Inventiva Reports Preliminary 2024 First-Half Financial Information¹

Cash and cash equivalents at €10.1 million as of June 30, 2024, compared to cash and cash equivalents at €26.9 million, €0.01 2million of short-term deposits and €9.0 3million of long-term deposits as of December 31, 2023.On July 18, 2024, Inventiva issued royalty certificates subscribed by Samsara BioCapital and existing shareholders (BVF Partners, NEA, Sofinnova and Yiheng) for an amount of approximately €20.1 million.No Revenues recorded in H1 2024, compared to €1.9 million for the...

DAIX, 31/07/2024 (informazione.news - comunicati stampa - salute e benessere)

– Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), also known as non-alcoholic steatohepatitis (“NASH”), and other diseases with significant unmet medical needs, today reported certain preliminary financial results for the first half of 2024, including its cash, cash equivalents, and revenues.

As of June 30, 2024, the Company's amounted to €10.1 million, compared to €26.9 million, €0.01 million of short-term deposit and €9.0 million of long-term deposit as of December 31, 2023.

amounted to (€48.3) million in the first half of 2024, compared to (€45.2) million for the same period in 2023 while the R&D expenses for the first half of 2024 were (€48.7) million, down 10% compared to the first half of 2023. The decrease in R&D expenses over the period is primarily due to the temporary pause in the recruitment of the patients in the NATiV3 Phase III clinical trial of lanifibranor in MASH/NASH (“NATiV3") following the Suspected Unexpected Serious Adverse Reaction (SUSAR) previously reported in the first quarter of 2024 and, to a lesser extent, due to the completion of the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with MASH/NASH and type 2 diabetes (“T2D”). R&D expenses are expected to increase in the second half of 2024 following the effective restart of patient recruitment in NATiV3, as well as the planned clinical development activities and related costs associated with the NATiV3 for the second half of 2024.

for the first half of 2024 amounted to €8.9 million, compared to (€7.7) million used in the first half of 2023. The change is mostly due to the variation in deposits between both periods.

for the first half of 2024 amounted to €22.6 million, compared to (€2.2) million used in the first half of 2023. The change is due to the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank (“EIB”). As a condition to the drawdown, the Company issued 3,144,654 warrants to the EIB.

Over the first half of 2024, the Company recorded a on cash and cash equivalents of €0.1 million, compared to a negative effect of (€0.4) million for the first half of 2023, due to the evolution of EUR/USD exchange rate.

On July 18, 2024, Inventiva announced the issuance of Royalty Certificates subscribed by Samsara BioCapital, and existing shareholders BVF Partners, NEA, Sofinnova, and Yiheng, for an amount of approximately €20.1 million. The royalty certificates give the holders the right to an annual payment of royalties equal to 3% of the potential future net sales of lanifibranor .

Considering its current cost structure and forecasted expenditures and including the proceeds of approximately €20.1 million from the issuance of the royalty certificates and the cash preservation measures in the short term set up by the Company with its creditors, the Company estimates that its cash, cash equivalents and deposits should allow the Company to . These factors raise substantial doubt regarding the Company's ability to continue as a going concern beyond the end of September 2024.

In order to finance its activities, the Company needs to raise additional funds, and it is continuing to actively review potential financing (including debt, equity and equity-linked or other instruments) and strategic options.

The Company did not record any revenues in the first half of 2024, as compared to €1.9 million amounted for the same period in 2023. The revenues recorded by the Company in the first half of 2023, were attributed to a milestone payment after CTTQ, Sino Biopharm's subsidiary, received the Investigational New Drug (IND) approval from the Chinese National Medical Products Administration (NMPA) in May 2023, allowing the initiation of the clinical development of lanifibranor in MASH/NASH in mainland China.

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH/NASH 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 and has a pipeline of two preclinical programs

Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH/NASH, a common and progressive chronic liver disease.

Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment of adult 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 a candidate for its Hippo signaling pathway program.

The Company has a scientific team of approximately 90 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 B 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

Preliminary, non-audited financial information
Short-term deposits were included in the category “other current assets” in the IFRS consolidated statement of financial position and were considered by the Company as liquid and easily available.
The long-term deposit had a two year-term, were accessible prior to the expiration of the term with a notice period of 31 days and were considered as liquid by the Company.
Inventiva-PR-Royalty-Deal-EN-07-18-2024.pdf (inventivapharma.com)
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.

 

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