- First data set from lacutamab TELLOMAK trial demonstrated encouraging 35% overall global response rate, including skin improvement in patients with mycosis fungoides that express KIR3DL2
- New pre-clinical data presented from next-generation NK cell engager platform, ANKET™, highlighted robust anti-tumor efficacy across several in vivo tumor models and manageable safety profile
- Cash position of €159.4 million1 as of
June 30, 2021 - Conference call to be held today at
2:00 p.m. CEST /8:00 a.m. EDT
“In the first half of 2021, we had two key advancements in our portfolio – encouraging new lacutamab data in a subtype of cutaneous T-cell lymphoma, mycosis fungoides, and new data from our proprietary, multi-specific NK cell engager platform, ANKET™. These progressions have set the stage for delivering both near and long-term value, while also highlighting the strength and depth of our core R&D efforts,” said
Webcast and conference call will be held today at Access to live webcast: https://edge.media-server.com/mmc/p/bi2jkpjr Participants may also join via telephone by registering in advance of the event at http://emea.directeventreg.com/registration/3774818. Upon registration, participants will be provided with dial-in numbers, a direct event passcode and a unique registrant ID that they may use 10 minutes prior to the event start to access the call. This information can also be found on the Investors section of the A replay of the webcast will be available on the Company website for 90 days following the event. |
Financial highlights for the first half of 2021:
The key elements of Innate’s financial position and financial results as of and for the six-month period ended
- Cash, cash equivalents, short-term investments and financial assets amounting to €159.4 million (€m) as of
June 30, 2021 (€190.6m as ofDecember 31 , 2020). - Revenue and other income amounted to €15.7m in the first half of 2021 (€36.7m in the first half of 2020) 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 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 decreased by €13.5m to €6.1m in the first half of 2021 (€19.6m in the first half of 2020), due to lower costs in connection with the collaboration works performed relating to the trials’ maturity;
- (ii) Revenue from collaboration and licensing agreements for IPH5201 are nil for the first half of 2021 (€8.7m in the first half of 2020), due to the Company having fulfilled all of its commitments on preclinical work related to the start of Phase 1 of the IPH5201 program as of
December 31, 2020 . - Revenue from invoicing of research and development (R&D) costs for avdoralimab (IPH5401) and IPH5201 are €1.2m the first half of 2021 (€1.1m in the first half of 2020), or an increase of €0.1m, or 11%, between the first half of 2020 and the first half of 2021.
- Government funding for research expenditures of €6.4m in the first half of 2021 (€6.9m in the first half of 2020).
- 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:
- Operating expenses are €41.1m in the first half of 2021 (€46.0m in the first half of 2020), of which 53.0% (€21.8m) are related to R&D.
- R&D expenses decreased by €9.7m to €21.8m in the first half of 2021 (€31.5m in the first half of 2020). This change mainly results from a decrease in depreciation and amortization expenses allocated to R&D, and a decrease in direct R&D expenses relating to Lumoxiti following the end of the transition period with AstraZeneca in
September 2020 and the return of commercialization rights in theU.S. andEurope , as well as the end of recruitment in trials evaluating avdoralimab in oncology. - Selling, general and administrative (SG&A) expenses increased by €4.8m to €19.3m in the first half of 2021 (€14.5m in the first half of 2020) primarily as a result of the provision for charges booked as of
June 30, 2021 relating to the payment of$6.2m (€5.2m as ofJune 30,2021 ) to be made to AstraZeneca onApril 30, 2022 . In the full year results 2020 announcement2, the Company reported a contingent liability of up to$12.8m in its consolidated financial statements, which was linked to the split of certain manufacturing costs. As part of the termination and transition agreement, effective onJune 30, 2021 , Innate and AstraZeneca agreed to split the manufacturing costs, and Innate will pay$6.2m onApril 30, 2022 .
- R&D expenses decreased by €9.7m to €21.8m in the first half of 2021 (€31.5m in the first half of 2020). This change mainly results from a decrease in depreciation and amortization expenses allocated to R&D, and a decrease in direct R&D expenses relating to Lumoxiti following the end of the transition period with AstraZeneca in
- Revenue from distribution agreement are nil in the first half of 2021 (net gain of €0.9m in the first half of 2020). As of
June 30, 2021 , following the end of the transition period relating to the commercialization of Lumoxiti in theU.S. onSeptember 30, 2020 , the Company recognized net sales of Lumoxiti for the first half of 2021 for an amount of €1.0m. - A net financial gain of €1.7m in the first half of 2021 (net financial loss of €2.0m in the first half of 2020), principally as a result of the decrease in fair value of certain of our financial instruments due to the negative impact of the COVID-19 outbreak on the financial markets in the first half of 2020.
- A net loss of €23.7m for the first half of 2021 (net loss of €10.3m for the first half of 2020).
The table below summarizes the IFRS consolidated financial statements as of and for the six months ended
In thousands of euros, except for data per share | ||
Revenue and other income | 15,686 | 36,745 |
Research and development expenses | (21,794) | (31,499) |
Selling, general and administrative expenses | (19,321) | (14,490) |
Operating expenses | (41,115) | (45,989) |
Net income / (loss) distribution agreements | — | 896 |
Operating income (loss) | (25,428) | (8,348) |
Net financial income (loss) | 1,709 | (1,986) |
Income tax expense | — | — |
Net income (loss) | (23,719) | (10,334) |
Weighted average number of shares ( in thousands) : | 78,998 | 78,892 |
- Basic income (loss) per share | (0.30) | (0.13) |
- Diluted income (loss) per share | (0.30) | (0.13) |
2020 | ||
Cash, cash equivalents and financial assets | 159,402 | 190,571 |
Total assets | 266,217 | 307,423 |
Total shareholders’ equity | 133,561 | 155,976 |
Total financial debt | 16,502 | 19,087 |
Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody):
- In
June 2021 , the Company announced promising preliminary data from its Phase 2 TELLOMAK trial, in which lacutamab demonstrated a 35% overall global response rate in patients with mycosis fungoides (MF) that express KIR3DL2 (cohort 2). This first trial data set also established safety and demonstrated skin improvement. Lacutamab reached the pre-determined threshold to advance to stage 2 (six confirmed responses). These results were presented in an oral presentation at the 16thInternational Conference on Malignant Lymphoma (16-ICML). - In the second half of the year, the Company will initiate two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL):
- Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
- Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial:
The Lymphoma Study Association (LYSA) plans to initiate 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.
- Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
ANKET™ (Antibody-based NK cell Engager Therapeutics):
- In
June 2021 , the Company presented new data on its next-generation NK cell engager platform, ANKET, at theFederation of Clinical Immunology Societies (FOCIS) meeting. Specifically, Innate shared data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen via a single molecule. In preclinical studies, the tetra-specific ANKET demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen. The tetra-specific ANKET also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKET also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates. - Progress was made in the IPH6101/
SAR443579 collaboration with Sanofi, resulting in the decision announced inJanuary 2021 that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. IPH6101 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multi-specific antibody format (Gauthier et al. Cell 2019). The decision triggered a €7 million milestone payment from Sanofi to Innate. In addition, inJanuary 2021 , a GLP-tox study was initiated for the IPH6101/SAR443579 program. - The Company will present further ANKET data at the
European Society for Medical Oncology (ESMO) Congress 2021 onSeptember 18, 2021 .
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
- On
September 17, 2021 , AstraZeneca will present a late-breaker abstract on the COAST Phase 2 trial, highlighting progression-free survival (PFS) results for novel durvalumab combinations with potential new medicines, including Innate’s lead partnered asset, monalizumab, and AstraZeneca’s oleclumab, an anti-CD73 monoclonal antibody, in unresectable, Stage III non-small cell lung cancer at theESMO Congress 2021. - The Company expects to publish data this year from the Phase 2 expansion cohort (‘cohort 3’), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with R/M SCCHN.
Avdoralimab (IPH5401, anti-C5aR antibody):
- In
July 2021 , the Company announced that FORCE (FOR COVID-19 Elimination), the investigator-sponsored, Phase 2 clinical trial evaluating the safety and efficacy of avdoralimab, in COVID-19 patients with severe pneumonia, did not meet its primary endpoints in all three cohorts of the trial. Results from this trial, including translational data, are planned to be submitted for publication. The Company’s COVID-19 activities were covered by public funding from the French government. - Following a strategic review, the Company will now solely pursue avdoralimab in bullous pemphigoid, an inflammatory disease, through an investigator-sponsored study and stop further development in all other indications.
Corporate Update:
Bpifrance informed Innate that its permanent representative at Innate’s Supervisory Board, Ms.Maylis Ferrere will be replaced by Mr.Olivier Martinez ,Senior Investment Director in theLife Sciences Investments Department of the Direction of Innovation of Bpifrance , who has been Observer of Innate’s Supervisory Board since 2010.- Announced on
May 28, 2021 , Novo Nordisk A/S, represented byMarcus Schindler , M.D., decided not to seek re-election to the Supervisory Board due to Dr. Schindler’s new role as Executive Vice President Research &Early Development and Chief Scientific Officer of Novo Nordisk A/S. Novo Nordisk A/S remains a shareholder in the Company but no longer has a seat on its Supervisory Board.
About
Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.
Innate is a pioneer in the understanding of Natural Killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca.
Headquartered in
Learn more about
Information about
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 and the overall impact of the COVID-19 outbreak on the global healthcare system as well as the Company’s business, financial condition and results of operations. 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
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
For additional information, please contact: | |
Investors | Media |
Tel.: +33 761 88 38 74 | Tel.: +1 240 801 0076 |
Henry.Wheeler@innate-pharma.fr | Tracy.Rossin@innate-pharma.com |
Marie Puvieux ( Tel. : +33 (0)9 81 87 46 72 | |
innate-pharma@atcg-partners.com |
Summary of Interim Condensed Consolidated Financial Statements and Notes as of
Interim Condensed Consolidated Statements of Financial Position
(in thousand euros)
Assets | ||
Current assets | ||
Cash and cash equivalents | 103,980 | 136,792 |
Short-term investments | 15,341 | 14,845 |
Trade receivables and others | 10,368 | 21,814 |
Total current assets | 129,688 | 173,451 |
Non-current assets | ||
Intangible assets | 45,193 | 46,289 |
Property and equipment | 10,891 | 11,694 |
Non-current financial assets | 40,081 | 38,934 |
Other non-current assets | 210 | 147 |
Trade receivables and others - non-current | 34,753 | 29,821 |
Deferred tax asset | 5,400 | 7,087 |
Total non-current assets | 136,528 | 133,972 |
Total assets | 266,217 | 307,423 |
Liabilities | ||
Current liabilities | ||
Trade payables and others | 17,026 | 29,538 |
Collaboration liabilities – current portion | 7,489 | 1,832 |
Financial liabilities – current portion | 2,017 | 2,142 |
Deferred revenue – current portion | 10,464 | 11,299 |
Provisions - current portion | 5,623 | 676 |
Total current liabilities | 42,619 | 45,488 |
Non-current liabilities | ||
Collaboration liabilities – non-current portion | 38,445 | 44,854 |
Financial liabilities – non-current portion | 14,485 | 16,945 |
Defined benefit obligations | 3,879 | 4,177 |
Deferred revenue – non-current portion | 27,602 | 32,674 |
Provisions - non-current portion | 226 | 221 |
Deferred tax liabilities | 5,400 | 7,087 |
Total non-current liabilities | 90,037 | 105,959 |
Shareholders’ equity | ||
Share capital | 3,952 | 3,950 |
Share premium | 373,043 | 372,130 |
Retained earnings | (220,431) | (156,476) |
Other reserves | 715 | 355 |
Net income (loss) | (23,719) | (63,983) |
Total shareholders’ equity | 133,561 | 155,976 |
Total liabilities and shareholders’ equity | 266,217 | 307,423 |
Interim Condensed Consolidated Statements of Income (loss) (in thousand euros)
Revenue from collaboration and licensing agreements | 8,304 | 29,841 |
Government financing for research expenditures | 6,368 | 6,904 |
Lumoxiti Sales | 1,015 | — |
Revenue and other income | 15,686 | 36,745 |
Research and development expenses | (21,794) | (31,499) |
Selling, general and administrative expenses | (19,321) | (14,490) |
Operating expenses | (41,115) | (45,989) |
Net income / (loss) distribution agreements | — | 896 |
Operating income (loss) | (25,428) | (8,348) |
Financial income | 3,490 | 2,446 |
Financial expenses | (1,781) | (4,431) |
Net financial income (loss) | 1,709 | (1,986) |
Net income (loss) before tax | (23,719) | (10,334) |
Income tax expense | — | — |
Net income (loss) | (23,719) | (10,334) |
- Basic income (loss) per share | (0.30) | (0.13) |
- Diluted income (loss) per share | (0.30) | (0.13) |
Interim Condensed Consolidated Statements of Cash Flow
(in thousand euros)
Net income (loss) | (23,719) | (10,334) |
Depreciation and amortization, net | 2,168 | 6,719 |
Employee benefits costs | 268 | 264 |
Change in provision for charges | 4,952 | 142 |
Share-based compensation expense | 853 | 824 |
Change in valuation allowance on financial assets | (1,031) | 2,536 |
Gains (losses) on financial assets | (443) | (48) |
Change in valuation allowance on financial instruments | (170) | 425 |
Gains on assets and other financial assets | (86) | (758) |
Interest paid | 160 | 173 |
Other profit or loss items with no cash effect | (1,476) | (373) |
Operating cash flow before change in working capital | (18,524) | (430) |
Change in working capital | (12,638) | (57,595) |
Net cash generated from / (used in) operating activities: | (31,162) | (58,025) |
Acquisition of intangible assets, net | (33) | (9,306) |
Acquisition of property and equipment, net | (240) | (544) |
Purchase of non-current financial instruments | — | (3,000) |
Disposal of property and equipment | 2 | 36 |
Purchase of other assets | (63) | (52) |
Interest received on financial assets | 86 | 758 |
Net cash generated from / (used in) investing activities: | (247) | (12,108) |
Proceeds from the exercise / subscription of equity instruments | 61 | 3 |
Repayment of borrowings | (1,127) | (1,029) |
Net interest paid | (160) | (173) |
Net cash generated / (used in) from financing activities: | (1,226) | (1,199) |
Effect of the exchange rate changes | (178) | (13) |
Net increase / (decrease) in cash and cash equivalents: | (32,813) | (71,345) |
Cash and cash equivalents at the beginning of the year: | 136,792 | 202,887 |
Cash and cash equivalents at the end of the six-months period: | 103,980 | 131,542 |
Revenue and other income
The following table summarizes operating revenue for the periods under review:
In thousands of euros | ||
Revenue from collaboration and licensing agreements | 8,304 | 29,841 |
Government funding for research expenditures | 6,368 | 6,904 |
Lumoxiti sales | 1,015 | — |
Revenue and other income | 15,686 | 36,745 |
Revenue from collaboration and licensing agreements
Revenue from collaboration and licensing agreements decreased by €21.5 million, or 72.2%, to €8.3 million for the six months ended
The evolution for the first half of 2021 is mainly due to:
- Revenue related to monalizumab decreased by €13.5 million, or 69.0%, to €6.1 million for the six months ended
June 30, 2021 , as compared to €19.6 million for the six months endedJune 30, 2020 . This decrease mainly results from lower costs in connection with the collaboration works performed relating to the trials’ maturity.
As of
- Revenue related to IPH5201 are nil for the six months ended
June 30, 2021 , as compared to €8.7 million for the six months endedJune 30, 2020 . As ofDecember 31, 2020 , since the Company had fulfilled all of its commitments on preclinical work related to the start of Phase 1 of the IPH5201 program, the initial payment of$50.0 million and the milestone payment of$5.0 million were fully recognized in revenue. Consequently, the Company has not recognized any revenue related to the spreading of the milestone received from the agreement with AstraZeneca on IPH5201 as ofJune 30, 2021 . - Invoicing of research and development costs: Pursuant to our agreements with AstraZeneca, clinical costs for the ongoing Phase 1 trial of avdoralimab are equally shared between
Innate Pharma and AstraZeneca and research and development costs related to IPH5201 are fully borne by AstraZeneca, resulting in periodic settlement invoices. These costs are invoiced back on a quarterly basis. Revenue from invoicing of research and development costs for the six months endedJune 30, 2021 increased by €0.1 million, or 11%, to €1.2 million, as compared to €1.1 million for the six months endedJune 30, 2020 .
Government funding for research expenditures
Government financing for research expenditures decreased by €0.5 million, or 7.8%, to €6.4 million for the six months ended
The research tax credit is calculated as 30% of the amount of research and development expenses, net of grants received, eligible for the research tax credit for the six months ended
Lumoxiti Sales
As of
Operating expenses
The table below presents our operating expenses for the six months periods ended
In thousands of euros | ||
Research and development expenses | (21,794) | (31,499) |
General and administrative expenses | (19,321) | (14,490) |
Operating expenses | (41,115) | (45,989) |
Research and development expenses
Research and development (“R&D”) expenses decreased by €9.7 million, or 30.8%, to €21.8 million for the six months ended
Direct expenses decreased by €3.8 million, or 23.8%, to €12.1 million for the six months ended
Personnel and other expenses allocated to R&D decreased by €5.9 million, or (37.9%), to €9.7 million for the six months ended
Selling, general and administrative expenses
Selling, general and administrative (“SG&A”) expenses increased by €4.8 million, or 33.3%, to €19.3 million for the six months ended
Personnel expenses are stable, to €6.4 million for the six months ended
Non-scientific advisory and consulting expenses mostly consist of auditing, accounting, taxation and legal fees as well as consulting fees in relation to business strategy and operations and hiring services. Non-scientific advisory and consulting expenses decreased by €0.8 million, or (19.9%), to €3.3 million for the six months ended
Selling, general and administrative expenses include the provision for charges relating to the payment of
Following the
The rise in other expenses mainly results from insurance costs, which increase following the listing of the Company on the Nasdaq.
Net income (loss) from distribution agreements
During the transition period which ended on
Financial income (loss), net
We recognized a net financial gain of €1.7 million in the six months ended
Balance sheet items
Cash, cash equivalents, short-term investments and non-current financial assets amounted to €159.4 million as of
The other key balance sheet items as of
- Deferred revenue of €38.1 million (including €27.6 million booked as ‘Deferred revenue – non-current portion’) and collaboration liabilities of €45.9 million (including €38.4 million booked as ‘Collaboration liabilities - non-current portion’) relating to the remainder of the initial payment received from AstraZeneca not yet recognized as revenue or used as part of the co-financing of the monalizumab program with AstraZeneca;
- Receivables from the French government amounting to €34.8 million in relation to the research tax credit for 2019 and 2020 and the six-month period ended
June 30, 2021 ; - Intangible assets for a net book value of €45.2 million, mainly corresponding to the rights and licenses relating to the acquisition of the monalizumab and avdoralimab;
- Shareholders’ equity of €133.6 million, including the net loss of the period of €23.7 million;
Cash-flow items
As of
The net cash flow generated during the period under review mainly results from the following:
- Net cash flow used by operations of €31.2 million for the six months ended
June 30, 2021 as compared to net cash flows used by operations of €58.0 million for the six months endedJune 30, 2020 . This change is mainly explained by the decrease in commercial activities relating to Lumoxiti, in connection with the decision taken by the Company inDecember 2020 to return the commercial rights inthe United States and inEurope to AstraZeneca. - Net cash flow used in investing activities of €0.2 million. The Company has not made any investments in tangible, intangible or significant financial assets during the first half of 2021.
As a reminder, our net cash flow used in investing activities for the six months ended
- Net cash flows used in financing activities for the six months ended
June 30, 2021 , are stable as compared to the six months endedJune 30, 2020 . These amounted to €1.2 million and were mainly related to repayments of financial liabilities.
Post period events
None.
Nota
The interim consolidated financial statements for the six-month period ended
Risk factors
Risk factors identified by the Company are presented in section 3 of the universal registration document (“Document d’Enregistrement Universel”) submitted to the French stock-market regulator, the “Autorité des Marchés Financiers”, on
Related party transactions:
Transactions with related parties during the periods under review are disclosed in Note 19 to the interim condensed consolidated financial statements for the period ended
1 Including short term investments (€15.3 million) and non-current financial instruments (€40.1 million)
2 See note 18) of the consolidated financial statements as of
Source:
2021 GlobeNewswire, Inc., source