On March 29, 2023 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 patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported its full-year results for 2022 (Press release, Inventiva Pharma, MAR 29, 2023, View Source [SID1234629605]).
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Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: "2022 has been a successful year for Inventiva in many ways. On the clinical front, we achieved substantial progress in the development of lanifibranor starting with clearance by the FDA of our "Investigational New Drug" application for our Phase II clinical trial combining lanifibranor and empagliflozin in patients with NASH and type 2 diabetes. In China, we established a partnership with Sino Biopharm to develop and commercialize lanifibranor in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan. As part of this collaboration, we received an upfront payment of €12.8 million, including €1.3 million of withholding taxes for net proceeds of €11.5 million, in November 2022, and are eligible to receive up to $290 million in potential milestone payments and royalties on potential net sales of lanifibranor in China, subject to marketing approval in China.
Over the year, we also strengthened our financial position through a loan agreement of up to €50 million with the European Investment Bank, subject to completion of certain conditions² , of which we drew the first €25 million tranche in December 2022. In July 2022, we raised nearly €15 million, including more than €9 million gross proceeds through our "At-The-Market" program and loan agreements with a syndicate of French banks for a total amount of €5.3 million.
Looking forward, we are continuing our effort to implement the new design of NATiV3 which has been submitted in almost all countries involved in the study and has already been cleared in key countries including the United States. Enrollment in our investigator initiated study, led by Dr. Cusi, was completed in September and we expect the publication of this Phase II clinical study evaluating lanifibranor for the treatment of NAFLD in patients with T2D by the middle of the second quarter of 2023. Finally, both the results from our LEGEND Phase II study combining lanifibranor and empagliflozin in patients with NASH and T2D and the first visit of the last patient in our NATiV3 study, are expected in the second half of 2023."
Key financial results for the full year of 2022
As of December 31, 2022, the Company had €86.7 million of cash and cash equivalents and €1.0 million of short-term deposits³ , compared to €86.6 million and €8.8 million, respectively, as of December 31, 2021.
Cash and cash equivalents at year end included the €12.8 million upfront payment (including €1.3 million of withholding taxes, amounting to net proceeds of €11.5 million) received on November 4, 2022 from Chia Tai Tianqing Pharmaceutical Group, Co., LTD ("CTTQ"), a subsidiary of Sino Biopharm, in connection with the previously announced license and collaboration agreement dated September 21, 2022.
Cash and cash equivalents at year end also included the €25.0 million tranche of the previously announced unsecured loan agreement executed with the EIB on May 16, 2022, which the Company received on December 8, 2022, the €9.4 million gross proceeds (€8.8 million net proceeds) raised through the Company’s At-The-Market ("ATM") Program on June 15, 2022, and the proceeds of three previously announced loan agreements with a syndicate of French banks for a total amount of €5.3 million. One of the loans was contracted as part of a French state-guaranteed loan facility with Bpifrance, and the two other loans were obtained as part of a French state stimulus economic plan granted by Crédit Agricole Champagne-Bourgogne and Société Générale.
Net cash used in operating activities amounted to (€44.9) million for the full year 2022, compared to (€47.6) million in 2021. Net cash used in operating expenses in 2022 was driven primarily by R&D expenses, partially offset by the upfront payment received from CTTQ.
Net cash generated from (used in) investing activities amounted to €8.9 million for the full year 2022 compared to (€1.8) million net cash used for the same period in 2021. The variance is mainly due to the change in short term deposits between both periods.
Net cash generated from financing activities amounted to €37.3 million for the full year 2022 compared to €25.4 million for 2021. Net cash generated from financing activities in 2022 has been driven by the proceeds of the first tranche of €25 million from the EIB loan, gross proceeds of €9.4 million from the sale of securities through the Company’s ATM program and proceeds of €5.3 million from three French state partially guaranteed loans, as described above.
For the full year 2022, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million, due to the strengthening of USD versus Euro, compared to a positive effect of €4.8 million for 2021.
Considering its current R&D and clinical development programs, the Company estimates that its existing cash, cash equivalents and short-term deposits should allow the Company to fund its operations until the end of the fourth quarter of 20234. This cash runway estimate does not include the conditional second tranche of €25.0 million of the EIB loan agreement2.
The Company’s revenues for the full year 2022 amounted to €12.2 million, as compared to €4.2 million for 2021. The revenues recorded in 2022 were driven mostly by the Company’s license and collaboration agreement with CTTQ, executed on September 21, 2022, and revenues recorded in 2021 primarily consisted of a €4.0 million milestone payment for a milestone that was recorded following the launch by AbbVie of the Phase IIb clinical trial with cedirogant. As previously disclosed, this trial of cedirogant has since been discontinued by AbbVie and the partnership with AbbVie has been terminated.
Other income amounted to €6.6 million for the full year 2022, as compared to €4.3 million for 2021, increased 54% mainly driven by the French R&D tax credit based on the increasing eligible expenses and to a lesser extent by the U.S. R&D tax credit.
R&D expenses for the fiscal year ended December 31, 2022 amounted to (€60.5) million compared to (€48.5) million for the same period in 2021. This 24.8% increase was driven mostly by the costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH, including a full twelve months of operation for the U.S. affiliate and, to a lesser extent, with the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes ("T2D").
Marketing and business development expenses stood at (€2.6) million for the fiscal year ended December 31, 2022 compared to (€0.4) million for the same period in 2021 mainly linked to the partnership with CTTQ and to a lesser extent to the increasing market access activities.
General and administrative expenses (G&A) amounted to (€12.9) million for the fiscal year ended December 31, 2022, increased +15.7% compared to (€11.2) million for the same period in 2021, mainly due to personnel costs linked to the non-cash share-based payment expenses, a full twelve months of operating for the U.S. affiliate and to a lesser extent an increase in compliance and consulting fees related to the dual listing of Inventiva securities and strategic projects
Other operating income (expenses) was €0 million for the fiscal year ended December 31, 2022 compared to (€0.6) million for the same period in 2021.
Net financial income stood at €2.8 million for the fiscal year ended December 31, 2022 compared to €2.8 million for the same period in 2021. The net financial income for both years mainly includes (i) the losses from the change in fair value linked to derivatives (warrants linked to the finance contract with EIB in 2022 and forward currency contracts in 2021) and (ii) the foreign exchange gain generated by cash and cash equivalents denominated in U.S. dollars and the favorable exchange rate of euro against the U.S. dollar over the period.
Income tax amounted to €0 million for the 2022 fiscal year, compared to (€0.4) million for 2021.
The Company’s net loss for the full year 2022 was (€54.3), compared to (€49.6) million for 2021.
The following table presents Inventiva’s income statement, prepared in accordance with IFRS, for the 2022 financial year, with comparatives for the 2021 financial year.
(in thousands of euros) Year ended December 31, 2022 Year ended December 31, 2021
Revenues 12,179 4,194
Other income 6,635 4,307
Research and development expenses (60,469) (48,452)
Marketing – business development expenses (2,583) (364)
General and administrative expenses (12,912) (11,155)
Other operating income (expenses) 40 (644)
Net operating loss (57,110) (52,114)
Net financial income 2,816 2,842
Income tax 20 (364)
Net loss for the period (54,274) (49,635)
Basic/diluted loss per share (euros/share) (1.31) (1.27)
Weighted average number of outstanding shares used for computing basic/diluted loss per share 41,449,732 39,168,152
Main areas of progress in the R&D portfolio
Lanifibranor in non-alcoholic steatohepatitis (NASH)
Changes to the Phase III NATiV3 trial evaluating lanifibranor in NASH — designed to align with the FDA’s public communication suggesting that an alternative approach to seek full approval in patients with NASH could be considered upon submission of positive results of a Phase III trial using a histology surrogate endpoint in patients with NASH and a Phase III clinical outcome trial in patients with NASH and compensated cirrhosis— that the Company believes will be beneficial to the overall lanifibranor clinical program by reducing the number of biopsies during the trial, reducing the trial duration from 7 years to 72 weeks or potentially expanding the addressable patient population to include patients with NASH and compensated cirrhosis – January 4, 2023
Approval of a new patent, protecting the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage, in the United States until November 2039 by the United States Patent and Trademark Office ("USPTO") – November 28, 2022
Completion of the recruitment for the investigator-initiated Phase II trial of lanifibranor in patients with Non-Alcoholic Fatty Liver Disease ("NAFLD") and with T2D, conducted by Dr. Cusi from the University of Florida – September 22, 2022
Screening in the United States of the first patient in Inventiva’s proof-of-concept LEGEND Phase IIa combination trial with lanifibranor and empagliflozin for the treatment of patients with NASH and T2D. All 36 sites in France, the United Kingdom, Belgium, the Netherlands, and the United States anticipated to participate in the trial have been qualified. Topline results are expected to be published in the second half of 2023 – July 7, 2022
Completion by the FDA of its safety review of Inventiva’s Investigational New Drug application (IND) for the LEGEND Phase II combination trial with lanifibranor and empagliflozin in patients with NASH and T2D – March 8, 2022
Odiparcil in mucopolysaccharidosis type VI (MPS VI)
FDA feedback that odiparcil can be dosed in pediatric MPS VI patients and that the single Phase II/III trial design presented by the Company could potentially support a future odiparcil marketing application. Inventiva continues to review potential options to further development of odiparcil for the treatment of MPS VI, which may include pursuing a partnership – August, 2022
Collaboration with AbbVie on cedirogant in autoimmune diseases
Decision by AbbVie to stop the development of cedirogant following the analysis of a nonclinical toxicology study – October 31, 2022
Receipt of a €4 million milestone payment from AbbVie following the inclusion of the first patient in the now-terminated Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis – January 31, 2022
Other significant milestones
Receipt of the €25 million payment under the first tranche of the unsecured loan agreement with the EIB on May 16, 2022, with a maturity date of December 2026 – December 12, 2022
Appointment of Dr. Lucy Lu as Director on Inventiva’s Board of Directors in lieu of Sofinnova Partners, effective on November 9th, 2022, after Dr. Lu had been Sofinnova Partners’ representative on Inventiva’s Board of Directors since January 4th, 2020. – November 21, 2022
Entry into a license and collaboration agreement with Sino Biopharm through their CTTQ subsidiary, Chia Tai Tianqing Pharmaceutical Group, to develop and commercialize lanifibranor for the treatment of NASH and other metabolic diseases in Greater China – September 21, 2022
Entry of Inventiva in the Euronext Tech Leaders segment, a new Euronext segment which includes more than 100 high-growth and leading tech companies across Europe – June 7, 2022
Entry into a credit facility agreement for up to €50 million, subject to conditions precedent2, with the European Investment Bank with the plan to use any potential borrowings under the facility towards Inventiva’s preclinical and clinical pipeline, including to help fund a portion of its Phase III clinical trial of lanifibranor in patients with NASH, subject to satisfaction of conditions precedent – May 16, 2022
Anticipated key milestones expected
After having finalized patient recruitment in September 2022, publication of the topline results of the investigator-initiated study with lanifibranor in patients with NAFLD and T2D – anticipated by the middle of the second quarter of 2023
Publication of the topline results of the LEGEND Phase IIa combination trial of lanifibranor in combination with empagliflozin in patients with NASH and T2D – anticipated in the second half of 2023
Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – anticipated in the second half of 2023
Upcoming investor conference participation
Evercore ISI NASH Renaissance – March 30 – Virtual
Kempen Life Sciences Conference – April 25-26 – Amsterdam
Jefferies Global Healthcare Conference – June 7-9 – New York City
Upcoming scientific conference participation
Digestive Disease Week – May 6-9 – Chicago, IL
Conference call
A conference call in English will be held tomorrow, Thursday, March 30, 2023 at 8:00 am (New York time)/2:00 pm (Paris time) to discuss 2022 financial results and business updates.
The conference call and the slides of the presentation will be webcast live at View Source and also available on Inventiva’s onwards in the "Investors" – "Financial results" section.
In order to receive the conference access information necessary to join the conference call, it is required to register in advance using the following link: https://register.vevent.com/register/BI64f8e310179a49e2a675a18f401f7241.
In the 10 minutes prior to the call start time, participants will need to use the conference access information provided in the e-mail received at the point of registering (dial-in number and access code).
A replay of the conference call and the presentation will be available after the event at: View Source
Next financial results publication
Revenues and cash, cash equivalents and short-term deposits for the first quarter of 2023: Monday, May 16, 2023 (after U.S. market close)