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PDSB

PDSB US Stock
$5.4
Open: $5.44 High: $5.44 Low: $5.05 Close: $5.3
Range: 2021-04-19 - 2021-04-20
Volume: 454,037
Market: Closed
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PDSB
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PDSB News
Latest news about the PDSB
  • PDS Biotech Announces Participation in Noble Capital Markets Virtual Road Show Series

    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: contact@noblecapitalmarkets.com 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: contact@channelchek.com CONTACT: Investor Contact: Rich Cockrell CG CAPITAL 404.736.3838 PDSB@cg.capital Company Contact: Deanne Randolph PDS Biotech Phone: 908.517.3613 drandolph@pdsbiotech.com

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  • PDS Biotech Reports Financial Results for the Year Ended December 31, 2020 and Provides Business Update

    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 RandolphPDS BiotechnologyPhone: +1 (908) 517-3613Email: drandolph@pdsbiotech.com Jacob GoldbergerCG CapitalPhone: +1 (404) 736-3841Email: jacob@cg.capital PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIESCondensed Consolidated Balance Sheets December 31,2020 December 31,2019ASSETS 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 SUBSIDIARIESCondensed 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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  • PDS Biotechnology Corp. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / March 18, 2021 / PDS Biotechnology Corp. (NASDAQ:PDSB) will be discussing their earnings results in their 2020 Fourth Quarter Earnings call to be held on March 18, 2021 at 8:00 AM Eastern Time.

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  • PDS Biotech Announces Presentation and Panel Participation at the Benzinga Biotech Small Cap Conference

    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 ...

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  • PDS Biotech Announces that its COVID-19 Vaccine Consortium Received a Commitment from The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund Clinical Development and Commercialization of a Versamune®-Based COVID-19 Vaccine with an Award of up to Approximately US$60 million

    Development and commercialization of novel T-cell activating vaccine to be performed in Brazil by consortium of PDS Biotech, Farmacore Biotechnology and Blanver FarmoquímicaFLORHAM 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 RandolphPDS BiotechPhone: +1 (908) 517-3613Email: drandolph@pdsbiotech.com Jacob GoldbergerCG CapitalPhone: +1 (404) 736-3841Email: jacob@cg.capital

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  • PDS Biotechnology Announces Conference Call and Webcast for Fourth Quarter and Full Year 2020 Financial Results

    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 RandolphPDS BiotechPhone: +1 (908) 517-3613Email: drandolph@pdsbiotech.com Jacob GoldbergerCG CapitalPhone: +1 (404) 736-3841Email: jacob@cg.capital

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  • PDS Biotech Announces Presentations in Upcoming Healthcare Investor Conferences

    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 ConferenceDate: Presentation Available On-Demand March 9-10, 2021Registration: Click Here 31st Annual Oppenheimer Healthcare ConferenceDate: March 16, 2021 at 1:10 PM Eastern TimeRegistration: 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 RandolphPDS BiotechPhone: +1 (908) 517-3613Email: drandolph@pdsbiotech.com Jacob GoldbergerCG CapitalPhone: +1 (404) 736-3841Email: jacob@cg.capital

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  • PDS Biotech and Farmacore Announce Blanver to Join Consortium to Commercialize Novel Versamune®-Based T-Cell Inducing COVID-19 Vaccine

    Brazilian-based Blanver brings depth of expertise in development and commercialization of innovative pharmaceuticals across Latin AmericaFLORHAM 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 RandolphPDS BiotechPhone: +1 (908) 517-3613Email: drandolph@pdsbiotech.com Jacob GoldbergerCG CapitalPhone: +1 (404) 736-3841Email: jacob@cg.capital

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  • PDS Biotechnology Moves Forward With Full Enrollment In PDS0101 Trial In HPV-Associated Cancers, Shares Retreat

    PDS Biotechnology Corporation (NASDAQ: PDSB) said it had achieved interim efficacy goal in Phase 2 trial evaluating the Company's PDS0101 to treat advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment. The trial, led by the National Cancer Institute (NCI), is evaluating 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. The study will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor naïve patients. Full enrollment is triggered by objective responses measured by radiographic tumor responses among at least three of the first eight patients. Also, preliminary efficacy assessment of the triple combination in an added group of approximately 20 patients who have failed prior therapy with checkpoint inhibitors is ongoing. Price Action: PDSB shares are trading lower by 13.1% at $3.37 on the last check Wednesday after trading higher in the pre-market session. See more from BenzingaClick here for options trades from BenzingaEnlivex Rallies On Encouraging Allocetra Data In Mid-Stage COVID-19 StudyDosing Underway In Sio Gene's Early-Stage Trial For GM2 Gangliosidosis Gene Therapy© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • PDS Biotech Announces Preliminary Efficacy Achievement in Phase 2 Combination Trial of PDS0101 Led by the National Cancer Institute

    Full enrollment triggered by observation of 3 objective responses in continued evaluation of the initial group of 8 patientsFLORHAM 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 NCIMO_Referrals@mail.nih.gov, 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 RandolphPDS BiotechPhone: +1 (908) 517-3613Email: drandolph@pdsbiotech.com Jacob GoldbergerCG CapitalPhone: +1 (404) 736-3841 Email: jacob@cg.capital

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  • PDS Biotech Releases White Paper Detailing the Potential of the Versamune® Platform in Overcoming a Major Limitation of Immuno-Oncology

    Promotes in-vivo tumor-attacking killer T-cells to facilitate cancer treatmentFLORHAM 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 BiotechnologyPDS 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 StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast.” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capital

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  • PDS Biotechnology Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

    FLORHAM PARK, N.J., Jan. 06, 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 Compensation Committee of the PDS Board of Directors approved the grant of inducement stock options covering an aggregate of 202,800 shares of PDS Biotech’s common stock to the newly appointed Chief Financial Officer, Seth Van Voorhees in accordance with Nasdaq Listing Rule 5635(c)(4). The awards were granted under PDS Biotech’s 2019 Inducement Plan, which was adopted on June 17, 2019 and provides for the granting of equity awards to new employees of PDS Biotech. The stock options have an exercise price of $2.28, the closing price of PDS Biotech’s common stock on January 4, 2021. Each stock option vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date and then monthly over the following 36 months, subject to continued employment with the company through the applicable vesting dates.About PDS BiotechnologyPDS 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 StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast.” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capital​

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  • PDS Biotech Announces Participation in H.C. Wainwright BioConnect 2021 Virtual Conference

    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 BiotechnologyPDS 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capital

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  • PDS Biotech Announces Mount Sinai Publication of Studies Showing Superior Induction of Antibodies by Versamune®-based COVID-19 Vaccine

    Versamune® T-cell activating platform demonstrates breadth of anti-SARS-CoV-2 immune responses in a COVID-19 vaccine PDS Biotech Announces Mount Sinai Publication of Studies Showing Superior Induction of Antibodies by Versamune®-based COVID-19 Vaccine Versamune® T-cell activating platform demonstrates breadth of anti-SARS-CoV-2 immune responses in a COVID-19 vaccineFLORHAM 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 BiotechnologyPDS 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 PDS0203PDS0203 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 StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast.” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capitalA photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/397e1ced-b7e5-4d82-aa9a-3ce8b9cf0f39

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  • PDS Biotechnology Appoints Seth Van Voorhees as Chief Financial Officer

    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 BiotechnologyPDS 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 StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast.” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capital

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  • Where Do Hedge Funds Stand On PDS Biotechnology Corporation (PDSB)?

    Although the masses and most of the financial media blame hedge funds for their exorbitant fee structure and disappointing performance, these investors have proved to have great stock picking abilities over the years (that’s why their assets under management continue to swell). We believe hedge fund sentiment should serve as a crucial tool of an […]

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  • PDS Biotech Announces New and Broad Versamune® Platform Patent Claims

    Granted methods patent for Versamune® platform by the United States Patent and Trademark OfficeFLORHAM 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 BiotechnologyPDS 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 StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast.” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capital

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  • PDS Biotech to Present at the Virtual Fall Investor Summit on November 16th-18th

    NEW YORK, NY / ACCESSWIRE / November 13, 2020 / 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.

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  • PDS Biotechnology Reports Financial Results for the Third Quarter 2020 and Provides Business Update

    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 ReviewFor 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 WebcastThe 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 BiotechnologyPDS 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 StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,”  “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capital PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIESCondensed 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 SUBSIDIARIESCondensed 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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  • PDS Biotech and Farmacore Announce Updates to Co-Development of Versamune®-Based COVID-19 Vaccine

    PDS0203 prioritized for clinical development by PDS Biotech and Farmacore after successful meeting with Brazilian Drug Regulatory AgencyFLORHAM 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 BiotechnologyPDS 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 FarmacoreFarmacore 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 PDS0203PDS0203 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 StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast.” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for 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: drandolph@pdsbiotech.comJacob Goldberger CG Capital Phone: +1 (404) 736-3841 Email: jacob@cg.capital

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