Latest news with #mPDAC
The Market Online
29-07-2025
- Business
- The Market Online
Oncolytics Biotech sparks FDA discussions for potential pivotal pancreatic cancer trial
Oncolytics Biotech (TSX:ONC) has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) to advance pelareorep, its lead immunotherapeutic candidate The FDA discussions will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy—with or without checkpoint inhibitors—and will use overall survival as the primary endpoint The company expects to move quickly and decisively down a clear regulatory path Oncolytics Biotech stock (TSX:ONC) opened trading at C$1.47 A clinical-stage immunotherapy company announced that it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) to advance its lead immunotherapeutic candidate. Oncolytics Biotech (TSX:ONC) wants to move pelareorep into a potential registration-enabled pivotal study for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Assuming productive engagement with the FDA, Oncolytics anticipates beginning study start-up activities before the end of 2025. This milestone underscores the company's confidence in pelareorep's differentiated mechanism of action and its promising survival signal in one of the most aggressive and underserved solid tumors. This content has been prepared as part of a partnership with Oncolytics Biotech Inc. and is intended for informational purposes only. The FDA discussions will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy—with or without checkpoint inhibitors—and will use overall survival as the primary endpoint. Among the trial design options under consideration is an adaptive study model, potentially in collaboration with a third-party partner. The announcement follows a recent event hosted by Oncolytics, where leading experts highlighted pelareorep's potential not only in mPDAC but also in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. The event reinforced the urgent need for innovative immunotherapies in pancreatic cancer, a field that has seen limited progress in recent decades. 'We expect to move quickly and decisively down a clear regulatory path,' Jared Kelly, Chief Oncolytics' CEO said in a media statement. 'This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors.' Pelareorep has already received both fast track and orphan drug designations from the FDA for mPDAC, and translational data continue to support its immunologic activity. These regulatory advantages, combined with compelling clinical data, position Oncolytics as an attractive partner for companies seeking to expand their GI oncology pipelines. Oncolytics Biotech is a clinical-stage biotechnology company developing immunotherapies against breast, anal and pancreatic cancer. Oncolytics Biotech stock (TSX:ONC) opened 0.66 per cent lower trading at C$1.47, but it has climbed 20.38 per cent since the year began and is up 4.76 per cent since this time last year. Join the discussion: Find out what the Bullboards are saying about Oncolytics Biotech and check out Stockhouse's stock forums and message boards. Stockhouse does not provide investment advice or recommendations. All investment decisions should be made based on your own research and consultation with a registered investment professional. The issuer is solely responsible for the accuracy of the information contained herein. For full disclaimer information, please click here .
Cision Canada
29-07-2025
- Business
- Cision Canada
Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End
Clear regulatory path and strong survival data in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) support accelerated strategy to drive shareholder value and partnership opportunities SAN DIEGO and CALGARY, AB, July 29, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Assuming discussions with the FDA go as expected, the Company expects to commence study start-up activities before the end of 2025. This milestone reflects Oncolytics' conviction in pelareorep's differentiated mechanism of action and its encouraging survival signal in one of the most lethal and underserved solid tumors. The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint. Among the potential options, Oncolytics will consider proposing an adaptive study in collaboration with a third party. "We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, Chief Executive Officer of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors." Oncolytics' recent Key Opinion Leader event reinforced the clinical promise of pelareorep in mPDAC and other gastrointestinal (GI) cancers, including KRAS-mutated colorectal cancer, and validated its ability to transform "cold" tumors into immunologically active ones. Experts emphasized the scarcity of innovation in pancreatic cancer and the urgent demand for new immunotherapies that can deliver a survival benefit in this setting. With Fast Track and Orphan Drug designations in mPDAC and translational data supporting pelareorep's immunologic activity, the Company believes it is well-positioned to engage potential partners seeking to bolster their GI oncology pipelines. The upcoming regulatory discussions and planned trial initiation represent major catalysts for strategic collaboration and long-term value creation. Additional information on the study design, timelines, and next steps will be provided following regulatory feedback. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and early-phase studies in pancreatic and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and checkpoint inhibitors in metastatic breast and pancreatic cancers, both of which have received Fast Track designation from the FDA. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @ oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans for a potential registration-enabled pivotal study in first-line mPDAC and the anticipated potential timing of commencement of start-up activities and enrollment in a study, the focus of our discussions with the FDA in respect of the study; the anticipated trial design; our plans to move quickly and decisively down a clear regulatory path; our goals, strategies and objectives; our belief in the clinical promise of pelareorep in mPDAC and other gastrointestinal cancers; our belief that we are well-positioned to engage potential partners seeking to bolster their GI oncology pipelines; and our active pursuit of strategic partnerships. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the U.S. and Canada for more information. The company assumes no obligation to update forward-looking statements, except as required by laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Owen Blaschak LifeSci Communications [email protected] SOURCE Oncolytics Biotech® Inc.
Globe and Mail
08-07-2025
- Business
- Globe and Mail
Oncolytics Biotech® Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies
Comparison with multiple landmark first-line metastatic pancreatic ductal adenocarcinoma studies substantiates strong two-year survival benefit of 21.9% vs. 9.2% historical benchmark Consistent survival benefit compared to standard-of-care chemotherapy in randomized studies in the large HR+/HER2- metastatic breast cancer indication Data from over 1,100 patients across tumor types reveals a favorable, well-understood safety profile SAN DIEGO and CALGARY, AB , July 8, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company's intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies. "We are no longer in the business of funding proof-of-concept studies," said Jared Kelly , Chief Executive Officer of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology." Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer. Currently, there are no approved immunotherapies for first-line treatment of mPDAC. Pelareorep's clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm. "Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman , Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies like mPDAC and unresectable HR+/HER2- breast cancer, creating new oncology entry points for immune-based combination therapies." Data from more than 1,100 patients enrolled in multiple studies across several tumor types affirm that pelareorep has a favorable, well-understood safety profile. The most common treatment-related adverse events (TRAEs) are "flu-like" symptoms, such as fever, chills, headache, fatigue, myalgia, cough, anorexia, nausea, diarrhea, or vomiting, and rarely resulted in clinically significant grade ≥3 TRAEs. Adverse events are typically transient and manageable with over-the-counter medications. Pelareorep received Fast Track designations from the U.S. Food and Drug Administration (FDA) in 2017 for metastatic breast cancer and in 2022 for mPDAC in combination with chemotherapy and atezolizumab. In 2015, pelareorep also received Orphan Drug Designations from the FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer. The Company released a new corporate presentation, available on its website, that provides detailed clinical and translational data. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype – turning "cold" tumors "hot" – through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans, objectives and strategies; our focus on advancing pelareorep directly into registration-enabling trials; our plans to use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication jpatton@ Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 mmoyer@ Media Contact for Oncolytics Owen Blaschak LifeSci Communications oblaschak@
Yahoo
03-06-2025
- Business
- Yahoo
Actuate Therapeutics shares highlights from KOL eventon elraglusib data
Actuate Therapeutics (ACTU) announced key takeaways from its Key Opinion Leader event held on May 31, 2025 discussing the topline results from the Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The study met its primary endpoint, demonstrating a clinically meaningful increase in median overall survival of 10.1 months compared to 7.2 months, with a 37% reduction in the risk of death. The elraglusib/GnP arm also doubled the 12-month survival rate in 44.1% of patients compared to GnP alone, with a favorable safety profile. The KOL event followed the presentation of topline trial data during an oral session at the American Society of Clinical Oncology Annual Meeting. The event featured a fireside discussion with leading mPDAC clinicians, all with direct participation in the elraglusib clinical trial program: Colin Weekes, MD, PhD, Massachusetts General Hospital; Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine; Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center; Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science. The panelists highlighted the implications of the Phase 2 Actuate 1801 Part 3B results in the broader context of the unmet need in mPDAC, the unique immune-modulating mechanism of elraglusib, and its potential to reshape the treatment landscape. Daniel Schmitt, CEO of Actuate said, 'The reception we received at ASCO confirms what we already believed – this data has the potential to change the trajectory of mPDAC treatment. As our KOLs highlighted in the panel discussion, there is a clear need for new drugs, like elraglusib, with new mechanistic pathways, and which can be successfully combined without overlapping toxicities for treatment of this devastating disease. As these thought leaders pointed out, due to a number of negative trials, there has been quite some time since we've had anything that improves outcomes for patients with these chemotherapy backbones. The thought leaders further highlighted the importance of the overall survival benefit and noted the magnitude of that benefit in the elraglusib trial is actually substantial. We are now laser-focused on turning this promise into patient access. With a clear survival benefit, favorable safety profile, and strong scientific rationale, we look forward to advancing elraglusib development and initiating regulatory discussions with both the FDA and EMA.' Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on ACTU: Disclaimer & DisclosureReport an Issue Actuate Therapeutics Reports Positive Phase 2 Trial Results Promising Clinical Trial Results Justify Buy Rating for Actuate Therapeutics' Elraglusib Actuate Therapeutics Elects Directors at Annual Meeting Actuate Therapeutics to host KOL event on Phase 2 elraglusib data Actuate Therapeutics Announces Positive Phase 2 Trial Results Sign in to access your portfolio
Yahoo
31-05-2025
- Business
- Yahoo
Actuate Therapeutics Presents Topline Elraglusib Phase 2 Data at ASCO 2025 Annual Meeting: Trial Meets Primary Endpoint of Median Overall Survival and Doubles 1-Year Survival in First-Line Treatment of Metastatic Pancreatic Cancer
Phase 2 (Actuate-1801 Part 3B) trial meets primary endpoint and demonstrates a clinically meaningful increase in median overall survival (10.1 months vs 7.2 months; log-rank p=0.01) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) receiving elraglusib/GnP Risk of death was reduced by 37% (HR=0.63) in patients treated with elraglusib/GnP Data featured as an oral presentation at the ASCO Annual Meeting Company plans to engage with FDA in the second half of 2025 to align on a path towards product registration Company to host KOL event today at 6:30 pm CDT to discuss 1801 Part 3B results CHICAGO and FORT WORTH, Texas, May 31, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) ('Actuate' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today presented topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) at the American Society of Clinical Oncology (ASCO) Annual Meeting. Abstract Title: Preliminary results from the randomized phase 2 study (1801 Part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).Abstract Number: 4006Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and HepatobiliaryPresenter: Devalingam Mahalingam, MD, PhDOral Presentation Date and Time: Saturday, May 31, 2025, 4:48 PM CDT The trial met its primary endpoint of improved median overall survival. Median overall survival (mOS) increased by almost three months (10.1 months vs 7.2 months, HR=0.63, log-rank p=0.01) with a 37% reduction in the risk of death and strong statistical significance, representing a clinically meaningful advance in the potential treatment of mPDAC. Patients receiving elraglusib with GnP achieved a 12-month survival rate in 44.1% of patients treated—double that of GnP alone (22.3%). Dr. Deva Mahalingam, MD, PhD, Northwestern University Feinberg School of Medicine, and lead principal investigator of the 1801 Part 3B trial commented, 'Pancreatic cancer continues to represent one of the highest unmet medical needs with no major treatment advances in recent years, bar some molecular targets in small subsets of patients. New mechanisms of action are urgently needed. The addition of elraglusib to the existing chemotherapy backbone of gemcitabine and nab-paclitaxel is promising and may represent a meaningful therapeutic advance for patients with pancreatic cancer.' Daniel Schmitt, President & Chief Executive Officer of Actuate added, 'We significantly improved mOS, cut the risk of death by 37%, and doubled the 12-month survival rate. Combined with a manageable safety profile and strong emerging mechanistic insights, these results reinforce the transformative potential of our GSK-3β inhibitor program. Based on the clear clinical benefit and well-tolerated safety profile, we intend to engage with the FDA and EMA in the second half of this year to align on a path to registration. We believe this enables us to move rapidly towards commercialization and delivery of this first-in-class therapy to patients with an urgent unmet need.' Efficacy Figure 1 below depicts the Kaplan-Meier estimate for mOS (10.1 months vs 7.2 months, HR=0.63, log-rank p=0.01) with a 37% reduction in the risk of death, displaying a clear clinical survival benefit for patients treated in the elraglusib/GnP combination arm vs GnP alone arm. Actuate-1801 Part 3B: Kaplan-Meier Estimate for mOS as of March 27, 2025 (Topline data cut-off).In addition to the improved mOS and one-year survival rate, a continued survival benefit was also observed at eighteen and twenty-four months (survival rates of 19.7% vs 4.4% and 13.8% vs 0% in the elraglusib/GnP combination arm vs the GnP arm, respectively). The elraglusib/GnP combination treatment also resulted in numerically improved overall response rates (29.0% in the elraglusib/GnP combination arm vs 21.8% in the GnP arm) and improvements in median progression-free survival and median duration of response of 5.6 months vs 5.1 months, and 5.5 months vs 4.0 months in the elraglusib/GnP combination arms vs GnP arms, respectively. Safety and Biomarker Findings The trial also met its primary safety endpoint. Treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) in the elraglusib/GnP combination arm were similar to those observed in the GnP arm, indicating a favorable risk-benefit profile for the elraglusib/GnP combination. Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most frequent TRAEs observed (in about two-thirds of patients) being transient visual impairments that were reversible and non-progressive While Grade 3 or higher neutropenia was observed, similar rates of febrile neutropenia and sepsis were observed in both treatment arms. Pre-dose cytokine analysis that suggested lower baseline levels of key immune modulators, including CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3, were correlated with improved 1-year survival. Increased CD8-positive and granzyme B-positive T cells, increased NK cells, and decreased myeloid-derived suppressor cells were observed in tumor biopsies only from elraglusib-treated patients. This exploratory result confirms elraglusib proposed immune modulating mechanism of action in patients with mPDAC. KOL Event Actuate will host a KOL event for the investment community today, May 31, 2025, at 6:30 PM CDT to review the data. The webinar will feature a fireside discussion moderated by Daniel Schmitt, President & Chief Executive Officer of Actuate, and will include four distinguished KOLs: Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science; Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine; Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center; and Colin Weekes, MD, PhD, Massachusetts General Hospital. Event Details: Date and Time: Saturday, May 31, 2025, at 6:30 pm CDT Format: In-person and via live webcast Registration: Click here A replay of the event will be available on the Investor Relations section of the Actuate website. About Actuate-1801 Part 3B Study The Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity, and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT). About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate's lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. For additional information, please visit the Company's website at Forward-Looking Statements This press release contains forward-looking statements about us, including our and other parties' clinical trials and development plans, and our industry. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would,' or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that preliminary and unpublished data may be subject to change and further interpretation following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities and within the medical community; clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve positive clinical results or favorable preclinical results, and we may not be able to make regulatory submissions or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we require additional capital to finance our operations beyond the second quarter of fiscal year 2025, and a failure to obtain this necessary capital in the near term on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading 'Item 1A. Risk Factors' in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. Investor ContactMike MoyerManaging DirectorLifeSci Advisors, LLCmmoyer@ A photo accompanying this announcement is available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
