Dr. Matt Coffey reports

ONCOLYTICS BIOTECH(TM) RECAPS 2023 ACCOMPLISHMENTS, PROVIDES OUTLOOK FOR 2024

Oncolytics Biotech Inc. has provided a recap of significant 2023 accomplishments and outlined corporate priorities and anticipated clinical development milestones for 2024.

Overview: "Two thousand twenty-three was an outstanding year for Oncolytics and the development of pelareorep as a potential cancer therapy. To date, we have studied pelareorep in more than 1,100 patients, and it has been shown to be well tolerated with mild side effects. Promising clinical and translational results from our phase 2 programs and mechanism of action learnings from a wide range of tumour types, as detailed below, provided consistent data and efficacy signals with durable responses that support the use of pelareorep as an immunotherapeutic agent, either as a monotherapy or in combination with other agents. These data readouts from multiple clinical studies at numerous sites and from diverse cancer indications that are clinically important make a compelling argument for pelareorep as a true backbone immunotherapy with the potential to help countless patients across a range of tumours," said Dr. Matt Coffey, president and chief executive officer of Oncolytics. "We believe our cash balance and strong data, supported by our active business development program, position us well for 2024."

Positive clinical and translational data: "Positive, early results from the phase 1/2 Goblet study in three gastrointestinal cancers -- pancreatic, anal and colorectal -- showed that the combination of pelareorep and atezolizumab produced clinically meaningful improvements in response rates and survival timelines that are notably improved compared to historical results with no toxicity concerns. Translational data from studies in solid tumours, breast, pancreatic and colorectal cancers showed that treatment with pelareorep remodels the tumour microenvironment and stimulates tumour-directed immune responses, affirming its mechanism of action as an immunotherapeutic agent. Together, these data provide a strong foundation to support advancing pelareorep into registrational-track studies, starting in 2024," continued Dr Coffey.

2024 outlook: Dr. Coffey concluded by saying: "Looking ahead to 2024, we expect to initiate the first phase 3 study for pelareorep in pancreatic cancer. The transition to a late-stage biopharmaceutical company will mark an important inflection point for investors, clinical collaborators and potential partners by providing a line of sight towards the path to regulatory approval and achieving our mission of developing pelareorep as an immunotherapeutic agent for cancer. We are excited to launch a new phase 1/2 pancreatic cancer study investigating, for the first time, pelareorep in combination with modified Folfirinox (mFolfirinox). Finally, our discussions with regulators on a pivotal phase 3 trial have been productive to date, and we expect to provide guidance on the registration path for metastatic breast cancer in the first half of 2024. We look forward to updating our stakeholders on our progress as the year unfolds."

Immunotherapeutic mechanism of action: Dr. Thomas Heineman, MD, PhD, chief medical officer at Oncolytics, said: "Translational data from multiple studies in 2023 have helped define pelareorep's role in shaping the tumour microenvironment and have provided a better understanding of its ability to induce the expansion of T-cell populations. Notably, the positive association between tumour response and TIL clone expansion could become a useful marker of clinical outcomes in future studies and during patient care. Moreover, these findings further distinguish pelareorep's mechanism of action from that of other immunotherapeutic agents and provide support for its immunologic effects, which are largely driven by the introduction of its double-stranded RNA genome into cancer cells."

Financial strength and partnering outlook: Kirk Look, Oncolytics' chief financial officer, commented: "Our $40-million cash balance as of Sept. 30, 2023, and the grant funding from the Pancreatic Cancer Action Network (PanCAN) provides us with over 12 months of runway to support our operations, including the initiation of our first phase 3 study and the Bracelet-1 survival data. We continue to have active conversations with potential partners and work diligently with clinical collaborators, including Roche and Pfizer. We believe the positive, extended data set, including continued and durable responses, survival results and translational observations, will provide potential partners with a well-defined and unique target product profile that will add to our discussions."

Anticipated milestones are expected to include:

• H1 2024: Guidance on the registration path for HR+/HER2- mBC (metastatic breast cancer);
• H1 2024: Initiation of the PanCAN-supported phase 2 pancreatic ductal adenocarcinoma (PDAC) trial incorporating mFolfirinox plus/minus atezolizumab and pelareorep;
• Mid-2024: Initiation of the adaptive phase 3 trial for pelareorep in PDAC;
• Overall survival results from the Bracelet-1 study;
• Expand enrolment following achievement of success criteria from the Goblet phase 1/2 study anal cancer cohort.

Highlights of Oncolytics Biotech's 2023 achievements

HR+/HER2- metastatic breast cancer program and the Bracelet-1 study:

• Promising randomized phase 2 data readout supports previous near doubling of median overall survival: Data presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting showed that pelareorep in combination with paclitaxel (cohort 2) resulted in a near tripling of confirmed overall response rate, a 50-per-cent increase in median progression-free survival, and a hazard ratio of 0.29 compared with paclitaxel monotherapy (cohort 1).

Overall survival (OS) data continue to mature since multiple patients continue to be followed for survival in the pelareorep plus paclitaxel cohort. Positive results would provide Oncolytics with two successful randomized phase 2 studies showing a meaningful OS benefit for pelareorep. The data reported so far support the initiation of a pivotal study in mBC and make the case for an overall survival and progression-free survival dual end point in a registrational trial, which could substantially reduce the time to potential approval.

Gastrointestinal cancers and the Goblet study cohorts:

• Pancreatic cancer survival data reported at ESMO support decision to move to phase 3: Updated data presented at the European Society for Medical Oncology (ESMO) Congress 2023 showed a 62-per-cent objective response rate, nearly triple what has been seen in historical control trials. In addition, interim survival data, including median progression-free survival and median overall survival timelines, exceed historical control trials by 25 per cent or more. Patients in this single-arm, open-label study with advanced PDAC were treated with pelareorep, atezolizumab, gemcitabine and nab-paclitaxel.

The company continues to follow the survival of several patients in this cohort as well as patients from the Goblet study with third-line colorectal cancer, which also met the predefined success criteria. Having received fast-track designation from the Food and Drug Administration for the treatment regimen of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel in metastatic PDAC patients last year, Oncolytics was very pleased to report additional promising data for this combination, paving the way to initiate its adaptive phase 3 trial which will now be conducted by Oncolytics, building on the positive feedback from its work with PanCAN.

Also, thanks to a $5-million (U.S.) grant from PanCAN, the company will examine the potential of pelareorep in combination with mFolfirinox plus/minus atezolizumab. With these data plus the results from the adaptive phase 3 PDAC study (pelareorep plus gemcitabine plus nab-paclitaxel plus atezolizumab), Oncolytics hopes to show efficacy data for pelareorep in combination with the two most commonly used treatment regimens for pancreatic cancer patients, which could help pave the way for future broad adoption by physicians and impact a substantial number of patients.

• Anal cancer data -- positive early results in an underserved patient population: Data presented at the second International Multidisciplinary Anal Cancer Conference (IMACC 2023) achieved the predefined Simon-two-step success criteria and showed a near tripling of objective response rates compared with historical control trials in addition to a complete response. Patients in this single-arm, open-label study with second-line, unresectable squamous cell carcinoma of the anal canal (SCCA) were treated with pelareorep and atezolizumab, marking an exciting signal of efficacy in an indication where checkpoint inhibitors have had limited impact historically, and there are few treatment options.

Having met the success criteria for efficacy for this cohort, the company will work closely with AIO-Studien-gGmbH (AIO), which is managing the Goblet study, to expand the number of patients who can be treated and, hopefully, accelerate the enrollment process. With continued positive data, this could become another high-priority indication for the company.

Other opportunities: Preclinical data published in Science Translational Medicine from studies in murine tumour models showed that combining CAR T-cells with pelareorep improved CAR T-cell persistence and efficacy in solid tumours. An intravenous boost of pelareorep enhanced this effect and led to tumour cures in greater than 80 per cent of cases. Oncolytics believes there is a significant opportunity here as CAR T-cell therapy is currently only effective in hematological cancers, and solid tumours are the vast majority of cancers diagnosed each year. While the company does not have an active program under way, it continues to have discussions on the best way to advance this effort.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumour phenotype -- turning cold tumours 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 and hematological malignancies as it advances toward registrational studies in metastatic breast cancer and pancreatic cancer.

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