UNC Lineberger Comprehensive Cancer Center

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 ResultsReported net loss was approximately $8.3 million, or $0.23 per basic share and diluted share, for the three months ended June 30, 2024, compared to a net loss of $11.5 million, or $0.37 per basic share and diluted share, for the three months ended June 30, 2023. The decrease was due to lower operating expenses. Research and development expenses decreased to approximately $4.5 million for the three months ended June 30, 2024, from $8.0 million for the three months ended June 30, 2023. The decrease of $3.5 million was primarily attributable to lower clinical trial and manufacturing costs. General and administrative expenses decreased to approximately $4.2 million for the three months ended June 30, 2024, from approximately $4.7 million for the three months ended June 30, 2023. The decrease of $0.5 million was primarily attributable to lower personnel costs and professional fees. Total operating expenses decreased to approximately $8.7 million for the three months ended June 30, 2024, from $12.7 million for the three months ended June 30, 2023. Net interest expenses increased to approximately $0.5 million for the three months ended June 30, 2024, from $0.2 million for the three months ended June 30, 2023. Cash and cash equivalents as of June 30, 2024, totaled approximately $57.7 million. About PDS BiotechnologyPDS 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 StatementsThis 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 MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Gina Mangiaracina6 DegreesPhone +1 (917) 797-7904Email: gmangiaracina@6degreespr.com PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARYUnaudited 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 SUBSIDIARYUnaudited 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

CHAPEL HILL, N.C.--(BUSINESS WIRE)-- Robert L. Ferris, MD, PhD, a head and neck surgical oncologist, leading expert in cancer immunotherapy and cancer center chief executive, has been named the executive director of UNC Lineberger Comprehensive Cancer Center, and UNC system chief of oncology services, effective October 1st, announced UNC School of Medicine Dean Wesley Burks, MD. This press release features multimedia. View the full release here: Robert L. Ferris, MD, PhD, has been named the executive director of UNC Lineberger Comprehensive Cancer Center, and UNC system chief of oncology services. (Photo: Business Wire) Ferris comes to UNC from the University of Pittsburgh Medical Center (UPMC), where he was the director of the Hillman Cancer Center. He succeeds Shelley Earp, MD, who served as UNC Lineberger director twice, 1997-2014 and 2018-2024. Earp announced his intent to stepdown as director last fall. He will continue as a faculty member of UNC School of Medicine and the cancer center, to lead his lab at UNC Lineberger, and service to external organizations, including as chair of the National Cancer Institute’s Board of Scientific Advisors. “Bob Ferris is an exceptional cancer physician-scientist, a highly skilled health executive with deep experience leading a NCI comprehensive cancer center, and a person with a genuine passion for service to others,” said Burks, vice chancellor for medical affairs at UNC School of Medicine and CEO of UNC Health. “This blend of skills, experience and vision makes Bob the ideal person to lead our cancer center and to expand on the leadership successes of Joe Pagano, Ned Sharpless and Shelley Earp, under whose direction UNC Lineberger has become one of our country’s great cancer centers.” The appointment marks a return to Chapel Hill for Ferris, who earned his bachelor’s degree in chemistry with honors and distinction from UNC-Chapel Hill. He earned his medical degree and his PhD in immunology from Johns Hopkins Medical School, where he also completed his residency, and was chief resident, in otolaryngology / head and neck surgery. Ferris has served as director and associate senior vice chancellor for cancer research at UPMC Hillman Cancer Center since 2017, and senior vice president for oncology programs at UPMC and associate senior vice chancellor for cancer research at the University of Pittsburgh starting in 2023. Under his leadership, UMPC Hillman’s clinical, academic and research faculty and activities were more closely aligned. This, among other things, generated a 29% increase in peer-reviewed cancer research funding ($106 million, up from $82 million) and a 53% increase in National Cancer Institute funding ($48 million, up from $31.2 million). The center also obtained or renewed three highly sought after NCI Specialized Programs of Research Excellence (SPORE) research grants (in head neck, skin and ovarian cancers) and multiple principal investigator grants. Ferris has led a highly productive clinical, translational and laboratory research enterprise during his tenure at Hillman Cancer Center, which has led to the founding of two companies and the publication of more than 450 peer-reviewed scientific papers and book chapters. He has been the principal investigator of multiple cancer immunotherapeutic trials, including several studies investigating treatment deintensification for HPV+ head and neck cancer after transoral surgery. He is the principal investigator of the Specialized Programs of Research Excellence in head and neck cancer. His translational research has generated fundamental insights into the mechanisms of anti-tumor immunity in the tumor microenvironment and tumor cell escape. His lab pioneered studies demonstrating innate and adaptive immune responses induced by cetuximab, the EGFR-specific monoclonal antibody, in head and neck cancer. The team is also investigating immunosuppressive molecules, including immune checkpoint receptors PD-1, CTLA-4, TIM-3, and LAG-3. Ferris also had a longstanding commitment to external service. He co-chaired the NCI Steering Committee for Head and Neck Cancer and is the immediate past president of the American Head and Neck Society. He serves on the external advisory boards for MD Anderson Cancer Center, University of Pennsylvania Abramson Cancer Center and the Georgetown Lombardi Cancer Center. He also is editor-in-chief of Oral Oncology and on the editorial board for Clinical Cancer Research and Cancer Immunology Research. About UNC Lineberger The UNC Lineberger Comprehensive Cancer Center is a cancer research and treatment center at the University of North Carolina at Chapel Hill. Serving patients at the N.C. Basnight Cancer Hospital, UNC Lineberger is the only public comprehensive cancer center in the state of North Carolina. As one of only 57 National Cancer Institute-designated Comprehensive Cancer Centers, UNC Lineberger was rated as exceptional – the highest category – by the National Cancer Institute. The center brings together some of the most exceptional physicians and scientists in the country to investigate and improve the prevention, early detection and treatment of cancer. With research that spans the spectrum from the laboratory to the bedside to the community, UNC Lineberger faculty work to understand the causes of cancer at the genetic and environmental levels, to conduct groundbreaking laboratory research, and to translate findings into pioneering and innovative clinical trials. View source version on businesswire.com: Contacts Phil Bridges (919) 457-6347 phil.bridges@unchealth.unc.edu Source: UNC Smart Multimedia Gallery Photo Robert L. Ferris, MD, PhD, has been named the executive director of UNC Lineberger Comprehensive Cancer Center, and UNC system chief of oncology services. (Photo: Business Wire) Logo View this news release and multimedia online at:

Researchers have established the most comprehensive molecular portrait of the workings of KRAS, a key cancer-causing gene or 'oncogene,' and how its activities impact pancreatic cancer outcomes. KRAS is one of the most commonly mutated genes in human cancers and it is found in more than 90% of pancreatic cancer tumors. Exactly how it spurs cancer growth, however, is poorly understood. That's why the researchers embarked on their extensive efforts to figure out what other genes and proteins make KRAS expression so lethal. Researchers at UNC Lineberger Comprehensive Cancer Center and colleagues have established the most comprehensive molecular portrait of the workings of KRAS, a key cancer-causing gene or "oncogene," and how its activities impact pancreatic cancer outcomes. Their findings could help to better inform treatment options for pancreatic cancer, which is the third leading cause of all cancer deaths in the United States. The research was published as two separate articles in Science. "Because less than 40% of pancreatic cancers respond to treatment with KRAS inhibitors, if we can establish molecular markers to predict which patients will respond, we can better provide them with specific treatments, which should improve their outcomes," said UNC Lineberger's Channing J. Der, PhD, Sarah Graham Kenan Distinguished Professor at UNC School of Medicine's Department of Pharmacology and a corresponding author of both articles. "From diagnosis to death, the average pancreatic cancer patient treated with chemotherapy lives 6 to 12 months, so there's a very limited time to offer a treatment which will work." KRAS is one of the most commonly mutated genes in human cancers and it is found in more than 90% of pancreatic cancer tumors. Exactly how it spurs cancer growth, however, is poorly understood. That's why UNC Lineberger researchers embarked on their extensive efforts to figure out what other genes and proteins make KRAS expression so lethal. In the most detailed analysis to date, they demonstrated that the molecular pathway most responsible for the cancer-driving functions of KRASis highly dependent on a protein called ERK that has dual functions in regulating which genes are expressed and which proteins are active. While ERK has been one of the most intensively studied cancer pathways, and it is well-established that ERK is among the significant players in KRAS function, its relative importance and precisely how ERK carries out its role have been unclear. Indeed, a core finding of the Science papers was that activation of the ERK protein alone is the key driver of resistance to drugs that inhibit KRAS. Taking advantage of improved methods to study cellular signaling, the researchers demonstrated that the ERK protein regulates the expression of a remarkably complex array of thousands of genes and changes the activity of thousands of proteins. Excitingly, the researchers confirmed that their findings in cancer models could accurately reflect responses in patients treated with ERK and KRAS therapies for their pancreatic, colorectal and lung cancers. Currently, two KRAS drugs have been approved for cancer treatment, and many more are currently being evaluated in ongoing clinical trials. In related studies, Der and colleagues contributed to two articles published in Nature in April about a promising anti-KRAS drug that is effective against many different KRAS mutations. They found that the MYC oncogene can cause resistance to KRAS therapies. Closing the circle, the new Science papers established that MYC is a significant component of how KRAS and ERK support cancer growth and a driver of resistance to KRAS and ERK therapies. "Our next steps are elucidating more aspects of basic and foundational research regarding KRAS," Der said. "We will continue to mine the growing body of scientific knowledge we have developed, with the ultimate goal of helping advance the clinical development of newer and better KRAS inhibitors."