INNOVATIVE THERAPEUTICS FOR PAIN MANAGEMENT FUND RAISING ROUND A TO REACH END PHASE I WITH EFFICACIE DATA FOR 2 DRUG CANDIDATES

1. Innovative therapeutics for pain management
Executive Summary
INNOVATIVE THERAPEUTICS FOR PAIN MANAGEMENT
FUND RAISING ROUND A
€5M TO REACH END PHASE I WITH EFFICACIE DATA FOR 2 DRUG CANDIDATES AND
CTA FOR ONE IN 3 YEARS
Theralpha SAS is a specialty biopharmaceutical company that develops novel and innovative drugs addressing
unmet needs in pain management. Theralpha was founded by David Dellamonica, Michel Lazdunski, and Marc
Vasseur, all experienced professionals, recognized internationally in the biotechnology and pharmaceutical
industry, who have complementary expertise in successfully managing drug development and business
operations. Founders own 100% of the Company. Damian Marron, CEO of Trophos and former executive VP of
NicOx, recently joined the board of directors of Theralpha. Theralpha is based in Sophia Antipolis, France.
Theralpha is a product development-oriented company. Theralpha is focused on rapidly advancing its lead
compounds through late-pre-clinical and early clinical development value-creating milestones.
By leveraging its founders’ experience, its pain expert network and a lean operations model, Theralpha intends
to proceed aggressively with the development of its assets and become an attractive acquisition target for a
Pharma/Biotech within 3-5 years.
The Company’s founding assets originate from worldwide exclusive licenses from IPMC (Institut de
Pharmacologie Moleculaire, CNRS, Sophia Antipolis, France) and ProTherapeutics (National University of
Singapore). Specifically, the IPMC-originating assets are based on research made by Professor Michel Lazdunski
and his team who have pioneered for more than 10 years the discovery of peptides found in animal venoms
that selectively inhibit Acid Sensing Ion Channels (ASICs) which are directly implicated in pain signal
transmission. The NUS originating drug candidate acts through nNOS pathway.
THA902 THA903 THA904
Target ASIC 3 – Nav 1.8 Indirect activation of the ASIC1a, ASIC1b, ASIC1a+2a,
Block pain perception by enkephalines system ASIC1a+1b
nociceptors
Stage Preclinical Late preclinical End Discovery
Patent 2029 2027 and 2031 2031
expiration
First in man Q3, year 3 Q2, year 2 Q4, year 2
First  Inflammatory pain : sever  Acute pain  Inflammatory and
Indication Osteoarthritis pain Neuropathic pain
The company’s drug candidates are small peptides composed of natural amino acids which are effective in
multiple animal models of pain. Our pipeline includes 3 candidate drugs: THA902 that targets ASIC3, Nav1.8
and THA904 that targets ASIC1a, ASIC1b and ASIC1a+2a; THA903 –the peptide licensed from NUS- is not
directed against ASICs, and has a mechanism of action involving activation of endogenous enkephalins. These
drug candidates have demonstrated strong activity in classical pharmacological models of chronic, neuropathic
and inflammatory pains, and acute pain. They all present an excellent safety profile.
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2. Innovative therapeutics for pain management
Theralpha pipeline & indications:
Drug Candidates Lead
MoA Administation Preclinical Clinical Partner
and Indications Confirmation
PHARMACO ADME, TOX IND Phase I Phase II
THA902 ASIC3 & Controlled-release
Subcutaneous (SC), formulation with
Inflammatory Pain : Nav1.8 Intra-articular (IA) CURRENT STATUS Flamel (NASDAQ:
Osteoarthritis ANTAGONIST FLML)
THA903 ENKEPHALINS
Sublingual CURRENT STATUS SubAlgic Consortium
Acute pain RELEASE
THA904
ASIC1a,1b Intrathecal,
Neuropathic pain - Subcutaneous CURRENT STATUS
ANTAGONIST
Inflammatory pain
The arrows indicate
what will be
achieved in 3 years
 THA902 is peptide which is a potent and specific ASIC3 & Nav1.8 inhibitor. It is effective by
subcutaneous injection and has a number of possible indications in inflammatory pain, including
osteoarthritis pain (First development), and post-operative pain.
 THA903 is a small peptide derived from venom, which is active by sublingual administration with
indications in the treatment of chronic nociceptive and acute pain.
 THA904 is a potent specific inhibitor of ASIC1a, ASIC1b and ASIC1a+2a, ASIC1a+1b. It can be
delivered both by intrathecal and subcutaneous route and has been demonstrated in animal
models to be effective for all types of pain.
THA902 has completed pharmacology, and is 24 months ahead of Phase I. THA903 has completed some
regulatory preclinical requirements and can enter Phase I in 20 months. THA904 is a recently patented
peptide, which is 36 months to first in man.
Since inception, the Company has successfully managed to:
 Acquire an exclusive worldwide license for venom-derived analgesic peptides THA902 and TH904
from CNRS. This includes the worldwide exclusive right on 4 families of patents covering the
peptides and their targets.
 Acquire an exclusive worldwide licence for a venom-derived analgesic peptide (THA903),
discovered at National University of Singapore (NUS, Singapore) and initially developed by
ProTherapeutics, a NUS spin-off. We filed a new patent (PCT) for this drug candidate on February
2011 .
 Conclude a first refusal right agreement in the domain of pain therapeutics with IPMC (CNRS,
Sophia Antipolis), an institution recognized worldwide as a leading place for ion channel
pharmacology.
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3. Innovative therapeutics for pain management
 Obtain sizeable non-dilutive financing leverage: Theralpha has succeeded in obtaining a total
€3,5M funding commitment from public bodies:
o €1M grant from OSEO for preclinical THA904 development
o €2,55M grant from Eurobiomed / FUI (Fond Unique Interministeriel) for preclinical and
clinical development of THA903 until end of Phase I
o €40 k PACA cluster support grant for G&A expenses
 Enter into a joint development program with Flamel Technologies (NASD: FLML) for a Medusa®-
enabled, long-acting formulation (xl) of Theralpha’s THA902.
o The development agreement has been structured to leverage Theralpha’s pioneering
intellectual property and Flamel’s expertise in creating long-acting formulations of
peptides, proteins, and other biologics. Flamel Technologies will be responsible for and will
fund formulation chemistry and large animals trials, with the objective to improve efficacy
and dosing, by reducing administration frequency, and consequently allowing better
patient compliance. Theralpha will be responsible for pre-clinical testing of THA902xl
pharmacodynamics.
In terms of strategy and operations, the Company :
 Will maintain a lean internal operations structure & will outsource most activities. The Company
outsources its Research & Development activities, including exploratory research, preclinical &,
clinical development, drug development, manufacturing and regulatory, while keeping internally
project management and strategic functions.
 Has built and will expand a strong worldwide network of renowned pain experts to support its
development activities. This is exemplified by the Medical Advisory Board which includes clinical
development experts and worldwide thought leaders.
 Has acquired and will maintain a strong IP portfolio. The company secures and maintains
intellectual property rights for its products and their applications.
 Will pursue leveraging French and European public support: on top of the usual support to
innovative companies, ie JEI status and tax credit, the company has already obtained €3.5M in
grants from public bodies and intends to pursue all non-dilutive funding opportunities.
 Is seeking alliances and partnership with pharma and large biotech. As exemplified by the
agreement with Flamel Technologies, the company intends to find partners to leverage its
development, obtain non-dilutive financing, and eventually to prepare for a future exit.
Theralpha aims to raise €5M. Thanks to non-dilutive public funding leverage, Theralpha’s total budget for 3
years will amount €7.6M and will allow taking 2 compounds up to Phase II. The founders are committed to
develop Theralpha as an attractive target for acquisition by mid/large pharmacos in a 3-5 years window.
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4. Innovative therapeutics for pain management
Founder’s team & Directors
David Dellamonica is CEO and member of the board of directors. Before founding Theralpha,
David Dellamonica was director of strategic development and intellectual property at TxCell (2006-
2009) where he demonstrated his skills in developing a biotechnology company, raising €10.5M
from public and private bodies. Before joining TxCell, David Dellamonica was director of life
sciences for the Agence Départementale d’Attraction des Investissements Internationaux (Nice,
2002-2006). David Dellamonica holds a diploma in Marketing and Management from Ecole
Supérieure de Gestion (Paris, 1998) and an MBA (Lausanne, 2001).
Michel Lazdunski, member of the board of directors is a world-renowned specialist of ion channels
and their pharmacology. Michel Lazdunski is author of more than 700 publications, among which
some of them have the highest rankings of citations. He has founded the Institute of Molecular
Pharmacology (IPMC) and the Institute of Neuromolecular Medicine, both at Sophia Antipolis.
Michel Lazdunski has also been advisor for a number of large pharmaceutical companies. Michel
Lazdunski received recently the CNRS Gold Medal and Ernest Jung Gold Medal for medicine in 2011.
Marc Vasseur, Chairman is an experienced biotechnology entrepreneur, who has founded,
managed, grown and developed start-up businesses in Europe, USA and Asia. He recently (2007)
founded and is CEO of a bio computing company named Sobios SA in partnership with Dassault
Systems, the worldwide leader for modelling and simulation. He is also the co-founder (2003) and is
non-executive chairman of Moleac Pte. Ltd. In 1990, Marc Vasseur co-founded and managed
Genset NASDAQ SA, initially as CSO and later as President and CEO. Marc Vasseur became
President and CEO of Serono Holding. Before, Marc Vasseur was Professor of virology at the
University of Paris.
Damian Marron, director, serves as Chief Executive Officer of Trophos SA. Mr. Marron has over 20
years biotechnology and pharmaceutical industry experience at the international level, in particular
in the fields of R&D and corporate development. He has raised over €200M in public and private
equity, patient association funding and non-dilutive grants. He served as Executive Vice President of
Corporate Development of NicOx SA from 2002 to May 30, 2008. Prior to this, he was Head of the
European Development Business at 3M Pharmaceuticals between 1997 and 2002.
MSAB: Medical & Scientific Advisory Board
Professor Michel Professor Christian Professor Claude Professor Alain Professor Carlos
Lanteri-Minet Head of Jorgensen Inflammatory DUBRAY Head of ESCHALIER Head of Pain Belmonte President of
department for pain specialist, Head of Pain Clinical Trial Pharmacology IBRO (International
Evaluation and Pain Immuno-Rhumatology, Center for Ph I, II, III, Laboratory and Pain Brain Research
Treatment (Nice Montpellier Hospital INSERM - Clermont Clinic, member of Organization) and
Hospital) President of Ferrand Hospital AFSSAPS, Clermont Director of the
the French & European Ferrand University and Institute of
Pain Society hospital Neurosciences of
Alicante (Spain)
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Copyright © 2012
2229, route des Crêtes 06560 Valbonne Sophia Antipolis France.
info@theralpha.com - www.theralpha.com