- Positive results with lacutamab from TELLOMAK Phase 2 study
in mycosis fungoides presented at ASCO 2024
- NK-Cell engager SAR443579/IPH61011 first-in-human study
advanced to Phase 2 and initiation of front-line AML Phase 1/2
combination study
- Updated data from dose-escalation part presented at EHA 2024
confirm clinical benefit and durable responses in patients with R/R
AML
- IPH45, proprietary anti Nectin-4 ADC progressing towards
Phase 1 in H2 2024
- Monalizumab data from AstraZeneca-sponsored Phase 2 study in
early NSCLC presented at WCLC
- Cash position of €102.1 million2 as of June 30, 2024,
anticipated cash runway to end of 2025
- Conference call to be held today at 2:00 p.m. CEST / 8:00
a.m. EDT
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today reported its
consolidated financial results for the six months ended June 30,
2024. The consolidated financial statements are attached to
this press release.
“We are focused on our growth strategy as we advance our
pipeline,” said Hervé Brailly, Chief Executive Officer ad
interim of Innate Pharma. “We recently presented Phase 2
results with lacutamab in mycosis fungoides at ASCO and are engaged
in discussions with the FDA on next steps in its development. We
are also progressing towards Phase 1 for our first and
differentiated ADC program IPH45, targeting Nectin-4.”
Webcast and conference call
will be held today at 2:00 p.m. CEST (8:00 a.m. ET)
Access to live webcast:
https://events.q4inc.com/attendee/127231232
Participants may also join via
telephone by registering in advance of the event at
https://registrations.events/direct/Q4I953384196
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
Developed by Sanofi
2
Including short term investments (€21.8
million) and non-current financial instruments (€10.3 million)
Pipeline highlights:
Lacutamab (anti-KIR3DL2
antibody):
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.
- Favorable results from the Phase 2 TELLOMAK study with
lacutamab in mycosis fungoides were presented at the American
Society of Clinical Oncology (ASCO) 2024 Annual Meeting in June
2024. The data demonstrate that treatment with lacutamab resulted
in meaningful antitumor activity, regardless of the KIR3DL2
baseline expression, and an overall favorable safety profile. The
global objective response rate was 16.8% (Olsen 2011) and 22.4%
(Olsen 2022), including 2 complete responses and 16 partial
responses.
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 in combination
with oxaliplatin) versus GEMOX alone in patients with
KIR3DL2-expressing relapsed/refractory PTCL is ongoing and
continues to recruit patients.
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. Innate’s pipeline includes five public drug
candidates born from the ANKET® platform: SAR443579/IPH6101
(SAR’579; trifunctional anti-CD123 NKp46-CD16 NKCE),
SAR445514/IPH6401 (SAR’514 trifunctional anti-BCMA NKp46-CD16
NKCE), IPH62 (anti-B7-H3), IPH67 (target undisclosed, solid tumors)
and tetra-specific IPH6501 (anti-CD20 with IL-2v). Several other
undisclosed proprietary preclinical targets are being explored.
IPH6501 (proprietary)
IPH6501 is Innate’s proprietary CD20-targeted IL-2v bearing
second-generation ANKET®. In March 2024 the first patient was dosed
in the Phase 1/2 clinical trial evaluating IPH6501 in B cell
Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up
to 184 patients.
- Innate presented preclinical data of IPH6501 at the ASCO Annual
Meeting and European Hematology Association (EHA) Annual congress
in June 2024. Preclinical data showed that IPH6501 depletes
autologous CD20+ B cells from healthy donors with greater efficacy
and lower induction of pro-inflammatory cytokines than a
CD20-T-cell engager. IPH6501 also effectively and preferentially
stimulates NK cell proliferation from peripheral blood mononuclear
cells of R/R NHL patients.
- The trial-in-progress of the Phase 1/2 study has been presented
at the European Hematology Association (EHA) and ASCO in 2024.
SAR’579, SAR’514, IPH62 and IPH67 (under development by
Sanofi)
SAR’579 / IPH6101
The Phase 1/2 clinical trial by Sanofi is progressing well,
evaluating SAR’579 / IPH6101, a trifunctional anti-CD123
NKp46-CD16 NK-cell engager and ANKET® platform lead asset, in
patients with relapsed or refractory acute myeloid leukemia (AML),
B-cell acute lymphoblastic leukemia (B-ALL) or high-risk
myelodysplastic syndrome (HR-MDS).
- Updated efficacy and safety results from the dose-escalation
part of the Phase 1/2 study with SAR'579 / IPH6101, were shared in
an oral presentation at the EHA 2024 Congress. The data
demonstrated that SAR’579 continues to show clinical benefit and
durable responses along with a favorable safety profile in patients
with R/R AML, with 5 complete remissions (4 CR / 1 CRi) achieved at
1 mg/kg, with durable CR (>10 months) observed in 3
patients.
- In April 2024, Sanofi advanced SAR’579 / IPH6101, to the Phase
2 preliminary dose expansion of the trial. Under the terms of the
2016 research collaboration with Sanofi, the progression to the
dose expansion part of the trial has triggered a milestone payment
from Sanofi to Innate of €4m.
In July 2024, Sanofi initiated a new Phase 1 / Phase 2,
randomized, open label, multi-cohort, multi-center study
(NCT06508489) assessing the safety, tolerability and preliminary
efficacy of SAR’579 / IPH6101 administered in combination with
azacitidine and venetoclax in patients with CD123 expressing
hematological malignancies in newly diagnosed AML.
SAR’514/IPH6401
The Sanofi led Phase 1/2 clinical trial with SAR’514 / IPH6401,
a trifunctional anti-BCMA Nkp46-CD16 NK-cell engager, in patients
with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory
Light-chain Amyloidosis is ongoing.
IPH62, IPH67 and option
- IPH62 is a NK-cell engager program targeting B7-H3 from
Innate’s ANKET® platform under development. Following a research
collaboration period and upon candidate selection, Sanofi will be
responsible for all development, manufacturing and
commercialization.
- IPH67 is a NK-cell engager program in solid tumors from
Innate’s ANKET® platform under development. 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:
Innate develops different approaches for the treatment of cancer
utilizing its antibody engineering capabilities to deliver novel
assets, with its innovative ANKET® platform and is also exploring
Antibody Drug Conjugates (ADC) formats.
IPH45 (Nectin-4 ADC):
IPH45 is Innate’s proprietary and differentiated
exatecan-antibody drug conjugate (ADC) targeting Nectin-4.
- First preclinical data were presented in an oral presentation
at the American Association for Cancer Research (AACR) Annual
Meeting 2024. In preclinical studies, IPH45 shows anti-tumor
efficacy in vivo, in Nectin-4 expressing tumors including in
enfortumab vedotin (EV) refractory models. Importantly, IPH45 shows
stronger activity than EV, in multiple urothelial carcinoma
patient-derived xenografted (PDX) mice models, across Nectin-4 high
and Nectin-4 low expression levels. In addition, IPH45 has
anti-tumor activity in combination with anti-PD1 treatment in PD-1
resistant model in vivo and has a favorable safety profile in
relevant animal toxicology models.
- IPH45 continues towards a Phase 1 trial in 2024.
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.
- After the period, the Independent Data Monitoring Committee
recommended the continuation of the Phase 3 PACIFIC-9 trial based
on a pre-planned analysis.
- Updated results from COAST, a Phase 2 study of durvalumab with
oleclumab or monalizumab in patients with Stage III unresectable
non-small-cell lung cancer were presented at the ASCO 2024 Annual
Meeting, in June 2024. In this analysis of updated results from
COAST, the combination of durvalumab plus oleclumab or monalizumab
increased objective response rate, prolonged progression free
survival, and trended toward improved overall survival compared to
durvalumab alone.
- AstraZeneca presented interim results from the randomized
NeoCOAST-2 Phase 2 platform trial during the 2024 World Conference
on Lung Cancer in September 2024. In this preliminary analysis on
the first 60 of 72 patients randomized to Arm 2, monalizumab added
to durvalumab plus platinum-based chemotherapy doublet induced a
pathological complete response rate of 26.7% [95% CI; 16.1–39.7]
and a major pathological response rate of 53.3% [95% CI; 40.0–66.3]
which are numerically higher than the durvalumab plus platinum
doublet approved regimen. Treatment in Arm 2 showed manageable
safety profile and no impact on surgical rate. The NeoCOAST-2
platform study is intended to assess the safety and efficacy of
neoadjuvant durvalumab alone or combined with novel immuno-oncology
agents and chemotherapy in resectable, early-stage NSCLC, followed
by adjuvant treatment with durvalumab with or without the novel
agents.
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. Following a pre-planned
interim analysis after the period, the MATISSE Phase 2 trial
continues according to plans.
IPH5301 (anti-CD73):
- The investigator-sponsored CHANCES Phase 1 trial of IPH5301
with Institut Paoli-Calmettes is ongoing. Preliminary results will
be presented at the upcoming (European Society of Medical Oncology)
ESMO Annual Meeting 2024. The abstract, available on the ESMO
website, states that IPH5301 was safe and well-tolerated with
preliminary signals of monotherapy antitumor activity.
Corporate Update:
- In connection with Innate’s previous announcement that it had
established an at-the-market (“ATM”) program, on January 16, 2024
Innate filed a new Registration Statement on Form F-3 (Registration
No. 333-276164). On February 6, 2024, Innate filed a prospectus
supplement relating to its previously established ATM program,
pursuant to which it may, from time to time, offer and sell to
eligible investors a total gross amount of up to $75 million of
American Depositary Shares (“ADS”). Each ADS represents one
ordinary share of Innate. As of June 30, 2024, no sales have been
made under the program.
- Takeda made a strategic decision to terminate the license
agreement executed in March 2023 for use of selected Innate
antibodies in antibody drug-conjugates. Innate will regain full
rights to these antibodies in Q4 2024.
Financial highlights for the first half of 2024:
The key elements of Innate’s financial position and financial
results as of and for the six-month period ended June 30, 2024 are
as follows:
- Cash, cash equivalents, short-term investments and financial
assets amounting to €102.1 million (€m) as of June 30, 2024
(€102.3m as of December 31, 2023).
- Revenue and other income amounted to €12.3m in the first half
of 2024 (€40.2m in the first half of 2023) and mainly comprised of:
- Revenue from collaboration and licensing agreements, which
mainly resulted from the partial or entire recognition of the
proceeds received pursuant to the agreements with AstraZeneca,
Sanofi and Takeda. They result from the partial or entire
recognition of the proceeds received pursuant to such agreements.
They are recognized when the entity's performance obligation is
met. They are recognized at a point in time or spread over time
according to the percentage of completion of the work that the
Company is committed to carry out under these agreements:
- (i) Revenue from collaboration and licensing agreements for
monalizumab decreased by €6.5m to €3.0m in the first half of 2024
(€9.5m in the first half of 2023). This change is mainly due to the
recognition of increased revenue in the first six months of 2023.
Indeed, as of June 30, 2023, the Company had analyzed the cost base
used to calculate the percentage of completion of Phase 1/2 trials
in connection with their progress. This analysis led to a reduction
in the cost base through a re-estimation of projected expenses. As
a result, this adjustment on the cost base had a positive impact on
the percentage of completion and led to the recognition of
additional revenue of €5.9 million for the first half of 2023 which
was not replicated in 2024.
- (ii) Revenue related to the license and collaboration agreement
signed with Sanofi in 2016 increased by €2.0m, to €4.0m for the six
months ended June 30, 2024, as compared to €2.0m for the six months
ended June 30, 2023. On April 15, 2024, the Company announced the
treatment of the first patient in the Phase 2 dose expansion part
of the Sanofi-sponsored clinical trial evaluating NK Cell Engager
SAR443579/ IPH6101 in various blood cancers. Under the terms of the
2016 agreement, this trial progress triggered a milestone payment
of €4.0 million fully recognized in revenue during the first
quarter of 2024. This amount was received by the Company on May 17,
2024. As a reminder, the Company announced that, in June 2023, the
first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical
trial evaluating IPH6401/SAR'514 in relapsed or refractory Multiple
Myeloma. As provided by the licensing agreement signed in 2016,
Sanofi made a milestone payment of €2.0 million, fully recognized
in revenue as of June 30, 2023. This amount was received by the
Company on July 21, 2023.
- (iii) Revenue related to the research collaboration and
licensing agreement signed with Sanofi in 2022 decreased by €18.3m,
to €0.4m for the six months ended June 30, 2024, as compared to
€18.7m for the six months ended June 30, 2023. As previously
announced, on January 25, 2023, the Company announced the
expiration of the waiting period under the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act of 1976 and the effectiveness of the
licensing agreement as of January 24, 2023. Consequently, the
Company received an upfront payment of €25.0 million in March 2023,
including €18.5 million for the exclusive license, €1.5 million for
the research activities and €5.0 million for the option on two
additional targets. The €18.5 million upfront payment relating to
the exclusive license was fully recognized in revenue as of June
30, 2023. The €1.5 million upfront payment is recognized on a
straight-line basis over the duration of the research activities
that the Company has agreed to carry out. As a result, a €0.2
million has been recognized in revenue as of June 30, 2024 and June
30, 2023. Then, on December 19, 2023, the Company announced that
Sanofi had exercised an option for one of the two targets. As a
consequence, the Company recognized related income of €2.5 million
as of December 31, 2023. This option exercise also resulted in a
milestone payment of €15.0 million, including €13.3 million in
respect of the exclusive license, which was fully recognized in
income as of December 31, 2023, and €1.7 million in respect of
research activities to be carried out by the Company, which will be
recognized in income on a straight-line basis over the duration of
the research activities that the Company has agreed to carry out.
Sanofi and Innate will collaborate and work on the research
activities defined in the contractual research program. These
activities began during the first half of 2024. An amount of €0.2
million has been recognized in revenue as of June 30, 2024. Amounts
not recognized in revenue are classified as deferred revenue.
- (iv) Revenues under the license agreement signed with Takeda in
2023 are nil for the first half of 2024, compared to €4.6 million
for the first half of 2023. On April 3, 2023, the Company announced
that it has entered into an exclusive license agreement with Takeda
under which Innate grants Takeda exclusive worldwide rights to
research and develop antibody drug conjugates (ADC) using a panel
of selected Innate antibodies against an undisclosed target, with a
primary focus in Celiac disease. Takeda will be responsible for the
future development, manufacture and commercialization of any
potential products developed using the licensed antibodies. As
such, the Company considers that the license granted is a right to
use the intellectual property, which is granted fully and
perpetually to Takeda. The agreement does not stipulate that
Innate's activities will significantly affect the intellectual
property granted during the life of the agreement. Consequently,
the $5.0 million (or €4.6 million) initial payment, received by the
Company in May 2023, was fully recognized in revenue as of June 30,
2023.
- Government funding for research expenditures of €4.1m in the
first half of 2024 (€4.9m in the first half of 2023).
- Operating expenses are €38.7m in the first half of 2024 (€40.6m
in the first half of 2023), of which 75.2% (€29.1m) are related to
R&D.
- R&D expenses decreased by €2.4m to €29.1m in the first half
of 2024 (€31.5m in the first half of 2023). This change is mainly
explained by lower personnel and other R&D expenses by
€2.2millions (-15.4%). This decrease is due to an non-recurring
amortization charge in the first half of 2023, related to the
IPH5201 rights (full amortization of the additional €2.0 million
invoice from Orega Biotech following the dosing of the first
patient in the Phase 2 MATISSE clinical trial in June 2023).
Additionally, direct R&D expenses, which slightly decreased by
€0.2 million, remained at €17.1 million, with an acceleration in
preclinical spending related to the Antibody-Drug Conjugates (ADC)
program offsetting the decrease in expenses related to certain more
mature clinical-stage programs.
- General and administrative (G&A) expenses increased by
€0.4m to €9.6m in the first half of 2024 (€9.1m in the first half
of 2023) mainly resulting from (i) a €0.4m decrease of personnel
expenses mainly due to a reduction of administrative staff, offset
by (ii) a €0.3m increase in non-scientific advisory and consulting
fees resulting from greater reliance on recruitment agencies, and
finally (iii) a €0.5 million increase in other expenses, mainly due
to the derecognition of returned spaces in the first half of 2023
(as a reminder, on March 13, 2023, the Company signed an amendment
to the lease of the 'Le Virage' building, aimed at reducing the
area of leased premises) and the sale of related furniture during
the same period, which led to an exceptional reduction in these
charges in the first half of 2023.
- A net financial gain of €1.5m in the first half of 2024 (€2.1m
in the first half of 2023). This variance mainly results from the
unfavorable evolution of the dollar exchange rate and its impact on
foreign exchange recorded during the first half of 2024. The
negative currency impact was offset by an increase in the fair
value of certain financial instruments.
- A net loss of €24.8m for the first half of 2024 (net income of
€1.7m for the first half of 2023).
The table below summarizes the IFRS consolidated financial
statements as of and for the six months ended June 30, 2024,
including 2023 comparative information.
In thousands of euros, except for data
per share
June 30, 2024
June 30, 2023
Revenue and other income
12,345
40,198
Research and development expenses
(29,076)
(31,453)
General and administrative expenses
(9,582)
(9,144)
Operating expenses
(38,657)
(40,597)
Operating income (loss)
(26,313)
(398)
Net financial income (loss)
1,549
2,116
Income tax expense
—
—
Net income (loss)
(24,764)
1,718
Weighted average number of shares (in
thousands) :
80,872
80,320
- Basic income (loss) per share
(0.31)
0.02
- Diluted income (loss) per share
(0.31)
0.02
June 30, 2024
December 31, 2023
Cash, cash equivalents and financial
assets
102,149
102,252
Total assets
151,497
184,193
Total shareholders’ equity
28,796
51,901
Total financial debt
35,503
39,893
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 therapeutic antibodies and its ANKET®
(Antibody-based NK cell Engager
Therapeutics) proprietary platform.
Innate’s portfolio includes lead proprietary program lacutamab,
developed in advanced form of cutaneous T cell lymphomas and
peripheral T cell lymphomas, monalizumab developed with AstraZeneca
in non-small cell lung cancer, as well as ANKET® multi-specific NK
cell engagers to address multiple tumor types.
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
Information about Innate Pharma shares:
ISIN code
FR0010331421
Ticker code
Euronext: IPH Nasdaq: IPHA
LEI
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,”
“expect” “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, 2023, 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.
Summary of Interim Condensed Consolidated
Financial Statements and Notes as of JUNE 30, 2024
Interim Condensed Consolidated
Statements of Financial Position
(in thousand euros)
June 30, 2024
December 31, 2023
Assets
Current assets
Cash and cash equivalents
69,990
70,605
Short-term investments
21,809
21,851
Trade receivables and others
19,795
55,557
Total current assets
111,594
148,012
Non-current assets
Intangible assets
119
416
Property and equipment
5,748
6,322
Non-current financial assets
10,350
9,796
Other non-current assets
85
87
Trade receivables and others -
non-current
14,478
10,554
Deferred tax asset
9,123
9,006
Total non-current assets
39,903
36,181
Total assets
151,497
184,193
Liabilities
Current liabilities
Trade payables and others
15,873
17,018
Collaboration liabilities – current
portion
10,248
7,647
Financial liabilities – current
portion
8,929
8,936
Deferred revenue – current portion
2,799
5,865
Provisions - current portion
375
171
Total current liabilities
38,224
39,637
Non-current liabilities
Collaboration liabilities – non-current
portion
41,901
45,030
Financial liabilities – non-current
portion
26,574
30,957
Defined benefit obligations
2,470
2,441
Deferred revenue – non-current portion
4,116
4,618
Provisions - non-current portion
294
603
Deferred tax liabilities
9,123
9,006
Total non-current liabilities
84,478
92,656
Shareholders’ equity
Share capital
4,049
4,044
Share premium
386,049
384,255
Retained earnings
(336,893)
(329,323)
Other reserves
354
495
Net income (loss)
(24,764)
(7,570)
Total shareholders’ equity
28,796
51,901
Total liabilities and shareholders’
equity
151,497
184,193
Interim Condensed Consolidated
Statements of Income (loss) (in thousand euros)
June 30, 2024
June 30, 2023
Revenue from collaboration and licensing
agreements
8,293
35,344
Government financing for research
expenditures
4,052
4,854
Revenue and other income
12,345
40,198
Research and development expenses
(29,076)
(31,453)
General and administrative expenses
(9,582)
(9,144)
Operating expenses
(38,657)
(40,597)
Operating income (loss)
(26,313)
(398)
Financial income
3,613
3,083
Financial expenses
(2,064)
(966)
Net financial income (loss)
1,549
2,116
Net income (loss) before tax
(24,764)
1,718
Income tax expense
—
—
Net income (loss)
(24,764)
1,718
Weighted average number of shares : (in
thousands)
80,872
80,320
- Basic income (loss) per share
(0.31)
0.02
- Diluted income (loss) per share
(0.31)
0.02
Interim Condensed Consolidated
Statements of Cash Flow
(in thousand euros)
June 30, 2024
June 30, 2023
Net income (loss)
(24,764)
1,718
Depreciation and amortization, net
1,142
3,645
Employee benefits costs
145
83
Change in provision for charges
(105)
507
Share-based compensation expense
1,705
1,401
Change in fair value of financial
assets
(992)
(1,044)
Foreign exchange (gains) losses on
financial assets
(524)
288
Change in accrued interests on financial
assets
(212)
(130)
Disposal of property and equipment
(scrapping)
18
591
Other profit or loss items with no cash
effect
26
6
Operating cash flow before change in
working capital
(23,561)
7,065
Change in working capital
26,597
(18,530)
Net cash generated from / (used in)
operating activities:
3,036
(11,465)
Acquisition of property and equipment,
net
(283)
(309)
Disposal of other assets
—
66
Purchase of other assets
—
(3)
Disposal of current financial
instruments
1,215
—
Net cash generated from / (used in)
investing activities:
932
(246)
Proceeds from the exercise / subscription
of equity instruments
93
348
Repayment of borrowings
(4,420)
(1,594)
Net cash generated / (used in) from
financing activities:
(4,327)
(1,246)
Effect of the exchange rate changes
(257)
145
Net increase / (decrease) in cash and
cash equivalents:
(615)
(12,811)
Cash and cash equivalents at the beginning
of the year:
70,605
84,225
Cash and cash equivalents at the end of
the six-months period:
69,990
71,414
Revenue and other income
The following table summarizes operating revenue for the periods
under review:
In thousands of euros
June 30, 2024
June 30, 2023
Revenue from collaboration and licensing
agreements
8,293
35,344
Government funding for research
expenditures (1)
4,052
4,854
Revenue and other income
12,345
40,198
(1) As of June 30, 2023, the amount is
mainly composed of (i) the research tax credit calculated and
recognized for the first half of 2023 for an amount of €5.0 million
from which is subtracted (ii) a provision amounting to €0.2 million
relating to the additional provision in connection with the tax
inspection carried out in 2022 by the French tax authorities
relating to the 2019 and 2020 financial years, as well as the
research tax credit and the accuracy of its calculation for the
2018 to 2020 financial years.
Revenue from collaboration and licensing agreements
Revenue from collaboration and licensing agreements decreased by
€27.1 million, to €8.3 million for the six months ended June 30,
2024, as compared to revenues from collaboration and licensing
agreements of €35.3 million for the six months ended June 30, 2023.
These revenues mainly result from the partial or entire recognition
of the proceeds received pursuant to the agreements with
AstraZeneca, Sanofi and Takeda. They are recognized when the
entity's performance obligation is met. They are recognized at a
point in time or spread over time according to the percentage of
completion of the work that the Company is committed to carry out
under these agreements.
The evolution for the first half of 2024 is mainly due to:
- A €6.5 million decrease in revenue related to monalizumab, to
€3.0 million for the six months ended June 30, 2024, as compared to
€9.5 million for the six months ended June 30, 2023. This change is
mainly due to the recognition of increased revenue in the first six
months of 2023. Indeed, as of June 30, 2023, the Company had
analyzed the cost base used to calculate the percentage of
completion of Phase 1/2 trials in connection with their progress.
This analysis led to a reduction in the cost base through a
re-estimation of projected expenses. As a result, this adjustment
on the cost base had a positive impact on the percentage of
completion and led to the recognition of additional revenue of €5.9
million for the first half of 2023 which was not replicated in
2024. As of June 30, 2024, the deferred revenue related to
monalizumab is €2.0 million entirely classified as “Deferred
revenue—Current portion” in connection with the progress of Phase
1/2 trials.
- A €2.0 million increase in revenue from the collaboration and
research license agreement signed with Sanofi in 2016, to €4.0
million for the six months ended June 30, 2024, as compared to €2.0
million for the six months ended June 30, 2023. On April 15, 2024,
the Company announced the treatment of the first patient in the
Phase 2 dose expansion part of the Sanofi-sponsored clinical trial
evaluating NK Cell Engager SAR443579/ IPH6101 in various blood
cancers. Under the terms of the 2016 agreement, this trial progress
triggered a milestone payment of €4.0 million fully recognized in
revenue during the first quarter of 2024. This amount was received
by the Company on May 17, 2024.As a reminder, the Company announced
that, in June 2023, the first patient was dosed in a
Sanofi-sponsored Phase 1/2 clinical trial evaluating
IPH6401/SAR'514 in relapsed or refractory Multiple Myeloma. As
provided by the licensing agreement signed in 2016, Sanofi made a
milestone payment of €2.0 million, fully recognized in revenue as
of June 30, 2023. This amount was received by the Company on July
21, 2023.
- A €18.3 million decrease in revenue from the research
collaboration and licensing agreement signed with Sanofi in 2022,
to €0.4m for the six months ended June 30, 2024, as compared to
€18.7m for the six months ended June 30, 2023. As previously
announced, on January 25, 2023, the Company announced the
expiration of the waiting period under the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act of 1976 and the effectiveness of the
licensing agreement as of January 24, 2023. Consequently, the
Company received an upfront payment of €25.0 million in March 2023,
including €18.5 million for the exclusive license, €1.5 million for
the research activities and €5.0 million for the option on two
additional targets. The €18.5 million upfront payment relating to
the exclusive license was fully recognized in revenue as of June
30, 2023. The €1.5 million upfront payment is recognized on a
straight-line basis over the duration of the research activities
that the Company has agreed to carry out. As a result, a €0.2
million has been recognized in revenue as of June 30, 2024 and June
30, 2023. Then, on December 19, 2023, the Company announced that
Sanofi had exercised an option for one of the two targets. As a
consequence, the Company recognized related income of €2.5 million
as of December 31, 2023. This option exercise also resulted in a
milestone payment of €15.0 million, including €13.3 million in
respect of the exclusive license, which was fully recognized in
income as of December 31, 2023, and €1.7 million in respect of
research activities to be carried out by the Company, which will be
recognized in income on a straight-line basis over the duration of
the research activities that the Company has agreed to carry out.
Sanofi and Innate will collaborate and work on the research
activities defined in the contractual work program. This work began
during the first half of 2024. An amount of €0.2 million has been
recognized in revenue as of June 30, 2024. Amounts not recognized
in revenue are classified as deferred revenue.
- A €4.6 million decrease in revenue from the licensing agreement
signed with Takeda in 2023. Revenues for the first half of 2024 are
nil, compared to €4.6 million for the first half of 2023. On April
3, 2023, the Company announced that it has entered into an
exclusive license agreement with Takeda under which Innate grants
Takeda exclusive worldwide rights to research and develop antibody
drug conjugates (ADC) using a panel of selected Innate antibodies
against an undisclosed target, with a primary focus in Celiac
disease. Takeda will be responsible for the future development,
manufacture and commercialization of any potential products
developed using the licensed antibodies. As such, the Company
considers that the license granted is a right to use the
intellectual property, which is granted fully and perpetually to
Takeda. The agreement does not stipulate that Innate's activities
will significantly affect the intellectual property granted during
the life of the agreement. Consequently, the $5.0 million (or €4.6
million) initial payment, received by the Company in May 2023, was
fully recognized in revenue as of June 30, 2023.
- A €0.3 million increase in revenue from invoicing of research
and development costs. The change between the two periods is mainly
explained by the increase in research and development costs
incurred by the Company under these agreements during the first
half of 2024 in line with the clinical trial progress.
Government financing for research expenditures
Government financing for research expenditures decreased by €0.8
million, or 16.5%, to €4.1 million for the six months ended June
30, 2024 as compared to €4.9 million the six months ended June 30,
2023. This change is mainly due to the €1.5 million decrease in the
research tax credit, resulting from (i) the absence of depreciation
for IPH5201 rights in the first half of 2024, compared with the
depreciation recognized in the first half of 2023 following the
additional payment of €2.0 million to Orega Biotech following the
dosing of the first patient in the MATISSE Phase 2 clinical trial,
(ii) a decrease in amortization expense for the monalizumab
intangible asset, which is nearing the end of its amortization
period, and (iii) a reduction in eligible R&D personnel
costs.
However, these decreases were offset by a €0.5 million increase
in Research tax credits (Crédits d’impôt Recherches or “CIR”) from
public and private R&D subcontracting expenses over the period
included in the calculation of the research tax credit, due to the
inclusion, for the first half of 2024, of R&D expenses incurred
with a third party whose approval was under renewal as of June 30,
2023, and whose expenses had been excluded from eligible expenses
for that period.
The Company has benefited from the early repayment of the
Research Tax Credit (Crédit Impôt Recherche - CIR) until December
31, 2019. As of December 31 2019 and December 31, 2023, the Company
no longer met the eligibility criteria for this status (criteria
not met after year-end analysis). As a result, the CIR for 2019 and
2020 represented a receivable from the French Treasury, which was
refunded to the Company in January for €16.7 million and July 2024
for €12.8 million. The CIR calculated in respect of 2023 and the
first half of 2024 is recognized as a non-current receivable. For
fiscal years 2021 and 2022, the Company met the definition of an
SME under European Union criteria and was therefore entitled to
early repayment of the CIR in 2022 in respect of the 2021 tax year
and in July 2023 in respect of the 2022 tax year.
Operating expenses
The table below presents our operating expenses for the six
months periods ended June 30, 2024 and 2023:
In thousands of euros
June 30, 2024
June 30, 2023
Research and development expenses
(29,076)
(31,453)
General and administrative expenses
(9,582)
(9,144)
Operating expenses
(38,657)
(40,597)
Research and development expenses
Research and development (“R&D”) expenses decreased by €2.4
million, or 7.6%, to €29.1 million for the six months ended June
30, 2024, as compared to €31.5 million for the six months ended
June 30, 2023, representing a total of 75.2% and 77.5% of the total
operating expenses, respectively. R&D expenses include direct
R&D expenses (subcontracting costs and consumables),
depreciation and amortization, personnel expenses and other
expenses.
Direct R&D expenses decreased by €0.2 million, or 1.1%, to
€17.1 million for the six months ended June 30, 2024, as compared
to €17.3 million for the six months ended June 30, 2023. This
decrease is mainly explained by a €2.5 million increase in expenses
related to preclinical programs, particularly in the field of
Antibody-Drug Conjugates (ADC), offset by a €2.7 million decrease
in expenses related to clinical programs. The variance relating to
clinical programs is composed of the following items: (i) a €0.5
million increase related to recruitment costs for the Phase 2
MATISSE trial of the IPH5201 program, offset by (ii) a €1.4 million
decrease in expenses for the IPH65 program, whose first patient was
dosed in March 2024, (iii) a €1.5 million decrease in expenses for
the lacutamab program, and (iv) a €0.5 million decrease in expenses
related to the monalizumab program, decrease related to maturation
of Phase I/II clinical trials under the collaboration with
AstraZeneca.
Also, as of June 30, 2024, the collaboration liabilities
relating to monalizumab and the agreements signed with AstraZeneca
in April 2015, October 2018 and September 2020 amounted to €52.1
million, as compared to collaborations liabilities to €52.7 million
as of December 31, 2023. This decrease of €0.5 million mainly
results from (i) the net reimbursements of €2.4 million made to
AstraZeneca in the first half of 2024 related to the co-funding of
the monalizumab program, including the INTERLINK-1 Phase 3 trial
launched in October 2020 and PACIFIC-9 launched in April 2022, and
(ii) the increase in the collaboration commitment by €1.7 million
due to exchange rate fluctuations observed during the period for
the euro-dollar exchange rate.
Personnel and other expenses allocated to R&D decreased by
€2.2 million, or 15.4%, to €12.0 million for the six months ended
June 30, 2024, as compared to an amount of €14.2 million for the
six months ended June 30, 2023. This decrease is mainly explained
by amortization charges related to the IPH5201 rights, following
the full amortization of the additional €2.0 million invoice from
Orega Biotech after the dosing of the first patient in the Phase 2
MATISSE clinical trial in June 2023.
General and administrative expenses
General and administrative expenses increased by €0.4 million,
or 4.8%, to €9.6 million for the six months ended June 30, 2024, as
compared to general and administrative expenses of €9.1 million for
the six months ended June 30, 2023. General and administrative
expenses represented a total of 24.8% and 22.5% of the total
operating expenses for the six months ended June 30, 2024 and 2023,
respectively.
Personnel expense includes the compensation paid to our
employees, and decreased by €0.4 million, to €4.0 million for the
six months ended June 30, 2024, as compared to €4.4 million for the
six months ended June 30, 2023. This decrease of €0.4 million is
mainly due to a reduction of administrative workforce.
Non-scientific advisory and consulting expenses mostly consist
of auditing, accounting, legal fees and hiring services.
Non-scientific advisory and consulting expenses increased by €0.3
million, or 16.4%, to €1.9 million for the six months ended June
30, 2024 as compared to €1.7 million for the six months ended June
30, 2023. This increase is mainly due to greater reliance on
recruitment agencies.
The rise in other expenses of €0.5 million mainly results from
rent, maintenance, and upkeep costs (primarily related to property
rentals; an exceptional effect related to the derecognition of
returned spaces—as a reminder, on March 13, 2023, the Company
signed an amendment to the lease of the "Le Virage" building, aimed
at reducing the area of leased premises. The effective date of the
lease amendment is March 15, 2023) as well as a €0.2 million
increase in other net income and expenses (primarily related to the
sale of office furniture following the reduction of leased
spaces).
Financial income (loss),
net
We recognized a net financial income of €1.5 million in the six
months ended June 30, 2024 as compared to €2.1 million in the six
months ended June 30, 2023. This variance mainly results from the
unfavorable evolution of the dollar exchange rate and its impact on
foreign exchange recorded during the first half of 2024, with a net
foreign exchange loss of €0.9 million for the first half of 2024 as
compared to a net foreign exchange gain of €0.4 million for the
first half of 2023. The negative currency impact was offset by an
increase in the fair value of certain financial instruments (net
gain of €1.5 million for the six months ended June 30, 2024 as
compared to a net gain of €1.0 million for the six months ended
June 30, 2023) and by an increase in interest income of €1.3
million in first-half 2024 as compared to €1.0 million in first
half of 2023.
Balance sheet items
Cash, cash equivalents, short-term investments and non-current
financial assets amounted to €102.1 million as of June 30, 2024, as
compared to €102.3 million as of December 31, 2023. Net cash as of
June 30, 2024 amounted to €82.9 million (€83.5 million as of
December 31, 2023). Net cash is equal to cash, cash equivalents and
short-term investments less current financial liabilities.
The Company also has bank borrowings of €34.9m, including €25.2m
of State Guaranteed Loans (“Prêts Garantis par l’Etat”) as of June
30, 2024 and €9.6m loans subscribed with Société Générale for the
construction of its head office as well as €0.6m of lease
liabilities.
The other key balance sheet items as of June 30, 2024 are:
- Deferred revenue of €6.9 million (including €4.1 million booked
as ‘Deferred revenue – non-current portion’) and collaboration
liabilities of €52.1 million (including €41.9 million booked as
‘Collaboration liabilities - non-current portion’) relating to the
remainder of the initial payment received from AstraZeneca not yet
recognized as revenue or used as part of the co-financing of the
monalizumab program with AstraZeneca;
- Receivables from the French government amounting to €26.6
million in relation to the research tax credit for 2020, 2023 and
the six-month period ended June 30, 2024. The Company has received
the CIR for 2019 and 2020 refunds from the French Treasury for an
amount of €16.7 million in January 2024 and €12.8 million in July
2024, respectively.
- Shareholders’ equity of €28.8 million, including the net loss
of the period of €24.8 million.
Cash-flow items
As of June 30, 2024, cash and cash equivalents amounted to €70.0
million, compared to €70.6 million as of December 31, 2023,
corresponding in a decrease of €0.6 million.
The net cash flow used during the period under review mainly
results from the following:
- Net cash flow generated from operating activities of €3.0
million for the six months ended June 30, 2024 as compared to net
cash flows used by operating activities of €11.5 million for the
six months ended June 30, 2023. Net cash flow from operating
activities for the first half of 2024 notably includes (i) the
collection of €15.0 million in January 2024 following Sanofi's
decision to exercise one of its two license option for an NK Cell
Engager program in solid tumors, derived from the Company's ANKET®
(Antibody-based NK Cell Engager Therapeutics) platform, pursuant to
the terms of the research collaboration and license agreement
signed in December 2022, (ii) the collection in May 2024 of €4.8
million (including value-added tax) the treatment of the first
patient in the Phase 2 dose expansion part of the Sanofi-sponsored
clinical trial evaluating NK Cell Engager SAR443579/ IPH6101 in
various blood cancers and (iii) the repayment by the French
Treasury of the research tax credit receivable relating to the 2019
financial year for an amount of €16.7 million during the first
quarter of 2024, as well as the carry-back receivable for an amount
of €0.3 million. As a reminder, for the first half of 2023, the net
cash flow used in operating activities included (i) the €25.0
million upfront payment received from Sanofi in March 2023
following the effectiveness of the research collaboration and
licensing agreement signed in December 2022 under which the Company
granted Sanofi an exclusive license to Innate Pharma's B7-H3 ANKET®
program and options on two additional targets, but also (ii) the
€4.6 million ($5.0 million) upfront payment received from Takeda
following the signing of an exclusive licensing agreement which the
Company grants Takeda exclusive worldwide rights for the research
and development of certain antibody drug conjugates (ADCs) (please
refer to Post Period Events). Restated for these transactions
linked to collaboration agreements and other non-recurring items
such as the CIR refund, net cash flow used in operating activities
for the first half of 2024 decreased by €7.3 million as compared to
the first half of 2023. This change mainly results from lower net
payments to suppliers and personnel costs.
- Net cash flow from investing activities of €0.9 million for the
six months ended June 30, 2024, as compared to net cash flow used
in investing activities of €0.2 million for the first half of 2023.
Net cash flow from investing activities for the first half of 2024
is mainly composed of a disposal of a current financial instrument
which generated a net cash collection of €1.2 million partially
offset by acquisitions of property, plant and equipment and
intangible assets for a net amount €0.3 million. For the first half
of 2023, the net cash flow used in investing activities was mainly
comprised of acquisitions of property, plant and equipment and
intangible assets net of disposals. The Company has not made any
other investments in tangible, intangible or significant financial
assets during the first half of 2024 and 2023.
- Net cash flows used in financing activities for the six months
ended June 30, 2024 was €4.3 million as compared to net cash flow
used in financing activities of €1.2 million the six months ended
June 30, 2023. These consumptions are mainly related to repayments
of financial liabilities. Their increase over the period is related
to the two State Guaranteed Loans, for which principal amortization
began in the first quarter of 2024. As a reminder, the Company
benefited from a one-year grace period in 2023, during which only
interests and guarantee fees were paid.
Post period events
On July 25, 2024, the Company received from Takeda a notice of
termination of the Exclusive License agreement signed on March 31,
2023. This termination will be effective upon expiry of a 90-day
notice period, i.e. on October 24, 2024.
Nota
The interim consolidated financial statements for the six-month
period ended June 30, 2024 have been subject to a limited review by
our Statutory Auditors and were approved by the Executive Board of
the Company on September 11, 2024. They were reviewed by the
Supervisory Board of the Company on September 11, 2024. They will
not be submitted for approval to the general meeting of
shareholders.
Risk factors
Risk factors identified by the Company are presented in the item
3.D of the annual report filed with the SEC (20-F), on April 4,
2024 (SEC Accession No. 0001598599-24-000020). The main risks and
uncertainties the Company may face in the six remaining months of
the year are the same as the ones presented in the annual report
available on the internet website of the Company.
Of note, the risks that are likely to arise during the remaining
six months of the current financial year could also occur during
subsequent years.
Related party
transactions:
Transactions with related parties during the periods under
review are disclosed in Note 18 to the interim condensed
consolidated financial statements for the period ended June 30,
2024 prepared in accordance with IAS 34.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240911695281/en/
Investors Innate
Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88
Henry.Wheeler@innate-pharma.fr
Media Relations
NewCap Arthur Rouille Tel. : +33 (0)1 44 71 00 15
innate@newcap.eu
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