Salute e Benessere
Inventiva reports 2024 Third Quarter Financial Information¹
– 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 its cash position as of September 30, 2024 and its revenues for the first nine months of 2024.
As of September 30, 2024, the Company's amounted to €13.9 million, compared to cash and cash equivalents at €26.9 million, short-term deposit at €0.01 million, and long-term deposit at €9.0 million as of December 31, 2023.
amounted to (€64.2) million in the first nine months of 2024, compared to (€69.0) million for the same period in 2023 down by 7.0%. R&D expenses, mainly driven by the development of lanifibranor in MASH/NASH, for the first nine months of 2024 amounted to €71.7 million and were down 10.0% compared to the €79.6 million for the first nine months of 2023. The decrease in R&D expenses over the period is primarily due to the temporary voluntary pause in the recruitment of patients in the NATiV3 Phase 3 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 2a combination trial with lanifibranor and empagliflozin in patients with MASH/NASH and type 2 diabetes (“T2D”). R&D expenses have started to increase as expected in the second half of 2024 following the 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 nine months of 2024 amounted to €8.7 million, compared to (€3.5) million used for the same period in 2023. The change is mostly due to the variation in term deposits between both periods.
for the first nine months of 2024 amounted to €42.3 million compared to €30.2 million in the same period in 2023. The change is due to (i) the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank (“EIB”) with the issue of 3,144,654 warrants to the EIB, and (ii) the issuance on July 18, 2024, of royalty certificates (the “2024 Royalty Certificates”) subscribed by Samsara BioCapital, and existing shareholders BVF Partners, NEA, Sofinnova, and Yiheng, for an amount of €20.1 million. The 2024 Royalty Certificates give the holders thereof the right to an annual payment of royalties equal to 3% of the potential future net sales of lanifibranor, if any, in the United States, the European Union and the United Kingdom over a 14-year term from the date of their issuance .
Over the first nine months of 2024, the Company did not record any exchange rate effect on cash and cash equivalents, compared to a negative exchange rate effect of (€0.7) million for the same period in 2023, due to the evolution of the EUR/USD exchange rate.
On October 14, 2024, the Company announced a multi-tranche equity financing (the “Equity Raise”) of up to €348 million from both new and existing investors . The Company closed the first part of the first tranche of the Equity Raise on October 17, 2024, and issued 34,600,507 new ordinary shares (the “T1 New Shares”) at a price of €1.35 per T1 New Share, and 35,399,481 prefunded warrants to purchase ordinary shares in the Company at an exercise price of €0.01 and a subscription price of €1.34 per new ordinary share and received €94.1 million in gross proceeds (net proceeds approximately €86.6 million). The second part of the first tranche and the second and third tranches of the Equity Raise remain subject to satisfaction of specified conditions, and in particular shareholder approval.
On October 14, 2024, the Company also announced that it had amended its license and collaboration agreement with Chia Tai Tianqing Pharmaceutical (Guangzhou) CO., LTD. (“CTTQ”). Pursuant to the amendment, if the Company receives commitments from investors to subscribe to an equity raise, in two or three tranches, prior to December 31, 2024, for an aggregate amount of at least €180 million, CTTQ shall pay to the Company (i) $10 million within 30 days of settlement-delivery of the new shares and prefunded warrants in the first tranche of the Equity Raise, (ii) $10 million upon the completion of the second tranche of the Equity Raise and (iii) $10 million upon the publication by the Company of positive topline data announcing that any key primary endpoint or key secondary endpoint of the NATiV3 trial, with any dosage regimen tested in the trial, have been met. Under the terms of the Amendment, the total amount of milestone payments remains unchanged, while the royalties that Inventiva is eligible to receive have been reduced to the low single digits. The signing of the Equity Raise satisfied the condition of receiving commitments for an aggregate amount of at least €180 million and the closing of the first part of the first tranche of the Equity Raise satisfied the condition (i) above. Subsequently, on November 18, 2024, the Company received the first milestone payment of $10 million from CTTQ pursuant to this amendment.
Considering its current cost structure and forecasted expenditures and including (i) the receipt of €94.1 million in gross proceeds from the closing of the first part of the first tranche of the Equity Raise, and (ii) the first milestone of $10 million (gross proceeds) received under the amendment to the licensing agreement with CTTQ, the Company estimates that its cash, cash equivalents and deposits would enable it to finance its operations until the end of the second quarter of 2025 . The Company currently expects that the conditions for the closing of the second part of the first tranche of the Equity Raise will be satisfied in December 2024. Considering its current cost structure and forecasted expenditures, the Company estimates that the anticipated receipt of the proceeds (a gross amount of €21.4 million) from the second part of the first tranche of the Equity Raise announced on October 14, 2024 would be sufficient to extend the Company's ability to finance its operations until middle of the third quarter of 2025.
The Company's revenues for the first nine months of 2024 amounted to €1.3 million, as compared to €1.9 million for the same period in 2023.
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 3 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
Non-audited financial information.
Press release of October 14, 2024
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.
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, was accessible prior to the expiration of the term with a notice period of 31 days and was considered as liquid by the Company.
Press release of July 18, 2024
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