Inventiva ADR Representing Ord Shs (NASDAQ: IVA) shares sky rocket to around 12% in pre trading session on Monday as in last session share rose to 72.79% to close at $7.05. A clinical-stage biopharmaceutical company, Inventiva (IVA) declared that it have entered into a licensing and collaboration agreement with Chia Tai-Tianqing Pharmaceutical Group Co Ltd, a Sino Biopharm subsidiary to develop and commercialize lanifibranor in mainland China, Hong Kong, Macau, and Taiwan for non-alcoholic steatohepatitis (NASH) and expectedly other metabolic diseases.
Inventiva will receive a $12 million upfront payment, with a potential additional $5 million payment in the near future if certain clinical milestones are met. Milestone payments might total up to $290 million for Inventiva.
Inventiva revealed in its first-quarter earnings report that the last patient’s first visit for the NATiV3 Phase 3 study of lanifibranor in NASH patients is now slated for H2 2023 rather than 1H 2023, with topline results from part 1 of the research now anticipated for the second half of 2025.
The firm claims that the delay is mostly due to a higher-than-expected screen failure rate, which has resulted in a slower-than-expected enrollment rate caused by the Russia-Ukraine war and the pandemic. Inventiva’s cash runway has been extended through Q4 2023, with a cash position of €76.4 million, including a $12 million advance payment from Sino Biopharm and a €25 million credit facility from the EIB.
In September, Inventiva (NASDAQ: IVA) signed a licensing and cooperation agreement with Sino Biopharm’s subsidiary Chia Tai-Tianqing Pharmaceutical Group (CTTQ) to develop and market lanifibranor in Greater China.
Regardless of CTTQ’s decision on the lanifibranor clinical development pathway in China, HC Wainwright points out that Sino Biopharm is a vertically-integrated corporation with extensive R&D, manufacturing, sales, and marketing competence.
Given Sino Biopharm’s track record as a commercial-stage startup in Greater China, the analyst views the arrangement as a financially prudent strategy for lanifibranor’s expansion into a crucial NASH market. HC Wainwright retains its Buy rating but lowers its price target from $42 to $36 owing to an expected delay in enrollment in the pivotal Phase 3 NATiV3 project.
Lanifibranor’s expected sales trajectory for the treatment of NASH was amended by the analyst to reflect the most current clinical schedule (last patient’s first visit in 2H23, and top-line data readout in 2H25). These changes reduced the analyst’s forecasted peak sales of lanifibranor in NASH to €1.7 billion in 2034 from €1.9 billion previously.
