On September 16, 2020 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, reported its interim financial results for the six months ended June 30, 2020, and provided an update on its business activities (Press release, Inventiva Pharma, SEP 16, 2020, View Source [SID1234568610]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "The first half of 2020 has been one of the most decisive periods since the founding of Inventiva in 2012. Looking at the development of our R&D portfolio, our lead drug candidate lanifibranor has shown very promising results in our Phase IIb clinical trial in NASH: with statistically significant results on both the FDA and European Medical Agency (EMA) primary endpoints relevant for seeking accelerated approval during Phase III clinical development, this trial has paved the way for lanifibranor to enter into pivotal Phase III In parallel, we have progressed in the development of odiparcil for the treatment of MPS VI: the recent acceptance of our IND application by the FDA will allow us to launch our first clinical trial with odiparcil in the USA and will lay the groundwork for its future development in this important market. I would also like to thank the whole Inventiva team who worked tirelessly over the last few months in a difficult context. I am proud of their work and commitment that contributed to these achievements. Looking ahead, we are now fully focused on moving forward with the clinical development of lanifibranor in NASH with the anticipated pivotal Phase III trial, while continuing to advance our different programs across MPS, psoriasis and oncology, in line with our multi-asset strategy."
Jean Volatier, Chief Financial Officer of Inventiva, added: "In addition to the significant progress of our R&D portfolio, especially in NASH, we were also able to considerably strengthen our financial position despite the challenging environment linked to the COVID-19 pandemic. Of particular note is our successful initial public offering on the Nasdaq Global Market in the U.S., which increases our visibility in this key market and has enabled us to extend our cash runway through the fourth quarter of 2022. Backed by a very solid financial position and important advances across our R&D portfolio, we are in an ideal position to pursue the development of our different drug candidates."
Key financial results for the first half of 2020
Revenues for the first half of 2020 reached €0.2 million compared to €1.3 million in the first half of 2019 and related primarily to research services in connection with Inventiva’s collaboration with Boehringer Ingelheim, which has since been terminated.
R&D expenses amounted to €12.6 million in the first half of 2020, down 36% compared to the first half of 2019. These expenses were mainly dedicated to the development of lanifibranor in NASH and odiparcil in MPS VI. The decrease compared to the previous year is mainly due to the halt in the clinical development of lanifibranor in the treatment of systemic sclerosis in February 2019 and the savings generated by the Employment Safeguard Plan subsequently introduced, with the first half of 2020 recording the full effect of the savings generated.
General and administrative expenses amounted to €3.4 million, compared to €3.1 million in the first half of 2019, up 8%, mainly due to increased labor costs.
Other operating income (expenses) amounted to (€1.4) million (compared with (€1.3) million in the first half of 2019). The first half of 2019 took into account the recording of a provision of €1.1 million relating to the Employment Safeguard Plan, while the first half of 2020 takes into account part of the expenses incurred as part of the Initial Public Offering in the United States.
Company’s net loss stood at (€15.7) million, compared to (€20.5) million in the first half of 2019.
Inventiva’s net cash flow amounted to €16.4 million in the six months ended June 30, 2020 compared to (€19.6) million in the first half of 2019. Net cash used in operating activities was (€7.2) million and (€18.7) million in the first half of 2020 and 2019, respectively.
In addition to the decrease in R&D expenses mentioned above, in the first half of 2020, cash flow from operating activities was positively impacted by the receipt in January 2020 of €4.2 million in respect of the 2018 Research Tax Credit (CIR), and the receipt in April and June 2020 of €4.2 million in total in respect of the 2019 CIR.
Net cash from financing activities amounted to €24.6 million in the first half of 2020, driven by: the issuance of €15 million (gross proceeds) of ordinary shares in February 2020 to certain existing investors in the Company and the entry into a €10.0 million credit agreement, guaranteed by the French State, with a syndicate of French banks.
Consequently, Inventiva’s cash and cash equivalents stood at €52.3 million as of June 30, 2020 compared to €35.8 million as of December 31, 2019.
The financial statements of the first half of 2020 were approved by the Board of Directors on September 15, 2020. The statutory auditors have issued a limited review report. For more details, Inventiva’s Half-Year Financial Report is available on the Company’s website at: www.inventivapharma.com.
Financial information after closing of the accounts
On July 15, 2020, Inventiva successfully closed its initial public offering on the Nasdaq Global Market of an aggregate of 7,478,261 new ordinary shares in the form of American Depositary Shares (ADSs), each representing one ordinary share, at an offering price of $14.40 per ADS. Aggregate gross proceeds of the initial public offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately $107.7 million (€94.9 million2). All of the securities as part of the initial public offering were offered by Inventiva. The Company’s ADSs, listed under the symbol "IVA", began trading on the Nasdaq Global Market on July 10, 2020.
The Company believes its cash, cash equivalents, short-term investments and non-current financial assets, together with the net proceeds of its successful initial public offering on the Nasdaq Global Market and its cash flow from operations will be sufficient to fund its operations through the fourth quarter of 2022.
Main areas of progress in the R&D portfolio
Lanifibranor in non-alcoholic steatohepatitis (NASH)
Following the publication of the positive results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH in June 2020, Inventiva has progressed with the analysis of the circulating biomarkers. The first results of this analysis have shown a positive and statistically significant decrease of some biomarkers under lanifibranor treatment. Of importance and in line with the mechanism of action of lanifibranor, patients treated with the drug candidate showed improvements on biomarkers of fibrosis (Pro-C3 – a marker of fibrogenesis and ratio TIMP-1/MMP2 – a ratio depicting the inhibition of matrix remodeling process), apoptosis (CK18-M30 – a marker of apoptosis) and inflammation (Ferritin and hs-CRP – markers of inflammation). These findings, including the table in appendix of this press release, will be presented in more detail during tomorrow’s webcast and conference call (see below for logistical details) – September 17, 2020
Following higher than expected observed effects of lanifibranor in reducing steatosis during the Phase IIb NATIVE clinical trial in NASH, Professor Kenneth Cusi, the investigator of the trial, decided to reduce the number of patients in the ongoing Phase II clinical trial evaluating lanifibranor in type 2 diabetes patients (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD); results are expected in 2021 – July 6, 2020
Publication of positive topline results from the Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial; decision to continue the clinical development of lanifibranor in NASH and enter into pivotal Phase III development – June 15, 2020
Inventiva announced positive topline results from the Phase IIb NATIVE clinical trial evaluating lanifibranor for the treatment of NASH on June 15, 2020.
In this 24-week clinical trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat (ITT3) and Per Protocol populations (PP4). The drug candidate also met key secondary endpoints, including NASH resolution with no worsening of fibrosis5 and improvement of liver fibrosis with no worsening of NASH6 in both ITT and PP populations. With these results, lanifibranor is the first drug candidate to achieve statistically significant results on NASH resolution with no worsening of fibrosis and improvement of fibrosis with no worsening of NASH, the two Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking accelerated approval during Phase III clinical development. Based on these positive topline results, Inventiva has decided to continue with the clinical development of lanifibranor in NASH and enter into pivotal Phase III development.
§ Approval of a new patent directed at the use of lanifibranor for the treatment of several fibrotic diseases, including NASH, in China until June 2035 by the China National Intellectual Property Administration (CNIPA) – May 25, 2020
Odiparcil in mucopolysaccharidosis type VI (MPS VI)
§ Acceptance of the Investigational New Drug (IND) application for odiparcil in MPS VI by the U.S. Food and Drug Administration (FDA) – August 10, 2020
On August 10, 2020, the FDA accepted Inventiva’s IND application for odiparcil for the treatment of MPS VI, allowing the Company to initiate clinical trials with this drug candidate in the United-States.
Decision by Inventiva to extend the duration of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children from 6 to 12 months following a scientific advice meeting with the EMA in July; launch of the trial is expected in the first half of 2021 – July 23, 2020
Publication of Inventiva’s latest research on odiparcil’s mechanism of action in the leading peer-reviewed scientific journal PLOS ONE, showing that the drug candidate was associated with decreased glycosaminoglycan (GAG) accumulation and increased GAG excretion, and highlighting its distribution in MPS VI disease-relevant tissues and organs – May 18, 2020
Other significant milestones
§ Appointment of Dr Arun J. Sanyal to Inventiva’s Scientific Advisory Board (SAB), further strengthening the Board’s expertise in the field of NASH – July 29, 2020
Inventiva has further reinforced its SAB in the field of NASH with the appointment of Dr Arun J. Sanyal on July 29, 2020. Professor of Medicine, Physiology and Molecular Pathology in the Division of Gastroenterology at Virginia Commonwealth University (VCU) Medical Center in Richmond, Virginia, Dr Sanyal’s research focuses on all aspects of NAFLD and NASH as well as complications of cirrhosis and End-stage Liver Disease. He also serves as Chairman of the National Institutes of Health (NIH) NASH Clinical Research Network, the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) consortium and the Liver Forum for NASH and Fibrosis. In addition to his participation in the SAB, Dr Sanyal is involved in preparing the protocol of the Phase III clinical trial for the development of lanifibranor in NASH.
Entry into a €10.0 million non-dilutive loan facility guaranteed by the French State ("Prêt Garanti par l’Etat"), with the support of Bpifrance, Crédit Agricole Champagne-Bourgogne and Société Générale, contributing to strengthening the Company’s cash position in the context of the COVID-19 pandemic – May 19, 2020
Capital increase of €15 million subscribed by BVF Partners L.P., New Enterprise Associates (NEA), Novo Holdings A/S and Sofinnova Partners – February 11, 2020
COVID-19 update
Following the updated recommendations of domestic public health authorities and a continuous risk assessment of the COVID-19 pandemic situation, Inventiva is pursuing the implementation of measures to minimize risks for its employees and support their health and safety in this unprecedented time. As of today, the R&D internal and support activities are not expected to be significantly impacted in the future.
The global pandemic of COVID-19 continues to evolve, and its ultimate impact remains uncertain. The Company cannot predict the full extent of potential delays or impacts on its clinical trials, or potential impact on its business. Inventiva is committed to continuing to implement measures aimed at minimizing any further potential business impact from the COVID-19 pandemic and continue to comply with the updated guidance documents of the regulatory authorities. The Company continues to closely monitor, assess and respond to the situation as it evolves overtime and continues to work closely with authorities, its contract research organizations, trial sites and investigators to critically reassess all its existing programs and communicates further when and if appropriate.
···
Next expected key milestones
End of NATIVE Phase IIb clinical trial meeting with the FDA and Scientific Advice meeting with the EMA – planned for fourth quarter of 2020
AbbVie’s completion of its ongoing Phase I clinical trial with ABBV-157 in psoriasis patients – expected fourth quarter of 2020
Preparation for commencement of the Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021
Initiation of the Phase I/II SAFE-KIDDS (SAFEty, pharmacoKInetics and pharmacoDynamics, Dose escalating Study) clinical trial evaluating odiparcil in MPS VI children – planned for the first half of 2021
Initiation of the Phase IIa extension clinical trial with odiparcil in MPS VI patients who completed the prior Phase IIa clinical trial (iMProveS) – planned for the first half of 2021
Upcoming investor conference participation
H.C. Wainwright 22nd Annual Global Investment Virtual Conference, September 15-16, 2020
Roth Analyst Management Talk Series, September 21, 2020
20th Annual Biotech in Europe Forum, September 21-24, 2020
KBC Securities Virtual Life Sciences Conference, September 22-23, 2020
Lyon Pôle Bourse Investment forum, Lyon, September 30, 2020
Portzamparc Health/Biotech Virtual Seminar, October 1, 2020
HealthTech Innovation Days, Paris, October 5-6, 2020
European Midcap Hybrid Event, Paris, October 19-20, 2020
Stifel Healthcare Conference 2020, New York, November 17-18, 2020
Jefferies 11th Global Healthcare conference, London, November 17-19, 2020
Piper Sandler 32nd Annual Healthcare Conference, New York, December 1-3, 2020
Upcoming scientific conference presentations
§ Presentation of the Phase IIb NATIVE clinical trial results at The Liver Meeting of the AASLD (American Association for the Study of Liver Diseases), November 13-16, 2020
Conference call
A conference call in English will be held on Thursday, September 17, at 2:00 pm (Paris time). To join the conference call, please use the code 6617599 after dialing one of the following numbers:
The presentation accompanying this conference call will be available on Inventiva’s website in the "Investors" – "Results & Presentations" section at the same time and can be followed live at: View Source
A replay of the conference call and the presentation will be available from 6:00 pm (Paris time) onwards at: View Source
Next financial results publication
§ Q3 2020 Revenues and cash position: Thursday, November 12, 2020 (after market close)
Appendix
Measure of circulating biomarkers in NATIVE Phase IIb trial: significant decrease under lanifibranor treatment compared to placebo after 24-weeks
(1) Level where it is estimated that fibrogenisis is active and corresponding to F2/F3 patients
FAS (Full Analysis Set) population with available data at baseline (pre-treatment) and at week 24 (post-treatment)
* Median change under lanifibranor are statistically significantly different compared to placebo, using the common threshold of 5% (Exploratory Wilcoxon test)