Paxmedica, Inc. · OTC:PXMD
Paxmedica — IPO Roadshow (August 2020)
29 slides from Paxmedica's IPO roadshow presentation, Aug 28, 2020
Slide 1: New Paths in Neurodevelopment
New Paths in Neurodevelopment August 2020 Confidential Overview Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated August 28, 2020 Relating to Preliminary Prospectus dated August 28, 2020 Registration Statement File No. 333 - 239676 © 2020. PaxMedica , Inc. Proprietary Information. All
Slide 2: Forward-looking statements
2 2 All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward - looking statements . The words “believe,” “ma
Slide 3: The Offering
3 3 The Offering Issuer PaxMedica , Inc. Type of Offering IPO Price Range $5.50 - $6.50 Shares Offered 2,500,000 Gross Proceeds $15 Million Over - Allotment 15% Proposed Listing/Symbol Nasdaq Capital Market / “PXMD” Use of Proceeds Product development activities and for working capital and general c
Slide 4: Overview
4 4 4 PaxMedica is a clinical stage biopharmaceutical company founded in 2018, focused on developing new treatments for the core symptoms of autism spectrum disorder (“ASD”) and other neurodevelopmental disorders. Overview © 2020. PaxMedica , Inc. Proprietary Information. All rights reserved
Slide 5: Our Clinical Development Plan
5 5 USD$100M Potential high - value Priority Review Voucher Autism and other neurodevelopmental disorders Multi - billion dollar potential Our Clinical Development Plan CNS – Central Nervous System 1. Plan to rapidly gain regulatory approval and market exclusivity for lead program, PAX - 101 for FDA
Slide 6: Investment highlights
6 6 • Proven management team leading efficient value creation strategy o Management team and independent directors have decades of combined experience in developing and commercializing specialty drugs for multiple companies and markets • Meaningful progress has been made toward obtaining a TD - PRV
Slide 7: Large and growing ASD market
7 7 • A large and growing market o Global ASD market was $3.3 Billion in 2018 and projected to exceed $4.6 Billion in 2026 1 o CAGR of 4.3% 1 • Incidence o In 2020, the CDC reported 1 in 54 children in the U.S. is diagnosed with an Autism Spectrum Disorder 2 o Boys are 4 times more likely to be diag
Slide 8: Development Pipeline
8 Development Pipeline Robust pipeline of late/mid - clinical and preclinical development - stage assets *Note: the remaining requirements for an NDA submission include the results of the ongoing retrospective pivotal Phase 3 study a nd of certain additional pharmacokinetic and safety clinical and a
Slide 9: Development Milestones
9 HAT development PAX - 101 Proprietary product supply development in process • Initial FDA feedback confirming expedited regulatory path in HAT Completed July 2018 • Exclusive license of clinical HAT data Completed Nov 2018 • Follow up meeting with FDA to review retrospective efficacy protocol in H
Slide 10: PAX-101 (I.V. Suramin) for HAT
10 10 PAX - 101 (I.V. Suramin) for HAT • Suramin is a 100+ year old drug, developed by Bayer, but never approved in the U.S. or Europe 1 • Still in use today as Standard of Care for early stage T. b. rhodesiense ( TbR) Human African Trypanosomiasis ( HAT), commonly known as African Sleeping Sickness
Slide 11: TD-PRV Program - Priority Review Voucher for Tropical Diseases
11 11 TD - PRV Program - Priority Review Voucher for Tropical Diseases • Awarded to sponsors of tropical disease product NDA’s that meet certain criteria o HAT is on the FDA’s current list of qualifying tropical diseases • Vouchers are like ”tickets” that may lead to an expedited review time by FDA
Slide 12: Antipurinergic Agents in Neurodevelopmental Disorders
12 12 • PaxMedica was founded to develop antipurinergic therapies for the treatment of neurodevelopmental disorders • Recently discovered mechanism that has been found to potentially implicate several neurodevelopmental disorders • Overexpression of purines can offset homeostasis and cause overprodu
Slide 13: Mitochondrial Dysfunction and Overproduction of Neurotransmitter ATP
13 13 Mitochondrial Dysfunction and Overproduction of Neurotransmitter ATP • Mitochondrial dysfunction has been hypothesised as a leading cause of neurodevelopmental disorders o Proposed as “Cell Danger Response” (CDR) by investigators at U.C. San Diego and elsewhere o Disruption in metabolic homeos
Slide 14: Antipurinergic Agent Suramin in Autism Spectrum Disorder
14 14 Antipurinergic Agent Suramin in Autism Spectrum Disorder (ASD)* • Several peer - reviewed publications suggest that antipurinergic therapy (through inhibition of extracellular ATP) may eliminate abnormal cell signaling in brain function and improve core symptoms in ASD • Investigators at UCSD
Slide 15: PAX-101 for ASD and FXTAS
15 15 15 PAX - 101 (I.V. Suramin) – a new approach for ASD and FXTAS Autism Spectrum Disorder (ASD) • Phase 2B study of PAX - 101 in ASD ongoing o Randomized, double blind, placebo - controlled design o Two doses studied vs placebo, with repeat dosing over 12 weeks of treatment o Multi - center (6 s
Slide 16: PAX-102 (Intranasal Suramin)
16 PAX - 102 (Intranasal Suramin) • Novel, proprietary intranasal formulation with potential for direct nose - to - brain delivery in development o More convenient and cost - effective delivery versus i.v. infusion, allowing for at - home dosing • Lower dose, with greater CNS targeting o Greater CNS
Slide 17: Potential Barriers to Competitive Entry
17 Potential Barriers to Competitive Entry Market protection from data exclusivity, regulatory exclusivity and pending patent protection Human African Trypanosomiasis (HAT) • Registrational historical clinical source data on use of suramin in HAT exclusively licensed to PaxMedica • New chemical enti
Slide 18: Management Team
18 Management Team • Founder/Managing Partner, TardiMed Sciences (parent company of PaxMedica) • Experienced biopharma entrepreneur, investor and operating executive • Castle Creek Pharma : Founded and built late stage rare dermatology biopharma company, raised >$120 million • Norphan Pharma : Found
Slide 19: Board of Directors
19 Board of Directors Michael Derby Executive Chairman Zach Rome Chief Operating Officer • Venture Partner, Advent Life Sciences • SVP, Corporate and Business Development, WindMIL Therapeutics • Chief Business Officer, Artax Biopharma • Previously Chief Business Officer, PsiOxus Therapeutics • 20+ y
Slide 20: Scientific and Clinical Advisors
20 Scientific and Clinical Advisors World class scientific and clinical advisors in neurodevelopmental disorders including Autism Spectrum Disorders • Clinical and scientific key opinion leader in the area of neurodevelopment disorders • Assistant Professor of Neurology, Johns Hopkins University • M
Slide 21: Capitalization Table
21 Capitalization Table (i) TardiMed Sciences is a Life Sciences Investment and Company Creation Firm. (ii) Exercise price of Management Options will have an exercise price equal to $5.57 per share Holder Shares Held TardiMed Sciences (i) 7,241,745 Minority Shareholder 91,588 Total Common Shares Out
Slide 22: Use of Proceeds
22 22 • Estimated IPO net proceeds of approximately $ 13 . 0 million • Excluding Underwriter's over - allotment option and after deducting the underwriting discounts and commissions and other estimated offering expenses payable by PaxMedica • R&D (drug substance/IV and IN formulations) $ 2 . 8 milli
Slide 23: Key Takeaways
23 23 USD$100M Autism and other neurodevelopmental disorders Multi billion dollar potential Key Takeaways • Significant upside market potential in Autism Spectrum and other neurodevelopmental disorders with high unmet clinical needs o Topline data from ongoing Phase 2B in early 2021 • Potential for
Slide 24: Appendix
24 24 Appendix © 2020. PaxMedica , Inc. Proprietary Information. All rights reserved
Slide 25: UCSD Pilot Phase 1/2 Clinical Study in ASD: Trial Design
25 UCSD Pilot Phase 1/2 Clinical Study in ASD Trial Design Source: Naviaux et al., Ann Clin Transl Neurol . 2017 May 26; 4(7):491 - 505. © 2020. PaxMedica , Inc. Proprietary Information. All rights reserved
Slide 26: UCSD Pilot Study: Summary of Efficacy Results
26 UCSD Pilot Phase 1/2 Clinical Study in ASD Summary of Efficacy Results Source: Naviaux et al., Ann Clin Transl Neurol . 2017 May 26; 4(7):491 - 505. Results Showed Improvement in a Number of Different Clinical Endpoints in ASD © 2020. PaxMedica , Inc. Proprietary Information. All rights reserved
Slide 27: UCSD Pilot Study: Excerpts from Parent Statements
27 UCSD Pilot Phase 1/2 Clinical Study in ASD Excerpts from personal statements of parents of the five suramin - treated boys Source: https://health.ucsd.edu/news/topics/Suramin - Autism/Pages/Parent - Statements.aspx Subject 1 “Two days after the infusion, at his follow - up visit to the infusion c
Slide 28: UCSD Pilot Study: Excerpts from Parent Statements (continued)
28 UCSD Pilot Phase 1/2 Clinical Study in ASD Excerpts from personal statements of parents of the five suramin - treated boys (continued) Source: https://health.ucsd.edu/news/topics/Suramin - Autism/Pages/Parent - Statements.aspx Subject 4 “In the second week after suramin, he said the first sentenc
Slide 29: Antipurinergic Therapy in ASD Mouse Model
29 Antipurinergic Therapy in ASD Mouse Model Response to suramin as antipurinergic therapy Source: Naviaux et al., PLoS ONE ; 2013 March; 8(3): e57380: 1 - 15. Suramin corrected 16 multisystem abnormalities that characterize the ASD - like phenotype in the poly(IC)/MIA mouse model of autism © 2020.