Candel Therapeutics Demonstrates Broad Efficacy in Oncolytic Immunotherapy Trials

Candel Therapeutics is a leader in oncolytic viral immunotherapy, with clinical data in prostate, pancreatic, and lung cancer showing broad anti-tumor effects. The company has announced three positive clinical data sets, establishing itself as a prominent player in the field.

Candel Therapeutics (NASDAQ:CADL) has established itself as a leader in oncolytic viral immunotherapy, with clinical data demonstrating broad anti-tumor effects in prostate, pancreatic, and lung cancer. The company has announced three positive clinical data sets, positioning itself as a prominent player in the field.

In prostate cancer, a phase III trial of 745 patients found an 80.4% 2-year complete biopsy response rate in the treatment group compared to 63.6% for patients receiving radiation alone (p=0.0015). The trial was implemented under an SPA (Special Protocol Assessment) with the Agency, signifying that the agreed-upon endpoints, including disease-free survival, should be sufficient to support a regulatory filing. Safety was favorable with no new adverse signals. Candel is preparing for submission of a Biologics License Application in Q4 2026 [1].

In pancreatic cancer, a randomized Phase 2a study in patients with borderline-resectable pancreatic ductal adenocarcinoma showed a threefold increase in median overall survival. The median OS was 31.4 months in the experimental arm and 12.5 months in the control group. Given the universally dismal prognosis in pancreatic cancer, an OS increase of 18 months is extraordinary. CAN-2409 has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for this indication [1].

In non-small cell lung cancer (NSCLC), CAN-2409 showed disproportionate benefit in an open-label Phase 2a trial in patients who progressed on checkpoint inhibitors. The median OS in this post-immune therapy population was 21.5 months, as compared to the 10 months of survival that is typical with standard-of-care chemotherapy such as docetaxel in this population. Twenty-nine percent of these heavily pre-treated patients lived two years or longer, with some surviving more than 30 months. The treatment also produced a systemic effect: the injection of one tumor led to a shrinkage of distant, un-injected tumors in 69% of patients with multiple lesions. This abscopal response constitutes robust evidence for the mechanism of action of CAN-2409 as an in situ vaccine. Fast Track designation has also been given by the FDA for this indication [1].

Candel has treated more than 1,000 patients to date, leaving the company with quite a lot of clinical data on its platform. In addition to its lead candidate, Candel is developing CAN-3110 as a first-in-class oncolytic herpes simplex virus (HSV-1). This agent also demonstrated signals of efficacy in a Phase 1b study in recurrent glioblastoma. In a study of 41 evaluable patients, median OS was ~11.6 months, relatively favorable when one considers the typical 7-to-9 month survival for this aggressive and heavily pretreated cancer. A potent local and systemic anti-tumoral effect was observed after a single injection without dose-limiting toxicities in this study. On the basis of this favorable safety and efficacy profile, the US Food and Drug Administration has awarded Fast Track and Orphan Drug designations. Candel is taking the program forward by experimenting with several injections of CAN-3110 in a Phase 1b dose-escalation study, with initial biomarker data from multiple administrations anticipated by the end of 2025 [1].

Candel's balance sheet was greatly improved by a December 2024 equity capital raise of 12 million shares and accompanying warrants that raised nearly $92 million. This infusion lifted the company’s pro forma cash to about $102.7 million through the end of 2024. Cash and cash equivalents totaled $92.2 million as of Q1 2025, with quarterly burn expected to be around $10 million. The firm has said this financing supplies enough cash to get to the first quarter of 2027, allowing it to accomplish certain development milestones without having to raise money in the near term. A 2024 financial review displays disciplined and focused execution. Full-year research and development expenses fell to $19.3 million in 2024 from $24.5 million in 2023, as key trials, including the prostate Phase III study and the pancreatic cancer Phase II study, were completed and operations were streamlined. General and administrative costs also were flat year over year at $14.1 million for 2024 and $13.9 million for 2023. The full year net loss widened to $55.2 million, from $37.9 million in the previous year, but that was mostly driven by a one-time, non-cash charge of $21.8 million for the revaluation of warrant liabilities. In the first quarter of 2025, GAAP results included a positive $15.5 million adjustment for this same warrant revaluation, resulting in a reported net income of $7.4 million compared to a $8.2 million net loss in the prior-year period. This non-cash accounting gain demonstrates that the underlying business (which is R&D-centric) is still in place; the reason for the operational losses is clinical trial related expenses. Crucially, Candel is now comfortably financed through all its most important milestones. The company is able to progress CAN-2409 through BLA-enabling activities, including manufacturing scale-up, over the next 18 months in advance of a potential filing in late 2026. The current funds are also sufficient to begin additional late-stage trials, such as a pivotal study in pancreatic cancer, or a confirmatory trial in high-grade glioma. With the modest quarterly cash burn based on resources on hand, I don't believe the company is at risk of diluting shareholders in the short-term. Recent numbers indicate a consistent burn: Q1 2025 R&D spending was ~$4.0m, and G&A was ~$4m. With $92 million in cash as of March 31, 2025, and a market capitalization of roughly $275 million, the enterprise value of the company is far less than the total of its programs and money in the bank. Candel is financially strong with aggressive growth strategies available [1].

Oncolytic-viral oncology is a catalyst-rich niche with explosive growth in immuno-oncology through checkpoint inhibitors and CAR-T therapies. Imlygic, from Amgen, was the first oncolytic virus to be approved by the F.D.A., for melanoma, in 2015. Major pharmaceutical companies have expressed substantial interest in the field, with over 70 companies believed to be actively developing more than 100 oncolytic virus therapies. The industry is forecasting the size of the global market to grow to ~$610 million by 2028 [1].

Multi-gene, multimodal, viro-immunotherapy is one of many ways in which Candel’s approach stands out from the many competitors in the space. Whereas Imlygic is single-armed HSV virus only for skin tumors, CAN-2409 adenovirus-platform delivers a component of HSV-thymidine kinase, which in combination with an oral prodrug, generates a self-amplifying local vaccine. This results in exposure to patient-specific tumor antigens, which works to teach the immune system to seek out and destroy the individual patient’s cancer. Theoretically, this allows for wide systemic attack on metastases, which became evident with the shrinking of distant lesions in the NSCLC trial and the prolonged survival tails in the pancreatic cancer trial. The granting of Fast Track designation to CAN-2409 in all three lead indications is indicative of the FDA’s recognition of its investigational candidate’s potential to address critical unmet medical needs. Its second asset, CAN-3110, represents an orthogonal approach through the combination of a replication-competent HSV that induces direct oncolysis with immune activation. Success in glioma, a notoriously “cold” tumor that has resisted other immunotherapies, could set a new standard for care in a population desperately in need of one [1].

With such promising and consistent data across various indications, Candel merits a re-valuation more in line with that of a late-stage biotech and not a preclinical company. With about $92 million in cash and no debt, its current enterprise value of roughly $150 million is significantly lower than the total value of its programs and money in the bank.

References:

[1] https://seekingalpha.com/article/4820031-candel-therapeutics-oncolytic-immunotherapy-showing-broad-efficacy-in-tough-tumors