Financial Data and Key Metrics Changes - The company reported a cash position of €96.6 million at the end of 2024, up from €36 million at the end of December 2023, representing a net positive variance of approximately €61 million [21] - Revenues for 2024 were €9.2 million, down from €17.5 million in 2023, primarily due to milestone payments from CTTQ [25] - The net loss for the full year was €184.2 million, compared to €110.4 million in 2023, reflecting an increase in financial losses [28] Business Line Data and Key Metrics Changes - R&D expenses decreased by 17% to €19.9 million in 2024 from €110 million in 2023, attributed to operational delays [26] - General and administrative expenses increased to €15.8 million in 2024 from €13.8 million in 2023, a rise of 14% [27] Market Data and Key Metrics Changes - The company is positioned to potentially become a leading oral drug for MASH in Japan, South Korea, and China through partnerships with Hepalys and CTTQ [13] - The demand for MASH treatment is increasing, with limited current treatment options available [31] Company Strategy and Development Direction - The company is focusing all resources on the development of lanifibranor, leading to a reduction of approximately 50% of its workforce [14] - A strategic review led to the reinforcement of the Board of Directors with three new members to support the company's mission [16] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in completing patient enrollment by the end of April 2025, which is crucial for securing additional financing [42] - The company anticipates a strong commercial opportunity for lanifibranor, especially given the recent approval of competing treatments in the MASH market [44][56] Other Important Information - The company raised approximately $184 million in gross proceeds through various financing operations in 2024 [18] - The company confirmed a cash runway until September 2025 without additional financing, extending to September 2026 with the anticipated second tranche [24] Q&A Session Summary Question: Are the background doses for patients on GLP1 low-dose diabetic doses or high-dose for weight loss? - Management confirmed that GLP1 is mostly anti-diabetic dosing, including various GLP1 agonists [36] Question: What is the level of confidence in randomizing the last patient to secure capital increase? - Management expressed high confidence in completing recruitment by the end of April 2025, with sufficient patients already in the screening process [42] Question: What are the plans for additional financing post-data readout in 2H 2026? - Management indicated that there is significant interest in the MASH market and they are actively evaluating options to secure necessary funding [46] Question: Is there any specific rate in the screening that could derail the last person from becoming randomized? - Management explained that the screening process has a defined timeline, and any delays in patient appointments could affect randomization [52] Question: How are R&D expenses expected to change considering workforce reduction and NATiV3? - Management expects a slight increase in R&D expenses by 10% to 20% as they prepare for NDA filing and commercialization [64] Question: What is the design and timing of an outcome study required by the FDA? - Management stated that the outcome study needs to be underway at the time of NDA filing, which is planned for the first half of 2027 [77]
Inventiva(IVA) - 2024 Q4 - Earnings Call Transcript