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DE BEER FUND MANAGEMENT LLC
   619 ORTON AVE, PENTHOUSE 601, FORT LAUDERDALE, FLORIDA 33304
               Email:dada7772@hotmail.com, USA TEL: 1-954-306-6545




               IS PROUD TO INTRODUCE




       Apogee
                                    TECHNOLOGY

H.D. De Beer
A Biotechnology Company Pioneering

     Vaccine and Drug Delivery Technologies

                         via Intradermal and

                              Polyphosphazene Platforms




                                               August 2011
Forward-Looking Statements




This presentation contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995. For this
purpose, any statements contained in this presentation that are not
statements of historical fact may be deemed to be forward-looking
statements. Without limiting the foregoing, the words “believes”,
“anticipates”, “plans”, “expects”, and similar expressions are
intended to identify forward-looking statements. Actual results may
differ significantly from results discussed in the forward-looking
statements. Factors that might cause such differences include those
set forth from time to time in the Company's SEC filings, including in
our annual report on Form 10-K.
Apogee Technology Inc.


Vision: To develop advanced and patient friendly technologies for the
prevention and treatment of infectious diseases and chronic conditions


•   Leader in the field of polyphosphazenes for biomedical applications
•   Intradermal technology licensed from Georgia Tech

•   Diversified Product Pipeline:
         ImmunoMer H; ImmunoMer AH; IgloPatch;
         Other biomedical polyphosphazenes planned
•   World class team of management, advisors and collaborators
World-Class Products, World-Class Partners



     Apogee established relationships and collaborated
     with leading institutions throughout the nation
         - Children’s Hospital Boston
         - Georgia Tech
         - VIDO
         - St. Jude Children’s Research Hospital
The Opportunity
                                                                                   145 Vaccines Under Development*

         Challenges in The Development of New and Improved Vaccines



• Insufficient protective immunity and memory

• High cost

• Need for cold chain distribution system

• No self-administration



                                                                  Apogee’s Integrated Microneedle and
                                                                   Immunoadjuvant Approach offers
                                                                        a compelling solution

Source
*Pharmaceutical Research and Manufacturers of America. 2010 Report. Medicines in
development for Infectious Diseases |
http://www.phrma.org/sites/default/files/422/infectiousdiseases2010.pdf
Polyphosphazenes as Biomedical Macromolecules

  Dial-In Biodegradability
                                               R

                                            (P            N)

                                               R


Unprecedented Structural Diversity – 1,000+ Derivatives
Tunable Properties – Various Potential Applications
 Vaccine    Adjuvants,   Biodegradable    Carriers,   Nanoparticulates,
 Microencapsulation and Modulated release, Microneedles, Biomaterials

High Throughput Discovery
Manufacturing Friendly Chemistry
Polyphosphazene Immunoadjuvants – ImmunoMer Platform


                 PCPP




           • Proven In Vivo Performance: 23 Antigens in 11 Animal Models
           • Enhanced Immune responses, Dose Sparing
           • Demonstrated potency and safety in Clinical Trials
           • CMC, DMF, Stability, Toxicology Data
           • Benign Degradation Products
           • 2 M Doses Available
           • GMP Process Developed
           • New Generation Molecules Synthesized
Immunoadjuvant Effect – Proof-of-Concept

             Enhanced Immune Response (up to 1000x), Long Lasting, Fast Onset, Single Dose



                                                                         Effective in Lethal Challenge Studies in a
                                                                          Relevant Preclinical Animal Model with
                                                                                    Commercial Vaccine:

                                                                       100% protection from mortality with reduced
                                                                                     dose of antigen



                                                                          Antigen Dose Sparing Effect (up to 25x)



                                                                                 Improves Vaccine Shelf-Life



                                                                       Demonstrated Potency in Large Animals with
                                                                            Animal Health Vaccine Antigen



Clinical Trials: Reported Safe and Immunogenic Formulations, ~ 4x increase in neutralizing antibodies
SOURCE:
Bouveret Le Cam NN, et al, Research in Immunology (1998) 149: 19-23; Ison MG, et al, Antiviral research (2002) 55: 227-278
IgloPatch Technology
                                              Band-Aid-Like Microneedle Patches To

                 PCPP - VACCINE                       Deliver Vaccine in The Skin




                                                  Scalable Production Process


 Enhanced with
         Metal
      Support




                                  Microneedle Array
IgloPatch - In Vivo Proof-of-Concept Studies

HBsAg specific IgG Titers
                                                       In Vivo POC studies in a relevant
                                                              animal model - pigs


                                                   5

                                               4



                                           3
                                                                    IgloPatch


                                       2                            Adjuvanted IM

                                  1
                                                                    Non-adjuvanted
                                                                    Microneedles

                                                                     Non-adjuvanted IM
                               Weeks

                 Single Dose
Potential Benefits of IgloPatch Technology



• Improved Efficacy and Single Administration

• Improved Shelf-Life with no Reliance on Refrigeration

• Convenient Band-Aid Like Patch Administration

• Self Application Possible

• Reduced Pain or Painless Compared to Conventional
Apogee’s Intellectual Property Portfolio

       Microneedle Technology Licensed from Georgia Tech:

       Coated Microstructures and Methods of Manufacture Thereof
       H.S. Gill, Harvinder Singh, M.R. Prausnitz
       US 11/917705 (06.19.2006); Pub. No. US 2008/0213461 A1;

       Apogee’s filings on Microneedle Technology and Adjuvanted Formulations:

       Methods and Systems for Coating a Microneedle…
       A.K. Andrianov, A. Marin
       US 12/133,505 (06.05.08); Pub. No. US 2009/0017210 A1;

       Coating Formulation Including Polyphosphazene…
       A.K. Andrianov, A. Marin
       US 12/217,437 (07.02.08); Pub. No. US/0016935 A1

       Immunostimulating Polyphosphazene Compounds for Intradermal Immunization
       A.K. Andrianov, D.P. DeCollibus, H.A. Gillis, H.H. Kha, A. Marin
       US 12/217,402 (07.03.08); Pub. No.2009/0041810 A1;



Apogee plans to get access to PS’s intellectual property portfolio to execute the development of product candidates in the proposed
timeframe. The portfolio relates to polyphosphazene immunoadjuvants, including “new generation” molecules, certain polyphosphazene
synthetic and production processes, microencapsulation and therapeutic protein stabilization methods, as well as some other biomedical
applications of polyphosphazenes that Apogee believes can be complementary to its technology.
Product Pipeline


•ImmunoMer H, immunopotentiating and antigen stabilizing
polyphosphazene agent for parenteral and mucosal human
vaccines

•ImmunoMer AH, immunopotentiating and antigen stabilizing
polyphosphazene agent for parenteral and mucosal animal
health vaccines

•IgloPatch, advanced immunopotentiated microneedle patch
for the application of vaccine to the skin. Potentially offers self-
applied vaccines with reduced dependence on cold chain
distribution
Product Pipeline -Timeline




Apogee plans to get access to PS’s intellectual property portfolio to execute the development of product candidates in the proposed
timeframe. The portfolio relates to polyphosphazene immunoadjuvants, including “new generation” molecules, certain polyphosphazene
synthetic and production processes, microencapsulation and therapeutic protein stabilization methods, as well as some other biomedical
applications of polyphosphazenes that Apogee believes can be complementary to its technology.
Strategy
                                             Assumption for 3 non-exclusive arrangements for 1-2
                                             antigens, $2 million access fee, $1 million and $6 million
Partnerships with vaccine developers
                                             milestones, royalties on sales of 5-15%.
(ImmunoMer H)                                Anticipated milestone timelines:1-2013/2014/2015; 2nd-
                                             2014/2015/2016; 3rd- 2015/2016/2017

                                             Generate valuable preclinical and clinical data at little or
                                             no cost to company (funded R&D) retaining rights for
Collaboration with Global Health
                                             commercial use of developed vaccine. One funded
organizations (all product candidates)       collaboration is currently under way, assumption for two
                                             more in 2011 ($1.1M) and in 2014 ($2M)


                                             Target deal profile: 1.5 million upfront payment in 2012, at
Licensing agreement with Animal Health
                                             least one milestone payment of $3 million in 2013, and
vaccine company (ImmunoMer AH)               royalties on net product sales starting in 2014.


                                         Target deal profile: exclusive or 3-6 antigens in a defined
Licensing agreement with a multinational field, upfront payment of $7 million (2015) and milestones
vaccine company (IgloPatch)              of $3 million and $7 million in 2016, royalties on sales of
                                         5-15%.
Vaccine Market Overview

                                                                        Global Market for preventive vaccines:

                                                                              $22.1 billion in 2009*
                                                       Others                        Predicted Growth:
                                                                                           9.7% *
                                                                             compound annual rate (next five years)




                                                                            **
                                                                                       Presence of current Top
                                                                                        Pharma Companies**
                                                                                            2005 - 3 of 10
                                                                                            2009 - 8 of 10
Sources:
* Kalorama Information | http://www.kaloramainformation.com/about/release.asp?id=1693
** 12th annual World Vaccine Congress Lyon 2010, J. Almond, Sanofi pasteur | http://www.terrapinn.com
Competitive Advantages


 • Worldwide exclusive license from Georgia Tech for coated
      microneedle technology

 • Know-how and world’s expert scientists in
      polyphosphazene field

 • Drug Master File for PCPP as an adjuvant *

 • cGMP produced PCPP*

 • Polyphosphazene immunoadjuvant library,
      polyphosphazene drug delivery library, and biomaterial
      product candidates*


* Upon closing PSI transaction after funding
Competition
Polyphosphazene Company

       Company                  Products                Applications             Customers                Finances
                            Polyphosphazene
  Celonova Bioscience                                  Empolization
                             Nanoparticles                                       Physicians                Private
  (Peachtree City, GA)                                PP coated stent
                              EmbozeneTM

Intradermal Delivery/Adjuvant Companies

       Company                  Products              Applications             Customers                 Finances
                                                   Pandemic Influenza
                                 Patch
                                                     and Traveler's                                   Public-$500MM
        Intercell          Vaccines/Bacterial                               Discovery- Market
                                                    Diarrhea Vaccine                                    Market Cap
                               Adjuvant
                                                        Patches
                             Microneedles                                                           Public-$61B Market
          3M                                            Multiple                 Clinical
                         (plastic)/TLR Adjuvant                                                             Cap
                           Microneedles with
                                                                                                   Private-$90MM NEA,
    Zosano Pharma            PTH, EPO, GM-            Osteoporosis               Phase II
                                                                                                          Numera
                          CSF/GMDP Adjuvant
                             Microinjection                                                         Public-$17B Market
   Becton Dickenson                                 Soluble Vaccines         On the market
                              device/Alum                                                                   Cap
                                                     Small and large
                           MicroCor™ Micro
 Corium International                               molecular weight             Private                  Private
                           Delivery System
                                                       molecules

Other examples of Immunoadjuvants: AF03 (Sanofi Pasteur), ASO3 (GSK Biologicals), MF 59 (Novartis), IC31 (Intercell)
Go to Market Strategy

•   Two additional funded contract research and development
    collaborations with global health or government organizations in
    Q4 2011 and in 2014

•   Licensing agreement with an animal health company by year-end
    2012 to develop ImmunoMer AH technology

•   Three R&D partnerships with vaccine developers in the 2013-2017
    time period for the development of ImmunoMer H adjuvanted
    vaccines

•   Licensing agreement with a multinational vaccine company for
    development of IgloPatch microneedle technology
Business Model

•   Product development partnerships with pharmaceutical and biotechnology
    companies worldwide, license out application rights, maintain manufacturing
    rights
•   IgloPatch Technology: licensing model with multinational vaccine producers:
     •   Exclusive arrangement for 3-6 antigens
     •   Upfront payment of $5 - $20 million
     •   Milestone payments of $5 - $15 million per antigen
     •   5 - 15% royalties on net product sales

•   ImmunoMer H Technology: licensing model with smaller vaccine producers
    or biotechnology companies:
     •   Non-exclusive arrangement for 1-2 antigens
     •   Upfront payment of $1 - $2 million (“Access Fee”)
     •   Milestone payments of $1 - $2 million per antigen
     •   10 - 25% of proceeds upon acquisition of vaccine by a multinational company
     •   5 - 15% royalties on net product sales

•   ImmunoMer AH Technology: collaboration with Animal Health company
•   Other: collaboration with Global Health or Government organizations
    generating technology transfer fees
Financing Requirements

•   Apogee seeks to raise $10 million in one or two rounds of funding
    to develop ImmunoMer H, ImmunoMer AH, IgloPatch technologies,
    as well as to purchase certain assets of Parallel Solutions

•   Anticipated use of proceeds:
     •   Acquisition of PSI

     •   ImmunoMer H Preclinical

     •   ImmunoMer AH Preclinical

     •   Development of IgloPatch

     •   IgloPatch Preclinical

     •   Working Capital (inclusive of transaction costs)
PROJECTED REVENUES AND EXPENSES 2010-2016

$20,000,000

                                                          Revenues

$15,000,000



                                                          Operating Loss/Gain
$10,000,000




 $5,000,000




          $0      1      2      3      4     5      6         7




                                                           Total Expenses
 ($5,000,000)




($10,000,000)

                2010   2011   2012   2013   2014   2015      2016
PROJECTED CONSLIDATED BALANCES 2010-2016

         $20,000,000

                                                                                                        Assets

         $15,000,000




         $10,000,000




          $5,000,000




                  $0          1            2             3            4            5         6      7




         ($5,000,000)
                                                                                                        Liabilities

        ($10,000,000)
                             2010        2011         2012          2013          2014       2015   2016

Financial Assumptions 2010-2016
1.     $10 Million Private Placement
2.      Restructuring of bridge loans (all but $156K) has been effected in the Financials.
3.     Legal fees of $1.5 MM being settled for $600k.
Investment Rationale

• A strong balance sheet will strengthen Apogee’s negotiating
  position with potential strategic partners

• Acquisition of certain assets of Parallel Solutions, Inc. (PSI)
  for 700,000 shares of Apogee stock and 25% of future joint
  venture payments will provide Apogee with access to
  •   PSI’s intellectual property portfolio
  •   Drug Master File
  •   cGMP produced material
  •   Polyphosphazene libraries (new adjuvants, drug delivery) and
      other polyphosphazenes for potential biomedical and industrial
      applications
Apogee Technology
                              Management Team
•   Herbert Stein, CEO and Chairman:
    Mr. Stein brings over fifty years of management experience to Apogee and has served on the boards
    and in executive management positions at several life sciences companies, including as Chairman
    and CEO of Organogenesis.

•   Paul J Murphy, Chief Financial Officer and Vice President of Finance:
     Mr. Murphy has 25 years of experience as Chief Financial Officer of public and private companies.
    Prior to joining Apogee, Mr. Murphy was an independent contractor with JH Cohn, LLP, where he
    worked with public companies to design, assess and test controls for compliance with Section 404 of
    the Sarbanes-Oxley Act of 2002.

•   Alexander K. Andrianov, Ph.D., Vice President of Research and Development:
    Dr. Andrianov, as the inventor of the polyphosphazene immunoadjuvant technology, has unique
    expertise in polyphosphazene chemistry. He is an author of more than 60 scientific papers and book
    chapters, an inventor on 41 issued and pending patents, and an editor of the book “Biomedical
    Applications of Polyphosphazenes”. He has ~20 years of experience in the biotechnology industry
    having served as Chief Scientific Officer of Parallel Solutions, Inc., and in various management
    positions at Avant Immunotherapeutics and Virus Research Institute Inc (VRI). Dr. Andrianov also has
    extensive academic experience as a faculty member in Moscow State University (MSU) and visiting
    scientist at Massachusetts Institute of Technology (MIT) with Professor Robert Langer.
Summary

•   Apogee Technology is a biotechnology company pioneering advanced
    vaccine and drug delivery systems via its proprietary technology platform
•   Core expertise: biomedical polyphosphazenes and their integration into
    value added products
•   Vaccine antigens stabilized and adjuvanted by polyphosphazenes and
    delivered via Apogee’s microneedle technology have demonstrated to
    confer a more potent immune response using reduced amounts of antigen
    and provide an extended shelf life
•   Potential self-administration and reduced dependence on cold chain
    distribution open up developing countries as attractive target markets
•   Licensing agreements with vaccine developers, an animal health company
    and Global Health or Government organizations are expected to generate
    significant revenue from upfront, milestone, and royalty payments, as well
    as funded collaborations
•   In addition to vaccine and drug delivery applications, potential uses of
    polyphosphazenes extend to biomaterials
Apogee Technology Inc.   Confidential




Apogee Technology, Inc.
     Business Plan




        August 2011


                                       1
Apogee Technology Inc.                              Confidential




Certain statements made herein that use the words "anticipate," "may," "hope," "estimate," "project,"
"will," "intend," "plan," "expect," "believe" and similar expressions are intended to identify forward-
looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve those related to the use of proceeds from the private placement,
the design, development and production efforts of our PyraDerm™ and Sensilica® technologies, known
and unknown risks and uncertainties, which could cause the actual results, performance or
achievements of the Company to be materially different from those that may be expressed or implied.
Please refer to the Company's risk factors as set forth in the Company's filings with the Securities and
Exchange Commission, including its report on Form 10-KSB, as amended, for the year ended December
31, 2008, as updated in its quarterly reports on Form 10-Q. The information contained in this press
release is believed to be current as of the date of original issue. The Company does not intend to update
any of the forward-looking statements after the date of this document to conform these statements to
actual results or to changes in the Company’s expectations, except as required by law.




                                                                                                       2
Apogee Technology Inc.                               Confidential




This business plan does not constitute an offer to sell or a solicitation of any offer to buy the securities
to which it relates in any jurisdiction in which, or to any person whom, it is unlawful to make such an
offer or solicitation. Neither the delivery of this business plan nor any offer of sale made hereunder
shall, under any circumstances, create any implication that there has been no change in the information
set forth herein or in the affairs of Apogee Technology since the date hereof.

       This business plan contains confidential and proprietary information of Apogee Technology, which
is for the sole use of its intended recipient. Any unauthorized review, use, disclosure or distribution is
prohibited.

     The financial projections in this business plan were developed by the management of Apogee
Technology and are based on a number of assumptions, some of which are listed here. These
assumptions include the timing and success of our future development efforts, acceptance of our
products, our ability to successfully implement our hiring goals, our average sales price, the size of the
market, our market share, general industry conditions and other matters.

      Although Apogee Technology believes that these assumptions are reasonable, they may be
incomplete or incorrect, and unanticipated events and circumstances are likely to occur. The assumptions
involve significant elements of subjective judgment and analysis, and no representation can be made as
to their attainability. The projected financial information has not been examined, reviewed or compiled
by independent accountants. The projections were not prepared with a view to public disclosure and do
not comply with the published guidelines of the SEC or any state securities commission or the guidelines
established by the American Institute of Certified Public Accountants. Actual results achieved during any
future period may vary from the projections, and the variations may be material and adverse.

       We do not intend to update or otherwise revise these projections to reflect circumstances existing
after the date hereof or to reflect the occurrence of future events, even if the assumptions or estimates
underlying the projections are shown to be in error. Prospective investors should not rely on, and will be
deemed not to have relied on, the projections in making an investment decision.




                                                                                                          3
Apogee Technology Inc.                                Confidential




Company
         Apogee Technology, Inc. is a (ATCS.OB) is a publicly traded development stage company,
developing vaccine and drug delivery technologies and immunomodulating systems for the prevention
and treatment of infectious diseases and chronic conditions. To address the unmet needs of the field,
the Company advances a unique approach based on polyphosphazene macromolecules, which are
designed to enhance biological activity of vaccines or drugs, and display synergistic effect when
integrated with non-conventional administration routes, such as topical (intradermal) delivery using
microneedle enhanced patches. The technology has the potential to enhance protective immunity
induced by vaccines, simplify and decrease the cost of drug or vaccine administration, improve the
efficacy of the treatment, and increase the product shelf-life. Apogee has established a strong
intellectual property position through licensing and filing of several patent applications in the field and
plans to extend it through the acquisition of Parallel Solutions, Inc. The Polyphosphazene approach can
be applied across a range of other disease areas and biomedical applications providing a broad and
flexible platform for the discovery and development of novel drug delivery systems and biomaterials.
Apogee is initially focused on the development of and for the prevention and treatment of infectious
diseases, cancer, and allergies using advanced immunopotentiating and microneedle delivery
technologies - ImmunoMer H, ImmunoMer AH, and IgloPatch.



Technology
Polyphosphazenes

Polyphosphazenes, macromolecules with a phosphorus and nitrogen backbone and organic side groups
(Scheme 1), possess a number of features that make them highly attractive for life sciences applications
and also distinguish them from other classes of biomedical polymers. Firstly, the inorganic backbone is
capable of hydrolytical degradation, which can be modulated through the selection of the appropriate
side group. Secondly, the unique synthetic pathway to these polymers, the so-called macromolecular
substitution, allows a huge selection of substituents to be introduced by common organic chemistry
methods, free of many ambiguities and restrictions associated with polymerization processes. Thirdly,
such methods lend themselves to high throughput synthesis, which accelerates the discovery process.
Fourthly, the unique flexibility of the backbone and its ability to participate in non-covalent bonding and
supramolecular assemblies create new opportunities for the interface with biological systems.




                                                                                                          4
Apogee Technology Inc.                              Confidential

                                DIVERSITY

                                                          BIODEGRADABILITY




                            HT COMPATIBLE
                                                            INTERACTIVE


                                     Scheme 1. Polyphosphazenes



Polyphosphazene Immunoadjuvants

The search for potent, well characterized, and safe vaccine adjuvants and delivery vehicles has been
widely recognized as a key strategic factor in the development of new and improved vaccines [1]. In this
regard, an emerging class of well defined macromolecules, based on a polyphosphazene backbone
(Scheme 2), offers a number of important advantages, both from immunostimulation and delivery
standpoints. Impressive immunopotentiation activity and dose sparing effects of these water-soluble
molecules [2-11] are augmented with the ease of their assembly into supramolecular microparticulate
structures to achieve optimal delivery performance [12-17]. The synthetic origin of polyphosphazene
adjuvants and their well characterized molecular structures assure a high level of reproducibility and
ease of quality control [18-20]. Adequate stability, the “mix and fix” aqueous formulation approach,
which does not involve covalent conjugation with antigen [3], long lasting immune responses, and a
good safety profile, which includes the results of clinical trials in humans, are among other advantages
of this adjuvant system. The polyphosphazene backbone of these molecules allows their biodegradation,
which can be modulated through the choice of the side group and results in the release of
physiologically benign compounds [4, 21-23]. The commercial development of the lead compound is
sustained by the existence of a robust GMP manufacturing process and the availability of a drug master
file to support regulatory applications. A substantial research effort has already been invested in the
field, including work in multiple animal models and with various antigens, both synthetic and
mechanistic studies [2-10]. It becomes evident that the polyphosphazene adjuvant technology evolves
through the discovery of new, more potent derivatives [24-26], development of microparticulate
delivery systems, and the investigation of alternative delivery routes, such as mucosal and intradermal.
The mechanism of action of ionic polyphosphazene immunoadjuvants, which are highly superior to their
non-polyphosphazene counterparts [3, 9], is still largely under discussion. It has been established that
adjuvant activity of PCPP is not associated with a depot formation, as the excision of the injection site
had no detectable effect on the kinetics of antibody induction [7]. The adjuvant activity of PCPP appears
to be linked to its ability to form water-soluble non-covalent complexes with the antigen, a process
which may enhance their interaction with antigen presenting cells [3]. This can be an important factor

                                                                                                       5
Apogee Technology Inc.                               Confidential

taking into account a unique antigen presenting function of dermal dendritic cells mentioned above
[27]. More recent evidence suggests that PCPP activates innate immune cells to secrete IL-4 and IL-12
[28]. Since these cytokines are known to influence adaptive immune responses, activation of innate
immunity may be important in mediating the adjuvant activity of PCPP. Regardless of the mechanism,
PCPP appears to display immunoadjuvant activity with a broad spectrum of viral and bacterial antigens,
which are of interest in combating such important infectious diseases as influenza, hepatitis B, herpes,
tetanus, and HIV [11].




             Scheme 2. A Representative Structure of a Polyphosphazene Vaccine Adjuvant



Intradermal Immunization

Skin is an attractive organ for administration of vaccines since it constitutes an anatomic barrier,
defending the body against external pathogens. Targeting of vaccine compounds to skin and/ or skin-
draining lymph node dendritic cells (DCs) is a valuable strategy to induce robust cellular responses that
protect against infectious and chronic diseases caused by intra-cellular pathogens. The unique antigen
presenting function of skin draining lymph node DCs has been the focus of intense studies for the
purpose of vaccine development [27]. Intradermal vaccination approaches have a potential to facilitate
induction of more potent immune responses and provide the basis for a significant antigen sparing
effect [29-34]. The latter can be highly desirable during times of vaccine shortages, such as epidemic
emergencies, and can also reduce the cost of vaccine manufacturing, which is especially important for
expanding vaccine use in less developed areas of the world [33, 35]. This could increase the possibility of
mass intradermal vaccination programs and result in major global health benefits, particularly in areas
where access to healthcare personnel is an issue.

Microneedle Technology for Intradermal Administration of Vaccines

Although the intradermal immunization approach appears to be promising, its technical realization faces
significant challenges, such as special training of personnel who would be needed to administer
vaccinations through the intradermal route effectively [36]. Microneedles and micro-injection devices


                                                                                                         6
Apogee Technology Inc.                               Confidential

can provide a convenient alternative potentially offering ease of application and distribution, possibility
of self-administration and pain-free delivery [37].

Apogee Technology, Inc. is engaged in the development of microneedle systems (Fig. 1), which utilize
sub-millimeter structures to pierce the stratum corneum and deliver vaccines in the epidermis or dermis
compartments [37-40]. Microneedles are designed to combine vaccine formulation as a solid coating,
and metal, as a supporting material to provide the required mechanical strength. Once applied to the
skin, these formulations dissolve to release vaccine antigen in the skin compartment. Solid vaccine
formulations used in such systems are especially attractive since they also potentially offer improved
shelf life and reduced dependence on temperature-controlled supply chains [41, 42]. These
microneedles can also potentially be self-
administered and safely disposed of. Thus the
technology can significantly reduce biohazard
risks and drastically lowers the cost of
disposal as compared to contaminated
needles and syringes.



Polyphosphazene    Immunoadjuvants          for
Intradermal Immunization



A significant barrier on the way to a successful
development of microneedle vaccines is a
reliance of modern vaccine technologies on
immune-enhancing            additives,      i.e.,
immunoadjuvants, to engender the desirable
protective      immune        responses     [1].
Unfortunately, many of the currently
employed vaccine adjuvants may not be
compatible with intradermal delivery
approaches. For example, alum, which is the
most common adjuvant used in the vaccine
market globally [1] and one of only two
adjuvants currently approved in the United
States, was shown to induce serious adverse
effects, such as formation of granulomas, when administered intradermally [43]. Other advanced
adjuvants, which contain biphasic systems, such as oil emulsions or liposomes, may not be sufficiently
stable to withstand the microneedle coating and drying processes. Although there are clear indications
that intradermal immunization can potentially offer significant improvements over intramuscular



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Apogee Technology Inc.                             Confidential

vaccination [37], it appears that the majority of studies have been conducted using non-adjuvanted
vaccine formulations.




Apogee Technology develops microneedle systems, which utilize polyphosphazene adjuvants, both as
immunostimulant and microfabrication material. Polyphosphazene polyelectrolytes are one of the most
remarkable classes of vaccine adjuvants due to their macromolecular nature, well-defined structure, and
synthetic origin and have demonstrated excellent immunomodulating potential when tested in multiple
animal models with both viral and bacterial antigens [2, 5, 7, 11, 44]. The lead compound,
poly[di(carboxylatophenoxy)phosphazene] (PCPP) has been advanced into clinical trials [45-47] and
PCPP formulated vaccines were reported to be safe and immunogenic in humans [45, 46]. Most
importantly, the macromolecular nature of PCPP ensures excellent film forming and microencapsulating
properties [12, 13]. It has been also demonstrated that PCPP can protect and stabilize vaccine antigens

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Apogee Technology Inc.                              Confidential

during the microfabrication process [48, 49]. PCPP is a water-soluble molecule, which can be formulated
with proteins in aqueous solutions under mild conditions [3] and has the potential to be dissolved easily
in a highly hydrated environment, such as skin. Finally, dual functionality of such a molecule, as an
immunoadjuvant and film forming/microfabrication material, eliminates the need for the use of
additional macromolecular excipients and thus can potentially result in a higher vaccine loading
capacity.

Synergy between Polyphosphazene Immunoadjuvant and Microneedle Technology Creates New
Approach to Intradermal Immunization

Recent studies conducted by Apogee have demonstrated that a macromolecular adjuvant, PCPP,
exhibits potent immunoadjuvant activity when delivered intradermally and also enables efficient
incorporation of vaccine antigens into microfabricated delivery devices.

In vivo proof-of-concept studies in pigs using recombinant Hepatitis B surface Antigen (HBsAg)
demonstrated that Apogee’s intradermal delivery systems dramatically increase antibody responses
                                          compared to intramuscular administration of non-
                                          adjuvanted and adjuvanted formulations after a single
     Residual activity, %
                                          dose immunization (Fig. 2a). They also provide significant
    100
                                          antigen sparing ability (Fig. 2b). These results appear
     80                                   especially significant as the anatomy of pig skin presents a
                             1
                                          reasonable model for human skin [50]. In fact, a powerful
     60                                   synergistic effect between microneedle system and
                                          polyphosphazene        adjuvants    observed      in   these
     40
                                          immunization studies requires further mechanistic studies
                                          focusing on the specifics of immunological pathways
     20
                                          associated with delivery to skin and the role of PCPP.
             2
     0
         0       5    10     15     20         PCPP is not only compatible with solid state microneedle
                                  Time, days   technology, but can potentially eliminate the need for
     Fig. 3. Residual enzymatic activity of    inert “engineering” polymers, such as CMC, whose sole
     HRP encapsulated on microneedles (1)
     and in aqueous solution (2) during
                                               role is to serve as a microfabrication material. Since both
     accelerated thermal stability studies as  immunostimulating and “engineering” functionalities can
     a f unction of time (80° C).
                                               now be integrated in a single compound - PCPP - the
                                               approach creates opportunities for maximizing antigen
doses or achieving faster dissolution profiles using the same amount of the formulation. The results also
suggest that PCPP can potentially provide surfactant-free or low surfactant coating solutions allowing
more flexibility in formulation development, which is especially important when high contents of
surfactant are undesirable [42, 51].

The micro-dip coating process utilized by Apogee is anticipated to be scaleable and inexpensive. A
number of proprietary methodologies have been developed to assure accurate and reproducible dosing
of the vaccine formulation [52]. The results of recent studies also showed no loss of activity in the


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coating process utilizing model protein compounds, which indicated high efficiency of encapsulation in
the process of microneedle fabrication [52].

One of the most significant potential advantages of solid state microneedle technology, being developed
by Apogee, is an expected improved shelf life of solid state formulations as compared to their solution
counterparts. Stability of microneedles containing model biological, Horse-Radish Peroxidase (HRP) was
compared to the same enzyme in aqueous formulation at 80 °C (Fig.3). The accelerated degradation
profiles show a dramatic improvement in the stability of a solid state formulation as compared to HRP in
solution [52]. As mentioned above, the stability and better shelf-life of the microneedle formulations
can be a critical parameter in decreasing the reliance of vaccine distribution on cold chain supply,
resulting in a major global health benefit.



Business Strategy
        Apogee’s business strategy is to develop high value vaccine and drug enabling systems based on
unique polyphosphazene technology synergized with advanced delivery approaches. Our core expertise
is the development of novel biomedical, immunopotentiating and protein stabilizing polyphosphazenes
and their integration into value added products. Due to high costs of vaccine development and
regulatory approval, we intend to develop products thru partnerships, further licensing out application
rights while maintaining manufacturing rights.

         Apogee will pursue partnerships with pharmaceutical and biotechnology companies worldwide,
which conduct preclinical and clinical development of cutting edge vaccine candidates with a need for
immunopotentiators or advanced delivery systems. Under a partnership agreement we would jointly
invest in the preclinical and, potentially, phase I/II clinical product development and then license them
either to a strategic partner or a third party for completion of clinical development, registration, and
product marketing. These deals will generate multi-million upfront payments, milestones and double
digit royalties.

         The company will also pursue licensing agreements with multinational vaccine producers that
are in the need of advanced immunopotentiators and delivery systems for multiple antigens. We would
provide rights to our intellectual property in exchange for license fees, milestone development
payments and royalties tied to product sales. Target deal profile may include exclusive or semi-exclusive
arrangement, use with 3 to 6 antigens in defined field (infectious disease, allergy or cancer), upfront
payment ($10M-20M), milestones ($5M - 15M per antigen), royalties (5 - 15% depending upon disease,
exclusivity), subsidized research, and follow-on or extension deals with other antigens or fields.

        Apogee may enter into collaborations with Global Health organizations for the development of
vaccines for developing countries. The Company anticipates these efforts to be subsidized, with a
potential technology transfer fee upon completion of preclinical or clinical evaluation. Since, each
immunopotentiator or delivery system can be used or tested with a variety of antigens, this provides an
opportunity to generate valuable, including clinical data and benchmarking against competing systems

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at little or no cost to the Company. Apogee intends to pursue similar opportunities for Public Health
vaccines in US actively seeking government subsidized R&D studies, also involving commercial partners.

        In the Animal Health vaccine industry we plan to enter into a short term joint evaluation studies
and sell our rights to one or two leading companies in the field, generating significant short term
revenues targeting Q4 2012, which will allow us to more aggressively, pursue other high value added
partnerships.

        Apogee has already initiated discussions with several potential partners. Apogee’s strategy for
establishing strong partnership deals include selecting antigens and animal models of relevance to
vaccine developers, compatibility with other immunopotentiators and delivery systems, and
benchmarking our systems against our competitors.



Product Pipeline
        Apogee’s product pipeline consists of the following proprietary systems: ImmunoMer H,
immunopotentiating and antigen stabilizing polyphosphazene agent for parenteral and mucosal human
vaccines, ImmunoMer AH, immunopotentiating and antigen stabilizing polyphosphazene agent for
parenteral and mucosal animal health vaccines, and IgloPatch, advanced immunopotentiated
microneedle patch for the application of vaccine to the skin. We plan to integrate these systems with
novel vaccine antigens in partnerships with industry leaders developing new vaccines, governmental and
world health organizations to develop breakthrough vaccines with enhanced protective immunity,
improved safety profiles, and superior term shelf-life, with IgloPatch product potentially offering self-
applied vaccines with reduced dependence on cold chain distribution.




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                            Table 1. Projected Product Development




         Apogee identified a number of novel vaccine candidates that are currently in clinical or pre-
clinical development, which we believe are ideally suited to be enhanced by our immunopotentiating
systems with many proof-of-concept in vivo experiments already completed. Apogee anticipates
entering into the agreements on the co-development of these vaccines within approximately 6 months
after receiving funding and conduct preclinical and clinical development of Public Health and World
Health vaccines under the terms of appropriate funding from potential partners.




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                                  Table 2. Identified Target Antigens




1
  A.K. Andrianov et al., Proc. Natl. Acad. Sci. USA, 2009, 106:18936
2
  G. Mutwiri, in “Polyphosphazenes for Biomedical Applications” A.K. Andrianov, Ed., John Wiley & Sons,
2009, 77
3
  A.K. Andrianov et al., J. Pharm. Sci., 2011, 100 (4), 1436
4
  K. Johansen, in “Polyphosphazenes for Biomedical Applications” A.K. Andrianov, Ed., John Wiley &
Sons, 2009, 85




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        In order to execute commercial development of ImmunoMer H, ImmunoMer AH, and
polyphosphazene related part of IgloPatch in the proposed timeframe, Apogee believes that it needs to
gain access to certain patents of Parallel Solutions, Inc. (PSI), which it plans to acquire upon receipt of
funding proceeds. Intellectual property of PSI also includes other biomedical polyphosphazene
technologies, such as therapeutic protein stabilization methods, which can be highly complementary to
Apogee’s microneedle system, IgloPatch, and can enhance characteristics of our patch systems for the
delivery of therapeutics. Upon acquisition of PSI, Apogee plans to seek externally funded partnership to
conduct in vivo proof-of-concept studies of these technologies.



Intellectual Property
          Apogee has already established a strong intellectual property position through licensing and
filing of several patent applications in the field. Patent application related to microneedle device, related
compositions and manufacturing methods was licensed from Georgia Institute of Technology (Professor
M.R. Prausnitz):

Coated Microstructures and Methods of Manufacture Thereof
H.S. Gill, Harvinder Singh, M.R. Prausnitz
US 11/917705 (06.19.2006); Pub. No. US 2008/0213461 A1; provisional No. 60/691,857 (06.17.2005), No
60/732,267 (11.1.2005); PCT/US2006/023814 (06.19.2006); Int. Publ. No. WO 2006/138719 A2;
EP20060785110.

        Apogee has filed the following patent applications related to microneedle technology and the
use of polyphosphazenes as intradermal immunopotentiator and as coating reagents for microneedle
technology.

Methods and Systems for Coating a Microneedle with a Dosage of a Biologically Active Compound
A.K. Andrianov, A. Marin
US 12/133,505 (06.05.08); Pub. No. US 2009/0017210 A1; provisional 60/948,500 (07.09.07);
PCT/US2008/007200 (06.09.08); Int. Publ. No. WO2009/008951 A2; EP20080768269.


Coating Formulation Including Polyphosphazene Polyelectrolytes and Biologically Active Agents and
Asperities Coated with Such Formulations
A.K. Andrianov, A. Marin
US 12/217,437 (07.02.08); Pub. No. US/0016935 A1, provisional 60/948,540 (07.09.2007)
PCT/US2008/008265 (07.03.08); Int. Publ. No. WO 2009/009004 A1; EP20080768862.

Immunostimulating Polyphosphazene Compounds for Intradermal Immunization
A.K. Andrianov, D.P. DeCollibus, H.A. Gillis, H.H. Kha, A. Marin
US 12/217,402 (07.03.08); Pub. No.2009/0041810 A1; provisional 61/125,576 (04.25.2008) and
60/948,540 (07.09.07); PCT/US2008/008230 (07.03.08); Int. Publ. No. WO 2009/008988A1;
EP20080779950.



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        In order to execute commercial development of ImmunoMer H, ImmunoMer AH, and
polyphosphazene related part of IgloPatch in the proposed timeframe, Apogee believes that it needs to
gain access to certain patents of Parallel Solutions, Inc. (PSI), which it plans to acquire upon receipt of
funding proceeds. Intellectual property of PSI also includes other biomedical polyphosphazene
technologies, such as therapeutic protein stabilization methods, which can be highly complementary to
Apogee’s microneedle system, IgloPatch, and can enhance characteristics of our patch systems for the
delivery of therapeutics.




Competitive Advantage
         There is an unmet need for new immunoadjuvants (immunopotentiators) and alternative
administration routes for the delivery of vaccines. A major bottleneck in vaccine development is the lack
of suitable adjuvants for adult and pediatric vaccine use. Until recently, vaccine research and
development focused nearly exclusively on the antigen component of the vaccine that induces a specific
immune response in the body to protect against a particular disease. Contemporary vaccines
increasingly rely on another component – immunoadjuvant, which does not induce the immune
response on its own, but is capable of amplifying it dramatically to make the vaccine more potent,
reduce the dose of the antigen and a number of required administrations, and achieve more rapid and
longer-lasting protective immunity. Alternative delivery routes, such as intradermal vaccination, further
have a potential to simplify and decrease the cost of drug or vaccine administration, improve the
efficacy of the treatment, and increase the product shelf-life.

         There are two vaccine adjuvants (immunopotentiators) currently approved in the United States
– Alum, which has been used with multiple vaccines for decades (public domain), and recently approved
ASO4 for use in Cervarix HPV Vaccine (GSK Biologicals). MF59 (Novartis Vaccines), has been also
approved in Europe. All of these immunopotentiators are heterogeneous (biphasic) systems that are
either incompatible with many advanced delivery systems, such as microneedles, or reactogenic or
inefficient when delivered intradermally or mucosally, important delivery modalities. Although there are
a number of immunopotentiators that are currently under development, such as AF03 (Sanofi Pasteur),
ASO3 (GSK Biologicals), IC31 (Intercell), various TLR agonists (3M), and others, they have similar
limitations and may face other challenges in the approval process.

        Polyphosphazene immunopotentiators, PCPP and newer generation molecules have the
following features, distinguishing them from other similar systems:

        Well-defined synthetic molecular immunopotentiator;
        Vaccine Stabilization Agents for prolonged shelf life;
        Proven Parenteral, Mucosal, Intradermal Immunopotentiator with higher, sustained immune
        response with quick onset and improved immunological memory;
        Antigen sparing effect;
        Strong safety and tolerability track record in clinical trials;

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Apogee Technology Inc.                             Confidential

       Compatibility with solid microneedles;
       Can be formulated in nanoparticulates for synergistic vaccine delivery effect;
       Technology platform with newer, more potent immunopotentiators through High Throughput
       Discovery;
       Excellent compatibility with other immunopotentiating systems.


    There are a number of companies developing solid microneedle technologies for biomedical
applications, such as Zosano, Corium, Theraject, and 3M, however most of them focus on therapeutic
applications and lack compatible immunopotentiators. Published report by Zosano on the use of small
molecule immunopotentiator (GMDP, not suitable as a microfabrication material), indicated that the
adjuvant worked intradermally, but its effect was 10 times less than when it was used parenterally. In
contrast, Apogee’s system showed at least order of magnitude higher performance of polyphosphazene
immunopotentiator when administered intradermally compared with intramuscular administration.

   The Company believes that the advantages of Apogee’s microneedle technology are as follows:

       Proven synergy of adjuvant and intradermal delivery;
       Dual role of polyphosphazene as microfabrication material provides higher loading
       Stabilization effect of polyphosphazene and improved microfabrication rate reduces stress on
       vaccine antigen improving efficiency of loading;
       Reduced reliance on surfactants in the microfabrication process;
       Precise dosing of antigen to overcome one of the most critical challenges of the technology.




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Market Analysis


                                     Vaccine Market Overview

                                                                              Global Market for preventive vaccines:

                                                                                    $22.1 billion in 2009*
                                                             Others                        Predicted Growth:
                                                                                                 9.7% *
                                                                                   compound annual rate (next five years)




                                                                                  **
                                                                                             Presence of current Top
                                                                                              Pharma Companies**
                                                                                                  2005 - 3 of 10
                                                                                                  2009 - 8 of 10
      Sources:
      * Kalorama Information | http://www.kaloramainformation.com/about/release.asp?id=1693
      ** 12th annual World Vaccine Congress Lyon 2010, J. Almond, Sanofi pasteur | http://www.terrapinn.com




        The global market for preventative vaccines topped $22 billion in 2009 and is predicted to
increase at a compound annual rate of 9.7% during the next five years, as new product introductions
continue and the use of current products expands further in all regions. Vaccines are commonly
segmented into two target markets, adult and pediatric. The pediatric vaccine market is larger,
accounting for more than half of the total market and is also growing at a faster rate than adult vaccines
and this is expected to continue over the next five years. Geographically US will continue to lead the
vaccines market followed by Europe. Japanese vaccine market has also started to open up further from
regulatory and political barriers. The large population in countries like India and China, high prevalence
of diseases and emergence of new pandemics are some of the important factors posting tremendous
growth in vaccine market. This sector is expected to grow at a rate of 14% during 2009-2012.

         In 2009, pandemic influenza vaccines were the best selling vaccines with sales of over $ 5 billion
followed by hepatitis B vaccines. The worldmarket of Hepatitis B Vaccine was $ 1.2 billion. Of the 350
million to 400 million individuals worldwide infected with the hepatitis B virus (HBV), one-third reside in

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China, with 130 million carriers and 30 million chronically infected. Pneumococcal vaccine (Prevnar) has
crossed the sales of US$ 1 Billion in 2007 and became the first vaccine to reach nearly US$ 3 Billion
annual sales by 2009. Pneumonia is the world's leading killer of children younger than 5 years, and is
one of the foremost vaccine-preventable killers of children today. Every year, pneumococcal disease kills
about 1 million children worldwide. The Advanced Market Commitment (AMC) initiative for
pneumococcal vaccine was launched in June, 2009 with the intention to help prevent pneumonia. With
$1.5 billion funding from Canada, Italy, Norway, Russia, the UK, and the Bill & Melinda Gates
Foundation, the initiative is aiming to create a market to ensure demand for, and supply of,
pneumococcal vaccines for developing countries. Sales of Cervical cancer vaccines (HPV) have crossed $
1 Billion by 2007 and are forecasted to cross $ 4 Billion mark by 2012. Market for Rotavirus and polio
vaccines has crossed $ 1 Billion each in 2009. Malaria vaccine market for public is expected to cross $
400 Million by 2025.

        Due to existing threat of terrorism Bio-protection vaccines are an important segment of the
market. US government poured billions into building strategic stockpiles of these vaccines (influenza,
bioterror) and R&D funding for new production technologies. The Bio-protection vaccines market is
expected to grow with an annual rate of 12.08% percent from 2009 to 2015.

         Pharmaceutical Research and Manufacturers of America lists 145 vaccines under development
in US only, to prevent a variety of infections. A large number of vaccines that are currently under
development, both in US and worldwide, are designed to combat important emerging or neglected
diseases, for which there is currently no preventive treatment. Norovirus infection, more commonly
known as the “stomach flu”, is the most common cause of acute gastroenteritis in the U.S. A systematic
review of studies performed by the CDC estimated that norovirus causes an annual 64,000
hospitalizations and 900,000 clinical visits among children in industrialized nations and up to 200,000
death of children < 5 years of age in developing countries. Chlamydia is a common sexually transmitted
disease (STD) caused by the bacterium, Chlamydia trachomatis. Chlamydial infections in women, which
are usually asymptomatic, can result in pelvic inflammatory disease, which is a major cause of infertility,
ectopic pregnancy, and chronic pelvic pain. CDC reports high prevalence of chlamydial infections in the
general U.S. population. Among young adults (aged 18–26 years) who participated in the nationally
representative National Longitudinal Study of Adolescent Health (Add Health) during 2001–2002,
chlamydia prevalence was 4.2%. A vaccine against recurrent vulvovaginal candidiasis (VVC) would
benefit a large number of women who suffer from this debilitating syndrome. The disease has a
significant effect on quality of life and poses a huge burden to the health care system. CDC estimates
that 75% of women will have at least one episode of VVC, and 40%–45% will have two or more episodes
within their lifetime. Approximately 10%–20% of women will have complicated VVC that necessitates
diagnostic and therapeutic considerations. Global candidiasis therapeutics market was valued at $1.57
bn in 2009. Hand, foot, and mouth disease (HFMD) is another common viral illness in infants and
children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although
most HFMD do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71)
can present with a high rate of neurological complications, including meningoencephalitis, pulmonary
complications, and possibly death. HFMD caused by EV71 has become a major emerging infectious


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disease in Asia with approximately 1,155,000 new cases of HFMD in mainland of China only, and 353
deaths. A number of commercial entities and academic groups are working on the development of
vaccines in these areas and Apogee’s immunopotentiating, delivery, and stabilization systems can
potentially play an important role in enabling these vaccines, accelerating their development, reducing
required doses, improving shelf-life and enhancing their protective immunity.

       The worldwide vaccine market is dominated by five major competitors: Merck & Co,
GlaxoSmithKline, Sanofi Pasteur, Pfizer, and Novartis. Examples of other vaccine companies include
AlphaVax, Inc., Bavarian Nordic A/S , Baxter Healthcare, Bharat Biotech, Celldex Therapeutics, Crucell,
Emergent Biosolutions, Medimmune, Nabi Biopharmaceuticals.

         Global Veterinary Vaccines Market to reach $5.6 Billion by 2015. The market is split between
Livestock Vaccines (Porcine Vaccines, Bovine Vaccines, Poultry Vaccines, Ovine Vaccines, Equine
Vaccines, & Other Animal Vaccines) and Companion Vaccines (Canine Vaccines, & Feline Vaccines) with
the first representing the largest product segment of about 63% in 2006. Growth in the Livestock
Vaccines market is essentially driven by Porcine Vaccines market, which not only accounts for a majority
share of the total market but is also one of the fastest growing segments. Revenues from porcine
vaccines market are estimated to be approximately $1 billion mark in 2010. United States and Europe
collectively capture more than 60% of the worldwide Veterinary Vaccines market. United States
companion animal vaccines market is estimated to be approximately $410 million in 2010. Europe is a
major market for veterinary vaccines and medicines across the globe. France, Germany and United
Kingdom account for over 40% of the veterinary vaccine sales in Europe.

        Key players in the marketplace include Bayer HealthCare AG, Biogenesis-Bago, Boehringer
Ingelheim GmbH, Heska Corporation, Imugene Limited, Indian Immunologicals Ltd, Lohmann Animal
Health, Merck & Co. Inc., Intervet/Schering-Plough Animal Health, Merial Ltd., Pfizer Inc., Embrex Inc.,
Fort Dodge Animal Health, Virbac Corporation, among others.



Operational Plan
Progress to Date

       Since the start of our biomedical project, the Company has reached a number of important
milestones including:

       Establishment of the laboratory and the initiation of R&D work in 2006;
       Completion of the licensing agreement for the microneedle technology from Georgia Tech;
       Development of the prototype microneedle fabrication process, arrays, and patches, and
       identification of critical external suppliers and main quality control methods;
       Completion of in vivo proof-of-concept study (in collaboration with Vaccine and Infectious
       Disease Institute) for Apogee’s microneedles which demonstrated superior potency of IgloPatch



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        and synergy between polyphosphazene and intradermal delivery and resulted in a publication in
        Proceedings of National Academy of Sciences U.S.A.;
        Filing of 3 patent applications;
        Completion of in vivo proof-of-concept study (in collaboration with St. Jude Hospital) of
        immunopotentiation technology and pandemic influenza vaccine, which demonstrated the
        ability of Apogee’s formulations to protect animals in a lethal challenge study at a significantly
        reduced dose;
        Demonstration of the stabilizing effect of Apogee’s technology on vaccine and other biologics as
        a proof-of-concept for the improved shelf-life;
        Award of R&D contract from Children Hospital Boston for the development of
        immunoadjuvanted formulations of vaccines for newborns, and successful and timely
        achievement of milestones to date.

Facilities and Equipment

          Apogee Technology is headquartered in Norwood, MA and established state-of-the art research
facilities include a formulation and characterization laboratory (360 sq.ft.) and an additional 670 sq.ft. of
lab support space.

The analytical section of the laboratory is equipped with Hitachi LaChrom Elite High Performance Liquid
Chromatography (HPLC) system with multi-detection capabilities (L-2I3OHTA pump and degasser, L-
2200 autosampler, L-2455 Diode array detector, and L-2490 refractive index detector), UV/Vis
spectrophotometer (HITACHI U-2810), analytical balance (AL204, Mettler Toledo), pH Meter (SevenEasy,
Mettler Toledo), a stereo zoom microscope (STZ-45-BS-FR) with a digital camera (Caltex Scientific, Irvine,
CA), Bunton MACROZOOM-FL microscope system (Bunton Instrument Company, Inc.), and a
stereomicroscope (model ML-40STER, Home Science tools).

The formulation section of the facilities is equipped with a fume hood, FreeZone 2.5 Lyophilizer
(Labconco), an incubated orbital shaker (model 4450), vortex mixers (12-810-1, Fisher Scientific;VM-
3000,VWR), an orbital shaker (model 51300-00, Cole Parmer), heated magnetic stirplates (models
12620-982, 12365-82 VWR), a vacuum oven (model 1410, VWR), a refrigerated vapor trap (model
RVT4104 Savant), vacuum pumps (VP 100, Savant and 8907, Welch), a centrifuge (model 5702,
Eppendorf), an ultrasonic water bath (model 50HT, VWR), and a heated water bath (model 182,
Precision). The microneedle coating facility is equipped with coating apparatuses, syringe pumps, and X-
Y-Z micro-positioning systems. Supporting facilities include flammable safety storage cabinet, gas supply
lines and manifolds (nitrogen, carbon dioxide and compressed air), B-Pure deionization and water
filtration system, a microwave oven, a freezer, and refrigerators.



Deal Throughput

      Apogee intends to finalize the acquisition of PSI technology as soon as funding is complete. The
Company plans to enter at least 3 research and commercialization collaboration in Q4 2011 and Q1-Q2

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2012, one with the animal health vaccine company, another for a funded R&D collaboration with Global
Health or Government organization, and one with the commercial developer of vaccine of interest. Each
collaboration envisaged will give the partner access to ImmunoMer for use with their antigens. These
collaborations are expected to provide significant cash flow to the company in the medium term. Based
on these and other collaborations, Company envisions one licensing agreement in Q4 2012, one in Q3
2013, and another in Q1 2014.



Projected growth

To meet our stated objectives and deliverables the Company will need to add personnel, equipment and
acquire additional laboratory and office space.



Employees: We project our total staff will increase to 24 employees by 2016. In the business operations
group, significant emphasis will be placed on adding individuals with partnering capabilities, program
management, business development, and regulatory experience. On the R&D side, expertise will be
added in immunology, polymer and biochemistry, various areas of assay development, formulation and
manufacturing. The ratio of PhD to Technician (BS or MS level) for our laboratory staff will be roughly
1:2. Many upstream capabilities will be accessed through the Company’s corporate alliances and
through a strong network of outside advisors and vendors.




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                                              Business Model
                                               Competition
        • Product development
Polyphosphazene Company            partnerships with pharmaceutical and biotechnology
             companies worldwide, license out application rights, maintain manufacturing
       Company           Products          Applications       Customers         Finances
             rights  Polyphosphazene
  Celonova Bioscience                                   Empolization
                        Nanoparticles                                            Physicians                Private
           • IgloPatch Technology:
  (Peachtree City, GA)
                        EmbozeneTM           licensing coated stent multinational vaccine producers:
                                                     PP model with

               •      Exclusive arrangement for 3-6 antigens
Intradermal Delivery/Adjuvant Companies
               •      Upfront payment of $5 - $20 million
       Company
               •      Milestone payments of $5 - $15 million per antigen
                              Products            Applications          Customers                        Finances
               •      5 - 15% royalties on net product sales
                                              Pandemic Influenza
                                Patch
                                                and Traveler's                            Public-$500MM
           • ImmunoMer H Technology: licensing model with smaller vaccine producers
       Intercell         Vaccines/Bacterial
                                               Diarrhea Vaccine
                                                                     Discovery- Market
                                                                                            Market Cap
                              Adjuvant
               or biotechnology companies: Patches
                           Microneedles
                 • Non-exclusive arrangement for 1-2 antigens                          Public-$61B Market
          3M                                       Multiple               Clinical
                       (plastic)/TLR Adjuvant                                                   Cap
                 • Upfront paymentwith$1 - $2 million (“Access Fee”)
                         Microneedles of
                 •                                                                     Private-$90MM NEA,
    Zosano Pharma Milestone payments of $1 - Osteoporosis
                           PTH, EPO, GM-         $2 million per antigen Phase II
                                                                                              Numera
                 • 10 -CSF/GMDP Adjuvant upon acquisition of vaccine by a multinational company
                         25% of proceeds
                 •         Microinjection
   Becton Dickenson 5 - 15% royalties on net product sales
                                               Soluble Vaccines        On the market
                                                                                       Public-$17B Market
                            device/Alum                                                         Cap
           •   ImmunoMer AH Technology:Small and large with Animal Health company
                                        collaboration
                          MicroCor™ Micro
 Corium International                               molecular weight             Private                  Private
           •   Other:      Delivery System
                        collaboration with
                                        Global Health or Government organizations
                                             molecules
               generating technology transfer fees
Other examples of Immunoadjuvants: AF03 (Sanofi Pasteur), ASO3 (GSK Biologicals), MF 59 (Novartis), IC31 (Intercell)




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                              Competitive Advantages


 •    Worldwide exclusive license from Georgia Tech for coated
      microneedle technology

 •    Know-how and world’s expert scientists in
      polyphosphazene field

 •    Drug Master File for PCPP as an adjuvant *

 •    cGMP produced PCPP*

 •    Polyphosphazene immunoadjuvant library,
      polyphosphazene drug delivery library, and biomaterial
      product candidates*


* Upon closing PSI transaction after funding




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Partnering

        Company envisions one licensing agreement in Q4 2012, two in Q3 2013, and another in Q1
2014.



Leverage external resources

         The Company does not plan to establish in-house capabilities to execute in-vivo evaluation of
our immunopotentiation and intradermal delivery. In addition to planned partnership, Apogee has
already established collaborations with Children Hospital Boston, and can reactivate previous
collaborations with VIDO and St. Jude Hospital and enter new R&D agreements to provide cost-effective,
flexible and timely access to animal models needed to evaluate our systems. The relationships with
governmental and university researchers provides a low cost (no cost) mechanism to investigate
broader applications of our platform.



Government funding

         Apogee plans to apply for grant funding from Global health organizations and governmental
agencies to support preclinical and clinical development of its technologies. The Company has already
applied this strategy in an ongoing collaboration with Children Hospital of Boston, which allowed to get
support for some of Companies vital R&D efforts.



Royalties paid on licenses

        The Company entered in a 50 year exclusive worldwide licensing agreement in March of 2007
for a microneedle technology with Georgia Institute of Technology.



Financial model assumptions – Revenues:

        Apogee has already generated revenues external collaborations and believes it can continue and
increase generation of revenues from partnerships. In the early years, revenue is projected to come
from milestone payments and royalties. Baseline business projections foresee the completion of 3
corporate deals by early 2014.

Each deal gives a partner the right to use PSI’s technology with the antigen of interest, although in the
animal health vaccine area we expect to give exclusive rights to our technology for livestock and
companion market segments. The deal structure envisions a series of success-based milestones and
subsequent product royalties for each of the antigens.


                                                                                                      24
Apogee Technology Inc.                 Confidential




            PROJECTED REVENUES AND EXPENSES 2010-2016

$20,000,000

                                                                       Revenues

$15,000,000



                                                                       Operating Loss/Gain
$10,000,000




 $5,000,000




          $0      1      2          3        4         5      6            7




                                                                        Total Expenses
 ($5,000,000)




($10,000,000)

                2010   2011       2012    2013        2014   2015         2016




                                                                                 25
Apogee Technology Inc.   Confidential




                                   26
Apogee Technology Inc.           Confidential




                   Investment Rationale

•   A strong balance sheet will strengthen Apogee’s negotiating
    position with potential strategic partners

•   Acquisition of certain assets of Parallel Solutions, Inc. (PSI)
    for 700,000 shares of Apogee stock and 25% of future joint
    venture payments will provide Apogee with access to
    •   PSI’s intellectual property portfolio
    •   Drug Master File
    •   cGMP produced material
    •   Polyphosphazene libraries (new adjuvants, drug delivery) and
        other polyphosphazenes for potential biomedical and industrial
        applications




                                                                 27
Apogee Technology Inc.                             Confidential



Management Team
Herbert Stein, CEO and Chairman: Mr. Stein brings over fifty years of management experience to
Apogee and has served on the boards and in executive management positions at several life sciences
companies, including as Chairman and CEO of Organogenesis.

Paul J Murphy, Chief Financial Officer and Vice President of Finance: Mr Murphy has 25 years of
experience as Chief Financial Officer of public and private companies. Prior to joining Apogee, Mr
Murphy was an independent contractor with JH Cohn, LLP, where he worked on engagements with
public companies to design, assess and test controls for compliance with Section 404 of the Sarbanes-
Oxley Act of 2002.

Alexander K. Andrianov, Ph.D., Vice President of Research and Development: Dr. Andrianov has ~20
years of experience in the biotechnology industry having served as Chief Scientific Officer of Parallel
Solutions, Inc., and in various management positions at Avant Immunotherapeutics and Virus Research
Institute Inc (VSI). He has unique expertise in polymer chemistry and is the inventor of the
polyphosphazene immunoadjuvant technology. Dr. Andrianov is an author of more than 60 scientific
papers and book chapters, an inventor on 41 issued and pending patents, and an editor of the book
“Biomedical Applications of Polyphosphazenes”. Dr. Andrianov also has extensive academic experience
as a faculty member in Moscow State University (MSU) and visiting scientist at Massachusetts Institute
of Technology (MIT) with Professor Robert Langer.




                                                                                                    28
Apogee Technology Inc.                    Confidential




                               Summary

•   Apogee Technology is a biotechnology company pioneering advanced
    vaccine and drug delivery systems via its proprietary technology platform
•   Core expertise: biomedical polyphosphazenes and their integration into
    value added products
•   Vaccine antigens stabilized and adjuvanted by polyphosphazenes and
    delivered via Apogee’s microneedle technology have demonstrated to
    confer a more potent immune response using reduced amounts of antigen
    and provide an extended shelf life
•   Potential self-administration and reduced dependence on cold chain
    distribution open up developing countries as attractive target markets
•   Licensing agreements with vaccine developers, an animal health company
    and Global Health or Government organizations are expected to generate
    significant revenue from upfront, milestone, and royalty payments, as well
    as funded collaborations
•   In addition to vaccine and drug delivery applications, potential uses of
    polyphosphazenes extend to biomaterials




                                                                                 29
Apogee Technology Inc.                                  Confidential



Appendix 1. References
[1]      Singh M, editor. Vaccine Adjuvants and Delivery Systems. Hoboken, New Jersey: Wiley-Interscience, 2006.
[2]      Andrianov AK, Marin A, Chen J. Synthesis, properties, and biological activity of Poly[di(sodium
carboxylatoethylphenoxy)phosphazene]. Biomacromolecules 2006;7(1):394-9.
[3]      Andrianov AK, Marin A, Roberts BE. Polyphosphazene polyelectrolytes: A link between the formation of
noncovalent complexes with antigenic proteins and immunostimulating activity. Biomacromolecules
2005;6(3):1375-9.
[4]      Andrianov AK, Sargent JR, Sule SS, Le Golvan MP, Woods AL, Jenkins SA, et al. Synthesis, physico-chemical
properties and immunoadjuvant activity of water-soluble phosphazene polyacids. Journal of Bioactive and
Compatible Polymers 1998;13(4):243-56.
[5]      Mutwiri G, Benjamin P, Soita H, Townsend H, Yost R, Roberts B, et al. Poly[di(sodium
carboxylatoethylphenoxy)phosphazene] (PCEP) is a potent enhancer of mixed Th1/Th2 immune responses in mice
immunized with influenza virus antigens. Vaccine 2007;25(7):1204-13.
[6]      Payne LG, Jenkins SA, Andrianov A, Roberts BE. Water-soluble phosphazene polymers for parenteral and
mucosal vaccine delivery. Pharmaceutical biotechnology 1995;6:473-93.
[7]      Payne LG, Jenkins SA, Woods AL, Grund EM, Geribo WE, Loebelenz JR, et al.
Poly[di(carboxylatophenoxy)phosphazene] (PCPP) is a potent immunoadjuvant for an influenza vaccine. Vaccine
1998;16(1):92-8.
[8]      Lu Y, Salvato MS, Pauza CD, Li J, Sodroski J, Manson K, et al. Utility of SHIV for testing HIV-1 vaccine
candidates in macaques. J Acquir Immune Defic Syndr Hum Retrovirol 1996;12(2):99-106.
[9]      Payne LG, Van Nest G, Barchfeld GL, Siber GR, Gupta RK, Jenkins SA. PCPP as a parenteral adjuvant for
diverse antigens. Dev Biol Stand 1998;92:79-87.
[10]     Payne LG, Jenkins SA, Andrianov A, Langer R, Roberts BE. Xenobiotic polymers as vaccine vehicles.
Advances in Experimental Medicine and Biology 1995;371(B):1475-80.
[11]     Andrianov AK. Polyphosphazenes as vaccine adjuvants. In: Singh M, editor. Vaccine Adjuvants and
Delivery Systems. Hoboken, New Jersey: John Wiley & Sons, 2007: 355-78.
[12]     Andrianov AK, Chen J. Polyphosphazene microspheres: Preparation by ionic complexation of phosphazene
polyacids with spermine. Journal of Applied Polymer Science 2006;101(1):414-9.
[13]     Andrianov AK, Chen J, Payne LG. Preparation of hydrogel microspheres by coacervation of aqueous
polyphosphazene solutions. Biomaterials 1998;19(1-3):109-15.
[14]     Andrianov AK, Chen J, Sule SS, Roberts BE. Ionically cross-linked polyphosphazene microspheres. ACS
Symposium Series 2000;752:395-406.
[15]     Andrianov AK, Payne LG. Polymeric carriers for oral uptake of microparticulates. Advanced Drug Delivery
Reviews 1998;34(2-3):155-70.
[16]     Andrianov AK, Payne LG. Protein release from polyphosphazene matrices. Advanced Drug Delivery
Reviews 1998;31(3):185-96.
[17]     Andrianov AK, Marin A, Peterson P, Chen J. Fluorinated polyphosphazene polyelectrolytes. Journal of
Applied Polymer Science 2007;103(1):53-8.
[18]     Andrianov AK, Chen J, LeGolvan MP. Poly(dichlorophosphazene) as a precursor for biologically active
polyphosphazenes: Synthesis, characterization, and stabilization. Macromolecules 2004;37(2):414-20.
[19]     Andrianov AK, Le Golvan MP. Characterization of poly[di(carboxylatophenoxy)-phosphazene] by an
aqueous gel permeation chromatography. Journal of Applied Polymer Science 1996;60(12):2289-95.
[20]     Andrianov AK, Svirkin YY, LeGolvan MP. Synthesis and biologically relevant properties of polyphosphazene
polyacids. Biomacromolecules 2004;5(5):1999-2006.
[21]     Andrianov AK, Marin A. Degradation of polyaminophosphazenes: Effects of hydrolytic environment and
polymer processing. Biomacromolecules 2006;7(5):1581-6.
[22]     Andrianov AK, Marin A, Peterson P. Water-soluble biodegradable polyphosphazenes containing N-
ethylpyrrolidone groups. Macromolecules 2005;38(19):7972-6.



                                                                                                               30
Apogee Technology Inc.                                    Confidential

[23]      Andrianov AK, Payne LG, Visscher KB, Allcock HR, Langer R. Hydrolytic degradation of ionically cross-linked
polyphosphazene microspheres. Journal of Applied Polymer Science 1994;53(12):1573-8.
[24]      Andrianov AK. Design and synthesis of functionalized polyphosphazenes with immune modulating activity.
PMSE Preprints, 2003;88.
[25]      Andrianov AK. Water-Soluble Biodegradable Polyphosphazenes - Emerging Systems for Biomedical
Applications. Polymer Preprints 2005;46(2):715.
[26]      Andrianov AK, Marin A, inventors; Immunostimulating polyphosphazene compounds 2.18.2005.
[27]      Larregina AT, Falo LD, Jr. Changing Paradigms in Cutaneous Immunology: Adapting with Dendritic Cells. J
Investig Dermatol 2004;124(1):1-12.
[28]      Mutwiri G, Benjamin P, Soita H, Babiuk LA. Co-administration of polyphosphazenes with CpG
oligodeoxynucleotides strongly enhances immune responses in mice immunized with Hepatitis B virus surface
antigen. Vaccine 2008;26(22):2680-8.
[29]      Holland D, Booy R, De Looze F, Eizenberg P, McDonald J, Karrasch J, et al. Intradermal influenza vaccine
administered using a new microinjection system produces superior immunogenicity in elderly adults: A
randomized controlled trial. Journal of Infectious Diseases 2008;198(5):650-8.
[30]      Alarcon JB, Hartley AW, Harvey NG, Mikszta JA. Preclinical evaluation of microneedle technology for
intradermal delivery of influenza vaccines. Clinical and Vaccine Immunology 2007;14(4):375-81.
[31]      Belshe RB, Newman FK, Cannon J, Duane C, Treanor J, Van Hoecke C, et al. Serum antibody responses
after intradermal vaccination against influenza. N Engl J Med 2004;351(22):2286-94.
[32]      Hooper JW, Golden JW, Ferro AM, King AD. Smallpox DNA vaccine delivered by novel skin electroporation
device protects mice against intranasal poxvirus challenge. Vaccine 2007;25(10):1814-23.
[33]      Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza
vaccine. N Engl J Med 2004;351(22):2295-301.
[34]      Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, Almagor Y, Sharon O, Levin Y. Safety and efficacy
of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine
2009;27(3):454-9.
[35]      Weeratna R, Comanita L, Davis HL. CPG ODN allows lower dose of antigen against hepatitis B surface
antigen in BALB//c mice. Immunol Cell Biol 2003;81(1):59-62.
[36]      La Montagne JR, Fauci AS. Intradermal influenza vaccination--can less be more? N Engl J Med
2004;351(22):2330-2.
[37]      Prausnitz MR, Mikszta JA, Cormier M, Andrianov AK. Microneedle-Based Vaccines. In: Compans RW,
Orenstein WA, editors. Curr Top Microbiol Immunol Vol 333: Vaccines for Pandemic Influenza Springer, 2009: 369-
93.
[38]      Mikszta JA, Alarcon JB, Brittingham JM, Sutter DE, Pettis RJ, Harvey NG. Improved genetic immunization
via micromechanical disruption of skin-barrier function and targeted epidermal delivery. Nature Medicine
2002;8(4):415-9.
[39]      Widera G, Johnson J, Kim L, Libiran L, Nyam K, Daddona PE, et al. Effect of delivery parameters on
immunization to ovalbumin following intracutaneous administration by a coated microneedle array patch system.
Vaccine 2006;24(10):1653-64.
[40]      McAllister DV, Wang PM, Davis SP, Park JH, Canatella PJ, Allen MG, et al. Microfabricated needles for
transdermal delivery of macromolecules and nanoparticles: Fabrication methods and transport studies.
Proceedings of the National Academy of Sciences of the United States of America 2003;100(SUPPL. 2):13755-60.
[41]      Rexroad J, Wiethoff CM, Jones LS, Middaugh CR. Lyophilization and the thermostability of vaccines. Cell
Preservation Technology 2002;1(2):91-104.
[42]      Wang W. Lyophilization and development of solid protein pharmaceuticals. International Journal of
Pharmaceutics 2000;203(1-2):1-60.
[43]      Vogelbruch M, Nuss B, Korner M, Kapp A, Kiehl P, Bohm W. Aluminium-induced granulomas after
inaccurate intradermal hyposensitization injections of aluminium-adsorbed depot preparations. Allergy
2000;55(9):883-7.
[44]      Andrianov AK. Water-soluble polyphosphazenes for biomedical applications. Journal of Inorganic and
Organometallic Polymers and Materials 2006;16(4):397-406.
[45]      Bouveret Le Cam NN, Ronco J, Francon A, Blondeau C, Fanget B. Adjuvants for influenza vaccine. Research
in Immunology 1998;149(1):19-23.

                                                                                                                  31
Apogee Technology Inc.                                  Confidential

[46]     Kim JH, Kirsch EA, Gilliam B, Michael NL, VanCott TC, Ratto-Kim S, et al. A Phase I, Open Label, Dose
Ranging Trial of The Pasteur Merieux Connaught (PMC) Oligomeric HIV-1 Gp160mn/LAI-2 Vaccine In HIV
Seronegative Adults. Abstracts of the 37th Annual Meeting of the Infectious Diseases Society of America; 1999;
Philadelphia, PA; 1999. p. 1028.
[47]     Thongcharoen P, Suriyanon V, Paris RM, Khamboonruang C, de Souza MS, Ratto-Kim S, et al. A Phase 1/2
Comparative Vaccine Trial of the Safety and Immunogenicity of a CRF01_AE (Subtype E) Candidate Vaccine: ALVAC-
HIV (vCP1521) Prime With Oligomeric gp160 (92TH023/LAI-DID) or Bivalent gp120 (CM235/SF2) Boost. JAIDS
Journal of Acquired Immune Deficiency Syndromes 2007;46(1):48.
[48]     Andrianov AK, Decollibus DP, Marin A, Webb A, Griffin Y, Webby RJ. PCPP-formulated H5N1 influenza
vaccine displays improved stability and dose-sparing effect in lethal challenge studies. Journal of Pharmaceutical
Sciences 2011:n/a-n/a.
[49]     Marin A, DeCollibus DP, Andrianov AK. Protein Stabilization in Aqueous Solutions of Polyphosphazene
Polyelectrolyte and Non-Ionic Surfactants. Biomacromolecules 2010;11(9):2268-73.
[50]     Monteiro-Riviere NA. Comparative anatomy, physiology, and biochemistry of mammalian skin. In: Hobson
D, editor. Dermal and Ocular Toxicology: Fundamentals and Methods. Boca Raton, FL: CRC Press, 1991: 3-71.
[51]     Katakam M, Bell LN, Banga AK. Effect of surfactants on the physical stability of recombinant human
growth hormone. Journal of Pharmaceutical Sciences 1995;84(6):713-6.
[52]     Andrianov AK, DeCollibus DP, Gillis HA, Kha HH, Marin A. Polyphosphazene Immunoadjuvants for
Intradermal Vaccine Delivery. In: Andrianov AK, editor. Polyphosphazene for Biomedical Applications. Hoboken,
New Jersey: John Wiley & Sons, 2009: 101-16.




                                                                                                               32

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Apogee Corp Presentation By Hans David De Beer

  • 1. DE BEER FUND MANAGEMENT LLC 619 ORTON AVE, PENTHOUSE 601, FORT LAUDERDALE, FLORIDA 33304 Email:dada7772@hotmail.com, USA TEL: 1-954-306-6545 IS PROUD TO INTRODUCE Apogee TECHNOLOGY H.D. De Beer
  • 2. A Biotechnology Company Pioneering Vaccine and Drug Delivery Technologies via Intradermal and Polyphosphazene Platforms August 2011
  • 3. Forward-Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this presentation that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “believes”, “anticipates”, “plans”, “expects”, and similar expressions are intended to identify forward-looking statements. Actual results may differ significantly from results discussed in the forward-looking statements. Factors that might cause such differences include those set forth from time to time in the Company's SEC filings, including in our annual report on Form 10-K.
  • 4. Apogee Technology Inc. Vision: To develop advanced and patient friendly technologies for the prevention and treatment of infectious diseases and chronic conditions • Leader in the field of polyphosphazenes for biomedical applications • Intradermal technology licensed from Georgia Tech • Diversified Product Pipeline: ImmunoMer H; ImmunoMer AH; IgloPatch; Other biomedical polyphosphazenes planned • World class team of management, advisors and collaborators
  • 5. World-Class Products, World-Class Partners Apogee established relationships and collaborated with leading institutions throughout the nation - Children’s Hospital Boston - Georgia Tech - VIDO - St. Jude Children’s Research Hospital
  • 6. The Opportunity 145 Vaccines Under Development* Challenges in The Development of New and Improved Vaccines • Insufficient protective immunity and memory • High cost • Need for cold chain distribution system • No self-administration Apogee’s Integrated Microneedle and Immunoadjuvant Approach offers a compelling solution Source *Pharmaceutical Research and Manufacturers of America. 2010 Report. Medicines in development for Infectious Diseases | http://www.phrma.org/sites/default/files/422/infectiousdiseases2010.pdf
  • 7. Polyphosphazenes as Biomedical Macromolecules Dial-In Biodegradability R (P N) R Unprecedented Structural Diversity – 1,000+ Derivatives Tunable Properties – Various Potential Applications Vaccine Adjuvants, Biodegradable Carriers, Nanoparticulates, Microencapsulation and Modulated release, Microneedles, Biomaterials High Throughput Discovery Manufacturing Friendly Chemistry
  • 8. Polyphosphazene Immunoadjuvants – ImmunoMer Platform PCPP • Proven In Vivo Performance: 23 Antigens in 11 Animal Models • Enhanced Immune responses, Dose Sparing • Demonstrated potency and safety in Clinical Trials • CMC, DMF, Stability, Toxicology Data • Benign Degradation Products • 2 M Doses Available • GMP Process Developed • New Generation Molecules Synthesized
  • 9. Immunoadjuvant Effect – Proof-of-Concept Enhanced Immune Response (up to 1000x), Long Lasting, Fast Onset, Single Dose Effective in Lethal Challenge Studies in a Relevant Preclinical Animal Model with Commercial Vaccine: 100% protection from mortality with reduced dose of antigen Antigen Dose Sparing Effect (up to 25x) Improves Vaccine Shelf-Life Demonstrated Potency in Large Animals with Animal Health Vaccine Antigen Clinical Trials: Reported Safe and Immunogenic Formulations, ~ 4x increase in neutralizing antibodies SOURCE: Bouveret Le Cam NN, et al, Research in Immunology (1998) 149: 19-23; Ison MG, et al, Antiviral research (2002) 55: 227-278
  • 10. IgloPatch Technology Band-Aid-Like Microneedle Patches To PCPP - VACCINE Deliver Vaccine in The Skin Scalable Production Process Enhanced with Metal Support Microneedle Array
  • 11. IgloPatch - In Vivo Proof-of-Concept Studies HBsAg specific IgG Titers In Vivo POC studies in a relevant animal model - pigs 5 4 3 IgloPatch 2 Adjuvanted IM 1 Non-adjuvanted Microneedles Non-adjuvanted IM Weeks Single Dose
  • 12. Potential Benefits of IgloPatch Technology • Improved Efficacy and Single Administration • Improved Shelf-Life with no Reliance on Refrigeration • Convenient Band-Aid Like Patch Administration • Self Application Possible • Reduced Pain or Painless Compared to Conventional
  • 13. Apogee’s Intellectual Property Portfolio Microneedle Technology Licensed from Georgia Tech: Coated Microstructures and Methods of Manufacture Thereof H.S. Gill, Harvinder Singh, M.R. Prausnitz US 11/917705 (06.19.2006); Pub. No. US 2008/0213461 A1; Apogee’s filings on Microneedle Technology and Adjuvanted Formulations: Methods and Systems for Coating a Microneedle… A.K. Andrianov, A. Marin US 12/133,505 (06.05.08); Pub. No. US 2009/0017210 A1; Coating Formulation Including Polyphosphazene… A.K. Andrianov, A. Marin US 12/217,437 (07.02.08); Pub. No. US/0016935 A1 Immunostimulating Polyphosphazene Compounds for Intradermal Immunization A.K. Andrianov, D.P. DeCollibus, H.A. Gillis, H.H. Kha, A. Marin US 12/217,402 (07.03.08); Pub. No.2009/0041810 A1; Apogee plans to get access to PS’s intellectual property portfolio to execute the development of product candidates in the proposed timeframe. The portfolio relates to polyphosphazene immunoadjuvants, including “new generation” molecules, certain polyphosphazene synthetic and production processes, microencapsulation and therapeutic protein stabilization methods, as well as some other biomedical applications of polyphosphazenes that Apogee believes can be complementary to its technology.
  • 14. Product Pipeline •ImmunoMer H, immunopotentiating and antigen stabilizing polyphosphazene agent for parenteral and mucosal human vaccines •ImmunoMer AH, immunopotentiating and antigen stabilizing polyphosphazene agent for parenteral and mucosal animal health vaccines •IgloPatch, advanced immunopotentiated microneedle patch for the application of vaccine to the skin. Potentially offers self- applied vaccines with reduced dependence on cold chain distribution
  • 15. Product Pipeline -Timeline Apogee plans to get access to PS’s intellectual property portfolio to execute the development of product candidates in the proposed timeframe. The portfolio relates to polyphosphazene immunoadjuvants, including “new generation” molecules, certain polyphosphazene synthetic and production processes, microencapsulation and therapeutic protein stabilization methods, as well as some other biomedical applications of polyphosphazenes that Apogee believes can be complementary to its technology.
  • 16. Strategy Assumption for 3 non-exclusive arrangements for 1-2 antigens, $2 million access fee, $1 million and $6 million Partnerships with vaccine developers milestones, royalties on sales of 5-15%. (ImmunoMer H) Anticipated milestone timelines:1-2013/2014/2015; 2nd- 2014/2015/2016; 3rd- 2015/2016/2017 Generate valuable preclinical and clinical data at little or no cost to company (funded R&D) retaining rights for Collaboration with Global Health commercial use of developed vaccine. One funded organizations (all product candidates) collaboration is currently under way, assumption for two more in 2011 ($1.1M) and in 2014 ($2M) Target deal profile: 1.5 million upfront payment in 2012, at Licensing agreement with Animal Health least one milestone payment of $3 million in 2013, and vaccine company (ImmunoMer AH) royalties on net product sales starting in 2014. Target deal profile: exclusive or 3-6 antigens in a defined Licensing agreement with a multinational field, upfront payment of $7 million (2015) and milestones vaccine company (IgloPatch) of $3 million and $7 million in 2016, royalties on sales of 5-15%.
  • 17. Vaccine Market Overview Global Market for preventive vaccines: $22.1 billion in 2009* Others Predicted Growth: 9.7% * compound annual rate (next five years) ** Presence of current Top Pharma Companies** 2005 - 3 of 10 2009 - 8 of 10 Sources: * Kalorama Information | http://www.kaloramainformation.com/about/release.asp?id=1693 ** 12th annual World Vaccine Congress Lyon 2010, J. Almond, Sanofi pasteur | http://www.terrapinn.com
  • 18. Competitive Advantages • Worldwide exclusive license from Georgia Tech for coated microneedle technology • Know-how and world’s expert scientists in polyphosphazene field • Drug Master File for PCPP as an adjuvant * • cGMP produced PCPP* • Polyphosphazene immunoadjuvant library, polyphosphazene drug delivery library, and biomaterial product candidates* * Upon closing PSI transaction after funding
  • 19. Competition Polyphosphazene Company Company Products Applications Customers Finances Polyphosphazene Celonova Bioscience Empolization Nanoparticles Physicians Private (Peachtree City, GA) PP coated stent EmbozeneTM Intradermal Delivery/Adjuvant Companies Company Products Applications Customers Finances Pandemic Influenza Patch and Traveler's Public-$500MM Intercell Vaccines/Bacterial Discovery- Market Diarrhea Vaccine Market Cap Adjuvant Patches Microneedles Public-$61B Market 3M Multiple Clinical (plastic)/TLR Adjuvant Cap Microneedles with Private-$90MM NEA, Zosano Pharma PTH, EPO, GM- Osteoporosis Phase II Numera CSF/GMDP Adjuvant Microinjection Public-$17B Market Becton Dickenson Soluble Vaccines On the market device/Alum Cap Small and large MicroCor™ Micro Corium International molecular weight Private Private Delivery System molecules Other examples of Immunoadjuvants: AF03 (Sanofi Pasteur), ASO3 (GSK Biologicals), MF 59 (Novartis), IC31 (Intercell)
  • 20. Go to Market Strategy • Two additional funded contract research and development collaborations with global health or government organizations in Q4 2011 and in 2014 • Licensing agreement with an animal health company by year-end 2012 to develop ImmunoMer AH technology • Three R&D partnerships with vaccine developers in the 2013-2017 time period for the development of ImmunoMer H adjuvanted vaccines • Licensing agreement with a multinational vaccine company for development of IgloPatch microneedle technology
  • 21. Business Model • Product development partnerships with pharmaceutical and biotechnology companies worldwide, license out application rights, maintain manufacturing rights • IgloPatch Technology: licensing model with multinational vaccine producers: • Exclusive arrangement for 3-6 antigens • Upfront payment of $5 - $20 million • Milestone payments of $5 - $15 million per antigen • 5 - 15% royalties on net product sales • ImmunoMer H Technology: licensing model with smaller vaccine producers or biotechnology companies: • Non-exclusive arrangement for 1-2 antigens • Upfront payment of $1 - $2 million (“Access Fee”) • Milestone payments of $1 - $2 million per antigen • 10 - 25% of proceeds upon acquisition of vaccine by a multinational company • 5 - 15% royalties on net product sales • ImmunoMer AH Technology: collaboration with Animal Health company • Other: collaboration with Global Health or Government organizations generating technology transfer fees
  • 22. Financing Requirements • Apogee seeks to raise $10 million in one or two rounds of funding to develop ImmunoMer H, ImmunoMer AH, IgloPatch technologies, as well as to purchase certain assets of Parallel Solutions • Anticipated use of proceeds: • Acquisition of PSI • ImmunoMer H Preclinical • ImmunoMer AH Preclinical • Development of IgloPatch • IgloPatch Preclinical • Working Capital (inclusive of transaction costs)
  • 23. PROJECTED REVENUES AND EXPENSES 2010-2016 $20,000,000 Revenues $15,000,000 Operating Loss/Gain $10,000,000 $5,000,000 $0 1 2 3 4 5 6 7 Total Expenses ($5,000,000) ($10,000,000) 2010 2011 2012 2013 2014 2015 2016
  • 24. PROJECTED CONSLIDATED BALANCES 2010-2016 $20,000,000 Assets $15,000,000 $10,000,000 $5,000,000 $0 1 2 3 4 5 6 7 ($5,000,000) Liabilities ($10,000,000) 2010 2011 2012 2013 2014 2015 2016 Financial Assumptions 2010-2016 1. $10 Million Private Placement 2. Restructuring of bridge loans (all but $156K) has been effected in the Financials. 3. Legal fees of $1.5 MM being settled for $600k.
  • 25. Investment Rationale • A strong balance sheet will strengthen Apogee’s negotiating position with potential strategic partners • Acquisition of certain assets of Parallel Solutions, Inc. (PSI) for 700,000 shares of Apogee stock and 25% of future joint venture payments will provide Apogee with access to • PSI’s intellectual property portfolio • Drug Master File • cGMP produced material • Polyphosphazene libraries (new adjuvants, drug delivery) and other polyphosphazenes for potential biomedical and industrial applications
  • 26. Apogee Technology Management Team • Herbert Stein, CEO and Chairman: Mr. Stein brings over fifty years of management experience to Apogee and has served on the boards and in executive management positions at several life sciences companies, including as Chairman and CEO of Organogenesis. • Paul J Murphy, Chief Financial Officer and Vice President of Finance: Mr. Murphy has 25 years of experience as Chief Financial Officer of public and private companies. Prior to joining Apogee, Mr. Murphy was an independent contractor with JH Cohn, LLP, where he worked with public companies to design, assess and test controls for compliance with Section 404 of the Sarbanes-Oxley Act of 2002. • Alexander K. Andrianov, Ph.D., Vice President of Research and Development: Dr. Andrianov, as the inventor of the polyphosphazene immunoadjuvant technology, has unique expertise in polyphosphazene chemistry. He is an author of more than 60 scientific papers and book chapters, an inventor on 41 issued and pending patents, and an editor of the book “Biomedical Applications of Polyphosphazenes”. He has ~20 years of experience in the biotechnology industry having served as Chief Scientific Officer of Parallel Solutions, Inc., and in various management positions at Avant Immunotherapeutics and Virus Research Institute Inc (VRI). Dr. Andrianov also has extensive academic experience as a faculty member in Moscow State University (MSU) and visiting scientist at Massachusetts Institute of Technology (MIT) with Professor Robert Langer.
  • 27. Summary • Apogee Technology is a biotechnology company pioneering advanced vaccine and drug delivery systems via its proprietary technology platform • Core expertise: biomedical polyphosphazenes and their integration into value added products • Vaccine antigens stabilized and adjuvanted by polyphosphazenes and delivered via Apogee’s microneedle technology have demonstrated to confer a more potent immune response using reduced amounts of antigen and provide an extended shelf life • Potential self-administration and reduced dependence on cold chain distribution open up developing countries as attractive target markets • Licensing agreements with vaccine developers, an animal health company and Global Health or Government organizations are expected to generate significant revenue from upfront, milestone, and royalty payments, as well as funded collaborations • In addition to vaccine and drug delivery applications, potential uses of polyphosphazenes extend to biomaterials
  • 28. Apogee Technology Inc. Confidential Apogee Technology, Inc. Business Plan August 2011 1
  • 29. Apogee Technology Inc. Confidential Certain statements made herein that use the words "anticipate," "may," "hope," "estimate," "project," "will," "intend," "plan," "expect," "believe" and similar expressions are intended to identify forward- looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve those related to the use of proceeds from the private placement, the design, development and production efforts of our PyraDerm™ and Sensilica® technologies, known and unknown risks and uncertainties, which could cause the actual results, performance or achievements of the Company to be materially different from those that may be expressed or implied. Please refer to the Company's risk factors as set forth in the Company's filings with the Securities and Exchange Commission, including its report on Form 10-KSB, as amended, for the year ended December 31, 2008, as updated in its quarterly reports on Form 10-Q. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company’s expectations, except as required by law. 2
  • 30. Apogee Technology Inc. Confidential This business plan does not constitute an offer to sell or a solicitation of any offer to buy the securities to which it relates in any jurisdiction in which, or to any person whom, it is unlawful to make such an offer or solicitation. Neither the delivery of this business plan nor any offer of sale made hereunder shall, under any circumstances, create any implication that there has been no change in the information set forth herein or in the affairs of Apogee Technology since the date hereof. This business plan contains confidential and proprietary information of Apogee Technology, which is for the sole use of its intended recipient. Any unauthorized review, use, disclosure or distribution is prohibited. The financial projections in this business plan were developed by the management of Apogee Technology and are based on a number of assumptions, some of which are listed here. These assumptions include the timing and success of our future development efforts, acceptance of our products, our ability to successfully implement our hiring goals, our average sales price, the size of the market, our market share, general industry conditions and other matters. Although Apogee Technology believes that these assumptions are reasonable, they may be incomplete or incorrect, and unanticipated events and circumstances are likely to occur. The assumptions involve significant elements of subjective judgment and analysis, and no representation can be made as to their attainability. The projected financial information has not been examined, reviewed or compiled by independent accountants. The projections were not prepared with a view to public disclosure and do not comply with the published guidelines of the SEC or any state securities commission or the guidelines established by the American Institute of Certified Public Accountants. Actual results achieved during any future period may vary from the projections, and the variations may be material and adverse. We do not intend to update or otherwise revise these projections to reflect circumstances existing after the date hereof or to reflect the occurrence of future events, even if the assumptions or estimates underlying the projections are shown to be in error. Prospective investors should not rely on, and will be deemed not to have relied on, the projections in making an investment decision. 3
  • 31. Apogee Technology Inc. Confidential Company Apogee Technology, Inc. is a (ATCS.OB) is a publicly traded development stage company, developing vaccine and drug delivery technologies and immunomodulating systems for the prevention and treatment of infectious diseases and chronic conditions. To address the unmet needs of the field, the Company advances a unique approach based on polyphosphazene macromolecules, which are designed to enhance biological activity of vaccines or drugs, and display synergistic effect when integrated with non-conventional administration routes, such as topical (intradermal) delivery using microneedle enhanced patches. The technology has the potential to enhance protective immunity induced by vaccines, simplify and decrease the cost of drug or vaccine administration, improve the efficacy of the treatment, and increase the product shelf-life. Apogee has established a strong intellectual property position through licensing and filing of several patent applications in the field and plans to extend it through the acquisition of Parallel Solutions, Inc. The Polyphosphazene approach can be applied across a range of other disease areas and biomedical applications providing a broad and flexible platform for the discovery and development of novel drug delivery systems and biomaterials. Apogee is initially focused on the development of and for the prevention and treatment of infectious diseases, cancer, and allergies using advanced immunopotentiating and microneedle delivery technologies - ImmunoMer H, ImmunoMer AH, and IgloPatch. Technology Polyphosphazenes Polyphosphazenes, macromolecules with a phosphorus and nitrogen backbone and organic side groups (Scheme 1), possess a number of features that make them highly attractive for life sciences applications and also distinguish them from other classes of biomedical polymers. Firstly, the inorganic backbone is capable of hydrolytical degradation, which can be modulated through the selection of the appropriate side group. Secondly, the unique synthetic pathway to these polymers, the so-called macromolecular substitution, allows a huge selection of substituents to be introduced by common organic chemistry methods, free of many ambiguities and restrictions associated with polymerization processes. Thirdly, such methods lend themselves to high throughput synthesis, which accelerates the discovery process. Fourthly, the unique flexibility of the backbone and its ability to participate in non-covalent bonding and supramolecular assemblies create new opportunities for the interface with biological systems. 4
  • 32. Apogee Technology Inc. Confidential DIVERSITY BIODEGRADABILITY HT COMPATIBLE INTERACTIVE Scheme 1. Polyphosphazenes Polyphosphazene Immunoadjuvants The search for potent, well characterized, and safe vaccine adjuvants and delivery vehicles has been widely recognized as a key strategic factor in the development of new and improved vaccines [1]. In this regard, an emerging class of well defined macromolecules, based on a polyphosphazene backbone (Scheme 2), offers a number of important advantages, both from immunostimulation and delivery standpoints. Impressive immunopotentiation activity and dose sparing effects of these water-soluble molecules [2-11] are augmented with the ease of their assembly into supramolecular microparticulate structures to achieve optimal delivery performance [12-17]. The synthetic origin of polyphosphazene adjuvants and their well characterized molecular structures assure a high level of reproducibility and ease of quality control [18-20]. Adequate stability, the “mix and fix” aqueous formulation approach, which does not involve covalent conjugation with antigen [3], long lasting immune responses, and a good safety profile, which includes the results of clinical trials in humans, are among other advantages of this adjuvant system. The polyphosphazene backbone of these molecules allows their biodegradation, which can be modulated through the choice of the side group and results in the release of physiologically benign compounds [4, 21-23]. The commercial development of the lead compound is sustained by the existence of a robust GMP manufacturing process and the availability of a drug master file to support regulatory applications. A substantial research effort has already been invested in the field, including work in multiple animal models and with various antigens, both synthetic and mechanistic studies [2-10]. It becomes evident that the polyphosphazene adjuvant technology evolves through the discovery of new, more potent derivatives [24-26], development of microparticulate delivery systems, and the investigation of alternative delivery routes, such as mucosal and intradermal. The mechanism of action of ionic polyphosphazene immunoadjuvants, which are highly superior to their non-polyphosphazene counterparts [3, 9], is still largely under discussion. It has been established that adjuvant activity of PCPP is not associated with a depot formation, as the excision of the injection site had no detectable effect on the kinetics of antibody induction [7]. The adjuvant activity of PCPP appears to be linked to its ability to form water-soluble non-covalent complexes with the antigen, a process which may enhance their interaction with antigen presenting cells [3]. This can be an important factor 5
  • 33. Apogee Technology Inc. Confidential taking into account a unique antigen presenting function of dermal dendritic cells mentioned above [27]. More recent evidence suggests that PCPP activates innate immune cells to secrete IL-4 and IL-12 [28]. Since these cytokines are known to influence adaptive immune responses, activation of innate immunity may be important in mediating the adjuvant activity of PCPP. Regardless of the mechanism, PCPP appears to display immunoadjuvant activity with a broad spectrum of viral and bacterial antigens, which are of interest in combating such important infectious diseases as influenza, hepatitis B, herpes, tetanus, and HIV [11]. Scheme 2. A Representative Structure of a Polyphosphazene Vaccine Adjuvant Intradermal Immunization Skin is an attractive organ for administration of vaccines since it constitutes an anatomic barrier, defending the body against external pathogens. Targeting of vaccine compounds to skin and/ or skin- draining lymph node dendritic cells (DCs) is a valuable strategy to induce robust cellular responses that protect against infectious and chronic diseases caused by intra-cellular pathogens. The unique antigen presenting function of skin draining lymph node DCs has been the focus of intense studies for the purpose of vaccine development [27]. Intradermal vaccination approaches have a potential to facilitate induction of more potent immune responses and provide the basis for a significant antigen sparing effect [29-34]. The latter can be highly desirable during times of vaccine shortages, such as epidemic emergencies, and can also reduce the cost of vaccine manufacturing, which is especially important for expanding vaccine use in less developed areas of the world [33, 35]. This could increase the possibility of mass intradermal vaccination programs and result in major global health benefits, particularly in areas where access to healthcare personnel is an issue. Microneedle Technology for Intradermal Administration of Vaccines Although the intradermal immunization approach appears to be promising, its technical realization faces significant challenges, such as special training of personnel who would be needed to administer vaccinations through the intradermal route effectively [36]. Microneedles and micro-injection devices 6
  • 34. Apogee Technology Inc. Confidential can provide a convenient alternative potentially offering ease of application and distribution, possibility of self-administration and pain-free delivery [37]. Apogee Technology, Inc. is engaged in the development of microneedle systems (Fig. 1), which utilize sub-millimeter structures to pierce the stratum corneum and deliver vaccines in the epidermis or dermis compartments [37-40]. Microneedles are designed to combine vaccine formulation as a solid coating, and metal, as a supporting material to provide the required mechanical strength. Once applied to the skin, these formulations dissolve to release vaccine antigen in the skin compartment. Solid vaccine formulations used in such systems are especially attractive since they also potentially offer improved shelf life and reduced dependence on temperature-controlled supply chains [41, 42]. These microneedles can also potentially be self- administered and safely disposed of. Thus the technology can significantly reduce biohazard risks and drastically lowers the cost of disposal as compared to contaminated needles and syringes. Polyphosphazene Immunoadjuvants for Intradermal Immunization A significant barrier on the way to a successful development of microneedle vaccines is a reliance of modern vaccine technologies on immune-enhancing additives, i.e., immunoadjuvants, to engender the desirable protective immune responses [1]. Unfortunately, many of the currently employed vaccine adjuvants may not be compatible with intradermal delivery approaches. For example, alum, which is the most common adjuvant used in the vaccine market globally [1] and one of only two adjuvants currently approved in the United States, was shown to induce serious adverse effects, such as formation of granulomas, when administered intradermally [43]. Other advanced adjuvants, which contain biphasic systems, such as oil emulsions or liposomes, may not be sufficiently stable to withstand the microneedle coating and drying processes. Although there are clear indications that intradermal immunization can potentially offer significant improvements over intramuscular 7
  • 35. Apogee Technology Inc. Confidential vaccination [37], it appears that the majority of studies have been conducted using non-adjuvanted vaccine formulations. Apogee Technology develops microneedle systems, which utilize polyphosphazene adjuvants, both as immunostimulant and microfabrication material. Polyphosphazene polyelectrolytes are one of the most remarkable classes of vaccine adjuvants due to their macromolecular nature, well-defined structure, and synthetic origin and have demonstrated excellent immunomodulating potential when tested in multiple animal models with both viral and bacterial antigens [2, 5, 7, 11, 44]. The lead compound, poly[di(carboxylatophenoxy)phosphazene] (PCPP) has been advanced into clinical trials [45-47] and PCPP formulated vaccines were reported to be safe and immunogenic in humans [45, 46]. Most importantly, the macromolecular nature of PCPP ensures excellent film forming and microencapsulating properties [12, 13]. It has been also demonstrated that PCPP can protect and stabilize vaccine antigens 8
  • 36. Apogee Technology Inc. Confidential during the microfabrication process [48, 49]. PCPP is a water-soluble molecule, which can be formulated with proteins in aqueous solutions under mild conditions [3] and has the potential to be dissolved easily in a highly hydrated environment, such as skin. Finally, dual functionality of such a molecule, as an immunoadjuvant and film forming/microfabrication material, eliminates the need for the use of additional macromolecular excipients and thus can potentially result in a higher vaccine loading capacity. Synergy between Polyphosphazene Immunoadjuvant and Microneedle Technology Creates New Approach to Intradermal Immunization Recent studies conducted by Apogee have demonstrated that a macromolecular adjuvant, PCPP, exhibits potent immunoadjuvant activity when delivered intradermally and also enables efficient incorporation of vaccine antigens into microfabricated delivery devices. In vivo proof-of-concept studies in pigs using recombinant Hepatitis B surface Antigen (HBsAg) demonstrated that Apogee’s intradermal delivery systems dramatically increase antibody responses compared to intramuscular administration of non- adjuvanted and adjuvanted formulations after a single Residual activity, % dose immunization (Fig. 2a). They also provide significant 100 antigen sparing ability (Fig. 2b). These results appear 80 especially significant as the anatomy of pig skin presents a 1 reasonable model for human skin [50]. In fact, a powerful 60 synergistic effect between microneedle system and polyphosphazene adjuvants observed in these 40 immunization studies requires further mechanistic studies focusing on the specifics of immunological pathways 20 associated with delivery to skin and the role of PCPP. 2 0 0 5 10 15 20 PCPP is not only compatible with solid state microneedle Time, days technology, but can potentially eliminate the need for Fig. 3. Residual enzymatic activity of inert “engineering” polymers, such as CMC, whose sole HRP encapsulated on microneedles (1) and in aqueous solution (2) during role is to serve as a microfabrication material. Since both accelerated thermal stability studies as immunostimulating and “engineering” functionalities can a f unction of time (80° C). now be integrated in a single compound - PCPP - the approach creates opportunities for maximizing antigen doses or achieving faster dissolution profiles using the same amount of the formulation. The results also suggest that PCPP can potentially provide surfactant-free or low surfactant coating solutions allowing more flexibility in formulation development, which is especially important when high contents of surfactant are undesirable [42, 51]. The micro-dip coating process utilized by Apogee is anticipated to be scaleable and inexpensive. A number of proprietary methodologies have been developed to assure accurate and reproducible dosing of the vaccine formulation [52]. The results of recent studies also showed no loss of activity in the 9
  • 37. Apogee Technology Inc. Confidential coating process utilizing model protein compounds, which indicated high efficiency of encapsulation in the process of microneedle fabrication [52]. One of the most significant potential advantages of solid state microneedle technology, being developed by Apogee, is an expected improved shelf life of solid state formulations as compared to their solution counterparts. Stability of microneedles containing model biological, Horse-Radish Peroxidase (HRP) was compared to the same enzyme in aqueous formulation at 80 °C (Fig.3). The accelerated degradation profiles show a dramatic improvement in the stability of a solid state formulation as compared to HRP in solution [52]. As mentioned above, the stability and better shelf-life of the microneedle formulations can be a critical parameter in decreasing the reliance of vaccine distribution on cold chain supply, resulting in a major global health benefit. Business Strategy Apogee’s business strategy is to develop high value vaccine and drug enabling systems based on unique polyphosphazene technology synergized with advanced delivery approaches. Our core expertise is the development of novel biomedical, immunopotentiating and protein stabilizing polyphosphazenes and their integration into value added products. Due to high costs of vaccine development and regulatory approval, we intend to develop products thru partnerships, further licensing out application rights while maintaining manufacturing rights. Apogee will pursue partnerships with pharmaceutical and biotechnology companies worldwide, which conduct preclinical and clinical development of cutting edge vaccine candidates with a need for immunopotentiators or advanced delivery systems. Under a partnership agreement we would jointly invest in the preclinical and, potentially, phase I/II clinical product development and then license them either to a strategic partner or a third party for completion of clinical development, registration, and product marketing. These deals will generate multi-million upfront payments, milestones and double digit royalties. The company will also pursue licensing agreements with multinational vaccine producers that are in the need of advanced immunopotentiators and delivery systems for multiple antigens. We would provide rights to our intellectual property in exchange for license fees, milestone development payments and royalties tied to product sales. Target deal profile may include exclusive or semi-exclusive arrangement, use with 3 to 6 antigens in defined field (infectious disease, allergy or cancer), upfront payment ($10M-20M), milestones ($5M - 15M per antigen), royalties (5 - 15% depending upon disease, exclusivity), subsidized research, and follow-on or extension deals with other antigens or fields. Apogee may enter into collaborations with Global Health organizations for the development of vaccines for developing countries. The Company anticipates these efforts to be subsidized, with a potential technology transfer fee upon completion of preclinical or clinical evaluation. Since, each immunopotentiator or delivery system can be used or tested with a variety of antigens, this provides an opportunity to generate valuable, including clinical data and benchmarking against competing systems 10
  • 38. Apogee Technology Inc. Confidential at little or no cost to the Company. Apogee intends to pursue similar opportunities for Public Health vaccines in US actively seeking government subsidized R&D studies, also involving commercial partners. In the Animal Health vaccine industry we plan to enter into a short term joint evaluation studies and sell our rights to one or two leading companies in the field, generating significant short term revenues targeting Q4 2012, which will allow us to more aggressively, pursue other high value added partnerships. Apogee has already initiated discussions with several potential partners. Apogee’s strategy for establishing strong partnership deals include selecting antigens and animal models of relevance to vaccine developers, compatibility with other immunopotentiators and delivery systems, and benchmarking our systems against our competitors. Product Pipeline Apogee’s product pipeline consists of the following proprietary systems: ImmunoMer H, immunopotentiating and antigen stabilizing polyphosphazene agent for parenteral and mucosal human vaccines, ImmunoMer AH, immunopotentiating and antigen stabilizing polyphosphazene agent for parenteral and mucosal animal health vaccines, and IgloPatch, advanced immunopotentiated microneedle patch for the application of vaccine to the skin. We plan to integrate these systems with novel vaccine antigens in partnerships with industry leaders developing new vaccines, governmental and world health organizations to develop breakthrough vaccines with enhanced protective immunity, improved safety profiles, and superior term shelf-life, with IgloPatch product potentially offering self- applied vaccines with reduced dependence on cold chain distribution. 11
  • 39. Apogee Technology Inc. Confidential Table 1. Projected Product Development Apogee identified a number of novel vaccine candidates that are currently in clinical or pre- clinical development, which we believe are ideally suited to be enhanced by our immunopotentiating systems with many proof-of-concept in vivo experiments already completed. Apogee anticipates entering into the agreements on the co-development of these vaccines within approximately 6 months after receiving funding and conduct preclinical and clinical development of Public Health and World Health vaccines under the terms of appropriate funding from potential partners. 12
  • 40. Apogee Technology Inc. Confidential Table 2. Identified Target Antigens 1 A.K. Andrianov et al., Proc. Natl. Acad. Sci. USA, 2009, 106:18936 2 G. Mutwiri, in “Polyphosphazenes for Biomedical Applications” A.K. Andrianov, Ed., John Wiley & Sons, 2009, 77 3 A.K. Andrianov et al., J. Pharm. Sci., 2011, 100 (4), 1436 4 K. Johansen, in “Polyphosphazenes for Biomedical Applications” A.K. Andrianov, Ed., John Wiley & Sons, 2009, 85 13
  • 41. Apogee Technology Inc. Confidential In order to execute commercial development of ImmunoMer H, ImmunoMer AH, and polyphosphazene related part of IgloPatch in the proposed timeframe, Apogee believes that it needs to gain access to certain patents of Parallel Solutions, Inc. (PSI), which it plans to acquire upon receipt of funding proceeds. Intellectual property of PSI also includes other biomedical polyphosphazene technologies, such as therapeutic protein stabilization methods, which can be highly complementary to Apogee’s microneedle system, IgloPatch, and can enhance characteristics of our patch systems for the delivery of therapeutics. Upon acquisition of PSI, Apogee plans to seek externally funded partnership to conduct in vivo proof-of-concept studies of these technologies. Intellectual Property Apogee has already established a strong intellectual property position through licensing and filing of several patent applications in the field. Patent application related to microneedle device, related compositions and manufacturing methods was licensed from Georgia Institute of Technology (Professor M.R. Prausnitz): Coated Microstructures and Methods of Manufacture Thereof H.S. Gill, Harvinder Singh, M.R. Prausnitz US 11/917705 (06.19.2006); Pub. No. US 2008/0213461 A1; provisional No. 60/691,857 (06.17.2005), No 60/732,267 (11.1.2005); PCT/US2006/023814 (06.19.2006); Int. Publ. No. WO 2006/138719 A2; EP20060785110. Apogee has filed the following patent applications related to microneedle technology and the use of polyphosphazenes as intradermal immunopotentiator and as coating reagents for microneedle technology. Methods and Systems for Coating a Microneedle with a Dosage of a Biologically Active Compound A.K. Andrianov, A. Marin US 12/133,505 (06.05.08); Pub. No. US 2009/0017210 A1; provisional 60/948,500 (07.09.07); PCT/US2008/007200 (06.09.08); Int. Publ. No. WO2009/008951 A2; EP20080768269. Coating Formulation Including Polyphosphazene Polyelectrolytes and Biologically Active Agents and Asperities Coated with Such Formulations A.K. Andrianov, A. Marin US 12/217,437 (07.02.08); Pub. No. US/0016935 A1, provisional 60/948,540 (07.09.2007) PCT/US2008/008265 (07.03.08); Int. Publ. No. WO 2009/009004 A1; EP20080768862. Immunostimulating Polyphosphazene Compounds for Intradermal Immunization A.K. Andrianov, D.P. DeCollibus, H.A. Gillis, H.H. Kha, A. Marin US 12/217,402 (07.03.08); Pub. No.2009/0041810 A1; provisional 61/125,576 (04.25.2008) and 60/948,540 (07.09.07); PCT/US2008/008230 (07.03.08); Int. Publ. No. WO 2009/008988A1; EP20080779950. 14
  • 42. Apogee Technology Inc. Confidential In order to execute commercial development of ImmunoMer H, ImmunoMer AH, and polyphosphazene related part of IgloPatch in the proposed timeframe, Apogee believes that it needs to gain access to certain patents of Parallel Solutions, Inc. (PSI), which it plans to acquire upon receipt of funding proceeds. Intellectual property of PSI also includes other biomedical polyphosphazene technologies, such as therapeutic protein stabilization methods, which can be highly complementary to Apogee’s microneedle system, IgloPatch, and can enhance characteristics of our patch systems for the delivery of therapeutics. Competitive Advantage There is an unmet need for new immunoadjuvants (immunopotentiators) and alternative administration routes for the delivery of vaccines. A major bottleneck in vaccine development is the lack of suitable adjuvants for adult and pediatric vaccine use. Until recently, vaccine research and development focused nearly exclusively on the antigen component of the vaccine that induces a specific immune response in the body to protect against a particular disease. Contemporary vaccines increasingly rely on another component – immunoadjuvant, which does not induce the immune response on its own, but is capable of amplifying it dramatically to make the vaccine more potent, reduce the dose of the antigen and a number of required administrations, and achieve more rapid and longer-lasting protective immunity. Alternative delivery routes, such as intradermal vaccination, further have a potential to simplify and decrease the cost of drug or vaccine administration, improve the efficacy of the treatment, and increase the product shelf-life. There are two vaccine adjuvants (immunopotentiators) currently approved in the United States – Alum, which has been used with multiple vaccines for decades (public domain), and recently approved ASO4 for use in Cervarix HPV Vaccine (GSK Biologicals). MF59 (Novartis Vaccines), has been also approved in Europe. All of these immunopotentiators are heterogeneous (biphasic) systems that are either incompatible with many advanced delivery systems, such as microneedles, or reactogenic or inefficient when delivered intradermally or mucosally, important delivery modalities. Although there are a number of immunopotentiators that are currently under development, such as AF03 (Sanofi Pasteur), ASO3 (GSK Biologicals), IC31 (Intercell), various TLR agonists (3M), and others, they have similar limitations and may face other challenges in the approval process. Polyphosphazene immunopotentiators, PCPP and newer generation molecules have the following features, distinguishing them from other similar systems: Well-defined synthetic molecular immunopotentiator; Vaccine Stabilization Agents for prolonged shelf life; Proven Parenteral, Mucosal, Intradermal Immunopotentiator with higher, sustained immune response with quick onset and improved immunological memory; Antigen sparing effect; Strong safety and tolerability track record in clinical trials; 15
  • 43. Apogee Technology Inc. Confidential Compatibility with solid microneedles; Can be formulated in nanoparticulates for synergistic vaccine delivery effect; Technology platform with newer, more potent immunopotentiators through High Throughput Discovery; Excellent compatibility with other immunopotentiating systems. There are a number of companies developing solid microneedle technologies for biomedical applications, such as Zosano, Corium, Theraject, and 3M, however most of them focus on therapeutic applications and lack compatible immunopotentiators. Published report by Zosano on the use of small molecule immunopotentiator (GMDP, not suitable as a microfabrication material), indicated that the adjuvant worked intradermally, but its effect was 10 times less than when it was used parenterally. In contrast, Apogee’s system showed at least order of magnitude higher performance of polyphosphazene immunopotentiator when administered intradermally compared with intramuscular administration. The Company believes that the advantages of Apogee’s microneedle technology are as follows: Proven synergy of adjuvant and intradermal delivery; Dual role of polyphosphazene as microfabrication material provides higher loading Stabilization effect of polyphosphazene and improved microfabrication rate reduces stress on vaccine antigen improving efficiency of loading; Reduced reliance on surfactants in the microfabrication process; Precise dosing of antigen to overcome one of the most critical challenges of the technology. 16
  • 44. Apogee Technology Inc. Confidential Market Analysis Vaccine Market Overview Global Market for preventive vaccines: $22.1 billion in 2009* Others Predicted Growth: 9.7% * compound annual rate (next five years) ** Presence of current Top Pharma Companies** 2005 - 3 of 10 2009 - 8 of 10 Sources: * Kalorama Information | http://www.kaloramainformation.com/about/release.asp?id=1693 ** 12th annual World Vaccine Congress Lyon 2010, J. Almond, Sanofi pasteur | http://www.terrapinn.com The global market for preventative vaccines topped $22 billion in 2009 and is predicted to increase at a compound annual rate of 9.7% during the next five years, as new product introductions continue and the use of current products expands further in all regions. Vaccines are commonly segmented into two target markets, adult and pediatric. The pediatric vaccine market is larger, accounting for more than half of the total market and is also growing at a faster rate than adult vaccines and this is expected to continue over the next five years. Geographically US will continue to lead the vaccines market followed by Europe. Japanese vaccine market has also started to open up further from regulatory and political barriers. The large population in countries like India and China, high prevalence of diseases and emergence of new pandemics are some of the important factors posting tremendous growth in vaccine market. This sector is expected to grow at a rate of 14% during 2009-2012. In 2009, pandemic influenza vaccines were the best selling vaccines with sales of over $ 5 billion followed by hepatitis B vaccines. The worldmarket of Hepatitis B Vaccine was $ 1.2 billion. Of the 350 million to 400 million individuals worldwide infected with the hepatitis B virus (HBV), one-third reside in 17
  • 45. Apogee Technology Inc. Confidential China, with 130 million carriers and 30 million chronically infected. Pneumococcal vaccine (Prevnar) has crossed the sales of US$ 1 Billion in 2007 and became the first vaccine to reach nearly US$ 3 Billion annual sales by 2009. Pneumonia is the world's leading killer of children younger than 5 years, and is one of the foremost vaccine-preventable killers of children today. Every year, pneumococcal disease kills about 1 million children worldwide. The Advanced Market Commitment (AMC) initiative for pneumococcal vaccine was launched in June, 2009 with the intention to help prevent pneumonia. With $1.5 billion funding from Canada, Italy, Norway, Russia, the UK, and the Bill & Melinda Gates Foundation, the initiative is aiming to create a market to ensure demand for, and supply of, pneumococcal vaccines for developing countries. Sales of Cervical cancer vaccines (HPV) have crossed $ 1 Billion by 2007 and are forecasted to cross $ 4 Billion mark by 2012. Market for Rotavirus and polio vaccines has crossed $ 1 Billion each in 2009. Malaria vaccine market for public is expected to cross $ 400 Million by 2025. Due to existing threat of terrorism Bio-protection vaccines are an important segment of the market. US government poured billions into building strategic stockpiles of these vaccines (influenza, bioterror) and R&D funding for new production technologies. The Bio-protection vaccines market is expected to grow with an annual rate of 12.08% percent from 2009 to 2015. Pharmaceutical Research and Manufacturers of America lists 145 vaccines under development in US only, to prevent a variety of infections. A large number of vaccines that are currently under development, both in US and worldwide, are designed to combat important emerging or neglected diseases, for which there is currently no preventive treatment. Norovirus infection, more commonly known as the “stomach flu”, is the most common cause of acute gastroenteritis in the U.S. A systematic review of studies performed by the CDC estimated that norovirus causes an annual 64,000 hospitalizations and 900,000 clinical visits among children in industrialized nations and up to 200,000 death of children < 5 years of age in developing countries. Chlamydia is a common sexually transmitted disease (STD) caused by the bacterium, Chlamydia trachomatis. Chlamydial infections in women, which are usually asymptomatic, can result in pelvic inflammatory disease, which is a major cause of infertility, ectopic pregnancy, and chronic pelvic pain. CDC reports high prevalence of chlamydial infections in the general U.S. population. Among young adults (aged 18–26 years) who participated in the nationally representative National Longitudinal Study of Adolescent Health (Add Health) during 2001–2002, chlamydia prevalence was 4.2%. A vaccine against recurrent vulvovaginal candidiasis (VVC) would benefit a large number of women who suffer from this debilitating syndrome. The disease has a significant effect on quality of life and poses a huge burden to the health care system. CDC estimates that 75% of women will have at least one episode of VVC, and 40%–45% will have two or more episodes within their lifetime. Approximately 10%–20% of women will have complicated VVC that necessitates diagnostic and therapeutic considerations. Global candidiasis therapeutics market was valued at $1.57 bn in 2009. Hand, foot, and mouth disease (HFMD) is another common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and possibly death. HFMD caused by EV71 has become a major emerging infectious 18
  • 46. Apogee Technology Inc. Confidential disease in Asia with approximately 1,155,000 new cases of HFMD in mainland of China only, and 353 deaths. A number of commercial entities and academic groups are working on the development of vaccines in these areas and Apogee’s immunopotentiating, delivery, and stabilization systems can potentially play an important role in enabling these vaccines, accelerating their development, reducing required doses, improving shelf-life and enhancing their protective immunity. The worldwide vaccine market is dominated by five major competitors: Merck & Co, GlaxoSmithKline, Sanofi Pasteur, Pfizer, and Novartis. Examples of other vaccine companies include AlphaVax, Inc., Bavarian Nordic A/S , Baxter Healthcare, Bharat Biotech, Celldex Therapeutics, Crucell, Emergent Biosolutions, Medimmune, Nabi Biopharmaceuticals. Global Veterinary Vaccines Market to reach $5.6 Billion by 2015. The market is split between Livestock Vaccines (Porcine Vaccines, Bovine Vaccines, Poultry Vaccines, Ovine Vaccines, Equine Vaccines, & Other Animal Vaccines) and Companion Vaccines (Canine Vaccines, & Feline Vaccines) with the first representing the largest product segment of about 63% in 2006. Growth in the Livestock Vaccines market is essentially driven by Porcine Vaccines market, which not only accounts for a majority share of the total market but is also one of the fastest growing segments. Revenues from porcine vaccines market are estimated to be approximately $1 billion mark in 2010. United States and Europe collectively capture more than 60% of the worldwide Veterinary Vaccines market. United States companion animal vaccines market is estimated to be approximately $410 million in 2010. Europe is a major market for veterinary vaccines and medicines across the globe. France, Germany and United Kingdom account for over 40% of the veterinary vaccine sales in Europe. Key players in the marketplace include Bayer HealthCare AG, Biogenesis-Bago, Boehringer Ingelheim GmbH, Heska Corporation, Imugene Limited, Indian Immunologicals Ltd, Lohmann Animal Health, Merck & Co. Inc., Intervet/Schering-Plough Animal Health, Merial Ltd., Pfizer Inc., Embrex Inc., Fort Dodge Animal Health, Virbac Corporation, among others. Operational Plan Progress to Date Since the start of our biomedical project, the Company has reached a number of important milestones including: Establishment of the laboratory and the initiation of R&D work in 2006; Completion of the licensing agreement for the microneedle technology from Georgia Tech; Development of the prototype microneedle fabrication process, arrays, and patches, and identification of critical external suppliers and main quality control methods; Completion of in vivo proof-of-concept study (in collaboration with Vaccine and Infectious Disease Institute) for Apogee’s microneedles which demonstrated superior potency of IgloPatch 19
  • 47. Apogee Technology Inc. Confidential and synergy between polyphosphazene and intradermal delivery and resulted in a publication in Proceedings of National Academy of Sciences U.S.A.; Filing of 3 patent applications; Completion of in vivo proof-of-concept study (in collaboration with St. Jude Hospital) of immunopotentiation technology and pandemic influenza vaccine, which demonstrated the ability of Apogee’s formulations to protect animals in a lethal challenge study at a significantly reduced dose; Demonstration of the stabilizing effect of Apogee’s technology on vaccine and other biologics as a proof-of-concept for the improved shelf-life; Award of R&D contract from Children Hospital Boston for the development of immunoadjuvanted formulations of vaccines for newborns, and successful and timely achievement of milestones to date. Facilities and Equipment Apogee Technology is headquartered in Norwood, MA and established state-of-the art research facilities include a formulation and characterization laboratory (360 sq.ft.) and an additional 670 sq.ft. of lab support space. The analytical section of the laboratory is equipped with Hitachi LaChrom Elite High Performance Liquid Chromatography (HPLC) system with multi-detection capabilities (L-2I3OHTA pump and degasser, L- 2200 autosampler, L-2455 Diode array detector, and L-2490 refractive index detector), UV/Vis spectrophotometer (HITACHI U-2810), analytical balance (AL204, Mettler Toledo), pH Meter (SevenEasy, Mettler Toledo), a stereo zoom microscope (STZ-45-BS-FR) with a digital camera (Caltex Scientific, Irvine, CA), Bunton MACROZOOM-FL microscope system (Bunton Instrument Company, Inc.), and a stereomicroscope (model ML-40STER, Home Science tools). The formulation section of the facilities is equipped with a fume hood, FreeZone 2.5 Lyophilizer (Labconco), an incubated orbital shaker (model 4450), vortex mixers (12-810-1, Fisher Scientific;VM- 3000,VWR), an orbital shaker (model 51300-00, Cole Parmer), heated magnetic stirplates (models 12620-982, 12365-82 VWR), a vacuum oven (model 1410, VWR), a refrigerated vapor trap (model RVT4104 Savant), vacuum pumps (VP 100, Savant and 8907, Welch), a centrifuge (model 5702, Eppendorf), an ultrasonic water bath (model 50HT, VWR), and a heated water bath (model 182, Precision). The microneedle coating facility is equipped with coating apparatuses, syringe pumps, and X- Y-Z micro-positioning systems. Supporting facilities include flammable safety storage cabinet, gas supply lines and manifolds (nitrogen, carbon dioxide and compressed air), B-Pure deionization and water filtration system, a microwave oven, a freezer, and refrigerators. Deal Throughput Apogee intends to finalize the acquisition of PSI technology as soon as funding is complete. The Company plans to enter at least 3 research and commercialization collaboration in Q4 2011 and Q1-Q2 20
  • 48. Apogee Technology Inc. Confidential 2012, one with the animal health vaccine company, another for a funded R&D collaboration with Global Health or Government organization, and one with the commercial developer of vaccine of interest. Each collaboration envisaged will give the partner access to ImmunoMer for use with their antigens. These collaborations are expected to provide significant cash flow to the company in the medium term. Based on these and other collaborations, Company envisions one licensing agreement in Q4 2012, one in Q3 2013, and another in Q1 2014. Projected growth To meet our stated objectives and deliverables the Company will need to add personnel, equipment and acquire additional laboratory and office space. Employees: We project our total staff will increase to 24 employees by 2016. In the business operations group, significant emphasis will be placed on adding individuals with partnering capabilities, program management, business development, and regulatory experience. On the R&D side, expertise will be added in immunology, polymer and biochemistry, various areas of assay development, formulation and manufacturing. The ratio of PhD to Technician (BS or MS level) for our laboratory staff will be roughly 1:2. Many upstream capabilities will be accessed through the Company’s corporate alliances and through a strong network of outside advisors and vendors. 21
  • 49. Apogee Technology Inc. Confidential Business Model Competition • Product development Polyphosphazene Company partnerships with pharmaceutical and biotechnology companies worldwide, license out application rights, maintain manufacturing Company Products Applications Customers Finances rights Polyphosphazene Celonova Bioscience Empolization Nanoparticles Physicians Private • IgloPatch Technology: (Peachtree City, GA) EmbozeneTM licensing coated stent multinational vaccine producers: PP model with • Exclusive arrangement for 3-6 antigens Intradermal Delivery/Adjuvant Companies • Upfront payment of $5 - $20 million Company • Milestone payments of $5 - $15 million per antigen Products Applications Customers Finances • 5 - 15% royalties on net product sales Pandemic Influenza Patch and Traveler's Public-$500MM • ImmunoMer H Technology: licensing model with smaller vaccine producers Intercell Vaccines/Bacterial Diarrhea Vaccine Discovery- Market Market Cap Adjuvant or biotechnology companies: Patches Microneedles • Non-exclusive arrangement for 1-2 antigens Public-$61B Market 3M Multiple Clinical (plastic)/TLR Adjuvant Cap • Upfront paymentwith$1 - $2 million (“Access Fee”) Microneedles of • Private-$90MM NEA, Zosano Pharma Milestone payments of $1 - Osteoporosis PTH, EPO, GM- $2 million per antigen Phase II Numera • 10 -CSF/GMDP Adjuvant upon acquisition of vaccine by a multinational company 25% of proceeds • Microinjection Becton Dickenson 5 - 15% royalties on net product sales Soluble Vaccines On the market Public-$17B Market device/Alum Cap • ImmunoMer AH Technology:Small and large with Animal Health company collaboration MicroCor™ Micro Corium International molecular weight Private Private • Other: Delivery System collaboration with Global Health or Government organizations molecules generating technology transfer fees Other examples of Immunoadjuvants: AF03 (Sanofi Pasteur), ASO3 (GSK Biologicals), MF 59 (Novartis), IC31 (Intercell) 22
  • 50. Apogee Technology Inc. Confidential Competitive Advantages • Worldwide exclusive license from Georgia Tech for coated microneedle technology • Know-how and world’s expert scientists in polyphosphazene field • Drug Master File for PCPP as an adjuvant * • cGMP produced PCPP* • Polyphosphazene immunoadjuvant library, polyphosphazene drug delivery library, and biomaterial product candidates* * Upon closing PSI transaction after funding 23
  • 51. Apogee Technology Inc. Confidential Partnering Company envisions one licensing agreement in Q4 2012, two in Q3 2013, and another in Q1 2014. Leverage external resources The Company does not plan to establish in-house capabilities to execute in-vivo evaluation of our immunopotentiation and intradermal delivery. In addition to planned partnership, Apogee has already established collaborations with Children Hospital Boston, and can reactivate previous collaborations with VIDO and St. Jude Hospital and enter new R&D agreements to provide cost-effective, flexible and timely access to animal models needed to evaluate our systems. The relationships with governmental and university researchers provides a low cost (no cost) mechanism to investigate broader applications of our platform. Government funding Apogee plans to apply for grant funding from Global health organizations and governmental agencies to support preclinical and clinical development of its technologies. The Company has already applied this strategy in an ongoing collaboration with Children Hospital of Boston, which allowed to get support for some of Companies vital R&D efforts. Royalties paid on licenses The Company entered in a 50 year exclusive worldwide licensing agreement in March of 2007 for a microneedle technology with Georgia Institute of Technology. Financial model assumptions – Revenues: Apogee has already generated revenues external collaborations and believes it can continue and increase generation of revenues from partnerships. In the early years, revenue is projected to come from milestone payments and royalties. Baseline business projections foresee the completion of 3 corporate deals by early 2014. Each deal gives a partner the right to use PSI’s technology with the antigen of interest, although in the animal health vaccine area we expect to give exclusive rights to our technology for livestock and companion market segments. The deal structure envisions a series of success-based milestones and subsequent product royalties for each of the antigens. 24
  • 52. Apogee Technology Inc. Confidential PROJECTED REVENUES AND EXPENSES 2010-2016 $20,000,000 Revenues $15,000,000 Operating Loss/Gain $10,000,000 $5,000,000 $0 1 2 3 4 5 6 7 Total Expenses ($5,000,000) ($10,000,000) 2010 2011 2012 2013 2014 2015 2016 25
  • 53. Apogee Technology Inc. Confidential 26
  • 54. Apogee Technology Inc. Confidential Investment Rationale • A strong balance sheet will strengthen Apogee’s negotiating position with potential strategic partners • Acquisition of certain assets of Parallel Solutions, Inc. (PSI) for 700,000 shares of Apogee stock and 25% of future joint venture payments will provide Apogee with access to • PSI’s intellectual property portfolio • Drug Master File • cGMP produced material • Polyphosphazene libraries (new adjuvants, drug delivery) and other polyphosphazenes for potential biomedical and industrial applications 27
  • 55. Apogee Technology Inc. Confidential Management Team Herbert Stein, CEO and Chairman: Mr. Stein brings over fifty years of management experience to Apogee and has served on the boards and in executive management positions at several life sciences companies, including as Chairman and CEO of Organogenesis. Paul J Murphy, Chief Financial Officer and Vice President of Finance: Mr Murphy has 25 years of experience as Chief Financial Officer of public and private companies. Prior to joining Apogee, Mr Murphy was an independent contractor with JH Cohn, LLP, where he worked on engagements with public companies to design, assess and test controls for compliance with Section 404 of the Sarbanes- Oxley Act of 2002. Alexander K. Andrianov, Ph.D., Vice President of Research and Development: Dr. Andrianov has ~20 years of experience in the biotechnology industry having served as Chief Scientific Officer of Parallel Solutions, Inc., and in various management positions at Avant Immunotherapeutics and Virus Research Institute Inc (VSI). He has unique expertise in polymer chemistry and is the inventor of the polyphosphazene immunoadjuvant technology. Dr. Andrianov is an author of more than 60 scientific papers and book chapters, an inventor on 41 issued and pending patents, and an editor of the book “Biomedical Applications of Polyphosphazenes”. Dr. Andrianov also has extensive academic experience as a faculty member in Moscow State University (MSU) and visiting scientist at Massachusetts Institute of Technology (MIT) with Professor Robert Langer. 28
  • 56. Apogee Technology Inc. Confidential Summary • Apogee Technology is a biotechnology company pioneering advanced vaccine and drug delivery systems via its proprietary technology platform • Core expertise: biomedical polyphosphazenes and their integration into value added products • Vaccine antigens stabilized and adjuvanted by polyphosphazenes and delivered via Apogee’s microneedle technology have demonstrated to confer a more potent immune response using reduced amounts of antigen and provide an extended shelf life • Potential self-administration and reduced dependence on cold chain distribution open up developing countries as attractive target markets • Licensing agreements with vaccine developers, an animal health company and Global Health or Government organizations are expected to generate significant revenue from upfront, milestone, and royalty payments, as well as funded collaborations • In addition to vaccine and drug delivery applications, potential uses of polyphosphazenes extend to biomaterials 29
  • 57. Apogee Technology Inc. Confidential Appendix 1. References [1] Singh M, editor. Vaccine Adjuvants and Delivery Systems. Hoboken, New Jersey: Wiley-Interscience, 2006. [2] Andrianov AK, Marin A, Chen J. Synthesis, properties, and biological activity of Poly[di(sodium carboxylatoethylphenoxy)phosphazene]. Biomacromolecules 2006;7(1):394-9. [3] Andrianov AK, Marin A, Roberts BE. Polyphosphazene polyelectrolytes: A link between the formation of noncovalent complexes with antigenic proteins and immunostimulating activity. Biomacromolecules 2005;6(3):1375-9. [4] Andrianov AK, Sargent JR, Sule SS, Le Golvan MP, Woods AL, Jenkins SA, et al. Synthesis, physico-chemical properties and immunoadjuvant activity of water-soluble phosphazene polyacids. Journal of Bioactive and Compatible Polymers 1998;13(4):243-56. [5] Mutwiri G, Benjamin P, Soita H, Townsend H, Yost R, Roberts B, et al. Poly[di(sodium carboxylatoethylphenoxy)phosphazene] (PCEP) is a potent enhancer of mixed Th1/Th2 immune responses in mice immunized with influenza virus antigens. Vaccine 2007;25(7):1204-13. [6] Payne LG, Jenkins SA, Andrianov A, Roberts BE. Water-soluble phosphazene polymers for parenteral and mucosal vaccine delivery. Pharmaceutical biotechnology 1995;6:473-93. [7] Payne LG, Jenkins SA, Woods AL, Grund EM, Geribo WE, Loebelenz JR, et al. Poly[di(carboxylatophenoxy)phosphazene] (PCPP) is a potent immunoadjuvant for an influenza vaccine. Vaccine 1998;16(1):92-8. [8] Lu Y, Salvato MS, Pauza CD, Li J, Sodroski J, Manson K, et al. Utility of SHIV for testing HIV-1 vaccine candidates in macaques. J Acquir Immune Defic Syndr Hum Retrovirol 1996;12(2):99-106. [9] Payne LG, Van Nest G, Barchfeld GL, Siber GR, Gupta RK, Jenkins SA. PCPP as a parenteral adjuvant for diverse antigens. Dev Biol Stand 1998;92:79-87. [10] Payne LG, Jenkins SA, Andrianov A, Langer R, Roberts BE. Xenobiotic polymers as vaccine vehicles. Advances in Experimental Medicine and Biology 1995;371(B):1475-80. [11] Andrianov AK. Polyphosphazenes as vaccine adjuvants. In: Singh M, editor. Vaccine Adjuvants and Delivery Systems. Hoboken, New Jersey: John Wiley & Sons, 2007: 355-78. [12] Andrianov AK, Chen J. Polyphosphazene microspheres: Preparation by ionic complexation of phosphazene polyacids with spermine. Journal of Applied Polymer Science 2006;101(1):414-9. [13] Andrianov AK, Chen J, Payne LG. Preparation of hydrogel microspheres by coacervation of aqueous polyphosphazene solutions. Biomaterials 1998;19(1-3):109-15. [14] Andrianov AK, Chen J, Sule SS, Roberts BE. Ionically cross-linked polyphosphazene microspheres. ACS Symposium Series 2000;752:395-406. [15] Andrianov AK, Payne LG. Polymeric carriers for oral uptake of microparticulates. Advanced Drug Delivery Reviews 1998;34(2-3):155-70. [16] Andrianov AK, Payne LG. Protein release from polyphosphazene matrices. Advanced Drug Delivery Reviews 1998;31(3):185-96. [17] Andrianov AK, Marin A, Peterson P, Chen J. Fluorinated polyphosphazene polyelectrolytes. Journal of Applied Polymer Science 2007;103(1):53-8. [18] Andrianov AK, Chen J, LeGolvan MP. Poly(dichlorophosphazene) as a precursor for biologically active polyphosphazenes: Synthesis, characterization, and stabilization. Macromolecules 2004;37(2):414-20. [19] Andrianov AK, Le Golvan MP. Characterization of poly[di(carboxylatophenoxy)-phosphazene] by an aqueous gel permeation chromatography. Journal of Applied Polymer Science 1996;60(12):2289-95. [20] Andrianov AK, Svirkin YY, LeGolvan MP. Synthesis and biologically relevant properties of polyphosphazene polyacids. Biomacromolecules 2004;5(5):1999-2006. [21] Andrianov AK, Marin A. Degradation of polyaminophosphazenes: Effects of hydrolytic environment and polymer processing. Biomacromolecules 2006;7(5):1581-6. [22] Andrianov AK, Marin A, Peterson P. Water-soluble biodegradable polyphosphazenes containing N- ethylpyrrolidone groups. Macromolecules 2005;38(19):7972-6. 30
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