Poxel Announces Multiple TWYMEEG® (Imeglimin) Abstracts Accepted for Oral Presentation

• Nine Imeglimin abstracts to be presented at the 66^th Annual Meeting of the Japanese Diabetes Society

LYON, France--(BUSINESS WIRE)--Regulatory News:

POXEL SA (Euronext: POXEL - FR0012432516) (Paris:POXEL), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, announced today that nine abstracts based on Imeglimin Phase 2b and Phase 3 clinical trials have been accepted for oral presentations at the 66^th Annual Meeting of the Japanese Diabetes Society (JDS), held in Kagoshima, Japan, May 11-13, 2023.

Partnered in Japan with the diabetes market leader, Sumitomo Pharma (Sumitomo), TWYMEEG is Poxel’s first commercialized product. Launched in 2021, sales have demonstrated a strong growth trajectory in recent months that led Sumitomo to increase its full year 2022 forecast¹. Sumitomo is continuing to strengthen TWYMEEG’s therapeutic profile, specifically exploring its potential benefits in Type-2-diabetes mellitus patients with chronic kidney disease with an open-label, multi-center Phase 4 study. The objective of this study is to assess the safety, efficacy and pharmacokinetics of TWYMEEG in Japanese type 2 diabetes patients with renal impairment.

The abstracts accepted for oral presentation² at the upcoming JDS are:

1. Analysis of early responders to Imeglimin monotherapy:
   a post-hoc analysis of clinical trial data in Japanese patients with Type-2-diabetes mellitus
2. Time analysis of treatment response and treatment failure to Imeglimin treatment:
   a post-hoc analysis of a study of Imeglimin monotherapy in Japanese patients with Type-2-diabetes mellitus
3. Characterization of responders to Imeglimin treatment:
   a post-hoc analysis of a study of Imeglimin add-on to insulin monotherapy in Japanese patients with Type-2-diabetes mellitus
4. Efficacy and safety of Imeglimin by concomitant insulin type:
   a post-hoc analysis of a study of Imeglimin add-on to insulin therapy in patients with Type-2-diabetes mellitus
5. Efficacy and safety of Imeglimin in Japanese patients with history of recent Type-2-diabetes mellitus: A post-hoc analysis of the Imeglimin monotherapy study
6. Efficacy and safety of imeglimin in patients with and without drinking habit:
   a post-hoc analysis of a clinical study of Imeglimin in Japanese patients with Type-2-diabetes mellitus
7. Efficacy and safety of Imeglimin in patients with and without smoking habit:
   a post-hoc analysis of a clinical trial of Imeglimin in Japanese patients with Type-2-diabetes mellitus
8. Antihyperglycemic effect of Imeglimin monotherapy: an analysis of response trajectories using time series cluster analysis
9. Effect of Imeglimin monotherapy on HOMA-β: a post-hoc analysis of a clinical study of Imeglimin in Japanese patients with type 2 diabetes mellitus.

Imeglimin is partnered with Sumitomo Pharma in Japan, and 12 other Asian countries³. Poxel is also considering potential additional partnerships in specific territories.

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders. For the treatment of NASH, 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 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, China, and eleven other Asian countries. 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.

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¹ Sumitomo’s fiscal year ends 0n March 31 2023.
² Official titles of presentations translated from original Japanese.
³ Includes: China, South Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, Philippines, Singapore, Myanmar, Cambodia, Laos