Pyc Therapeutics Limited · ASX:PYC
Pyc Therapeutics — Investor Presentation (March 2024)
41 slides from Pyc Therapeutics's investor presentation, Mar 14, 2024
Slide 1: Life-changing science: $75m capital raising to drive human data read-outs
For personal use only Life-changing science $75m capital raising to drive human data read-outs March 2024
Slide 2: Important Information & Disclaimer
Important Notices Important Information & Disclaimer For personal use only You must read the following notices before reading or making any use of this document or any information contained in this document. By continuing to read, use or otherwise act on this document, you agree to be bound by the f
Slide 3: Important Notices: Not financial product advice
Important Notices Not financial product advice For personal use only This Presentation does not constitute financial product or investment advice or any recommendation to acquire New Shares or accounting, legal or tax advice. It has been prepared without taking into account the objectives, financial
Slide 4: Important Notices: Forward-looking statements
Important Notices Forward-looking statements are provided as a general guide only and should not be relied on as a guarantee of future performance. Forward-looking statements may be affected by a range of variables and risks that could cause actual results to differ from anticipated results and may
Slide 5: Important Notices: Industry data and trademarks
Important Notices Industry data For personal use only Certain market and industry data used in connection with this Presentation, including in relation other companies in PYC’s peer group, may have been obtained from public filings, research, surveys or studies conducted by third parties, including
Slide 6: Corporate Structure
Corporate Structure For personal use only Capital structure pre-raise¹ Relative price performance Shares on issue 3,733 million 158 148 Rebased to 100 138 128 Market capitalisation $317.3 million 118 108 98 88 Cash at bank $25.4 million 78 68 21-Apr-23 14-Jul-23 02-Nov-23 30-Nov-23 28-Dec-23 11-Aug-
Slide 7: PYC Therapeutics – a clinical stage drug development company
PYC Therapeutics – a clinical stage drug development company • With first-in-class assets For personal use only • Dedicated to patients who have no treatment options available today • Developing drugs with the highest probability of success in the clinic¹ • In commercially attractive markets ($1 to
Slide 8: Equity raise structure
Equity raise structure For personal use only • A pro rata Entitlement Offer to all shareholders • At a single-digit discount to the last-traded price • To fund major technical milestones (human safety and efficacy) across multiple pipeline assets1 • In the context of an improving macro environment f
Slide 9: Funding PYC through multiple major milestones
Funding PYC through multiple major milestones1 2024 2025 For personal use only Program Q2 Q3 Q4 Q1 Q2 RP11 Ongoing Single Ascending Dose (SAD) study 1 First formal human safety and efficacy data VP-001 2 Clinical proof of Monogenic blinding eye disease of childhood Open label Multiple Ascending Dose
Slide 10: Major milestone in polycystic kidney disease program
PYC is set to deliver a major milestone in its polycystic kidney disease program in the immediate future1 • PYC anticipates completion of non-GLP Non-Human Primate (NHP) toxicology studies of PYC- For personal use only 003 in Q2 2024 • The results of this study will demonstrate: • The safety and tol
Slide 11: Overview of the Offer
For personal use only Life-changing science Overview of the Offer
Slide 12: Overview of the Offer
Overview of the Offer Offer • PYC is seeking to raise approximately A$74.6 million via the issue of approximately 933 million new fully paid ordinary shares (“New Shares”) • The Offer will consist of a 1 for 4 pro-rata accelerated non-renounceable entitlement offer (“ANREO”) (“Entitlement Offer”) (t
Slide 13: Indicative timeline
Indicative timeline* Event Timing (AWST) For personal use only Trading halt Thursday, 14 March 2024 Announcement of Entitlement Offer Thursday, 14 March 2024 Institutional Entitlement Offer opens Thursday, 14 March 2024 Institutional Entitlement Offer closes 4.00pm (AWST) Friday, 15 March 2024 Annou
Slide 14: Use of proceeds and Pro Forma Capital Structure - $75m raise
Use of proceeds and Pro Forma Capital Structure - $75m raise1 Sources of funds2 Amount Pro Forma Capital Structure Amount For personal use only Cash on hand $25m Ordinary shares on issue prior to the Offer 3,733m Anticipated FY24 R&D rebate $16m Undiluted market capitalisation prior to the Offer4 $3
Slide 15: Life-changing science
For personal use only Life-changing science Corporate Presentation
Slide 16: PYC Therapeutics
PYC Therapeutics • PYC is a clinical-stage drug discovery and development company with operations in Australia and the For personal use only US • The company is an emerging leader in the field of precision RNA therapies for patients with severe diseases caused by insufficient expression of a single
Slide 17: PYC creates treatment options for diseases with none available today
PYC creates treatment options for the 1 in every 1,000 people* who have one of these diseases and none available today For personal use only Historical progress Progress expected in 2024 Program Pre-clinical Clinical Prevalence and market size*^ VP-001* Retinitis Pigmentosa Type 11 1 in 100,000 $1 b
Slide 18: PYC's strategy creates a unique profile for drug programs
PYC’s strategy creates a unique profile for these drug programs – differentiated assets with a high probability of success For personal use only 1 2 3 4 Pillar Single gene disorders Effective in human 3D Turning gene Drugs that overcome ‘mini-organs’ expression ‘up’ the delivery challenge3 Clinical
Slide 19: Features of PYC's path to market
Features of PYC’s path to market 1. Drugs with the highest probability of success For personal use only • Single gene diseases1 • Effective in models derived from patients2 2. In the human data generation window now • Clinical proof of concept for multiple assets within 24 months3 • With high succes
Slide 20: PYC targets rare diseases caused by a single-gene mutation
PYC targets rare diseases caused by a mutation in a single-gene For personal use only Drugs targeting single-gene disorders ‘are at least five times as likely to be successful’ in human trials1 UK Biobank PYC THERAPEUTICS 20 1. Advancing Human Genetics Research and Drug Discovery through Exome Seque
Slide 21: Drug candidates are effective in patient-derived models
PYC’s drug candidates are effective in models derived from patients1 For personal use only Polycystic Untreated PYC-003 treated Unaffected kidney kidney 3D model derived from a patient with end-stage renal failure due to polycystic kidney disease PYC THERAPEUTICS 21 1. Refer ASX announcements 13 Nov
Slide 22: PYC is translating these outcomes into patients now
PYC is translating these outcomes into patients now PYC’s path to market is staged with human data read-outs for first-in-class drugs with disease-modifying potential1 For personal use only Program 2024 2025 2026 2027 2028 RP11 Ph1/2 study (underway) Registrational study NDA Product launch and VP-00
Slide 23: Genetic medicines highly successful in late-stage clinical trials
Genetic medicines have been highly successful in late-stage clinical trials For personal use only “All targets with clear [human] genetic evidence … produce the clinical effect predicted” (assessment of Phase 3 studies)1 Kamb et al., Nature Biotech PYC THERAPEUTICS 23 1. Kamb, A., Harper, S. & Stefa
Slide 24: PYC anticipates its first product launch in 2028
PYC anticipates its first product launch in 2028¹ For personal use only Commercialisation² Indication Market size² 2028 2029 2030 Retinitis Pigmentosa 11 $1 billion p.a. Polycystic Kidney Disease $10 billion p.a. Optic Atrophy $2 billion p.a. PYC THERAPEUTICS 24 1. Based on management forecasts as a
Slide 25: FDA is seeking to accelerate approval of genetic medicines
The FDA is seeking to accelerate approval of genetic medicines for rare diseases For personal use only “Accelerated approval is going to be the norm for a lot of our initial approvals of gene therapies”1 Peter Marks, Director FDA Center for Biologics Evaluation and Research PYC THERAPEUTICS 25 1. ht
Slide 26: The 'Holy Trinity' in Rare Disease
The ‘Holy Trinity’ in Rare Disease – PYC is developing multiple drug candidates with ‘Holy Trinity’ potential Stifel – the ideal company in rare disease(s) would have three positive traits, and companies with all For personal use only three of these traits garner outstanding valuations1 Median EV ($
Slide 27: The PYC Team
For personal use only Life-changing science The PYC Team
Slide 28: PYC's Board and Executive
PYC’s Board and Executive For personal use only Alan Tribe Dr Rohan Hockings Sri Mudumba Andrew Taylor Chairman Chief Executive Officer Chief Research & Development Officer Chief Financial Officer Experience commercialising Dual-trained in medicine and law with Over 20 years of experience Held senio
Slide 29: PYC's Scientific Advisory Board
PYC’s Scientific Advisory Board For personal use only Prof Ian Constable Prof Alice Pebay Dr Josephine Prener-Holtan Dr Naveed Shams Advisory Board Advisory Board Advisory Board Advisory Board Renowned Ophthalmologist for over Stem cell biology expert. Principal Clinician-Researcher and specialist i
Slide 30: References
For personal use only Life-changing science References
Slide 31: Prevalence references
Prevalence references Program References for prevalence estimate For personal use only Retinitis Pigmentosa • Daiger S, et al. ‘Genes and Mutations Causing Autosomal Dominant Retinitis Pigmentosa’ Cold Spring Harb. Perspect. Med. 2014;5 • Ellingford J, et al. ‘Molecular findings from 537 individuals
Slide 32: Appendix A: Key Risks
For personal use only Life-changing science Appendix A: Key Risks
Slide 33: Appendix A: Key Risks – Disclaimer
Appendix A: Key Risks Disclaimer For personal use only This section discusses some of the key risks associated with any investment in PYC, which may affect the value of PYC shares. The risks set out below are not listed in order of importance and do not constitute an exhaustive list of all risks inv
Slide 34: Key Risks: Research and development
Appendix A: Key Risks contd. Research and development PYC can make no representations that any of its research and development will be successful, that PYC’s development milestones will be achieved or that PYC will develop products that are commercially exploitable. Prior to commercialisation, proje
Slide 35: Key Risks: Competition and funding
Appendix A: Key Risks contd. Competition The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change, both in Australia and internationally, and there are no guarantees about PYC’s ability to successfully compete. Although the B
Slide 36: Key Risks: Key personnel and R&D tax rebate
Appendix A: Key Risks contd. PYC is dependent on key personnel PYC depends on being able to attract and retain personnel with specialist expertise, and to ensure continuity of key management. The loss of one or more key members of the management team could material affect PYC’s ability to pursue its
Slide 37: Key Risks: Regulatory approval
Appendix A: Key Risks contd. Regulatory Approval PYC operates within a highly regulated industry, relating to the manufacture, distribution and supply of pharmaceutical products. Accordingly, PYC is continually exposed to the risk of changes in laws, regulation and government policies in Australia,
Slide 38: Key Risks: Cyber security
Appendix A: Key Risks contd. Cyber security PYC relies heavily on its information technology systems including its networks, equipment, hardware, software, telecommunications and other information technology (collectively, IT Systems), and the IT Systems of third-party service providers, to operate
Slide 39: Key Risks: Dilution, liquidity and taxation
Appendix A: Key Risks contd. Dilution risk Existing shareholders who do not participate in the Offer will be diluted as a result of the issue of new shares. A participating shareholder may still be diluted even though they participate in the Offer, depending on the number of shares issued to them. I
Slide 40: Appendix B: International Offer Restrictions
For personal use only Life-changing science Appendix B: International Offer Restrictions
Slide 41: International Offer Restrictions
Appendix B: International Offer Restrictions NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES International Offer Restrictions For personal use only This document does not constitute an offer of new ordinary shares (New Shares) of the Company in any jurisdiction in which it would be unlawful. In
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