Noxopharm Corporate Presentation
2020-01-15 · Noxopharm Limited · original noxopharm.com ↗
Noxopharm Limited. Suite 3, Level 4, 828 Pacific Highway, Gordon, NSW, 2072, AUSTRALIA Date: 15th January 2020 Sydney, Australia ASX Limited 20 Bridge Street SYDNEY NSW 2000 Noxopharm Corporate Presentation Sydney, 15th January 2020: Noxopharm (ASX: NOX) is pleased to provide shareholders and the market the attached Noxopharm corporate presentation “Corporate & Clinical Overview”. This document is being used by Noxopharm for presentation during meetings with investment banks, fund managers and other attendees of the JP Morgan Healthcare Conf erence in San Francisco, California. The presentation can be found at www.noxopharm.com Graham Kelly, CEO and Chairman of Noxopharm has approved the release of this document to the market. ---------------------------------------------- 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 9299 9690 E: [email protected] E: [email protected] Media queries: Catherine Strong Citadel-MAGNUS T: 02 8234 0111 E: [email protected] Noxopharm Limited. Suite 3, Level 4, 828 Pacific Highway, Gordon, NSW, 2072, AUSTRALIA 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, 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 January 2020 Corporate & Clinical Overview 15th January 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. TABLE OF CONTENTS Company Details Executive Summary Veyonda® DARRT LuPIN Clinical Program Timing*indicative Market Opportunity Nyrada Inc. Veyonda® Noxopharm is seeking to bring Veyonda® to market as a first-in- class drug that boosts the efficacy of radiotherapy in prostate cancer Investment Highlights © 2020 Noxopharm Ltd. All rights reserved. Executive Summary ➢ Australian biotech company listed on Australian Securities Exchange (ASX:NOX) ➢ Oncology focus ➢ Proprietary drug Veyonda® ➢ First-in-class inhibitor of sphingosine-1-phosphate ➢ Intended as adjunct to radiotherapy ➢ 2 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 ➢ Preparing for Phase 2 DARRT clinical trial ➢ Unique dual market opportunity for Veyonda® in late-stage prostate cancer space ➢ ~30% equity in Nyrada Inc., a promising listed subsidiary focused on novel small molecule drugs (ASX:NYR) ➢ 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 (Dec 2019) Listed on Australian Securities Exchange (ASX:NOX) Aug 2016 Shares on issue 130m Share Price A$0.40 Market Cap A$52m Cash A$3.5m Convertible notes A$5.2m Board and Key Management Dr Graham Kelly. PhD Chairman & CEO Ian Dixon. PhD, MBA Non-Executive Director Peter Marks. MBA, BEc, LLB Non-Executive Director Alex Hunter. MBA, BE Chief Commercial Officer Greg Ambra. MS SVP North American Ops Dr Gisela Mautner. MD-PHD, MPH, MBA Chief Medical Officer Dr John Wilkinson. PhD Chief Scientific Officer Shawn Van Boheemen. BBus MCom Chief Financial Officer 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 Traded Volume (m) Price (A$) NOX historic share performance © 2020 Noxopharm Ltd. All rights reserved. Veyonda® Patent and IP ▪ Veyonda® is a Noxopharm registered trade name ▪ Noxopharm has lodged 6 patent families around Veyonda®, the first of which has entered the national examination phase in 80 countries Veyonda ® ▪ Veyonda® (previously known as NOX66) is the Company's proprietary oncology drug currently in Phase 1b and Phase 2a clinical trials ▪ Final results from the DARRT-1 study show that Veyonda® in combination with EBRT achieved a durable and meaningful anti- cancer response in a high proportion of late-stage prostate cancer patients in a well tolerated way ▪ Interim results from the LuPIN study suggest that Veyonda® is also boosting the response to 177Lu-PSMA-617 (Novartis), enabling more men to complete their full course of radiation therapy, again, in a well tolerated way How Veyonda® works ▪ The active ingredient in Veyonda® is the experimental anti-cancer drug, idronoxil ▪ The molecular target of idronoxil is the pan oncogene, Ecto-Nox disulfide-thiol exchanger Type 2 (ENOX2) ▪ A principal downstream consequence of ENOX2 inhibition is down- regulation of sphingosine-1-phosphate (S1P) ▪ S1P is a key secondary messenger, activating five S-1-P receptors that play critical roles in pro-survival signalling and immune cell function ▪ Pro-survival signalling includes cell growth, DNA repair and multi-drug resistance mechanisms ▪ Immune cell function includes a negative feed-back mechanism that blocks inflammatory response/immune cell trafficking in order to dampen an immune response following inflammation ▪ Most cancers over-express S1P levels, effectively blocking the ability of the body to mount inflammatory and immune responses against cancer cell growth ▪ By removing this block, Veyonda® helps to restore the body’s inherent ability to fight cancer tumours Veyonda® boosts radiation in two ways 1. Palliative external radiotherapy ▪ DARRT clinical trials underway 2. Palliative internal radiotherapy ▪ LuPIN clinical trial underway DARRT Veyonda® + EBRT LuPIN Veyonda® + 177Lu-PSMA-617 © 2020 Noxopharm Ltd. All rights reserved. DARRT - a novel radiation therapy enhancer Direct and Abscopal Response to Radiotherapy DARRT-1: Headline Conclusions ▪ 25 men started the Phase 1b DARRT-1 study; 4 withdrawals = 21 remaining in the study ▪ 16 alive and completed the study, with 15 radiographically assessable by RECIST ▪ Primary end-point of safety met with no significant or dose-limiting toxicities ▪ Secondary end-point of efficacy achieved At 6-month follow up: ▪ 11/21 (53%) had progressive disease or died (unrelated to treatment) ▪ Anti-cancer response achieved as evidenced by: o Stable disease or better (RECIST) - 10/15 (66%) o PSA Response – 5/16 (31%) o Pain Response – 10/16 (62%) The key to the success of the DARRT treatment is a combination of two actions: ▪ First: expose a small number (1 or 2) of individual tumours to low-dose (20 Gy) radiation. Low-dose is critical because the goal is to damage the tumour, not to destroy all cells including beneficial cells such as those responsible for inflammation and immune responses—these cells need to be preserved. The key to DARRT is initiating an inflammatory response that serves as a trigger to an immune response ▪ Second: the presence of idronoxil in all tumours boosts the pro- inflammatory (STING) effect of the radiation in the irradiated tumours as well as restoring local immune function in all tumours, promoting an all- of-body immune response leading to an anti-cancer effect in all tumours in what is known as an abscopal response. A durable and meaningful anti-cancer response was achieved at 6-months in 48% of men with end- stage progressive prostate cancer with no remaining treatment options © 2020 Noxopharm Ltd. All rights reserved. DARRT-2 DARRT-2 Trial Design ▪ Phase 2 clinical trial protocol development under way ▪ Men with mCRPC post-taxane and post-enzalutamide/abiraterone ▪ In combination with best supportive treatment/best standard of care ▪ Multiple sites, multi-national ▪ Single course (5 fractionated doses) of radiotherapy with repeat cycles of Veyonda® ▪ Compared to the single treatment cycle in DARRT-1, the repeat cycles expected to provide an additional monotherapy anti-cancer effect with potential for an increase in overall anti-cancer effect ▪ Medical advisory boards established ▪ Anticipated regulatory submissions late-2020 Potential Indicative Trial Design Anticipated endpoints ▪ Key primary endpoint: Overall survival at 12-months ▪ Secondary endpoints: ❖ Progression-free survival (radiographic, clinical, PSA) ❖ RECIST response ❖ pain response (BPI-SF) ❖ Health-related quality of life ❖ Safety and tolerability ❖ Health economics DARRT-2 Timeline ▪ Clinical protocol planning has commenced with medical advisory board input ▪ Trial commencement date subject to current planning, targeted for early 2021 © 2020 Noxopharm Ltd. All rights reserved. LuPIN Aim of the LuPIN study A major aim of the LuPIN trial is to see if Veyonda® can boost the effectiveness of 177Lu-PSMA-617 radiation therapy so that more men are able to complete their full course of treatment (up to 6 cycles) before their cancer progresses and they need to stop treatment What is 177Lu-PSMA-617 177Lu-PSMA-617 is an experimental radioactive drug that was the subject of a US$6 billion series of acquisitions by Novartis in 2018 and currently is in a Phase 3 registration study expected to finish in 2020 About LuPIN ▪ LuPIN is an Investigator-Initiated Phase 1b/2a, single-arm, open label study being conducted at St Vincent’s Hospital, Sydney ▪ The study is enrolling 56 men with PSMA-positive mCRPC that has progressed after docetaxel, cabazitaxel and either abiraterone and/or enzalutamide Rx ▪ Men receive intravenous 177Lu-PSMA-617 at 6-weekly intervals; up to 6 cycles providing no progression based on PSA; Veyonda® dosed days 1- 10 each cycle. ▪ Phase 1b arm was dose-escalation: 400 mg (8 patients), 800 mg (8 patients), 800 mg (16 patients) of Veyonda® to establish the safety of the combination treatment ▪ Based on evidence of efficacy and good tolerability, the trial progressed to a Phase 2a expansion arm of 1200 mg (24 patients) of Veyonda® intended to establish the dose-response effect of increasing Veyonda® levels in treatment safety and efficacy Results so far ▪ Preliminary data published in September 2019 demonstrated that the three endpoints used to measure anti-cancer effect all showed a benefit from combining Veyonda® with 177Lu-PSMA therapy ▪ PSA response refers to a fall in PSA levels in blood of greater than 50%. This is accepted by oncologists as a surrogate marker of disease activity. ▪ Adding Veyonda® to 177Lu-PSMA therapy almost doubled the PSA response (69% with Veyonda® vs 36% with 177Lu-PSMA alone) ▪ Progression-free survival (PFS) is a measure of the time from the start of treatment until the disease progresses. PFS quadrupled through the addition of Veyonda® (8.4 months vs 2.0 months with 177Lu-PSMA alone) ▪ Treatment duration. The addition of Veyonda® meant that the number of men able to start the 4th treatment cycle tripled to 69% from 21% with 177Lu-PSMA alone ▪ The combination therapy also was well tolerated, pointing to Veyonda® being safe to use in combination with intravenous radiotherapy 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 © 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 •Appoint CRO Commence trial (indicative) Early 2021 DARRT-2 trial under way (indicative) 2021 onwards LuPIN Trials complete Dec Q 2020 Commercial partnerships 2020 & 2021 now- Sep Q 2020 © 2020 Noxopharm Ltd. All rights reserved. Market Opportunity 2 2019 Prostate Cancer Australia USA 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: o DARRT-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 o Management of mCRPC is a major unmet need, with palliative treatment the current standard of care o The need is predicted to grow with increasing longevity and a growing global middle class o Ease 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 o Potential 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 mCRPC currently 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. 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 ▪ 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: o Cardiovascular: A PCSK9 inhibitor for the treatment of high blood LDL-cholesterol levels in patients poorly responsive to, or unable to take statin drugs o Neuroprotection: A neuroprotectant drug to improve patient outcomes and prevent long -term disability in patients with ischaemic stroke and traumatic brain injury o Inflammation/pain: A drug to treat pain associated with peripheral nerve damage (such as sciatica), and o Inflammation/autoimmunity: A drug to treat autoimmune diseases such as psoriasis Nyrada will list on the Australian Securities Exchange (ASX:NYR) on 16 Jan 2020 Nyrada is a U.S.-registered spin-off subsidiary of Noxopharm Board and Key Management John Moore Non-executive Chairman Dr Graham Kelly PhD Founder, Non-executive 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 Focusing on novel small molecules for major non- oncology indications © 2020 Noxopharm Ltd. All rights reserved. Investment Highlights USA Greg Ambra – Senior V-P North America Operations +1 732 595 7508 [email protected] Australia Dr Graham Kelly – Chairman & CEO +61 429 854 390 [email protected] Alex Hunter – Chief Commercial Officer +61 467 570 063 [email protected] Dr Gisela Mautner – Chief Medical Officer +61 499 005 012 [email protected] www.noxopharm.com 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
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