PDS Biotech Provides Clinical Programs Update and Reports Third Quarter 2024 Financial Results
PDS Biotech (PDSB) reported Q3 2024 financial results and provided clinical program updates. The company reported a net loss of $10.7 million ($0.29 per share) compared to $10.8 million ($0.35 per share) in Q3 2023. Research and development expenses increased to $6.8 million from $6.4 million, while general and administrative expenses decreased to $3.4 million from $4.1 million. Cash position stood at $49.8 million as of September 30, 2024.
The company announced modifications to its VERSATILE-003 Phase 3 trial design, reducing costs and time to interim data readout. The updated design will include approximately 350 patients and maintains 2:1 randomization with median overall survival as the primary endpoint.
PDS Biotech (PDSB) ha riportato i risultati finanziari per il terzo trimestre del 2024 e aggiornamenti sui programmi clinici. L'azienda ha registrato una perdita netta di 10,7 milioni di dollari (0,29 dollari per azione) rispetto a 10,8 milioni di dollari (0,35 dollari per azione) nel terzo trimestre del 2023. Le spese per ricerca e sviluppo sono aumentate a 6,8 milioni di dollari rispetto ai 6,4 milioni, mentre le spese generali e amministrative sono diminuite a 3,4 milioni di dollari rispetto ai 4,1 milioni. La posizione di cassa ammontava a 49,8 milioni di dollari al 30 settembre 2024.
L'azienda ha annunciato modifiche al design del suo studio clinico di fase 3 VERSATILE-003, riducendo costi e tempi per la lettura intermedia dei dati. Il design aggiornato includerà circa 350 pazienti e manterrà una randomizzazione 2:1, con la sopravvivenza globale mediana come obiettivo primario.
PDS Biotech (PDSB) informó sobre los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre los programas clínicos. La compañía reportó una pérdida neta de 10,7 millones de dólares (0,29 dólares por acción) en comparación con 10,8 millones de dólares (0,35 dólares por acción) en el tercer trimestre de 2023. Los gastos en investigación y desarrollo aumentaron a 6,8 millones de dólares desde 6,4 millones, mientras que los gastos generales y administrativos disminuyeron a 3,4 millones de dólares desde 4,1 millones. La posición de efectivo se situó en 49,8 millones de dólares al 30 de septiembre de 2024.
La compañía anunció modificaciones en el diseño de su ensayo clínico de fase 3 VERSATILE-003, reduciendo costos y tiempo para la lectura de datos intermedios. El diseño actualizado incluirá aproximadamente 350 pacientes y mantendrá una aleatorización de 2:1 con la supervivencia global mediana como objetivo principal.
PDS Biotech (PDSB)는 2024년 3분기 재무 결과를 보고하고 임상 프로그램 업데이트를 제공했습니다. 회사는 1,070만 달러의 순손실을 기록했으며 (주당 0.29 달러) 이는 2023년 3분기의 1,080만 달러 (주당 0.35 달러)와 비교됩니다. 연구 및 개발 비용은 680만 달러로 증가했으며, 일반 및 관리 비용은 340만 달러로 감소했습니다. 2024년 9월 30일 기준 현금 보유액은 4,980만 달러였습니다.
회사는 VERSATILE-003 3상 시험 설계를 변경하여 비용과 중간 데이터 보고 시간을 줄였음을 발표했습니다. 업데이트된 설계는 약 350명의 환자를 포함하며, 중앙 생존 시간을 주요 목표로 하고 2:1 비율의 무작위 배정을 유지합니다.
PDS Biotech (PDSB) a annoncé les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur les programmes cliniques. L'entreprise a enregistré une perte nette de 10,7 millions de dollars (0,29 dollar par action) comparativement à 10,8 millions de dollars (0,35 dollar par action) au troisième trimestre 2023. Les dépenses de recherche et développement ont augmenté à 6,8 millions de dollars contre 6,4 millions de dollars, tandis que les dépenses générales et administratives ont diminué à 3,4 millions de dollars contre 4,1 millions de dollars. La position de trésorerie s'élevait à 49,8 millions de dollars au 30 septembre 2024.
L'entreprise a annoncé des modifications de la conception de son essai de phase 3 VERSATILE-003, réduisant les coûts et le temps pour la lecture intermédiaire des données. Le nouveau design inclura environ 350 patients et maintiendra une randomisation de 2:1 avec la survie globale médiane comme objectif principal.
PDS Biotech (PDSB) hat die Finanzergebnisse für das 3. Quartal 2024 bekannt gegeben und Updates zu den klinischen Programmen bereitgestellt. Das Unternehmen meldete einen Nettoverlust von 10,7 Millionen Dollar (0,29 Dollar pro Aktie) im Vergleich zu 10,8 Millionen Dollar (0,35 Dollar pro Aktie) im 3. Quartal 2023. Die Forschungs- und Entwicklungskosten stiegen auf 6,8 Millionen Dollar von 6,4 Millionen, während die allgemeinen und administrativen Aufwendungen auf 3,4 Millionen Dollar von 4,1 Millionen sanken. Die liquide Mittel beliefen sich zum 30. September 2024 auf 49,8 Millionen Dollar.
Das Unternehmen gab Änderungen im Design der Phase-3-Studie VERSATILE-003 bekannt, um Kosten und Zeit für die Zwischenanalyse der Daten zu reduzieren. Das aktualisierte Design wird etwa 350 Patienten umfassen und beibehält eine Randomisierung von 2:1 mit der medianen Gesamtüberlebenszeit als primärem Endpunkt.
- Reduced net loss per share to $0.29 from $0.35 year-over-year
- Decreased general and administrative expenses by $0.7 million
- Modified VERSATILE-003 trial design to reduce costs and time to completion
- Maintained strong cash position of $49.8 million
- Increased R&D expenses by $0.4 million to $6.8 million
- Net loss of $10.7 million in Q3 2024
- Higher net interest expenses of $0.5 million vs $0.3 million YoY
Insights
The Q3 2024 results reveal both challenges and strategic adjustments. The company reported a
The streamlined VERSATILE-003 Phase 3 trial design, reducing patient count to 350, demonstrates financial prudence. While G&A expenses decreased by
The modified VERSATILE-003 trial design maintains statistical power while potentially accelerating timelines - a strategic enhancement that could expedite market entry if successful. The durability of responses in VERSATILE-002 supports this optimization. The pipeline shows promising diversity with positive data from IMMUNOCERV in cervical cancer and expansion into prostate cancer treatment.
The retention of 2:1 randomization and overall survival as the primary endpoint while reducing patient numbers indicates confidence in the treatment's efficacy. The FDA submission timing suggests potential trial initiation in Q1 2025, marking a critical phase for Versamune® HPV's development trajectory.
Conference call and webcast today at 8:30 a.m. Eastern Time
PRINCETON, N.J., Nov. 14, 2024 (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 and the development of infectious disease vaccines, today provided a business update and reported financial results for the third quarter of 2024.
“Since our last update in August, we have been actively engaged with investors and clinicians to discuss our strategy and funding requirements for our VERSATILE-003 Phase 3 trial of Versamune® HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC),” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. Dr. Bedu-Addo further noted that “based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion.”
With submission of the updated Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) this week, the Company expects the FDA clearance decision by mid-December, allowing the Company to initiate site activation in the first quarter of 2025.
“Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting. The presented data demonstrated promising clinical activity and a compelling safety profile. Based on continued research in various HPV-positive cancers conducted by PDS Biotech and independent researchers who recognize its potential, Versamune® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with favorable toxicity. We are exploring the next steps in the development of Versamune® HPV for cervical cancer,” concluded Dr. Bedu-Addo.
Recent Developments
- Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive first-line recurrent and/or metastatic HNSCC
- Updated trial design to include approximately 350 patients
- VERSATILE-002 results have shown broadly improving clinical responses across multiple parameters with increases in patient size and duration of patient follow up over the last year, demonstrating durability of the anti-tumor responses
- The design, which is informed by the observed durability of the clinical responses, retains statistical power and remains within the confines of our agreement with the FDA on registrational design
- Design maintains 2:1 randomization and median overall survival as primary endpoint
- Design imparts potential for earlier interim readouts and study completion
- Design presents potential for reduced execution costs
- Amended IND (updated design) submitted November 2024
- In September 2024, we provided updated results from our VERSATILE-002 Phase 2 clinical trial in recurrent and/or metastatic HPV16-positive HNSCC patients treated with the combination of Versamune® HPV and pembrolizumab presented at European Society for Medical Oncology (ESMO) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. Press release here.
- In October 2024, we provided updated results from our IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy presented at the ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. Press release here.
- Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health presented the rationale and design of recurrent prostate cancer trial combining Xtandi® + PDS01ADC vs Xtandi® alone during an oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society, October 2024. Press release here.
Third Quarter 2024 Financial Results
Reported net loss was approximately
Research and development expenses increased to approximately
General and administrative expenses decreased to approximately
Total operating expenses decreased to approximately
Net interest expenses increased to approximately
Cash and cash equivalents as of September 30, 2024 totaled approximately
Conference Details
Date: November 14, 2024
Time: 8:30 a.m. ET
Dial-in 1-877-704-4453 or 1-201-389-0920
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 and the development of infectious disease vaccines. The Company plans to initiate 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 also 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 initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® 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 and other Versamune® and Infectimune® 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® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.
Keytruda® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.
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
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | ||||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||||
| (Unaudited) | ||||||||||||||||||
| Three Months Ended Sep 30, | Nine Months Ended Sep 30, | |||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development expenses | $ | 6,803,900 | $ | 6,448,528 | $ | 18,035,762 | $ | 20,297,066 | ||||||||||
| General and administrative expenses | $ | 3,374,794 | $ | 4,071,158 | $ | 10,924,863 | $ | 12,341,207 | ||||||||||
| Total operating expenses | $ | 10,178,694 | $ | 10,519,686 | $ | 28,960,625 | $ | 32,638,273 | ||||||||||
| Loss from operations | $ | (10,178,694 | ) | $ | (10,519,686 | ) | $ | (28,960,625 | ) | $ | (32,638,273 | ) | ||||||
| Interest income (expense), net | ||||||||||||||||||
| Interest income | $ | 666,770 | $ | 739,404 | $ | 2,010,874 | $ | 2,219,399 | ||||||||||
| Interest expense | $ | (1,214,734 | ) | $ | (1,068,887 | ) | $ | (3,577,450 | ) | $ | (3,031,129 | ) | ||||||
| Interest income (expense), net | $ | (547,964 | ) | $ | (329,483 | ) | $ | (1,566,576 | ) | $ | (811,730 | ) | ||||||
| Loss before income taxes | $ | (10,726,658 | ) | $ | (10,849,169 | ) | $ | (30,527,201 | ) | $ | (33,450,003 | ) | ||||||
| Benefit for income taxes | $ | 869,169 | $ | 1,406,021 | ||||||||||||||
| Net loss and comprehensive loss | $ | (10,726,658 | ) | $ | (10,849,169 | ) | $ | (29,658,032 | ) | $ | (32,043,982 | ) | ||||||
| Per share information: | ||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.29 | ) | $ | (0.35 | ) | $ | (0.82 | ) | $ | (1.04 | ) | ||||||
| Weighted average common shares outstanding basic and diluted | 36,806,592 | 30,910,520 | 36,107,900 | 30,715,458 | ||||||||||||||
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | ||||||
| Unaudited Selected Balance Sheet Data | ||||||
| Sep 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Cash and cash equivalents | $ | 49,751,252 | $ | 56,560,517 | ||
| Working capital | $ | 33,791,108 | $ | 45,425,098 | ||
| Total assets | $ | 52,450,653 | $ | 59,390,080 | ||
| Long term debt | $ | 12,031,986 | $ | 19,506,183 | ||
| Accumulated deficit | $ | (174,158,647 | ) | $ | (144,500,615 | ) |
| Total stockholders’ equity | $ | 22,000,805 | $ | 26,130,947 | ||
FAQ
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