Oncolytics Biotech$(R)$ Reports First Quarter Financial Results and Highlights Clinical Momentum

Canada NewsWire

SAN DIEGO, Calif. and CALGARY, AB, May 14, 2025

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 /CNW/ -- Oncolytics Biotech(R) Inc. $(ONCY)$ (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 $(BIG.UK)$ 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 $(SPA.UK)$ 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#.

 
ONCOLYTICS BIOTECH INC. 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL 
 POSITION 
(unaudited) 
(in thousands of Canadian dollars, except share amounts) 
As at                                               March 31,   December 31, 
                                                     2025        2024 
Assets 
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 and Shareholders' Equity 
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 
Commitments 
Shareholders' equity 
Share capitalAuthorized: unlimitedIssued: March 
 31, 2025 -- 86,421,592December 31, 2024 -- 
 80,020,131                                           445,533        438,193 
Contributed surplus                                    44,403         44,542 
Accumulated other comprehensive income                    958            961 
Accumulated deficit                                 (484,400)      (477,713) 
Total shareholders' equity                              6,494          5,983 
Total liabilities and shareholders' equity           $ 19,702       $ 20,187 
 
 
ONCOLYTICS BIOTECH INC. 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS 
 AND COMPREHENSIVE LOSS 
(unaudited) 
(in thousands of Canadian dollars, except share amounts) 
                                              Three Months Ended March 31, 
                                              2025            2024 
Expenses 
  Research and development                           $ 4,083         $ 5,743 
  General and administrative                           2,916           2,983 

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