant Issuances

In July 2015, the Company issued a $3 million 10% Senior Secured Collateralized Convertible Promissory Note (the “Note”) plus a
warrant to purchase 10 million shares of common stock to OJSC Pharmsythez. The net proceeds of approximately $3 million were used for
general working capital needs of the Company.

This  Note  was  issued  in  a  private  placement  by  the  Company  pursuant  to  an  exemption  from  the  registration  either  (a)  under  the
Securities Act generally, in that the transactions are between an issuer and sophisticated investors and do not involve any public offering
within the meaning of Section 4(a)(2) or (b) under Regulation S promulgated under the Securities Act in that offers, sales and issuances are
not made to persons in the United States and no directed selling efforts are made in the United States.

SynBio LLC Common Stock Warrant Issuance

On  December  31,  2014,  the  Company  issued  a  warrant  to  purchase  6,745,000  shares  of  the  Company’s  common  stock,  par  value
$0.01, to SynBio in furtherance of our co-development clinical objectives. The exercise price for the purchase of the warrant is $0.77 per
share with a term of five years from the grant date. Simultaneously, warrants to purchase 320,000 shares of the Company’s common stock,
par  value  $0.01,  were  issued  to  SynBio  and  Pharmsynthez  non-director  designees  under  the  same  terms  and  conditions  of  the  SynBio
warrant. Pharmsynthez is a related party of SynBio, which is an affiliate of the Company. These warrants contain vesting triggers based on
the achievement by SynBio of specific clinical development objectives.

Serum Institute of India Limited Common Stock Warrant Issuance

On  December  31,  2014,  the  Company  issued  a  warrant  to  purchase  3,200,000  shares  of  the  Company’s  common  stock,  par  value
$0.01,  to  Serum  Institute  in  furtherance  of  our  co-development  clinical  objectives.  The  exercise  price  for  the  purchase  of  the  warrant  is
$0.77  per  share  with  a  term  of  five  years  from  the  grant  date.  Simultaneously,  warrants  to  purchase  160,000  shares  of  the  Company’s
common stock, par value $0.01, were issued to Serum Institute non-director designees under the same terms and conditions of the Serum
Institute  warrant.  These  warrants  contain  vesting  triggers  based  on  the  achievement  by  Serum  Institute  of  specific  clinical  development
objectives. Serum Institute is a related party of the Company.

33

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-Employee Director Common Stock Warrant Issuance

On  December  31,  2014,  the  Company  issued  a  warrant  to  purchase  1,600,000  shares  of  the  Company’s  common  stock,  par  value
$0.01, to a non-employee director for services provided to the Company. The exercise price for the purchase of the warrant is $0.77 per
share with a term of five years from the grant date. This warrant was fully vested on the date of grant.

These  warrants  are  issued  by  the  Company  pursuant  to  an  exemption  from  the  registration  either  (a)  under  the  Securities  Act
generally,  in  that  the  transactions  are  between  an  issuer  and  sophisticated  investors  and  do  not  involve  any  public  offering  within  the
meaning of Section 4(a)(2) or (b) under Regulation S promulgated under the Securities Act in that offers, sales and issuances are not made
to persons in the United States and no directed selling efforts are made in the United States.

FDS Pharma ASS Intellectual Property Assignment and Share Issuance

On  December  31,  2014,  in  consideration  of  the  assignment  of  certain  intellectual  property  rights  by  Dr.  Dmitry  Genkin  and  FDS
Pharma ASS  to  Lipoxen  Technologies  Limited,  the  Company  issued  to  FDS  Pharma ASS  3,244,784  shares  of  the  Company’s  common
stock, par value $0.01 per share. FDS Pharma ASS is related party of SynBio, which is an affiliate of the Company.

These shares were issued in a private placement and were not registered under the Securities Act, or the securities laws of any state,
and  were  offered  and  issued  in  reliance  on  the  exemption  from  registration  afforded  by  Regulation  D  under  the  Securities  Act  and
corresponding provisions of state securities laws, which exempt transactions by an issuer not involving any public offering. FDS Pharma
ASS is an “Accredited Investor” as such term is defined in Regulation D promulgated under the Securities Act.

Baxter SA Purchase Agreement – Unregistered Shares Sold in January 2014

On January 29, 2014, the Company entered into a Stock Purchase Agreement (the “Purchase Agreement”) with Baxter SA, pursuant
to which the Company sold to Baxter SA 10,695,187 shares of the Company’s common stock, par value $0.01 per share (the “Shares”) for
$10 million (the “Purchase Price”).

Pursuant to the Purchase Agreement, Baxter SA agreed that until the earlier of (i) three months after the effective date of the listing of
the  Company’s  common  stock  on  the  NASDAQ  Stock  Market;  or  (ii)  January  29,  2015,  Baxter  SA  would  not  assign,  transfer,  sell  or
dispose of the Shares to any party other than a wholly owned subsidiary. In addition, Baxter SA agreed that until the 12 month anniversary
of the Lock-Up Expiration Date, it would not sell or offer to sell any shares of common stock of the Company in an amount that would
exceed 15% of the daily trading volume of the Company’s common stock on the principal market or exchange on which the Company’s
shares of common stock are traded, and in no event would Baxter SA sell or offer to sell more than 15% of the Shares in any one month
period. During 2015, Baxter agreed in writing to a further lock-up period expiring in June 2016 and certain other related restrictions.

The Shares were sold in a private placement and were not registered under the Securities Act, or the securities laws of any state, and
were offered and sold in reliance on the exemption from registration afforded by Section 4(a)(2) and Regulation D (Rule 506) under the
Securities Act  and  corresponding  provisions  of  state  securities  laws,  which  exempt  transactions  by  an  issuer  not  involving  any  public
offering. Baxter SA is an “Accredited Investor” as such term is defined in Regulation D promulgated under the Securities Act.

Repurchases of Equity Securities of the Issuer

During 2015 and 2014, we did not repurchase any of our outstanding securities.

ITEM 6 – SELECTED FINANCIAL DATA

We are not required to provide the information required by this Item because we are a smaller reporting company.

34

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ITEM  7  –  MANAGEMENT’S  DISCUSSION  AND  ANALYSIS  OF  FINANCIAL  CONDITION  AND  RESULTS  OF
OPERATIONS

BUSINESS OVERVIEW

The  Company  is  a  clinical  stage  biopharmaceutical  company  that  is  focused  on  the  research  and  development  of  certain
pharmaceutical products for use in humans that incorporate the use of its patented and proprietary platform technologies that we believe
will  enable  the  creation  of  next-generation  biologic  drugs  and  novel  oncology  therapeutics  with  an  emphasis  primarily  on  orphan
indications.

We  hold  more  than  201  United  States  (“U.S.”)  and  international  patents  in  addition  to  certain  proprietary  rights  to  four  core
technologies that are designed to treat a variety of indications with potential use advantages over competing products, in addition we have
approximately  90  pending  patents.  In  June  2014,  the  U.S.  Patent  and  Trademark  Office  (the  “USPTO”)  has  granted  the  Company  U.S.
Patent No. 8,735,557, entitled "Activated Sialic Acid Derivatives for Protein Derivatization and Conjugation," which contains claims that
cover the compound, ErepoXen™, and Xenetic's broader polysialic acid technologies.

The Company’s core technologies are summarized below:

PolyXen™

Virexxa®

OncoHist™

ImuXen™

An enabling technology that utilizes Polysialic Acid (“PSA”), a biopolymer, consisting of a chain of sialic acids,  which is
a natural constituent of the human body. PSA is designed to extend the half-life in circulation in the human body  for  a
variety of existing drug molecules and, thereby, to create potentially superior next generation drug candidates.
Virexxa®, sodium cridanimod, belongs to a class of low-molecular weight synthetic interferon inducers. In addition to its
immunomodulatory properties, Virexxa® has been shown to increase levels of  progesterone receptor expression in tumor
tissue of patients who are progesterone receptor deficient, and thus may restore sensitivity of non-responsive endometrial
cancers  to  hormonal (e.g.  progestin)  therapy.  Based  on  preclinical  observations,  Virexxa®  may  also  be  therapeutically
relevant in other hormone-resistant cancers, such as triple-negative breast cancer.  Virexxa® has been granted an Orphan
Drug  Designation  by  the USFDA  for  use  in  conjunction  with  medroxyprogesterone  in  progesterone  receptor  negative
endometrial cancer.
A novel therapeutic platform that utilizes the properties of the human histone H1.3 (“H1.3”) for the development of drug
candidates  for  the  treatment  of  a  broad  range  of  cancer  indications.  OncoHist™,  unlike  many  competing  oncology
therapies, is based on a molecule occurring naturally in the human body, in the cell nucleus, and is therefore expected to be
less toxic and immunogenic than other oncology therapies.
A  novel  liposomal  co-entrapment  encapsulation  technology  designed  to  create  new  vaccines  and  improve  the  use  and
efficacy  of certain  existing  vaccines  for  use  in  the  human  body.  The  technology  is  based  on  the  co-entrapment  of  the
nominated antigen(s) in a liposomal vesicle, a design that is intended to maximize both cell and immune system mediated
responses.

All  of  the  Company’s  current  drug  candidates  are  in  the  development  stage  and  none  has  yet  received  regulatory  approval  for

marketing in the U.S. by the U.S. Food and Drug Administration (the “FDA”) or by any applicable agencies in other countries.

Critical Accounting Estimates

The preparation of our financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and
assumptions  that  affect  the  reported  amounts  of  assets  and  liabilities  at  the  date  of  the  financial  statements  and  the  reported  amount  of
expenses during the reporting period. On an ongoing basis, we evaluate our estimates that are based on historical experience and on various
assumptions  that  we  believe  to  be  reasonable  under  the  circumstances.  The  result  of  these  evaluations  forms  the  basis  for  making
judgments about the carrying values of assets and liabilities and the reported amount of expenses that are not readily apparent from other
sources. Because future events and their effects cannot be determined with certainty, actual results could differ from our assumptions and
estimates, and such differences could be material.

Management believes that the following accounting estimates are the most critical to aid in fully understanding and evaluating our
reported financial results, and they require management’s most difficult subjective or complex judgments, resulting from the need to make
estimates about the effect of matters that are inherently uncertain. The following narrative describes these critical accounting estimates, the
judgments and assumptions and the effect if actual results differ from these assumptions.

35

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Revenue Recognition

We  derive  our  revenue  from  our  license  and  collaboration  arrangements  with  pharmaceutical  and  biotechnology  partners,  some  of
which  include  royalty  agreements  based  on  potential  net  sales  of  approved  commercial  pharmaceutical  products.  Revenue  from  our
collaborative partners are generally paid directly by the partners and are recognized on the accrual basis when all the following criteria are
met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services have been rendered, (iii) the
seller's price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured.

The  terms  of  our  license  agreements  include  delivery  of  an  IP  license  to  a  collaboration  partner.  We  may  be  compensated  under
license arrangements through a combination of non-refundable upfront receipts, development and regulatory objective receipts and royalty
receipts  on  future  product  sales  by  partners.  We  make  our  best  estimate  of  the  period  over  which  we  expect  to  fulfil  our  performance
obligations,  which  may  include  technology  transfer  assistance,  research  activities,  clinical  development  activities,  and  manufacturing
activities  from  development  through  the  commercialization  of  the  product.  Given  the  uncertainties  of  these  collaboration  arrangements,
significant judgment is required to determine the duration of the performance period.

Non-refundable  upfront  license  fees  received,  whereby  our  continued  performance  or  future  obligations  are  considered
inconsequential  or  perfunctory  to  the  relevant  licensed  technology,  are  recognized  as  revenue  upon  delivery  of  the  technology  in
accordance  with  U.S.  GAAP.  This  determination  requires  significant  judgment  to  assess  the  nature  of  any  continuing  obligations.
Reimbursements  for  research  and  development  services  completed  by  us  related  to  the  collaboration  agreements  are  recognized  in
operations as revenue on a gross basis.

We expect to receive royalty receipts in the future as products are sold. We expect to recognize royalty revenue in the period of sale,
based on the underlying contract terms, provided that the reported sales are reliably measurable and we have no remaining performance
obligations, assuming all other revenue recognition criteria are met.

Our license and collaboration agreements with certain collaboration partners could also provide for future receipts to us based solely
upon the performance of the respective collaboration partner in consideration of milestone extensions or upon the achievement of specified
sales  volumes  of  approved  drugs.  For  such  receipts,  we  expect  to  recognize  the  receipts  as  revenue  when  earned  under  the  applicable
contract terms on a performance basis or ratably over the term of the agreement. These receipts may also be recognized as revenue when
our continued performance or future obligations are considered inconsequential or perfunctory.

Embedded Derivatives Related to Debt Instruments

In  our  financing  arrangements,  we  issue  debt  instruments  that  may  include  features  that  meet  the  criteria  of  embedded  derivatives
requiring bifurcation. The fair value of each embedded derivative is valued independently using a “with-and-without” method.  The “with-
and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual
embedded  derivative.  The  difference  between  the  entire  instrument  with  all  of  the  embedded  derivatives  compared  to  the  instrument
without the individual embedded derivative is the fair value of that individual derivative. The embedded derivatives are settled when the
underlying debt instrument is settled. Therefore, there are three possible settlement mechanisms: the debt instrument can be converted into
equity, repaid early, or held to maturity.

In connection with our July 2015 financing, we developed a set of potential outcomes resulting in the settlement of the SPA Note
consisting of a future qualifying capital raise with conversion, default of the SPA Note, the SPA Note being converted to equity and the
SPA Note being held to maturity.  These were included in a valuation model utilizing Monte Carlo Simulations to develop the fair value of
the  embedded  derivatives,  which  included  a  simulation  of  the  Company’s  stock  price  with  consideration  provided  for  the  expected
volatility of the Company, the expected life of the host instrument, and risk free rate.  The assumptions used in calculating the fair value
represents  our  best  estimates  and  involves  inherent  uncertainties  and  the  application  of  our  judgment.   As  a  result,  the  use  of  alternate
assumptions would result in outcomes that could be materially different. Additionally, the Company is required to update its assumptions
and estimates at each valuation date. Based on updated circumstances, factors and knowledge of the Company at future valuation dates,
then applicable assumptions and estimates could result in material changes in the estimated fair value of the embedded derivatives.

36

 
 
 
 
 
 
 
 
 
 
 
 
 
Share-based Payments

Share-based  payments  includes  grants  of  options  to  employees  and  non-employees  to  purchase  shares  of  common  stock,  grants  of
Joint Share Ownership Plan (“JSOP”) awards to employees, as well as agreements to issue common stock in exchange for services provided
by non-employees. Currently, we utilize one option plan, the Xenetic Biosciences, Inc. Equity Incentive Plan pursuant to which we may
grant  options  to  purchase  shares  of  common  stock  to  employees  and  non-employees.  Prior  to  the  acquisition  of  Xenetic  UK  in  January
2014,  the  Company  had  two  option  plans,  the  Lipoxen  plc  Unapproved  Share  Option  Plan  and  the  Xenetic  Biosciences  plc  2007  Share
Option Scheme. Both of these plans were converted subsequent to year end to reflect the new shares of common stock issued related to the
Acquisition. As part of the conversion, option holders under both plans have the right to subscribe for a number of shares of common stock
in exchange for the cancellation and surrender by the option holder in a manner similar to which the shareholders prior to the Acquisition
were given the right to acquire shares of common stock in the new company according to the terms of the Acquisition.

We  measure  share-based  payments  to  employees  in  accordance  with  Financial Accounting  Standards  Board Accounting  Standards
Codification (“ASC”) Topic 718,  Compensation – Stock Compensation and to non-employees in accordance with ASC Topic 505, Equity.
Stock  option  compensation  expenses  are  based  on  the  estimated  fair  value  of  the  underlying  option  calculated  using  the  Black-Scholes
option  pricing  model,  which  requires  the  input  of  subjective  assumptions  and  judgments,  including  estimating  share  price  volatility  and
expected term of the awards. Our shares do not have a sufficient trading history for us to adequately assess the fair value of the stock option
grants. Therefore, for all share-based payments, we determine the expected volatility based on a weighted-average of the historical volatility
of  a  peer  group  of  comparable  publicly  traded  companies  with  product  candidates  in  similar  stages  of  development  to  our  product
candidates  in  conjunction  with  our  historical  volatility.  We  intend  to  consistently  apply  this  methodology  of  using  a  peer  group  of
comparable companies until the historical volatility of our own share price is relevant to measure expected volatility for future equity based
awards.  For  employee  stock  options  issued  in  2014  that  qualify  as  “plain  vanilla”  stock  options  in  accordance  with  Staff Accounting
Bulletin No. 110 (“SAB 110”) issued by the SEC, the expected term is estimated using the simplified method, as defined in SAB 110. The
Company  has  a  limited  history  of  stock  option  exercises,  which  does  not  provide  a  reasonable  basis  for  the  Company  to  estimate  the
expected term of employee stock options. For all other employee stock options, we estimate the expected life using judgment based on the
anticipated  research  and  development  milestones  of  the  Company’s  clinical  projects  and  behavior  of  the  Company’s  employees.  The
expected life of non-employee options is the contractual life of the option. The assumptions used in calculating the fair value of the stock
option  grants  represent  our  best  estimates  and  involve  inherent  uncertainties  and  the  application  of  our  judgment. As  a  result,  if  factors
change and we use different assumptions, share-based payments expense could be materially different in the future.

For employee options that vest based solely on service conditions, the fair value measurement date is generally on the date of grant
and the related compensation expense, less expense for expected forfeitures, is recognized on a straight-line basis over the requisite vesting
period of the awards. For non-employee options, the fair value measurement date is the earlier of the date the performance of services is
complete  or  the  date  the  performance  commitment  has  been  reached.  We  generally  determine  that  the  fair  value  of  the  stock  options  is
more  reliably  measurable  than  the  fair  value  of  the  services  received.  Compensation  expense  related  to  stock  options  granted  to  non-
employees that vest based solely on service conditions is subject to re-measurement at each reporting period until the options vest and is
recognized on a straight-line basis over the estimated vesting period of the awards.

We estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual forfeitures differ from those
estimates. During 2015 and 2014, we applied a forfeiture rate of 0% as we have not historically experienced forfeitures. Upon exercise,
stock options are redeemed for newly issued shares of common stock.

37

 
 
 
 
 
 
 
 
 
The fair value of common stock awards issued in exchange for services provided by non-employees is generally determined by using
the fair value of the services provided, as this provides the most reliable measure of the fair value of the awards. Share-based payments
expense is recognized as services are rendered on a straight-line basis. The assumptions used in calculating the fair value of the common
stock  awards  represent  our  best  estimates  and  involve  inherent  uncertainties  and  the  application  of  our  judgment. As  a  result,  if  factors
change and we use different assumptions, share-based payments expense related to the common stock awards could be materially different
in the future.

Under the JSOP, shares of the Company are jointly purchased at fair market value by the participating executives and the trustees of
the JSOP trust, with shares held in the JSOP trust. For U.S. GAAP purposes the awards are valued as employee options. The JSOP trust
holds the shares of the JSOP until such time as the JSOP shares are vested and the participating executives exercise their rights under the
JSOP. The JSOP trust is granted an interest bearing loan by the Company in order to fund the purchase of its interest in the JSOP shares.
The loan held by the trust is eliminated on consolidation in the financial statements of the Company. The Company funded portion of the
share purchase price is deemed to be held in treasury until such time as they are transferred to the employee and is recorded as a reduction
in equity.

The exercise price of the JSOP “option” is deemed to be the market value of the shares at the date of issue. The awards vest based on
certain market conditions, which require each tranche of shares to meet specific market share price hurdles, or change in control conditions,
as defined by the plan. Under the JSOP and subject to the vesting of the participants’ interest, participating executives will, when the JSOP
shares are sold, be entitled to a share of the proceeds of sale equal to the growth in market value of the JSOP shares versus the exercise
price, less simple interest on the original share purchase price, net of executives’ cash contribution at inception, as agreed for each grant
(the “Carry Charge”). The balance of the proceeds will remain to the benefit of the JSOP trust and be applied to the repayment of the loan
originally made by the Company to the JSOP trust. Any funds remaining in the JSOP trust after settlement of the loan and any expenses of
the JSOP trust are for the benefit of the Company.

We  measure  the  fair  value  of  JSOP  awards  using  Monte  Carlo  simulations,  which  requires  estimates  based  on  the  Company’s
judgment,  as  well  as  other  assumptions.  These  estimates  include  the  expected  term  of  each  tranche  of  the  JSOP  awards,  which  the
Company  determines  to  be  the  initial  life  of  the  awards,  and  expected  volatility,  which  is  based  on  a  weighted  average  of  the  historical
volatility  of  a  peer  group  of  comparable  publicly  traded  companies  with  product  candidates  in  similar  stages  of  development  to  the
Company’s  product  candidates  in  conjunction  with  the  historical  volatility  of  Xenetic  Biosciences  plc’s  shares  when  traded  on  the  U.K.
AIM market. The Company has applied an expected dividend yield of 0% as the Company has not historically declared a dividend and does
not anticipate declaring a dividend during the expected life of the awards. The risk-free rate is based upon the US Treasury yield curve in
effect at the time of grant, with a term that approximates the expected life of the awards. The compensation expense is recorded over the
expected life of the option, regardless of whether the awards vest. Having established the full value of the JSOP awards using the Monte
Carlo simulation outlined above, a deduction is made in respect of the anticipated Carry Charge in order that the expense recorded in the
financial  statements  only  represents  the  participating  executives’  net  interest  in  the  awards.  The  assumptions  used  in  calculating  the  fair
value of the JSOP awards represent our best estimates and involve inherent uncertainties and the application of our judgment. As a result, if
factors change and we use different assumptions, share-based payments expense related to the JSOP awards could be materially different in
the future.

On  exercise  of  the  JSOP  awards  by  the  executives  the  Carry  Charge  due  to  the  Company  will  be  recognized  as  additional  paid-in

capital, arising from the sale of treasury stock.

Warrants

In  connection  with  certain  financing,  consulting  and  collaboration  arrangements,  we  issue  warrants  to  purchase  shares  of  the
Company’s common stock. Outstanding warrants are standalone instruments that are not puttable or mandatorily redeemable by the holder
and are classified as equity awards. We measure the fair value of the awards using the Black-Scholes option pricing model, which requires
the input of subjective assumptions and judgments, including estimating the expected term of the awards and the share price volatility, at
each reporting period until the measurement date is reached. The expected term is deemed to be the contractual life of the warrant and we
determine  the  expected  volatility  based  on  a  weighted-average  of  the  historical  volatility  of  a  peer  group  of  comparable  publicly  traded
companies with product candidates in similar stages of development to our product candidates in conjunction with our historical volatility.

38

 
  
 
 
 
 
 
 
 
 
 
All other warrants are recorded at fair value as compensation expense on a straight-line basis over the requisite service period or at
the date of issuance, if there is not a service period or if service has already been rendered. For warrants that contain vesting triggers based
on the achievement of certain objectives, the Company applies judgment to estimate the probability and timing of the achievement of those
objectives.  These  estimates  involve  inherent  uncertainties,  and  as  a  result,  if  the  probability  or  timing  of  the  achievement  of  those
objectives change, expense related warrants could be materially different in the future.

Warrants issued to collaboration partners in conjunction with the issuance of common stock are recorded at fair value as a reduction

in additional paid-in capital of the common stock issued.

Goodwill and Indefinite-lived Intangible Assets

Goodwill

Goodwill  is  not  amortized  but  is  reviewed  for  impairment  annually  as  of  October  1,  or  when  events  or  changes  in  the  business
environment indicate that all, or a portion, of the carrying value of the reporting unit may no longer be recoverable. Under this method, we
compare the fair value of our reporting unit to its carrying value. If the fair value is less than the carrying amount, a more detailed analysis
is performed to determine if goodwill is impaired. An impairment loss, if any, is measured as the excess of the carrying value of goodwill
over the fair value of goodwill. We also have the option to first assess qualitative factors to determine whether the existence of events or
circumstances leads us to determine that it is more likely than not (that is, a likelihood of more than 50%) that goodwill is impaired. If we
choose to first assess qualitative factors and it is determined that it is not more likely than not goodwill is impaired, we are not required to
take further action to test for impairment. We also have the option to bypass the qualitative assessment and perform only the quantitative
impairment test, which we may choose to do in some periods but not in others. As the option to perform the qualitative assessment is not a
permanent election, we reassess this option during each annual impairment review.

We determine our reporting unit by identifying the components of our operating segment with similar economic characteristics based
on quantitative and qualitative factors that have discrete financial information available. We determined that we have one reporting unit as
of  October  1,  2015  and  2014,  the  dates  of  our  annual  impairment  reviews.  Based  on  our  annual  impairment  reviews,  we  used  the
quantitative method and determined no adjustment to the carrying value of goodwill would be necessary as the fair value of our reporting
unit significantly exceeded its respective carrying value as of October 1, 2015 and 2014, respectively. If the fair value of our reporting unit
were to be reduced by one-half, the fair value would still significantly exceed the carrying value of the reporting unit at October 1, 2015.
There can be no assurance that future events will not result in an impairment of goodwill.

Indefinite-lived Intangible Assets

Our indefinite-lived intangible assets consist of acquired IPR&D. IPR&D intangible assets are considered indefinite-lived intangible
assets until completion or abandonment of the associated research and development efforts. IPR&D is not amortized but is reviewed for
impairment annually as of October 1, or when events or changes in the business environment indicate the carrying value may be impaired.
If  the  fair  value  of  the  intangible  asset  is  less  than  the  carrying  amount,  we  perform  a  quantitative  test  to  determine  the  fair  value.  The
impairment loss, if any, is measured as the excess of the carrying value of the intangible asset over its fair value. We also have the option to
first assess qualitative factors to determine whether the existence of events or circumstances leads us to determine that it is more likely than
not (that is, a likelihood of more than 50%)  that  our  indefinite-lived  intangible  asset  is  impaired.  If  we  choose  to  first  assess  qualitative
factors and it is determined that it is not more likely than not our indefinite-lived intangible asset is impaired, we are not required to take
further  action  to  test  for  impairment.  We  also  have  the  option  to  bypass  the  qualitative  assessment  and  perform  only  the  quantitative
impairment test, which we may choose to do in some periods but not in others. As the option to perform the qualitative assessment is not a
permanent election, we reassess this option during each annual impairment review. During 2015 and 2014, we used the quantitative method
and determined the fair value of the indefinite-lived intangible asset exceeded its carrying value as of October 1, 2015 and 2014.

39

 
  
 
 
 
 
 
 
 
 
 
 
Significant judgments are inherent in the calculation of fair value. With the assistance of an independent third party, we calculated
the fair value of our IPR&D by using the Multi-Period Excess Earnings Method (the “MPEEM”) which is a form of the income approach.
Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s incremental after-tax cash flows (excess
earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its
remaining useful life. This method requires us to make long-term projections of the amount and timing of income and expenses related to
development and commercialization of the acquired intangible asset and assumptions regarding the rate of return on contributory assets, the
weighted average cost of capital and the discount rate for estimated future after-tax cash flows. Specifically, this method took into account
our estimates of future incremental milestone payments that may be achieved upon completion of clinical trial stages, regulatory approval
and sales goals upon commercialization, as well as our expected royalty income based on sales upon commercialization. Projected expenses
are based on our forecasted spend required to complete the development of our IPR&D, which will require the Company to raise further
capital to fund the development. Our projections are estimates subject to change based on several factors including the results of clinical
trials  and  delays  in  regulatory  approval.  The  discount  rate  used  is  commensurate  with  the  uncertainties  associated  with  the  economic
estimates described above and reflects the stage of development, the time and resources needed to complete the development of the product
and the risks of advancement through regulatory approval processes.

Key assumptions utilized in the fair valuation of our indefinite-lived intangible asset OncoHist™ are as follows:

· Discount rate – 47.5%
· Weighted average cost of capital – 16.0%
·
·

Estimated aggregate milestone receipts – approximately $300 million
Royalty rates – 10% of net sales

While  we  believe  reasonable  estimates  and  appropriate  assumptions  were  utilized  to  calculate  the  fair  value  of  OncoHist™,  it  is
possible a material change could occur. Use of different estimates and judgments could yield materially different results in our analysis and
could result in materially different asset values or expense.

There can be no assurance that we will be able to successfully develop and complete the acquired IPR&D program and profitably
commercialize the underlying product candidates before our competitors develop and commercialize similar products, or at all. Moreover,
if  the  acquired  IPR&D  program  fails  or  is  abandoned  during  development,  then  we  may  not  realize  the  value  we  have  estimated  and
recorded in our financial statements on the acquisition date, and we may also not recover the research and development investment made
since  the  acquisition  date  to  further  develop  that  program.  If  such  circumstances  were  to  occur,  our  future  operating  results  could  be
materially adversely impacted.

We did not record an impairment charge as a result of our goodwill or indefinite-lived intangible asset impairment tests in 2015 or
2014.  We  will  continue  to  closely  monitor  the  performance  of  our  indefinite-lived  intangible  asset  and  reporting  unit.  If  the  business
experiences adverse changes in our key assumptions and judgments, we will perform an interim goodwill and/or indefinite-lived intangible
asset impairment analysis. There can be no assurance that future events will not result in an impairment of our goodwill or indefinite-lived
intangible asset. As a result of the going concern uncertainty discussed under Liquidity and Capital Resources below, the recoverability and
classification of the Company’s intangible assets and goodwill could be adversely affected.

40

 
 
 
 
 
 
 
 
 
 
RESULTS OF OPERATIONS

The comparison of our historical results of operations for the year ended December 31, 2015 to the year ended December 31, 2014 is

as follows:

Description
Operating costs and expenses:
 Research and development
 General and administrative
Loss from operations
Other income (expense):
 Change in fair value of derivative liability
 Loss on disposal of subsidiaries
 Other expense
 Interest income
 Interest expense

Net loss

Revenue

2015

2014

Increase
(Decrease)

Percentage
Change

$

$

3,434,016  $
6,388,000 
(9,822,016)  

(2,125,117) 
- 
(295,033) 
1,694 
(266,999)  

(2,685,455) 
(12,507,471) $

6,323,896  $
6,600,870 
(12,924,766)  

- 
(1,069,675) 
(326,916) 
18,959 
(4,706)  

(1,382,338) 
(14,307,104) $

(2,889,880)  
(212,870)  
(3,102,750)  

2,125,117 
(1,069,675)  
(31,883)  
(17,265)  
262,293 
1,303,117 
(1,799,633)  

45.7 
3.2 
24.0 

100.0 
100.0 
9.8 
91.1 
5,573.6 
94.3 
12.6 

The Company recorded no revenues for the years ended December 31, 2015 and 2014.

Cost of Revenue

The Company incurred no cost of revenue for the years ended December 31, 2015 and 2014.

Research and Development

The  Company  engages  in  independent  research  and  development  (“R&D”)  in  connection  with  its  various  technologies.  Overall,
corporate R&D expenses for the year ended December 31, 2015 decreased by approximately $2.89 million, or 45.7% to $3.43 million from
$6.32 million in 2014. The table below sets forth the R&D costs incurred by the Company, by category of expense, for the years ended
December 31, 2015 and 2014:

Category of Expense

Outside services and Contract Research Organizations
Share-based expense
Salaries and wages
Rents
Lab consumables
Other
Total research and development expense

Research and Development by Subsidiary Location

Year ended December 31,
2014

2015

1,794,523$
886,805  
491,623  
89,354  
23,711  
148,000  
3,434,016$

5,107,990
141,634
729,082
78,076
26,280
240,834
6,323,896

$

$

The decrease in R&D expenses in the U.S. during 2015 was primarily due to the planned deferral of IND-enabling preclinical work
conducted  in  connection  with  the  OncoHist™  program  due  to  working  capital  constraints.  The  costs  of  conducting  the  ongoing
ErepoXen™ human clinical trials in Australia, which are borne by the U.K. subsidiary Lipoxen, were relatively unchanged during 2015 as
compared to 2014.

41

 
 
 
 
 
   
   
   
 
 
  
  
 
 
  
 
  
 
 
 
 
 
  
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research and Development by Category of Expense

Outside Services and Contract Research Organization Costs

The significant decrease in outside services and contract research organization costs of approximately $3.31 million, or 64.9% for the
year ended December 31, 2015 is primarily due to the planned deferral of IND-enabling preclinical work conducted in connection with the
OncoHist™  program  due  to  working  capital  constraints.  The  costs  of  conducting  the  ongoing  ErepoXen™  human  clinical  trials  were
relatively  unchanged  as  the  trials  proceeded  as  planned,  with  costs  of  approximately  $1.07  million  and  $1.12  in  2015  and  2014,
respectively.

Share-based Expense

Share-based  expense  increased  approximately  $745,000  or  526.12%  to  $886,805  for  the  year  ended  December  31,  2015  from
$141,634 for the prior year. The fluctuation is primarily due to the normal expensing of the fair value of stock option awards granted to
R&D personnel in September 2015 and December 2014. The December 2014 grants did not have a significant impact on the 2014 shared-
based payments expense.

Salaries and Wages

Salaries  and  wages  decreased  by  approximately  $237,000  or  32.6%  to  $491,623  for  the  year  ended  December  31,  2014  from
$729,082 for the prior year. The decrease is due to the planned overall reduction in the number of scientific personnel following the closing
of the U.K. lab facility. The layoffs of three U.K.-based scientific personnel at various points during 2014 were only partially offset by the
hiring of two new scientists in the U.S. during  the  same  year.  The  decrease  is  also  partially  related  to  certain  non-recurring  layoff  costs
incurred in 2014. There were no new R&D personnel hired in 2015.

Rents

Rent  expense  allocated  to  research  and  development  increased  approximately  $11,000,  or  14.1%  to  $89,354  from  $78,076  for  the
year  ended  December  31,  2015  over  the  comparable  period  in  2014.  During  each  period,  the  Company  operated  the  same  research  and
development facility, which shares its space with general and administrative employees. While the overall rent expense for this facility did
not change during these periods, the expense allocated to research and development increased during the year ended December 31, 2015
due to a change in the Company’s method of allocation.

Lab Consumables

The slight decrease of approximately $2,000 in lab consumables expense is due to normal fluctuations in the amount of those supplies

required for in-house research activities.

Other

Other expenses decreased approximately $93,000, or 38.5%, to $148,000 for the year ended December 31, 2015 from $240,834 for
the prior year. The decrease in other expense results from the net aggregate change of all miscellaneous costs, including an approximately
$36,000 decrease in computer and equipment costs, approximately $30,000 decrease in recruiting costs and approximately $30,000 decrease
in general travel costs.

42

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
General and Administrative

General  and  administrative  (“G&A”)  expenses  decreased  by  approximately  $213,000,  or  3.2%,  to  $6,388,000  for  the  year  ended
December  31,  2015  from  $6,600,870  for  the  prior  year.  Although  the  total  level  of  general  and  administrative  costs  did  not  change
significantly,  there  were  significant  changes  of  certain  expenses  as  follows.  Stock  compensation  expense  increased  approximately  $1.04
million due to the normal expensing of the fair value of stock option awards granted to G&A personnel in September 2015 and December
2014. This increase was offset by a decrease in consulting, accounting and legal professional service costs of approximately $810,000 due
to certain non-recurring costs during 2014 related to the Company’s transition to the U.S. as a U.S. public company and short term cost
reduction  initiatives.  In  addition,  travel  expenses  and  rent  and  utilities  costs  in  2015  decreased  approximately  $202,000  and  $115,000,
respectively, due to the closure of the U.K. office in March 2015.

All other general and administrative expenses resulted in a net decrease of approximately $121,000 for the year ended December 31,

2015 over the comparable period in 2014.

Change in Fair Value of Derivative Liability

The loss of approximately $2.1 million is recognized on the change in fair value of the Company’s compound derivative instrument
during the year ended December 31, 2015. This change is primarily driven by the change in our stock price from period  to  period.  The
Company did not have debt instruments with embedded derivatives outstanding during the comparable period in 2014.

Loss on Disposal of Subsidiaries

The loss on disposal of subsidiaries is related to one transaction, the Hive Out Agreement, during the year ended December 31, 2014.

There were no disposals of subsidiaries during the year ended December 31, 2015.

Other Income (Expense)

Other expense decreased approximately $32,000, or 9.8% to $295,033 for the year ended December 31, 2015 from $326,916 in 2014.
This  decrease  is  primarily  related  to  decreased  foreign  currency  transaction  expenses  following  the  change  in  functional  currency  of  the
Company’s foreign subsidiaries to the U.S. dollar in April 2015. This was offset by an approximately $60,000 loss recorded on the issuance
of debt in July 2015.

Interest Income

Interest income decreased by approximately $17,000, or 91% to approximately $2,000 for the year ended December 31, 2015 from
approximately  $19,000  in  2014.  The  decrease  is  proportional  to  the  decrease  in  average  cash  balances  held  by  the  Company  during  the
period from January 1, 2014 to December 31, 2015 and is not due to any change in investment strategies.

43

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Interest Expense

Interest expense increased by approximately $262,000, or 5,574%, to approximately $267,000 for the year ended December 31, 2015
from  approximately  $5,000  in  2014.  The  increase  in  interest  expense  is  primarily  due  to  interest  charges  associated  with  the  SPA  Note.
There  was  not  a  similar  promissory  note  in  the  comparable  period  in  2014.  The  Company  also  recognized  interest  expense  related  to  a
financing arrangement with the landlord of the Company’s office and laboratory lease in the U.S., which commenced in January 2014.

Liquidity and Capital Resources

At  December  31,  2015  and  2014  we  had  working  capital  deficits  of  approximately  $3.2  million  and  $78,000,  respectively.  At
December 31, 2015, we had approximately $0.13 million in cash and $3.3 million in accounts payable and accrued expenses. At December
31, 2014 we had cash and accounts payable and accrued expenses of $2.5 million and $2.3 million, respectively. Our working capital has
been  reduced  in  2015  due  to  our  net  loss  of  $12.5  million  that  includes  $5.3  million  net  cash  used  in  operating  activities  comprised  of
approximately  $1.8  million  in  consulting,  legal  and  other  professional  service  fees,  approximately  $1.5  million  in  salaries  and  wages,
including scientific staff, approximately $1.3 million in program-specific clinical development costs and approximately $232,000 in rent
and utilities expenses. The $1.8 million in consulting, legal and other professional service fees cash outflows in 2015 includes $0.9 million
of  costs  that  were  incurred  during  2014  but  paid  in  2015.  The  $1.3  million  applied  to  external  research  and  development  and  clinical
program costs primarily related to our ErepoXen™ drug candidate.

We have historically relied upon equity financing to fund our operations. Since 2005, we have raised approximately $47 million in
equity financing, including $10 million from the sale of shares to Baxter in January 2014, as well as received $10 million from revenue
producing activities in the years prior to 2014. Approximately 90% of that revenue is from a single customer, Baxter, in connection with
milestone receipts and fees for services. We expect the majority of our funding through equity or equity linked instruments to continue as a
trend for the foreseeable future.

On  July  1,  2015,  the  Company  entered  into  the  SPA  with  Pharmsynthez  for  the  issuance  of  the  SPA  Note,  which  provided  net

proceeds of approximately $3 million in July 2015 for the general working capital needs of the Company.

In  November  2015  we  entered  into  the  APA  which  included  the  1 st  amendment  to  the  SPA  (the  “Amended  SPA”)  wherein
Pharmsynthez  agreed  to  purchase  from  the  Company  up  to  $3.5  million  of  additional  10%  Convertible  Promissory  Notes  (the  “APA
Notes”).  The APA  contains  a  total  financing  commitment  from  Pharmsynthez  in  the  amount  of  $10  million.  The APA  Notes  represent
bridge financing to be drawn down from this $10 million. As of March 30, 2016, the Company has received net proceeds of $3.5 million
from the APA Notes, leaving a balance of $6.5 million in funding commitment from Pharmsynthez.

As of March 30, 2016 the Company will be required to raise additional working capital in order to meet its financial obligations for

the next 12 months.

Pharmsynthez, as part of the APA, has agreed to invest $6.5 million (the “Additional Investment”) as part of our planned total capital
raise  and  planned  up-list  to  a  national  securities  exchange  (the  “Capital  Raise”).  The  $6.5  million  would  be  a  draw  down  from
Pharmsynthez’s  $10  million  total  financing  commitment.  The  total  amount  of  financing  contemplated  in  the  APA  is  $18.5  million
consisting of $3.5 million in the APA Notes (which has been drawn down as of March 30, 2016), $6.5 million in the Additional Investment
and  a  minimum  of  $8.5  million  in  other  public  offering  proceeds.  The  Company  believes  this  total  financing  will  be  sufficient  for  the
Company to meet its financial obligations and to continue its planned operations for the next 12 months.

 
 
 
 
 
 
 
 
 
 
 
In the event that the Company is unable to cause a listing of its securities on a national securities exchange, after March 31, 2016,
Pharmsynthez shall loan to the Company the Additional Investment on essentially similar terms as the APA Notes. This outcome would
require  the  Company  to  seek  additional  financing  and/or  defer  certain  research  and  development  activities  in  order  to  meet  its  financial
obligations over the next 12 months.

The Company is optimistic that it will be successful in obtaining the financing contemplated in the APA; however, there can be no
assurance that it will be able to do so or, if it is able to, that it can do so under commercially reasonable terms. Further, Pharmsynthez’s
$6.5 million commitment is an important factor in the Capital Raise. If Pharmsynthez becomes unable or unwilling to fulfill its $6.5 million
commitment,  the  completion  of  the  Capital  Raise  will  be  adversely  affected.  These  financial  statements  have  been  prepared  on  a  going
concern basis; however, if we are unable to complete the Capital Raise for any reason, there will be substantial doubt about our ability to
continue as a going concern.

Until we reach commercialization of our technology or receive significant and regular cash flows from our current collaborations or
from  planned  out-licensing  of  our  technology,  we  expect  the  trend  of  accessing  capital  markets  to  finance  our  working  capital  needs  to
continue.

The  only  significant  cash  receipts  that  we  could  expect  from  our  current  collaborations  would  be  from  Baxalta.  Due  to  the
uncertainties and risks inherent in the clinical development process, we are unable to predict precisely when those receipts may occur, if
ever. We do not expect any significant receipts to become due within the next 12 months; however, there can be no assurance that future
receipts will ever become due because they are contingent on positive outcomes from Baxalta’s clinical development efforts in connection
with the Factor VIII drug candidate.

We  have  commenced  the  process  of  seeking  out-license  arrangements  for  our  ErepoXen™  technology  but  are  currently  unable  to
reliably  predict  when  that  process  may  result  in  an  agreement.  Due  to  the  uncertainties  inherent  in  the  clinical  research  process  and
unknown future market conditions, there can be no assurance our ErepoXen™ technology will lead to any future income.

Cash Flows Used in Operating Activities

Cash flows used in operating activities for the year ended December 31, 2015 totaled approximately $5.3 million. The $5.3 million
includes  net  operating  cash  uses  of  approximately  $1.78  million  in  consulting,  legal  and  other  professional  service  fees,  approximately
$1.54 million in salaries and wages, including scientific staff, approximately $1.25 million in program-specific clinical development costs
and approximately $232,000 in rent and utilities expenses.

Cash flows used in operating activities for the year ended December 31, 2014 totaled approximately $12.3 million. The $12.3 million
includes  net  operating  cash  uses  of  approximately  $7.00  million  in  consulting,  legal  and  other  professional  service  fees,  approximately
$3.01 million in salaries and wages, including scientific staff, and approximately $1.80 million in program-specific clinical development
costs.

 
 
 
 
 
 
 
 
 
 
Cash Flows from Investing Activities

Cash flows used in investing activities for the year ended December 31, 2015 included approximately $2,000 from the purchase of
assets consisting of laboratory equipment, offset by approximately $8,000 derived from the disposition of certain property and equipment
during the year.

Cash flows used in investing activities for the year ended December 31, 2014 included approximately $58,000 from the purchase of
assets  consisting  of  office  furniture  and  fixtures  and  laboratory  equipment,  partially  offset  by  approximately  $5,500  derived  from  the
disposition of certain property and equipment during the year.

Cash Flow from Financing Activities

For the year ended December 31, 2015, we raised $3.0 million and $0.1 million with the issuances of the SPA Note and a short-term

promissory note, respectively. From the proceeds of the SPA Note, we repaid our $0.1 million short-term promissory note.

For  the  year  ended  December  31,  2014  we  received  $10  million  in  proceeds  in  exchange  for  the  issuance  of  approximately  10.7
million shares of common stock to Baxter and we received approximately $102,000 in proceeds in connection with the exercise of stock
options by the CEO of the company. The proceeds were applied toward our working capital needs during the year. During the year, we
repaid approximately $286,000 on our loan to an affiliate of the Company.

Off Balance Sheet Arrangements

The  Company  has  no  off  balance  sheet  financing  arrangements.  The  Company  has  two  facility  lease  obligations  and  written

employment agreements with three key employees.

Recent Accounting Pronouncements

In March 2016, Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-06, Derivatives
and Hedging (Topic 815)  (“ASU 2016-06”). ASU 2016-06 clarifies the requirements for assessing whether contingent call or put options
that  can  accelerate  the  payment  of  principal  on  debt  instruments  are  clearly  and  closely  related  to  their  debt  hosts.  This  guidance  is
effective  for  annual  reporting  periods  beginning  after  December  15,  2016,  including  interim  periods  within  those  annual  periods.  Early
application is permitted. The Company is currently evaluating the impact of this new standard.

In February 2016, FASB issued ASU 2016-02,  Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 will require lessees to recognize
a lease liability and a right-of-use asset for all leases, with the exception of short-term leases, at the commencement date. This guidance is
effective  for  annual  reporting  periods  beginning  after  December  15,  2018,  including  interim  periods  within  those  annual  periods.  Early
application is permitted. The Company is currently evaluating the impact of this new standard.

In  November  2015,  FASB  issued  ASU  2015-17,  Income  Taxes  (Topic  740)  (“ASU  2015-17”).  ASU  2015-17  simplifies  the
presentation  of  deferred  income  taxes  by  requiring  that  deferred  tax  assets  and  liabilities  be  classified  as  non-current  in  a  classified
statement  of  financial  position.  This  guidance  is  effective  for  annual  reporting  periods  beginning  after  December  15,  2016,  including
interim periods within those annual periods, with early adoption permitted. The Company early adopted ASU 2015-17 for the year ended
December  31,  2015  on  a  prospective  basis,  as  permitted.  There  was  no  impact  of  early  adoption  of ASU  2015-17  on  the  Company’s
consolidated financial statements previously reported.

44

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In April 2015, FASB issued ASU 2015-03,  Interest – Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt
Issuance Costs (“ASU 2015-03”). ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the
balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. This guidance is effective
for  annual  reporting  periods  beginning  after  December  15,  2015,  and  interim  periods  within  fiscal  years  beginning  after  December  15,
2016, with early adoption permitted. The Company early adopted ASU 2015-03 in July 2015, as permitted. There was no impact of early
adoption of ASU 2015-03 on the Company’s consolidated financial statements previously reported.

In August 2014, the FASB issued ASU 2014-15,  Presentation of Financial Statements – Going Concern (Subtopic  205-40) (“ASU
2014-15”). ASU 2014-15 defines management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability
to continue as a going concern and provides guidance on the related footnote disclosures. This guidance is effective for annual reporting
periods  beginning  after  December  15,  2016,  and  interim  periods  within  annual  periods  beginning  after  December  15,  2016.  Early
application is permitted. The Company is currently evaluating the impact of this new standard.

In May 2014, the FASB issued ASU 2014-09,  Revenue from Contracts with Customers (Topic 606)  (“ASU 2014-09”). ASU 2014-09
supersedes  the  revenue  recognition  requirements  in Accounting  Standards  Codification  (“ASC”)  Topic  605,  Revenue  Recognition,  and
most  industry-specific  guidance.  The  core  principle  of  the  guidance  is  that  an  entity  should  recognize  revenue  to  depict  the  transfer  of
promised  goods  or  services  to  customers  in  an  amount  that  reflects  the  consideration  to  which  the  entity  expects  to  be  entitled  to  in
exchange  for  those  goods  or  services.  In August  2015,  the  FASB  issued ASU  2015-15,  Revenue  from  Contracts  with  Customers  (Topic
606): Deferral of the Effective Date, which defers the effective date of ASU 2014-09 for all entities by one year. This guidance is currently
effective  for  annual  reporting  periods  beginning  after  December  15,  2017,  including  interim  periods  within  that  reporting  period,  under
either full or modified retrospective approach. Early application is permitted as of annual reporting periods beginning after December 15,
2016. The Company is currently evaluating the impact of this new standard on its revenue recognition policy.

The  Company  has  considered  other  recent  accounting  pronouncements  and  concluded  that  they  are  either  not  applicable  to  the

business, or that no material effect is expected on the consolidated financial statements as a result of future adoption.

ITEM 7A – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are not required to provide the information required by this Item because we are a smaller reporting company.

45

 
 
 
 
 
 
 
 
 
 
Item 8

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Report of Independent Registered Public Accounting Firm (Marcum LLP)

Report of Independent Registered Public Accounting Firm (Ernst & Young LLP)

Consolidated Balance Sheets as of December 31, 2015 and 2014

Consolidated Statements of Comprehensive Loss for the years ended December 31, 2015 and 2014

Consolidated Statements of Cash Flows for the years ended December 31, 2015 and 2014

Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2015 and 2014

Notes to the Consolidated Financial Statements

F-1

F-2

F-3

F-4

F-5

F-6

F-7

46

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Shareholders of Xenetic Biosciences, Inc.

We  have  audited  the  accompanying  consolidated  balance  sheet  of  Xenetic  Biosciences,  Inc.  (the  “Company”)  as  of  December  31,
2015, and the related consolidated statements of comprehensive loss, changes in stockholders’ equity, and cash flows for the year ended
December 31, 2015. Our audit also includes the financial statement schedule. These consolidated financial statements and schedule are the
responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based
on our audit.

We conducted our audit in accordance with standards of the Public Company Accounting  Oversight  Board  (United  States).  Those
standards  require  that  we  plan  and  perform  the  audit  to  obtain  reasonable  assurance  about  whether  the  financial  statements  are  free  of
material  misstatement.  We  were  not  engaged  to  perform  an  audit  of  the  Company’s  internal  control  over  financial  reporting.  Our  audit
included  consideration  of  internal  control  over  financial  reporting  as  a  basis  for  designing  audit  procedures  that  are  appropriate  in  the
circumstances,  but  not  for  the  purpose  of  expressing  an  opinion  on  the  effectiveness  of  the  Company’s  internal  control  over  financial
reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts
and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and
evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In  our  opinion,  the  consolidated  financial  statements  referred  to  above  present  fairly,  in  all  material  respects,  the  consolidated
financial position of Xenetic Biosciences, Inc. at December 31, 2015, and the consolidated results of its operations and its cash flows for the
year ended December 31, 2015, in conformity with accounting principles generally accepted in the United States of America. Also, in our
opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents
fairly, in all material respects, the information set forth therein.

The  accompanying  financial  statements  have  been  prepared  assuming  that  the  Company  will  continue  as  a  going  concern.  As
discussed in Note 1 to the financial statements, the Company has had recurring net losses and continues to experience negative cash flows
from operations. These conditions raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding
those matters also are described in Note 1. The financial statements do not include any adjustments that might result from the outcome of
this uncertainty.

/s/ Marcum LLP

Boston, MA

March 30, 2016

F-1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Shareholders of Xenetic Biosciences, Inc.

We  have  audited  the  accompanying  consolidated  balance  sheet  of  Xenetic  Biosciences,  Inc.  (the  “Company”)  as  of  December  31,
2014, and the related consolidated statements of comprehensive loss, changes in stockholders’ equity, and cash flows for the year ended
December 31, 2014. Our audit also includes the financial statement schedule. These financial statements and schedule are the responsibility
of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.

We conducted our audit in accordance with standards of the Public Company Accounting  Oversight  Board  (United  States).  Those
standards  require  that  we  plan  and  perform  the  audit  to  obtain  reasonable  assurance  about  whether  the  financial  statements  are  free  of
material  misstatement.  We  were  not  engaged  to  perform  an  audit  of  the  Company’s  internal  control  over  financial  reporting.  Our  audit
included  consideration  of  internal  control  over  financial  reporting  as  a  basis  for  designing  audit  procedures  that  are  appropriate  in  the
circumstances,  but  not  for  the  purpose  of  expressing  an  opinion  on  the  effectiveness  of  the  Company’s  internal  control  over  financial
reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts
and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and
evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of
Xenetic  Biosciences,  Inc.  at  December  31,  2014,  and  the  consolidated  results  of  its  operations  and  its  cash  flows  for  the  year  ended
December 31, 2014, in conformity with US generally accepted accounting principles. Also, in our opinion, the related financial statement
schedule,  when  considered  in  relation  to  the  basic  financial  statements  taken  as  a  whole,  presents  fairly,  in  all  material  respects,  the
information set forth therein.

The  accompanying  consolidated  financial  statements  have  been  prepared  assuming  that  the  Company  will  continue  as  a  going
concern. As disclosed in Note 1 to the Financial Statements, the Company’s recurring losses from operations and its requirement to raise
funds  to  continue  operations  beyond April  2015,  raise  substantial  doubt  about  its  ability  to  continue  as  a  going  concern.  Management’s
plans in regard to these matters are also described in Note 1. The 2014 consolidated financial statements do not include any adjustments to
reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may
result from the outcome of this uncertainty.

/s/ Ernst & Young LLP

Reading, United Kingdom

April 15, 2015

F-2

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XENETIC BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS

ASSETS
Current assets:

Cash
Restricted cash
Prepayment on acquisition
Prepaid expenses and other
Total current assets

Property and equipment, net
Goodwill
Indefinite-lived intangible assets
Other assets

Total assets

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:

Accounts payable
Accrued expenses
Hybrid debt instrument, net
Other current liabilities
Loans due to related parties
Total current liabilities

Deferred tax liability
Other liabilities

Total liabilities

Commitments and contingent liabilities (Note 14)

Stockholders' equity:

Common stock, $0.001 par value; 1,500,000,000 and 215,456,000 shares authorized as of

December 31, 2015 and December 31, 2014, respectively; 162,013,011 and 149,985,476
shares issued as of December 31, 2015 and December 31, 2014, respectively; 151,324,817
and 139,297,282 shares outstanding as of December 31, 2015 and December 31, 2014,
respectively

Additional paid in capital
Accumulated deficit
Accumulated other comprehensive income
Treasury stock

Total stockholders' equity

Total liabilities and stockholders' equity

December 31,
2015

December 31,
2014

  $

132,229    $
66,510   
3,744,517   
247,298   
4,190,554   

62,021   
3,283,379   
9,243,128   
129,306   

2,507,401 
66,000 
– 
204,012 
2,777,413 

119,449 
3,465,157 
9,754,857 
199,270 

  $

16,908,388    $

16,316,146 

  $

1,788,521    $
1,487,046   
3,652,749   
19,098   
395,000   
7,342,414   

2,918,518   
38,791   

852,760 
1,409,691 
– 
41,472 
395,000 
2,698,923 

3,080,097 
56,383 

10,299,723   

5,835,403 

–   

– 

162,013   
99,605,997   
(88,131,899)  
253,734   
(5,281,180)  
6,608,665   

149,986 
90,660,689 
(75,624,428)
575,676 
(5,281,180)
10,480,743 

  $

16,908,388    $

16,316,146 

The accompanying notes are an integral part of these consolidated financial statements.

F-3

 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
    
 
  
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
XENETIC BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

Operating costs and expenses:
Research and development
General and administrative

Loss from operations

Other income (expense):

Change in fair value of derivative liability
Loss on disposal of subsidiaries
Other expense
Interest income
Interest expense

Net loss

Other comprehensive loss from foreign currency translation adjustment

YEAR ENDED DECEMBER 31,

2015

2014

  $

(3,434,016)   $
(6,388,000)  
(9,822,016)  

(6,323,896)
(6,600,870)
(12,924,766)

(2,125,117)  
–   
(295,033)  
1,694   
(266,999)  
(2,685,455)  

– 
(1,069,675)
(326,916)
18,959 
(4,706)
(1,382,338)

(12,507,471)  

(14,307,104)

(321,942)  

(324,578)

Total comprehensive loss

  $

(12,829,413)   $

(14,631,682)

Net loss per share of common stock, basic and diluted

  $

(0.09)   $

(0.11)

Weighted-average shares of common stock outstanding, basic and diluted

140,397,488   

135,896,022 

The accompanying notes are an integral part of these consolidated financial statements.

F-4

 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
    
 
  
 
 
 
    
 
  
 
 
 
    
 
  
 
 
 
 
 
 
 
XENETIC BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization
Amortization of hybrid debt instrument discount
Non-cash interest expense
Share-based payments
Warrant expense for services
Change in fair value of derivative liability
Loss on issuance of hybrid debt instrument
Hybrid debt instrument issuance costs
Loss on disposal of subsidiaries
Fee paid on disposal of subsidiaries
Foreign currency translation
Other non-cash transactions

Changes in operating assets and liabilities:

Other receivables, prepayments and other assets
Accounts payable, accrued expenses and other liabilities

Net cash used in operating activities

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchases of property and equipment
Disposition of property and equipment
Cash acquired from acquisition
Cash transferred in connection with Hive Out Agreement

Net cash provided by (used in) investing activities

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of debt
Payments on debt
Proceeds from issuance of common stock
Proceeds from exercise of stock options
Payments on loan from related party
Net cash provided by financing activities

Effect of exchange rate change on cash

Net change in cash, excluding restricted cash
Cash at beginning of period

Cash at end of period

SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest

SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING

ACTIVITIES:

Interest paid in common stock
Non-cash issuance of common stock in connection with pending asset acquisition
Non-cash issuance of warrants in connection with debt
Non-cash recording of derivative liability in connection with debt
Equity consideration transferred in the acquisition
Repurchase and cancellation of common stock in disposal of subsidiaries

YEAR ENDED DECEMBER 31,

2015

2014

  $

(12,507,471)   $

(14,307,104)

56,115   
108,527   
153,791   
2,594,113   
933,195   
2,125,117   
59,612   
(30,933)  
–   
–   
369,947   
(127,875)  

88,689 
– 
– 
1,513,238 
239,889 
– 
– 
– 
1,069,675 
(430,000)
(353,952)
– 

21,227   
943,909   
(5,300,726)  

(24,468)
(479,015)
(12,683,048)

(1,663)  
7,882   
–   
–   
6,219   

3,100,000   
(100,000)  
–   
–   
–   
3,000,000   

(57,669)
5,487 
43,502 
(43,502)
(52,182)

– 
– 
10,000,000 
101,933 
(286,124)
9,815,809 

(80,665)  

587,336 

(2,375,172)  
2,507,401   

(2,332,085)
4,839,486 

  $

132,229    $

2,507,401 

  $

592    $

4,706 

  $
  $
  $
  $
  $
  $

75,935    $
3,744,517    $
1,626,344    $
1,419,105    $
–    $
–    $

– 
– 
– 
– 
3,750,000 
(3,750,000)

The accompanying notes are an integral part of these consolidated financial statements.

F-5

 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
    
 
  
 
 
    
 
  
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
XENETIC BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

Common Stock

Number of
Shares

Par Value
($0.001)

Additional
Paid in
Capital

Accumulated
Other

Comprehensive      

Accumulated
Deficit

Income 
(Loss)

Treasury
Stock

Total
Stockholders'
Equity

130,575,516    $

130,576    $

75,175,039    $

(58,306,999)   $

900,254    $

(5,281,180)   $

12,617,690 

1,984,080     
13,939,971     
–     

1,984     
13,940     
–     

99,949     
10,797,256     
239,889     

13,500,000     

13,500     

3,736,500     

–     
–     
–     

–     

(10,000,000)    

(10,000)    

(90,000)    

(3,010,325)    

–     
–     
–     

–     

–     

(14,091)    
–     
–     
–     

(14)    
–     
–     
–     

14     
702,042     
–     
–     

–     
–     
(14,307,104)    
–     

–     
–     
–     
(324,578)    

–     
–     
–     

101,933 
10,811,196 
239,889 

–     

3,750,000 

–     

(3,110,325)

–     
–     
–     
–     

– 
702,042 
(14,307,104)
(324,578)

149,985,476    $

149,986    $

90,660,689    $

(75,624,428)   $

575,676    $

(5,281,180)   $

10,480,743 

1,027,535     

1,027     

336,313     

11,000,000     
–     

11,000     
–     

3,733,517     
933,195     

–     

–     
–     

–     

–     
–     

–     

337,340 

–     
–     

3,744,517 
933,195 

–     

–     
–     
–     
–     

–     

1,609,575     

–     

–     

–     

1,609,575 

–     
–     
–     
–     

75,935     
2,256,773     
–     
–     

–     
–     
(12,507,471)    
–     

–     
–     
–     
(321,942)    

–     
–     
–     
–     

75,935 
2,256,773 
(12,507,471)
(321,942)

162,013,011    $

162,013    $

99,605,997    $

(88,131,899)   $

253,734    $

(5,281,180)   $

6,608,665 

Balance as of January 1,

2014

Exercise of stock options
Issuance of common stock
Issuance of warrants
Deemed issuance of shares in

reverse merger

Repurchase and cancellation

of shares in Hive Out
Agreement

Repurchase and cancellation
of shares in Acquisition

Share-based payments
Net loss
Foreign currency translation    

Balance as of December 31,

2014

Issuance of common stock
Issuance of common stock in
connection with pending
asset acquisition
Issuance of warrants
Issuance of warrants in

connection with debt (net
of issuance costs of
$16,769)

Settlement of accrued

interest in common stock

Share-based payments
Net loss

Foreign currency translation

Balance as of December 31,

2015

The accompanying notes are an integral part of these consolidated financial statements.

F-6

 
 
 
 
 
   
   
     
 
   
 
   
 
 
   
   
   
   
   
   
   
 
   
 
   
      
      
      
      
      
      
  
   
   
   
   
   
   
   
   
 
   
      
      
      
      
      
      
  
   
 
   
      
      
      
      
      
      
  
   
   
   
   
   
   
   
   
 
   
      
      
      
      
      
      
  
   
 
 
 
 
XENETIC BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1.

The Company

Background

Xenetic Biosciences, Inc. (the “Company”), incorporated in the state of Nevada and based in Lexington, Massachusetts, is a clinical
stage  biopharmaceutical  company  that  is  focused  on  the  discovery,  development  and  planned  commercialization  of  a  new  generation  of
human drug therapies for the treatment of a variety of conditions including anemia, refractory Acute Myeloid Leukemia, Cystic Fibrosis
and certain other cancers based upon its proprietary and patented drug delivery platform systems and drug development collaborations with
major third party pharmaceutical companies around the world.

The  Company’s  core  technologies  include  PolyXen™  a  platform  for  creating  next  generation  biologic  drugs  by  extending  the
efficacy,  safety  and  half-life  of  existing  biologic  drugs,  OncoHist™,  for  the  development  of  novel  oncology  drug  therapies  focused  on
orphan  indications  in  humans,  and  ImuXen™,  for  the  development  of  vaccines  that  can  simultaneously  deliver  multiple  active
pharmaceutical ingredients. The Company is also developing a broad pipeline of drug candidates for next generation biologics and novel
oncology therapeutics in a number of orphan disease indications.

Going Concern and Management’s Plan

While these consolidated financial statements have been prepared on a going concern basis, if the Company does not successfully
raise additional working capital, there can be no assurance that the Company will be able to continue its operations and these conditions
raise substantial doubt about its ability to continue as a going concern.  The accompanying consolidated financial statements do not include
any adjustments related to the recoverability or classification of asset-carrying amounts or the amounts and classification of liabilities that
may result should the Company be unable to continue as a going concern.

In March 2016, the Company engaged an investment banking firm to assist with a proposed sale of the Company’s securities. The
Company is optimistic that it will be successful in obtaining financing, however there can be no assurance that it will be able to do so or, if
it is able to, that is can do so under commercially reasonable terms. In the event the Company is unsuccessful in this proposed sale, the
Company  will  plan  to  rely  upon  proceeds  from  the  sale  of  up  to  $6.5  million  in  securities  to  OJSC  Pharmsynthez  (“Pharmsynthez”)  as
provided for in the AS Kevelt Asset Purchase Agreement.

AS Kevelt Asset Purchase Agreement

In  November  2015,  the  Company  entered  into  an Asset  Purchase Agreement  (the  “APA”)  with AS  Kevelt,  an  Estonian  company
(“Kevelt”),  and  Pharmsynthez,  parent  of  Kevelt  (together  referred  to  as  the  “Sellers”).  Pursuant  to  the APA,  Kevelt  will  transfer  to  the
Company certain intellectual property rights held by the Sellers with respect to the immunomodulatory product candidate Virexxa® held
by Kevelt and the Sellers will grant the Company the worldwide right to develop, market and license Virexxa® for certain uses, except for
excluded uses in Russia, the Commonwealth of Independent States and certain other countries. In consideration, the Company will issue to
Pharmsynthez  100.5  million  shares  of  its  common  stock.  The APA  also  provides  for  the  Company’s  issuance  of  10%  Senior  Secured
Convertible  Promissory  Notes  of  up  to  $3.5  million  to  Pharmsynthez  (the  “APA  Notes”)  and  certain  warrants  to  purchase  a  number  of
shares equal to the issuable shares of the Company’s stock upon conversion of the APA Notes. There is also a provision in the APA for the
contingent sale of up to $6.5 million of the Company’s common stock in the event of a qualifying capital raise. Also as part of the APA,
Dr. Dmitry Genkin and Kirill Surkhov, shareholders and founders of Pharmsynthez, will assign a U.S. provisional patent application to the
Company in exchange for 11 million shares of the Company’s common stock. The Company issued 11 million shares in November 2015 as
a prepayment toward completing the APA transaction, recording $3.74 million as the proportional fair value of the total consideration to be
recorded upon the completion of the APA transaction.

In connection with the APA, certain terms in the Securities Purchase Agreement (the “SPA”) with Pharmsynthez issued in July 2015
were  modified.  See  Note  8, Hybrid Debt Instrument, for further discussion of the SPA. As of December 31, 2015, the APA was not yet
consummated and is contingent upon the parties meeting their respective closing conditions as set forth in the APA. The APA transaction
is expected to be completed during 2016.

F-7

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2014 Business Combination

On January 23, 2014, the Company consummated a reverse merger (the “Acquisition”) pursuant to a written plan of reorganization,
in  which  the  Company  merged  with  Xenetic  Biosciences  (UK)  Limited  (formerly  Xenetic  Biosciences  plc)  (“Xenetic  UK”),  a  company
incorporated  in  England  and  Wales  under  the  Companies Act  of  1985,  such  that  Xenetic  UK  became  a  wholly  owned  subsidiary  of  the
Company. Upon completion of the Acquisition, the Company acquired all issued and outstanding shares of capital stock of Xenetic UK. As
a result, 132,545,504 shares of the Company’s common stock were newly issued and, immediately following the Acquisition, there were
136,045,504 shares of common stock issued and outstanding. At that time, because former Xenetic UK shareholders owned approximately
97%  of  the  combined  company  on  a  fully  diluted  basis  and  all  members  of  the  combined  company’s  executive  management  were  from
Xenetic  UK,  Xenetic  UK  was  deemed  to  be  the  acquiring  company  for  accounting  purposes  and  the  transaction  was  accounted  for  as  a
reverse acquisition in accordance with accounting principles generally accepted in the United States (“US GAAP”).

Prior to the Acquisition, the Company changed its name from General Sales and Leasing, Inc. to Xenetic Biosciences, Inc. As used in
these consolidated financial statements, unless otherwise indicated, all references herein to “Xenetic”, the “Company”, “we” or “us” refer
to Xenetic Biosciences, Inc. and its wholly owned subsidiaries.

2.

Summary of Significant Accounting Policies

Preparation of Financial Statements

These consolidated financial statements have been prepared on the assumption that the Company will be able to realize its assets and
discharge  its  liabilities  in  the  normal  course  of  business.  This  assumption  is  presently  in  question  and  contingent  upon  the  Company’s
ability  to  raise  additional  working  capital.  The  financial  statements  do  not  include  any  adjustments  relating  to  recoverability  and
classification  of  recorded  asset  amounts  or  the  amounts  and  classification  of  liabilities  that  might  be  necessary  should  the  Company  be
unable to continue as a going concern.

Certain prior period amounts have been reclassified to conform to the presentation for the current period.

Principles of Consolidation

The  financial  statements  of  the  Company  include  the  accounts  of  Xenetic  UK  and  its  wholly  owned  subsidiaries:  Lipoxen
Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated, and SymbioTec GmbH (“SymbioTec”). All material intercompany
balances and transactions have been eliminated on consolidation.

Use of Estimates

The consolidated financial statements and accompanying notes are prepared in accordance with U.S. generally accepted accounting
principles  (“U.S.  GAAP”).  The  preparation  of  the  financial  statements  in  accordance  with  US  GAAP  requires  management  to  make
estimates,  judgments  and  assumptions  that  affect  the  reported  amounts  of  assets  and  liabilities,  the  reported  amounts  of  revenue  and
expenses in the financial statements and disclosures in the accompanying notes. Actual results and outcomes may differ materially from
management’s estimates, judgments and assumptions.

Change in Accounting Principle

During the second quarter of 2015, the Company elected to apply pushdown accounting to the Company’s acquisition of SymbioTec
that occurred in 2012. Pushdown accounting refers to the use of the acquirer’s basis in the preparation of the acquiree’s separate financial
statements  as  the  new  basis  of  accounting  for  the  acquiree. Application  of  pushdown  accounting  is  treated  as  a  change  in  accounting
principle  and  was  applied  retrospectively  to  the  Company’s  consolidated  financial  statements.  This  change  resulted  in  no  impact  to  the
consolidated financial statements for the year ended December 31, 2015 or 2014.

Functional Currency Change

Effective April 1, 2015, the functional currency of the Company’s foreign subsidiaries changed from the British Pound Sterling to
the United States (“U.S.”) dollar. The changes in the economic facts and circumstances that caused the functional currency to change to
that of the parent company include: the closing of the Company’s last office outside of the U.S. during the first quarter of 2015, a shift of
financial dependence of the subsidiaries to the parent and the growth of the Company’s operations in U.S. dollar-denominated expenses.
The  Company  translated  assets  and  liabilities  of  these  foreign  subsidiaries  at  the  exchange  rate  in  effect  at  the  balance  sheet  date  and
included  accumulated  net  translation  adjustments  in  equity  as  a  component  of  accumulated  other  comprehensive  loss.  The  change  in
functional currency is applied on a prospective basis. Therefore, any gains and losses that were previously recorded in accumulated other
comprehensive loss remain unchanged through March 31, 2015. Foreign currency transaction gains and losses are the result of exchange
rate changes on transactions denominated in currencies other than the functional currency. The remeasurement of those foreign currency
transactions is included in determining net income or loss for the period of exchange.

F-8

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Foreign Currency Translation

The  Company’s  reporting  currency  is  U.S.  dollars.  During  the  years  ended  December  31,  2015  and  2014,  the  Company  had
operations in the U.S., United Kingdom (“U.K.”) and Germany. Assets and liabilities of foreign operations were translated to U.S. dollars
at the exchange rate in effect at the balance sheet date and revenue and expenses at the average exchange rate for the period. Gains and
losses from the translation of the consolidated financial statements of foreign subsidiaries into U.S. dollars were included in stockholders’
equity  as  a  component  of  other  comprehensive  income.  The  Company  did  not  record  tax  provisions  or  benefits  for  the  net  changes  in
foreign currency translation adjustments, as the Company intends to permanently reinvest undistributed earnings in its foreign subsidiaries.
Following the change in the functional currency of the Company’s foreign subsidiaries to the U.S. dollar on April 1, 2015, it is no longer
necessary  to  record  gains  and  losses  from  the  translation  of  the  consolidated  financial  statements  of  foreign  subsidiaries  from  a  foreign
functional currency into the reporting currency.

Realized  and  unrealized  gains  and  losses  resulting  from  foreign  currency  transactions  arising  from  exchange  rate  fluctuations  on
balances denominated in currencies other than the functional currencies, are recognized in “Other (expense) income” in the consolidated
statements of comprehensive loss. Monetary assets and liabilities that are denominated in a currency other than the functional currency are
re-measured to the functional currency using the exchange rate at the balance sheet date and gains or losses are recorded within the “Other
income (expense)” section of the consolidated statements of comprehensive loss.

Correction of Identified Errors

During the second quarter of 2015, the Company identified an error in the consolidated financial statements related to the accounting
for foreign currency matters. One of the Company’s subsidiary’s functional currency had been incorrectly designated as the Euro instead of
British Pound Sterling during the period January 1, 2013 through March 31, 2015. As a result, certain applicable financial results of this
entity  were  being  translated  to  the  reporting  currency  when  they  should  have  been  first  remeasured  into  the  functional  currency.  In
addition, the Company identified an error in the consolidated financial statements related to the pushdown accounting of that subsidiary.
The  new  basis  of  accounting  of  the  acquired  entity  formed  as  a  result  of  the  acquisition  was  not  first  remeasured  into  the  functional
currency before being translated to the reporting currency.

The correction of the errors identified above resulted in the recognition of foreign currency net gains and foreign currency translation
net losses. We concluded that these adjustments were not material to the Company’s financial position or results of operations for any of
the prior periods presented. Therefore, we recognized the cumulative impact during the three months ended June 30, 2015, which resulted
in a net gain in other income (expenses) in the consolidated statement of comprehensive loss of $0.24 million for the year ended December
31,  2015  and  a  cumulative  impact  in  accumulated  other  comprehensive  income  in  the  consolidated  balance  sheet  of  $0.31  million  as  of
June 30, 2015.

Fair Value of Financial Instruments

ASC Topic 820 Fair Value Measurement defines fair value as the price that would be received to sell an asset or be paid to transfer a
liability  in  an  orderly  transaction  between  market  participants  at  the  measurement  date.  The  Company  applies  the  following  fair  value
hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon
the lowest level of input that is available and significant to the fair value measurement. Level 1 inputs are quoted prices in active markets
for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 utilizes quoted market
prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency.
Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the
measurement date. See Note 9, Fair Value Measurements, for discussion of the Company’s fair value measurements.

Cash, Cash Equivalents and Investments

The  Company  considers  all  highly  liquid  investments  with  maturities  of  90  days  or  less  from  the  date  of  purchase  to  be  cash
equivalents. Investments with original maturities of greater than 90 days from the date of purchase but less than one year from the balance
sheet date are classified as short-term investments, while investments with maturities of one year or beyond from the balance sheet date are
classified as long-term investments. Management determines the appropriate classification of its cash equivalents and investment securities
at the time of purchase and re-evaluates such determination as of each balance sheet date.

F-9

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Restricted Cash

As  of  December  31,  2015  and  2014,  restricted  cash  represents  a  certificate  of  deposit  that  matures  annually,  and  secures  the
Company’s outstanding letter of credit of $66,000 for the operating lease for office and laboratory space in Lexington, Massachusetts. The
letter of credit is required to be maintained through the term of the lease, which expires in January 2019.

Concentration of Credit Risk

Financial  instruments  that  subject  the  Company  to  concentrations  of  credit  risk  include  cash  and  cash  equivalents.  The  Company
maintains cash and cash equivalents with various major financial institutions. The Company performs periodic evaluations of the relative
credit standing of these financial institutions and limits the amount of credit exposure with any one institution.

Property and Equipment

The  Company  records  property  and  equipment  at  cost  less  accumulated  depreciation.  Expenditures  for  major  renewals  and
improvements  which  extend  the  life  or  usefulness  of  the  asset  are  capitalized.  Items  of  an  ordinary  repair  or  maintenance  nature  are
charged directly to operating expense as incurred. The Company calculates depreciation using the straight-line method over the estimated
useful lives of the assets:

Asset Classification
Laboratory equipment
Office and computer equipment
Leasehold improvements
Furniture and fixtures

Estimated Useful Life

  3 years
  3 years
  5 years or the remaining term of the lease, if shorter
  5 years

The Company eliminates the cost of assets retired or otherwise disposed of, along with the corresponding accumulated depreciation,

from the related accounts, and the resulting gain or loss is reflected in the results of operations.

Indefinite-Lived Intangible Assets

Acquired  indefinite-lived  intangible  assets  consist  of  In-Process  Research  and  Development  (“IPR&D”)  related  to  the  Company’s
business combination with SymbioTec, which was recorded at fair value on the acquisition date. IPR&D intangible assets are considered
indefinite-lived  intangible  assets  until  completion  or  abandonment  of  the  associated  research  and  development  efforts.  Substantial
additional research and development may be required before the Company’s IPR&D reaches technological feasibility. Upon completion of
the IPR&D project, the IPR&D assets will be amortized over their estimated useful lives.

In  accordance  with ASC  Topic  350,  Intangibles  -  Goodwill  and  Other  (“ASC  350”),  the  Company  assesses  intangible  assets  with
indefinite  lives  for  impairment  at  least  annually  as  of  October  1,  or  when  events  or  changes  in  the  business  environment  indicate  the
carrying value may not be fully recoverable. The Company also has the option to first assess qualitative factors to determine whether the
existence of events or circumstances leads to the determination that it is more likely than not (that is, a likelihood of more than 50%) that
the acquired IPR&D is impaired. If the Company chooses to first assess the qualitative factors and it is determined that it is not more likely
than not acquired IPR&D is impaired, the Company is not required to take further action to test for impairment. The Company also has the
option to bypass the qualitative assessment and perform only the quantitative impairment test, which the Company may choose to perform
in some periods but not in others.

No impairment was recorded during the years ended December 31, 2015 and 2014.

F-10

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Goodwill

Goodwill is comprised of the purchase price of business combinations in excess of the fair value assigned at acquisition to the net
tangible  and  identifiable  intangible  assets  acquired.  Goodwill  is  not  amortized,  but  in  accordance  with ASC  350,  the  Company  assesses
goodwill for impairment at least annually, or when events or changes in the business environment indicate the carrying value may not be
fully  recoverable.  The  Company  also  has  the  option  to  first  assess  qualitative  factors  to  determine  whether  the  existence  of  events  or
circumstances leads to the determination that it is more likely than not (that is, a likelihood of more than 50%) that goodwill is impaired. If
the  Company  chooses  to  first  assess  qualitative  factors  and  it  is  determined  that  it  is  not  more  likely  than  not  goodwill  is  impaired,  the
Company  is  not  required  to  take  further  action  to  test  for  impairment.  The  Company  also  has  the  option  to  bypass  the  qualitative
assessment and perform only the quantitative impairment test, which the Company may choose to do in some periods but not in others. The
Company performs its annual impairment review as of October 1.

No impairment was recorded during the years ended December 31, 2015 and 2014.

Impairment of Long-Lived Assets

In  accordance  with ASC  Topic  360  Property,  Plant  and  Equipment ,  the  Company  reviews  long-lived  assets  to  be  held  and  used,
including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of the
assets or asset group may not be fully recoverable. No such impairments were recorded during the years ended December 31, 2015 and
2014.

Evaluation  of  recoverability  is  based  on  an  estimate  of  undiscounted  future  cash  flows  resulting  from  the  use  of  the  asset  or  asset
group and its eventual disposition. Impairment, if any, is calculated as the amount by which an asset’s carrying value exceeds its fair value,
typically using discounted cash flows to determine fair value.

Embedded Derivatives Related to Debt Instruments

Embedded derivatives that are required to be bifurcated from their host contract are evaluated and valued separately from the host
contract (i.e., the debt instrument). Features of the Company’s debt instrument that meet the definition of a derivative and the criteria for
separate accounting include the conversion feature and certain put options. Embedded derivatives are valued individually and recorded as a
compound  derivative.  The  compound  derivative  is  presented  together  with  the  host  debt  instrument  and  the  related  debt  discount  on  a
combined  basis.  Changes  in  the  estimated  fair  value  of  the  bifurcated  embedded  derivatives  are  reported  as  gains  and  losses  in  the
consolidated statement of comprehensive loss each reporting period.

Revenue Recognition

The Company enters into supply, license and collaboration arrangements with pharmaceutical and biotechnology partners, some of
which include royalty agreements based on potential net sales of approved commercial pharmaceutical products. The Company recognizes
revenue in accordance with the authoritative guidance, ASC Topic 605,  Revenue Recognition. The Company recognizes revenue when all
of the following criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services
have been rendered, (iii) the seller’s price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured.

The terms of the Company’s license agreements include delivery of an Intellectual Property (“IP”) license to a collaboration partner.
The Company may be compensated under license arrangements through a combination of non-refundable upfront payments, development
and  regulatory  objective  payments  and  royalty  payments  on  future  product  sales  by  partners.  Non-refundable  upfront  payments  and
development  and  regulatory  objective  payments  received  by  the  Company  in  license  and  collaboration  arrangements  that  include  future
obligations,  such  as  supply  obligations,  are  recognized  ratably  over  the  Company’s  expected  performance  period  under  each  respective
arrangement. The Company makes its best estimate of the period over which the Company expects to fulfil the Company’s performance
obligations,  which  may  include  technology  transfer  assistance,  research  activities,  clinical  development  activities,  and  manufacturing
activities  from  development  through  the  commercialization  of  the  product.  Given  the  uncertainties  of  these  collaboration  arrangements,
significant  judgment  is  required  to  determine  the  duration  of  the  performance  period.  Non-refundable  upfront  license  fees  received,
whereby continued performance or future obligations are considered inconsequential or perfunctory to the relevant licensed technology, are
recognized as revenue upon delivery of the technology.

F-11

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Company expects to recognize royalty revenue in the period of sale, based on the underlying contract terms, provided that the
reported sales are reliably measurable and the Company has no remaining performance obligations, assuming all other revenue recognition
criteria are met.

Reimbursements  for  research  and  development  services  completed  by  the  Company  related  to  the  collaboration  agreements  are

recognized in operations as revenue on a gross basis.

The Company’s license and collaboration agreements with certain collaboration partners could also provide for future payments to
the Company based solely upon the performance of the respective collaboration partner in consideration of deadline extensions or upon the
achievement of specified sales volumes of approved drugs. For such payments, the Company expects to recognize the payments as revenue
when earned under the applicable contract terms on a performance basis or ratably over the term of the agreement. These payments may
also  be  recognized  as  revenue  when  continued  performance  or  future  obligations  by  the  Company  are  considered  inconsequential  or
perfunctory.

Research and Development Expenses

Research  and  development  expenses  consist  of  expenses  incurred  in  performing  research  and  development  activities,  including
compensation and benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing expenses, fees paid to
clinical research organizations and clinical manufacturing organizations and other outside expenses. The Company expenses research and
development costs as incurred. The Company expenses upfront, non-refundable payments made for research and development services as
obligations  are  incurred.  The  value  ascribed  to  intangible  assets  acquired  but  which  have  not  met  capitalization  criteria  is  expensed  as
research and development at the time of acquisition.

Share-based Payments

Stock options

The  Company  grants  share-based  payments  in  the  form  of  options  to  employees  and  non-employees,  Joint  Share  Ownership  Plan
(“JSOP”) awards to employees, as well as agreements to issue common stock in exchange for services provided by non-employees. The
Company measures share-based payments to employees in accordance with ASC Topic 718,  Compensation – Stock Compensation and to
non-employees in accordance with ASC Topic 505, Equity.

Stock  option  compensation  expenses  are  based  on  the  fair  value  of  the  option  calculated  using  the  Black-Scholes  option  pricing
model. Determining the appropriate fair value model and related assumptions requires judgment, including estimating share price volatility
and  expected  terms  of  the  awards.  The  expected  volatility  rates  are  estimated  based  on  the  actual  volatility  of  the  Company  and  of
comparable public companies over the expected term. The expected terms represent the time that options are expected to be outstanding.
The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual forfeitures differ from
those  estimates.  The  Company  has  not  paid  dividends  and  does  not  anticipate  paying  cash  dividends  in  the  foreseeable  future  and,
accordingly,  uses  an  expected  dividend  yield  of  zero.  The  risk-free  interest  rate  is  based  on  the  rate  of  US  Treasury  securities  with
maturities consistent with the estimated expected term of the awards. Upon exercise, stock options are redeemed for newly issued shares of
common stock.

For employee options that vest based solely on service conditions, the fair value measurement date is generally on the date of grant
and the related compensation expense, less expense for expected forfeitures, is recognized on a straight-line basis over the requisite vesting
period of the awards.

For non-employee options, the fair value measurement date is the earlier of the date the performance of services is complete or the
date the performance commitment has been reached. The Company generally determines that the fair value of the stock options is more
reliably measurable than the fair value of the services received. Compensation expense related to stock options granted to non-employees
that vest based solely on service conditions is subject to re-measurement at each reporting period until the options vest and is recognized on
a straight-line basis over the requisite vesting period of the awards.

Common stock awards

The Company grants common stock awards to non-employees in exchange for services provided. The Company generally measures
the fair value of these awards using the fair value of the services provided as it is a more reliable measure of the fair value of the awards.
The  fair  value  measurement  date  of  these  awards  is  generally  the  date  the  performance  of  services  is  complete.  The  fair  value  of  the
awards is recognized on a straight-line basis as services are rendered. The share-based payments related to common stock awards for the
settlement of services provided by non-employees is recorded on the consolidated statement of comprehensive loss in the same manner and
charged to the same account as if such settlements had been made in cash.

F-12

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Joint Share Ownership Plan awards

The Company measures the fair value of JSOP awards using Monte Carlo simulations based on the terms of the plan, which includes
vesting  conditions  based  on  the  achievement  of  certain  market  conditions  in  the  form  of  share  price  hurdles.  Determination  of  the
appropriate fair value model and related assumptions requires judgment, including estimating share price volatility and the expected term of
the awards. Accordingly, the Company recognizes compensation expense related to its JSOP awards using a graded vesting model.

Warrants

In connection with certain financing, consulting and collaboration arrangements, the Company issues warrants to purchase shares of
its common stock. The outstanding warrants are standalone instruments that are not puttable or mandatorily redeemable by the holder and
are classified as equity awards. The Company measures the fair value of the awards using the Black-Scholes option pricing model as of the
measurement date. Warrants issued to collaboration partners in conjunction with the issuance of common stock are initally recorded at fair
value as a reduction in additional paid-in capital of the common stock issued.

All other warrants are recorded at fair value as expense over the requisite service period or at the date of issuance, if there is not a

service period. Warrants granted in connection with ongoing arrangements are more fully described in Note 11, Stockholders’ Equity.

Income Taxes

The Company accounts for income taxes using the liability method in accordance with ASC Topic 740,  Income Taxes.  Under  this
method, deferred tax assets and liabilities are determined based on temporary differences resulting from the different treatment of items for
tax and financial reporting purposes. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable
income in the years in which those temporary differences are expected to reverse. Additionally, the Company must assess the likelihood
that  deferred  tax  assets  will  be  recovered  as  deductions  from  future  taxable  income.  The  Company  evaluates  the  recoverability  of  its
deferred tax assets on a quarterly basis.

Basic and Diluted Net Loss per Share

The Company computes basic net loss per share by dividing net loss attributable to common stockholders by the weighted-average
number  of  shares  of  common  stock  outstanding  during  the  period.  The  Company  computes  diluted  net  loss  per  share  after  giving
consideration to the dilutive effect of stock options that are outstanding during the period, except where such non-participating securities
would  be  anti-dilutive.  The  Company’s  JSOP  awards,  prior  to  exercise,  are  considered  treasury  shares  by  the  Company  and  thus  do  not
impact the Company’s net loss per share calculation. As of December 31, 2015 and 2014, there were 10,688,194 JSOP awards issued.

Basic and diluted net loss per share are the same for the years ended December 31, 2015 and 2014 as the Company was in a net loss
position. Potentially dilutive non-participating securities have not been included in the calculations of diluted net loss per share, as their
inclusion would be anti-dilutive. As of December 31, 2015 and 2014, approximately 12.03 million and 11.87 million potentially dilutive
securities were deemed anti-dilutive.

Segment Information

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for
evaluation by the chief operating decision maker, who is the Company’s Chief Executive Officer, in making decisions on how to allocate
resources and assess performance. The Company views its operations and manages its business in one operating segment.

F-13

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Operating Leases

The Company leases an administrative and laboratory facility under an operating lease. Lease agreements may include rent holidays,
rent escalation clauses and tenant improvement allowances. The Company recognizes scheduled rent increases on a straight-line basis over
the lease term beginning with the date the Company takes possession of the leased space.

Acquisitions

The  Company  has  a  history  of  engaging  in  acquisition  transactions  that  require  the  Company  to  evaluate  whether  the  transaction
meets the criteria of a business combination and, in some cases, whether it meets the definition of a reverse merger. For those acquisitions
that meet the criteria for a reverse merger, the Company evaluates the entities involved to distinguish the appropriate accounting acquirer
and acquiree according to ASC 805. If the transaction does not meet the business combination requirements, the transaction is accounted
for  as  an  asset  acquisition  or  recapitalization  and  no  goodwill  is  recognized.  If  the  acquisition  meets  the  definition  of  a  business
combination, the Company allocates the purchase price, including any contingent consideration, to the  assets  acquired  and  the  liabilities
assumed at their estimated fair values as of the date of the acquisition with any excess of the purchase price paid over the estimated fair
value of net assets acquired recorded as goodwill. The fair value of the assets acquired and liabilities assumed is typically determined by
using either estimates of replacement costs or discounted cash flow valuation methods.

When determining the fair value of tangible assets acquired, the Company estimates the cost to replace the asset with a new asset,
taking  into  consideration  such  factors  as  age,  condition  and  the  economic  useful  life  of  the  asset.  When  determining  the  fair  value  of
intangible assets acquired, the Company uses judgment to estimate the applicable discount rate, growth rates and the timing and amount of
future cash flows. The fair value of assets acquired and liabilities assumed is typically determined using the assistance of an independent
third party specialist.

Business combination related costs are expensed in the period in which the costs are incurred and the services are received. Asset

acquisition related costs are generally capitalized as a component of cost of the assets acquired.

Recent Accounting Pronouncements

In March 2016, Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-06, Derivatives
and Hedging (Topic 815)  (“ASU 2016-06”). ASU 2016-06 clarifies the requirements for assessing whether contingent call or put options
that  can  accelerate  the  payment  of  principal  on  debt  instruments  are  clearly  and  closely  related  to  their  debt  hosts.  This  guidance  is
effective  for  annual  reporting  periods  beginning  after  December  15,  2016,  including  interim  periods  within  those  annual  periods.  Early
application is permitted. The Company is currently evaluating the impact of this new standard.

In February 2016, FASB issued ASU 2016-02,  Leases (Topic 842) (“ASU 2016-02”). ASU 2016-02 will require lessees to recognize
a lease liability and a right-of-use asset for all leases, with the exception of short-term leases, at the commencement date. This guidance is
effective  for  annual  reporting  periods  beginning  after  December  15,  2018,  including  interim  periods  within  those  annual  periods.  Early
application is permitted. The Company is currently evaluating the impact of this new standard.

F-14

 
 
 
 
 
 
 
 
 
 
 
 
 
In  November  2015,  FASB  issued  ASU  2015-17,  Income  Taxes  (Topic  740)  (“ASU  2015-17”).  ASU  2015-17  simplifies  the
presentation  of  deferred  income  taxes  by  requiring  that  deferred  tax  assets  and  liabilities  be  classified  as  non-current  in  a  classified
statement  of  financial  position.  This  guidance  is  effective  for  annual  reporting  periods  beginning  after  December  15,  2016,  including
interim periods within those annual periods, with early adoption permitted. The Company early adopted ASU 2015-17 for the year ended
December 31, 2015 on a prospective basis, as permitted.

In April 2015, FASB issued ASU 2015-03,  Interest – Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt
Issuance Costs (“ASU 2015-03”). ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the
balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. This guidance is effective
for  annual  reporting  periods  beginning  after  December  15,  2015,  and  interim  periods  within  fiscal  years  beginning  after  December  15,
2016, with early adoption permitted. The Company early adopted ASU 2015-03 in July 2015, as permitted. There was no impact of early
adoption of ASU 2015-03 on the Company’s consolidated financial statements previously reported.

In August 2014, the FASB issued ASU 2014-15,  Presentation of Financial Statements – Going Concern (Subtopic 205-40) (“ASU
2014-15”). ASU 2014-15 defines management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability
to continue as a going concern and provides guidance on the related footnote disclosures. This guidance is effective for annual reporting
periods  beginning  after  December  15,  2016,  and  interim  periods  within  annual  periods  beginning  after  December  15,  2016.  Early
application is permitted. The Company is currently evaluating the impact of this new standard.

In May 2014, the FASB issued ASU 2014-09,  Revenue from Contracts with Customers (Topic 606)  (“ASU 2014-09”). ASU 2014-09
supersedes  the  revenue  recognition  requirements  in Accounting  Standards  Codification  (“ASC”)  Topic  605,  Revenue  Recognition,  and
most  industry-specific  guidance.  The  core  principle  of  the  guidance  is  that  an  entity  should  recognize  revenue  to  depict  the  transfer  of
promised  goods  or  services  to  customers  in  an  amount  that  reflects  the  consideration  to  which  the  entity  expects  to  be  entitled  to  in
exchange  for  those  goods  or  services.  In August  2015,  the  FASB  issued ASU  2015-15,  Revenue  from  Contracts  with  Customers  (Topic
606): Deferral of the Effective Date, which defers the effective date of ASU 2014-09 for all entities by one year. This guidance is currently
effective  for  annual  reporting  periods  beginning  after  December  15,  2017,  including  interim  periods  within  that  reporting  period,  under
either full or modified retrospective approach. Early application is permitted as of annual reporting periods beginning after December 15,
2016. The Company is currently evaluating the impact of this new standard on its revenue recognition policy.

The  Company  has  considered  other  recent  accounting  pronouncements  and  concluded  that  they  are  either  not  applicable  to  the

business, or that no material effect is expected on the consolidated financial statements as a result of future adoption.

3.

Acquisitions

2014 Business Combination

On January 23, 2014, the Company completed the Acquisition transaction with Xenetic UK which resulted in the Company acquiring
all  of  the  issued  and  outstanding  common  stock  of  Xenetic  UK.  The Acquisition  was  accounted  for  as  a  reverse  acquisition  under  the
acquisition  method  of  accounting  per ASC  805,  with  Xenetic  UK  treated  as  the  accounting  acquirer  and  the  Company  treated  as  the
“acquired”  company  for  financial  reporting  purposes.  This  was  determined  based  on  the  following  facts:  (i)  after  the  reverse  merger,
former  shareholders  of  Xenetic  UK  held  a  majority  of  the  voting  interest  of  the  combined  company;  (ii)  former  Board  of  Directors  of
Xenetic UK possess majority control of the Board of Directors of the combined company; and (iii) members of the management of Xenetic
UK  are  responsible  for  the  management  of  the  combined  company. As  such,  the  financial  statements  of  Xenetic  UK  are  treated  as  the
historical financial statements of the combined company.

The fair value of the consideration transferred in the reverse merger was $3.75 million. This was calculated as the number of shares
of common stock that Xenetic UK would have had to issue in order for the Company’s shareholders to hold the same equity interest in the
combined  entity  immediately  following  the  acquisition  (approximately  9.2%),  multiplied  by  the  estimated  fair  value  of  the  Company’s
common stock on the acquisition date (£0.06 per share). The estimated fair value of the Company’s common stock was based on the price
of  the  Company’s  stock  on  the  acquisition  date,  which  was  actively  traded  on  the Alternative  Investments  Market  of  the  London  Stock
Exchange  in  the  United  Kingdom.  In  addition,  Xenetic  UK  incurred  approximately  $3  million  of  transaction  costs  related  to  the  reverse
merger.  The  Company  recognized  approximately  $0.5  million  of  transaction  costs  related  to  the  reverse  merger  in  general  and
administrative  expenses  on  the  consolidated  statement  of  comprehensive  loss  during  the  year  ended  December  31,  2014.  No  transaction
costs related to the reverse merger were recognized during the year ended December 31, 2015.

F-15

 
 
 
 
 
 
 
 
 
 
 
 
 
As of December 31, 2014, the Company finalized the purchase accounting for the Acquisition. Management determined the purchase
price  allocations  based  on  estimates  of  the  fair  values  of  all  assets  acquired  and  liabilities  assumed.  The  Company  believe  that  such
information  provides  a  reasonable  basis  for  estimating  the  fair  values  of  assets  acquired  and  liabilities  assumed.  The  fair  values  of  the
acquired assets and liabilities assumed are as follows:

Cash
Accounts receivable
Prepaid expenses
Property, plant and equipment
Accounts payable
Accrued expenses
Long-term debt

Total identifiable net assets

Goodwill
Total

  $

  $

43,502 
145 
8,643 
331,500 
(354,079)
(36,146)
(372,813)
(379,248)
4,129,248 
3,750,000 

Following the Acquisition, an Agreement of Conveyance, Transfer and Assignment of Subsidiaries and Assumption of Obligations
(the  “Hive  Out Agreement”)  was  executed,  whereupon  10,000,000  outstanding  shares  of  common  stock  held  by  Oxbridge  Technology
Partners  SA  (“Oxbridge”)  were  returned  to  the  Company  and  recorded  as  treasury  shares  and  were  subsequently  canceled.  In  exchange,
Oxbridge  acquired  all  issued  and  outstanding  shares  of  both  of  the  Company’s  former  operating  subsidiaries,  Shift  It  Media  Co.  and
General  Aircraft,  Inc.  (the  “Disposed  Subsidiaries”),  including  all  assets  and  liabilities  connected  with  the  businesses  transferred.  In
addition, the Company disposed of the associated goodwill. The Hive Out Agreement also required a payment to Oxbridge of $430,000,
which was paid by the Company shortly after the Acquisition.

The  Company  recorded  this  divestiture  as  a  separate  transaction  from  the Acquisition  that  results  in  the  disposal  of  two  of  the
Company’s subsidiaries. The Disposed Subsidiaries did not record any operations in the combined entity following the Acquisition before
they  were  disposed  and  these  financial  statements  do  not  reflect  the  historical  financial  statements  of  the  Disposed  Subsidiaries  as  they
were previously owned by the accounting acquiree. Accordingly, there are no balances to be recorded as discontinued operations on the
statement of comprehensive loss. As a result of the divestiture of the Disposed Subsidiaries, the Company recorded a loss on disposal of
subsidiaries of $1,069,675 during the year ended December 31, 2014.

Due  to  the  nature  of  the Acquisition  and  related  Hive  Out Agreement,  the  transaction  did  not  result  in  any  adjustments  with  a

continuing impact on the Company’s results of operations.

2015 Asset Purchase Agreement

In November 2015, the Company entered into the APA with Kevelt and Pharmsynthez, parent of Kevelt. Pursuant to the APA, the
Sellers will transfer to the Company certain intellectual property rights held by the Sellers with respect to the immunomodulatory product
candidate Virexxa® held by Kevelt and the Sellers will grant the Company the worldwide right to develop, market and license Virexxa®
for certain uses except for excluded uses in Russia, the Commonwealth of Independent States and certain other countries. In consideration,
the  Company  will  issue  to  Pharmsynthez  100.5  million  shares  of  the  Company’s  common  stock. Also  as  part  of  the APA,  Dr.  Dmitry
Genkin and Kirill Surkhov, shareholders and founders of Pharmsynthez, will assign a U.S. provisional patent application to the Company in
exchange for 11 million shares of the Company’s common stock.

During December 2015, the 11 million shares were issued to Dr. Genkin and Mr. Surkhov under the terms of the APA. However, as
of December 31, 2015, the APA transaction was not yet consummated and is contingent upon the parties meeting their respective closing
conditions  as  set  forth  in  the APA. As  a  result,  the  Company  recorded  approximately  $3.74  million,  the  fair  value  of  the  proportional
consideration provided, as a prepayment within current assets on the consolidated balance sheet as of December 31, 2015.

The APA also provides for the Company’s issuance of 10% Senior Secured Convertible Promissory Notes of up to $3.5 million to
Pharmsynthez and certain warrants to purchase shares of the Company’s common stock. In connection with the APA, certain terms in the
SPA with Pharmsynthez issued in July 2015 were modified. See Note 8,  Hybrid Debt Instrument, for discussion of the SPA and Note 11,
Stockholders’ Equity, for discussion of the warrants.

There is also a provision in the APA for the contingent sale of up to $6.5 million of the Company’s common stock in the event of a

qualifying capital raise.

The APA transaction is expected to be completed during 2016.

F-16

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.

Significant Strategic Drug Development Collaborations - Related Parties

Baxalta Incorporated

In August 2005, the Company entered into an exclusive research, development, license and supply agreement with Baxter Healthcare
SA (“Baxter SA”) and Baxter Healthcare Corporation (together referred to as “Baxter”) to develop products with an extended half-life of
certain proteins and molecules using the Company’s patent protected PolyXen™ technology whereby polysialic acid (“PSA” – a chain of
polysialic  acids)  is  conjugated  with  Baxter’s  proprietary  molecule(s)  to  create  a  new  generation  of  drugs  to  treat  the  failure  of  blood  to
coagulate  in  the  therapeutic  treatment  of  blood  and  bleeding  disorders,  such  as  hemophilia.  The  lead  candidate  in  this  collaboration  is  a
longer-acting  form  of  a  recombinant  Factor  VIII  (“rFVIII”)  protein.  During  June  2015,  in  connection  with  the  separation  of  its
biopharmaceuticals business to form Baxalta Incorporated (“Baxalta”), Baxter assigned all of its rights and obligations under its existing
agreement with the Company to Baxalta.

This agreement has been amended several times since 2005, most recently in January 2014. The January 2014 amendment provides
for  increased  future  development,  regulatory,  sales  and  deadline  extension  receipts,  restructured  target  deadlines  and  royalty  receipts  on
potential  net  sales.  The  Company  is  entitled  to  up  to  $100  million  in  potential  development,  regulatory,  sales  and  deadline  extension
receipts, which are contingent on the performance of Baxalta achieving certain milestones. The Company is also entitled to royalties on
potential net sales varying by country of sale. The Company’s right to receive these royalties in any particular country will expire upon the
later of ten years after the first commercial sale of the product in that country or the expiration of patent rights in that particular country. In
connection with this amendment, Baxter SA also made a $10 million equity investment in the Company in exchange for 10,695,187 shares
of the Company’s common stock during January 2014.

Through December 31, 2015, the Company and Baxalta continued to engage in research and development activities with no resultant
commercial products. The Company did not recognize revenue in connection with this collaboration during the years ended December 31,
2015 and 2014.

Baxalta is a related party of the Company, with a share ownership of approximately 8.0% and 8.7% of the total issued common stock

of the Company as of December 31, 2015 and 2014, respectively.

SynBio LLC

In August,  2011,  SynBio  LLC  (“SynBio”)  and  the  Company  entered  into  a  stock  subscription  and  collaborative  development  of
pharmaceutical products agreement (the “Co-Development Agreement”). The Company granted an exclusive license to SynBio to develop
pharmaceutical products using certain molecule(s) based on SynBio’s technology and the Company’s proprietary technology (PolyXen™,
OncoHist™ and ImuXen™) that prolongs the active life and/or improves the pharmacokinetics of certain therapeutic proteins and peptides
(as  well  as  conventional  drugs).  In  return,  SynBio  granted  an  exclusive  license  to  the  Company  to  use  the  pre-clinical  and  clinical  data
generated by SynBio in certain agreed products and engage in the development of commercial candidates.

SynBio and the Company are each responsible for funding their own research activities. There are no milestone or other research-
related  payments  due  under  the  agreement  other  than  fees  for  the  supply  of  each  company’s  respective  research  supplies  based  on  their
technology, which, when provided, are due to mutual convenience and not representative of an ongoing or recurring obligation to supply
research supplies. Most recently, similar to the Company’s agreement with Baxalta, Serum Institute of India Limited (“Serum Institute”)
has  agreed  to  directly  provide  the  research  supplies  to  SynBio,  where  the  Company  is  not  liable  for  any  failure  to  supply  the  research
supplies as a result of any act or fault of Serum Institute’s. Upon successful commercialization of any resultant products, the Company is
entitled to receive royalties on sales in certain territories and pay royalties to SynBio for sales outside those certain territories.

F-17

 
 
 
 
 
 
 
 
 
 
 
 
 
Through December 31, 2015, the Company and SynBio continued to engage in research and development activities with no resultant
commercial products. The Company did not recognize revenue in connection with the Co-Development Agreement during the years ended
December 31, 2015 and 2014.

SynBio is an affiliate of the Company, with a share ownership of approximately 39.0% and 41.6% of the total issued common stock
of  the  Company  as  of  December  31,  2015  and  2014,  respectively.  On  December  31,  2014,  the  Company  granted  SynBio  a  warrant  to
purchase  6,745,000  shares  of  common  stock  in  connection  with  ongoing  collaborative  activities.  See  Note  9, Stockholders’  Equity,  for
further information on the warrant.

Serum Institute of India Limited

In the period from 2004 through 2011, the Company entered into and amended certain license and supply agreements with Serum
Institute. The original license agreement with Serum Institute was a collaborative Development and Manufacturing Arrangement (“DMA”)
to  develop  agreed  upon  potential  commercial  product  candidates  using  the  Company’s  PolyXen ™  technology.  Serum  Institute  then
endeavored  to  further  develop  the  potential  commercial  product  candidates  and  eventually  initiate  pre-clinical  and  clinical  trials  at  their
own  cost.  The  agreement  was  amended  in  2011,  resulting  in  the  surrender  of  development  rights  for  14  potential  commercial  product
candidates in 2012, which were vested to Serum Institute under the terms of the previous agreements, back to the Company.

Following  the  2011  amendment,  Serum  Institute  retained  an  exclusive  license  to  use  the  Company’s  PolyXen™  technology  to
research and develop one potential commercial product, Polysialylated Erythropoietin (“PSA-EPO”). Serum Institute will be responsible
for  conducting  all  pre-clinical  and  clinical  trials  required  to  achieve  regulatory  approvals  within  the  certain  predetermined  territories  at
Serum Institute’s own expense. The royalty payment schedule based on net revenues on the future commercial sales of PSA-EPO under the
DMA was also modified as a result of the 2011 amendment. Royalty payments are payable by Serum Institute to the Company for net sales
to certain customers in the Serum Institute sales territory. Royalty payments are payable by the Company to Serum Institute for net sales
received by the Company over the term of the license. There are no milestone or other research-related payments due under the DMA.

Through December 31, 2015, the Company and Serum Institute continued to engage in research and development activities with no
resultant commercial products. No royalty revenue or expense was recognized by the Company related to the Serum Institute arrangement
during the years ended December 31, 2015 and 2014.

Serum  Institute  is  a  related  party  of  the  Company,  with  a  share  ownership  of  approximately  8.5%  and  9.2%  of  the  total  issued
common  stock  of  the  Company  as  of  December  31,  2015  and  2014,  respectively.  On  December  31,  2014,  the  Company  granted  Serum
Institute  a  warrant  to  purchase  3,200,000  shares  of  common  stock  in  connection  with  ongoing  collaborative  activities.  See  Note  9,
Stockholders’ Equity, for further information on the warrant.

OJSC Pharmsynthez

In November 2011, the Company entered into a collaborative research and development license agreement with OJSC Pharmsynthez
(the  “Pharmsynthez  Arrangement”)  pursuant  to  which  the  Company  granted  an  exclusive  license  to  Pharmsynthez  to  develop,
commercialize and market six product candidates based on the Company’s PolyXen™ and ImuXen™ technology in certain territories. In
exchange, Pharmsynthez granted an exclusive license to the Company to use any pre-clinical and clinical data developed by Pharmsynthez,
within  the  scope  of  the  Pharmsynthez  Arrangement,  and  to  engage  in  further  research,  development  and  commercialization  of  drug
candidates outside of certain territories at the Company’s own expense.

In  July  2015,  the  Company  entered  into  the  SPA  with  Pharmsynthez  providing  for  the  issuance  of  certain  promissory  notes  and
certain warrants to purchase shares of the Company’s common stock. See Note 8, Hybrid Debt Instrument, for discussion of the SPA and
Note 11, Stockholders’ Equity, for discussion of the warrants.

In November 2015, the Company entered into the APA with the Sellers. Pursuant to the APA, Kevelt will transfer to the Company
certain  intellectual  property  rights  with  respect  to  the  immunomodulatory  product  candidate  Virexxa®  held  by  Kevelt.  See  Note  3,
Acquisitions, for further discussion of the APA. The APA also provides for the Company’s issuance of certain promissory notes and certain
warrants to purchase shares of the Company’s common stock. See Note 11, Stockholders’ Equity, for discussion of the warrants.

Pharmsynthez is a related party of SynBio, which is an affiliate of the Company. In addition, one of the Company’s directors is also a

director of SynBio and Pharmsynthez.

F-18

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.

Property and Equipment, net

Property and equipment, net consists of the following:

Laboratory equipment
Office and computer equipment
Leasehold improvements
Furniture and fixtures
Property and equipment
Less accumulated depreciation
Property and equipment – net

December 31,
2015

December 31,
2014

  $

  $

249,969    $
35,190   
26,841   
20,263   
332,263   
(270,242)  

62,021    $

254,150 
189,459 
92,354 
50,150 
586,113 
(466,664)
119,449 

In connection with the closing of the London office in March 2015, the Company disposed of approximately $247,000 of depreciated
fixed assets with a net book value of approximately $6,000 for cash proceeds of approximately $8,000, resulting in a gain of approximately
$2,000. Depreciation expense was $48,750 and $83,863 for the years ended December 31, 2015 and 2014, respectively.

6.

Goodwill and Indefinite-Lived Intangible Assets

Goodwill

A reconciliation of the change in the carrying value of goodwill is as follows:

Balance as of January 1, 2014
Acquired from acquisitions
Disposed with Hive Out Agreement
Foreign currency translation
Balance as of December 31, 2014
Foreign currency translation
Balance as of December 31, 2015

  $

  $

  $

3,665,199 
4,129,248 
(4,129,248)
(200,042)
3,465,157 
(181,778)
3,283,379 

The goodwill acquired from the Acquisition was disposed in connection with the Hive Out Agreement. See Footnote 3,  Acquisitions,
for further discussion on the Acquisition and the Hive Out Agreement. As of October 1, 2015 and 2014, the dates of the Company’s annual
impairment review, the fair value of the Company’s goodwill balance significantly exceeded its carrying value.

Indefinite-Lived Intangible Assets

The Company’s acquired indefinite-lived intangible asset, OncoHist™, is IPR&D relating to the Company’s business combination
with  SymbioTec  in  2012. The  carrying  value  of  OncoHist™  was  $9.24  million  and  $9.75  million  as  of  December  31,  2015  and  2014,
respectively.  No  impairment  was  recorded  during  the  years  ended  December  31,  2015  and  2014.  The  changes  in  the  carrying  value
reflected herein are solely comprised of the effects of changes in foreign currency.

OncoHist™ is not yet commercialized and has not yet begun to be amortized as of December 31, 2015.

F-19

 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.

Accrued Expenses

Accrued expenses consist of the following:

Accrued payroll and benefits
Accrued professional fees
Accrued research costs
Accrued interest
Other

8.

Hybrid Debt Instrument

Securities Purchase Agreement

December 31,
2015

December 31,
2014

  $

  $

625,289    $
413,945   
145,026   
77,857   
224,929   
1,487,046    $

67,120 
574,186 
573,879 
– 
194,506 
1,409,691 

On July 1, 2015, the Company entered into the  SPA  with  Pharmsynthez  providing  for  the  issuance  of  a  minimum  of  a  $3  million
10%  Senior  Secured  Collateralized  Convertible  Promissory  Note  (the  “SPA  Note”).  The  SPA  also  provides  for  the  issuance  of  certain
warrants up to the amount of the SPA Note. See Note 11,  Stockholders’ Equity, for discussion of the accounting treatment of the warrants.
The convertible debt and its embedded debt-like features have been recorded on the face of the consolidated balance sheet within current
liabilities as an aggregate hybrid debt instrument with a balance of $3.7 million as of December 31, 2015.

On July 1, 2015, the Company issued the SPA Note for $3 million plus a warrant to purchase 10 million shares of common stock in
accordance with the terms of the SPA. In the event the SPA Note remains outstanding at April 1, 2016, Pharmsynthez will be granted an
additional warrant to purchase $10 million shares of common stock. The SPA Note carries a term of one year and is convertible, in whole
or in part, at the option of Pharmsynthez into shares of common stock at a conversion price of $0.15. The SPA Note bears interest at the
rate of 10% annually, payable quarterly in cash or, at the Company’s option, in shares of common stock at the lessor of $0.15 or the then
applicable conversion price. At any point after six months following the issuance of the SPA Note, but before the maturity date of the SPA
Note,  the  Company  has  the  option  of  prepayment  of  the  SPA  Note  and  any  accrued  interest.  If  the  Company  exercises  the  prepayment
option, the Company is obligated to pay the outstanding principal amount of the SPA Note and accrued interest multiplied by 115%. If the
SPA Note is converted or redeemed, prior to the maturity date, the Company will pay cash to Pharmsynthez equal to the interest that would
have accrued from the conversion or redemption date to the maturity date.

Upon a qualifying capital raise in which the Company obtains financing of $7 million or greater (“Capital Raise”), Pharmsynthez has
the  option  to  either  redeem  the  SPA  Note  for  cash  at  the  balance  of  principal  plus  accrued  interest  multiplied  by  115%  or  convert  the
principal plus accrued interest multiplied by 115% into common stock at the effective conversion price. In the event of default, as defined
under the terms of the SPA Note, all obligations will be immediately due and payable and the interest rate will increase to 18% annually.
The Company determined these two features represent contingent put options for Pharmsynthez.

The  Company  concluded  the  two  contingent  put  option  features  related  to  a  Capital  Raise  and  event  of  default,  the  SPA  Note
conversion feature and the ability for interest to be paid in shares of common stock feature each meet the definition of a derivative under
ASC  Topic  815, Derivatives  and  Hedging  (“ASC  815”),  and  require  bifurcation  and  accounting  as  embedded  derivatives.  The  four
embedded derivatives, which were bifurcated and individually fair valued by the Company, have been recorded as a compound derivative
within  the  Hybrid  Debt  Instrument.  The  Company  calculated  the  fair  values  of  each  individual  embedded  derivative  by  taking  the
difference between the fair value of the SPA Note with each embedded derivative and the fair value of the SPA Note without the individual
embedded  derivative.  The  Company  calculated  the  fair  values  using  the  discounted  present  value  of  each  embedded  derivative  value  as
determined by Monte Carlo Simulations. The key valuation assumptions used consist of the Company’s stock price, the risk free interest
rate and expected volatility. The embedded derivatives were recorded within the Hybrid Debt Instrument as a compound derivative liability
at an estimated fair value of $1.4 million at issuance and created an offsetting debt discount on the consolidated balance sheet that will be
amortized over the life of the SPA Note using the effective interest rate method.

The fair value of the compound derivative is remeasured at each report date until settled, with changes in fair value recognized in the
consolidated  statement  of  comprehensive  loss  as  a  gain  or  loss  on  derivative.  The  fair  value  of  the  compound  derivative  increased  $2.1
million since issuance to $3.5 million as of December 31, 2015. This change was recognized as a loss in Other Expense in the consolidated
statement of comprehensive loss for the year ended December 31, 2015.

F-20

 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The key assumptions used to calculate the estimated fair value of the compound derivative liability at issuance and as of December

31, 2015 are as follows:

Company stock price
Expected volatility (%)
Risk-free interest rate (%)

  December 31, 2015 
0.51 
  $
105% 
0.65% 

  $

July 1, 2015

0.22 
115%
0.28%

The  offset  to  debt  arising  from  the  recording  of  the  compound  derivative  liability,  the  warrants  and  the  associated  issuance  costs
exceeded the debt proceeds by approximately $60,000. This amount was recorded as a loss in Other Expense in the consolidated statement
of comprehensive loss for the year ended December 31, 2015.

Interest  expense  related  to  the  SPA  Note  of  approximately  $154,000  was  recognized  in  Interest  Expense  in  the  consolidated
statement  of  comprehensive  loss  for  the  year  ended  December  31,  2015.  Of  this  amount,  approximately  $78,000  is  recorded  as  accrued
interest on the hybrid debt instrument and approximately $76,000 was settled in shares of issuable common stock as of December 31, 2015,
as provided in the APA.

The  Company  also  evaluated  the  provision  in  the  SPA  Note  that  increases  the  annual  interest  rate  in  the  event  of  default  and
concluded that the initial value of this contingent feature is immaterial to the consolidated financial statements as of December 31, 2015.
The Company will evaluate the value of this contingent feature at each reporting period.

Asset Purchase Agreement

In  November  2015,  the  Company  entered  into  the APA  with  Kevelt  and  Pharmsynthez  providing  for  the  issuance  of  10%  Senior
Secured Convertible Promissory Notes of up to $3.5 million to Pharmsynthez (the “APA Notes”) and warrants to purchase a number of
shares of the Company’s common stock equal to 50% of the number of shares issuable under the APA Notes. In the event that the APA
Notes remain outstanding at May 11, 2016, Pharmsynthez shall be granted an additional warrant to purchase an additional number of shares
of the Company’s common stock equal to 50% of the number of shares issuable under the APA Notes. The APA Notes will be issued under
similar terms and conditions as the SPA Note. No APA Notes were issued by the Company during the year ended December 31, 2015.

9.

Fair Value Measurements

ASC Topic 820, Fair Value Measurement, defines fair value as the price that would be received to sell an asset or be paid to transfer
a liability in an orderly transaction between market participants at the measurement date. The Company applies the following fair value
hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon
the lowest level of input that is available and significant to the fair value measurement. Level 1 inputs are quoted prices in active markets
for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 utilizes quoted market
prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency.
Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the
measurement date.

The  Company’s  cash  and  restricted  cash  are  measured  at  fair  value  and  are  classified  as  Level  1  in  the  fair  value  hierarchy.  The
carrying  amount  of  certain  of  the  Company’s  financial  instruments  approximate  fair  value  due  to  their  short  maturities.  The  Company’s
derivative liabilities are measured at fair value on a recurring basis and are classified as Level 3 in the fair value hierarchy.

The  following  table  provides  a  summary  of  the  changes  in  fair  value  of  the  compound  derivative  measured  at  fair  value  on  a

recurring basis using significant unobservable inputs during the year ended December 31, 2015.

Balance as of January 1, 2015
Issuance of compound derivative instrument
Change in fair value of compound derivative instrument
Balance as of December 31, 2015

  $

  $

– 
(1,419,105)
(2,125,117)
(3,544,222)

There were no financial instruments classified as Level 3 in the fair value hierarchy during the year ended December 31, 2014.

F-21

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.

Income Taxes

The  Company  accounts  for  income  taxes  using  the  liability  method  under  ASC  Topic  740,  Income  Taxes.  Under  this  method,
deferred tax assets and liabilities are determined based on temporary differences resulting from the different treatment of items for tax and
financial reporting purposes. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in
the years in which those temporary differences are expected to reverse. Additionally, the Company must assess the likelihood that deferred
tax  assets  will  be  recovered  as  deductions  from  future  taxable  income.  The  Company  has  provided  a  full  valuation  allowance  on  the
Company’s deferred tax assets because the Company believes it is more likely than not that its deferred tax assets will not be realized. The
Company evaluates the recoverability of its deferred tax assets on a quarterly basis. Currently, there is no provision for income taxes as the
Company has incurred losses to date.

The components of (loss) before income taxes are as follows:

Domestic (U.S.)
Foreign (U.K.)
Foreign (Germany)
Loss before income taxes

Year ended December 31,
2014
2015
(4,040,654)
(7,724,418)   $
(10,003,427)
(4,767,363)  
(263,023)
(15,690)  
(14,307,104)
(12,507,471)   $

  $

  $

The  reconciliation  of  income  tax  provision  (benefit)  at  the  U.S.  corporation  tax  rate,  being  the  rate  applicable  to  the  country  of

domicile of Xenetic Biosciences, Inc. to net income tax provision (benefit) is as follows:

Federal
State
Increase in tax losses not recognized
Permanent differences, net
Mark to market
Foreign rate differential
Share-based payments, net
Other
Enhanced research and development tax credits
Net provision (benefit) for income taxes

Year ended December 31,
2014
2015
(4,860,256)
(4,252,540)   $
(145,209)
(276,601)  
4,949,805 
2,238,879   
(1,529,190)
800,891   
– 
722,540   
1,184,770 
502,357   
505,035 
308,888   
7,273 
–   
(112,228)
(44,414)  
– 

–    $

  $

  $

Deferred  tax  assets  and  liabilities  reflect  the  net  tax  effect  of  temporary  differences  between  the  carrying  amount  of  assets  and
liabilities  for  financial  reporting  purposes  and  the  amounts  used  for  income  tax  purposes.  Significant  components  of  the  Company’s
deferred tax assets are as follows:

Deferred tax assets:

U.K. net operating loss carryforwards
U.K. capital loss carryforwards
U.S. federal net operating loss carryforwards
Share-based payments
Enhanced research and development tax credits
Germany net operating loss carryforwards
U.S. state net operating loss carryforwards
Accrued expenses
Depreciation
Other

Total deferred tax assets before valuation allowance

Deferred tax liabilities:

Indefinite-lived intangible asset
Debt discount

Total deferred tax liabilities
Less valuation allowance
Total net deferred tax liability

F-22

  $

Year ended December 31,
2014
2015

9,402,398    $
1,775,932   
1,659,050   
1,313,226   
852,272   
401,906   
422,622   
44,557   
25,823   
4,998   
15,902,784   

9,198,798 
1,874,254 
923,816 
52,320 
786,342 
393,638 
233,825 
157,329 
37,703 
115,384 
13,773,409 

(2,918,518)  
(578,346)  
(3,496,864)  
(15,324,438)  
(2,918,518)   $

(3,080,096)
– 
(3,080,096)
(13,773,409)
(3,080,096)

  $

 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
For the years ended December 31, 2015 and 2014, the Company had U.K. net operating loss carryforwards of $47.01 million and
$45.99 million, respectively, U.S. federal net operating loss carryforwards of $5.30 million and $2.95 million, respectively, U.S. state net
operating  loss  carryforwards  of  $5.28  million  and  $2.92  million,  respectively,  and  Germany  net  operating  loss  carryforwards  of
approximately  $1.27  million  and  $1.25  million,  respectively.  The  U.K.  and  Germany  net  operating  loss  carryforwards  can  be  carried
forward indefinitely. The U.S. federal and state net operating loss carryforwards begin to expire in 2032.

The Company’s ability to use its operating loss carryforwards and tax credits generated in the U.S. to offset future taxable income is
subject to restrictions under Section 382 of the United States Internal Revenue Code (the “Internal Revenue Code”). These restrictions may
limit the future use of the operating loss carryforwards and tax credits if certain ownership changes described in the Internal Revenue Code
occur.  Future  changes  in  stock  ownership  may  occur  that  would  create  further  limitations  on  the  Company’s  use  of  the  operating  loss
carryforwards and tax credits. In such a situation, the Company may be required to pay income taxes, even though significant operating loss
carryforwards and tax credits exist.

The Company’s ability to use its operating loss carryforwards and tax credits generated in the U.K. are subject to restrictions under
U.K.  tax  legislation.  These  regulations  may  limit  the  future  use  of  operating  loss  carryforwards  if  there  is  a  change  in  ownership  and  a
change in the nature or conduct of the business carried on by the Company, and in certain circumstances where there is a change in the
nature or conduct of the business only. In such cases the carryforwards would cease to be available to set against future income.

The Company’s ability to use its operating loss carryforwards and tax credits generated in Germany are also subject to restrictions
under German tax legislation. These regulations may limit the future use of operating loss carryforwards if there is a change in ownership.
In such cases the carryforwards would cease to be available to set against future income.

As of December 31, 2015 and 2014, the Company did not record any uncertain tax positions. As of January 1, 2014, the Company
had  recorded  an  uncertain  tax  position  due  to  a  claim  for  research  and  development  tax  credits  with  a  full  valuation  allowance.  During
2014, the Company determined that it is unable to obtain and compile the necessary information to support and defend the recoverability of
the research and development tax credits, resulting in the write-off of the previously fully reserved balance. The changes to uncertain tax
positions for 2015 and 2014 were as follows:

Uncertain tax benefits as of January 1
Gross adjustments in tax positions
Uncertain tax positions as of December 31

Year ended December 31,
2014
2015

  $

  $

–    $
–   
–    $

185,961 
(185,961)
– 

The Company files income tax returns in the U.S. federal tax jurisdiction and Massachusetts state tax jurisdiction, and certain foreign
tax jurisdictions. The Company is subject to examination by the U.S. federal, state, foreign, and local income tax authorities for calendar
tax years ending 2012 through 2015 due to available net operating loss carryforwards and research and development tax credits arising in
those years. The Company has not been notified of  any  examinations  by  the  Internal  Revenue  Service  or  any  other  tax  authorities  as  of
December 31, 2015. The Company has not recorded any interest or penalties for unrecognized tax benefits since its inception.

Potential 382 Limitation

The Company’s net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue
Service.    The  Company’s  ability  to  utilize  our  net  operating  loss  (“NOL”)  and  alternative  minimum  tax  (“AMT”)  and  research  and
development credit (“R&D”) carryforwards may be substantially limited due to ownership changes that may have occurred or that could
occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state
provisions.  These ownership changes may limit the amount of NOL, AMT and R&D credit carryforwards that can be utilized annually to
offset future taxable income and tax, respectively.  In general, an ownership change, as defined in Section 382 of the Code, results from a
transaction or series of transactions over a three-year period resulting in an ownership change of more than 50% of the outstanding stock of
a company by certain stockholders or public groups.

F-23

 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
The  Company  has  not  completed  a  study  to  assess  whether  one  or  more  ownership  changes  have  occurred  since  we  became  a  loss
corporation  as  defined  in  Section  382  of  the  Code,  but  we  believe  that  it  is  likely  that  an  ownership  change  has  occurred.    If  we  have
experienced an ownership change, utilization of the NOL, AMT and R&D credit carryforwards would be subject to an annual limitation,
which is determined by first multiplying the value of our common stock at the time of the ownership change by the applicable long-term,
tax-exempt  rate,  and  then  could  be  subject  to  additional  adjustments,  as  required.   Any  such  limitation  may  result  in  the  expiration  of  a
portion  of  the  NOL, AMT  or  R&D  credit  carryforwards  before  utilization.    Until  a  study  is  completed  and  any  limitation  known,  no
amounts are being considered as an uncertain tax position or disclosed as an unrecognized tax benefit under ASC 740.  Any carryforwards
that expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding adjustment to
the  valuation  allowance.    Due  to  the  existence  of  the  valuation  allowance,  it  is  not  expected  that  any  potential  limitation  will  have  a
material impact on our operating results.

From time to time the Company may be assessed interest or penalties by major tax jurisdictions, namely the state of Massachusetts. As
of  December  31,  2015,  the  Company  had  no  material  unrecognized  tax  benefits  and  no  adjustments  to  liabilities  or  operations  were
required. No interest and penalties have been recognized by the Company to date.

The Company net operating loss carryforwards are subject to review and possible adjustment by the Internal Revenue Service and are
subject  to  certain  limitations  in  the  event  of  cumulative  changes  in  the  ownership  interest  of  significant  stockholders  over  a  three-year
period in excess of 50%.

11.

Stockholders’ Equity

Common Stock

Each  share  of  common  stock  entitles  the  holder  to  one  vote  on  all  matters  submitted  to  a  vote  of  the  Company’s  stockholders.
Common  stockholders  are  entitled  to  dividends  when  and  if  declared  by  the  Board  of  Directors.  In  the  event  of  any  voluntary  or
involuntary liquidation, dissolution or winding-up of the Company, the holders of common stock are entitled to share ratably in the assets
of the Company available for distribution.

On September 30, 2015, the Company filed an Amendment to the Articles of Incorporation with the Secretary of State of the State of
Nevada  to  increase  the  authorized  shares  of  common  stock  of  the  Company  and  change  the  par  value  per  share  of  common  stock  (the
“Amendment”). The Amendment authorizes the Company to issue 1,500,000,000 shares of Common Stock and changes the par value to
$0.001 per share. Prior periods have been reclassified to reflect the change in the par value per share to conform to the presentation in the
present period.

On January 30, 2014, the Company announced the amendment of the licensing agreement with Baxter in which certain financial and
timing aspects of the agreement were modified. As a result, the Company is entitled to receive certain amounts in development, regulatory
and sales milestone payments as well as increased royalties on potential net sales. In addition, Baxter SA made a direct equity investment of
$10  million  in  cash  in  exchange  for  10,695,187  shares  of  the  Company’s  common  stock.  During  June  2015,  in  connection  with  the
separation  of  its  biopharmaceuticals  business  to  form  Baxalta  Incorporated  (“Baxalta”),  Baxter  assigned  all  of  its  rights  and  obligations
under its existing agreement with the Company to Baxalta.

F-24

 
 
 
 
 
 
 
 
 
 
 
 
In December 2015, 11 million shares of new common stock were issued to Dr. Genkin and Mr. Surkhov in connection with the APA.
As a result, the Company recorded approximately $3.74 million, the fair value of the proportional consideration provided, as a prepayment
within current assets on the consolidated balance sheet as of December 31, 2015.

Warrants

In  connection  with  the  Company’s  collaboration  and  consultant  agreements  and  financing  arrangements,  the  Company  issues
warrants  to  purchase  shares  of  common  stock.  These  warrants  were  fair  valued  at  issuance  date  using  the  Black-Scholes  option  pricing
model. The warrants are subject to re-measurement at each reporting period until the measurement date is reached. Expense is recognized
on a straight-line basis over the expected service period or at the date of issuance, if there is not a service period.

Warrants Related to Collaboration and Consulting Agreements

In  2010,  the  Company  granted  Baxter  SA  a  warrant  to  purchase  4,588,298  new  shares  of  common  stock.  During  June  2015,  in
connection with the separation of its biopharmaceuticals business to form Baxalta, Baxter assigned the warrant to Baxalta. The warrant was
exercisable  immediately  after  issuance  and  had  an  initial  expiration  date  of  June  30,  2015,  which  the  Company  expects  to  extend
subsequent to December 31, 2015. These warrants, which were fair valued at $932,000 at the time of issuance, were not exercised during
the years ended December 31, 2015 and 2014.

In  2011,  the  Company  granted  SynBio  a  warrant  to  purchase  3,545,600  new  shares  of  common  stock,  which  was  exercisable  two
years after issuance and expires on December 2, 2016 (“SynBio 2011 Warrant”). On December 31, 2014, SynBio was granted a warrant to
purchase  6,745,000  new  shares  of  common  stock  at  an  exercise  price  of  $0.77  per  share  (“SynBio  2014  Warrant”).  The  SynBio  2014
Warrant  is  exercisable  in  four  equal  tranches,  each  with  separate  non-market,  performance-based  vesting  criteria.  The  Company  uses  its
judgment to assess the probability and timing of SynBio achieving this vesting criteria and estimated that it is not probable that the vesting
criteria for any tranche will be achieved. As a result, the Company did not recognize expense related to this warrant during the years ended
December  31,  2015  and  2014.  These  judgments  are  reassessed  at  each  reporting  period  until  the  measurement  date  is  reached.  Upon
issuance of the SynBio 2014 Warrant on December 31, 2014, the SynBio 2011 Warrant was canceled and of no further force and effect.

In connection with the SynBio 2014 Warrant grant, warrants to purchase 320,000 aggregate new shares of common stock were issued
to  SynBio  and  Pharmsynthez  non-director  designees  (“SynBio  Partner  Warrants”)  on  December  31,  2014  under  the  same  terms  and
conditions  of  the  SynBio  2014  Warrant.  The  Company  estimated  that  it  is  not  probable  that  the  vesting  criteria  for  any  trance  will  be
achieved and, as a result, the Company did not recognize expense related to the SynBio Partner Warrants during the years ended December
31, 2015 and 2014. The SynBio 2014 Warrant and SynBio Partner Warrants expire on December 30, 2019 and no warrants were exercised
during the years ended December 31, 2015 and 2014.

On December 31, 2014, the Company granted Serum Institute a warrant to purchase 3,200,000 new shares of common stock at an
exercise  price  of  $0.77  per  share  (“Serum  Institute  2014  Warrant”).  The  Serum  Institute  2014  Warrant,  which  was  fair  valued  at
approximately $480,000 at the time of issuance, is exercisable in two equal tranches, each with separate non-market, performance-based
vesting criteria. The Company uses its judgment to assess the probability and timing of Serum Institute achieving this vesting criteria and
estimated that it is probable that the vesting criteria will be achieved for each tranche. These judgments are reassessed at each reporting
period until the measurement date is reached.

F-25

 
 
 
 
 
 
 
 
 
 
 
 
In  connection  with  the  Serum  Institute  2014  Warrant  grant,  warrants  to  purchase  160,000  aggregate  new  shares  of  common  stock
were issued to Serum Institute employees (“Serum Institute Partner Warrants”) on December 31, 2014 under the same terms and conditions
of  the  Serum  Institute  2014  Warrant.  The  Serum  Institute  Partner  Warrants  were  fair  valued  at  approximately  $24,000  at  the  time  of
issuance.  The  Company  recognized  warrant  expense  of  $706,500  and  zero  during  the  years  ended  December  31,  2015  and  2014,
respectively,  related  to  the  Serum  Institute  2014  Warrant  and  Serum  Institute  Partner  Warrants.  The  Serum  Institute  2014  Warrant  and
Serum Institute Partner Warrants expire on December 30, 2019 and no warrants were exercised during the years ended December 31, 2015
and 2014.

On December 31, 2014, the Company granted a non-employee director a warrant to purchase 1,600,000 new shares of common stock
at an exercise price of $0.77 per share for services provided to the Company. The warrant is a standalone instrument that is not puttable or
mandatorily redeemable by the holder and is classified as an equity award. The Company determined that the fair value of the warrant is
more reliably measureable than the fair value of the services received. As a result, the warrant was fair valued at approximately $240,000
at the time of issuance. As performance was completed and the measurement date reached at the time of issuance, the Company recorded
expense of approximately $240,000 to general and administrative expenses in the consolidated statement of comprehensive loss during the
year ended December 31, 2014. The warrant is exercisable two years after issuance and expires on December 30, 2019.

In August  2015,  the  Company  issued  a  warrant  to  purchase  approximately  833,000  shares  of  common  stock  to  a  consultant  upon
engagement of services to be provided to the Company. The warrant has a term of five years and an exercise price of $0.77. The warrant is
a standalone instrument that is not puttable or mandatorily redeemable by the holder and is classified as an equity award. The Company
determined  that  the  fair  value  of  the  warrant  is  more  reliably  measureable  than  the  fair  value  of  the  services  received. As  a  result,  the
warrant was fair valued at approximately $227,000 at the time of issuance using the Black-Scholes option pricing model. As all services
were completed as of December 31, 2015, the warrant expense was recognized during the year ended December 31, 2015.

Key  assumptions  used  in  the  Black-Scholes  option  pricing  model  for  warrants  related  to  collaboration  and  consultant  agreements

granted during the years ended December 31, 2015 and 2014 are as follows:

Weighted-average expected dividend yield (%)
Weighted-average expected volatility (%)
Weighted-average risk-free interest rate (%)
Weighted-average expected life of option (years)
Weighted-average exercise price ($)
Model used

2015

–   
104.81   
1.03   
5.00   
0.77   
Black-Scholes   

2014

– 
103.32 
0.96 
5.00 
0.77 
Black-Scholes 

F-26

 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Warrants Related to Financing Arrangements

In connection with the Company’s issuance of the SPA Note on July 1, 2015, the Company issued a warrant to purchase 10 million
shares  of  common  stock  in  accordance  with  the  terms  of  the  SPA  (the  “Warrant”).  The  Warrant  has  a  five-year  term  and  is  exercisable
commencing January 1, 2016. The exercise price per share under the Warrant is the lessor of $0.20 or 120% of the Capital Raise price, in
the event there is a Capital Raise. If the SPA Note is not repaid or converted on or before six months from the date of issuance, the Holder
will be issued an additional warrant to purchase 10 million shares of common stock under the same terms as the Warrant (the “Contingent
Warrant”, or together referred to as the “Warrants”). The Company determined there is a high probability that the SPA Note will not be
repaid or converted within the period six months from the date of issuance, resulting in the issuance of the Contingent Warrant. As such,
the Company concluded the Contingent Warrant is considered to be issued and outstanding as of the SPA Note issuance date in accordance
with  ASC  815.  The  fair  values  of  the  Warrants  were  calculated  using  the  Black-Scholes  option  pricing  model.  The  key  valuation
assumptions used consist of the Company’s stock price, a risk free rate of 1.70% and an expected volatility of 125%. Using an allocation of
the SPA Note proceeds between the relative fair values of the Warrants and the SPA Note, the Company recorded the Warrants at a value
of $1.6 million on the consolidated balance sheet as equity paid-in-capital. This created a debt discount of $1.6 million that will amortize
from the date of issuance through the term of the SPA Note.

In November 2015, the Company entered into the APA with Kevelt and Pharmsynthez, which provided for the issuance of certain
warrants to purchase a number of share of the Company’s common stock equal to 50% of the number of shares issuable under the APA
Notes.  In  the  event  that  the APA  Notes  remain  outstanding  at  May  11,  2016,  Pharmsynthez  shall  be  granted  an  additional  warrant  to
purchase an additional number of shares of the Company’s common stock equal to 50% of the number of shares issuable under the APA
Notes. The warrants will be issued under the same terms and conditions as the warrants under the SPA. No warrants under the APA were
issued by the Company during the year ended December 31, 2015.

12.

Share-Based Payments

Total  share-based  payments  related  to  employee  and  non-employee  stock  options,  common  stock  awards  and  JSOP  awards  was

$2,594,113 and $1,513,238 for the years ended December 31, 2015 and 2014, respectively.

Share-based payments is classified in the consolidated statements of comprehensive loss as follows:

Research and development expenses
General and administrative expenses

Stock Option Modifications

Year Ended December 31,
2014
2015

  $

  $

229,964    $

2,364,149   
2,594,113    $

952,829 
560,409 
1,513,238 

Prior to the Acquisition in 2014, the Company had two incentive stock plans, the Lipoxen plc Unapproved Share Option Plan (the
“2000 Stock Plan”) and the Xenetic Biosciences plc 2007 Share Option Scheme (the “2007 Stock Plan”). Subsequent to the Acquisition, the
2000 and 2007 Stock Plans were converted to reflect the new shares issued by the Company under the Scheme of Arrangement related to
the Acquisition. As part of the conversion, option holders under the 2000 and 2007 Stock Plan have the right to subscribe for a number of
shares of common stock in the Company (the “Replacement Option Shares”) in exchange for the cancellation and surrender by the option
holder of the original options granted by the 2000 and 2007 Stock Plans. The number of Replacement Option Shares is determined in the
same manner in which the shareholders of Xenetic UK were given the right to acquire shares of common stock in the Company according
to  the Acquisition.  The  aggregate  exercise  price  payable  in  U.S.  dollars  for  Replacement  Option  Shares  is  the  same  as  the  aggregate
exercise price in pounds sterling of the original options, using a foreign currency exchange rate for pounds sterling into U.S. dollars quoted
by Barclays Bank plc at 12 noon Greenwich Mean Time (“GMT”) on January 23, 2014, the date of the Acquisition. The conversion of the
options is treated as an option modification. The Company accounted for the option modification under ASC Topic 718,  Compensation –
Stock Compensation, and determined the option modification did not result in incremental stock compensation cost that is material to the
Company’s results of operations during the year ended December 31, 2014.

F-27

 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
During the year ended December 31, 2015, the Company modified 688,408 employee stock option awards to extend the expiry dates
through March 31, 2016. The Company accounted for the option modification under ASC Topic 718, Compensation – Stock Compensation,
and as a result, recognized $25,008 in incremental compensation expense during the year ended December 31, 2015.

Stock Options

The  Company  grants  stock  option  awards  to  employees  and  non-employees  with  varying  vesting  terms  under  the  Xenetic
Biosciences,  Inc.  Equity  Incentive  Plan  (“Stock  Plan”).  The  Company  measures  the  fair  value  of  stock  option  awards  using  the  Black-
Scholes option pricing model, which uses the assumptions noted in the tables below, including the risk-free interest rate, expected term,
share price volatility, dividend yield and forfeiture rate. The risk-free interest rate is based upon the U.S. Treasury yield curve in effect at
the time of grant, with a term that approximates the expected life of the option. For employee stock options issued in 2015 and 2014 that
qualify as “plain vanilla” stock options in accordance with Staff Accounting Bulletin No. 110 (“SAB 110”), the expected term is based on
the simplified method, as defined by SAB 110. The  Company  has  a  limited  history  of  stock  option  exercises,  which  does  not  provide  a
reasonable  basis  for  the  Company  to  estimate  the  expected  term  of  employee  stock  options.  For  all  other  employee  stock  options,  the
Company  estimates  the  expected  life  using  judgment  based  on  the  anticipated  research  and  development  milestones  of  the  Company’s
clinical  projects  and  behaviour  of  the  Company’s  employees.  The  expected  life  of  non-employee  options  is  the  contractual  life  of  the
option.  The  Company  determines  the  expected  volatility  based  on  a  blended  volatility  rate  of  its  own  historical  volatility  with  that  of
comparable  publicly  traded  companies  with  product  candidates  in  similar  therapeutic  areas  and  stages  of  nonclinical  and  clinical
development to the Company’s product candidates. The Company has applied an expected dividend yield of 0% as the Company has not
historically declared a dividend and does not anticipate declaring a dividend during the expected life of the options. Further, the Company
has applied a forfeiture rate of 0% as the Company has not historically experienced forfeitures.

Employee Stock Options

During the years ended December 31, 2015 and 2014, 16.3 million and 1.08 million total stock options to purchase shares of common
stock were granted under the Stock Plan, respectively, with a weighted average grant date fair value per option share of $0.28 and $0.23,
respectively. During the year ended December 31, 2014, 1,984,080 stock options were exercised and cash received from those stock option
exercises was $101,933. No stock options were exercised during the year ended December 31, 2015.

During the year ended December 31, 2015 and 2014, 5.33 million and 0.68 million total stock options vested, with total fair values of
$1,391,450 and $115,864, respectively. As of December 31, 2015, there was $2,931,117 of unrecognized share-based payments related to
employee  stock  options  that  are  expected  to  vest.  The  Company  expects  to  recognize  this  expense  over  a  weighted-average  period  of
approximately 2 years.

Key assumptions used in the Black-Scholes option pricing model for options granted to employees during the years ending December

31, 2015 and 2014 are as follows:

Weighted-average expected dividend yield (%)
Weighted-average expected volatility (%)
Weighted-average risk-free interest rate (%)
Weighted-average expected life of option (years)
Weighted-average exercise price ($)
Model used

F-28

Year Ended December 31,

2015

–   
124.17   
0.44   
2.50   
0.42   
Black-Scholes   

2014

– 
103.36 
1.48 
5.33 
0.31 
Black-Scholes 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The following is a summary of employee stock option activity for the years ended December 31, 2015 and 2014:

Number of
shares

Weighted-
average exercise
price

Weighted-
average
remaining life
(years)

Aggregate
intrinsic value  

Outstanding as of January 1, 2014
Granted
Exercised
Expired
Outstanding as of December 31, 2014
Granted
Expired
Outstanding as of December 31, 2015

5,222,430   
1,080,000   
(1,984,080)  
(132,422)  
4,185,928   
16,300,000   
(51,072)  
20,434,856   

Vested or expected to vest as of December 31, 2015

20,434,856   

Exercisable as of December 31, 2014
Exercisable as of December 31, 2015

2,630,024    $
7,913,567    $

0.47   
0.31   
0.05   
0.93   
0.62   
0.42   
0.47   
0.46   

0.46   

0.60   
0.52   

     $

509,622 

6.86    $

80,338 

8.92    $

1,915,942 

8.92    $

1,915,942 

5.48    $
7.78    $

80,338 
688,343 

A  summary  of  the  status  of  the  Company’s  non-vested  employee  stock  option  shares  as  of  December  31,  2015  and  the  changes

during the year ended December 31, 2015 is as follows:

Balance as of January 1, 2015
Granted
Vested
Balance as of December 31, 2015

Non-Employee Stock Options

Number of
shares

1,555,904    $
16,300,000    $
(5,334,615)   $
12,521,289    $

Weighted-
average grant
date fair value  
0.15 
0.28 
0.26 
0.28 

Share-based  payments  expense  related  to  stock  options  granted  to  non-employees  is  recognized  as  the  services  are  rendered  on  a
straight-line basis. The Company determined that the fair value of the stock options is more reliably measurable than the fair value of the
services received. Compensation expense related to stock options granted to non-employees is subject to re-measurement at each reporting
period until the options vest.

During the years ended December 31, 2015 and 2014, 1 million and 0.48 million non-employee stock options were granted under the
Stock Plan, respectively, with a weighted average grant date fair value per option share of $0.40 and $0.23, respectively. No non-employee
stock options were exercised during years ended December 31, 2015 and 2014.

During the year ended December 31, 2015 and 2014, 0.59 million and 0.26 million total stock options vested, with total fair values of
$195,575 and $62,121, respectively. As of December 31, 2015, there was $263,778 of unrecognized share-based payments related to non-
employee  stock  options  that  are  expected  to  vest.  The  Company  expects  to  recognize  this  expense  over  a  weighted-average  period  of
approximately 1.5 years.

Key assumptions used in the Black-Scholes option pricing model for non-employees options during the years ended December 31,

2015 and 2014 are as follows:

Weighted-average expected dividend yield (%)
Weighted-average expected volatility (%)
Weighted-average risk-free interest rate (%)
Weighted-average expected life of option (years)
Weighted-average exercise price ($)
Model used

F-29

Year Ended December 31,

2015

–   
120.51   
1.54   
10.00   
0.42   
Black-Scholes   

2014

– 
116.22 
1.62 
7.60 
0.39 
Black-Scholes 

 
 
 
 
 
   
   
   
 
 
 
 
    
 
  
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
    
 
  
 
 
 
 
 
 
 
    
 
    
 
    
 
  
 
 
 
 
 
 
 
    
 
    
 
    
 
  
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The following is a summary of non-employee stock option activity for the years ended December 31, 2015 and 2014:

Number of
shares

Weighted-
average exercise
price

Weighted-
average
remaining life
(years)

Outstanding as of January 1, 2014
Granted
Outstanding as of December 31, 2014
Granted
Outstanding as of December 31, 2015

415,520    $
480,000   
895,520   
1,000,000   
1,895,520   

Vested or expected to vest as of December 31, 2015

1,895,520   

Exercisable as of December 31, 2014
Exercisable as of December 31, 2015

383,664    $
972,926    $

0.52   
0.25   
0.39   
0.42   
0.41   

0.41   

0.42   
0.41   

Aggregate
intrinsic value  
49 

5.90    $

7.60    $

159 

8.23    $

220,764 

8.23    $

220,764 

6.40    $
7.37    $

159 
119,164 

A summary of the status of the Company’s non-vested non-employee stock option shares as of December 31, 2015 and the changes

during the year ended December 31, 2015 is as follows:

Balance as of January 1, 2015
Granted
Vested
Balance as of December 31, 2015

Common Stock Awards

Number of
shares

511,856    $
1,000,000    $
(589,262)   $
922,594    $

Weighted-
average grant
date fair value  
0.21 
0.40 
0.33 
0.36 

The Company granted common stock awards to several non-employees in exchange for services provided. The Company measures
the  fair  value  of  these  awards  using  the  fair  value  of  the  services  provided  or  the  fair  value  of  the  awards  granted,  whichever  is  more
reliably measurable. The fair value measurement date of these awards is generally the date the performance of services is complete. The
fair value of the awards is recognized as services are rendered on a straight-line basis.

A summary of the Company’s common stock awards granted and issued during the years ended December 31, 2015 and 2014 are as

follows:

Balance as of January 1, 2014
Granted
Issued
Balance as of December 31, 2014
Granted
Issued
Balance as of December 31, 2015

Number of
shares

460,116 
3,432,190 
(3,244,784)
647,522 
1,135,280 
(1,027,535)
755,267 

The  Company  granted  1,135,280  and  187,406  shares  of  common  stock  during  the  years  ended  December  31,  2015  and  2014,
respectively,  in  exchange  for  professional  services. As  all  services  were  rendered  in  each  respective  period,  expense  related  to  common
stock awards of $392,661 and $102,000 was recognized during the years ended December 31, 2015 and 2014, respectively.

F-30

 
 
 
 
 
   
   
   
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
    
 
    
 
    
 
  
 
 
 
 
 
 
 
    
 
    
 
    
 
  
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In December 2014, 3,244,784 shares of new common stock were granted and issued to FDS Pharma ASS (“FDS”) in consideration
for the performance of services and termination of a prior collaboration agreement between Lipoxen and FDS. The Company determined
that  the  fair  value  of  the  shares  of  common  stock  granted  is  more  reliably  measurable  than  the  fair  value  of  the  services  received.  The
Company  assessed  the  fair  value  of  one  share  of  common  stock  on  the  measurement  date  to  be  $0.25. As  performance  by  FDS  was
complete  at  the  issuance  date,  the  Company  recorded  expense  of  approximately  $812,000  to  research  and  development  expense  in  the
consolidated statement of comprehensive loss during the year ended December 31, 2014. FDS is a related party of SynBio, an affiliate of
the Company.

Joint Share Ownership Plan

In  2010  and  2012,  the  Company  issued  1,701,913  and  8,986,281  JSOP  awards,  respectively,  to  two  senior  executives  under  the
JSOP. Under the JSOP, shares in the Company are jointly purchased at fair market value by the participating executives and the trustees of
the JSOP trust, with such shares held in the JSOP trust. For US GAAP purposes the awards were valued as employee options and recorded
as a reduction in equity as treasury shares until such time as they are exercised by the employee.

During 2011, the 2010 JSOP awards fully vested under the terms of the JSOP due to a significant change in beneficial ownership of
the  Company  and  the  related  compensation  charges  were  fully  recorded  during  periods  prior  to  2013  related  to  this  accelerated  vesting.
During the first quarter of 2014, the 2012 JSOP awards fully vested under the terms of the JSOP due the achievement  of  specific  share
price hurdles and the related compensation charges were fully recorded during the first quarter of 2014 related to this accelerated vesting.
As  of  December  31,  2014,  all  JSOP  awards  were  fully  vested.  The  Company  recognized  zero  and  $344,905,  respectively,  of  JSOP
compensation expense during the years ended December 31, 2015 and 2014. As of December 2015 and 2014, there were 10,688,194 JSOP
awards issued.

13. Employee Benefit Plans

The  Company  has  a  defined  contribution  401(k)  savings  plan  (the  “401(k)  Plan”).  The  401(k)  Plan  covers  substantially  all  U.S.
employees, and allows participants to defer a portion of their annual compensation on a pre-tax basis. Company contributions to the 401(k)
Plan may be made at the discretion of the Board of Directors. During the year ended December 31, 2015 and 2014, the Company made
contributions of approximately $34,000 and $32,000, respectively, to the 401(k) Plan.

In the U.K., the Company has adopted a defined contribution plan (the “UK Plan”) which qualifies under the rules established by HM
Revenue & Customs. The UK Plan generally allows all U.K. employees to contribute a minimum of 3% of salary with no maximum limit.
The  Company  contributes  to  the  plan  between  8%  and  12%  of  the  employee’s  salary,  depending  upon  seniority  of  the  employee.  The
Company,  at  its  discretion,  may  also  contribute  to  an  employee’s  personal  pension  plan.  The  Company  paid  total  contributions  of
approximately $144,000 and $108,000 during the years ended December 31, 2015 and 2014, respectively.

14. Commitments and Contingent Liabilities

Lease

In August 2013, the Company entered into an agreement to lease office and laboratory space in Lexington, Massachusetts under an
operating lease with a commencement date of January 1, 2014 and a termination date of January 31, 2019. With the execution of this lease,
the  Company  is  required  to  maintain  a  $66,000  letter  of  credit  as  a  security  deposit,  which  is  classified  as  a  current  asset  within  the
consolidated  balance  sheet.  In  connection  with  the  Lexington  lease,  the  Company  recorded  $90,838  as  prepaid  rent  as  of  December  31,
2015,  with  $61,377  recorded  as  a  non-current  asset.  The  Company  also  incurred  a  liability  of  $89,074  with  respect  to  the  Company’s
contribution to the landlord’s leasehold improvements, of which $56,538 is outstanding as of December 31, 2015, with $38,791 recorded as
a non-current liability. This liability is repayable as additional rent expense over the term of the lease and bears interest at 6%. In addition,
the Company leased office space in London, U.K. during 2014 and 2015. The U.K. lease was terminated in March 2015 in accordance with
the terms of the lease.

F-31

 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Company’s contractual commitments under all non-cancelable operating leases as of December 31, 2015 are as follows:

As of December 31,
2016
2017
2018
2019
Total minimum lease payments

Total Operating
Leases

  $

  $

98,645 
102,604 
106,563 
8,908 
316,720 

Rent expense is calculated on a straight-line basis over the term of the lease. Rent expense under the Company’s operating leases was

$134,875 and $172,821 for the years ended December 31, 2015 and 2014, respectively.

Employment Agreements

The  Company  has  contingent  bonus  compensation  agreements  with  certain  of  the  Company’s  employees.  The  bonuses  become
payable upon the achievement of certain capital raise and stock listing metrics. The amount of contingent bonuses that may be paid out in
future periods is a range of approximately $380,000 to $680,000 as of December 31, 2015.

15. Related Party Transactions

In  May  2011,  the  Company  received  a  short  term  unsecured  loan  facility  of  up  to  $1.7  million  from  SynBio,  an  affiliate  of  the
Company, of which $395,000 was outstanding as of December 31, 2015 and 2014, respectively. A payment of $286,124 on the outstanding
loan was made to SynBio during the year ended December 31, 2014. No payments were made during the year ended December 31, 2015.
The loan had an interest rate of 8.04% per annum as of the date of grant, with interest payable upon repayment of the loan, which was to be
seven months after the closing date of the loan. During 2012, the loan matured and it was agreed by both parties that the loan can be called
due with full repayment of the outstanding principal including accrued interest upon future agreement by both parties. It was also agreed as
of July 1, 2012 that no further interest on the outstanding loan balance would be accrued. The loan is recorded in “Loans due to related
parties”  within  current  liabilities  as  of  December  31,  2015  and  2014.  The  loan  does  not  bear  interest  at  the  prevailing  market  rate  for
instruments with similar characteristics.

During the years ended December 31, 2015 and 2014, the Company received research and consulting services from a non-employee
director  of  the  Company.  The  total  amount  of  services  received  was  $72,594  and  $74,582  for  the  years  ended  December  31,  2015  and
2014, respectively, with $17,791 and zero included in accounts payable on the consolidated balance sheet as of December 31, 2015 and
2014, respectively.

During the years ended December 31, 2015 and 2014, the Company also received consulting services from a firm owned by a non-
employee  director  of  the  Company.  The  total  amount  of  services  received  was  $4,000  and  $133,381  for  the  years  ended  December  31,
2015 and 2014, respectively, with zero and $51,708 included in accounts payable on the consolidated balance sheet as of December 31,
2015 and 2014, respectively.

Please  refer  to  Note  4, Significant  Strategic  Drug  Development  Collaborations,  and  Note  11, Stockholder’s Equity,  for  details  on

arrangements with collaboration partners and non-employee directors that are also related parties.

16.

Subsequent Events

The  Company  performed  a  review  of  events  subsequent  to  the  balance  sheet  date  through  the  date  the  financial  statements  were
issued and determined, except as disclosed herein, that there were no other such events requiring recognition or disclosure in the financial
statements.

During  the  first  quarter  of  2016,  the  Company  received  total  proceeds  of  $3.5  million  in  connection  with  the  APA  financing
arrangement. The APA provided for the issuance of certain warrants to purchase a number of share of the Company’s common stock equal
to 50% of the number of shares issuable under the APA Notes. The Warrant has a five-year term and is exercisable commencing March 31,
2016.  The  exercise  price  per  share  under  the  Warrant  is  the  lessor  of  $0.20  or  120%  of  the  Capital  Raise  price,  in  the  event  there  is  a
Capital Raise. If the APA Note is not repaid or converted on or before six months from the date of issuance, the Holder will be issued an
additional warrant under the same terms as the Warrant.

F-32

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XENETIC BIOSCIENCES, INC.

SCHEDULE II

VALUATION AND QUALIFYING ACCOUNTS

FOR THE YEARS ENDED DECEMBER 31, 2015 AND 2014

Valuation Allowance on
Deferred Tax Assets

Balance Beginning of
Period

Additions (Deductions)
Charged to (from)
Income Tax Expense

  Other Changes to
Valuation
Allowance

2015
2014

$
$

(13,773,409)
(9,521,260)

(1,551,029)
(4,252,149)

Balance End of Period
(15,324,438)
(13,773,409)

- $
- $

48

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ITEM  9  –  CHANGES  IN  AND  DISAGREEMENTS  WITH  ACCOUNTANTS  ON  ACCOUNTING  AND  FINANCIAL
DISCLOSURE

The Company, as reported in its Current Report filed on Form 8-K on June 25, 2015, changed its accountants to Marcum LLP. The

Company has no disagreements with the current or predecessor accountants on any accounting and financial disclosure matters.

ITEM 9A – CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated 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”), as of the end of the period covered by this Annual Report on Form 10-K.

Based on this evaluation our management, including our Chief Executive Officer and Chief Financial Officer concluded that, as of
the end of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures are designed at a reasonable
assurance  level  and  are  effective  to  provide  reasonable  assurance  that  information  we  are  required  to  disclose  in  reports  that  we  file  or
submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in 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 Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is
defined  in  Rule  13a-15(f)  of  the  Exchange Act.  Management  under  the  supervision  and  with  the  participation  of  our  Chief  Executive
Officer and Chief Financial Officer, conducted an assessment of the design and effectiveness of our internal control over financial reporting
as  of  the  end  of  the  period  covered  by  this Annual  Report  on  Form  10-K.  In  making  its  assessment  of  internal  control  over  financial
reporting, management used the criteria set forth by the Committee of Sponsoring Organizations (“COSO”) of the Treadway Commission
in Internal  Control  —  Integrated  Framework.  Based  on  this  assessment,  our  management  concluded  that,  as  of  the  end  of  the  period
covered by this Annual Report on Form 10-K, our internal control over financial reporting was effective based on the criteria set forth by
COSO of the Treadway Commission in Internal Control — Integrated Framework.

This  annual  report  does  not  include  an  attestation  report  of  our  registered  public  accounting  firm  regarding  internal  control  over
financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to an exemption
for non-accelerated filers set forth in Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act.

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting that occurred during the period covered by this Annual
Report  on  Form  10-K  that  have  materially  affected,  or  are  reasonably  likely  to  materially  affect,  our  internal  control  over  financial
reporting.

49

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Limitations on Effectiveness of Controls and Procedures

In  designing  and  evaluating  the  disclosure  controls  and  procedures,  management  recognizes  that  any  controls  and  procedures,  no
matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. The Company’s
internal control over financial reporting includes those policies and procedures that:

(1)

(2)

(3)

Pertain to  the  maintenance  of  records  that,  in  reasonable  detail,  accurately  and  fairly  reflect  the  transactions  and  dispositions of  the
Company’s 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 the Company’s receipts and expenditures are being made only in accordance
with authorizations of the Company’s management and directors; and
Provide  reasonable assurance  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.

Management, including the Company’s Chief Executive Officer and Chief Financial Officer, does not expect that the Company’s
internal controls will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide
only  reasonable,  not  absolute,  assurance  that  the  objectives  of  the  control  system  are  met.  Further,  the  design  of  a  control  system  must
reflect  the  fact  that  there  are  resource  constraints,  and  the  benefits  of  controls  must  be  considered  relative  to  their  costs.  Because  of  the
inherent  limitations  in  all  control  systems,  no  evaluation  of  internal  controls  can  provide  absolute  assurance  that  all  control  issues  and
instances of fraud, if any, have been detected. Also, any evaluation of the effectiveness of controls in future periods are subject to the risk
that those internal controls may become inadequate because of changes in business conditions, or that the degree of compliance with the
policies or procedures may deteriorate.

ITEM 9B – OTHER INFORMATION

None.

50

 
 
 
 
 
 
 
 
 
 
ITEM 10 – DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

PART III

The  information  required  by  this  Item  is  incorporated  by  reference  from  the  Company’s  proxy  statement  for  the  2016  annual
meeting of stockholders or a Form 10-K/A, to be filed with the Securities and Exchange Commission within 120 days of the end of the
Company’s fiscal year ended December 31, 2015, except for certain information with respect to our executive officers, which is included in
“Part I – Item 1” of this Annual Report on Form 10-K under the caption “Directors and Executive Officers”.

ITEM 11 – EXECUTIVE COMPENSATION

The  information  required  by  this  Item  is  incorporated  by  reference  from  the  Company’s  proxy  statement  for  the  2016  annual
meeting of stockholders or a Form 10-K/A, to be filed with the Securities and Exchange Commission within 120 days of the end of the
Company’s fiscal year ended December 31, 2015.

ITEM  12  –  SECURITY  OWNERSHIP  OF  CERTAIN  BENEFICIAL  OWNERS  AND  MANAGEMENT  AND  RELATED
STOCKHOLDER MATTERS

The  information  required  by  this  Item  is  incorporated  by  reference  from  the  Company’s  proxy  statement  for  the  2016  annual
meeting of stockholders or a Form 10-K/A, to be filed with the Securities and Exchange Commission within 120 days of the end of the
Company’s fiscal year ended December 31, 2015.

ITEM 13 – CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The  information  required  by  this  Item  is  incorporated  by  reference  from  the  Company’s  proxy  statement  for  the  2016  annual
meeting of stockholders or a Form 10-K/A, to be filed with the Securities and Exchange Commission within 120 days of the end of the
Company’s fiscal year ended December 31, 2015.

ITEM 14 – PRINCIPAL ACCOUNTING FEES AND SERVICES

The  information  required  by  this  Item  is  incorporated  by  reference  from  the  Company’s  proxy  statement  for  the  2016  annual
meeting of stockholders or a Form 10-K/A, to be filed with the Securities and Exchange Commission within 120 days of the end of the
Company’s fiscal year ended December 31, 2015.

51

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ITEM 15 – EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

(a)

The following is filed as part of this Annual Report on Form 10-K:

PART IV

·

·

Consolidated Financial Statements: The consolidated financial statements and report of independent registered public accounting
firm required by this item are included in Part II, Item 8;

Financial Statement Schedules:  Schedule II, Valuation and Qualifying Accounts, is included in Part II, Item 8.

All other schedules are omitted because they are not applicable or not required, or because the required information is shown either in
the consolidated financial statements or in the notes thereto.

(b) Exhibits: The attached  list  of  exhibits  in  the  “Exhibit  Index”  immediately  preceding  the  exhibits  to  this Annual  Report  on

Form 10-K is incorporated herein by reference in response to this item.

52

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report

to be signed on its behalf by the undersigned, thereunto duly authorized.

SIGNATURES

March 30, 2016

By:

XENETIC BIOSCIENCES, INC.

/s/ MICHAEL SCOTT MAGUIRE
Michael Scott Maguire
Chief Executive Officer and President

POWER OF ATTORNEY AND SIGNATURES

We,  the  undersigned  officers  and  directors  of  Xenetic  Biosciences,  Inc.,  hereby  severally  constitute  and  appoint  Michael  Scott
Maguire, our true and lawful attorney, with full power to him, to sign for us in our names in the capacities indicated below, all amendments
to this report, and generally to do all things in our names and on our behalf in such capacities to enable Xenetic Biosciences, Inc. to comply
with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on

behalf of the registrant and in the capacities indicated below on the 30th day of March, 2016.

Signature

Title(s)

/S/ MICHAEL SCOTT MAGUIRE
Michael Scott Maguire

  President, Chief Executive Officer and Director

(Principal Executive Officer)

/S/ FIRDAUS JAL DASTOOR FCS
Firdaus Jal Dastoor FCS

  Director

/S/ DMITRY GENKIN
Dmitry Genkin

/S/ ROMAN KNYAZEV
Roman Knyazev

  Director

  Director

/S/ DARLENE DEPTULA-HICKS
Darlene Deptula-Hicks

  Director

/S/ ROGER KORNBERG
Roger Kornberg

  Director

53

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EXHIBIT
NUMBER
10.01

10.02
10.03
10.04
10.05
10.06
10.07
10.08
10.09
10.10
10.11
10.12
10.13
10.14
10.15
10.16
10.17
10.18

31.1 *

31.2 *

EXHIBIT INDEX

DESCRIPTION

  Form of Asset Purchase Agreement, dated as of November 13 2015, by and among Xenetic Biosciences, Inc., Lipoxen

Technologies, LTD, a U.K. corporation, AS Kevelt, an Estonian company and OJSC Pharmsynthez (1)

  Form of Ten Percent Senior Secured Convertible Promissory Note (1)
  Form of Common Stock Purchase Warrant (1)
  Form of Management Common Stock Purchase Warrant (1)
  Form of Amended and Restated Ten Percent Senior Secured Convertible Promissory Note (1)
  Form of Amended and Restated Common Stock Purchase Warrant (1)
  Form of Amendment to Securities Purchase Agreement (1)
  Form of Amendment to Registration Rights Agreement (1)
  Form of Amendment to Security Agreement (1)
  Form of Amendment to Subsidiary Guarantee (1)
  Form of Transition Services and Resupply Agreement (1)
  Securities Purchase Agreement (2)
  Ten Percent Senior Secured Collateralized Convertible Promissory Note, dated July 1, 2015 (2)
  Registration Rights Agreement (2)
  Security Agreement (2)
  Subsidiary Guarantee (2)
  Common Stock Purchase Warrant (2)
  Form of Assignment and Assumption Agreement (2)

  Certification of Michael Scott Maguire, Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act

of 2002

  Certification of Michael Scott Maguire, Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act

of 2002

32.1 **

  Certifications of Michael Scott Maguire, Chief Executive Officer and Chief Financial Officer, pursuant to Section 906 of

the Sarbanes-Oxley Act of 2002.

101 *

  The following materials from Xenetic Biosciences, Inc.’s Annual Report on Form 10-K for the year ended December 31,
2015,  formatted  in  XBRL (Extensible  Business  Reporting  Language):  (i)  the  Consolidated  Balance  Sheets,  (ii)  the
Consolidated Statements of Comprehensive Loss, (iii) the Consolidated Statements of Cash Flows, (iv) the Consolidated
Statements of Changes in Stockholders’ Equity, and (v) Notes to Consolidated Financial Statements.

(1)
(2)
*
**

Incorporated by reference to Current Report on Form 8-K filed November 13, 2015
Incorporated by reference to Current Report on Form 8-K filed July 3, 2015
Filed herewith
Furnished herewith

54

 
 
 
 
 
 
 
 
 
 
 
 
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO EXCHANGE ACT RULES 13a-14(a) AND 15d-14(a),
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

EXHIBIT 31.1 

I, Michael Scott Maguire, certify that:

1.

2.

3.

4.

I have reviewed this Annual Report on Form 10-K of Xenetic Biosciences, Inc.;

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;

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;

The registrant’s  other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and  internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a.

b.

c.

d.

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;

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;

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

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.

b.

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

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.

Dated: March 30, 2016

By: /s/ Michael Scott Maguire
Michael Scott Maguire
Principal Executive Officer and President

 
 
 
 
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO EXCHANGE ACT RULES 13a-14(a) AND 15d-14(a),
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

EXHIBIT 31.2

I, Michael Scott Maguire, certify that:

1.

2.

3.

4.

I have reviewed this Annual Report on Form 10-K of Xenetic Biosciences, Inc.;

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;

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;

The registrant’s  other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and  internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a.

b.

c.

d.

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;

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;

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

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.

b.

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

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.

Dated: March 30, 2016

By: /s/ Michael Scott Maguire
Michael Scott Maguire
Principal Financial Officer

 
 
 
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

EXHIBIT 32.1

In connection with the Annual Report of Xenetic Biosciences, Inc. (the “Company”) on Form 10K for the fiscal year ended
December 31, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, the undersigned officer of
the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to
the best of my knowledge:

1.

2.

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company.

Dated: March 30, 2016

By: /s/ Michael Scott Maguire
Michael Scott Maguire
Chief Executive Officer, President and Chief Financial Officer