6-K
Inventiva S.A. (IVA)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TORULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of October 2022
Commission File Number: 001-39374
InventivaS.A.
(Translation of registrant's name into English)
50rue de Dijon21121 Daix France+33 3 80 44 75 00(Address, including zip code, and telephone number, including area code, of registrant's principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
**Note:**Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
**Note:**Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
On October 31, 2022, the Registrant announced that AbbVie communicated that they decided to stop the development of cedirogant. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
This Report on Form 6-K, including Exhibit 99.1 hereto, shall be deemed to be incorporated by reference into the registration statement on Form F-3 (Registration No. 333-258369) of Inventiva S.A. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
| ExhibitNo. | Description |
|---|---|
| 99.1 | Press release dated October 31, 2022. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Inventiva S.A. | |
|---|---|
| (Registrant) | |
| Date: October 31, 2022 | /s/ Frédéric<br> Cren |
| Frédéric Cren | |
| Chief Executive Officer |
Exhibit 99.1
| PRESS RELEASE |
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Inventiva providesan update on the development of cedirogant by AbbVie
Daix(France), Long Island City (New York, United States), October 31, 2022 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced that AbbVie communicated during their third-quarter financial results^1^ on Friday October 28^th^, that they decided to stop the development of cedirogant (ABBV-157), an oral RORg inverse agonist jointly discovered by Inventiva and AbbVie for the treatment of autoimmune diseases, following the analysis of a recently concluded nonclinical toxicology study.
The Company’s cash runway, including the expected $12 million upfront payment from Sino Biopharm and the €25 million from the EIB credit facility^2^, is not impacted by the discontinuation of the cedirogant clinical program and should allow to fund as previously announced operations through Q4 2023^3^. Inventiva’s R&D capabilities and objectives remain unaltered.
Frédéric Cren, Chairman, ChiefExecutive Officer and cofounder of Inventiva, stated: “Although we are disappointed to see the end of cedirogant’sclinical program following the analysis of a nonclinical toxicology study, we wish to thank our partner AbbVie for 10 years of collaboration.We are now fully focused on the development of our lead asset lanifibranor, a promising treatment which is currently in Phase III clinicaldevelopment for the treatment of NASH, a disease for which there are currently no treatments approved by regulatory agencies. We continueto make progress in our NATiV3 pivotal Phase III trial and we recently reached a major milestone in this respect by entering into a partnershipwith Sino Biopharm, a leading Chinese pharmaceutical group, to develop and potentially commercialize lanifibranor in Greater China.”
In 2012, Inventiva and AbbVie signed a multi-year drug discovery collaboration agreement to identify potent RORg inverse agonists for the treatment of several autoimmune diseases. Inventiva’s and AbbVie’s joint efforts led to the discovery of cedirogant, which was being evaluated in a Phase II clinical trial at the time of AbbVie’s decision to discontinue further clinical development.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with NASH, MPS and other diseases with significant unmet medical need. The company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of adult patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.
^1^ Q3 2022 AbbVie Inc. Earnings Conference Call (media-server.com)
^2^ This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company and any additional expenditures related to the potential continued development of the odiparcil program or resulting from the potential in-licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect and the Company may end up using its resources sooner than anticipated.
^3^ Inventiva-PR-H1-2022-EN-22092022-FINAL-2.pdf (inventivapharma.com)
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Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult mucopolysaccharidoses (MPS) VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting an oncology development candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 80 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It 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.
Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com
Contacts
| Inventiva<br><br> <br>Pascaline Clerc<br><br> <br>VP of Global External Affairs<br><br> <br>media@inventivapharma.com<br><br> <br>+1 240 620 9175 | Brunswick Group<br><br> <br>Laurence Frost /<br><br> <br>Tristan Roquet Montegon<br> /<br><br> <br>Aude Lepreux<br><br> <br>Media relations<br><br> <br>inventiva@brunswickgroup.com<br><br> <br>+33 1 53 96 83 83 | Westwicke, an ICR Company<br><br> <br>Patricia L. Bank<br><br> <br>Investor relations<br><br> <br>patti.bank@westwicke.com<br><br> <br>+1 415 513 1284 |
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Important Notice
This press release contains “forward-lookingstatements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements,other than statements of historical facts, included in this press release are forward-looking statements. These statements include, butare not limited to, forecasts and estimates with respect to Inventiva’s pre-clinical programs and clinical trials, including recruitment,screening and enrolment for those trials, including the NATiV3 Phase III clinical trial with lanifibranor in NASH, potential developmentof and regulatory pathway for odiparcil, clinical trial data releases and publications, the information, insights and impacts that maybe gathered from clinical trials, the potential therapeutic benefits of lanifibranor, pipeline and preclinical and clinical developmentplans, future activities, expectations, plans, growth and prospects of Inventiva and the sufficiency of Inventiva’s cash resourcesand cash runway. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “plans”, “designed”, “hopefully”, “target”, “aim”, and “continue”and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-lookingstatements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of thestatements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differmaterially from those expressed or implied in such statements. Future events are difficult to predict and may depend upon factors thatare beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial resultswill be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidateswill receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reachedon their expected timeline, or at all. Actual results may turn out to be materially different from the anticipated future results, performanceor achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventivais a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses sinceinception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additionalcapital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approvaland subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are notnecessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidateclaims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy tothe satisfaction of applicable regulatory authorities, enrolment and retention of patients in clinical trials is an expensive and time-consumingprocess and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidatesmay cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercialpotential, Inventiva faces substantial competition and Inventiva’s business, and preclinical studies and clinical development programsand timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemicand geopolitical events, such as the conflict between Russia and Ukraine, related sanctions and related impacts and potential impactson the initiation, enrolment and completion of Inventiva’s clinical trials on anticipated timelines, and macroeconomic conditions,including global inflation and uncertain financial markets. Given these risks and uncertainties, no representations are made as to theaccuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts andestimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-lookingstatements.
Please refer to the Universal RegistrationDocument for the year ended December 31, 2021 filed with the Autorité des Marchés Financiers on March 11, 2022, the AnnualReport on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 11, 2022 and the financialreport for the first half of 2022 filed Securities and Exchange Commission on September 22, 2022 for additional information in relationto such factors, risks and uncertainties.
All information in this press release is asof the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-lookingstatements referred to above.
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