Oncolytics Biotech (ONCY) - 2023 Q1 - Quarterly Report

Report Overview and Operational Highlights This section highlights the company's significant progress in 2022, detailing advancements in breast and pancreatic cancer programs and strategic paths toward registrational studies CEO's Statement The CEO highlighted significant progress in 2022, establishing clear, de-risked paths toward registrational studies for pelareorep in both breast and pancreatic cancer - The company has established clear and de-risked paths to registrational studies for pelareorep in both breast and pancreatic cancer[2] - The upcoming BRACELET-1 readout in Q2 2023 is a key inflection point, expected to show pelareorep-based regimens outperforming paclitaxel monotherapy, which would accelerate advancement into a registrational trial and enhance business development[2] - Interim data from the GOBLET trial in pancreatic cancer showed an objective response rate nearly three times greater than historical controls, establishing it as a second core pillar of the company's pipeline[2] Pancreatic Cancer Program The pancreatic cancer program showed highly promising results in the Phase 1/2 GOBLET trial, with a 69% objective response rate and FDA Fast Track designation - In the GOBLET trial's PDAC cohort, treatment with pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel resulted in a 69% objective response rate (ORR) among 13 evaluable patients, including one confirmed complete response[3] - The reported 69% ORR is nearly three times the average ~25% ORR from historical control trials using gemcitabine plus nab-paclitaxel[3] - The FDA granted Fast Track designation for pelareorep for the treatment of advanced/metastatic PDAC, which allows for more frequent FDA meetings and potential for Accelerated Approval and Priority Review[5] Breast Cancer Program The breast cancer program is advancing with positive interim data from a bridging trial and anticipates a key data readout from the BRACELET-1 trial in Q2 2023 - Interim results from Adlai Nortye's bridging trial in China showed that among 14 evaluable patients, 13 achieved disease control, and 7 achieved a partial response One patient maintained a partial response at week 48[6] - The combination of pelareorep and paclitaxel was well tolerated, with no dose-limiting toxicities or serious adverse events reported in the bridging trial[6] - Oncolytics expects to announce overall response rate and progression-free survival data from the randomized Phase 2 BRACELET-1 trial in Q2 2023[7] Financial Highlights and Results This section details the company's financial performance for 2022, including cash position, net loss, and changes in financial statements Fourth Quarter and Full Year 2022 Financial Summary Oncolytics ended 2022 with $32.1 million in cash, projecting a runway into 2024, with a reduced net loss compared to 2021 - As of December 31, 2022, the company had $32.1 million in cash, cash equivalents, and marketable securities, providing a projected runway through the BRACELET-1 readout and into 2024[1][8] Full Year 2022 vs 2021 Financial Performance (CAD) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Net Loss | $24.8 million | $26.3 million | | Loss Per Share (basic and diluted) | $0.43 | $0.49 | | Net Cash Used in Operating Activities | $23.4 million | $22.4 million | | General & Administrative Expenses | $11.5 million | $13.3 million | | Research & Development Expenses | $15.4 million | $12.9 million | Consolidated Statements of Financial Position The company's total assets decreased to $37.3 million by year-end 2022, primarily due to reduced cash, while liabilities slightly increased Consolidated Financial Position (in thousands of CAD) | As at December 31, | 2022 | 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,666 | $41,262 | | Total current assets | $35,684 | $44,904 | | Total assets | $37,334 | $45,880 | | Total current liabilities | $3,945 | $2,690 | | Total liabilities | $10,832 | $9,781 | | Total shareholders' equity | $26,502 | $36,099 | Consolidated Statements of Loss and Comprehensive Loss For 2022, the company reported a net loss of $24.8 million, an improvement from 2021, influenced by lower G&A and a foreign exchange gain Consolidated Loss (in thousands of CAD) | For the years ended December 31, | 2022 | 2021 | | :--- | :--- | :--- | | Research and development | $15,432 | $12,920 | | General and administrative | $11,492 | $13,315 | | Foreign exchange gain (loss) | $1,665 | $(136) | | Net loss | $(24,835) | $(26,304) | | Basic and diluted loss per common share | $(0.43) | $(0.49) | Consolidated Statements of Changes in Equity Total shareholders' equity decreased to $26.5 million by year-end 2022, primarily due to the net loss, partially offset by equity raised Changes in Shareholders' Equity (in thousands of CAD) | Description | 2022 | 2021 | | :--- | :--- | :--- | | Equity at Start of Year | $36,099 | $24,752 | | Net loss and other comprehensive income/loss | $(24,561) | $(26,316) | | Proceeds from "At the Market" Agreement | $13,338 | $34,168 | | Equity at End of Year | $26,502 | $36,099 | Consolidated Statements of Cash Flows Net cash used in operating activities increased slightly in 2022, with significant cash used in investing activities, leading to a net decrease in cash Cash Flow Summary (in thousands of CAD) | For the years ended December 31, | 2022 | 2021 | | :--- | :--- | :--- | | Cash used in operating activities | $(23,355) | $(22,433) | | Cash used in investing activities | $(20,403) | $(286) | | Cash provided by financing activities | $12,205 | $33,015 | | (Decrease) increase in cash and cash equivalents | $(31,553) | $10,296 | | Cash and cash equivalents, end of year | $11,666 | $41,262 | Outlook and Future Milestones This section outlines key anticipated milestones and catalysts for 2023, focusing on clinical program advancements and regulatory guidance 2023 Anticipated Milestones and Catalysts Oncolytics has outlined several key milestones for 2023, including pivotal data readouts and guidance on registration paths for its clinical programs - Key anticipated milestones for 2023 include: * Q2 2023: Data readout (ORR, PFS, OS) from the Phase 2 BRACELET-1 metastatic breast cancer study * Q2 2023: Preclinical data from the combination of pelareorep and CAR T therapy * H2 2023: Updated data from the GOBLET study in advanced/metastatic PDAC * H2 2023: Updates on other cohorts (colorectal, anal) from the GOBLET study * H2 2023: Guidance on registration paths for both HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC[12] Company Information and Forward-Looking Statements This section provides an overview of Oncolytics Biotech Inc. and includes important disclaimers regarding forward-looking statements and associated risks About Oncolytics Biotech Inc. Oncolytics Biotech is a biotechnology company developing pelareorep, an immunotherapeutic agent, for metastatic breast cancer and pancreatic cancer - Oncolytics is developing pelareorep, an intravenously delivered immunotherapeutic agent designed to induce anti-cancer immune responses[23] - The company is advancing towards registration studies in metastatic breast cancer and pancreatic cancer, with clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies[24] Forward-Looking Statements This report contains forward-looking statements subject to risks and uncertainties, including clinical trial success and regulatory processes - The press release includes forward-looking statements concerning pelareorep's potential, clinical trial timing, regulatory plans, and business development[25] - Investors are cautioned that these statements involve risks and uncertainties, such as the availability of funds, clinical trial success, and potential business interruptions from events like the COVID-19 pandemic[25]