Albumin-Bound Paclitaxel

American Society of Clinical Oncology (ASCO) GI Symposium data underscores pelareorep's clinical benefit in anal and pancreatic cancers Pelareorep featured in Key Opinion Leader event on oncolytic immunotherapies in breast and pancreatic cancers Poster on pelareorep's stimulation of adaptive and innate immunity to be shared at ASCO Annual Meeting Conference call and webcast today at 4:30 p.m. ET to discuss Q1 results and clinical outlook SAN DIEGO, Calif. and CALGARY, AB, May 14, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today reported on highlights and financial results for the first quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted. "Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "We remain focused on optimizing the development pathway for pelareorep. Importantly, pelareorep has demonstrated a meaningful clinical benefit in two randomized phase 2 breast cancer studies, in multiple pancreatic cancer studies, and now in anal cancer as well. This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile." First Quarter and Subsequent Highlights Upcoming poster presentation at this year's ASCO Annual Meeting. The title of the poster that will be presented at the conference is: Role of pelareorep in activating anti-tumor immunity in PDAC and will share data exhibiting pelareorep's ability to elicit innate as well as adaptive immune responses in an extremely challenging indication (link to the PR). Two posters were presented at the 2025 ASCO Gastrointestinal Cancers Symposium, one in anal carcinoma and one in pancreatic ductal adenocarcinoma (link to the PR). Updated interim efficacy results from GOBLET Cohort 4 showed pelareorep combined with atezolizumab demonstrated an objective response rate of 33% in twelve evaluable patients with second-line or later unresectable squamous cell anal carcinoma, including a complete and durable response lasting over 15 months - an encouraging signal in this difficult-to-treat cancer (link to the poster). The response rates recorded continue to exceed historical control trials, and enrollment has been expanded to confirm the promising efficacy signal and potentially pave the way for a registration-enabling study. In GOBLET Cohort 5, patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) were treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. As required by the protocol, six patients completed the safety run-in and follow-up period. A review of safety data was completed by the independent Data Safety Monitoring Board (DSMB) and the Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and both groups recommended study continuation (link to the poster). This cohort is being funded by the Pancreatic Cancer Action Network (PanCAN) and, depending on the results, could expand the potential of pelareorep combination therapy in this indication. Key opinion leader event highlights oncolytic immunotherapies in breast and pancreatic cancers. In a webinar hosted by H.C. Wainwright, key opinion leaders Professor Martine Piccart, a co-founder of the Breast International Group (BIG) and member of the Belgian Royal Academy of Medicine, and Alexander Eggermont, Professor of Immunotherapy at Utrecht University Medical and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, discussed the need for new treatment options as well as pelareorep's ability to activate the immune system to identify and attack tumors (link to the PR). Share purchase agreement with institutional investor Alumni Capital LP supports ongoing clinical development. Oncolytics entered into a US$20 million share purchase agreement (SPA) providing a flexible source of funding, enabling the Company to progress towards key clinical milestones. Under the terms of the SPA, the Company, at its sole discretion, controls the timing and amount of all sales of common stock and does not entail any warrant coverage or other classes of shares (link to the PR). Financial Highlights As of March 31, 2025, the Company reported $15.3 million in cash and cash equivalents, projecting a cash runway through key milestones and through the third quarter of 2025. The net loss for the first quarter of 2025 was $6.7 million, compared to a net loss of $6.9 million for the first quarter of 2024. The basic and diluted loss per share was $0.08 in the first quarter of 2025, compared to a basic and diluted loss per share of $0.09 in the first quarter of 2024. Research and development expenses for the first quarter of 2025 were $4.1 million, compared to $5.7 million for the first quarter of 2024. The decrease was primarily attributable to lower manufacturing and clinical trial expenses. This decrease was partially offset by higher personnel-related and share-based compensation expenses associated with CEO transition activities. General and administrative expenses for the first quarter of 2025 were $3.0 million, consistent with $3.0 million for the first quarter of 2024. Net cash used in operating activities for the three months ended March 31, 2025, was $6.5 million, compared to $7.5 million for the three months ended March 31, 2024. The decrease reflected lower net operating activities, partly offset by higher non-cash working capital changes. Anticipated Milestones Q2 2025: Pancreatic cancer translational data from Cohort 1 of the GOBLET study evaluating pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab H1 2026: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer Webcast and Conference Call Management will host a conference call for analysts and investors at 4:30 p.m. ET today, May 14, 2025. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 28038. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 28038#. 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 further information, 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 upcoming milestones, including pancreatic cancer translational data from Cohort 1 of the GOBLET study and initial efficacy results from Cohort 5 of the GOBLET study; 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. Oncolytics 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 [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

- VCN-01 Achieves Primary Efficacy and Safety Endpoints for Pancreatic Ductal Adenocarcinoma in VIRAGE Phase 2b Clinical Trial - - Closed a public offering on May 8, 2025, raising the Company’s cash balance and extending its cash runway into the first quarter of 2026 - ROCKVILLE, Md., May 14, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the first quarter ended March 31, 2025, and provided a corporate update. “We have started 2025 with outstanding clinical progress,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “The VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) with gemcitabine/nab-paclitaxel in newly diagnosed metastatic pancreatic cancer patients achieved its primary survival and safety endpoints, highlighting the potential therapeutic benefits of our oncolytic virus platform. We are working to scale up manufacturing and finalize the design of a Phase 3 trial of VCN-01 with gemcitabine/nab-paclitaxel which if successful, may allow us to deliver this innovative treatment option to patients suffering this fatal disease.” Recent Highlights and Anticipated Milestones VCN-01 Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC): As recently announced, mPDAC patients treated with VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy had increased overall survival (OS), progression free survival (PFS), and duration of response (DOR) compared to patients treated with gemcitabine/nab-paclitaxel SoC.VCN-01 was well-tolerated, with transient and reversible adverse events (AEs).The increase in OS was greater for patients who received 2 doses of VCN-01 and 4 or more cycles of gemcitabine/nab-paclitaxel compared with patients who received 4 or more cycles of gemcitabine/nab-paclitaxel SoC alone, suggesting that the second dose of VCN-01 (administered 3 months after the first dose) provides a meaningful additional benefit in this treatment subgroup.Theriva had hosted a virtual event featuring feature eminent pancreatic cancer clinician/researchers to review and discuss the data from the VIRAGE trial of VCN-01. To access the replay of the event, click HERE.The Company is currently working to scale up manufacturing of VCN-01 and finalizing the design of a potential Phase 3 confirmatory trial for VCN-01 in mPDAC. SYN-004 Allogeneic hematopoietic cell transplant (HCT): As recently announced, data from a Phase 1b/2a trial investigating SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD) was presented at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in April. Corporate Updates As recently announced, Theriva closed a public offering of 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offering price of $1.10 per share and accompanying warrant (the “Offering”). The Company received aggregate gross proceeds of approximately $7.5 million, before deducting placement agent fees and other offering expenses. The warrants have an exercise price of $1.10 per share, are exercisable immediately and expire five years from the issuance date.The Company intends to use the net proceeds from the Offering primarily for working capital and general corporate purposes, including for research and development, and manufacturing scale-up of VCN-01 for a potential Phase 3 clinical trial. First Quarter Ended March 31, 2025 Financial Results General and administrative expenses decreased to $1.4 million for the three months ended March 31, 2025, from $1.9 million for the three months ended March 31, 2024. This decrease of 25% is primarily comprised of the decrease in salary costs, travel, lower director and officer insurance, and a decrease in fair value of the contingent consideration adjustment. The charge related to stock-based compensation expense was $54,000 for the three months ended March 31, 2025, compared to $101,000 for the three months ended March 31, 2024. Research and development expenses decreased to $3.0 million for the three months ended March 31, 2025, from approximately $3.5 million for the three months ended March 31, 2024. This decrease of 14% is primarily the result of lower indirect cost related to decreased VCN-01 manufacturing costs and lower clinical trial expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, offset by slightly higher clinical trial expenses related to our VIRAGE Phase 2b clinical trial of VCN-01 in PDAC and higher patent expenses related to SYN-020. We anticipate research and development expense to increase as we complete our VIRAGE Phase 2b clinical trial of VCN-01 and plan for our Phase 3 clinical trial of VCN-01 in PDAC, advance our VCN-01 program in retinoblastoma, expand GMP scale-up manufacturing activities for VCN-01, and continue supporting our other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $46,000 for the three months ended March 31, 2025, compared to $58,000 related to stock-based compensation expense for the three months ended March 31, 2024. Other income was $93,000 for the three months ended March 31, 2025 compared to other income of $227,000 for the three months ended March 31, 2024. Other income for the three months ended March 31, 2025 is primarily comprised of interest income of $96,000 and an exchange loss of $3,000. Other income for the three months ended March 31, 2024 is primarily comprised of interest income of $228,000 and exchange loss of $1,000. Cash and cash equivalents totaled $10 million as of March 31, 2025, compared to $11.6 million as of December 31, 2024. Subsequent to closing of the public offering on May 8 2025, the Company’s cash balance was $14.1 million. About Pancreatic Ductal Adenocarcinoma Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms, so in most cases it is diagnosed in its late stages (locally advanced non-metastatic or metastatic disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases. About VIRAGE VIRAGE was a two-arm, Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. Patients were enrolled at 5 sites in the U.S. and 9 sites in Spain. In both the control and VCN-01 (zabilugene almadenorepvec) treatment arms, patients received gemcitabine/nab-paclitaxel standard-of-care chemotherapy in repeated 28-day cycles until disease progression. In the VCN-01 treatment arm only, patients were also administered intravenous VCN-01 seven-days prior to starting the first and fourth cycles of gemcitabine/nab-paclitaxel treatment (study days 1 and ~92 respectively). Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, duration of response, and measures of VCN-01 biodistribution, replication, and immune response. More information about the trial is available on Clinicaltrials.gov (NCT05673811), through the Spanish Clinical Trials Registry and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2022-000897-24). About VCN-01 VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov. About Theriva™ Biologics, Inc. Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at www.therivabio.com. Forward-Looking Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding having a cash runway into the first quarter of 2026; the potential therapeutic benefits of the Company’s oncolytic virus platform; the design of a Phase 3 trial of VCN-01 with gemcitabine/nab-paclitaxel if successful, allowing the Company to deliver this innovative treatment option to patients suffering this fatal disease; the intended use of net proceeds from the offering; the suggestion that the second dose of VCN-01 (administered 3 months after the first dose) provides a meaningful additional benefit in the treatment subgroup; a potential Phase 3 confirmatory trial for VCN-01 in PDAC; and research and development expense increasing as the Company completes its VIRAGE Phase 2b clinical trial of VCN-01and plans for its Phase 3 clinical trial of VCN-01 in PDAC, advances its VCN-01 program in retinoblastoma, expands GMP scale-up manufacturing activities for VCN-01, and continues supporting its other preclinical and discovery initiatives. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Important factors that could cause actual results to differ materially from those in the forward-looking statements include the ability of VCN-01 to have therapeutic benefits and continue to do so in future trials; the Company’s cash being able to support increases in research and development expenses and the risk factors that are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and other documents filed by the Company from time to time with the SEC, including the Company’s subsequent Quarterly Reports on Form 10-Q filed with the SEC that are incorporated by reference therein. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based. For further information, please contact: Investor Relations Kevin GardnerLifeSci Advisors, LLC kgardner@lifesciadvisors.com Theriva Biologics, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(In thousands except share and par value amounts)(Unaudited) March 31, 2025 December 31, 2024Assets Current Assets Cash and cash equivalents $10,014 $11,609 Tax credit receivable 1,587 3,228 Prepaid expenses and other current assets 875 1,444 Total Current Assets 12,476 16,281 Non-Current Assets Property and equipment, net 253 270 Restricted cash 100 96 Right of use asset 1,171 1,272 In-process research and development 18,084 17,358 Deposits and other assets 77 75 Total Assets $32,161 $35,352 Liabilities and Stockholders’ Equity Current Liabilities: Accounts payable $437 $859 Accrued expenses 3,769 3,368 Contingent consideration, current portion 1,309 — Accrued employee benefits 554 1,144 Deferred research and development tax credit-current portion 1,460 1,614 Loans payable-current 51 61 Operating lease liability-current portion 568 539 Total Current Liabilities 8,148 7,585 Non-current Liabilities Non-current contingent consideration 5,685 6,973 Loan Payable - non-current 1,504 92 Non-current deferred research and development tax credit 595 762 Non-current operating lease liability 732 873 Total Liabilities 16,664 16,285 Commitments and Contingencies (Note 13) Stockholders’ Equity: Preferred Stock; 10,000,000 authorized; none issued or outstanding at March 31 ,2025 and December 31 ,2024 — — Common stock, $0.001 par value; 350,000,000 shares authorized, 2,811,259 issued and 2,782,449 outstanding at March 31, 2025 and 2,811,259 issued and 2,782,449 outstanding at December 31, 2024 3 3 Additional paid-in capital 355,601 355,501 Treasury stock at cost, 28,809 shares at March 31, 2025 and at December 31, 2024 (288) (288)Accumulated other comprehensive loss (524) (1,178)Accumulated deficit (339,295) (334,971)Total Stockholders’ Equity 15,497 19,067 Total Liabilities and Stockholders’ Equity $32,161 $35,352 Theriva Biologics, Inc. and SubsidiariesCondensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts)(Unaudited) For the Three Months Ended March 31, 2025 2024 Operating Costs and Expenses: General and administrative $1,449 $1,933 Research and development 2,968 3,459 Total Operating Costs and Expenses 4,417 5,392 Loss from Operations (4,417) (5,392) Other Income: Foreign currency exchange (loss) gain (3) (1)Interest income 96 228 Total Other Income 93 227 Net Loss before income taxes (4,324) (5,165)Income tax benefit — — Net Loss Attributable to Common Stockholders $(4,324) $(5,165) Net Loss Per Share - Basic and Dilutive $(1.55) $(7.53) Weighted average number of shares outstanding during the period - basic and dilutive 2,782,449 685,923 Net Loss (4,324) (5,165)Gain (loss) on foreign currency translation 654 (569)Total comprehensive loss (3,670) (5,734)