Altimmune, Inc. · NASDAQ:ALT
Altimmune — Pharmathene — Merger or Acquisition (September 2013)
36 slides from Altimmune's merger presentation, Sep 9, 2013
Slide 1: Creating a Diversified Biologics Company Addressing Government and Commercial Markets
Creating a Diversified Biologics Company Addressing Government and Commercial Markets
Slide 2: Safe Harbor Statement
2 Safe Harbor Statement Except for the historical information presented herein, matters discussed may constitute forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties that could cause actual results
Slide 3: Important Additional Information About the Merger
3 Important Additional Information About the Merger This communication is being made in respect of the proposed merger involving Theraclone Sciences, Inc. (“Theraclone”) and PharmAthene. On August 1, 2013, PharmAthene filed with the SEC a current report on Form 8 - K, which includes the merger agree
Slide 4: No Offer or Solicitation
4 No Offer or Solicitation This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction in connection
Slide 5: PharmAthene / Theraclone
5 PharmAthene / Theraclone PharmAthene, Inc., (NYSE MKT: PIP) a leading biodefense company, and Theraclone Sciences, Inc., a monoclonal antibody discovery and development company, announced an intention to merge to form a commercially - focused biologics company with extensive vaccines and therapeut
Slide 6: Combined Company – Investment Opportunity
6 Combined Company – Investment Opportunity Compelling transaction with complementary capabilities to realize synergies and accelerate value Premier biologics company with vaccine and antibody expertise and a focus on infectious diseases and oncology Four clinical programs and multiple partnered pre
Slide 7: Biologics Company with Significant Growth Potential
7 Biologics Company with Significant Growth Potential Non - dilutive funding to drive near - term growth Product development milestones and deals to drive long - term growth DEVELOP SIGNIFICANT COMMERCIAL PRODUCTS DEVELOP GOVERNMENT MARKETS LEVERAGE PROPRIETARY I - STAR™ PLATFORM • Flu Antibody (TCN
Slide 8: New Market Opportunity – Antibody Therapeutics
8 New Market Opportunity – Antibody Therapeutics • Fastest growing segment of the biopharmaceutical industry • Top 5 antibody products have sales of $5 billion each annually * • 5 of the top 10 selling drugs are monoclonal antibodies * • Clear regulatory pathway to approval • Proven manufacturing pr
Slide 9: Diversified Clinical Pipeline Targeting Large Market Opportunities
9 PRODUCT INDICATION PRE - CLINICAL PHASE I PHASE IIa PHASE IIb MARKET OPPORTUNITIES MARKET POTENTIAL SparVax ® Recombinant protective antigen (rPA) anthrax vaccine Anthrax Infection >$1B USG Stockpile Opportunity* Flu mAb TCN - 032 Influenza A Therapeutic Severe Seasonal and Pandemic Flu ~$ 600MM E
Slide 10: I-STAR Validating Partnerships
10 I - STAR TM Validating Partnerships January 2011 I - STAR™ collaboration to discover antibodies against up to four undisclosed targets in the areas of infectious disease and cancer. Pfizer has Worldwide licensing rights. February 2008 IAVI collaboration to discover HIV - neutralizing antibodies M
Slide 11: Flu Antibody: TCN-032
11 Flu Antibody: TCN - 032 • IgG mAb that binds to a novel, highly - conserved universal epitope – Influenza A (H1N1; H5N1; H7N9) • Annually, 200,000 U.S. patients are hospitalized; 36,000 die from serious influenza infections* • Government stockpile market offers significant upside potential • Phas
Slide 12: TCN-032: Phase 2a Human Viral Challenge Study
12 TCN - 032: Phase 2a Human Viral Challenge Study • Demonstrated reductions in total clinical symptom scores and viral load • S afe and well - tolerated with no increase in adverse events compared to placebo , including lower respiratory tract symptoms • P harmacokinetics consistent with Phase 1 st
Slide 13: Cytomegalovirus (CMV) Antibody: TCN-202
13 Cytomegalovirus (CMV) Antibody: TCN - 202 • Recognizes broadly conserved epitope on CMV • Neutralizes CMV viral infection in many cell types – Epithelia, endothelial, fibroblasts, etc. • ~1,000x more potent than plasma - derived CMV - IGIV (preclinical studies)* • Phase 1 completed; favorable saf
Slide 14: TCN-202: Phase 1 Clinical Study
14 TCN - 202: Phase 1 Clinical Study • Well - tolerated in single doses of 1 - 50 mg/kg and multiple doses at 15 mg/kg x2 • AEs were mild to moderate – Most were unrelated to study drug • Pharmacokinetics – Dose proportional (Cmax and AUC) – Half - life ~14 days – Volume of distribution and clearanc
Slide 15: SparVax Next Generation Anthrax Vaccine
15 SparVax ® Next Generation Anthrax Vaccine • Highly purified recombinant p rotective antigen – Modern E. coli - based production • 770 individuals in Phase I and Phase II clinical trials • Pre - and post - exposure protection • Enhanced convenience and cost - effectiveness (PEP regimen) – 3 dose I
Slide 16: Valortim Anthrax Anti-Toxin
16 Valortim ® Anthrax Anti - Toxin • Dept. of Homeland Security Material Threat Assessment: 200,000 treatments • HHS procurement program to fulfill requirement Fully human monoclonal antibody (mAb) • Novel mechanism of action similar to natural immune response • Effective Pre - and Post - exposure •
Slide 17: Nerve Agent Bioscavenger rBChE
17 Nerve Agent Bioscavenger rBChE Nerve Agent Bioscavenger to Address Chemical Threats • Prevents physiological damage from chemical nerve agents • Robust advanced expression system (AES) technology platform • $5.7MM in DoD funding • Cell culture - based manufacturing • Scalable manufacturing proces
Slide 18: I-STAR: Generating Highly-Specific Human Antibodies
18 I - STAR ™ Generating Highly - Specific Human Antibodies for Significant Unmet Medical Needs Selected donor population convalescent/vaccinated subjects = protective Abs Superior B - cell activation Deep sequencing of all hit wells Rapid screen for binding and function IgG+ Memory B - cells “Archi
Slide 19: Significant Near-Term Revenue Opportunity: Arestvyr (SIGA Technologies)
19 Significant Near - Term Revenue Opportunity Arestvyr™ (SIGA Technologies) Oral Smallpox Antiviral Up to ~$2.8B* NOTE: The above is based solely on information from the following public sources: SIGA press releases and other public statem ent s, research analyst reports, SEC filings • $2.8B* U.S.
Slide 20: Significant Revenue Opportunity: Arestvyr (SIGA Technologies)
20 Significant Revenue Opportunity Arestvyr™ (SIGA Technologies) Oral Smallpox Antiviral • Breach of contract lawsuit filed by PharmAthene in December 2006 • Trial court awarded PharmAthene 50% of net profits on WW sales of Arestvyr™ for 10 years once SIGA retains the first $40MM in profit • Decisio
Slide 21: Combined Company Executive Team
21 Combined Company Executive Team Clifford J. Stocks Chief Executive Officer Calistoga Pharmaceuticals, Inc., ICOS Corporation Francesca Cook SVP, Policy and Government Affairs Guilford Pharmaceuticals Covance Health Econ., U.S. HHS Russ Hawkinson Chief Financial Officer Corixa Corporation Ernst &
Slide 22: Combined Company Board of Directors
22 Combined Company Board of Directors Mitch Sayare, Ph.D. Chairman ImmunoGen XenoGen John M. Gill Tetralogic Pharmaceuticals 3D Pharma, SKB Steve Gillis, Ph.D. Immunex, Corixa, ARCH Venture Partners Wende Hutton Canaan Partners Mayfield Fund, GenPharma International Brian Markison King Pharmaceutic
Slide 23: Near-Term Valuation Catalysts
23 Near - Term Valuation Catalysts Initiate CMV antibody Phase 2a study Q3 13 Present Flu Antibody Phase 2a results Q3 13 Present CMV Antibody Phase 1 results Q3 13 Secure additional USG SparVax ® funding Q4 13 Initiate SparVax ® Phase 2 clinical trial Q4 13 Event* Date *The Milestones listed above
Slide 24: Key Terms of the Transaction
24 Key Terms of the Transaction Proposed Transaction: Tax - free, all stock transaction Pro Forma Ownership: Merger of Equals Next Steps: Proxy Statement / Prospectus / Consent Solicitation Stockholder meeting and vote Name: PharmAthene Public Market: NYSE MKT; symbol “PIP”
Slide 25: TCN-032: Flu Antibody Phase 2a Viral Challenge Study
25 TCN - 032: Flu Antibody Phase 2a Viral Challenge Study
Slide 26: Viral Challenge Protocol: Study Design
26 Viral Challenge Protocol: Study Design • Double - blind, placebo - controlled, randomized study • Population – Normal healthy subjects; males or females, age 18 - 45 years – Seronegative (HAI titer ≤ 10) to H3N2 challenge strain (A/Wisconsin/67/05) • Treatment: TCN - 032 40 mg/kg or placebo, give
Slide 27: Clinical Symptoms
27 Clinical Symptoms Clinical Symptoms TCN - 032 n=24 Placebo n=24 % Difference p value (one - sided) Proportion of subjects with grade 2 symptoms or pyrexia 10/24=41.2% 13/24=54.2% 12.5% p=0.21 CMH test AUC (Day 1 - 7) median 25.5 39 35% p=0.0466* Wilcoxon
Slide 28: Median Time to Peak, Time to Resolution and Duration of Symptoms
28 Median Time to Peak, Time to Resolution and Duration of Symptoms TCN - 032 n=24 Placebo n=24 p value (one - sided) Time to Peak Symptoms Day 3 Day 3 p=0.21 Wilcoxon Time to Resolution of Symptoms Day 6.5 Day 7.5 p=0.06 Wilcoxon Duration of Symptoms 4.5 days 6 days p=0.11 Wilcoxon
Slide 29: Viral Shedding and Viral Escape Analysis
29 Viral Shedding and Viral Escape Analysis TCN - 032 AUC (log 10 TCID 50 /mL) Placebo AUC (log 10 TCID 50 /mL) Absolute Log Decrease p value (one - sided) PCR Day 2 - 7 Median=5.2 Median=7.4 2.2 p=0.09* Wilcoxon Viral escape genotypic analysis ▪ Sequence analysis (454 Next Generation) TCN - 032 epi
Slide 30: Clinical Symptoms and Viral Shedding by PCR
30 Clinical Symptoms and Viral Shedding by PCR Clinical symptoms and viral shedding in both treatment arms follow similar patterns
Slide 31: Summary and Conclusions
31 Summary and Conclusions • In a human viral challenge model, TCN - 032 showed reductions in clinical symptoms and viral shedding • TCN - 032 was safe and tolerable, with no increase in adverse events compared to placebo , including lower respiratory tract symptoms • TCN - 032 pharmacokinetics were
Slide 32: TCN-202: CMV Antibody Phase 1 Study Results
32 TCN - 202: CMV Antibody Phase 1 Study Results
Slide 33: TCN-202: Background
33 TCN - 202: Background • TCN - 202 is a fully human mAb that targets the highly conserved antigenic domain (AD - 2) epitope in glycoprotein B (gB) of human cytomegalovirus (HCMV) gB plays important roles in viral entry and spread to adjacent cells • Antibodies against AD - 2 neutralize the infecti
Slide 34: Pharmacokinetic Profile: Single Dose SAD Cohorts
34 Pharmacokinetic Profile: Single Dose SAD Cohorts Time Post - start of Infusion (days) 0 14 28 42 56 70 0.1 1 10 100 1000 10000 1 mg/kg 3 mg/kg 10 mg/kg 30 mg/kg 50 mg/kg TCN - 202 Concentration (µg/mL)
Slide 35: Pharmacokinetic Profile: Multiple Dose
35 15 mg/kg x 2 doses Time Post - start of 1 st Infusion (days) 0 14 28 42 56 70 84 10 100 1000 TCN - 202 Concentration (µg/mL) Pharmacokinetic Profile: Multiple Dose
Slide 36: Summary
36 Summary • TCN - 202 at single doses of 1 - 50 mg/kg and multi - dose at 15 mg/kg x2: well - tolerated • AEs were mild to moderate – Most were unrelated to study drug • Pharmacokinetics – Dose proportional (Cmax and AUC) – Half - life ~14 days – Volume of distribution and clearance - consistent wi