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Investor Presentation Seeking $500,000 Convertible Note Financing, P receding $13MM Series B Round . October 2011. NON-CONFIDENTIAL. Formula Pharmaceuticals – Investment Opportunity. Formula’s Executive Leadership. Formula Key Advisors . Corporate
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Investor Presentation Seeking $500,000 Convertible Note Financing, Preceding $13MM Series B Round October 2011 NON-CONFIDENTIAL
Formula Key Advisors • Corporate • Martyn Greenacre – formerly, Chairman SmithKlineBeecham-Europe * • Dave Williams – formerly, Chairman & CEO of Sanofi Pasteur • Frederick (“Fred”) Frank – Vice Chairman at Peter J. Solomon Company • Tommy Thompson – formerly, US Secretary of Health & Human Services • Adelene Perkins – CEO, Infinity Pharmaceuticals • Warren Cooper – formerly CEO, Prism Pharmaceuticals • Richard (“Dick”) Sherman – Venture Partner, SCP Partners • Mickey Flynn – formerly, President & current Vice-Chair of Pennsylvania-BIO • Steve Goodman – Partner at Morgan Lewis Bockius, LLP • Clinical & Regulatory (partial list) • Bruce Burlington – formerly Deputy Director, CBER Division of FDA; formerly EVP of Regulatory Affairs & Quality Controls at Wyeth Pharma • Andrea Biondi – Professor, University of Milan; San Gerardo Hospital * Also on Formula Board of Directors
FPI-01 – Clinical Results From Phase I Pilot Study in AML MSKCC pilot study: 5 of 9 patients were ≥ 64 years old; 7 of 9 patients had intermediate-risk cytogenecity Completed phase-1 trial at MSKCC: Median overall survival not yet reached at 54+ months Historic controls Historic controls Expected median overall survival in comparable patients receiving standard of care: 9 – 12 months Kantarjian H et al. Cancer 2006; 106:1090-1098 Appelbaum FR et al. Blood 2006; 107:3481-3485
The Product - FPI-01 An effective target-specific immune response • Four synthetic peptides targeting Wilms’ Tumor 1 (WT1) antigen • WT1 over-expressed in many hematologic and solid tumors • Designed to make for a powerful immune response against WT1 • Treating patients with minimal residual disease following standard chemotherapy and who cannot further tolerate cytotoxic therapy • Preventing relapse = extending overall survival • No products approved in the US for 1st remission AML
What large pharma wants to see – key product features • Combinable with standard of care (safe; no change in practice) • Targeting minimal residual disease settings • Composition of matter patent protection • Off-the-shelf product • Measurable biomarkers specific for product • Clear regulatory guidance for clinical development path √ √ √ √ √ √
FPI-01 in AML: 17% of G7 incidence = $500+MM peak salesCombined Revenue Forecast in 7 largest markets • WW Peak Revenue (AML): ~$500MM (1) Datamonitor, Pipeline Insight: Leukemias, March 2010
AML Competitive Landscape • Limited competition exists for agents seeking to prevent a relapse following the 1st remission in AML patients Sources: Datamonitor, Medtrack, Kelley WN (ed): Textbook of Internal Medicine. (*) Among development-stage competitors for1st remission AML most are autologous, dentritic cell-based vaccines
Formula’s Pipeline OverviewLead Product In Multiple Indications Phase I Phase II Formula start 2Q2012 First-remission AML Completed MSKCC started 1Q2011 Mesothelioma Completed MSKCC started 2Q2011 Melanoma Planned Elderly ALL Planned Ovarian cancer Planned MSKCC sponsored trials
Total Investment, Milestones & Timeline (Series A & B) . $12.6MM operating budget $5.4MM $4.3MM $2.9MM $1.1MM $10MM $3MM 1/1/2012 beginning cash Complete Ph2 AML trial Start company-sponsored Ph2 AML trial Start Immune Response SOPs Orphan Status application Complete ph-2 AML trial enrollment Start second indication phase-2 trial M&A or Strategic Partnership Start Ph3 Start Event Regulatory Event Business Event Expense Complete Event
Formula - Investor Exit • FPI-01 program designed with investors’ exit strategy in mind • Potential for up to 10x return, upon positive completion of Formula’s planned randomized controlled phase-2 trial • Management has deep experience in strategic licensing and M&A Recently closed deals by companies roughly comparable with Formula’s projected business and product profile:
Potential Risk-Reducing Factors For Investors • Strategic partnering with pharmato finance phase-2 trial and to broaden clinical indications • Preliminary discussions with various large multinational biopharmaceutical companies have initiated • Broaden pipeline by acquiring additional affordable high-quality product candidates • Formula has identified promising acquisition candidates that could fit with it’s investment philosophy (near-term exit, high-value inflection point) • Raising non-dilutive capital from government- (e.g. SBIR, HHS, NCI) and Non-Government Organizations (e.g. CVAF, LLS, CPRIT) • Sign-off from FDA on clinical development path towards approval, following recent positive FDA meeting
Formula Pharmaceuticals – Investment Highlights • Virtual company developing a clinical stage product that has shown a compelling survival benefit in AML patients • Strong scientific and clinical rationale, supported by scientific integrity of Memorial Sloan Kettering Cancer Center • Experienced operational and business team • Straight development path to exit within a 4 year timeframe • Seeking $500,000 to supplement recently raised Series A round, which precedes an $13 million Series B financing by 4Q2011 • Sustainable business model through additional product candidates
Company address Formula Pharmaceuticals, Inc. Three Westlakes, 1055 Westlakes Drive, 3rd Floor Berwyn, PA 19312 http://www.formulapharma.com Maurits W. Geerlings, MD, MBA Chief Executive Officer Ph: 610-727-4172 Fx: 610-23-0111 Mobile: 301-461-7828 mgeerlings@formulapharma.com