- Cash position1 at €87.2 million as of June 30, 2022, compared
to €95.4 million as of December 31, 2021
- Receipt of a €4 million milestone payment from Inventiva’s
partner AbbVie for cedirogant Phase IIb clinical trial initiation
accounted for in 2021 revenues and H1 2022 cash flow
- Inventiva entered into a credit facility for up to €50 million,
subject to conditions, and a related warrant agreement with the
European Investment Bank (EIB)2
- Inventiva raised approximately €14.7 million through a
combination of Inventiva’s At-The-Market (ATM) program (for €9.4
million in gross proceeds) and new state-backed bank financing (for
€5.3 million)
- Screening of the first patients in Phase IIa combination
trial LEGEND with lanifibranor and empagliflozin in patients with
NASH and T2D
- Inventiva entered into a licensing and collaboration agreement
with Sino Biopharm to develop and commercialize lanifibranor in
Greater China
- Under the agreement with Sino Biopharm, Inventiva is expected
to receive $12 million upfront, which is expected to complete
the funding conditions to draw on the first €25 million
tranche of the EIB facility2
- Cash runway extended through Q4 2023, including the expected
$12 million upfront payment from Sino Biopharm and the €25 million
from the EIB credit facility
- Feedback from FDA that a single Phase 2/3 clinical trial with
odiparcil in children with MPS VI could potentially support a
marketing application
- Last patient first visit for the ongoing NATiV3 Phase III
clinical trial evaluating lanifibranor in patients with NASH is now
targeted for H2 2023
Daix (France), Long
Island City (New York, United States), September
22, 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 interim financial results for the six months
ended June 30, 2022, and provided a corporate update.
Frédéric Cren, Chairman, Chief Executive Officer and
cofounder of Inventiva, stated: “The first half of this
year has been paved with several successes for Inventiva, both
financially and in terms of research & development. Our
collaboration with AbbVie led to a new €4 million milestone payment
following the initiation of the Phase IIb clinical trial with
cedirogant which is expected to finish H1 2023. We estimate our
current cash position, combined with the expected $12 million
upfront payment from the agreement with Sino Biopharm and the
anticipated first €25 million tranche under the EIB credit facility
extends our cash runway through Q4 2023. This agreement with Sino
Biopharm represents an important milestone and allows us to start
the development of lanifibranor for the treatment of NASH in a
country where the prevalence of NASH is particularly high. We also
continued to progress our NASH programs with the screening of the
first patient in our LEGEND trial and the clearance of our IND
application by the FDA. Looking ahead, we expect even more exciting
developments, including with the results from our Phase II clinical
trial evaluating lanifibranor for the treatment of NAFLD in
patients with type 2 diabetes planned for Q1 2023. Finally, we are
also very pleased to have feedback from the FDA that a single phase
2/3 trial could potentially support a marketing application for
odiparcil.”
Key financial results for the first half
of 2022
(in thousands of euros, except share and per share amounts) |
|
|
June 30, 2022 |
|
June 30, 2021 |
Revenues |
|
|
67 |
|
139 |
Other income |
|
|
3,325 |
|
2,009 |
Research and development expenses |
|
|
(29,866) |
|
(19,109) |
Marketing – business development expenses |
|
|
(278) |
|
(258) |
General and administrative expenses |
|
|
(6,847) |
|
(5,779) |
Other operating income (expenses) |
|
|
131 |
|
(607) |
Net operating loss |
|
|
(33,468) |
|
(23,605) |
Net financial income |
|
|
3,983 |
|
824 |
Income (expense) tax |
|
|
19 |
|
(355) |
Net loss for the period |
|
|
(29,466) |
|
(23,136) |
Basic/diluted loss per share (euros/share) |
|
|
(0.72) |
|
(0.60) |
Weighted average number of outstanding shares used to calculate
basic/diluted loss per share |
|
|
40,864,457 |
|
38,677,187 |
Revenues for the first half of 2022 reached
€0.1 million in line with the same period in 2021.
R&D expenses for the first
half of 2022 amounted to €29.9 million, mainly driven by the
development of lanifibranor in NASH, and were up 56% compared to
the €19.1 million for the first half of 2021. This significant
increase was driven mostly by the costs associated with the NATiV3
Phase III clinical trial of lanifibranor in NASH including a full
six months of operating 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.
General and administrative expenses
(G&A) amounted to €6.8 million in the first half of
2022, an increase of 18% compared to €5.8 million in the first half
of 2021, mainly due to personnel costs linked to the share-based
payment expenses, a full six months of operating for the U.S.
affiliate and to a lesser extent an increase in compliance fees
related to the dual listing of Inventiva securities.
Other operating income
(expenses) amounted to €0.1 million in
the first half of 2022 compared to (€0.6) million
in the first half of 2021.
Net financial income amounted
to €4.0 million in the first half of 2022, mainly
linked to foreign exchange gains due to the appreciation of the
U.S. dollar against the euro during the period.
The Company’s net loss stood at
(€29.5) million in the first half of 2022 compared
to (€23.1) million in the first half of 2021.
Inventiva’s net cash flow
(excluding any exchange rate effect) amounted to
(€12.5) million in the six months ended June 30,
2022, compared to (€15.0) million
in the same period in 2021.
Net cash used in operating
activities amounted to €26.2 million in the first half of
2022 compared to €19.8 million for the same period in 2021. This
increase in cash use is mainly due to higher R&D expenses. Cash
flow from operating activities was also positively impacted in the
first half of 2022 by the payment in January 2022 of €4 million
milestone payment from AbbVie following the inclusion of the first
patient in the ongoing Phase IIb clinical trial with cedirogant
(formerly ABBV-157) in adult patients with moderate to severe
chronic plaque psoriasis, and the 2021 French Research tax credit
(“CIR”) for €3.6 million that was received in
April 2022.
Net cash generated used in investing
activities for the first half of 2022 amounted to (€0.3)
million, compared to €4.7 million3 for the same period in 2021.
Net cash generated from financing
activities for the first half of 2022 amounted to €14.0
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 €9.4 million (gross proceeds) on June 15, 2022, and
three loan agreements with a syndicate French banks for a total
amount of €5.3 million. One of the loans has been contracted as
part of a French state-guaranteed loan facility ("Prêt
Garanti par l’Etat" or “PGE”) with
Bpifrance and the two others obtained as part of a French State
stimulus economic plan, ("Prêts Participatifs
Relance" or “PPR”) 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 €2.4 million3 versus €3.0 million for the
first half of 2021, due to the favourable evolution of USD versus
Euro.
As of June 30, 2022, Inventiva’s cash
and cash equivalent position was €76.4 million compared to
€86.6 million as of December 31, 2021. The cash position including
short term deposits1 reach €87,2 million compared to €95.4 million
as of December 31, 2021.
Considering its current R&D and clinical
development programs and excluding any potential 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 Q4 2023 [including the expected €25
million upfront payment from Sino Biopharm and the €25 million from
the EIB credit facility3.
The financial statements of the first half of
2022 were approved by Inventiva’s Board of Directors on September
21, 2022. 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.
Financial information after closing the
accounts
On July 1st, 2022, in connection with the EIB
credit facility, Inventiva agreed to issue warrants to EIB as a
condition to the potential funding of each tranche of the credit
facility. During July 2022, the Company rebalanced its foreign
currency accounts by taking advantage of the favorable exchange
rate of the euro against the dollar; it converted 25 million
dollars from current and term accounts into euros.
Main areas of progress in the R&D
portfolio
Lanifibranor in non-alcoholic
steatohepatitis (NASH)
- Inventiva is now targeting the last patient first visit for
NATiV3, the Company’s ongoing Phase III clinical trial evaluating
lanifibranor in patients with NASH, for H2 2023, subject to the
continuing implementation of measures to accelerate the enrollment
rate. The delay we face is primarily due to a higher than
originally projected screen failure rate resulting in slower than
anticipated enrollment rate. In addition, we continue to see slower
than predicted site activation, screening and enrollment due to
negative impacts from the COVID-19 pandemic and we continue to be
unable to conduct clinical trial activities at sites originally
located in Ukraine and Russia. Inventiva has implemented and is
planning further measures designed to accelerate enrollment and
reduce screen failures in the NATiV3 trial, and additional sites
have been identified to help compensate for the inability to use
sites in Ukraine and Russia.
Accordingly, the publication
of the topline results of the part 1 of NATiV3 is now targeted for
second half of 2025.
- Completion of the recruitment for the investigator-initiated
Phase II trial of lanifibranor in patients with Non-Alcoholic Fatty
Liver Disease (“NAFLD”) and with type 2 diabetes (“T2D”), conducted
by Professor Cusi from the University of Florida. However due to a
late enrollment of the last patient, the results are now expected
in the first quarter 2023.
- Screening in the United States of the first patient in
Inventiva’s LEGEND’s proof-of-concept Phase IIa combination trial
with lanifibranor and empagliflozin for the treatment of patients
with NASH and T2D. All the 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.
- 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.
Collaboration with AbbVie on cedirogant
in autoimmune diseases
- Receipt of a €4 million milestone payment from AbbVie in
January 2022. This follows the inclusion of the first patient with
psoriasis in the ongoing Phase IIb clinical trial with cedirogant,
an oral RORγ inverse agonist jointly discovered by Inventiva and
AbbVie for the treatment of autoimmune diseases, in November 2021.
– January 31, 2022
Other significant
milestones
- Signature of a licensing 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 2022
- 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’s current plans not to pursue odiparcil
development directly remain; however, the Company believes this
feedback increases the potential for the development of
odiparcil for the treatment of MPS VI and continues to review
potential options to further development of odiparcil for the
treatment of MPS VI, which may include pursuing a partnership –
August, 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
- Signature of a credit facility agreement for up to €50 million,
subject to conditions precedent, with the European Investment Bank
(“EIB”) 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
Next key expected
milestones
- Publication of the results of the investigator-initiated study
with lanifibranor in patients with NAFLD and T2D – now planned for
the first quarter of 2023
- Study completion of Phase IIb trial with cedirogant in patients
with psoriasis conducted by AbbVie – planned for first half of
2023
- Publication of the topline results of the Phase IIa LEGEND of
lanifibranor in combination with empagliflozin in patients with
NASH and T2D – planned for second half of 2023
- Last Patient First Visit of the Phase III NATiV3 clinical trial
evaluating lanifibranor in NASH – now targeted for second
half of 2023
Upcoming investor conference
participation
- Guggenheim Nantucket Therapeutics Conference – September 27-29,
Nantucket
- Lyon Pôle Bourse – September 28, Lyon
- HealthTech Innovation Days – October 12-14, Paris
- Portzamparc BNP Paribas Biotech & Santé – October 4,
Virtual
- H.C. Wainwright 6th Annual NASH Investor Conference – October
17, Virtual
- Jefferies 2022 London Healthcare Conference – November
15-17, London
Upcoming scientific conference
participation
- 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 1, Boston
- MOSAIC Conference – December 5-6, Washington, DC
Conference call
A conference call in English
will be held tomorrow, Thursday, September 22, 2022 at 8:00
am (New York time) 2:00 pm (Paris time).
The conference call and the slides of the
presentation will be webcast live at:
https://edge.media-server.com/mmc/p/v5uzhkr8 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/BI3a0c8ee6960a4b7a9db4026550ff3f51.
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
- Q3 2022 Revenues and cash position: Thursday,
November 10, 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). Contacts
InventivaPascaline ClercVP of Global External
Affairs media@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. 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, 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, the
investigator-initiated Phase II trial of lanifibranor in patients
with NAFLD and T2D, and the expected Phase IIb clinical trial of
cedirogant led by AbbVie, potential development of and regulatory
pathway for odiparcil, clinical trial data releases and
publications, the information, insights and impacts that may be
gathered from clinical trials the potential therapeutic benefits of
lanifibranor generally and in combination with empagliflozin, the
design of trials and any potential amendments to trial design, any
measures to implement or to decrease the screen failure rate
or increase the enrollment rate or other intended impacts on the
NATiV3 trial, and the anticipated benefits related thereto, the
Company’s agreement with Sino Biopharm, including expectations with
respect to enrollment of patients in Greater China in the NATiV3
trial, 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” , “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,
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 uncertain 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, 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 to be filed Securities
and Exchange Commission 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 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 for €10.7 million as of June 30, 2022, and for
€8.8 million as of December 31, 2021, but are considered by the
Company as liquid and easily available. 2 As previously
disclosed by the Company, the credit facility is divided in two
tranches of €25 million, each which are subject to the completion
of certain condition precedents. The disbursement of the first
tranche 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
receipt by the Company from the date of the EIB credit facility of
an aggregate amount of at least €18 million, paid either in
exchange for Company shares, or through upfront or milestone
payments, The disbursement of the second tranche is further subject
to, among other conditions, (i) the full drawdown of the first
tranche, (ii) the receipt by the Company from the date of the
EIB credit facility of an aggregate amount of at least €70 million
(inclusive of the €18 million set forth above), paid either in
exchange for Company shares, or through upfront or milestone
payments, , (iii) (a) an out-licensing, partnership or royalty
transaction with an upfront payment of at least €10 million, or
(b) the initiation of a Phase III clinical trial of cedirogant
by AbbVie Inc; and ( iv) operational criteria based on patient
enrollment and number of sites activated in the Company’s Phase III
clinical trial of lanifibranor in patients with NASH. Any funds not
disbursed within 36 months following the execution of the EIB
credit facility shall be cancelled.3 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 - EN - 22092022 - FINAL
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