New Risk • Apr 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$7.3m free cash flow). Negative equity (-AU$1.1m). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Revenue is less than US$5m (AU$3.4m revenue, or US$2.4m). Market cap is less than US$100m (AU$23.4m market cap, or US$16.7m). New Risk • Mar 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$7.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$7.3m free cash flow). Negative equity (-AU$1.1m). Minor Risks Revenue is less than US$5m (AU$2.7m revenue, or US$1.9m). Market cap is less than US$100m (AU$20.3m market cap, or US$14.4m). New Risk • Jan 30
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 1.6% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$2.8m revenue, or US$2.0m). Market cap is less than US$100m (AU$22.5m market cap, or US$15.9m). Announcement • Dec 13
Noxopharm Limited announced that it has received AUD 1.25 million in funding Noxopharm Limited announced a private placement that it has issued 1,250,000 convertible notes of the company to 4F Investments Pty Limited at an issue price of AUD 1 for the gross proceeds of up to AUD 1,250,000 on December 12, 2025. It attracts an interest rate of 12% capitalized until the date it is fully repaid or converted into shares. Expiring on 2 January 2027, the note has a conversion price of AUD 0.0992 or a lower price if the company undertakes a capital raise at any time before the expiry date. The note has a conversion floor price of AUD 0.07. Announcement • Oct 14
Noxopharm Limited, Annual General Meeting, Nov 18, 2025 Noxopharm Limited, Annual General Meeting, Nov 18, 2025. Location: a physical meeting, at level 5, 126 phillip street, nsw 2000, sydney Australia New Risk • Jul 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$4.1m free cash flow). Earnings have declined by 4.6% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Revenue is less than US$5m (AU$2.3m revenue, or US$1.5m). Market cap is less than US$100m (AU$18.1m market cap, or US$11.8m). New Risk • Jun 23
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.9m (US$9.51m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$4.1m free cash flow). Earnings have declined by 4.6% per year over the past 5 years. Market cap is less than US$10m (AU$14.9m market cap, or US$9.51m). Minor Risk Revenue is less than US$5m (AU$2.3m revenue, or US$1.5m). New Risk • Feb 26
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$4.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$4.1m free cash flow). Earnings have declined by 4.6% per year over the past 5 years. Minor Risks Revenue is less than US$5m (AU$3.7m revenue, or US$2.3m). Market cap is less than US$100m (AU$27.2m market cap, or US$17.2m). New Risk • Nov 14
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 9.5% per year over the past 5 years. Minor Risks Revenue is less than US$5m (AU$2.4m revenue, or US$1.6m). Market cap is less than US$100m (AU$35.1m market cap, or US$22.7m). Announcement • Oct 14
Noxopharm Limited, Annual General Meeting, Nov 19, 2024 Noxopharm Limited, Annual General Meeting, Nov 19, 2024. Location: at level 5, 126 phillip street, sydney nsw 2000., sydney Australia New Risk • Aug 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.1m free cash flow). Earnings have declined by 14% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Revenue is less than US$5m (AU$3.9m revenue, or US$2.6m). Market cap is less than US$100m (AU$27.2m market cap, or US$18.0m). New Risk • Feb 01
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.9m (US$9.72m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$11m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 6.7% per year over the past 5 years. Market cap is less than US$10m (AU$14.9m market cap, or US$9.72m). Minor Risk Revenue is less than US$5m (AU$6.0m revenue, or US$3.9m). New Risk • Oct 05
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 26% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$11m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings have declined by 6.7% per year over the past 5 years. Market cap is less than US$10m (AU$12.3m market cap, or US$7.77m). Minor Risk Revenue is less than US$5m (AU$6.0m revenue, or US$3.8m). New Risk • Sep 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$11m free cash flow). Earnings have declined by 6.7% per year over the past 5 years. Market cap is less than US$10m (AU$10.5m market cap, or US$6.82m). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Revenue is less than US$5m (AU$1.6m revenue, or US$1.1m). Announcement • Aug 31
Noxopharm Limited, Annual General Meeting, Nov 16, 2023 Noxopharm Limited, Annual General Meeting, Nov 16, 2023, at 13:00 AUS Eastern Standard Time. New Risk • Aug 27
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Market cap is less than US$10m (AU$11.1m market cap, or US$7.12m). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Share price has been volatile over the past 3 months (15% average weekly change). Revenue is less than US$5m (AU$7.0m revenue, or US$4.5m). Recent Insider Transactions • May 05
Non-Executive Chairman recently bought AU$50k worth of stock On the 4th of May, Frederick Bart bought around 1m shares on-market at roughly AU$0.05 per share. This transaction amounted to 18% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Frederick's only on-market trade for the last 12 months. Announcement • Jan 17
Noxopharm Limited Reviews Safety Data from the Third Cohort of Patients from the Dose Escalation Part of the DARRT-2 Trial Noxopharm Limited announced the DARRT-2 Safety Steering Committee has reviewed safety data from the third cohort of patients from the dose escalation part of the DARRT-2 trial. The DARRT-2 Phase 2 trial is evaluating Noxopharm's clinical drug candidate Veyonda® in combination with low-dose external beam radiotherapy with a focus on the treatment of prostate cancer. The third cohort of patients was treated with a 1600 mg dose, which was found to be safe. This means that no further dose escalations will occur and the trial can soon progress into Part 2, which will evaluate efficacy signals while safety data continues to be collected. Pending some protocol requirements, Part 2 is expected to begin in late First Quarter or early Second Quarter this year. Announcement • Dec 06
Noxopharm Limited Announces Award of Federal Innovation Connections Grant Noxopharm Limited has been awarded an Innovation Connections grant for $50,000, to part fund research into new therapies for the treatment of inflammatory diseases. Innovation Connections is a service delivered by CSIRO as part of the Australian Government's Entrepreneurs' Programme, which drives business growth and competitiveness by supporting business improvement and research collaboration in targeted growth sectors, and the commercialisation of novel products, processes and services. The non-dilutive funding, alongside a company contribution, will fully fund the work of a postdoctoral medicinal chemist, under the supervision of Professor Naresh Kumar at the UNSW Sydney campus, to synthesise novel drug candidates and optimise their design. This activity will deepen Noxopharm's relationship with the UNSW team and complement other work already underway. The grant is the third recently awarded to Noxopharm, and reflects the company's strategy of seeking non-dilutive grant funding that supports its pipeline while validating its scientific approach and partnerships with leading research institutions. Announcement • Nov 17
Noxopharm Limited Announces CEP-2 Safety Milestone Shows Veyonda Progress Noxopharm Limited announced the CEP-2 Safety Steering Committee has reviewed the safety data from the second cohort of patients in the trial. The 1,200 mg dose was found to be safe and well tolerated, allowing enrolment to continue with the next patient cohort to be treated with an increased Veyonda® dose of 1,800 mg. This will be the last dose cohort for the safety phase of this study, and if tolerated satisfactorily, will pave the way for the efficacy phase to begin. The CEP-2 Phase 1 trial is evaluating Noxopharm's clinical drug candidate Veyonda in combination with the chemotherapy drug doxorubicin as a first-line treatment of soft tissue sarcoma. In order to speed up patient enrolment, two new sites have also been added to the trial, which is underway in several prestigious hospitals in the US. Northwestern University in Illinois and the Medical College of Wisconsin join other prominent names already participating in the trial, including the City of Hope Cancer Center in Los Angeles, Mayo Clinic (Minnesota and Florida sites), and Washington University in St. Louis. Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Non-Executive Chairman Fred Bart was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Oct 27
Insider recently sold AU$278k worth of stock On the 18th of October, Graham Kelly sold around 1m shares on-market at roughly AU$0.20 per share. This transaction amounted to 3.9% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Announcement • Sep 19
Noxopharm Limited Announces Resignation of Dr. Graham Kelly as Non-Executive Director, Effective 20 September 2022 Noxopharm Limited announced Dr. Graham Kelly's resignation as a non-executive director, effective 20 September 2022. Reported Earnings • Aug 26
Full year 2022 earnings released: AU$0.064 loss per share (vs AU$0.035 loss in FY 2021) Full year 2022 results: AU$0.064 loss per share (down from AU$0.035 loss in FY 2021). Net loss: AU$18.7m (loss widened 100% from FY 2021). Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings. Announcement • Aug 25
Noxopharm Limited, Annual General Meeting, Nov 17, 2022 Noxopharm Limited, Annual General Meeting, Nov 17, 2022, at 13:00 AUS Eastern Standard Time. Announcement • Aug 10
Noxopharm Limited Reviews the Safety Data from the First Cohort of Patients in the Trial Noxopharm Limited reviewed the safety data from the first cohort of patients in the trial. The 800 mg dose was found to be safe and well tolerated, allowing enrolment to continue with the next patient cohort to be treated with an increased Veyonda® dose of 1200 mg. The CEP-2 Phase 1 trial is evaluating Noxopharm's clinical drug candidate Veyonda® in combination with the chemotherapy drug doxorubicin as a first-line treatment of soft tissue sarcoma. The trial is underway in several prestigious hospitals in the US, including the world-renowned Mayo Clinic. CEP-2 is a Phase 1, open-label, dose-escalation and dose-expansion study of Veyonda® administered to cohorts of patients being treated with doxorubicin for the treatment of metastatic soft tissue sarcoma. Approximately 30 patients in the United States with a range of soft tissue sarcomas are being enrolled to be treated with the Veyonda /doxorubicin combination as a first-line treatment. A number of top-ranked US sites are participating in CEP-2 which include the City of Hope Cancer Center in Los Angeles, the Mayo Clinic with its two campuses, the original hospital in Rochester, Minnesota, and the campus in Florida, and Washington University in St. Louis. Soft tissue sarcomas are generally very aggressive cancers. Up to 50% of high-grade sarcoma patients develop metastases and die within 12 months. They are defined as a rare cancer, with fewer than 20,000 new cases diagnosed in the US in 2021. The CEP-Program is based on preclinical and clinical findings of Veyonda enhancing the anti-cancer effect of a number of standard chemotherapeutic agents. The findings from the CEP-1 clinical trial have been published in Current Therapeutic Research in April 2021. Veyonda has been granted US FDA Orphan Drug Designation (ODD) for the treatment of sarcoma. This confers a period of market exclusivity and a number of financial and regulatory benefits. Announcement • Aug 02
Noxopharm Limited Announces DARRT-2 Trial Safety Milestone and European Site Activated Noxopharm Limited announced the DARRT-2 Safety Steering Committee has reviewed the safety data from the second cohort of patients from the dose escalation part of the DARRT-2 trial. The dose was found to be safe and well tolerated, enabling the trial to advance to enrol patients into a third cohort with an increased dose level. The DARRT-2 Phase 2 trial is evaluating Noxopharm's clinical drug candidate Veyonda in combination with external beam radiotherapy for the treatment of prostate, breast and lung cancer. The second dose cohort of patients in the trial was treated with 1200 mg of Veyonda, and the dose was found to be safe and well tolerated. Approval has been given to progress the study, and therefore treatment of the third cohort of patients with a 1600 mg dose of Veyonda will now commence. Additionally, a new DARRT-2 trial site in Hungary is now active and will soon begin enrolling patients. The DARRT-2 trial has been authorised to proceed by major regulatory bodies in the US, Europe and Australia, and is now open for enrolment across three continents. The Hungarian site joins, among others, two prestigious hospitals in the US; the Beverly Hills Cancer Center in Los Angeles, and the renowned MD Anderson Cancer Center in Houston. Announcement • Jul 05
Noxopharm Limited Announces Mayo Clinic and Washington University Join Its Sarcoma Trial Noxopharm Limited announced the addition of three US sites for its CEP-2 sarcoma study; Washington University in St Louis and two Mayo Clinic sites in Florida and Minnesota. Mayo Clinic is one of the world's best-known medical providers, caring for more than 1.3 million US and visiting international patients every year. Its Rochester site in Minnesota was recently named the best hospital in the US in 2021-2022 by US News & World Report and is also in its top three for cancer care. Washington University's School of Medicine in St. Louis is a leader in medical research, teaching and patient care, and is one of the largest recipients of funding from the US National Institutes of Health (NIH) for research and training. The participation of Mayo Clinic and Washington University in the trial reinforces Noxopharm's ability to attract leading medical researchers, as the company continues its science-driven strategy of advancing its most promising therapies to key value inflection points. The three new sites are in addition to the City of Hope Cancer Center, another of the top ranked cancer hospitals in the US, which is currently treating patients with Veyonda and doxorubicin for metastatic soft tissue sarcoma. The Phase 1 CEP-2 trial builds on the findings from CEP-1, as published in the peer-reviewed journal Current Therapeutic Research. Additionally, Orphan Drug Designation has been granted by the US FDA for the use of Veyonda in the treatment of sarcoma. Noxopharm will keep the market updated as the trial progresses. Announcement • May 28
Veyonda Abstract Published at ASCO Annual Meeting 2022 Noxopharm Limited announced that the prestigious ASCO (American Society of Clinical Oncology) Annual Meeting 2022 has published an abstract summarising scientific research related to idronoxil, the active ingredient in Noxopharm's lead drug candidate Veyonda®. The research was conducted at The University of Hong Kong and focused on nasopharyngeal carcinoma, a cancer that is common in Southern China. The study examined the effect of idronoxil in combination with standard chemotherapy drug cisplatin on cell lines established from human nasopharyngeal tumours and in animal models of that cancer type. The findings confirmed that using idronoxil in combination with cisplatin could change the tumour environment, allowing a larger number of immune cells to infiltrate the tumours compared to the control. The level of immune cell infiltration, measured as the number of immune cells in the tumour vs blood, increased significantly by 67% in the combination treatment compared to the control group. Turning `cold' tumours to `hot' by enabling the immune cells to reach the tumour cells, is an important objective in current cancer therapy developments as it can increase the anti-cancer effect of commonly used cancer drugs. These results further validate the rationale behind Noxopharm's clinical trials CEP-2 and IONIC which are currently ongoing in the USA and Australia. The full study is currently being written up and will be submitted to a highly ranked peer-reviewed scientific journal for publication. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Non-Executive Chairman Fred Bart was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Mar 30
FDA Grants Orphan Drug Designation to Noxopharm for Sarcoma Treatment Noxopharm has announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Veyonda®, its lead oncology drug candidate, for use in the treatment of soft tissue sarcoma. The ODD program was established by the FDA to encourage development of safe and effective treatments of rare diseases and disorders that affect fewer than 200,000 people in the U.S. annually. Soft tissue sarcomas are rare but often fatal cancers — up to 50% of high-grade sarcoma patients develop metastases and die within 12 months. Noxopharmrecently began its Phase 1 CEP-2 trial [4] at City of Hope in Los Angeles for Veyonda, in combination with the chemotherapy drug doxorubicin, for first-line treatment of soft tissue sarcoma. The ODD program provides a number of significant benefits, including: A seven-year period of market exclusivity — the FDA will not approve a subsequent drug for the same use within this timeframe; Waiver of new drug application fees, valued at approximately $2.9 million in 2021; Opportunities for grant funding from the Office of Orphan Products Development; Regulatory guidance and assistance from the FDA for the drug development process. Announcement • Mar 10
Noxopharm Limited Announces Phase 1 CEP-2 Sarcoma Trial is Underway with a First Patient Enrolled and Dosed At City of Hope in Los Angeles, California Noxopharm has announced its Phase 1 CEP-2 sarcoma trial is underway with a first patient enrolled and dosed at City of Hope in Los Angeles, California. City of Hope, a world-renowned cancer center in the U.S., is the first site to commence treatment, but recruitment is ongoing and Noxopharm plans to open future major U.S. trial sites. The first safety results for the CEP-2 study will be available after patient cohort 1 has completed the first cycle of combination therapy. The CEP-2 study is building on the CEP-1 study, which was a Phase 1a/1b trial that was published in April 2021 in the peer-reviewed journal Current Therapeutic Research, and showed the success of Veyonda in boosting the efficacy and safety of chemotherapy in late-stage cancer patients. Announcement • Mar 01
Noxopharm Limited Announces First Patient Dosed in CEP-2 Sarcoma Trial at the US City of Hope Cancer Center Noxopharm Limited announced the first patient in its phase 1 CEP-2 trial has been enrolled and dosed at the City of Hope Cancer Center, California. Patient recruitment is ongoing, and the Company expects to open further US trial sites in due course. The first safety results will be reported once patient cohort 1 has completed the first cycle of combination therapy. The City of Hope Cancer Center is an influential medical institution and is considered one of the most world-renowned cancer hospitals in the USA according to the US News & World Report. It is consistently ranked as a top cancer treatment centre in the US and is also a founding member of the National Comprehensive Cancer Network, a non-profit alliance of 21 US cancer centres that publishes clinical practice guidelines for cancer treatment. The CEP-2 study builds on the findings from CEP-1, as published in the peer-reviewed journal Current Therapeutic Research (announced 30 April 2021). Reported Earnings • Feb 24
First half 2022 earnings: Revenues and EPS in line with analyst expectations First half 2022 results: AU$0.03 loss per share (up from AU$0.031 loss in 1H 2021). Net loss: AU$8.61m (loss widened 28% from 1H 2021). Revenue was in line with analyst estimates. Over the last 3 years on average, earnings per share has increased by 55% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Announcement • Sep 27
Noxopharm Limited Announces Veyonda Achieves Important U.S. Patent Claims Noxopharm Limited announced that the U.S. Patent Office has allowed patent claims relating to the use of a combination of Veyonda and radiotherapy, including external beam radiotherapy (EBRT), with the purpose of generating abscopal responses in patients with metastatic prostate cancer. These claims are fundamental to helping secure the commercial success of the Company's DARRT (Direct and Abscopal Response to Radiotherapy) therapy involving a combination of Veyonda and low-dose EBRT. DARRT therapy is a form of immuno-oncology treatment. It involves the delivery of a short course of a low dose of radiotherapy to a single tumour in the body of a patient with metastatic disease. The aim is to trigger a local immune response in the irradiated tumour that spills over into an all-of-body immune response resulting in the resolution of all (complete response) or some (partial response) of the other tumours in the body. Most solid cancers, including the common prostate, breast and colorectal cancers, have proved to be overwhelmingly resistant to immuno-oncology (IO) treatments to date. This includes immunecheckpoint inhibitors and CAR-T cell therapy. Against that background, the Company's DARRT-1 study already has delivered a 25% partial abscopal response rate in men with late-stage prostate cancer (ASX announcement 1 June 2020), something that the Company is confident can be repeated in other forms of solid cancer. Compared to current IO treatments, the abscopal response is substantially better tolerated, potentially effective across a broader spectrum of cancer types, considerably more affordable, and more accessible. However, the challenge remains developing a method of lifting the abscopal response rate to a level where it will be accepted as a mainstream treatment. Idronoxil, the active ingredient in Veyonda, meets two putative key prerequisites for an abscopal response: i. the need to augment the local radiation-induced immune response by blocking autophagic clearance of mitochondrial DNA fragments following irradiation (ASX announcement 13 November 2020); ii. the need to facilitate the entry of activated immune cells into non-irradiated tumours (the so-called COLD to HOT tumour effect) (ASX announcement 18 November 2020). Compared to the DARRT-1 trial, patients in the multi-national Phase 2 DARRT-2 trial will receive considerably higher Veyonda doses as well as an increased number of Veyonda treatment cycles. DARRT-2 currently is preparing to enrol patients with late-stage prostate, breast and lung cancer. The patent application number is US 16/091706 and will be in force until at least 6 April 2037. This is just the seventh known patent issued by the U.S. Patent Office in the field of abscopal responses. Only two of the other six patents cite clinical examples, and none of those six patents involve technologies related in any way to the Noxopharm patent. The significance of patent grant lies in providing Noxopharm with an exclusive market position in the U.S. should the DARRT treatment of Veyonda plus low-dose radiotherapy be approved for use in the treatment of prostate cancers. While the Company's initial focus is on the use of DARRT therapy in late-stage prostate cancer, the Company sees the DARRT concept potentially applicable to early-stage disease where radiotherapy remains a standard form of treatment. With approximately 250,000 men diagnosed each year in the U.S. with prostate cancer, it is understandable that deals for new prostate cancer treatments in recent years have included multi-billion dollar corporate transactions. Announcement • Aug 27
Noxopharm Announces Preclinical Data Further Supports Anti-Inflammatory Role of Idronoxil in the Treatment of COVID-19 Noxopharm has reported preclinical data that further supports the role of experimental anti-cancer drug, idronoxil, the active ingredient in Veyonda, as an anti-inflammatory drug for early-stage COVID-19 treatments. A recent preclinical trial, conducted in partnership with Australia’s Hudson Institute of Medical Research (Hudson Institute), has identified that idronoxil inhibits the enzyme, TANK-binding kinase 1 (TBK1), an action that potentially dampens the inflammatory response causing the progression of COVID-19 disease from mild-to-severe, but not compromising the body’s ability to fight the virus. These preclinical findings support preliminary top-line positive results the company shared earlier from its NOXCOVID Phase I clinical trial, which tested the suitability of idronoxil (Veyonda) as an effective anti-inflammatory in patients hospitalized with moderate COVID-19 disease. One particular relevance of TBK1 as a drug target is its role in responding to infections from RNA viruses including the respiratory RNA viruses - coronaviruses, influenza virus and respiratory syncytial virus. Reported Earnings • Aug 27
Full year 2021 earnings released: AU$0.035 loss per share (vs AU$0.002 loss in FY 2020) The company reported a mediocre full year result with increased losses and weaker control over costs, although revenues improved. Full year 2021 results: Revenue: AU$14.6m (up 75% from FY 2020). Net loss: AU$9.35m (loss widened AU$9.07m from FY 2020). Over the last 3 years on average, earnings per share has increased by 69% per year but the company’s share price has fallen by 4% per year, which means it is significantly lagging earnings. Announcement • Aug 26
Noxopharm Phase I Clinical Trial Shows Anti-Inflammatory Response in COVID-19 Patients Noxopharm has released preliminary top-line data from its NOXCOVID Phase I clinical trial testing the suitability of idronoxil (Veyonda), a TBK1 (TANK-binding kinase 1) inhibitor, as an anti-inflammatory in patients with moderate COVID-19 disease. Based on initial positive results, Noxopharm has started discussions to add Veyonda to one of the global clinical trial programs looking at identifying effective anti-inflammatory therapies in COVID-19 disease. The relevance of blocking TBK1 is seen as important in two respects: ability to block a dysfunctional immune response to RNA viruses such as coronavirus and influenza virus; potential to avoid the adverse immune-suppressing effects of standard anti-inflammatory drugs such as prednisone and dexamethasone in potentially slowing viral clearance and increasing the risk of secondary infections. Announcement • Aug 24
Noxopharm Limited Releases Preliminary Top Line Data of Its NOXCOVID Phase 1 Clinical Trial Noxopharm Limited released preliminary top line data of its NOXCOVID phase 1 clinical trial. The Company cautions that the preliminary data released is top-line only and has been released for the purpose of allowing the Company to speak openly with health authorities. The full data continues to be analysed and is expected to be released in several weeks. The role being proposed for Veyonda is an anti-inflammatory drug that does not compromise the ability of the body to fight coronavirus infection. Over 90% of individuals infected with the SARS-CoV-2 virus recover from the infection with non-critical symptoms. Those patients who do go on to develop critical symptoms, in many cases do so because of an excessive inflammatory response to viral-induced damage in the lungs and other organs.1,2 This hyper-inflammation can go on to trigger widespread inflammation of the lining of blood vessels, disseminated coagulation, septic shock and multi-organ failure. This has led to standard anti-inflammatory drugs such as prednisone and dexamethasone becoming standard of care in the management of hospitalised COVID-19 patients.5 However, the appropriateness of these drugs in less severe cases remains a point of concern given their immune-suppressing effects, potentially slowing the clearance of the virus from the lungs and increasing the risk of secondary infections from bacteria and other viruses. The unique mechanism of action of idronoxil points to an anti-inflammatory action while still preserving the body's ability to fight the virus, potentially making it a suitable anti-inflammatory in patients with early or moderate COVID-19 disease. On the basis of the data, Noxopharm, in partnership with Hudson Institute of Medical Research (`Hudson Institute'), now will seek to have Veyonda join one or more of the platform programs being conducted globally looking to identify a basket of treatments for COVID-19 disease. These global clinical studies are being undertaken as a matter of urgency in the expectation that new variants may challenge the protection offered by current vaccines, potentially returning the world to an emergency situation where hospital services are under stress. Noxopharm is unaware of any drugs with a similar purpose to that of Veyonda being tested in those studies. Following this phase 1 study, it will be important to test the effects of Veyonda in a larger randomised controlled study. The lack of any safety concerns with Veyonda in COVID-19 patients, plus its self-administration, leads Noxopharm to see Veyonda holding promise in at least 2 clinical scenarios: treating patients with moderate disease who are admitted to hospital, and treating patients with milder disease on an out-patient basis to avoid hospitalization. Announcement • Jul 02
Noxopharm Limited's DARRT-2 Study Receives IND Approval from FDA Noxopharm Limited announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval to the DARRT-2 study, allowing the study to start in the U.S. DARRT-2 is a multi-national clinical study being conducted in up to 15 sites across Australia, France, Hungary and the U.S. DARRT combines Veyonda® with low-dose external beam radiotherapy (EBRT) delivered to an isolated tumour to trigger a whole-of-body anti-cancer outcome known as an abscopal response. The rationale is that low-dose EBRT activates a local immune/inflammatory response within the irradiated tumour that is amplified by Veyonda, converting a local anti-cancer response into a systemic response. Ethics review currently is underway in Australia. Those sites and the timing of patient recruitment are expected to be announced very shortly. DARRT-2 will involve approximately 100 patients with progressive, metastatic cancers whose cancers have failed standard treatment options and who are eligible for low-dose, palliative external beam radiotherapy. The cancers will be mainly prostate cancer, with a smaller cohort of breast or lung cancer. The international clinical research organisation, Parexel, is facilitating the study. Announcement • Jun 10
Noxopharm Limited Updates the Market on Progress with its DARRT-2 Trial Noxopharm Limited updated the market on progress with its DARRT-2 trial and to correct a typographical error in the company's latest Newsletter in which the trial was noted as being Phase 1. DARRT-2 is a Phase 2 trial seeking to generate the phenomenon of the abscopal response in cancer patients. This response is a phenomenon where an immune/inflammatory response within a single lesion following low-dose radiotherapy, in turn triggers a whole of body immune response that results in shrinkage of non-irradiated lesions elsewhere in the body. DARRT-2 will involve approximately 100 patients with progressive, metastatic prostate, breast or lung cancers that have failed standard treatment options and are eligible for low-dose,
palliative external beam radiotherapy (RT) to a single lesion. The multi-national trial will be conducted in Australia, U.S., France and Hungary in
approximately 15 sites. The international contract research organisation, Parexel, is overseeing the study, with final trial logistics being put in place.
Recent research has pointed to a reason for this being the need to block a certain type of repair process called autophagy of mitochondrial DNA damaged by the radiation. Other research points to idronoxil, the active ingredient in Veyonda, blocking autophagy. It is the combination of that effect and the drug's known immuno-stimulatory effects, together with the earlier DARRT-1 trial data, that provides the confidence that the company might have the ability to achieve consistently higher response rates to make DARRT a practical treatment option. Announcement • Jun 04
Noxopharm Limited Announces the Release of Clinical Data Relating to the Experimental Radioligand Noxopharm Limited announced the release of clinical data relating to the experimental radioligand, [177Lu]Lutetium-PSMA-617 (Lu-PSMA-617). Headline data from the Phase 3 VISION trial was released overnight, with full details to be presented to the Annual Meeting of the American Society of Clinical Oncology (ASCO). The VISION trial looked at the effectiveness of Lu-PSMA-617 as a treatment for late-stage prostate cancer. Lu-PSMA-617 is owned by Novartis. The first is that it confirms that Veyonda in combination with Lu-PSMA-617 provides a considerable survival advantage over Lu-PSMA-617 alone. The LuPIN mOS outcome of 19.7 months still remains the best survival outcome of any drug approved for use in men with end-stage prostate cancer including enzalutamide, abiraterone, docetaxel, cabazitaxel, and now Lu-PSMA-617. The second is that having Lu-PSMA-617 likely to come to market as a 3rd line therapy provides a clear development pathway now for Veyonda to come to market itself, with a distinct opportunity to make the Veyonda/Lu-PSMA-617 combination a new standard of care for end-stage prostate cancer. The VISION study compared Lu-PSMA-617 with standard of care in men with metastatic castrate-resistant prostate cancer (mCRPC) who had received at least two previous lines of therapy. The trial met its primary endpoint of a median Overall Survival of 15.3 months versus 11.3 months for standard of care alone. This compares with the LuPIN trial that tested the combination of Lu-PSMA-617 and Veyonda in men with end-stage mCRPC who had progressed on at least three previous lines of therapy. The interim median Overall Survival from the LuPIN study currently stands at 19.7 months. Due to the strong overall survival benefit in the VISION trial of 4 months (15.3 vs 11.3), Noxopharm believes that it will see Lu-PSMA-617 receive marketing approval in major territories such as the U.S. and EC. with likely introduction to the market in early-2022. The company believes that the LuPIN study has demonstrated that Veyonda has the ability to nhance the efficacy of Lu-PSMA-617, with a greater survival benefit from the combination han Lu-PSMA-617 alone. This well-tolerated combination therapy should increase the attractiveness of radioligand therapy for men with late-stage prostate cancer even more. Announcement • May 31
Noxopharm Limited Announces New Independent Trial Data Supports Potential of Veyonda as Major New Anti-Cancer Drug Noxopharm Limited report on the recent publication of independent clinical trial data involving the experimental radiopharmaceutical drug, 177lutetium-PSMA-617 (Lu-PSMA) owned by Novartis. Known as the WARMTH (World Association of Radiopharmaceutical and Molecular Therapy) study, it is an 18-centre, multi-national, retrospective trial reviewing the experience of 319 men with late-stage progressive metastatic castrate-resistant prostate cancer (mCRPC) receiving Lu-PSMA following prior therapies. The trial data was published on-line last week in the European Journal of Nuclear Medicine and Molecular Imaging. The key outcome of the WARMTH study is a median overall survival (mOS) outcome of 11.6 months. Given that both WARMTH and LuPIN studies involved men with similar disease status (end-stage, progressive) and similar pre-treatment histories, the Company believes that the WARMTH trial provides meaningful context for the LuPIN trial. That context is that the combination of Veyonda and Lu-PSMA in LuPIN delivered a median overall survival outcome of 19.7 months,2 a 71% increase in survival outcome over the WARMTH trial. In this instance, Veyonda is being combined with the Novartis radioligand, 177lutetium-PSMA-617, for the treatment of metastatic prostate cancer. This particular combination is one of so-called 4-Pillars oncology program where are looking to use Veyonda to improve survival prospects across a range of cancer treatments and forms of cancer. Based on early data from CEP-1 and DARRT-1 clinical studies, believe that the unique
multiple anti-cancer actions of Veyonda have the potential to produce meaningful survival benefits as a combination treatment across multiple treatment combinations. The striking difference in mOS outcomes between the LuPIN and WARMTH trials serves to further support that belief. The LuPIN study completed the final treatment of the last (56 th) patient in October 2020 and will conclude formally in October 2021, after which the final data, including the final mOS outcome, will be announced. The LuPIN trial involved Veyonda doses 400-1200 mg. Since then, Noxopharm has established in its NOXCOVID trial that a 1800 mg dosage is well tolerated with the potential for an even greater anti-cancer effect. A larger Phase 2 LuPIN study is under consideration in light of the anticipated pending marketing approval of 177lutetium-PSMA-617 and its likely adoption as a standard treatment. Announcement • May 12
Noxopharm Limited’s Veyonda to Begin First-Line Sarcoma Treatment Testing Noxopharm Limited announced its CEP-2 study will begin shortly. CEP-2 is related to the Investigational New Drug (IND) approval of Veyonda by the FDA based on evidence that Veyonda may increase generally poor response rates of sarcoma cancers to chemotherapy in combination with common chemotherapy drug, doxorubicin, for patients with soft tissue sarcomas. The announcement marks the Company's commitment to act on this valuable opportunity with the appointment of a contract research organization to oversee the study. Sarcoma was deliberately selected as a rare cancer carrying important funding and regulatory approval benefits including seven-year exclusive marketing opportunities. Sarcomas have very limited treatment options with only an estimated 14% of soft tissue sarcomas responding to chemotherapy. The Company is confident that Veyonda, with its unique mix of immunotherapy actions, has the means to increase both survival and response rates significantly when combined with doxorubicin. Announcement • May 08
Oxopharm Limited Announces That Its Cep-2 Study Will Open Shortly Noxopharm Limited announces that its CEP-2 study will open shortly. As previously announced, the U.S. Food and Drug Administration has approved the Investigational New Drug application for Veyonda in combination with common chemotherapy drug, doxorubicin, for patients with soft tissue sarcomas. Announcement marks the company's commitment to act on this valuable opportunity with the appointment of a contract research organisation to oversee the study. Sarcomas have very limited treatment options with only an estimated 14% of soft tissue sarcomas responding to chemotherapy.1 The Company is confident that Veyonda, with its unique mix of immunotherapy actions, has the means to change that by increasing both survival and response rates significantly when combined with the sarcoma standard of care drug, doxorubicin. The ultimate aim is to establish Veyonda as a standard booster of all four major forms of cancer therapy chemotherapy, external radiotherapy, internal radiotherapy, and checkpoint inhibitor therapy Each of those 4 sectors represents a major commercial opportunity, but collective success in 2 or more sectors stands to raise the potential industry value of Veyonda immeasurably The CEP-2 study, part of the Company's Chemotherapy Enhancement Program, is a key plank in that strategy, because after 50 years, chemotherapy still remains the backbone of cancer therapy, a position anticipated to continue for the foreseeable future with the global chemotherapy market widely predicted to reach $50+ billion by 2024. Based on its mechanisms of action, Noxopharm is confident that the majority of chemotherapy drugs in use would benefit from being combined with Veyonda, thereby creating a multi-billiondollar drug opportunity in its own right. However, there is an additional commercial imperative which is that the current market is dominated by drugs that either are off-patent or nearing the end of their patent life. Combining drugs with Veyonda to achieve greater anti-cancer potency offers the potential for renewed patent life, a highly prized outcome in the pharmaceutical industry. The Company has a patent application currently under examination that relates to the use of idronoxil in combination with various chemotherapy drugs. The Company has selected soft tissue sarcomas as its proof-of-principle indication for demonstrating chemotherapy enhancement by Veyonda Sarcoma is a rare cancer, with an estimated 13,400 new cases to be diagnosed in the U.S. in 20212 Rare cancers offer important commercial incentives including Orphan Drug designation carrying valuable funding benefits/regulatory review benefits/7-year market exclusivities/extended patent life Little competition. CEP-2 builds on the encouraging outcomes of the CEP-1 pilot study where the chemo- enhancing effect of Veyonda was used to lower dosages of chemotherapy in patients with advanced solid cancers CEP-2 builds on that positive experience by using higher dosages of Veyonda and patients undergoing first-line treatment CEP-2 is a Phase I study where approximately 40 patients with a range of soft tissue sarcomas will receive the Veyonda/doxorubicin combination as a first-line treatment Global clinical research organisation, Parexel® Biotech, has been engaged to oversee the study and site selection currently is underway in both the U.S. and Australia. The clinical protocol has been established and the study will start enrolling patients following site selection and ethics approvals. The company's strong cash position around a successful $23 million capital raise in December 2020 means it can proceed with this study, although the Company continues to seek global sources of non-dilutive funding. Announcement • Apr 28
Clinical Data Shows Noxopharm’s Veyonda May Prevent Cytokine Storm Noxopharm Limted announced that in a cohort of 18 patients with moderately severe cases of COVID-19, interim data in its NOXCOVID study suggests Veyonda provides protection against progression of the severe inflammation associated with a worsening of the disease. The major challenge for hospital services during the current pandemic is the high level of care required for those patients experiencing rapid deterioration of lung function, leading to acute respiratory distress syndrome, septic shock, and major disabilities or death. A key factor associated with disease worsening is the excessive production of inflammatory factors normally invoked to facilitate tissue repair and combat infection in a process known as the cytokine storm. Biomarker data from the top Veyonda dose cohort is expected within the next few weeks. That will be followed by a review of the final clinical data on completion of treatment of the final patient. Clinical status (WHO COVID-19 grade, comorbidities) and other therapies will be considered, and after reviewing all the data, the company will then consult with government, regulatory, medical, and business development advisors. Announcement • Mar 19
Noxopharm IONIC Immuno-Oncology Trial Commences Noxopharm Limited announce that the IONIC-1 trial supported by Noxopharm and Bristol Myers Squibb (BMS) received final ethics approval to start recruiting patients. The IONIC-1 trial (previously announced on 9 November 2020) is a Phase 1b trial in approximately 30 cancer patients, combining Veyonda® with the BMS immune checkpoint inhibitor, Opdivo® (nivolumab), for the treatment of a range of tumour types. Immune checkpoint inhibitors (ICI) such as nivolumab have had spectacular results in some patients with a small number of cancer types, but remain inactive in most forms of cancer. The IONIC-1 study will explore whether adding Veyonda to ICI therapy will overcome tumor resistance to nivolumab, making more cancer types responsive to nivolumab. The ICI market is a multi-billion-dollar market predicted by market analysts to generate sales of up to USD 45 billion by 2025 through strong year-on-year growth. Increasing the number of cancer types that respond to ICI therapy would expand the market even more, leaving any company with the technology to help achieve that goal in a highly valuable position. The potential of this trial to bring effective checkpoint inhibitor treatment to a broader range of patients is an exciting prospect. If we're able to enhance the effect of BMS's nivolumab with Veyonda, this will bring some truly life-changing treatment to cancer patients' lives and will change the way that cancer is treated worldwide.' The IONIC-1 trial will commence immediately. There will be two cohorts of patients, one cohort comprising patients who have not had previous nivolumab treatment because they have cancers considered unsuitable for ICI use, and the other cohort will be patients whose cancers have displayed resistance to nivolumab treatment. Trial endpoints are (i) safety and tolerability of the drug combination, (ii) efficacy (based on regular scans), and (iii) effect on various blood biomarkers. The trial is open-label, with the Company anticipating being able to report on progress at intervals. The Company regards a successful outcome as the combination treatment achieving stable disease or better in patients with cancer types regarded as inherently resistant to ICI drugs, and/or in patients whose cancer has progressed on nivolumab treatment, and to have done so without creating additional safety issues compared to nivolumab on its own. Announcement • Mar 09
Noxopharm Limited Announces Veyonda Approved to Move into Second and Final Stage of the NOXCOVID-1 Clinical Trial on the Advice of the Clinicians Treating the NOXCOVID-1 Patients Noxopharm Limited announced that Veyonda has been approved to move into its second and final stage of the NOXCOVID-1 clinical trial on the advice of the clinicians treating the NOXCOVID-1 patients. Part 1 of the NOXCOVID-1 trial involved 26 patients and was a dose-escalation arm testing the safety of increasing (400, 600, 800, 1200, 1800 mg) daily Veyonda dosages. The 1800 mg dose was deemed by the clinicians to be sufficiently well tolerated in patients with moderate COVID-19 disease to become the preferred dose. The high tolerance of the drug by patients with very poor lung function provides further evidence of the safety of Veyonda in patients with acute illness. NOXCOVID-1 Trial Recap: Veyonda is being tested for its ability to block the phenomenon known as cytokine release syndrome (CRS), or cytokine storm, and thereby reduce long-term disabilities and death in COVID-19 patients. This `storm' leads on to a life-threatening condition known as septic shock, associated with a broad range of long-term disabilities in both young and older patients, and death in severe cases. It is not specific to the current pandemic, although the death rate from the pandemic currently stands at over 2.5M, many of which are believed to involve CRS and septic shock. To put this in context, pre-pandemic, septic shock was believed responsible for an estimated 10 million death p.a., putting it in the top 5 major causes of human death globally from disease. It is a so-called `storm' because of a sudden and entirely inappropriate surge in the blood of dozens of pro-inflammatory chemicals known as cytokines, resulting in damaging levels of inflammation in blood vessels and major organs. In the case of infection with the COVID-19 virus or other viruses such as the influenza virus, the trigger for CRS is virally-induced lung damage. Veyonda is being tested for its ability to block the development of CRS in COVID-19 patients with moderate lung damage that is placing them at high risk of developing CRS and septic shock. The aim is to prevent their progression on to needing mechanical ventilation and ICU care, the development of a range of long-term disabilities identified as being associated with COVID-19 disease, and death. Next steps: Part 2 of the NOXCOVID-1 trial now is starting to recruit a minimum of 10 and up to 15 patients with moderate to severe lung dysfunction. Patients will be treated for up to 14 days with an 1800 mg Veyonda dose each day. Part 1 patient blood (Cohorts 1-4) currently is being analysed for 60 pro-inflammatory (cytokines, chemokines) factors in what the Company believes will be one of the most comprehensive analyses of its kind in COVID-19 disease. Recent Insider Transactions Derivative • Feb 27
Founder exercised options to buy AU$5.5m worth of stock. On the 26th of February, Graham Kelly exercised options to buy 8m shares at a strike price of around AU$0.31, costing a total of AU$2.5m. This transaction amounted to 28% of their direct individual holding at the time of the trade. Since June 2020, Graham's direct individual holding has decreased from 37.00m shares to . Company insiders have collectively bought AU$1.2m more than they sold, via options and on-market transactions, in the last 12 months. Announcement • Feb 16
Noxopharm Limited Provides More Detailed Summary of Data from the Lupin Study That Formally Presented to the American Society of Clinical Oncology Genitourinary Cancers Symposium Noxopharm Limited provided a more detailed summary of the data from the LuPIN study that was formally presented to the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on 13 February 2021. The company also note that 46% of men were able to complete the full 6 cycles of treatment. This is important from a commercial point of view because the ability to administer up to 6 cycles of the Novartis radiopharmaceutical over a treatment course of about 7-8 months is dependent on PSA levels continuing to indicate a response to treatment. Getting almost half of the men to receive a full 6 cycle treatment course carries important clinical and commercial implications. The exact degree of survival benefit the drug combination is providing will require a placebo-controlled study. Nevertheless, given that men with Stage 4 prostate cancer who have exhausted all standard treatment options have very limited survival prospects, having half of the men in the LuPIN study survive at least 19.7 months, with 19 of the 56 still alive, is a remarkable outcome pointing to a major anti-cancer effect. The way that Veyonda is joining with the Novartis drug to produce this potent anti-cancer effect is the subject of ongoing studies. As a selective inhibitor of sphingosine kinase and STING signaling, Veyonda is associated with multiple anti-cancer functions, falling mainly into oncotoxic and immunotherapy functions. The company's working hypothesis, based on pre-clinical data, is that the LuPIN effect of Veyonda is an oncotoxic effect via two mechanisms. First, by blocking cell division, it is holding cancer cells at a point in their cycle where their DNA is most susceptible to the damaging effects of the 177lutetium radiation. Second, by blocking the repair of the damaged DNA, the damaged cell then self-destructs. Statistical analysis will be conducted at the conclusion of the study to determine if there is a dose-response effect of Veyonda, although the 1200 mg dose looks to be therapeutic dose. Announcement • Feb 10
Noxopharm Limited Reports the Publication in Abstract Form of the Latest Survival Data from the LuPIN Study Noxopharm Limited reported the publication in abstract form of the latest survival data from the LuPIN study ahead of a formal presentation to the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (11-13 Feb. 2021), the pre-eminent medical conference dedicated to sharing the most recent innovations in the treatment of genitourinary cancers. A team of eminent medical researchers from Sydney's St Vincent's Hospital and Melbourne's Peter MacCallum Cancer Centre and led by Professor Louise Emmett conducted the independent Phase I/II study. They reported that Veyonda was safe and efficacious in combination with 177Lu-PSMA-617, an experimental radiopharmaceutical acquired by major Swiss pharma company, Novartis, three years ago for USD 6 billion across a series of transactions. The LuPIN study enrolled a total of 56 patients with metastatic castration-resistant prostate cancer (mCRPC) whose cancer had progressed on all three standard lines of therapy for late-stage disease. Thesemen were regarded as having reached the end of their treatment journey. The goal of the combined (LuPIN) treatment was to slow or to block tumour progression in order to deliver a better quality of life and extended survival and to do so in a well-tolerated way. The median Overall Survival (mOS) for the 56 men in the LuPIN study was 19.7 months, an increase on the 17.1 months reported 12 months ago at the same conference for the first 32 men in the study. mOS is a standard measure of efficacy in cancer studies and is the time at which half the patients remain alive and half are deceased. In terms of how much of a survival benefit the LuPIN drug combination has offered, 19.7 months compares with 4.5 months reported in a study by Buonerba1 in men with Stage 4 mCRPC whose disease had progressed on standard therapies In terms of how much Veyonda is contributing to the combined drug effect, 19.7 months compares to 13.3 months reported in an Australian study where Lu-PSMA-617 was used on its own. Overall, the men in that other study had less advanced disease than the men in the LuPIN study, emphasising even more the benefit of the combination versus the Novartis drug on its own. The data also showed that: 86% of men had a reduction in blood PSA (prostate specific antigen) levels, indicating a very high rate of response of the cancer to the treatment 53% of men suffering moderate to strong pain associated with cancer reported a significant reduction in pain. Pain is a particular feature of mCRPC due to secondary prostate tumours spreading predominantly to the skeleton. 46% of men were able to complete the full 6 cycles of treatment without cancer progression. Is New 90 Day High Low • Jan 29
New 90-day high: AU$0.69 The company is up 39% from its price of AU$0.50 on 30 October 2020. The Australian market is up 14% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 6.0% over the same period. Announcement • Jan 13
Noxopharm Limited Announces the Latest Formal Review by the NOXCOVID-1 Safety Steering Committee Cleared it to Advance to the Fifth and Final Dosage Cohort Noxopharm Limited announced that the latest formal review by the NOXCOVID-1 Safety Steering Committee has cleared it to advance to the fifth and final dosage cohort. The Committee is independent of the company, with investigators unanimously voting to move to the 1800 mg dose after they reviewed the safety profile of Veyonda in 12 patients from Cohorts 3 and 4 (involving 800 and 1200 mg Veyonda respectively). The company regards this as a highly encouraging outcome given the advanced nature of COVID-19 disease in these study patients, in particular suffering serious lung dysfunction. The company will be reporting formally on efficacy in due course, with the overall objective being to use Veyonda to block the cytokine release syndrome (so-called `cytokine storm') that leads to patients requiring intensive care, and is a primary cause of the multi-organ damage responsible for much of the long-term disability and death in COVID-19 patients. The issues of drug safety and ease of administration look set to become major issues as the pandemic evolves. The emerging situations in the UK and parts of the U.S. are causing alarm, with hospitals reportedly being overwhelmed to the point of having insufficient ICU beds and staff to meet demand. The need for effective triage treatments able to be administered under minimal medical supervision in both developed and developing countries where lack of ICU facilities is even more concerning, looks set to grow exponentially. The Company sees Veyonda as having the properties to meet this need. Announcement • Nov 18
Noxopharm Limited Provides Update on Its Ongoing New Immuno-Oncology Drug Noxopharm Limited announced that ongoing studies by independent university researchers continue to support the Company's confidence in its lead drug candidate, Veyonda, becoming an important new immuno-oncology drug. The results of the study were presented to the Annual Meeting of the Clinical Oncology Society of Australia (COSA), Australia's premiere cancer conference (11 November to 13 November 2020). Noxopharm currently is developing Veyonda as a next-generation immunotherapy drug that works by restoring immune function to tumours, a fundamental step in efforts to make all forms of cancer therapy, including chemotherapy, radiotherapy and checkpoint inhibitor therapies, work more effectively. The Company is employing this ability to boost the effectiveness of radiotherapy (DARRT and LuPIN programs), checkpoint inhibitors (IONIC program) and standard chemotherapy drugs (CEP program). Announcement • Nov 14
Noxopharm Limited Announces Independent Discovery Validates Darrt Cancer Therapy Noxopharm Limited announced that a recent discovery by a major U.S. university group significantly validates the Company's novel DARRT treatment program comprising Veyonda and radiotherapy. The discovery relates to how Veyonda combines with radiotherapy to produce a striking whole-of-body anti-cancer response known as an `abscopal response' in patients with metastatic cancer. A complete abscopal response is regarded as the ultimate form of treatment for metastatic cancer. In a patient with multiple tumours it involves delivering a well-tolerated low dose of radiation to a single tumour, triggering an immune response in that single tumour that results in other tumours throughout the body literally `melting' away in a matter of weeks. Patients with a complete abscopal response generally remain in remission for life. Up to now the abscopal response has remained an extraordinarily rare and elusive phenomenon with the mechanisms behind it remaining a mystery. Now a study conducted by the Weill Cornell Medical College, New York, and recently published in the prestigious scientific journal, Nature Immunology, sheds light on the mechanism, finally offering a path to making it more commonplace. This discovery provides a rational explanation for why the Company has seen Veyonda deliver clear evidence of abscopal responses: the first two patients ever treated with DARRT treatment (on a compassionate use basis) delivered notable abscopal responses one complete (late-stage prostate cancer) and one partial (leiomyosarcoma). in the DARRT-1 Phase 1b study (involving men with late-stage prostate cancer, meaningful tumour responses including abscopal responses were observed in a significant number of men, marking the first time that abscopal responses were reported in prostate cancer in more than extremely isolated cases. It is even more notable that this encouraging outcome in DARRT-1 was achieved using what the Company now regards as a sub-optimal course of Veyonda treatment. in the DARRT-1 Phase 1b study (involving men with late-stage prostate cancer, meaningful tumour responses including abscopal responses were observed in a significant number of men, marking the first time that abscopal responses were reported in prostate cancer in more than extremely isolated cases. It is even more notable that this encouraging outcome in DARRT-1 was achieved using what the Company now regards as a sub-optimal course of Veyonda treatment. Is New 90 Day High Low • Nov 09
New 90-day high: AU$0.54 The company is up 57% from its price of AU$0.34 on 11 August 2020. The Australian market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 7.0% over the same period. Announcement • Nov 06
Noxopharm Limited Announce Partnership with Hudson Institute of Medical Research and Australian National University for the Formation of the New Australian Drug Development Company Noxopharm Limited announce a partnership with Hudson Institute of Medical Research (`Hudson Institute') and a collaboration with The Australian National University (`ANU') that has led to the formation of the new Australian drug development company, Pharmorage Pty Ltd. (`Pharmorage'). Pharmorage starts out with the primary aim of developing a better treatment for septic shock, a major and highly underserved condition within the community. The same drug technology platform with its anti-inflammatory actions is seen as having application to a growing number of autoimmune diseases, also in urgent need of better treatments. STING (Stimulator of Interferon Genes) signalling has emerged in recent years as playing a key role in the
inflammatory process associated with viral and bacterial infections, cancer and cell damage in general. In the process it has become an important new drug target in chronic inflammatory diseases as well as hyper-inflammatory diseases such as septic shock. Drugs targeting the STING signalling pathway have become the subject of considerable M&A activity in the industry. The NOX drug technology platform has yielded compounds with novel actions against a range of biological pathways involved in inflammation, including STING. Pharmorage sees these novel kinase-inhibitory
actions as the basis for major drug development programs in fields like septic shock and certain autoimmune diseases that have largely defied the development of safe, effective therapies. Is New 90 Day High Low • Oct 16
New 90-day high: AU$0.44 The company is up 33% from its price of AU$0.33 on 17 July 2020. The Australian market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 6.0% over the same period. Announcement • Oct 13
Noxopharm Limited Announces the Final Patient Has Completes Treatment in the Lupin Study Noxopharm Limited announced that the final patient has completed treatment in the LuPIN study. LuPIN is examining the combination of Veyonda and 177LuPSMA-617 in 56 late-stage prostate cancer patients at St Vincent's Hospital, Sydney. LuPIN is a dose-response study involving 400, 800 and 1200 mg Veyonda dosages with a constant LuPSMA-617 dosage. Interim data on the first 32 patients (400 and 800 mg dosages) has been presented at major medical conferences and published in a peer-reviewed journal. These two lower dosages have produced highly encouraging data with impressive tumour response outcomes, most notably a median overall survival of 17.1 months in men with limited survival expectations. Announcement • Oct 10
Noxopharm Announces First COVID-19 Patient Treated in Veyonda Study Noxopharm announced treatment of the first patient with its lead pipeline candidate, Veyonda®, in the Company’s Phase 1 NOXCOVID-1 study. NOXCOVID-1 is looking at treating those COVID-19 patients hospitalized with moderate lung dysfunction requiring low oxygen support who are at risk of progressing rapidly into requiring intensive care and mechanical ventilation. This rapid progression increasingly is being seen as an inappropriately strong inflammatory reaction known as a cytokine storm by the body’s immune system in response to lung damage caused by the virus. The experimental anti-cancer drug, Veyonda®, joins a number of approved and experimental drugs with an anti-inflammatory action being tested globally for their ability to block rapid progression of COVID-19 disease from moderate to severe level. The distinction of the NOXCOVID-1 study in this global effort is that it offers a unique opportunity to test an emerging theory that the so-called STING signalling pathway is a key trigger of the cytokine storm syndrome. Recent research conducted by Hudson Institute of Medical Research in Melbourne (Australia) has shown that part of the anti-cancer effect of Veyonda® is an anti-inflammatory effect stemming from potent inhibition of the STING signalling pathway. Announcement • Oct 04
Noxopharm Limited Announces the Enrolment and Treatment of the First Patient into the Phase 1 NOXCOVID-1 Noxopharm Limited announced the enrolment and treatment of the first patient into the Phase 1 NOXCOVID-1 study examining the potential use of Veyonda in blocking the rapid progression of COVID- 19 disease from moderate to severe level. Most COVID-19 patients hospitalised with moderate lung dysfunction requiring low oxygen support recover uneventfully. However, a proportion progress into requiring intensive care and mechanical ventilation, with that proportion rising with increasing age and incidence of co-diseases such as diabetes. The aim of the NOXCOVID-1 study is to test the ability of Veyonda to stop that deterioration in high-risk patients both safely and effectively. As reported previously recent pre-clinical research has shown that at least part of the anti-cancer action of Veyonda comes via a novel anti-inflammatory action involving the STING signaling pathway. With COVID-19 disease increasingly being seen as a hyper- inflammatory response to damage caused by the virus, recent Australian research conducted by Hudson Institute of Medical Research in Melbourne suggests that the novel anti-inflammatory action of Veyonda could potentially prevent progression of COVID-19 disease.1-3 NOXCOVID-1 is being conducted in a number of hospitals in Eastern Europe. This first patient is hospitalised in the Republic of Moldova, a country with ongoing growth in COVID-19 cases.4 Patients will be monitored closely by experienced medical investigators and the whole trial overseen by a UK-based contract research organisation. Noxopharm and its study partners have worked to expedite the NOXCOVID-1 study, leading to the very short timeframe between study approval and implementation with the treatment of the first patient hospitalised with COVID19. The NOXCOVID-1 trial will enrol up to approximately 40 patients, with enrolment due to be completed before the end of the year. Patients will be treated with Veyonda between 14-28 days depending on clinical response using a two-step dose-escalation and -expansion trial design. The endpoints will include a large number of safety and efficacy parameters standard for COVID-19 trials. As a pilot study, the Company anticipates releasing interim clinical response data on a rolling basis over the next 3-4 months. Noxopharm is making a commitment to its NOXCOVID program on the basis that until the world is certain of the efficacy and safety of vaccines and the proportion of the community willing to be vaccinated, there is an urgent need to continue to search for therapies that will lessen the rates of death and long-term disabilities from COVID-19. Is New 90 Day High Low • Sep 18
New 90-day high: AU$0.39 The company is up 90% from its price of AU$0.20 on 19 June 2020. The Australian market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is flat over the same period.