PDS Biotech to Host Key Opinion Leader Event to Discuss Versamune® HPV for the Treatment of HPV16+ HNSCC
Event to Discuss the Changing Landscape of HNSCC in context with the Merck KN-689 study and the Rapidly Increasing Incidences of HPV16-positive HNSCC in the United States and Europe
Webinar to be held Tuesday, June 17, 2025, 12:00 PM ET
PRINCETON, N.J., June 09, 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 announced that it will host a virtual key opinion leader (KOL) event featuring Kevin Harrington, MBBS, PhD (The Institute of Cancer Research, United Kingdom) and Katharine A. Price, MD (Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center), to discuss the unmet need and current treatment landscape for recurrent/metastatic HPV16-positive (head and neck squamous cell carcinoma) HNSCC.
The event will review the changing landscape of HNSCC in context with Merck’s KEYNOTE-689 (KN-689) study and the rapidly increasing incidences of HPV16-positive HNSCC in the US and Europe. The event will also include a review of Versamune® HPV, which is currently being evaluated in a Phase 3 clinical trial in combination with pembrolizumab as a first-line treatment for R/M HPV16+ HNSCC, as well as in Phase 2 clinical trials for the treatment of various types of HPV16-positive cancers. Versamune® HPV is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. The panel will discuss the emerging treatment landscape in 1L R/M HNSCC and the view of HPV-positive and HPV-negative HNSCC as two distinct diseases with different underlying causes, pathology, and contributions to the development of HNSCC, as well as identification and treatment of HPV16+ HNSCC.
The event will be moderated by Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. A live question and answer session will follow the formal presentations.
Webcast and Registration Details
Date: Tuesday, June 17, 2025
Time: 12 p.m. - 1:30 p.m. ET
Registration: Click here
About Our Speakers
Kevin Harrington, MBBS, PhD, is Head of the Division of Radiotherapy and Imaging at The Institute of Cancer Research in the United Kingdom. In addition to expertise in radiotherapy and chemoradiotherapy, he is an authority on therapeutic approaches to treat metastatic head and neck cancer. Dr. Harrington is a Professor of Biological Cancer Therapies at The Institute of Cancer Research. He was the principal investigator for KEYNOTE-048, the pivotal clinical trial that supported the U.S. Food and Drug Administration approval for the use of pembrolizumab and pembrolizumab + chemotherapy in the first-line treatment of recurrent and/or metastatic HNSCC. Dr. Harrington was an investigator for the VERSATILE-002 clinical trial. He studied medicine at St. Bartholomew's Hospital in London and began focusing on head and neck cancer as a Ph.D. student at Hammersmith Hospital. Dr. Harrington completed post-doctoral research in molecular medicine at the Mayo Clinic, before being appointed as a Consultant Oncologist at The Royal Marsden National Health Service Foundation in 2001. He has published more than 600 articles on cancer treatment.
Katharine A. Price, MD, is a medical oncologist who specializes in treating patients with cancers of the head and neck, including squamous cell cancers of the upper aerodigestive tract and salivary gland cancers. Dr. Price's primary research interests include new, deintensified treatments for patients with throat (oropharyngeal) cancer related to human papillomavirus (HPV). She also investigates new therapies for patients with squamous cell cancer of the head and neck, treatments for salivary gland cancer, and cancer survivorship. Dr. Price is an investigator for the VERSATILE-002 study and is the global principal investigator for the VERSATILE-003 study. Dr. Price is also interested in health equity and is working to improve access to cancer screening and treatment for diverse patient populations and awareness of the importance of HPV vaccination to prevent cancer.
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 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® 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® 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.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:

PDS Biotech to Host Key Opinion Leader Event to Discuss Versamune® HPV for the Treatment of HPV16+ HNSCC
Event to Discuss the Changing Landscape of HNSCC in context with the Merck KN-689 study and the Rapidly Increasing Incidences of HPV16-positive HNSCC in the United States and Europe
Webinar to be held Tuesday, June 17, 2025, 12:00 PM ET
PRINCETON, N.J., June 09, 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 announced that it will host a virtual key opinion leader (KOL) event featuring Kevin Harrington, MBBS, PhD (The Institute of Cancer Research, United Kingdom) and Katharine A. Price, MD (Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center), to discuss the unmet need and current treatment landscape for recurrent/metastatic HPV16-positive (head and neck squamous cell carcinoma) HNSCC.
The event will review the changing landscape of HNSCC in context with Merck’s KEYNOTE-689 (KN-689) study and the rapidly increasing incidences of HPV16-positive HNSCC in the US and Europe. The event will also include a review of Versamune® HPV, which is currently being evaluated in a Phase 3 clinical trial in combination with pembrolizumab as a first-line treatment for R/M HPV16+ HNSCC, as well as in Phase 2 clinical trials for the treatment of various types of HPV16-positive cancers. Versamune® HPV is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. The panel will discuss the emerging treatment landscape in 1L R/M HNSCC and the view of HPV-positive and HPV-negative HNSCC as two distinct diseases with different underlying causes, pathology, and contributions to the development of HNSCC, as well as identification and treatment of HPV16+ HNSCC.
The event will be moderated by Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. A live question and answer session will follow the formal presentations.
Webcast and Registration Details
Date: Tuesday, June 17, 2025
Time: 12 p.m. - 1:30 p.m. ET
Registration: Click here
About Our Speakers
Kevin Harrington, MBBS, PhD, is Head of the Division of Radiotherapy and Imaging at The Institute of Cancer Research in the United Kingdom. In addition to expertise in radiotherapy and chemoradiotherapy, he is an authority on therapeutic approaches to treat metastatic head and neck cancer. Dr. Harrington is a Professor of Biological Cancer Therapies at The Institute of Cancer Research. He was the principal investigator for KEYNOTE-048, the pivotal clinical trial that supported the U.S. Food and Drug Administration approval for the use of pembrolizumab and pembrolizumab + chemotherapy in the first-line treatment of recurrent and/or metastatic HNSCC. Dr. Harrington was an investigator for the VERSATILE-002 clinical trial. He studied medicine at St. Bartholomew's Hospital in London and began focusing on head and neck cancer as a Ph.D. student at Hammersmith Hospital. Dr. Harrington completed post-doctoral research in molecular medicine at the Mayo Clinic, before being appointed as a Consultant Oncologist at The Royal Marsden National Health Service Foundation in 2001. He has published more than 600 articles on cancer treatment.
Katharine A. Price, MD, is a medical oncologist who specializes in treating patients with cancers of the head and neck, including squamous cell cancers of the upper aerodigestive tract and salivary gland cancers. Dr. Price's primary research interests include new, deintensified treatments for patients with throat (oropharyngeal) cancer related to human papillomavirus (HPV). She also investigates new therapies for patients with squamous cell cancer of the head and neck, treatments for salivary gland cancer, and cancer survivorship. Dr. Price is an investigator for the VERSATILE-002 study and is the global principal investigator for the VERSATILE-003 study. Dr. Price is also interested in health equity and is working to improve access to cancer screening and treatment for diverse patient populations and awareness of the importance of HPV vaccination to prevent cancer.
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 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® 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® 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.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
PDS Biotech Announces 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 NCI-Led Multi-Cohort Study Demonstrates Promising Response Rate, Triggering Enrollment Expansion Under Simon Two-Stage Design
PRINCETON, N.J., July 10, 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 announced patient recruitment has been completed in Stage 1 of a clinical trial of the Company’s PDS01ADC therapeutic administered systemically in combination with floxuridine (FUDR) administered by hepatic artery infusion pump (HAIP) for patients with metastatic colorectal cancer (NCT05286814), led by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH). The study met the pre-set RECIST v1.1 criteria for expansion into Stage 2 of the study.
The trial is an open label, single center, non-randomized Phase 2 study with three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. It is led by Dr. Jonathan Hernandez, Chief of the Surgical Oncology Section, Surgical Oncology Program, Center for Cancer Research, at the NCI. A Simon two-stage trial design is being used for each cohort. For the colorectal cancer cohort, if at least 6 of 9 participants experienced an objective response by RECIST v1.1 criteria, the cohort would continue to enroll up to a total of 22 participants. This milestone has been achieved for the colorectal cancer cohort, and enrollment has progressed to Stage 2. The cholangiocarcinoma and adrenocortical cancer cohorts continue to enroll in Stage 1. The study is being performed under the Company’s collaborative research and development agreement with the NCI.
PDS01ADC is a fused antibody drug conjugate composed of two Interleukin-12 (IL-12) heterodimers, each fused to the NHS76 antibody, which binds to both single- and double-stranded DNA (dsDNA), and therefore targets regions of tumor necrosis where DNA has become exposed.
“Colorectal cancer is among the most deadly and difficult to treat cancers. In 2020, it was estimated that more than 930,000 deaths were due to colorectal cancer worldwide according to the World Health Organization, and more effective treatments are desperately needed,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “This novel investigational approach to the targeting and use of IL-12 results in little, or no systemic exposure to IL-12, and may allow patients to reap the benefits of cytokine therapy without the typical treatment-limiting toxicities. We are delighted that the NCI has achieved this milestone and anticipate completion of patient recruitment for the metastatic colorectal cancer cohort of the study by the fourth quarter of 2025.”
Each year, more than 150,000 new cases of colorectal cancer are diagnosed in the U.S. Approximately 20% of these cases are already metastatic at the time of diagnosis, and an additional 25% of patients with initially localized disease will eventually progress to metastatic disease (Biller LH, 2021;325;(7):669-685). According to the American Cancer Society, colorectal cancer is the second leading cause of cancer-related deaths in the U.S.
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 also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
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® 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® 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® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
PDS Biotech Announces Conference Call and Webcast for Second Quarter 2025 Financial Results
PRINCETON, N.J., Aug. 06, 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 announced that the Company will host a conference call to report financial results for the quarter ended June 30, 2025 and provide a clinical programs update on Wednesday, August 13, 2025 at 8:00 am Eastern Time.
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)
After the live webcast, the event will be archived on PDS Biotech’s website for six months.
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 planned clinical trials for PDS0101 (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 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® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
PDS Biotech Reports Second Quarter 2025 Financial Results and Provides Clinical Programs Update
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 $9.4 million, or $0.21 per basic and diluted share, for the three months ended June 30, 2025, compared to $8.3 million, or $0.23 per basic share and diluted share, for the three months ended June 30, 2024. The increase in net loss was primarily due to higher net interest expenses, partially offset by lower personnel costs.
Research and development expenses were $4.2 million for the three months ended June 30, 2025, compared to $4.5 million for the three months ended June 30, 2024. The decrease was primarily due to lower personnel costs, partially offset by higher manufacturing costs.
General and administrative expenses were $3.4 million, for the three months ended June 30, 2025, compared to $4.2 million for the three months ended June 30, 2024. The decrease was primarily due to lower personnel costs and lower professional fees.
Total operating expenses were $7.6 million for the three months ended June 30, 2025, compared to $8.7 million for the three months ended June 30, 2024.
Net interest expenses were $1.8 million for the three months ended June 30, 2025, compared to $0.5 million for the three months ended June 30, 2024. The increase was primarily due to debt repayment costs.
The Company’s cash balance as of June 30, 2025 was $31.9 million, compared to $41.7 million as of December 31, 2024.
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:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
| ---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 | ||||||||||||
PDS Biotech Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer
Median Overall Survival (mOS) of 39.3 months in patients with CPS ≥ 1 – best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months*
VERSATILE-003 Phase 3 trial in progress
PRINCETON, N.J., Aug. 25, 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 announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 (Versamune® HPV) + Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (“1L R/M HNSCC”).
- 53 patients were enrolled in the 1L R/M HNSCC arm of the trial.
- PDS0101 was administered by subcutaneous injection together with IV infusion of pembrolizumab during the first 4 treatment cycles. The 5th and final subcutaneous dose of PDS0101 was administered on cycle 12. On every other cycle where PDS0101 was not administered, pembrolizumab monotherapy was administered. This continued until disease progression, death, or to cycle 35.
- The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet estimable.
- Durable patient survival is promoted by high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 and was similar across patient demographics and clinical characteristics such as age, CPS status, and prior treatment.
“We believe this final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “We believe PDS0101, which is simple and easy to administer, brings new hope to the rapidly growing population of HPV16-positive head and neck cancer patients. We look forward to publishing the full data set for this trial later this year.”
“With these results, PDS Biotech is well positioned for leadership in the largest and most rapidly growing segment of HNSCC in the US and Europe. HPV16-positive HNSCC constitutes a significant and rapidly growing unmet medical need, and a targeted therapy to treat the underlying cause of the disease is urgently needed. We believe that oncologists will continue to prioritize therapies that give their patients the best chance for survival. With PDS0101 plus pembrolizumab, an added benefit appears to be that the combination is well tolerated, and no patients discontinued the trial due to treatment-related adverse events,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech.
*No head-to-head studies have been performed comparing pembrolizumab and PDS0101
About the VERSATILE-002 Trial
VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. The trial is designed to assess the combination therapy's impact on patients who are either naive to or refractory to immune checkpoint inhibitors.
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 also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
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® is a registered trademark of PDS Biotechnology Corporation.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
PDS Biotech to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
PRINCETON, N.J., Sept. 02, 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 announced that the Company will participate in the 27th Annual H.C. Wainwright Global Investment Conference, to be held in New York, NY and virtually September 8-10, 2025. Frank Bedu-Addo, Ph.D., Chief Executive Officer, and Lars Boesgaard, Chief Financial Officer, will be available to meet with investors in one-on-one meetings during the conference.
Investors interested in speaking with management should contact their H.C. Wainwright representative.
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 standard-of-care immune checkpoint inhibitor pembrolizumab.
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® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population
First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda® (pembrolizumab) alone (10.8 months) and Keytruda® + chemotherapy (12.3 months) in patients with CPS 1-19*
Encouraging efficacy signal observed in difficult to treat category of advanced head and neck cancer patients
PRINCETON, N.J., Sept. 18, 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 announced details of a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) from the final data for its recently completed VERSATILE-002 Phase 2 clinical trial. The VERSATILE-002 trial evaluated PDS0101 (Versamune® HPV) + Keytruda® in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (“1L R/M HNSCC”).
“This is great news for these patients who may now have the possibility of a well-tolerated treatment without chemotherapy” stated Prof. Kevin Harrington, M.D., Head of the Division of Radiotherapy, The Institute of Cancer Research, London.
“Patients with low levels of PD-L1 expression have typically shown poor response to immune checkpoint inhibitor therapy, leaving HNSCC patients in this sub-type with few viable treatment options and a poor prognosis,” said Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “This sub-analysis of survival data from the CPS 1-19 patient cohort appears to show that the multifunctional T cell immune response of PDS0101 treatment may overcome the documented limitations of immune checkpoint inhibitor therapy and significantly improve survival in one of the most difficult-to-treat patient populations. This is a very encouraging finding, pointing to the potential of PDS0101 to improve treatment outcomes in a patient group that has historically derived limited benefit from current standards of care.”
Approximately 60% of the patients enrolled (n=53) in the VERSATILE-002 trial had low PD-L1 expression, a difficult to treat subset of the overall HNSCC patient population. The sub-analysis of this patient cohort shows:
- Median overall survival (mOS) for patients within the CPS 1-19 cohort (n=32) was 29.5 months.
- Published mOS in this CPS cohort was 10.8 months with Keytruda® monotherapy and 12.3 months with Keytruda® plus chemotherapy*
The Company announced mOS results for the full study population of 39.3 months from the VERSATILE-002 trial on August 25, 2025, and the full data set for the trial is expected to be published later this year.
*No head-to-head studies have been performed comparing Keytruda® (pembrolizumab) monotherapy and Keytruda® plus chemotherapy with PDS0101 *
About the VERSATILE-002 Trial
VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. The trial is designed to assess the combination therapy's impact on patients who are either naive to or refractory to immune checkpoint inhibitors.
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 also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
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® is a registered trademark of PDS Biotechnology Corporation.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
PDS Biotech to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer
Company aims to shorten time frame to make PDS0101 available to patients with HPV16-positive head and neck cancer, projected to be the most dominant type of head and neck cancer in the US by mid 2030s
Proposed Amendment to Ongoing VERSATILE-003 Trial to include PFS Endpoint Based Upon Final VERSATILE-002 Trial Data Showing Robust Median Progression Free Survival of 6.3 months and Increased Median Overall Survival of 39.3 months
PRINCETON, N.J., Oct. 29, 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 announced that after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration (“FDA”) to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE-002 trial and a proposed amendment to the VERSATILE-003 Phase 3 trial to reduce the number of patients, while maintaining statistical power, and to add progression free survival (PFS) as an earlier primary endpoint in addition to median overall survival (mOS). If the PFS endpoint is met, it would allow for an accelerated approval submission to the FDA. While the Company’s trial amendment is undergoing review by the FDA, the VERSATILE-003 trial will be temporarily paused.
“The final survival results and durable clinical responses from our VERSATILE-002 trial are very exciting. It’s the first time that a trial in the recurrent/metastatic Head and Neck Cancer population has reported a mOS of almost 40 months,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “The fact that our Phase 3 study has mOS as its primary endpoint and PFS as a secondary endpoint inherently lengthens the duration of the trial. To shorten the trial duration, we believe a meeting with the FDA to discuss changes to the current trial protocol to include PFS as an earlier primary endpoint independent of mOS is warranted. We look forward to keeping all PDS Biotech stakeholders informed as our discussions with the FDA progress.”
Dr. Kirk Shepard, MD, Chief Medical Officer added, “Based on the increasing incidence of HPV16-positive head and neck cancer, our goal is to seek the fastest and most cost-effective regulatory pathway to approval. Our goal is to be efficient in providing a well-tolerated treatment without chemotherapy as an option for patients who currently have no effective therapies for this deadly disease. Treatment with PDS0101 for currently enrolled patients in our VERSATILE-003 Phase 3 trial will continue during the temporary pause of the trial.”
About the VERSATILE-002 Trial
VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive Head and Neck Cancer. The trial is designed to assess the combination therapy's impact on patients who are either naive to or refractory to immune checkpoint inhibitors. The full data set from VERSATILE-002 is mature and expected to be submitted for publication later this year.
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 also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
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® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:
New Clinical and Translational Data on PDS Biotechnology’s Novel Investigational Cancer Therapies PDS0101 and PDS01ADC to be Presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting
- Three abstracts accepted for presentation, including one rapid oral abstract session
- Presentations to highlight ongoing clinical and translational research across PDS Biotechnology’s immunotherapy platforms
PRINCETON, N.J., Oct. 30, 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 announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place in National Harbor, Maryland. The NCI will present three abstracts highlighting emerging clinical and translational findings from its novel investigational immunotherapy platforms, including the tumor-targeting IL-12 fused antibody drug conjugate (PDS01ADC) and PDS0101, its lead Phase 3 clinical stage HPV-targeted immunotherapy. Together, these abstract presentations reflect PDS Biotechnology’s continued focus on advancing differentiated immunotherapy candidates designed to engage both adaptive and innate immune responses against cancer.
“We look forward to sharing new data generated as part of the company’s ongoing collaboration with the NCI at SITC that further highlight the potential of our platforms to reshape how the immune system recognizes and eliminates cancer,” said Frank Bedu-Addo, Ph.D., CEO of PDS Biotechnology. “Our programs are built on a strong foundation of translational science and clinical collaboration, with the goal of developing immunotherapies that activate both adaptive and innate immune responses in a precise and targeted way. The presentations at SITC reflect our ongoing commitment to advancing innovative approaches that may ultimately improve outcomes for patients with difficult-to-treat cancers.”
Abstracts Details
Title: Early changes in serum proteomic profiles predict anti-tumor activity in patients with advanced HPV-associated malignancies treated with novel combination immunotherapy
Authors: Megan Lynch, Meghali Goswami, Charalampos Floudas, Julius Strauss, Yo-Ting Tsai, Jennifer Marte, James Gulley, Jeffrey Schlom, Renee Donahue
Abstract Number: 37
Presentation Type: Rapid Oral Abstract
Session: Concurrent Session 105b: Rapid Oral Abstract Session - Clinical
Primary Category: Biomarkers, Immune Monitoring and Novel Technologies
Date and Time: Friday, Nov. 7, 12:30 - 12:38 p.m. Eastern Time
Location: Gaylord National Resort and Convention Center- Maryland Ballroom CD
Title: A tumor-targeting IL-12 immunocytokine therapy in patients with advanced solid tumors increases peripheral natural killer (NK) cells with phenotypes associated with increased tumor cell lysis
Authors: Stephanie Pitts, Nicole Toney, Jennifer Marte, James Gulley, Jeffrey Schlom, Renee Donahue
Abstract Number: 47
Presentation Type: Poster
Primary Category: Biomarkers, Immune Monitoring and Novel Technologies
Date and Time: Friday, Nov. 7 from 10 a.m.–7 p.m. Eastern Time
Location: Gaylord National Resort & Convention Center – Exhibit Halls AB
Title: Increases in peripheral memory T cells with self-renewing properties in patients with advanced solid tumors treated with tumor-targeting IL-12 immunocytokine therapy
Authors: Meghali Goswami, Carolina Celades, Christine Minnar, Asma Khelifa, Lisa Poppe, Dara Bracken-Clarke, Nicole Toney, Megan Lynch, Jennifer Marte, Sofia Gameiro, James Gulley, Jeffrey Schlom, Renee Donahue
Abstract Number: 168
Presentation Type: Poster
Primary Category: Biomarkers, Immune Monitoring and Novel Technologies
Date and Time: Saturday, Nov. 8 from 10 a.m.–6:35 p.m. Eastern Time
Location: Gaylord National Resort & Convention Center – Exhibit Halls AB
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 also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
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® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email:
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email:


