- Cash and cash equivalents at €86.7 million and short term
deposits at €1 million as of December 31, 2022 compared to €86.6
million and €8.8 million, respectively as of December 31, 2021
- Inventiva entered into a license and collaboration agreement
with Sino Biopharm a leading Chinese pharmaceutical group, through
CTTQ, to develop, manufacture and commercialize lanifibranor in
Greater China
- Under this agreement with Sino Biopharm, Inventiva received a
€12.8 million¹ upfront payment
- Inventiva received the first tranche of €25 million under its
credit facility with the European Investment Bank (EIB)
- Screening of the first patients in LEGEND, a Phase IIa
combination trial with lanifibranor and empagliflozin in patients
with NASH and T2D
- Secured a new patent expanding the IP protection of
lanifibranor in the U.S.
- In January 2023, Inventiva announced changes to NATiV3, a
Phase III trial with lanifibranor in patients with NASH, that are
expected to be beneficial to the clinical program
Daix
(France), Long Island City (New York, United
States), 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,
today reported its full-year results for 2022.
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
https://edge.media-server.com/mmc/p/jdzcm24d 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:
https://inventivapharma.com/investors/financial-results-presentations/.
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)
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,
mucopolysaccharidoses (“MPS”) 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 is currently advancing one clinical candidate, has a
pipeline of two preclinical programs and continues to explore other
development opportunities to add to its pipeline.
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.
Inventiva’s pipeline also includes odiparcil, a
drug candidate for the treatment of adult 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 also in
the process of selecting an oncology development candidate for its
Hippo signaling pathway program.
The Company has a scientific team of
approximately 90 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 B 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
Affairs media@inventivapharma.com+1 240 620 9175 |
Brunswick GroupTristan Roquet Montegon Aude
LepreuxMatthieu BenoistMedia
relationsinventiva@brunswickgroup.com+33 1 53 96 83 83 |
Westwicke,
an ICR CompanyPatricia L. Bank Investor
relationspatti.bank@westwicke.com+1 415 513 1284 |
|
|
|
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, statements regarding forecasts and
estimates with respect to Inventiva’s pre-clinical programs and
clinical trials, including design, duration, timing, recruitment
costs, screening and enrolment for those trials, including the
ongoing NATiV3 Phase III clinical trial with lanifibranor in NASH,
the LEGEND Phase IIa combination trial with lanifibranor and
empagliflozin in patients with NASH and type 2 diabetes, and the
Phase II clinical study evaluating lanifibranor for the treatment
of NAFLD in patients with T2D, the potential benefits of the
modification of the Phase III NATiV3 trial evaluating lanifibranor
in NASH, the potential development of and regulatory pathway for
odiparcil including a potential partnership, clinical trial data
releases and publications, the information, insights and impacts
that may be gathered from clinical trials, the addressable patient
population, the potential therapeutic benefits of Inventiva’s
product candidates, including lanifibranor, potential regulatory
submissions and approvals, Inventiva’s pipeline and preclinical and
clinical development plans, future activities, expectations, plans,
growth and prospects of Inventiva, the potential receipt of the
second tranche under the EIB loan and any potential transaction or
receipt of additional funds, and the sufficiency of Inventiva’s
cash resources and cash runway and the ability of the Company to
continue as a going concern. 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”,
“target”, “aim”, 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, in the absence of which, Inventiva may be required
to significantly curtail, delay or discontinue one or more of its
research or development programs or be unable to expand its
operations or otherwise capitalize on its business opportunities
and may be unable to continue as a going concern, 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’s expectations with
respect to the changes to the clinical development plan for
lanifibranor for the treatment of NASH may not be realized and may
not support the approval of a New Drug Application, 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, the ability of Inventiva to
recruit and retain patients in clinical studies, 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, uncertain financial markets
and disruptions in banking systems. 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, 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, and
the financial report for the first half of 2022 filed with the
Securities and Exchange Commission on September 22, 2022, for
additional information in relation to such factors, risks and
uncertainties, in addition to the Universal Registration Document
for the year ended December 31, 2022 expected to be filed with the
Autorité des Marchés Financiers on March 30, 2023 and the Annual
Report on Form 20-F for the year ended December 31, 2022 expected
to be filed with the Securities and Exchange Commission on March
30, 2023.
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 This amount includes €1.3 million of withholding taxes,
amounting to net proceeds of €11.5 million. ² The disbursement of
the second tranche of €25 million is subject to, among other
conditions, (i) the Company issuing warrants to EIB in accordance
with the terms and conditions of the warrants agreements entered
into July 1, 2022, (ii) the full drawdown of the first tranche,
(iii) the receipt by the Company from the date of the EIB credit
facility of an aggregate amount of at least €70.0 million
(inclusive of the €18.0 million that was a condition for the
disbursement of the first tranche), paid either in exchange for
Company shares, or through upfront or milestone payments, (iv) an
out-licensing, partnership or royalty transaction with an upfront
payment of at least €10.0 million; and (v) operational criteria
based on patient enrolment and number of sites activated in the
Company’s NATiV3 Phase III clinical trial of lanifibranor in
patients with NASH3 Short-term deposits are included in the
category “other current assets” in the IFRS consolidated statement
of financial position as of December 31, 2022, but are considered
by the Company as liquid and easily available.
4This 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 - FY 2022 - EN - 29.03.2023
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