drugset / Press release

Noxopharm Corporate Presentation February 2020

2020-02-27 · Noxopharm Limited · original noxopharm.com ↗

Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA ABN 50 608 966 123 27 February 2020 Sydney, Australia Noxopharm Corporate Presentation February 2020 Noxopharm (ASX: NOX) is pleased to provide shareholders and the market the attached corporate presentation, “Kalkine Invest Nest Presentation 27 February 2020”. This document will be used at the Kalkine Invest Nest 2020 Small Cap Investor Conference. 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. 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 Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA ABN 50 608 966 123 expressions. Forward-looking statements are based on estimates, projections and assumptions made by Noxopharm about circumstances and events that hav e not yet taken place. Although Noxopharm believes the forward- looking statements to be reasonable, they are not certain. Forward -looking statements involve known and unknown risks, 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® D E V E L O P D E L I V E RD I S C O V E R ASX: NOX February 2020 Kalkine Invest-Nest Presentation – 27 Feb 2020 © 2020 Noxopharm Ltd. All rights reserved. Disclaimer This 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 the law 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. Dr Gisela Mautner, MD-PHD, MPH, MBA, FACPE Chief Medical Officer Veyonda® DARRT-Studies LuPIN-Study Prostate Cancer Veyonda® Market Potential Veyonda® Clinical Program © 2020 Noxopharm Ltd. All rights reserved. Did you know? EACH DAY in Australia 50 MEN are diagnosed with PROSTATE CANCER © 2019 Noxopharm Ltd. All rights reserved. 1 in 5 men develop prostate cancer before they turn 85 © 2019 Noxopharm Ltd. All rights reserved. In India ➢The prevalence of prostate cancer in India was previously thought to be far lower compared to western countries ➢BUT … ―Increased migration from rural to urban areas ―Changing life styles and diet ―Increased awareness ―Easier access to medical facilities ―… ―More cases of prostate cancer are being picked up © 2020 Noxopharm Ltd. All rights reserved. Drug Development Process Veyonda® © 2020 Noxopharm Ltd. All rights reserved. Veyonda® – Our Lead Drug Veyonda® Low-dose Radio Therapy Cancer cells Immune cells © 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 Prostate Cancer and Treatment Options Rising PSA levels in blood & Veyonda® DARRT-1 © 2020 Noxopharm Ltd. All rights reserved. ➢ 26 men enrolled with late-stage prostate cancer ➢ Metastatic castration-resistant prostate cancer (mCRPC) ➢ Progressive disease ➢ No remaining standard treatment options ➢ Eligible for palliative RT for symptomatic relief DARRT = Direct and Abscopal Response to Radiation Therapy; RT = Radiation Therapy Veyonda® – Clinical Study DARRT-1 1 Bone scan with metastatic disease © 2020 Noxopharm Ltd. All rights reserved. DARRT-1: Efficacy Results - PSA ➢Veyonda® in combination with radiation therapy appeared to be safe and well-tolerated1 ➢In the 16* patients who were evaluable at 6 months1 PSA = prostate specific antigen 1. Noxopharm. Data on file. 1 1 * 9 patients lost to follow-up, died or withdrew from study Over 50% drop in PSA in 5/16 patients © 2020 Noxopharm Ltd. All rights reserved. DARRT-1: Efficacy Results - Pain ➢Veyonda® in combination with radiation therapy appeared to be safe and well-tolerated1 ➢In the 16* patients who were evaluable at 6 months1 1. Noxopharm. Data on file. 1 1 * 9 patients lost to follow-up, died or withdrew from study Over 30% drop in pain levels In 10/16 patients 4 patients became completely pain-free © 2020 Noxopharm Ltd. All rights reserved. DARRT-1: Efficacy Results – Tumour Response ➢In the 15* patients who were evaluable at 6 months1 1. Noxopharm. Data on file. 1 1 * 10 patients lost to follow-up, died, were not measurable or withdrew from study Tumors stopped growing in 9 patients Tumors reduced in size in 1 patient In summary, combination therapy of Veyonda® and radiotherapy showed major benefits to patients and underscores the Company’s confidence in Veyonda® eventually becoming a standard drug in the management of prostate cancer © 2020 Noxopharm Ltd. All rights reserved. Veyonda® Acts in a Unique Space 1 drug RT & Veyonda® RT & Veyonda® RT & Veyonda® RT & Veyonda® 1 drug 1 drug 1 drug 1 drug 1 drug 1 drug 1 drug 1 drug 1 drug Irrespective of how many new drugs are coming to market, they will generally not affect the market space of Veyonda® Life-extending treatment Palliative treatment © 2020 Noxopharm Ltd. All rights reserved. DARRT-2 Trial: In Planning ➢ Building on the experience and data of DAART-1 ➢ Phase 2 trial ➢ Multinational ➢ Min. 60 patients ➢ Same patient population as in DARRT-1 ➢ Radiation therapy plus repeated cycles of Veyonda® ➢ Medical Advisory Boards established ➢ Protocol synopsis being drafted ➢ Anticipated regulatory submissions late-2020 ➢ Study expected to commence in early-2021 2 ✓ We are developing the most efficient and impactful study possible! © 2020 Noxopharm Ltd. All rights reserved. Additional Opportunity in Prostate Cancer External Radiation ➢ Standard-of-Care ➢ Widely used Internal Radiation ➢ Experimental ➢ Billion-dollar Acquisition by Novartis DARRT LuPIN © 2020 Noxopharm Ltd. All rights reserved. LuPIN Trial: Key Interim Results ❖ Comparison Veyonda® +177Lu-PSMA-617 vs 177Lu-PSMA-617 alone ▪ Progression-free survival (PFS) is a measure of the time from the start of treatment until the disease progresses. 2 months 8.4 months 177Lu-PSMA-617 alone 177Lu-PSMA-617 + Veyonda® ✓ Median PFS quadrupled through the addition of Veyonda® (8.4 months vs 2.0 months with 177Lu-PSMA-617 alone) © 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 ❖ Veyonda® + 177Lu-PSMA-617 ▪ Overall Survival (OS) is a measure of the time from the start of treatment until death. 17.1 months ✓ The combination therapy was well tolerated, pointing to Veyonda® being safe to use in combination with intravenous radiotherapy ✓ Median OS was 17.1 months – a remarkable result at this late stage of the disease © 2020 Noxopharm Ltd. All rights reserved. DARRT-1 LuPIN DARRT-2 Become standard of care adjunct to radiotherapy in prostate cancer Combined with chemotherapy Combined with immunotherapy In Planning Ongoing Completed CEP-1 CEP-2 Veyonda® - Pipeline Being Explored IONIC © 2020 Noxopharm Ltd. All rights reserved. Market Potential – Radiotherapy in Prostate Cancer Radiotherapy & Veyonda® Prostate Cancer FUTURE treatment opportunity Radiotherapy alone CURRENT treatment © 2020 Noxopharm Ltd. All rights reserved. Palliative radio therapy Potential Market Opportunities – Radiotherapy plus Veyonda® Veyonda® Prostate Cancer Breast Cancer Lung Cancer Kidney Cancer Thyroid Cancer Others © 2020 Noxopharm Ltd. All rights reserved. Mr Alex Hunter MBA, BE, GradDipCorpSecFinLaw, GradDipAppFin Corporate Overview Executive Summary Company Details Veyonda® © 2020 Noxopharm Ltd. All rights reserved. Executive Summary ➢ ASX listed (NOX) since 2016 ➢ Clinical stage drug development Company (mid-stage = substantially de-risked) ➢ Oncology focus. Proprietary drug Veyonda® ➢ Aiming at largest market sector in oncology – late-stage solid cancers where patients receiving just palliative care ➢ Successful drug = high probability of sharing in current US$100 billion + oncology drug market ➢ Focus initially on late-stage prostate cancer ➢ Last 2 deals in prostate cancer field were US$13 billion (Pfizer - 2016) and US$6 billion (Novartis - 2018) ➢ Experienced board and management team, strong technical & commercial experience Noxopharm believes that its DARRT and LuPIN treatments will become standard of care for late-stage prostate cancer, offering patients and doctors two new treatment options © 2020 Noxopharm Ltd. All rights reserved. Company Details Noxopharm Limited (Feb 2020) Listed on Australian Securities Exchange (ASX:NOX) Shares on issue 152m Share Price A$0.205-A$0.365 Market Cap A$31-55m Cash ~A$3.5m Board and Key Management Dr Graham Kelly. PhD Chairman & CEO Ian Dixon. PhD, MBA Non-Executive Director Peter Marks. MBA, BEc, LLB Non-Executive Director Dr Gisela Mautner. MD-PHD, MPH, MBA Chief Medical Officer Alex Hunter. MBA, BE Chief Commercial Officer Greg Ambra. MS SVP North American Ops Dr John Wilkinson. PhD Chief Scientific Officer Shawn Van Boheemen. BBus MCom Chief Financial Officer © 2020 Noxopharm Ltd. All rights reserved. Veyonda® D E V E L O P D E L I V E RD I S C O V E R ASX: NOX For further information please visit www.noxopharm.com

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