PDS Biotechnology (PDSB -5.69%), a clinical-stage immunotherapy company focused on innovative oncology and infectious disease solutions, released its second quarter results on August 13, 2025, for the period ending June 30. The most significant news was a $0.02 per share beat on net loss (GAAP) versus analyst expectations, as net loss per share (GAAP) came in at ($0.21) against an estimated ($0.23). No revenue was reported, which aligns with the company's pre-commercial status. Total operating expenses (GAAP) declined to $7.6 million, compared to $8.7 million for the three months ended June 30, 2024. Persistent operating losses and increasing interest expense added financial pressure, but the period was notable for progress in core clinical trials, particularly in the Versamune® HPV and PDS01ADC programs. Overall, the quarter demonstrated disciplined spending, ongoing advancement across clinical assets, and highlighted financial headwinds with a shrinking cash position.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS | ($0.21) | ($0.23) | ($0.23) | -8.7 % |
| Revenue | $0.0 | $0.0 | $0.0 | 0.0 % |
| Total Operating Expenses | $7.6 million | $8.7 million | (12.6 %) | |
| Net Loss | $9.4 million | $8.3 million | 13.3 % | |
| Cash and Cash Equivalents (quarter-end) | $31.9 million | N/A |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Success Factors
PDS Biotechnology develops immunotherapies using its proprietary technology platforms, Versamune® and Infectimune®. Versamune® is designed to boost the immune system's ability to detect and destroy cancer cells. Infectimune® enhances immune responses against infectious diseases, aiming to overcome critical shortcomings of existing vaccine and immunotherapy options.
The business has recently focused on progressing its lead candidates through clinical trials and expanding strategic partnerships. Success for the company centers on proving clinical efficacy and safety, forming development alliances, and effectively managing costs. Successful trial outcomes and regulatory milestones are vital for future revenue generation and commercial progress.
Quarter Highlights: Financial and Clinical Developments
This period saw the company reduce total operating expenses by 12.6% (GAAP), driven mainly by lower personnel and professional service fees. Research and development, or R&D, costs (GAAP) decreased from $4.5 million to $4.2 million year over year, while manufacturing expenses edged up slightly. The company did not generate any revenue, which is typical for firms in this clinical development stage.
Net interest expenses (GAAP) rose sharply, reaching $1.8 million, up from $0.5 million in Q2 2024. Higher debt repayment costs were cited as the main explanation for this spike. Cash and cash equivalents (GAAP) totaled $31.9 million, down from $41.7 million at year-end 2024, reflecting continued spending on clinical development as well as growing interest obligations.
From a clinical perspective, the period delivered multiple advances. The VERSATILE-003 Phase 3 trial began enrolling patients to test PDS0101, the Versamune®-HPV immunotherapy candidate for head and neck squamous cell carcinoma. This registrational trial targets HPV16-positive cases and aims to test whether the combination with pembrolizumab offers survival benefits versus standard therapy. Management pointed to prior VERSATILE-002 data showing a median overall survival of 30 months for these patients, based on interim data with a May 17, 2024, cut-off, comparing favorably to an approximate 12 months for the current standard of care.
In early-stage pipeline news, preclinical studies of the Infectimune®-based universal flu vaccine delivered positive immune response data, showcased at the IMMUNOLOGY2025 meeting. A new colorectal cancer program, PDS01ADC, advanced past pre-specified study thresholds and entered an expanded testing phase, following notable response rates in early National Cancer Institute-led trials. These developments broaden the company's reach in both oncology and infectious disease immunotherapy.
Strategic partnerships continue to play a key role. The collaboration with Merck KGaA for PDS01ADC, an antibody-drug conjugate designed to improve targeted anti-tumor effects, is based on an exclusive global license agreement covering the compound and related intellectual property. Engagements with the National Cancer Institute also support early clinical programs.
On the regulatory front, while no new Food and Drug Administration, or FDA, milestones were reached in the quarter, recent fast track designations and Investigational New Drug, or IND, clearances remain supportive for advancement. The company reported no product discontinuations or clinical trial setbacks in the period.
Material one-time financial events included earlier-year equity and debt financings. The company’s share base increased by approximately 25% over the past year due to these capital raises, though no dividend was declared or adjusted in the period.
Product Pipeline and Technology Context
The Versamune® family consists of immune-activating therapies, presently aimed at treating cancers linked to the human papillomavirus type 16, or HPV16. Versamune® HPV, also known as PDS0101, is being combined with pembrolizumab, a checkpoint inhibitor drug, to treat recurrent or metastatic head and neck cancer. This therapy aims to improve durability of response and overall survival measured in months, with earlier clinical data showing potential for major improvements over existing standards.
PDS01ADC is an antibody-drug conjugate. It combines an antibody with interleukin-12 (IL-12), an immune-cytokine, to stimulate immune-mediated cancer cell killing while sparing healthy tissue. Developed in partnership with external collaborators, this program progressed in metastatic colorectal cancer trials during the quarter. The Infectimune® platform is being tested as a universal flu vaccine, with recent preclinical animal studies showing promising immune activation. These assets are in various phases, from preclinical to registrational trials.
Looking Ahead: Financial Outlook and Risks
Management did not offer any forward-looking financial guidance or projections for the upcoming quarter or fiscal year. As a result, investors have limited visibility into future spending patterns or the duration of the cash runway.
Key areas to watch in coming quarters include the pace of patient enrollment in the VERSATILE-003 Phase 3 trial and progression of expanded PDS01ADC and Infectimune® programs. The company's continued investment in clinical studies and higher debt service costs are likely to keep cash burn rates elevated. With no near-term commercial revenue expected, balance sheet management and the securing of additional capital or new non-dilutive funding will remain central themes for the business. PDSB does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
