DARRT-1 study advancing on basis of positive clinical data

Date: 11 December 2018 Sydney, Australia ASX Limited 20 Bridge Street SYDNEY NSW 2000 DARRT-1 STUDY ADVANCING ON BASIS OF POSITIVE CLINICAL DATA • Trial to enrol final 12 patients at 1200mg dose • Based on positive safety and clinical response data • Next scheduled review late-January 2019 SYDNEY, December 11, 2018: Noxopharm (ASX: NOX) announc es that the Company’s DARRT-1 clinical study has been approved to move to its final stage, with enrollment of the final 12 patients at a Veyonda dosage of 1200 mg. The first stage, now fully enrolled, was a dose -finding study to establish the therapeutic dosage of Veyonda (400, 800 or 1200 mg). A committee comprising 2 independent medical monitors and all study investigators with patients enrolled in the study, reviewed the first 3 dosage cohorts on the basis of the following end- points: Safety: blood chemistry, ECG, adverse events/serious adverse events. Efficacy: scans (RECIST), PSA response, pain scores, Quality of Life (ECOG Score). All 3 dose levels of Veyonda in combination with radiotherapy were well tolerated and without any reported safety issues. Signs of positive clinical responses with the two highest dosages of Veyonda (800 and 1200 mg) included partial responses, declines in PSA greater than 50%, and material reductions in pain scores. Greg van Wyk MD, Noxopharm Chief Medical Officer, said, “ The DARRT program aims to provide meaningful clinical and quality of life benefits for men with end -stage prostate cancer using a treatment regimen that is just 3 weeks long, minimally invasive, and well tolerated. Currently these men have no approved therapy options. And while any assistance for these men would be worthwhile, even if it just to relieve debilitating bone pain, the clinical responses we are seeing already suggests that Veyonda is capable of delivering a considerably greater clinical benefit.” “The DARRT-1 study is meant to inform the design of the Company’s upcoming registration study for Veyonda. End-points acceptable to regulators such as the FDA can range from providing better quality of life via, for example, pain reduction, through to better survival outcomes. We are hopeful of achieving both outcomes, but strategically we want to identify the best end-point that will allow the program to advance as rapidly as possible,” van Wyk said. Patients are reviewed at 6, 12 and 24 weeks post-treatment. The current review was conducted on all Cohort 1, 2 and 3 participants and included some patients who have only reached their 6 week review point. All patients will have completed 12 weeks post-treatment at the end of January 2019 and that data will provide a better view of the depth and durability of the response. Th e Company expects to ASX: NOX Noxopharm Limited ABN 50 608 966 123 Registered Office and Operational Office: Suite 3, Level 4 828 Pacific Highway Gordon NSW 2072 Australia Board of Directors Mr Peter Marks Chairman Non-Executive Director Dr Graham Kelly Chief Executive Officer Managing Director Dr Ian Dixon Non-Executive Director Mr John Moore Non-Executive Director release that data to the market shortly after that. It also plans on submitting that data to a major international cancer conference. The DARRT -1 program is being developed as a potentially transformative approach to the management of men with late -stage, metastatic, castrate -resistant prostate cancer . DARRT-1 trial participants have progressive disease with no remaining standard treatment options. T ypically, such men have bone metastases causing significant pain. The DARRT regimen involves exposing a single tumour (primary or secondary) to a low dose of external beam radiotherapy (approximately one -third of a standard dose) in combination with Veyonda treatment. Veyonda, as a cancer-specific radio-enhancer, aims to boost the cancer-killing effect of the radiation on the exposed tumour(s), at the same time stimulating the patient’s innate immune system (natural killer cells). The objective is to tr igger an immune response that leads to an anti-cancer outcome in both irradiated and non-irradiated tumours throughout the body. The Company anticipates Veyonda entering its final clinical step before the end of next year and currently is making all necessary preparations accordingly. Graham Kelly Ph.D., Noxopharm CEO, said, “An estimated 30,000 men will die of prostate cancer in the US. alone this year, and new treatment approaches desperately are needed. We are taking a dual approach to the use of Veyonda in the treatment of late -stage prostate cancer with our ongoing DARRT and LuPIN programs. Prostate cancer comes in multiple forms depending on which prostate gland cells are involved and the expression of different pro-cancer genes. For that reason, we expect it will be likely that we will end up needing to match one of these two treatments to each situation.” About Veyonda Veyonda (previously known as NOX66) is an innovative dosage formulation of the experimental anti -cancer drug, idronoxil, developed specifically to preserve the anti-cancer activity of idronoxil in the body and to enhance its drug-like behaviour. Idronoxil is a kinase inhibitor that works by inhibiting a range of enzymes, pre -eminent among which is sphingosine kinase, a key regulator of cell pro-survival mechanisms, and which is over-expressed in many cancer cells. Idronoxil also is an immuno -oncology drug, activating the body’s innate immune system e.g. natural killer (NK) cells. About DARRT-1 DARRT stands for Direct and Abscopal Response to RadioTherapy. It involved using Veyonda to increase tumor response to palliative dosages of radiotherapy. The DARRT treatment regimen entails a 5 -day course of radiotherapy (20-30 Gy) in 5 fractionated dosages targeting 1-2 larger tumors, and the Veyonda administered daily for up to 3 weeks. The rationale of DARRT is to combine the radio-enhancing properties of Veyonda that stem from its sphingosine kinase inhibition, with its ability to stimulate the body’s first line immune defense cells against cancer. The clinical outcome being sought is greater shrinkage of irradiated tumors and shrinkage of all non-irradiated tumors (abscopal response). End-points include scans to determine the size and number of lesions (RECIST = Response Evaluation Criteria in Solid Tumors), blood levels of PSA (Prostate Specific Antig en), a 0 -10 Pain Score, and a 0 -5 Quality of Life Performance Score (ECOG = Eastern Cooperative Oncology Performance Status). About Noxopharm Noxopharm is a clinical-stage Australian drug development company with offices in Sydney, Hong Kong and New York. The Company has a primary focus on the development of drugs based on an isoflavonoid chemical structure. Veyonda is the first pipeline product, with 3 other drug candidates for non -oncology indications under development in a subsidiary company (Nyrada Inc). 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 Contact: Allison Blum, Ph.D. LifeSci Public Relations T: +1 516 655 0842 E: [email protected] www.noxopharm.com 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. No representation, warranty or assurance (express or implied) is given or made by Noxo pharm that the forward-looking statements contained in this announcement are accurate and undue reliance should not be placed upon such statements.

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