drugset / Press release

Noxopharm Presents to H.C. Wainwright Global Conference

2021-03-05 · Noxopharm Limited · original noxopharm.com ↗

Noxopharm Limited. ABN 50 608 966 123 Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA ASX Announcement | 5 March 2021 Noxopharm Limited (ASX:NOX) Noxopharm Presents to H.C. Wainwright Global Life Sciences Conference Sydney 5 March 2021: Australian clinical -stage drug development company Noxopharm Limited (ASX:NOX) announces that the CEO and Managing Director, Dr Graham Kelly, will present to the virtual H.C. Wainwright Global Life Sciences Conference on 9-10 March 2021. Dr Kelly’s presentation entitled “Noxopharm Investor Presentation March 2021” is attached. Graham Kelly, CEO and Managing Director of Noxopharm, has approved the release of this document to the market on behalf of the Board of Directors. -ENDS- About Noxopharm Noxopharm Limited (ASX:NOX) is an Australian clinical-stage drug development company focused on the treatment of cancer and cytokine release syndrome/septic shock. Veyonda® is the Company’s first pipe-line drug candidate currently in Phase 2 clinical trialling. Veyonda® has two main drug actions – inhibition of sphingosine kinase and inhibition of STING signalling. Activity a gainst the former target contributes to its dual-acting oncotoxic and immuno-oncology functions designed to enhance the effectiveness and safety of standard oncology treatments, i.e. , chemotherapies, radiotherapy and immune checkpoint inhibitors. Activity against the latter target provides an anti-inflammatory effect, also contributing to an anti-cancer action, but also potentially blocking sepsis. Noxopharm also is the major shareholder of US biotechnology company Nyrada Inc (ASX:NYR). To learn more, please visit: 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 Enquiries Julia Maguire The Capital Network E: [email protected] T: + 61 2 8999 3699 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 Noxopharm Limited. ABN 50 608 966 123 Suite 3, Level 4, 828 Pacific Highway, Gordon NSW 2072 AUSTRALIA 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, uncertainties and other factors that are in some cases beyond the Company’s control t hat could cause the actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statement. 1 NOXOPHARM LIMITED (ASX:NOX) Develop Deliver Discover Noxopharm Limited (ASX:NOX) INVESTOR PRESENTATION March 2021 Dr Graham Kelly CEO and Managing Director 2 NOXOPHARM LIMITED (ASX:NOX) Disclaimer This presentation has been prepared by NoxopharmLimited (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 of this 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 the date 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 presentation are 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 in relation 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. 3 NOXOPHARM LIMITED (ASX:NOX) Latest News LuPIN TRIAL. Major cancer conference hears NOX + NovarJs drug combinaJon delivers major survival benefit of median 19.7 months in Stage 4 prostate cancer IONIC TRIAL. IONIC study start pending ethics approval BUSINESS DEVELOPMENT. BD team assembled to advise on anJcipated commercial and transacJonal strategies NOXCOVID TRIAL. First 4 (of 5) dosage cohorts successfully completed. Veyonda found to be well- tolerated DARRT-2 TRIAL.Study expanded into wide range of cancers. Hospital selection for multinational study being finalisedwith Part 1 of the study due to commence Q3 2021 ABSCOPAL RESPONSE BREAKTHROUGH. Large US university confirms abscopal response dependent on a drug acJon that Veyonda possesses CASH. Dec 2020 cap raise, exercised opJons, and 2019/2020 R&D rebate put A$31.7M in bank 4 NOXOPHARM LIMITED (ASX:NOX) Source: Dana-Faber Cancer InsPtute Veyonda® breakthrough mulJple-acJng immunotherapy drug AcJvates immune cells Increases trafficking of activated immune cells Blocks autophagy abscopal responses Converts COLDtumors to HOTtumors Inhibits inflammaJon 5 NOXOPHARM LIMITED (ASX:NOX) Veyonda® Clinical program IONIC-1 Phase I/II trial Veyonda + Opdivo®(Bristol Myers Squibb) DARRT-2 Phase II trial Veyonda + external radiotherapy LuPIN-1 PhaseI/II trial Veyonda + 177Lu-PSMA (NovarNs) NOXCOVID-1 Phase Ibtrial Veyonda 6 NOXOPHARM LIMITED (ASX:NOX) LuPIN An exciting new treatment for prostate cancer Veyon d a®+ 177lutetium-PSMA-617 7 NOXOPHARM LIMITED (ASX:NOX) A proposed new treatment for prostate cancer once the cancer has spread widely (metastatic disease) Not curaNve 177luteNum-PSMA-617. Acquired by NovarJs (4thlargest pharma company/US$195 billion market cap) in 2018 for US$6 billion Lu-PSMA-617 is a radioacJve drug injected IV and designed to deliver radiaJon to every prostate cancer cell throughout the body Variable response rates.~1/3rdmen have lifle or no response But …… LuPIN (Veyonda + Lu-PSMA-617 8 NOXOPHARM LIMITED (ASX:NOX) LuPIN Study QUESTION: would adding Veyonda boost the effecJveness of the NovarJs drug, with more men responding as well as achieving significantly longer survival Jmes? Phase I/II study. St Vincent’s Hospital Sydney. Prof Louise Emmef 56 men. Late-stage cancer. No remaining standard treatments. AnJcipated median survival approximately 4.5 months 6 cycles. 6 weeks apart.177Lu-PSMA-617 (1 day) + Veyonda (14 days) 9 NOXOPHARM LIMITED (ASX:NOX) LuPIN: Interim Data ReporJng Median Overall Survival: 19.7 monthsa remarkable result for this late stage of the disease CombinaNon was well tolerated American Society of Clinical Oncology Genitourinary Cancers Symposium Feb 11-13 2021 56 men400 + 800 mg + 1200 mg Veyonda Noxopharm believes this to be a potenNal major breakthrough in the treatment of Stage 4 prostate cancer ANSWER: Yes, the combinaJon of Veyonda and Lu-PSMA-617 looks to considerably more effecJve than Lu-PSMA-617 on its own (based on published Phase 2 data1) 1. hRps://ascopubs.org/doi/abs/10.1200/JCO.2019.37.7_suppl.228 10 NOXOPHARM LIMITED (ASX:NOX) LuPIN: Interim Survival Data Median overall survival = time when half the patients have died and half still alive Three standard lines of drug therapy once prostate cancer becomes metastaJc 1stline 2nd line 3rd line End-stage ~ 4.5 monthsHistorical data1 177Lu-PSMA-617 alone2 13.3 months 177Lu-PSMA-617 + Veyonda (56 paJents)3 19.7 months 1. BuonerbaC, et al. (2014) Future Oncol 10:1353–60. 2. HofmanM, et al. (2018) Lancet Oncol 19, 825. 3. Noxopharm ASX announcement 15 Feb 2021 11 NOXOPHARM LIMITED (ASX:NOX) Three standard lines of drug therapy once prostate cancer becomes metastaJc 1stline 2nd line 3rd line End-stage NovarJs preferred treatment opJons1 LuPIN Study PotenJal opportuniJes for LuPIN VISION Study 1. NovarPs Oncology Pipeline Update June 2020 12 NOXOPHARM LIMITED (ASX:NOX) IONIC Overcoming resistance to checkpoint inhibitors Veyon d a®+ nivolumab (Opdivo®) 13 NOXOPHARM LIMITED (ASX:NOX) IONIC Study Opdivosales (2019) US$8 billion 15 patients pre-treated with Opdivobut tumours not responsive Veyon d a + Opdivo 15 patients not pre-treated with Opdivobecause cancers considered to be unresponsive Phase I/II proof-of-concept study All other cancer types Typically 0-3% response rate Increasing response rate to checkpoint inhibitors projected to increase sales >US$50 billion • Melanoma • Lung • Kidney • Bladder • Head & neck Typically 10-30% response rate 14 NOXOPHARM LIMITED (ASX:NOX) DARRT Making the rare abscopal response common-place Veyon d a®+ external beam radiotherapy 15 NOXOPHARM LIMITED (ASX:NOX) DARRT Direct and Abscopal Response to Radiotherapy Veyonda® ☛blocks autophagic repair of cell damage in irradiated tumours ☛triggers systemic immune response in non-irradiated tumours DIRECT RESPONSE ABSCOPAL RESPONSE Veyonda® ☛enhances the damaging effects of radiation in irradiated tumours DARRTDirect and Abscopal Response to Radiotherapy 16 NOXOPHARM LIMITED (ASX:NOX) DARRTResult of Veyonda selecJvely blocking sphingosine kinase in cancer cells, resulJng in elevated ceramide and depressed S1P levels DIRECT RESPONSE ABSCOPAL RESPONSE Radio-enhancement through: ☛Mitotic arrest (G2M) ☛Blocking DNA repair (topo 1 and 2, PARP1) Sphingomyelin pathway Sphingosine ↔CERAMIDE↔SPHINGOSINE-1-PHOSPHATE Sphingosine kinase Systemic immune activation through: ☛Blocking autophagy leads to systemic interferon release ☛Increased immune cell trafficking into non-irradiated tumours DARRTVeyonda selec,vely blocks sphingosine kinase in cancer cells, resul,ng in elevated ceramide and depressed S1P levels 17 NOXOPHARM LIMITED (ASX:NOX) Veyonda®(NOX66) ☛21-day cycle: daily dosing for 14 days (7 days rest) ☛starting Day -1 ☛repeat monthly cycles (in DARRT-2) until disease progression [one cycle in DARRT-1] Low-dose radiotherapy to a single lesion ☛external beam radiotherapy ☛8-30 Gy ☛1-10 fractionated doses ☛single cycle of RT DARRT: Treatment regimen 18 NOXOPHARM LIMITED (ASX:NOX) •Veyonda® was safe and well tolerated •Promising efficacy signals were obtained, including evidence of abscopal response in 4 paJents •Efficacy signals (pain response, PSA response)were maintained from 3 to at least 6 months DARRT Direct and Abscopal Response to RadiotherapyDARRT-1 conclusions 19 NOXOPHARM LIMITED (ASX:NOX) A Phase 1b/2a Multicenter Study of NOX66 and External Beam Radiotherapy in Patients with Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors Part 1 Part 2 Solid Tumours 3 Dose Cohorts At least 2 mCRPCin each cohort mCRPC NSCLC Breast Cancer Patient Population: Patients who are eligible for low-dose EBRT for at least one symptomatic or minimally symptomatic lesion (for the prevention of symptoms). Primary Objec5ve •Safety •MTD/RP2D Primary Objec5ve •PSA Response (mCRPC) •DCR (Other Tumours) Other Objec5ves ORR, PFS, OS, Pain response, PK, Biomarkers, QOLs DARRT Direct and Abscopal Response to Radiotherapy DARRT-2 Study Design 20 NOXOPHARM LIMITED (ASX:NOX) LuPIN trial Study ends Oct 2021. All treatments completed. Final Report expected Q1 2022 NOXCOVID trial Part 1 (dose-escalaJon) complete. Part 2 to start March 2021 Drug pipeline First-in-class drug with novel approach to treatment of brain cancer progressing enters pre- clinical tesJng OTHER UPDATES Pharmorage subsidiary Major opportunity underway to develop new family of drugs for sepsis and autoimmunity 21 NOXOPHARM LIMITED (ASX:NOX) Our commercial end-point for Veyonda A number of important blockbuster (>US$1 B annual sales) drugs are losing their exclusivity over coming years. This is putting pressure on big pharma to refresh revenue streams through M&A activity Programs focusing on immuno-oncology and cell therapy remain the most attractive targets for partnering In 2020, 52 deals >US$1 billion were transacted, 31 of these were for immuno-oncology and cell therapy assets and platforms 22 NOXOPHARM LIMITED (ASX:NOX) Key metricsas at 4 March 2021 Market cap A$192m Share price A$0.69 Issued cap 278.9m shares Cash A$31.7m News Flow (next 6 months) •IONIC-1 and DARRT-2 start paJent recruitment •COVID-19 clinical trial compleJon •Growing first-in-class drug pipeline •Pharmorage (subsidiary) progressing novel drug development for sepsis and autoimmunity 23 NOXOPHARM LIMITED (ASX:NOX) Develop Deliver Discover For further informa.onemail: [email protected] web: www.noxopharm.com twi]er: @noxopharm

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