ROCKVILLE, MD and SHENZHEN, CHINA, June 6, 2026 – HighTide Therapeutics, Inc. (2511.HK), an innovative biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for cardiovascular–kidney–metabolic (CKM) diseases, today announced the presentation of clinical and preclinical data for its lead asset, HTD1801, at the 86th Scientific Sessions of the American Diabetes Association (ADA) in New Orleans. The presentations feature long-term extension data, head-to-head Phase III results, and combination data in weight management, building upon the compound’s clinical momentum following the coming publication of its Phase III SYMPHONY-2 study in NEJM Evidence, a journal from the NEJM Group.
Abstract Title: Long-term Safety and Efficacy of HTD1801 In Patients with Type 2 Diabetes: Two Phase III Open-label Extensions
Poster Number: 1823-P
Date/Time: Sunday, June 7, 2026, 12:30-1:30 p.m. CDT
Format: Poster Presentation
Author: Yingying Luo, Jianhua Ma, Zhifeng Cheng, Shenglian Gan, Kui Liu, Meng Yu, Leigh MacConell, Liping Liu, Linong Ji
Abstract: In two 52-week open-label extension studies, HTD1801 demonstrated durable glycemic control and sustained treatment benefits. In SYMPHONY-1 and SYMPHONY-2, patients who continued HTD1801 maintained HbA1c reductions of -1.2% and -1.1%, respectively, while patients switched from placebo to HTD1801 achieved HbA1c reductions of -1.3% and -1.2%. Sustained improvements were also observed in LDL-C, hs-CRP, and eGFR. These findings support HTD1801 as a well-tolerated, effective therapy for patients with T2DM.
Abstract Title: HARMONY: A Head-to-head Phase III Study of HTD1801 Versus Dapagliflozin
Poster Number: 1781-P
Date/Time: Sunday, June 7, 2026, 12:30-1:30 p.m. CDT
Format: Poster Presentation
Author: Linong Ji, Zhifeng Cheng, Hanqing Cai, Jie Han, Li Lu, Qingju Li, Huihui Wang, Yan Wang, Jianhua Ma, Chunrong Xu, Dijun Zhou, Bin Lu, Yan Bi, Yuqian Bao, Zhiguang Zhou, Kui Liu, Leigh MacConell, Meng Yu, Liping Liu
Abstract: In the head-to-head Phase III HARMONY study versus dapagliflozin (Dapa), HTD1801 met its primary endpoint in patients with T2DM. At Week 24, HbA1c decreased by -1.12% with HTD1801 versus -0.93% with Dapa (LS mean difference: -0.20%), with a higher proportion of patients achieving HbA1c <7%. Beyond glycemic control, HTD1801 showed superiority for key lipid parameters, and eGFR increased in the overall population with HTD1801 compared to no change with Dapa. These findings suggest that HTD1801 may provide greater glycemic efficacy, with more pronounced and distinctive effects on cardiovascular and renal risk factors, and therefore may provide a unique treatment option for patients with CKM diseases.
Abstract Title: Enhanced Weight Loss When HTD1801 Is Combined With GLP-1RAs In DIO Mice
Poster Number: 2550-P
Date/Time: Monday, June 8, 2026, 12:30-1:30 p.m. CDT
Format: Poster Presentation
Author: Ru Bai, Liping Liu, Junwei Cheng, Meng Yu, Leigh MacConell, Filip Surmont
Abstract: The preclinical study evaluated the weight loss effect of HTD1801 in combination with GLP-1RAs. Compared with semaglutide (Sema) or tirzepatide (Tirze) monotherapy, combination with HTD1801 produced significantly greater weight loss, driven by further reductions in fat mass with minimal impact on lean mass. Furthermore, after Sema discontinuation, HTD1801 significantly reduced body weight rebound with lower fat mass ratio, higher lean mass ratio, and significantly attenuated glucose rebound.
“The three studies presented this year at the ADA Scientific Sessions showcase the comprehensive benefit profile of HTD1801 in CKM diseases,” said Dr. Filip Surmont, Chief Medical Officer of HighTide Therapeutics. “With the New Drug Application (NDA) for HTD1801 accepted for review by China’s National Medical Products Administration (NMPA), we will continue to advance its clinical development and commercialization, and to bring innovative treatment options to patients with CKM diseases in China and worldwide.”
About HTD1801
HTD1801 is a first-in-class new molecular entity that targets the residual risks underlying cardiovascular–kidney–metabolic (CKM) diseases. It is an orally delivered, anti-inflammatory metabolic modulator (AIMM) that, as a single molecule, exerts a unique dual mechanism of action through activation of AMP Kinase and inhibition of the NLRP3 inflammasome, two complementary pathways that mitigate metabolic dysfunction. Multiple global clinical studies have demonstrated the comprehensive benefits of HTD1801, including improved insulin sensitivity, glycemic control, lipid lowering, renal protection, weight reduction, hepatic improvement, and anti-inflammatory effects. Collectively, these findings support the potential of HTD1801 to serve as a foundational therapy in CKM disease management.
About HighTide Therapeutics
HighTide Therapeutics, Inc. (2511.HK) is an innovative biopharmaceutical company dedicated to developing multifunctional, multi-targeted therapies for cardiovascular-kidney-metabolic (CKM) diseases. The company focuses on delivering breakthrough treatments that generate comprehensive, multi-organ benefits for patients worldwide. HighTide has built an innovative, globally integrated pipeline of proprietary assets and advanced multiple clinical programs across CKM diseases. The company’s lead asset, HTD1801, has received two Fast Track designations and one Orphan Drug designation from the US Food and Drug Administration (FDA), and has been selected for China’s National Major Science and Technology Project for Significant New Drug Development.
For more information, please visit www.hightidetx.com Contact: pr@hightidetx.com