Innate Pharma reports third quarter 2020 financial results and
business update
Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq:
IPHA) (“
Innate” or the “
Company”)
today announced its revenues and cash position for the first nine
months of 2020.
“In November, we were very pleased that our lead
proprietary asset, lacutamab, was awarded PRIME designation in
Sézary Syndrome by the European Medicines Agency, which follows the
US Fast Track designation by the FDA last year. Lacutamab is
an important part of our strategy to build a focused proprietary
pipeline, and these regulatory milestones further validate the
unmet need in this patient population,” said Mondher
Mahjoubi, Chief Executive Officer of Innate
Pharma. “In addition, the Phase 3 monalizumab
clinical trial recently initiated by AstraZeneca is an important
achievement for the Company, as it both validates our scientific
approach while fortifying our cash position until the end of 2022.
Collectively, these milestones are strong proof points in executing
on our strategy and accelerating our efforts to deliver meaningful
medicines to patients.”
Third quarter 2020 and post-period
events:
Lacutamab (IPH4102, anti-KIR3DL2
antibody):
- The Company recently announced that the European Medicines
Agency (EMA) has granted PRIME designation to lacutamab for the
treatment of patients with relapsed or refractory Sézary syndrome
(SS) who have received at least two prior systemic therapies.
- The TELLOMAK Phase 2 clinical trial, which is evaluating the
efficacy and safety of lacutamab in patients with advanced
cutaneous T-cell lymphomas, is now fully open to enrollment.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- As recently announced, AstraZeneca has dosed the first patient
in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab
in combination with cetuximab in patients with recurrent or
metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
who have been previously treated with platinum-based chemotherapy
and PD-(L)1 inhibitors. Dosing of the first patient in this trial,
which occurred in October 2020, has triggered a $50 million
milestone upcoming payment from AstraZeneca to Innate. Upon this
milestone payment, the Company will have received a total of $400
million to date from the AstraZeneca partnership.
- Updated data from the IPH2201-203 Phase 2 trial regarding
patients previously treated with a platinum-based chemotherapy and
a PD(L)1 inhibitor will be presented via an e-poster at the ESMO
Immuno-Oncology Virtual Congress in December 2020.
Avdoralimab in Inflammation (IPH5401,
anti-C5aR antibody):
- The first patient has been dosed in the investigator-sponsored
Phase 2 clinical trial in bullous pemphigoid (BP) where the C5aR1
pathway has been shown to be involved in the physiopathology of the
disease. The trial is investigating the clinical efficacy of
avdoralimab in addition to topical steroids compared to topical
steroids alone in BP patients. More information on this study can
be found at clinical trials.gov.
Avdoralimab in COVID-19:
- The investigator-sponsored Phase 2 clinical trial,
FORCE (FOR COVID-19
Elimination), is ongoing. A third cohort was
recently added to the trial, which is addressing COVID-19 related
Acute Respiratory Distress Syndrome (ARDS) patients requiring
mechanical ventilation. More information on this study can be found
at clinical trials.gov.
- The investigator-sponsored Phase 2 clinical trial,
ImmunoONCOVID-20, has resumed. This study is exploring the
potential efficacy of monalizumab and avdoralimab amongst other
treatment arms, against COVID-19 in cancer patients with mild
symptoms and pneumonia respectively.
Lumoxiti, a first-in-class marketed
product for the treatment of relapsed or refractory hairy cell
leukemia:
- The global COVID-19 pandemic and slower adoption rate continues
to impact the sales of Lumoxiti in 2020.
- As previously stated, following completion of the transition of
US Lumoxiti commercial operations from AstraZeneca, sales will be
fully booked by Innate beginning in Q4 2020.
- The Lumoxiti EU regulatory decision remains on track for 1H
2021.
Financial results:
Cash, cash equivalents and financial assets of
the Company amounted to €163.6 million as of September 30, 2020. As
it is a post closing event, the $50 million milestone upcoming
payment for the first patient dosed in the Interlink-1 Phase 3
study of monalizumab are not included in those figures. Financial
liabilities amounted to €19.8 million.
For the nine-month periods ended September 30,
2019 and 2020, revenue from collaboration and licensing agreements
mainly results from the spreading of the initial payments received
under our agreements with AstraZeneca. Due to accounting rules and
the timing of costs related to development activities under the
collaboration with AstraZeneca, the recognition of this revenue can
vary on a quarter by quarter each year. As a reminder, this has no
impact on cash. Revenues for the first nine-months of 2020 amounted
to €33.6 million, compared to €65.4 million for the same
period in 2019.
About Innate Pharma:
Innate Pharma S.A. is a commercial stage
oncology-focused biotech company dedicated to improving treatment
and clinical outcomes for patients through therapeutic antibodies
that harness the immune system to fight cancer.
Innate Pharma’s commercial-stage product,
Lumoxiti, in-licensed from AstraZeneca in the US, EU and
Switzerland, was approved by the FDA in September 2018. Lumoxiti is
a first-in class specialty oncology product for hairy cell
leukemia. Innate Pharma’s broad pipeline of antibodies includes
several potentially first-in-class clinical and preclinical
candidates in cancers with high unmet medical need.
Innate has been a pioneer in the understanding
of natural killer cell biology and has expanded its expertise in
the tumor microenvironment and tumor-antigens, as well as antibody
engineering. This innovative approach has resulted in a diversified
proprietary portfolio and major alliances with leaders in the
biopharmaceutical industry including Bristol-Myers Squibb, Novo
Nordisk A/S, Sanofi, and a multi-products collaboration with
AstraZeneca.
Based in Marseille, France, Innate Pharma is
listed on Euronext Paris and Nasdaq in the US.
Learn more about Innate Pharma at
www.innate-pharma.com
Information about Innate Pharma
shares:
ISIN codeTicker
codeLEI |
FR0010331421Euronext: IPH Nasdaq: IPHA9695002Y8420ZB8HJE29 |
Disclaimer on forward-looking
information and risk factors:
This press release contains certain
forward-looking statements, including those within the meaning of
the Private Securities Litigation Reform Act of 1995.The use of
certain words, including “believe,” “potential,” “expect” and
“will” and similar expressions, is intended to identify
forward-looking statements. Although the company believes its
expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those anticipated. These risks and uncertainties
include, among other things, the uncertainties inherent in research
and development, including related to safety, progression of and
results from its ongoing and planned clinical trials and
preclinical studies, review and approvals by regulatory authorities
of its product candidates, the Company’s commercialization efforts,
the Company’s continued ability to raise capital to fund its
development and the overall impact of the COVID-19 outbreak on the
global healthcare system as well as the Company’s business,
financial condition and results of operations. For an additional
discussion of risks and uncertainties which could cause the
company's actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risque")
section of the Universal Registration Document filed with the
French Financial Markets Authority (“AMF”), which is available on
the AMF website http://www.amf-france.org or on Innate Pharma’s
website, and public filings and reports filed with the U.S.
Securities and Exchange Commission (“SEC”), including the Company’s
Annual Report on Form 20-F for the year ended December 31, 2019,
and subsequent filings and reports filed with the AMF or SEC, or
otherwise made public, by the Company.
This press release and the information contained
herein do not constitute an offer to sell or a solicitation of an
offer to buy or subscribe to shares in Innate Pharma in any
country.
For additional information, please
contact:
Investors Innate
Pharma
Tel.: +33 (0)4 30 30 30 30investors@innate-pharma.com
|
Media Innate Pharma Tracy
Rossin (Global/US)Tel.: +1 240 801
0076Tracy.Rossin@innate-pharma.comATCG Press Marie
Puvieux (France)Tel.: +33 (0)9 81 87 46
72innate-pharma@atcg-partners.com |
1 Including short term investments (€15.5 million) and
non-current financial instruments (€37.3 million). Not including
the $50mn milestone payment from AstraZeneca for the first patient
dosed in the Interlink-1 Phase 3 study of monalizumab.
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