Candel Therapeutics (CADL -5.00%), a clinical-stage biotech developing viral immunotherapies for cancer, released second-quarter results on August 14, 2025, for the period ended June 30. The most notable news was a significantly narrower net loss per share of $(0.09) (GAAP), beating analyst estimates of $(0.16). The quarter brought no revenue, as expected for a pre-commercial biotechnology company. Operating expenses increased in research and development (R&D) and general and administrative (G&A) as the company progressed toward regulatory filings. Overall, the quarter was marked by significant clinical, regulatory, and financial progress as Candel secured a longer cash runway to fund key initiatives.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.09) | $(0.16) | $(0.74) | 87.8% |
| Revenue | $0.0 | $0.0 | $0.0 | -- |
| Research & Development Expenses | $7.0 million | $5.0 million | 40.0% | |
| General & Administrative Expenses | $4.2 million | $3.6 million | 16.7% | |
| Net Loss | $(4.8 million) | $(22.2 million) | 78.4% | |
| Cash and Cash Equivalents | $100.7 millionas of June 30, 2025 | $102.7 millionas of December 31, 2024 | N/A |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Focus Areas
Candel Therapeutics develops viral immunotherapy platforms for treating solid tumors. Its main technologies use engineered viruses—adenovirus and herpes simplex virus (HSV)—to transform the tumor environment and trigger the immune system to attack cancer.
Recent efforts center on two leading candidates: CAN-2409, based on an adenovirus vector, and CAN-3110, utilizing a HSV-based vector. The company's success relies on pushing these therapies through advanced clinical trials, showing strong safety and impact, and achieving regulatory designations like fast track or orphan status from the U.S. Food and Drug Administration (FDA). Continued clinical progress and proven patient benefit remain central success factors, with particular aims at solid tumors with few effective treatments.
Quarter Review: Clinical, Regulatory, and Financial Progress
During the quarter, Candel made headline progress in its clinical programs. Most notably, data from the phase 3 trial of CAN-2409 for intermediate-to-high risk localized prostate cancer showed a 30% improvement in disease-free survival compared to placebo, as reported at the 2025 ASCO Annual Meeting, with a hazard ratio (HR) of 0.70 and p-value of 0.0155, providing statistically significant evidence for the therapy's benefit. This pivotal data, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, was generated under an FDA Special Protocol Assessment, which increases confidence the results can support a future Biologics License Application (BLA).
In other key disease areas, CAN-2409 signaled impact for difficult cancers. Updated phase 2a data in non-small cell lung cancer (NSCLC) showed a median overall survival (mOS) of 24.5 months for patients who had failed immune checkpoint inhibitor (ICI) therapy as of the March 3, 2025, data cut, and median overall survival of 21.5 months for patients with progressive disease in the phase 2a CAN-2409 NSCLC clinical trial as of March 3, 2025, compared to 9.8–11.8 months historically observed with standard chemotherapy in published literature. Pancreatic cancer patients receiving CAN-2409 with chemoradiation achieved a median overall survival (mOS) of 31.4 months, compared to 12.5 months for the control group, as reported in a randomized, controlled, phase 2a clinical trial with a data cut-off in February 2025, highlighting durability and potential benefit in a notoriously hard-to-treat cancer. The company expects the next update for CAN-3110, its HSV-based immunotherapy for high-grade glioma, in the fourth quarter of 2025.
Candel achieved key regulatory milestones in the quarter. In July 2025, the European Medicines Agency (EMA) awarded orphan designation for CAN-2409 in pancreatic cancer. The company confirmed plans to submit a BLA for CAN-2409 targeting prostate cancer in the fourth quarter of 2026, setting the stage for a possible market launch if approved.
Financially, the quarter included a $15 million equity raise in June, specifically aimed at supporting manufacturing, regulatory submission, and launch-readiness. The company's net loss narrowed significantly due to a non-cash gain from the change in the fair value of its warrant liability—$5.7 million in benefit—leading to the smaller reported net loss. Operating expenses (GAAP) grew, driven mainly by increased R&D spending linked to product manufacturing and expanded trial activity, as well as higher administrative costs tied to commercial preparation. Cash and cash equivalents stood at $100.7 million as of the end of Q2 2025, which management believes is sufficient to fund operations into the first quarter of 2027. There was no product revenue, typical for clinical-stage biotechs.
Looking Ahead: Guidance and Future Focus
Management did not issue formal financial guidance for fiscal 2025 or the coming quarter. However, it stated that its cash reserves are expected to cover operations through the first quarter of 2027, factoring in planned R&D, regulatory submission, and commercial readiness costs. Upcoming catalysts include a BLA submission for CAN-2409 in prostate cancer in late 2026, new clinical data on CAN-3110, and further R&D events in the fourth quarter of 2025.
Investors should monitor several areas in the quarters ahead: further clinical milestones, pending regulatory steps, and ongoing management of expenses as pre-commercial activities ramp up. The absence of recurring revenue and ongoing increases in expenses highlight the importance of execution, especially as the company moves closer to possible commercialization of its lead therapy.
CADL does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
