Noxopharm Non-Deal Roadshow Presentation
2020-01-29 · Noxopharm Limited · original noxopharm.com ↗
Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA ABN 50 608 966 123 Date: 29th January 2020 Sydney, Australia Noxopharm Non-Deal Roadshow Presentation Sydney, 29th January 2020: Noxopharm (ASX: NOX) is pleased to provide shareholders and the market the attached Noxopharm corporate presentation “Non-Deal Roadshow Presentation”. This document is being used by Noxopharm for presentation during a non-deal roadshow by the company in Melbourne and Sydney on the 29th and 30th January 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. 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 taken 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 January 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. Non-Deal Roadshow Presentation Veyonda® Noxopharm is seeking to bring Veyonda® to market as a first-in-class drug that combineswithradiotherapy to provide a potent anti-cancer effect in prostate cancer Dr Gisela Mautner Medical Overview Mr Alex Hunter Corporate Overview 1 2 © 2020 Noxopharm Ltd. All rights reserved. Dr Gisela Mautner MD-PHD, MPH, MBA Medical Overview Veyonda® DARRT LuPIN Drug development process Prostate cancer Veyonda® market potential Veyonda® Indicative clinical program timing © 2020 Noxopharm Ltd. All rights reserved. Drug Development Process Veyonda® © 2020 Noxopharm Ltd. All rights reserved. 1in 5 mendevelop prostate cancer before they turn 85 © 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 OptionsRising PSA levels in blood & Veyonda® DARRT-1 © 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 Veyonda’sspace Life-extending treatment © 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®–Clinical Study DARRT-1 1 Bone scan with metastatic disease © 2020 Noxopharm Ltd. All rights reserved. DARRT-1: Safety and Tolerability üVeyonda® in combination with radiation therapy was reported to be safe and well-tolerated1 1. Noxopharm. Data on file. 1 1 ØPrimary end-point of acceptable safety and tolerability was met ØTreatment well tolerated with no serious side-effects due to Veyonda® ØNo dose-limiting toxicities © 2020 Noxopharm Ltd. All rights reserved. DARRT-1: Efficacy –Tumour Response 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. DARRT-2 –In Planning ØBuilding on the experience and data of DAART-1 ØPhase 2 trial ØMultinational ØMin. 60 patients ØSame patient population as in DARRT-1 ØRadiation therapy plus repeated cycles of Veyonda® ØMedical Advisory Boards established ØProtocol synopsis being drafted 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 –Comparative Results In summary, combination therapy of Veyonda® and 177Lu-PSMA-617 shows benefits to patients well above that achieved with 177Lu-PSMA-617 therapy alone and underscores the Company’s confidence in Veyonda® eventually becoming a standard drug in the management of prostate cancer §Progression-free survival (PFS)is a measure of the time from the start of treatment until the disease progresses. üMedian PFS quadrupledthrough the addition of Veyonda® (8.4 months vs 2.0 months with 177Lu-PSMA alone) §Treatment duration üThe addition of Veyonda® meant that the number of men able to start the 4th treatment cycle tripledto 69% from 21% with 177Lu- PSMA alone üThe combination therapy also was well tolerated, pointing to Veyonda® being safe to use in combination with intravenous radiotherapy © 2020 Noxopharm Ltd. All rights reserved. Market Potential –Prostate Cancer Radiotherapy & Veyonda® Prostate Cancer FUTURE treatment opportunity Radiotherapy alone CURRENT treatment © 2020 Noxopharm Ltd. All rights reserved. Palliative therapy Market Opportunities –RT plus Veyonda® Prostate Cancer Breast Cancer Lung Cancer Kidney Cancer Thyroid Cancer Others (20%) © 2020 Noxopharm Ltd. All rights reserved. Indicative Clinical Program Timing DARRT-2 protocol development under way DARRT -1 complete, final statistical results due March 2020 DARRT-2 clinical trial indicative commencement early 2021 Indicative Clinical Program Timing DecQ2019 MarQ2020 JunQ2020 SepQ2020 DecQ2020 MarQ2021 JunQ2021 SepQ2021 DecQ2021 DARRT-1 Phase 1 clinical trial complete Dec Q 2019 Phase 1 statistical report Mar Q 2020 DARRT-2 Protocol Development/CRO appoin't •Medical advisory board consultation •Appoi nt CRO Commence trial (indicative) Earl y 2021 DARRT-2 trial under way (indicative) 2021 onwards LuPIN Tri al s compl ete Dec Q 2020 Commercial partnerships 2020 & 2021 now- Sep Q 2020 © 2020 Noxopharm Ltd. All rights reserved. Mr Alex Hunter MBA, BE, GradDipCorpSecFinLaw, GradDipAppFin Corporate Overview Market Opportunity Nyrada Inc. Investment Highlights Executive Summary Company Details Veyonda® © 2020 Noxopharm Ltd. All rights reserved. Executive Summary ØAustralian biotech company listed on Australian Securities Exchange (ASX:NOX) ØOncology focus ØProprietary drug Veyonda® well advanced in clinical development phase ØFirst-in-class inhibitor of sphingosine-1-phosphate ØIntended as adjunct to radiotherapy Ø2 active clinical trials studying improved efficacy of radiotherapy in late-stage mCRPC: ―(Phase 1b) DARRT , Veyonda® + external beam radiotherapy ―(Phase 2a) LuPIN, Veyonda® + 177Lu-PSMA-617 ―Strong clinical signals achieved in both trials ØPreparing for Phase 2 DARRT clinical trial ØUnique dual market opportunity for Veyonda® in late-stage prostate cancer space Ø~30% equity in Nyrada Inc., a promising listed subsidiary focused on novel small molecule drugs (ASX:NYR) ØExperienced 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 (Jan 2020) Listed on Australian Securities Exchange (ASX:NOX) Aug 2016 Shares on issue 132m Share Price A$0.23.5-A$0.29 Market Cap A$31-38m Cash A$1.7m Convertible notes A$4.7m 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. Market Opportunity 2 2019 Prostate Cancer AustraliaUSA New cases of Prostate Cancer diagnosed 19,500 175,000 Deaths from Prostate Cancer 3,300 31,600 Market Opportunity §Noxopharm believes Veyonda® has potential applications in most forms of solid cancer as both a radio-enhancer and chemo-enhancer §Noxopharm has selected radio-enhancement (DARRT regimen) in metastatic prostate cancer (mCRPC) as the path to first market approval: oDARRT-1 has shown that Veyonda® provides a meaningful anti-cancer effect including cessation of tumour growth in about half of mCRPC patients, and considerable (average 80%) pain relief oManagement of mCRPC is a major unmet need, with palliative treatment the current standard of care oThe need is predicted to grow with increasing longevity and a growing global middle class oEase of enrolment due to high disease incidence and 12-months end-points (limited life expectancy of typically 6-9 months) suggests relatively short trial duration oPotential high demand and low drug costs could result in blockbuster revenue •A number of recent multi-billion dollar deals in the mCRPC space (see table below) Noxopharm believes the fastest, lowest risk path to market for Veyonda® is as a treatment for mCRPC Noxopharm believes Veyonda® has potential use in most forms of solid cancer mCRPCcurrently is treated palliatively. Noxopharm is intended to go beyond palliation and provide a meaningful, durable and well tolerated anti-cancer effect 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 © 2020 Noxopharm Ltd. All rights reserved. Nyrada Inc. (ASX:NYR) 2 NYRADA §Nyrada is a pre-clinical stage, drug company specialising in the development of novel small molecule drugs pertaining to the underlying pathological processes involved in cardiovascular, neurodegenerative and chronic inflammatory diseases §Nyrada listed on the ASX on 16thJanuary 2020 §The Company’s vision is to become a high growth pharmaceutical company specialising in drug discovery where few if any, effective or well-tolerated therapies exist §The Company has four current drug development programs: oCardiovascular: A PCSK9 inhibitor for the treatment of high blood LDL-cholesterol levels in patients poorly responsive to, or unable to take statin drugs oNeuroprotection: A neuroprotectant drug to improve patient outcomes and prevent long-term disability in patients with ischaemic stroke and traumatic brain injury oInflammation/pain: A drug to treat pain associated with peripheral nerve damage (such as sciatica), and oInflammation/autoimmunity: A drug to treat autoimmune diseases such as psoriasis Noxopharm’s shareholding in Nyrada has a market value of $10-14m based on Nyrada’s recent trading range Board and Key Management John Moore Non-executive Chairman Dr Graham Kelly PhD Founder, Non-exec Director Peter Marks Non-executive Director Marcus Frampton Non-executive Director Rudiger Weseloh PhD Non-executive Director Christopher Cox Non-executive Director James Bonnar Chief Executive Officer Benny Evison PhD Chief Scientific Officer Nyrada Share price trading range Noxohparm shareholding* Implied market value NOX shareholding $0.215 45,373,845 $9.8m $0.305 $13.8m *Includes33.4mCDI’sand12mperformanceshares © 2020 Noxopharm Ltd. All rights reserved. Investment Highlights Australia Dr Graham Kelly –Chairman & CEO +61 429 854 390 [email protected] Dr Gisela Mautner –Chief Medical Officer +61 499 005 012 [email protected] Contact Details Noxopharm Investment Highlights §Significant clinical milestones over next 12 months from DARRT and LuPIN trials §Potential standard of care: Noxopharm believes that its DARRT and LuPIN treatments have the potential to become standard of care for late-stage prostate cancer where treatment currently is palliative §Potential dominant position: Company in unique position of having two potential treatments for late-stage mCRPC, providing a likely dominant position in a critical sector §DARRT marketing approval: With planning now in progress for DARRT-2 pivotal trial, Company within reach of Veyonda® generating significant revenue §LuPIN treatment: Current LuPIN clinical trial suggesting that Veyonda® is at least doubling the anti-cancer activity of 177Lu- PSMA-617, a drug candidate the subject of a US$6 billion series of acquisitions in 2018 §Broader market opportunity: Approval of Veyonda® for mCRPC cancers (DARRT & LuPIN), including early-stage prostate cancer, likely to substantially increase the commercial value of the Company §Equity in Nyrada provides additional corporate value $10-15m Australia Alex Hunter –Chief Commercial Officer +61 467 570 063 [email protected] USA Greg Ambra –Senior VP North America Operations +1 732 595 7508 [email protected] © 2020 Noxopharm Ltd. All rights reserved. Veyonda® DEVELOP DELIVERDISCOVER ASX: NOX For further information please visit www.noxopharm.com
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