National Cancer Institute

NCI presentation to highlight IL-12 fused antibody drug conjugate during poster presentation PRINCETON, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that an abstract submitted by the National Cancer Institute (“NCI”) reporting clinical data on PDS01ADC, the Company’s IL-12 fused antibody drug conjugate, has been accepted for presentation at the American Association for Cancer Research (“AACR”) Annual Meeting 2025, taking place April 25-30, 2025, in Chicago, Illinois. Details of the presentation are as follows: Title: Alterations in peripheral T stem-like memory cells in patients with advanced solid tumors treated with tumor-targeting IL-12 therapyAbstract: 5800 / 9Session Type: Poster Session Session Title: PO.CL06.10 - Immune Response to TherapiesDate and Time: April 29, 2025, 2:00 PM - 5:00 PM CTPresenter: Meghali Goswami, Postdoctoral Fellow, The National Institutes of Health About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com Forward Looking StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® 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 Versamune® HPV, PDS01ADC and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.   Versamune® is a registered trademark of PDS Biotechnology Corporation. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Janine McCargo6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com

FRIENDSWOOD, Texas, April 08, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, is supporting key educational programs and initiatives throughout the month of April in recognition of Esophageal Cancer Awareness Month. The Company is proudly collaborating with the Esophageal Cancer Action Network (ECAN), the American Foregut Society (AFS) and The Gut Doctor PodcastLLC to promote esophageal cancer prevention, education and advocacy. “As esophageal cancer is often diagnosed in its late stages, its five-year survival rate remains alarmingly low at around 20%,”1 said Emmanuel Gorospe, M.D., board-certified gastroenterologist and medical director, gastroenterology, of Castle Biosciences. “This makes early detection and prevention critical. Through our collaboration with advocacy groups and the gastrointestinal (GI) community, we are committed to raising awareness of esophageal cancer risk factors and providing meaningful support to patients and healthcare professionals alike.” Detection of esophageal cancer and its precursor, Barrett's esophagus (BE), presents significant challenges because the main symptoms — heartburn and gastroesophageal reflux disease (GERD) —commonly occur in many less serious conditions that typically don't warrant concern. Doctors have very good methods to eliminate precancerous cells in BE patients at risk of developing cancer. The challenge, however, is finding which BE patients among the 1.5 million in the U.S. with the condition are in the 0.5% who will progress to cancer. TissueCypher® is Castle’s risk-stratification test for patients with BE designed to predict a patient’s individual risk of progression to high-grade dysplasia or esophageal cancer. Knowing which patients are likely to progress to cancer can help physicians treat them earlier, potentially creating an opportunity to save their lives. Esophageal Cancer Action Network (ECAN)Castle is collaborating with ECAN through a dedicated Esophageal Cancer Awareness Month sponsorship that encompasses a digital media campaign and awareness kits containing brochures, posters and wrist bands that will be distributed to ECAN supporters seeking to raise awareness about esophageal cancer. The media campaign will emphasize several key points: 1) the link between reflux and cancer, 2) esophageal cancer is preventable, and 3) new technology creates vast opportunities to save lives, particularly in the areas of screening/detection, risk stratification, diagnostics and treatment. Additionally, the campaign will focus on human interest stories featuring those who have been affected by esophageal cancer and experienced this alarming diagnosis. “Awareness is key to ending this devastating disease that is the fastest increasing cancer diagnosis in American men today and has tripled among young people in recent decades,”2,3 said Mindy Mintz Mordecai, founder, president and chief executive officer of ECAN. “The heart of our mission at ECAN is to save lives, and we are grateful for the support of our corporate partners and our many supporters who help us carry out this mission through education, prevention and awareness initiatives.” All Fore Guts! An American Foregut Society PodcastCastle teamed up with the American Foregut Society (AFS) for a special All Fore Guts! podcast episode, AFS Celebrates Esophageal Cancer Awareness Month — GET SCREENED, which launched April 1. Moderated by AFS President and Co-Founder Dan Lister, M.D., FACS, FAFS, the episode features a discussion with ECAN’s Mordecai and John C. Lipham, M.D., chairman of ECAN’s board of directors, chief of the division of upper GI and general surgery, and professor of surgery at the Keck School of Medicine of USC, highlighting the importance of esophageal cancer screening. Listen to the episode on the American Foregut Society’s website or stream it on Spotify. The Gut Doctor PodcastLLCHosted by Neil D. Parikh, M.D., a community gastroenterologist in Connecticut, The Gut Doctor Podcast provides general education around common gut-related topics through engaging conversations with gastroenterological specialists. For an April episode, Castle collaborated with Parikh and J. George Sun, M.D., a gastroenterologist with Digestive Health Associates in Houston, to discuss esophageal cancer, common risk factors and treatment to raise awareness around the disease. The episode will be available at The Gut Doctor Podcast and through major podcast streaming platforms. About Esophageal Cancer Action NetworkThe Esophageal Cancer Action Network (ECAN) is a non-profit, 501 (c)(3) organization supporting esophageal cancer patients and their families. ECAN started Esophageal Cancer Awareness Month in 2009 in support of its mission to save lives by 1) promoting early detection by increasing awareness about the link between reflux disease and cancer, 2) supporting medical innovation to prevent, detect, treat and cure esophageal cancer and 3) providing patients and families with the latest, most reliable medical information and compassionate support. ECAN’s relentless advocacy has increased the federal budget for Esophageal Cancer research by more than $20 million in the past four years, and millions more is expected in the years to come. Visit https://ecan.org/ for more information. About All Fore Guts! PodcastHosted by the American Foregut Society (AFS), the All Fore Guts! Podcast brings gastroenterologists and surgeons together to discuss common foregut conditions. Episodes can be found on the AFS website or on Spotify. AFS is the only society where GIs and surgeons collaborate to personalize treatment and improve patient outcomes in foregut disease. Visit https://www.americanforegutsociety.org/ for more information. About The Gut Doctor PodcastLLCThe Gut Doctor Podcast is hosted by Neil D. Parikh, M.D., a community gastroenterologist in Connecticut, and discusses common gut topics in a patient-friendly manner. Dr. Parikh interviews fellow GI specialists to provide a better understanding for the general public and medical providers and also features episodes on food as medicine as the worlds of culinary medicine and gastrointestinal health intertwine. Access episodes online at https://thegutdoctor.buzzsprout.com/ and via various podcast streaming platforms. About Castle BiosciencesCastle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.  DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: Castle’s ability to raise awareness of esophageal cancer risk factors and provide meaningful support to patients and healthcare professionals; and TissueCypher’s ability to (i) predict a patient’s individual risk of progression to high-grade dysplasia or esophageal cancer and (ii) help physicians prevent the development of life-threatening cancer in BE patients. The words “believe,” “can” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. 1. Center for Cancer Research at the National Cancer Institute (National Institutes of Health); https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-digestive-system-tumors/esophageal; accessed 3/26/25 2. Esophageal Cancer Action Network; https://ecan.org/; accessed 3/26/25 3. Mayo Clinic: Young-onset esophageal adenocarcinoma: Results from a population-based study; https://www.mayoclinic.org/medical-professionals/digestive-diseases/news/young-onset-esophageal-adenocarcinoma-results-from-a-population-based-study/mac-20511018; accessed 3/26/25 Investor Contact:Camilla Zuckeroczuckero@castlebiosciences.com Media Contact:Allison Marshallamarshall@castlebiosciences.com Source: Castle Biosciences, Inc.

Gelclair® is the company's third commercialized prescription product Oral mucositis, also called "chemo mouth," a painful inflammation of the mouth's mucous membranes, has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force Napo's core target patient audiences for Gelclair are head and neck cancer patients and bone marrow transplant patients SAN FRANCISCO, CA / ACCESS Newswire / April 8, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family company Napo Pharmaceuticals ("Napo") is exhibiting at the 50th anniversary Oncology Nursing Society (ONS) Congress taking place April 9-13, 2025 in Denver, Colorado as part of ongoing commercial activities for Gelclair. "We have expanded our footprint beyond HIV-related supportive care to include cancer-related supportive care, and our recent in-licensing of the FDA-approved oral mucositis product Gelclair is a first building block," said Lisa Conte , Jaguar's president and CEO. "Cancer is chaotic, because patients feel a loss of control - over their life, their treatment, and their supportive care needs," said Conte. "Jaguar's mission is to change patients' lives for the better, especially in the area of supportive care for complex disease states like cancer. We look forward to driving awareness among the oncology nursing community at ONS about Gelclair. Oral mucositis, also called "chemo mouth," is among the most common, painful, and debilitating cancer treatment-related side effects, and it is undertreated and underappreciated. We believe we can help cancer patients by giving them a supportive care product for oral mucositis that provides soothing, quick, and lasting pain relief without stinging, drying or burning." "If it weren't for Gelclair, I don't know if I would have continued with chemo. It was that painful. Gelclair gave me relief when nothing else did - it allowed me to keep going," said Megan-Claire, a Gelclair patient brand ambassador for Napo. Gelclair is a protective gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth. "Nurses play a vital role in providing integrated supportive care to cancer survivors to meet various physical, psychological, and social support needs," added Conte. "Jaguar and Napo acknowledge the rigors of both short-term and chronic treatment and do not believe any cancer therapy-related side effect, whether it is extreme fatigue, debilitating diarrhea, oral mucositis, hair loss, chronic pain, or others, should ever be viewed as ‘acceptable' or ‘tolerable.' We live in the age of targeted therapies, and thanks to these amazing drugs, cancer patients are living longer - 5, 10, 20 years. Targeted therapies often lead to more severe side effects, however, and patients want to live, not just survive." Napo's core target audiences for Gelclair are head and neck cancer patients and bone marrow transplant patients, and oncology-focused health care professionals. Head and neck cancers account for nearly 4 percent of all cancers in the United States , according to the National Cancer Institute (NCI).1 Counting cancers of the oral cavity, pharynx, and larynx, the NCI estimates that about 71,110 cases were diagnosed in the U.S. in 2024.2 Approximately another 23,000 patients each year undergo bone marrow transplant procedures. Oral mucositis has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force.3 Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy.4 Of the latter, 19% may end up being hospitalized, experiencing a delay in antineoplastic treatment for high-grade mucositis management, resulting in a reduction of the quality of life, a worse prognosis, and an increase in patient management costs.4 Oral mucositis impacts a patient's ability to swallow, speak, eat, and drink - and may lead to cancer treatment discontinuation.5 It is estimated that at least 11% of head and neck cancer patients experience cancer treatment interruption due to oral mucositis.6 "Those of us working in the oncology field know the impact that side effect-related delays or cessation of cancer treatment can have on overall survival and on the efficacy of treatment," Conte said. "Of patients with head and neck cancers treated with chemotherapy and radiotherapy who develop oral mucositis, half of the cases are typically considered severe - meaning oral mucositis of grade 3 or 4, which may require hospitalization and may require parenteral nutrition and IV hydration, and the morbidity and expense associated with those interventions." Jaguar also remains focused on development of crofelemer for cancer therapy-related diarrhea (CTD). As announced, the analysis of the prespecified subgroup of adult patients with breast cancer from Napo's recently conducted Phase 3 prophylactic OnTarget clinical trial for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy indicates that crofelemer achieved statistically significant results in this subgroup. These results were the subject of a December 11, 2024 poster presentation at the San Antonio Breast Cancer Symposium and the late-breaker abstract recently submitted to the Multinational Association of Supportive Care in Cancer (MASCC) for consideration for presentation at the June 2025 MASCC Annual Meeting. As also announced, the U.S. Food and Drug Administration (FDA) has granted Napo a Type C Meeting in the second quarter of 2025 to discuss the responder analysis in the prespecified subgroup of patients with breast cancer for crofelemer in OnTarget . The company's goal is to discuss the most efficient pathways to make crofelemer available to this patient population for CTD. The annual ONS Congress is a prominent event for professionals and organizations who are committed to the promotion of excellence in oncology nursing and the transformation of cancer care. ONS is a professional association that represents 100,000 nurses and is the professional home to more than 35,000 members. Since 1975, ONS has provided a professional community for oncology nurses, developed evidence-based education programs and treatment information, and advocated for patient care, all in an effort to improve the quality of life and outcomes for patients with cancer and their families. Learn more at www.ons.org. About Gelclair® INDICATIONS GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers. Please see full Prescribing Information at: https://www.gelclairhcp.com/pdf/prescribing-information-instructions-for-use.pdf About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Napo will exhibit at the April 2025 ONS Congress , and the expectation that Napo will meet with the FDA in the second quarter of 2025 regarding the statistically significant results of the OnTarget trial in the prespecified subgroup of patients with breast cancer. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet 2 https://www.aacr.org/patients-caregivers/awareness-months/head-and-neck-cancer-awareness-month/ 3 NCCN Task Force Report : Prevention and Management of Mucositis in Cancer Care . Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw , 6(S1), S-1-S-21. https://doi.org/10.6004/jnccn.2008.2001 4 Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7 ;39(1):210. doi: 10.1186/s13046-020-01715-7. PMID: 33028357; PMCID: PMC7542970 5 Vera-Llonch M , Oster G, Hagiwara M, Sonis S. Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma. Cancer. 2006;106(2):329-336. doi:10.1002/cncr.21622. 6 Trotti A, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8 . PMID: 12742264. Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc.