TZD

Poxel Reports Financial Results for First Half 2023 and Provides a Corporate Update

Retrieved on: 
Tuesday, September 26, 2023

POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2023 and provided a corporate update.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2023 and provided a corporate update.
  • For the Sumitomo Pharma FY 2023, as a conservative assumption in line with Sumitomo Pharma’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD.
  • This recently issued patent provides additional protection through 2041, with the potential for an additional 5 years through patent term extension.

Poxel Reports Cash and Revenue for the Second Quarter and First Half 2023 and Provides Corporate Update

Retrieved on: 
Wednesday, August 30, 2023

These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo, and thus inventories are temporarily tight.

Key Points: 
  • These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo, and thus inventories are temporarily tight.
  • For the Sumitomo FY 2023, as a conservative assumption in line with Sumitomo’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD.
  • As of June 30, 2023, cash and cash equivalents were EUR 7.6 million (USD 8.2 million), as compared to EUR 13.1 million (USD 14.0 million) as of December 31, 2022.

Poxel Announces its Participation at Patient Association Conferences in Adrenoleukodystrophy

Retrieved on: 
Thursday, June 15, 2023

Poxel remains committed to discover, develop, and commercialize innovative therapies for patients suffering from serious chronic and rare diseases with underlying metabolic pathophysiology, starting with ALD.

Key Points: 
  • Poxel remains committed to discover, develop, and commercialize innovative therapies for patients suffering from serious chronic and rare diseases with underlying metabolic pathophysiology, starting with ALD.
  • PXL770 and PXL065 have demonstrated preclinically their efficacy in adrenomyeloneuropathy (AMN) and cerebral ALD (c-ALD) in mouse and human models1.
  • In line with his mission to bring therapeutic options to treat ALD, Poxel recently supported the Alex Leukodystrophy Charity during their Community Weekend, which took place from April 28th to May 1st in Birmingham, England.
  • This event brings together leukodystrophy sufferers and their families, alongside doctors, researchers and scientists from around the world to discuss leukodystrophies.

Poxel Reports Financial Results for Full Year 2022 and Provides Corporate Update

Retrieved on: 
Thursday, March 23, 2023

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, today announced its results for the year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • 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, today announced its results for the year ended December 31, 2022 and provided a corporate update.
  • Based on recent sales trends, Sumitomo has increased its fiscal year 20223 forecast by 20% to JPY 1.8 billion6 (EUR 12.8 million)5.
  • For the Sumitomo fiscal year 2023 (ending March 31, 2024), as a conservative assumption, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • Beyond 2024, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds.

Poxel Reports Cash and Revenue for the Full Year 2022 and Provides Corporate Update

Retrieved on: 
Wednesday, February 15, 2023

Thomas Kuhn, Chief Executive Officer of Poxel, stated: “We are very pleased with the most recent figures of TWYMEEG sales in Japan.

Key Points: 
  • Thomas Kuhn, Chief Executive Officer of Poxel, stated: “We are very pleased with the most recent figures of TWYMEEG sales in Japan.
  • For the Sumitomo fiscal year 2023 (ending March 31, 2024), as a conservative assumption Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • In Q4 2022, Poxel initiated a corporate savings plan which includes a significant workforce reduction.
  • Full-Year Cash and Revenue ended December 31, 2022
    As of December 31, 2022, total cash and cash equivalents were EUR 13,1 million (USD 14 million)3, as compared to EUR 32,3 million at December 31, 2021 and EUR 17.1 million at September 30, 2022.

Poxel Provides Corporate Update and Reports Cash and Revenue for the Third Quarter and Nine Months 2022

Retrieved on: 
Tuesday, November 8, 2022

The royalty stream from TWYMEEGs growth is poised to deliver significant value to Poxel, noted Thomas Kuhn, Chief Executive Officer of Poxel.

Key Points: 
  • The royalty stream from TWYMEEGs growth is poised to deliver significant value to Poxel, noted Thomas Kuhn, Chief Executive Officer of Poxel.
  • This is an important milestone for Poxel, but also more broadly for NASH, for which there is still no approved treatment.
  • Based on these results, we are prioritizing PXL065 in NASH and are actively looking for a partner to advance its development.
  • Third Quarter and Nine Months Ended September 30, 2022 Cash and Revenue
    As of September 30, 2022, total cash and cash equivalents were EUR 17.1 million (USD 16.6 million), as compared to EUR 16.1 million at June 30, 2022.

Poxel Presents DESTINY-1 Phase 2 Results for PXL065 in NASH at AASLD The Liver Meeting® 2022

Retrieved on: 
Monday, November 7, 2022

The study also assessed the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers.

Key Points: 
  • The study also assessed the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers.
  • Analysis of histologic changes was based on paired liver biopsies in PXL065 vs. placebo-treated NASH patients before and after the 36-week treatment period.
  • 40% of patients who received PXL065 at the 22.5 mg dose achieved a >30% relative reduction in liver fat content.
  • For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1).

Poxel Reports Financial Results for First Half 2022 and Provides a Corporate Update

Retrieved on: 
Wednesday, September 21, 2022

POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2022 and provided a corporate update.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2022 and provided a corporate update.
  • Thomas Kuhn, Chief Executive Officer of Poxel, stated: Thus far, 2022 has been marked by important achievements for Poxel.
  • Over the summer, we also extended our cash runway through the restructuring of our debt and an equity-linked financing facility.
  • This accomplishment provides us further flexibility to secure additional financing solutions necessary to execute our rare disease strategy.

Poxel Announces Positive Histology Results from Phase 2 NASH Trial (DESTINY-1) for PXL065, a Novel, Proprietary Deuterium-Stabilized R-stereoisomer of Pioglitazone

Retrieved on: 
Wednesday, September 21, 2022

PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which has reduced PPAR activity, but retains non-genomic thiazolidinedione (TZD) actions.

Key Points: 
  • PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which has reduced PPAR activity, but retains non-genomic thiazolidinedione (TZD) actions.
  • Pioglitazones positive effects in 6 independent prior trials where NASH patients were assessed via liver biopsy propelled the study of PXL065 in patients with NASH and fibrosis.
  • Based on pioglitazones proven efficacy in NASH, PXL065 could become a key product for the treatment of NASH, alone and in combination with other treatment modalities.
  • For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1).

Poxel Announces the Publication of Two Preclinical Articles on X-Linked Adrenoleukodystrophy for PXL065 and PXL770

Retrieved on: 
Tuesday, July 5, 2022

POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announces the publication of two preclinical articles on X-Linked Adrenoleukodystrophy (ALD) for PXL065 and PXL770.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announces the publication of two preclinical articles on X-Linked Adrenoleukodystrophy (ALD) for PXL065 and PXL770.
  • An article on PXL065 has been published in The Journal of Inherited Metabolic Disease (JIMD) and is entitled Therapeutic potential of deuterium-stabilized (R)-pioglitazone - PXL065 - for X-linked adrenoleukodystrophy.
  • These publications describe similar beneficial preclinical profiles of PXL770 and PXL065 in models of ALD.
  • Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.