Imeglimin

Poxel to Report Its 2023 Annual Results by the End of April 2024

Retrieved on: 
Thursday, March 28, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Imeglimin, NASH, DSM-IV codes, Fatty liver disease

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, announces the publication at the end of April 2024 of its 2023 Annual Results, originally scheduled for April 9, 2024, given the expected completion of a transaction by the end of April.

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, announces the publication at the end of April 2024 of its 2023 Annual Results, originally scheduled for April 9, 2024, given the expected completion of a transaction by the end of April.
  • The Company, which has made significant progress in securing additional financing, is targeting to close, by the end of April, a transaction relating to the monetization of royalties from TWYMEEG® (Imeglimin) sales in Japan.
  • Poxel expects that its financial resources will be sufficient to maintain its operations until the finalization of this monetization transaction.
  • The Company will communicate its new financial calendar in April 2024 upon completion of this transaction.

Poxel Provides Corporate Update

Retrieved on: 
Thursday, December 21, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, IRIS, Imeglimin, NASH, Sumitomo Pharma, Fatty liver disease, DSM-IV codes, Pharmaceutical industry

POXEL SA (Euronext: POXEL - FR0012432516) (Paris:POXEL), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, provides a corporate update.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516) (Paris:POXEL), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, provides a corporate update.
  • With the priority objective of relaunching its R&D activities and executing its strategic plan in rare diseases, the Company has focused in recent months on securing additional financing, in particular non-dilutive solutions.
  • In this context, the Company entered into exclusive negotiations with a leading investor to monetize royalties from TWYMEEG® (Imeglimin) sales in Japan.
  • Poxel’s goal is to finalize one or more of these financing options and/or partnerships by the end of the first quarter of 2024.

Poxel Provides Corporate Update and Reports Cash and Revenue for the Third Quarter and Nine Months 2023

Retrieved on: 
Wednesday, November 8, 2023
Biotechnology, Pharmaceutical, Health, Adrenoleukodystrophy, Patient, Serono, ALD, Plasma, AMN, Patent, Biomarker, Sumitomo Pharma, Diabetes, Merck, SGLT2, Jaguar 3.4 Litre, EPO, Pharmacokinetics, Male, DPP4, Disease, Prescription, Marshal of France, Pioglitazone, European Patent Office, EUR, United States patent law, Merck Serono, VLCFA, Safety, European Patent Convention, JPY, Estonia, Kidney, POC, Pharmaceutical industry, Imeglimin

Sumitomo Pharma has worked diligently to increase the production and secure inventory capacity to meet this increasing demand.

Key Points: 
  • Sumitomo Pharma has worked diligently to increase the production and secure inventory capacity to meet this increasing demand.
  • 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.
  • Next Financial Press Release: Fourth Quarter 2023 Cash and Revenue update, on February 15, 2024

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

Retrieved on: 
Tuesday, September 26, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Diabetes, ULF, Adrenoleukodystrophy, Prescription, Plasma, JPY, Patent, Patient, Serono, Merck, R, Estonia, POC, Pioglitazone, Sumitomo Group, Disease, Male, NASH, Pharmacokinetics, Sumitomo Pharma, EPO, Fatty liver disease, Leukodystrophy, Marshal of France, Rare, Kidney, Conference, Safety, Abstract, DPP4, ALD, JDS, Merck Serono, European Patent Office, Biomarker, DSM-IV codes, AMN, IRIS, Scientific communication, United States patent law, SGLT2, VLCFA, EUR, European Patent Convention, Pharmacology, TZD, Pharmaceutical industry, Medical device, Imeglimin, Euronext

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
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, ULF, Senior, Adrenoleukodystrophy, Prescription, Plasma, JPY, Patent, Patient, Serono, Merck, R, Estonia, POC, Pioglitazone, Sumitomo Group, Disease, Male, NASH, Pharmacokinetics, USD, EPO, Fatty liver disease, Leukodystrophy, Marshal of France, Rare, Kidney, Conference, Safety, Abstract, DPP4, ALD, JDS, Merck Serono, European Patent Office, Biomarker, DSM-IV codes, Communication, AMN, IRIS, Scientific communication, Sumitomo Pharma, United States patent law, SGLT2, VLCFA, European Patent Convention, Pharmacology, TZD, Pharmaceutical industry, Medical device, Cryptocurrency, Imeglimin, EUR, Euronext

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

Retrieved on: 
Wednesday, May 17, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Adrenoleukodystrophy, Prescription, Imeglimin, Adenosine, Plasma, Journal, JPY, Patient, Serono, Merck, POC, Sumitomo Group, Disease, Male, Business development, FY, Pharmacokinetics, Autosomal dominant polycystic kidney disease, American Association for the Study of Liver Diseases, USD, European Commission, Polycystic kidney disease, Kidney International, HIV disease progression rates, Fatty liver disease, ADPKD, FDA, IPF, Safety, Abstract, DPP4, ALD, ODD, JDS, Merck Serono, Biomarker, DSM-IV codes, AMN, Non-U.S. operators of the M60 Patton, IRIS, Sumitomo Pharma, SGLT2, VLCFA, Life Sciences (journal), Regulation of tobacco by the U.S. Food and Drug Administration, Food, Autosome, Pharmaceutical industry, Bank, Management, EUR, Euronext

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 provided a corporate update and announced its cash position and revenue for the first quarter ended March 31, 2023.

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 provided a corporate update and announced its cash position and revenue for the first quarter ended March 31, 2023.
  • Thomas Kuhn, Chief Executive Officer of Poxel, stated: “This quarter we successfully restructured our debt obligations and increased our financial flexibility with a new equity-linked financing with IRIS.
  • 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.
  • As of March 31, 2023, cash and cash equivalents were EUR 10.6 million (USD 11.6 million), as compared to EUR 13.1 million (USD 14.0 million) as of December 31, 2022.

Poxel Announces TWYMEEG® (Imeglimin) Fiscal Year 2022 Sales

Retrieved on: 
Monday, May 15, 2023
Research, Diabetes, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, Abstract, DPP4, FY, NASH, Sumitomo Pharma, JDS, Merck Serono, Prescription, Imeglimin, SGLT2, DSM-IV codes, EUR, JPY, Patient, Fatty liver disease, Serono, Merck, Sumitomo Group, Pharmaceutical industry, Video game, Euronext

As a result, for Sumitomo’s FY 2022, TWYMEEG gross sales reached JPY 2.2 billion (EUR 15.0 million)3, exceeding Sumitomo’s most recent FY 2022 forecast4 by 22%.

Key Points: 
  • As a result, for Sumitomo’s FY 2022, TWYMEEG gross sales reached JPY 2.2 billion (EUR 15.0 million)3, exceeding Sumitomo’s most recent FY 2022 forecast4 by 22%.
  • 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.
  • As part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of TWYMEEG, independent of the level of 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 Announces Multiple TWYMEEG® (Imeglimin) Abstracts Accepted for Oral Presentation

Retrieved on: 
Thursday, April 20, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Abstract, Chronic kidney disease, NASH, Sumitomo Pharma, JDS, Pharmacokinetics, History, DSM-IV codes, Trial of the century, Kidney, Mellitus, Patient, Fatty liver disease, Type, Conditional sentence, Sumitomo Group, Smoking, Safety, Pharmaceutical industry, Imeglimin, Euronext

Partnered in Japan with the diabetes market leader, Sumitomo Pharma (Sumitomo), TWYMEEG is Poxel’s first commercialized product.

Key Points: 
  • 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.
  • The objective of this study is to assess the safety, efficacy and pharmacokinetics of TWYMEEG in Japanese type 2 diabetes patients with renal impairment.
  • Poxel is also considering potential additional partnerships in specific territories.

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

Retrieved on: 
Thursday, March 23, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Journal of Hepatology, Prescription, Imeglimin, Adenosine, Plasma, Journal, Magnetic resonance imaging, JPY, Patient, Serono, Histology, Conditional sentence, Merck, POC, Pioglitazone, Sumitomo Group, Disease, Male, Pharmacokinetics, Autosomal dominant polycystic kidney disease, European Commission, Kidney International, HIV disease progression rates, Fatty liver disease, ADPKD, FDA, IPF, Safety, ALD, ODD, Merck Serono, Medicine, Biomarker, DSM-IV codes, Fibrosis, Human, Adrenoleukodystrophy, Acceleration, AMN, Workforce, Partnership, IRIS, Sumitomo Pharma, Edema, Clinical trial, VLCFA, EUR, Life Sciences (journal), Regulation of tobacco by the U.S. Food and Drug Administration, Food, TZD, Pharmaceutical industry, Management, Security (finance), Euronext

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
Biotechnology, Pharmaceutical, Health, Clinical Trials, NASH, Sumitomo Pharma, Biomarker, CFO, ALD, ODD, European Commission, Edema, Acceleration, ADPKD, Prescription, Safety, Human, Patient, Clinical trial, Workforce, Fibrosis, Autosomal dominant polycystic kidney disease, Merck Serono, Serono, Food, Adrenoleukodystrophy, Histology, EUR, POC, IRIS, Merck, IPF, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Male, USD, VLCFA, Plasma, Fatty liver disease, Disease, FDA, Magnetic resonance imaging, Pioglitazone, TZD, JPY, Imeglimin, DSM-IV codes, COVID-19, AMN, Pharmacokinetics, Pharmaceutical industry, Security (finance), Management, Sumitomo Group, Euronext

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.