ONCY 10-K & 10-Q changes, risk factors and insider trading
Oncolytics Biotech Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1129928 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Comparison not available: Not available: fewer than two 10-K filings on EDGAR to compare (only one so far)..
What changed in the latest 10-Q
Risk Factors
There have been no material changes to our risk factors from those disclosed in our annual report on Form 10-K for the fiscal year ended December 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Preclinical program”
New heading “Functional and Reporting Currency”
Removed heading “First-line metastatic pancreatic ductal adenocarcinoma (“mPDAC”)”
Removed heading “GOBLET Cohort 5”
Removed heading “Potential first-line pancreatic cancer registration study”
Largest changes
“First-line metastatic pancreatic ductal adenocarcinoma (“mPDAC”)”see in full comparison
“In June 2026, we secured a new U.S. patent protecting our proprietary manufacturing process for pelareorep. Developed through our contracted collaboration with the National Research Council of Canada (“NRC”), this jointly arising intellectual property is automatically assigned to NRC and exclusively licensed to Oncolytics, subject to a nominal royalty, for the production and commercialization of pelareorep. The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide patent protection until 2044. …”see in full comparison
Full comparison: every changed paragraph (65)
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read together with our condensed consolidated financial statements and related notes included elsewhere in this quarterly report and our audited financial statements and related notes included in our annual report on Form 10-K for the year ended December 31, 2025.2025 . The following discussion contains forward-looking statements that involve numerous risks and uncertainties. Our actual results could differ materially from the results described in or implied by these forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements” for additional cautionary information.
We are a clinical-stage biopharmaceutical company developing pelareorep, a well-tolerated intravenously delivered immunotherapeutic agent that selectively replicates in RAS-mutated tumors andtumors, activates the innate and adaptive immune systemssystems, and weakens tumor defense mechanisms. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments.
Pelareorep is a proprietary isolate of reovirus, a naturally occurring, non-pathogenic double-stranded RNA virus commonly found in environmental waters. Pelareorep has shown promising results in changing the tumor microenvironment (“TME”). This creates a more immunologically favorable TME, making the tumor more susceptible to various treatment combinations. These treatments include chemotherapies, checkpoint inhibitors, and other immuno-oncology approaches such as CAR T therapies, bispecific antibodies, and RAS or CDK4/6 inhibitors. Pelareorep induces a new army of tumor-reactive T cells, helps these cells to infiltrate the tumor through an inflammatory process, and upregulates key inflammatory cytokines resulting in the expressionformation of PD-1/PD-L1.tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. By priming the immune system with pelareorep, we believe we can increase the proportion of patients who respond to various cancer treatments, including immunotherapies, especially in cancers where existing treatment regimens have failed or provided limited benefit.
Our primary focus is to position pelareorep as a platform immunotherapy for the treatment of gastrointestinal (“GI”) cancers and advance our GI programs to registration-enabled clinical studies. We are exploring opportunities for registrational programsstudies and investigator-sponsored trials in metastatic colorectal cancer, second-line or later anal cancer, and metastatic pancreatic cancer.
As of MarchJune 31,30, 2026, we had cash and cash equivalents of $5,493.$4,115. Based on our current operating plan, we expect that our existing cash resources, even when considered together with available capital under our equity distribution arrangements, are sufficient to fund near‑term operating milestones but are not sufficient to fund our planned operations for at least twelve months from the date of issuance of our condensed consolidated financial statements included in this quarterly report. These conditions raise substantial doubt about our ability to continue as a going concern.
The following are the development updates and outlook for each of our programsprogram for the three months ended MarchJune 31,30, 2026, through to the date of this quarterly report.
In latethe 2025,first quarter of 2026, we filed forreceived Fast Track Designation for pelareorep in combination with bevacizumab and fluorouracil, leucovorin, irinotecan (“FOLFIRI”) for the treatment of patients with Kirsten rat sarcoma (“KRAS”)-mutant, microsatellite-stable (“MSS”) mCRC in the second-line setting. The application was supported by clinical data demonstrating a 33% objective response rate (“ORR”) for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care1 in this patient population. In addition, pelareorep combination therapy was associated with a median progression-free survival (“PFS”) of 16.6 months, compared to 5.7 months with standard-of-care2, a duration of response of 19.5 months, compared to historical benchmarks of approximately 4–6 months3 in this setting, and a median overall survival of 27 months, compared to 11.2 months with standard-of-care4. The FDA granted our application, awarding Fast Track Designation for this indication in 2026.
Randomized Phase 2 second-line mCRC study – REO 033
In March 2026, we launchedannounced the launch of a randomized Phase 2 studystudy, known as REO 033, evaluating second-line RAS-mutated (which includes KRAS) MSS mCRC patients. Patients will receive either the control arm of bevacizumab (Avastin®) and FOLFIRI or the experimental arm of pelareorep, bevacizumab, and FOLFIRI. The first study site was initiated in early April 2026.
1 Bennouna J. Lancet Oncol (14):29-37, 2013 / Iwamoto S. Ann Oncol. Jul;26(7); 1427-33, 2015 2 Bennouna J. Lancet Oncol (14):29-37, 2023 3 FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C–mutated colorectal cancer. Published June 21, 2024. Accessed April 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer 4 Bennouna J. Lancet Oncol (14):29-37, 2023 During the second quarter of 2026, we continued with site initiation and expect that approximately half of the planned clinical sites will be activated during the third quarter of 2026.
Second-line or later squamousSquamous cell carcinoma of the anal canal (“SCAC”)
In January 2026, we reported updated clinical data from patients with third-line SCAC. The data showed four of 14 evaluable third-line patients receiving pelareorep and atezolizumab achieved objective responses, resulting in an ORR of approximately 29%. These responses included two complete responses and two partial responses. The median duration of response is approximately 17 months (67 weeks), indicating both depth and durability of clinical benefit in a heavily pretreated population. In historical third-line SCAC studies, objective response rates are typically approximately 10% or less5, with limited durability. In the second-line setting, pelareorep and atezolizumab achieved a 30% ORR, more than doubling the 13.8% ORR that was approved by the FDA for the current standard of care therapy6. We are no longer enrolling patientsEnrollment in Cohort 4 has been completed and we will continue to monitor patients on the study and provide a final analysis once sufficient data has been collected.
In July 2026, the FDA granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for the treatment of patients with inoperable, locally recurrent or metastatic SCAC who have progressed on or were intolerant to one or more prior lines of systemic therapy.
Preclinical program
In June 2026, we announced initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone. Based on these findings, we are planning additional studies in models of colorectal cancer and in pancreatic ductal adenocarcinoma designed to further evaluate the combinations’ effects on immune activation, tumor response durability, and time-to-resistance. The ongoing work includes evaluations of pelareorep in combination with KRAS G12C inhibitors, pan-RAS inhibitors, and additional next-generation RAS pathway-targeting agents in RAS-mutated tumor models.
First-line metastatic pancreatic ductal adenocarcinoma (“mPDAC”)
GOBLET Cohort 5
In a randomized two-arm cohort, pelareorep is being evaluated in combination with modified FOLFIRINOX with or without atezolizumab to gain greater clarity regarding the contribution of the checkpoint inhibitor to the efficacy achieved in GOBLET Cohort 1. In that cohort, pelareorep combined with gemcitabine/nab-paclitaxel and atezolizumab achieved a 62% ORR in 13 evaluable patients. GOBLET Cohort 5 is supported by the Pancreatic Cancer Action Network (“PanCAN”) Therapeutic Accelerator Award for up to $5 million.
In the first quarter of 2026, we made the determination that we had sufficient patients enrolled in Cohort 5 that would allow us to properly analyze the combinations being tested in the cohort. We expect to present preliminary analysis of the data in the second half of 2026 once survival data has matured sufficiently.
Potential first-line pancreatic cancer registration study
We participated in a Type C meeting with the FDA in the fourth quarter of 2025 and agreed on the key elements of a Phase 3 trial of pelareorep in combination with standard-of-care therapy for the first-line treatment of mPDAC. This trial would evaluate pelareorep and gemcitabine/nab-paclitaxel with or without a checkpoint inhibitor compared to chemotherapy alone. The primary endpoint of the study is overall survival, and PFS and ORR are secondary endpoints. We remain in active discussions with potential partners to supply a checkpoint inhibitor and fund our proposed first-line PDAC study. Until we enter into a transaction agreement with a partner, we do not expect to advance this study on our own and plan to focus our resources on other high-value indications that provide a more efficient path to registration for pelareorep.
ClinicalProgram development for the remainder of 2026
In 2026, our clinical objectives will primarily revolve around our randomized second-line mCRC clinical study. We are actively evaluating multiple strategic partnership options and continue to engage with collaborators, academic partners, and other stakeholders to determine the most effective path forward for pelareorep in PDACmPDAC and second-line or later SCAC. Preclinical objectives this year will focus on studies planned to evaluate pelareorep in combination with a range of RAS inhibitor modalities with initial results expected in the fall or winter of 2026.
While we currently have sufficient drug product supply to support our clinical development program, we continued our activities to expand our production capabilities as we focus on advancing our active drug substance and finished drug product towards registration and commercial readiness. In the firstsecond quarter of 2026, we completedinitiated an analytical testingstudy forutilizing the cGMPhuman productiontumor runcell andline drugpotency product fill initiated in 2025.assay. We also updated the formal assessment of the drug substance production process with additional batch production and begandevelopment data and progressed analytical development activities to support upcoming process characterization in preparation for process performance qualification. We also incurred storage and distribution costs to maintain our product supply. Ongoing bulk manufacturing and expanded filling capabilities are both part of the planned process validation. Process validation is required to ensure that the resulting product meets the specifications and quality standards and will form part of our submission to regulators, including the FDA, for product approval.
At MarchJune 31,30, 2026, we had 138139 patents, including 11 U.S. and 7 Canadian patents, and issuances in other jurisdictions. We have an extensive patent portfolio covering pelareorep and formulations that we use in our clinical trial program. We also have patents covering methods for manufacturing pelareorep and screening for susceptibility to pelareorep. These patent rights extend to at least the end of 2031. We are continuing to analyze additional patent protections and have placed an emphasis on patent extension strategy and growing our patent portfolio. In addition, we have submitted new patent applications that we expect to extend certain patent protections and grant new rights into the 2040s.2040s including method-of-using protection until 2040 and method-of-making protection until 2044.
In June 2026, we secured a new U.S. patent protecting our proprietary manufacturing process for pelareorep. Developed through our contracted collaboration with the National Research Council of Canada (“NRC”), this jointly arising intellectual property is automatically assigned to NRC and exclusively licensed to Oncolytics, subject to a nominal royalty, for the production and commercialization of pelareorep. The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide patent protection until 2044. The patent is designed to protect the Company’s ability to consistently produce pelareorep at commercial scale and represents a significant addition to the Company’s growing intellectual property portfolio. The Company also announced that a previously filed method-of-use patent application remains under review and, if issued, is expected to provide protection until at least 2046. In addition, Oncolytics plans to file further patent applications this year that are designed to expand and strengthen the pelareorep intellectual property estate across additional therapeutic applications, treatment settings, and combination approaches.
On April 6, 2026, we entered into an Open Market Sale Agreement (the “Sales Agreement”) with Jefferies LLC (the “Agent”), pursuant to which we may offer and sell from time to time through or to the agent, acting as agent or principal, shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $75,000. During the three months ended June 30, 2026, we sold 7,859,359 common shares for gross proceeds of $7,152 at an average price of $0.91 per share. We received net proceeds of $6,771 after issuance costs of $381 (including commissions of $215).
During the three months ended March 31, 2026, we sold 7,446,574 common shares pursuant to at-the-market (“ATM”) offering agreements for gross proceeds of $7,861 at an average price of $1.06 per share, resulting in net proceeds of $7,614 after issuance costs of $247 (including commissions of $236).
From AprilJuly 1, 2026 to MayAugust 12,10, 2026, we sold 2,575,9052,322,984 common shares pursuant to athe Sales Agreement (see “Other Corporate Matters”) for gross proceeds of $2,363$1,890 at an average price of $0.92$0.81 per share. We received net proceeds of $2,292$1,834 after commissions of $71.$57.
As of MarchJune 31,30, 2026, we had cash and cash equivalents of $5,493$4,115 (see “Liquidity and Capital Resources”).
On April 6, 2026, we entered into an Open Market Sale Agreement (the “Sales Agreement”) with Jefferies LLC (the “Agent”), pursuant to which we may offer and sell from time to time through or to the agent, acting as agent or principal, shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $75,000.
Comparison of the three and six months ended MarchJune 31,30, 2026 and 2025:
Net loss for the three months ended MarchJune 31,30, 2026 was $9,243$9,442 compared to $4,711$5,277 for the three months ended MarchJune 31,30, 2025. Net loss for the six months ended June 30, 2026 was $18,685 compared to $9,988 for the six months ended June 30, 2025.
Our R&D expenses increased by $1,752$2,346 from $2,800$1,916 for the three months ended MarchJune 31,30, 2025, to $4,552$4,262 for the three months ended MarchJune 31,30, 2026. The following table summarizes our R&D expenses for the three months ended MarchJune 31,30, 2026 and 2025:
The increase in our R&D expenses for the three months ended MarchJune 31,30, 2026, was primarily due to the following:
•Increased personnel-related expenses due to increased stock-based compensation expense and increased headcount. The increase in stock-based compensation expense was due to new stock option grants in the second half of 2025 and an adjustment to reclassify options from equity-classified to liability classified as discussed in note 3 of the condensed consolidated financial statements. This increase was partly offset by CEO transition-related activities in the first quarter of 2025.
•Increased clinical trial expenses due to start-up costs for our phase 2 second-line mCRC study launched in the first quarter of 2026 and higher registration program planning-related expenses. Our clinical trial expenses for the three months ended March 31, 2026 included $143 of non-cash stock-based compensation expense for consulting services.2026.
•Increased personnel-related expenses due to increased non-cash stock-based compensation expense and increased headcount.
Our R&D expenses increased by $4,098 from $4,716 for the six months ended June 30, 2025, to $8,814 for the six months ended June 30, 2026. The following table summarizes our R&D expenses for the six months ended June 30, 2026 and 2025:
The increase in our R&D expenses for the six months ended June 30, 2026, was primarily due to the following:
•Increased clinical trial expenses due to start-up costs for our phase 2 second-line mCRC study launched in the first quarter of 2026 and higher registration program planning-related expenses.
•Increased personnel-related expenses due to increased non-cash stock-based compensation expense and increased headcount. Our non-cash stock-based compensation expense also included an adjustment to reclassify options from equity-classified to liability classified as discussed in note 3 of the condensed consolidated financial statements. This increase was partly offset by CEO transition-related activities in the first quarter of 2025.
Our G&A expenses increased by $2,508$2,382 from $2,221$2,735 for the three months ended MarchJune 31,30, 2025, to $4,729$5,117 for the three months ended MarchJune 31,30, 2026. The following table summarizes our G&A expenses for the three months ended MarchJune 31,30, 2026 and 2025:
The increase in our G&A expenses for the three months ended MarchJune 31,30, 2026 was primarily due to the following:
•Increased public company-related expenses due to higher investor relations activities and additional legal and tax professional fees relatedassociated towith the Domestication. Our public company-related expenses for the three months ended MarchJune 31,30, 2026 included $587$603 of non-cash stock-based compensation expense for consulting services.
•Increased personnel-related expenses due to increased non-cash stock-based compensation expense asand aincreased result of new stock options grants in the second half of 2025.headcount.
Our G&A expenses increased by $4,890 from $4,956 for the six months ended June 30, 2025, to $9,846 for the six months ended June 30, 2026. The following table summarizes our G&A expenses for the six months ended June 30, 2026 and 2025:
The increase in our G&A expenses for the six months ended June 30, 2026 was primarily due to the following:
•Increased public company-related expenses due to higher investor relations activities and legal, tax, audit and accounting professional fees related to the Domestication. Our public company-related expenses for the six months ended June 30, 2026 included $1,187 of non-cash stock-based compensation expense for consulting services.
•Increased personnel-related expenses due to increased non-cash stock-based compensation expense and increased headcount.
As of MarchJune 31,30, 2026 and December 31, 2025, we had cash and cash equivalents as follows:
The increase in net cash used in operating activities reflects higher operating activities and higher non-cash working capital changes in 2026. Overall, net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 and 2025 was primarily related to the funding of our research and development activities, including personnel-related expenses, manufacturing and clinical trial costs, and other costs associated with general and administrative expenses.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 consisted of a net loss of $9,243$18,685 and non-cash working capital changes of $1,181,$2,415, partially offset by non-cash adjustments of $3,131.$5,669. Non-cash items primarily included stock-based compensation expense and the value of shares issued for consulting services. Non-cash working capital changes mainlywere reflectedprimarily increaseddriven accountsby payableincreases in prepaid expenses and increased other receivablesreceivables, including amounts related to the PanCAN Therapeutic Accelerator Award.Award, and decreases in accrued liabilities and accounts payable.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 consisted of a net loss of $4,711$9,988, andoffset by non-cash adjustments of $2,325, less non-cash working capital changes of $749, partially offset by non-cash adjustments of $727. Non-cash items primarily included stock-based compensation expense.$1,176. Non-cash working capital changes mainly reflected decreasedincreased otherprepaid liabilities reflecting utilization of funding received from PanCANexpenses and increased accounts payable and accrued liabilities and decreased other liabilities.
Net cash used by investing activities for the threesix months ended MarchJune 31,30, 2026 and 2025 were related to the acquisition of property and equipment.
Net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026 and 2025 consisted of net proceeds from sales of our common shares pursuant to ATM offering agreements. Net cash provided by financing activities during the six months ended June 30, 2025 consisted of net proceeds from sales of our common shares pursuant to our ATM and SEPA arrangements.
For the threesix months ended MarchJune 31,30, 2026, we raised net cash proceeds of $7,614$14,385 from the issuance of 7,446,57415,305,933 common shares through our ATM offering agreement.
As of MarchJune 31,30, 2026, our contractual obligations are comprised primarily of our accounts payable, accrued liabilities and operating lease obligations. In addition, we are committed to payments of approximately $350$347 for activities mainly related to our contract manufacturing program, which are expected to occur over the next one year. We are able to cancel most of these agreements with notice. The ultimate amount and timing of these payments are subject to changes in our research and development plan.
As of MarchJune 31,30, 2026, we had not entered into any off-balance sheet arrangements.
There have been no material changes to our critical accounting policies and estimates from those disclosed in “Part II.
ONCY insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding ONCY (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 715,838 | $607.6K | — | Sold out |
| Renaissance Technologies | 2026-06-30 | 62,010 | $58.9K | 0.0% | New position |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 19,813 | $18.8K | 0.0% | New position |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 17,938 | $15.2K | — | Sold out |
| Millennium Management (Israel Englander) | 2026-06-30 | 10,541 | $10.0K | 0.0% | New position |