- Cash, cash equivalents and financial instruments* amounted to €230.7m (million euros) as of December 31, 2016
- Revenue and other income amounted to €65.7m (€25.1m in 2015), including $15m (€13.8m) milestone payment from Bristol-Myers Squibb related to progress with lirilumab
- Operating expenses amounted to €58.2m (€35.9m in 2015); increase driven by continued investment in its portfolio of drug candidates
- First report of potential clinical benefit for lirilumab in combination with nivolumab and for IPH4102, validating Innate Pharma’s positioning and strategy
- Broadening of proprietary preclinical pipeline and new bispecific antibodies technology
- Key leadership changes to support next phase of growth, with appointment of Mondher Mahjoubi as CEO of the Company
Marseille, France, March 7, 2017 – Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH) today reports its consolidated financial results for the year ended December 31, 2016. The consolidated financial statements are attached to this press release.
Over the course of 2016, Innate Pharma made significant progress across its portfolio of partnered and proprietary programs. The Company reported encouraging clinical activity for lirilumab in combination with nivolumab in a Phase I/II trial and for IPH4102 in monotherapy in a Phase I trial. Clinical investigators also reported a favorable safety profile for monalizumab as a monotherapy. The Company continued to broaden and advance its portfolio of early stage programs with two new programs targeting the tumor microenvironment (respectively targeting CD39 and CD73) and a new bispecific antibodies technology engaging NK cells. During the year, the program IPH4301 has started IND-enabling studies and is expected to enter clinic in 2018.
At the beginning of 2017, the Company announced top-line results from the EffiKIR study which evaluated the efficacy of lirilumab as a single agent for maintenance of remission in patients with acute myeloid leukemia; further development of lirilumab in this setting will not be pursued.
In terms of organization, Mondher Mahjoubi was appointed Chief Executive Officer and Chairman of the Executive Board of Innate Pharma on December 30, 2016, succeeding Hervé Brailly, who became Chairman of the Supervisory Board. Dr. Mahjoubi’s appointment was designed to support the Company’s evolution as it advances its key programs towards late-stage development.
Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, said
“2016 was marked by the first report of potential clinical benefit for lirilumab in combination with nivolumab in patients with squamous cell carcinoma of the head and neck and for IPH4102 in cutaneous T cell lymphomas. These data further validate the Company’s rationale for the development of these drug candidates, and more broadly support the fundamental rationale underpinning Innate Pharma’s broad pipeline of drug candidates and technologies”. He added: “The Company maintained a strong financial position whilst continuing to invest and advance its portfolio of drug candidates and enters a period where it becomes eligible to further milestone payments. Looking ahead to 2017, we are confident in building on the progress seen in 2016 with the release of more clinical data in the months ahead.”
*current and non-current
A conference call for institutional investors and sell-side analysts will be held today at 2:00pm (CET)
Dial in numbers: +33 (0)1 70 77 09 43
The FY2016 results presentation will be made available on the Company’s website 30 minutes before the conference call begins.
A replay will be available on Innate Pharma’s website after the conference call.
Financial highlights for 2016
The key elements are as follows:
- Cash, cash equivalents and financial instruments amounting to €230.7m (million euros) as of December 31, 2016 (€273.7m as of December 31, 2015), including non-current financial instruments (€33.0m);
- At the same date, the financial liabilities amounted to €5.3m (€3.8m as of December 31, 2015).
- Revenue and other income amounting to €65.7m (€25.1m in 2015). This amount mainly results from licensing revenue (€56.2m) and from research tax credit (€9.1m).
- Revenue from collaboration and licensing agreements mainly results from the spreading of the initial payment received by Innate Pharma in the context of the agreement signed in April 2015 with AstraZeneca/MedImmune (€41.6m in 2016 and €12.1m in 2015).
- The 2016 revenue also includes a $15m (€13.8m) milestone payment received from Bristol-Myers Squibb for the continued exploration of lirilumab in combination with nivolumab. The milestone payment followed the presentation at the SITC annual meeting (November 2016) of encouraging preliminary activity results from the cohort of patients with squamous cell carcinoma of the head and neck (SCCHN) of a Phase I/II trial. The payment was received in January 2017.
- Operating expenses amounting to €58.2m (€35.9m in 2015) of which 84% related to research and development. The majority of the increase results from the increase in subcontracting costs in relation with the clinical development of the Company’s drug candidates (+€15.6m).
- A net financial income amounting to €5.4m.
- As a consequence of the items mentioned previously, the net profit for 2016 amounts to €12.6m to be compared to a loss of €6.7m for 2015.
The table below summarizes the IFRS consolidated financial statements for fiscal year 2016, with a comparison with 2015:
Pipeline update (second half of 2016) Lirilumab (anti-KIR antibody), licensed to Bristol-Myers Squibb
Lirilumab is a fully human monoclonal antibody that is designed to block the interaction between KIR2DL-1,-2,-3 inhibitory receptors and their ligands. Blocking these receptors facilitates activation of NK cells and, potentially some subsets of T cells, ultimately leading to destruction of tumor cells.
- In the second half of 2016, several sets of clinical data were presented on lirilumab:
- At the ESMO conference in October 2016, clinical investigators from the Memorial Sloan-Kettering Cancer Center, New York, US, presented safety data from the Phase I trial testing lirilumab in combination with nivolumab in advanced refractory solid tumors in 159 patients. The safety profile of lirilumab and nivolumab was similar to that observed with nivolumab monotherapy, with the exception of low-grade and clinically manageable infusion-related reactions. They also presented safety data from lirilumab in combination with ipilimumab in advanced solid tumors in 22 patients. There did not appear to be additional safety concerns when compared to that observed with ipilimumab monotherapy based on the limited population studied.
- At the SITC conference in November 2016, clinical investigators from the Earle A. Chiles Research Institute, Oregon, US, presented preliminary efficacy data pertaining to a cohort of patients with squamous cell carcinoma of the head and neck (SCCHN) from the Phase I/II trial testing lirilumab with nivolumab in solid tumors. The data marked the first report of potential clinical benefit of an anti-KIR antibody in combination with a PD-1 pathway blocker. The objective response rate (ORR), a secondary endpoint measured by Response Evaluation Criteria In Solid Tumors (RECIST), among 29 evaluable patients was 24% (7/29), with complete responses in 10% of patients (3/29), including confirmed and unconfirmed responses. Seventeen percent (5/29) of these evaluable patients had deep responses, with reductions in tumor burden greater than 80%. Early signals of enhanced clinical benefit were observed in PD-L1 positive tumors, with an ORR of 41% (7/17) in patients with ≥1% PD-L1 expression.
- At the ASH conference in December 2016, clinical investigators from the MD Anderson Cancer Center, Texas, US, presented preliminary safety data from the Phase Ib/II testing lirilumab in combination with 5-azacitidine in a heavily pretreated patient population with relapsed acute myeloid leukemia. The combination showed a good safety profile, full doses of lirilumab and 5-azacitidine were well tolerated and no dose-limiting toxicities were observed. The preliminary efficacy data for 25 evaluable patients showed a response rate of 20%, including two patients that achieved a complete response or complete response with insufficient count recovery and three patients that achieved hematologic improvement.
- In January 2017, the Company announced that, as per the licensing agreement for lirilumab, Bristol-Myers Squibb paid Innate Pharma a US$15 million milestone payment for the continued exploration of lirilumab in combination with nivolumab. This milestone payment followed the presentation at the SITC annual meeting (November 2016) of encouraging preliminary activity results from the cohort of patients with SCCHN of a Phase I/II trial.
- At the beginning of 2017, the Company announced top-line results from its EffiKIR trial (see the “post period events” section).
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca/Medimmune
Monalizumab is a checkpoint inhibitor targeting NKG2A, an inhibitory receptor expressed on tumor infiltrating cytotoxic CD8 T lymphocytes and NK cells. This monoclonal antibody is currently being tested in an exploratory program of Phase I or I/II clinical trials in various cancer indications in monotherapy and combinations in solid tumors and in hematology.
- In November 2016, clinical investigators from the Canadian Cancer Trials Group (CCTG) presented the first data from the dose-ranging part of a Phase I/II clinical trial of monalizumab as a single agent in patients with advanced gynecological malignancies. The dose-ranging part involved 18 patients with advanced, heavily pretreated ovarian cancer receiving monalizumab at three dose levels (1, 4 and 10 mg/kg, every two weeks – six patients at each dose level). The data showed that monalizumab was well tolerated with no dose-limiting toxicities observed. Preliminary efficacy data showed short-term disease stabilization in 41% of patients, including one patient with a mixed response. The cohort-expansion part of the trial is ongoing with at the recommended Phase II dose of 10 mg/kg every two weeks.
- During the second half of 2016, the Company closed the Phase I/II trial testing monalizumab in head and neck cancers in a preoperative setting. The decision to stop this trial was due to slow enrollment and not based on any safety considerations.
IPH4102 (anti-KIR3DL2 antibody)
IPH4102 is a first-in-class cytotoxicity-inducing antibody currently being tested in a Phase I clinical trial for the treatment of KIR3DL2-expressing cutaneous T-cell lymphomas (CTCL), in particular their aggressive forms, Sezary syndrome and transformed mycosis fungoides. IPH4102 was granted the orphan designation status in Europe.
- Clinical investigators presented preliminary safety and efficacy data on the first seven dose levels at the 3WCCL conference in October 2016 and at the ASH conference in December 2016. The preliminary safety data showed that IPH4102 was well tolerated in 16 patients with heavily pretreated relapsed/refractory CTCL. No dose-limiting toxicity was observed. The majority of adverse events was typical for CTCL or reflected low-grade infusion reactions. The eighth dose level out of ten was completed without dose-limiting toxicity.The preliminary efficacy data showed signs of clinical activity with a global objective response rate of 38%. At the time of the presentation, the median response duration was at least 126 days and all responses were ongoing. Complete responses were seen in skin (two patients) and blood (three patients). The results of exploratory biological endpoints such as pharmacodynamics in skin and blood are in line with clinical activity results.The completion of the dose-escalation part of the trial is expected by the second quarter of 2017.
IPH4301 (anti-MICA/B antibody)
IPH4301 is a first-in-class anti-MICA/B therapeutic antibody that exhibits dual anti-tumor mechanism: direct killing of MICA/B-expressing tumor cells (antibody-dependant cell-mediated cytotoxicity – ADCC) as well as immunomodulatory effects through the restoration of NKG2D expression on immune cells.
The program is expected to enter clinical trials in 2018.
IPH52 (anti-CD39 antibody)
This program, currently in preclinical development, aims at developing an anti-CD39 monoclonal antibody. CD39 plays a major role in promoting immunosuppression through the pathway degrading adenosine triphosphate (ATP) into adenosine. Within the tumor microenvironment, ATP promotes immune cell-mediated killing of cancer cells. In contrast, adenosine accumulation causes immune suppression and dysregulation of immune cell infiltrates resulting in tumor spreading. Blockade of CD39 may stimulate anti-tumor immunity across a wide range of tumors.
Innate Pharma has generated a first-in-class anti-CD39 antibody which is currently in lead optimization.
IPH53 (anti-CD73† antibody)
This program, currently in preclinical development, aims at developing an anti-CD73 monoclonal antibody. CD73 plays a major role in promoting immunosuppression through the pathway degrading ATP into adenosine. CD73 is active on the last step of the degradation pathway, where it is the enzyme that actually degrades AMP into adenosine. CD73-blockade could promote an anti-tumor immune responses across a wide range of tumors.
Innate Pharma has generated a panel of novel anti-CD73 antibodies.
In December, the Company announced the appointment of Mondher Mahjoubi as Chairman of Innate Pharma’s Executive Board, succeeding Hervé Brailly who became Chairman of the Supervisory Board. As part of the governance changes, Laure-Hélène Mercier was appointed Chief Financial Officer. She was previously EVP, Finance, in charge of financial operations and, before that, Head of Investor Relations. Catherine Moukheibir, Senior Advisor for financial strategy, left the Executive Board and maintains an advisory position.
In 2016, Innate Pharma recruited 36 new people, mostly in research and development, to support the expansion of the preclinical portfolio and the increase in the number of clinical trials performed by the Company. As at December 31, 2016, the headcount was 154 employees.
Post period event EffiKIR study
In February 2017, the Company announced top-line results from the EffiKIR trial, a randomized, double-blind, placebo-controlled Phase II trial testing the efficacy of lirilumab as a single agent maintenance treatment in elderly patients with acute myeloid leukemia in first complete remission. The study did not meet its primary efficacy endpoint of leukemia-free survival (“LFS”).
†This program is developed within the TumAdoR project (www.tumador.eu), coordinated by Dr C. Caux (Centre Léon Bérard and Centre de Recherche en Cancérologie, Lyon, France), and funded under the European Community’s seventh framework Program (European Community’s Seventh Framework Program (FP7/2007-2013) under grant agreement n°602200).
There was no statistically significant difference between either lirilumab arms and the placebo arm on the LFS nor on other efficacy endpoints. The adverse events encountered with lirilumab were consistent with its previously reported safety profile. Data analyses are ongoing and the full trial data will be submitted to a future medical conference and for publication.
Next scientific publications
As a reminder, preclinical and clinical data on monalizumab will be presented at the AACR Annual Meeting 2017 being held April 1 – 5, 2017, in Washington, D.C. Abstracts are available on the conference website.
Notes to the Editors
About Innate Pharma
Innate Pharma S.A. is a clinical-stage biotechnology company with a focus on discovering and developing first-in-class therapeutic antibodies that harness the innate immune system to improve cancer treatment and clinical outcomes for patients.
Innate Pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body’s immune system to recognize and kill cancer cells.
The Company’s aim is to become a fully-integrated biopharmaceutical company in the area of immunotherapy and focused on serious unmet medical needs in cancer. Innate Pharma has pioneered the discovery and development of checkpoint inhibitors to activate the innate immune system. Innate Pharma’s innovative approach has resulted in three first-in-class, clinical-stage antibodies targeting natural killer cell receptors that may address a broad range of solid and hematological cancer indications as well as additional preclinical product candidates and technologies. Targeting receptors involved in innate immunity also creates opportunities for the Company to develop therapies for inflammatory diseases.
The Company’s expertise and understanding of natural killer cell biology have enabled it to enter into major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb and Sanofi.
Based in Marseille, France, Innate Pharma has more than 160 employees and is listed on Euronext Paris.
Learn more about Innate Pharma at www.innate-pharma.com.
Information about Innate Pharma shares
ISIN code: FR0010331421
Ticker code: IPH
This press release contains certain 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. For a 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 Document de Reference prospectus filed with the AMF, which is available on the AMF website (http://www.amf-france.org) or on Innate Pharma’s website.
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.
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