NOX EGM Chairman's Address and Presentation
2019-09-16 · Noxopharm Limited · original noxopharm.com ↗
Date: 16 September 2019 Sydney, Australia ASX Limited 20 Bridge Street SYDNEY NSW 2000 NOXOPHARM EGM CHAIRMAN’S ADDRESS AND PRESENTATION • Chairman’s Address featuring short-term and medium-term funding strategies ahead of proposed U.S. listing • Presentation detailing clinical strategy in developing Veyonda as a potentially transformative treatment for prostate cancer • Review of LuPIN data released by investigators Sydney, 16 September 2019: Noxopharm Limited (ASX: NOX) (‘ Noxopharm’ or the ‘ Company’) today releases the Chairman’s Address and Presentation for today’s Extraordinary General Meeting. ………………………………………… About Noxopharm Noxopharm is a clinical -stage Australian drug development comp any 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, a spin - off company developing a pipeline of non-oncology drugs. About Veyonda Veyonda (previously known as NOX66) is a suppository dosage formulation of the experimental anti -cancer drug, idronoxil, that l eads in the body to the formation of a proprietary pro -drug form. Idronoxil specifically inhibits the ability of cancer cells to respond to stress, such as that induced by radiation, leading to loss of pro-survival signaling via sphingosine-1-phosphate. Idronoxil is also a STING modulator, activating both the body’s innate and adaptive immune systems. www.noxopharm.com Investor & Corporate Enquiries: Company Secretary: Noxopharm Ltd David Franks T: +61 2 9144 2223 T: +61 2 9299 9690 E: [email protected] E: [email protected] Media Contact USA: Media Contact Australia Frank de Maria Marianne Gould Purposeful Communications Noxopharm Ltd T: +1 347 647 0284 T: +61 429 216 194 E: [email protected] E: [email protected] 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 o f 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. No representation, warranty or assurance (express or implied) is given or made by Noxopharm that the forward-looking statements contained in this announcement are accurate and undue reliance should not be placed upon such statements. Chairman’s Address This EGM has been called to seek shareholder approval to provide the company with further funding capacity with a facility with a potential total value of A$26 million. I am going to focus in this address on 3 major topics. The first is the short- and medium-term funding strategies adopted by the Board. The second is about a change in Board remuneration. The third is about some clinical data involving Veyonda that has be en made public in recent days and which we need to provide some commentary on. Let me start with the obvious question of why we need funding. Noxopharm has on its hands what it believes to be a potentially transformative anti-cancer drug in Veyonda and it wants to add value to this drug candidate as quickly and as cost-effectively as possible. Drug development is expensive. The only way to not be expensive is to be unsuccessful. We have achieved significant progress to date with remarkably little funding when you consider the cost of bringing a new drug through to the market . Taking Veyonda to the next level of clinical testing means larger, more extensive and more expensive clinical studies. The cost of these programs, plus the general cost of running a growing business, we estimate will cost at least A$40-50 million over the next two years. If we have ongoing success, potentially propelling the drug candidate into a registration study, there may be more costs involved. The Board has given considerable thought as to how to fund that growth. A key part of the strategy is to seek to dual list the Company on a U.S. securities exchange in the first half of 2020. The logistics of this are well advanced and we expect to be able to inform shareholders more about this process in the coming months. A dual listing offers a number of positives. The first is that U.S. capital market participants are very familiar with the cost and timelines involved in drug development , backed up by strong market research capabilities . They are adept at placing a value on opportunit ies and they are good at recognising that a return on investment is a stepwise process over the 8-10 years it generally takes to bring a drug through the clinic to market. All of these feed into achieving what the Board believes is recognition of the true value of the Company’s opportunity. That’s how we plan to address the medium-term funding situation. Today’s meeting is about the short-term situation and how we intend to fund the Company up until a U.S. listing and IPO. And I refer everyone to the July 19, 2019 ASX announcement for the key details of this funding facility. I want to emphasise that if at any stage the Board believes it is in the best interests of the Company to vary this bridging financing arrangement, then it will do so. We last raised capital 16 months ago. Since then, and prior to the current funding facility, the share price has undergone considerable movement. While we share some of the concern our shareholders may feel around these movements as we are also shareholders, t he Board and management are not driven by movements in the share price to the extent that they are outside our control. Our focus is on bringing Veyonda through its development program. Some matters we can control, such as engaging the best medical advisors we can find in Australia and the U.S. to help steer our clinical program, ensuring we bring news of that program to the market as quickly as possible, and investing time and money in investor relations activities on the back of key developments. My second topic is some thing we can do as a Board to demonstrate our confidence in the Company’s future , and that is pegging Board remuneration to the Company’s market capitalisation. Apart from preserving cash, this puts the Board on an equal footing with shareholders in terms of the fortunes of the Compan y. This change has been acted on immediately with a substantial cut in remuneration packages and I will have more to say about this ahead of our upcoming AGM. Finally, to the third topic – the matter of clinical data. We originally scheduled two key clini cal data reports for later this year. The first is the 6 -month data from the second arm of DARRT -1. This data will reveal the depth and durability of the anti -cancer effect of a combination of Veyonda and external beam radiotherapy in late-stage prostate cancer. The DARRT program is our leading clinical program, so that data will be important. That is due late-November. The second data report concerns the LuPIN study. This is an important Investigator -Initiated Study being conducted at St Vincent’s Hospital, Sydney. The Company’s involvement is to provide Veyonda along with some contributory funding. LuPIN involves treating 56 men with late-stage prostate cancer with a combination of Veyonda plus the experimental radiopharmaceutical drug, 177lutetium-PSMA-617. The purpose of the Study is to see if Veyonda can increase the clinical response rate to 177lutetium-PSMA-617, an emerging new treatment for late -stage prostate cancer. This study is expected to provide a final read-out in late-2020. The Hospital previously has reported on the clinical outcome of their patients treated with 177lutetium-PSMA-617 alone or in comb ination with Veyonda ; these have been separate reports. The investigators recently combined the two sets of data to provide a comparison and this was accepted for presentation at a conference in mid-November 2019. There is nothing new in these two sets of data; the novelty being in putting them together into the one report. We had been informed that this data would not be made public until early -November, but w e have discovered in the last 24 hours that it has in fact been made public, which means we will need to issue a clarifying statement within the next 24 hours. In the meantime, and with the data now public, we can report what was apparent to anyone familiar with the two sets of data that the combination treatment has had a significantly better clinica l response compared to 177lutetium- PSMA-617 alone. This, and other ongoing work, is what underwrites the Board’s excitement about the Company’s future. We have a drug candidate that we believe continues to prove to have what it takes to be a major new immuno-oncology drug. We also believe we have the right team to bring it through its clinical program. In addition, we have a proposed dual Australia-U.S. listing to help raise the Company’s profile, and we have secured the necessary short-term funding to see us to that point. Something like only 1 in 9 drugs that enter the clinic in the U.S. go on to receive FDA approval. The further we go with Veyonda , the more confident we are that Veyonda is poised to join that elite club. The fundamentals of the Company remain strong and we look forward to bringing you progress reports as we can, starting with what we regard as key clinical milestones in November this year. I also want to point out that we are close to seeing our U.S.-registered subsidiary company, Nyrada Inc, being offered to the public. Noxopharm will be a majority shareholder in Nyrada . Which was the whole point in creating Nyrada in order to crystallise some meaningful value for Noxopharm and its shareholders in non-oncology IP. Thank you for your time, and I commend today’s resolutions to you. Yours sincerely Graham Kelly Executive Chairman © 2019 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 September 2019 Extraordinary General Meeting © 2019 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 the 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 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. © 2019 Noxopharm Ltd. All rights reserved. The Opportunity © 2019 Noxopharm Ltd. All rights reserved. According to Australian and U.S. Govt sources: • 1 in 7 men will be diagnosed with PC by age 85 • New cases annually 19,000 (Aust) 175,000 (U.S.) • Deaths from prostate cancer annually 3,300 (Aust) 31,000 (U.S.) The Opportunity for Veyonda®* in the management of prostate cancer is huge * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval © 2019 Noxopharm Ltd. All rights reserved. Stage I The cancer is small and confined to the prostate. Stage II The cancer is still confined to the prostate but is large enough to be detected by physical examination. Stage IV The cancer has spread locally and to distant organs and bones. Stage III The cancer has spread beyond the prostate into the pelvis (bladder, rectum, lymph nodes). Prostate Cancer – four main stages © 2019 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 phase death Prostate Cancer Treatment Options Rising PSA & © 2019 Noxopharm Ltd. All rights reserved. Hormone-sensitive Hormone-refractory Non-metastatic Metastatic Palliative therapy phase death Proposed Uses of Veyonda®* LuPIN DARRT DARRT Rising PSA * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval Aim is to use a combination of radiation and drug to restore the ability of the immune system to fight the cancer. At the very least seeking to convert an aggressive cancer into a chronic, slower- growing disease. At most, complete remission. © 2019 Noxopharm Ltd. All rights reserved. Veyonda®️ DARRT © 2019 Noxopharm Ltd. All rights reserved. Hormone-sensitive Hormone-refractory Non-metastatic Metastatic Palliative therapy phase death Proposed Uses of Veyonda®* DARRT Rising PSA * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval © 2019 Noxopharm Ltd. All rights reserved. Characteristics of late-stage, metastatic, castrate-resistant prostate cancer (mCRPC) • Progressive disease • Rising PSA levels • Significant and increasing pain from bone secondaries • Rising opioid use • Poor quality of life • Small (5-9%) PSA response (>50% decline) with palliative RT alone • 30% 5-year survival rate • Expected survival < 12 months DARRT – Late-stage cancer What would the Company, patients, doctors and regulators be likely to regard as a worthwhile treatment in late-stage mCRPC? Delivering in a significant number of men: • PSA response (> 50% decline) • No disease progression over 6 months • Reduction in pain (> 30% decline) • Improved quality of life • Increased overall tumour response © 2019 Noxopharm Ltd. All rights reserved. Part A (Dose-finding: 400/800/1200 mg) 14 patients 6 months FINAL • 5/14 (36%) with PSA response at any time • 8/14 (57%) no tumour progression at 6 months • 6/14 (43%) with pain reduction (>30%) and 2/14 pain-free at 6 months Part B (Dose-expansion: 1200 mg) 11 patients 3 months INTERIM • 6/11 (55%) PSA response rate* * 6-month data expected late-Nov 2019 DARRT-1 Clinical data to date highly encouraging NB. Combination of Veyonda®️* + low-dose EBRT well-tolerated * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval © 2019 Noxopharm Ltd. All rights reserved. Hormone-sensitive Hormone-refractory Non-metastatic Metastatic Palliative therapy phase death Proposed Uses of Veyonda®* DARRT Rising PSA * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval © 2019 Noxopharm Ltd. All rights reserved. • Short courses of Veyonda®️* • Veyonda®️ self-administered • Short course of radiotherapy • Well-tolerated combination treatment • No in-patient hospitalization required Potential benefits for early- stage prostate cancer: • Lower dosage of radiation less damaging to bowel and bladder (lower rates of infection and treatment- generated cancers) • Delay or abrogate need for hormone therapy (feminization of men, loss of libido) DARRT – Early-stage cancer * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval © 2019 Noxopharm Ltd. All rights reserved. Veyonda®️ LuPIN © 2019 Noxopharm Ltd. All rights reserved. Hormone-sensitive Hormone-refractory Non-metastatic Metastatic Palliative therapy phase death Proposed Uses of Veyonda®*Rising PSA * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval LuPIN © 2019 Noxopharm Ltd. All rights reserved. Seeking to show that combination versus 177Lutetium-PSMA-617 alone leads to a significant increase in ….. • PSA responses (> 50% decline) • Progression-free survival • ability to complete at least 4 treatment cycles • pain responses and quality of life • overall survival LuPIN - 177Lutetium-PSMA-617 + Veyonda®* Interim data (July 2019) Dose-finding: 400/800mg 16 patients • 10/16 (69%) PSA rate overall • 9/16 (56%) completed 6 cycles • 13/16 (93%) overall survival at 6 months • 10/16 (81%) overall survival at 12 months * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval © 2019 Noxopharm Ltd. All rights reserved. Outlook and Next Steps © 2019 Noxopharm Ltd. All rights reserved. DARRT-1 Upcoming clinical data reports Upcoming Results 6-month, cohort 4: 1200 mg Veyonda®️* (11 patients) • PSA response rate • Pain response rate • Progression-free survival • Overall tumour response (RECIST) * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval Data expected late-November 2019 © 2019 Noxopharm Ltd. All rights reserved. Upcoming clinical data reports LuPIN 177Lu-PSMA-617 alone vs 177Lu-PSMA-617 + Veyonda® Upcoming Results * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval Comparison of two previously published sets of data: 177Lu-PSMA-617 alone https://www.ncbi.nlm.nih.gov/pubmed/30425003 177Lu-PSMA-617 + Veyonda https://www.noxopharm.com/site/PDF/2007_4/Conference HearsofPositiveInterimDatafromLuPINTrial © 2019 Noxopharm Ltd. All rights reserved. LuPIN - 177Lutetium-PSMA-617 + Veyonda®* 177lut-PSMA alone 177lut-PSMA + Veyonda®️ No. patients 14 16 Median PSA (ng/ml) 88 147 PSA response (>50% fall) 36% 69% PFS (months) 2.0 8.4 Complete 4 cycles 21% 69% No significant adverse treatment-related events reported * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval Accepted for presentation at the 46th Annual Scientific Meeting of the Clinical Oncology Society of Australia 12-14 November 2019 Ardolino L et al. 177Lu-PSMA-617 as monotherapy or in combination with NOX66 for the treatment of men with late- stage metastatic castrate resistant prostate cancer (mCRPC): An exploratory analysis. (66985) © 2019 Noxopharm Ltd. All rights reserved. DARRT Early-stage, hormone- sensitive prostate cancer Late-stage metastatic, castration- resistant prostate cancer Multi-centre, multi-national, randomised controlled study Veyonda®* + palliative EBRT versus palliative RT alone Phase 1 study First-line therapy Veyonda ®* + RT LuPIN Completion of current Phase 2 study The Veyonda® Radiotherapy Program Late-stage metastatic, castration- resistant prostate cancer * Veyonda®️ (NOX66/idronoxil) has yet to receive marketing approval DARRT © 2019 Noxopharm Ltd. All rights reserved. Managing the Opportunity © 2019 Noxopharm Ltd. All rights reserved. Proposed dual U.S. listing H1 2020 + IPO to raise funding for extensive clinical trial program Flexible funding facility (bridging finance arrangement) in place until U.S. IPO, with ability to change Major PR/IR effort planned for U.S. Q4 2019 and Q1 2020 around Nov 2019 clinical data Managing the Opportunity Putting an experienced team in place, both at executive and Board level Having experienced advisors, both CRO and Medical Advisory Boards (both Australian and U.S.) © 2019 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 www.noxopharm.com
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