Full Year 2020
Financial and Corporate Update
March 25, 2021
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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 outbreak of the COVID-19, which has been declared a "pandemic" by the World Health Organization on March 12, 2020, the Company has undertaken a full review of the impact of such outbreak on its business. Considering the rapidly evolving situation, the Company is updating this assessment on a regular basis.
As of the date of this presentation, and based on publicly available information, the Company has not identified the occurrence of a material negative effect on its business due to the COVID-19 pandemic.
However, the Company anticipates that the COVID-19 pandemic may have a material negative impact in the near future. First, the worldwide deteriorated economic environment may notably impact the Company's internal organization and efficiency, particularly in countries where it operates and where confinement measures have been implemented by the authorities, as well as its ability to raise additional funding and / or to enter into partnerships. Secondly, while the Company's timelines for its manufacturing, pre-clinical and clinical operations remain unchanged on the date hereof, the COVID-19 outbreak is likely to have an impact on the Company's operations, in the same way as for any company operating within the healthcare industry. Particularly, delays in the supply of drug substance or drug products, in pre-clinical and/or clinical trials, as well as delays linked to the responsiveness of regulatory authorities could occur, which
could potentially have an impact on certain or all of the Company's development programs.
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Corporate Update During Coronavirus (COVID-19) Pandemic
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Proactive Corporate Initiatives
- Continuous monitoring of the situation worldwide and its impact on our people, operations and plan
- Employees used to working remotely due to global locations, supported by appropriate IT infrastructure
Imeglimin - T2D
- J-NDAprocess on track, Target launch expected in 20211 in JP, as planned, by Sumitomo Dainippon Pharma, #1 diabetes company in Japan
- Business Opportunity for Imeglimin in US, EU & Other Countries
PXL770 & PXL065 - NASH
- Significant progress of both programs in 2020
- Positive Phase 2a results for PXL770, leading to Phase 2b preparation
- Phase 2 recruitment ongoing for PXL065, following study initiation in Sept. 2020 due to Covid-19 context in the US
Manufacturing
- Imeglimin: DSP responsible for manufacturing; Batches available for progress in US & EU. We are currently not aware of COVID-19 disruptions
- NASH programs: we rely on outsourcing and have options for alternative venders, as needed
Finance
- Financial position strengthened through capital increase of EUR 17.7 million in May 2020 and EUR 6 million in Oct. 2020
in non-dilutive funding in the form of a French Government Guarantee Loan in the context of the COVID-19 pandemic.
1. Sumitomo fiscal year April-March.
Poxel's Mission and Vision
To discover, develop and commercialize innovative therapies for patients suffering from serious chronic diseases with underlying metabolic pathophysiology
acetyl CoA
METABOLIC | INFLAMMATION |
DISORDERS | |
(cellular energy | TISSUE |
homeostasis | |
DEGENERATION | |
imbalances) | |
& CELL DEATH | |
apoptosis, | |
necrosis |
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Three Pillars of Poxel's Strategy
First-in-Class Programs Leading to Key Value Inflection Points
Unique platforms | |||||
Partnered in Asia1 with diabetes | Oral First-in- | AMPK | D-TZD | Pipeline | |
Platform | Platform | expansion | External | ||
market leader in Japan | |||||
Class Phase 2 | into new | ||||
Sumitomo Dainippon Pharma | Opportunities | ||||
Programs | indications | ||||
Imeglimin | PXL770 | Next |
generation | ||
PXL065 | compounds | |
Expected approval in 20212 | Phase 2 biopsy data for both | New clinical programs in |
triggering milestones | programs in 2022-2023 | next 12-24 months |
Phase 3 ready partnership | Combination potential | Further strengthening |
opportunity in US/EUR | product pipeline | |
1. Including: Japan, China, South Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia, and Laos. 2. Sumitomo fiscal year April-March.
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Poxel SA published this content on 25 March 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 April 2021 12:15:02 UTC.