On September 14, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the six months ended June 30, 2023 (Press release, Innate Pharma, SEP 14, 2023, View Source [SID1234635163]). The consolidated financial statements are attached to this press release.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Based on our strong financial position, we continue momentum with our clinical pipeline and were encouraged by the clinical data from our first ANKET NK cell engager, SAR’579/IPH6101 – in partnership with Sanofi presented at the ASCO (Free ASCO Whitepaper) 2023 annual meeting. We look forward to further data readouts in the future from this and other exciting pipeline projects including on our ADC pipeline, where we signed a partnership earlier this year with Takeda. Importantly, already in the second half of this year, we expect to report final results from our Phase 2 TELLOMAK trial with lacutamab," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We have also continued to strengthen the team at Innate and it is with great pleasure that we welcome Dr Sonia Quarantino as Chief Medical Officer. She has outstanding international industry experience in clinical development, including in senior roles at leading global pharmaceutical companies. I would like to thank outgoing Joyson Karakunnel for his great work in building/shaping the pipeline and the R&D team during the past years at Innate and wish him well in his future endeavors."
Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody):
•Innate continues to see progress for lacutamab with final data from the TELLOMAK Phase 2 trial for both mycosis fungoides and Sézary syndrome expected in H2 2023.
•In June 2023, interim efficacy results from the TELLOMAK Phase 2 study in advanced mycosis fungoides (MF) according to updated lymph node classification were presented at the 17th International Conference on Malignant Lymphoma, in Lugano, Switzerland. Results confirm clinical activity and favorable safety profile of lacutamab. Results showed that lacutamab produced an increased global objective response rate (ORR) of 42.9% (95% confidence interval [CI], 24.5-63.5) in patients with KIR3DL2 ≥ 1% MF (cohort 2, n=21), including 2 complete responses and 7 partial responses.
•Initial PTCL data are expected in H2 2023. Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are 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 four public drug candidates born from the ANKET platform: SAR’579 / IPH6101 (CD123-targeted), SAR’514 / IPH6401 (BCMA-targeted), IPH62 (B7-H3-targeted) and tetra-specific IPH65 (CD20-targeted). Several other undisclosed proprietary preclinical targets are being explored.
SAR’579 / IPH6101, SAR’514 / IPH6401 and IPH62 (partnered with 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).
◦Phase 1/2 dose escalation safety and preliminary efficacy of SAR’579 / IPH6101 in R/R AML, B-ALL and HR-MDS were presented during an oral presentation at the ASCO (Free ASCO Whitepaper) (American Society for Clinical Oncology) 2023 Annual Meeting in June. Preliminary data showed SAR’579 / IPH6101 was well tolerated and induced 3 complete responses in the 8 patients at 1 mg/kg as highest dose.
◦In June, SAR’579 / IPH6101 received U.S. Food and Drug Administration (FDA) Fast Track Designation for the treatment of hematological malignancies.
◦Preclinical data showing the control of AML cells by a trifunctional NKp46-CD16a-NK cell engager targeting CD123 were published in Nature Biotechnology in January 2023.
SAR’514 / IPH6401
•In July 2023, partner Sanofi advanced SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, to first-in-human clinical trial in Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
◦Our partner presented preclinical data showing SAR’514 / IPH6401 has potent in-vitro, in-vivo and ex-vivo anti-myeloma effect through dual NK cell engagement in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 in April.
IPH62
•As announced on December 19, 2022, Sanofi licensed IPH62, a NK cell engager program targeting B7-H3 from Innate’s ANKET platform, and the company has the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Under the terms of the agreement, 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.
IPH65 (proprietary)
•Following approval of the IND-filing by the FDA in July 2023, IPH65, Innate’s proprietary CD20 targeted tetra-specific ANKET continues toward a Phase 1 clinical trial in 2023.
◦Updated preclinical data on IPH65 were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 congress in June.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
•Innate continues to see progress for monalizumab in the early non-small cell lung cancer (NSCLC) setting, with the ongoing Phase 3 PACIFIC-9 study run by AstraZeneca. The study is evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT).
◦Monalizumab was highlighted in two "Trial in progress" posters at the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting in June:
▪Phase 3 study of durvalumab combined with oleclumab or monalizumab in patients with unresectable stage III NSCLC (PACIFIC-9).
▪NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC).
IPH5201 (anti-CD39), partnered with AstraZeneca:
•In June 2023, the first patient was dosed in 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.
IPH5301 (anti-CD73):
•The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.
Antibody Drug Conjugates:
•Fueling its R&D engine, the Company 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 continuing to explore Antibody Drug Conjugates (ADC) formats.
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.
IPH45 (nectin-4 ADC):
◦Innate’s proprietary nectin-4 targeted antibody drug conjugate, IPH45 continues toward a Phase 1 clinical trial.
Corporate Update:
•On April 26, Innate announced the establishment of a new 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.
•Dr. Sonia Quaratino, MD, PhD, will join Innate Pharma as Executive Vice President and Chief Medical Officer, effective October 2023. Dr. Sonia Quaratino succeeds to Dr. Karakunnel who is leaving the Company to pursue other challenges. Dr. Quaratino brings over 25 years of experience in basic research, clinical development, and translational medicine, having worked in academia, global large pharmaceuticals, and biotechs. Recently, Dr. Quaratino was Chief Medical Officer at Georgiamune INC.(USA) and prior to that she was Chief Medical Officer at Kymab (UK), a clinical-stage biopharmaceutical company with a focus on immune-mediated diseases and immuno-oncology, acquired by Sanofi in 2021. Previously, she held roles at Novartis (Switzerland) and Merck Serono (Germany), and was Professor of Immunology in UK at the University of Southampton. Her research has been published in high impact scientific journals.
Financial highlights for the first half of 2023:
The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2023 are as follows:
•Cash, cash equivalents, short-term investments and financial assets amounting to €124.7 million (€m) as of June 30, 2023 (€136.6m as of December 31, 2022).
•Revenue and other income from continuing operations amounted to €40.2m in the first half of 2023 (€45.6m in the first half of 2022) and mainly comprise 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 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 €6.9m to €9.5m in the first half of 2023 (€16.4m in the first half of 2022). This change mainly results from the transaction price increase of €13.4 million ($14.0 million) in the first half of 2022, triggered by the launch of the "PACIFIC-9" Phase 3 trial on April 28, 2022. As a reminder, this increase in the transaction price led to the recognition of an additional revenue of €12.5 million for the first half of 2022. However, this decrease is partially offset by an increase in monalizumab-related revenues for the first half of 2023, in line with the progress of Phase 1/2 trials over the period.
▪(ii) Revenue related to the license and collaboration agreement signed with Sanofi in 2016 decreased by €1.0m, to €2.0m for the six months ended June 30, 2023, as compared to €3.0m for the six months ended June 30, 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 as of June 30, 2023. This amount was received by the Company on July 21, 2023. As a reminder, the revenue recognized in the first half of 2022 resulted from Sanofi’s decision to advance SAR’514/IPH6401 into investigational new drug (IND)-enabling studies. As such, Sanofi had selected a second multispecific antibody engaging NK cells as a drug candidate. This selection triggered a €3.0 million milestone payment from Sanofi to the Company, fully recognized in revenue as of June 30, 2022.
▪(iii) Revenue of €18.7 million related to the research collaboration and licensing agreement signed with Sanofi in 2022. 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 work and €5.0 million for the two additional targets options. The €18.5 million upfront payment relating to the exclusive license has been fully recognized in revenue as of June 30, 2023. The €1.5 million upfront payment will be recognized on a straight-line basis over the duration of the research work that the Company has agreed to carry out. The €5.0 million initial payment relating to the options is recognized in deferred revenue—non-current portion as of June 30, 2023. The Company will recognize the related revenues either at the reporting date or three years after the effective date.
▪(iv) Revenue of €4.6m related to the licensing agreement signed with Takeda in 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 €4.9m in the first half of 2023 (€4.3m in the first half of 2022).
•Operating expenses from continuing operations are €40.6m in the first half of 2023 (€37.1m in the first half of 2022), of which 77.5% (€31.5m) are related to R&D.
◦R&D expenses from continuing operations increased by €6.5m to €31.5m in the first half of 2023 (€25.0m in the first half of 2022). This change mainly results from (i) a €4.9m increase in direct R&D expenses relating to €4.8m non-clinical program in the Antibody Drug Conjugates (ADC) field and a slight increase of clinical programs of €0.1m; (ii) Personnel expenses and other R&D expenses increased by €1.6m (12.9%) to reach €14.2m in the first half 2023 compared to €12.6m in the first half 2022. This increase is mainly explained by €2.0m amortization for the rights relating to IPH5201 following the first patient dosed in the Phase 2 MATISSE clinical trial. The amortization of rights related to the monalizumab decreased by €0.3m.
◦General and administrative (G&A) expenses from continuing operations decreased by €3.0m to €9.1m in the first half of 2023 (€12.1m in the first half of 2022) mainly resulting from ((i) a €1.4m decrease of personnel expenses mainly due to a reduction of administrative workforce, (ii) a €0.6m decrease on non-scientific advisory and consulting fees (limited use of recruitment agencies and strategic consulting), and finally (iii) a decrease on other expenses for €1.0m mainly related to a decrease on leasing and maintenance for €0.5m to the benefit of research and development enabling a more consistent allocation of support expenses to the company’s research laboratory as well as a reduction of 0.2 million following more limited use of external communication and investor relations service providers.
•Net income from discontinued operations related to Lumoxiti are nil compared to a net loss of €0.1 million for the first half of 2022 corresponding to residual costs associated with the transfer of activities to AstraZeneca. This transfer has now been completed.
•A net financial gain of €2.1m in the first half of 2023 (net financial loss of €2.1m in the first half of 2022), principally as a result of the increase in fair value of certain of our financial instruments and net foreign exchange gain over the period.
•A net income of €1.7m for the first half of 2023 (net income of €6.3m for the first half of 2022).
The table below summarizes the IFRS consolidated financial statements as of and for the six months ended June 30, 2023, including 2022 comparative information.