- Cash and cash equivalents at €93.6 m as of June 30, 2021
- Revenues of €0.2 m in H1 2021
Daix (France), July 28, 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
cash position as of June 30, 2021 and its revenues for the first
half of 20211.
Cash Position
As of June 30, 2021, Inventiva’s cash
and cash equivalents stood at €93.6 million compared to
€107.8 million as of March 31, 2021 and €113.02 million as of
December 31, 2020.
Net cash used in operating
activities amounted to €19.8 million in the first half of
2021 compared to €7.2 million for the same period in 2020. R&D
expenses for the first half of 2021 were up 56% compared to the
first half of 2020, mainly driven by the development of
lanifibranor in NASH and costs linked to the preparation for the
initiation of NATiV3, the Company’s Phase III clinical trial
evaluating lanifibranor in NASH. This amount includes the payment
received on June 30, 2021 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), while the first half of 2020 had been positively
impacted by the receipt of a €4.2 million non-recurrent late
payment of the 2018 Research Tax Credit and a €4.2 million payment
in respect of the 2019 Research Tax Credit.
Net cash used from investing
activities amounted to €1.2 million in the first half of
2021 compared to 1.0 million for the same period in 2020.
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 €15 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 semester of 2021, the Company
recorded a positive exchange rate effect on cash and cash
equivalent of €1.2 million.
Considering its current R&D and clinical
development programs, and excluding additional financial resources,
Inventiva’s cash runway will allow to fund its operating activities
through the third quarter of 2022.
Revenues
The Company’s revenues for the first half of
2021 amounted to €0.2 million, as compared to €0.1 million for the
same period in 2020.
As part of its collaboration with Abbvie in
auto-immune diseases3, 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 before the end of
2021.
***
Next key milestones expected
- First patient first visit of NATiV3 Phase III clinical trial
evaluating lanifibranor in NASH – planned for the third quarter of
2021
- Initiation by AbbVie of a Phase IIb clinical trial with
cedirogant – expected in the second half of 2021
- Strategy update on the development of odiparcil – planned for
the second half of 2021
- 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) –
planned for the first half of 2022
Upcoming investor conference
participation
- Citi’s 16th Annual BioPharma Conference 2021, September 8-9,
2021
- KBC Virtual Life Science Conference, September 7-9, 2021
- H.C. Wainwright 23rd Annual Global Investment Conference,
September 13-15, 2021
- Lyon Pôle Bourse Forum, September 27-28, 2021
- HealthTech Innovation Days 2021, October 4-5, 2021
- Portzamparc Health Biotech Seminar 2021, October 6, 2021
- Guggenheim CV&M Disease Day, October 7, 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
participation
- Paris NASH Meeting, October 22-23, 2021
- AASLD The Liver Meeting, November 12-15, 2021
Next financial results
publication
- H1 2021 Financial results: Monday, September
20, 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.
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
Affairsmedia@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. BankInvestor
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 full-year financial report for the year ended December 31, 2020
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 Non-audited financial information.
2 The cash position includes cash and cash equivalents as well
as short-term deposits which are included in the category “other
current assets” in the IFRS statement of financial position as of
December 31, 2020.
3 See AbbVie Q1 2021 earnings call on April 30, 2021, 9 AM ET;
Transcript from FactSet.
- Inventiva - PR - H1 2021 CA Cash - EN - 28072021
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