Transcript Investor Presentation - Pharmaceutical Consulting Consortium

Investor Presentation
Seeking $500,000 Convertible Note Financing,
Preceding $13MM Series B Round
October 2011
NON-CONFIDENTIAL
Formula Pharmaceuticals – Investment Opportunity
Business
Model
• Targeting large markets characterized by great unmet medical
needs
• In-licensing drug candidates with investor exit in mind; 4-year
timeframe
• Developed at Memorial Sloan Kettering Cancer Center
Lead product
FPI-01
• Compelling survival data in pilot study for first-remission Acute
Myeloid Leukemia (AML)
• Operating as a virtual company; 3 FTEs + 5 contractors initially
Management
• Seasoned management team, with on average > 20 years of
functional-area experience
• Seeking a $0.5 million Series A, preceding $13MM Series B
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NON-CONFIDENTIAL
Formula’s Executive Leadership
Name / organization
Functional role
Present affiliation
years of experience
Area of expertise
Past affiliations
Maurits Geerlings, MD, MBA (*)
Chief Executive Officer;
Co-Founder
>17 yrs
General management in lifesciences 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; CoFounder
>20 yrs
Pharmaceutical operations;
regulatory affairs (US & EU);
business development
Pierrell S.p.A., Acureon, Vicuron;
BristolMyersSquibb; Biosearch
Italia; Marion Merrell Dow
SVP, Clinical
Development
> 17 yrs
Clinical Development &
Operations
Vion Pharmaceuticals, Schering
Plough, New Britain General
Hospital
General Counsel &
Secretary
>20 yrs
Corporate legal affairs, deal
making , compliance
Safeguard Scientifics, Pepper
Hamilton LLP, Ballard Spahr LLP,
White and Williams LLP
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
Ann Lee Cahill
Clinical Development Group LLC
Steve Feder, Esq.
GenCounsel LLC
Eric Steager, MBA
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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
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* Also on Formula Board of Directors
NON-CONFIDENTIAL
FPI-01 – Clinical Results From Phase I Pilot Study in AML
Completed phase-1 trial
at MSKCC:
MSKCC pilot study: 5 of 9 patients were ≥ 64 years old; 7 of 9
patients had intermediate-risk cytogenecity
Median overall survival
not yet reached at 54+
months
Expected median overall
survival in comparable
patients receiving standard
of care: 9 – 12 months
Age
No. of patients
< 56 yo
368
56-65 yo 66-75 yo
246
274
>75 yo
80
Median survival, mo. 18.8
9.0
6.9
3.5
(95% CI)
(14.9-22.6) (8.1-10.2) (5.4-7.7) (1.4-6.1)
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Kantarjian H et al. Cancer 2006; 106:1090-1098
Appelbaum FR et al. Blood 2006;
107:3481-3485
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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
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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
√
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NON-CONFIDENTIAL
FPI-01 in AML: 17% of G7 incidence = $500+MM peak sales
Combined Revenue Forecast in 7 largest markets
• WW Peak Revenue (AML): ~$500MM
FPI-01 in AML Forecast Assumptions
Launch
2018
Yearly Incident Growth
0.8%
>60 Years AML
75%
WT1 Expression
80%
CR1
40% - 70%
$/Injection
$8,000
Price Growth
1%
Average Injections
8
Revenue per Patient
$64,000
Peak Penetration (2022)
50%
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Yearly Incidence1
United States
Japan
G7
2002
2010f
2013f
2016f
2019f
11,578 13,023 13,593 14,167 14,740
3,054
3,173
3,204
3,228
3,242
26,586 29,119 30,039 30,931 31,790
(1) Datamonitor, Pipeline Insight: Leukemias, March 2010
NON-CONFIDENTIAL
AML Competitive Landscape
• Limited competition exists for agents seeking to prevent a relapse
following the 1st remission in AML patients
1st Line
1st Remission
2nd Line
29,000
20,500
24,000
Standard of
care
Anthracycline/cytarabine
none
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
35
5 (*)
61
2010 Patient
incidence (G7)
Total agents in
development
Sources: Datamonitor, Medtrack, Kelley WN (ed): Textbook of Internal Medicine.
(*) Among development-stage competitors for1st remission AML most are autologous, dentritic cell-based vaccines
NON-CONFIDENTIAL
Formula’s Pipeline Overview
Lead Product In Multiple Indications
First-remission AML
Phase I
Phase II
Completed
Formula start 2Q2012
MSKCC started
1Q2011
Mesothelioma
10
Completed
MSKCC started
2Q2011
Melanoma
Planned
Elderly ALL
Planned
Ovarian cancer
Planned
MSKCC sponsored trials
NON-CONFIDENTIAL
Total Investment, Milestones & Timeline (Series A & B)
2011
Q2 Q3 Q4
Q1
2012
Q2 Q3
Q4
2013
Q2 Q3
Q1
Q4
Q1
2014
Q2 Q3
Q4
2015
Q1 Q2
$12.6MM operating budget
$1.1MM
$10MM
$3MM
$5.4MM
.
$4.3MM
$2.9MM
1/1/2012 beginning cash
Complete
ph-2 AML
trial
enrollment
Start
Immune
Response
SOPs
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Start
companysponsored
Ph2 AML
trial
Orphan
Status
application
Start Event
Regulatory Event
Complete Event
Expense
Start second
indication
phase-2 trial
Business Event
NON-CONFIDENTIAL
Complete
Ph2 AML trial
M&A or
Strategic
Partnership
Start Ph3
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:
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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
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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
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NON-CONFIDENTIAL
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
[email protected]
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NON-CONFIDENTIAL