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TICKERS: ONCY

Pancreas Cancer Becoming Top Focus for Biotech Co.?
Research Report

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Oncolytics Biotech Inc. (ONCY:NASDAQ; ONC:TSX) published survival data for the use of its immunotherapy pelareorep in pancreatic cancer, and these support the view that this indication should be primary, noted a Leede Financial Inc. report.

Oncolytics Biotech Inc. (ONCY:NASDAQ; ONC:TSX) may be shifting priority focus for its proprietary oncolytic reovirus formulation pelareorep to pancreatic cancer from breast cancer, based on "several lines of evidence," reported Dr. Douglas Loe, managing director and analyst at Leede Financial Inc., in a July 9 research note.

"Consolidated pancreatic cancer survival data support our view that [pancreatic cancer] could/should be Oncolytics' lead indication," Loe wrote.

Along with breast and pancreatic, pelareorep is being tested in several Phase 2 cancer trials, including multiple myeloma.

283% Return Implied

Leede Financial reiterated its CA$5.25 per share one-year price target on the Canadian biotech firm, trading at about CA$1.37 per share at the time of Loe's report, noted the analyst.

From this price, the return to target is 283%.

Oncolytics is a Speculative Buy.

Compelling Survival Data

The Alberta-headquartered biotech released a summary of its survival data from some published Phase 1/2 clinical studies evaluating pelareorep in pancreatic cancer, reported Loe. According to the results, use of pelareorep in combination with other standard-of-care therapies such as paclitaxel, "was associated with a survival benefit that, if replicated in a controlled pivotal Phase 3 advanced pancreatic study, would have a nontrivial chance of clinical and regulatory success," the analyst wrote.

Oncolytics pointed out that median progression-free survival for patients treated with a pelareorep-paclitaxel combination was 12.1 months versus 6.4 months for paclitaxel alone. In contrast, median progression-free survival was lowest at 5.8 months for pelareorep-paclitaxel when combined with Bavencio.

In his report, Loe presented other positive pelareorep survival clinical trial data:

1) Data from the ongoing, 55-patient pancreatic cancer cohort of the GOBLET trial showed a 62% overall response rate, an 85% disease control rate and a 45% one-year survival rate, in 13 evaluable subjects.

2) Data from a Phase 2 trial published in 2023 in the British Medical Journal reported a clinical benefit rate of 42% (one partial responder, four other patients with stable disease) when pelareorep was combined Keytruda.

3) Data from an 11-patient Phase 1b trial published in 2020 in Clinical Cancer Research showed disease control in three of 10 evaluable subjects, with one partial response lasting for 17.4 months, for patients treated with a combination of pelareorep, Keytruda and one or more small-molecule anti-cancer agents often used in pancreatic cancer therapy (5-fluorouracil, gemcitabine or irinotecan).

4) Data from a 34-patient Phase 2 trial published in 2018 in Cancers demonstrated that pelareorep, used in combination with gemcitabine, Abraxane or FOLFIRINOX (leucovirin, 5-fluorouracil, irinotecan and oxaliplatin), resulted in a median overall survival of 10.2 months, with a one- and two-year survival rate of 45% and 24%, respectively.

5) Data from a 73-patient Phase 2 advanced pancreatic cancer trial published in 2016 in Molecular Therapy showed no differences in progression-free survival in patients treated with paclitaxel-carboplatin chemotherapy and in patients treated with paclitaxel-carboplatin plus pelareorep (4.9 months versus 5.2). However, one- and two-year overall survival rates were more impressive for pelareorep-treated patients at 34% and 20%, respectively, compared to control patients (28% and 6%).

Breast Cancer Indication

Loe reported that just as for pancreatic cancer, Phase 2 data from the evaluation of pelareorep as a treatment for breast cancer were positive. In fact, Phase 2 breast cancer data from Oncolytics' 48-patient BRACELET-I trial, published just this month in Clinical Cancer Research, again showed that combination pelareorep-paclitaxel positively affected breast cancer survival in a reproducible way, unlike other pelareorep-containing chemotherapy regimens. As such, Oncolytics likely will test pelareorep-paclitaxel in at least one study arm in a future metastatic breast cancer Phase 2/3 trial.

Despite the positive data, the analyst noted, the breast cancer arena already is well-populated by small molecule cyclin-dependent kinase inhibitors, including Ibrance, and other drugs with a similar mechanism of action, making it a less attractive primary indication.

Look at Revised Model

Leede Financial revised its model on Oncolytics to reflect advanced pancreatic cancer as Oncolytics' lead indication for pelareorep, and this only minimally affects the financial services firm's estimated timelines to approval by the U.S. Food and Drug Administration (FDA), reported Loe. In the model, Phase 2/3 testing in pancreatic cancer is completed by year-end 2028, and FDA approval and commercial launch by future partners follow in H2/29.

The model still has Oncolytics receiving royalty payments from future partners at a royalty rate of 23% and still has a single course of therapy costing US$20,000, which is conservative, Loe noted.

Leede Financial's model assumes that Oncolytics will explore HER2-negative/hormone receptor-positive metastatic breast cancer as a secondary pelareorep indication, the analyst wrote.

"Phase 2 performance of pelareorep-paclitaxel has been sufficiently positive in our view to justify advanced testing in this indication, but we expect Oncolytics to proceed more cautiously on this indication at least until cash-contributing codevelopment partners can be identified," added Loe.


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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2.  This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company. 
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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Disclosures for Leede Financial Inc., Oncolytics Biotech, July 9, 2025

Disclosures None Important Information and Legal Disclaimers Leede Financial Inc. (Leede) is a member of the Canadian Investment Regulatory Organization (CIRO) and a member of the Canadian Investor Protection Fund (CIPF). This document is not an offer to buy or sell or a solicitation of an offer to buy or sell any security or instrument or to participate in any particular investing strategy. Data from various sources were used in the preparation of these documents; the information is believed but in no way warranted to be reliable, accurate and appropriate. All information is as of the date of publication and is subject to change without notice. Any opinions or recommendations expressed herein do not necessarily reflect those of Leede. Leede cannot accept any trading instructions via e-mail as the timely receipt of e-mail messages, or their integrity over the Internet, cannot be guaranteed. Dividend yields change as stock prices change, and companies may change or cancel dividend payments in the future. All securities involve varying amounts of risk, and their values will fluctuate, and the fluctuation of foreign currency exchange rates will also impact your investment returns if measured in Canadian Dollars. Past performance does not guarantee future returns, investments may increase or decrease in value, and you may lose money. Leede employees may buy and sell shares of the companies that are recommended for their own accounts and for the accounts of other clients. Disclosure codes are used in accordance with Policy 3600 of CIRO. Description of Disclosure Codes 1. Leede and its affiliates collectively beneficially own 1% or more of any class of equity securities of the company as of the end of the preceding month or the month prior to the preceding month if the report was issued prior to the 10th. 2. The analyst or any associate of the analyst responsible for the report or public comment hold shares or is short any of the company's securities directly or through derivatives. 3. Leede or a director or officer of Leede or any analyst provided services to the company for remuneration other than normal investment advisory or trade execution services within the preceding 12 months. 4. Leede provided investment banking services for the company during the 12 months preceding the publication of the research report. 5. Leede expects to receive or intends to seek compensation for investment banking services in the next three months. 6. The analyst preparing the report received compensation based upon Leede investment banking revenues for this issuer within the preceding 12 months. 7. The director, officer, employee, or research analyst is an officer, director or employee of the company, or serves in an advisory capacity to the company. 8. Leede acts as a market maker of the company. 9. The analyst has conducted a site visit and has viewed a major facility or operation of the issuer. 10. The company has paid for all, or a material portion, of the travel costs associated with the site visit by the analyst. Dissemination All final research reports are disseminated to existing and potential institutional clients of Leede Financial Inc. (Leede) in electronic form to intended recipients thorough e-mail and third-party aggregators. Research reports are posted to the Leede website and are accessible to customers who are entitled to the firm’s research. Reproduction of this report in whole or in part without permission is prohibited. Research Analyst Certification The Research Analyst(s) who prepare this report certify that their respective report accurately reflects his/her personal opinion and that no part of his/her compensation was, is, or will be directly or indirectly related to the specific recommendations or views as to the securities or companies. Leede Financial Inc. (Leede) compensates its research analysts from a variety of sources and research analysts may or may not receive compensation based upon Leede investment banking revenue. Canadian Disclosures This research has been approved by Leede Financial Inc. (Leede), which accepts sole responsibility for this research and its dissemination in Canada. Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). Canadian clients wishing to effect transactions in any designated investment discussed should do so through a Leede Registered Representative. U.S. Disclosures This research report was prepared by Leede Financial Inc. (Leede). Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). This report does not constitute an offer to sell or the solicitation of an offer to buy any of the securities discussed herein. Leede is not registered as a broker-dealer in the United States and is not subject to U.S. rules regarding the preparation of research reports and the independence of research analysts. Any resulting transactions should be effected through a U.S. broker-dealer.





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