PDS Biotech Reports Second Quarter 2025 Financial Results and Provides Clinical Programs Update
PDS Biotech (NASDAQ: PDSB) reported its Q2 2025 financial results and provided clinical updates. The company reported a net loss of $9.4 million ($0.21 per share), compared to $8.3 million in Q2 2024. Key highlights include positive progress in the VERSATILE-003 Phase 3 trial evaluating PDS0101 for HPV16-positive head and neck cancer.
The company's colorectal cancer cohort in their Phase 2 trial met expansion criteria with promising response rates of ≥6 of 9 confirmed objective responses. Research and development expenses decreased to $4.2 million from $4.5 million year-over-year. The company's cash position stood at $31.9 million as of June 30, 2025, down from $41.7 million at the end of 2024.
PDS Biotech (NASDAQ: PDSB) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti clinici. La società ha registrato una perdita netta di $9,4 milioni ($0,21 per azione), rispetto a $8,3 milioni nel secondo trimestre 2024. Tra i punti salienti, è stato riportato un progresso positivo nello studio VERSATILE-003 di Fase 3 che valuta PDS0101 per i tumori testa-collo positivi per HPV16.
La coorte per il cancro colorettale nel loro studio di Fase 2 ha soddisfatto i criteri per l'espansione, con tassi di risposta promettenti: ≥6 risposte oggettive confermate su 9. Le spese per ricerca e sviluppo sono diminuite a $4,2 milioni da $4,5 milioni su base annua. La posizione di cassa era di $31,9 milioni al 30 giugno 2025, in calo rispetto a $41,7 milioni a fine 2024.
PDS Biotech (NASDAQ: PDSB) anunció sus resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones clínicas. La compañía reportó una pérdida neta de $9,4 millones ($0,21 por acción), frente a $8,3 millones en el segundo trimestre de 2024. Entre los aspectos destacados se informó un progreso positivo en el ensayo de fase 3 VERSATILE-003 que evalúa PDS0101 para cáncer de cabeza y cuello positivo para HPV16.
La cohorte de cáncer colorrectal en su ensayo de fase 2 cumplió los criterios de ampliación, con tasas de respuesta prometedoras: ≥6 respuestas objetivas confirmadas de 9. Los gastos de investigación y desarrollo disminuyeron a $4,2 millones desde $4,5 millones interanual. La posición de efectivo era de $31,9 millones al 30 de junio de 2025, frente a $41,7 millones a finales de 2024.
PDS Biotech (NASDAQ: PDSB)는 2025년 2분기 재무실적과 임상 업데이트를 발표했습니다. 회사는 순손실 $9.4 million (주�� $0.21)을 기록했으며, 이는 2024년 2분기의 $8.3 million과 비교됩니다. 주요 내용으로는 HPV16 양성 두경부암에 대한 PDS0101을 평가하는 VERSATILE-003 3상 시험에서의 긍정적인 진전이 있습니다.
자사의 2상 시험 내 대장암 코호트는 확대 기준을 충족했으며, 확인된 객관적 반응 9건 중 ≥6건의 유망한 반응률을 보였습니다. 연구개발비는 전년 대비 $4.2 million로 감소했습니다. 현금 보유액은 2025년 6월 30일 기준 $31.9 million로, 2024년 말의 $41.7 million에서 감소했습니다.
PDS Biotech (NASDAQ: PDSB) a publié ses résultats financiers du deuxième trimestre 2025 et a fourni des mises à jour cliniques. La société a enregistré une perte nette de $9,4 millions ($0,21 par action), contre $8,3 millions au T2 2024. Parmi les points clés, on note des progrès positifs dans l'essai de phase 3 VERSATILE-003 évaluant PDS0101 pour les cancers tête-et-cou positifs pour HPV16.
La cohorte pour le cancer colorectal de leur essai de phase 2 a rempli les critères d'extension, avec des taux de réponse prometteurs : ≥6 réponses objectives confirmées sur 9. Les dépenses de recherche et développement ont diminué à $4,2 millions contre $4,5 millions en glissement annuel. La trésorerie s'élevait à $31,9 millions au 30 juin 2025, contre $41,7 millions fin 2024.
PDS Biotech (NASDAQ: PDSB) meldete seine Finanzergebnisse für das zweite Quartal 2025 und gab klinische Updates bekannt. Das Unternehmen verzeichnete einen Nettoverlust von $9,4 Millionen ($0,21 je Aktie), gegenüber $8,3 Millionen im zweiten Quartal 2024. Zu den wichtigsten Punkten zählt der positive Fortschritt in der VERSATILE-003 Phase‑3‑Studie, die PDS0101 bei HPV16‑positiven Kopf-Hals-Tumoren untersucht.
Die kolorektale Kohorte der Phase‑2‑Studie erfüllte die Kriterien für eine Erweiterung und wies vielversprechende Ansprechraten von ≥6 von 9 bestätigten objektiven Ansprechen auf. Die Forschungs‑ und Entwicklungskosten sanken im Jahresvergleich auf $4,2 Mio. von $4,5 Mio. Die liquiden Mittel beliefen sich zum 30. Juni 2025 auf $31,9 Mio., gegenüber $41,7 Mio. Ende 2024.
- Colorectal cancer cohort showed strong response rate (≥6 of 9 confirmed objective responses)
- VERSATILE-003 Phase 3 trial continues to progress well
- Three abstracts on PDS0101 presented at ASCO 2025
- Operating expenses decreased to $7.6M from $8.7M year-over-year
- Net loss increased to $9.4M from $8.3M year-over-year
- Cash position declined to $31.9M from $41.7M since December 2024
- Net interest expenses increased significantly to $1.8M from $0.5M
Insights
PDS Biotech reports mixed Q2 results with promising clinical progress despite widening losses and declining cash reserves.
PDS Biotechnology's Q2 2025 results present a mix of promising clinical developments alongside concerning financial metrics. The company's net loss increased to
The clinical side shows more encouraging signs. Their VERSATILE-003 Phase 3 trial for PDS0101 in HPV16-positive head and neck cancer continues to advance as the only registrational-stage trial specifically targeting this patient population. Additionally, their colorectal cancer cohort in the Phase 2 trial with PDS01ADC met expansion criteria with ≥6 of 9 confirmed objective responses, triggering enrollment expansion under the Simon Two-Stage design – a statistically rigorous approach that allows trials to proceed only when showing sufficient efficacy.
The company also highlighted multiple scientific presentations, including three abstracts on PDS0101 at ASCO 2025 and preclinical data for their Infectimune-based universal flu vaccine. These presentations at major scientific conferences provide validation from the scientific community and help establish PDS Biotech's credibility in the competitive immuno-oncology space.
Looking at the financial trajectory, the quarterly cash burn rate of approximately
Multiple Abstracts Presented at the 2025 American Society of Clinical Oncology Annual Meeting
Conference call and webcast today at 8:00 a.m. Eastern Time
PRINCETON, N.J., Aug. 13, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business update and reported financial results for the second quarter ended June 30, 2025.
“Our second quarter of 2025 and recent weeks have been a productive period for PDS Biotech, highlighted by the continued progress in our VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 (Versamune® HPV) in HPV16-positive recurrent/metastatic (“R/M”) head and neck squamous cell carcinoma (“HNSCC”). Highlights also included the announcement and presentation of data from our VERSATILE-002 trial which we believe demonstrates the potential durable clinical benefit of PDS0101,” said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. “We look forward to publishing the full data set for this trial later this year, as we continue to progress our VERSATILE-003 trial, the only registrational stage trial specifically targeting HPV16-positive HNSCC patients.”
Clinical and Corporate Update
- Announced Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC. Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results
- Metastatic colorectal cancer cohort in study led by the National Cancer Institute demonstrated promising response rate (≥6 of 9 confirmed objective responses by RECIST v1.1), triggering enrollment expansion under Simon Two-Stage design
- Three abstracts on PDS0101 (Versamune® HPV) were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, highlighting updated positive data from the VERSATILE-002 trial, and additional trials evaluating PDS0101 to treat head and neck cancers
- On May 8, 2025, the Company announced preclinical immune response data with a novel Infectimune® based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral symposium at the American Association of Immunologists’ IMMUNOLOGY2025™ Annual Meeting.
Second Quarter 2025 Financial Results
Reported net loss was
Research and development expenses were
General and administrative expenses were
Total operating expenses were
Net interest expenses were
The Company’s cash balance as of June 30, 2025 was
Conference Call Details
Date: August 13, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
Webcast Registration: Click Here
Call Me™ Registration: Click Here (Available 15 minutes prior to call)
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
For more information, please visit www.pdsbiotech.com
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email: david.schull@russopartnersllc.com
| ---financial tables to follow--- |
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY Selected Balance Sheet Data (Unaudited) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| Cash and cash equivalents | $ | 31,873,495 | $ | 41,689,591 | ||||
| Working capital | $ | 22,116,593 | $ | 27,967,242 | ||||
| Total assets | $ | 40,476,065 | $ | 45,358,657 | ||||
| Long term debt | $ | 12,943,656 | $ | 9,204,755 | ||||
| Accumulated deficit | $ | (200,034,174 | ) | $ | (182,110,999 | ) | ||
| Total stockholders’ equity | $ | 15,959,784 | $ | 19,004,848 | ||||
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 4,212,918 | $ | 4,527,698 | $ | 10,043,918 | $ | 11,231,862 | ||||||||
| General and administrative expenses | 3,410,433 | 4,156,606 | 6,685,191 | 7,550,069 | ||||||||||||
| Total operating expenses | $ | 7,623,351 | $ | 8,684,304 | $ | 16,729,109 | $ | 18,781,931 | ||||||||
| Loss from operations | $ | (7,623,351 | ) | $ | (8,684,304 | ) | $ | (16,729,109 | ) | $ | (18,781,931 | ) | ||||
| Interest income (expense) | ||||||||||||||||
| Interest income | $ | 333,624 | $ | 675,209 | $ | 711,473 | $ | 1,344,104 | ||||||||
| Interest expense | (2,144,481 | ) | (1,187,971 | ) | (3,075,359 | ) | (2,362,716 | ) | ||||||||
| Interest income (expense), net | $ | (1,810,857 | ) | $ | (512,762 | ) | $ | (2,363,886 | ) | $ | (1,018,612 | ) | ||||
| Loss before income taxes | $ | (9,434,208 | ) | $ | (9,197,066 | ) | $ | (19,092,995 | ) | $ | (19,800,543 | ) | ||||
| Benefit from income taxes | - | 869,169 | 1,169,820 | 869,169 | ||||||||||||
| Net loss and comprehensive loss | $ | (9,434,208 | ) | $ | (8,327,897 | ) | $ | (17,923,175 | ) | $ | (18,931,374 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.21 | ) | $ | (0.23 | ) | $ | (0.41 | ) | $ | (0.53 | ) | ||||
| Weighted average common shares outstanding basic and diluted | 45,902,502 | 36,693,561 | 43,226,618 | 35,754,715 | ||||||||||||
FAQ
What were PDS Biotech's (PDSB) Q2 2025 financial results?
What are the latest developments in PDS Biotech's VERSATILE-003 trial?
How did the colorectal cancer cohort perform in PDS Biotech's Phase 2 trial?
What was presented at ASCO 2025 regarding PDS Biotech's treatments?
How much cash does PDS Biotech (PDSB) have as of Q2 2025?
