On March 21, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2023 (Press release, Innate Pharma, MAR 21, 2024, View Source [SID1234641366]). The consolidated financial statements are attached to this press release.
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"We ended 2023 with a cash runway to the end of 2025 and achieved significant milestones in advancing our pipeline," said Hervé Brailly, Chief Executive Officer ad interim of Innate Pharma. "We reported positive data with lacutamab in Sézary syndrome, began Phase 1 testing of our proprietary, second-generation ANKET IPH6501 and secured further validation of our ANKET platform with Sanofi having licensed four ANKET candidates for hematologic malignancies and solid tumors. The Phase 3 trial for monalizumab in non-small lung cancer that is being led by Astra Zeneca continues to advance. Looking ahead to 2024, we expect notable milestones including final results from the TELLOMAK Phase 2 trial with lacutamab in mycosis fungoides, and progressing our first proprietary ADC program, IPH45 towards an IND filing."
Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody):
Cutaneous T Cell lymphoma
Innate reported positive final data from the Phase 2 TELLOMAK study in Sézary syndrome at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Congress. Data demonstrate that lacutamab showed robust clinical activity and an overall favorable safety profile. In this heavily pre-treated population, post-mogamulizumab, with a median of five prior lines of therapy, the global confirmed objective response rate (ORR) was 37.5% (21/56). Confirmed ORR in the skin was 46.4% (26/56) and confirmed ORR in the blood was 48.2% (27/56). Median progression-free survival was 8.0 months (95% confidence interval [CI] 4.7-21.2).
In 2023, Innate reported interim data with lacutamab in mycosis fungoides (MF) patients at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting (September 2023) and the 17th International Conference on Malignant Lymphoma (June 2023). The interim data set confirmed clinical activity and favorable safety profile of lacutamab in line with the Phase 1 data.
The top-line results in MF patients are currently being analyzed and Innate intends to present the data in 2024 at a medical conference.
In January 2024, Innate announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold previously placed on the lacutamab IND on October 2023 following a patient death in the TELLOMAK study. The FDA decision to lift the partial clinical hold is based on the FDA review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated.
Peripheral T Cell lymphoma (PTCL)
Despite objective responses observed, the Company-sponsored Phase 1b clinical trial evaluating lacutamab as monotherapy in patients with KIR3DL2-expressing refractory/relapsing PTCL will not be reopened to recruitment as the prespecified threshold for meaningful clinical activity was not reached.
At the ASH (Free ASH Whitepaper) Annual Congress 2023, Innate presented a poster with preclinical data demonstrating a synergistic effect between lacutamab and chemotherapy in preclinical models of PTCL, supporting the rationale for combination strategy in this clinical indication.
The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized 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.
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 (SAR’579/IPH6101) (CD123-targeted), SAR445514 (SAR’514/IPH6401) (BCMA-targeted), IPH62 (B7-H3-targeted), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (CD20-targeted with IL-2v). Several other undisclosed proprietary preclinical targets are being explored.
SAR’579, SAR’514, IPH62 and IPH67 (partnered with Sanofi)
SAR443579/IPH6101
The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 NK cell engager and ANKET platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).
At the ASH (Free ASH Whitepaper) Annual Congress 2023, Sanofi reported updated efficacy and safety results and data across all dose levels tested for SAR443579. As of October 23, 2023, 43 patients (42 R/R AML and 1 HR-MDS) across 8 Dose Levels (DLs) at 10 – 6000 μg/kg/dose were included. Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoietic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. In DLs with a highest dose of 1000 μg/kg QW, 5/15 AML (33.3%) patients achieved a CR (4 CR / 1 CRi) as of the cut-off date. As of the data cut-off on October 23, 2023, two responders remain in remission after more than 12 and 14 months of treatment. SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML. The results are consistent with the predicted favorable safety profile.
Preliminary Pharmacokinetics (PK) and Pharmacodynamic (PD) Analysis of the CD123 NK Cell Engager SAR’579/IPH6101 in patients with relapsed or refractory AML, B-ALL or HR-MDS were presented during the ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) Congress 2023.
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR’579 / IPH6101 for the treatment of acute myeloid leukemia.
SAR’514/IPH6401
The Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, led by Sanofi, in patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis is ongoing.
IPH62
As announced on December 19, 2022, Sanofi licensed IPH62, a NK cell engager program targeting B7-H3 from Innate’s ANKET platform. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Under the terms of the research collaboration and license agreement signed in December 2022, Innate received a €25m upfront payment and is eligible for up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.
IPH67
In December 2023, Sanofi exercised its option to license a NK cell engager program in solid tumors from Innate’s ANKET platform pursuant to the terms of the research collaboration and license agreement signed in December 2022. Following a research collaboration period, Sanofi will be responsible for all development, manufacturing and commercialization. Sanofi still retains the option to one additional ANKET target. Innate received a €15m payment as option exercise.
IPH6501 (proprietary)
In March 2024 the first patient was dosed in the Phase 1/2 clinical trial evaluating IPH6501, Innate’s proprietary CD20-targeted IL-2v bearing second-generation ANKET in B cell Non-Hodgkin’s lymphoma (B-NHL). The study is ongoing and planned to enroll up to 184 patients.
Innate presented preclinical data on IPH6501 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 congress. In preclinical settings, IPH6501 was shown to induce NK cell proliferation and to trigger high NK cell cytotoxicity against CD20+ target cells in in vitro assays, in ex vivo assays with relapse/refractory (R/R) B-NHL patient samples who received at least one prior treatment, as well as in in vivo studies in non-human primates. A surrogate of IPH6501 mediated a potent anti-tumor activity in vivo in CD20+ tumor models in mice. In addition, in ex vivo assays with R/R B-NHL patient samples, IPH6501 was shown to be more efficient than a T-cell engager targeting CD20.
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.
IPH5201 (anti-CD39), partnered with AstraZeneca:
The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track.
IPH5301 (anti-CD73):
The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing.
Antibody Drug Conjugates:
Fueling its R&D pipeline, Innate continues to develop different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET platform and exploring Antibody Drug Conjugates (ADC) formats. Beyond its proprietary programs, Innate has an ongoing agreement with Takeda on ADCs.
IPH45 (Nectin-4 ADC):
IPH45 is Innate’s proprietary Nectin-4 targeting antibody drug conjugate including a Topoisomerase I inhibitor payload. IPH45 continues towards IND filing this year.
Innate will share first preclinical data with IPH45 in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024.
Takeda license agreement:
In April 2023, Innate 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. Under the terms of the license agreement, Innate received a $5m upfront payment and is eligible to receive up to $410m in future development, regulatory and commercial milestones if all milestones are achieved during the term of the agreement, plus royalties on potential net sales of any commercial product resulting from the license.
Corporate Update:
On April 26, 2023, Innate announced the establishment of an At-The-Market (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 American Depositary Shares ("ADS"). Each ADS representing one ordinary share of Innate. As of December 31, 2023, the balance available under our April 2023 sales agreement remains at $75 million.
Dr. Sonia Quaratino, MD, PhD, has been appointed as Executive Vice President and Chief Medical Officer of Innate Pharma, effective October 2023.
On December 18, 2023, Innate announced that Mondher Mahjoubi has resigned from his position as Chief Executive Officer (CEO) and Chairman of the Executive Board of the Company, effective as of January 2024. Hervé Brailly, Innate Pharma’s Chairman of the Supervisory Board, former CEO and co-founder was appointed as interim CEO and Chairman of the Executive Board while a permanent successor is sought.
Irina Staatz-Granzer, who has been Vice-Chairwoman of the Supervisory Board for several years was appointed Chairwoman of the Supervisory Board.
Post period event
Early January 2024, Innate announced that it has strengthened the Company’s leadership and corporate governance with the appointment of two new Executive Board members. Arvind Sood, Executive Vice President (EVP), President of US Operations, Dr Sonia Quaratino, EVP, Chief Medical Officer, joining Hervé Brailly, interim Chief Executive Officer and Yannis Morel, EVP, appointed Chief Operating Officer.
Innate announced that Arvind Sood had joined the Company in a newly created position of Executive Vice President and President of US Operations.
Financial highlights for 2023:
The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2023 are as follows:
Cash, cash equivalents, short-term investments and financial assets amounting to €102.3 million (€m) as of December 31, 2023 (€136.6m as of December 31, 2022), including financial instruments amounting to €9.8m (€35.1m as of December 31, 2022). Cash, cash equivalents as of December 31, 2023 do not include the €15.0 million payment made by Sanofi following the exercise of the license option announced in December 2023. This amount was received by the Company in January 2024.
As of December 31, 2023, financial liabilities amount to €39.9m (€42.3m as of December 31, 2022). This change is mainly due to loan repayments.
Revenue and other income from continuing operations amounted to €61.6m in 2023 (2022: €57.7m, +6.9%). It mainly comprises revenue from collaboration and licensing agreements (€51.9m in 2023 vs €49.6m in 2022, +4.7%), and research tax credit (€9.7m in 2023 vs €7.9m in 2022, +22.8%):
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 results 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. 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 €12.9m to €9.5m in 2023 ( €22.4m in 2022). This change mainly results from the transaction price increase of €13.4m ($14.0m), in the first half of 2022, triggered by the launch of the "PACIFIC-9" Phase 3 trial announced on April 29, 2022. As a reminder, this increase in the transaction price generated a €12.6 million favorable cumulative adjustment in the revenue related to monalizumab agreements as of December 31,2022;
(ii) Revenue related to the research collaboration and licensing agreement signed with Sanofi in 2022 amounted €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 three 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;
(iii) Revenue related to the license and collaboration agreement signed with Sanofi in 2016 decreased by €2.0m, to €2.0m for year ended December 31, 2023, as compared to €4.0m for year ended December 31, 2022. 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. As a reminder, the revenue recognized 2022 mainly resulted from Sanofi’s decision to advance SAR’514/IPH6401 into investigational new drug (IND)- enabling studies. This decision triggered a €3.0 million milestone payment from Sanofi to the Company, fully recognized in revenue as of June 30, 2022;
(iv) Revenue related to the licensing agreement signed with Takeda in 2023 amounted €4.6m for year ended December 31, 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 $5.0m (or €4.6m) initial payment, received by the Company in May 2023, was fully recognized in revenue since June 30, 2023.
The research tax credit (CIR) of €9.7m of as December 31, 2023 (€7.9m for year ended December 31 December, 2022, including 2022 fiscal year CIR for an amount of €9.2 million reduced by €1.3 million related to a provision following the tax inspection carried out in 2022 by the French tax authorities).
Operating expenses from continuing operations and before impairment amounted to €74.3m in 2023 (2022: €74.1m, +0.3%):
General and administrative (G&A) expenses from continuing activities amounted to €18.3m in 2023 (2022: €22.4m, -18.5%). This variation results cumulatively from (i) a reduction in personnel expenses, (ii) a reduction in non-scientific fees, (iii) the pursuit of cost savings (reduction in office space), (iv) a reclassification of expenses relating to the support of R&D laboratory activities (maintenance, depreciation of R&D equipment) in the amount of €1.0 million.
Research and development (R&D) expenses from continuing activities amounted to €56.0m in 2023 (2022: €51.7m, +8.4%). This change was mainly due to an increase in direct research and development expenses, notably for non-clinical development programs, partially offset by a decrease in expenses for clinical programs over the period. Indirect research and development expenses increased, mainly in the fields of personnel costs and depreciation, amortization and impairment.
As a reminder, as of December 31, 2022, the Company recognized the full impairment of the avdoralimab intangible asset (anti-C5aR rights) for an amount of €41,0m (non-cash expense) following the Company’s decision to stop avdoralimab development in bullous pemphigoid indication in inflammation.
A net financial income of €5.1m in 2023 (2022: €0.5m loss).
Net income from Lumoxiti discontinued operations are nil for year ended December 31, 2023 as compared to a net loss of €0.1m for year ended December 31, 2022 corresponding to residual costs associated with the transfer of activities to AstraZeneca. This transfer has now been completed.
A net loss of €7.6m in 2023 (2022: net loss of €58.1m).
The table below summarizes the IFRS consolidated financial statements as of and for the year ended December 31, 2023, including 2022 comparative information.
In thousands of euros, except for data per share
December 31, 2023
December 31, 2022
Revenue and other income
61,641
57,674
Research and development
(56,022)
(51,663)
Selling, general and administrative
(18,288)
(22,436)
Total operating expenses
(74,310)
(74,099)
Operating income (loss) before impairment
(12,669)
(57,425)
Impairment of intangible asset
—
(41,000)
Operating income (loss) after impairment
(12,669)
(57,425)
Net financial income (loss)
5,099
(546)
Income tax expense
—
—
Net income (loss) from continuing operations
(7,570)
(57,972)
Net income (loss) from discontinued operations
—
(131)
Net income (loss)
(7,570)
(58,103)
Weighted average number of shares outstanding (in thousands)
80,453
79,640
Basic income (loss) per share
(0.09)
(0.73)
Diluted income (loss) per share
(0.09)
(0.73)
Basic income (loss) per share from continuing operations
(0.09)
(0.73)
Diluted income (loss) per share from continuing operations
(0.09)
(0.73)
Basic income (loss) per share from discontinued operations
—
—
Diluted income (loss) per share from discontinued operations
—
—
December 31, 2023
December 31, 2021
Cash, cash equivalents and financial asset
102,252
136,604
Total assets
184,193
207,863
Shareholders’ equity
51,901
54,151
Total financial debt
39,893
42,251