First Half 2020

Financial and Corporate Update

September 15, 2020

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Disclaimer

Some of the statements contained in this presentation constitute forward-looking statements. Statements that are not

historical facts are forward-looking statements. Forward-looking statements generally can be identified by the use of

forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "continue" or

similar terminology. These statements are based on the Company's current strategy, plans, objectives, assumptions,

estimates and projections. Investors should therefore not place undue reliance on those statements. The Company

makes no representation, warranty or prediction that the results anticipated by such forward-looking statements will be

achieved, and such forward-looking statements represent, in each case, only one of many possible scenarios and should

not be viewed as the most likely or standard scenario. Forward-looking statements speak only as of the date that they

are made and the Company does not undertake to update any forward-looking statements in light of new information or

future events. Forward-looking statements involve inherent risks and uncertainties. The Company cautions that a number

of important factors could cause actual results to differ materially from those contained in any forward-looking statement.

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

presentation, 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

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continue to actively monitor the situation.

1H 2020: Significant R&D and Corporate Accomplishments

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Imeglimin for Type 2 Diabetes (T2D)

  • Japanese New Drug Application submission by Sumitomo; product launch targeted for 2021*
  • Metavant regulatory discussions for Ph 3 program in patients with T2D and CKD stages 3b/4

PXL770 for NASH

  • Positive PK/PD results; trial met primary endpoint and objectives
  • Presented new preclinical results related to improvement in inflammation
  • Ph 2a efficacy & safety results in ~100 patients expected around the end of September 2020

PXL065 for NASH

  • Initiation of Ph 2 efficacy and safety study in ~120 biopsy-proven patients; goal to identify optimal dose or doses for Ph 3 registration trial
  • Streamlined development with single Ph 2 trial given knowledge of pioglitazone, including data in NASH, and 505(b)(2) regulatory pathway, which offers opportunity for efficient and lower risk program

Preclinical NASH Combination Results

  • Positive results for PXL770 combinations with FXR agonist (obeticholic acid), a GLP-1 receptor agonist (semaglutide) and a thyroid receptor β agonist (MGL-3196)

Preclinical AMPK Platform Results

  • Positive results for PXL770 and AMPK activation in chronic and rare metabolic diseases
    Strengthened Financial Position with Multiple Sources (EUR 31.7M)
  • Drew down second tranche of IPF loan of EUR 10M and capital raise of EUR 17.7M (1H 2020)
  • Sumitomo milestone triggered EUR 4M for J-NDA submission (Q3 2020)

Expanded Management Team

Appointed David E. Moller, MD, as CSO

* Year noted is Fiscal Year from April 2021 to March 2022, which is Sumitomo Dainippon Pharma's Fiscal Year.

Financial Update

First Half 2020

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Poxel SA published this content on 15 September 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 September 2020 15:49:06 UTC