FACTSHEET
July 2021
KEY HIGHLIGHTS
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
CONTACTS
- Corporate headquarters in Lyon, France
- Poxel also has subsidiaries in Tokyo, Japan, and in the Boston, Massachusetts area
Thomas Kuhn
CEO and Co-founder
Anne Renevot
Chief Financial Officer
Elizabeth Woo
SVP, Investor Relations & Communication
elizabeth.woo@poxelpharma.com
Aurélie Bozza
Investor Relations & Communication
aurelie.bozza@poxelpharma.com
Catherine David
Investor Relations & Communication
catherine.david@poxelpharma.com
NewCap
Investor Relations
and Public Relations - France
poxel@newcap.eu
Trophic Communications
Investor Relations
and Public Relations - EU/US
poxel@trophic.eu
ABOUT POXEL
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), and selected rare inherited disorders including adrenoleukodystrophy. In its mid-to-late-stagepipeline, the Company is currently advancing three drug candidates; several earlier-stageopportunities are also underway.
Imeglimin, Poxel's first-in-class lead product, targets mitochondrial dysfunction. Poxel has a strategic partnership with Sumitomo Dainippon Pharma for TWYMEEG® (Imeglimin) in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. A new drug application for TWYMEEG for the treatment of type 2 diabetes, was approved in Japan, on June 23, 2021. Japan is the first country in the world to approve Imeglimin.
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
LEAD PROGRAMS
TWYMEEG: orally-available drug 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. Dosage and administration: in general, for adults, 1,000 mg of Imeglimin hydrochloride is orally administered twice daily in the morning and evening.
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). Poxel also has additional earlier-stage programs from its AMPK activator and deuterated thiazolidinediones (TZD) platforms for targeting chronic and rare metabolic diseases.
www.poxel.com | © POXEL |
FACTSHEET | July 2021
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 TWYMEEG
Poxel and Sumitomo Dainippon Pharma have a strategic partnership for the development and commercialization of TWYMEEG in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries1.
On June 23, 2021, TWYMEEG was approved for the treatment of Type 2 Diabetes in Japan. Japan is the first country in the world to approve Imeglimin hydrochloride.
- On June 23, 2021, TWYMEEG was approved for the treatment of Type 2 Diabetes in Japan
- The approval in Japan triggers a milestone payment of EUR 13.3 million (USD 15.9 million)2 from Sumitomo and EUR 13.5 million loan from IPF
- Sumitomo product launch targeted in October 2021 in Japan
- Sumitomo #1 diabetes franchise; Guidance FY20 USD 900 million2
- Escalating double-digit royalties on net sales
- Potential of up to approximately EUR 200 million (USD 230 million)3 in development and regulatory milestones, and sales-based payments
- Phase 3 TIMES program successfully completed in Japan observed to show robust efficacy with favorable safety and tolerability profile
- Three pivotal trials involving over 1,100 patients
- Positive results from TIMES 1, TIMES 2 and TIMES 3
- Including: Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia, and Laos.
- Converted at the exchange rates as of June 21, 2021
- Converted at the exchange rate at the date of the agreement
NEAR-TERM MILESTONES EXPECTED TO DRIVE VALUE | PREVALENCE |
TWYMEEG (Imeglimin)
2021
- Approval in Japan triggers ~EUR13.32 million and ability to draw down EUR 13.5 million from IPF loan
- Japan launch targeted for October 2021
- 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.
PXL770
H2 2021
- Initiation of Ph 2b trial with biopsy- proven NASH patients
PXL065
2021
-
Complete Ph 2 recruitment mid-2021
2022 - Results for single Ph 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 26% of T2DM patients have NASH
SHAREHOLDER TOOLS
If you wish to receive upcoming press releases from POXEL via email, simply send your surname, name and email address to poxel@trophic.eu
POXEL ON THE STOCK EXCHANGE | SHAREHOLDER STRUCTURE** | |||
Market | Euronext Paris | |||
since February 2015 | ||||
Ticker | POXEL | |||
ISIN | FR0012432516 | |||
Market cap. | EUR 190 million* | |||
Number of shares | 28,611,254 | |||
Share price | EUR 7.05* | |||
52-week trading range | EUR 5.49 - EUR 9.63 | |||
*as of June 25, 2021. **At the date of the presentation, based on the Company's knowledge. | ||||
www.poxel.com | © POXEL | |||
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Poxel SA published this content on 13 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 July 2021 09:42:05 UTC.