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 | |
2 | 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
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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