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Inventiva: highlights

Clinical stage biotech with focus onoral small molecules for high unmet needin fibrosis, lysosomal storage disorders and oncology

Two unencumbered late stage assetsin two high value indications-Lanifibranor- only pan-PPAR agonist in clinical development for NASH, Phase IIb data due in June-Odiparcil- first orally available therapy for MPS

A clinical stage partnership with AbbVie

  • -ABBV-157 RORprogramwith potential in several auto-immune indications currently in clinical development in patients with psoriasis

  • -Inventiva eligible to milestone payments and sales royalties

Compelling early stage pipeline-YAP-TEAD program in late pre-clinical stage approaching clinical candidate selection

State of the art R&D capabilitiesincluding wholly owned 'pharma scale' discovery facilities with adiscovery enginefocused on nuclear receptors, transcription factors and epigenetic targets-240,000 compound library, 60% of which are proprietary

Strong US and European shareholder base and experienced senior managementteam with a track record of operational and scientific excellence

Cash position allowing arunway until end of Q3 2021

Lanifibranor: theonly pan-PPAR agonist in clinical development for the treatment of NASH

Moderate and balanced pan-PPAR agonist activity(PPAR, PPARand PPAR) with differentiated chemical structure

Once daily oral administration

Efficacy demonstratedon insulin-sensitivity, dyslipidemia, steatosis, ballooning, inflammation, hepatic fibrosis and cirrhosis in preclinical models

Phase IIa(1)trial demonstrated pan-PPAR agonist activity,supporting dose selection for NASH clinical trial

Favorable safety profiledemonstrated in:

  • 24-months rodent and 12-month monkey studies leading toPPAR class clinical hold liftedby FDA

  • Phase I trials with more than200healthy volunteers(2)and Phase IIa study with47TD2M patients

  • Approximately250patients have been treated for 24 or 48 weeks in our ongoing and completed Phase IIb clinical trials

  • In connection with these trials, lanifibranor has undergone a total of7 positive DSMB reviews

Composition of matter patent delivered in 59 countries and method of use patent granted in the US,

China and in the EU:limit of exclusivity 2035

FAST Trackdesignation granted by FDA

(1) Conducted by Abbott prior to our funding; (2) Including 125 healthy volunteers in the phase I conducted by Abbott prior to our funding

PPARefficacy is well established in NASH

PPARactivation by pioglitazone improves steatosis, ballooning, inflammation and metabolic markers in NASH patients after 6 months or 18 months of treatment

Pioglitazone (PPAR)

Belfort NASH study 6 month treatmentCusi NASH study 18 month treatment

Placebo

Pio

P

Placebo

Pio

P

Steatosis (% patients improved)

38%

65%

0.001

26%

71%

< 0.001

Inflammation (% patients improved)

29%

65%

0.001

22%

49%

= 0,004

Ballooning (% patients improved)

24%

54%

0.001

24%

51%

= 0,004

NASH resolution (% patients)

-

NA

-

19%

51%

< 0.001

Fibrosis (mean change in score)

-

NS

-

0

- 0.5

= 0.039

Pioglitazone improves advanced fibrosis

Pioglitazone improves advanced fibrosis(stage F3-F4) as indicated by an increase in the number of NASH patients whose fibrosis stage changed from F3-F4 to F0-F2 at the end of treatment

Source: Corey KE and Malhi H, Hepatology 2016. Note: clinical trial not conducted by InventivaCorporate Presentation | 2020

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Inventiva SA published this content on 04 June 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 June 2020 07:26:07 UTC