PDE4B

Bruce Sands, MD, MS., Dr. Burrill B. Crohn Professor of Medicine, Icahn School of Medicine at Mount Sinai and System Chief, Division of Gastroenterology, Mount Sinai Health SystemFlorian Rieder, MD, Associate Staff in the Department of Gastroenterology, Hepatology, and Nutrition, as well as an Investigator in the Department of Pathobiology at the Cleveland Clinic Carlsbad, CA, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today announced the appointments of Bruce Sands, MD, MS and Florian Rieder, MD to its Clinical Advisory Board (CAB). Drs. Sands and Rieder will be advising Palisade on the advancement of its product candidates from preclinical studies to clinical trials. “We are committed to advancing the treatment landscape for Inflammatory Bowel Disease (IBD) and believe that the appointment of these preeminent key opinion leaders will assist in the development of a precision approach for IBD treatment,” commented J.D. Finley, Chief Executive Officer of Palisade. “The leadership and guidance that Drs. Sands and Rieder bring to our CAB will greatly assist us as we advance the development of our program, beginning with our lead asset PALI-2108 for the treatment of ulcerative colitis, which remains on track for the launch of a Phase 1 clinical study next year.” About Bruce Sands MD, MS Bruce Sands, MD, MS is the Dr. Burrill B. Crohn Professor of Medicine. Dr. Sands is an expert in the management of IBD and has earned an international reputation for his care of patients with complex and refractory disease. He joined Mount Sinai in 2010 as Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Prior to joining Mount Sinai, Dr. Sands was Medical Co-Director of the Crohn's & Colitis Center at Massachusetts General Hospital in Boston, where he also served as the hospital's Acting Chief of the Gastrointestinal Unit as well as Associate Professor of Medicine at Harvard Medical School. A longtime advocate for the continued translational research in Crohn's disease and ulcerative colitis, Dr. Sands is widely recognized for his innovative treatment of IBD and for his clinical investigations of new therapeutics. He was among the first to report the efficacy of infliximab-a drug used to treat autoimmune diseases-in ulcerative colitis, a result later confirmed in large, multi-center randomized controlled trials. Dr. Sands was also principal investigator for the landmark ACCENT II study, an international project that demonstrated the efficacy of the anti-tumor necrosis factor antibody infliximab as a long-term treatment for fistulizing Crohn's disease. Dr. Sands' research also explores IBD epidemiology and includes the creation of a population-based cohort of IBD in Rhode Island, a project that is funded by the Centers for Disease Control and Prevention. A leader in several major professional organizations, Dr. Sands has served as the chair of the Clinical Research Alliance of the Crohn's Foundation of America, Chair of the Immunology, Microbiology and Inflammatory Bowel Disease Section of the American Gastroenterological Association (AGA), and chair of the International Organization for the Study of IBD. He is an AGA Fellow (AGAF) and a fellow of the American College of Gastroenterology (FACG). In 2006 he was named Humanitarian of the Year by the New England Chapter of the Crohn's and Colitis Foundation of America, the Crohn’s & Colitis Foundations Henry D. Janowitz Lifetime Achievement Award and Mount Sinai’s Jacobi Medallion. Dr. Bruce Sands is a paid advisory board member for Palisades Bio. Dr. Sands stated, “I am pleased to join Palisade Bio's Clinical Advisory Board, and I see tremendous potential in PALI-2108 as a transformative therapy for Ulcerative Colitis. If successful, PALI-2108 would offer the convenience of oral delivery with colonic activation and activity, thereby minimizing systemic exposure and the risk of adverse events while achieving superior efficacy. The added potential for a precision medicine approach to identify patients who can benefit most based on their PDE4B-associated biomarker profile could lead to a truly superior risk-benefit profile for this agent in ulcerative colitis.” About Florian Rieder, MD Dr. Rieder is Vice Chair, Co-Director of the IBD section, and Director of the Program for Global Translational IBD at the Department of Gastroenterology, Hepatology and Nutrition at the Cleveland Clinic, Cleveland. His clinical focus is patients with IBD with a special emphasis on the field of pathogenesis, prediction and therapy of intestinal fibrosis. Dr. Rieder has published more than 150 articles (h-index 52) and book chapters and has been recognized for his expertise as indicated through invitations to clinical guideline steering committees of the European Crohn’s and Colitis Organization (ECCO). He is lead author of the ECCO guidelines on Ulcerative colitis and lead author of the first ECCO clinical consensus on ‘Diagnosis and Management of Intestinal Fibrosis’. He received multiple international invitations as a speaker, session chair or conference faculty. Dr. Rieder serves as an abstract reviewer for all major GI conferences, he is past associate editor (Clinical and Translational Gastroenterology) and on several editorial boards of medical journals. He is proud of his significant ties to the ECCO, which he served as the chair of Y-ECCO, member of the ECCO operational board, prior Y-ECCO committee member and member of the scientific committee. He is past chair of REACH-IBD and Co-Chair of the Professional Education Committee of the Crohn’s and Colitis Foundation. Dr. Rieder is the leading PI on the international Stenosis Therapy and Research (STAR) Consortium with the goal to build a pathway to test anti-fibrotic medications in stricturing Crohn’s disease. Dr. Rieder added, "It is with great enthusiasm that I join Palisade Bio's Clinical Advisory Board. While we are excited about both programs, the PALI-1908 program is tailored to address fibro stenotic Crohn's Disease, an area where there are currently no FDA-approved therapies. PALI-1908 boasts several advantages, including oral delivery for patient convenience, localized activation, and activity in the colon, and a true pleiotropic mechanism with both anti-inflammatory and anti-fibrotic properties. This combination of attributes positions PALI-1908 as a highly competitive candidate in the treatment landscape for fibro stenotic Crohn's Disease, and we look forward to advancing this program to meet the pressing needs of these patients." About Palisade Bio Palisade Bio is a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com. Forward Looking Statements This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic or any global event on our business, and operations, and supply. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, as well as the Company’s Quarterly Report on Form 10-Q, for the three and nine month periods ended September 30, 2023, filed with the SEC on November 9, 2023. These forward-looking statements speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Investor Relations Contact JTC Team, LLCJenene Thomas 833-475-8247PALI@jtcir.com Source: Palisade Bio Attachments Palisade Bio, Inc. Palisade Bio, Inc.

Boehringer Ingelheim intends to create breakthrough therapies’to enhance patient outcomes. Credit: Boehringer Ingelheim International. Boehringer Ingelheim has signed a licensing agreement with Japan’s Kyowa Kirin to develop a new treatment for fibro-inflammatory diseases. The deal aligns with Boehringer Ingelheim’s strategy to create breakthrough therapies in this disease area to enhance patient outcomes. Boehringer Ingelheim will receive exclusive rights from the Japanese pharmaceutical and biotechnology company to develop treatments globally. Kyowa Kirin will receive €410m, including an upfront payment and additional success-based milestones, along with sales royalties. Kyowa Kirin senior managing executive officer, chief medical officer and board director Takeyoshi Yamashita stated: “We are pleased to announce that we have signed the licence agreement with Boehringer Ingelheim. “The compound was discovered through Kyowa Kirin’s expertise in innovative technology and disease biology. Boehringer Ingelheim is highly regarded for its expertise in fibro-inflammatory diseases, and we believe that it should be the best partner to maximise and deliver the value of our compound for patients in need.” Fibro-inflammatory diseases, which include conditions such as systemic sclerosis and lung fibrosis, are caused by chronic inflammation and are a significant source of morbidity and mortality globally. Such diseases severely affect a patient’s quality of life and are responsible for more than one-third of deaths worldwide. Boehringer Ingelheim corporate senior vice-president and discovery research global head Clive Wood stated: “We are very excited about partnering with Kyowa Kirin and being able to add this opportunity to our portfolio to develop breakthrough treatments for patients with this new collaboration.” Boehringer is conducting Phase III clinical trials for BI 1015550, a PDE4B inhibitor, targeting idiopathic pulmonary fibrosis and other progressive fibrosing interstitial lung diseases. Boehringer recently signed a partnership and licensing agreement with 3T Biosciences for the discovery and development of next-generation cancer immunotherapies.

FDA clears IND to launch CONQUEST trial platform with initial focus on Interstitial Lung Disease Secondary to Scleroderma (SSc-ILD) SCLERODERMA RESEARCH FOUNDATION (SRF) holds the IND as trial Sponsor Sanofi and Boehringer Ingelheim share the platform; patient enrollment to begin early in 2024 SAN FRANCISCO, Dec. 19, 2023 /PRNewswire/ -- The Scleroderma Research Foundation (SRF), the nation's largest non-profit funder of scleroderma research, today announced that the FDA has cleared its Investigational New Drug application (IND) to launch the CONQUEST clinical trial platform and begin enrolling patients. Sanofi and Boehringer Ingelheim will each contribute an experimental agent to CONQUEST, and as such they are the first pharma partners to commit to this protocol designed to efficiently advance new scleroderma treatments through clinical development. The first two nominated investigational drugs will be evaluated for safety and efficacy in scleroderma patients burdened by interstitial lung disease (SSc-ILD). The Sanofi agent is amlitelimab, a non-depleting monoclonal antibody that binds to OX40-Ligand; the Boehringer Ingelheim agent is BI -1015550, an oral PDE-4B inhibitor. Both investigational agents have shown preliminary evidence of efficacy in prior clinical trials for non-scleroderma indications in modifying disease processes. Luke Evnin, Ph.D., Chairman of the Scleroderma Research Foundation, commented, "Both Sanofi and Boehringer Ingelheim have a rich history of innovation in the immunologic and fibrotic disease arena, and they are bringing their considerable expertise to CONQUEST. With these two partners, CONQUEST is well positioned to ensure that the platform will animate the SRF vision of building a global community tuned to rapid and efficient clinical development of promising novel therapeutic agents for the high unmet needs of scleroderma patients. I am proud and excited to see two promising experimental agents for SSc-ILD advancing, and I have high hopes that these agents will prove safe and efficacious in our patients." Boehringer Ingelheim's BI - 1015550 is an orally-administered phosphodiesterase 4B (PDE4B) inhibitor that is being investigated as a potential treatment for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Preclinical studies have shown that BI 1015550 has anti-inflammatory and antifibrotic properties. The FIBRONEER™ global program includes two Phase III studies – FIBRONEER-IPF (NCT05321069) in patients with IPF and FIBRONEER-ILD (NCT05321082) in people living with other progressive fibrosing interstitial lung diseases (ILDs) and was initiated in 2022. The FDA granted BI - 1015550 Breakthrough Therapy Designation for the treatment of IPF in February 2022 and Orphan Drug Designation for BI -1015550 in IPF in October 2022. According to Ioannis Sapountzis, Global Head of Therapeutic Areas, Boehringer Ingelheim, "As a global innovation leader, we remain steadfast in our commitment for people living with scleroderma. Mounting our agents into CONQUEST is a critical step to help bring forward this next generation of treatment to those in need as quickly as possible." Sanofi's amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-ligand, a key immune regulator, and has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis, asthma and hidradenitis suppurativa. By targeting OX40-ligand, amlitelimab aims to restore balance between pro-inflammatory and regulatory T cells. According to Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation, Research & Development, Sanofi, "We look forward to initiating the amlitelimab development program in scleroderma, an underserved condition with high morbidity and mortality rates and limited treatment options. With our knowledge about the underlying biology of the disease and amlitelimab's unique mechanism of action, we hypothesize that amlitelimab could have benefits on ILD and dermal fibrosis endpoints of scleroderma. To date, amlitelimab's potential has been encouraging and we look forward to further advancing this asset as part of our commitment to delivering best-in-class treatments that improve the lives of people living with chronic inflammatory diseases." Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. The CONQUEST platform will be open to adding additional investigational agents starting in 2025. One of the key features of the platform is that new drugs can be added at any time with minimal regulatory overhead and an opportunity to take maximum benefit of the infrastructure of the platform. In addition, the anonymized patient-by-patient data from the placebo arm will be owned by the SRF and become an invaluable resource for the entire community. About CONQUEST Using a model first created over a decade ago to accelerate oncology drug development, the SRF platform clinical trial is the first of its kind in autoimmune diseases. In its initial iteration, CONQUEST will focus on Interstitial Lung Disease secondary to Scleroderma (SSc-ILD) which manifests in patients as lung fibrosis. In the future, the CONQUEST platform will be expanded to address other manifestations of scleroderma. The ground-breaking effort, conceived and led by the SRF, will enroll patients across more than 130 centers in more than 22 countries. CONQUEST allows multiple therapies to be evaluated under a common trial infrastructure with a common control arm. CONQUEST will initially enroll approximately 400 patients but with the advantages of the platform design, only approximately 134 patients will be randomized to the placebo arm (to receive standard-of-care). Accordingly, the design is very patient-centric since patients generally enroll in a trial to get access to novel medicines. However, the trial retains high statistical power for analysis of efficacy endpoints since the data from the placebo patients from all concurrently enrolled sub-protocols (e.g. Sanofi and Boehringer Ingelheim) will be pooled for efficacy analysis. This efficiency is not available in traditional trials and is one of the features that underscore the uniqueness of CONQUEST. By assembling a global network of high-performing centers that are dedicated to treating scleroderma, the SRF and its pharmaceutical partners expect to make enduring contributions to the scleroderma community by creating an ecosystem designed to enable success in new drug development. Sanofi and Boehringer Ingelheim are the inaugural partners for CONQUEST, which was first announced on August 1, 2023. About Scleroderma Scleroderma is a systemic autoimmune disease that affects approximately 100,000 patients in the US with high morbidity and mortality rates and for which there are limited treatment options. The disease presents multiple challenges for patients with a spectrum of symptoms that prominently include vascular disease and internal organ fibrosis. About the Scleroderma Research Foundation The Scleroderma Research Foundation (SRF), a 501(c)(3) organization, was established in 1987 with a mission to fund and facilitate the most promising, highest-quality research aimed at new treatments and, ultimately, a cure for scleroderma. Led by a Scientific Advisory Board comprised of some of the most highly regarded scientists in the nation, the SRF's research program actively seeks out the leading scientific minds from disparate fields including autoimmunity, immunology, genetics, and fibrosis to join the scleroderma research community. In addition to its core research program, the SRF has also led the formation of two other large-scale projects aimed at accelerating scleroderma research: The CONQUER Registry, the first nationwide longitudinal registry for scleroderma patients, and The GRASP Project, which examines scleroderma in the African American community. The SRF is also dedicated to educating people living with scleroderma and their caregivers as they learn about how to best manage the challenges of the disease. About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the two business areas, Human Pharma and Animal Health. Learn more at . For more information about the FIBRONEER™ program, please visit ClinicalTrials.gov. BI -1015550 is an investigational therapy, which has not been approved for any proposed indication by any regulatory authority including the U.S. Food and Drug Administration (FDA). Boehringer Ingelheim is currently investigating its efficacy and safety profile. Shari Annes Annes Associates Cell 650 888 0902 370254@email4pr.com View original content to download multimedia: SOURCE Scleroderma Research Foundation