LYON - POXEL SA, a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today reported its financial results for the period ended June 30, 2020 and provided a corporate update.
'Through September, we accomplished several important corporate and clinical objectives, including strengthening our financial position through multiple financial sources including the drawdown of the IPF loan of EUR 10 million in March, a capital raise of EUR 17.7 million in May and a subsequent milestone payment of EUR 4 million during the third quarter from our partner Sumitomo Dainippon Pharma for the Imeglimin J-NDA submission,' said Thomas Kuhn, CEO of Poxel. 'We also continued to make solid progress with our development programs. We reported positive results from preclinical and clinical studies for PXL770 and are continuing to evaluate broader metabolic diseases, including chronic and rare diseases, for our AMPK activation and D-TZD platforms.'
'From an execution standpoint in the context of the COVID-19 pandemic, I am very pleased to report that we recently initiated the Phase 2 trial for PXL065 in biopsy-proven NASH patients across multiple clinical sites in the U.S.,' continued Thomas Kuhn, CEO of Poxel. 'This is a streamlined development program with a single Phase 2 trial given the knowledge of pioglitazone, including data in NASH, and the 505(b)(2) regulatory pathway. Based on pioglitazone's known efficacy and safety results in NASH, its cardiovascular benefits combined with the exciting PXL065 results to-date, we believe that PXL065 has the potential to produce compelling results and become a leading oral drug candidate in development for this important unmet medical need.'
'For the remainder of 2020, we expect several important upcoming milestones and events, including the PXL770 Phase 2a efficacy and safety results in approximately 100 likely-NASH patients around the end of September 2020, finalization of the Imeglimin Phase 3 plan in the U.S. by Metavant, additional preclinical data related to our AMPK and D-TZD platforms and presentations for Imeglimin, PXL770 and PXL065 at several scientific meetings and published results in peer-reviewed scientific journals,' added Thomas Kuhn.
About Poxel SA
Poxel is a dynamic biopharmaceutical company that uses its extensive expertise in developing innovative drugs for metabolic diseases, with a focus on type 2 diabetes and non-alcoholic steatohepatitis (NASH). In its mid-to-late stage pipeline, the Company is currently advancing three drug candidates as well as earlier-stage opportunities. Imeglimin, Poxel's first-in-class lead product, targets mitochondrial dysfunction. Poxel has a strategic partnership with Sumitomo Dainippon Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. A Japanese new drug application (J-NDA) is under review by the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes. Poxel also established a partnership with Roivant Sciences for Imeglimin's development and commercialization in countries outside of the partnership with Sumitomo Dainippon Pharma, including the U.S. and Europe. PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is in a Phase 2a proof-of-concept program for the treatment of NASH. PXL770 could also have the potential to treat additional metabolic diseases. PXL065 (deuterium-stabilized R-pioglitazone), a MPC inhibitor, is in a single Phase 2 clinical trial for the treatment of NASH. Poxel also has additional earlier-stage programs from its AMPK activator and deuterated TZD platforms targeting chronic and rare metabolic diseases. The Company intends to generate further growth through strategic partnerships and pipeline development. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.
In the context of the COVID-19 outbreak, which was declared a pandemic by the World Health Organization (WHO) on March 12, 2020, the Company is regularly reviewing the impact of the outbreak on its business.
As of the date of this press release, and based on publicly available information, the Company has not identified the occurrence of any material negative effect on its business due to the COVID-19 pandemic that remains unresolved. However, the Company anticipates that the COVID-19 pandemic could have further material negative impact on its business operations. The worldwide impact of COVID-19 may notably affect the Company's internal organization and efficiency, particularly in countries where it operates and where confinement measures are implemented by the authorities. In addition, COVID-19 may impact market conditions and the Company's ability to seek additional funding or enter into partnerships. Particularly, delays in the supply of drug substance or drug products, in the initiation or the timing of results of preclinical and/or clinical trials, as well as delays linked to the responsiveness of regulatory authorities could occur, which could potentially have an impact on the Company's development programs and partnered programs. The Company will continue to actively monitor the situation.
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.
Jonae R. Barnes
Tel: +1 617 818 2985