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Innate Pharma Reports Full Year 2022(1) Financial Results and Business Update Sanofi collaboration for Natural Killer cell engager therapeutics expanded to B7-H3 ANKET program and two additional targets, with 25 million

Key Takeaway: Innate Pharma (IPHA) has announced its financial results for the year ending December 31, 2022, highlighting significant advancements in its clinical pipeline. The company expanded its collaboration with Sanofi for NK Cell Engager Therapeutics, receiving a $25 million payment. Early efficacy signals for lacutamab in advanced cutaneous T cell lymphoma were released, with final results expected in late 2023. Additionally, Innate's cash position stands at $136.6 million, providing strategic support for upcoming trials and initiatives.

Market Sentiment Analysis

POSITIVE FACTORS

  • Expansion of Sanofi collaboration with $25 million payment.
  • Encouraging preliminary efficacy data for lacutamab in advanced cutaneous T cell lymphomas.
  • Strengthened cash position of $136.6 million, supporting future operations.

CONCERNS & RISKS

  • Dependence on partnerships for development and commercialization.
  • Ongoing clinical trials present inherent risks in efficacy and safety outcomes.

Full Press Release Details

Innate Pharma Reports Full Year 2022(1) Financial Results and Business Update

Sanofi collaboration for Natural Killer cell engager therapeutics expanded to B7-H3 ANKET program and two additional targets, with 25 million payment
Encouraging preliminary TELLOMAK Phase 2 efficacy data for lacutamab in advanced cutaneous T cell lymphoma in S zary syndrome and mycosis fungoides
First patient dosed in monalizumab PACIFIC-9 Phase 3 lung cancer clinical trial with $50M payment from AstraZeneca
Cash position of 136.6 million2 as of December 31, 2022 (not including the 25 million payment from Sanofi), anticipated cash runway into mid 2025
Conference call to be held today at 2:00 p.m. CET / 9:00 a.m. EDT
MARSEILLE, France--(BUSINESS WIRE)--March 23, 2023--Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today reported its consolidated financial results1 for the year ending December 31,
2022. The consolidated financial statements are attached to this press release.
"In 2022 we made important progress in our pipeline, both on our clinical and preclinical projects as well as maintaining a strong financial position. We're continuing to see encouraging efficacy signals for our proprietary program
lacutamab in advanced cutaneous T cell lymphomas. In the meantime, our innovative R&D pipeline progression was marked by the expansion of our partnership with Sanofi to develop new NK Cell Engager Therapeutics from our ANKET
platform, including solid tumors. The Sanofi collaboration is an example of how we use partnerships to build value at Innate, also underlined by our partnership with AstraZeneca for monalizumab which is in a Phase 3 trial for non-small cell
lung cancer," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "As we look to progress our pipeline in house or with partnerships, we look forward to new milestones in 2023 with important inflection points, including
final readouts from the TELLOMAK Phase 2 trial with lacutamab and further updates for our ANKET assets."
1 This press release contains financial data approved by the Executive Board based on our consolidated financial statements for the year ended December 31, 2022. The audit is in progress at the date of this communication.
2 Including short term investments ( 17.3m) and non-current financial instruments ( 35.1m).
Pipeline highlights:
Lacutamab (IPH4102, anti-KIR3DL2 antibody):
Innate continues to see progress for lacutamab with final data from the TELLOMAK Phase 2 trial for both mycosis fungoides and S zary syndrome expected in H2 2023.
In preliminary results confirming clinical activity and a favorable safety profile in patients with mycosis fungoides (MF) who were previously treated with at least two lines of systemic therapy, lacutamab produced a global objective
response rate (ORR) of 28.6% (95% confidence interval [CI]: 13.8-50.0) in the KIR3DL2-expressing MF patients (n=21), including 2 complete responses and 4 partial responses (EORTC-CLTG (European Organisation for Research and Treatment
of Cancer - Cutaneous Lymphoma Tumours Group) 2022 meeting - September 2022).
In a preliminary analysis, lacutamab demonstrated clinical activity and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced S zary syndrome. In the Intention To Treat (ITT) population (n=37),
the global ORR was 21.6% (8/37). ORR in the blood was 37.8% (95% CI: 24.1-53.9), with 21.6% (8/37) achieving complete response (CR). ORR in the skin was 35.1% (95% CI: 21.8-51.2). In the Evaluable for Efficacy (EES) population (n=35),
global objective response rate (ORR) was 22.9% (8/35). ORR in the blood was 40.0% (95% CI: 25.6-56.4) and ORR in the skin was 37.1% (95% CI: 23.2 53.7) (2022 ASH (American Society Hematology) Annual Meeting - December 2022).
Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are ongoing. Initial PTCL data are expected in H2 2023.
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL. A poster on the trial design was presented at the ESMO (European Society
for Medical Oncology) 2022 conference.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) initiated an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in
combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
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: IPH6101 (CD123-targeted), IPH6401 (BCMA-targeted), IPH62 (B7-H3-targeted) and tetra-specific IPH6501 (CD20-targeted). Several other undisclosed proprietary preclinical targets are being explored.
IPH6101, IPH6401 and IPH62 (partnered with Sanofi)
The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating IPH6101/SAR'579, the first NKp46/CD16-based CD123-targeted ANKET platform NK cell engager, in patients with relapsed or refractory acute myeloid leukemia
(AML), B-cell acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.
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.
On July 21, 2022, the Company announced that its partner Sanofi had made the decision to progress IPH6401/SAR'514, a BCMA-targeting NK cell engager into investigational new drug (IND)-enabling studies. Selection of IPH6401/SAR'514
triggered a 3M milestone payment to Innate.
As announced on December 19, 2022, Sanofi licensed IPH62, a NK cell engager program targeting B7-H3 from Innate's ANKET platform. Sanofi also have 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.
IPH6501 (proprietary)
Progress continues toward a Phase 1 clinical trial in 2023 for the proprietary CD20 targeted tetra-specific ANKET , IPH6501.
An October 2022 edition of Cell Reports Medicine described the development of Innate's fit-for-purpose ANKET antibody-based tetra-specific molecule to harness the antitumor functions of NK cells, boosting their
capacity to proliferate, to accumulate at the tumor site and to kill tumor cells.
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).
On April 29, 2022, Innate announced a $50 million milestone payment from AstraZeneca was triggered for dosing the first patient in the PACIFIC-9 Phase 3 clinical trial.
Detailed results from the randomized AstraZeneca-sponsored Phase 2 COAST clinical trial, including monalizumab data in combination with durvalumab, were published in the Journal of Clinical Oncology in April 2022. The results
were initially presented during the European Society for Medical Oncology (ESMO) Congress 2021. The results of the interim analysis showed monalizumab in combination with durvalumab reduced the risk of disease progression by 58% (improved
progression-free survival (PFS) with a hazard ratio of 0.42) and improved objective response rate (ORR) compared to durvalumab alone in patients with unresectable, Stage III NSCLC who had not progressed after concurrent CRT. The Journal of
Clinical Oncology publication includes exploratory subgroup analysis.
Partner AstraZeneca presented data from Phase 2 NeoCOAST randomized trial in resectable, early-stage NSCLC at the 2022 American Association for Cancer Research (AACR) Annual Meeting and ESMO 2022 congress. The presentations highlighted
improved disease responses with durvalumab in combination with monalizumab, oleclumab or danvatirsen, when compared to durvalumab alone. The follow-up randomized Phase 2 clinical trial, NeoCOAST-2, is enrolling patients with resectable,
stage IIA-IIIB NSCLC to receive neoadjuvant durvalumab combined with chemotherapy and either oleclumab or monalizumab, followed by surgery and adjuvant durvalumab plus oleclumab or monalizumab.
On August 1, 2022, Innate announced that a planned futility interim analysis of the Phase 3 INTERLINK-1 study sponsored by AstraZeneca did not meet a pre-defined threshold for efficacy. The Company announced that, based on the result and
the recommendation of an Independent Data Monitoring Committee, the study was to be discontinued. There were no new safety findings. AstraZeneca plan to share the data in due course. The INTERLINK-1 study evaluated monalizumab in
combination with cetuximab vs. cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
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, has started and is awaiting first patient dosed.
In August 2022 Innate received a $5 million milestone payment from AstraZeneca and will be responsible for conducting the study. AstraZeneca and Innate will share study costs and AstraZeneca will supply clinical trial drugs.
Preclinical data supporting the rationale for the Phase 2 development in NSCLC were presented at the 2022 ESMO Immuno-Oncology (IO) Annual Congress in December.
AstraZeneca conducted a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab and presented a poster entitled "IPH5201 as Monotherapy or in Combination with Durvalumab in Advanced Solid Tumours" at the
2022 ESMO IO Annual Congress in December.
IPH5301 (anti-CD73):
The investigator-sponsored CHANCES Phase 1 trial of IPH5301, in collaboration with Institut Paoli-Calmettes is ongoing. The trial will be conducted in two parts, Part 1, the dose escalation, followed by a Part 2 safety expansion study
cohort. Part 2 will evaluate IPH5301 in combination with chemotherapy and trastuzumab in HER2+ cancer patients. The design of the Phase 1 study was highlighted at the 2022 ESMO IO congress in December.
Avdoralimab (anti-C5aR1):
The Company has decided to discontinue the development of avdoralimab in bullous pemphigoid. The Company will continue to evaluate out-licensing as a potential next step.
Fueling the 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.
During the period, the Company received from AstraZeneca a notice that it will not exercise its option to license the four preclinical programs covered in the "Future Programs Option Agreement". This option agreement was part 2018
multi-term agreement between AstraZeneca and Innate. Innate regained full rights to further develop the four preclinical molecules.
On May 3, 2022 Innate announced the commencement 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, 2022, the balance available under our May 2022 sales agreement remains at $75 million.
Dr Sally Bennett was appointed as new member of the Supervisory Board in May 2022. She was appointed as a member of the Audit Committee. On the same date it was announced that Mr Patrick Langlois decided to resign from his mandate of
Supervisory Board member of Innate Pharma.
In January 2023, Mrs Claire de Saint Blanquat, Vice President Legal and Corporate Affairs, and Mr Henry Wheeler, Vice President Investor Relations and Communications, were appointed to the Leadership Team.
Financial highlights for 2022:
The key elements of Innate's financial position and financial results as of and for the year ended December 31, 2022 are as follows:
Cash, cash equivalents, short-term investments and financial assets amounting to 136.6 million ( m) as of December 31, 2022 ( 159.7m as of December 31, 2021), including financial instruments amounting to 35.1m ( 39.9m as of December
31, 2021). Cash, cash equivalents as of December 31, 2022 do not include the 25.0 million payment received from Sanofi in March 2023.
As of December 31, 2022, financial liabilities amount to 42.3m ( 44.3m as of December 31, 2021). In August 2022, the Company obtained an extension for a period of five year (starting in 2022) with a one-year grace period (2023) of its
State-Guaranted Loans (Pr ts Garantis par l'Etat "PGE") from Soci t G n rale ( 20.0m) and BNP Paribas ( 8.7m).
Revenue and other income from continuing operations amounted to 57.7m in 2022 (2021: 24.7m). It mainly comprises revenue from collaboration and licensing agreements ( 49.6m in 2022 vs 12.1m in 2021), and research tax credit ( 7.9m in
2022 vs 10.3m in 2021, -23.1%):
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 and Sanofi and which are recognized on the basis
of the percentage of completion of the works performed by the Company under such agreements:
(i) Revenue from collaboration and licensing agreements for monalizumab increased by 14.9m to 22.4m in 2022 ( 7.5m in 2021). This change mainly results from the transaction price increase of 13.4m ($14.0m) triggered by the
launch of the "PACIFIC-9" Phase 3 trial announced on April 29, 2022. This change in the transaction price generated a 12.6 million favorable cumulative adjustment in the revenue related to monalizumab agreements for the first half
of 2022, partially offset by effects of the decrease in direct monalizumab research and development costs over the period as compared to the first half of 2021, in connection with the Phase 1 & 2 trials maturity;
(ii) Revenue related to IPH5201 for the year ended 2022 amounted to 4.7m and results from the entire recognition in revenue of the $5.0m milestone payment received in August 2022 from AstraZeneca following the signature on June
1, 2022 of an amendment to the initial contract signed in October 2018. This amendment sets the terms of the collaboration following AstraZeneca's decision to advance IPH5201 to a Phase 2 study;
(iii) During 2022 first semester, the Company received from AstraZeneca a notice that it will not exercise its option to license the four preclinical programs covered in the "Future Programs Option Agreement". This option
agreement was part of the 2018 multi-term agreement between AstraZeneca and the Company under which the Company received an upfront payment of $20.0m ( 17.4m). Innate has now regained full rights to further develop the four
preclinical molecules. Consequently, the entire initial payment of $20.0m, or 17.4m was recognized as revenue in 2022.
(iv) During 2022 first semester, the Company was informed of Sanofi's decision to advance IPH6401/SAR'514 into investigational new drug (IND)-enabling studies. As such, Sanofi has selected a second multispecific antibody engaging
NK cells as a drug candidate. This selection triggered a 3.0m milestone payment from Sanofi. This amount was received by the Company on September 9, 2022.
The variation in the research tax credit mainly results from a decrease in the amortization for the intangible assets related to acquired licenses (monalizumab and IPH5201) and to the decrease in personnel expenses allocated to
research and development operations. In addition, there was a decrease in public subcontracting included in the calculation of the CIR. This decrease is the consequence of the end of the doubling of public subcontracting expenses

Frequently Asked Questions

What was Innate Pharma's cash position at the end of 2022?

Innate Pharma reported a cash position of €136.6 million as of December 31, 2022.

What clinical trial involves lacutamab for T cell lymphomas?

Lacutamab is being evaluated in the TELLOMAK Phase 2 trial for advanced cutaneous T cell lymphomas.

What milestone did AstraZeneca trigger for Innate Pharma?

AstraZeneca triggered a $50 million milestone payment by dosing the first patient in the PACIFIC-9 trial.

What does the ANKET platform focus on?

The ANKET platform focuses on developing multi-specific NK cell engagers for cancer treatment.

What is the objective of the PACIFIC-9 clinical trial?

The PACIFIC-9 trial aims to evaluate monalizumab combined with durvalumab in NSCLC patients.

Last updated: Mar 23, 2023