- Cash and cash equivalents at €93.6 m as of
June 30, 2021 compared to €105.7 m1 as ofDecember 31, 2020
- Initiation of the NATiV3 Phase III clinical study with lanifibranor in NASH
- R&D expenses of €19.1 m in H1 2021, up 52% compared to H1 2020, mainly driven by the preparation and initiation of the NATiV3 Phase III clinical trial
- Decision by AbbVie to initiate a Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis following the demonstration of clinical proof of concept during AbbVie’s Phase Ib clinical trial
- Publication by AbbVie of the design of the Phase IIb clinical trial with cedirogant to be initiated in
November 2021 with completion expected inMarch 2023
- Major recruitments to reinforce Inventiva’s clinical expertise, medical team and corporate functions, as well as its presence in
France and the United States
- Implementation of an At-The-Market (“ATM”) program in
the United States providing the Company with important financial flexibility and additional funding possibility of up to$100.0 m
Daix (
Key financial results for the first half of 2021
(in thousands of euros, except share and per share amounts) | |||||
Revenues | 139 | 161 | |||
Other income | 2,009 | 1,607 | |||
Research and development expenses | (19,109) | (12,574) | |||
Marketing – business development expenses | (258) | (123) | |||
General and administrative expenses | (5,779) | (3,383) | |||
Other operating income (expenses) | (607) | (1,354) | |||
Net operating loss | (23,605) | (15,665) | |||
Net financial income | 824 | 6 | |||
Income tax | (355) | - | |||
Net loss for the period | (23,136) | (15,659) | |||
Basic/diluted loss per share (euros/share) | (0.60) | (0.40) | |||
Weighted average number of outstanding shares used for computing basic/diluted loss per share | 38,677,187 | 38,677,187 |
Revenues for the first half of 2021 reached €0.1 million, stable compared to the first half of 2020. As part of its collaboration with AbbVie in auto-immune diseases,
R&D expenses amounted to €19.1 million in the first half of 2021, an increase of 52% compared to €12.6 million in the first half of 2020, mainly driven by the costs associated with the preparation and initiation of the NATiV3 Phase III clinical trial with lanifibranor in NASH.
General and administrative expenses (G&A) amounted to €5.8 million, an increase of 71% compared to €3.4 million in the first half of 2020, mainly due to higher compliance costs resulting from Inventiva’s new dual listing status since
Other operating income (expenses) stood at (€0.6) million compared to (€1.4) million in the first half of 2020. The lower expenses incurred during the first half of 2021 included costs related to the preparation of the ATM project and the amortization costs of the one-off POSI insurance covering the Company’s Initial Public Offering (IPO) on the Nasdaq Global Market.
Net financial income amounted to €0.8 million in the first half of 2021, mainly linked to exchange rate variation.
The Company’s net loss stood at (€23.1) million compared to (€15.7) million in the first half of 2020.
Inventiva’s net cash flow (excluding any exchange rate effect) amounted to (€15.0) million in the six months ended
Net cash used in operating activities amounted to €19.8 million and €7.2 million in the first half of 2021 and 2020, respectively. This increase in cash use is due to higher R&D and G&A expenses.
Cash flow from operating activities was also positively impacted in the first half of 2021 by the payment of €8.0 million of Research Tax Credit (CIR - Crédit Impôt Recherche) (€3.8 million related to complementary filings following the 2020 Conseil d’État judgement covering prior years, and €4.2 million related to the 2020 Research Tax Credit) received on
Net cash generated by investing activities amounted to €4.7 million2 in the first half of 2021 compared to (€1.0) million for the same period in 2020. This variation is essentially due to the decrease in short term deposits.
No net cash from financing activities was generated over the first half of 2021 while
€24.6 million of net cash from financing activities for the same period in 2020, notably related to the issuance of €14.7 million (gross proceeds) of ordinary shares in
Over the first half of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.0 million2.
As of
Considering its current R&D and clinical development programs, and excluding additional financial resources that may originate from funding activities such as the ATM program, Inventiva’s cash runway will allow the Company to fund its operations through the third quarter of 2022.
The financial statements of the first half of 2021 were approved by Inventiva’s Board of Directors on
Main areas of progress in the R&D portfolio
Lanifibranor in non-alcoholic steatohepatitis (NASH)
- Initiation of the NATiV3 Phase III clinical trial evaluating lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis, with the activation of the first clinical sites in
the United States and the start of patient screening –September 8, 2021
Odiparcil in mucopolysaccharidosis type VI (MPS VI)
Inventiva continues to review all available options to optimize the development of its second clinical-stage asset odiparcil for the treatment of MPS VI. All MPS-related R&D activities remain on hold pending the outcome of this review process, now expected to conclude in 2022 (rather than in 2021 as previously anticipated).3
Collaboration with AbbVie on cedirogant in autoimmune diseases
- Decision by AbbVie to initiate a Phase IIb clinical trial with cedirogant4 in patients with moderate to severe psoriasis after having achieved clinical proof of concept during AbbVie's
Phase Ib clinical trial –May 12, 2021 5 - Publication by AbbVie of the study design of the Phase IIb clinical trial with cedirogant: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety and efficacy of cedirogant in adult patients with moderate to severe psoriasis. AbbVie plans to enroll about 200 adult participants in approximately 45 sites, who will receive oral daily doses of cedirogant or placebo capsules for 16 weeks. The primary endpoint has been defined as the percentage of participants achieving >=75% reduction from baseline on the Psoriasis Area Severity Index (PASI) score (PASI 75)6. The trial is expected to start in
November 2021 and be completed inMarch 2023 –September 14, 2021 7
Other significant milestones
- Major recruitments to reinforce Inventiva’s clinical expertise, medical team and corporate functions, as well as its presence in
France andthe United States –September 16, 2021 - Implementation of an ATM program in
the United States , to be activated if and when required, providing the Company with important financial flexibility to strengthen funding of its R&D pipeline by issuing and selling ordinary shares in the form of American Depositary Shares (ADSs), with aggregate gross sales proceeds of up to$100 million . The ATM program will be effective untilAugust 2, 2024 –August 2, 2021 - Appointment of
Martine Zimmerman as Independent Director to Inventiva’s Board of Directors to replace Nawal Ouzren. Martine Zimmerman’s appointment will be submitted to Inventiva’s shareholders for ratification at the Company’s next Combined Shareholders’ Meeting –April 19, 2021
•••
Next expected key milestones
- Initiation by AbbVie of the Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis – planned for
November 2021 - Strategy update on the development of odiparcil – planned for 2022 vs the second half of 2021 as previously anticipated
- Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) led by
Professor Cusi – planned for the first half of 2022
Upcoming investor conference participation
- Lyon Pôle
Bourse Forum ,September 27-28, 2021 - HealthTech Innovation Days 2021,
October 4-5, 2021 Portzamparc Health Biotech Seminar 2021,October 6, 2021 H.C. Wainwright 5th AnnualNASH Investor Conference ,October 11, 2021 Stifel Healthcare Conference 2021,November 16-17, 2021 - Jefferies 2021
London Healthcare Conference ,November 16-18, 2021
Upcoming scientific conference presentations
- AASLD The Liver Meeting,
November 12-15, 2021
Conference call
A conference call in English will be held tomorrow,
The presentation accompanying this conference call will be available on Inventiva’s website in the “Investors” – “Financial Results & Presentations” section at the same time and can be followed live at: https://edge.media-server.com/mmc/p/2kk6k5k7.
A replay of the conference call and the presentation will be available after the event at: https://inventivapharma.com/investors/financial-results-presentations/.
Next financial results publication
- Q3 2021 Revenues and cash position:
Wednesday, November 10, 2021 (after U.S. market close)
About
Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation,
Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. In 2020,
In parallel,
The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.
Contacts
VP of Global External Affairs media@inventivapharma.com +1 240 620 9175 | Aude Lepreux Media relations inventiva@brunswickgroup.com +33 1 53 96 83 83 | Westwicke, an Investor relations patti.bank@westwicke.com +1 415 513 1284 |
Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva’s clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of
Please refer to the Universal Registration Document for the year ended
Except as required by law,
1 The cash position as of
2 The cash position as of
3 Please refer to Inventiva’s press release entitled “Inventiva receives positive FDA feedback to advance its lead drug candidate lanifibranor into pivotal Phase III in NASH” and published on
4 Cedirogant is a clinical stage RORγ inverse agonist co-discovered by
5 See AbbVie Q1 2021 earnings call on
6 The PASI is a tool that provides a numeric scoring for participants' overall psoriasis disease state, ranging from 0 to 72, with a higher score indicating a more severe form of the disease.
7 For more details regarding the Phase IIb clinical trial, please refer to clinicaltrials.gov (NCT05044234).
Attachment
Inventiva - PR - H1 2021 - EN - 20092021
Source:
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