Oncolytics Biotech$(R)$ Reports Third Quarter 2024 Financial Results and Operational Highlights
PR Newswire
SAN DIEGO and CALGARY, AB, Nov. 12, 2024
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(R) Inc. $(ONCY)$ (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 $(GCAR.UK)$ 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)
September 30, December 31,
As at 2024 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 $ 24,262 $ 38,820
====================== ===================
ONCOLYTICS BIOTECH INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands of Canadian dollars, except share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------------------------ ------------------------------------------
2024 2023 2024 2023
-------------------- -------------------- -------------------- --------------------
Expenses
Research and
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