Dr. Matt Coffey reports

ONCOLYTICS BIOTECH REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

Oncolytics Biotech Inc. has released its recent operational highlights and financial results for the first quarter ended March 31, 2023.

"Our core programs in breast and pancreatic cancer are moving towards registrational studies with compelling clinical data and important milestones expected this year," said Dr. Matt Coffey, president and chief executive officer. "The first of these milestones will come later this month when we report data from Bracelet-1, a randomized phase 2 trial expected to inform the design of a subsequent pivotal registrational study in HR-positive/HER2-negative metastatic breast cancer. Stakeholders across the breast cancer community have demonstrated a keen interest in this readout, which will add to a data set that already includes statistically significant phase 2 results showing pelareorep's ability to drive a robust overall survival benefit in this indication. Notably, the Bracelet-1 abstract was selected for an oral presentation at the upcoming ASCO [American Society of Clinical Oncology] meeting, providing a highly prestigious venue to discuss the results with potential partners and the clinical community."

Dr. Coffey continued: "Looking into the second half of 2023, we expect to report updated results from Goblet's first-line pancreatic cancer cohort and provide guidance on the optimal registration paths for our breast and pancreatic cancer programs. With these programs both targeting large markets with significant clinical unmet needs and supported by robust clinical proof-of-concept data, we believe confirming their paths towards approval will represent important value-creating events and substantially derisk and maintain pelareorep's development pathway."

First quarter and subsequent highlights

Breast cancer program

Bracelet-1 data to be shared in an oral presentation at the ASCO annual meeting

Bracelet-1 is designed to confirm and expand upon Oncolytics' prior positive clinical results for pelareorep in HR-positive/HER2-negative metastatic breast cancer and inform the design of a subsequent registrational study. These prior data include phase 1 results demonstrating pelareorep's single-agent activity as well as randomized phase 2 data that showed a statistically significant near doubling of median overall survival in patients treated with pelareorep combined with paclitaxel compared with those treated with paclitaxel monotherapy. Additionally, data from early-stage HR-positive/HER2-negative breast cancer patients demonstrated pelareorep's ability to stimulate anti-tumour immunity, remodel tumour microenvironments and potentially improve patient prognosis by decreasing the risk of cancer recurrence score.

Bracelet-1 includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep and paclitaxel plus pelareorep in combination with avelumab in HR-positive/HER2-negative metastatic breast cancer. The trial was designed to enroll a total of 48 patients and is not powered to detect statistical significance. An abstract corresponding to the coming oral presentation will be published by ASCO on May 25, 2023, at 5 p.m. ET. The oral presentation will take place on June 3, 2023, during a session being held from 2:15 p.m. ET to 3:45 p.m. ET.

Additional immunotherapeutic opportunity

Upcoming ASCO poster on preclinical pelareorep/chimeric antigen receptor (CAR) T cell therapy combination program

The poster, titled "Efficacy of function-enhanced, reactivatable, dual-specific CAR T cells preloaded with oncolytic virus for immunotherapy of high-grade glioma," will be presented in Poster Hall A from 2:15 p.m. ET to 5:15 p.m. ET on June 3, 2023. The corresponding abstract will be published prior to the ASCO meeting on May 25, 2023, at 5 p.m. ET.

The data to be presented at the ASCO meeting follow preclinical results published in Science Translational Medicine (STM), which showed pelareorep synergistically enhancing the efficacy of CAR T cell therapy in murine solid tumour models. Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep/CAR T cell combination therapies, one of which has generated results with a potential partner's own CAR T constructs that are in line with those published in the STM publication.

Key opinion leader webinar

Oncolytics will host a key opinion leader (KOL) webinar on June 5, 2023, at 8 a.m. ET, where KOLs and the Oncolytics management team will discuss recent data from the Bracelet-1 study. A live question-and-answer session will follow the formal presentation.

Financial highlights:

• As of March 31, 2023, the company reported $29.7-million in cash, cash equivalents and marketable securities.
• The net loss for the first quarter of 2023 was $6.4-million, compared with a net loss of $6.8-million for the first quarter of 2022. The basic and diluted loss per share was 10 cents in the first quarter of 2023, compared with a basic and diluted loss per share of 12 cents in the first quarter of 2022.
• Net cash used in operating activities for the three months ended March 31, 2023, was $7.8-million, compared with $6.3-million for the three months ended March 31, 2022. The change reflected higher net operating activities and non-cash working capital changes.
• General and administrative expenses for the first quarter of 2023 were $3.2-million, compared with $2.6-million for the first quarter of 2022. The increase was mainly due to increased investor relations activities, partly offset by lower share-based compensation expense.
• Research and development expenses for the first quarter of 2023 were $3.5-million, compared with $3.7-million for the first quarter of 2022. The decrease was primarily due to lower Bracelet-1 study costs and share-based compensation expense, partly offset by increased manufacturing expenses associated with a process development production run and higher personnel-related expenses.

2023 anticipated milestones and catalysts:

• Overall response rate and progression-free survival data from phase 2 Bracelet-1 metastatic breast cancer study -- Q2 2023;
• Preclinical data from the combination of pelareorep and CAR T cell therapy -- Q2 2023;
• Updated data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) from the Goblet study -- second half of 2023;
• Update on the metastatic colorectal and anal cancer cohorts from the Goblet study -- second half of 2023;
• Guidance for the registration paths for HR-positive/HER2-negative metastatic breast cancer and advanced/metastatic PDAC -- second half of 2023.

Webcast and conference call

Management will host a conference call for analysts and investors at 8:30 a.m. ET on May 5, 2023. To access the call, please dial 888-664-6383 (North America) or 416-764-8650 (international) and, if needed, provide confirmation No. 3550-3191. A live webcast of the call will also be available on the investor relations page of Oncolytics' website and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialling 888-390-0541 (North America) or 416-764-8677 (international) and using replay code 503-191 followed by the number sign.

We seek Safe Harbor.