Noxopharm Virtual Roadshow Corporate Presentation
2020-03-31 · Noxopharm Limited · original noxopharm.com ↗
Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA ABN 50 608 966 123 31 March 2020 Sydney, Australia Noxopharm Virtual Roadshow Corporate Presentation Sydney, 31 March 2020 : Noxopharm (ASX: NOX) is pleased to provide shareholders and the market the attached Noxopharm “Corporate Presentation”. This document is being used by Noxopharm for presentation during a non-deal virtual roadshow being held by the company from 31st March to 2nd April 2020. The presentation can be found at www.noxopharm.com About Noxopharm Noxopharm is a clinical-stage Australian drug development company with offices in Sydney and New York. The Company has a primary focus on the development of Veyonda and is the major shareholder in Nyrada Inc. (ASX:NYR). www.noxopharm.com Investor & Corporate Enquiries: Company Secretary: Prue Kelly David Franks M: 0459 022 445 T: +61 2 8072 1400 E: [email protected] E: [email protected] Media queries: Catherine Strong Citadel-MAGNUS T: 02 8234 0111 E: [email protected] Graham Kelly, CEO and Chairman of Noxopharm has approved the release of this document to the market. Forward Looking Statements This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward-looking statements are based on estimates, projections and assumptions made by Noxopharm about circumstances and events that have not yet t aken place. Although Noxopharm believes the forward- looking statements to be reasonable, they are not certain. Forward -looking statements involve known and unknown risks, Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA ABN 50 608 966 123 uncertainties and other factors that are in some cases beyond the Company’s control that could cause the actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statement. © 2020 Noxopharm Ltd. All rights reserved. Noxopharm Limited Veyonda® DEVELOP DELIVERDISCOVER ASX: NOX March/April 2020 Non-Deal Roadshow Presentation © 2020 Noxopharm Ltd. All rights reserved. DisclaimerThis presentation has been prepared by Noxopharm Limited (NOX or the Company). It should not be considered as an offer or invitation to subscribe for , or purchase any shares in NOX, or as an inducement to purchase any shares in NOX. No agreement to subscribe for securities in NOX will be entered into on the basis of this presentation or any information, opinions or conclusions expressed in the course ofthis presentation. This presentation is not a prospectus, product disclosure document, or other offering document under Australian law or under thelaw of any other jurisdiction. It has been prepared for information purposes only. This presentation contains general summary information and does not take into account the investment objectives, financial situation and particular needs of an individual investor . It is not a financial product advice and the Company is not licenced to, and does not provide, financial advice. This presentation may contain forward-looking statements which are identified by words such as ‘may’ , ‘could’ , ‘believes’ , ‘estimates’ , ‘targets’ , ‘expects’, or ‘intends’ and other similar words that involve risks and uncertainties. These statements are based on an assessment of past and present economic and operating conditions, and on a number of assumptions regarding future events and actions that, as at thedate of this presentation, are expected to take place. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors many of which are beyond the control of the Company, its Directors and management. Although the Company believes that the expectations reflected in the forward looking statements included in this presentationare reasonable, none of the Company, its Directors or officers can give, or gives, any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this document will actually occur or that the assumptions on which those statements are based are exhaustive or will prove to be correct beyond the date of its making. Readers are cautioned not to place undue reliance on these forward- looking statements. Except to the extent required by law, the Company has no intention to update or revise forward-looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this presentation. Readers should make their own independent assessment of the information and take their own independent professional advice inrelation to the information and any proposed action to be taken on the basis of the information. To the maximum extent permitted by law, the Company and its professional advisors and their related bodies corporate, affiliates and each of their respective directors, officers, management, employees, advisers and agents and any other person involved in the preparation of this presentation disclaim all liability and responsibility (including without limitation and liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use of or reliance on anything contained in, or omitted from, this presentation. Neither the Company nor its advisors have any responsibility or obligation to update this presentation or inform the reader of any matter arising or coming to their notice after the date of this presentation document which may affect any matter referred to in the presentation. © 2020 Noxopharm Ltd. All rights reserved. Contents Clinical Strategy Commercial Strategy Market Opportunities Introduction Investment Highlights Veyonda® © 2020 Noxopharm Ltd. All rights reserved. Introduction Technology platfor m qisoflavonoid molecular structure offering new generation of therapeutics built around polypharmaactions (tyrosine and serine-threonine kinase inhibition) and restriction to prion-like (abnormal functioning) kinase targets Proprietary IP qstructure/functional relationship; delivery technology Veyonda® qdual cytotoxic/immuno-oncology drug for late-stage prostate cancer Drug pipeline qoral cytotoxic for pancreatic/gall-bladder cancers qfirst-in-class glutamate G-protein receptor inhibitor for GBM We are a drug discovery and drug development company. We will seek strategic partnerships for pipeline drugs when they attain key valuation points © 2020 Noxopharm Ltd. All rights reserved. Investment Case Veyonda® being positioned for the largest sector in the oncology market -end-stage cancer where treatment limited to palliative care -little competition -multi-billion $ market opportunity Veyonda® immediate goal is late-stage prostate cancer -estimated 300,000 p.a. deaths globally -estimated 33,000 in the U.S. in 2020 -U.S. market alone estimated at US$1 billion + Veyonda® considerably de-risked -safety confirmed -evidence of meaningful clinical efficacy in Phase I/II trials -multiple programs (DARRT, LuPIN, CEP , IONIC) Commercial outreach commenced -GenesisCarerelationship -territorial carve-outs being explored Lean operation. Virtual company * American Cancer Society Cancer Statistics Centre 2020 © 2020 Noxopharm Ltd. All rights reserved. Clinical Strategy for Prostate Cancer ØMain objective: To provide a clinical data package that is attractive for future commercial partners ØImplementation Steps: ―First Prostate Cancer clinical trial (DARRT-1) has finished and was successful ―Second Prostate Cancer clinical trial (LuPIN-1) is ongoing and showing encouraging interim results ―Next clinical trial (DARRT-2) will build on these results and will include more patients ―News flow and a growing data portfolio will be ensured © 2020 Noxopharm Ltd. All rights reserved. Hormone-sensitive Hormone-refractory Non-metastatic Metastatic Course of Disease and Treatment Journey for Stage I -IV Prostate Cancer Surgery and/or local radiotherapy Chemical castration therapy Androgen receptor inhibitors Chemo- therapy Palliative therapy Which Market Segment does Veyonda occupy?Rising PSA levels in blood & Veyonda® DARRT-1 © 2020 Noxopharm Ltd. All rights reserved. Ø26 men enrolled with late-stage prostate cancer ØMetastatic castration-resistant prostate cancer (mCRPC) ØProgressive disease ØNo remaining standard treatment options ØEligible for palliative RT for symptomatic relief ØTreatment with low-dose RT (20Gy in 5 fractions) and 14 days of NOX66 (400, 800, 1200 mg) DARRT = Direct and Abscopal Response to Radiation Therapy; RT = Radiation Therapy Veyonda®–What does the Clinical Data show? 1 Bone scan with metastatic disease © 2020 Noxopharm Ltd. All rights reserved. DARRT-1: Does Veyonda work? ØIn the 15* patients who were evaluable at 6 months1 The Tumours stopped growing or reduced in size in 10 patients (1 patient achieved a partial response and 9 achieved stable disease at 6 months) 1. Noxopharm. Data on file. 1 1 * 10 patients lost to follow-up, were not measurable, withdrew from study or died (unrelated to treatment) Overall (RECIST1.1) N=10 N=5 N=15 Complete response 0 0 0 Partial response 1 (10%) 0 1 (7%) Stabledisease 7 (70%) 2 (40%) 9 (60%) Progressive disease 2 (20%) 3 (60%) 5 (33%) © 2020 Noxopharm Ltd. All rights reserved. What is the Aim of the next Trial? ØObjectives: ―The DARRT-2 trial is designed to provide the data that Commercial Partners are looking for ―It also aims to satisfy the Regulatory Authorities ØBuilding on the experience and data of DARRT-1 ØPhase 2 trial; multinational ØMedical Advisory Boards established ØAnticipated regulatory submissions late-2020 ØStudy expected to commence in early-2021 2 üWe are developing the most efficient and impactful study possible © 2020 Noxopharm Ltd. All rights reserved. Additional Opportunity in Prostate Cancer External Radiation ØStandard-of-Care ØWidely used Internal Radiation ØExperimental ØBillion-dollar Acquisition by Novartis DARRT LuPIN © 2020 Noxopharm Ltd. All rights reserved. LuPIN Trial: Key Interim Results In summary, combination therapy of Veyonda® and 177Lu-PSMA-617 showed major benefits to patients and underscores the Company’s confidence in Veyonda® eventually becoming a standard drug in the management of prostate cancer vVeyonda® +177Lu-PSMA-617 §Overall Survival (OS) is a measure of the time from the start of treatment until death. 17.1 months üThe combination therapy was well tolerated, pointing to Veyonda® being safe to use in combination with intravenous radiotherapy üMedian OS was 17.1 months –a remarkable result at this late stage of the disease © 2020 Noxopharm Ltd. All rights reserved. Commercial Strategy 2 Noxopharm commercial priorities 1.Attract potential partners by continuing to undertake clinical trials to develop Veyonda® as standard of care in treatment of prostate cancer 2.Develop alliances to strengthen the commerciality of Veyonda® 3.Investigate commercial agreements to build revenue prior to commercialisation of Veyonda® DARRT-2 Phase 2 clinical trial planning underway GenesisCare use of Veyonda® for compassionate treatment Pursuing regional licencing agreements for Veyonda® © 2020 Noxopharm Ltd. All rights reserved. Market Opportunity 2 Recent acquisitions Buyer Seller Price range XTANDI® mCRPC (2016) US$14 billion 177Lu-PSMA-617 mCRPC (2018) US$2.1 billion 177Lu-PSMA-617 & others mCRPC (2018) US$3.9 billion Recent acquisitions in the prostate cancer space Prostate cancer market opportunity •33,330 prostate cancer deaths are forecast in the US in 2020* •Potentially all of these patients could benefit from treatment with Veyonda® •The potential global demand of late stage cancer patients for multiple cycles of Veyonda® indicates potential for multi-million dollar revenue from Veyonda® àpositioning Veyonda® for acquisition by big pharmaceutical companies * American Cancer Society Cancer Statistics Centre 2020 © 2020 Noxopharm Ltd. All rights reserved. Veyonda® DEVELOP DELIVERDISCOVER ASX: NOX For further information please visit www.noxopharm.com
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