Oncolytics Biotech® Reports Third Quarter 2024 Financial Results and Operational Highlights

BRACELET-1 data showing impressive overall survival benefit in HR+/HER2- metastatic breast cancer affirms pelareorep + paclitaxel combination should be evaluated in a registrational study

Upcoming GOBLET milestones include updated efficacy data from anal cancer cohort and safety run-in data from the modified FOLFIRINOX pancreatic cancer cohort

Cash position of $19.6 million as of September 30, 2024

Management hosting conference call and webcast today at 8:30 a.m. ET

SAN DIEGO and CALGARY, AB, Nov. 12, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced third quarter financial results and operational highlights.

 

 

Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO, stated, "With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep's potential in HR+/HER2- metastatic breast cancer. After discussions with regulators and key opinion leaders and based on an estimated overall survival benefit of more than a year provided by pelareorep-based therapy, a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep." Pisano continued, "We continue to develop our gastrointestinal cancer program and look forward to presenting updated efficacy data from our anal cancer cohort and safety data from our new modified FOLFIRNOX pancreatic cancer cohort. Both of these indications represent a significant unmet medical need, and we have shown pelareorep provides the potential to meaningfully improve patient outcomes. This coming year will be critical for pelareorep, as well as for Oncolytics, and I've never been more confident in the potential pelareorep can deliver to cancer patients in need."

Third Quarter Highlights

BRACELET-1 data exceeds expectations, providing clear evidence of pelareorep's ability to improve outcomes in patients with advanced HR+/HER2- breast cancer (link to press release), demonstrating progression-free survival of 12.1 months for pelareorep + paclitaxel compared to 6.4 months for paclitaxel alone, yielding a benefit of 5.7 months. Additionally, 64% of patients treated with pelareorep + paclitaxel lived at least two years compared to only 33% of patients treated with paclitaxel alone. Overall survival could not be calculated as more than half of the pelareorep + paclitaxel patients were alive at the end of the study. Assuming the remaining patients survived only until their next planned follow-up visit, the median overall survival would have been 32.1 months, which compares favorably to the 18.2 months recorded for patients who received paclitaxel monotherapy.

Financial Highlights

As of September 30, 2024, the Company reported $19.6 million in cash and cash equivalents. The Company has a projected cash runway through key milestones and into 2025.

The net loss for the third quarter of 2024 was $9.5 million, compared to a net loss of $9.9 million for the third quarter of 2023. The basic and diluted loss per share was $0.12 in the third quarter of 2024, compared to a basic and diluted loss per share of $0.14 in the third quarter of 2023.

Research and development expenses for the third quarter of 2024 were $6.8 million, compared to $5.8 million for the third quarter of 2023. The increase was primarily due to higher manufacturing expenses and clinical trial expenses.  

General and administrative expenses for the third quarter of 2024 were $3.1 million, compared with $5.2 million for the third quarter of 2023. The decrease was primarily due to lower investor relations activities and transaction costs as part of our public offering in 2023.

Net cash used in operating activities for the nine months ended September 30, 2024 was $19.1 million, compared to $22.3 million for the nine months ended September 30, 2023. The decrease reflected non-cash working capital changes, partly offset by higher net operating activities in 2024.

Recent and Anticipated Milestones

H1 2025: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA

H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer

H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer

Mid 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer

H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer

Webcast and Conference Call

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, November 12, 2024. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 68336. 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: 68336#.

ONCOLYTICS BIOTECH INC.

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)

(in thousands of Canadian dollars, except share amounts)

As at

September 30,2024

December 31,2023

Assets

Current assets

Cash and cash equivalents

$              19,598

$                       34,912

Other receivables

104

15

Prepaid expenses

2,119

3,246

Warrant derivative

1,092



Total current assets

22,913

38,173

Property and equipment

422

282

Right-of-use assets

927

365

Total assets

$              24,262

$                       38,820

Liabilities and Shareholders' Equity

Current liabilities

Accounts payable and accrued liabilities

$                 6,922

$                         3,572

Other liabilities

489

332

Lease liabilities

251

133

Warrant derivative



200

Total current liabilities

7,662

4,237

Contract liability

6,730

6,730

Lease liabilities

813

290

Total liabilities

15,205

11,257

Commitments

Shareholders' equity

Share capital

  Authorized: unlimited

  Issued: September 30, 2024, 77,074,089

  December 31, 2023, 74,423,960

434,460

430,906

Contributed surplus

43,640

42,116

Accumulated other comprehensive income

653

544

Accumulated deficit

(469,696)

(446,003)

Total shareholders' equity

9,057

27,563

Total liabilities and shareholders' equity