Innate Pharma Reports Full Year 2024 Financial Results and Business Update

• FDA Breakthrough Therapy Designation granted to lacutamab for relapsed or refractory Sézary syndrome
  • New data, including lacutamab improved health-related quality of life data from TELLOMAK Phase 2 study in patients with cutaneous T cell lymphoma were presented at ASH 2024
• The first patient was dosed in a Phase 1 study for IPH4502, Nectin-4 ADC in patients with selected advanced solid tumors
• IPH6501, Innate’s proprietary ANKET^® drug candidate, is being evaluated in a Phase 1/2 clinical trial in patients with B-cell non-Hodgkin’s lymphoma
  • Innate Pharma and the Institute for Follicular Lymphoma Innovation (IFLI) announced up to $7.9m investment from IFLI to support IPH6501 development in Follicular Lymphoma
• Cash position of €91.1 million¹ as of December 31, 2024 with a cash horizon extended to mid 2026
• Conference call to be held today at 2:00 p.m. CET / 9:00 a.m. EDT

MARSEILLE, France–(BUSINESS WIRE)–#ADC–Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today reported its consolidated financial results for the year ending December 31, 2024. The consolidated financial statements are attached to this press release.

“Our strategy is clear: drive innovation through our ANKET^® NK-cell engager platform and accelerate our ADC programs. We are making strong clinical progress, with our lead proprietary ANKET^®, IPH6501 advancing in B-cell non-Hodgkin’s lymphoma and commencing the Phase 1 study for the Nectin-4 ADC IPH4502 in solid tumors. The FDA’s Breakthrough Therapy Designation for lacutamab highlights its potential to transform treatment for Sézary syndrome. With these achievements as well as disciplined financial management, we are pleased to extend our cash runway to mid 2026, reinforcing our commitment to delivering innovative new therapies for patients,” said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

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. Innate’s pipeline includes five drug candidates that have emerged from the ANKET^® platform: SAR443579/IPH6101 (SAR’579; trifunctional anti-CD123 NKp46xCD16 NKCE), SAR445514/IPH6401 (SAR’514 trifunctional anti-BCMA NKp46xCD16 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. Clinical sites are open in the US, Australia and France and the first safety and preliminary activity data are expected in late 2025.

• Innate presented preclinical data of IPH6501 at the American Society of Clinical Oncology (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 relapsed /refractory B-cell non-hodgkin’s lymphoma (R/R NHL) patients.
• In November 2024, preclinical data demonstrating the potential of IPH6501 were published in Science Immunology.
• Innate Pharma and the Institute for Follicular Lymphoma (IFLI) entered into an agreement to clinically study the potential of IPH6501 in follicular lymphoma (FL). To support the Phase 1/2 trial and inclusion of FL patients, IFLI will initially invest 3m USD into new shares of Innate, issued through a capital increase reserved to IFLI at a price of €1.56 per share and representing 2.26% of the share capital of Innate. IFLI may also invest up to an additional 4.9m USD into new shares of Innate, depending on the completion of certain milestones, at a price to be determined at the time of the said investments.

IPH67 (proprietary)

Following termination of its license by Sanofi during the third quarter 2024, Innate regained full rights on IPH67, a NK-cell engager program in solid tumors from Innate’s ANKET^® platform under development.

SAR’579/IPH6101, SAR’514/IPH6401, IPH62 (partnered with Sanofi)

SAR’579/IPH6101

• The Phase 1/2 clinical trial by Sanofi is progressing well. 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 relapsed or refractory acute myeloid leukemia (AML), with 5 complete responses (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.

SAR’514/IPH6401

• The 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 as SAR’514/IPH6401 will now be pursued 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):

IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4.

• First preclinical data for IPH45 were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 and the Society for Immunotherapy of Cancer (SITC) 2024. In preclinical studies, IPH4502 showed anti-tumor efficacy in vivo, in Nectin-4 expressing tumors including in enfortumab vedotin refractory models.
• In September, the U.S Food and Drug Administration cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications.
• The first patient was dosed in a Phase 1 study in January 2025. The Phase 1 includes a part 1 dose escalation and a part 2 dose optimization, and 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.
• New preclinical data will be presented at the AACR Annual Meeting 2025.

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 ASCO 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.
• Quality of life data and translational analysis from the TELLOMAK trial in patients with relapsed/refractory cutaneous T-cell lymphoma were presented at the ASH Annual Meeting 2024.
• Long Term Follow up for Sezary syndrome and mycosis fungoides will be presented at an upcoming medical congress.
• During the financial quarter ending September 30, 2024, the FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, and the Company continues to align with the FDA around the confirmatory Phase 3 trial.
• 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.

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.
• 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 showing 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, 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.

Corporate Update:

• As of December 31, 2024, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.

Post period event

• In February 2025, Arvind Sood, Executive Vice President, President of U.S. Operations left the Company and resigned from his position as member of the Executive Board.

Financial highlights for 2024:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2024 are as follows:

• Cash, cash equivalents, short-term investments and financial assets amounting to €91.1 million (€m) as of December 31, 2024 (€102.3m as of December 31, 2023), including €10.3m in short-term investments (€9.8m as of December 31, 2023).
• As of December 31, 2024, financial liabilities amount to €31.0m (€39.9m as of December 31, 2023). This change is mainly due to loan repayments.
• Revenue and other income from continuing operations amounted to €20.1m in 2024 (2023: €61.6m, -67.4%). It mainly comprises revenue from collaboration and licensing agreements (€12.6m in 2024 vs €51.9m in 2023, -75.7%), and research tax credit (€7.5m in 2024 vs €9.7m in 2023, -23.3%):
  • 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. They are recognized when the entity’s performance obligation is met. Their accounting is made 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 €5.1m to €4.4m in 2024 ( €9.5m in 2023). This decrease is mainly due to the recognition of an increase in revenues in the first half of 2023. Indeed, at June 30, 2023, the Company had carried out an analysis of the cost base used to calculate the progress of Phase 1/2 trials, taking into account their progression. This analysis led to a reduction in the cost base through a re-estimation of projected expenditure. Consequently, this adjustment to the cost base had a positive impact on the percentage of completion and led to the recognition of additional revenue of 5.9 million euros for the first half of 2023, which did not recur in 2024;
    • (ii) Revenue related to the research collaboration and licensing agreement signed with Sanofi in 2022 amounted €2.1m as of December 31, 2024 (€34.7m as of December 31, 2023). 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 €25.0m in March 2023, including €18.5m for the exclusive license, €1.5m for the research work and €5.0m for the two additional targets options, for which the Company will recognize the related revenues either at the reporting date or the latest five years after the effective date. The €18.5m upfront payment relating to the exclusive license has been fully recognized in revenue since June 30, 2023. On December 19, 2023, the Company announced that Sanofi had exercised one of the two license options for a new program based on the Company’s ANKET^® platform. This decision triggered a milestone payment of €15.0m, including €13.3m for the exclusive license, fully recognized in revenue as of December 31, 2023, and €1.7m for research work to be carried out by the Company as well as the recognition in revenue of an amount of €2.5m initially received in March 2023 in connection with this option. On October 9, 2024, the company received a letter terminating the license agreement for IPH67, a NKCE program, from ANKET^® platform, currently under development in solid tumors. Termination was effective at the end of a 90 days notice period, i.e. on January 7, 2025. As a result, Innate did recover full rights to IPH67;
    • (iii) Revenue related to the license and collaboration agreement signed with Sanofi in 2016 increased by €2.0m, to €4.0m for year ended December 31, 2024, as compared to €2.0m for year ended December 31, 2023. On April 15, 2024, the Company announced the treatment of the first patient in the phase 2 dose extension of the Sanofi-led study evaluating the 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 euros, fully recognized in revenue during the first quarter of 2024 and collected by the Company on May 17, 2024. As a reminder, last year, the Company announced that, in June 2023, the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial evaluating SAR’514/IPH6401 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 since of June 30, 2023. This amount was received by the Company on July 21, 2023;
  • The research tax credit (CIR) of €7.5m of as December 31, 2024 (€9.7m for year ended December 31, 2023. The 24% decrease resulted from the eligible costs decrease.
• Operating expenses from continuing operations amounted to €71.7m in 2024 (2023: €74.3m, -3.5%):
  • General and administrative (G&A) expenses from continuing activities amounted to €19.7m in 2024 (2023: €18.3m, 7.8%). These expenses represented 25% and 27% of net operating expenses for continuing operations for the years ended December 31, 2023 and 2024 respectively. G&A expenses mainly comprise personnel costs not allocated to research and development, as well as costs of services relating to the management of the Company. The increase in this item between 2023 and 2024 results cumulatively from (i) the increase in Other income and expenses, mainly related to the financing of the 2023 R&D tax credit for €0.8m; (ii) the increase in non-scientific fees, partially offset by (iii) the decrease in personnel expenses, and (iv) the decrease in depreciation and amortization.
  • Research and development (R&D) expenses from continuing activities amounted to €52.0m in 2024 (2023: €56.0m, -7.2%). This change was mainly due to a decrease in direct research and development expenses in line with the maturity of clinical development programs and a decrease in indirect research and development expenses mainly in the fields of personnel costs and depreciation, amortization and impairment.
• A net financial income of €2.1m in 2024 (2023: €5.1m gain). The financial income has been reduced due to unfavorable fx impact.
• A net loss of €49.5m in 2024 (2023: net loss of €7.6m).

The table below summarizes the IFRS consolidated financial statements as of and for the year ended December 31, 2024, including 2023 comparative information.

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 and follow us on LinkedIn and X.

Information about Innate Pharma shares:

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 C

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