PDS Biotech Provides Business Update and Reports Second Quarter 2024 Financial Results
PDS Biotechnology (PDSB) has provided a business update and reported financial results for Q2 2024. Key highlights include:
Clinical Progress: Alignment with FDA on Phase 3 VERSATILE-003 trial design for HPV16-positive HNSCC, set to start in Q4 2024. Updated VERSATILE-002 trial data to be presented at ESMO 2024.
Financial Results: Net loss of $8.3 million ($0.23 per share) in Q2 2024, compared to $11.5 million ($0.37 per share) in Q2 2023. R&D expenses decreased to $4.5 million from $8.0 million, while G&A expenses reduced to $4.2 million from $4.7 million. Cash and cash equivalents stood at $57.7 million as of June 30, 2024.
The company is progressing with its Versamune® HPV immunotherapy platform, showing potential in various cancer indications.
PDS Biotechnology (PDSB) ha fornito un aggiornamento aziendale e riportato i risultati finanziari per il secondo trimestre del 2024. I punti salienti includono:
Progresso Clinico: Allineamento con la FDA sul design della sperimentazione di Fase 3 VERSATILE-003 per HNSCC positivo all'HPV16, che dovrebbe iniziare nel quarto trimestre del 2024. Dati aggiornati della sperimentazione VERSATILE-002 verranno presentati all'ESMO 2024.
Risultati Finanziari: Perdita netta di 8,3 milioni di dollari (0,23 dollari per azione) nel secondo trimestre del 2024, rispetto a 11,5 milioni di dollari (0,37 dollari per azione) nel secondo trimestre del 2023. Le spese per R&S sono diminuite a 4,5 milioni di dollari da 8,0 milioni di dollari, mentre le spese generali e amministrative sono scese a 4,2 milioni di dollari da 4,7 milioni di dollari. La liquidità e gli equivalenti di liquidità ammontavano a 57,7 milioni di dollari al 30 giugno 2024.
La società sta progredendo con la sua piattaforma di immunoterapia Versamune® HPV, mostrando potenziale in diverse indicazioni cancerose.
PDS Biotechnology (PDSB) ha proporcionado una actualización empresarial y reportó resultados financieros para el segundo trimestre de 2024. Los aspectos más destacados incluyen:
Progreso Clínico: Alineación con la FDA sobre el diseño del ensayo Fase 3 VERSATILE-003 para HNSCC positivo para HPV16, que se iniciará en el cuarto trimestre de 2024. Los datos actualizados del ensayo VERSATILE-002 se presentarán en ESMO 2024.
Resultados Financieros: Pérdida neta de 8.3 millones de dólares (0.23 dólares por acción) en el segundo trimestre de 2024, comparado con 11.5 millones de dólares (0.37 dólares por acción) en el segundo trimestre de 2023. Los gastos de I+D disminuyeron a 4.5 millones de dólares desde 8.0 millones de dólares, mientras que los gastos generales y administrativos se redujeron a 4.2 millones de dólares desde 4.7 millones de dólares. El efectivo y equivalentes de efectivo se situaban en 57.7 millones de dólares al 30 de junio de 2024.
La empresa avanza con su plataforma de inmunoterapia Versamune® HPV, mostrando potencial en varias indicaciones de cáncer.
PDS 바이오테크놀로지 (PDSB)는 2024년 2분기 재무 결과 및 사업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
임상 진행: HPV16 양성 HNSCC에 대한 3상 VERSATILE-003 시험 설계에 대해 FDA와 협의하였으며, 2024년 4분기에 시작될 예정입니다. VERSATILE-002 시험의 업데이트된 데이터를 ESMO 2024에서 발표할 예정입니다.
재무 결과: 2024년 2분기 순손실 830만 달러(주당 0.23달러)로, 2023년 2분기 순손실 1150만 달러(주당 0.37달러)에서 감소했습니다. 연구개발비는 800만 달러에서 450만 달러로 감소했으며, 일반관리비는 470만 달러에서 420만 달러로 줄었습니다. 2024년 6월 30일 기준으로 현금 및 현금성 자산은 5770만 달러에 달했습니다.
회사는 Versamune® HPV 면역 요법 플랫폼의 진행 상황을 보이고 있으며, 여러 암 적응증에서 잠재력을 보여주고 있습니다.
PDS Biotechnology (PDSB) a fourni une mise à jour commerciale et a rapporté ses résultats financiers pour le deuxième trimestre 2024. Les points forts incluent :
Progrès Clinique : Alignement avec la FDA sur le design de l'essai de phase 3 VERSATILE-003 pour HNSCC positif au HPV16, qui devrait débuter au quatrième trimestre 2024. Des données mises à jour de l'essai VERSATILE-002 seront présentées à l'ESMO 2024.
Résultats Financiers : Perte nette de 8,3 millions de dollars (0,23 dollar par action) au deuxième trimestre 2024, comparée à 11,5 millions de dollars (0,37 dollar par action) au deuxième trimestre 2023. Les dépenses en R&D ont diminué à 4,5 millions de dollars contre 8,0 millions de dollars, tandis que les dépenses générales et administratives sont passées de 4,7 millions de dollars à 4,2 millions de dollars. Les liquidités et équivalents de liquidités s'élevaient à 57,7 millions de dollars au 30 juin 2024.
L'entreprise progresse avec sa plateforme d'immunothérapie Versamune® HPV, montrant un potentiel dans diverses indications cancéreuses.
PDS Biotechnology (PDSB) hat ein Unternehmens-Update gegeben und die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht. Zu den wichtigsten Highlights gehören:
Klinischer Fortschritt: Einigung mit der FDA über das Design der Phase-3-Studie VERSATILE-003 für HPV16-positives HNSCC, die im vierten Quartal 2024 beginnen soll. Aktualisierte Daten der VERSATILE-002-Studie werden auf der ESMO 2024 vorgestellt.
Finanzergebnisse: Nettverlust von 8,3 Millionen Dollar (0,23 Dollar pro Aktie) im zweiten Quartal 2024, verglichen mit 11,5 Millionen Dollar (0,37 Dollar pro Aktie) im zweiten Quartal 2023. Die F&E-Ausgaben gingen auf 4,5 Millionen Dollar zurück von 8,0 Millionen Dollar, während die allgemeinen und administrativen Ausgaben auf 4,2 Millionen Dollar von 4,7 Millionen Dollar sanken. Zum 30. Juni 2024 betrugen die liquiden Mittel und Äquivalente 57,7 Millionen Dollar.
Das Unternehmen macht Fortschritte mit seiner Versamune® HPV-Immuntherapieplattform, die Potenzial bei verschiedenen Krebsindikationen zeigt.
- Alignment with FDA on Phase 3 VERSATILE-003 trial design for HPV16-positive HNSCC
- Planned initiation of Phase 3 VERSATILE-003 trial in Q4 2024
- Acceptance of VERSATILE-002 trial data presentation at ESMO Congress 2024
- Median overall survival of 30 months in VERSATILE-002 trial
- Decreased net loss from $11.5 million in Q2 2023 to $8.3 million in Q2 2024
- Reduction in R&D expenses by $3.5 million year-over-year
- Decrease in G&A expenses by $0.5 million year-over-year
- Cash and cash equivalents of $57.7 million as of June 30, 2024
- Net loss of $8.3 million in Q2 2024
- Increased net interest expenses from $0.2 million to $0.5 million year-over-year
Insights
PDS Biotech's Q2 2024 results show a narrowing net loss of
The alignment with FDA on the Phase 3 VERSATILE-003 trial design for Versamune® HPV + pembrolizumab in first-line recurrent/metastatic HPV16-positive HNSCC is a significant milestone. The 30-month median overall survival from the VERSATILE-002 trial is promising, potentially indicating improved efficacy over current standards. The expansion into high-risk locally advanced cervical cancer (IMMUNOCERV trial) and biochemically recurrent prostate cancer showcases the platform's versatility. However, it's important to await full data presentations at ESMO and ASTRO to assess the true clinical impact and potential market positioning.
PDS Biotech's focus on HPV-related cancers positions it in a growing market with significant unmet needs. The potential first-in-class targeted immunotherapy for HPV16-positive HNSCC could be a game-changer if Phase 3 results mirror early data. The company's pipeline diversification into cervical and prostate cancers broadens its market potential. However, competition in the immuno-oncology space is fierce and success will hinge on demonstrating superior efficacy and safety profiles. The planned Q4 2024 start for VERSATILE-003 suggests a timeline to market that investors should monitor closely.
PRINCETON, N.J., Aug. 13, 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 second quarter of 2024.
“We are exiting the second quarter with momentum. We have aligned with the FDA on the design of the Phase 3 registrational trial of Versamune® HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (“HNSCC”),” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “This clinical trial is supported by the maturing data from our VERSATILE-002 Phase 2 trial, including encouraging survival, disease control response rates and safety data. We look forward to the presentation of updated data from the VERSATILE-002 trial at the European Society for Medical Oncology (ESMO) 2024 Congress in September.”
Kirk Shepard, M.D., Chief Medical Officer stated, “As a result of the recent VERSATILE-002 trial results, we have revised the statistical endpoints of the VERSATILE-003 Phase 3 trial to provide additional robustness to our trial design. Our goal now is to work with our clinical research organization to initiate the trial of the combination, which we believe has potential as the first targeted immunotherapy for HPV16-positive HNSCC. We anticipate that future studies of PDS01ADC have the potential to provide additional clinical benefit to an effective targeted immunotherapy.”
Recent Developments
- Announced alignment with FDA to initiate Phase 3 VERSATILE-003 trial in HPV16-positive first-line recurrent or metastatic HNSCC.
- This trial will be designed to investigate the combination of Versamune® HPV + pembrolizumab compared to pembrolizumab, and this design reflects updated statistical endpoints based on recent and more mature survival data from the VERSATILE-002 trial.
- PDS Biotech has initiated preparatory activities in connection with the planned start of the Phase 3 VERSATILE-003 trial in Q4 2024.
- Abstract by Jared Weiss, M.D., UNC Lineberger Cancer Center (Lead Investigator), presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune® HPV in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positive recurrent/metastatic HNSCC accepted for presentation at the ESMO Congress 2024.
- Provided a survival data update from the ongoing VERSATILE-002 trial in HPV16-positive HNSCC based on data cut from May 17, 2024.
- Median overall survival is 30 months, consistent with data cut as of November 30, 2023.
- Abstract by Adam Grippin, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center presenting updated results from the IMMUNOCERV trial evaluating treatment of high-risk locally advanced cervical cancer with Versamune® HPV in combination with chemoradiotherapy accepted for oral presentation at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024.
- Abstract by Renee Donahue, Ph.D., of the National Cancer Institute presenting preliminary biomarker results from a Phase 2 trial evaluating treatment of biochemically recurrent prostate cancer with PDS01ADC in combination with enzalutamide accepted for oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society 2024.
Second Quarter 2024 Financial Results
Reported net loss was approximately
Research and development expenses decreased 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 June 30, 2024, totaled approximately
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 in 2024 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 PDS01ADC, PDS0101, PDS0203 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 PDS01ADC, PDS0101, PDS0203 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.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | ||||||||||||||||
| Unaudited Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 4,527,698 | $ | 8,004,852 | $ | 11,231,862 | $ | 13,848,538 | ||||||||
| General and administrative expenses | $ | 4,156,606 | $ | 4,691,321 | $ | 7,550,069 | $ | 8,270,049 | ||||||||
| Total operating expenses | $ | 8,684,304 | $ | 12,696,173 | $ | 18,781,931 | $ | 22,118,587 | ||||||||
| Loss from operations | $ | (8,684,304 | ) | $ | (12,696,173 | ) | $ | (18,781,931 | ) | $ | (22,118,587 | ) | ||||
| Interest income (expense), net | ||||||||||||||||
| Interest income | $ | 675,209 | $ | 750,654 | $ | 1,344,104 | $ | 1,479,995 | ||||||||
| Interest expense | $ | (1,187,971 | ) | $ | (995,397 | ) | $ | (2,362,716 | ) | $ | (1,962,242 | ) | ||||
| Interest income (expense), net | $ | (512,762 | ) | $ | (244,743 | ) | $ | (1,018,612 | ) | $ | (482,247 | ) | ||||
| Loss before income taxes | $ | (9,197,066 | ) | $ | (12,940,916 | ) | $ | (19,800,543 | ) | $ | (22,600,834 | ) | ||||
| Benefit for income taxes | $ | 869,169 | $ | 1,406,021 | $ | 869,169 | $ | 1,406,021 | ||||||||
| Net loss and comprehensive loss | $ | (8,327,897 | ) | $ | (11,534,895 | ) | $ | (18,931,374 | ) | $ | (21,194,813 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (0.37 | ) | $ | (0.53 | ) | $ | (0.69 | ) | ||||
Weighted average common shares outstanding basic and diluted | 36,693,561 | 30,802,498 | 35,754,715 | 30,613,310 | ||||||||||||
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | ||||||
| Unaudited Selected Balance Sheet Data | ||||||
| June 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Cash and cash equivalents | $ | 57,733,724 | $ | 56,560,517 | ||
| Working capital | $ | 44,486,702 | $ | 45,425,098 | ||
| Total assets | $ | 60,495,947 | $ | 59,390,080 | ||
| Long term debt | $ | 13,810,194 | $ | 19,506,183 | ||
| Accumulated deficit | $ | (163,431,989 | ) | $ | (144,500,615 | ) |
| Total stockholders’ equity | $ | 30,917,870 | $ | 26,130,947 | ||
FAQ
What is the status of PDS Biotech's (PDSB) Phase 3 VERSATILE-003 trial?
What were PDS Biotech's (PDSB) financial results for Q2 2024?
What is the median overall survival in PDS Biotech's (PDSB) VERSATILE-002 trial?
When will PDS Biotech (PDSB) present updated VERSATILE-002 trial data?
