Poxel Reports Cash and Revenue for the Full Year 2023 and Provides Corporate Update - Seite 2

TWYMEEG (Imeglimin)

• Following the much higher increase in demand for TWYMEEG than expected, and temporarily tight inventories, Sumitomo Pharma continues to work diligently to increase production to ensure sustained inventory capacity.
• The Long-Term, 52-week, Open-label, Phase 4 Study conducted by Sumitomo Pharma of Imeglimin in Japanese Type 2 Diabetic Patients with Renal Impairment is currently ongoing in Japan to strengthen TWYMEEG profile in this key subpopulation. Top line results are expected in 2024.

Rare metabolic diseases

• In February 2024, the European Patent Office (EPO) granted Poxel a new patent for PXL770, a novel, proprietary direct adenosine monophosphate kinase activator, which describes the use of PXL770 in the treatment of Autosomal-dominant polycystic kidney disease (ADPKD). This issued patent provides additional protection for PXL770 through 2041, with the potential for an additional 5 years through patent term extension. End of 2023, Poxel had been granted the same patent for PXL770 from the Japan Patent Office and the obtention is currently under review in other territories, including in the US.
• In adrenoleukodystrophy (ALD), PXL770 and PXL065 are prepared to advance, subject to additional financing, into two Phase 2a biomarker proof-of-concept (POC) clinical trials in male patients with adrenomyeloneuropathy (AMN), the most common ALD subtype. The studies will evaluate pharmacokinetics, safety and potential for efficacy, following 12-week treatment, based on relevant disease biomarkers, such as the effect on very long chain fatty acids (VLCFA), the characteristic plasma marker of the disease.

Full-Year Cash and Revenue, ended December 31, 2023

Cash

As of December 31, 2023, total cash and cash equivalents were EUR 2.3 million (USD 2.6 million)¹, as compared to EUR 13.1 million (USD 14.0 million) as of December 31, 2022.

EUR (in thousands)	Q4 2023	Q4 2022
Cash	2,341	13,058
Cash equivalents	-	-
Total cash and cash equivalents*	2,341