Oncolytics Biotech® Reports First Quarter Financial Results and Highlights Clinical Momentum
Oncolytics Biotech (NASDAQ: ONCY) reported its Q1 2025 financial results and clinical progress. The company's lead drug pelareorep showed promising results across multiple cancer types. Key highlights include a 33% objective response rate in anal carcinoma patients and positive safety data in pancreatic cancer trials. The company reported $15.3 million in cash and equivalents, with a net loss of $6.7 million ($0.08 per share) compared to $6.9 million ($0.09 per share) in Q1 2024. R&D expenses decreased to $4.1 million from $5.7 million year-over-year. Oncolytics secured a US$20 million share purchase agreement with Alumni Capital LP to support ongoing clinical development.
Oncolytics Biotech (NASDAQ: ONCY) ha comunicato i risultati finanziari del primo trimestre 2025 e i progressi clinici. Il farmaco principale pelareorep ha mostrato risultati promettenti in diversi tipi di cancro. Tra i punti salienti, un tasso di risposta obiettiva del 33% nei pazienti con carcinoma anale e dati di sicurezza positivi negli studi sul cancro al pancreas. L'azienda ha riportato 15,3 milioni di dollari in liquidità e equivalenti, con una perdita netta di 6,7 milioni di dollari (0,08 dollari per azione) rispetto ai 6,9 milioni (0,09 dollari per azione) del primo trimestre 2024. Le spese per R&S sono diminuite a 4,1 milioni di dollari da 5,7 milioni anno su anno. Oncolytics ha inoltre ottenuto un accordo di acquisto azionario da 20 milioni di dollari USA con Alumni Capital LP per sostenere lo sviluppo clinico in corso.
Oncolytics Biotech (NASDAQ: ONCY) informó sus resultados financieros del primer trimestre de 2025 y avances clínicos. El fármaco principal pelareorep mostró resultados prometedores en varios tipos de cáncer. Destacan un 33% de tasa de respuesta objetiva en pacientes con carcinoma anal y datos positivos de seguridad en ensayos de cáncer pancreático. La compañía reportó 15,3 millones de dólares en efectivo y equivalentes, con una pérdida neta de 6,7 millones de dólares (0,08 dólares por acción) frente a 6,9 millones (0,09 dólares por acción) en el primer trimestre de 2024. Los gastos en I+D disminuyeron a 4,1 millones de dólares desde 5,7 millones año tras año. Oncolytics aseguró un acuerdo de compra de acciones por 20 millones de dólares estadounidenses con Alumni Capital LP para apoyar el desarrollo clínico en curso.
Oncolytics Biotech (NASDAQ: ONCY)는 2025년 1분기 재무 실적과 임상 진전을 발표했습니다. 회사의 주요 약물 pelareorep는 여러 암종에서 유망한 결과를 보였습니다. 주요 내용으로는 항문암 환자에서 33% 객관적 반응률과 췌장암 임상시험에서 긍정적인 안전성 데이터가 포함됩니다. 회사는 현금 및 현금성 자산으로 1,530만 달러를 보고했으며, 순손실은 1분기 2024년의 690만 달러(주당 0.09달러) 대비 670만 달러(주당 0.08달러)였습니다. 연구개발비는 전년 대비 410만 달러로 감소했습니다. Oncolytics는 진행 중인 임상 개발을 지원하기 위해 Alumni Capital LP와 2,000만 달러 규모의 주식 매입 계약을 체결했습니다.
Oncolytics Biotech (NASDAQ : ONCY) a publié ses résultats financiers du premier trimestre 2025 ainsi que ses avancées cliniques. Le médicament principal de la société, pelareorep, a montré des résultats prometteurs dans plusieurs types de cancers. Parmi les points clés, un taux de réponse objective de 33% chez les patients atteints de carcinome anal et des données de sécurité positives dans les essais sur le cancer du pancréas. La société a déclaré disposer de 15,3 millions de dollars en liquidités et équivalents, avec une perte nette de 6,7 millions de dollars (0,08 dollar par action) contre 6,9 millions (0,09 dollar par action) au premier trimestre 2024. Les dépenses en R&D ont diminué à 4,1 millions de dollars contre 5,7 millions d’une année sur l’autre. Oncolytics a également sécurisé un accord d'achat d'actions de 20 millions de dollars US avec Alumni Capital LP pour soutenir le développement clinique en cours.
Oncolytics Biotech (NASDAQ: ONCY) berichtete über seine Finanzergebnisse für das erste Quartal 2025 und den klinischen Fortschritt. Das führende Medikament pelareorep zeigte vielversprechende Ergebnisse bei verschiedenen Krebsarten. Zu den Highlights zählen eine objektive Ansprechrate von 33% bei Patienten mit Analkarzinom sowie positive Sicherheitsdaten in Studien zum Pankreaskrebs. Das Unternehmen meldete 15,3 Millionen US-Dollar an liquiden Mitteln und Äquivalenten, mit einem Nettoverlust von 6,7 Millionen US-Dollar (0,08 US-Dollar pro Aktie) im Vergleich zu 6,9 Millionen (0,09 US-Dollar pro Aktie) im ersten Quartal 2024. Die F&E-Ausgaben sanken von 5,7 Millionen auf 4,1 Millionen US-Dollar im Jahresvergleich. Oncolytics sicherte sich zudem eine 20 Millionen US-Dollar Aktienkaufvereinbarung mit Alumni Capital LP zur Unterstützung der laufenden klinischen Entwicklung.
- None.
- Net loss of $6.7 million in Q1 2025
- Cash runway only extends through Q3 2025
- Cash and equivalents decreased from $29.6M in Q1 2024 to $15.3M in Q1 2025
Insights
Oncolytics shows promising clinical data for pelareorep in multiple cancers while managing expenses, but faces limited cash runway through Q3 2025.
Oncolytics Biotech's Q1 2025 results reveal both encouraging clinical developments and financial challenges. The company's lead drug pelareorep is demonstrating meaningful clinical benefits across multiple difficult-to-treat cancers. Most notably, in the GOBLET Cohort 4 trial for anal carcinoma, pelareorep combined with atezolizumab achieved a
The drug's versatility is particularly impressive, showing efficacy in breast cancer, pancreatic cancer, and now anal cancer. This broad applicability stems from pelareorep's intravenous administration and compatibility with both chemotherapies and checkpoint inhibitors while maintaining favorable safety.
Financially, Oncolytics has managed to reduce their quarterly net loss to
However, the financial position reveals concerning constraints. With
Looking ahead, Oncolytics has important catalysts including pancreatic cancer translational data expected in Q2 2025 and initial efficacy results from GOBLET Cohort 5 in H1 2026. The company's ability to deliver positive clinical results while extending its financial runway will be crucial for long-term success in developing this promising cancer immunotherapy.
American Society of Clinical Oncology (ASCO) GI Symposium data underscores pelareorep's clinical benefit in anal and pancreatic cancers
Pelareorep featured in Key Opinion Leader event on oncolytic immunotherapies in breast and pancreatic cancers
Poster on pelareorep's stimulation of adaptive and innate immunity to be shared at ASCO Annual Meeting
Conference call and webcast today at 4:30 p.m. ET to discuss Q1 results and clinical outlook
"Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "We remain focused on optimizing the development pathway for pelareorep. Importantly, pelareorep has demonstrated a meaningful clinical benefit in two randomized phase 2 breast cancer studies, in multiple pancreatic cancer studies, and now in anal cancer as well. This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile."
First Quarter and Subsequent Highlights
Upcoming poster presentation at this year's ASCO Annual Meeting. The title of the poster that will be presented at the conference is: Role of pelareorep in activating anti-tumor immunity in PDAC and will share data exhibiting pelareorep's ability to elicit innate as well as adaptive immune responses in an extremely challenging indication (link to the PR).
Two posters were presented at the 2025 ASCO Gastrointestinal Cancers Symposium, one in anal carcinoma and one in pancreatic ductal adenocarcinoma (link to the PR).
- Updated interim efficacy results from GOBLET Cohort 4 showed pelareorep combined with atezolizumab demonstrated an objective response rate of
33% in twelve evaluable patients with second-line or later unresectable squamous cell anal carcinoma, including a complete and durable response lasting over 15 months - an encouraging signal in this difficult-to-treat cancer (link to the poster). The response rates recorded continue to exceed historical control trials, and enrollment has been expanded to confirm the promising efficacy signal and potentially pave the way for a registration-enabling study. - In GOBLET Cohort 5, patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) were treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. As required by the protocol, six patients completed the safety run-in and follow-up period. A review of safety data was completed by the independent Data Safety Monitoring Board (DSMB) and the Paul Ehrlich Institute (PEI),
Germany's medical regulatory body, and both groups recommended study continuation (link to the poster). This cohort is being funded by the Pancreatic Cancer Action Network (PanCAN) and, depending on the results, could expand the potential of pelareorep combination therapy in this indication.
Key opinion leader event highlights oncolytic immunotherapies in breast and pancreatic cancers. In a webinar hosted by H.C. Wainwright, key opinion leaders Professor Martine Piccart, a co-founder of the Breast International Group (BIG) and member of the Belgian Royal Academy of Medicine, and Alexander Eggermont, Professor of Immunotherapy at Utrecht University Medical and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, discussed the need for new treatment options as well as pelareorep's ability to activate the immune system to identify and attack tumors (link to the PR).
Share purchase agreement with institutional investor Alumni Capital LP supports ongoing clinical development. Oncolytics entered into a
Financial Highlights
- As of March 31, 2025, the Company reported
$15.3 million - The net loss for the first quarter of 2025 was
$6.7 million $6.9 million $0.08 $0.09 - Research and development expenses for the first quarter of 2025 were
$4.1 million $5.7 million - General and administrative expenses for the first quarter of 2025 were
$3.0 million $3.0 million - Net cash used in operating activities for the three months ended March 31, 2025, was
$6.5 million $7.5 million
Anticipated Milestones
- Q2 2025: Pancreatic cancer translational data from Cohort 1 of the GOBLET study evaluating pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab
- H1 2026: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer
Webcast and Conference Call
Management will host a conference call for analysts and investors at 4:30 p.m. ET today, May 14, 2025. To access the call, please dial (888) 510-2154 (
ONCOLYTICS BIOTECH INC. | |||
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | |||
(unaudited) | |||
(in thousands of Canadian dollars, except share amounts) | |||
As at | March 31, | December 31, | |
Assets | |||
Current assets | |||
Cash and cash equivalents | $ 15,303 | $ 15,942 | |
Other receivables | 89 | 68 | |
Prepaid expenses | 1,875 | 1,885 | |
Warrant derivative | 1,220 | 980 | |
Total current assets | 18,487 | 18,875 | |
Property and equipment | 386 | 411 | |
Right-of-use assets | 829 | 901 | |
Total assets | $ 19,702 | $ 20,187 | |
Liabilities and Shareholders' Equity | |||
Current liabilities | |||
Accounts payable and accrued liabilities | $ 4,948 | $ 4,792 | |
Other liabilities | 530 | 1,618 | |
Lease liabilities | 290 | 277 | |
Total current liabilities | 5,768 | 6,687 | |
Contract liability | 6,730 | 6,730 | |
Lease liabilities | 710 | 787 | |
Total liabilities | 13,208 | 14,204 | |
Commitments | |||
Shareholders' equity | |||
Share capital Authorized: unlimited Issued: March 31, 2025 – 86,421,592 December 31, 2024 – 80,020,131 | 445,533 | 438,193 | |
Contributed surplus | 44,403 | 44,542 | |
Accumulated other comprehensive income | 958 | 961 | |
Accumulated deficit | (484,400) | (477,713) | |
Total shareholders' equity | 6,494 | 5,983 | |
Total liabilities and shareholders' equity | $ 19,702 | $ 20,187 | |
ONCOLYTICS BIOTECH INC. | |||
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS | |||
(unaudited) | |||
(in thousands of Canadian dollars, except share amounts) | |||
Three Months Ended March 31, | |||
2025 | 2024 | ||
Expenses | |||
Research and development | $ 4,083 | $ 5,743 | |
General and administrative | 2,916 | 2,983 | |
Loss before the following | (6,999) | (8,726) | |
Change in fair value of warrant derivative | 240 | 869 | |
Foreign exchange (loss) gain | (51) | 517 | |
Interest income, net | 123 | 446 | |
Net loss | (6,687) | (6,894) | |
Other comprehensive (loss) income items that may be reclassified to net loss | |||
Translation adjustment | (3) | 126 | |
Comprehensive loss | $ (6,690) | $ (6,768) | |
Basic and diluted loss per common share | $ (0.08) | $ (0.09) | |
Weighted average number of shares (basic and diluted) | 84,631,445 | 75,244,637 | |
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, 2023 | $ 430,906 | $ 42,116 | $ 544 | $ (446,003) | $ 27,563 | ||||
Net loss and other comprehensive income | — | — | 126 | (6,894) | (6,768) | ||||
Issued pursuant to incentive share award plan | 3 | (3) | — | — | — | ||||
Issued pursuant to "At the Market" Agreement | 1,669 | — | — | — | 1,669 | ||||
Share issue costs | (71) | — | — | — | (71) | ||||
Share-based compensation expense | — | 576 | — | — | 576 | ||||
As at March 31, 2024 | $ 432,507 | $ 42,689 | $ 670 | $ (452,897) | $ 22,969 | ||||
As at December 31, 2024 | $ 438,193 | $ 44,542 | $ 961 | $ (477,713) | $ 5,983 | ||||
Net loss and other comprehensive loss | — | — | (3) | (6,687) | (6,690) | ||||
Issued pursuant to incentive share award plan | 1,347 | (1,347) | — | — | — | ||||
Issued pursuant to "At the Market" Agreement | 6,228 | — | — | — | 6,228 | ||||
Share issue costs | (235) | — | — | — | (235) | ||||
Share-based compensation expense | — | 1,208 | — | — | 1,208 | ||||
As at March 31, 2025 | $ 445,533 | $ 44,403 | $ 958 | $ (484,400) | $ 6,494 | ||||
ONCOLYTICS BIOTECH INC. | ||||
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
(unaudited) | ||||
(in thousands of Canadian dollars) | ||||
Three Months Ended March 31, | ||||
2025 | 2024 | |||
Operating Activities | ||||
Net loss for the period | $ (6,687) | $ (6,894) | ||
Depreciation - property and equipment | 26 | 28 | ||
Depreciation - right-of-use-assets | 71 | 95 | ||
Share-based compensation expense | 1,208 | 576 | ||
Interest expense on lease liabilities | 39 | 15 | ||
Unrealized foreign exchange gain | (61) | (387) | ||
Change in fair value of warrant derivative | (240) | (869) | ||
Net change in non-cash working capital | (854) | (33) | ||
Cash used in operating activities | (6,498) | (7,469) | ||
Investing Activities | ||||
Acquisition of property and equipment | — | (46) | ||
Cash used in investing activities | — | (46) | ||
Financing Activities | ||||
Proceeds from "At the Market" equity distribution agreement, net | 5,993 | 1,598 | ||
Payment of lease liabilities | (103) | (103) | ||
Cash provided by financing activities | 5,890 | 1,495 | ||
Decrease in cash and cash equivalents | (608) | (6,020) | ||
Cash and cash equivalents, beginning of period | 15,942 | 34,912 | ||
Impact of foreign exchange on cash and cash equivalents | (31) | 711 | ||
Cash and cash equivalents, end of period | $ 15,303 | $ 29,603 | ||
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our upcoming milestones, including pancreatic cancer translational data from Cohort 1 of the GOBLET study and initial efficacy results from Cohort 5 of the GOBLET study; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and
Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mrubenstein@lifescicomms.com
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SOURCE Oncolytics Biotech® Inc.
FAQ
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