MARSEILLE, France / Sep 12, 2024 / Business Wire / 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.
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.
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).
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
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.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
IPH5201 (anti-CD39), partnered with AstraZeneca:
IPH5301 (anti-CD73):
Corporate Update:
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:
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:
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:
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:
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.
Last Trade: | US$1.67 |
Daily Change: | -0.01 -0.63 |
Daily Volume: | 5,737 |
Market Cap: | US$134.780M |
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