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Herantis Pharma - A new pharmaceutical company

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  • 1. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Herantis – new pharmaceutical company Company overview and future prospects CEO Pekka Simula 12 May 2014 1
  • 2. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved.Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Disclaimer •  Hermo Pharma Ltd (”Company”) has prepared this presentation of the Company as background material only. This presentation is intended for use only with the formal prospectus approved by Finand’s Financial Supervisory Authority (Finanssivalvonta). •  This presentation does not intend to provide a thorough and detailed view of the Company. The information provided in this presentation shall not be considered sufficient for making any investment decisions related to the Company. Anyone considering an investment in the Company shall read and consider carefully all information provided in the formal prospectus approved by Finand’s Financial Supervisory Authority (Finanssivalvonta). •  This presentation may include forward-looking statements, estimates, and calculations related e.g. to the Company and its markets. Such forward-looking statements, estimates, and calculations are based on expectations and assumptions of the Company, which may be inaccurate or untrue. They also involve known and unknown risks and other factors, which might cause any estimates made by the Company to materially deviate from those actualized, including the operations, financial situation, and achievements of the Company. The Company cannot be held liable for any such deviations or for any actions taken by any party based on this presentation. Known risks related to the future of the Company and its business have been described in the formal prospectus approved by Finand’s Financial Supervisory Authority (Finanssivalvonta).
  • 3. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Herantis Pharma Plc •  Drug development company formed through Hermo Pharma Ltd’s acquisition of 99% of shares in Laurantis Pharma Ltd in Apr 2014 •  Develops medicinal products especially for the treatment of inflammatory, CNS, and lymphatic diseases –  Emphasis in areas of unmet clinical need •  Expertise in early clinical development –  Obtaining drug candidates based on scientific research –  Preclinical research –  Early clinical research –  Proof-of-Concept in clinical development •  Expert organization with a light cost structure 12 May 2014 3
  • 4. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Herantis’ background •  Herantis formed in 2014 through the merger of two pharmaceutical companies, Hermo Pharma and Laurantis Pharma –  Hermo Pharma’s development based on Academy Professor Mart Saarma’s scientific research –  Laurantis Pharma’s drug candidates are based on research by e.g. Academy Professor Kari Alitalo, and Professor Kai Kaarniranta •  Companies’ justifications on merger: –  Scientific research in Finland in the field of medicine is internationally appreciated –  As a merged company Herantis has a broader portfolio and better financial and other resources 12 May 2014 4
  • 5. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved.Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. 5 Board of directors and management Jonathan Knowles" PhD, Board member, Ex- Management team Roche, Ex-Board member Genentech, Ex-Chairman IMI, Professor" Timo Veromaa" MD, PhD, Board member, CEO Biotie Therapies" " Pekka Mattila" MSc, Chairman, CEO Desentum, 
 Ex-CEO Finnzymes" Frans Wuite" MD, MBA, Board member, CEO Oncos Therapeutics, 
 Ex-CEOAraim Pharma, Ex-CEO Warren Pharma" " James Phillips" MD, MBA, Board member, CEO Midatech, Board member Insense, Ex- Chairman Prosonix" " Aki Prihti" MSc, Board member, Chairman Inveni, Chairman Medeia, Board member Medtentia, Onbone" " Pekka Simula" MSc, CEO, Ex-CEO Oncos Therapeutics, Ex-director CRF Health, Ex-Global program manager Varian Medical Systems" Burkhard Blank" MD, CMO, Ex-CEO Laurantis Pharma, Ex-director Boehringer-Ingelheim, Board member Riemser Pharma"
  • 6. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved.Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Introduction to clinical development Preclinical stage" Research and development searching for and assessing new drug candidates for safety and efficacy in appropriate models. Preclinical models can be based on cell or animal models" Early clinical development: Phase 1 and Phase 2 clinical studies" Phase 1 and Phase 2 clinical studies aim at suggesting e.g. the initial safety, efficacy, and optimal dosing of the drug candidate. This involves typically in the range of 10-300 subjects per clinical study." Late stage clinical development: Phase 3" Phase 3 clinical studies aim at establishing the safety and efficacy of the drug candidate with high statistical significance. This typically involves 300-1000 subjects per clinical study. Market approvals can be applied for based on the results." Idea Medicine" 0-5 years" 3-5 years" 3-5 years"
  • 7. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Herantis’ strategy Herantis’ field of activity is pharmaceutical research and development in collaboration with its academic and commercial partners and: •  Aiming at profitable growth in the long term: –  Possible income from commercial partnership agreements is largely invested in new development programs –  New drug candidates are screened for e.g. from academic research in Finland •  Focus on early stage development: Preclinical, Phase 1, and Phase 2 •  Seeking commercial partnerships with large pharmaceutical companies for late stage clinical development beyond Proof-of-Concept 12 May 2014 7
  • 8. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Herantis portfolio (drug candidates) 12 May 2014 8 Drug candidate Indication Preclin Phase 1 Phase 2 Phase 3 Launch Cis-UCA Eye Drops Dry Eye * CDNF growth factor Parkinson’s disease * Lymfactin Secondary lymphedema * Cis-UCA Emulsion Cream Atopic dermatitis** CDNF growth factor Amyotrofic 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.
  • 9. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Cis-UCA Eye Drops for dry eye Based on preclinical and Phase 1 clinical results the Company believes that Cis-UCA Eye Drops have the potential of being the most efficacious and best tolerated prescription medicine in the treatment of dry eye. 12 May 2014 9 •  Dry eye syndrome is the most common cause of irritation in the eye –  Estimated 45 million people in the USA and Europe suffer from dry eye syndrome •  Herantis’ target is to launch its Phase 2 clinical study in 2014 –  Randomized study with estimated 150 patients •  With a positive outcome Proof-of-Concept is reached 2015 •  Restasis® is the only approved prescription drug in the USA for the treatment of Dry eye syndrome (in Europe there are none) –  Restasis®: Annual sales $ 900M Illustration is not related to the text on this page.
  • 10. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. CDNF for Parkinson’s disease Based on preclinical data the Company believes that CDNF is one of the most promising new compounds for the treatment of Parkinson’s disease. •  Parkinson’s disease is a progressive neurodegenerative disease, which cannot be cured –  Estimated seven million patients worldwide –  Caused by the death of dopamine producing neurons for an unknown reason –  Available treatments help the motor symptoms caused by disease •  Herantis’ goal: Phase 1 clinical study started in 2015 –  At least 12 patients, randomized setup •  In preclinical models CDNF has protected dopamine producing neurons and recovered dysfunctional neurons •  Estimated sales of pharmaceutical products for treatment of Parkinson’s disease in 2018: $ 3.5 Bn 12 May 2014 Figure: Illustration of a possible way to administer CDNF ARTICLE IN PRESS GModel NSM65701–10 8 N.U. Barua et al. / Journal of Neuroscience Methods xxx (2013) xxx–xxx Fig. 7. (a) A successful BAHA implanted in a patient shows no evidence of adverse skin reaction (Courtesy of Science Photo Library). Based on surgery, the TBAP for intermittent CED could be implanted in a similar position on the skull. A schematic diagram shows the proposed relationsh in-line filters and catheters in a clinical application (b). Barua et al. J. Neurosci. Methods. 214: 223-232, 2013."
  • 11. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Lymfactin for secondary lymphedema Based on scientific studies Herantis believes that damage to lymphatic system leading to secondary lymphedema can be treated with Lymfactin. •  Lymphedema is a chronic progressing disease with no approved medicines –  Secondary lymphedema develops in estimated 15,000 – 18,000 breast cancer patients annually in the USA as a consequence of breast cancer therapy; the Company assumes a similar number of new cases in Europe –  Symptoms include permanent swelling of the affected limb, limited functioning, susceptibility to infections –  Significant impact on the patients’ quality of life •  In preclinical models Lymfactin has promoted new lymphatic growth in the damaged area •  Herantis’ goal: Phase 1 clinical study with 24 patients launched in 2015 •  Market size estimated in € hundreds of millions 12 May 2014
  • 12. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved.Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Target development schedule 2014 •  Initial public offering and listing in NASDAQ OMX First North Helsinki •  Cis-UCA Eye Drops: Phase 2 clinical study launched 2015 •  Lymfactin Phase 1 clinical study launched •  Cis-UCA Eye Drops: Phase 2 clinical study completed •  CDNF / Parkinson’s disease: Phase 1 clinical study launched 2016 •  Cis-UCA Eye Drops: commercial partnership •  CDNF / Parkinson’s disease and Lymfactin: Phase 1 studies ongoing 2017 •  CDNF / Parkinson’s disease: initial results and commercial partnership •  Lymfactin: Initial results and commercial partnership •  Company profitable if at least one product candidate reaches commercial partnership
  • 13. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Risks* In addition to normal financial risks, risks related to securities, and other related risks there are essential risks related to Herantis and its business. •  No commercial products –  The Initial Public Offering in First North Helsinki aims to fund the Company to develop its three main product candidates through commercialization •  Product development includes e.g. –  Clinical risks –  Risks related to regulatory authorities –  Production related risks •  Commercialization includes e.g. –  IPR risks –  Risks related to the pharmaceutical industry and third parties 12 May 2014 13 *Risks are described in detail in the formal prospectus approved by Finland’s Financial Supervisory Authority (Finanssivalvonta)
  • 14. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Strengths •  Three drug candidates –  Independent development programs, each individually with potential to reach a strong position in the global market for pharmaceutical products •  Experienced team and international network of collaborators –  International experience in each phase of drug development –  Commercialization of pharmaceutical products –  Regulatory processes in Europe and USA –  Network of experts related to each drug in development •  Strong background of drug candidates –  Internationally acclaimed, widely published research scientists •  Acceptable cost structure and need for capitalization –  6-person expert organization capable of adjusting to changes 12 May 2014 14
  • 15. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Herantis IPO in First North Helsinki – HRTIS: Selected details •  Offering at most 1,600,000 new shares for 10.50 € per share –  Approximately 37% of shares and votes in Herantis –  Over-allotment option of at most additional 1.000.000 new shares, in which case the total amount is approximately 49% of shares and votes in Herantis –  Expected net proceedings approximately € 16.0 million (+ possible over- allotment option approximately € 10.1 million) •  The proceedings are intended to be used for product development of Herantis, in specific the clinical studies of the three main products –  Successful IPO in First North Helsinki (without over-allotment option) funds Company’s operations until end of 2017, enables reaching commercial partnerships for each successful product •  Subscription period begins 14 May.2014 •  Subscription period ends 30 May 2014 (by latest) •  Trading commences 11 Jun 2014 (estimated) 12 May 2014 15
  • 16. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Main shareholders at the time of IPO* 12 May 2014 16 Shareholder # of shares % votes/ shares* Inveni Life Sciences Fund I Ky 614.271 22,8 % Helsingin yliopiston rahastot (Helsinki University Funds) 473.638 17,6 % Aloitusrahasto Vera Oy 449.660 16,7 % Mart Saarma 159.000 5,9 % Eero Castrén 155.000 5,8 % Heikki Rauvala 155.000 5,8 % Eläkevakuutusyhtiö Veritas 126.346 4,7 % Inveni Pre-Exit Financing Vehicle Ky 81.773 3,0 % Henri Huttunen 74.000 2,7 % Pergamum AB 68.268 2,5 % Broadview Ventures I, LLC 48.467 1,8 % Lasse Leino 41.736 1,5 % Erkki Etola 25.435 0,9 % Oy Etra Invest Ab 22.183 0,8 % Start Fund I Ky (Finnish Industry Investment) 20.505 0,8% Total 2.515.282 93,4 % *All shares owned at the time of the IPO are under a 12-month lock-up agreement
  • 17. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Thank you! 12 May 2014 17