Anal Canal Carcinoma

Several companies are advancing treatments for anal cancer, including Merck (KEYTRUDA), BioMimetix (BMX-001), Novartis (KFA115), and Bicara Therapeutics (BCA101), among others. As immunotherapy and targeted therapies gain traction, competition will increase, raising the bar for efficacy and safety. The market is shifting toward personalized, less toxic treatments, creating opportunities for novel entrants but demanding strong differentiation. LAS VEGAS, May 29, 2025 /PRNewswire/ -- Anal cancer is relatively uncommon, accounting for approximately 2.5% of all gastrointestinal cancers. Nonetheless, its incidence has been gradually increasing over the past 30 to 40 years. The disease is more frequently diagnosed in women than in men and typically affects individuals between the ages of 45 and 75. Anal squamous cell carcinoma (ASCC) is the predominant type, comprising around 80–85% of anal canal cancer cases. Less frequent forms include adenocarcinomas, melanomas, and basal cell carcinomas. According to DelveInsight's analysis, there were around 20,000 new cases of anal cancer across the seven major markets in 2023, a figure projected to rise by 2034. In the United States, approximately 82% of anal cancer cases were linked to HPV, underlining it as the primary cause. Combination chemoradiotherapy (CRT) is the standard first-line treatment for locoregional anal cancer. However, an exception is made for early-stage perianal tumors that do not involve the anal sphincter and for superficially invasive squamous cell carcinoma (SCC) of the anus, where wide local excision may be appropriate. The treatment approach for anal cancer has evolved from surgery to combined chemoradiation, enabling preservation of anal function. Despite trials investigating induction chemotherapy, maintenance therapy, and planned treatment breaks, the established standard remains a combination of mitomycin C (MMC), 5-fluorouracil (5-FU), and radiotherapy (RT) without these additional modifications. In recent years, intensity-modulated radiotherapy (IMRT) has replaced older radiotherapy methods and is now considered standard practice. Current research efforts also aim to reduce radiation-related side effects, with bone marrow-sparing IMRT emerging as a promising technique to limit hematologic toxicity. While immunotherapy is currently recommended as a second-line option for metastatic disease, its role is being actively explored in the locoregional setting. In particular, immune checkpoint inhibitors (ICIs) have garnered significant attention in recent studies involving patients with locoregional squamous cell carcinoma of the anus (SCCA). Learn more about the anal cancer treatment @ New Treatment for Anal Cancer Incyte's PD-1 inhibitor Zynyz has re-emerged in the treatment of anal cancer following two concurrent FDA approvals, marking a significant turnaround four years after its initial rejection. In May, 2025, the FDA approved Zynyz, a humanized monoclonal antibody targeting PD-1, for use alongside carboplatin and paclitaxel as a first-line therapy for adults with inoperable, locally recurrent, or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, Zynyz received approval as a monotherapy for adults with locally recurrent or metastatic SCAC who have either progressed on or are unable to tolerate platinum-based chemotherapy. Previously approved in 2023 for treating metastatic, recurrent, or locally advanced Merkel cell carcinoma, Zynyz has now become a cornerstone of Incyte's oncology pipeline. Its latest approval follows a Priority Review of a supplemental Biologics License Application (sBLA), backed by data from two clinical trials: the Phase III POD1UM-303/InterAACT2 and the Phase II POD1UM-202 studies. The Phase III POD1UM-303/InterAACT2 trial evaluated Zynyz in combination with carboplatin and paclitaxel in patients with metastatic or inoperable, locally recurrent SCAC who had not previously received systemic chemotherapy. The Phase II POD1UM-202 trial focused on Zynyz as a standalone therapy for patients with advanced SCAC who had relapsed after or were intolerant to platinum-based regimens. The intravenous monotherapy approval was based on results from POD1UM-202, which demonstrated a 14% objective response rate (ORR) and a 49% disease control rate. The safety profile was consistent with expectations for PD-1 inhibitors and showed no negative impact on HIV management in infected patients. Serious adverse events occurred in 40% of patients, with the most common (≥2%) including infections (excluding urinary tract), abdominal and perineal pain, anemia, bleeding, diarrhea, fever, urinary tract infections, musculoskeletal pain, and respiratory symptoms. Find out more on FDA-approved anal cancer drugs @ Anal Cancer Treatment Options Alongside the US submission, Incyte has also filed a Type II variation Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) and a Japanese New Drug Application (J-NDA) with the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC. Both applications are currently under review. The approval of Zynyz has heightened competition among pharmaceutical players such as Merck, BioMimetix, Novartis, and Bicara Therapeutics, pushing them to fast-track the development of their flagship drug candidates to gain market share and challenge Incyte's foothold. Discover which therapies are expected to grab major anal cancer market share @ Anal Cancer Market Report Merck is advancing its blockbuster PD-1 inhibitor, KEYTRUDA, which is currently in Phase II trials. Upon approval, it is expected to directly rival Incyte's Zynyz in the anal cancer treatment space. Zynyz (retifanlimab) could soon face competition not only from other PD-1 inhibitors but also from innovative therapies beyond this class. A notable example is BioMimetix's BMX-001, a redox-active metalloporphyrin (MnP) small molecule known for its strong anti-inflammatory effects. BMX-001 acts through a dual mechanism that affects both tumor and healthy tissues. In cancer cells, it inhibits critical signaling pathways such as NF-κB and HIF-1α, which are key to inflammation, angiogenesis, and tumor survival. This inhibition supports cancer cell death, reduces blood vessel formation, and curtails long-term tumor growth. BioMimetix is currently enrolling patients in a Phase I/II clinical trial involving newly diagnosed anal cancer cases. Other emerging anal cancer treatments include Novartis' immunomodulator KFA115 and Bicara Therapeutics' bifunctional antibody BCA101, which targets both EGFR and TGFβ pathways. Discover more about drugs for anal cancer in development @ Anal Cancer Clinical Trials Overall, the anal cancer therapeutic pipeline appears robust, with a variety of innovative strategies in development that could transform treatment paradigms and enhance patient outcomes. The anticipated launch of these emerging therapies for anal cancer are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for anal cancer is expected to grow from USD 7 million in the 7MM in 2023 at a significant CAGR by 2034. The anal cancer market is witnessing steady growth, driven by rising incidence rates, increased awareness, and advancements in diagnostic and treatment options. HPV remains a major contributing factor, prompting the development of targeted therapies and preventive vaccines. Improved screening programs and the approval of novel immunotherapies are further fueling market expansion. Additionally, growing investments in oncology research are supporting innovation and long-term market potential. DelveInsight's latest published market report, titled as Anal Cancer Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the anal cancer country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The anal cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Incident Cases of Anal Cancer Gender-specific Cases Age-specific Cases Histology-specific Cases HPV Status-specific Cases Stage-specific Cases Line-wise Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM anal cancer market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this anal cancer market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the anal cancer market. Also, stay abreast of the mitigating factors to improve your market position in the anal cancer therapeutic space. Related Reports HPV16-Positive Head and Neck Squamous Cell Carcinoma HPV16-Positive Head and Neck Squamous Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report shows that the 7MM market size is predicted to rise from USD 750 million in 2023 at a significant CAGR by 2034 owing to the active participation of key companies, including Bristol Myers Squibb, Merck, Merus, Exelixis, ISA Pharmaceuticals, Regeneron Pharmaceuticals, PDS Biotechnology, BioNTech, Cue Biopharma, Immutep, Iovance Biotherapeutics, Inovio Pharmaceuticals, MedImmune, Nykode Therapeutics, RAPT Therapeutics, among others. Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report shows that the 7MM market size is predicted to rise from USD 10.7 billion in 2024 at a significant CAGR by 2034 owing to the active participation of key companies, including Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, Tillotts Pharma (Zeria Pharmaceutical), Gilead Sciences, Galapagos NV, Boehringer Ingelheim, Celgene (Bristol Myers Squibb), Eli Lilly and Company, RedHill Biopharma, Arena Pharmaceuticals, Mesoblast, among others. Human Papillomavirus Market Human Papillomavirus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HPV companies, including Inovio Pharmaceuticals, ISA Pharmaceuticals, Regeneron Pharmaceuticals, Merck, Pattern Pharma, Nykode, Vaccibody A/S, among others. Human Papillomavirus Pipeline Human Papillomavirus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HPV companies, including Inovio Pharmaceuticals, ISA Pharmaceuticals, Regeneron Pharmaceuticals, Merck, Pattern Pharma, Nykode, Vaccibody A/S, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Jan. 27, 2025 -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the presentation of data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab in patients with second line (2L) or later squamous cancer of the anal canal (SCAC). The results were presented in a poster session during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium on Saturday, January 25, 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β), and is being evaluated in multiple solid tumor types. “We are encouraged by the preliminary data in SCAC, which demonstrate enhanced efficacy of the combination of ficerafusp alfa and pembrolizumab in a high-need patient population,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “The addition of ficerafusp alfa shows the potential to improve efficacy compared to historical data with pembrolizumab monotherapy in SCAC, with increased overall response rate, disease control rate, and 12-month progression-free survival, indicative of improved speed, depth, and durability of response. Importantly, responses were observed even in patients with liver metastases, which is a significant outcome in this setting. These data provide additional insights into the complimentary mechanisms of ficerafusp alfa and pembrolizumab, and support further development in squamous cell carcinomas, including first-line recurrent/metastatic head and neck squamous cell carcinoma.” “These early data with ficerafusp alfa and pembrolizumab suggest that ficerafusp alfa could play an important role in the future treatment of SCAC, underscoring the need for further investigation to assess the combination's potential in improving outcomes for patients,” said Van K. Morris, MD, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. Presentation Highlights: As of the data cut-off date of December 5, 2024, the single-arm, multicenter dose expansion cohort from an ongoing Phase 1/1b trial evaluated ficerafusp alfa in combination with pembrolizumab in 28 patients with immune checkpoint inhibitor-naive SCAC that was locally advanced/unresectable or metastatic, and who had received 1-2 prior lines of chemotherapy. The confirmed overall response rate was 25.0% (7/28 patients), irrespective of PD-L1 CPS score, including 6 partial responses (PR) and 1 complete response. In addition to the confirmed responses, there was 1 patient pending a confirmed PR. Median progression-free survival (PFS) was 2.9 months and the PFS rate at 12 months was 40.7% (27 evaluable patients). Tolerable safety profile with the most common treatment-related adverse events of any grade including, acneiform dermatitis (16/28 patients; 57.1%), epistaxis (14/28 patients; 50.0%), and pruritus (13/28 patients; 46.4%). Presentation Details: Title: Preliminary Phase 1/1b dose expansion results of the bifunctional EGFR/TGFβ inhibitor ficerafusp alfa (BCA101) with pembrolizumab in patients with squamous cell carcinoma of the anal canal Presenter: Van K. Morris, MD, Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center The poster presentation is available on the Bicara website under the Presentations & Publications section. Squamous cancer of the anal canal (SCAC) is the most common type of anal canal cancer, with an incidence in the United States. SCAC is typically associated with prior Human Papillomavirus (HPV) infection. Treatment is most commonly chemoradiation for patients with localized disease at diagnosis. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X. The content above comes from the network. if any infringement, please contact us to modify.

77% of checkpoint inhibitor (CPI) refractory patients alive at median follow up of 12 months 75% of CPI naïve patients alive at median follow up of 17 months Anti-tumor objective responses seen in 88% of CPI naïve patients and 63% CPI refractory patients (high dose of M9241) Study shows early evidence of durable clinical responses Company to host conference call and webcast on June 7, 2022 at 8:00 AM EDT FLORHAM PARK, N.J., May 26, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines, today announced an upcoming poster discussion presentation of clinical data from the ongoing Phase 2 triple combination trial led by the National Cancer Institute (NCI), of the National Institutes of Health (NIH), at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7, 2022 in Chicago and online. The Phase 2 triple combination trial (NCT04287868) is evaluating the safety and efficacy of PDS0101, an investigational HPV16-targeted immunotherapy, in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in CPI-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. PDS0101 is administered as two separate 0.5 ml subcutaneous injections every 4 weeks; bintrafusp alfa at 1,200 mg by IV infusion every 2 weeks; and M9241 at an initial high dose of 16.8 mcg/kg by subcutaneous injection every 4 weeks or at a low dose of 8 mcg/kg by subcutaneous injection every 2 weeks. Objective response is measured by radiographic tumor responses according to RECIST 1.1. Early data from the study suggests that the triple combination is preferentially active in HPV16-positive cancer. Immune checkpoint inhibitors (CPIs) have been evaluated in the treatment of advanced HPV-associated cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers. In these published studies, objective response rates have ranged from 13–24%*, and two CPIs are FDA- approved to treat head and neck cancer and cervical cancer. Unfortunately, the majority of patients who receive CPI therapy continue to progress. Historical median survival rates for CPI refractory patients, is 3-4 months**. Combinations of CPI and chemotherapy are being evaluated in refractory HPV-associated cancers. For most patients with CPI refractory HPV-associated disease, there is no clear effective standard of care therapy. Data from 30 cancer patients (9 cervical, 2 vaginal/vulvar, 6 anal, 13 oropharyngeal) are included in the poster. Highlights are as follows: Objective response (OR = >30% tumor reduction) was seen in 88% (7/8) of patients with checkpoint-naive disease; 4/7 (57%) patients’ responses are ongoing (median 17 months).With checkpoint refractory patients: M9241 dosing appears to affect response rates, with 5/8 (63%) patients receiving M9241 at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received M9241 at 8 mcg/kg achieving an OR; 4/6 (67%) patients’ responses are ongoing (median 12 months).Tumor reduction was seen in 45% (10/22) of patients with checkpoint-refractory disease, including patients receiving high or low dose M9241.In checkpoint refractory patients treated with high or low dose M9241, survival outcomes were similar (p=0.96 by Kaplan Meier analysis). At a median of 12 months of follow up 17/22 (77%) of patients were alive.In checkpoint naïve patients 6/8 (75%) were alive at median 17 months of follow up.Similar OR and survival were seen across all types of HPV16-positive cancers.Preliminary safety data: 13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.The study results to date strongly suggest, in agreement with the published preclinical studies, that all 3 drugs contribute to the clinical outcomes. “We believe achieving a 77% survival at 12 months follow up in CPI refractory patients and 75% survival at 17 months follow up in CPI naïve patients, as well as significant tumor reduction in these refractory patients with advanced HPV16-positive cancers is promising. These data continue to support clinical investigation of our Versamune® platform’s potential to induce high levels of tumor-specific CD8+ killer T-cells to attack a broad range of cancers,” stated Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “These results, combined with the previously reported data from this trial, strengthen our confidence that this novel combination has the potential to provide improved clinical outcomes and overall survival for patients with refractory HPV-associated cancers.” “Based on these results, the combination of PDS0101, bintrafusp alfa, and M9241 appears to have a manageable safety profile along with early evidence of clinical activity in patients with CPI-naïve and -refractory advanced HPV16-positive cancer,” said, James Gulley, M.D., Ph.D., Acting NCI Clinical Director, Co-Director of the Center for Immuno-Oncology, Center for Cancer Research, NCI. “Observing patients with ongoing clinical responses to treatment after 17 and 12 months is encouraging, as patients with advanced, refractory HPV16-associated cancers typically have limited treatment options.” The abstract is now available online on the ASCO conference website: https://am.asco.org/. Abstract/Poster Number: 2518Abstract Title: Phase II evaluation of the combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16+ malignancies.Presenting Author: James Gulley, Ph.D., National Cancer InstituteDate: Sunday, June 5, 2022Time: 8:00 AM-11:00 AM; 11:30 AM-1:00 PM CDT PDS Biotech is presenting a second abstract #6041 from a non-NCI clinical study which presents clinical results for a PDS0101-KEYTRUDA® combination in HPV16-positive head and neck cancer. The press release describing these data can be seen on the company website here. The company will be hosting a conference call on Tuesday, June 7 at 8:00 AM EDT to discuss the data presented at ASCO from the two clinical studies. To participate on the live call, please dial 877-407-3088 (US) or +1 201-389-0927 (International) and provide the conference ID “13729901” five to ten minutes before the start of the call. A live webcast of the event will be available online in the investor relations section of the company's website at https://pdsbiotech.com/investors/news-center/events. For patients interested in enrolling in the NCI-led clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov. *Bauml J, Seiwert TY, Pfister DG, et al. Pembrolizumab for platinum and cetuximab-refractory head and neck cancer: results from a single-arm, phase II study. J Clin Oncol 2017;35:1542–9.Ott PA, Piha-Paul SA, Munster P, et al. Safety and antitumor activity of the anti-PD- 1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol 2017;28:1036–41.Mehra R, Seiwert TY, Gupta S, et al. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012. Br J Cancer 2018;119:153–9.Ferris RL, Blumenschein G, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med 2016;375:1856–67.Morris VK, Salem ME, Nimeiri H, et al. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol 2017;18:446–53.Chung HC, Ros W, Delord J-P, et al. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol 2019;37:1470–8.**Strauss J, et al. J Immunother Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395 About PDS BiotechnologyPDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. We believe our Versamune®-based products are demonstrating the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells including long-lasting memory T-cell responses. 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. The Company continues to advance its pipeline of candidates to address a wide range of cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers. 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 PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; 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. Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck &Co.; Inc., Rahway, NJ, USA. Investor Contact:Rich CockrellCG CapitalPhone: +1 (404) 736-3838Email: pdsb@cg.capital