- Cash position2 at €87.2 m as of June 30, 2022
- Revenues of €0.1 m in H1 2022
- Inventiva entered into a finance loan and a warrant agreement
for up to €50 million with the European Investment Bank (EIB)
- Inventiva raised approximately €14.6m through a combination of
its At-The-Market program (for €9.3m in gross proceeds) and new
State backed bank financing (for €5.3m)
- Cash runway extended until the end of second quarter 2023
without taking into account the €50m finance loan from the EIB
Daix (France), Long
Island City (New York, United States), July 28,
2022 – 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, today reported its
cash position as of June 30, 2022, and its revenues for the first
half of 2022.
Cash Position
As of June 30, 2022, Inventiva’s cash
position was €87.2 million compared to €80.5 million as of
March 31, 2022 and €95.4 million as of December 31, 2021.
Net cash used in operating
activities amounted to €26.1 million in the first half of
2022 compared to €19.8 million for the same period in 2021. R&D
expenses for the first half of 2022, mainly driven by the
development of lanifibranor in NASH, were up 53% compared to the
first half of 2021. This significant increase in R&D expenses
was driven by the costs associated with the NATiV3 Phase III
clinical trial of lanifibranor in NASH and, to a lesser extent,
with the Legend Phase IIa combination trial with lanifibranor
and empagliflozin in patients with NASH and type 2 diabetes . In
January 2022, the Company received a €4 million milestone payment
from AbbVie following the inclusion of the first patient in the
ongoing Phase IIb clinical trial with cedirogant (previously
ABBV-157) in adult patients with moderate to severe chronic plaque
psoriasis, and the 2021 R&D tax credit (“CIR”) for €3.6 million
was received in May 2022.
Net cash generated from investing
activities for the first half of 2022 amounted to €0.8
million, compared to -€1.2 million for the same period in 2021.
Net cash from financing
activities for the first half of 2022 amounted to €13.96
million compared to no net cash generated from financing activities
over the first half of 2021. This increase is mainly driven by the
equity raised through the Company’s At-The-Market Program for
approximately €9.3 million (gross proceeds) on June 15, 2022,
and three loan agreements with French banks for a total
amount of €5.3 million. One of the loans has been contracted as
part of a state-guaranteed PGE loan facility ("Prêt Garanti par
l’Etat") with Bpifrance and the two others from a stimulus economic
plan ("Prêts Participatifs Relance") granted by Crédit Agricole
Champagne-Bourgogne and Société Générale.
Over the first half of 2022, the Company
recorded a positive exchange rate effect on cash and cash
equivalents of €3.2 million versus €1.5 million for the first half
of 2021, due to the strengthening of USD versus Euro.
Furthermore, the Company also finalized the
documentation requirement under the credit facility for up to $50
million with the European Investment Bank (the “EIB”) announced on
May 16, 2022, by signing a warrant agreement with the EIB on July
1, 2022. The Company plans to use the proceeds from the EIB
facility, when received, towards its clinical studies and
preclinical pipeline, including to help fund a portion of its
NATiV3 Phase III clinical trial of lanifibranor in patients with
NASH3.
Considering its current R&D and clinical
development programs and excluding any proceeds from the EIB credit
facility and any potential additional financial resources, the
Company estimates that its existing cash, cash equivalents and
short-term deposits should allow the Company to fund its operations
through the end of the second quarter 20234.
Revenues
The Company’s revenues for the first half of
2022 amounted to €0.1 million, as compared to €0.2 million for the
same period in 2021.
***
Next key milestones expected
- Strategy update on the potential development of odiparcil –
anticipated by end of 2022
- Publication of the results of the investigator-initiated study
with lanifibranor in patients with NAFLD and T2D – previously
planned for second half of 2022 is now expected in the first
quarter of 2023
- Last Patient First Visit of the NATiV3 Phase III clinical trial
evaluating lanifibranor in NASH – planned for first half of
2023
- Study completion of phase IIb trial of cedirogant in patient
with psoriasis conducted by AbbVie – planned for first half of
2023
- Topline results of Phase IIa LEGEND of lanifibranor in
combination with empagliflozin in patients with NASH and T2D–
planned for second half of 2023
Upcoming investor conference
participation
- H.C. Wainwright 24th Annual Global Investment Conference –
September 12-14, New York City
- KBC Life Sciences Conferences – September 15-16, Virtual
- Lyon Pôle Bourse- September 28, Lyon
- HealthTech Innovation Days – October 12-14, Paris
- Portzamparc BNP Paribas Biotech & Santé - October 4,
Virtual
- Jefferies 2022 London Healthcare Conference - November
15-17, London
Upcoming scientific conference
participation
- Paris Nash Meeting - September 8-9, Paris
- 91èmes Journées Scientifiques de l’AFEF - October 5-8,
Dijon
- AASLD - The Liver Meeting - November 4-8, Washington, DC
- 6th Obesity and NASH Drug Development Summit – November 29
through December 1st, Boston
Next financial results
publication
- Financial results for the first half of 2022:
Wednesday, September 21, 2022 (after U.S. market close)
About Inventiva
Inventiva is a clinical-stage biopharmaceutical
company focused on the research and development of oral small
molecule therapies for the treatment of patients with 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’s lead product candidate,
lanifibranor, is currently in a pivotal Phase III clinical trial,
NATiV3, for the treatment of adult patients with NASH, a common and
progressive chronic liver disease for which there are currently no
approved therapies.
The Company has established a strategic
collaboration with AbbVie in the area of autoimmune diseases that
resulted in the discovery of the drug candidate cedirogant
(ABBV-157), an oral RORγ inverse agonist which is being evaluated
in a Phase IIb clinical trial, led by AbbVie, in adult patients
with moderate to severe chronic plaque psoriasis. Inventiva’s
pipeline also includes odiparcil, a drug candidate for the
treatment of adult mucopolysaccharidoses (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 in the
process of selecting an oncology development candidate for its
Hippo signalling pathway program.
The Company has a scientific team of
approximately 80 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 C 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.
Contacts
InventivaPascaline ClercVP of Global External
Affairsmedia@inventivapharma.com+1 240 620 9175 |
Brunswick GroupTristan Roquet Montegon / Aude
Lepreux / Matthieu BenoistMedia
relationsinventiva@brunswickgroup.com+33 1 53 96 83 83 |
Westwicke, an ICR CompanyPatricia L. BankInvestor
relationspatti.bank@westwicke.com+1 415 513 1284 |
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Important Notice
This press release contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this press
release are forward-looking statements. These statements include,
but are not limited to, forecasts and estimates with respect to
Inventiva’s pre-clinical programs and clinical trials, including
recruitment, screening and enrolment for those trials,
including the LEGEND trial for the treatment of NAFLD, the NATiV3
Phase III clinical trial with lanifibranor in NASH and the expected
Phase IIb clinical trial of cedirogant led by AbbVie, potential
development of odiparcil, clinical trial data releases and
publications, the information, insights and impacts that may be
gathered from clinical trials, including LEGEND, the potential
therapeutic benefits of lanifibranor in combination with
empagliflozin, the design of trials, including LEGEND,
pipeline and preclinical and clinical development plans, milestone
payments, royalties and product sales, potential proceeds under the
Company’s financing arrangements, future activities, expectations,
plans, growth and prospects of Inventiva and the sufficiency of
Inventiva’s cash resources and cash runway. Certain of these
statements, forecasts and estimates can be recognized by the use of
words such as, without limitation, “believes”, “anticipates”,
“expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”,
“would”, “could”, “might”, “should”, “plans”, “designed”,
“hopefully” and “continue” and similar expressions. Such statements
are not historical facts but rather are statements of future
expectations and other forward-looking statements that are based on
management's beliefs. These statements reflect such views and
assumptions prevailing as of the date of the statements and involve
known and unknown risks and uncertainties that could cause future
results, performance or future events to differ materially from
those expressed or implied in such statements. Future events are
difficult to predict and may depend upon factors that are beyond
Inventiva's control. There can be no guarantees with respect to
pipeline product candidates that the clinical trial results will be
available on their anticipated timeline, that future clinical
trials will be initiated as anticipated, that product candidates
will receive the necessary regulatory approvals, or that any of the
anticipated milestones by Inventiva or its partners will be reached
on their expected timeline, or at all. Actual results may turn out
to be materially different from the anticipated future results,
performance or achievements expressed or implied by such
statements, forecasts and estimates, due to a number of factors,
including that Inventiva is a clinical-stage company with no
approved products and no historical product revenues, Inventiva has
incurred significant losses since inception, Inventiva has a
limited operating history and has never generated any revenue from
product sales, Inventiva will require additional capital to finance
its operations, Inventiva's future success is dependent on the
successful clinical development, regulatory approval and subsequent
commercialization of current and any future product candidates,
preclinical studies or earlier clinical trials are not necessarily
predictive of future results and the results of Inventiva's
clinical trials may not support Inventiva's product candidate
claims, Inventiva may encounter substantial delays in its clinical
trials or Inventiva may fail to demonstrate safety and efficacy to
the satisfaction of applicable regulatory authorities, enrolment
and retention of patients in clinical trials is an expensive and
time-consuming process and could be made more difficult or rendered
impossible by multiple factors outside Inventiva's control,
Inventiva's product candidates may cause adverse drug reactions or
have other properties that could delay or prevent their regulatory
approval, or limit their commercial potential, Inventiva faces
substantial competition and Inventiva’s business, and preclinical
studies and clinical development programs and timelines, its
financial condition and results of operations could be materially
and adversely affected by the current COVID-19 pandemic and
geopolitical events, such as the conflict between Russia and
Ukraine, related sanctions and related impacts and potential
impacts on the initiation, enrolment and completion of Inventiva’s
clinical trials on anticipated timelines, and macroeconomic
conditions, including global inflation and financial markets. Given
these risks and uncertainties, no representations are made as to
the accuracy or fairness of such forward-looking statements,
forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates only speak as of the date of this press
release. Readers are cautioned not to place undue reliance on any
of these forward-looking statements.
Please refer to the Universal Registration
Document for the year ended December 31, 2021 filed with the
Autorité des Marchés Financiers on March 11, 2022 and the Annual
Report on Form 20-F for the year ended December 31, 2021 filed with
the Securities and Exchange Commission on March 11, 2022 for
additional information in relation to such factors, risks and
uncertainties.
All information in this press release is as of
the date of the release. Except as required by law, Inventiva has
no intention and is under no obligation to update or review the
forward-looking statements referred to above.
1 Non-audited financial information.
2 The cash position is defined as cash and cash equivalents as
well as short-term deposits which are included in the category
“other current assets” in the IFRS consolidated statement of
financial position as of June 30, 2022 but are considered by the
Company as liquid and easily available.
3As announced by the Company, the facility loan
is divided in two tranches of €25 million, each which are subject
to the completion of certain condition precedents. For a detailed
description of the conditions, consult the press release of July 4,
2022.
4 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.
- Inventiva - PR - H1 2022 CA Cash - EN - 28072022
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