- €15 million investment by Sanofi, in addition to the ongoing
partnership including the development of BCMA targeting ANKET®
program in autoimmune indications
- First patient dosed in a Phase 1 study for IPH4502, Nectin-4
ADC in patients with selected advanced solid tumors. Presentations
at AACR Annual Meeting 2025 and ASCO 2025 Annual Meeting
- FDA Breakthrough Therapy Designation granted to lacutamab
for relapsed or refractory Sézary syndrome; long term follow up
data from TELLOMAK Phase 2 to be presented at ASCO Annual Meeting
2025
- Cash position of €72.5 million1 as of March 31, 2025,
excluding the €15 million received from Sanofi, with a cash horizon
to mid 2026
- Conference call to be held today at 2:00 p.m. CEST / 8:00
a.m. ET
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate”
or the “Company”) today reported its consolidated financial results
for the quarter ending March 31, 2025.
“The first quarter of 2025 was marked by significant progress
across both our pipeline and strategic partnerships,” said
Jonathan Dickinson, Chief Executive Officer of Innate Pharma.
“Sanofi’s €15 million equity investment reflects our shared
conviction in the potential of our pipeline and the strength of our
partnership. With the initiation of the Phase 1 study for our
Nectin-4 ADC, IPH4502 and presentation at AACR and the FDA’s
Breakthrough Therapy Designation for lacutamab with upcoming ASCO
presentations, we are well-positioned to deliver innovative
therapies to patients. Our strengthened financial position provides
a cash runway into mid 2026.”
Webcast and conference call
will be held today at 2:00pm CEST (8:00am ET)
Access to live webcast:
https://events.q4inc.com/attendee/806006771
Participants may also join via
telephone using the registration link below:
https://registrations.events/direct/Q4I227404000000000000
This information can also be
found on the Investors section of the Innate Pharma website,
www.innate-pharma.com.
A replay of the webcast will be
available on the Company website for 90 days following the
event.
1 Including short term investments
(€13.6m) and non-current financial instruments (€10.4m).
Pipeline highlights
ANKET® (Antibody-based NK cell Engager
Therapeutics):
ANKET® is Innate’s proprietary platform for developing
next-generation, multi-specific NK cell engagers to treat certain
types of cancer.
IPH6501 (ANKET® anti-CD20 with IL-2V, proprietary)
The Phase 1/2 clinical trial evaluating IPH6501 in B-cell
Non-Hodgkin’s lymphoma (B-NHL) is ongoing. The study is planned to
enroll up to 184 patients. Clinical sites are open in the US,
Australia and France and the first safety and preliminary activity
data are expected in late 2025.
IPH6101 (ANKET® anti-CD123)
In alignment with both companies' current strategic priorities,
Sanofi and Innate agreed to terminate the 2016 Research
Collaboration and Licence Agreement (the “2016 Agreement”) as it
relates to SAR’579/IPH6101 (CD123 ANKET®); Innate will regain its
rights on SAR’579/IPH6101 (CD123 ANKET®).
- The originally Sanofi-led Phase 1/2 study with SAR’579 /
IPH6101 (clinical study identifier: NCT05086315) is ongoing.
Efficacy and safety results from the dose-escalation part, were
shared in an oral presentation at the EHA 2024 Congress.
- In April 2024, Sanofi advanced SAR’579 / IPH6101 to the Phase 2
preliminary dose expansion of the trial.
- The Parties will discuss a transition plan with regard to
ongoing studies.
SAR’514/IPH6401, IPH62 (partnered with Sanofi)
SAR’514/IPH6401
As previously disclosed, Sanofi will opt to pursue the
development of SAR’514/IPH6401 (BCMA ANKET®) in autoimmune
indications under the terms of the 2016 Agreement.
- The continued Sanofi-led Phase 1/2 study (clinical study
identifier: NCT05839626) for the treatment of patients with
relapsed or refractory multiple myeloma will be terminated early
and SAR’514/IPH6401 will now be refocused to pursue development in
autoimmune indications.
IPH62 and other target
- IPH62 is a NK-cell engager program targeting B7-H3 under
development from Innate’s ANKET® platform. Following a research
collaboration period and upon candidate selection, Sanofi will be
responsible for all development, manufacturing and
commercialization.
- Sanofi still retains the option of one additional ANKET® target
under the terms of the 2022 research collaboration and license
agreement.
Antibody Drug
Conjugates:
IPH4502 (Nectin-4 ADC, proprietary):
IPH4502 is Innate’s novel and differentiated topoisomerase I
inhibitor ADC targeting Nectin‑4.
- The first patient was dosed in a Phase 1 study in January 2025.
The Phase 1 will assess the safety, tolerability, and preliminary
efficacy of IPH4502 in advanced solid tumors known to express
Nectin-4, including but not limited to urothelial carcinoma,
non-small cell lung, breast, ovarian, gastric, esophageal, and
colorectal cancers. The study plans to enroll approximately 105
patients. A Trial in Progress Poster will be shared at the upcoming
American Society of Clinical Oncology (ASCO) Annual Meeting in June
2025.
- New preclinical data were presented at the American Association
for Cancer Research (AACR) Annual Meeting 2025. IPH4502
demonstrated superior preclinical anti-tumor activity compared to
enfortumab vedotin (EV) in urothelial carcinoma models with low or
heterogeneous Nectin-4 expression, as well as in models resistant
to EV. Beyond UC, IPH4502 also exhibited anti-tumor activity in
preclinical models of triple-negative breast cancer, head and neck
squamous cell carcinoma, and esophageal cancer, suggesting broader
potential clinical applicability.
Lacutamab (anti-KIR3DL2 antibody,
proprietary):
Cutaneous T Cell Lymphoma
TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical
trial evaluating lacutamab in patients with Sézary syndrome and
mycosis fungoides.
- In February 2025, the FDA granted Breakthrough Therapy
Designation to lacutamab for relapsed or refractory Sézary syndrome
based on TELLOMAK Phase 2 results demonstrating efficacy and a
favorable safety profile in patients with advanced Sézary syndrome,
heavily pretreated, post-mogamulizumab. Breakthrough Therapy
Designation is intended to accelerate the development and
regulatory review in the U.S. of drugs that are intended to treat a
serious condition. Partnering discussions are underway. Phase 3
preparation is advancing with the FDA and EMA.
- Long-term follow-up for Sezary syndrome and mycosis fungoides
will be presented at the ASCO Annual Meeting in June 2025.
Peripheral T Cell lymphoma
(PTCL)
The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an
investigator-sponsored, randomized controlled trial led by the
Lymphoma Study Association (LYSA) to evaluate lacutamab in
combination with chemotherapy GEMOX (gemcitabine and oxaliplatin)
versus GEMOX alone in patients with KIR3DL2-expressing
relapsed/refractory PTCL is ongoing and continues to recruit
patients.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating
durvalumab (anti-PD-L1) in combination with monalizumab or
AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable,
Stage III non-small cell lung cancer (NSCLC) who have not
progressed following definitive platinum-based concurrent
chemoradiation therapy (CRT) is ongoing.
- AstraZeneca will present an update on the outcomes of the Phase
2 study NeoCOAST-2 at the upcoming ASCO Annual Meeting in June
2025. NeoCOAST-2 is evaluating neoadjuvant durvalumab plus
chemotherapy and novel anticancer agents and adjuvant durvalumab
with or without novel agents in resectable non-small-cell lung
cancer.
IPH5201 (anti-CD39), partnered with
AstraZeneca:
- The MATISSE Phase 2 clinical trial conducted by Innate in
neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking
monoclonal antibody developed in collaboration with AstraZeneca, is
ongoing and recruitment is on track.
IPH5301 (anti-CD73):
- The investigator-sponsored CHANCES Phase 1 trial of IPH5301
with Institut Paoli-Calmettes is ongoing.
Corporate Update
- As of March 31, 2025, the balance available under our April
2023 sales agreement under the At-The-Market program remains at $75
million.
Post period event
- As announced on April 23, 2025, as part of the discussions with
regard to the review of their 2016 Agreement, Sanofi and Innate
agreed to a potential investment by Sanofi of up to €15 million in
new shares of Innate. Sanofi then subscribed to 8,345,387 new
ordinary shares of Innate, at a price of €1.7974 per share,
representing a total capital increase of €14,999,998.59
(€417,269.35 in nominal amount and €14,582,729.24 of issue
premium), representing 9.05% of Innate’s total outstanding shares
as of the time of such capital increase.
- Innate Pharma will propose to its Annual General Meeting taking
place on May 22, 2025, to move from an executive board/supervisory
board corporate governance structure to a board of directors
structure with a Chief Executive Officer. This transformation is
part of the Company’s strategic plan to simplify and align its
governance with international standards.
Financial Results
Cash, cash equivalents and financial assets of the Company
amounted to €72.5 million as of March 31, 2025. At the same date,
financial liabilities amounted to €29.2 million. Cash, cash
equivalents and financial assets as of March 31, 2025 do not
include the €15.0 million payment received from Sanofi.
Revenue for the three month period ending March 31, 2025,
amounted to €1.2 million (€6.6 million for the same period in
2024). Revenue from collaboration and licensing agreements mainly
resulted from the partial or entire recognition of the proceeds
received pursuant to the agreements with AstraZeneca and
Sanofi.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology
company developing immunotherapies for cancer patients. Its
innovative approach aims to harness the innate immune system
through three therapeutic approaches: multi-specific NK Cell
Engagers via its ANKET® (Antibody-based NK cell Engager
Therapeutics) proprietary platform and Antibody Drug Conjugates
(ADC) and monoclonal antibodies (mAbs).
Innate’s portfolio includes several ANKET® drug candidates to
address multiple tumor types as well as IPH4502, a differentiated
ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb
lacutamab is developed in advanced form of cutaneous T cell
lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb
monalizumab is developed with AstraZeneca in non-small cell lung
cancer.
Innate Pharma is a trusted partner to biopharmaceutical
companies such as Sanofi and AstraZeneca, as well as leading
research institutions, to accelerate innovation, research and
development for the benefit of patients.
Headquartered in Marseille, France with a US office in
Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq
in the US.
Learn more about Innate Pharma at www.innate-pharma.com. Follow
us on LinkedIn and X.
Information about Innate Pharma shares
ISIN code
Ticker code
LEI
FR0010331421
Euronext: IPH Nasdaq: IPHA
9695002Y8420ZB8HJE29
Disclaimer on forward-looking information and risk
factors
This press release contains certain forward-looking statements,
including those within the meaning of applicable securities laws,
including the Private Securities Litigation Reform Act of 1995. The
use of certain words, including “anticipate,” “believe,” “can,”
“could,” “estimate,” “expect,” “may,” “might,” “potential,”
“underway,” “intend,” “should,” “will,” or the negative of these
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 reliance on third parties to manufacture its product
candidates, the Company’s commercialization efforts and the
Company’s continued ability to raise capital to fund its
development. 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, 2024, and subsequent filings
and reports filed with the AMF or SEC, or otherwise made public by
the Company. References to the Company’s website and the AMF
website are included for information only and the content contained
therein, or that can be accessed through them, are not incorporated
by reference into, and do not constitute a part of, this press
release.
In light of the significant uncertainties in these
forward-looking statements, you should not regard these statements
as a representation or warranty by the Company or any other person
that the Company will achieve its objectives and plans in any
specified time frame or at all. The Company undertakes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250512043208/en/
For additional information, please contact:
Investors Innate Pharma
Henry Wheeler Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr
Media Relations
NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15
innate@newcap.eu
Innate Pharma (NASDAQ:IPHA)
Gráfico Histórico do Ativo
De Mai 2025 até Jun 2025
Innate Pharma (NASDAQ:IPHA)
Gráfico Histórico do Ativo
De Jun 2024 até Jun 2025