Inventiva reports 2021 first half financial results and provides a
corporate update
- Cash and cash equivalents at €93.6 m as of June 30, 2021
compared to €105.7 m1 as of December 31, 2020
- Initiation of the NATiV3 Phase III clinical study with
lanifibranor in NASH
- R&D expenses of €19.1 m in H1 2021, up 52% compared to H1
2020, mainly driven by the preparation and initiation of the NATiV3
Phase III clinical trial
- Decision by AbbVie to initiate a Phase IIb clinical trial with
cedirogant in patients with moderate to severe psoriasis following
the demonstration of clinical proof of concept during AbbVie’s
Phase Ib clinical trial
- Publication by AbbVie of the design of the Phase IIb clinical
trial with cedirogant to be initiated in November 2021 with
completion expected in March 2023
- Major recruitments to reinforce Inventiva’s clinical expertise,
medical team and corporate functions, as well as its presence in
France and the United States
- Implementation of an At-The-Market (“ATM”) program in the
United States providing the Company with important financial
flexibility and additional funding possibility of up to $100.0
m
Daix (France), Long Island City (New
York, United States), September 20, 2021
– 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, today reported its
interim financial results for the six months ended June 30, 2021
and provided a corporate update.
Frédéric Cren,
Chairman, Chief Executive Officer and cofounder of
Inventiva, stated: “Over
the first six months of this year, we continued to progress in the
development of our programs for the treatment of NASH and in the
area of autoimmune diseases with our partner AbbVie. The initiation
of our highly anticipated Phase III clinical trial in NASH, with
the opening of the first clinical sites in the United States and
the start of patient screening, is a major milestone in the pivotal
development phase of our drug candidate lanifibranor. Moreover, the
decision by AbbVie to move into Phase IIb clinical development with
cedirogant for the treatment of psoriasis and the recent
publication of the trial design are excellent news for this program
in which Inventiva remains eligible to receive milestone payments
as well as sales royalties. Last month, we also took the step to
implement an ATM program in the United States, which provides us
with the financial flexibility to bolster funding of our R&D
portfolio and should allow us to accelerate the development of our
pipeline looking ahead. In parallel, we reinforced our teams across
key markets through the recruitment of seven highly talented and
seasoned professionals, ideally positioning us to master the
upcoming milestones.”
Key financial results for the first half
of 2021
(in thousands of euros, except share and per share amounts) |
|
|
June 30, 2021 |
|
June 30, 2020 |
Revenues |
|
|
139 |
|
161 |
Other income |
|
|
2,009 |
|
1,607 |
Research and development
expenses |
|
|
(19,109) |
|
(12,574) |
Marketing – business development
expenses |
|
|
(258) |
|
(123) |
General and administrative
expenses |
|
|
(5,779) |
|
(3,383) |
Other operating income (expenses) |
|
|
(607) |
|
(1,354) |
Net operating loss |
|
|
(23,605) |
|
(15,665) |
Net financial income |
|
|
824 |
|
6 |
Income tax |
|
|
(355) |
|
- |
Net loss for the period |
|
|
(23,136) |
|
(15,659) |
|
|
|
|
|
|
Basic/diluted loss per share (euros/share) |
|
|
(0.60) |
|
(0.40) |
Weighted average number of outstanding shares used for computing
basic/diluted loss per share |
|
|
38,677,187 |
|
38,677,187 |
Revenues for the first half of
2021 reached €0.1 million, stable compared to the first half of
2020. As part of its collaboration with AbbVie in auto-immune
diseases, Inventiva is eligible to receive development, regulatory
and commercial milestone payments as well as royalty payments. As
such, the Company expects to receive another milestone payment upon
the initiation by AbbVie of the Phase IIb clinical trial with
cedirogant (see details in the “Main areas of progress in the
R&D portfolio” section below).
R&D expenses amounted to
€19.1 million in the first half of 2021, an increase of 52%
compared to €12.6 million in the first half of 2020, mainly driven
by the costs associated with the preparation and initiation of the
NATiV3 Phase III clinical trial with lanifibranor in NASH.
General and administrative expenses
(G&A) amounted to €5.8 million, an increase of 71%
compared to €3.4 million in the first half of 2020, mainly due to
higher compliance costs resulting from Inventiva’s new dual listing
status since July 2020.
Other operating income
(expenses) stood at (€0.6) million compared to (€1.4)
million in the first half of 2020. The lower expenses incurred
during the first half of 2021 included costs related to the
preparation of the ATM project and the amortization costs of the
one-off POSI insurance covering the Company’s Initial Public
Offering (IPO) on the Nasdaq Global Market.
Net financial income amounted
to €0.8 million in the first half of 2021, mainly linked to
exchange rate variation.
The Company’s net loss stood at
(€23.1) million compared to (€15.7) million in the first half of
2020.
Inventiva’s net cash flow
(excluding any exchange rate effect) amounted to (€15.0) million in
the six months ended June 30, 2021 compared to €16.4 million in the
same period in 2020.
Net cash used in operating
activities amounted to €19.8 million and €7.2 million in
the first half of 2021 and 2020, respectively. This increase in
cash use is due to higher R&D and G&A expenses.
Cash flow from operating activities was also
positively impacted in the first half of 2021 by the payment of
€8.0 million of Research Tax Credit (CIR - Crédit Impôt Recherche)
(€3.8 million related to complementary filings following the 2020
Conseil d’État judgement covering prior years, and €4.2 million
related to the 2020 Research Tax Credit) received on June 30,
2021.
Net cash generated
by investing activities amounted to €4.7
million2 in the first half of 2021 compared to (€1.0) million for
the same period in 2020. This variation is essentially due to the
decrease in short term deposits.
No net cash from
financing activities was generated over the first half of
2021 while Inventiva recorded €24.6 million of net cash from
financing activities for the same period in 2020, notably related
to the issuance of €14.7 million (gross proceeds) of ordinary
shares in February 2020 and the entry into a €10.0 million
State-guaranteed loan with a syndicate of French banks in May
2020.
Over the first half of 2021, the Company recorded a
positive exchange rate effect on cash and cash
equivalents of €3.0 million2.
As of June 30, 2021, Inventiva’s cash
and cash equivalents stood at €93.6 million compared to
€105.7 million2 as of December 31, 2020.
Considering its current R&D and clinical
development programs, and excluding additional financial resources
that may originate from funding activities such as the ATM program,
Inventiva’s cash runway will allow the Company to fund its
operations through the third quarter of 2022.
The financial statements of the first half of
2021 were approved by Inventiva’s Board of Directors on September
16, 2021. The statutory auditors have issued a limited review
report. For more details, the Half-Year Financial Report is
available on the Company’s website at: www.inventivapharma.com.
Main areas of progress in the R&D
portfolio
Lanifibranor in non-alcoholic
steatohepatitis (NASH)
- 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 all available options to optimize
the 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, now expected to
conclude in 2022 (rather than in 2021 as previously
anticipated).3
Collaboration with AbbVie on cedirogant
in autoimmune diseases
- Decision by AbbVie to initiate a Phase IIb clinical trial with
cedirogant4 in patients with moderate to severe psoriasis after
having achieved clinical proof of concept during AbbVie's Phase Ib
clinical trial – May 12, 20215
- Publication by AbbVie of the study design of the Phase IIb
clinical trial with cedirogant: a multicenter, randomized,
double-blind, placebo-controlled, dose-ranging study to evaluate
the safety and efficacy of cedirogant in adult patients with
moderate to severe psoriasis. AbbVie plans to enroll about 200
adult participants in approximately 45 sites, who will receive oral
daily doses of cedirogant or placebo capsules for 16 weeks. The
primary endpoint has been defined as the percentage of participants
achieving >=75% reduction from baseline on the Psoriasis Area
Severity Index (PASI) score (PASI 75)6. The trial is expected to
start in November 2021 and be completed in March 2023 – September
14, 20217
Other significant
milestones
- Major 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, to be
activated if and when required, providing the Company with
important financial flexibility to strengthen funding of its
R&D pipeline by issuing and selling ordinary shares in the form
of American Depositary Shares (ADSs), with aggregate gross sales
proceeds of up to $100 million. The ATM program will be effective
until August 2, 2024 – 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
•••
Next expected key
milestones
- Initiation by AbbVie of the Phase IIb clinical trial with
cedirogant in patients with moderate to severe psoriasis – planned
for November 2021
- Strategy update on the development of odiparcil – planned for
2022 vs the second half of 2021 as previously anticipated
- Publication of the results of the Phase II clinical trial
evaluating lanifibranor for the treatment of Non-Alcoholic Fatty
Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) led
by Professor Cusi – planned for the first half of 2022
Upcoming investor conference
participation
- Lyon Pôle Bourse Forum, September 27-28, 2021
- HealthTech Innovation Days 2021, October 4-5, 2021Portzamparc
Health Biotech Seminar 2021, October 6, 2021
- H.C. Wainwright 5th Annual NASH Investor Conference, October
11, 2021
- Stifel Healthcare Conference 2021, November 16-17, 2021
- Jefferies 2021 London Healthcare Conference, November 16-18,
2021
Upcoming scientific conference
presentations
- AASLD The Liver Meeting, November 12-15, 2021
Conference call
A conference call in English
will be held tomorrow, Tuesday, September 21, 2021 at 2:00
pm (Paris time). To join the conference call, please use
the code 8573858 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/2kk6k5k7.
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
- Q3 2021 Revenues and cash position: Wednesday,
November 10, 2021 (after U.S. market close)
About Inventiva
Inventiva is a clinical-stage biopharmaceutical
company focused on the development of oral small molecule therapies
for the treatment of NASH, MPS and other diseases with significant
unmet medical need.
Leveraging its expertise and experience in the
domain of compounds targeting nuclear receptors, transcription
factors and epigenetic modulation, Inventiva is currently advancing
two clinical candidates, as well as a deep pipeline of preclinical
programs.
Lanifibranor, its lead product candidate, is
being developed for the treatment of patients with NASH, a common
and progressive chronic liver disease for which there are currently
no approved therapies. In 2020, Inventiva announced positive
topline data from its Phase IIb clinical trial evaluating
lanifibranor for the treatment of patients with NASH and obtained
Breakthrough Therapy and Fast Track designation for lanifibranor in
the treatment of NASH. Lanifibranor is currently being evaluated in
a pivotal Phase III clinical trial.
Inventiva is also developing odiparcil, a second
clinical stage asset, for the treatment of patients with subtypes
of MPS, a group of rare genetic disorders. Inventiva announced
positive topline data from its Phase IIa clinical trial evaluating
odiparcil for the treatment of adult MPS VI patients at the end of
2019 and received FDA Fast Track designation in MPS VI for
odiparcil in October 2020.
In parallel, Inventiva is in the process of
selecting an oncology development candidate for its Hippo
signalling pathway program. Furthermore, the Company has
established a strategic collaboration with AbbVie in the area of
autoimmune diseases. AbbVie has started the clinical development of
ABBV‑157, a drug candidate for the treatment of moderate to severe
psoriasis resulting from its collaboration with Inventiva. This
collaboration enables Inventiva to receive milestone payments upon
the achievement of pre-clinical, clinical, regulatory and
commercial milestones, in addition to royalties on any approved
products resulting from the collaboration.
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, as well as in clinical development. It also 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 GroupYannick Tetzlaff / 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 |
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Important Notice
This press release contains forward-looking
statements, forecasts and estimates with respect to Inventiva’s
clinical trials, clinical trial data releases, clinical development
plans and anticipated future activities of Inventiva. 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” 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, or that candidates will
receive the necessary regulatory approvals. 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 current COVID-19 pandemic. 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.
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 The cash position as of December 31, 2020
amounted to €113.7 million as published in the press releases on
March 4, 2021, May 12, 2021 and July 28, 2021 and included cash and
cash equivalents as well as short-term deposits which were included
in the category “other current assets” in the IFRS statement of
financial position. Under IFRS, the variation of short-term
deposits and its related exchange effects are reflected in the line
items “net cash flows from investing activities” for €5.9 million
and “exchange gains (losses)” for €1.4 million, respectively.
2 The cash position as of December 31, 2020
amounted to €113.7 million, as published in the press releases on
March 4, 2021, May 12, 2021 and July 28, 2021, and included cash
and cash equivalents as well as short-term deposits which were
included in the category “other current assets” in the IFRS
statement of financial position. Under IFRS, the variation of
short-term deposits and its related exchange effects are reflected
in the line items “net cash flows from investing activities” for
€5.9 million and “exchange gains (losses)” for €1.4 million,
respectively.
3 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.
4 Cedirogant is a clinical stage RORγ inverse agonist
co-discovered by Inventiva with potential in several auto-immune
diseases.
5 See AbbVie Q1 2021 earnings call on April 30, 2021, 9 AM ET;
Transcript from FactSet. The Phase Ib clinical trial led by AbbVie
was a randomized, double-blind, placebo-controlled, multiple-dose
trial to evaluate the pharmacokinetics, safety and tolerability of
cedirogant in 60 healthy volunteers and patients with chronic
plaque psoriasis (clinicaltrials.gov identifier: NCT03922607).
6 The PASI is a tool that provides a numeric
scoring for participants' overall psoriasis disease state, ranging
from 0 to 72, with a higher score indicating a more severe form of
the disease.
7 For more details regarding the Phase IIb clinical trial,
please refer to clinicaltrials.gov (NCT05044234).
- Inventiva - PR - H1 2021 - EN - 20092021
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