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Oncolytics Biotech® Reports Second Quarter 2024 Financial Results and Operational Highlights
Received productive feedback from Type C meeting with the FDA for the planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer
On track to report overall survival results from randomized BRACELET-1 breast cancer study in H2 2024
Dosed first patient in new GOBLET study pancreatic cancer cohort; supported by funding from PanCAN
Entered into collaboration with GCAR for inclusion of pelareorep in adaptive registration-enabling pancreatic cancer trial
Cash position of $24.9 million provides runway through key milestones into 2025
Management hosting conference call and webcast today at 4:30 p.m. ET
SAN DIEGO and CALGARY, AB, Aug. 1, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced recent operational highlights and financial results for the second quarter ended June 30, 2024. All dollar amounts are expressed in Canadian currency unless otherwise noted.
"In the second quarter, we continued to build regulatory and clinical momentum for our differentiated and potentially leading immunotherapeutic agent, pelareorep, which is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "Notably, we are pleased to have aligned with the FDA on key elements for the path forward in HR+/HER2- metastatic breast cancer (mBC). Based on guidance from regulators and compelling data from two randomized breast cancer studies, we are confident in pelareorep's potential to demonstrate a clinically meaningful benefit in a future registration-enabling study, and we remain on track to report overall survival results from the BRACELET-1 trial in the second half of 2024."
Mr. Pisano continued, "In parallel, we initiated dosing in the mFOLFIRINOX cohort of the GOBLET study, an exciting opportunity to evaluate the combination of pelareorep with another first-line pancreatic cancer chemotherapy regimen that could result in a second registration program in this indication. The study builds on positive data demonstrating that the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy treatment alone. That combination received Fast Track Designation from the FDA and, through our collaboration with the Global Coalition for Adaptive Research (GCAR), will be evaluated in an adaptive registration-enabling trial. Taken together, we are encouraged by the robust clinical and translational data supporting pelareorep's unique mechanism of action, and we look forward to providing updates on our progress."
Second Quarter Highlights
Received productive feedback from the Type C meeting with the FDA, supportive of the planned potential registration-enabling study for pelareorep in HR+/HER2- mBC. The FDA supports progression-free survival as the primary endpoint of the study and overall survival as a secondary endpoint. The patient population is expected to include those who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy (link to the PR). The control arm is expected to be paclitaxel monotherapy, and the test arm is expected to be pelareorep combined with paclitaxel. Notably, the combination of pelareorep and paclitaxel has already shown a meaningful patient benefit compared to paclitaxel in two previous randomized studies (BRACELET-1 and IND-213).
First patient dosed in the new GOBLET study pancreatic cancer cohort supported by PanCAN. The fifth cohort of the GOBLET study has been initiated and will evaluate pelareorep plus modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients (link to the PR). The Pancreatic Cancer Action Network (PanCAN) awarded Oncolytics the Therapeutic Accelerator Award and US$5 million to evaluate this treatment regimen, which includes mFOLFIRINOX, a commonly used chemotherapy for PDAC patients. Having already reported compelling data for pelareorep in combination with another chemotherapy regimen (gemcitabine + nab-paclitaxel) and atezolizumab in pancreatic cancer in cohort 1 of the GOBLET study, similar data with this treatment regimen could result in another registrational opportunity for pelareorep in this challenging indication.
Announced preliminary collaboration with GCAR for adaptive registrational pancreatic cancer study. The preliminary collaboration has enabled planning activities to begin for the evaluation of pelareorep in the treatment of first-line metastatic PDAC as part of GCAR's anticipated master protocol for metastatic pancreatic cancer (link to the PR). An anticipated outcome of the study is to produce registration-enabling data. The treatment regimen expected to be evaluated is pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab, which has already more than doubled the objective response rate compared to historical trials (link to the PR, link to the poster) and received Fast Track Designation from the FDA. This innovative adaptive Phase 2/3 design allows for multiple investigational therapies to be evaluated and could accelerate the registrational study timeline and provide substantial cost savings compared to traditional trial designs. This collaboration and the new cohort of the GOBLET study are part of the Company's strategy to improve treatment options and outcomes for patients with pancreatic cancer.
Two presentations at the Annual Meeting of the American Society for Clinical Oncology (ASCO). A poster presented at ASCO included a trial-in-progress update for cohort 5 of the GOBLET study evaluating the combination of pelareorep and mFOLFIRINOX with and without atezolizumab in newly diagnosed PDAC patients. There will be a three-patient safety run-in for each treatment arm followed by enrollment of 15 total patients per arm if the safety criteria are met. One or both arms could expand enrollment by 17 patients per arm to stage 2 if certain efficacy criteria are met (link to the poster). The study cohort is being conducted in collaboration with AIO-Studien-gGmbH (AIO), a medical oncology working group within the German Cancer Society, as part of GOBLET, a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers. An abstract presented at the meeting detailed pelareorep's unique ability to induce the expansion of tumor-infiltrating lymphocytes (TILs) via intravenous administration across multiple cancers, including breast, pancreatic, and colorectal (link to the abstract). The abstract also discussed the correlation between TIL expansion and tumor response while noting pelareorep's ability to expand TILs, highlighting its immunotherapeutic mechanism of action and potential as a backbone immunotherapy for multiple indications (link to the PR).
Announced Wayne Pisano, Chair of Oncolytics' Board of Directors, will serve as Interim CEO during Dr. Matt Coffey's medical leave of absence. Chair of the Oncolytics Board since 2013, Mr. Pisano has more than 30 years of experience as a pharmaceutical industry executive, including as a CEO on multiple occasions. In 2010, he was recognized as Pharma Executive of the Year by the World Vaccine Congress.
Financial Highlights
- As of June 30, 2024, the Company reported $24.9 million in cash and cash equivalents, with a projected cash runway through key milestones and into 2025.
- The net loss for the second quarter of 2024 was $7.3 million, compared to a net loss of $7.4 million for the second quarter of 2023. The basic and diluted loss per share was $0.10 in the second quarter of 2024, compared to a basic and diluted loss per share of $0.12 in the second quarter of 2023.
- Research and development expenses for the second quarter of 2024 were $4.6 million, compared to $3.7 million for the second quarter of 2023. The increase was primarily due to higher clinical trial expenses, including BRACELET-1 data analysis and the GCAR collaboration, and higher share-based compensation expense. The increase was partly offset by lower production run and process and analytical development activities.
- General and administrative expenses for the second quarter of 2024 were $3.4 million, consistent with $3.5 million for the second quarter of 2023.
- Net cash used in operating activities for the six months ended June 30, 2024 was $14.3 million, compared to $16.3 million for the six months ended June 30, 2023. The decrease reflects non-cash working capital changes, partly offset by higher net operating activities in 2024.
Recent and Anticipated Milestones
- H2 2024: Overall survival results from the randomized BRACELET-1 trial in HR+/HER2- mBC
- H2 2024: Guidance on the registration path for HR+/HER2- mBC
- H2 2024: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line PDAC with GCAR
- H1 2025: GOBLET mFOLFIRINOX cohort safety run-in update
Webcast and Conference Call
Management will host a conference call for analysts and investors at 4:30 p.m. ET today, August 1, 2024. To access the call, please dial (800) 836-8184 (North America) or (646) 357-8785 (International), and if needed, provide Conference ID: 34386. 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: 34386#.
ONCOLYTICS BIOTECH INC. | |||
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | |||
(unaudited) | |||
(in thousands of Canadian dollars, except share amounts) | |||
As at | June 30, | December 31, | |
Assets | |||
Current assets | |||
Cash and cash equivalents | $ 24,850 | $ 34,912 | |
Other receivables | 1,571 | 15 | |
Prepaid expenses | 3,364 | 3,246 | |
Warrant derivative | 848 | — | |
Total current assets | 30,633 | 38,173 | |
Property and equipment | 430 | 282 | |
Right-of-use assets | 1,006 | 365 | |
Total assets | $ 32,069 | $ 38,820 | |
Liabilities and Shareholders' Equity | |||
Current liabilities | |||
Accounts payable and accrued liabilities | $ 4,653 | $ 3,572 | |
Other liabilities | 1,259 | 332 | |
Lease liabilities | 225 | 133 | |
Warrant derivative | — | 200 | |
Total current liabilities | 6,137 | 4,237 | |
Contract liability | 6,730 | 6,730 | |
Lease liabilities | 891 | 290 | |
Total liabilities | 13,758 | 11,257 | |
Commitments and contingencies | |||
Shareholders' equity | |||
Share capital Authorized: unlimited Issued: June 30, 2024 – 76,857,199 December 31, 2023 – 74,423,960 | 434,547 | 430,906 | |
Contributed surplus | 43,195 | 42,116 | |
Accumulated other comprehensive income | 722 | 544 | |
Accumulated deficit | (460,153) | (446,003) | |
Total shareholders' equity | 18,311 | 27,563 | |
Total liabilities and shareholders' equity | $ 32,069 | $ 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 June 30, | Six Months Ended June 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Expenses | |||||||
Research and development | $ 4,558 | $ 3,701 | $ 10,301 | $ 7,240 | |||
General and administrative | 3,362 | 3,459 | 6,345 | 6,654 | |||
Loss before the following | (7,920) | (7,160) | (16,646) | (13,894) | |||
Change in fair value of warrant derivative | 235 | (107) | 1,104 | (76) | |||
Foreign exchange gain (loss) | 184 | (394) | 701 | (393) | |||
Interest income, net | 340 | 267 | 786 | 532 | |||
Loss before income taxes | (7,161) | (7,394) | (14,055) | (13,831) | |||
Income tax expense | (95) | (47) | (95) | (47) | |||
Net loss | (7,256) | (7,441) | (14,150) | (13,878) | |||
Other comprehensive income (loss) items that may be | |||||||
Translation adjustment | 52 | (105) | 178 | (108) | |||
Net comprehensive loss | $ (7,204) | $ (7,546) | $ (13,972) | $ (13,986) | |||
Basic and diluted loss per common share | $ (0.10) | $ (0.12) | $ (0.19) | $ (0.22) | |||
Weighted average number of shares (basic and diluted) | 76,090,406 | 64,467,908 | 75,667,521 | 63,412,091 | |||
ONCOLYTICS BIOTECH INC. | |||||||||
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY | |||||||||
(unaudited) | |||||||||
(in thousands of Canadian dollars) | |||||||||
Share Capital | Contributed | Accumulated | Accumulated | Total | |||||
As at December 31, 2022 | $ 404,040 | $ 40,051 | $ 662 | $ (418,251) | $ 26,502 | ||||
Net loss and other comprehensive loss | — | — | (108) | (13,878) | (13,986) | ||||
Issued pursuant to stock option plan | 563 | (220) | — | — | 343 | ||||
Issued pursuant to "At the Market" Agreement | 9,128 | — | — | — | 9,128 | ||||
Share issue costs | (307) | — | — | — | (307) | ||||
Share-based compensation expense | — | 559 | — | — | 559 | ||||
As at June 30, 2023 | $ 413,424 | $ 40,390 | $ 554 | $ (432,129) | $ 22,239 | ||||
As at December 31, 2023 | $ 430,906 | $ 42,116 | $ 544 | $ (446,003) | $ 27,563 | ||||
Net loss and other comprehensive income | — | — | 178 | (14,150) | (13,972) | ||||
Issued pursuant to incentive share award plan | 3 | (3) | — | — | — | ||||
Issued pursuant to "At the Market" Agreement | 3,840 | — | — | — | 3,840 | ||||
Share issue costs | (202) | — | — | — | (202) | ||||
Share-based compensation expense | — | 1,082 | — | — | 1,082 | ||||
As at June 30, 2024 | $ 434,547 | $ 43,195 | $ 722 | $ (460,153) | $ 18,311 | ||||
ONCOLYTICS BIOTECH INC. | ||||
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
(unaudited) | ||||
(in thousands of Canadian dollars) | ||||
Six Months Ended June 30, | ||||
2024 | 2023 | |||
Operating Activities | ||||
Net loss for the period | $ (14,150) | $ (13,878) | ||
Depreciation - property and equipment | 56 | 42 | ||
Depreciation - right-of-use-assets | 165 | 151 | ||
Share-based compensation expense | 1,082 | 559 | ||
Interest expense (income), net | 57 | (21) | ||
Unrealized foreign exchange (gain) loss | (576) | 213 | ||
Change in fair value of warrant derivative | (1,104) | 76 | ||
Net change in non-cash working capital | 182 | (3,436) | ||
Cash used in operating activities | (14,288) | (16,294) | ||
Investing Activities | ||||
By: PR Newswire Association LLC.
- 01 Aug 2024
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