Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 –
IPH; Nasdaq: IPHA) today announced its revenue and cash position
for the three-month period ended March 31, 2020.
“During this quarter, we have maintained
momentum with our pipeline as well as ensuring business continuity
despite this challenging and unprecedented time,” said
Mondher Mahjoubi, Chief Executive Officer, Innate Pharma.
“As an agile company with potential molecules in our pipeline that
could make an impact in the fight against COVID-19, we have
initiated the FORCE Phase II trial evaluating avdoralimab in
COVID-19 patients with severe pneumonia with the goal of helping
improve their prognosis. Additionally, we look forward to sharing
new efficacy data on the Phase Ib/II monalizumab and cetuximab
combination in IO-pretreated head and neck patients at the ASCO20
Virtual Scientific Program. We are committed to executing across
our pipeline programs and pursuing innovative therapies for high
unmet patient populations.”
First quarter of 2020 and recent
pipeline highlights:
COVID-19 Impact:
As we navigate the COVID-19 pandemic, we are
dedicated to supporting our patients, our employees and their
families, and the communities where we live and work.
Currently, there is varying impact to our
pipeline assets in relation to COVID-19, as outlined below. The
COVID-19 pandemic could impair our ability to achieve our product
development or commercialization objectives in the timeframes we
had expected.
We are closely monitoring the rapidly evolving
environment and will continue to provide relevant information on
our COVID-19 web page as the situation evolves.
_________________________iIncluding short term investments
(€16.3 million) and non-current financial instruments (€33.9
million).
Lumoxiti, a first-in-Class marketed
product in-licensed from AstraZeneca for the treatment of relapsed
or refractory hairy cell leukemia:
- In January, we announced that the European Medicines Agency
(EMA) validated the Marketing Authorization Application (MAA) for
Lumoxiti.
- In March 2020, the Biologics License Application for Lumoxiti
was transitioned from AstraZeneca (LSE/STO/NYSE: AZN) to Innate.
The transition is on track to be completed in 2020.
- Due to the COVID-19 pandemic, widespread restrictions and
social distancing measures have limited opportunities for in-person
marketing of Lumoxiti to oncology healthcare professionals and
access to physicians causing interruptions of treatments for
patients. As a result, the rate of new Lumoxiti
patients has slowed which is expected to impact 2020
sales.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- At the ASCO20 Virtual Scientific Conference, new efficacy data
will be presented from a Phase II expansion cohort of IO-pretreated
patients.• ASCO abstract (Abstract #6516, Poster#177), entitled
“Combination of Monalizumab and Cetuximab in Patients with
Recurrent or Metastatic Head and Neck Squamous Cell Cancer
Previously Treated with Platinum-based Chemotherapy and PD-(L)1
Inhibitors.”
- The advancement of monalizumab in combination with cetuximab to
a Phase III trial in IO-pretreated patients suffering from
recurrent or metastatic (R/M) squamous cell carcinoma of the head
and neck (SCCHN) is expected in 2020.
- A controlled, randomized, study will explore monalizumab,
amongst other treatment arms, to investigate the potential efficacy
versus standard of care against COVID-19 in cancer patients with
mild symptoms. This study is sponsored by Centre Léon Bérard,
Lyon.
Lacutamab (IPH4102, anti-KIR3DL2
antibody):
- In January, the French and UK regulatory agencies agreed the
lacutamab TELLOMAK trial could resume recruitment in Sézary
syndrome and mycosis fungoides patients. In all other geographies,
no new patients may be enrolled in the trial until a new Good
Manufacturing Practice (GMP)-certified batch is available.
Currently enrolled patients can continue treatment in the trial
except in Italy.• New batches of drug product have been
successfully manufactured. A new clinical GMP-certified batch is on
track to be available in the second half of 2020.• The Company is
progressing PTCL in alternative clinical development pathways and
therefore, has taken the decision to stop the PTCL cohort in the
TELLOMAK study.
- Due to slower clinical trial recruitment as a result of the
regulatory status of TELLOMAK, compounded by the COVID-19 pandemic,
potential delays in clinical development timelines may occur. The
Company will provide an update in due time.
Avdoralimab (IPH5401, anti-C5aR
antibody):
- The first patient was dosed in a randomized, double-blind,
placebo-controlled, FORCE clinical trial, evaluating the safety and
efficacy of its anti-C5aR antibody, avdoralimab, in COVID-19
patients with severe pneumonia.• The Phase II trial is supported by
an exploratory translational study, EXPLORE, which suggests that
patients who progress towards severe COVID-19 disease exhibit an
increase of the C5a/C5aR pathway.
- A controlled, randomized, study will explore avdoralimab,
amongst other treatment arms, to investigate the potential efficacy
versus standard of care against COVID-19 in cancer patients with
pneumonia. This study is sponsored by Centre Léon Bérard,
Lyon.
IPH5201 (anti-CD39 antibody), partnered
with AstraZeneca:
- In February 2020, the multicenter, open-label, dose-escalation
Phase I trial started, which is evaluating IPH5201 as monotherapy
or in combination with durvalumab (anti-PD-L1) with or without
oleclumab (anti-CD73) in advanced solid tumors.• The Phase I
clinical trial evaluating IPH5201 in adult patients with advanced
solid tumors has reactivated, following a temporary pause due to
the COVID-19 pandemic.
Post-period events:
- Following the dosing of the first patient on March 9, 2020 in
the IPH5201 Phase I clinical trial, AstraZeneca made a $5.0 million
milestone payment in April to Innate Pharma. In May, Innate made a
€2.7 million milestone payment to Orega Biotech SAS pursuant to
Innate’s exclusive licensing agreement.
Financial results:
Cash, cash equivalents and financial assets of
the Company amounted to €206.9 million as of March 31, 2020. At the
same date, financial liabilities amounted to €19.3 million.
During the first quarter of the year 2020
notably:
- A $15.0m (€13.4m) milestone payment was made to AstraZeneca in
January 2020 following the submission by AstraZeneca of the
Marketing Authorization Access relating to the commercialization of
Lumoxiti in Europe.
- A €5.8m adverse variance in the fair value of our financial
instruments was booked, resulting from the impact of the COVID-19
crisis on the financial markets.
Revenues for the first three-months of 2020
amounted to €19.3 million (€13.9 million for the same period
in 2019). For the three-month period ended March 31, 2020, revenue
from collaboration and licensing agreements mainly results from the
spreading of the initial payments received under our agreements
with AstraZeneca.
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
(HCL). 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 NK 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.
Innate Pharma is a public company listed in
compartment B of Euronext’s regulated market in Paris (Euronext:
IPH - ISIN: FR0010331421) and in the Nasdaq Global Select Market
(Nasdaq: IPHA).
Disclaimer:
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:
Investor relations Innate
PharmaDanielle Spangler Tel.: +1 917 608
1134Danielle.Spangler@innate-pharma.frJérôme Marino 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.com ATCG Press
Marie Puvieux (France)Tel.: +33 (0)9 81 87 46
72innate-pharma@atcg-partners.com |
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