{"success":true,"data":{"pressRelease":{"id":"115390","rtpr_id":"nGNXc4W0J8","ticker":"PDSB","exchange":"NASDAQ","all_tickers":["PDSB"],"title":"PDS Biotech Announces Strategic Refocus Prioritizing PDS0301 in Metastatic Colorectal Cancer (mCRC) and Partnership Strategy for PDS0101","author":"Globe Newswire","published_at":"2026-08-11T12:25:00.128Z","article_body":"PRINCETON, N.J., Aug. 11, 2026 (GLOBE NEWSWIRE) -- PDS Biotechnology\nCorporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a\nlate-stage immunotherapy company focused on developing targeted\nimmunotherapies for cancer, today issued a Letter to Shareholders from Frank\nBedu-Addo, Ph.D., Chief Executive Officer and Director of PDS Biotech:\n\n“Dear Fellow Shareholders,\n\nOver the past several months, our Board of Directors and management team\nconducted a comprehensive review of our development portfolio, capital\nallocation priorities and long-term strategy. Following this review, we\nbelieve the best path to creating long-term shareholder value is to prioritize\nthe advancement of PDS0301, our tumor-targeted immunocytokine, while pursuing\nstrategic partnership opportunities for PDS0101.\n\nThe oncology treatment landscape is rapidly evolving with the emergence of\nvarious precision medicines. Despite these advances, treatment resistance and\nlimited durability of response remain significant challenges for many patients\nwith advanced solid tumors. Based on supportive preclinical and clinical data,\nwe believe PDS0301 has the potential to address these challenges by precisely\ntargeting and remodeling the tumor microenvironment, potentially enhancing the\neffectiveness and durability of current and emerging oncology therapies. To\naddress this medical need, we have designed PDS0301 for use, in combination\nwith other oncology therapies, to remodel the tumor microenvironment to\npotentially promote more effective anti-tumor responses in patients. We\nbelieve the remodeling of the tumor microenvironment is an important factor in\naddressing treatment resistance and reversing disease progression. Further,\nthis mechanism could enable PDS0301 to complement a broad range of current and\nemerging oncology therapies, including RAS pathway inhibitors, bispecific\nantibodies, ADCs and radioligand therapies.\n\nWe concluded that our resources should be redirected toward PDS0301, where we\nbelieve the combination of encouraging clinical data, development opportunity\nand capital requirements provide a potentially more attractive path to\nlong-term shareholder value.\n\nPhase 2 mCRC Results\n\nPatients with metastatic microsatellite stable (MSS) and mismatch\nrepair-proficient (pMMR) colorectal cancer, particularly those with liver\nmetastases, continue to face substantial unmet medical needs, and median\noverall survival is reported to be less than 10 months and objective response\nrates (ORR) less than 25%(1). Clinical data generated in collaboration with\nthe National Cancer Institute demonstrated encouraging and durable activity,\nincluding a 71% ORR at 6 months and an 80% 24-month survival rate in patients\nwith metastatic MSS and pMMR colorectal cancer and liver metastases(2).\nTogether with safety observed in more than 380 treated patients, these\nfindings strengthen our conviction that PDS0301 has the potential to address\none of the more significant limitations of current oncology therapies.\n\nStrategic Partnering Opportunities for PDS0101\n\nWe have decided that we will cease further internal investment in the PDS0101\nPhase 3 VERSATILE-003 trial, including the discontinuation of the\nVERSATILE-003 Phase 3 trial, and intend to pursue strategic partnerships or\nother externally funded opportunities for the continued development of\nPDS0101. This decision follows a comprehensive assessment of the capital, time\nand resources required to complete the Phase 3 trial and support\ncommercialization of PDS0101. This decision reflects our commitment to\ndisciplined capital allocation rather than a change in our view of the\nunderlying PDS0101 science and clinical data. We believe the strength of the\nPhase 2 clinical results allows us to preserve the potential value of PDS0101\nthrough a strategic partnership.\n\nWhy We Believe PDS0301 Represents Our Greatest Opportunity\n\nOur objective is to establish PDS0301 as a foundational component of\nnext-generation oncology therapies for multiple difficult-to-treat solid\ntumors.\n\nWe believe PDS0301 offers several important differentiators:\n* Encouraging efficacy as a single agent (monotherapy) in advanced, recurrent\ncancer.\n* Encouraging efficacy with chemotherapy in difficult-to-treat metastatic\ncolorectal cancer.\n* More than 380 patients treated with an encouraging safety and tolerability\nprofile.\n* A mechanism designed to remodel the tumor microenvironment and to reshape\nthe anti-tumor immune response in patients, leading to more effective and more\ndurable or long-lasting therapy. The mechanism also has the potential to\nimprove the durability of ADCs, bispecific antibodies, radioligands, targeted\ntherapies and immunotherapies.\n* Clinical activity and tolerability observed across multiple\ndifficult-to-treat solid tumors as a single agent and in double and triple\ncombinations.\n* A Phase 2b development strategy designed to take into account feedback from\nthe FDA.\nAlthough metastatic colorectal cancer is our lead development program, our\nmaturing clinical data in various solid tumors suggests that PDS0301 may have\nbroader application. By targeting the tumor microenvironment rather than a\nsingle oncogenic pathway, PDS0301 appears to have applicability across\nmultiple difficult-to-treat solid tumors which could result in several\ncombination oncology therapy strategies.\n\nBeyond colorectal cancer, PDS0301 is also being evaluated in recurrent\nprostate cancer, metastatic castration resistant prostate cancer, Kaposi\nsarcoma, HPV16-positive cancers, and other National Cancer Institute-sponsored\nclinical trials, providing additional opportunities to demonstrate the breadth\nof PDS0301.\n\nLooking Ahead\n\nA randomized Phase 2b trial with PDS0301 has been designed taking into account\nfeedback received from the FDA and is intended to generate meaningful clinical\ndata with disciplined capital investment.\n\nOver the next 18 to 24 months, we expect to:\n* Advance PDS0301 through a randomized Phase 2b development program.\n* Identify and assess strategic partnering opportunities for PDS0101.\n* Maintain disciplined capital allocation while delivering meaningful clinical\nand business milestones.\nWe believe PDS Biotechnology is well positioned at the intersection of one of\noncology's most important emerging trends: improving the effectiveness and\ndurability of oncology therapies through precision remodeling of the tumor\nmicroenvironment. By focusing our resources on PDS0301, identifying strategic\npartnerships for PDS0101, and executing with financial discipline, we believe\nwe can create meaningful long-term value for both patients and shareholders.\nWe look forward to updating you on our progress as we move forward with this\nnew strategy.”\n\nSincerely,\n\nFrank Bedu-Addo, Ph.D.\nChief Executive Officer, Director\n\nPDS Biotechnology will announce its financial results for the quarter ending\nJune 30, 2026, on August 13, 2026.\n\nAbout PDS Biotechnology\n\nPDS Biotechnology is a clinical-stage biotechnology company focused on\ndeveloping targeted immunotherapies for cancer. Following a strategic review,\nthe Company has prioritized PDS0301, its investigational tumor-targeted\ninterleukin-12 (IL-12) immunocytokine, as its lead development program.\nPDS0301 is designed to deliver IL-12 preferentially to the tumor\nmicroenvironment, with the goal of enhancing anti-tumor immune activity while\nlimiting systemic exposure. PDS0301 has been clinically evaluated across\nmultiple solid tumors, including metastatic colorectal cancer and prostate\ncancer. The Company is focused on advancing PDS0301 in indications where its\ntumor-targeted mechanism and potential to modify the tumor microenvironment\nmay complement established and emerging cancer therapies and help address\nmechanisms of treatment resistance. PDS Biotechnology also owns the\nVersamune(®) platform, including PDS0101, which has been evaluated in\nHPV16-positive cancers. Following its strategic review, the Company determined\nto prioritize its capital and development resources toward PDS0301 and intends\nto pursue strategic partnership or other externally funded opportunities for\nthe continued development of PDS0101.\n\nFor more information, please visit www.pdsbiotech.com\n\nForward Looking Statements\n\nThis communication contains forward-looking statements (including within the\nmeaning of Section 21E of the United States Securities Exchange Act of 1934,\nas amended, and Section 27A of the United States Securities Act of 1933, as\namended) concerning PDS Biotechnology Corporation (the “Company”) and\nother matters. These statements may discuss goals, intentions and expectations\nas to future plans, trends, events, results of operations or financial\ncondition, or otherwise, based on current beliefs of the Company’s\nmanagement, as well as assumptions made by, and information currently\navailable to, management. Forward-looking statements generally include\nstatements that are predictive in nature and depend upon or refer to future\nevents or conditions, and include words such as “may,” “will,”\n“should,” “would,” “expect,” “anticipate,” “plan,”\n“likely,” “believe,” “estimate,” “project,” “intend,”\n“forecast,” “guidance”, “outlook” and other similar expressions\namong others. Forward-looking statements are based on current beliefs and\nassumptions that are subject to risks and uncertainties and are not guarantees\nof future performance. Actual results could differ materially from those\ncontained in any forward-looking statement as a result of various factors,\nincluding, without limitation: the Company’s ability to protect its\nintellectual property rights; the Company’s anticipated capital\nrequirements, including the Company’s anticipated cash runway and the\nCompany’s current expectations regarding its plans for future equity\nfinancings; the Company’s dependence on additional financing to fund its\noperations and complete the development and commercialization of its product\ncandidates, and the risks that raising such additional capital may restrict\nthe Company’s operations or require the Company to relinquish rights to the\nCompany’s technologies or product candidates; the Company’s limited\noperating history in the Company’s current line of business, which makes it\ndifficult to evaluate the Company’s prospects, the Company’s business plan\nor the likelihood of the Company’s successful implementation of such\nbusiness plan; the timing for the Company or its partners to conduct clinical\ntrials for PDS0301 (formerly PDS01ADC), PDS0103 (Versamune(®) MUC1) and\nother Versamune(®) based product candidates; the future success of such\ntrials; the successful implementation of the Company’s research and\ndevelopment programs and collaborations, including any collaboration studies\nconcerning PDS0101, PDS0301, PDS0103 and other Versamune(®) based product\ncandidates and the Company’s interpretation of the results and findings of\nsuch programs and collaborations and whether such results are sufficient to\nsupport the future success of the Company’s product candidates; the success,\ntiming and cost of the Company’s or its partners’ ongoing clinical trials\nand anticipated clinical trials for the Company’s current product\ncandidates, including statements regarding response rates, the timing of\ninitiation, pace of enrollment and completion of the trials (including the\nCompany’s ability to fully fund its disclosed clinical trials, which assumes\nno material changes to the Company’s currently projected expenses), futility\nanalyses, presentations at conferences and data reported in an abstract, and\nreceipt of interim or preliminary results (including, without limitation, any\npreclinical results or data), which are not necessarily indicative of the\nfinal results of the Company’s ongoing clinical trials; any Company\nstatements about its understanding of product candidates mechanisms of action\nand interpretation of preclinical and early clinical results from its clinical\ndevelopment programs and any collaboration studies; the Company’s ability to\ncontinue as a going concern; the anticipated benefits of the Company strategic\nrefocus on PDS0301; the Company's ability to identify, negotiate and\nconsummate strategic partnerships or other externally funded opportunities for\nPDS0101; the Company's ability to preserve, realize or enhance the value of\nits development programs; the Company's expectations regarding the timing,\navailability and sufficiency of capital resources to execute its business\nstrategy; and other factors, including legislative, regulatory, political and\neconomic developments not within the Company’s control. The foregoing review\nof important factors that could cause actual events to differ from\nexpectations should not be construed as exhaustive and should be read in\nconjunction with statements that are included herein and elsewhere, including\nthe other risks, uncertainties, and other factors described under “Risk\nFactors,” “Management’s Discussion and Analysis of Financial Condition\nand Results of Operations” and elsewhere in the documents we file with the\nU.S. Securities and Exchange Commission. The forward-looking statements are\nmade only as of the date of this communication and, except as required by\napplicable law, the Company undertakes no obligation to revise or update any\nforward-looking statement, or to make any other forward-looking statements,\nwhether as a result of new information, future events or otherwise.\n\nVersamune(®) is a registered trademark of PDS Biotechnology Corporation.\n\nReferences\n1. Aruquipa MPS et al, Liver metastasis and resistance to immunotherapy in\nmicrosatellite stable colorectal cancer. A literature review; ecancer 2024,\n18:1771.\n2. Eade AV et al; Tumor-Targeted IL-12 (NHS-IL12) with Hepatic Artery Infusion\nPump Therapy for Colorectal Liver Metastases: Interim Analysis of a\nNon-randomized Phase II Tria; JCO Oncol Adv 3, e2500173 (2026) Vol. 3 #1.\nInvestor Contact:\nMike Moyer\nLifeSci Advisors\nPhone +1 (617) 308-4306\nEmail: mmoyer@lifesciadvisors.com\n\nMedia Contact:\nJude Gorman / Kiki Torpey\nCollected Strategies\nPDS-CS@collectedstrategies.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e2e7d124-dbd4-4140-9cc5-449d3488a902)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXc4W0J8","title":"PDS Biotech Announces Strategic Refocus Prioritizing PDS0301 in Metastatic Colorectal Cancer (mCRC) and Partnership Strategy for PDS0101","author":"Globe Newswire","ticker":"PDSB","created":"2026-08-11T12:25:00.128Z","tickers":["PDSB"],"exchange":"NASDAQ","article_body":"PRINCETON, N.J., Aug. 11, 2026 (GLOBE NEWSWIRE) -- PDS Biotechnology\nCorporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a\nlate-stage immunotherapy company focused on developing targeted\nimmunotherapies for cancer, today issued a Letter to Shareholders from Frank\nBedu-Addo, Ph.D., Chief Executive Officer and Director of PDS Biotech:\n\n“Dear Fellow Shareholders,\n\nOver the past several months, our Board of Directors and management team\nconducted a comprehensive review of our development portfolio, capital\nallocation priorities and long-term strategy. Following this review, we\nbelieve the best path to creating long-term shareholder value is to prioritize\nthe advancement of PDS0301, our tumor-targeted immunocytokine, while pursuing\nstrategic partnership opportunities for PDS0101.\n\nThe oncology treatment landscape is rapidly evolving with the emergence of\nvarious precision medicines. Despite these advances, treatment resistance and\nlimited durability of response remain significant challenges for many patients\nwith advanced solid tumors. Based on supportive preclinical and clinical data,\nwe believe PDS0301 has the potential to address these challenges by precisely\ntargeting and remodeling the tumor microenvironment, potentially enhancing the\neffectiveness and durability of current and emerging oncology therapies. To\naddress this medical need, we have designed PDS0301 for use, in combination\nwith other oncology therapies, to remodel the tumor microenvironment to\npotentially promote more effective anti-tumor responses in patients. We\nbelieve the remodeling of the tumor microenvironment is an important factor in\naddressing treatment resistance and reversing disease progression. Further,\nthis mechanism could enable PDS0301 to complement a broad range of current and\nemerging oncology therapies, including RAS pathway inhibitors, bispecific\nantibodies, ADCs and radioligand therapies.\n\nWe concluded that our resources should be redirected toward PDS0301, where we\nbelieve the combination of encouraging clinical data, development opportunity\nand capital requirements provide a potentially more attractive path to\nlong-term shareholder value.\n\nPhase 2 mCRC Results\n\nPatients with metastatic microsatellite stable (MSS) and mismatch\nrepair-proficient (pMMR) colorectal cancer, particularly those with liver\nmetastases, continue to face substantial unmet medical needs, and median\noverall survival is reported to be less than 10 months and objective response\nrates (ORR) less than 25%(1). Clinical data generated in collaboration with\nthe National Cancer Institute demonstrated encouraging and durable activity,\nincluding a 71% ORR at 6 months and an 80% 24-month survival rate in patients\nwith metastatic MSS and pMMR colorectal cancer and liver metastases(2).\nTogether with safety observed in more than 380 treated patients, these\nfindings strengthen our conviction that PDS0301 has the potential to address\none of the more significant limitations of current oncology therapies.\n\nStrategic Partnering Opportunities for PDS0101\n\nWe have decided that we will cease further internal investment in the PDS0101\nPhase 3 VERSATILE-003 trial, including the discontinuation of the\nVERSATILE-003 Phase 3 trial, and intend to pursue strategic partnerships or\nother externally funded opportunities for the continued development of\nPDS0101. This decision follows a comprehensive assessment of the capital, time\nand resources required to complete the Phase 3 trial and support\ncommercialization of PDS0101. This decision reflects our commitment to\ndisciplined capital allocation rather than a change in our view of the\nunderlying PDS0101 science and clinical data. We believe the strength of the\nPhase 2 clinical results allows us to preserve the potential value of PDS0101\nthrough a strategic partnership.\n\nWhy We Believe PDS0301 Represents Our Greatest Opportunity\n\nOur objective is to establish PDS0301 as a foundational component of\nnext-generation oncology therapies for multiple difficult-to-treat solid\ntumors.\n\nWe believe PDS0301 offers several important differentiators:\n* Encouraging efficacy as a single agent (monotherapy) in advanced, recurrent\ncancer.\n* Encouraging efficacy with chemotherapy in difficult-to-treat metastatic\ncolorectal cancer.\n* More than 380 patients treated with an encouraging safety and tolerability\nprofile.\n* A mechanism designed to remodel the tumor microenvironment and to reshape\nthe anti-tumor immune response in patients, leading to more effective and more\ndurable or long-lasting therapy. The mechanism also has the potential to\nimprove the durability of ADCs, bispecific antibodies, radioligands, targeted\ntherapies and immunotherapies.\n* Clinical activity and tolerability observed across multiple\ndifficult-to-treat solid tumors as a single agent and in double and triple\ncombinations.\n* A Phase 2b development strategy designed to take into account feedback from\nthe FDA.\nAlthough metastatic colorectal cancer is our lead development program, our\nmaturing clinical data in various solid tumors suggests that PDS0301 may have\nbroader application. By targeting the tumor microenvironment rather than a\nsingle oncogenic pathway, PDS0301 appears to have applicability across\nmultiple difficult-to-treat solid tumors which could result in several\ncombination oncology therapy strategies.\n\nBeyond colorectal cancer, PDS0301 is also being evaluated in recurrent\nprostate cancer, metastatic castration resistant prostate cancer, Kaposi\nsarcoma, HPV16-positive cancers, and other National Cancer Institute-sponsored\nclinical trials, providing additional opportunities to demonstrate the breadth\nof PDS0301.\n\nLooking Ahead\n\nA randomized Phase 2b trial with PDS0301 has been designed taking into account\nfeedback received from the FDA and is intended to generate meaningful clinical\ndata with disciplined capital investment.\n\nOver the next 18 to 24 months, we expect to:\n* Advance PDS0301 through a randomized Phase 2b development program.\n* Identify and assess strategic partnering opportunities for PDS0101.\n* Maintain disciplined capital allocation while delivering meaningful clinical\nand business milestones.\nWe believe PDS Biotechnology is well positioned at the intersection of one of\noncology's most important emerging trends: improving the effectiveness and\ndurability of oncology therapies through precision remodeling of the tumor\nmicroenvironment. By focusing our resources on PDS0301, identifying strategic\npartnerships for PDS0101, and executing with financial discipline, we believe\nwe can create meaningful long-term value for both patients and shareholders.\nWe look forward to updating you on our progress as we move forward with this\nnew strategy.”\n\nSincerely,\n\nFrank Bedu-Addo, Ph.D.\nChief Executive Officer, Director\n\nPDS Biotechnology will announce its financial results for the quarter ending\nJune 30, 2026, on August 13, 2026.\n\nAbout PDS Biotechnology\n\nPDS Biotechnology is a clinical-stage biotechnology company focused on\ndeveloping targeted immunotherapies for cancer. Following a strategic review,\nthe Company has prioritized PDS0301, its investigational tumor-targeted\ninterleukin-12 (IL-12) immunocytokine, as its lead development program.\nPDS0301 is designed to deliver IL-12 preferentially to the tumor\nmicroenvironment, with the goal of enhancing anti-tumor immune activity while\nlimiting systemic exposure. PDS0301 has been clinically evaluated across\nmultiple solid tumors, including metastatic colorectal cancer and prostate\ncancer. The Company is focused on advancing PDS0301 in indications where its\ntumor-targeted mechanism and potential to modify the tumor microenvironment\nmay complement established and emerging cancer therapies and help address\nmechanisms of treatment resistance. PDS Biotechnology also owns the\nVersamune(®) platform, including PDS0101, which has been evaluated in\nHPV16-positive cancers. Following its strategic review, the Company determined\nto prioritize its capital and development resources toward PDS0301 and intends\nto pursue strategic partnership or other externally funded opportunities for\nthe continued development of PDS0101.\n\nFor more information, please visit www.pdsbiotech.com\n\nForward Looking Statements\n\nThis communication contains forward-looking statements (including within the\nmeaning of Section 21E of the United States Securities Exchange Act of 1934,\nas amended, and Section 27A of the United States Securities Act of 1933, as\namended) concerning PDS Biotechnology Corporation (the “Company”) and\nother matters. These statements may discuss goals, intentions and expectations\nas to future plans, trends, events, results of operations or financial\ncondition, or otherwise, based on current beliefs of the Company’s\nmanagement, as well as assumptions made by, and information currently\navailable to, management. Forward-looking statements generally include\nstatements that are predictive in nature and depend upon or refer to future\nevents or conditions, and include words such as “may,” “will,”\n“should,” “would,” “expect,” “anticipate,” “plan,”\n“likely,” “believe,” “estimate,” “project,” “intend,”\n“forecast,” “guidance”, “outlook” and other similar expressions\namong others. Forward-looking statements are based on current beliefs and\nassumptions that are subject to risks and uncertainties and are not guarantees\nof future performance. Actual results could differ materially from those\ncontained in any forward-looking statement as a result of various factors,\nincluding, without limitation: the Company’s ability to protect its\nintellectual property rights; the Company’s anticipated capital\nrequirements, including the Company’s anticipated cash runway and the\nCompany’s current expectations regarding its plans for future equity\nfinancings; the Company’s dependence on additional financing to fund its\noperations and complete the development and commercialization of its product\ncandidates, and the risks that raising such additional capital may restrict\nthe Company’s operations or require the Company to relinquish rights to the\nCompany’s technologies or product candidates; the Company’s limited\noperating history in the Company’s current line of business, which makes it\ndifficult to evaluate the Company’s prospects, the Company’s business plan\nor the likelihood of the Company’s successful implementation of such\nbusiness plan; the timing for the Company or its partners to conduct clinical\ntrials for PDS0301 (formerly PDS01ADC), PDS0103 (Versamune(®) MUC1) and\nother Versamune(®) based product candidates; the future success of such\ntrials; the successful implementation of the Company’s research and\ndevelopment programs and collaborations, including any collaboration studies\nconcerning PDS0101, PDS0301, PDS0103 and other Versamune(®) based product\ncandidates and the Company’s interpretation of the results and findings of\nsuch programs and collaborations and whether such results are sufficient to\nsupport the future success of the Company’s product candidates; the success,\ntiming and cost of the Company’s or its partners’ ongoing clinical trials\nand anticipated clinical trials for the Company’s current product\ncandidates, including statements regarding response rates, the timing of\ninitiation, pace of enrollment and completion of the trials (including the\nCompany’s ability to fully fund its disclosed clinical trials, which assumes\nno material changes to the Company’s currently projected expenses), futility\nanalyses, presentations at conferences and data reported in an abstract, and\nreceipt of interim or preliminary results (including, without limitation, any\npreclinical results or data), which are not necessarily indicative of the\nfinal results of the Company’s ongoing clinical trials; any Company\nstatements about its understanding of product candidates mechanisms of action\nand interpretation of preclinical and early clinical results from its clinical\ndevelopment programs and any collaboration studies; the Company’s ability to\ncontinue as a going concern; the anticipated benefits of the Company strategic\nrefocus on PDS0301; the Company's ability to identify, negotiate and\nconsummate strategic partnerships or other externally funded opportunities for\nPDS0101; the Company's ability to preserve, realize or enhance the value of\nits development programs; the Company's expectations regarding the timing,\navailability and sufficiency of capital resources to execute its business\nstrategy; and other factors, including legislative, regulatory, political and\neconomic developments not within the Company’s control. The foregoing review\nof important factors that could cause actual events to differ from\nexpectations should not be construed as exhaustive and should be read in\nconjunction with statements that are included herein and elsewhere, including\nthe other risks, uncertainties, and other factors described under “Risk\nFactors,” “Management’s Discussion and Analysis of Financial Condition\nand Results of Operations” and elsewhere in the documents we file with the\nU.S. Securities and Exchange Commission. The forward-looking statements are\nmade only as of the date of this communication and, except as required by\napplicable law, the Company undertakes no obligation to revise or update any\nforward-looking statement, or to make any other forward-looking statements,\nwhether as a result of new information, future events or otherwise.\n\nVersamune(®) is a registered trademark of PDS Biotechnology Corporation.\n\nReferences\n1. Aruquipa MPS et al, Liver metastasis and resistance to immunotherapy in\nmicrosatellite stable colorectal cancer. A literature review; ecancer 2024,\n18:1771.\n2. Eade AV et al; Tumor-Targeted IL-12 (NHS-IL12) with Hepatic Artery Infusion\nPump Therapy for Colorectal Liver Metastases: Interim Analysis of a\nNon-randomized Phase II Tria; JCO Oncol Adv 3, e2500173 (2026) Vol. 3 #1.\nInvestor Contact:\nMike Moyer\nLifeSci Advisors\nPhone +1 (617) 308-4306\nEmail: mmoyer@lifesciadvisors.com\n\nMedia Contact:\nJude Gorman / Kiki Torpey\nCollected Strategies\nPDS-CS@collectedstrategies.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e2e7d124-dbd4-4140-9cc5-449d3488a902)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-11T12:25:00.178280401Z","server_sent_at_ms":1786451100178},"received_at":"2026-08-11T12:25:00.370Z","source_url":"https://www.globenewswire.com/news-release/2026/08/11/3342690/37149/en/pds-biotech-announces-strategic-refocus-prioritizing-pds0301-in-metastatic-colorectal-cancer-mcrc-and-partnership-strategy-for-pds0101.html"},"analysis":{"id":"104386","press_release_id":"115390","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Discontinuation of Phase 3 VERSATILE-003 trial for PDS0101 due to capital/resource constraints","Shift from late-stage (Phase 3) to mid-stage (Phase 2b) development extends path to commercialization"],"eventType":"operations_update","narrative":"PDS Biotech announced a strategic refocus to prioritize PDS0301, discontinuing the Phase 3 VERSATILE-003 trial for PDS0101 to conserve capital and redirect resources.\n\nThe pivot is based on Phase 2 data for PDS0301 showing a 71% objective response rate at 6 months and an 80% survival rate at 24 months in metastatic MSS/pMMR colorectal cancer patients with liver metastases.\n\nManagement plans to advance PDS0301 into a randomized Phase 2b trial over the next 18-24 months while seeking strategic partnerships for PDS0101.","sentiment":"bearish","agentHooks":{"shouldPost":true,"suggestedAngle":"Pipeline reset: PDS Biotech scraps Phase 3 PDS0101 trial to focus resources on earlier-stage PDS0301."},"keyFigures":{"drugName":"PDS0301","guidance":"Advance PDS0301 through randomized Phase 2b program over 18-24 months; pursue partnerships for PDS0101","phaseOfTrial":"Phase 2b","customDimensions":{"orr_pds0301_6mo":"71%","pds0101_trial_status":"discontinued","survival_pds0301_24mo":"80%","patients_treated_safety":">380"}},"quotedText":"We have decided that we will cease further internal investment in the PDS0101 Phase 3 VERSATILE-003 trial... and intend to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101.","namedEntities":{"people":[{"name":"Frank Bedu-Addo","role":"Chief Executive Officer and Director"}],"products":["PDS0301","PDS0101","Versamune"],"companies":[{"name":"PDS Biotechnology Corporation","ticker":"PDSB"},{"name":"National Cancer Institute","relationship":"research collaborator"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Discontinuation of the Phase 3 VERSATILE-003 trial for PDS0101 constitutes a major pipeline reduction, signaling capital constraints or strategic retreat from late-stage development. The shift to a Phase 2b program for PDS0301 extends the timeline to potential commercialization."},"tickerRelevance":{"others":[],"primary":"PDSB"},"globalImportance":25,"audienceRelevance":30,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"small-mid-cap","eventGravity":"major-pipeline-cut","sectorWeight":"biotech"}},"event_type":"operations_update","event_type_secondary":["clinical_trial"],"sentiment":"bearish","material_impact_score":4,"narrative":"PDS Biotech announced a strategic refocus to prioritize PDS0301, discontinuing the Phase 3 VERSATILE-003 trial for PDS0101 to conserve capital and redirect resources.\n\nThe pivot is based on Phase 2 data for PDS0301 showing a 71% objective response rate at 6 months and an 80% survival rate at 24 months in metastatic MSS/pMMR colorectal cancer patients with liver metastases.\n\nManagement plans to advance PDS0301 into a randomized Phase 2b trial over the next 18-24 months while seeking strategic partnerships for PDS0101.","key_figures":{"drugName":"PDS0301","guidance":"Advance PDS0301 through randomized Phase 2b program over 18-24 months; pursue partnerships for PDS0101","phaseOfTrial":"Phase 2b","customDimensions":{"orr_pds0301_6mo":"71%","pds0101_trial_status":"discontinued","survival_pds0301_24mo":"80%","patients_treated_safety":">380"}},"named_entities":{"people":[{"name":"Frank Bedu-Addo","role":"Chief Executive Officer and Director"}],"products":["PDS0301","PDS0101","Versamune"],"companies":[{"name":"PDS Biotechnology Corporation","ticker":"PDSB"},{"name":"National Cancer Institute","relationship":"research collaborator"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-11T16:15:21.116Z","global_importance":25,"audience_relevance":30,"importance_components":{"tickerTier":"small-mid-cap","eventGravity":"major-pipeline-cut","sectorWeight":"biotech"}},"durationMs":202936,"modelName":"glm-4.7"}}