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© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com © 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
From Basic Research to Listing Herantis Pharma on the Stock Exchange
Henri J. Huttunen Chief Scientific Officer
11/13/2014 1
© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
11/13/14 2
IP
IP
IP
Spin-off
Merger
Merger
© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
How Hermo Pharma got started in 2008 • Long-term research program in molecular neuroscience at the University
of Helsinki had generated several novel therapeutic concepts • Too little activity in commercialization of academic inventions in Finland • Professors Mart Saarma, Eero Castrén and Heikki Rauvala had explored
commercialization options in a Tekes-funded Neuprotec-project (2006-07) • Hermo Pharma Ltd was founded in June 2008
– Henri Huttunen joined as the fourth co-founder and the first managing director
• Company goals for 2009-2012 – Transfer all key intellectual property to the company and secure basic funding – Plan and execute a Phase 2 clinical study in adult amblyopia
à if results positive, licensing income could help finance the next clinical study (Phase 1 in Parkinson’s disease)
– Manufacture GMP quality CDNF protein for Parkinson’s disease clinical studies
11/13/14 3
© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
Brief History of Neurotrophic factors in Treatment of Neurodegenerative Diseases
A new GDNF Phase 2 in PD begins in Bristol"
GDNF protein in PD, an open-label study(Gill et al, significant improvement)"
Discovery of NTFs:"• NGF in 1953"• BDNF in 1982"• NT3, NT4, CNTF in 1990-91"• GDNF in 1993"• Neurturin, persephin and
artemin in 1996-1998"• MANF in 2003"• CDNF in 2007"
2000! 2005! 2010!1995! 2015!
GDNF protein in PD (Amgen, phase 1 & 2,
failed)"
Neurturin gene therapy in PD (Ceregene, phase 1 & 2, failed)"
BDNF protein in ALS(phase 1-3, failed)"
Amgen sued by trial participants for continued
access to GDNF "
CDNF Phase 1/2 in PD to begin"
Additional evidence of GDNF’s effects on DA neurons from autopsy of Bristol trial participant"
© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
Merger of Hermo Pharma and
Laurantis Pharma Seed financing round
Key patents transferred to the
company
Hermo Pharma 2008-2014
11/13/14 5
2009 2010 2011 2012 2013 2014 2008
Hermo Pharma founded
Herantis Pharma IPO and listing to NASDAQ OMX Helsinki First North Michael J Fox-
Foundation grant for a major preclinical study
Amblyopia clinical study
begins
Amblyopia clinical study
ends Round A financing
CDNF GMP manufact-
uring begins
Joint venture Opia Games Ltd founded
© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
Herantis portfolio (2014)
6
Drug candidate Indication Preclin Phase 1 Phase 2 Phase 3 Launch
Cis-UCA Eye Drops Dry Eye
CDNF Neuroprotective Factor Parkinson’s disease *
Lymfactin® Secondary lymphedema *
Cis-UCA Emulsion Cream Atopic dermatitis**
CDNF Neuroprotective Factor
Amyotrophic lateral sclerosis (ALS)**
*This stage of clinical development in planning and scheduled **Currently not one of the main products of the Company. The next steps are pending later decisions. Not a funding priority.
© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
Lessons learned: Basic structure • Strong science carries a young company a long way
• Strong team – from management to the board and advisors – is more valuable than any investment – Identify your weak spots; acknowledge what you
don’t know à active efforts to fix them
• Virtual biotech model has its pros and cons – The perspective of the investor: “fail early, fail cheap” – Heavy outsourcing requires attentive management of projects – All team members have to be able to do a wide variety of tasks
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© 2014 HERANTIS PHARMA Plc. All rights reserved. www.herantis.com
Lessons learned: Operative • Prepare for surprises – drug development never goes as planned
– E.g. a NASDAQ-listed clinical CRO can go bankrupt in the middle of your clinical study, with a VERY short notice
– Patient recruitment ALWAYS takes longer than your clinical experts estimate
– Budget everything 1.5x higher than true costs – and you still WILL run out of money sooner than expected
– Make sure that your funding is sufficient to take you beyond the next value creation point
• Be mentally prepared for killing research projects early • Underpromise, overdeliver!
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