UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  December 9, 2008

 

PHARMATHENE, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-32587

 

20-2726770

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

One Park Place, Suite 450, Annapolis, Maryland

 

21401

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number including area code: (410) 269-2600

 

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o                 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 7.01.                                          Regulation FD Disclosure

 

We are furnishing as an exhibit to this report a PowerPoint presentation that representatives of PharmAthene, Inc. (the “Company”) plan to use for discussions with certain of the Company’s stockholders and other interested persons.

 

Any information contained in the presentation should be read in the context of and with due regard to the more detailed information provided in other documents we file with or furnish to the Securities and Exchange Commission, including, but not limited to, our annual report on Form 10-K for the year ended December 31, 2007 and our quarterly report on Form 10-Q for the quarter ended September 30, 2008.

 

In accordance with General Instruction B.2. of Form 8-K, the information in this Current Report on Form 8-K, including the attached Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01.                                          Financial Statements and Exhibits.

 

(d)                                 Exhibits:

 

Exhibit No.

 

Description

 

 

 

99.1

 

PowerPoint Presentation

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

PHARMATHENE, INC.

 

 (Registrant)

 

 

 

 

Date: December 9, 2008

By:

/s/ Christopher C. Camut

 

 

Christopher C. Camut
Chief Financial Officer

 

3


Exhibit 99.1

 

GRAPHIC

Dedicated to a safer world December 2008

 


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2 2 Safe Harbor Statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. This information may involve known and unknown risks, uncertainties and other factors that are difficult to predict and may cause the Company’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements. Forward-looking statements, which involve assumptions and describe management’s current expectations regarding the Company’s future plans, strategies and objectives, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” “potential” or “plan” or the negative of these words or other variations on these words or comparable terminology. Such statements include, but are not limited to, statements about future government contract awards, potential payments under government contracts, potential regulatory approvals, future product advancements, anticipated financial results and expected benefits of the acquisition of Avecia Vaccines. These forward-looking statements are based on assumptions that may be incorrect, and we cannot assure you that the projections included in these forward-looking statements will come to pass. The Company’s actual results could differ materially from those expressed or implied by the forward looking statements as a result of various factors, including, but not limited to the “Risk Factors” included in the Company’s annual report on Form 10-K and other reports filed with the SEC.

 


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3 Investment Highlights • Penetrating multi-billion dollar global biodefense market • Building highly competitive portfolio of next generation products • Pursuing focused acquisition strategy with significant revenue opportunities • Demonstrating strong track record obtaining significant government funding

 


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4 Smallpox Rad/nuclear Botulism Other viruses Other Penetrating a Multi-Billion Dollar Market Project BioShield: $5.6B Market Opportunity Anthrax vaccines Anthrax anti-toxins Total anthrax share 36% or $2B opportunity targeted by PharmAthene Source: HHS Public Health Emergency Medical Countermeasure Enterprise Implementation Plan; BioShield contracts awarded vaccines

 


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5 Opportunities Beyond Project BioShield Department of Defense purchases $5B International purchases $6B Commercial purchases $1B Fortune 500 companies Leasing opportunities Total biodefense market opportunity ~$50B Project BioShield funding is only the tip of the iceberg $5.6B Actively pursuing additional markets: Execution of DHHS Implementation Plan $35B Source: MedaCorp Reports * Chemical & Biological Defense Program – Oct 2005; DHHS Implementation Plan; Company Estimates through 2018

 


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6 Biodefense Development Process Typical Biotech Development Process Biodefense Development Process Safe & effective Safe & effective Discovery Pre-Clinical Proof of Concept Efficacy Non-Clinical Efficacy* EUA Sales FDA Approval Discovery Pre-Clinical Phase I Phase II Phase III FDA Approval Sales Human Safety Phase I / II * Biodefense timeline assumes no delays due to demonstrating validation of animal models under the FDA’s Animal Rule

 


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7 PharmAthene’s Strategic Advantage • Focus - Biodefense market • Experience - Identifying high-priority government needs - Identifying and acquiring best-in-class products - Collaborating with government to develop and commercialize products • Success - Up to $554MM* in contracts and funding awarded to date - Partner of choice for biodefense * If all milestones are met and options exercised by government

 


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8 Executive Leadership Senior Officers: Previous Affiliations: David P. Wright MedImmune, Guilford, GenVec, Smith-Kline President & Chief Executive Officer & French, G.D. Searle, Glaxo Christopher C. Camut RecoverCare, Wachovia, Alex Brown & Sons Chief Financial Officer Francesca Cook Guilford, Covance, US Senate, DHHS VP, Policy & Government Affairs Wayne Morges, PhD Baxter Healthcare, Merck VP, Regulatory Affairs & Quality Eric I. Richman MedImmune, HealthCare Ventures SVP, Bus. Dev. & Strategic Planning Valerie Riddle, MD, FACP MedImmune, Guilford, Washington Hospital VP and Medical Director Joan Fusco, PhD Acambis, Baxter Healthcare SVP, Operations Jordan Karp, JD Guilford, Constellation Energy, Mentor, MCI SVP, General Counsel

 


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9 Investment Highlights • Penetrating multi-billion dollar global biodefense market • Building highly competitive portfolio of next generation products • Pursuing focused acquisition strategy with significant revenue opportunities • Demonstrating strong track record obtaining significant government funding

 


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10 Best-in-Class Portfolio 2 3rd Generation rPA Anthrax Vaccine 1 rPA Anthrax Vaccine SparVax 3 Anthrax Anti-Toxin Valortim® 4 Nerve Agent Prophylaxis Protexia®

 


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11 rPA Anthrax Vaccine – SparVax™ • Highly purified recombinant version of Protective Antigen • Produces vaccine-induced antibody response comparable to current licensed vaccine Recombinant Protective Antigen (rPA) anthrax vaccine Characteristics Advantages • 3 dose intramuscular regimen vs 6 dose subcutaneous for BioThrax® • Improved consistency • Completed Ph II testing in 770 individuals; safe & well tolerated

 


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12 Anthrax Vaccines - Market Opportunity • rPA Anthrax Vaccine Opportunity – Initial DHHS procurement contract (rPA vaccine): 25MM doses – Potential market opportunity in RFP: $350MM - $600MM • Worldwide Anthrax Vaccine Market Source : analyst reports; company estimates 2007-2012 $1.1B 2012-2018 $1.2B 2018-2024 $1.5B

 


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13 3rd Generation rPA Anthrax Vaccine • Government Requirement – Develop 3rd generation rPA-based anthrax vaccine with • Enhanced stability – maintain stability for 3 years at 35ºC • Improved potency – induce protective immunity in 2 or fewer doses • PharmAthene’s 3rd generation product – Room temperature stable with enhanced immunogenicity – Grant and contract funding of up to $97.9M awarded from NIH – Awarded NIH development contract 9/26/08 for up to $83.9M • PharmAthene Goal – Capture significant market share in both 2nd and 3rd generation vaccine market

 


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14 Anthrax Anti-Toxin – Valortim® • Fully human monoclonal antibody (MAb) of action • Potent anthrax toxin neutralizing activity • Mechanism of action appears similar to natural immune response Fully human monoclonal antibody (MAb) with a unique mechanism Characteristics Advantages • Capable of neutralizing both free and cell-bound anthrax toxin • Efficacious as both prophylaxis and therapy • Potential sporicidal activity • Provides significant, sustained protection to monkeys with a single dose

 


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15 Valortim® - Impressive Data Package • Initial Phase I in humans complete; no SAE’s attributed to Valortim® • Multiple animal studies have demonstrated efficacy 56% At time of ECL for PA AG Monkeys Treatment 42% 48 hrs post-exposure Rabbits Treatment 88% 24 hrs post-exposure Rabbits Treatment 100% 1 hr post-exposure Monkeys Prophylaxis 85% 1 hr post-exposure Rabbits Prophylaxis Survival Time to Treatment Animal 0% All Above All Above Control

 


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16 Anthrax Anti-Toxins Market Opportunity • Current options are inadequate - Antibiotics are ineffective - Vaccines are inappropriate for treatment • USG requirements established for anti-toxins - DHS Material Threat Assessment: 200,000 treatments - DHHS procurements to date under 2004 RFP requirement • HGSI – 20,000 doses; $8,260 cost/dose • Cangene – 10,000 doses; $14,383 cost/dose • Valortim® is well positioned for procurement - USG funding awarded to date ~$24MM

 


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17 Nerve Agent Prophylaxis - Protexia® • Novel recombinant form of naturally occurring bioscavenger protein • Produced using innovative transgenic manufacturing platform Recombinant human BChE (Butyrylcholinesterase) Mimics natural “bioscavenger” Characteristics Advantages Over Standard of Care • Protection pre- and post-exposure • Protection against broad spectrum of nerve agents • Superior efficacy to standard of care • No observable neurological deficits

 


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18 Guinea pig exposed to only 1.5 x LD50 Soman and immediately given the conventional treatment of atropine / 2-PAM / Diazapam Conventional Treatment Does Not Prevent Neurological Toxicity Conventional Treatment • Only 50% of those exposed survived • Severe neurological deficits Source of the film: U.S. Army Medical Research Institute of Chemical Defense

 


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19 Guinea pig pretreated with Protexia® and then 18 hours later exposed to 5.5x LD50 of Soman Only Protexia® Provides Superior Survival and Prevents Neurological Toxicity Protexia® Solution • 100% survival rate • No neurological deficits Source of the film: U.S. Army Medical Research Institute of Chemical Defense

 


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20 Nerve Agents - Market Opportunity • Department of Defense advanced development procurement contract – Total value of up to $219MM* • $106MM in development funding • $113MM for procurement of initial 90,000 doses • Additional opportunity for civilian (SNS); ex-US military & civilian commercial purchases • Phase I clinical trial commenced Oct 08 • Expanding applications to non-biodefense markets – Alzheimer’s disease *If all milestones are met and options exercised by the USG.

 


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21 Investment Highlights • Penetrating multi-billion dollar global biodefense market • Building highly competitive portfolio of next generation products • Pursuing focused acquisition strategy with significant revenue opportunities • Demonstrating strong track record obtaining significant government contracts

 


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22 Unparalleled Track Record in this Sector Diversified biodefense portfolio 5 products Significant DoD contract for Protexia® up to $219M* NIH contract for 3rd generation anthrax vaccine up to $83.9M* Advanced development funding for Valortim® up to $24M* Total vaccines government funding to date up to $310M* Total biodefense government funding to date up to $554M** *If all milestones are met and options exercised by government **Includes amounts not set forth above

 


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23 Clear Roadmap to Create Value Develop and position products for commercial uses 4 Develop multiple government users and non-government customers 3 Expand portfolio through strategic acquisitions 2 Continue to obtain procurement contracts and increase revenues 1

 


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24 2009 H1 H2 2010 H1 H2 Key 2009-10 Value Creation Events Potential SparVax™ procurement contract – 25M doses Complete Valortim® initial dose-ranging study (AGM) Potential for Valortim® advanced development funding Begin Valortim® Phase I clinical trial with antibiotics Complete Protexia® Phase I clinical trial Potential for DoD Protexia® contract extension - $65MM Complete SparVax™ consistency lots Complete Protexia® proof-of-concept therapeutic studies

 


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25 Investment Highlights • Large and growing market – Urgent requirements, multi-billion dollar market • Experienced management team – Previous long-term working relationships with strong execution skills • Successful execution of growth strategy – Advancing four best-in-class, next-generation products • Solid track record validates our approach – Potential government funding/contracts of up to $554MM* to date • Clear roadmap for success and value creation *If all milestones are met and options exercised by the USG.

 


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Dedicated to a safer world December 2008