14 January :30pm. Anthony Filippis, PhD MBA Executive Director Senz Oncology Pty Ltd. Biotech Showcase Presentation January 2014

Transcription

1 Anthony Filippis, PhD MBA Executive Director Senz Oncology Pty Ltd 14 4:30pm

2 Safe Harbor Statement Senz Oncology Pty Ltd ( the Company ) is a privately- held emerging biotechnology company. The information contained in this presentation is intended only to give prospective accredited investors and/or prospective corporate partners a general idea of our Company s business, and R&D current status and future plans. This presentation contains forward- looking statements that are not limited to historic facts, but rejlect the Company s current beliefs, expectations or intentions regarding future events. All forward- looking statements herein including the projected return on investments involve risks and are inherently subject to signijicant economic and competitive uncertainties and contingencies, many of which are beyond the control of the Company and its management. For example of such risks and uncertainties: ability to raise adequate funds in time, regulatory matters, the availability of corporate partners, the timing, success and cost of preclinical research and clinical studies, and things which are not in the control of the Company and its management. Therefore, prospective investors and/ or prospective corporate partners are hereby advised to consult their Jinancial and legal advisors, prior to making an investment and/or partnering decision in the Company. Thank you. 2

3 The Business Model 3

4 Rationale for Conducting Early Clinical Development in Australia Australia USA Regulatory Framework Clinical Trial Notification (CTN) Investigational New Drug (IND) Application Abbreviated data package Full IND data package Review by local ethics committee Review by FDA Cost structures 45% R&D tax rebate in cash No cash tax benefit Cost in $AU 0.89) Reduced cost of regulatory package Cost in US$ Increased cost of full regulatory package $500k+ Impact estimated at 88% higher costs 4

5 Board of Directors Anthony Filippis, PhD MBA Executive Director, Co-Founder Ian Nisbet, PhD Executive Director, Co-Founder Dennis Brown, PhD Non-Executive Director Afandin Partners (Co-Founder) Drawbridge Pharmaceuticals (CEO) Xenome (VP, BD) Meditech/Alchemia (Head, Corp Dev) Metabolic Pharmaceuticals (Dir, BD) Qponics (NED) Corporate strategy, licensing, M&A, capital raising, operations Afandin Partners (Co-Founder) Xenome (CEO/MD) Meditech (CEO/MD) Millennium CSL Verva (Chairman) vivopharm (Chairman) Velacor (NED) General management, product development, M&A, licensing, capital raising Valent Technologies (Founder & Pres.) Del Mar Pharmaceuticals (Co-Founder) Matrix Pharmaceuticals Inc (Founder) ChemGenex Therapeutics Inc (Founder) Chemistry, development advisor, coordinator of US-based consultants and advisors 5

6 Track Record The founders have a track record in drug development: VELCADE developed by Millennium Pharmaceuticals; marketed with sales >USD$2 Billion; Millennium acquired by Takeda in 2008 for USD$8.9 Billion Synribo developed by Chemgenex Pharmaceuticals to NDA filing (as Omapro); acquired by Cephalon for USD$231 Million HyCAMP developed by Meditech Research to Phase 2b; acquired by Alchemia for AUD$16.9 Million; currently completing Phase 3 The founders have experience in raising capital and in the in- and outlicensing, acquisition and development of numerous other compounds including VVP808, Xen2174, ACV-1 and Phaxan 6

7 Product Pipeline Pre-clinical Phase I Phase II Partner VAL-1000 AML VAL-1000 Other Allyence Research SO-1224 SO-1224 Other Valent Technologies 7

8 Lead Product: VAL-1000 Orally available small molecule Fully synthetic derivative of natural product alkaloid Extensive history of use in humans Effective, chronically-administered chemotherapeutic agent with low toxicity In vitro and in vivo activity in AML and other leukemias Potentially novel MOA Active against several different kinases, including cyclin-dependent kinases, however effect is probably via induction of apoptosis 8

9 VAL-1000 Development Team Name Position Responsibility Sarath Kanekal, PhD Advisor Non-clinical pharmacology and toxicology Mike Li Advisor CMC Shawnya Michaels, MBA Advisor Pre-clinical pharmacology Richard Schwarz, MD Advisor Clinical hematology Kathy Skoff VP Clinical Operations Australian clinical and regulatory operations Luana Staiger Advisor US regulatory affairs 9

10 VAL-1000 Clinical Development Phase I/II in Australia (under CTN) Up to 30 evaluable patients with AML, ALL or high-risk MDS Safety and tolerability A positive outcome to the SO clinical trial will be indicated by: An acceptable safety profile A remission rate >15% in patients treated at or below the MTD US IND filing based on positive data Inclusion of human data from CTN clinical trial in IND submission 10

11 VAL-1000 Intellectual Property PCT patent application filed Claims methods of treatment, drug formulations, etc. relating to VAL-1000 and analogues Proprietary position will be supplemented via regulatory strategies, such as Orphan drug status NCE designation (in US) 11

12 Second Product: SO-1224 Senz is in discussions with multiple companies regarding potential licensing, co-development and fee-for-service projects Senz has an exclusive option to license SO-1224 from Valent Technologies, LLC (Menlo Park, CA) SO-1224 Small molecule, potentially orally available Topoisomerase II inhibitor/dna intercalator Extensive history of use in humans in multiple tumor types (as an i/v infusion) Commence Phase I/II clinical trial of SO-1224 under the CTN scheme in Australia in 2014 Assessment of potential indication(s) Generate additional preclinical data Initiating investment discussions at Biotech Showcase 12

13 Fee-for-service Projects The Senz model provides for fee-for-service projects First client is a Boston-based, VC-backed company developing a hematology drug Other Fee-for-service opportunities are currently under investigation as a source of operating revenues Interested companies wanting to conduct early clinical trials in Australia should contact Senz 13

14 Forward Financing Plans VAL-1000 Phase I/II clinical study is fully funded through seed financing round Further VAL-1000 studies and other programs will require further rounds of financing Financing of ~$5M will enable creation of a portfolio of 3-4 compounds, with at least 2 compounds through to human POC Phase I/II in 2-3 years 14

15 Investment Proposition An investment in Senz Oncology is an investment in An experienced management and development team A potential pipeline, not just a single product Products that Are based on strong science from highly credible investigators Have a short path to proof-of-concept in humans Are likely to be highly valued by major partners Have the potential to significantly improve the health and wellbeing of cancer patients A company that should grow in value rapidly with the progress of its development programs and fee-for-service projects 15

16 Biotech Showcase 2014 What are we looking for from this meeting: Investors in the company Companies wanting to co-develop drugs with Senz to access the Australian CTN scheme and potentailly R&D Tax Incentive Companies wanting to develop drugs, but on a fee-forservice basis with Senz 16

17 Contact Anthony Filippis, PhD MBA Executive Director Senz Oncology Pty Ltd T: +61 (0) E: W: 17