Well diversified mid-to-late stage pipeline with first-in-class drug candidates
A highly experienced management team with extensive metabolic expertise
Key partnership with type-2- diabetes market leader in Japan for its most advanced clinical program, Imeglimin
Two differentiated programs for NASH (PXL770 / PXL065), a large and growing disease worldwide
Cash and cash equivalents were EUR 32.8 million (USD 38.4 million) as of March 31, 2021, sufficient to fund operations through 2022
Corporate headquarters in Lyon, France
Poxel also has subsidiaries in Tokyo, Japan, and in the Boston, Massachusetts area
CEO and Co-founder
Chief Financial Officer
Investor Relations & Communication
Investor Relations & Communication
and Public Relations - France
and Public Relations - EU/USpoxel@trophic.eu
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,non-alcoholicsteatohepatitis (NASH), and selected rare inherited disorders including adrenoleukodystrophy. In its mid-to-late stage pipeline, the Company is currently advancing three drug candidates; several earlier-stage opportunities are also under way.
Imeglimin, Poxel's first-in-class lead drug candidate, 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.
PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is being developed for the treatment of NASH. After successfully completing a Phase 2a proof-of-concept trial, which met its primary endpoint and study objectives, Poxel plans to initiate a Phase 2b program in the second half of 2021. PXL770 also has the potential to treat additional metabolic diseases.
PXL065 is the R-enantiomer of pioglitazone, stabilized by deuterium, and targets non- genomic (non-PPARγ) pathways. It is being developed for the treatment of NASH, and is currently being studied in a streamlined Phase 2 study with biopsy proven NASH patients with results anticipated in mid-2022.
Poxel also has additional earlier-stage programs from its AMPK activator and deuterated TZD platforms targeting chronic and rare metabolic diseases.
A WELL-DIVERSIFIED METABOLIC PIPELINE
Imeglimin: orally-available drug candidate for the treatment of type 2 diabetes. It has a unique mechanism of action targeting mitochondrial dysfunction, enabling it to simultaneously target the two key defects that cause diabetes - impaired pancreatic b-cell function and insulin resistance. It has an extensive and consistent data package with 25 clinical studies in over 2,500 subjects and has been shown to have robust efficacy both alone and in combination with other drugs currently on the market. Imeglimin has also been shown to be well tolerated and to have a safety profile similar to placebo.
PXL770: orally available first-in-class product targeting adenosine monophosphate-activated protein kinase (AMPK). Through its unique mechanism of action that directly activates AMPK, PXL770 modulates multiple metabolic and immune-related pathways. This target, which plays a key role as a master regulator of cellular energy, has the potential to treat several chronic metabolic diseases, including diseases that affect the liver, such as NASH.
PXL065: (deuterium-stabilizedR-pioglitazone), modulates non-genomic metabolic pathways, it is advancing into a Phase 2 clinical trial. Based upon preclinical and Phase 1a results, PXL065 is expected to exhibit a better therapeutic profile than pioglitazone for NASH, including efficacy with reduced side effects, such as those associated with the activation of PPAR-γ (weight gain, fractures and edema).
Due to COVID-19, Poxel is monitoring all developments that might impact the timelines for achievement of our corporate objectives and we will continue to update you as needed.
A STRATEGIC PARTNERSHIP FOR IMEGLIMIN
Poxel and Sumitomo Dainippon Pharma have a strategic partnership for the development and commercialization of Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries1. On July 30, 2020, Poxel announced that Sumitomo Dainippon Pharma submitted a J-NDA to the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.
Phase 3 TIMES program successfully completed in Japan observed to show robust efficacy with favorable safety and tolerability profile
Positive results from TIMES 1, TIMES 2 and TIMES 3
A New Drug Application in Japan (J-NDA) is currently advancing through regulatory review
Product launch targeted in 2021 in Japan2
Potential of up to $253M3 in development and regulatory milestones, and sales-based payments
Escalating double-digit royalties on net sales
The J-NDA approval would trigger a milestone payment of EUR 14.2 million ($16.6 million)4
including: Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia, and Laos.
Year noted is Fiscal Year from April 2021 to March 2022, which is Sumitomo Dainippon Pharma's Fiscal Year
Converted at the exchange rate at the date of the agreement
Converted at the exchange rates as of June 30, 2020.
NEAR-TERM MILESTONES EXPECTED TO DRIVE VALUE
J-NDAapproval; triggers ~€14.2M and ability to draw down €13.5M from
Poxel regained Imeglimin rights from Metavant for the US, Europe and other countries not covered by our agreement with Sumitomo Dainippon Pharma and is considering various options to advance Imeglimin in those countries
Initiation ofPh 2b trial with biopsy- proven NASH patients
CompletePh 2 recruitment mid-2021
Results for singlePh 2 trial mid-2022
Prevalence of type 2 diabetes
In 2017, 425 million people aged 20 to 79 years old worldwide were suffering from diabetes, with over 90% from type 2 diabetes (International Diabetes Federation)
Prevalence of NASH
Today, approximately 40 million people are affected by NASH in the U.S., France, Germany, Italy, Spain, the United Kingdom and Japan (Decision Resources); Prevalence of type 2 diabetes in patients with NASH estimated to be 47%; approximately
*Converted at the exchange rates as of June 30, 2020.
26% of T2DM patients have NASH
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POXEL ON THE STOCK EXCHANGE
since February 2015
Number of shares
52-week trading range
€5.49 - €9.63
*as of March 29, 2021. **At the date of the presentation, based on the Company's knowledge.