Maxcyte Executive Summary Suggestions
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One Park Place, Ste. 450 Annapolis, MD 21401 (410) 269-2600 www.PharmAthene.com OVERVIEW (NYSE ALTERNEXT US: ‘PIP’) PharmAthene was formed in March 2001 with a mission to become the premier company worldwide specializing in therapeutic and prophylactic products for defense against terrorist threats, with the opportunity for expansion into broader commercial applications. Since its inception, PharmAthene has pursued an acquisitive growth strategy focused on high priority biodefense products that the government has expressed a clear need and intent to procure. Currently, its portfolio includes five potential best-in-class biodefense medical countermeasures: • SparVax™ - recombinant protective Antigen (rPA) anthrax vaccine • Valortim® - fully human monoclonal antibody being co-developed with Medarex for the prevention and treatment of anthrax infection • Protexia® - novel bioscavenger to prevent and treat organophosphate nerve agent poisoning • RypVax™ - recombinant dual antigen plague vaccine; and, • rPA anthrax vaccine - Third generation PharmAthene’s core strengths are its: Unique focus in biological and chemical defense products Experienced management team which has been previously involved in the development and marketing of over 30 pharmaceutical and biotechnology products. Substantial capitalization and access to U.S. capital markets. Strong investor base of top-tier life sciences investors, including, MPM Capital, Healthcare Ventures, Bear Stearns Health Innoventures, and MDS Capital. PHARMATHENE’S STRATEGY To seize leadership in biodefense, PharmAthene has assembled and will continue to build a strong portfolio of development-stage products, which it believes are essential for the biosecurity needs of the United States and its Allies. These products must meet certain criteria including: • Demonstration of proof of concept • Demonstrated interest by the U.S. government in procurement • Clearly defined development and regulatory strategy In 2004, PharmAthene signed a collaborative agreement with Medarex, Inc. to develop Valortim®, a fully human monoclonal antibody targeted at the anthrax protective antigen (PA) for use in the prevention and treatment of anthrax infection. In 2005, PharmAthene acquired all of the assets related to Protexia®, a recombinant human butyrylcholinesterase for use as a defense against chemical nerve agents, from Nexia Biotechnologies, Inc. in Montreal, Canada. In 2008, PharmAthene acquired all of the assets related to Avecia’s biodefense vaccines business unit, including the intellectual property rights associated with a second and third generation rPA anthrax vaccine and plague vaccine. Other efforts to acquire or co-develop promising countermeasure technologies are ongoing. FINANCING ISTORY PharmAthene has been successful in obtaining critical funding to finance the development of its portfolio products. In September 2008, the Company announced a strategic financing with Panacea Biotec Ltd. of $13.1 million in exchange for the sale of common stock and warrants. In August 2007, the Company completed a reverse merger with a special purpose acquisition company – Healthcare Acquisition Corp. (HAQ). As a result of the merger, PharmAthene began trading publicly on the American Stock Exchange under the ticker symbol ‘PIP’; also, the Company obtained approximately $60 million in capital, which was raised at the time of HAQ’s Initial Public Offering. Prior to its merger with HAQ, PharmAthene had raised approximately $65 million in venture capital and private equity financing. In October 2006, PharmAthene was awarded a multi-year contract originally valued at up to $213 million from the Department of Defense for advanced development of the Company’s broad spectrum chemical nerve agent prophylaxis, Protexia®. In 2008, the DoD awarded PharmAthene a contract modification which provided an additional $5.8 million in funding under the advanced development contract, bringing the total potential value of the contract to approximately $219 million, provided that certain milestones are achieved and that all contract options and extensions are exercised by the government. The company has also received total government funding of approximately $24 million for the development of its anthrax therapeutic, Valortim®. On March 31, 2008 PharmAthene completed its acquisition of the biodefense vaccines business unit of Avecia, a privately-owned, UK-based company. In addition to acquiring Avecia’s vaccine technologies, PharmAthene assumed all of Avecia’s vaccine-related government grant and contract funding, which totaled approximately $220 million. At the time of the acquisition, approximately $65 million remained outstanding and may be accessible to PharmAthene to support ongoing development of its biodefense vaccine programs, provided that certain milestones are achieved and that all contract options and extensions are exercised by the government. In September 2008 PharmAthene was awarded a multi-year contract for up to $83.9 million for advanced development of a third generation recombinant protective antigen (rPA) anthrax vaccine from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Including the funding provided to Avecia for its biodefense vaccine programs, the cumulative total value of all potential government funding awarded to PharmAthene and all PharmAthene-related biodefense products and technologies is approximately $569 million. UNIQUE INVESTMENT OPPORTUNITY “The specter of biological weapons Urgent Biodefense Need use is an ugly one, every bit as grim and foreboding as that of a nuclear Late Stage Preclinical Products winter. It is not 'if' but 'when' ... Accelerated Clinical Strategy and I hope we're going to be prepared." Highly Leveraged Development Guaranteed Large Market D.A. Henderson, Johns Hopkins University School of Public Contract in Advance of FDA Approval Health Accelerated Profitability Likely 2 ADDRESSING THE THREAT OF CHEMICAL AND BIOLOGICAL WEAPONS The threat of chemical and biological warfare has not been adequately addressed by the established pharmaceutical industry. Indeed, improved medical countermeasures continue to be needed by a larger segment of the civilian population, both within the U.S. and abroad, and sooner than originally anticipated before the terrorist attacks of 9/11. The urgent need to significantly enhance the protection of our nation and its allies is a societal challenge of the highest order. PharmAthene’s scientists and management team are committed to meeting that challenge and believe the company is uniquely positioned to do so. MEDICAL COUNTERMEASURES PORTFOLIO Anthrax is generally regarded as the single most important and imminent threat to North American biosecurity. Inhalational anthrax infection, caused by exposure to the bacterium Bacillus anthracis, is a serious disease with fever, shortness of breath and low blood pressure appearing within several days of exposure. There is a 95% to 100% mortality rate if left untreated, and at least a 50% mortality rate in patients treated aggressively with antibiotics. There is no effective therapy for the treatment of symptomatic anthrax infection and antibiotics have proven to be only 50% effective. Currently, PharmAthene’s portfolio includes three potential best-in-class biodefense medical countermeasures to prevent and treat anthrax infection, a second generation rPA anthrax vaccine; an anthrax anti-toxin, Valortim®, and a third generation rPA anthrax vaccine. SparVax™ - Recombinant Protective Antigen (rPA) Anthrax Vaccine PharmAthene’s recombinant protective antigen (rPA) anthrax vaccine, SparVax™ is a second generation recombinant version of Protective Antigen for use against human anthrax infection. The SparVax™ vaccine program has been funded by NIH contracts and grants totaling approximately $135 million to date. Phase I and II clinical trials have been completed in over 700 individuals, and demonstrated that SparVax™ is safe and well tolerated and produced a vaccine-induced antibody response in humans. The vaccine has a number of distinct advantages: it is a highly purified recombinant form of a single protein – protective antigen (PA), which is produced using standard biotechnology processes. Also, it appears to be effective when given as a three dose intramuscular regimen over a two month period. There remains a tremendous unmet need for a second generation anthrax vaccine that offers the potential for improved safety and convenience, and PharmAthene believes that SparVax™ is uniquely positioned to meet the current government requirements. The rPA anthrax vaccine program presents a promising near-term procurement opportunity for PharmAthene. In February 2008, the Department of Health and Human Services (DHHS) issued a solicitation outlining a requirement to procure 25 million doses of an rPA vaccine for the Strategic National Stockpile. PharmAthene believes that SparVax™ meets the criteria outlined in the solicitation and on July 31, 2008 submitted a proposal for consideration by DHHS. Anthrax Anti-Toxin - Valortim® PharmAthene entered into a collaboration agreement with Medarex, Inc. (NASDAQ: MEDEX) to co-develop its fully human monoclonal antibody, Valortim®. An antibody is a protein produced by the body, in response to the introduction of a foreign substance called an antigen that fights the invading organism. The antigen elicits a broad response including the release of antibodies to neutralize the antigen by binding to different