1. Pelareorep shows clinical benefits in anal and pancreatic cancers. 2. ASCO presentations highlight pelareorep’s immune response activation. 3. 33% objective response rate noted in anal cancer studies. 4. Study continues with positive safety feedback from regulatory bodies. 5. Company secured $20 million funding to support clinical development.
Recent clinical results indicate increased potential and investor confidence, similar to historical trends observed in successful biotech advancements. Prior instances, such as companies showing improved results in key trials, often saw share values rise substantially.
The article indicates significant potential for ONCY's key drug, raising investor interest and financial outlook, much like past developments in the sector that positively affected stock prices.
Ongoing studies and anticipated pivotal data releases may uplift ONCY’s stock value in the longer term, reflecting historical patterns in biotech where breakthroughs are rewarded after extensive validation periods.
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."
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#.
(in thousands of Canadian dollars, except share amounts)
| Assets | March 31, 2025 | December 31, 2024 |
|---|---|---|
| Current assets | ||
| Cash and cash equivalents | $ 15,303 | $ 15,942 |
| Other receivables | 89 | 68 |
| Prepaid expenses | 1,875 | 1,885 |
| Warrant derivative | 1,220 | 980 |
| Total current assets | 18,487 | 18,875 |
| Property and equipment | 386 | 411 |
| Right-of-use assets | 829 | 901 |
| Total assets | $ 19,702 | $ 20,187 |
| Liabilities | March 31, 2025 | December 31, 2024 |
|---|---|---|
| Current liabilities | ||
| Accounts payable and accrued liabilities | $ 4,948 | $ 4,792 |
| Other liabilities | 530 | 1,618 |
| Lease liabilities | 290 | 277 |
| Total current liabilities | 5,768 | 6,687 |
| Contract liability | 6,730 | 6,730 |
| Lease liabilities | 710 | 787 |
| Total liabilities | $ 13,208 | $ 14,204 |
| Total liabilities and shareholders' equity | $ 19,702 | $ 20,187 |
(in thousands of Canadian dollars, except share amounts)
| Expenses | 2025 | 2024 |
|---|---|---|
| Research and development | $ 4,083 | $ 5,743 |
| General and administrative | 2,916 | 2,983 |
| Loss before the following | (6,999) | (8,726) |
| Change in fair value of warrant derivative | 240 | 869 |
| Foreign exchange (loss) gain | (51) | 517 |
| Interest income, net | 123 | 446 |
| Net loss | (6,687) | (6,894) |
| Other comprehensive (loss) income items that may be reclassified to net loss | ||
| Translation adjustment | (3) | 126 |
| Comprehensive loss | $ (6,690) | $ (6,768) |
| Basic and diluted loss per common share | $ (0.08) | $ (0.09) |
| Weighted average number of shares (basic and diluted) | 84,631,445 | 75,244,637 |
(in thousands of Canadian dollars)
| Share Capital | Contributed Surplus | Accumulated Other Comprehensive Income | Accumulated Deficit | Total |
|---|---|---|---|---|
| $ 430,906 | $ 42,116 | $ 544 | $ (446,003) | $ 27,563 |
| Net loss | Comprehensive income |
|---|---|
| — | $ — |
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: www.oncolyticsbiotech.com 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.
Jon Patton
Director of IR & Communication
info@oncolyticsbiotech.com
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mike@lifesciadvisors.com
Michael Rubenstein
LifeSci Communications
michael@lifescicommunications.com
SOURCE Oncolytics Biotech® Inc.