Imeglimin Hydrochloride

LYON, France--(BUSINESS WIRE)--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including Metabolic dysfunction-Associated SteatoHepatitis (MASH) and rare metabolic disorders, today announces the postponement of its 2025 Annual General Meeting, which is intended to approve the financial statements for the year ended December 31, 2024, and provides a corporate update. By order dated June 24, 2025, the President of the Lyon Court for Economic Activities, granted the Company’s request to postpone Poxel’s 2025 Annual General Meeting by extending the deadline for holding it until December 31, 2025, at the latest. Initially scheduled for June 26, 2025, the Annual General Meeting has been postponed to a later date due to the delay in the approval of its statutory and consolidated financial statements for the fiscal year ended December 31, 2024. As announced on April 16, 2025, due to the potential impact of ongoing negotiations on its financial statements with the Company’s financial creditors and with potential partners for the development of its product pipeline, Poxel postponed the closing and publication of its 2024 annual results. The holding of the Annual General Meeting remains subject to the approval of the financial statements for the year ended December 31, 2024, by the Board of Directors. Pending the outcome of ongoing negotiations, the Company currently estimates that its cash runway extends though the course of July 2025. Poxel will update the market and its shareholders on its revised 2025 financial calendar as soon as possible, including the date of its next General Meeting. About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: www.poxelpharma.com All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

LYON, France--(BUSINESS WIRE)--Regulatory News: POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces that new clinical and scientific data on TWYMEEG® will be presented at the 68th Annual Meeting of the Japan Diabetes Society (JDS 2025), taking place from May 29 to 31, 2025, in Okayama, Japan. A total of 15 presentations1, including results from 7 clinical trials, 3 post-hoc analyses2 and 5 non-clinical studies supported by Sumitomo Pharma, will be delivered by leading Japanese diabetes experts. These findings further confirm TWYMEEG®’s efficacy in monotherapy and combination therapies, safety, dual mechanism of action and potential benefits in specific patient populations. Main topics include: TWINKLE ( TW YMEEG ® in d i abetic patients with re n al impairment: A post-mar k eting l ong-t e rm study) study (Phase 4 study) : confirmation of TWYMEEG ® efficacy and safety in diabetic patients with renal impairment FAMILIAR Study : confirmation of TWYMEEG ® efficacy and safety in combination with DPP-4 inhibitors PARADIME Clamp : confirmation of TWYMEEG ® dual mechanism of action in diabetic patients – clinical data showing effects on insulin sensitivity (clamp part) and glucose stimulated insulin secretion (OGTT part) PARADIME TIR : confirmation of TWYMEEG ® effects on glucose variability PET/MRI Study : confirmation of TWYMEEG ® effect on glucose excretion in the gut Thomas Kuhn, Chief Executive Officer of Poxel, stated: “We are proud to see the scientific community’s continued interest and the commitment of our partner Sumitomo Pharma to document and promote TWYMEEG®’s attributes and value. These presentations further support the product’s clinical and commercial trajectory in Japan. They also highlight its value proposition for Japan and other territories and its unique profile across diverse patient subgroups.” About Poxel SA Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan. For more information, please visit: www.poxelpharma.com All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release. Appendix Title Main Results Speaker Institution Type A post-marketing clinical trial to evaluate the safety, tolerability, and efficacy of Imeglimin in Japanese type 2 diabetes patients with renal impairment (Twinkle Study results;Phase 4) Imeglimin was shown to be safe and effective in patients with T2D associated with renal dysfunction with eGFR less than 45 mL/min/1.73 m2 Dr. Babazono Ishikawa Memorial Association Clinical Efficacy and safety of Imeglimin as an add-on treatment in type 2 diabetes patients treated with DPP-4 inhibitors: interim analysis of the FAMILIAR study Combination therapy of Imeglimin and DPP-4 inhibitors significantly reduced HbA1c at 24 weeks in type 2 diabetes patients with inadequate glycemic control with DPP-4 inhibitor therapy, confirming that Imeglimin may be a new treatment option when combined with a DPP-4 inhibitor regardless of age. Dr. Kaku Kawasaki Medical School Clinical Comparison of the effects of Imeglimin and metformin on insulin and incretin secretion Imeglimin enhanced insulin secretion as well as increased not only GLP-1 but also GIP secretion, unlike metformin Dr. Omori Kansai Electric Power Hospital Clinical Effect of Imeglimin use on Time in Range in type 2 diabetes: A multicenter randomized controlled trial (Paradime-TIR) Imeglimin alone and in combination with DPPIV inhibitors increased Time in Range by more than 10% without increasing Time Below Range, confirming the efficacy of the product in reducing glycemic variability Dr. Ueda Kobe Univ. Clinical The effects of Imeglimin and metformin on insulin secretion and sensitivity (Paradime-Clamp; OGTT part) No differences were observed between Imeglimin and Metformin on glucose lowering effects, and on insulin secretion and insulin sensitivity effects Dr. Yamada Kobe Univ. Clinical The effects of Imeglimin and metformin on insulin secretion and sensitivity (Paradime-Clamp; Clamp part) No differences were observed between Imeglimin and Metformin on insulin secretion, insulin sensitivity and their ability to switch energy sources Dr. Katsura Kobe Univ. Clinical Effects on glucose excretion to gut by using FDG/PET MRI study Imeglimin improved glucose excretion into the intestinal lumen Dr. Fukumitsu Kobe Univ. Clinical Post-hoc analysis (Atypical cluster analysis of Imeglimin + Metformin) The highest A1c reduction of the combination Imeglimin + metformin was observed in obese patients or those with a high baseline HbA1c Kitayama SMP Clinical Post-hoc analysis: Insulin combination therapy Combination therapy with Imeglimin and insulin exerted glucose lowering effects independent of obesity type Hagi, PhD SMP Clinical Post-hoc analysis: Monotherapy Imeglimin monotherapy exerted glucose lowering effects independent of obesity type Maruyama SMP Clinical Vascular protection effects of Imeglimin, a mitochondrial function-improving drug Imeglimin showed protective effect against vascular lesions like SGLT2 inhibitors and GLP-1 receptor agonists Dr. Iwazawa Juntendo Univ. Shizuoka Hospital Non-clinical Effect of Imeglimin on diabetic neuropathy in type 1 diabetic rat models Imeglimin may be effective against diabetic neuropathy as shown in this study in STZ-induced diabetic rats, Dr. Nihei Aichi Gakuin Univ. Non-clinical Combined effects of anaerobic exercise and Imeglimin on skeletal muscles The combination of Resistance Training and Imeglimin may be an effective treatment by improving mitochondrial function, glucose metabolism and glucose uptake Dr. Ishiguro Niigata Univ. Non-clinical Effect of Imeglimin on periodontitis associated with type 1 diabetes Imeglimin may be useful in preventing the worsening of periodontal disease due to type 1 diabetes. Dr. Kondo Aichi Gakuin Univ. Non-clinical Imeglimin effect on intestinal gene expression Imeglimin induced similar gene expression as metformin in the whole intestinal tissue, but single-cell analysis revealed different effects on specific cell types, including intestinal cell clusters and macrophage clusters Dr. Hozumi Kobe Univ. Non-clinical 1 Detailed program included in Appendix 2 Refers to a statistical analysis specified after a study has been concluded and the data collected