• Non-adoption of key financial delegations at the Combined General Meeting held on February 11, 2025 resulted in an adverse and uncertain situation regarding the continuation of the Company’s activities
  • Event of default triggered by this non-adoption under the financing agreements with IRIS and IPF Partners, allowing each of them to request immediate redemption of the outstanding bonds they hold (EUR 4.3 million and EUR 13.4 million respectively as of March 31,2025)
  • With a cash position of EUR 2 million as of March 31, 2025, the Company is unable to repay IRIS and IPF Partners if they redeem their outstanding bonds, which significantly compromises its ability to continue as a going concern
  • The Board of Directors and the Management are actively engaged in negotiations with Poxel’s creditors to find potential solutions
• Pending the outcome of ongoing negotiations with its creditors, the Company postpones the approval and release of its 2024 annual accounts

LYON, France, April 16, 2025--(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 reported its cash position as of March 31, 2025, provided an update on its financial situation and ongoing negotiations with its creditors, and announced the postponement of its 2024 full-year results approval and publication, pending the outcome of ongoing negotiations.

Consolidated cash and cash equivalents (unaudited)

As of March 31, 2025, total consolidated cash and cash equivalents amounted to EUR 2 million (USD 2.1 million¹), as compared to EUR 3.7 million as of December 31, 2024.

(1) Including EUR 550 thousand corresponding to cash held in security trusts bank accounts to secure their financing for several years, in accordance with the royalty monetization agreement

(2) Excluding OrbiMed deposit for an amount of EUR 4,8 million (USD 5 million) allocated, in Q1 2025, to the reimbursement of the IPF Partners debt as per bonds documentation

Financial risk and update on negotiations

The non-adoption of the financial delegations at the Combined General Meeting held on February 11, 2025, and, in particular, on the issuance of new shares in redemption for bonds redeemable into new or existing shares (ORANE) held, or to be potentially issued and held by IRIS, triggered an event of default under the IRIS and IPF Partners bond financing agreements allowing each of them to request mandatory redemption of the bonds they hold (EUR 4.3 million and EUR 13.4 million respectively as of March 31, 2025).

Since then, the Board of Directors and the Management of Poxel have been actively negotiating with the Company’s creditors, with the aim of reaching a structuring solution that would ensure the continuity of the Company’s operations. In parallel the Company is also progressing discussions with several potential partners for its pipeline products.

Notwithstanding the recent restructuring of the Company's debt made possible in particular by the royalty monetization transaction with OrbiMed, and based on the cash position as of March 31, 2025, Poxel’s financial outlook remains highly constrained with a cash runway currently estimated between mid to end Q2 2025, depending on the outcome of current discussions with creditors. The situation and the uncertainty surrounding the outcome of ongoing negotiations represent a material risk to the Company’s ability to continue as a going concern.

Given the potential impact of the negotiations on the Company’s financial statements, Poxel announces the postponement of the approval and publication of its 2024 Full-Year Results, initially scheduled for April 22, 2025. A new date will be communicated once the negotiations are finalized.

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.

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¹ Converted at the exchange rate on March 31, 2025

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Contacts

Contacts - Investor relations / Media

NewCap
Aurélie Manavarere, Théo Martin / Arthur Rouillé
investors@poxelpharma.com
+33 1 44 71 94 94