- Cash and cash equivalents at €124.6m as of September 30, 2020,
allowing the Company to finance its operating activities through Q4
2022
- Revenues of €0.3m for the first nine months of 2020
Daix (France), November 12,
2020 – 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 September 30, 2020 and its revenues for the
first nine months of 2020.
Cash Position
As of September 30, 2020, Inventiva’s cash and
cash equivalents stood at €124.6 million, compared to €52.2 million
as of June 30, 2020 and €35.8 million as of December 31, 2019.
Inventiva’s net cash flow
amounted to €88.8 million (net of (€2.4) million exchange rate
effect) for the nine months ended September 30, 2020, compared to
(€21.3) million for the first nine months of 2019.
Net cash used in operating
activities was (€19.4) million for the first nine months
of 2020, compared to (€28.3) million for the same period in 2019.
This decrease is mainly due to the halt in the clinical development
of lanifibranor for the treatment of systemic sclerosis in February
2019 and the savings generated by the Employment Safeguard Plan
subsequently introduced mid-2019, with the first nine months of
2020 recording the full effect of the savings generated. The cash
flow from operating activities was also positively impacted by the
receipt in January 2020 of €4.2 million in respect of the 2018
Research Tax Credit (CIR - Crédit Impôt Recherche), and the receipt
in April and June 2020 of €4.2 million in total in respect of the
2019 CIR.
Net cash from financing
activities amounted to €111.6 million for the first nine
months of 2020, driven by: the issuance of €15.0 million (gross
proceeds) of ordinary shares in February 2020 to certain existing
investors in the Company, the entry into €10.0 million credit
agreements, guaranteed by the French State, with a syndicate of
French banks in May 2020, and the receipt of €94.9 million2 (gross
proceeds) following the successful IPO on the Nasdaq Global Market
in July 2020, extending Inventiva’s cash runway through the fourth
quarter of 2022.
Revenues
The Company’s revenues for the first nine months
of 2020 amounted to €0.3 million, compared to €3.4 million for the
same period in 2019.
***
Next key milestones expected
- Regulatory feedback on Phase III development of lanifibranor in
NASH from the European Medicines Agency (EMA) – planned for the
fourth quarter of 2020
- AbbVie’s completion of its ongoing Phase I clinical trial with
ABBV-157 in psoriasis patients – expected in the first quarter of
20213 vs fourth quarter of 2020 as initially planned
- Initiation of Phase III clinical trial evaluating lanifibranor
in NASH – planned for the first half of 2021
Upcoming investor conference
participation
- Stifel Virtual Healthcare Conference 2020, November 17-18,
2020
- Jefferies 11th Virtual Healthcare Conference, November 17-19,
2020
- Piper Sandler 32nd Annual Virtual Healthcare Conference,
November 30 - December 3, 2020
Upcoming scientific conference
presentations
- Presentation of the NATIVE Phase IIb clinical trial results at
The Liver Meeting Digital Experience™ 2020 of the AASLD (American
Association for the Study of Liver Diseases), November 15,
2020
- Key Opinion Leader webcast focused on NASH, hosted by Inventiva
from The Liver Meeting Digital Experience™ 2020 of the AASLD,
November 16, 2020
Next financial results
publication
§ Q4 2020 Revenues and cash
position: Thursday, February 11, 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 earlier
stage 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. Inventiva recently 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
Inventiva Frédéric Cren Chairman & CEO
info@inventivapharma.com +33 3 80 44 75 00
Brunswick Group Yannick Tetzlaff / Tristan
Roquet Montegon / Aude Lepreux Media relations
inventiva@brunswickgroup.com +33 1 53 96 83 83
Westwicke, an ICR Company
Patricia L. Bank Investor relations patti.bank@westwicke.com
+1 415 513 1284
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 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 undesirable side effects 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, 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 filed with the Autorité des Marchés Financiers on June 19,
2020 under n° D.20-0551 and its amendment filed on July 10, 2020
under n° D. 20-0551-A01 as well as the half-year financial report
on June 30, 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 Based on an exchange rate of $1.1342 per euro, the exchange
rate published by the European Central Bank on July 9, 2020.
3 Source: clinicaltrials.gov.
- Inventiva - PR - Q3 2020 - EN - 12 11 20
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