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Investor Presentation Seeking $500,000 Convertible Note Financing, Preceding $13MM Series B Round NON-CONFIDENTIAL October 2011.

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Presentation on theme: "Investor Presentation Seeking $500,000 Convertible Note Financing, Preceding $13MM Series B Round NON-CONFIDENTIAL October 2011."— Presentation transcript:

1 Investor Presentation Seeking $500,000 Convertible Note Financing, Preceding $13MM Series B Round NON-CONFIDENTIAL October 2011

2 NON-CONFIDENTIAL Formula Pharmaceuticals – Investment Opportunity Targeting large markets characterized by great unmet medical needs In-licensing drug candidates with investor exit in mind; 4-year timeframe Business Model Developed at Memorial Sloan Kettering Cancer Center Compelling survival data in pilot study for first-remission Acute Myeloid Leukemia (AML) Lead product FPI-01 Operating as a virtual company; 3 FTEs + 5 contractors initially Seasoned management team, with on average > 20 years of functional-area experience Seeking a $0.5 million Series A, preceding $13MM Series B Management 2

3 NON-CONFIDENTIAL Formula’s Executive Leadership Name / organization Present affiliation Functional role years of experience Area of expertisePast affiliations Maurits Geerlings, MD, MBA (*) Chief Executive Officer; Co-Founder >17 yrs General management in life- sciences industry; investor relations; corp. development Infinity Pharma, Cephalon, Prism Pharma, Alexion Pharma, Actinium Pharma, Memorial Sloan Kettering Cancer Center Giorgio Mosconi, MD, PhD (*) President & COO; Co- Founder >20 yrs Pharmaceutical operations; regulatory affairs (US & EU); business development Pierrell S.p.A., Acureon, Vicuron; BristolMyersSquibb; Biosearch Italia; Marion Merrell Dow Ann Lee Cahill Clinical Development Group LLC SVP, Clinical Development > 17 yrs Clinical Development & Operations Vion Pharmaceuticals, Schering Plough, New Britain General Hospital Steve Feder, Esq. GenCounsel LLC General Counsel & Secretary >20 yrs Corporate legal affairs, deal making, compliance Safeguard Scientifics, Pepper Hamilton LLP, Ballard Spahr LLP, White and Williams LLP Eric Steager, MBA SVP, Finance & Treasurer > 19 yrs Financial management, corporate finance, financial planning & analysis GPX Enterprises, Safeguard Scientifics, Ankaa Capital Partners, Banc One, Ernst & Young, Capital Valuation Group 3

4 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 4 * Also on Formula Board of Directors

5 NON-CONFIDENTIAL FPI-01 – Clinical Results From Phase I Pilot Study in AML 5 Completed phase-1 trial at MSKCC: Median overall survival not yet reached at 54+ months Kantarjian H et al. Cancer 2006; 106: Appelbaum FR et al. Blood 2006; 107: MSKCC pilot study: 5 of 9 patients were ≥ 64 years old; 7 of 9 patients had intermediate-risk cytogenecity Historic controls Expected median overall survival in comparable patients receiving standard of care: 9 – 12 months

6 NON-CONFIDENTIAL 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 1 st remission AML 6

7 NON-CONFIDENTIAL 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 7 √ √ √ √ √ √

8 NON-CONFIDENTIAL FPI-01 in AML: 17% of G7 incidence = $500+MM peak sales Combined Revenue Forecast in 7 largest markets 8 WW Peak Revenue (AML): ~$500MM (1) Datamonitor, Pipeline Insight: Leukemias, March 2010

9 NON-CONFIDENTIAL AML Competitive Landscape Limited competition exists for agents seeking to prevent a relapse following the 1 st remission in AML patients 1 st Line1 st Remission2 nd Line 2010 Patient incidence (G7) 29,00020,50024,000 Standard of care Anthracycline/cytarabinenone IDAC, HDAC, LDAC, HSCT Hypomethylating agents Agents in development by stage Phase III: 3 Phase II: 20 Phase I: 11 Pre-phase III: 1 (Ceplene) Phase II: 2 Phase I: 2 Phase III: 3 Phase II: 35 Phase I: 22 Total agents in development 355 (*) 61 Sources: Datamonitor, Medtrack, Kelley WN (ed): Textbook of Internal Medicine. (*) Among development-stage competitors for1 st remission AML most are autologous, dentritic cell-based vaccines

10 NON-CONFIDENTIAL Formula’s Pipeline Overview Lead Product In Multiple Indications 10 First-remission AML Mesothelioma Elderly ALL Ovarian cancer Completed Phase IPhase II Completed MSKCC started 1Q2011 MSKCC started 2Q2011 Planned MSKCC sponsored trials Formula start 2Q2012 MelanomaPlanned

11 NON-CONFIDENTIAL Total Investment, Milestones & Timeline (Series A & B) 11 Complete Event Start Event Regulatory Event Start Immune Response SOPs Start company- sponsored Ph2 AML trial Orphan Status application Complete Ph2 AML trial Expense $5.4MM$4.3MM$2.9MM $12.6MM operating budget. Start Ph3 M&A or Strategic Partnership Business Event Start second indication phase-2 trial Complete ph-2 AML trial enrollment $1.1MM 1/1/2012 beginning cash $10MM$3MM

12 NON-CONFIDENTIAL 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 12 Recently closed deals by companies roughly comparable with Formula’s projected business and product profile:

13 NON-CONFIDENTIAL Potential Risk-Reducing Factors For Investors Strategic partnering with pharma to 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 13

14 NON-CONFIDENTIAL 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 14

15 NON-CONFIDENTIAL Company address Formula Pharmaceuticals, Inc. Three Westlakes, 1055 Westlakes Drive, 3 rd Floor Berwyn, PA Maurits W. Geerlings, MD, MBA Chief Executive Officer Ph: Fx: Mobile:


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