UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

Oncolytics Biotech Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights ® Management hosting conference call and webcast today at 4:30 p.m. ET SAN DIEGO, CA and CALGARY, AB, March 7, 2024 -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the fourth quarter and year ended December 31, 2023. All dollar amounts are expressed in Canadian c ...

Condensed Interim Consolidated Financial Statements (unaudited) Oncolytics Biotech Inc. For the three and nine months ended September 30, 2023 ® 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 | | 2023 | | 2022 | | Assets | | | | | | Current assets | | | | | | Cash and cash equivalents (note 4) | $ | 39,981 | $ | 11,666 | ...

2 ONCOLYTICS BIOTECH INC. Condensed Interim Consolidated Financial Statements (unaudited) Oncolytics Biotech Inc. For the three and six months ended June 30, 2023 ® ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) (in thousands of Canadian dollars, except share amounts) | | | June 30, | | December 31, | | --- | --- | --- | --- | --- | | As at | | 2023 | | 2022 | | Assets | | | | | | Current assets | | | | | | Cash and cash equivalents (note 4) | $ | 17,520 ...

[Condensed Interim Consolidated Financial Statements](index=1&type=section&id=Condensed%20Interim%20Consolidated%20Financial%20Statements) [Consolidated Statements of Financial Position](index=2&type=section&id=ONCOLYTICS%20BIOTECH%20INC.%20CONDENSED%20INTERIM%20CONSOLIDATED%20STATEMENTS%20OF%20FINANCIAL%20POSITION) Total assets decreased to **$35.3 million** from **$37.3 million** as of March 31, 2023, driven by reduced marketable securities Key Balance Sheet Items (in thousands of Canadian dollars) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,872 | $11,666 | | Marketable securities | $13,798 | $20,472 | | Total current assets | $34,261 | $35,684 | | **Total assets** | **$35,328** | **$37,334** | | **Liabilities** | | | | Accounts payable and accrued liabilities | $2,232 | $3,650 | | Total current liabilities | $2,469 | $3,945 | | **Total liabilities** | **$9,577** | **$10,832** | | **Shareholders' Equity** | | | | Total shareholders' equity | $25,751 | $26,502 | [Consolidated Statements of Loss and Comprehensive Loss](index=3&type=section&id=ONCOLYTICS%20BIOTECH%20INC.%20CONDENSED%20INTERIM%20CONSOLIDATED%20STATEMENTS%20OF%20LOSS%20AND%20COMPREHENSIVE%20LOSS) Q1 2023 net loss improved to **$6.4 million** from **$6.8 million** in Q1 2022, due to lower R&D and increased interest income Quarterly Loss and Expense Comparison (in thousands of Canadian dollars) | Item | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Research and development | $3,539 | $3,708 | | General and administrative | $3,195 | $2,602 | | Interest income, net | $265 | $18 | | **Net loss** | **($6,437)** | **($6,779)** | | Net comprehensive loss | ($6,440) | ($6,826) | | **Basic and diluted loss per share** | **($0.10)** | **($0.12)** | [Consolidated Statements of Changes in Equity](index=4&type=section&id=ONCOLYTICS%20BIOTECH%20INC.%20CONDENSED%20INTERIM%20CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20EQUITY) Shareholders' equity declined in Q1 2023, primarily due to the net loss, partially offset by ATM equity program proceeds Reconciliation of Shareholders' Equity for Q1 2023 (in thousands of Canadian dollars) | Description | Amount | | :--- | :--- | | Balance as at December 31, 2022 | $26,502 | | Net loss and other comprehensive loss | ($6,440) | | Proceeds from 'At the Market' Agreement | $5,552 | | Share issue costs | ($180) | | Share-based compensation expense | $317 | | **Balance as at March 31, 2023** | **$25,751** | [Consolidated Statements of Cash Flows](index=5&type=section&id=ONCOLYTICS%20BIOTECH%20INC.%20CONDENSED%20INTERIM%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Cash and cash equivalents increased by **$4.1 million** in Q1 2023, driven by financing and investing activities, offset by operating cash usage Cash Flow Summary for Q1 (in thousands of Canadian dollars) | Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Cash used in operating activities | ($7,829) | ($6,252) | | Cash provided by (used in) investing activities | $6,669 | ($36) | | Cash provided by financing activities | $5,271 | $5,014 | | **Increase (decrease) in cash** | **$4,111** | **($1,274)** | | **Cash and cash equivalents, end of period** | **$15,872** | **$39,483** | [Notes to Condensed Interim Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) Notes provide context on the company's biopharmaceutical operations, financing, cash sufficiency, share capital, commitments, and financial risks [Note 1: Nature of Operations](index=6&type=section&id=Note%201%3A%20Nature%20of%20Operations) Oncolytics is a clinical-stage biopharmaceutical company developing pelareorep for cancer, funding operations via equity, with sufficient cash for 12 months - The company is a clinical-stage biopharmaceutical firm developing pelareorep, an intravenously delivered immunotherapeutic agent, with a primary focus on advancing programs in HR+/HER2- metastatic breast cancer and pancreatic cancer[12](index=12&type=chunk) - The company has not been profitable since inception and funds operations mainly through issuing capital. As of March 31, 2023, the accumulated deficit was **$424.7 million**[13](index=13&type=chunk) - As of March 31, 2023, the company had cash, cash equivalents, and marketable securities of **$29.7 million**, which it believes is sufficient to fund operations for at least the next twelve months[13](index=13&type=chunk) [Note 6: Share Capital](index=9&type=section&id=Note%206%3A%20Share%20Capital) The company raised **$5.55 million** (US$4.1 million) in Q1 2023 through ATM share sales, part of a larger **US$65 million** offering program - In Q1 2023, the company sold **2,663,036 common shares** under its ATM agreement for gross proceeds of **$5,552,000** (**US$4,100,000**) at an average price of **$2.08 per share**[33](index=33&type=chunk) - The current ATM agreement, established in June 2022, allows the company to issue common shares with an aggregate offering value of up to **US$65 million** over a 25-month period[33](index=33&type=chunk) [Note 9: Commitments](index=11&type=section&id=Note%209%3A%20Commitments) As of March 31, 2023, the company has approximately **$16.6 million** in financial commitments for clinical trials and manufacturing - The company is committed to payments totaling approximately **$16,600,000** for activities mainly related to its clinical trial and manufacturing programs, expected to occur over the next three years[40](index=40&type=chunk) [Note 10: Capital Disclosures](index=11&type=section&id=Note%2010%3A%20Capital%20Disclosures) Capital management supports R&D via equity issuances, leveraging a shelf prospectus for up to **$150 million** in securities until July 2024 - The company's objective is to maintain a strong statement of financial position to support its clinical trial program, manufacturing, and other costs, primarily through obtaining cash resources via equity financing[41](index=41&type=chunk) - In June 2022, the company renewed its short form base shelf prospectus, qualifying for the distribution of up to **$150,000,000** of securities in Canada and/or the U.S. until July 16, 2024[45](index=45&type=chunk)[47](index=47&type=chunk) [Note 11: Financial Instruments](index=13&type=section&id=Note%2011%3A%20Financial%20Instruments) The company manages credit, foreign exchange, and liquidity risks; a **$0.01** USD/CAD increase would decrease net loss by **$231,000** - The company is primarily exposed to foreign exchange risk from the U.S. dollar. As of March 31, 2023, it held a net position of **US$18.3 million** in financial instruments[55](index=55&type=chunk)[56](index=56&type=chunk) - A hypothetical **$0.01** increase in the value of the U.S. dollar against the Canadian dollar would have decreased the company's net comprehensive loss in 2023 by approximately **$231,000**[55](index=55&type=chunk) - Credit risk is managed by holding cash with Schedule I banks in Canada and restricting investments to investment-grade securities with short-term maturities[51](index=51&type=chunk)[52](index=52&type=chunk) [Note 13: Components of Expenses](index=15&type=section&id=Note%2013%3A%20Components%20of%20Expenses) Q1 2023 R&D expenses were **$3.5 million** (down from **$3.7 million**), while G&A increased to **$3.2 million** (up from **$2.6 million**) Expense Breakdown for Q1 (in thousands of Canadian dollars) | Expense Category | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | **Research and Development** | | | | Clinical trial expenses | $909 | $1,093 | | Personnel-related expenses | $1,380 | $1,226 | | **Total R&D Expenses** | **$3,539** | **$3,708** | | **General and Administrative** | | | | Public company-related expenses | $2,201 | $1,564 | | Office expenses | $774 | $660 | | **Total G&A Expenses** | **$3,195** | **$2,602** |

Oncolytics Biotech Inc. (NASDAQ:ONCY) Q4 2022 Earnings Conference Call March 3, 2023 8:30 AM ET Company Participants Jon Patton - Director, Investor Relations and Communications Matt Coffey - Chief Executive Officer Thomas Heineman - Chief Medical Officer Andrew de Guttadauro - Global Head, Business Development Kirk Look - Chief Financial Officer Conference Call Participants John Newman - Canaccord Genuity Patrick Trucchio - H.C. Wainwright Operator Welcome to Oncolytics Biotech’s Fourth Quarter and Full Ye ...

PART I [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) This section outlines significant investment risks, focusing on product development, financial condition, and funding [Risk Factors](index=7&type=section&id=D.%20Risk%20Factors) The company identifies numerous material risks, including early R&D stage, clinical trial failures, reliance on third parties, and financing needs - The company's lead product, pelareorep, is in the research and development stage, requiring significant further testing before it can be commercially marketed[17](index=17&type=chunk)[26](index=26&type=chunk) - The company relies on third-party drugs for its combination therapies and has limited control over their supply, which could delay product development if collaborations are unsuccessful[17](index=17&type=chunk)[34](index=34&type=chunk) - The company has a history of losses, with an accumulated deficit of **$418.3 million** as of December 31, 2022, and anticipates needing additional financing to fund future research and development[18](index=18&type=chunk)[47](index=47&type=chunk)[50](index=50&type=chunk) - The company believes it was classified as a passive foreign investment company (PFIC) for the 2022 tax year, which may have adverse U.S. federal income tax consequences for U.S. shareholders[19](index=19&type=chunk)[130](index=130&type=chunk) [Information on the Company](index=31&type=section&id=Item%204.%20Information%20on%20the%20Company) Oncolytics Biotech Inc. is a clinical-stage biopharmaceutical company developing pelareorep for cancer treatment, focusing on clinical trials and strategic partnerships [History and Development of the Company](index=31&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) Oncolytics Biotech Inc. was incorporated in Alberta, Canada on April 2, 1998, with its principal business in Calgary - The company was incorporated in Alberta, Canada on April **2**, **1998**[139](index=139&type=chunk) [Business Overview](index=31&type=section&id=B.%20Business%20Overview) The company develops pelareorep, an immunotherapeutic agent for cancer, advancing clinical programs for breast and pancreatic cancers, and leveraging its patent portfolio - Oncolytics is a clinical-stage biopharmaceutical company developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the immune system to fight cancer[141](index=141&type=chunk) - The primary strategic focus is advancing pelareorep programs for hormone receptor-positive / human epidermal growth factor **2**-negative (HR+/HER2-) metastatic breast cancer (mBC) and advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) to Phase **3** studies[146](index=146&type=chunk) - Pelareorep's mechanism of action is threefold: selective viral replication leading to tumor cell lysis, activation of innate immunity (NK cells), and priming a specific adaptive immune response (T cells) against tumors[149](index=149&type=chunk) - Interim results from the GOBLET study's pancreatic cancer cohort showed an Objective Response Rate (ORR) of **69%** and a Clinical Benefit Rate (CBR) of **85%**, substantially higher than historical controls[151](index=151&type=chunk)[168](index=168&type=chunk) - The company holds a robust intellectual property portfolio with **243** issued patents globally, covering compositions of matter, pharmaceutical use, combination therapies, and manufacturing methods for reovirus[170](index=170&type=chunk)[172](index=172&type=chunk) [Organizational Structure](index=41&type=section&id=C.%20Organizational%20Structure) As of December 31, 2022, Oncolytics Biotech Inc. operates through its wholly-owned subsidiaries in Barbados and the U.S - The company's main subsidiaries are Oncolytics Biotech (Barbados) Inc. and Oncolytics Biotech (U.S.) Inc[194](index=194&type=chunk) [Property, Plant and Equipment](index=41&type=section&id=D.%20Property,%20Plant%20and%20Equipment) The company leases all its office spaces in Calgary, San Diego, and Barbados, owning no manufacturing facilities or real estate - The company leases all its office spaces and does not own any real estate or manufacturing facilities[195](index=195&type=chunk) [Operating and Financial Review and Prospects](index=41&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section discusses operating results, liquidity, capital resources, and R&D activities, noting future expenditures are uncertain and depend on funding - The company's Management Discussion and Analysis (MD&A) for **2022** is incorporated by reference to provide details on operating results and liquidity[199](index=199&type=chunk)[200](index=200&type=chunk) - Future expenditures are subject to significant uncertainty, depending on the timing and costs of R&D activities and the availability of funding[202](index=202&type=chunk) [Directors, Senior Management and Employees](index=42&type=section&id=Item%206.%20Directors,%20Senior%20Management%20and%20Employees) This section details leadership, compensation, board practices, and employee statistics, including equity compensation plans and share ownership [Directors and Senior Management](index=42&type=section&id=A.%20Directors%20and%20Senior%20Management) The report lists directors and senior management as of December 31, 2022, including their positions and share ownership - As of February **27**, **2023**, the directors and senior management as a group beneficially owned **847,866** common shares, representing **1.35%** of the issued and outstanding shares[210](index=210&type=chunk) [Compensation](index=46&type=section&id=B.%20Compensation) Details of 2022 compensation for directors and senior management are provided, including base retainers, bonuses, and equity awards | Name | Position | Salary ($) | Option-based awards ($) | Bonus ($) | Total compensation ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Dr. Matthew C. Coffey | President and CEO | 654,404 | 136,616 | 310,842 | 1,185,060 | | Kirk J. Look | CFO | 486,593 | 109,293 | 184,905 | 850,145 | | Dr. Thomas C. Heineman | CMO | 599,999 | 109,293 | 228,000 | 981,971 | - Non-employee directors receive a base retainer of **US$40,000**, with additional retainers for the Board Chair (**US$40,000**) and committee chairs (**US$10,000**-**US$20,000**)[217](index=217&type=chunk) - Employment agreements include severance provisions. In the event of a change of control, the CEO would be entitled to a severance payment of **$1,475,205**, and the CFO would be entitled to **$1,111,894**, as of December **31**, **2022**[228](index=228&type=chunk)[229](index=229&type=chunk) [Employees](index=52&type=section&id=D.%20Employees) The company's workforce grew from 25 in 2020 to 29 in 2022, with employees split between R&D and general/administrative functions | Year | Total Employees | R&D | General & Admin | | :--- | :--- | :--- | :--- | | 2022 | 29 | 17 | 12 | | 2021 | 26 | 15 | 11 | | 2020 | 25 | 14 | 11 | [Share Ownership](index=54&type=section&id=E.%20Share%20Ownership) This subsection details common share and stock option holdings of directors and officers, and describes the company's equity compensation plans - As of February **27**, **2023**, directors and officers collectively held **847,866** common shares and **4,034,942** outstanding options[249](index=249&type=chunk)[250](index=250&type=chunk) - The company's Stock Option Plan and Share Award Plan combined cannot exceed **10%** of the total number of issued and outstanding Common Shares[254](index=254&type=chunk)[267](index=267&type=chunk) [Major Shareholders and Related Party Transactions](index=59&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) The company reports no shareholders owning over 5% of voting shares and no material related party transactions for the fiscal year - As of March **3**, **2023**, the company is not aware of any shareholder beneficially owning more than **5%** of its voting shares[274](index=274&type=chunk) | Date | Total Shares Outstanding | U.S. Holders of Record | Shares Held by U.S. Holders | % Held by U.S. Holders | | :--- | :--- | :--- | :--- | :--- | | Feb 24, 2023 | 62,826,958 | 59 | 54,495,601 | 86.74% | [Financial Information](index=60&type=section&id=Item%208.%20Financial%20Information) This section confirms consolidated financial statements are filed under Item 18, reports no material legal proceedings, and states no dividends will be paid - The company has not paid any dividends since its incorporation and does not intend to in the foreseeable future, retaining earnings to finance growth[284](index=284&type=chunk) - There are no material, active, or pending legal proceedings against the company, its directors, or management[283](index=283&type=chunk) [Additional Information](index=61&type=section&id=Item%2010.%20Additional%20Information) This section covers corporate governance, Canadian exchange controls, and material Canadian and U.S. federal income tax considerations for shareholders - The company is governed by the Business Corporations Act of Alberta. A quorum for shareholder meetings requires representation of at least **5%** of issued and outstanding shares[289](index=289&type=chunk)[295](index=295&type=chunk) - Canada has no system of exchange controls, but acquisitions of 'control' (generally **one-third** or more of voting shares) by a non-Canadian may require review under the Investment Canada Act[301](index=301&type=chunk)[302](index=302&type=chunk) - Dividends paid to non-resident holders are subject to a **25%** Canadian withholding tax, which may be reduced by applicable tax treaties (e.g., to **15%** for eligible U.S. residents)[311](index=311&type=chunk) - The company believes it was a Passive Foreign Investment Company (PFIC) for the **2022** tax year, which has significant and potentially adverse U.S. federal income tax implications for U.S. Holders, who are advised to consult their tax advisors[322](index=322&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=76&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company discloses exposure to credit, interest rate, and foreign exchange risks, noting it does not use financial instruments for trading or hedging - The company does not currently have long-term debt or use derivative instruments for hedging against interest rate or other market risks[368](index=368&type=chunk) PART II [Controls and Procedures](index=76&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the fiscal year **2022**[373](index=373&type=chunk) - Management assessed the company's internal control over financial reporting as effective as of December **31**, **2022**, using the COSO framework[376](index=376&type=chunk) [Corporate Governance](index=78&type=section&id=Item%2016G.%20Corporate%20Governance) As a foreign private issuer, the company follows Canadian corporate governance practices, which differ from Nasdaq's requirements, notably in quorum rules - As a foreign private issuer, the company is exempt from certain Nasdaq corporate governance rules and follows Canadian practices[388](index=388&type=chunk) - A significant governance difference is the shareholder meeting quorum, which is **5%** of outstanding shares, lower than the Nasdaq minimum requirement of **one-third**[389](index=389&type=chunk) PART III [Financial Statements](index=83&type=section&id=Item%2018.%20Financial%20Statements) This section contains audited consolidated financial statements for 2022, showing a net loss of **$24.8 million** and an unqualified auditor opinion [Consolidated Statements of Financial Position](index=86&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) As of December 31, 2022, total assets decreased to **$37.3 million**, total liabilities increased to **$10.8 million**, and equity decreased to **$26.5 million** | (in thousands of CAD) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,666 | $41,262 | | Marketable securities | $20,472 | $0 | | **Total Assets** | **$37,334** | **$45,880** | | Total current liabilities | $3,945 | $2,690 | | **Total Liabilities** | **$10,832** | **$9,781** | | Accumulated deficit | ($418,251) | ($393,416) | | **Total Shareholders' Equity** | **$26,502** | **$36,099** | [Consolidated Statements of Loss and Comprehensive Loss](index=87&type=section&id=Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) For 2022, the company reported a net loss of **$24.8 million**, a decrease from **$26.3 million** in 2021, primarily due to lower G&A expenses | (in thousands of CAD) | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Research and development | $15,432 | $12,920 | $12,945 | | General and administrative | $11,492 | $13,315 | $12,514 | | **Net Loss** | **($24,835)** | **($26,304)** | **($22,505)** | | **Loss per common share** | **($0.43)** | **($0.49)** | **($0.56)** | [Consolidated Statements of Cash Flows](index=89&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2022, cash used in operations was **$23.4 million**, resulting in a net decrease of **$31.6 million**, with year-end cash at **$11.7 million** | (in thousands of CAD) | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Cash used in operating activities | ($23,355) | ($22,433) | ($22,068) | | Cash used in investing activities | ($20,403) | ($286) | ($29) | | Cash provided by financing activities | $12,205 | $33,015 | $39,773 | | **(Decrease) increase in cash** | **($31,553)** | **$10,296** | **$17,676** | | **Cash, end of year** | **$11,666** | **$41,262** | **$31,220** |

[Report Overview and Operational Highlights](index=1&type=section&id=Report%20Overview%20and%20Operational%20Highlights) 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](index=1&type=section&id=CEO's%20Statement) 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](index=2&type=chunk) - 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](index=2&type=chunk) - 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](index=2&type=chunk) [Pancreatic Cancer Program](index=1&type=section&id=Pancreatic%20Cancer%20Program) 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](index=3&type=chunk) - The reported **69% ORR** is nearly three times the average **~25% ORR** from historical control trials using gemcitabine plus nab-paclitaxel[3](index=3&type=chunk) - 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](index=5&type=chunk) [Breast Cancer Program](index=2&type=section&id=Breast%20Cancer%20Program) 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](index=6&type=chunk) - The combination of pelareorep and paclitaxel was well tolerated, with no dose-limiting toxicities or serious adverse events reported in the bridging trial[6](index=6&type=chunk) - Oncolytics expects to announce overall response rate and progression-free survival data from the randomized Phase 2 BRACELET-1 trial in **Q2 2023**[7](index=7&type=chunk) [Financial Highlights and Results](index=2&type=section&id=Financial%20Highlights%20and%20Results) 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](index=2&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202022%20Financial%20Summary) 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](index=1&type=chunk)[8](index=8&type=chunk) 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](index=4&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) 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](index=5&type=section&id=Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) 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](index=6&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Equity) 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](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) 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](index=3&type=section&id=Outlook%20and%20Future%20Milestones) This section outlines key anticipated milestones and catalysts for 2023, focusing on clinical program advancements and regulatory guidance [2023 Anticipated Milestones and Catalysts](index=3&type=section&id=2023%20Anticipated%20Milestones%20and%20Catalysts) 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](index=12&type=chunk) [Company Information and Forward-Looking Statements](index=8&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) This section provides an overview of Oncolytics Biotech Inc. and includes important disclaimers regarding forward-looking statements and associated risks [About Oncolytics Biotech Inc.](index=8&type=section&id=About%20Oncolytics%20Biotech%20Inc.) 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](index=23&type=chunk) - 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](index=24&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Forward-Looking%20Statements) 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](index=25&type=chunk) - 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](index=25&type=chunk)

Oncolytics Biotech, Inc. (NASDAQ:ONCY) Q3 2022 Earnings Conference Call November 7, 2022 8:30 AM ET Company Participants Jon Patton - Director, IR & Communication Matt Coffey - CEO Tom Heineman - CMO Andrew de Guttadauro - Global Head, Business Development Kirk Look - CFO Conference Call Participants John Newman - Canaccord Operator Good morning, and welcome to Oncolytics Biotech's Third Quarter 2022 Conference Call. All participants are now in a listen-only mode. There will be a question-and-answer session ...

[Condensed Interim Consolidated Financial Statements](index=2&type=section&id=Condensed%20Interim%20Consolidated%20Financial%20Statements) [Statements of Financial Position](index=2&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Financial%20Position) The company's total assets decreased to $39.0 million, driven by lower cash, while liabilities increased and shareholders' equity declined Consolidated Statements of Financial Position (unaudited) | As at | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Total current assets** | $38,205,271 | $44,903,899 | | **Total assets** | **$38,958,977** | **$45,880,191** | | **Total current liabilities** | $3,666,145 | $2,689,838 | | **Total liabilities** | $10,562,350 | $9,781,206 | | **Total shareholders' equity** | $28,396,627 | $36,098,985 | | **Total liabilities and shareholders' equity** | **$38,958,977** | **$45,880,191** | [Statements of Loss and Comprehensive Loss](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) The company's net loss for the nine-month period improved to $16.3 million from $18.6 million year-over-year due to lower expenses and a foreign exchange gain Statement of Loss Highlights (Nine Months Ended September 30) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Research and development expenses | $10,590,464 | $9,240,900 | | General and administrative expenses | $7,825,659 | $9,539,188 | | Foreign exchange gain | $1,939,468 | $190,164 | | **Net loss** | **($16,280,513)** | **($18,553,023)** | | **Net comprehensive loss** | **($15,945,620)** | **($18,546,798)** | | **Basic and diluted loss per common share** | **($0.28)** | **($0.35)** | [Statements of Changes in Equity](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Shareholders' equity decreased to $28.4 million, primarily driven by a net comprehensive loss partially offset by proceeds from financing activities - Total shareholders' equity decreased by **$7.7 million** during the first nine months of 2022, from $36.1 million to $28.4 million[7](index=7&type=chunk) - The decrease was primarily due to a **net comprehensive loss of $15.9 million**[7](index=7&type=chunk) - Financing activities, mainly from the "At the Market" Agreement, contributed **$7.2 million** to share capital[7](index=7&type=chunk) - Equity warrants with a book value of **$3.6 million** expired and were transferred to Contributed Surplus[7](index=7&type=chunk) [Statements of Cash Flows](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents decreased by $11.1 million to $32.4 million, reflecting cash used in operations partially offset by financing inflows Cash Flow Summary (Nine Months Ended September 30) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Cash used in operating activities | ($17,416,436) | ($16,098,335) | | Cash used in investing activities | ($55,740) | ($211,236) | | Cash provided by financing activities | $6,334,841 | $33,067,387 | | **(Decrease) increase in cash** | **($11,137,335)** | **$16,757,816** | | **Cash and cash equivalents, end of period** | **$32,362,063** | **$48,087,369** | [Notes to Condensed Interim Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) [Note 1: Nature of Operations](index=6&type=section&id=Note%201%3A%20Nature%20of%20Operations) The company is a clinical-stage biopharmaceutical firm with a significant accumulated deficit but believes its current cash position is sufficient for the next year - The company is a clinical-stage biopharmaceutical firm developing pelareorep, an intravenously delivered immunotherapeutic agent for cancer[10](index=10&type=chunk) - Primary focus is advancing its program in HR+/HER2- metastatic breast cancer to a phase 3 study[10](index=10&type=chunk) - The company has an accumulated deficit of **$409,696,122** as of September 30, 2022, and has historically funded operations through equity issuance[11](index=11&type=chunk) - As of September 30, 2022, the company had cash and cash equivalents of **$32,362,063**, which is believed to be sufficient to fund operations for at least the next twelve months[12](index=12&type=chunk) [Note 5: Share Capital](index=8&type=section&id=Note%205%3A%20Share%20Capital) Share capital increased to $398.1 million due to share issuance via its ATM equity agreements, while a significant number of warrants expired Share Capital Reconciliation | Description | Number of Shares | Amount | | :--- | :--- | :--- | | **As at December 31, 2021** | **55,043,789** | **$391,348,183** | | Issued pursuant to ATM agreement | 3,613,760 | $7,159,552 | | Issued pursuant to stock option/incentive plan | 48,893 | $117,958 | | Share issue costs | — | ($557,389) | | **As at September 30, 2022** | **58,706,442** | **$398,068,304** | - The company utilized three separate "At the Market" (ATM) equity distribution agreements to raise capital, with the most recent one for up to **US$65 million** established in June 2022[27](index=27&type=chunk) - Equity warrants for **16,443,500 common shares** expired on June 1, 2022, and their value of $3,617,570 was transferred from Warrants to Contributed Surplus[28](index=28&type=chunk)[29](index=29&type=chunk) [Note 6: Share-Based Compensation](index=9&type=section&id=Note%206%3A%20Share-Based%20Compensation) Share-based compensation expense decreased to $1.6 million year-over-year, with approximately 5.3 million stock options outstanding at period end Stock Option Activity (Nine Months Ended Sept 30) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Outstanding, beginning of period | 5,334,420 | 3,764,055 | | Granted | 292,500 | 1,267,500 | | Forfeited/Expired/Exercised | (327,189) | (189,594) | | **Outstanding, end of period** | **5,299,731** | **4,841,961** | - Total share-based compensation expense for the nine months ended September 30, 2022, was **$1,629,016**, compared to $2,697,238 for the same period in 2021[34](index=34&type=chunk) [Note 8: Commitments](index=10&type=section&id=Note%208%3A%20Commitments) The company has future commitments of approximately $16.8 million for clinical trials and manufacturing, plus lease obligations - The company is committed to payments of approximately **$16,800,000** over the next three years for clinical trials, manufacturing, and science programs[36](index=36&type=chunk) - Commitments include the jointly funded BRACELET-1 phase 2 clinical trial with Pfizer[37](index=37&type=chunk) Total Undiscounted Lease Liability (as at Sept 30, 2022) | Period | Amount | | :--- | :--- | | Less than one year | $340,272 | | One to five years | $211,244 | | **Total** | **$551,516** | [Note 9: Capital Disclosures](index=11&type=section&id=Note%209%3A%20Capital%20Disclosures) The company manages capital primarily through equity issuance, renewing its $150 million base shelf prospectus and a US$65 million ATM agreement - The company's objective is to maintain a strong statement of financial position to support its clinical trial program, manufacturing, and other costs[41](index=41&type=chunk) - Funding is primarily managed through the issuance of additional common shares and warrants[44](index=44&type=chunk) - In June 2022, the company renewed its Base Shelf prospectus to qualify for the distribution of up to **$150,000,000** of securities until July 2024[45](index=45&type=chunk)[46](index=46&type=chunk) - The Base Shelf allowed the company to enter into a **US$65,000,000** ATM equity distribution agreement in June 2022[47](index=47&type=chunk) [Note 10: Financial Instruments](index=12&type=section&id=Note%2010%3A%20Financial%20Instruments) The company is exposed to various financial risks, with a primary foreign exchange risk related to its net U.S. dollar position of US$20.0 million - The company is exposed to credit risk, interest rate risk, foreign exchange risk, and liquidity risk[49](index=49&type=chunk)[51](index=51&type=chunk)[53](index=53&type=chunk)[56](index=56&type=chunk) - Foreign exchange risk is primarily from the U.S. dollar. A **$0.01 increase in the USD** against the CAD would have decreased the net comprehensive loss in 2022 by approximately **$188,000**[53](index=53&type=chunk) Significant Balances in Foreign Currencies (Sept 30, 2022) | Currency | Amount | | :--- | :--- | | **U.S. dollars** | | | Cash and cash equivalents | $21,377,467 | | Accounts payable and accrued liabilities | ($1,345,402) | | **Net U.S. dollar position** | **$20,032,065** | | **Euro** | | | Accounts payable and accrued liabilities | (€705,472) | [Note 12: Components of Expenses](index=14&type=section&id=Note%2012%3A%20Components%20of%20Expenses) R&D expenses increased to $10.6 million due to higher trial costs, while G&A expenses decreased to $7.8 million on lower public company costs Components of Expenses (Nine Months Ended September 30) | Expense Category | 2022 | 2021 | | :--- | :--- | :--- | | **Research and development** | **$10,590,464** | **$9,240,900** | | Clinical trial expenses | $3,674,955 | $2,576,886 | | Personnel-related expenses (R&D) | $3,592,412 | $2,906,119 | | **General and administrative** | **$7,825,659** | **$9,539,188** | | Public company related expenses | $4,787,000 | $6,066,646 | | Share-based compensation (G&A) | $718,043 | $1,226,669 | [Note 13: Related Party Transactions](index=14&type=section&id=Note%2013%3A%20Related%20Party%20Transactions) Key management personnel compensation decreased to $3.5 million from $4.2 million year-over-year, driven by lower share-based compensation Compensation of Key Management Personnel (Nine Months Ended September 30) | Compensation Type | 2022 | 2021 | | :--- | :--- | :--- | | Compensation and short-term benefits | $2,405,350 | $2,320,516 | | Share-based compensation | $1,128,096 | $1,869,090 | | **Total** | **$3,533,446** | **$4,189,606** |