1. FLORHAM PARK, N.J., May 18, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the appointment of Dr. Olivera Finn and Dr. Mark Frohlich to its Scientific Advisory Board.

    Dr. Olivera Finn is a Distinguished Professor of Immunology at the University of Pittsburgh, School of Medicine. Dr. Finn brings over three decades of expertise in translational research in immunology and oncology, including the discovery of the first tumor-associated protein (antigen) recognized by T-cells, called MUC-1. In 2016, she received the National…

    FLORHAM PARK, N.J., May 18, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the appointment of Dr. Olivera Finn and Dr. Mark Frohlich to its Scientific Advisory Board.

    Dr. Olivera Finn is a Distinguished Professor of Immunology at the University of Pittsburgh, School of Medicine. Dr. Finn brings over three decades of expertise in translational research in immunology and oncology, including the discovery of the first tumor-associated protein (antigen) recognized by T-cells, called MUC-1. In 2016, she received the National Cancer Institute's Outstanding Investigator Award for her pioneering and extensive ground-breaking research in cancer immunotherapy. Previously, Dr. Finn served as the Director of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute and is a Distinguished Fellow of the American Association of Immunologists. Dr. Finn obtained a Ph.D. in Immunology, and subsequently completed her postdoctoral fellowship at Stanford University.

    Dr. Mark Frohlich is a renowned medical oncologist and biopharma executive who brings over 20 years of experience in developing immunotherapies for cancer. Dr. Frohlich has extensive clinical drug development and translational research expertise. As the Chief Medical Officer and Executive VP of R&D at Dendreon Corporation, he led the clinical team responsible for the development and approval of Provenge® for the treatment of advanced prostate cancer. Provenge® was the first therapeutic cancer vaccine to gain FDA approval. He subsequently served as Executive VP of Portfolio Strategy at Juno Therapeutics. Dr. Frohlich received his Doctor of Medicine degree from Harvard Medical School and completed his internal medicine residency and oncology fellowship at University of California San Francisco.

    "We are excited to add Dr. Olivera Finn, Ph.D. and Dr. Mark Frohlich, M.D., two world-renowned immunotherapy experts, to our Scientific Advisory Board," commented Dr. Lauren V. Wood, M.D., Chief Medical Officer of PDS Biotech. "These appointments further strengthen our translational research expertise in immuno-oncology as we prepare to progress clinical development of PDS0102 and PDS0103 for prostate and MUC-1 associated cancers respectively, and continue to advance our lead cancer immunotherapy PDS0101 through Phase 2 clinical testing. We very much look forward to adding their experience and guidance to our team of accomplished advisors."

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company's lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. PDS Biotech is also collaborating with the National Cancer Institute to develop PDS0102 for prostate and breast cancers and to develop PDS0103, a MUC-1 targeting immunotherapy for breast, colon, lung and ovarian cancers. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 PDS0101, PDS0203 and other Versamune® based products; 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, PDS0203 and other Versamune® based products 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 our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials; the acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Rich Cockrell

    CG Capital

    Phone: +1 (404) 736-3838

    Email:



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  2. FLORHAM PARK, N.J., May 17, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company's participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

    "We are pleased to receive an allocation from the New Jersey NOL program," said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The funding will be beneficial to us as…

    FLORHAM PARK, N.J., May 17, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company's participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

    "We are pleased to receive an allocation from the New Jersey NOL program," said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development."

    The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company's lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 PDS0101, PDS0203 and other Versamune® based products; 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, PDS0203 and other Versamune® based products 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 our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials; the acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Rich Cockrell

    CG Capital

    Phone: +1 (404) 736-3838

    Email:



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  3. FLORHAM PARK, N.J., May 13, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, will discuss its financial results for the quarter ended March 31, 2021 and provide a business update on its conference call today.

    Recent Business Highlights:

    • National Cancer Institute to present interim efficacy and safety data of PDS0101 Phase 2 clinical trial in an oral presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting on June 7, 2021. This trial is evaluating PDS0101 with two clinical stage immunotherapies from EMD Serono…

    FLORHAM PARK, N.J., May 13, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, will discuss its financial results for the quarter ended March 31, 2021 and provide a business update on its conference call today.

    Recent Business Highlights:

    • National Cancer Institute to present interim efficacy and safety data of PDS0101 Phase 2 clinical trial in an oral presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting on June 7, 2021. This trial is evaluating PDS0101 with two clinical stage immunotherapies from EMD Serono, a first in class bifunctional checkpoint inhibitor Bintrafusp Alfa (M7824) and an antibody conjugated cytokine M9241 (NHS-IL12), in patients with all types of advanced HPV-associated cancers, whose cancer has returned or spread after treatment.
    • COVID-19 consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund up to approximately US$60 million to support the clinical development and commercialization of a Versamune®-based COVID-19 vaccine by Farmacore in Brazil. 

    "We look forward to the presentation of preliminary efficacy and safety data from the National Cancer Institute (NCI)-led Phase 2 combination study of PDS0101 at the ASCO conference in early June.  ASCO provides an important opportunity to present the potential of PDS0101 and the Versamune® platform in oncology to the research and medical community," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech, "The presentation of the human clinical efficacy data at ASCO is an important milestone both for PDS0101 and our entire Versamune®-based oncology pipeline."

    First Quarter 2021 Financial Results

    PDS Biotech reported a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021 compared to a net loss of approximately $4.0 million, or $0.39 per basic share and diluted share, for the three months ended March 31, 2020.

    Research and development (R&D) expenses decreased 28% to approximately $1.4 million for the three months ended March 31, 2021 from approximately $2.0 million for the three months ended March 31, 2020. The decrease of approximately $0.6 million in 2021 was primarily attributable to a decrease of $0.3 million in professional services and $0.3 million in clinical studies.

    General and administrative expenses decreased 21% to approximately $1.6 million for the three months ended March 31, 2021 from approximately $2.1 million for the three months ended March 31, 2020. The decrease of approximately $0.5 million is primarily attributable to a decrease in professional services of approximately $0.7 million which includes legal fees of approximately $0.2 million, offset by an increase of approximately $0.2 million in personnel costs.

    Total operating expenses decreased 24% to approximately $3.0 million for the three months ended March 31, 2021 from approximately $4.0 million for the three months ended March 31, 2020. 

    PDS Biotech's cash balance as of March 31, 2021 was approximately $25.0 million.

    Conference Call and Webcast

    The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotech. Participants can also access the conference call via webcast on the investor relations page of the Company's corporate website (link).

    The event will be archived in the investor relations section of PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13716518.

    About PDS Biotech

    PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional  tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The Company's lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 PDS0101, PDS0203 and other Versamune® based products; 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, PDS0203 and other Versamune® based products 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 our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials; the acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    Rich Cockrell

    CG Capital

    Phone: +1 (404) 736-3838 

    Email:





    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

     March 31, 2021 December 31, 2020
    ASSETS(unaudited)  
    Current assets:   
    Cash and cash equivalents$25,037,374  $28,839,565 
    Prepaid expenses and other 2,219,514   1,497,665 
         Total current assets 27,256,888   30,337,230 
          
    Property and equipment, net 3,583   5,443 
    Operating lease right-to-use asset 501,194   547,706 
          
    Total assets$27,761,665  $30,890,379 
          
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    LIABILITIES     
    Current liabilities:     
    Accounts payable$950,598  $1,415,224 
    Accrued expenses 1,854,795   1,735,322 
    Operating lease obligation-short term 123,654   119,904 
         Total current liabilities 2,929,047   3,270,450 
          
    Noncurrent liability:     
         Operating lease obligation-long term 458,291   490,353 
          
    Total Liabilities:$3,387,338  $3,760,803 
              
          
    STOCKHOLDERS' EQUITY     
    Common stock, $0.00033 par value, 75,000,000 shares authorized at March 31, 2021 and December 31, 2020, 22,278,261 shares and 22,261,619 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively 7,346   7,346 
    Additional paid-in capital 71,200,684   70,907,315 
    Accumulated deficit (46,833,703)  (43,785,085)
    Total stockholders' equity 24,374,327   27,129,576 
          
    Total liabilities and stockholders' equity$27,761,665  $30,890,379 
     
     

    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

     Three Months Ended March 31,
     2021

     2020

    Operating expenses:     
    Research and development expenses$1,413,057  $1,971,679 
    General and administrative expenses 1,636,216   2,060,148 
          
    Total operating expenses 3,049,273   4,031,827 
          
    Loss from operations (3,049,273)  (4,031,827)
          
    Other income     
    Interest income 655   46,419 
          
    Net loss and comprehensive loss$(3,048,618) $(3,985,408)
          
    Per share information:     
    Net loss per share, basic$(0.14) $(0.39)
    Net loss per share, diluted$(0.14) $(0.39)
          
    Weighted average common shares outstanding, basic 22,263,838   10,314,761 
    Weighted average common shares outstanding, diluted 22,263,838   10,314,761 



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  4. FLORHAM PARK, N.J., May 12, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced their participation in Noble Capital Markets' C-Suite Interview Series, presented by Channelchek.

    PDS Biotech's President and CEO, Dr. Frank Bedu-Addo, Chief Medical Officer, Dr. Lauren Wood, M.D. and Chief Financial Officer, Dr. Seth Van Voorhees sat down with Noble Capital Markets Senior Research Analyst Robert LeBoyer for this exclusive interview.

    In this interview, Robert and the PDS Biotech leadership team discuss the PDS Biotech pipeline…

    FLORHAM PARK, N.J., May 12, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced their participation in Noble Capital Markets' C-Suite Interview Series, presented by Channelchek.

    PDS Biotech's President and CEO, Dr. Frank Bedu-Addo, Chief Medical Officer, Dr. Lauren Wood, M.D. and Chief Financial Officer, Dr. Seth Van Voorhees sat down with Noble Capital Markets Senior Research Analyst Robert LeBoyer for this exclusive interview.

    In this interview, Robert and the PDS Biotech leadership team discuss the PDS Biotech pipeline, including an in-depth overview of the proprietary Versamune® platform, a T-cell activating platform designed to address key limitations of current cancer immunotherapy. They also discuss each of the three ongoing phase 2 clinical trials of PDS0101 as well as the upcoming interim data readout for the National Cancer Institute-led combination trial of PDS0101 with 2 immunotherapies owned by EMD Serono expected at ASCO in June. The PDS Biotech team also discussed the Versamune®-based COVID-19 vaccine being developed in Brazil by their consortium partner Farmacore.

    The interview was recorded on May 5, 2021, and is available now on Channelchek and the PDS Biotech website.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech is developing multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company's lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

    About Noble Capital Markets

    Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email:

    About Channelchek

    Channelchek (.com) is a comprehensive investor-centric portal - featuring more than 6,000 emerging growth companies - that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email:

    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 PDS0101, PDS0203 and other Versamune® based products; 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, PDS0203 and other Versamune® based products 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 our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials; the acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.





    Media & Investor Relations Contact:
    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email: 
    
    Rich Cockrell
    CG Capital
    Phone: +1 (404) 736-3838
    Email: 

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  5. FLORHAM PARK, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that initial efficacy and safety data from the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment (NCT04287868) has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting taking place June 4-8.

    The accepted abstract summarizes initial findings from the…



    FLORHAM PARK, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that initial efficacy and safety data from the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment (NCT04287868) has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting taking place June 4-8.

    The accepted abstract summarizes initial findings from the ongoing trial, which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Earlier this year, it was announced that the trial had achieved its preliminary efficacy threshold of an objective response in 3 or more of the first 8 patients as measured by RECIST 1.1. The trial subsequently expanded enrollment to both checkpoint inhibitor naïve patients and patients who have failed prior therapy with checkpoint inhibitors. "We are encouraged by the data and look forward to the presentation of initial findings from the study," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "ASCO provides an important opportunity to share the potential of both PDS0101 and the Versamune® platform with the research and medical community."

    Abstract Number: 2501

    Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.

    Presenting Author: Julius Strauss, MD, National Cancer Institute

    Session: Developmental Therapeutics—Immunotherapy

    Date: June 7, 2021

    Time: 3:00 PM-6:00 PM EDT

    The abstract will be available on Wednesday, May 19 at 5:00 PM EDT on ASCO.org.

    For patients interested in enrolling in this clinical study, please call NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615), email , and/or visit the website:  https://trials.cancer.gov.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. The company's lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in multiple indications. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

    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 PDS0101, PDS0203 and other Versamune® based products; 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, PDS0203 and other Versamune® based products 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 our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials; the acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.



    Media & Investor Relations Contact:
    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email: 
    
    Rich Cockrell
    CG Capital
    Phone: +1 (404) 736-3838
    Email: 

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  6. FLORHAM PARK, N.J., April 26, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will release financial results for the first quarter of 2021 on Thursday, May 13, 2021, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology…

    FLORHAM PARK, N.J., April 26, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will release financial results for the first quarter of 2021 on Thursday, May 13, 2021, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.

    After the live webcast, the event will be archived on PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13718826.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.







    Media & Investor Relations Contact:
    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email: 
    
    Rich Cockrell
    CG Capital
    Phone: +1 (404) 736-3838
    Email: 

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  7. Florham Park, NJ, April 19, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced their participation in Noble Capital Markets' Virtual Road Show Series, presented by Channelchek, scheduled for April 21, 2021.

    The virtual roadshow will feature a corporate presentation from PDS Biotech President and CEO Dr. Frank Bedu-Addo, Chief Medical Officer Dr. Lauren Wood and Chief Financial Officer Seth Van Voorhees followed by a question and answer session proctored by Noble Senior Research Analyst Robert LeBoyer, featuring questions submitted…

    Florham Park, NJ, April 19, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced their participation in Noble Capital Markets' Virtual Road Show Series, presented by Channelchek, scheduled for April 21, 2021.

    The virtual roadshow will feature a corporate presentation from PDS Biotech President and CEO Dr. Frank Bedu-Addo, Chief Medical Officer Dr. Lauren Wood and Chief Financial Officer Seth Van Voorhees followed by a question and answer session proctored by Noble Senior Research Analyst Robert LeBoyer, featuring questions submitted by the audience.

    The live broadcast of the virtual roadshow is scheduled for April 21, 2021, at 1 PM EDT. Registration is free and open to all investors, at any level. Register Here.

    Noble's research, as well as news and advanced market data on PDS Biotechnology is available on Channelchek.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Noble Capital Markets

    Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 36 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email:

    About Channelchek

    Channelchek (.com) is a comprehensive investor-centric portal - featuring more than 6,000 emerging growth companies - that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email:

     

     



    Investor Contact:
    Rich Cockrell
    CG CAPITAL
    404.736.3838
    
    
    Company Contact:
    Deanne Randolph
    PDS Biotech
    Phone: 908.517.3613
    

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  8. FLORHAM PARK, N.J., March 18, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the year ended December 31, 2020 and provided a business update.

    Recent Business Highlights:

    • Achieved preliminary efficacy benchmark in the Phase 2 combination trial of PDS0101 led by the National Cancer Institute.
    • Initiated VERSATILE-002, a Phase 2 trial of lead investigational drug candidate PDS0101, in combination with standard of care KEYTRUDA® for first-line treatment of patients with metastatic or recurrent…

    FLORHAM PARK, N.J., March 18, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the year ended December 31, 2020 and provided a business update.

    Recent Business Highlights:

    • Achieved preliminary efficacy benchmark in the Phase 2 combination trial of PDS0101 led by the National Cancer Institute.
    • Initiated VERSATILE-002, a Phase 2 trial of lead investigational drug candidate PDS0101, in combination with standard of care KEYTRUDA® for first-line treatment of patients with metastatic or recurrent HPV-positive head and neck cancer.
    • Phase 2 trial of lead investigational drug candidate PDS0101, in combination with standard of care chemoradiotherapy for patients with advanced cervical cancer was initiated by the University of Texas MD Anderson Cancer Center.
    • Expanded consortium for development of PDS0203, a novel, Versamune®-based second-generation COVID-19 vaccine to include Blanver Farmoquímica in addition to Farmacore.
    • Received award commitment of up to $60 million from Brazil's Ministry of Science, Technology and Innovation (MCTI) to fund clinical development and commercialization of PDS0203.
    • Strengthened leadership team with the appointment of Seth Van Voorhees as Chief Financial Officer and addition of preeminent oncologist Otis Brawley, M.D. to the board of directors.

    "Despite the challenges of 2020, the PDS Biotech team remained focused on the advancement of our Versamune®-based drug pipeline," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "Through that commitment and the strength of our partnerships with leading institutions in the fields of immuno-oncology and infectious disease, we made significant strides in solidifying the safety profile and establishing the efficacy of our Versamune® platform and products as we continue to progress our portfolio towards commercialization."

    Full Year 2020 Financial Results

    For the year ended December 31, 2020, the net loss was approximately $14.8 million, or $0.89 per basic share and diluted share, compared to a net loss of approximately $7.0 million, or $1.44 per basic share and diluted share for the year ended December 31, 2019.

    For the year ended December 31, 2020, research and development expenses increased to $7.9 million compared to $6.1 million during the prior year. The increase was primarily the result of increased expenses related to manufacturing and personnel costs for the ongoing clinical studies.

    For the year ended December 31, 2020, general and administrative expenses decreased to $7.0 million compared to $11.0 million during 2019. The $4.0 million decrease was due to decreases in personnel costs of $0.4 million, non-cash stock-based compensation of $2.4 million, D&O insurance costs of $0.5 million, legal fees of $0.5 million and professional fees of $0.2 million.

    Total operating expenses for 2020 were $14.9 million, a decrease of approximately 29% compared to $21.0 million during the prior year.

    The company's cash balance as of December 31, 2020 was $28.8 million.

    Conference Call and Webcast

    The conference call is scheduled to begin at 8:00 am ET on Thursday, March 18, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotech. Participants can also access the conference call via webcast on the investor relations page of the Company's corporate website (link).

    The event will be archived in the investor relations section of PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13716518.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 PDS0101, PDS0203 and other Versamune® based products; 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, PDS0203 and other Versamune® based products 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

     December 31,

    2020
     December 31,

    2019
    ASSETS   
    Current assets:   
    Cash and cash equivalents$28,839,565  $12,161,739 
    Prepaid expenses and other 1,497,665   2,308,462 
    Total current assets 30,337,230   14,470,201 
          
    Property and equipment, net 5,443   21,051 
    Operating lease right-to-use asset 547,706    
          
    Total assets$30,890,379  $14,491,252 
          
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    Current liabilities:     
    Accounts payable$1,415,224  $1,197,720 
    Accrued expenses 1,735,322   1,097,640 
    Restructuring reserve    498,185 
    Operating lease obligation - short term 119,904    
    Total current liabilities 3,270,450   2,793,545 
          
    Noncurrent liability:     
    Operating lease obligation - long term 490,353    




    Total liabilities
    $3,760,803  $2,793,545 
          
          
    STOCKHOLDERS' EQUITY     
    Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2020 and

       December 31, 2019, 22,261,619 shares and 5,281,237 shares issued and outstanding at

       December 31, 2020 and December 31, 2019, respectively
     7,346   1,742 
    Additional paid-in capital 70,907,315   40,633,670 
    Accumulated deficit (43,785,085)  (28,937,705)
    Total stockholders' equity 27,129,576   11,697,707 
          
    Total liabilities and stockholders' equity$30,890,379  $14,491,252 





    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

     Year Ended December 31,
     2020  2019 
    Operating expenses:   
    Research and development expenses$7,924,450  $6,099,580 
    General and administrative expenses 6,962,328   10,981,765 
    Impairment expense IPRD    2,974,000 
    Lease termination costs    979,273 
    Depreciation 15,608    
          
    Total operating expenses 14,902,386   21,034,618 
          
    Loss from operations (14,902,386)  (21,034,618)
          
    Other income (expense):     
    Gain on bargain purchase upon merger    13,334,568 
    Interest income 55,006   353,490 
    Interest expense    (33,559)
          
    Loss before income taxes (14,847,380)

      (7,380,119)
          
    Income taxes (benefit)    (381,513)
    Net loss and comprehensive loss$(14,847,380) $(6,998,606)
          
    Per share information:     
    Net loss per share, basic and diluted$(0.89) $(1.44)
          
    Weighted average common shares outstanding basic and diluted 16,745,044   4,868,079 



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  9. Florham Park, New Jersey--(Newsfile Corp. - March 17, 2021) - PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Dr. Frank Bedu-Addo, CEO of PDS Biotech, will present the company's immunotherapy platform, ongoing phase 2 clinical programs, product pipeline and upcoming milestones virtually at the Benzinga Biotech Small Cap Conference on Wednesday, March 24 at 10:05 am ET. In addition, Dr. Bedu-Addo will participate in the "Cancer Immunotherapies: Fighting Cancer with the power of the Immune System" panel immediately following his presentation at 10:25am…

    Florham Park, New Jersey--(Newsfile Corp. - March 17, 2021) - PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Dr. Frank Bedu-Addo, CEO of PDS Biotech, will present the company's immunotherapy platform, ongoing phase 2 clinical programs, product pipeline and upcoming milestones virtually at the Benzinga Biotech Small Cap Conference on Wednesday, March 24 at 10:05 am ET. In addition, Dr. Bedu-Addo will participate in the "Cancer Immunotherapies: Fighting Cancer with the power of the Immune System" panel immediately following his presentation at 10:25am ET on Wednesday, March 24.

    Individuals interested in attending the event can register online here: https://www.benzinga.com/events/small-cap/biotech/. A replay of the Company's presentation will be available online in the investor relations section of the Company's website for 90 days following the event.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Jacob Goldberger
    CG Capital
    Phone: +1 (404) 736-3841
    Email:

    ​To view the source version of this press release, please visit https://www.newsfilecorp.com/release/77530

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  10. FLORHAM PARK, N.J., March 11, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on PDS Biotech's proprietary Versamune® T-cell activating technology, today announced that its COVID-19 vaccine consortium consisting of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica, has received a commitment from the Secretary for Research and Scientific Training of the MCTI to fund up to approximately US$60 million to support the clinical development and commercialization of a novel, Versamune®-based, second generation COVID-19 vaccine in Brazil.

    MCTI intends to start making the funds available to prepare to perform…

    FLORHAM PARK, N.J., March 11, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on PDS Biotech's proprietary Versamune® T-cell activating technology, today announced that its COVID-19 vaccine consortium consisting of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica, has received a commitment from the Secretary for Research and Scientific Training of the MCTI to fund up to approximately US$60 million to support the clinical development and commercialization of a novel, Versamune®-based, second generation COVID-19 vaccine in Brazil.

    MCTI intends to start making the funds available to prepare to perform a combined Phase 1/2 clinical trial, upon authorization by the Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (Anvisa) to initiate the proposed Versamune®-based COVID-19 vaccine clinical program in Brazil.

    The pre-IMPD package for the Phase 1/2 trial is currently under review by Anvisa and the trial is anticipated to begin by Q2/3 2021. The majority of the capital provided by MCTI will fund the manufacturing process scale up, production and the Phase 3 trial, pending the results of the Phase 1/2 trial. The consortium members will work under a mutually agreed work plan to guide the vaccine efficiently through development in compliance with regulatory standards. The consortium anticipates working to initiate manufacturing scale up activities in the second quarter.

    This award is based on the preclinical studies of the Versamune®-based COVID-19 vaccine. The vaccine combines PDS Biotech's Versamune® T-cell activating platform technology with a SARS-CoV-2 recombinant protein derived from the spike (S) protein. Notably, the protein in this fully synthetic vaccine includes conserved and non-mutating regions of the virus. The vaccine has demonstrated strong potential in preclinical studies to efficiently promote the induction of killer (CD8+) and helper (CD4+) T-cells that recognize and induce immune responses against such non-mutating regions of the virus. The protein also includes regions of the spike protein that result in the induction of neutralizing antibodies.

    The Phase 1 and 2 trials, which will be run together, are anticipated to enroll approximately 360 patients and will assess the safety and efficacy of the vaccine as well as both the antibody and killer T-cell responses induced by the vaccine to the novel coronavirus. The clinical trials are planned to be conducted in Brazil.

    "PDS Biotech and Farmacore Biotechnology have taken the important step of advancing our Versamune®-based COVID-19 vaccine into the clinic," said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech." The preclinical results demonstrate the vaccine's potential to induce a broad range of robust anti SARS-CoV-2 immune responses. The rapidly increasing number of SARS-CoV-2 mutations highlights the need for novel, second generation vaccines capable of generating both killer and helper T-cells that can recognize and attack conserved and non-mutating regions of the virus. We applaud Farmacore Biotechnology and Blanver Farmoquímica for reaching this important milestone and look forward to the results of the planned human clinical trials and hopefully a rapid advancement towards commercialization of the product. These clinical trials will also advance our understanding of the potential for novel Versamune®-based vaccines to provide long-term protection against infection with viruses with pandemic potential such as SARS-CoV-2."

    "We are excited to continue advancing the program with PDS Biotech, and we are thrilled to have had the continued support of the Brazilian government as we finalize clinical study protocols with Anvisa for human testing of the novel vaccine combining the Versamune® T-cell activating technology with the SARS-CoV-2 recombinant protein antigen. We are proud to advance this promising medicine in Brazil in the fight against this global pandemic," said Helena Faccioli, CEO of Farmacore Biotechnology.

    As the license holder of PDS0203 in Latin America, Farmacore Biotechnology will continue to lead the regulatory and clinical trial efforts in Brazil and has selected a top clinical research organization, to conduct clinical trials in Brazil. PDS Biotech will continue to contribute scientific expertise and operational support and oversee scale up of the manufacturing process. Blanver Farmoquímica will manufacture, promote, distribute, and commercialize the Versamune®-based COVID-19 vaccine in Latin America.

    All funding is contingent on the availability of financial resources within the MCTI, and The Secretary for Research and Scientific Training of the MCTI has committed to making every effort to finance all clinical and development stages of the program.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Farmacore Biotechnology

    Farmacore Biotechnology is a biotechnology company, founded in 2005, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.

    About Blanver Farmoquímica

    Blanver Farmoquímica e Farmacêutica S.A. is a Brazilian company, founded in 1984, focused on R&D, manufacture and sale of innovative medicines and active pharmaceutical ingredients. The company plays in the segments of HIV, Hepatitis, Oncology and Hematology, providing high quality products for expanding the population's access to medicines through partnerships with the Ministry of Health and official laboratories. Blanver Farmoquímica is committed in always looking for innovations that will improve people's health and quality of life.

    About PDS0203

    PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being jointly developed for Latin America by a consortium that includes PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica. The vaccine combines the utility of PDS Biotech's Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune® platform, due to its unique ability to induce both antibody and polyfunctional CD8+ killer and CD4+ helper T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.

    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 PDS0101 and PDS0203 ; 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 and PDS0203 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



    Primary Logo

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  11. FLORHAM PARK, N.J., March 08, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will release financial results for the three- and twelve-month periods ended December 31, 2020 on Thursday, March 18, 2021, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am ET on Thursday, March 18, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International…

    FLORHAM PARK, N.J., March 08, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will release financial results for the three- and twelve-month periods ended December 31, 2020 on Thursday, March 18, 2021, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am ET on Thursday, March 18, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.

    After the live webcast, the event will be archived on PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13716518.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



    Primary Logo

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  12. FLORHAM PARK, N.J., March 03, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Frank Bedu-Addo, CEO of PDS Biotech, will present at the H.C. Wainwright Global Life Sciences Conference being held from March 9-10, and at the 31st Annual Oppenheimer Healthcare Conference being held from March 16-18. Both conferences are being hosted virtually.

    H.C. Wainwright & Co. Global Life Sciences Conference
    Date: Presentation Available On-Demand March 9-10, 2021
    Registration: Click Here

    31st Annual Oppenheimer Healthcare Conference

    FLORHAM PARK, N.J., March 03, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Frank Bedu-Addo, CEO of PDS Biotech, will present at the H.C. Wainwright Global Life Sciences Conference being held from March 9-10, and at the 31st Annual Oppenheimer Healthcare Conference being held from March 16-18. Both conferences are being hosted virtually.

    H.C. Wainwright & Co. Global Life Sciences Conference

    Date: Presentation Available On-Demand March 9-10, 2021

    Registration: Click Here

    31st Annual Oppenheimer Healthcare Conference

    Date: March 16, 2021 at 1:10 PM Eastern Time

    Registration: Click Here

    Replays of the presentations will be available online in the investor relations section of the Company's website for 90 days following the events.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:  

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:  



    Primary Logo

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  13. FLORHAM PARK, N.J., Feb. 22, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, and Farmacore Biotechnology today announced that Blanver Farmoquímica e Farmacêutica S.A. has joined their consortium to develop and commercialize a novel COVID-19 vaccine in Latin America.

    Blanver is a leading Brazilian Pharmaceutical Company focused on the development, manufacture, and commercialization of innovative pharmaceutical products. Under the terms of the agreement, São Paulo-based Blanver will manufacture, promote, distribute, and commercialize the Versamune®-based…

    FLORHAM PARK, N.J., Feb. 22, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, and Farmacore Biotechnology today announced that Blanver Farmoquímica e Farmacêutica S.A. has joined their consortium to develop and commercialize a novel COVID-19 vaccine in Latin America.

    Blanver is a leading Brazilian Pharmaceutical Company focused on the development, manufacture, and commercialization of innovative pharmaceutical products. Under the terms of the agreement, São Paulo-based Blanver will manufacture, promote, distribute, and commercialize the Versamune®-based COVID-19 vaccine in Latin America. As the license holder of Versamune-CoV2-FC (PDS0203) in Latin America, Farmacore will continue to lead the regulatory and clinical trial efforts in Brazil and has selected a top clinical research organization to conduct clinical trials in Brazil. PDS Biotech will continue to contribute scientific expertise and operational support.

    "Innovation is part of Blanver's DNA," commented Sergio Frangioni, Blanver Group CEO. "We are honored to join the consortium with PDS Biotech and Farmacore as our partners in Latin America to advance this innovative treatment to patients quickly in the fight against this deadly disease."

    "We are delighted to have these two expert partners in Latin America, who provide a combination of scientific and manufacturing expertise in addition to local market experience to help broaden the potential reach of a Versamune®-based COVID-19 vaccine to patients," said Dr. Frank Bedu-Addo, CEO of PDS Biotech.

    "We are excited to add Blanver's wealth of experience in development and commercialization across Latin America to this consortium as we continue in the fight against this global pandemic," said Helena Faccioli, CEO of Farmacore.

    The consortium is in active discussions with specific agencies of the Brazilian government to extend the preclinical funding to cover the upcoming human clinical trials anticipated to begin during the first half of 2021.

    The novel vaccine combines PDS Biotech's Versamune® T-cell activating technology with a SARS-CoV-2 recombinant protein antigen co-developed with Farmacore. As previously disclosed, preclinical data demonstrated that the vaccine elicits a 30-45 fold increase in the induction of highly active and potent virus-specific T-cells within 14 days of treatment compared to the antigen without Versamune®. The study also demonstrated induction of long-lasting virus-specific memory T-cells necessary for longer term protection. The studies also demonstrated strong, long-lasting induction of neutralizing antibodies. Notably, the vaccine contains a protein derived from the spike (S) protein that also includes the receptor binding domain (RBD) as well as other potentially non-mutating regions of the virus that can be recognized and attacked by T-cells. The vaccine is based on recombinant proteins (subunit vaccine) and does not require the use of attenuated viruses, traditional adjuvants, DNA or RNA to induce robust protective immune responses. In addition, a recent Phase I study of PDS0101, a Versamune®-based HPV16 subunit vaccine, demonstrated powerful T-cell responses and an attractive human safety profile with no serious or dose-limiting toxicities, presenting strong potential for an attractive safety profile for the novel Versamune®-based SARS-CoV-2 vaccine.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Farmacore Biotechnology

    Farmacore Biotechnology is a biotechnology company, founded in 2005 as a startup, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.

    About Blanver Farmoquímica

    Blanver Farmoquímica e Farmacêutica S.A. is a Brazilian company, founded in 1984, focused on R&D, manufacture and sale of innovative medicines and active pharmaceutical ingredients (APIs). The company plays in the segments of HIV, Hepatitis, Oncology and Hematology, providing high quality products for expanding the population's access to medicines through partnerships with the Ministry of Health and official laboratories. Blanver is committed in always looking for innovations that will improve people's health and quality of life.

    About Versamune-CoV-2FC/PDS0203

    PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being developed for Latin America by a consortium that includes PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica. The vaccine combines the utility of PDS Biotech's Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune® platform, due to its unique ability to induce both antibody and polyfunctional CD8+ killer and CD4+ helper T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



    Primary Logo

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  14. FLORHAM PARK, N.J., Feb. 03, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment achieved its preliminary objective response. The trial, which studies PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824), a TGF-β "trap"/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted…

    FLORHAM PARK, N.J., Feb. 03, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment achieved its preliminary objective response. The trial, which studies PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824), a TGF-β "trap"/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted immunocytokine, will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor (CPI) naïve patients.   As a result of achieving this milestone, preliminary efficacy assessment of the triple combination in an added group of approximately 20 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.

    The NCI Center for Cancer Research's Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial. The trial is evaluating the treatment combination in two patient groups: one in patients who failed prior treatment, but are naïve to checkpoint inhibitor treatment; and the second in patients who have failed treatment with checkpoint inhibitors. As prespecified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 or iRECIST among at least three of the first eight patients allows the trial to progress to full enrollment.

    Pooled data from phase 1 and 2 trials reported in the October 2020 issue of the Journal for Immunotherapy of Cancer (J ImmunoTher Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395) showed that bintrafusp alfa (M7824) a first-in-class bifunctional fusion protein composed of the extracellular domain of human TGF-β (TGF-β "trap") fused to an IgG1 antibody blocking PD-L1 (anti–PD-L1) protein, demonstrated efficacy in checkpoint inhibitor-naïve patients with HPV-associated malignancies. The observed response rate was 30.5%. M9241 is an immunocytokine composed of 2 heterodimers of IL-12 fused to the heavy chains of a human antibody targeting DNA released from necrotic tumor cells. In preclinical studies performed at the NCI comparing each drug alone versus all three agents used in combination, the triple combination achieved the highest induction of tumor-specific CD8+ killer T-cells and superior antitumor effect (J ImmunoTher Cancer 2020;8:e000612. doi:10.1136/jitc-2020-000612).

    "The achievement of this important milestone in this NCI-led Phase 2 clinical trial strengthens the evidence of our novel Versamune® platform's potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our belief that PDS0101's demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced and currently untreatable HPV-associated cancers."

    The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI are serving as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech's Chief Executive Officer and Chief Medical Officer respectively, are serving as PDS Biotech's investigators.

    Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial in advanced HPV-associated cancers.   For patients interested in enrolling in this clinical study, please call NCI's toll-free number 1-800-4-CANCER (1-800-422-6237), email , or visit the website: https://trials.cancer.gov.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is studying a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. In separate partnership with the National Cancer Institute (NCI), and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



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  15. FLORHAM PARK, N.J., Jan. 14, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today released a white paper detailing how the Versamune® platform works to treat cancer, and the potential of Versamune® in the treatment of a broad range of cancers.

    Cancer immunotherapy is a form of cancer treatment that utilizes the power of the body's own immune system to recognize, attack and eliminate cancer. The goal of cancer immunotherapy is tumor eradication and regression or, at least, disease stabilization. Cancer immunotherapies have significant potential…

    FLORHAM PARK, N.J., Jan. 14, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today released a white paper detailing how the Versamune® platform works to treat cancer, and the potential of Versamune® in the treatment of a broad range of cancers.

    Cancer immunotherapy is a form of cancer treatment that utilizes the power of the body's own immune system to recognize, attack and eliminate cancer. The goal of cancer immunotherapy is tumor eradication and regression or, at least, disease stabilization. Cancer immunotherapies have significant potential to treat a broad range of cancers, and multiple agents have been approved by the FDA to treat a wide range of cancers at various stages. Though progress has been made in developing new anti-cancer immunotherapeutic technologies and products, significant challenges limiting their clinical effectiveness and safety remain.

    There are well recognized hurdles impeding the ability of immunotherapy to harness the body's immune system most effectively. For example, approved checkpoint inhibitors have resulted in effective, durable responses. Unfortunately, the rates of response reported are only in the range of 15-20% and are most likely to occur in patients with evidence of a pre-existing immune response to their tumor. Furthermore, immune therapies, including checkpoint inhibitors, CAR-Ts and live-vector vaccines, may cause significant systemic toxicities limiting their use either in the early-stage cancer setting or in combination with other approved anti-cancer treatments.

    A significant challenge in the development of an effective cancer immunotherapy is creating a simple and easy to administer therapy that can promote the induction of highly potent, targeted, tumor-specific CD8+ killer and CD4+ helper T-cells within patients, that will effectively treat their cancer with minimal side effects. There is scientific consensus that induction of an adequate number and potency of tumor-recognizing T-cells is necessary for effective immunotherapy. However, suboptimal T-cell activation remains a key limitation of many immunotherapies.

    In two recent peer reviewed articles in the Journal of Immunology and the Journal for Immunotherapy of Cancer (available on the company's website), Versamune®-based immunotherapies were shown to induce superior quantity and quality of tumor-recognizing killer T-cells in-vivo. This resulted in superior preclinical anti-tumor efficacy. Versamune®'s ability to be combined with specific proteins found primarily on the tumor cells and its ability to induce an effective anti-tumor immune response specific to the protein and cancer, offers opportunities to treat a variety of cancers. Further, its diverse mechanisms of action and favorable safety profile suggest therapeutic promise when used alone in the single-agent monotherapy setting or when used in combination with standard of care therapies such as checkpoint inhibitors as well as chemo and radiation therapy to enhance the efficacy of treatment.

    The current PDS Biotech pipeline of Versamune®-based therapies focuses on four key antigens associated with a broad variety of solid tumors that remain challenging to treat. According to PDS Biotech CEO, Dr. Frank Bedu-Addo, "We are currently pursuing an ambitious development strategy, working with leading oncology experts to assess the potential of Versamune® to bring new and improved treatments to cancer patients."

    Read Versamune®: A New Generation of Cancer Immunotherapies here.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. The company's lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in multiple indications. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



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  16. FLORHAM PARK, N.J., Jan. 05, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Chief Executive Officer Dr. Frank Bedu-Addo will be presenting at H.C. Wainwright's BioConnect virtual conference. PDS Biotech's presentation will be available on-demand beginning January 11, 2021 at 6:00 AM ET and can be accessed online here.

    A replay of the presentation will be available online in the investor relations section of the Company's website.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing…

    FLORHAM PARK, N.J., Jan. 05, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Chief Executive Officer Dr. Frank Bedu-Addo will be presenting at H.C. Wainwright's BioConnect virtual conference. PDS Biotech's presentation will be available on-demand beginning January 11, 2021 at 6:00 AM ET and can be accessed online here.

    A replay of the presentation will be available online in the investor relations section of the Company's website.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



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  17. FLORHAM PARK, N.J., Dec. 21, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the publication of data generated by a leading vaccine research team at the Icahn School of Medicine at Mount Sinai. The research demonstrated powerful antibody induction by Versamune® against SARS-CoV-2 at low antigen doses suggesting potential for an effective antigen dose sparing COVID-19 vaccine. These data are based on preclinical studies combining PDS Biotech's Versamune® technology with an inactivated Newcastle disease virus (NDV)/SARS-CoV-2…

    FLORHAM PARK, N.J., Dec. 21, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the publication of data generated by a leading vaccine research team at the Icahn School of Medicine at Mount Sinai. The research demonstrated powerful antibody induction by Versamune® against SARS-CoV-2 at low antigen doses suggesting potential for an effective antigen dose sparing COVID-19 vaccine. These data are based on preclinical studies combining PDS Biotech's Versamune® technology with an inactivated Newcastle disease virus (NDV)/SARS-CoV-2 vaccine (NDV vaccine) developed at Mount Sinai. The peer-reviewed scientific publication "A Newcastle Disease Virus (NDV) Expressing a Membrane-Anchored Spike as a Cost-Effective Inactivated SARS-CoV-2 Vaccine" by Sun et al. was published December 17th, 2020 in Vaccines (2020, volume 8, issue 4, page 771) and provides strong rationale for clinical development of a Versamune®-based COVID-19 vaccine to maximize the full breadth of immune responses induced against SARS-CoV-2.

    The preclinical study compared various treatment regimens in their ability to induce antibodies against SARS-CoV-2:

    • the NDV vaccine alone at doses of 5µg, 10µg and 20µg,
    • the NDV vaccine in combination with Versamune® at 0.2µg, 1µg and 5µg,
    • and the NDV vaccine in combination with Addavax, an adjuvant well-known for its ability to induce powerful antibody responses, at 0.2µg, 1µg and 5µg.

    As seen in Figure 3B of the publication, shown below, the NDV vaccine with R-DOTAP, the active ingredient in Versamune, yielded the strongest antibody responses. Figure 3C, also shown below, highlighted Versamune's ability to induce the highest levels of neutralizing antibodies even at the lowest studied antigen dose of 0.2µg. Challenge studies also demonstrated that the Versamune-containing vaccine conferred protection against SARS-CoV-2 infection.

    PDS Biotech is jointly developing PDS0203 with the Brazilian company Farmacore. PDS0203 is a second-generation Versamune-based COVID-19 vaccine: a simple subunit vaccine that utilizes a recombinant protein derived from the Spike protein of SARS-CoV-2, as opposed to an inactivated virus-based vaccine. Preclinical studies of PDS0203 have confirmed the induction of strong neutralizing antibodies, virus-specific polyfunctional CD8+ (killer) and CD4+ (helper) T-cells, and long-term memory T-cell responses.

    Dr. Frank Bedu-Addo, PDS Biotech's Chief Executive Officer, commented "The results of this independent preclinical study highlight the versatility and breadth of immune responses induced by Versamune®. The power of Versamune® to confer rapid and long-term protection against infectious agents lies in its ability to quickly induce effective neutralizing antibody responses in addition to strong CD8+ and CD4+ T-cell responses."

    "The first wave of COVID-19 vaccines focused on antibody generation. However, there is a growing body of literature that establishes the importance of T-cells in providing more durable protection against COVID-19," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech, "The preclinical data that has been generated with our COVID-19 vaccine candidate, PDS0203, establishes the rapid induction of both protective neutralizing antibodies and attacking T-cells against the virus.   Our encouragement of independent, expert validation of Versamune®'s ability to induce powerful and effective immune responses underscores our commitment to developing superior cancer therapies and vaccines."

    The studies detailed in Vaccine were conducted under a drug testing agreement between PDS Biotech and Icahn School of Medicine at Mount Sinai. The full publication can be accessed here.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. The company's lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in multiple indications. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0203

    PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being jointly developed by PDS Biotech and Farmacore. PDS0203 combines the utility of PDS Biotech's Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune® platform, due to its unique ability to induce both antibody and T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/397e1ced-b7e5-4d82-aa9a-3ce8b9cf0f39

     



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  18. FLORHAM PARK, N.J., Dec. 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the appointment of Seth Van Voorhees, Ph.D. as its new Chief Financial Officer effective January 1, 2021.

    "Dr. Van Voorhees is a highly accomplished CFO with extensive experience in corporate finance, capital markets, investment banking and licensing. His appointment comes at a time of significant opportunity and growth for our Company. His business and financial expertise will be instrumental in helping us to continue to grow the Company" said Frank…

    FLORHAM PARK, N.J., Dec. 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the appointment of Seth Van Voorhees, Ph.D. as its new Chief Financial Officer effective January 1, 2021.

    "Dr. Van Voorhees is a highly accomplished CFO with extensive experience in corporate finance, capital markets, investment banking and licensing. His appointment comes at a time of significant opportunity and growth for our Company. His business and financial expertise will be instrumental in helping us to continue to grow the Company" said Frank Bedu-Addo, Chief Executive Officer of PDS Biotechnology. "We are grateful to Michael King for his services as our interim CFO, and for the contributions he made, which have enabled meaningful advancements in the development of our Versamune® platform and our lead oncology asset PDS0101."

    Dr. Van Voorhees most recently served as the CFO of Research Frontiers (NASDAQ:REFR) and for American Pacific (NASDAQ:APFC). Earlier in his career, he was an investment banking officer responsible for chemical/pharmaceutical clients at Merrill Lynch, UBS Warburg, and Wasserstein Perella. His background includes a Ph.D. in chemistry from the University of Pennsylvania and an MBA in finance from Columbia University.

    "I am pleased to be joining PDS Biotechnology at this exciting stage of its development. Its foundational science and distinctive technology platform create enormous opportunities. I look forward to helping the Company reach its strategic and financial objectives." said Dr. Van Voorhees.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



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  19. FLORHAM PARK, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that it has been granted U.S. Patent No. 10,828,364 titled "Method for Reducing a Myeloid Derived Suppressor Cell Population With Cationic Lipid Vaccine Compositions" by the United States Patent and Trademark Office (USPTO).

    "The award of this patent provides broad protections for our Versamune® platform," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Today, there are three active mid-stage clinical trials of our lead program, PDS0101 partnered…

    FLORHAM PARK, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that it has been granted U.S. Patent No. 10,828,364 titled "Method for Reducing a Myeloid Derived Suppressor Cell Population With Cationic Lipid Vaccine Compositions" by the United States Patent and Trademark Office (USPTO).

    "The award of this patent provides broad protections for our Versamune® platform," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Today, there are three active mid-stage clinical trials of our lead program, PDS0101 partnered with leaders in immuno-oncology, and we believe that the Versamune® platform may provide improved clinical outcomes for patients."

    The U.S. Patent No. 10,828,364 titled "Method for Reducing a Myeloid Derived Suppressor Cell Population With Cationic Lipid Vaccine Compositions" provides protection for the Versamune® platform including its chemical design and method of use. The patent covers methods for reduction of myeloid derived suppressor cell (MDSC) populations, which are known to suppress immune responses, by administering any positively charged (cationic) lipid combined with therapeutic factors including cytokines and interleukins. The patent also covers the combination of any cationic lipid and therapeutic factor to augment the anti-tumor immune response. The PDS Versamune® patent portfolio also includes broader cationic lipid compositions and methods of activating the immune system. The combination of Versamune® with various antigens forms the basis for PDS Biotech's broad immuno-oncology pipeline, including its lead candidate PDS0101 for the treatment of advanced human papillomavirus (HPV) related cancers.

    A portion of the work leading to this invention was carried out with support from the United States Government provided under the National Cancer Institute CRADA No. 2644. Therefore, the United States Government has certain rights in and to the present invention.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



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  20. FLORHAM PARK, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.

    Third Quarter 2020 and Recent Business Highlights

    • Successfully raised approximately $19 million via a public offering of common stock.
    • Initiated VERSATILE-002, a Phase 2 trial of PDS0101, our investigational drug candidate, in combination with standard of care KEYTRUDA® for first-line treatment of patients with metastatic or recurrent HPV-positive…

    FLORHAM PARK, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.

    Third Quarter 2020 and Recent Business Highlights

    • Successfully raised approximately $19 million via a public offering of common stock.
    • Initiated VERSATILE-002, a Phase 2 trial of PDS0101, our investigational drug candidate, in combination with standard of care KEYTRUDA® for first-line treatment of patients with metastatic or recurrent HPV-positive head and neck cancer.
    • Initiated a Phase 2 study of PDS0101 in combination with standard of care chemoradiotherapy at the MD Anderson Cancer Center for treatment of locally advanced cervical cancer.
    • Continued development of PDS0103 in partnership with the National Cancer Institute.
    • Advanced co-development program with Farmacore with plans to move the PDS0203 COVID-19 vaccine into clinical development with the support of the Brazilian government.
    • Expanded Board of Directors with appointment of preeminent oncologist, Otis Brawley, M.D.

    "As a result of our team's dedicated efforts during the third quarter and our clinical partnerships with leading institutions in immuno-oncology, today PDS0101 is being evaluated in three phase 2 clinical trials for multiple HPV-associated cancers," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotechnology. "Furthermore, the successful equity raise we completed in August strengthened our balance sheet, ensuring we can continue to progress the clinical development of our oncology programs as well as expand both our oncology and infectious disease programs despite the challenges posed by the COVID-19 pandemic."

    Third Quarter 2020 Financial Review

    For the third quarter of 2020, net loss was approximately $3.9 million, or $0.23 per basic share and diluted share, compared to a net loss of approximately $5.8 million, or $1.10 per basic share and diluted share for the third quarter of 2019.

    Research and development expenses totaled approximately $2.1 million for the third quarter of 2020, compared to approximately $1.8 million for the same period in 2019, an increase of 12%. The increase was primarily attributable to an increase of $0.1 million in technical operations (manufacturing) and $0.3 million in clinical studies, offset by a decrease of $0.1 million in professional fees and $0.1 million in regulatory expenses.

    For the third quarter of 2020, general and administrative expenses were approximately $1.8 million compared with approximately $3.0 million during the third quarter of 2019, a decrease of 40%. The decrease was primarily attributable to a decrease of $0.2 million in salary and benefits, $0.1 million in facilities and office expense, $0.3 million in insurance expense, $0.6 million in professional fees, and $0.1 million in legal fees offset by an increase of $0.1 million in licenses, taxes and fees.

    Total operating expenses for the third quarter of 2020 were approximately $3.9 million, compared to total operating expenses of approximately $5.8 million during the same period of 2019, a decrease of 33%.

    As of September 30, 2020, the Company's cash balance was approximately $33.5 million.

    Conference Call and Webcast

    The conference call is scheduled to begin at 8:00 am ET on Thursday, November 12, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.

    After the live webcast, the event will be archived on PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13712632.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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 its lead asset PDS0101 and other Versamune® based products; 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 and other Versamune® based products 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:



    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

     September 30, 2020 December 31, 2019
    ASSETS(unaudited)  
    Current assets:   
    Cash and cash equivalents$33,468,935  $12,161,739 
    Prepaid expenses and other 373,395   2,308,462 
    Total current assets 33,842,330   14,470,201 
          
    Property and equipment, net 9,345   21,051 
    Operating lease right-to-use asset 593,580    
          
    Total assets$34,445,255  $14,491,252 
          
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    LIABILITIES     
    Current liabilities:     
    Accounts payable$1,559,591  $1,197,720 
    Accrued expenses 1,222,773   1,097,640 
    Restructuring reserve    498,185 
    Operating lease obligation - short term 116,240    
    Total current liabilities 2,898,604   2,793,545 
          
    Noncurrent liability:     
    Operating lease obligation - long term 521,692    
          
    STOCKHOLDERS' EQUITY     
    Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2020 and December 31, 2019, 22,261,619 shares and 5,281,237 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 7,346   1,742 
    Additional paid-in capital 70,775,892   40,633,670 
    Accumulated deficit (39,758,279)  (28,937,705)
    Total stockholders' equity 31,024,959   11,697,707 
          
    Total liabilities and stockholders' equity$34,445,255  $14,491,252 
            

    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020  2019  2020  2019 
    Operating expenses:       
    Research and development expenses$2,060,815  $1,834,371  $5,446,718  $4,751,308 
    General and administrative expenses 1,846,214   3,068,581   5,428,098   9,358,429 
    Lease termination costs    944,445      944,445 
                
    Total operating expenses 3,907,029   5,847,397   10,874,816   15,054,182 
                
    Loss from operations (3,907,029)  (5,847,397)  (10,874,816)  (15,054,182)
                
    Other income (expense):           
    Gain on bargain purchase upon merger          11,939,331 
    Interest income 1,207   95,787   54,242   294,694 
    Interest expense          (606)
                
    Net loss and comprehensive loss (3,905,822)  (5,751,610)  (10,820,574)  (2,820,763)
    Per share information:           
    Net loss per share, basic and diluted$(0.23) $(1.10) $(0.73) $(0.60)
                
    Weighted average common shares outstanding, basic and diluted$17,169,257  $5,246,829  $14,892,764  $4,729,153 

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  21. FLORHAM PARK, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced progress on its co-development program with Farmacore Biotechnology for a Versamune®-based vaccine aimed at preventing COVID-19 infection.

    Based on promising and robust preclinical data with PDS0203, and in the interest of rapid development, PDS Biotech and Farmacore have jointly prioritized advancement of PDS0203 to human clinical trials. PDS Biotech had previously announced the parallel development of two Versamune®-based COVID-19 vaccines PDS0203…

    FLORHAM PARK, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced progress on its co-development program with Farmacore Biotechnology for a Versamune®-based vaccine aimed at preventing COVID-19 infection.

    Based on promising and robust preclinical data with PDS0203, and in the interest of rapid development, PDS Biotech and Farmacore have jointly prioritized advancement of PDS0203 to human clinical trials. PDS Biotech had previously announced the parallel development of two Versamune®-based COVID-19 vaccines PDS0203 and PDS0204 each containing different SARS-CoV-2 proteins. The decision to jointly develop PDS0203 was made with the support of the Agência Nacional de Vigilância Sanitária (ANVISA) following a successful pre-investigational new drug meeting on November 06, 2020. ANVISA and Farmacore reviewed the PDS0203 data and agreed on the path forward for official submission of a final data package and the phase 1/2 human clinical trial protocol. Farmacore is in discussions with specific agencies of the government to extend the preclinical funding to cover the upcoming human clinical trial anticipated to begin during the first half of 2021.

    As previously disclosed, PDS Biotech has generated robust preclinical data demonstrating that PDS0203 elicits a 30-45 fold increase in the induction of highly active and potent virus-specific T-cells within 14 days of treatment compared to the vaccine without Versamune®. Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection. The vaccine has also demonstrated strong and long-lasting induction of neutralizing antibodies. The PDS0203 subunit vaccine is based on recombinant proteins and does not require the use of inactivated viruses, traditional adjuvants, DNA or RNA to induce robust protective immune responses.

    "PDS0203 may present strong potential to provide the breadth and level of immune responses necessary for a safe and effective vaccine with long-term protection against COVID-19," said Dr. Greg Conn, Chief Scientific Officer of PDS Biotechnology.

    "PDS Biotech and Farmacore are now one step closer to advancing our Versamune®-based COVID-19 vaccine into the clinic," said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The preclinical results of PDS0203 demonstrate its potential to induce a robust and broad immune response. We look forward to evaluating our next-generation vaccine in planned human clinical trials in partnership with Farmacore and to advance our understanding of the potential of novel Versamune®-based vaccines like PDS0203 to provide long-term protection against infection with viruses such as SARS-CoV-2."

    "In this global pandemic, it is incumbent upon the scientific community to be flexible and to ensure we are prioritizing the vaccine with the most clinical potential and that we can progress most quickly," said Helena Faccioli, CEO of Farmacore. "We are excited to continue advancing the partnership with PDS Biotech, and we are thrilled to have the support of ANVISA to provide the opportunity to develop a treatment in Brazil in the fight against this pandemic."

    The companies plan to utilize multiple research and development sites in the United States and Brazil to progress preclinical and clinical development PDS0203.  Farmacore will lead the regulatory and clinical trial efforts in Brazil while PDS Biotech will continue to contribute scientific expertise and operational support.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Farmacore

    Farmacore is a biotechnology company, founded in 2005 as a startup, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.

    About PDS0203

    PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being jointly developed by PDS Biotech and Farmacore. PDS0203 combines the utility of PDS Biotech's Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune® platform, due to its unique ability to induce both antibody and T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.

    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 its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:

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  22. FLORHAM PARK, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that its VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the first-line treatment of head and neck cancer that has returned or spread is now open. The trial is being conducted in collaboration with Merck.

    The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that plans to enroll approximately 100 patients across 25 sites in the U.S. The University…

    FLORHAM PARK, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that its VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the first-line treatment of head and neck cancer that has returned or spread is now open. The trial is being conducted in collaboration with Merck.

    The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that plans to enroll approximately 100 patients across 25 sites in the U.S. The University of Tennessee Medical Center is the first site to open. The studies to be performed at the UT Medical Center will be led by Principal Investigator Dr. Timothy Panella, M.D. The clinical study will evaluate the efficacy and safety of PDS0101, PDS Biotech's lead Versamune®-based immunotherapy targeting human papillomavirus (HPV)-associated cancers, in combination with KEYTRUDA® (pembrolizumab), Merck's checkpoint inhibitor, in the first-line treatment of patients with HPV16-positive head and neck cancer that has returned or spread. KEYTRUDA® was approved by the FDA in June 2019 as first-line treatment for recurrent or metastatic head and neck cancer. VERSATILE-002 will study if combining PDS0101 with KEYTRUDA® is more effective than what has been previously shown with KEYTRUDA® alone. The main efficacy endpoint in this study is shrinkage of the tumor referred to as the objective response rate (ORR) at nine months following the initiation of treatment with the combination.

    "The launch of the VERSATILE-002 Phase 2 trial demonstrates our commitment to developing a safe and effective treatment option that builds upon the current standard of care for patients with this aggressive cancer and further strengthens our collaboration with Merck," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Though the COVID-19 pandemic impacted our initial timeline, we are pleased to open up this trial to patients."

    Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech added, "Initial studies suggest that Versamune®-based immunotherapies administered in combination with checkpoint inhibitors, such as KEYTRUDA®, have the potential to enhance the immune system's ability to induce a more powerful and targeted anti-tumor response. We look forward to sharing updates as this study progresses."

    "We are thrilled to offer our patients with recurrent or metastatic head and neck cancer such an exciting and potentially safe treatment option," commented Dr. Timothy Panella, who is the VERSATILE-002 Principal Investigator at the UT Medical Center, "this type of combination approach is attractive to patients and offers a novel targeted therapy in the fight against this very challenging disease."

    Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck and Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. In separate partnership with the National Cancer Institute (NCI), and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.

    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 its lead asset, PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:

     

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  23. FLORHAM PARK, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Otis Brawley, M.D., has been appointed to PDS Biotech's Board of Directors.

    Dr. Otis Brawley, M.D. is a renowned oncologist and a seasoned pharmaceutical director who has served on several boards including the boards of companies developing and commercializing oncology products. Dr. Brawley is currently the Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University. Dr. Brawley served as the Chief Medical and Scientific…

    FLORHAM PARK, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Otis Brawley, M.D., has been appointed to PDS Biotech's Board of Directors.

    Dr. Otis Brawley, M.D. is a renowned oncologist and a seasoned pharmaceutical director who has served on several boards including the boards of companies developing and commercializing oncology products. Dr. Brawley is currently the Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University. Dr. Brawley served as the Chief Medical and Scientific Officer at the American Cancer Society from 2007 through 2018, and is a former member of the FDA Oncologic Drug Advisory Committee (ODAC). Dr. Brawley is a current member of the National Cancer Institute's (NCI) Board of Scientific Counselors. Formerly, Dr. Brawley was a professor in the Department of Hematology and Oncology at the Emory University School of Medicine. He was also previously a senior investigator at the National Institute of Health (NIH) and NCI. In 2013, he was the recipient of a Special Recognition Award from the American Society of Clinical Oncology.

    Dr. Brawley is currently a director at Jackson Laboratories, a nonprofit biomedical research center focused on developing genomic solutions to disease including personalized, tailored therapeutics for individual cancers; formerly, he was a Director at the National Coalition for Cancer Research, and for the Theragenics Corporation, a publicly traded company with commercialized medical devices for brachytherapy, surgery and wound closure.

    Dr. Brawley received an M.D. from the University of Chicago, Pritzker School of Medicine. He completed an internal medicine residency at Case-Western Reserve University and a fellowship in medical oncology at the NCI. He is board certified in internal medicine and medical oncology.

    "We are thrilled to welcome Dr. Brawley to the PDS Biotech Board of Directors. His board experience as well as his prodigious experience in oncology, from both a regulatory and a clinical perspective, will be invaluable for our team at this important point in our clinical progression," said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech.

    "I am pleased to join the PDS Biotech Board of Directors, and I am grateful for the opportunity to bring my expertise and knowledge to the board of PDS Biotech to help in any way to progress the development of the novel and promising cancer therapies being developed by PDS Biotech. These products have the potential to fulfil a significant need in providing safe and effective treatments for cancer," said Dr. Otis Brawley.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:

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    • PDS Biotech to participate in "Grand Rounds: a Webinar in Biotech and Specialty Pharma" hosted by Alliance Global Partners Monday November 2, 2020
    • PDS Biotech to announce Third Quarter 2020 Financial Results Wednesday November 11, 2020 and host a conference call on Thursday, November 12, 2020

    FLORHAM PARK, N.J., Oct. 29, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will be featured in a live webinar, "Grand Rounds: A Webinar in Biotech and Specialty Pharma," hosted by James Molloy, Managing Director of Equity…

    • PDS Biotech to participate in "Grand Rounds: a Webinar in Biotech and Specialty Pharma" hosted by Alliance Global Partners Monday November 2, 2020

    • PDS Biotech to announce Third Quarter 2020 Financial Results Wednesday November 11, 2020 and host a conference call on Thursday, November 12, 2020

    FLORHAM PARK, N.J., Oct. 29, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will be featured in a live webinar, "Grand Rounds: A Webinar in Biotech and Specialty Pharma," hosted by James Molloy, Managing Director of Equity Research, Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners, on Monday, November 2nd at 10:30 am Eastern Time.

    "Grand Rounds" Webinar Presentation Information:

    Date: Monday, November 2, 2020

    Time: 10:30 am Eastern Time

    Webcast link: Click Here

    Conference Call and Webcast for Third Quarter 2020 Financial Results

    The Company also announced that it plans to report financial results for the third quarter ended September 30, 2020 on Wednesday November 11, 2020, after the close of the market. On Thursday, November 12, 2020, Dr. Frank Bedu-Addo, Chief Executive Officer, Michael King, Interim Chief Financial Officer, and Dr. Lauren Wood, Chief Medical Officer will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am Eastern Time on Thursday, November 12, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.

    After the live webcast, the event will be archived on PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13712632.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:

     

    Primary Logo

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  24. FLORHAM PARK, N.J., Oct. 26, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy (CRT) for treatment of locally advanced cervical cancer is now open.

    This Phase 2 trial is being led by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D., Resident in Radiation Oncology at The University of Texas MD Anderson Cancer Center. The trial will investigate the anti-tumor efficacy and safety of the…

    FLORHAM PARK, N.J., Oct. 26, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy (CRT) for treatment of locally advanced cervical cancer is now open.

    This Phase 2 trial is being led by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D., Resident in Radiation Oncology at The University of Texas MD Anderson Cancer Center. The trial will investigate the anti-tumor efficacy and safety of the PDS0101-CRT combination, and their correlation with critical biomarkers of immune response, in approximately 35 patients.

    "We are excited to have initiated this Phase 2 human study of PDS0101 administered with the current standard of care.   We believe that the demonstrated potential of PDS0101 to activate the immune system to induce tumor-targeting T-cells provides strong potential to present improved treatments to patients with cervical cancer," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.

    Dr. Lauren Wood, PDS Biotech's Chief Medical Officer, will serve as PDS Biotech's liaison. The study is being performed pursuant to an Investigator Initiated Study Agreement between PDS Biotech and MD Anderson.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead clinical product, PDS0101, combines the utility of the Versamune® platform with targeted antigens against HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is has initiated a phase 2 study studying a combination of PDS0101 and two clinical-stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Jacob Goldberger

    CG Capital

    Phone: +1 (404) 736-3841

    Email:  

    Primary Logo

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  25. FLORHAM PARK, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced their participation in Noble Capital Markets' Virtual Road Show Series, presented by Channelchek, scheduled for October 6, 2020.

    The virtual road show will feature a corporate presentation from PDS Biotech CEO, Frank Bedu-Addo, Ph.D., followed by a Q & A session proctored by Noble Biotechnology Analyst Ahu Demir, Ph.D., featuring questions submitted by the audience.

    The live broadcast of the virtual road show is scheduled for October 6, 2020, at 1…

    FLORHAM PARK, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced their participation in Noble Capital Markets' Virtual Road Show Series, presented by Channelchek, scheduled for October 6, 2020.

    The virtual road show will feature a corporate presentation from PDS Biotech CEO, Frank Bedu-Addo, Ph.D., followed by a Q & A session proctored by Noble Biotechnology Analyst Ahu Demir, Ph.D., featuring questions submitted by the audience.

    The live broadcast of the virtual road show is scheduled for October 6, 2020, at 1 PM EDT. Registration is free, but is limited to 100 participants. Register Here.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Noble Capital Markets

    Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 36 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email:

    About Channelchek

    Channelchek (.com) is a comprehensive investor-centric portal - featuring more than 6,000 emerging growth companies - that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email:

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    James Salierno

    The Ruth Group

    Phone: +1 (646) 536-7028

    Email:

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  26. FLORHAM PARK, N.J., Sept. 28, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that its Chief Medical Officer, Lauren V. Wood, M.D. will present key data from the company's previously reported Phase 1 trial of PDS0101 and planned Phase 2 clinical studies in patients with advanced HPV-associated malignancies at the World Vaccine Congress, being held virtually September 28 – October 1, 2020.

    Abstract: Versamune® Plus Multi-Epitopic HPV16 Peptides in the Treatment of HPV-Associated Cancers
    Session:

    FLORHAM PARK, N.J., Sept. 28, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that its Chief Medical Officer, Lauren V. Wood, M.D. will present key data from the company's previously reported Phase 1 trial of PDS0101 and planned Phase 2 clinical studies in patients with advanced HPV-associated malignancies at the World Vaccine Congress, being held virtually September 28 – October 1, 2020.

    Abstract: Versamune® Plus Multi-Epitopic HPV16 Peptides in the Treatment of HPV-Associated Cancers
    Session:Cancer & Immunotherapy, Viral Associated Cancers
    Date: Wednesday, September 30, 2020
    Time:2:05 p.m. ET

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them.

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations, and assumptions and include statements regarding the proposed public offering and anticipated closing. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions, whether the proposed offering is completed, the satisfaction of customary closing conditions related to the proposed offering and the other factors described in PDS Biotech's filings with the SEC. The information in this release is provided only as of the date of this release, and PDS Biotech undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    James Salierno

    The Ruth Group

    Phone: +1 (646) 536-7028 / +1 (973) 255-8361

    Email:

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  27. FLORHAM PARK, N.J., Sept. 08, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Frank Bedu-Addo, CEO of PDS Biotech, will present virtually at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 16th and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 23rd.

    FLORHAM PARK, N.J., Sept. 08, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Frank Bedu-Addo, CEO of PDS Biotech, will present virtually at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 16th and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 23rd.

    H.C. Wainwright & Co. 22nd Annual Global Investment Conference:

    Date:                     Wednesday, September 16th, 2020

    Location:               https://wsw.com/webcast/hcw7/pdsb/1599649

    Time:                     2:30 PM ET

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit:

    Date:                     Wednesday, September 23rd, 2020

    Location:               https://wsw.com/webcast/oppenheimer5/pdsb/2703033

    Time:                     4:10 PM ET

    A replay of the Oppenheimer presentation will be available on the Company's website for 90 days following the event. Investors attending the conferences virtually who are interested in meeting with Company management should contact their H.C. Wainwright & Co. and Oppenheimer representatives.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. 

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations, and assumptions and include statements regarding the proposed public offering and anticipated closing. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions, whether the proposed offering is completed, the satisfaction of customary closing conditions related to the proposed offering and the other factors described in PDS Biotech's filings with the SEC. The information in this release is provided only as of the date of this release, and PDS Biotech undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    James Salierno

    The Ruth Group

    Phone: +1 (646) 536-7028 / +1 (973) 255-8361

    Email:

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  28. FLORHAM PARK, N.J., Aug. 31, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its participation in Noble Capital Markets' C-Suite Interview Series, presented by Channelchek. 

    The interview was led by Noble Capital Markets Biotechnology Analyst Ahu Demir, Ph.D.  Joining Ahu was Frank Bedu-Addo, Ph.D., Chief Executive Officer of PDS Biotech.  Key topics discussed in this interview include:

    • Oncology and infectious disease portfolio overview
    • PDS0101 oncology candidate – status of three Phase 2 clinical trials and competitive outlook…

    FLORHAM PARK, N.J., Aug. 31, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its participation in Noble Capital Markets' C-Suite Interview Series, presented by Channelchek. 

    The interview was led by Noble Capital Markets Biotechnology Analyst Ahu Demir, Ph.D.  Joining Ahu was Frank Bedu-Addo, Ph.D., Chief Executive Officer of PDS Biotech.  Key topics discussed in this interview include:

    • Oncology and infectious disease portfolio overview
    • PDS0101 oncology candidate – status of three Phase 2 clinical trials and competitive outlook
    • Other oncology pipeline assets and indications - including products targeting prostate, breast, colorectal, and ovarian cancers
    • Growing infectious disease portfolio, including products targeting universal flu and COVID-19
    • Financial overview – current cash position, burn rate, and prioritization
    • Value-generating catalysts for the next 12 months

    The interview was recorded on August 21, and is available now on Channelchek. 

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them.  To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Noble Capital Markets

    Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 36 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email:

    About Channelchek

    Channelchek (.com) is a comprehensive investor-centric portal - featuring more than 6,000 emerging growth companies - that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email:

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    James Salierno

    The Ruth Group

    Phone: +1 (646) 536-7028

    Email:

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  29. FLORHAM PARK, N.J., Aug. 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotechnology" or the "Company"), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the closing of its previously announced underwritten public offering of 6,900,000 shares of common stock (inclusive of the 900,000 shares that were sold pursuant to the underwriter's full exercise of its option to purchase additional shares of common stock) at a public offering price of $2.75 per share. Certain insiders, including certain of the Company's officers, purchased shares of PDS Biotechnology common stock…

    FLORHAM PARK, N.J., Aug. 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotechnology" or the "Company"), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the closing of its previously announced underwritten public offering of 6,900,000 shares of common stock (inclusive of the 900,000 shares that were sold pursuant to the underwriter's full exercise of its option to purchase additional shares of common stock) at a public offering price of $2.75 per share. Certain insiders, including certain of the Company's officers, purchased shares of PDS Biotechnology common stock in the offering.

    The gross proceeds to PDS Biotechnology from this offering, before deducting underwriting discounts, commissions and other offering expenses were approximately $19.0 million.

    Oppenheimer & Co. Inc. acted as the sole book-running manager for the offering.

    The shares of common stock described above were offered by the Company pursuant to a registration statement on Form S-3 (File No. 333-240011) previously filed with the U.S. Securities and Exchange Commission ("SEC") on July 22, 2020 and declared effective on July 31, 2020, and the accompanying prospectus contained therein. The offering of the shares of common stock was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website, located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by telephone at (212) 667-8055, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About PDS Biotechnology

    PDS Biotechnology is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotechnology has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them.

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations, and assumptions and include statements regarding the proposed public offering and anticipated closing. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions, whether the proposed offering is completed, the satisfaction of customary closing conditions related to the proposed offering and the other factors described in PDS Biotech's filings with the SEC. The information in this release is provided only as of the date of this release, and PDS Biotechnology undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7037

    Email:

     

    Primary Logo

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  30. FLORHAM PARK, N.J., Aug. 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the second quarter ended June 30, 2020 and provided a business update.

    Second Quarter 2020 and Recent Business Highlights

    • Announced publication of PDS0101 triple combination preclinical study by the National Cancer Institute;
    • Initiated Phase 2 clinical trial of PDS0101 triple combination, led by the National Cancer Institute, for the treatment of advanced human papillomavirus (HPV)-associated cancers;
    • Announced Phase 2 trial…

    FLORHAM PARK, N.J., Aug. 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the second quarter ended June 30, 2020 and provided a business update.

    Second Quarter 2020 and Recent Business Highlights

    • Announced publication of PDS0101 triple combination preclinical study by the National Cancer Institute;
    • Initiated Phase 2 clinical trial of PDS0101 triple combination, led by the National Cancer Institute, for the treatment of advanced human papillomavirus (HPV)-associated cancers;
    • Announced Phase 2 trial to evaluate PDS0101 in combination with standard of care for treatment of locally advanced cervical cancer at The University of Texas MD Anderson Cancer Center;
    • Launched novel PDS Biotech-owned vaccine development programs for COVID-19, PDS0203, and universal influenza, PDS0202;
    • Broadened existing co-development agreement with Farmacore Biotechnology to include development of a second COVID-19 vaccine candidate, PDS0204;
    • Expanded existing Cooperative Research and Development Agreement with the National Cancer Institute to include preclinical and clinical development of PDS0103 in MUC-1 expressing- cancers including breast, colon, lung and ovarian cancers;
    • PDS Biotech collaborator at the University of Kentucky School of Medicine granted NIAID award to accelerate Versamune®-based PDS0202 universal influenza vaccine;
    • Published abstract on preclinical studies of PDS0102, a product for the treatment of breast and prostate cancers, at the American Society of Clinical Oncology; and
    • Appointed Dr. Ilian Iliev to Board of Directors.

    "PDS Biotech has made significant progress across both our immuno-oncology and infectious disease programs despite the challenging environment due to the global pandemic," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "We are pleased despite the pandemic to have recently initiated our first of three Phase 2 clinical studies of PDS0101.  This study is being run by the National Cancer Institute for the treatment of advanced HPV-associated cancers.  We anticipate initiation in the near term a second Phase 2 study for PDS0101 with standard of care chemoradiotherapy at the MD Anderson Cancer Center for the treatment of locally advanced cervical cancer. We believe these trials, partnered with leading organizations hold significant potential to demonstrate that our Versamune® platform, in combination with other anti-cancer agents, will provide improved clinical outcomes for patients with advanced HPV-associated cancers. We are evaluating the potential to initiate the VERSATILE-002 trial that was put on hold due to the COVID-19 epidemic by the end of the year if possible."

    "We have also been conducting preclinical studies of PDS0203, our COVID-19 vaccine program and recently announced an expanded development collaboration with Farmacore to advance PDS0204, a second COVID-19 vaccine candidate into Phase 1 clinical testing in Brazil, with initial financial support for preclinical work provided by the Brazilian Ministry of Science, Technology, Innovation and Communication (MCTIC). Furthermore, the grant by the NIAID to our long-term collaborator at The University of Kentucky School of Medicine to accelerate the Versamune®-based universal influenza vaccine program, PDS0202, further validates the potential value of Versamune® in infectious diseases. With these significant developments in both our cancer and infectious disease programs, we believe that PDS Biotech is well positioned to progress our programs through initial human clinical data generation over the next 12-18 months, barring any unforeseen events," concluded Dr. Bedu-Addo.

    Second Quarter 2020 Financial Review

    For the second quarter of 2020, net loss was approximately $2.9 million, or $.19 per basic share and diluted share, compared to a net loss of approximately $3.9 million, or $0.75 per basic share and diluted share for the second quarter of 2019.

    Research and development expenses totaled approximately $1.4 million for the second quarter of 2020, compared to approximately $1.9 million for the same period in 2019, a decrease of 26%.

    For the second quarter of 2020, general and administrative expenses were approximately $1.5 million compared with approximately $2.4 million for the second quarter of 2019, a decrease of 38%.

    Total operating expenses for the second quarter of 2020 were approximately $2.9 million, compared to total operating expenses of approximately $4.3 million for the same period in 2019, a decrease of 33%.

    As of June 30, 2020, the Company's cash balance was approximately $16.9 million.

    Conference Call and Webcast

    The conference call is scheduled to begin at 8:00 am ET on Thursday, August 13, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.

    After the live webcast, the event will be archived on PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13707451.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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. All such written or oral statements made in this press release, filings with the Securities and Exchange Commission, reports to stockholders and in meetings with investors and analysts, other than statements of historical fact, are forward-looking statements and are intended to be covered by the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. 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 or words that convey uncertainty of future events or outcomes. 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; our dependence on additional financing to fund our operations and complete the development and commercialization of our product candidates, and the risks that raising such additional capital may restrict our operations or require us to relinquish rights to our technologies or product candidates; our limited operating history in our current line of business, which makes it difficult to evaluate our prospects, our business plan or the likelihood of our successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7037

    Email:

    (Financial Statements to Follow)

    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Balance Sheets

     June 30, 2020 December 31, 2019
    ASSETS(unaudited)  
    Current assets:   
    Cash and cash equivalents$16,934,495  $12,161,739 
    Prepaid expenses and other 2,506,646   2,308,462 
    Total current assets 19,441,141   14,470,201 
          
    Property and equipment, net 13,247   21,051 
    Right-to-use asset 638,831    
          
    Total assets$20,093,219  $14,491,252 
          
    LIABILITIES AND STOCKHOLDERS' EQUITY     
    LIABILITIES     
    Current liabilities:     
    Accounts payable$1,092,527  $1,197,720 
    Accrued expenses 1,194,358   1,097,640 
    Restructuring reserve 126,862   498,185 
    Operating lease liability - short term 112,657    
    Total current liabilities 2,526,404   2,793,545 
          
    noncurrent liability:     
      Operating lease liability - long term 552,326    
    STOCKHOLDERS' EQUITY     
    Common stock, $0.00033 par value, 75,000,000 shares authorized at June 30, 2020 and December 31, 2019, 15,361,619 shares and 5,281,237 shares issued and outstanding at June 30, 2020 and  December 31, 2019, respectively 5,064   1,742 
    Additional paid-in capital 52,861,882   40,633,670 
    Accumulated deficit (35,852,457)  (28,937,705)
    Total stockholders' equity 17,014,489   11,697,707 
          
    Total liabilities and stockholders' equity$20,093,219  $14,491,252 



    PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

    Condensed Consolidated Statements of Operations and Comprehensive Loss

     (Unaudited)

     Three Months Ended June 30, Six Months Ended June 30,
     2020  2019  2020  2019 
    Operating expenses:       
    Research and development expenses$1,414,225  $1,886,934  $3,385,904  $2,916,937 
    General and administrative expenses 1,521,736   2,383,972   3,581,884   6,289,848 
                
    Total operating expenses 2,935,961   4,270,906   6,967,788   9,206,785 
                
    Loss from operations (2,935,961)  (4,270,906)  (6,967,788)  (9,206,785)
                
    Other income (expense):           
    Gain on bargain purchase upon merger    209,449      11,939,331 
    Interest income 6,617   175,605   53,036   198,907 
    Interest expense          (606)
                
    Net loss and comprehensive loss (2,929,344)  (3,885,852)  (6,914,752)  2,930,847 
     



    Per share information:
               
    Net loss per share, basic$(0.19) $(0.75) $(0.54) $0.66 
    Net loss per share, diluted$(0.19) $(0.75) $(0.54) $0.52 



    Weighted average common shares outstanding, basic$15,357,199 $5,175,837 $12,835,980 $4,466,025
    Weighted average common shares outstanding, diluted$15,357,199 $5,175,837 $12,835,980 $5,677,360

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  31. FLORHAM PARK, N.J., Aug. 11, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the pricing of its previously announced underwritten public offering consisting of 6,000,000 shares of common stock at a public offering price of $2.75 per share. The gross proceeds to PDS Biotech from this offering are expected to be $16,500,000, before deducting underwriting discounts, commissions and other offering expenses. In addition, PDS Biotech has granted the underwriter a 30-day option to purchase up to 900,000…

    FLORHAM PARK, N.J., Aug. 11, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the pricing of its previously announced underwritten public offering consisting of 6,000,000 shares of common stock at a public offering price of $2.75 per share. The gross proceeds to PDS Biotech from this offering are expected to be $16,500,000, before deducting underwriting discounts, commissions and other offering expenses. In addition, PDS Biotech has granted the underwriter a 30-day option to purchase up to 900,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on Thursday, August 13, 2020, subject to customary closing conditions.   

    PDS Biotech intends to use the proceeds from this offering to fund working capital and general corporate purposes.

    Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.

    This offering by PDS Biotech is being made pursuant to an effective registration statement on Form S-3 (File No. 333-240011) previously filed with the U.S. Securities and Exchange Commission ("SEC") on July 22, 2020 and declared effective on July 31, 2020, and the accompanying prospectus contained therein.  The offering of the shares of common stock will be made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.  A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC's website at http://www.sec.gov or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by telephone at (212) 667-8055, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. 

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations, and assumptions and include statements regarding the proposed public offering and anticipated closing. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions, whether the proposed offering is completed, the satisfaction of customary closing conditions related to the proposed offering and the other factors described in PDS Biotech's filings with the SEC. The information in this release is provided only as of the date of this release, and PDS Biotech undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:  

    Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7037

    Email:  

     

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  32. FLORHAM PARK, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All of the shares in the offering are to be sold by PDS Biotech. PDS Biotech intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares sold in the offering to cover over-allotments, if any.  The offering is subject to market and other conditions, and there can be no assurance as to…

    FLORHAM PARK, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All of the shares in the offering are to be sold by PDS Biotech. PDS Biotech intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares sold in the offering to cover over-allotments, if any.  The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. 

    PDS Biotech intends to use the proceeds from this offering to fund working capital and general corporate purposes.

    Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.

    This offering by PDS Biotech is being made pursuant to an effective registration statement on Form S-3 (File No. 333-240011) previously filed with the U.S. Securities and Exchange Commission ("SEC") on July 22, 2020 and declared effective on July 31, 2020, and the accompanying prospectus contained therein.  The offering of the shares of common stock will be made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.  A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC's website at http://www.sec.gov or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by telephone at (212) 667-8055, or by email at .

    Before investing in this offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that PDS Biotech has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about PDS Biotech and such offering.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. 

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations, and assumptions and include statements regarding the proposed public offering and anticipated closing. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions, whether the proposed offering is completed, the satisfaction of customary closing conditions related to the proposed offering and the other factors described in PDS Biotech's filings with the SEC. The information in this release is provided only as of the date of this release, and PDS Biotech undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotechnology

    Phone: +1 (908) 517-3613

    Email:

    Alexander Lobo

    The Ruth Group

    Phone: 1 (646) 536-7037

    Email:

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  33. FLORHAM PARK, N.J., July 30, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will report financial results for the second quarter ended June 30, 2020 on Thursday, August 13, 2020, before the market opens. Following the release, Dr. Frank Bedu-Addo, Chief Executive Officer, Michael King, Interim Chief Financial Officer, and Dr. Lauren Wood, Chief Medical Officer will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am…

    FLORHAM PARK, N.J., July 30, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will report financial results for the second quarter ended June 30, 2020 on Thursday, August 13, 2020, before the market opens. Following the release, Dr. Frank Bedu-Addo, Chief Executive Officer, Michael King, Interim Chief Financial Officer, and Dr. Lauren Wood, Chief Medical Officer will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am ET on Thursday, August 13, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.

    After the live webcast, the event will be archived on PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13707451.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7037

    Email:

    Primary Logo

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  34. FLORHAM PARK, N.J., July 27, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced preclinical data for its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS0203).  PDS0203 pairs the Versamune® platform with a recombinant protein recognized by the human immune system that is derived from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus that causes COVID-19.  The protein included in PDS0203 encompasses SARS-CoV-2 sections that induce an antibody response, as well as sections that are recognized by CD8 and CD4 T-cells…

    FLORHAM PARK, N.J., July 27, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced preclinical data for its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS0203).  PDS0203 pairs the Versamune® platform with a recombinant protein recognized by the human immune system that is derived from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus that causes COVID-19.  The protein included in PDS0203 encompasses SARS-CoV-2 sections that induce an antibody response, as well as sections that are recognized by CD8 and CD4 T-cells.  

    PDS Biotech has generated robust preclinical data confirming that PDS0203 elicits induction of highly active and potent virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment.  Importantly, the study also demonstrated induction of the long-lasting virus-specific memory T-cells necessary for longer term protection.  PDS0203 demonstrated a 30-45 fold increase in COVID-19 specific T-cells by Day 14 when compared to the vaccine without Versamune®.  These preclinical studies also confirmed induction of strong anti-SARS-CoV-2 neutralizing antibodies within 14 days, with a 20-25-fold increase when compared to the vaccine without Versamune®.  Lastly, these preclinical studies showed a further substantial increase in neutralizing antibody levels continuing more than 30 days after vaccination.  PDS Biotech plans to submit details of the preclinical studies to a peer reviewed scientific journal.

    "Recent COVID-19 research has highlighted the critical importance of developing vaccines capable of generating high levels of targeted CD8 and CD4 T-cells, in addition to neutralizing antibodies, to achieve durable protection against COVID-19 infection. Our preclinical data shows PDS0203's ability to rapidly induce both protective antibodies and long-lasting T-cells specific for COVID-19," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech, "Due to the mechanism by which Versamune® activates a disease-specific immune response, our PDS0101 program demonstrated successful translation of T-cell induction and safety data from preclinical models to humans.  We therefore believe that this encouraging PDS0203 preclinical data may similarly translate to humans.  If so, then it may present unique potential to provide the breadth and level of immune responses necessary for a safe and effective vaccine with long-term protection against COVID-19."

    As previously announced, the Company has also initiated preclinical development of Versamune®-CoV-2FC (PDS0204), a COVID-19 vaccine candidate being developed in partnership with Brazil-based Farmacore Biotechnology, which combines the immune-activating Versamune® platform with a Farmacore-developed SARS-CoV-2 recombinant fusion protein.

    About the Versamune® technology platform

    The Versamune® technology is based on proprietary immune activating lipids that uniquely activate an important immunological signaling pathway, called the Type 1 interferon signaling pathway, known to be important in the induction of both anti-viral and anti-tumor immune responses.  It also promotes efficient access of the disease-specific immunologically recognized protein (antigen) into two important immunological pathways called the Class I and II MHC pathways, therefore enabling powerful induction and activation if CD8 (Killer) and CD4 (helper) T-cells that can recognize, kill and protect against the specific disease.  The technology is protected by multiple international composition and application patents.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0203

    PDS0203 is a COVID-19 vaccine candidate that combines the utility of the Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein.  The World Health Organization (WHO) declared the COVID-19 outbreak caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health emergency in January of 2020. Within three months of initial discovery COVID-19 was declared a global pandemic, reflecting alarming levels of spread and severity and resulting in unprecedented action by local and national governments to restrict the movement of citizens to contain the spread.  Building immunity to the disease is the key to stopping its spread. A COVID-19 vaccine would train the immune system to recognize and destroy the virus without the vaccinated person getting sick.

    About PDS0204

    PDS0204 is a COVID-19 vaccine candidate that combines the utility of the Versamune® platform with a Farmacore-developed recombinant fusion protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).  The World Health Organization (WHO) declared the COVID-19 outbreak caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health emergency in January of 2020. Within three months of initial discovery COVID-19 was declared a global pandemic, reflecting alarming levels of spread and severity and resulting in unprecedented action by local and national governments to restrict the movement of citizens to contain the spread.  Building immunity to the disease is the key to stopping its spread. A COVID-19 vaccine would train the immune system to recognize and destroy the virus without the vaccinated person getting sick.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the preclinical results of the Company's PDS0203 and PDS0204 product candidates, which will be subject to more rigorous testing and which are not necessarily indicative of future clinical results; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and PDS0204, 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 acceptance by the market of the Company's product candidates, if approved, and  the overall performance and success of the Company's product candidates; the number or type of studies or nature of results necessary to support the filing of a new drug application for any of the Company's current product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7037

    Email:

     

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  35. FLORHAM PARK, N.J., July 14, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that PDS Biotech collaborator, Professor J. Woodward of the University of Kentucky School of Medicine, has been awarded a grant from the National Institute of Allergy and Infectious Diseases' (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) program to progress development of a Versamune®-based universal influenza vaccine.

    The key objective of the NIAID's CIVICs program is to develop more durable, broadly protective, and longer-lasting…

    FLORHAM PARK, N.J., July 14, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that PDS Biotech collaborator, Professor J. Woodward of the University of Kentucky School of Medicine, has been awarded a grant from the National Institute of Allergy and Infectious Diseases' (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) program to progress development of a Versamune®-based universal influenza vaccine.

    The key objective of the NIAID's CIVICs program is to develop more durable, broadly protective, and longer-lasting vaccines effective against multiple strains of influenza, specifically including pandemic strains. Under the award, PDS Biotech will continue development of its PDS0202 vaccine program, which combines Versamune® with novel influenza vaccine antigens, with a goal of rapidly progressing into a human clinical trial.   Preclinical development studies will be performed at three sites: PDS Biotech's Princeton, NJ laboratories, The University of Kentucky School of Medicine, and the CIVICs Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP).   

    "We are excited to accelerate PDS0202 development to further demonstrate Versamune®'s ability to induce the immune system to generate high levels of neutralizing antibodies, killer T-cells, and long acting memory T-cells, that for PDS0202 could provide broad and long-term protection against multiple influenza strains," commented Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "NIAID support for the upcoming PDS0202 preclinical studies could speed development of a more durable and broadly protective influenza vaccine, thus reducing the public health consequences of both seasonal and pandemic influenza."

    PDS Biotech's infectious disease portfolio consists of PDS0201 (tuberculosis), PDS0202 (universal flu) and PDS0203 (COVID-19), all of which are based on the Versamune® platform and are designed to induce a broad range of long-term protective immune responses against these pathogens.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0201

    PDS0201 is an investigational vaccine designed for the prevention of tuberculosis.  PDS0201 combines the utility of the Versamune® platform with bacillus Mycobacterium tuberculosis (M. tuberculosis) antigens. Tuberculosis (TB) is the leading cause of death from a single infectious agent and is caused by the bacillus M. tuberculosis, which is spread when people who are sick with TB expel bacteria into the air. About a quarter of the world's population is infected with M. tuberculosis and thus at risk of developing TB disease.  PDS0201 is currently in preclinical development.

    About PDS0202

    PDS0202 is an investigational vaccine designed for the prevention of a broad range of influenza strains. PDS0202 combines the utility of the Versamune® platform with a mix of influenza antigens including conserved regions of the virus.  Influenza is estimated to result in about 3 to 5 million cases of severe illness, and about 290,000 to 650,000 respiratory deaths globally. Some strains of influenza are known to have strong pandemic potential. PDS0202 is currently in preclinical development.

    About PDS0203

    PDS0203 is a COVID-19 vaccine candidate that combines the utility of the Versamune® platform with a mix of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigens.  The World Health Organization (WHO) declared the COVID-19 outbreak caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health emergency in January of 2020. Within three months of initial discovery COVID-19 was declared a global pandemic, reflecting alarming levels of spread and severity and resulting in unprecedented action by local and national governments to restrict the movement of citizens to contain the spread.  Building immunity to the disease is the key to stopping its spread. A COVID-19 vaccine would train the immune system to recognize and destroy the virus without the vaccinated person getting sick.  PDS0203 is currently in preclinical development.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Tram Bui / Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7035 / +1 (646) 536-7037

    Email: /

    Primary Logo

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  36. FLORHAM PARK, N.J., June 22, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the publication of data generated by the National Cancer Institute (NCI) based on preclinical studies of PDS Biotech's lead clinical program, PDS0101, in combination with two other investigational anti-cancer agents.  The article "Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine" by Rumfield et al. was published in the Journal for ImmunoTherapy of Cancer, and provides strong rationale for clinical evaluation of this three-component…

    FLORHAM PARK, N.J., June 22, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the publication of data generated by the National Cancer Institute (NCI) based on preclinical studies of PDS Biotech's lead clinical program, PDS0101, in combination with two other investigational anti-cancer agents.  The article "Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine" by Rumfield et al. was published in the Journal for ImmunoTherapy of Cancer, and provides strong rationale for clinical evaluation of this three-component treatment combination in a recently initiated NCI-led Phase 2 clinical trial. 

    The results of the NCI's preclinical study indicated that PDS0101 generated both human papillomavirus (HPV)-specific T-cells and an associated antitumor response when used as a monotherapy.  When PDS0101 was combined with two other development-stage anti-cancer agents, Bintrafusp alfa (M7824) and NHS-IL12, the data suggest the agents worked synergistically to provide enhanced tumor regression and T-cell response as compared to the agents alone.    

    Dr. Frank Bedu-Addo, PDS Biotech's Chief Executive Officer, commented, "The results of this preclinical study highlight the potential of PDS0101, Bintrafusp alfa (M7824) and NHS-IL12 when administered in combination, to improve treatment outcomes in patients with advanced HPV-associated cancers such as anal, cervical, head and neck and vulvar cancers.  We look forward to progressing development of this triple therapeutic combination in the upcoming Phase 2 study in patients with HPV-associated cancers."

    The studies detailed in the Journal for ImmunoTherapy of Cancer were conducted under an existing Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. The CRADA includes collaborative development work on both PDS0101 and a second development stage compound, PDS0103. 

    The full publication can be accessed here.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In separate partnership with the National Cancer Institute (NCI), and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Tram Bui / Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7035 / +1 (646) 536-7037

    Email: /

    Primary Logo

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  37. Brazilian government to provide initial funding support to progress development of Versamune®-based vaccine to prevent COVID-19 infection

    FLORHAM PARK, N.J., June 17, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced a co-development agreement with Farmacore Biotechnology for Versamune®-CoV-2FC, a Versamune®-based vaccine aimed at preventing COVID-19 infection.

    Under the collaboration, PDS Biotech and Farmacore will accelerate development of Versamune®-CoV-2FC into Phase 1 clinical testing in Brazil, with initial financial support…

    Brazilian government to provide initial funding support to progress development of Versamune®-based vaccine to prevent COVID-19 infection

    FLORHAM PARK, N.J., June 17, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced a co-development agreement with Farmacore Biotechnology for Versamune®-CoV-2FC, a Versamune®-based vaccine aimed at preventing COVID-19 infection.

    Under the collaboration, PDS Biotech and Farmacore will accelerate development of Versamune®-CoV-2FC into Phase 1 clinical testing in Brazil, with initial financial support provided by the Brazilian Ministry of Science, Technology, Innovation and Communication (MCTIC). Versamune®-CoV-2FC combines a Farmacore-developed recombinant SARS-CoV-2 protein with PDS Biotech's Versamune® platform nanotechnology. The rapid advancement of this joint COVID-19 program expands upon a previously announced research and development collaboration between PDS Biotech and Farmacore to develop a Versamune®-based vaccine for tuberculosis.

    "We are excited to expand our ongoing collaboration with Farmacore, which provides an opportunity to rapidly accelerate development of a novel COVID-19 vaccine into Phase 1 clinical testing in Brazil," said Dr. Frank Bedu-Addo, Chief Executive Officer, PDS Biotech. "We believe that pairing PDS Biotech's Versamune® T-cell activating vaccine technology with Farmacore's recombinant SARS-CoV-2 protein will allow us to quickly assess the efficacy of Versamune®-CoV-2FC to potentially reduce the continuing spread of COVID-19 infections."

    "This is a global pandemic, which requires a global effort. In joining forces with our partner PDS Biotech, we believe we can substantially accelerate our development efforts to bring an effective COVID-19 vaccine, inducing a broader range of long-term protective immune responses, to people around the world," said Helena Faccioli, Executive Director of Farmacore.

    The companies plan to utilize multiple research and development sites in the United States and Brazil to progress preclinical and clinical development of Versamune®-CoV-2FC. Under the terms of the agreement, Farmacore retains commercialization rights in Latin America, and revenues from Latin America sales will be shared between the two companies. PDS Biotech retains the right of first refusal for commercialization outside of Latin America. PDS Biotech is in discussions with other governmental and non-governmental agencies regarding additional funding for a COVID-19 vaccine.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Farmacore

    Farmacore is a biotechnology company, founded in 2005 as a startup, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.

    About Versamune®-CoV-2FC

    Versamune®-CoV-2FC (PDS0204) is a COVID-19 vaccine candidate that combines the immune-activating Versamune® platform with a Farmacore-developed recombinant fusion protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) recognizable by our immune system (antigen). The vaccine's target profile is to provide rapid induction of neutralizing antibodies, as well as killer T-cells and memory T-cells against the SARS-CoV-2 virus, in patients vaccinated with PDS0204 to protect against COVID-19 and to prevent spread of the infection.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead asset PDS0101; 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Tram Bui / Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7035 / +1 (646) 536-7037

    Email: /

    Primary Logo

    View Full Article Hide Full Article
  38. FLORHAM PARK, N.J., June 15, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the first patient has been dosed in the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 in the treatment of advanced human papillomavirus (HPV) associated cancers. This clinical trial involves a combination of PDS0101 with two clinical development-stage immune-modulating agents, Bintrafusp alfa (M7824) and NHS-IL12.

    The NCI Center for Cancer Research's Genitourinary Malignancies Branch (GMB) and Laboratory of Tumor Immunology…

    FLORHAM PARK, N.J., June 15, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the first patient has been dosed in the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 in the treatment of advanced human papillomavirus (HPV) associated cancers. This clinical trial involves a combination of PDS0101 with two clinical development-stage immune-modulating agents, Bintrafusp alfa (M7824) and NHS-IL12.

    The NCI Center for Cancer Research's Genitourinary Malignancies Branch (GMB) and Laboratory of Tumor Immunology and Biology (LTIB) are jointly leading this Phase 2 trial evaluating PDS0101, which combines the Versamune® platform with targeted antigens in HPV-expressing cancers, in combination with Bintrafusp alfa (M7824) and NHS-IL12.

    The trial will evaluate the objective response rate of this novel triple combination in approximately 35 patients with advanced HPV-associated cancers. The first eight patients will be evaluated for safety and objective response before the trial progresses to full enrollment.

    "We are excited to have the first patient dosed in this NCI-led Phase 2 clinical trial, which is an important next step in further demonstrating the power of our novel Versamune® platform to induce high levels of tumor-specific CD8 killer T-cells," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "We believe that PDS0101's demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced HPV-associated cancers."

    Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI are serving as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech's Chief Executive Officer and Chief Medical Officer respectively, will serve as PDS Biotech's investigators. The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI.

    Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the principal investigator of this phase 2 clinical trial of PDS0101 in advanced HPV-associated cancers.  For patients interested in enrolling in this clinical study, please call NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615), email , and/or visit the website:  https://trials.cancer.gov.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is also advancing a combination of PDS0101 and two clinical stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers. A third phase 2 study is to be performed in advanced localized cervical cancer combining PDS0101 with standard of care chemoradiotherapy.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph

    PDS Biotech

    Phone: +1 (908) 517-3613

    Email:

    Tram Bui / Alexander Lobo

    The Ruth Group

    Phone: +1 (646) 536-7035 / +1 (646) 536-7037

    Email: /

    Primary Logo

    View Full Article Hide Full Article
  39. FLORHAM PARK, N.J., June 04, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced a Phase 2 clinical trial to evaluate its lead immunotherapy product, PDS0101, in combination with standard of care chemoradiotherapy for treatment of locally advanced cervical cancer.

    The clinical trial will be conducted at The University of Texas MD Anderson Cancer Center and the Lyndon B. Johnson Hospital in Houston by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D. The clinical trial will investigate…

    FLORHAM PARK, N.J., June 04, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced a Phase 2 clinical trial to evaluate its lead immunotherapy product, PDS0101, in combination with standard of care chemoradiotherapy for treatment of locally advanced cervical cancer.

    The clinical trial will be conducted at The University of Texas MD Anderson Cancer Center and the Lyndon B. Johnson Hospital in Houston by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D. The clinical trial will investigate the safety and anti-tumor efficacy of the PDS0101-chemoradiation combination, and their correlation with critical biomarkers of an immune response in patients with locally advanced cervical cancer. 

    On September 19, 2019, PDS Biotech announced the results of a PDS0101 Phase 1 clinical study in cervical neoplasia (pre-cervical cancer) patients.  PDS0101 is being developed to treat multiple cancers associated with HPV infection, including anal, cervical and head and neck cancers.  In the Phase 1 study, PDS0101 demonstrated potent in vivo induction of active killer T-cells that target cancer cells containing the cancer-causing HPV proteins, as well as an excellent safety profile with no limiting toxicities.  Treatment with PDS0101 resulted in complete lesion regression in most of the patients. HPV infection is responsible for over 99% of cervical cancers.  PDS Biotech currently anticipates initiating this clinical study within a few months.

    "We are pleased to announce this Phase 2 clinical trial being performed to further validate our novel Versamune®-based immunotherapy platform and lead asset PDS0101," said Dr. Frank Bedu-Addo, CEO of PDS Biotech. "We look forward to investigating PDS0101 as a potentially safe and effective immunotherapeutic combination with standard of care chemoradiotherapy to improve the treatment options for women with locally advanced cervical cancer."

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them.  To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In separate partnerships with Merck and Co. and the National Cancer Institute (NCI), PDS Biotech is preparing to initiate two additional Phase 2 studies in head and neck cancer and in HPV-related advanced cancer respectively.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead asset PDS0101; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037  
    Email: /

    Primary Logo

    View Full Article Hide Full Article
  40. NEW YORK, NY / ACCESSWIRE / June 3, 2020 / The Virtual Summer Summit will take place on June 9th-12th, connecting 47 presenting small and microcap companies with distinguished investors from around the globe. A full list of issuers are listed below along with webcasting links to view presentations.

    Company

    Ticker

    Webcasting Link

    ACCO Brands Corporation

    ACCO

    Participating in meetings only

    Alimera Sciences, Inc.

    ALIM

    https://www.webcaster4.com/Webcast/Page/2038/35019

    Annovis Bio

    ANVS

    https://www.webcaster4.com/Webcast/Page/2038/35035

    AquaBounty Technologies, Inc.

    AQB

    https://www.webcaster4.com/Webcast/Page/2038/35133

    Arch Therapeutics, Inc.

    ARTH

    https://www.webcaster4.com/Webcast/Page/2038/35130

    Artelo Biosciences…

    NEW YORK, NY / ACCESSWIRE / June 3, 2020 / The Virtual Summer Summit will take place on June 9th-12th, connecting 47 presenting small and microcap companies with distinguished investors from around the globe. A full list of issuers are listed below along with webcasting links to view presentations.

    Company

    Ticker

    Webcasting Link

    ACCO Brands Corporation

    ACCO

    Participating in meetings only

    Alimera Sciences, Inc.

    ALIM

    https://www.webcaster4.com/Webcast/Page/2038/35019

    Annovis Bio

    ANVS

    https://www.webcaster4.com/Webcast/Page/2038/35035

    AquaBounty Technologies, Inc.

    AQB

    https://www.webcaster4.com/Webcast/Page/2038/35133

    Arch Therapeutics, Inc.

    ARTH

    https://www.webcaster4.com/Webcast/Page/2038/35130

    Artelo Biosciences, Inc.

    ARTL

    https://www.webcaster4.com/Webcast/Page/2038/35016

    Avalon Adv Materials

    AVLNF

    https://www.webcaster4.com/Webcast/Page/2038/35132

    Bellicum Pharmaceuticals

    BLCM

    https://www.webcaster4.com/Webcast/Page/2038/35045

    C-Bond Systems

    CBNT

    https://www.webcaster4.com/Webcast/Page/2038/35029

    Endra Life Sciences

    NDRA

    https://www.webcaster4.com/Webcast/Page/2038/35129

    Energy Focus, Inc.

    EFOI

    https://www.webcaster4.com/Webcast/Page/2038/35027

    Equillium

    EQ

    https://www.webcaster4.com/Webcast/Page/2038/35188

    Exro Technologies Inc.

    EXROF

    https://www.webcaster4.com/Webcast/Page/2038/35052

    GreenPower Motor Company

    GPV

    https://www.webcaster4.com/Webcast/Page/2038/35185

    Hecla Mining Company

    HL

    Participating in meetings only

    Heidrick & Struggles International, Inc.

    HSII

    https://www.webcaster4.com/Webcast/Page/2038/35053

    Helius Medical Technologies

    HSDT

    https://www.webcaster4.com/Webcast/Page/2038/35021

    Heritage Global Inc

    HGBL

    https://www.webcaster4.com/Webcast/Page/2038/35131

    Ideal Power

    IPWR

    https://www.webcaster4.com/Webcast/Page/2038/35031

    IMAC Holdings, Inc.

    IMAC

    https://www.webcaster4.com/Webcast/Page/2038/35146

    Lincoln Educational Services

    LINC

    https://www.webcaster4.com/Webcast/Page/2038/35028

    MailUp Group

    MAIL

    https://www.webcaster4.com/Webcast/Page/2038/35047

    Marrone Bio

    MBII

    https://www.webcaster4.com/Webcast/Page/2038/35033

    Medexus

    MDP.V

    https://www.webcaster4.com/Webcast/Page/2038/35128

    Medicenna Therapeutics

    TSX: MDNA

    https://www.webcaster4.com/Webcast/Page/2038/35034

    Milestone Scientific

    MLSS

    https://www.webcaster4.com/Webcast/Page/2038/35125

    My Size, Inc.

    MYSZ

    https://www.webcaster4.com/Webcast/Page/2038/35024

    Nephros

    NEPH

    https://www.webcaster4.com/Webcast/Page/2038/35014

    NewAge Beverage

    NBEV

    https://www.webcaster4.com/Webcast/Page/2038/35141

    Nova Leap Health Corp

    NLH

    https://www.webcaster4.com/Webcast/Page/2038/35042

    Oblong Inc.

    OBLG

    https://www.webcaster4.com/Webcast/Page/2038/35025

    OncoSec Medical Incorporated

    ONCS

    https://www.webcaster4.com/Webcast/Page/2038/35011

    Oragenics

    OGEN

    https://www.webcaster4.com/Webcast/Page/2038/35043

    PDS Biotechnology Corporation

    PDSB

    https://www.webcaster4.com/Webcast/Page/2038/35018

    Safeguard Scientifics, Inc.

    SFE

    https://www.webcaster4.com/Webcast/Page/2038/35143

    SELLAS Life Sciences Group, Inc.

    SLS

    Participating in meetings only

    ShiftPixy

    PIXY

    https://www.webcaster4.com/Webcast/Page/2038/35032

    Sigma Labs, Inc.

    SGLB

    https://www.webcaster4.com/Webcast/Page/2038/35153

    Sono-Tek Corporation

    SOTK

    https://www.webcaster4.com/Webcast/Page/2038/35022

    Timber

    Private

    https://www.webcaster4.com/Webcast/Page/2038/35017

    Tinybeans Group Limited

    TNY.AX

    https://www.webcaster4.com/Webcast/Page/2038/35046

    Tonix Pharmaceuticals Holding Corp.

    TNXP

    https://www.webcaster4.com/Webcast/Page/2038/35044

    TransGlobe Energy

    TGA

    https://www.webcaster4.com/Webcast/Page/2038/35051

    Trxade Group, Inc.

    MEDS

    https://www.webcaster4.com/Webcast/Page/2038/35123

    Ur-Energy Inc.

    URG

    https://www.webcaster4.com/Webcast/Page/2038/35030

    VIQ Solutions, Inc.

    VQS.V

    https://www.webcaster4.com/Webcast/Page/2038/35145

    Western Magnesium

    MLYF

    https://www.webcaster4.com/Webcast/Page/2038/35050

    About the Investor Summit

    The Investor Summit Group (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors. Having produced successful conferences over the past 5 years, the upcoming event will be the 2nd virtual edition added to our growing portfolio where hundreds of high-quality meetings between executives and investors will take place over 4 days. We pride ourselves on building community and providing a platform for our industry and look forward to launching new features at the upcoming Summer Summit such as virtual roundtable discussions and a stock pitch session to promote networking in a virtual format.

    To register for the upcoming Investor Summit, visit our website at www.investorsummitgroup.com

    Media Partner: Investor Brand Network, www.InvestorBrandNetwork.com

    News Compliments of ACCESSWIRE

    FOR MORE INFORMATION

    Please visit: www.investorsummitgroup.com
    Or, contact Cassandra Miller at

    SOURCE: The Investor Summit Group

    View source version on accesswire.com:
    https://www.accesswire.com/592484/47-Public-Companies-to-present-at-the-Summer-Virtual-Investor-Summit-on-June-9th-12th

    View Full Article Hide Full Article
  41. FLORHAM PARK, N.J., June 02, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Dr. Frank Bedu-Addo, President and Chief Executive Officer, is scheduled to present  at the 2020 Virtual Investor Summit being held on June 9-12, 2020.

    Details of the presentation are as follows:

    Presentation: PDS Biotechnology Corporate Presentation
    Date: Tuesday, June 9, 2020
    Time: 3:20pm ET
    Presenter: Dr. Frank Bedu-Addo
    Location: https://www.webcaster4.com/Webcast/Page/2038/35018

    PDS Biotech's management team will also be available for one-on-one…

    FLORHAM PARK, N.J., June 02, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that Dr. Frank Bedu-Addo, President and Chief Executive Officer, is scheduled to present  at the 2020 Virtual Investor Summit being held on June 9-12, 2020.

    Details of the presentation are as follows:

    Presentation: PDS Biotechnology Corporate Presentation
    Date: Tuesday, June 9, 2020
    Time: 3:20pm ET
    Presenter: Dr. Frank Bedu-Addo
    Location: https://www.webcaster4.com/Webcast/Page/2038/35018

    PDS Biotech's management team will also be available for one-on-one conference calls with investors who are registered to attend the event. Alternatively, interested investors may contact Tram Bui of The Ruth Group at to schedule a call.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

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  42. FLORHAM PARK, N.J., May 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the publication of its abstract on preclinical studies of PDS0102 at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program being held May 29-31, 2020. The abstract confirms the ability of the Versamune® platform to induce powerful killer T-cell responses across tumor types.

    Versamune® is a proprietary T-cell activating platform technology designed to train the immune system to detect and attack cancer cells. The published data demonstrate…

    FLORHAM PARK, N.J., May 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced the publication of its abstract on preclinical studies of PDS0102 at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program being held May 29-31, 2020. The abstract confirms the ability of the Versamune® platform to induce powerful killer T-cell responses across tumor types.

    Versamune® is a proprietary T-cell activating platform technology designed to train the immune system to detect and attack cancer cells. The published data demonstrate that Versamune®, when combined with the proprietary T-cell receptor gamma alternate reading frame protein (TARP), has the ability to activate a powerful killer T-cell response which specifically recognizes and attacks TARP-expressing cancer cells.  PDS0102 is being developed to treat prostate and breast cancers, the majority of which express the TARP protein. The results of this study mirror the anti-HPV responses observed with the company's lead program, PDS0101 which is entering Phase 2 for HPV-associated cancers.

    "These data being presented at ASCO are significant for our oncology portfolio and highlight the versatility of our Versamune® platform in immuno-oncology," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "Our ongoing studies continue to demonstrate the ability of our Versamune® platform to induce higher levels of potent, cancer-attacking T-cells in vivo compared to other immunotherapy technologies."

    Abstract e15211: "R-DOTAP (Versamune®): A Novel Enantiospecific Cationic Lipid Nanoparticle That Induces CD4 and CD8 Cellular Immune Responses to Whole Protein and Tumor-Specific Peptide Antigens" is available on the ASCO meeting website at abstracts.asco.org.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific proteins for in vivo uptake and processing by the immune system, while also activating the critical type 1 interferon immunological pathway.  This results in the production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the Versamune® platform with tumor-associated HPV-proteins in order to induce a powerful T-cell attack against HPV-containing cancer cells.  PDS0101 is being developed to treat HPV-associated cancers such as head and neck, anal and cervical cancers.  In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer in which Keytruda has been approved as the standard of care.  In partnership with the National Cancer Institute (NCI), PDS Biotech is advancing a combination of PDS0101 with the promising clinical stage immunotherapies M7824 and NHS-IL12 into a Phase 2 clinical study in advanced HPV-associated cancers.  A third phase 2 study in advanced localized cervical cancer combines PDS0101 with standard of care chemoradiotherapy.

    About PDS0102

    PDS0102 combines the utility of the Versamune® platform with the proprietary T-cell receptor gamma alternate reading frame protein (TARP), a tumor antigen identified by the National Cancer Institute (NCI) which is strongly associated with prostate and breast cancers. Approximately 450,000 patients are projected to be diagnosed with prostate or breast cancer this year, most of which are associated with TARP.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

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  43. FLORHAM PARK, N.J., May 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the first quarter ended March 31, 2020 and provided a business update.

    First Quarter 2020 and Recent Business Highlights

    • Initiated novel vaccine development programs for COVID-19 and universal influenza;
    • Announced pre-clinical collaboration with Farmacore Biotechnology for tuberculosis;
    • Delayed initiation of Phase 2 VERSATILE-002 trial for PDS0101 in recurrent/metastatic head and neck cancer due to the global COVID-19 pandemic…

    FLORHAM PARK, N.J., May 13, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced its financial results for the first quarter ended March 31, 2020 and provided a business update.

    First Quarter 2020 and Recent Business Highlights

    • Initiated novel vaccine development programs for COVID-19 and universal influenza;
    • Announced pre-clinical collaboration with Farmacore Biotechnology for tuberculosis;
    • Delayed initiation of Phase 2 VERSATILE-002 trial for PDS0101 in recurrent/metastatic head and neck cancer due to the global COVID-19 pandemic;
    • Secured the U.S. composition of matter patent for the Versamune® platform;
    • Expanded the previously disclosed Cooperative Research and Development Agreement with the National Cancer Institute to include preclinical and clinical development of PDS0103;
    • Appointed Kamil Ali-Jackson, Esq. and Dr. Ilian Iliev to the Board of Directors; and
    • Successfully completed an underwritten public offering of our common stock in February 2020 with net proceeds of approximately $11.9 million after deducting underwriting discounts and commissions, not including other offering expenses.

    "We have continued to leverage the versatility and potency of our Versamune® platform, as we expand our development program to include vaccines to protect against infectious diseases such as COVID-19 and influenza. We believe that Versamune's® ability to induce a superior range of protective immune responses - including neutralizing antibodies, killer T-cells and memory T-cells - uniquely positions PDS to develop more effective vaccines to provide long-term protection against the spread of  agents with pandemic potential. We have recently initiated pre-clinical testing for our COVID-19 vaccine candidates and are in active discussions with both government agencies and NGOs to determine the most expeditious path forward," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech.

    "We remain committed to our immuno-oncology programs, including two upcoming Phase 2 studies for PDS0101 with our partners at the National Cancer Institute. We also look forward to initiating our third Phase 2 program evaluating the combination of PDS0101 and Merck's KEYTRUDA® in HPV16-associated head and neck cancer for first line treatment of recurrent/metastatic disease when conditions to conduct the study improve," Dr. Bedu-Addo concluded.

    First Quarter 2020 Financial Review

    For the first quarter of 2020, net loss was approximately $4.0 million, or $0.39 per basic share and $0.39 per diluted share, compared to a net income of approximately $6.8 million, or $1.82 per basic share and $1.47 per diluted share for the first quarter of 2019 related to the reverse merger transaction with Edge Therapeutics.

    Research and development expenses totaled approximately $1.9 million for the first quarter of 2020, compared to approximately $1.0 million for the same period in 2019, an increase of 91%.

    For the first quarter of 2020, general and administrative expenses were approximately $2.1 million compared with approximately $3.9 million for the first quarter of 2019, a decrease of 47%.

    Total operating expenses for the first quarter of 2020 were approximately $4.0 million, compared to total operating expenses of approximately $4.9 million for the same period in 2019, a decrease of 18%.

    As of March 31, 2020, the Company's cash balance was approximately $21.0 million. This amount includes the approximately $11.9 million in net proceeds after deducting underwriting discounts and commissions, not including other offering expenses from PDS Biotech's underwritten public offering including the exercise of the underwriters' overallotment option, which closed on February 14, 2020.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /


    (Financial Statements to Follow)


    PDS BIOTECHNOLOGY CORPORATION

    Consolidated Balance Sheets

    Balance Sheets      
      March 31, 2020 December 31, 2019  
    ASSETS      
    Current assets:      
    Cash and cash equivalents 21,037,806   12,161,739    
    Prepaid expenses and other current assets 2,879,378   2,308,462    
    Total current assets 23,917,184   14,470,201    
           
    Property and equipment, net 17,149   21,051    
           
    Total assets 23,934,333   14,491,252    
           
    LIABILITIES AND STOCKHOLDERS'  EQUITY      
    LIABILITIES      
    Current liabilities:      
    Accounts payable 2,556,703   1,197,720    
    Accrued expenses 1,220,191   1,097,640    
    Restructuring reserve 269,887   498,185    
    Total current liabilities 4,046,781   2,793,545    
           
    Total liabilities: 4,046,781   2,793,545    
           
    STOCKHOLDERS'  EQUITY      
    Common stock, $0.00033 par value, 75,000,000 shares authorized at March 31, 2020 and December 31, 2019, 15,350,445 shares and 5,281,237 shares issued and outstanding at March 31, 2020 and  December 31, 2019, respectively 5,064   1,742    
    Additional paid-in capital 52,805,601   40,633,670    
    Accumulated deficit (32,923,113 ) (28,937,705 )  
    Total stockholders' equity 19,887,552   11,697,707    
           
    Total liabilities and stockholders' equity 23,934,333   14,491,252    
           


    PDS BIOTECHNOLOGY CORPORATION

    Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

           
      Three Months Ended Three Months Ended  
      March 31, 2020 March 31, 2019  
    Operating expenses:      
    Research and development expenses 1,971,679   1,030,003    
    General and administrative expenses 2,060,148   3,905,877    
           
    Total operating expenses 4,031,827   4,935,880    
           
    Loss from operations (4,031,827 ) (4,935,880 )  
           
    Other income (expense):      
    Gain on bargain purchase -   11,729,882    
    Interest income 46,419   23,302    
    Interest expense -   (606 )  
           
    Net (loss) and comprehensive gain (3,985,408 ) 6,816,698    
           
    Per share information:      
    Net income (loss) per share, basic and diluted (0.39 ) 1.82    
    Net income (loss) per share, diluted (0.39 ) 1.47    
           
    Weighted average common shares outstanding, basic and diluted 10,314,761   3,748,325    
    Weighted average common shares outstanding, diluted 10,314,761   4,625,295    
           

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  44. FLORHAM PARK, N.J., May 04, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will release financial results for the first quarter ended March 31, 2020 on Wednesday, May 13, 2020, before the market opens. Following the release, Dr. Frank Bedu-Addo, Chief Executive Officer, will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am ET on Wednesday, May 13, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927…

    FLORHAM PARK, N.J., May 04, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that the Company will release financial results for the first quarter ended March 31, 2020 on Wednesday, May 13, 2020, before the market opens. Following the release, Dr. Frank Bedu-Addo, Chief Executive Officer, will host a conference call to review the financial results and provide a business update.

    The conference call is scheduled to begin at 8:00 am ET on Wednesday, May 13, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.

    After the live webcast, the event will be archived on PDS Biotech's website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13703263.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /


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  45. PRINCETON, N.J., April 29, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced an expansion of its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to include studies of PDS0103, a Versamune®-based product incorporating novel mucin-1 (MUC1) epitopes developed by the NCI. This expansion adds to the NCI's ongoing evaluation of PDS0101 in combination with two separate immune-modulating agents, NHS-IL12 and M7824, which will be evaluated in a phase 2 clinical trial…

    PRINCETON, N.J., April 29, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced an expansion of its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to include studies of PDS0103, a Versamune®-based product incorporating novel mucin-1 (MUC1) epitopes developed by the NCI. This expansion adds to the NCI's ongoing evaluation of PDS0101 in combination with two separate immune-modulating agents, NHS-IL12 and M7824, which will be evaluated in a phase 2 clinical trial in advanced HPV-associated cancers (NCT04287868).

    Under the expanded CRADA, PDS Biotech will collaborate with the NCI Center for Cancer Research's Genitourinary Malignancies Branch (GMB) and the Laboratory of Tumor Immunology and Biology (LTIB) to conduct preclinical studies of PDS0103, and potentially human clinical studies in combination with other therapeutic agents. PDS0103 combines Versamune® with novel highly immunogenic agonist epitopes of the mucin-1 (MUC1) oncogenic C-terminal region, designed and developed by the LTIB. PDS0103 is targeting ovarian, breast, colorectal and lung cancers where over-expression of MUC1 is associated with a high degree of unmet need.

    "We are excited to further our collaboration with Dr. Schlom, Dr. Gulley, and their teams at the NCI to progress the development of PDS0103 and expand the CRADA beyond the previously announced collaboration involving PDS0101. PDS0103 monotherapy has demonstrated encouraging results in ongoing preclinical studies," commented Dr. Bedu-Addo, Chief Executive Officer of PDS Biotechnology. "Based on the strong T-cell activation potential of the Versamune®-based products, we believe that PDS0101 and PDS0103 present an opportunity to improve immunotherapeutic treatment outcomes across multiple cancer indications. We look forward to working with the NCI as we jointly advance the development of PDS0101 and PDS0103."

    Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI will serve as principal investigators for the NCI for both the PDS0101 and PDS0103 programs, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech's Chief Medical Officer, will serve as the Company's investigators. 

    Dr. Julius Strauss, Staff Clinician, LTIB, will serve as the principal investigator of the phase 2 clinical trial of PDS0101 in advanced HPV-associated cancers.  For patients interested in enrolling in this clinical study, please call NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615), email , and/or visit the website:  https://trials.cancer.gov.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer.  In partnership with the National Cancer Institute (NCI), PDS Biotech is advancing a combination of PDS0101, M7824 and NHS-IL12 to a Phase 2 study in advanced HPV-associated cancers.  A third phase 2 study in advanced localized cervical cancer combines PDS0101 with standard of care chemoradiotherapy.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead asset, PDS0101; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

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  46. Expanded infectious disease program to address current and potential pandemics builds on existing tuberculosis collaboration

    Initiation of Phase 2 VERSATILE-002 trial for PDS0101 in advanced/metastatic head and neck cancer delayed due to global COVID-19 pandemic

    PRINCETON, N.J., April 16, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced an expanded infectious disease pandemic development program, including novel vaccines for COVID-19 and universal influenza, in addition to its previously announced tuberculosis development collaboration…

    Expanded infectious disease program to address current and potential pandemics builds on existing tuberculosis collaboration

    Initiation of Phase 2 VERSATILE-002 trial for PDS0101 in advanced/metastatic head and neck cancer delayed due to global COVID-19 pandemic

    PRINCETON, N.J., April 16, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced an expanded infectious disease pandemic development program, including novel vaccines for COVID-19 and universal influenza, in addition to its previously announced tuberculosis development collaboration with Farmacore Biotechnology. The Company also announced that initiation of its multi-center Phase 2 VERSATILE-002 trial for PDS0101 in advanced/metastatic head and neck cancer has been delayed due to the severe adverse impact on clinical trial operations from the COVID-19 pandemic.

    PDS Biotech's products combine its novel Versamune® technology with custom-designed, disease-specific proteins to induce both neutralizing antibody and killer (CD8+) T-cell responses, which when co-induced are more powerful in fighting disease than either alone.  This proven Versamune® mechanism, combined with a favorable safety profile, provides a strong rationale to expand the development of Versamune®-based products beyond its initial series of cancer immunotherapies to add potentially transformative vaccines to protect and fight against infectious agents, including COVID-19, influenza, and tuberculosis.

    In the Company's previously reported Phase I clinical study of PDS0101 (NCT02065973), Versamune® was confirmed to be safe and to uniquely facilitate the induction of strong antigen-specific CD8+ and CD4+ T-cells in vivo, including memory T-cell responses against the HPV viral target, leading to regression of disease.

    "The potency and versatility of the proprietary Versamune® T-cell activating platform makes it possible for PDS Biotech to immediately start development of novel vaccines to protect against infectious disease agents with pandemic potential, starting with COVID-19 and influenza," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Preventive vaccines to date have focused on induction of neutralizing antibodies. However, both neutralizing antibodies and killer (CD8+) T-cells have now been confirmed to be important in addressing pathogen-induced diseases such as COVID-19, influenza and tuberculosis. We believe that there is a clear opportunity to leverage our Versamune® platform to develop more effective vaccines that have the potential to safely generate a broader range of immune responses, including antibodies, killer T-cells, and memory T-cells, to prevent and to provide long-term protection against the spread of pandemic agents."

    "While we are adding these new programs, we remain committed to our immuno-oncology programs, including two upcoming single-site Phase 2 studies – one with the NCI to evaluate PDS0101 in combination with two promising immuno-modulating agents in advanced HPV-associated cancers, and another to evaluate the combination of PDS0101 and chemoradiation in patients with locally advanced cervical cancer.  We will continue to closely monitor the impact of COVID-19 on these trials and on oncology clinical trial operations in the US, and will seek to initiate our Phase 2 head and neck cancer trial in the near future if possible," Dr. Bedu-Addo concluded.

    Dr. Lauren Wood, Chief Medical Officer of PDS Biotech added, "Versamune® has demonstrated a superior ability to present viral antigens to our immune system, while simultaneously activating critical immunological pathways that enable the immune system to more effectively respond to and protect against disease. The engineered simplicity, ease of administration, and scalability of Versamune® also enhances the potential of Versamune®-based products to better mitigate the devastating impact of emerging pathogens such as coronaviruses on human health. As we seek to advance our expanded infectious disease development effort, we look forward to discussions with relevant government and non-governmental organizations to determine the most expeditious path forward into human testing."

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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; potential adverse reactions or changes to business relationships resulting from the resignation of the Company's Chief Financial Officer or the Company's ability to find a replacement Chief Financial Officerthe 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

     

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  47. PRINCETON, N.J., April 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotechnology") (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on T-cell activating technology called Versamune® today announced that it has appointed Ilian Iliev, Ph.D. to its Board of Directors.

    "We are very pleased to welcome Dr. Iliev to the Board of Directors. He brings a wealth of experience to PDS Biotech as a recognized entrepreneur and venture capitalist across multiple industries, including healthcare," commented Steve Glover, Chairman of the Board of PDS Biotech. "Together, we will help guide PDS Biotech through its near and long-term milestones as we advance our programs in infectious disease and…

    PRINCETON, N.J., April 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotechnology") (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on T-cell activating technology called Versamune® today announced that it has appointed Ilian Iliev, Ph.D. to its Board of Directors.

    "We are very pleased to welcome Dr. Iliev to the Board of Directors. He brings a wealth of experience to PDS Biotech as a recognized entrepreneur and venture capitalist across multiple industries, including healthcare," commented Steve Glover, Chairman of the Board of PDS Biotech. "Together, we will help guide PDS Biotech through its near and long-term milestones as we advance our programs in infectious disease and immuno-oncology with leading research institutions and pharmaceutical companies."

    Currently, Dr. Iliev is a Managing Director of EMV Capital, a London-based investor in B2B companies in the healthcare, transportation, energy and technology sectors. Previously he founded CambridgeIP, a boutique consultancy focused on IP commercialization based out of Cambridge, UK and working with clients in healthcare, energy and other sectors. Dr. Iliev is a Board Member of NetScientific PLC, a transatlantic healthcare IP commercialization group that funds and develops companies that are working to significantly improve the health and well-being of people with chronic diseases. He also serves on the Board of Directors of Sofant Technologies, Pointgrab, Q-Bot, Glycotest, Vortex Biosciences and Wanda Health.

    Dr. Iliev holds a Ph.D. from Cambridge University's Judge Business School, focused on Venture Capital business models in emerging economies. He also received a Master of Commerce in Economics, and Bachelor of Arts in Politics, Economics and International Relations from the University of Witwatersrand. He has published widely on entrepreneurship, venture capital, and market trends in healthcare and energy and is an Associate Fellow at the Royal Institute of International Affairs

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of infectious disease vaccines and cancer immunotherapy based on the Company's proprietary Versamune® T-cell activating technology platform. The Versamune® platform effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of both neutralizing antibodies and potent disease-specific killer T-cells. Using Versamune®, PDS Biotech is engineering therapies designed to better recognize disease cells to effectively attack and destroy them. PDS Biotech's pipeline combines the Versamune® technology with disease-specific antigens across several therapeutic areas. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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; potential adverse reactions or changes to business relationships resulting from the resignation of the Company's Chief Financial Officer or the Company's ability to find a replacement Chief Financial Officer 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

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  48. PRINCETON, N.J., March 27, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotechnology") (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on T-cell activating technology called Versamune® today announced its financial results for the full year ended December 31, 2019 and provided a business update.

    Fourth Quarter 2019 and Recent Business Highlights

    • Reported promising Phase 1 clinical outcome data of PDS0101 in patients with cervical intraepithelial neoplasia (CIN) infected with multiple high-risk, cancer-causing types of human papillomavirus (HPV). Study demonstrated robust treatment-induced HPV16-specific killer T-cell (CD8+) responses as well as clearance of the disease and regression…

    PRINCETON, N.J., March 27, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ("PDS Biotechnology") (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on T-cell activating technology called Versamune® today announced its financial results for the full year ended December 31, 2019 and provided a business update.

    Fourth Quarter 2019 and Recent Business Highlights

    • Reported promising Phase 1 clinical outcome data of PDS0101 in patients with cervical intraepithelial neoplasia (CIN) infected with multiple high-risk, cancer-causing types of human papillomavirus (HPV). Study demonstrated robust treatment-induced HPV16-specific killer T-cell (CD8+) responses as well as clearance of the disease and regression of lesions in the majority of evaluable patients;
    • Announced clinical collaboration with Merck to evaluate PDS0101 in combination with KEYTRUDA® (pembrolizumab) in first line treatment of metastatic head and neck cancer;
    • Selected Dr. Jared Weiss as Principal Investigator for Phase 2 Clinical Collaboration with Merck and formed an Independent Data Monitoring Committee;
    • Completed manufacturing of clinical batches of HPV mix component of PDS0101 for upcoming Phase 2 combination trials with Merck and National Cancer Institute;
    • Announced pre-clinical collaboration with Farmacore Biotechnology for tuberculosis;
    • Granted U.S. and European Patents for Versamune® - GM-CSF Combination to Overcome Tumor Immune Suppression and US composition of matter patent for Versamune;
    • Appointed Kamil Ali-Jackson, Esq. to the Board of Directors; and
    • Successfully completed an underwritten public offering of its common stock with net proceeds of approximately $11.9 million after deducting underwriting discounts and commissions, not including other offering expenses in February 2020.

    "We have made significant progress over the last year as we transitioned to a public company, strengthened our partnerships with leaders in immuno-oncology, such as Merck and National Cancer Institute and reported encouraging human data from our lead program, PDS0101," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotechnology. "As we forge ahead in 2020, we look forward to leveraging the highly encouraging Phase I human clinical outcome data, which demonstrated complete lesion regression in 60% of evaluable patients with cervical intraepithelial neoplasia (CIN) and human papillomavirus (HPV) within 1-3 months of treatment. These results support our combination approach in our upcoming clinical trials and provide evidence that PDS0101 could be essential in expanding the clinical efficacy of checkpoint inhibitors and improving clinical outcomes for patients."

    "With a strengthened balance sheet, we look forward to initiating three studies, including; a Phase 2 combination study to evaluate PDS0101 in combination with KEYTRUDA® in the first line treatment of metastatic head and neck cancer, a Phase 2 study to evaluate PDS0101 in combination with two promising immune-modulating agents in advanced HPV-associated cancers with the NCI and a Phase 2a study to evaluate the combination of PDS0101 and chemoradiation in patients with locally advanced cervical cancer. We remain committed to developing our novel Versamune platform in collaboration with our partners and would like to thank our shareholders for their continued support," concluded Dr. Bedu-Addo.

    Full Year 2019 Financial Review

    For the year ended December 31, 2019, the net loss was approximately $6.9 million, or $1.44 per basic and diluted share. This compares to a net loss of approximately $3.8 million, or $1.15 per basic and diluted share for the year ended December 31, 2018.

    For the year ended December 31, 2019, research and development expenses increased approximately 634% to approximately $6.1 million compared to approximately $0.8 million in the prior year. The increase is primarily attributable to an increase in external expenses for clinical studies, internal R&D personnel costs, non-cash stock-based compensation and departmental costs.

    For the year ended December 31, 2019, general and administrative expenses increased approximately 294% to approximately $11.0 million compared to approximately $2.8 million in the prior year.  The increase was due to increases in personnel costs, non-cash stock-based compensation, facilities costs, D&O insurance costs, legal fees, professional fees and other operating expenses.

    For the year ended December 31, 2019, total operating expenses increased approximately 477% to approximately $21.0 million compared to approximately $3.6 million in the prior year.

    As of December 31, 2019, the Company's cash balance was approximately $12.2 million. This amount does not include the approximately $11.9 million in net proceeds after deducting underwriting discounts and commissions, not including other offering expenses from PDS Biotech's underwritten public offering including the full exercise of the underwriters' overallotment option, which closed in February.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology platform. The Versamune® platform effectively delivers tumor-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune®, PDS Biotech is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotech's pipeline combines the Versamune® technology with tumor-specific antigens across several cancer types. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is also advancing a combination of PDS0101 and two clinical stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers. A third phase 2 study is to be performed in advanced localized cervical cancer combining PDS0101 with the chemoradiotherapy, which is the standard of care.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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; potential adverse reactions or changes to business relationships resulting from the resignation of the Company's Chief Financial Officer or the Company's ability to find a replacement Chief Financial Officer; 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

    (Financial Statements to Follow) 

    PDS BIOTECHNOLOGY CORPORATION and Subsidiaries

    Consolidated Balance Sheets

      December 31,
    2019
      December 31,
     2018
    ASSETS      
    Current assets:      
    Cash and cash equivalents $  12,161,739     $  103,695  
    Prepaid expenses and other    2,308,462        18,428  
    Total current assets    14,470,201        122,123  
               
    Property and equipment, net    21,051        29,508  
    Other assets    –        12,800  
               
    Total assets $  14,491,252     $  164,431  
               
    LIABILITIES AND STOCKHOLDERS' EQUITY          
    LIABILITIES          
    Current liabilities:          
    Accounts payable $  1,197,720     $  1,307,529  
    Accrued expenses    1,097,640        601,889  
    Restructuring reserve    498,185        –  
    Total current liabilities    2,793,545        1,909,418  
               
    Noncurrent liability:          
     Warranty liability    –        291,225  
     Convertible promissory notes payable    –        30,000  
    Total liabilities    2,793,545        2,230,643  
               
    STOCKHOLDERS' EQUITY          
    Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31,  2019 and December 31,  2018, 5,281,237 shares and  3,417,187 shares issued and outstanding at December 31,  2019  and December 31,  2018, respectively    1,742        1,128  
    Additional paid-in capital    40,633,670        19,871,759  
    Accumulated deficit    (28,937,705  )      (21,939,099  )
    Total stockholders' equity (deficit)    11,697,707        (2,066,212  )
               
    Total liabilities and stockholders' equity (deficit) $  14,491,252     $  164,431  
                   

    PDS BIOTECHNOLOGY CORPORATION and Subsidiaries

    Consolidated Statements of Operations and Comprehensive Loss

      Year Ended December 31,
       2019    2018 
    Operating expenses:      
    Research and development expenses $  6,099,580     $  830,744  
    General and administrative expenses    10,981,765        2,788,016  
    Impairment expense-IPRD    2,974,000        –  
    Lease termination costs    979,273        –  
    Depreciation and amortization    –        27,426  
               
    Total operating expenses    21,034,618        3,646,186  
               
    Loss from operations    (21,034,618  )      (3,646,186  )
               
    Other income (expense):          
    Gain on bargain purchase upon merger    13,334,568        –  
    Interest income    353,490        –  
    Interest expense    (33,559  )      (3,595  )
    Other    –        (900  )
    Loss on extinguishment of debt    –        (185,800  )
               
    Loss before income taxes    (7,380,119      (3,836,481  )
      Income taxes (benefit)    (381,513  )      –  
    Net loss and comprehensive loss $  (6,998,606  )   $  (3,836,481  )
               
    Net loss per share, basic and diluted $  1.44     $  1.15  
               
    Weighted average common shares outstanding basic and diluted    4,868,079        3,337,351  
                   

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  49. PRINCETON, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced that Andrew Saik has resigned as the Company's Chief Financial Officer (CFO) and a director of the board to pursue other professional opportunities, effective immediately.  Mr. Saik joined PDS Biotech following the merger with Edge Therapeutics in March 2019, where he was the CFO. The board of directors has initiated a search to identify a successor.

    The Company's board of directors has appointed Frank Bedu-Addo, Ph.D., the Company's President and Chief Executive Officer, as interim Principal…

    PRINCETON, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced that Andrew Saik has resigned as the Company's Chief Financial Officer (CFO) and a director of the board to pursue other professional opportunities, effective immediately.  Mr. Saik joined PDS Biotech following the merger with Edge Therapeutics in March 2019, where he was the CFO. The board of directors has initiated a search to identify a successor.

    The Company's board of directors has appointed Frank Bedu-Addo, Ph.D., the Company's President and Chief Executive Officer, as interim Principal Financial Officer and Janetta Trochimiuk, PDS Biotech's Controller as interim Principal Accounting Officer until a permanent replacement has been named.  Ms. Trochimiuk is a seasoned finance professional with over 20 years of experience, serving as Controller and CFO of private and publicly listed companies. Ms. Trochimiuk holds a Bachelor of Business Administration from Bernard M. Baruch College and is a licensed CPA.

    "On behalf of our board of directors, we would like to thank Andrew for his service and contributions as we transitioned to a public company and successfully bolstered our balance sheet with the recent capital raise based on our promising Versamune platform technology. We wish him continued success in his future endeavors and look forward to announcing a permanent successor in the near term," said Dr. Frank Bedu-Addo, CEO of PDS Biotech.

    About PDS Biotechnology
    PDS Biotech is a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology platform.  The Versamune® platform effectively delivers tumor-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells.  Using Versamune®, PDS Biotech is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors.  PDS Biotech's pipeline combines the Versamune® technology with tumor-specific antigens across several cancer types.  To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer.  In partnership with the National Cancer Institute (NCI), PDS Biotech is also advancing a combination of PDS0101 and two clinical stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers.  A third phase 2 study is to be performed in advanced localized cervical cancer combining PDS0101 with the chemoradiotherapy, which is the standard of care.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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; potential adverse reactions or changes to business relationships resulting from the  resignation of the Company's Chief Financial Officer or the Company's ability to find a replacement Chief Financial Officerthe 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

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  50. PRINCETON, N.J., March 05, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced that it has been granted U.S. Patent No. 15/702,063 titled "Stimulation of an Immune Response by Enantiomers of Cationic Lipids" by the United States Patent and Trademark Office (USPTO).

    "The expansion of our international patent portfolio furthers protects our novel Versamune® platform and the development of our robust pipeline," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "As we advance our lead program, PDS0101 towards three Phase 2 studies this year with leaders in the field…

    PRINCETON, N.J., March 05, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced that it has been granted U.S. Patent No. 15/702,063 titled "Stimulation of an Immune Response by Enantiomers of Cationic Lipids" by the United States Patent and Trademark Office (USPTO).

    "The expansion of our international patent portfolio furthers protects our novel Versamune® platform and the development of our robust pipeline," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "As we advance our lead program, PDS0101 towards three Phase 2 studies this year with leaders in the field of immuno-oncology, we believe that our Versamune® platform holds the potential to significantly improve clinical outcomes for patients."

    The U.S. Patent No. 15/702,063 titled "Stimulation of an Immune Response by Enantiomers of Cationic Lipids" provides protection for compositions of matter for the Versamune® platform including its chemical design and methods of delivery including oral, injectable and topical. The patent covers immune activating compositions containing the immunologically active enantiomer of the cationic lipid 1,2-dioleoyl-3-trimethyl-ammonium-propane (R-DOTAP) and a specific antigen. This patent has also been issued in several other countries including the European Union, Japan, Canada and Australia. The PDS Versamune® patent portfolio also includes broader cationic lipid compositions that activate the immune system. The combination of Versamune® with various antigens forms the basis for PDS Biotech's broad immuno-oncology pipeline, including its lead candidate PDS0101 for the treatment of advanced human papillomavirus (HPV) related cancers.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology platform. The Versamune® platform effectively delivers tumor-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune®, PDS Biotech is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotech's pipeline combines the Versamune® technology with tumor-specific antigens across several cancer types. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About PDS0101

    PDS Biotech's lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is also advancing a combination of PDS0101 and two clinical stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers. A third phase 2 study is to be performed in advanced localized cervical cancer combining PDS0101 with the chemoradiotherapy, which is the standard of care.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead asset, PDS0101; the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 acceptance by the market of the Company's product candidates, if approved; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company's product candidates; 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

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  51. PRINCETON, N.J., Feb. 27, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced commencement of work under an Amended and Restated Material Transfer Agreement with Farmacore Biotechnology, experts in infectious diseases, to develop a novel tuberculosis (TB) immunotherapy based on Farmacore's proprietary TB antigens and PDS Bio's Versamune® platform technology.  The prior Material Transfer Agreement under which preliminary work commenced was Amended and Restated in December 2019 due to promising early pre-clinical results and to progress this next phase of development…

    PRINCETON, N.J., Feb. 27, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced commencement of work under an Amended and Restated Material Transfer Agreement with Farmacore Biotechnology, experts in infectious diseases, to develop a novel tuberculosis (TB) immunotherapy based on Farmacore's proprietary TB antigens and PDS Bio's Versamune® platform technology.  The prior Material Transfer Agreement under which preliminary work commenced was Amended and Restated in December 2019 due to promising early pre-clinical results and to progress this next phase of development.

    In preliminary evaluations, Versamune® based product demonstrated highly promising in-vivo TB-specific T-cell induction.  The collaboration will focus on evaluation and optimization of efficacy in in-vivo pre-clinical models.   Under terms of the agreement, PDS Biotech will undertake product development and Farmacore will conduct studies to evaluate efficacy of the formulated product. 

    "Our goal for the collaboration is to explore the unique capabilities of our proprietary Versamune® technology to address critical unmet medical needs beyond oncology. The role of T-cells in the management of pathogen-induced diseases such as tuberculosis and influenza are well established, however, the development of vaccines and immunotherapies to address such diseases has been limited," said Dr. Bedu-Addo, CEO of PDS Biotech. "Versamune® has demonstrated the ability to induce high levels of in-vivo disease specific CD8+ killer and CD4+ helper T-cells in humans without any significant side effects. We believe that there is an opportunity to leverage our Versamune®  technology to overcome these major hurdles and develop effective immunotherapies to better manage and treat several deadly infectious diseases."

    Helena Faccioli Lopes, CEO of Farmacore added, "Farmacore focuses on developing immunotherapeutic products and vaccines for Infectious Diseases, specifically for Tuberculosis, where we have identified a great potential peptide-based vaccine. We believe that based on published data about Versamune®  and our preliminary evaluation, the Versamune® platform technology is well-suited to effectively deliver the peptides to induce an immune response. We are very excited to have Versamune® available to support and potentially enhance our chances of success in the development of a new Tuberculosis vaccine."

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology platform. The Versamune® platform effectively delivers tumor-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune®, PDS Biotech is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotech's pipeline combines the Versamune® technology with tumor-specific antigens across several cancer types. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

    About Farmacore

    Farmacore Biotechnology is a privately held animal and human health research company focused on carrying out research and development of products and process with therapeutic and biotechnological potential in the areas of infectious diseases and oncology. The Company also acts in services (analytical methods, preclinical tests, upstream and downstream development methods), technology transfer, protection of intellectual property, management of innovation projects and evaluation of technological feasibility.  To learn more, please visit www.farmacore.com.br.

    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," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 ability of the Company to integrate Edge and PDS Biotechnology following the merger; the Company's ability to protect its intellectual property rights; competitive responses to the completion of the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger; the Company's ability to access capital markets, the timing for the Company to initiate two clinical trials for its lead asset, PDS0101; (and statements regarding the Company's interpretation of the results of its Phase 1 trial for PDS0101 and whether such are sufficient to support additional trials or the future success of such trials); the successful implementation of the Company's research and development programs and collaborations; the acceptance by the market of the Company's product candidates, if approved; 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 risk factors included in the Company's annual and periodic reports filed with the SEC. 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.

    Media & Investor Relations Contact:

    Deanne Randolph
    PDS Biotech
    Phone: +1 (908) 517-3613
    Email:

    Tram Bui / Alexander Lobo
    The Ruth Group
    Phone: +1 (646) 536-7035 / +1 (646) 536-7037
    Email: /

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  52. PRINCETON, N.J., Feb. 24, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced that it has appointed Kamil Ali-Jackson, Esq. to its Board of Directors. Ms. Ali-Jackson will be a member of the Board's audit committee.

    "We are very pleased to welcome Kamil to the Board of Directors and look forward to her insights and contributions as we continue to progress the company's Versamune®-based clinical and preclinical pipeline and grow PDS into a leading immuno-oncology company. Kamil's extensive legal experience, particularly with financial transactions, strategic alliances…

    PRINCETON, N.J., Feb. 24, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology, today announced that it has appointed Kamil Ali-Jackson, Esq. to its Board of Directors. Ms. Ali-Jackson will be a member of the Board's audit committee.

    "We are very pleased to welcome Kamil to the Board of Directors and look forward to her insights and contributions as we continue to progress the company's Versamune®-based clinical and preclinical pipeline and grow PDS into a leading immuno-oncology company. Kamil's extensive legal experience, particularly with financial transactions, strategic alliances, and development and commercialization transactions, will be an invaluable asset to the team and help guide the Company," commented Steve Glover, Chairman of the Board of PDS. "With our successful financing complete we look forward to initiating three Phase 2 clinical trials for our lead product candidate PDS0101 over the coming months."

    Kamil Ali-Jackson, Esq. has more than 30 years of experience as legal counsel in the life sciences industry with public and private specialty pharmaceutical, biotech and biopharmaceutical companies. Ms. Ali-Jackson has extensive domestic and international experience with strategic alliances, drug development and commercialization collaborations and M&A transactions. She is a co-founder of Aclaris Therapeutics, Inc. and has served as Chief Legal Officer since its inception in 2012. In addition, since 2013, she has served as Chief Legal Officer of NeXeption II, LLC and its affiliates. Previously, Kamil served as Chief Legal Officer of Ralexar Therapeutics, Inc. (formerly known as Alexar Therapeutics Inc.). She has also served as legal counsel and as a licensing business executive for large pharmaceutical companies, including Merck & Co. Inc., Dr. Reddy's Laboratories Ltd., and Endo Pharmaceuticals, Inc.

    Ms. Ali-Jackson holds her Juris Doctorate from Harvard Law School in addition to a Bachelor of Arts degree in politics from Princeton University. She was a 2011 Philadelphia Business Journal Woman of Distinction winner. She has served on several nonprofit boards and is currently on the board of Rosemont College, a private liberal arts college located in Pennsylvania.

    About PDS Biotechnology

    PDS Biotech is a clinical-stage immuno-oncology company developing multiple therapies based on the Company's proprietary Versamune® T-cell activating technology platform. The Versamune® platform effectively delivers tumor-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune®, PDS Biotech is enginee