Inventiva reports its 2021 Full-Year Results: key milestones
achieved with lanifibranor in NASH and cedirogant in psoriasis
- Initiation of the NATiV3 Phase III clinical trial with
lanifibranor in NASH
- Receipt of a €4 m milestone payment from AbbVie following the
inclusion of the first patient in the ongoing Phase IIb clinical
trial with cedirogant1 in patients with moderate to severe
psoriasis
- R&D expenses doubled for full year 2021 reaching €48.4 m
compared to 2020, mainly driven by the preparation and initiation
of the NATiV3 Phase III clinical trial
- Cash position2 at €95.4 m as of December 31, 2021 compared to
€113.0 m as of December 31, 2020
- Implementation of an At-The-Market (“ATM”) program in the
United States for the sale up to $100 m of ADS
Daix
(France), Long Island City (New York, United
States), March 7, 2022 – 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) and other diseases with
significant unmet medical needs, today reported its full-year
results for 2021.
Frédéric Cren,
Chairman, CEO and cofounder of Inventiva,
stated: “We are extremely proud of the strong progress of
our clinical pipeline which has now two advanced clinical programs:
a Phase III clinical trial in NASH with lanifibranor and a Phase
IIb trial in patients with psoriasis initiated and fully financed
by our partner AbbVie with cedirogant. Inventiva also announced the
design of LEGEND, a Phase II combination trial with lanifibranor
and SGLT2 inhibitor empagliflozin in patients with NASH and type 2
diabetes and we are looking forward to the results of our Phase II
clinical trial in patients with type 2 diabetes and NAFLD expected
in the second half of 2022.Furthermore, we believe the publication
of our NATIVE Phase IIb clinical trial results by The New England
Journal of Medicine strengthened the legitimacy of lanifibranor as
a potential key treatment in NASH.
In addition, we have strengthened our financial
position with existing and new institutional investors, notably
with the sale of approximately $32 million of ADS via our ATM
program in September. We have also received a €4 million milestone
payment from our partner AbbVie, in connection with the cedirogant
Phase IIb initiation, further supporting Inventiva’s cash position
of €95.4 million as of December 31, 2021.
This combination of our clinical development
advancement and financial results underpins our great confidence in
Inventiva’s future. Lanifibranor which we believe has the potential
to be a promising treatment for patients suffering from NASH, and
cedirogant having the potential to be a promising treatment for
patients with moderate to severe psoriasis, could potentially
provide important sources of revenues for us in the future.”
Key financial results
Inventiva’s key financial results for its 2021
full-year results are as follows:
As of December 31, 2021, the Company’s
cash position stood at €95.4 million compared to €105.7 million as
of September 30, 2021, and €113.0 million as of December 31,
2020.
- For the full year 2021, net cash used in operating
activities amounted to (€47.6) million, compared to
(€30.6) million for 2020, mainly driven by the strong increase in
R&D expenses linked to the costs associated with the
preparation and initiation of the NATiV3 Phase III clinical trial
with lanifibranor in NASH.
- Net cash used from investing activities
(excluding the increase in short-term deposits of €1.4 million for
the 2021 full year and €7.7 million for 2020) amounted to (€0.5)
million for the full year 2021, a slight decrease compared to
(€0.9) million in 2020.
- Finally, net cash from financing activities
for the full year 2021 amounted to €25.4 million, mainly due to the
sale of $31.9 million (or €27.3 million3) in gross proceeds of the
Company’s American Depositary Shares in the third quarter of 2021.
The sales were made through the Company's At-The-Market program
established on August 2, 2021, to existing and new institutional
investors. For the same period in 2020, net cash generated from
financing activities amounted to €111.7 million, driven by the
issuance of €15 million (gross proceeds) of ordinary shares to
certain existing investors in the Company, the entry into €10
million in French state-guaranteed credit agreements with a
syndicate of French banks, and the receipt of €94.9 million (gross
proceeds) following the Company’s initial public offering on the
Nasdaq Global Market in July 2020.
For the 2021 fiscal year, the Company recorded a
positive exchange rate effect on cash and cash equivalents of €4.8
million.
Considering its current R&D and clinical
development programs and excluding any potential additional
financial resources that may originate from potential funding
activities, the Company estimates that its cash, cash equivalents
and short-term deposits should allow the Company to fund its
operations through the first quarter of 20234.
For the 2021 fiscal year, Inventiva's
revenues amounted to €4.2 million compared to €0.4
million for 2020 primarily due to the payment to the Company of
€4.0 million for a milestone reached at the end of 2021, and
received on January 31, 2022, following the launch by AbbVie of the
Phase IIb clinical trial with cedirogant in the fourth quarter of
2021. As part of its collaboration with AbbVie in auto-immune
diseases on cedirogant, Inventiva is eligible to receive potential
development, regulatory and commercial milestone payments as well
as royalty payments from AbbVie.
Other income amounted to €4.3
million for the 2021 fiscal year versus €4.9 million for 2020, down
11.9% mainly driven by the level of eligible expenses for an
R&D tax credit.
R&D expenses doubled for
the fiscal year ended December 31, 2021 €48.4 million compared to
€23.7 million for the same period in 2020, mainly driven by the
costs associated with the preparation and initiation of the NATiV3
Phase III clinical trial with lanifibranor in NASH in the second
half of 2021.
General and administrative
expenses (G&A) amounted to €11.2
million for the fiscal year ended December 31, 2021, an increase of
31% compared to €8.5 million for the same period in 2020, mainly
due to higher compliance costs resulting from Inventiva’s first
full fiscal year as a dual listed company in 2021.
Other operating income
(expenses) stood at (€0.6) million for the fiscal year
ended December 31, 2021 compared to (€2.2) million for the same
period in 2020. The lower expenses incurred in 2021 included costs
related to the preparation of the At-the-Market program and the
amortization costs of the one-off Public Offering of Securities
Insurance covering the Company’s initial public offering on the
Nasdaq Global Market compared to the total costs related to Nasdaq
Global Market listing in 2020.
Net income amounted to €2.8
million for the 2021 fiscal year, compared to a net financial loss
of €3.9 million for 2020, mainly linked to exchange rate
variation.
The Company’s net loss stood at
€49.6 million as of December 31,2021 compared to €33.6 million
as of December 31, 2020.
The following table presents Inventiva’s income
statement, prepared in accordance with IFRS, for the 2021 financial
year, with comparatives for the 2020 financial year:
(in thousands of euros, except share and per share
amounts) |
|
|
December 31, 2021 |
|
December 31, 2020 |
Revenues |
|
|
4 194 |
|
372 |
Other income |
|
|
4
307 |
|
4 891 |
Research and development expenses |
|
|
(48
452) |
|
(23
717) |
Marketing — Business development expenses |
|
|
(364) |
|
(563) |
General and administrative expenses |
|
|
(11
156) |
|
(8
499) |
Other operating income (expenses) |
|
|
(644) |
|
(2
202) |
Operating profit (loss) |
|
|
(52 114) |
|
(29 718) |
Financial income |
|
|
5
478 |
|
2
057 |
Financial expenses |
|
|
(2
635) |
|
(5 959) |
Financial income (loss) |
|
|
2 843 |
|
(3 902) |
Income tax |
|
|
(364) |
|
- |
Net loss for the period |
|
|
(49 635) |
|
(33 619) |
|
|
|
|
|
|
Basic / diluted loss per share (euros/share) |
|
|
(1,27) |
|
(0,99) |
Weighted average number of outstanding shares used for computing
basic/diluted loss per share |
|
|
39 168 152 |
|
33 874 751 |
Main areas of progress in the R&D
portfolio
Lanifibranor in non-alcoholic
steatohepatitis (NASH)
- Publication of positive results of a clinical thorough QT/QTc5
study demonstrating the safety of lanifibranor on cardiac
electrical activity. The trial was conducted in accordance with U.S
Food and Drug Administration guidance (FDA) in 217 patients to
evaluate the potential effect of lanifibranor on the QT/QTc
interval in healthy subjects and to support lanifibranor New Drug
Application (NDA) package in NASH – December 6, 2021
- Publication of the study design of LEGEND, a multi-center,
randomized, placebo-controlled proof-of-concept Phase IIa
combination trial to assess the safety and efficacy of lanifibranor
in combination with the SGLT2 inhibitor empagliflozin for the
treatment of patients with type 2 diabetes (T2D) and non-cirrhotic
NASH. A total of 63 patients are expected to be selected for the
trial in several sites in the United States and Europe. The
initiation of the trial is planned for the first half of 2022 and
the publication of top line results is expected for the second half
of 2023 – October 27, 2021
- Publication of the results of the NATIVE Phase IIb clinical
trial with lanifibranor for the treatment of NASH in the
peer-reviewed medical journal The New England Journal of Medicine
(NEJM). The results showed that lanifibranor met both the primary
and key secondary endpoints, including the composite endpoint of
NASH resolution and improvement of liver fibrosis – October 20,
2021
- Receipt of the U.S. FDA “Fast Track” designation, previously
granted to lanifibranor in NASH, encompasses the treatment of NASH
patients with compensated cirrhosis – September 21, 2021
- Initiation of the NATiV3 Phase III clinical trial evaluating
lanifibranor in adult patients with non-cirrhotic NASH and F2/F3
stage of liver fibrosis, with the activation of the first clinical
sites in the United States and the start of patient screening –
September 8, 2021
Odiparcil in mucopolysaccharidosis type
VI (MPS VI)
- Inventiva continues to review available options for the
potential development of its second clinical-stage asset odiparcil
for the treatment of MPS VI. All MPS-related R&D activities
remain on hold pending the outcome of this review process expected
to conclude in 20226.
Collaboration with AbbVie on cedirogant
in autoimmune diseases
- Receipt of 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 patients
with moderate to severe psoriasis – January 31, 2022
- Decision by AbbVie to initiate a Phase IIb clinical trial with
cedirogant in patients with moderate to severe psoriasis after
AbbVie reported showing promising activity as an oral psoriasis
agent during its Phase Ib clinical trial – May 12, 2021
Other significant
milestones
- Sales of 2,083,334 of American Depositary Shares pursuant to
the Company's ATM program established on August 2, 2021. The sales
were issued to existing and new institutional investors– September
23, 2021
- Recruitments to reinforce Inventiva’s clinical expertise,
medical team and corporate functions, as well as its presence in
France and the United States – September 16, 2021
- Implementation of an ATM program in the United States for the
sale of up to $100 million– August 2, 2021
- Appointment of Martine Zimmerman as Independent Director to
Inventiva’s Board of Directors to replace Nawal Ouzren. Martine
Zimmerman’s appointment will be submitted to Inventiva’s
shareholders for ratification at the Company’s next Combined
Shareholders’ Meeting – April 19, 2021
Anticipated potential key
milestones
- Activation of first clinical sites for Phase IIa combination
trial with lanifibranor and SGLT2 inhibitor empagliflozin in
patients with NASH and T2D – planned for the first half of
2022
- Last Patient First Visit of the NATiV3 Phase III clinical trial
evaluating lanifibranor in NASH – planned for the second half of
2022
- Publication of the results of the Phase II clinical trial
evaluating lanifibranor for the treatment of NAFLD in patients with
T2D – planned for the second half of 2022
- Strategy update on the potential development of odiparcil –
planned for 2022
Upcoming investor conference
participation
- Cowen 42nd Annual Health Care Conference, March 7-9, 2022
- Invest securities Biomed Event, March 8, 2022
- H.C. Wainwright Annual Global Life Sciences Conference, May
23-25, 2022
- Jefferies 2021 Healthcare Conference, June 8-10, 2022
Upcoming scientific conference
participation
- International Conference on Fatty Liver – April 28-30,
2022
Conference call
A conference call in English
will be held tomorrow, Tuesday, March 8, 2022 at 2:00 pm
(Paris time). To join the conference call, please use the
code 8738647 after dialing one of the following
numbers:
France: +33 1 70 70 07 81
Belgium: +32 27 93 38 47 Germany: +49 69 22 22
26 25Netherlands: +31 20 79 56 614Switzerland: +41 44 58 07
145United Kingdom: +44 207 19 28 338
United States: +1 646-741-3167
The presentation accompanying this conference
call will be available on Inventiva’s website in the “Investors” –
“Financial Results & Presentations” section at the same time
and can be followed live at:
https://edge.media-server.com/mmc/p/wo3raaz4.
A replay of the conference call and the
presentation will be available during 12 months after the event at:
https://inventivapharma.com/investors/financial-results-presentations/.
Next financial results
publication
- Revenues and cash position for the first quarter of
2022: Monday, May 16, 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 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 RORg 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 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 70 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
Affairs media@inventivapharma.com+1 240 620 9175 |
Brunswick GroupLaurence Frost / Tristan Roquet
Montegon / Aude LepreuxMedia
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, forecasts and estimates with respect to
Inventiva’s pre-clinical programs and clinical trials, clinical
trial data releases, pipeline and preclinical and clinical
development plans, anticipated milestones, milestone payments,
royalties and product sales, future activities, expectations, plans
and prospects of Inventiva, the sufficiency of Inventiva’s cash
resources and expectations with respect to the potential commercial
success and potential revenues of Inventiva’s product candidates.
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”,
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. Actual 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, enrollment
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 COVID-19 pandemic and geopolitical
events, such as the conflict between Russia and Ukraine, which
could delay the initiation, enrollment and completion of
Inventiva’s clinical trials on anticipated timelines or at all.
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, 2020 filed with the
Autorité des Marchés Financiers on March 15, 2021, the Annual
Report on Form 20-F for the year ended December 31, 2020 filed with
the Securities and Exchange Commission on March 15, 2021 as well as
the half-year financial report for the six months ended June 30,
2021 for additional information in relation to such factors, risks
and uncertainties, in addition to the Universal Registration
Document for the year ended December 31, 2021 expected to be filed
with the Autorité des Marchés Financiers on March 16, 2021 and the
Annual Report on Form 20-F for the year ended December 31, 2021
expected to be filed with the Securities and Exchange Commission on
March 16, 2021.
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. Consequently,
Inventiva accepts no liability for any consequences arising from
the use of any of the above statements.
1 Cedirogant is a clinical stage RORγ inverse agonist
co-discovered by Inventiva with potential in several auto-immune
diseases.
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 December 31, 2021, but are considered by
the Company as liquid and easily available.
3 Based on the U.S. dollar euro exchange rates published by the
European Central Bank on the sale dates.
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.
5 The QT interval is the time between the Q and
T waves on an electrocardiogram. It quantifies the time between the
onset of depolarization of myocardial cells and their
repolarization. A classic side effect of many classes of drugs is
the prolongation of this QT interval.
6 Please refer to Inventiva’s press release
entitled “Inventiva receives positive FDA feedback to advance its
lead drug candidate lanifibranor into pivotal Phase III in NASH”
and published on November 10, 2020.
- Inventiva - PR - FY 2021 - EN - 07 03 2022
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