- Phase 1/2 dose escalation safety and preliminary efficacy of ANKET® NK cell engager, SAR’579/IPH6101, developed by Sanofi, showed it was well tolerated with observed clinical benefit in patients with R/R AML (ASCO 2023 annual meeting), FDA Fast Track Designation awarded
- Exclusive worldwide rights granted to Takeda to research and develop antibody drug conjugates (ADC) using a panel of selected Innate antibodies; $5m upfront payment to Innate and up to $410m in future milestones plus royalties
- Proprietary ANKET® IPH65 IND approved, progressing to Phase 1
- Proprietary IPH45 ADC target, nectin-4 disclosed
- Innate announces new Chief Medical Officer, Sonia Quaratino
- Cash position of €124.7 million1 as of June 30, 2023, anticipated cash runway into H2 2025
- Conference call to be held today at 2:00 p.m. CEST / 8:00 a.m. EDT
MARSEILLE, France–(BUSINESS WIRE)–#ANKET–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, 2023. The consolidated financial statements are attached to this press release.
“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 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 Quaratino 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.”
|
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/859850812
Participants may also join via telephone by registering in advance of the event at https://registrations.events/direct/Q4E60903
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 Including short term investments (€17.5 million) and non-current financial instruments (€35.8 million) |
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 (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) 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) 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 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).
-
Monalizumab was highlighted in two “Trial in progress” posters at the ASCO 2023 Annual Meeting in June:
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).
-
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:
-
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.
|
In thousands of euros, except for data per share |
June 30, 2023 |
June 30, 2022 |
||
|
Revenue and other income |
40,198 |
45,589 |
||
|
Research and development expenses |
(31,453) |
(24,956) |
||
|
General and administrative expenses |
(9,144) |
(12,140) |
||
|
Operating expenses |
(40,597) |
(37,096) |
||
|
Operating income (loss) |
(398) |
8,494 |
||
|
Net financial income (loss) |
2,116 |
(2,118) |
||
|
Income tax expense |
— |
— |
||
|
Net income (loss) from continuing operations |
1,718 |
6,376 |
||
|
Net income (loss) from discontinued operations |
— |
(73) |
||
|
Net income (loss) |
1,718 |
6,303 |
||
|
Weighted average number of shares ( in thousands) : |
80,320 |
79,754 |
||
|
– Basic income (loss) per share |
0.02 |
0.08 |
||
|
– Diluted income (loss) per share |
0.02 |
0.08 |
||
|
– Basic income (loss) per share from continuing operations |
0.02 |
0.08 |
||
|
– Diluted income (loss) per share from continuing operations |
0.02 |
0.08 |
||
|
– Basic income (loss) per share from discontinued operations |
— |
— |
||
|
– Diluted income (loss) per share from discontinued operations |
— |
— |
|
|
June 30, 2023 |
December 31, 2022 |
||
|
Cash, cash equivalents and financial assets |
124,679 |
136,604 |
||
|
Total assets |
199,049 |
207,863 |
||
|
Total shareholders’ equity |
57,863 |
54,151 |
||
|
Total financial debt |
40,658 |
42,251 |
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 Ticker code LEI |
FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 |
Disclaimer on forward-looking information and risk factors:
This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” 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 commercialization efforts, 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, 2022, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.
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, 2023
|
Interim Condensed Consolidated Statements of Financial Position (in thousand euros)
|
||||||
|
|
June 30, 2023 |
December 31, 2022 |
||||
|
Assets |
|
|
||||
|
|
|
|
||||
|
Current assets |
|
|
||||
|
Cash and cash equivalents |
71,414 |
|
84,225 |
|
||
|
Short-term investments |
17,475 |
|
17,260 |
|
||
|
Trade receivables and others |
55,566 |
|
38,346 |
|
||
|
Total current assets |
144,455 |
|
139,831 |
|
||
|
|
|
|
||||
|
Non-current assets |
|
|
||||
|
Intangible assets |
903 |
|
1,556 |
|
||
|
Property and equipment |
7,262 |
|
8,542 |
|
||
|
Non-current financial assets |
35,790 |
|
35,119 |
|
||
|
Other non-current assets |
86 |
|
149 |
|
||
|
Trade receivables and others – non-current |
880 |
|
14,099 |
|
||
|
Deferred tax asset |
9,674 |
|
8,568 |
|
||
|
Total non-current assets |
54,594 |
|
68,033 |
|
||
|
|
|
|
||||
|
Total assets |
199,049 |
|
207,863 |
|
||
|
Liabilities |
|
|
||||
|
|
|
|
||||
|
Current liabilities |
|
|
||||
|
Trade payables and others |
18,991 |
|
20,911 |
|
||
|
Collaboration liabilities – current portion |
6,538 |
|
10,223 |
|
||
|
Financial liabilities – current portion |
5,335 |
|
2,102 |
|
||
|
Deferred revenue – current portion |
5,050 |
|
6,560 |
|
||
|
Provisions – current portion |
1,753 |
|
1,542 |
|
||
|
Total current liabilities |
37,667 |
|
41,338 |
|
||
|
|
|
|
||||
|
Non-current liabilities |
|
|
||||
|
Collaboration liabilities – non-current portion |
49,520 |
|
52,988 |
|
||
|
Financial liabilities – non-current portion |
35,323 |
|
40,149 |
|
||
|
Defined benefit obligations |
2,532 |
|
2,550 |
|
||
|
Deferred revenue – non-current portion |
5,974 |
|
7,921 |
|
||
|
Provisions – non-current portion |
494 |
|
198 |
|
||
|
Deferred tax liabilities |
9,674 |
|
8,568 |
|
||
|
Total non-current liabilities |
103,518 |
|
112,374 |
|
||
|
|
|
|
||||
|
Shareholders’ equity |
|
|
||||
|
Share capital |
4,027 |
|
4,011 |
|
||
|
Share premium |
381,371 |
|
379,637 |
|
||
|
Retained earnings |
(330,315 |
) |
(272,213 |
) |
||
|
Other reserves |
1,064 |
|
819 |
|
||
|
Net income (loss) |
1,718 |
|
(58,103 |
) |
||
|
Total shareholders’ equity |
57,863 |
|
54,151 |
|
||
|
|
|
|
||||
|
Total liabilities and shareholders’ equity |
199,049 |
|
207,863 |
|
||
Contacts
For additional information, please contact:
Investors
Innate Pharma
Henry Wheeler
Tel.: +33 (0)4 84 90 32 88
Henry.Wheeler@innate-pharma.fr
Media Relations
NewCap
Arthur Rouille
Tel. : +33 (0)1 44 71 00 15
innate@newcap.eu