PDS Biotech Reports Full Year 2024 Financial Results and Provides Clinical Programs Update
PDS Biotech (PDSB) has reported its full year 2024 financial results and provided clinical program updates. The company has initiated the VERSATILE-003 Phase 3 clinical trial evaluating Versamune® HPV in HPV16-positive head and neck cancer, designed to include approximately 350 patients. The trial received FDA Fast Track designation.
Financial highlights for 2024 include a net loss of $37.6 million ($1.03 per share), compared to $42.9 million in 2023. Research and development expenses decreased to $22.6 million from $27.8 million, while general and administrative expenses reduced to $13.8 million from $15.3 million. The company's cash balance as of December 31, 2024, stood at $41.7 million.
In March 2025, PDS Biotech received FDA clearance for its IND application combining Versamune® MUC1 and PDS01ADC to treat MUC1-positive metastatic colorectal carcinoma. The company also secured up to $22 million through a registered direct offering in February 2025.
PDS Biotech (PDSB) ha riportato i risultati finanziari per l'intero anno 2024 e fornito aggiornamenti sui programmi clinici. L'azienda ha avviato il trial clinico di fase 3 VERSATILE-003 per valutare Versamune® HPV nel carcinoma della testa e del collo positivo per HPV16, progettato per includere circa 350 pazienti. Lo studio ha ricevuto la designazione Fast Track dalla FDA.
I punti salienti finanziari per il 2024 includono una perdita netta di 37,6 milioni di dollari (1,03 dollari per azione), rispetto ai 42,9 milioni di dollari del 2023. Le spese per ricerca e sviluppo sono diminuite a 22,6 milioni di dollari da 27,8 milioni di dollari, mentre le spese generali e amministrative sono scese a 13,8 milioni di dollari da 15,3 milioni di dollari. Il saldo di cassa dell'azienda al 31 dicembre 2024 era di 41,7 milioni di dollari.
Nel marzo 2025, PDS Biotech ha ricevuto l'approvazione della FDA per la sua domanda IND che combina Versamune® MUC1 e PDS01ADC per trattare il carcinoma colorettale metastatico positivo per MUC1. L'azienda ha anche ottenuto fino a 22 milioni di dollari attraverso un'offerta diretta registrata a febbraio 2025.
PDS Biotech (PDSB) ha reportado sus resultados financieros del año completo 2024 y ha proporcionado actualizaciones sobre los programas clínicos. La compañía ha iniciado el ensayo clínico de fase 3 VERSATILE-003 que evalúa Versamune® HPV en cáncer de cabeza y cuello positivo para HPV16, diseñado para incluir aproximadamente 350 pacientes. El ensayo recibió la designación Fast Track de la FDA.
Los aspectos financieros destacados para 2024 incluyen una pérdida neta de 37,6 millones de dólares (1,03 dólares por acción), en comparación con 42,9 millones de dólares en 2023. Los gastos de investigación y desarrollo disminuyeron a 22,6 millones de dólares desde 27,8 millones de dólares, mientras que los gastos generales y administrativos se redujeron a 13,8 millones de dólares desde 15,3 millones de dólares. El saldo de efectivo de la compañía al 31 de diciembre de 2024 era de 41,7 millones de dólares.
En marzo de 2025, PDS Biotech recibió la autorización de la FDA para su solicitud IND que combina Versamune® MUC1 y PDS01ADC para tratar el carcinoma colorrectal metastásico positivo para MUC1. La compañía también aseguró hasta 22 millones de dólares a través de una oferta directa registrada en febrero de 2025.
PDS Biotech (PDSB)는 2024년 전체 재무 결과를 보고하고 임상 프로그램 업데이트를 제공했습니다. 이 회사는 HPV16 양성 두경부암에서 Versamune® HPV를 평가하는 VERSATILE-003 3상 임상 시험을 시작했으며, 약 350명의 환자를 포함하도록 설계되었습니다. 이 시험은 FDA의 패스트 트랙 지정을 받았습니다.
2024년의 재무 주요 사항은 3760만 달러의 순손실 (주당 1.03달러)로, 2023년의 4290만 달러에 비해 감소했습니다. 연구 및 개발 비용은 2780만 달러에서 2260만 달러로 줄어들었고, 일반 및 관리 비용은 1530만 달러에서 1380만 달러로 감소했습니다. 2024년 12월 31일 기준으로 회사의 현금 잔고는 4170만 달러였습니다.
2025년 3월, PDS Biotech는 MUC1 양성 전이성 대장암 치료를 위해 Versamune® MUC1과 PDS01ADC를 결합한 IND 신청서에 대해 FDA 승인을 받았습니다. 이 회사는 2025년 2월에 등록된 직접 제공을 통해 최대 2200만 달러를 확보했습니다.
PDS Biotech (PDSB) a publié ses résultats financiers pour l'année complète 2024 et a fourni des mises à jour sur ses programmes cliniques. L'entreprise a lancé l'
Les faits saillants financiers pour 2024 incluent une perte nette de 37,6 millions de dollars (1,03 dollar par action), contre 42,9 millions de dollars en 2023. Les dépenses de recherche et développement ont diminué à 22,6 millions de dollars contre 27,8 millions de dollars, tandis que les dépenses générales et administratives ont été réduites à 13,8 millions de dollars contre 15,3 millions de dollars. Le solde de trésorerie de l'entreprise au 31 décembre 2024 s'élevait à 41,7 millions de dollars.
En mars 2025, PDS Biotech a reçu l'approbation de la FDA pour sa demande IND combinant Versamune® MUC1 et PDS01ADC pour traiter le carcinome colorectal métastatique positif pour MUC1. L'entreprise a également sécurisé jusqu'à 22 millions de dollars grâce à une offre directe enregistrée en février 2025.
PDS Biotech (PDSB) hat die Finanzergebnisse für das gesamte Jahr 2024 veröffentlicht und Aktualisierungen zu den klinischen Programmen bereitgestellt. Das Unternehmen hat die VERSATILE-003 Phase 3 klinische Studie gestartet, die Versamune® HPV bei HPV16-positivem Kopf- und Halskrebs bewertet und etwa 350 Patienten umfassen soll. Die Studie erhielt die Fast Track-Zulassung der FDA.
Die finanziellen Höhepunkte für 2024 umfassen einen Nettoverlust von 37,6 Millionen Dollar (1,03 Dollar pro Aktie), verglichen mit 42,9 Millionen Dollar im Jahr 2023. Die Forschungs- und Entwicklungskosten sanken auf 22,6 Millionen Dollar von 27,8 Millionen Dollar, während die allgemeinen und Verwaltungskosten auf 13,8 Millionen Dollar von 15,3 Millionen Dollar gesenkt wurden. Der Bargeldbestand des Unternehmens betrug am 31. Dezember 2024 41,7 Millionen Dollar.
Im März 2025 erhielt PDS Biotech die FDA-Zulassung für seinen IND-Antrag, der Versamune® MUC1 und PDS01ADC zur Behandlung von MUC1-positivem metastasiertem Kolorektalkarzinom kombiniert. Das Unternehmen sicherte sich auch bis zu 22 Millionen Dollar durch ein registriertes Direktangebot im Februar 2025.
- Reduced net loss by $5.3 million compared to previous year
- Decreased operating expenses by $6.7 million year-over-year
- FDA Fast Track designation received for Versamune HPV combination therapy
- Secured up to $22 million in new funding through registered direct offering
- FDA clearance received for new IND application in colorectal carcinoma
- Net loss of $37.6 million in 2024
- Increased net interest expense to $2.2 million from $1.3 million
- Lower interest income on cash balances
Insights
PDS Biotech's 2024 results show narrowed losses with a net loss of
The company's cash position stood at
While the reduced operating expenses demonstrate fiscal discipline, investors should note that Phase 3 trial costs will likely increase the company's burn rate moving forward. With approximately
The initiation of VERSATILE-003, a Phase 3 registrational trial for Versamune HPV in HPV16-positive head and neck cancer, represents a significant advancement for PDS Biotech's clinical program. This 350-patient study employs a 2:1 randomization design with median overall survival as the primary endpoint, suggesting confidence in the therapy's potential survival benefit.
The trial design follows strong and durable responses observed in the VERSATILE-002 study, with FDA alignment on endpoints reducing regulatory uncertainty. The Fast Track designation granted by the FDA further validates the therapy's potential to address unmet needs in recurrent/metastatic HPV16-positive HNSCC, a rapidly growing patient population.
Beyond their lead program, PDS is expanding their pipeline with an FDA-cleared IND for Versamune MUC1 combined with PDS01ADC in MUC1-positive colorectal cancer. This represents their second Versamune-based candidate advancing to clinical trials, demonstrating platform versatility. The company also presented updated results from their IMMUNOCERV Phase 2 trial in cervical cancer and outlined a trial in recurrent prostate cancer.
The progression to Phase 3 trials, particularly with FDA alignment on design and endpoints, significantly derisks the clinical development pathway. The planned interim readouts could provide important data inflection points while the trial progresses. For patients with HPV16-positive HNSCC, this immunotherapy approach targeting the underlying cause of cancer could potentially offer improved outcomes compared to current standards of care.
Initiated VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer
Conference call and webcast today at 8:00 a.m. Eastern Time
PRINCETON, N.J., March 27, 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 clinical programs update and reported financial results for the full year ended December 31, 2024.
“We are pleased with the progress made over the past year and in recent weeks, culminating with the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune® HPV in recurrent/metastatic (“R/M”) HPV16-positive head and neck squamous carcinoma (“HNSCC”),” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Patients with HPV16-positive HNSCC represent a large and rapidly growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. Considering the strength and durability of the clinical responses observed in our VERSATILE-002 study, we are excited that this registrational trial is underway and are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care. In the coming weeks, we expect to continue activating additional clinical sites, and look forward to the progression of this registrational trial.”
Clinical Strategy Summary
- Phase 3 VERSATILE-003 Trial in HPV16-positive first-line recurrent and/or metastatic HNSCC
- Announced activation of the first site in March 2025
- Trial designed to include approximately 350 patients
- PDS Biotech is aligned with the U.S. Food and Drug Administration (“FDA”) on the design of the registrational trial and clinical endpoints.
- Two-arm controlled trial with 2:1 randomization
- Median overall survival is primary endpoint
- Design based on strong and durable responses seen in the VERSATILE-002 trial
- Interim readouts included in study design
- The Company received Fast Track designation from the FDA for the combination of Versamune® HPV and pembrolizumab in R/M HNSCC.
- For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966)
- In March 2025, announced FDA Clearance of Investigational New Drug (“IND”) application for the combination of Versamune® MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma.
- Phase 1/2 clinical trial evaluating the proprietary combination to be run under PDS Biotech’s Cooperative Research and Development Agreement with the National Cancer Institute
- Second Versamune® platform candidate targets MUC1-positive solid tumors
- In October 2024, updated results from the IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy were presented at the 66th American Society for Radiation Oncology (ASTRO) Annual Meeting.
- In October 2024, the rationale and design of a recurrent prostate cancer trial combining Xtandi® + PDS01ADC vs. Xtandi® were presented at the 12th Annual Meeting of the International Cytokine and Interferon Society (Cytokines 2024).
Full Year 2024 Financial Results
Net loss for the year ended December 31, 2024, was approximately
Research and development expenses for the year ended December 31, 2024, were
General and administrative expenses for the year ended December 31, 2024, were
Total operating expenses for the year ended December 31, 2024, were
Net interest expense was
On February 27, 2025, the Company announced an up to
The Company’s cash balance as of December 31, 2024, was
Conference Details
Date: March 27, 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 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 Versamune® HPV, PDS01ADC, 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 Versamune® HPV, PDS01ADC, 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 ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding 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® is a registered trademark of PDS Biotechnology Corporation.
Xtandi® is a registered trademark of Astellas Pharma, Inc.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com
---financial tables to follow---
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | ||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||
| (Unaudited) | ||||||||||
| Year Ended Dec 31, | ||||||||||
| 2024 | 2023 | |||||||||
| Operating expenses: | ||||||||||
| Research and development expenses | $ | 22,565,524 | $ | 27,762,784 | ||||||
| General and administrative expenses | 13,755,671 | 15,282,450 | ||||||||
| Total operating expenses | $ | 36,321,195 | $ | 43,045,234 | ||||||
| Loss from operations | $ | (36,321,195 | ) | $ | (43,045,234 | ) | ||||
| Interest income (expense) | ||||||||||
| Interest income | $ | 2,514,816 | $ | 2,902,939 | ||||||
| Interest expense | (4,673,174 | ) | (4,205,922 | ) | ||||||
| Interest income (expense), net | $ | (2,158,358 | ) | $ | (1,302,983 | ) | ||||
| Loss before income taxes | $ | (38,479,553 | ) | $ | (44,348,217 | ) | ||||
| Benefit for income taxes | 869,169 | 1,406,019 | ||||||||
| Net loss and comprehensive loss | $ | (37,610,384 | ) | $ | (42,942,198 | ) | ||||
| Per share information: | ||||||||||
| Net loss per share, basic and diluted | $ | (1.03 | ) | $ | (1.39 | ) | ||||
| Weighted average common shares outstanding basic and diluted | 36,452,707 | 30,952,060 | ||||||||
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | ||||||||||
| Selected Balance Sheet Data | ||||||||||
| (Unaudited) | ||||||||||
| December 31, | ||||||||||
| 2024 | 2023 | |||||||||
| Cash and cash equivalents | $ | 41,689,591 | $ | 56,560,517 | ||||||
| Working capital | $ | 27,967,242 | $ | 45,425,098 | ||||||
| Total assets | $ | 45,358,657 | $ | 59,390,080 | ||||||
| Long term debt | $ | 9,204,755 | $ | 19,506,183 | ||||||
| Accumulated deficit | $ | (182,110,999 | ) | $ | (144,500,615 | ) | ||||
| Total stockholders’ equity | $ | 19,004,848 | $ | 26,130,947 | ||||||
FAQ
What are the key financial results for PDS Biotech (PDSB) in 2024?
What is the VERSATILE-003 Phase 3 trial for PDSB's Versamune HPV?
How much funding did PDSB secure in the February 2025 offering?
What new FDA clearance did PDSB receive in March 2025?
