New Risk • 12h
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 16% 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 Shareholders have been substantially diluted in the past year (89% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$34m net loss in 2 years). Share price has been volatile over the past 3 months (16% average weekly change). Revenue is less than US$5m (AU$3.9m revenue, or US$2.8m). Market cap is less than US$100m (AU$54.1m market cap, or US$38.5m). Recent Insider Transactions • 12h
CEO, MD & Executive Director recently bought AU$61k worth of stock On the 14th of May, Leslie Chong bought around 585k shares on-market at roughly AU$0.10 per share. This transaction amounted to 20% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Leslie has been a buyer over the last 12 months, purchasing a net total of AU$71k worth in shares. Recent Insider Transactions • May 19
CEO, MD & Executive Director recently bought AU$61k worth of stock On the 14th of May, Leslie Chong bought around 585k shares on-market at roughly AU$0.10 per share. This transaction amounted to 20% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Leslie has been a buyer over the last 12 months, purchasing a net total of AU$71k worth in shares. New Risk • May 07
New major risk - Revenue and earnings growth Earnings have declined by 32% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 32% per year over the past 5 years. Shareholders have been substantially diluted in the past year (84% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$3.9m revenue, or US$2.9m). Market cap is less than US$100m (AU$46.4m market cap, or US$33.7m). Ankündigung • Apr 30
Imugene Limited has completed a Follow-on Equity Offering in the amount of AUD 12 million. Imugene Limited has completed a Follow-on Equity Offering in the amount of AUD 12 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 35,445,999
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 31,220,668
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing 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$67m 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$67m free cash flow). Shareholders have been substantially diluted in the past year (46% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$36m net loss in 2 years). Revenue is less than US$5m (AU$4.7m revenue, or US$3.3m). Market cap is less than US$100m (AU$77.2m market cap, or US$54.9m). Ankündigung • Jan 02
Imugene Limited Announces Resignation of Dr. Bradley Glover as Chief Operating Officer Imugene Limited announced that Dr. Bradley Glover has resigned from his position as Chief Operating Officer of Imugene to focus on his other business interests. The Company will manage the transition of responsibilities with no impact on business operations or ongoing programs. Breakeven Date Change • Oct 16
No longer forecast to breakeven The 2 analysts covering Imugene no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$370.1m in 2028. New consensus forecast suggests the company will make a loss of AU$19.2m in 2028. Ankündigung • Oct 14
Imugene Limited, Annual General Meeting, Nov 13, 2025 Imugene Limited, Annual General Meeting, Nov 13, 2025. Location: at automic pty ltd, level 5, 126 phillip street, sydney nsw 2000 Australia New Risk • Aug 27
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 13% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (33% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$93m net loss in 2 years). Share price has been volatile over the past 3 months (14% average weekly change). Revenue is less than US$5m (AU$4.4m revenue, or US$2.9m). Market cap is less than US$100m (AU$75.0m market cap, or US$48.7m). New Risk • Jul 31
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 33% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (33% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$109m net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (AU$80.8m market cap, or US$52.3m). Ankündigung • Jul 14
Imugene Limited Announces Outstanding Response Rates from the Phase 1b Trial of the Azer-cel Allogeneic CAR T in 3L+ DLBCL Imugene Limited announced new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappear of all signs of cancer in response to treatment. Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand). Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, Imugene will request a Type B (End of Phase 1) Meeting in Fourth Quarter 2025, with the US FDA to present the data and to discuss designs for a pivotal /registrational trial for azer-cel. The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. New Risk • Jul 11
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 Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$109m net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (AU$87.8m market cap, or US$57.8m). New Risk • May 20
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: AU$141.9m (US$91.0m) This is considered a minor 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 Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$108m net loss in 2 years). Market cap is less than US$100m (AU$141.9m market cap, or US$91.0m). New Risk • Feb 28
New major risk - Revenue size The company makes less than US$1m in revenue. This is considered a major risk. Companies with a small amount of revenue 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 Risk Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (AU$88m net loss in 2 years). Breakeven Date Change • Nov 16
No longer forecast to breakeven The 3 analysts covering Imugene no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$150.9m in 2027. New consensus forecast suggests the company will make a loss of AU$8.30m in 2027. Ankündigung • Nov 15
Imugene Limited Announces Retirement of Jens Eckstein as Non-Executive Director Imugene Limited announced Jens Eckstein has resigned from his position as a non-executive director of the company to focus on his other business interests. Jens has been a valued member of the company's board since May 2019, providing extensive insights and guidance to the company. Price Target Changed • Oct 24
Price target decreased by 17% to AU$0.29 Down from AU$0.35, the current price target is an average from 4 analysts. New target price is 490% above last closing price of AU$0.05. Stock is up 19% over the past year. The company is forecast to post a net loss per share of AU$0.014 next year compared to a net loss per share of AU$0.021 last year. Ankündigung • Oct 14
Imugene Limited, Annual General Meeting, Nov 14, 2024 Imugene Limited, Annual General Meeting, Nov 14, 2024. Location: mccullough robertson, level 32, 25 martin place, sydney, nsw 2000 Australia Ankündigung • Sep 03
Imugene Limited Announces Promising Results from its Phase 1b Clinical Trial with Azer-Cel Imugene Limited announced promising results from its Phase 1b clinical trial with azer-cel (azercabtagene zapreleucel, an allogeneic off-the-shelf CD19 CAR T), in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL), a type of non-Hodgkin's lymphoma (NHL). All enrolled patients had cancer that had returned following autologous CAR T therapy, a high unmet need for this patient population. Patients in the trial are being recruited across 15 leading cancer centres in the U.S. including, Columbia University, University of Minnesota, Emory, and Moffitt Cancer Centres and plans are ongoing to open up to 5 sites in Australia. Results: Evaluable: patients who qualify for at least their first 28-day scan; Overall response rate (ORR): the percentage of people in the study who have a complete response (CR) or partial response (PR) to the treatment as confirmed by scan; Responses: a complete response (CR) is defined as disappearance of all tumours; a partial response (PR) is defined as a reduction in tumours as confirmed by scan; Durability of Response (DOR): how long responses last. Nine (9) patients total from Cohorts A and B are considered evaluable (qualified for at least day 28 scan). One (1) patient (Cohort B) has been treated and is awaiting their 28-day scan: Of the 6 evaluable patients in Cohort A: 1 CR, 1 PR = 33% Overall Response Rate (ORR);1 CR = 17% CR; Durability of response was < 60 days; All patients no longer on trial. Of the 3 evaluable patients in Cohort B: 2 CRs = 67% ORR; 2 CRs = 67% CR; 1 Stable Disease (SD): On PET/CT scan imaging, patient’s tumour has decreased however, due to potential T-cell infiltration, noted an increase in signal intensity. This could represent pseudoprogression. The patient remains on trial and continues to be assessed for response at the follow up scans. Durability of response thus far: >120 days and >90 days (all patients are ongoing) All 4 patients (including 1 patient awaiting 28-day scan) continue on trial. The company will continue to enrol additional patients in Cohort B and follow patients for durability of response with the goal of providing a comprehensive package to the FDA for the potential Phase 2/3 registrational trial. Subject to patient recruitment, the company aims to provide an interim Phase 1b data update. If successful, azer-cel has the potential to become the first approved allogeneic CAR T cell therapy for blood cancer. Beyond studying its efficacy in blood cancers, in the future, Imugene plans to combine azer-cel with its novel onCARlytics program for the treatment of patients with solid tumours, opening a potentially large market for azer-cel in the 90% of cancer not classified as blood cancers. New Risk • Aug 31
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -AU$111m This is considered a minor 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 Risk Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$111m). Shareholders have been diluted in the past year (7.5% increase in shares outstanding). Breakeven Date Change • Jun 30
Forecast to breakeven in 2027 The 3 analysts covering Imugene expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$150.9m in 2027. Average annual earnings growth of 51% is required to achieve expected profit on schedule. Recent Insider Transactions • Apr 24
Executive Chairman recently sold AU$1.1m worth of stock On the 19th of April, Paul Hopper sold around 14m shares on-market at roughly AU$0.079 per share. This transaction amounted to 3.3% 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 Paul's only on-market trade for the last 12 months. Ankündigung • Apr 17
Imugene Limited Announce Enrolment Opened for Its Expansion Study in Bile Tract Cancer (Cholangiocarcinoma) Patients Imugene Limited announced that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA). The expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial is planned for 10 patients with bile tract cancers, after early positive responses were observed in gastrointestinal cancers, particularly in cholangiocarcinoma. Cholangiocarcinoma is a rare disease in which malignant cancer cells form in the bile ducts. It is difficult to treat and generally responds poorly to immunotherapy drugs. One patient with cholangiocarcinoma who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, with no known recurrence in more than 430 days. A second patient with cholangiocarcinoma, who has also progressed on prior drug therapies, achieved stable disease for more than four months upon receiving IV-administered VAXINIA. In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile duct cancer (cholangiocarcinoma), which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process. This designation followed the promising data detailing Phase 1 efficacy and tolerability. On Friday 12 April 2024, the Cohort Review Committee cleared the fifth cohort in the IT arm of the monotherapy dose escalation portion of the MAST trial, with no safety signals seen to date. In addition to the patients dosed in the monotherapy dose escalation portion of the trial, enrolment is ongoing for the VAXINIA and pembrolizumab combination portion of the trial, with 16 patients dosed to date. The multicenter, Phase 1, MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. CF33 oncolytic virus, developed by City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Further dose escalation to continue as long as no safety issues are observed. Ankündigung • Mar 12
Imugene Limited Announces Phase 1 onCARlytics Solid Tumour Trial Advances to Combination Arm Treatment Imugene Limited announced that its Phase 1 clinical trial of CD19 oncolytic virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4) has cleared its first cohort within the intratumoral monotherapy arm of the study and is therefore ready to commence combination dosing solid tumour patients with CD19 targeting drug blinatumomab (Blincyto marketed by Amgen). Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours, and aims to evaluate the safety and efficacy of two routes of administration, intratumoral (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab. The combination arm of the study will see onCARlytics combined with CD19 targeting bispecific monoclonal antibody blinatumomab (marketed as Blincyto by Amgen which currently is specifically approved only for liquid blood cancers). onCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blincyto therapy alone and will represent a paradigm shift in solid tumour treatment. OASIS is a dose escalation trial that will be conducted across multiple sites across the United States, with 52 patients proposed to take part in the trial. onCARlytics is a CD19-expressing oncolytic virus that enters tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies. Price Target Changed • Mar 11
Price target decreased by 8.2% to AU$0.34 Down from AU$0.37, the current price target is an average from 3 analysts. New target price is 221% above last closing price of AU$0.10. Stock is down 19% over the past year. The company is forecast to post a net loss per share of AU$0.0087 next year compared to a net loss per share of AU$0.006 last year. New Risk • Nov 07
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: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$7.8m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (13% increase in shares outstanding). Ankündigung • Oct 30
Imugene Limited, Annual General Meeting, Nov 30, 2023 Imugene Limited, Annual General Meeting, Nov 30, 2023, at 15:00 AUS Eastern Standard Time. Location: McCullough Robertson, Level 32, 25 Martin Place, Sydney NSW 2000 Sydney New South Wales Australia Agenda: To consider and receive the financial report, the Directors’ report and the auditor’s report for the year ended 30 June 2023; to consider the Election of Director – Ms Kim Drapkin; to consider the Approval of amended Employee Share Option Plan; to consider the Issue of performance rights to Director – Mr Paul Hopper; and to consider other matters. New Risk • Oct 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: AU$38m Forecast net loss in 3 years: AU$7.3m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$7.3m net loss in 3 years). Shareholders have been diluted in the past year (14% increase in shares outstanding). Breakeven Date Change • Oct 14
No longer forecast to breakeven The 3 analysts covering Imugene no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$18.6m in 2026. New consensus forecast suggests the company will make a loss of AU$7.33m in 2026. Price Target Changed • Oct 06
Price target decreased by 14% to AU$0.42 Down from AU$0.49, the current price target is an average from 3 analysts. New target price is 877% above last closing price of AU$0.043. Stock is down 78% over the past year. The company is forecast to post a net loss per share of AU$0.0087 next year compared to a net loss per share of AU$0.006 last year. Board Change • Oct 06
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Non-Executive Director Jens Eckstein was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Price Target Changed • Sep 06
Price target decreased by 14% to AU$0.42 Down from AU$0.49, the current price target is an average from 3 analysts. New target price is 556% above last closing price of AU$0.064. Stock is down 71% over the past year. The company is forecast to post a net loss per share of AU$0.0087 next year compared to a net loss per share of AU$0.0062 last year. Ankündigung • Sep 05
Imugene Limited Appoints Paul Woodard as Chief Medical Officer Imugene Limited announced the appointment of Dr Paul Woodard as Chief Medical Officer. Prior to joining Imugene Ltd, Dr Woodard worked on a wide range of drug development projects in solid tumours, haematologic malignancies, and non-malignant haematologic disorders. Most recently, Dr Woodard served as the Senior Vice President and Chief Medical Officer at Immune-Onc Therapeutics. In this role, he played a pivotal part in clinical oversight, notably directing the submission of four novel INDs (investigational new drug application) and initiating Phase 1 clinical trials. At Exelixis, Dr Woodard worked on small molecule tyrosine kinase inhibitors for solid tumours. At Amgen, Dr Woodard was the global development leader for Nplate® (romiplostim) in immune thrombocytopenia and myelodysplastic syndromes. At Genentech, Dr. Woodard was the global development team leader for Tecentriq® (atezolizumab) in haematologic malignancies and was an integral team member for the development of Tecentriq® combinations in solid tumours (including triple negative breast cancer) and haematologic malignancies. At Bellicum, Dr Woodard was the Senior Vice President of Clinical and Medical Affairs, with oversight of the company's cellular therapy portfolio and clinical trials in haematologic malignancies and solid tumours. Dr Woodard has an extensive haematology and oncology background gained in academia and industry. His academic experience focused on paediatric haematopoietic stem cell transplantation and haematologic disorders at world-renowned institutions, including St. Jude Children's Research Hospital, University of California, San Francisco, and Children'sHospital, Los Angeles. In addition to patient care, at St. Jude, Dr Woodard was responsible for Phase 1/2 trials in paediatric haematopoietic stem cell transplantation for malignant and non-malignant disorders. Dr Woodard earned his B.A. in Chemistry and M.D. from the University of North Carolina. His post-graduate journey includes a Residency at the University of Virginia andFellowships at both the University of North Carolina and the University of Minnesota. Ankündigung • Sep 01
Imugene Limited Appoints John Byon as Senior Vice President of Clinical Development Imugene Limited announced the appointment of Dr. John Byon as Senior Vice President of Clinical Development. Dr. Byon boasts an extensive background in the development of novel therapeutics for cancer patients. He has occupied several leadership roles at major biopharmaceutical companies, spearheading clinical development activities. Most recently, Dr. Byon served as Vice President of Clinical Development in Hematology and subsequently in acute myeloid leukemia (AML) at Fate Therapeutics. Here, he directed the clinical strategy for the Hematology portfolio, which comprises five assets in B-cell malignancies, AML, and Multiple Myeloma. He provided oversight for all ongoing Hematology trials as well as playing a pivotal role in restructuring the Clinical Development team. Before his tenure at Fate, Dr. Byon was the Senior Medical Director, Head of Clinical Science at Lyell Immunopharma. In this capacity, Dr. Byon led clinical strategy development for portfolio assets, established the internal clinical science function, and represented clinical development in joint collaborations. Additionally, Dr. Byon served as Senior Medical Director at Juno Therapeutics, where as the Global Clinical Development Lead he was instrumental in the clinical development of orvacabtagene autoleucel (orva-cel/JCARH125) for relapsed/refractory multiple myeloma and other novel CAR T-cell targets. He also assumed various Medical Director roles over a four-year span at Genentech, focused largely on managing clinical development activities for Tecentriq® (Atezolizumab) in various hematological malignancies. During this period, he conceptualized new clinical trials and represented the company at global advisory board meetings. Dr. Byon holds both a Doctor of Medicine and a Doctor of Philosophy from Tulane University. Beyond his corporate experience, Dr Byon has contributed to multiple academic publications in the hematology and oncology spaces. Ankündigung • Aug 21
Imugene Limited Appoints Dr Bradley Glover as Chief Operating Officer Imugene Limited announced the appointment of Dr Bradley Glover as the Company's Chief Operating Officer. Dr Glover brings a wealth of experience to Imugene, with a career spanning various sectors such as cell therapy, biopharmaceuticals, diagnostics, venture capital, finance, research and development, and education. He has demonstrated expertise in deal negotiations, strategic collaborations, acquisitions, and licensing agreements.Additionally, he has made significant academic contributions, with published research articles in biochemistry and genetics. Prior to joining Imugene, Dr Glover served as the Executive Vice President and Chief Operating Officer at Celularity, playing a pivotal role in strategic planning, business development, and technical operations. Prior to this he was Vice President and Head of Corporate Strategy & Operations at renowned cell therapy company Kite Pharma, overseeing global corporate strategy, planning, portfolio management, product and program management, and global business transformation. Dr Glover also brings eight years' experience at Genentech /Roche, where he held leadership positions, concentrating on business development, integration, and strategic planning. Notably, he helped lead the integration of Roche's acquisitions, totalling $1.2 Billion, for its Diagnostics Sequencing business. Dr Glover holds a PhD in Biochemistry & Molecular Genetics from the University of Colorado and an MBA in Marketing & Finance from the Rady School of Management, University of California San Diego. Ankündigung • Jul 18
Imugene Appoints Dr Weitzman Interim Chief Medical Officer Imugene Limited announced the appointment of Dr Ron Weitzman as the Company's Interim Chief Medical Officer. Dr Weitzman brings to Imugene over two decades of global experience in the biopharmaceutical industry, with expertise in the therapeutic areas of solid-tumour and hematologic malignancies. He has an extensive record in creating and executing clinical development plans, directing Phase I - III clinical trials, and preparing US and EU regulatory submissions. Prior to joining Imugene, Dr Weitzman held leadership roles at various global biopharmaceutical companies, including Tango Therapeutics, Exelixis, Genentech, and Novartis. Most recently as Chief Medical Officer at Tango Therapeutics, Dr Weitzman oversaw development of multiple oncology drugs, including three Investigational New Drug (IND) submissions, while leading the clinical and clinical operations teams. Prior to his tenure at Tango Therapeutics, Dr Weitzman served as Vice President of Clinical Development at Exelixis for almost seven years. His role saw him take on the overall responsibility for the strategy and execution of the clinical plan for cabozantinib, a drug therapy for prostate cancer. This role included numerous visits to FDA and EMEA, authorship of regulatory documents, active participation in industry partnership meetings, and presentations to investors and the Exelixis Board of Directors. California-based Dr Weitzman graduated from the University of Western Ontario, Canada, and is Board Certified by the American Board of Internal Medicine in Medical Oncology. He is an active member of several professional societies including the College of Physicians and Surgeons of Ontario, the American College of Physicians, and the American Society of Clinical Oncology. Dr Weitzman replaces the departing Dr Giovanni Selvaggi in the role of Interim Chief Medical Officer. Imugene's board and management thanks Dr Selvaggi for his service to Imugene. Breakeven Date Change • Jun 30
Forecast to breakeven in 2026 The 3 analysts covering Imugene expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$18.6m in 2026. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Ankündigung • Jun 21
Imugene Limited Announces Board Changes Imugene Limited announced the appointment of Ms Kim Drapkin as Non- Executive Director. With more than 25 years of experience in the biotechnology and pharmaceutical sectors, Ms Drapkin possesses a strong background in finance, capital raising, and strategic financial planning. She held the position of CFO and Treasurer at Jounce Therapeutics Inc. from 2015 until its acquisition in May 2023, having played a pivotal role in the company's growth and financing since its inception. Alongside the CEO, she represented Jounce in the investment and analyst community and was a key figure in the company's IPO and subsequent NASDAQ listing. Before joining Jounce, Ms Drapkin managed a financial consulting firm and served as interim CFO for various early-stage biotech companies, including Eleven Biotherapeutics Inc., NinePoint Medical Inc., Blueprint Medicines Corporation, Warp Drive Bio LLC, Edimer Pharmaceuticals, Avila Therapeutics Inc., and Voyager Therapeutics Inc. Prior to that, she held CFO positions at EPIX Pharmaceuticals and gained valuable experience at Millennium Pharmaceuticals. Ms Drapkin also currently serves as the audit committee chair and compensation committee member on Acumen Pharmaceuticals' board. Previously, she served on Proteostasis Therapeutics' board from 2019 to 2020 and continued on Yumanity Therapeutics' board following its merger with PTI in December 2020 until December 2022. In PTI and Yumanity, she chaired the audit committee and participated in the governance and compensation committees. Ms. Drapkin also served on transaction committees for both companies. Imugene also announces that Charles Walker has resigned from his position as a NED of Imugene on 30 June 2023 after a long period of service to focus on his other business interests. Charles has served on Imugene's Board since August 2014, including a tenure as CEO, and has provided a valued contribution and wise counsel to the Company. Price Target Changed • May 22
Price target decreased by 9.8% to AU$0.46 Down from AU$0.51, the current price target is an average from 3 analysts. New target price is 283% above last closing price of AU$0.12. Stock is down 47% over the past year. The company is forecast to post a net loss per share of AU$0.0087 next year compared to a net loss per share of AU$0.0067 last year. Ankündigung • Feb 02
Imugene Limited Announces VAXINIA Trial Advances to Combination Cohort 1 & Monotherapy Cohort 3 Imugene Limited announced that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33- hNIS (VAXINIA) has cleared cohort 2 of both the intravenous (IV) and intratumoral (IT) arms of the monotherapy trial, allowing it to open cohort 1 of the combination study (with Pembrolizumab) and cohort 3 for both arms of the monotherapy dose escalation. The company announced the first patient had been dosed in IV cohort 2 on 5 December 2022, with the trial continuing its unimpeded progress since. The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. The patients treated to date in the monotherapy group have received the lowest doses of VAXINIA and have demonstrated acceptable safety, allowing new study participants to receive it in combination with the immunotherapy pembrolizumab. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia. Ankündigung • Jan 09
Imugene Limited Receives Vaxinia Ethics Approval in Australia Imugene Limited announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its oncolytic virotherapy candidate, VAXINIA in Australia. Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of VAXINIA required to commence human clinical trials in Australia. The Australian component of the Phase I trial will be conducted under Australia's Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities. The first hospital to receive ethics approval is Tasman Oncology Research, a comprehensive cancer hospital located in Eastwood, South Australia. Additional clinical sites will be opened in Australia, as have already been in the US following a Food and Drug Administration (FDA) investigational new drug (IND) approval 12 months ago. The primary aim of the Phase 1 trial is to determine safety and an optimal biological dose of VAXINIA (CF33-hNIS) as a monotherapy and later in combination with immune checkpoint inhibitors. Efficacy, tolerability and immune response will also be measured. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models. Ankündigung • Dec 10
Imugene Limited Presents New and First CHECKvacc Data At the 2022 San Antonio Breast Cancer Symposium Imugene Limited announced new and first data from triple negative breast cancer (TNBC) patients in the Phase I CHECKVacc trial has been presented as a poster presentation at the 2022 San Antonio Breast Cancer Symposium (SABC 2022) on 9 December 2022 AEDT in San Antonio, Texas. CF33-hNIS-antiPD-L1 administered by intratumoral injection in patients with metatstatic TNBC is safe and well tolerated at the dose levels tested. Highlights and results include: From October 2021 to June 2022, 6 patients were enrolled in this ongoing study and received at least 1 dose of CHECKvacc injection at dose level 1 (1 x 10^5 pfu) or dose level 2 (3 x 10^5 pfu). No dose-limiting toxicities were observed. No treatment related adverse events were reported for 6 patients except 1 patient with injection site discoloration. 99mTc SPECT imaging for virus tracking from virus induced replication of the human sodium iodide (hNIS) transgene shows enhancement in 4/6 (67%) patients in the first 2 dose levels. Enhancement was greater in patients with injection of nodal disease compared to dermal metastasis. SPECT imaging of patient COH-004 (DL-2) on C1D8 showed significant enhancement of injected lymph node. Baseline and on-treatment tumor biopsies of patient COH-004 using spatial immune profiling showed an increase in PD-L1 positive cells following treatment with CHECKVacc, demonstrating immune activation and tumor microenvironment changes in association with response to therapy. Taken together, these data support further evaluation of CHECKVacc in TNBC. CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, one of the cancer research and treatment organizations in the United States, and a noted expert in the oncolytic virus field. Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival. Board Change • Dec 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Chair of Oncolytic Virotherapy Scientific Advisory Board Yuman Fong was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Price Target Changed • Nov 16
Price target decreased to AU$0.52 Down from AU$0.58, the current price target is an average from 3 analysts. New target price is 172% above last closing price of AU$0.19. Stock is down 65% over the past year. The company is forecast to post a net loss per share of AU$0.009 next year compared to a net loss per share of AU$0.0067 last year. Recent Insider Transactions Derivative • Nov 10
Independent Non-Executive Director exercised options to buy AU$3.2m worth of stock. On the 4th of November, Charles Walker exercised 25.00m options at around AU$0.045, then sold 8.25m of them at AU$0.20 each and kept the remainder. Since December 2021, Charles' direct individual holding has increased from 5.69m shares to 5.82m. Company insiders have collectively sold AU$40m more than they bought, via options and on-market transactions in the last 12 months. Ankündigung • Oct 31
Imugene Limited Announces That First Patient Dosed in VAXINIA Intratumoral Cohort 2 Imugene Limited announced that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has advanced with the first patient dosed within intratumoral (IT) cohort 2 of the trial. This follows the announcement in September that the first patient had been dosed as part of the intravenous (IV) cohort 1 of the study. A multicenter Phase 1 trial, the VAXINIA Phase 1 MAST study has to date delivered a low dose to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources. Ankündigung • Oct 14
Imugene Limited, Annual General Meeting, Nov 17, 2022 Imugene Limited, Annual General Meeting, Nov 17, 2022, at 10:00 AUS Eastern Standard Time. Location: Level 3, 62 Lygon Street, Carlton Victoria Australia Agenda: To consider and receive the financial report, the Directors' report and the auditor's report for the year ended 30 June 2022; to consider Directors' remuneration report; to consider re-election of Director - Mr Paul Hopper; to consider re-election of Director - Dr Lesley Russell; to consider re-election of Director - Dr Jens Eckstein; to consider election of Director - Dr Jakob Dupont; to consider issue of options to Director - Ms Leslie Chong; and to consider other matters. Price Target Changed • Sep 30
Price target decreased to AU$0.51 Down from AU$0.55, the current price target is an average from 3 analysts. New target price is 185% above last closing price of AU$0.18. Stock is down 62% over the past year. The company is forecast to post a net loss per share of AU$0.009 next year compared to a net loss per share of AU$0.0067 last year. Ankündigung • Sep 22
Imugene Limited Announces First patient IV dosed in VAXINIA Phase 1 clinical trial Imugene Limited announced that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has seen the first patient dosed as part of intravenous (IV) cohort 1 in the trial. The dosing of this patient follows the recent announcement that intratumoral (IT) cohort 1 had cleared,paving the way for both cohort 2 of IT administration and cohort 1 of IV administration. A multicenter Phase 1 trial, the VAXINIA Phase 1 MAST study has to date delivered a low dose to patientswith metastatic or advanced solid tumours who have had at least two prior lines of standard of caretreatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarianand pancreatic cancer tumours in preclinical laboratory and animal models. The study aims to recruit 100 patients across approximately 10 trial sites in the United States and Australia.Earlier this week, Imugene announced it had received the DIR licence from the Australian Government'sOffice of Gene Technology Regulator, allowing for expansion of the trial within Australia. Ankündigung • Sep 19
Imugene Limited Announces That Australian Government's Office of the Gene Technology Regulator (Ogtr) Has Granted Imugene the Dir Licence Required to Expand Its Vaxinia Phase 1 Clinical Trial Within Australia Imugene Limited announced that the Australian Government's Office of the Gene Technology Regulator (OGTR) has granted Imugene the DIR licence required to expand its VAXINIA Phase 1 clinical trial within Australia. The licence, numbered DIR 192 and titled `Clinical trial of a genetically modified (GM) chimeric Orthopoxvirus (CF33-hNIS) as a cancer treatment', is required as part of the Australian regulatory framework for dealings involving the intentional release of genetically modified organisms into the environment. Imugene's multicenter Phase 1 VAXINIA trial commenced in May 2022 at US sites, delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." Overall the study aims to recruit 100 patients across approximately 10 clinical trial sites in the United States and Australia. The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources. Major Estimate Revision • Sep 17
Consensus forecasts updated The consensus outlook for 2023 has been updated. 2023 revenue forecast increased from AU$7.90m to AU$18.0m. EPS estimate unchanged from -AU$0.0087 at last update. Biotechs industry in Australia expected to see average net income growth of 8.6% next year. Consensus price target down from AU$0.55 to AU$0.52. Share price fell 2.2% to AU$0.22 over the past week. Price Target Changed • Sep 16
Price target decreased to AU$0.52 Down from AU$0.58, the current price target is an average from 2 analysts. New target price is 138% above last closing price of AU$0.22. Stock is down 53% over the past year. The company is forecast to post a net loss per share of AU$0.0087 next year compared to a net loss per share of AU$0.0067 last year. Ankündigung • Sep 08
Imugene Limited Doses First Patient in nextHERIZON Phase 2 Trial Imugene Limited announced the first patient has been dosed in the nextHERIZON Phase 2 clinical trial investigating Imugene's immunotherapy candidate HER-Vaxx in combination with chemotherapy or pembrolizumab in patients with HER-2+ gastric cancer.The first patient was dosed at the Queen Elizabeth Hospital in Adelaide, Australia, under the direction of the Principal Investigator Professor Tim Price. Imugene expects to open additional study sites in Australia, as well as the USA under the Food and Drug Administration (FDA) investigational new drug (IND) approval received in December 2021. Commencement of the trial comes following ethics approval announced on 10 May 2022. The open-label, multi-center, signal generating, Phase 2 clinical trial is designed to assess the safety and efficacy of HER-Vaxx in combination with chemotherapy or pembrolizumab in patients with metastatic HER-2/neu over- expressing gastric or gastroesophageal junction adenocarcinomas, who have previously progressed ontrastuzumab. The study's primary endpoints are safety and response rate, while secondary endpoints include duration of response, progression free survival, overall survival, and biomarker evaluation. Ankündigung • Sep 07
Imugene Appoints Jakob Dupont as Non- Executive Director Imugene Limited announced the appointment of Dr. Jakob Dupont as a Non-Executive Director (NED). Dr. Dupont is an industry and academic drug development expert, specialising in oncology and other therapeutic areas, with more than 20 years of experience. He has made major contributions to the development and approval of ten oncology drugs and has orchestrated successful development programs for numerous drugs. Dr. Dupont is currently the Global Head of Research and Development at Atara Biotherapeutics, where he oversees all research and development including three clinical stage programs spanning Phase 1 through to Phase 3, and numerous pre-clinical programs. He also oversees key collaborations with academic and pharma partners, holds leadership and guidance roles for various teams within the business and acts as a spokesperson to investors and the Board of Directors. Prior to Atara, Dr. Dupont spent more than six years in various roles at Genentech/Hoffman-La Roche including as Vice President, Global Head of Breast and GYN Cancer Development, in addition to a further five years at Oncomed Pharmaceuticals as Senior Vice President and Chief Medical Officer. Dr. Dupont is currently an Independent Director at Apexigen and a Scientific Advisory Board Member at AMBRX. Ankündigung • Sep 01
Imugene Dose Escalates in Phase I Clinical Trial of New Oncolytic Virus VAXINIA Imugene Limited announced that its Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has reached key next milestones in the trial. The intratumoral (IT) cohort 1 has now cleared, which sees the opening of cohort 2 for IT administration, while in parallel intravenous (IV) cohort 1 has also opened. Multiple sites in the United States, have dosed the patients in IT cohort 1. The Cohort Review Committee (CRC) unanimously agreed VAXINIA to be safe, with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after CRC review of all safety and tolerability data for the first three patients dosed with the lowest dose of VAXINIA as monotherapy. At completion of the review meeting, the CRC advised Imugene to proceed with opening the second VAXINIA Phase 1 cohort at the mid- dose level. The multicenter Phase 1 trial has commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Once patients in the monotherapy group have been treated with the lowest doses of VAXINIA and acceptable safety has been demonstrated, new study participants will receive it in combination with the immunotherapy pembrolizumab. This is expected to begin following cohort 2 being cleared per route of administration. Overall the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia. Ankündigung • Aug 10
Imugene Limited Announces First Cohort 3 Patient Dosed in Clinical Trial of CHECKvacc Imugene Limited announced that City of Hope®, one of the largest cancer research and treatment organizations in the United State, has dosed the first patient in cohort 3 in the Phase I clinical trial of oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1). The first-in-human, Phase 1, single-centre, dose escalation study of CHECKvacc is recruiting patients with triple negative breast cancer (TNBC). The purpose of the study is to evaluate the safety and initial evidence of efficacy of intra-tumoural administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The current trial design will involve a dose escalation, followed by an expansion to 12 patients at the final dose, which will be the recommended phase 2 dose (RP2D). CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field. Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival. Ankündigung • Jul 18
Imugene Limited Appoints Mike Tonroe as Chief Financial Officer, Effective from September 2022 Imugene Limited announced the appointment of Mike Tonroe as Chief Financial Officer (CFO) who will commence in the newly created in house role, subject to finalization of Mike's transition arrangements expected to be in early September 2022. Mr. Tonroe has extensive experience as a CFO and Company Secretary within the biopharmaceutical industry and also brings international finance leadership experience having worked in the US, Canada, UK and Hong Kong, in addition to Australia. Most recently, Mr. Tonroe was CFO and Company Secretary at Genetic Technologies Limited and Opthea Limited, and prior to that was in the same role for private business Australian Synchotron Company Ltd. Adding to the depth of Mr. Tonroe's experience, he has exposure to the technology, energy and travel sectors from earlier roles which also include time with major accounting firms KPMG and Deloitte. Mr. Tonroe graduated in Business Studies with Honours from Buckingham University UK, later becoming a Member then Fellow of the Institute of Chartered Accountants in England & Wales and being Australian Institute of Company Directors accredited. Ankündigung • Jul 02
Imugene Limited Announces Appointment of Dr. Sharon Yavrom as Executive Director, Clinical Scientist Imugene Limited announced the appointment of Dr. Sharon Yavrom as Executive Director, Clinical Scientist, effective July 1, 2022. Dr. Yavrom is an accomplished clinical scientist with nearly 20 years of industry experience in bothestablished and emerging pharmaceutical companies. She has previously held positions at industry leading companies such as TAP Pharmaceuticals, Amgen and BMS and has spent her recent career lending her expertise to start-up companies such as Synta Pharmaceuticals, Puma Biotechnology, Tocagen, Aduro, MEI Pharma and Oncternal, with a focus on the oncology therapeutics space. Dr. Yavrom has been the clinical study lead for several clinical trials and has experience with multiple tumour types including HER2+ breast cancer, NSCLC, glioblastoma, colorectal cancer, non-invasive bladder cancer, NHL, CLL and Ewing's Sarcoma. Dr. Yavrom received her Bachelor of Science degree in Biology from San Jose State University and her Ph.D. in Pathobiology from University of Southern California, Keck School of Medicine. Ankündigung • Jun 28
Imugene Limited Announces Final HER-Vaxx Phase 2 Trial Overall Survival Results Imugene Limited is to present positive final overall survival data from its Phase 2 study of HER-Vaxx in Her-2/Neu overexpressing advanced/metastatic gastric/GEJ cancer following analysis of safety and efficacy data. The final analysis results from the randomised clinical HERIZON study, which was designed with a specified 1-sided false positive probability of 0.10, showed a 41.5% survival benefit for patients treated with HER-Vaxx plus SOC chemotherapy compared to SOC chemotherapy alone. This translated into an overall survival HR of 0.585 (80% 2-sided CI: 0.368, 0.930) with a statistically significant p-value of 0.066. There was no difference in safety events between the two treatment arms, suggesting that HER-Vaxx does not add toxicity to SOC chemotherapy. The longest HER-Vaxx treated patients remain alive 2.5 years (with one patient approaching 3 years) after starting therapy. It is noteworthy that these patients generated the strongest anti-Her-2 antibody levels from their dosing schedule on HER-Vaxx. Historical data from the large ToGA Phase 3 study which examined the effect of Herceptin plus chemotherapy versus chemotherapy alone in advanced gastric cancer, had an overall survival HR of 0.65 for the analysis of the same patient population of HER2 overexpressing patients included in the HER-Vaxx Phase 2 study.Imugene is also pleased to announce the HERIZON-extension Cohort Review Committee (CRC) has confirmed a new higher dose of HER-Vaxx (100µg) has been approved for use in the nextHERIZON (pretreated metastatic HER2 positive gastric cancer) and neoHERIZON (perioperative HER2 positive gastric cancer) studies commencing soon. The CRC unanimously agreed HER-Vaxx at 100µg to be safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed. The higher dose is expected to accelerate and strengthen antibody generation to further improve the clinical response for HER-Vaxx. Importantly, Imugene announces completion and delivery of a large-scale batch of HER-Vaxx for use in all planned clinical trials (nextHERIZON and neoHERIZON) in patients with HER-2 positive gastric cancer. The batch which is manufactured by piCHEM (Austria) with final sterile fill and finish at Baccinex (Switzerland) has been QA/QC/QP released and delivered to Imugene's drug depot at Marken (Singapore). The Phase 2 HER-Vaxx study was designed to measure the efficacy, safety and immune response in patients with metastatic gastric cancer overexpressing the HER-2 protein. The study was randomised into two arms of either HER-Vaxx plus SOC chemotherapy or SOC chemotherapy alone. The primary endpoint was overall survival and secondary endpoint was progression-free survival. Safety, tolerability and immune response was also measured. The Phase 2 trial was conducted at multiple sites across Eastern Europe and India where clinicians have difficulty accessing approved antibody treatments such as Herceptin® and Perjeta®, marketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in the countries selected. Major Estimate Revision • Jun 28
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -AU$0.01 to -AU$0.01 per share. Revenue forecast of AU$6.75m unchanged since last update. Biotechs industry in Australia expected to see average net income growth of 9.5% next year. Consensus price target of AU$0.55 unchanged from last update. Share price rose 48% to AU$0.21 over the past week. Recent Insider Transactions Derivative • Jun 13
Independent Non-Executive Director exercised options to buy AU$1.5m worth of stock. On the 7th of June, Lesley Russell exercised options to buy 10m shares at a strike price of around AU$0.045, costing a total of AU$450k. This transaction amounted to 95% of their direct individual holding at the time of the trade. Since June 2021, Lesley's direct individual holding has decreased from 13.70m shares to 10.50m. Company insiders have collectively sold AU$43m more than they bought, via options and on-market transactions in the last 12 months. Ankündigung • Jun 01
Imugene Limited Announces Board Changes Imugene Limited announced the appointment of Dr. Yanghee Woo, MD, FACS, Surgical Oncologist and Associate Professor of Surgery, City of Hope to the Company's Scientific Advisory Board (SAB). Dr. Woo is an internationally recognised surgeon-scientist with clinical expertise in robotic surgery and gastric cancer. She holds several key positions at City of Hope including Director of GI Minimally Invasive Therapies Program, Vice Chair of International Affairs and is also a Visiting Professor at Xiangya Medical School, China. In addition to her clinical and teaching experience, Dr. Woo is currently researching gastric cancer inception and viral oncolytic therapy based on the CF33-platform. Dr. Woo is part of the team that created a chimeric orthopoxvirus, CF33-hNIS-antiPDL1, which has exhibited strong potential in targeting solid tumours and the most common type of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC). Previous to commencing at the Department of Surgery at City of Hope in 2015, Dr. Woo held various positions at Columbia University Medical Center's (CUMU) Pancreas Center where she was Assistant Professor of Surgery and later Director of Center for Global Excellence in Gastric Cancer Care. Dr. Woo received her Medical Doctorate from Drexel University Medical School and completed the Health Careers Program at Harvard University. She completed a general surgery residency at CUMC, a research fellowship at Memorial Sloan Kettering Cancer Center and a clinical fellowship at Severance Hospital, Yonsei University, Seoul. Imugene also announced that its Chief Medical Officer, Dr. Steven Cha, is regretfully resigning from his position due to family reasons. The Company wishes him the very best and will announce a replacement in due course. Ankündigung • May 10
Imugene Limited Receives Ethics Approval to Start Phase 2 nextHERIZON Clinical Trial of Cancer Immunotherapy HER-VAXX Imugene Limited announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase 2 clinical trial of its immunotherapy candidate, HER-Vaxx in Australia. Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of HER-Vaxx required to commence its nextHERIZON clinical trial in Australia. nextHERIZON is an open-label, multi-center, signal generating, Phase 2 clinical trial designed to assess the safety and efficacy of HER-vaxx in combination with chemotherapy or pembrolizumab in patients with metastaticHER-2/neu over-expressing gastric or gastroesophageal junction adenocarcinomas who have previously progressed on trastuzumab. The study's primary endpoints are safety and response rate. Secondary endpoints include duration of response, progression free survival, overall survival, and biomarker evaluation. The Australian component of the Phase 2 trial will be conducted under Australia's Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities. The first hospital to receive ethics approval is the Queen Elizabeth Hospital, Adelaide Australia under the direction of Principal Investigator Dr Tim Price. Additional clinical sites will be opened in Australia, and also in the US under Food and Drug Administration (FDA) investigational new drug (IND) approval in December 2021. Ankündigung • Apr 13
Imugene Limited Announces First Cohort 2 Patient Dosed in Clinical Trial of CHECKvacc Imugene Limited announced that City of Hope® has dosed the first cohort 2 patient in the Phase I clinical trial of oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1). The first-in-human, Phase 1, single-centre, dose escalation study of CHECKvacc is recruiting patients with triple negative breast cancer (TNBC). The purpose of the study is to evaluate the safety and initial evidence of efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The current trial design will involve a dose escalation, followed by an expansion to 12 patients at the final dose, which will be the recommended phase 2 dose (RP2D). The clinical trial is titled "A Phase I Study of Intratumoral Administration of CF33-hNIS-antiPDL1 in Patients with Advanced or Metastatic Triple Negative Breast Cancer". The Principal Investigator leading the trial is Dr. Yuan Yuan MD, PhD. CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field. Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival. Major Estimate Revision • Mar 22
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -AU$0.01 to -AU$0.01 per share. Revenue forecast unchanged from AU$13.5m at last update. Biotechs industry in Australia expected to see average net income growth of 19% next year. Consensus price target down from AU$0.58 to AU$0.55. Share price was steady at AU$0.26 over the past week. Ankündigung • Feb 01
Imugene Limited Announces Appointment of Steven Cha as Chief Medical Officer and Member of the Executive Management Team Imugene Limited announced the appointment of Dr. Steven Cha, MD, as Chief Medical Officer (CMO) and a member of the Company's executive management team. Prior to this he was Vice President, Oncology at Samumed, LLC, where he was responsible for building and establishing the oncology therapeutic indication and associated team, including the Clinical Development, Pre-Clinical, Toxicology, Clinical Operations, Medical Affairs, Clinical Pharmacology, and Translational Oncology Groups. Ankündigung • Jan 29
Imugene Limited Receives Notice of Grant from the European Patent Office for Patent Application Number Imugene Limited announced it has received a Notice of Grant from the European Patent Office for Patent Application number 16779340.5 (granted patent number 1111/3283105) which protects its HER-Vaxx immunotherapy, currently in development for HER-2 positive gastric cancer. The patent titled "A VACCINE COMPOSITION AND USES THEREOF" protects the method of composition and method of use of Imugene's HER-Vaxx immunotherapy to 2036. Imugene's HER-Vaxx is a B-cell activating immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies, in Phase I and now Phase 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target. Ankündigung • Jan 04
Imugene Completes Phase 1a Monotherapy Dose Escalation of Immunotherapy PD1-Vaxx Imugene Limited announced the Cohort Review Committee (CRC) has confirmed its checkpoint immunotherapy candidate, PD1-Vaxx, has completed its Phase 1a monotherapy dose escalation and will proceed to combination dose escalation. The Phase 1a monotherapy dose escalation was performed with 10, 50 and 100µg of PD1-Vaxx in non-small cell lung cancer (NSCLC) patients who progressed on one or more immune checkpoint inhibitors (ICIs). After CRC review of monotherapy safety, tolerability and biomarker data, it advised Imugene to proceed to the combination phase of clinical development of PD1-Vaxx. The primary objective of the phase 1 trial is to determine safety and optimal biological dose as monotherapy and in combination with immune checkpoint inhibitors (ICI). Plans are now being finalized to combine PD1-Vaxx with Roche/Genentech's PD-L1 targeting blockbuster ICI atezolizumab (Tecentriq) as first-line in ICI treatment naïve NSCLC patients. Dual targeting of the PD-1/PD-L1 axis is an area of considerable interest with ongoing clinical results creating strong interest inside the pharma industry¹. Combination with PD1-Vaxx may overcome treatment resistance to ICIs² with dual inhibition of the PD-1/PD-L1 axis extending the treatment benefit of atezolizumab. In contrast to combination of two monoclonal antibodies, PD1-Vaxx has the advantage that it induces a unique polyclonal immune response which may increase response rates for the combination therapy. Recent Insider Transactions • Dec 19
Executive Chairman recently sold AU$37m worth of stock On the 13th of December, Paul Hopper sold around 75m shares on-market at roughly AU$0.49 per share. This was the largest sale by an insider in the last 3 months. This was Paul's only on-market trade for the last 12 months. Ankündigung • Dec 08
Imugene Limited Provides Update on Clinical Trial of Oncolytic Virotherapy CHECKvacc Imugene Limited announced that City of Hope® has dosed the second patient in the Phase I clinical trial of oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1). This follows the first patient clearing the 28-day safety window between patient dosing in the initial cohort, as instructed by the FDA. The first-in-human, Phase 1, single-centre, dose escalation study of CHECKvacc is recruiting patients with triple negative breast cancer (TNBC). The purpose of the study is to evaluate the safety and initial evidence of efficacy of intratumoural administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The current trial design will involve a dose escalation, followed by an expansion to 12 patients at the final dose, which will be the recommended phase 2 dose (RP2D). The clinical trial is titled "A Phase I Study of Intratumoural Administration of CF33-hNIS-antiPDL1 in Patients with Advanced or Metastatic Triple Negative Breast Cancer". The Principal Investigator leading the trial is Dr. Yuan Yuan MD, PhD. CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field. Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival. Recent Insider Transactions • Oct 13
Insider recently sold AU$1.4m worth of stock On the 6th of October, Lesley Russell sold around 3m shares on-market at roughly AU$0.42 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of AU$5.7m more than they bought in the last 12 months. Ankündigung • Aug 27
Imugene Limited Provides Phase 1 Clinical Trial Update of Its Immunotherapy Pd1-Vaxx Imugene Limited provide a Phase 1 clinical trial update of its immunotherapy PD1-Vaxx. Three patients have now commenced their dosing schedule for the third monotherapy cohort of the Phase 1 trial. Barring any unforeseen clinical observations, the optimal biological dose of 100µg is expected to be ratified at the next Cohort Review Committee (CRC) currently scheduled for the first week of October. The clinical results continue to indicate that PD1-Vaxx is showing early signs of an immune response in patients, with antibodies to the target biomarker PD-1 evident in validated assays. The first-in-human, Phase 1, multi-centre, dose escalation study of PD1-Vaxx is recruiting patients with non-small cell lung cancer. Medical investigators are testing three different doses of PD1-Vaxx. The primary goal of the Phase 1 trial is to determine safety and an optimal biological dose as a monotherapy (mOBD). Efficacy, tolerability and immune response will also be measured. Determination of mOBD will be made by the CRC and requires successive dosing within cohorts of at least three patients each. Company's PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction, and produce an anti-cancer effect similar to Keytruda®, Opdivo® and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers. Ankündigung • Jul 06
Imugene Presents HER-Vaxx Update at ESMO World GI Congress Imugene Limited announced the company presented on the HER-Vaxx cancer immunotherapy program at the ESMO World Congress on Gastrointestinal Cancer 2021 Annual Meeting. The abstract presentation was entitled `HERIZON: A PHASE 1B/2 OPEN-LABEL STUDY OF IMU-131 HER2/NEU PEPTIDE VACCINE PLUS STANDARD OF CARE CHEMOTHERAPY WITH RANDOMIZATION IN PHASE 2 IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC OR ADVANCED ADENOCARCINOMA OF THE STOMACH OR GASTROESOPHAGEAL JUNCTION' Updated Interim Analysis Results. The presentation expanded on previously presented interim analysis data presented at AACR2021. To recap previously released results: Interim analysis in the randomized Phase 2 study showed statistically significant overall survival Hazard Ratio (HR) of 0.418 (80% 2-sided CI: 0.186, 0.942); HER-Vaxx showed a reduced risk of death of 58.2% in the HER-Vaxx plus chemotherapy group as compared to chemotherapy alone. The median overall survival (OS) for patients receiving HER-Vaxx plus chemotherapy was 14.2 months, compared to 8.8 months in patients treated with chemotherapy alone. The Phase 2 data represent a clinical proof-of-concept signal for HER-Vaxx when added to chemotherapy and indicate that B-cell activating immunotherapy vaccines can induce clinically active antibody responses. Recruitment of the Phase 2 trial was completed in January 2021. The ESMO presentation highlights and presents the following new data: HER-Vaxx treatment resulted in a 50% Overall Response Rate (ORR) compared to 29% in patients treated with chemotherapy alone. The ORR measures the percentage of patients who responded to treatment with a partial response (PR) or better. Treatment with HER-Vaxx clearly demonstrates patients develop high levels of HER2-specific antibodies early in the treatment protocol and are maintained during treatment and maintenance phase with only a few booster injections. Tumour response is correlated with the amount of antibody levels. Patients with antibody levels higher than 1,050ng/ml received greater than 50% tumour reduction and may serve as a potential biomarker. In contrast to patients on chemotherapy alone, the reduction of tumour size is substantially higher in patients that received HER-Vaxx + chemotherapy. Overall, this data demonstrates HER-Vaxx may provide treatment benefits consistent with traditional monoclonal antibodies with a corresponding adaptive immune response without added toxicity. Imugene's HER-Vaxx is a B-cell activating cancer immunotherapy designed to treat tumours that over- express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER- 2/neu. It has been shown in pre-clinical studies and in Phase 1 and 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target. Ankündigung • Jul 03
Imugene Limited Announces FDA IND Approval of New Oncolytic Virotherapy Checkvacc Virotherapy Checkvacc Imugene Limited announced the City of Hope®, a world-renowned independent cancer research and treatment center near Los Angeles has received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a Phase I clinical trial of its oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1) on 30 June 2021. The FDA approval of the IND allows Imugene and City of Hope to start patient recruitment and dosing in a Phase 1 clinical trial for triple-negative breast cancer (TNBC) patients. The purpose of the study is to evaluate the safety and initial evidence of efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The trial will involve a dose escalation, followed by an expansion to 12 patients at the final dose, the recommended phase 2 dose (RP2D). CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field. Recent Insider Transactions Derivative • May 28
CEO, MD & Executive Director exercised options and sold AU$1.6m worth of stock On the 25th of May, Leslie Chong exercised 36.16m options at around AU$0.04, then sold 4m of the shares acquired at an average of AU$0.41 per share and kept the remainder. For the year to June 2020, Leslie's total compensation was 51% salary and 49% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2020, Leslie's direct individual holding has increased from 4.39m shares to 31.49m. Company insiders have collectively sold AU$4.9m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • May 28
Independent Non-Executive Director recently sold AU$1.2m worth of stock On the 21st of May, Charles Walker sold around 4m shares on-market at roughly AU$0.35 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of AU$3.4m more than they bought in the last 12 months. 
