GLY-200

Planned Leadership Transition to Accelerate the Company’s Next Stage of Growth; Founding CEO Ashish Nimgaonkar, M.D., Transitions to Chief Medical Officer and Head of R&D Lead Candidate, GLY-200, Ready to Begin Phase 2b Development for Obesity and Type 2 Diabetes BOSTON--(BUSINESS WIRE)-- Glyscend Therapeutics, a clinical-stage biopharmaceutical company that is reshaping the treatment of metabolic disease, including obesity and type 2 diabetes, with first-in-class oral polymer medicines that address unmet needs for patients globally, today announced the appointment of Sapan Shah, Ph.D., as Chief Executive Officer. Dr. Shah has more than 25 years of experience leading innovative life science companies as CEO, founder, board member and strategic advisor. His appointment is part of a planned leadership transition to accelerate Glyscend’s growth as it further advances lead product candidate, GLY-200, a clinical stage oral polymer medicine targeting gut mediated metabolic signaling. In conjunction with the transition, founding CEO, Ashish Nimgaonkar, M.D., was appointed to the newly created role of Chief Medical Officer and Head of Research and Development. “I am thrilled to welcome Sapan to the team and excited to partner with him through the next phase of Glyscend’s growth. I also want to commend the entire Glyscend team for their dedication and efforts in getting the company to its current stage,” stated Dr. Nimgaonkar. “GLY-200 is well-positioned to advance into a Phase 2b trial for patients with obesity and type 2 diabetes, and I look forward to collaborating with Sapan to progress our lead program and bring forward additional therapies for patients living with metabolic diseases.” “Under Ashish’s leadership, Glyscend has made tremendous progress going from scientific hypothesis to clinical proof-of-concept in a positive Phase 2a trial. His insights across our clinical and research portfolio will be crucial to our continued success,” said Dennis McWilliams, Partner at Santé Ventures and Chair of Glyscend’s Board of Directors. “We are delighted to bring in Sapan at this pivotal time, with his deep experience in executing financings, business development deals and operational buildouts for development-stage companies. Together with our existing leadership, we have a clear path toward execution of our near- and long-term goals.” Dr. Shah has significant leadership experience in the biopharma industry, with a focus on building, financing and operating innovative companies advancing novel therapeutics that address critical areas of unmet medical need. His previous CEO roles have included StrideBio, a leading developer of novel adeno-associated virus (AAV) based gene therapies with a pioneering structure-driven capsid engineering platform that was acquired by Gingko Bioworks in 2023; ARMGO Pharma, a clinical-stage company advancing treatments for debilitating cardiac and rare muscle diseases; Ezose Sciences, a high-throughput glycomics platform company acquired by Sumitomo Bakelite in 2014; and Shionogi Inc., the U.S. pharmaceutical business of Shionogi & Co, Ltd. At StrideBio, Dr. Shah led efforts to expand the company’s capabilities and pipeline, execute multiple pharmaceutical partnerships and close a Series B financing with a top venture syndicate. At Shionogi, Dr. Shah launched the company’s initial U.S. business, ultimately building a fully integrated clinical development and commercial organization, including overseeing development programs and marketed products in the obesity and diabetes area. Dr. Shah began his career as a consultant with McKinsey & Company, where he advised pharmaceutical and biotech clients on a wide range of R&D, commercial and corporate strategy initiatives. Dr. Shah holds a Ph.D. in Molecular Biophysics and Biochemistry from Yale University and B.A. degrees in Mathematics, Biochemistry and Integrated Science from Northwestern University. “I am grateful for the opportunity to build on the fantastic progress made by Ashish and the entire Glyscend team, and to lead the next phase of growth. This is a transformative time for obesity and type 2 diabetes patients with current therapies showing remarkable results. However, significant unmet needs persist with large numbers of patients remaining uncontrolled or unable to tolerate available treatments. Given the magnitude of the global obesity-diabetes epidemic, new oral therapies with mechanisms of action that are complementary to existing approaches are urgently needed,” said Dr. Shah. “Based on recent Phase 2a clinical results, GLY-200 has the potential to offer obesity and type 2 diabetes patients an oral, well-tolerated and effective therapy. I look forward to working alongside the Glyscend team and Board to bring this important medicine to patients.” About Glyscend, Inc. Glyscend Therapeutics is a clinical-stage biopharmaceutical company that is reshaping the treatment of metabolic disease, led by obesity and type 2 diabetes (T2D), with first-in-class oral polymer medicines with the potential to address significant unmet needs for patients globally. The company’s lead candidate, GLY-200, is designed to be non-absorbed and selectively target and bind to the inner lining of the upper GI tract, where it can modulate nutrient sensing and downstream metabolic signaling pathways. Based on its unique mechanism of action, GLY-200 mimics the beneficial effects of metabolic surgery and duodenal exclusion devices. In a Phase 2a study in patients with T2D, GLY-200 was well-tolerated and demonstrated clinical proof-of-concept, with statistically significant improvements on glycemic control and body weight as well as potential beneficial effects on other metabolic markers. Glyscend plans to advance GLY-200 into longer term Phase 2b studies in patients with obesity and T2D. The company is backed by healthcare innovators, Santé Ventures and Brandon Capital Partners, and was founded based on research and funding from Johns Hopkins University, the Thiel Foundation and Breakout Labs. For more information, please visit .

GLY-200 Represents the First Orally Administered Agent for Obesity & Type 2 Diabetes with a Mechanism Designed to Replicate the Effects of Metabolic Surgery and Duodenal Exclusion Devices GLY-200 Appeared Well-Tolerated in Phase 1 and Phase 2a Trials, with No Safety Signals or Serious Adverse Events Observed Across Multiple Doses Evaluated Phase 1 and Phase 2a Data Support the Oral Pharmacologic Duodenal Exclusion Approach Clinical Proof-of-Concept Established in Phase 2a Trial in Patients with Type 2 Diabetes; Phase 2b Trial to be Initiated in the Near Future BOSTON--(BUSINESS WIRE)-- Glyscend Therapeutics, a clinical-stage biotechnology company pioneering a new generation of orally administered first-in-class gut-targeted polymer therapies for the treatment of metabolic diseases including obesity and type 2 diabetes (T2D) today announced that safety and pharmacodynamic data from the first-in-human Phase 1 trial of GLY-200 were published in Diabetes, Obesity and Metabolism. The data published demonstrate that GLY-200, the company’s lead clinical candidate, mimics the biomarker signature seen with metabolic surgery and appeared to be safe and generally well-tolerated. Glyscend also presented additional data from its Phase 2a clinical trial of GLY-200 at the recent American Diabetes Association (ADA) 83rd Scientific Sessions, which provide clinical proof-of-concept on its ability to reduce glucose and bodyweight in patients with T2D. Phase 1 First-in-Human Data As highlighted in the publication, safety and pharmacodynamics were assessed in a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending-dose study in healthy volunteers. No safety signals, serious adverse events, or dose-limiting toxicities were observed. Only mild to moderate dose-dependent gastrointestinal (GI) events occurred, showing that GLY-200 is likely safe and generally well tolerated at doses of ≤2.0 g twice daily. Pharmacodynamic results were consistent with the biomarker signature observed after Roux-en-Y gastric bypass surgery and duodenal exclusion devices making this the first clinical demonstration that duodenal exclusion can be achieved with an orally administered drug. Phase 2a Proof-of-Concept Data Data presented at ADA showed that, consistent with the Phase 1 study, no treatment- or dose-related safety signals were observed in the Phase 2a study in patients with T2D. No serious or severe adverse events were reported, and the most common adverse events were constipation, nausea, and diarrhea, all of which were mild. In general, the incidence of GI side effects decreased over time during the 2-week treatment period. Following a standardized meal, incremental plasma glucose AUC was reduced by approximately 45% in subjects receiving 2.0 g GLY-200 twice daily compared to placebo. The same subjects also reported reduced appetite, reduced food intake, and weight loss while on treatment. “Metabolic surgery is an established efficacious treatment for patients with T2D and obesity; however, its invasive and costly nature hinders its use and it can lead to serious complications in some patients,” said Mark Fineman, Ph.D., Glyscend’s Chief Development Officer and first author on the recent Phase 1 publication. “We are highly encouraged to see the acute clinical benefits of our orally administered first-in-class drug. The totality of the data on GLY-200 suggest it has the potential to replicate the mechanism of surgery and provide a non-invasive alternative to today’s invasive approaches. Given the orthogonal and upstream mechanism of GLY-200, it could be additive to other therapies used to manage these diseases. We are enthusiastic about the level of support we have seen in the patient treatment community and industry for GLY-200 and are working toward initiating a larger and longer Phase 2b trial in patients to more fully pro body weight loss and HbA1c reduction.” About Glyscend, Inc. Glyscend Therapeutics is a clinical-stage biopharmaceutical company developing novel, orally administered, polymer therapies that work on targets inside the gastrointestinal tract to treat a variety of metabolic and chronic disorders. Polymer-based therapies are a unique class of therapeutics with more than three decades of clinical experience in a wide range of applications. Glyscend’s polymer therapeutic platform evolved out of research at Johns Hopkins University where scientists were evaluating the mechanisms that result in significantly improved glucose and metabolic regulation that precedes weight loss in certain types of metabolic surgery. The company’s lead product candidate, GLY-200, is in clinical development for the treatment of type 2 diabetes and obesity. For more information, please visit .