Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. France
  4. Euronext Paris
  5. Poxel
  6. News
  7. Summary
    POXEL   FR0012432516

POXEL

(POXEL)
  Report
Real-time Quote. Real-time Euronext Paris - 07/29 11:35:26 am
6 EUR   +1.27%
07/28POXEL : Corporate Profile July 2021
PU
07/26POXEL : Corporate Profile July 2021
PU
07/22GLOBAL MARKETS LIVE : AT&T, American Airlines, Biogen, Netflix, ABB...
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

Poxel : Corporate Profile May 2021

05/14/2021 | 09:21am EDT

FACTSHEET

May 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

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, 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

LEAD PROGRAMS

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).

www.poxel.com

© POXEL

FACTSHEET | May 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 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
  • Sumitomo #1 diabetes franchise; Guidance FY20 $900M2
  1. including: Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia, and Laos.
  2. Year noted is Fiscal Year from April 2021 to March 2022, which is Sumitomo Dainippon Pharma's Fiscal Year
  3. Converted at the exchange rate at the date of the agreement
  4. Converted at the exchange rates as of June 30, 2020.

NEAR-TERM MILESTONES EXPECTED TO DRIVE VALUE

PREVALENCE

IMEGLIMIN

2021

  • J-NDAapproval; triggers ~€14.2M and ability to draw down €13.5M from
    IPF loan*
  • 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

*Converted at the exchange rates as of June 30, 2020.

SHAREHOLDER TOOLS

26% of T2DM patients have NASH

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

5.0%

since February 2015

Roivant

Ticker

POXEL

9.2%

ISIN

FR0012432516

Founders

Market cap.

€190 million*

19.2%

56.7%

Number of shares

28,611,254

Bpifrance

Free Float

Share price

€6,65*

52-week trading range

€5.49 - €9.63

9.9%

Andera

*as of March 29, 2021. **At the date of the presentation, based on the Company's knowledge.

www.poxel.com

© POXEL

Disclaimer

Poxel SA published this content on 14 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 May 2021 13:20:01 UTC.


ę Publicnow 2021
All news about POXEL
07/28POXEL : Corporate Profile July 2021
PU
07/26POXEL : Corporate Profile July 2021
PU
07/22GLOBAL MARKETS LIVE : AT&T, American Airlines, Biogen, Netflix, ABB...
07/21Poxel S.A. Reports Revenue Results for the Second Quarter and Six Months Ende..
CI
07/13POXEL : Corporate Profile July 2021
PU
07/13POXEL : Corporate Presentation
PU
07/12GLOBAL MARKETS LIVE : Volkswagen, Amazon, Credit Suisse, Tesla, Walmart...
07/12Poxel S.A. Announces New Strategic Direction with Increasing Focus on Rare Me..
CI
06/25POXEL : Agreement 2021
PU
06/25POXEL : présente les résultats de deux études cliniques sur son activateur direc..
PU
More news
Financials
Sales 2021 22,8 M 27,0 M 27,0 M
Net income 2021 -23,2 M -27,5 M -27,5 M
Net cash 2021 8,20 M 9,74 M 9,74 M
P/E ratio 2021 -7,48x
Yield 2021 -
Capitalization 172 M 204 M 204 M
EV / Sales 2021 7,19x
EV / Sales 2022 8,52x
Nbr of Employees 50
Free-Float 80,3%
Chart POXEL
Duration : Period :
Poxel Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends POXEL
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 4
Last Close Price 6,00 €
Average target price 15,95 €
Spread / Average Target 166%
EPS Revisions
Managers and Directors
Thomas Kuhn Chief Executive Officer & Director
Anne Renevot Chief Financial Officer & Executive Vice President
Pierre Legault Chairman
Sophie Hallakou-Bozec Senior Vice President-Research & Development
Takashi Kaneko Senior Vice President-Medical
Sector and Competitors
1st jan.Capi. (M$)
POXEL-5.66%204
GILEAD SCIENCES, INC.20.25%87 868
BIONTECH SE283.45%75 705
WUXI APPTEC CO., LTD.38.94%68 994
REGENERON PHARMACEUTICALS21.38%60 726
VERTEX PHARMACEUTICALS-15.22%52 353