8th March 2018

2017: CLINiCAL PROGRESS, Portfolio expansion and financial strength create the foundation for future growth

 

  • Cash, cash equivalents and financial assets[1] amounted to €176.6m (million euros) as of December 31, 2017

    • Revenue and other income amounted to €44.0m (€65.7m in 2016, including a €13.8m milestone payment from Bristol-Myers Squibb)

    • Operating expenses amounted to €84.0m (€58.2m in 2016), driven by continued investment in preclinical and clinical portfolio

  • Significant progress across Innate Pharma’s partnered and proprietary clinical programs, with new focus on clinical development in tumor microenvironment

    • Dose-escalation data show favorable safety profile and promising clinical activity for IPH4102 in patients with Sézary syndrome, an advanced form of cutanous T-cell lymphoma – cohort expansion ongoing

    • Acquisition of anti-C5aR, now called IPH5401, a clinical-stage antibody, strengthens Innate’s proprietary pipeline targeting the tumor microenvironment - a clinical collaboration is now underway with MedImmune

  • World renowned immunologist, Professor Eric Vivier, joins Innate Pharma as Chief Scientific Officer

  • Innate Pharma will hold a R&D Day for institutional investors and sell-side analysts in London today, to update on its clinical development activities

Marseille, France, March 8, 2018 – 07:00 AM CET

Innate Pharma (the “Company” - Euronext Paris: FR0010331421 – IPH) today reports its consolidated financial results for the year ended December 31, 2017. The consolidated financial statements are attached to this press release.

During 2017, Innate Pharma has made significant progress across its portfolio of partnered and proprietary programs and has laid the foundations for continued clinical development during 2018. The Company reported a favorable safety profile and encouraging clinical activity for IPH4102 in monotherapy in a Phase I trial in patients with Sézary syndrome, an advanced form of cutanous T-cell lymphoma. First data from a cohort expansion part of the ongoing trial are expected in 2018.

In June 2017, the Company strengthened its proprietary pipeline with the acquisition of IPH5401, a first-in-class anti-C5aR antibody targeting the tumor microenvironment, from Novo Nordisk S/A for a total of €40.0m (€2.8m in cash and €37.2m in new Innate Pharma shares). IPH5401 is a clinical-stage, proprietary product that reinforces Innate Pharma’s position in the field of antibodies targeting the tumor microenvironment beyond the Company’s existing activities in the adenosine pathway. Preclinical findings suggest that C5aR blockade increases immune-mediated tumor killing and efficacy of checkpoint inhibitors. IPH5401 will enter first clinical studies in oncology in 2018, as part of a non-exclusive clinical collaboration with MedImmune/AstraZeneca.

The Company also continued to advance its portfolio of early stage programs targeting the tumor microenvironment with two antibodies directed against enzymes in the adenosine pathway, CD39 and CD73, respectively. Preclinical experiments have demonstrated superior blocking activity of IPH52 (anti-CD39) and IPH53 (anti-CD73) for both the cell surface and soluble forms of the enzymes. Significant progress could also be recorded in the Company’s collaboration with Sanofi on NK-cell bispecific engagers, who bring together tumor cells and NK cells and trigger NK cell killing of tumor cells. While the project on a first tumor target is on the way to lead candidate selection, Sanofi decided to include a second target into the framework of the collaborative agreement.

During 2017, the Company announced 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. The study did not meet its primary efficacy endpoint of leukemia-free survival. Towards the end of the year, Innate’s partner Bristol-Myers Squibb updated on the lirilumab program in combination with Opdivo (nivolumab) in patients with solid tumors. The assessment of efficacy did not provide an obvious development path. Discussions are ongoing regarding next steps.

After the period, Eric Vivier was appointed Chief Scientific Officer on January 8, 2018. In his new role, Professor Vivier will lead Innate Pharma’s science and technology platforms as well as the development of collaborations between fundamental, translational and clinical research.

 

[1] current and non-current

“During 2017, Innate Pharma has made significant clinical advances, within both its wholly-owned and partnered portfolios, laying the foundations for the future focus of our immuno-oncology development strategy. We expect clinical read-outs for both our monalizumab and IPH4102 program in 2018. Moreover, we are very pleased with the acquisition of IPH5401, a first-in-class anti-C5aR antibody, which strengthens our portfolio in the tumor microenvironment.” “We have a robust financial position, giving us the flexibility to invest for future portfolio growth. With multiple value catalysts ahead in 2018, we believe we are poised for a pivotal year.”

Mondher Mahjoubi

Chief Executive Officer of Innate Pharma

***

Innate Pharma will host a R&D Day for institutional investors and sell-side analysts on March 8 from 1:30 to 5:00 pm GMT (8:30 to 12:00 pm ET) in London.

To join the live webcast today at 1:30pm (GMT) please use the following link:

https://www.innate-pharma.com/en/news-events/events/rd-day-2018 

 

To join the event by conference call only, please use the following dial-in numbers:

USA: +1 646-828-8156

INTERNATIONAL: 0800 279 7204

PIN code: 3997784

The presentation will be made available on the Company’s website 30 minutes before the start of the event.

 

A webcast replay will be available on Innate Pharma’s website after the event.

***

 

Financial highlights for 2017:

The key elements are as follows:

  • Cash, cash equivalents and financial assets amounting to €176.6m (million euros) as of December 31, 2017 (€230.7m as of December 31, 2016), including non-current financial instruments (€60.5m).
    • At the same date, the financial liabilities amounted to €5.9m (€5.3m as of December 31, 2016).
  • Revenue and other income amounting to €44.0m (€65.7m in 2016). This amount mainly results from licensing revenue (€32.6m) and from research tax credit (€11.0m).
    • 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 (€32.3m in 2017 and €41.6m in 2016).
    • The 2016 revenue also included 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 and has generated an exchange gain of €0.3m.
  • Operating expenses amounting to €84.0m (€58.2m in 2016) of which 80% related to research and development. The majority of the rise results from the increase in subcontracting costs in relation with the clinical development of the Company’s drug candidates (+ €9.7m), in share-based payments (+ €9.0m) and in staff costs (+ €2.4m).
  • A net financial loss amounting to €8.0m.
  • As a consequence of the items mentioned previously, the net loss for 2017 amounts to €48.4m to be compared to a profit of €12.6m for 2016.

The table below summarizes the IFRS consolidated financial statements for fiscal year 2017, with a comparison to 2016:

Year ended December 31

In thousand euros (IFRS)

2017

2016

 

 

 

Revenue from collaboration and licensing agreements

32,631

56,159

Government financing for research expenditures

11,402

9,561

Revenue and other income

44,033

65,721

Research and Development expenses

(67,000)

(48,628)

General and Administrative expenses

(17,015)

(9,522)

Operating expenses

(84,015)

(58,150)

Operating income / (loss)

(39,983)

7,571

Financial income / (expenses), net

(8,034)

5,370

Income tax

(368)

(301)

Net income / (loss)

(48,385)

12,640

 

Pipeline update (second half of 2017):

IPH4102 (anti-KIR3DL2 antibody):

IPH4102 is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed for treatment of CTCL, an orphan disease, and in particular, its most aggressive subtypes, Sézary Syndrome and transformed mycosis fungoides.

In October 2017, the final results of the dose-escalation part of the ongoing Phase I study investigating IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL), an orphan disease, were presented by Pr. Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, in an oral session at the EORTC CLTF  in London.

  • These data confirm the good safety profile and promising activity of IPH4102 in this elderly and heavily pretreated patients population (n=25). The objective response rate in the 20 patients with Sézary syndrome was 50%; the rate of response lasting at least more than 4 months (ORR4was 40%, the disease control rate (DCR), 90%, the median duration of response (DOR), 9.9 months and the median progression free survival (PFS), 10.8 months, respectively. Data on pruritus were reported for the first time and show substantial improvement in patients having a global clinical response but also in patients with stable disease. The Recommended Phase 2 Dose (RP2D) has been identified at 750 mg, a fixed dose equivalent to 10 mg/kg. Expansion cohorts started, including 2 cohorts of 15 patients each in two CTCL subtypes: Sézary syndrome and transformed mycosis fungoides.
  • Biomarker results were presented in an oral presentation by Dr. Maxime Battistella, Assistant Professor Pathology and Dermatopathology at St Louis Hospital and Université L. Diderot.
  • Data from a cohort expansion part of the ongoing phase I trial in patients with Sézary syndrome are expected in 2018 and will be presented at an upcoming medical conference.

 

IPH5401 (anti-C5aR antibody):

IPH5401 is a first-in-class fully human therapeutic antibody that specifically binds and blocks C5a receptors (C5aR) expressed on subsets of myeloid-derived suppressor cells (MDSC) and neutrophils.

  • In September 2017, at the third CRI-CIMT-EATI-AACR International Cancer Immunotherapy conference, Innate Pharma has presented preclinical data that reinforce the IPH5401 rationale. This data show the selective expression of C5aR on myeloid-derived suppressor cells (MDSC) and neutrophils. These cells accumulate within the tumor microenvironment and secrete pro-angiogenic factors which promote tumor progression. They also inhibit NK and T cells and suppress anti-tumor immunity. In this poster, the data demonstrate that IPH5401 selectively inhibits the activation of neutrophils. Moreover, the data show that the combined administration of anti-C5aR with anti-PD-1 synergistically reduced tumor growth. Taken together, these data suggest that C5aR blockade may result in a more permissive environment for immune-mediated tumor killing and treatment with checkpoint inhibitors.
  • IPH5401 will enter clinical studies in oncology in 2018.

 

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 combinations in solid tumors.

  • In September 2017, the Company presented new preclinical data at the third CRI-CIMT-EATI-AACR International Cancer Immunotherapy conference that reinforce the rationale, that combined NKG2A/HLA-E and PD-1/PD-L1 blockade enhance CD8+ T Cell-mediated killing of tumors.
  • First clinical data read-outs from the Phase I/II trial in advanced solid tumors are expected in the course of 2018 and will be presented at upcoming medical conferences.

 

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 November 2017, Innate Pharma provided an update on the clinical study program of lirilumab, licensed to Bristol-Myers Squibb. While lirilumab was shown to be well-tolerated, the assessment of efficacy from the ongoing exploration of doublet combinations, notably the nivolumab combination in an extended population of SCCHN patients, did not provide clear evidence of benefit to patients or an obvious development path. Discussions are ongoing regarding next steps for the program.
  • In December 2017, full data for EffiKIR[2] study have been disclosed in an oral presentation by Pr. Norbert Vey, Team leader Translational Medicine – Hematology at the Paoli-Calmettes Institute (IPC), at the ASH  annual meeting. These data suggest that alternate dosing regimens, where KIR receptors are not permanently occupied and allow the interaction with their cognate ligands during maturation, could be worth exploring.

IPH52 (anti-CD39 antibody) and IPH53 (anti-CD73[3] antibody):

CD39 and CD73 are membrane-bound extracellular enzyme which play a major role in promoting immunosuppression through the pathway degrading adenosine triphosphate (ATP) into adenosine. The blockade of CD39 and CD73 has the potential to promote anti-tumor immune responses across a wide range of tumors.

In November 2017, preclinical data for IPH52 and IPH53 were presented at the Immune Checkpoint Inhibitors Summit in Munich. These data demonstrate the expression of CD39 and CD73 in the tumor microenvironment, the blockade rationale in tumor models, especially in combination with checkpoint inhibitors, as well as the efficacy in blocking the ATP/Adenosine pathway.

Corporate update:

In January 2018, Innate Pharma announced the appointment of Prof. Eric Vivier as Chief Scientific Officer of the Company.

Also in January, the Company announced the appointment of Prof. Jean-Yves Blay to the Innate Pharma’s Supervisory Board. Additionally, Marcus Schindler, SVP and Head of External Innovation and Strategy at Novo Nordisk A/S has replaced Karsten Munk Knudsen as Novo Nordisk A/S’ s permanent representative on the Supervisory Board effective March 7, 2018. Karsten Munk Knudsen was appointed Executive Vice President & Chief Financial Officer of Novo Nordisk A/S on February 15, 2018.

In 2017, Innate Pharma recruited 34 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, 2017, the headcount was 188 employees.

Post period events:

Clinical collaborations:

On January 30, the Company announced  a non-exclusive clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca. The Phase I/II study (STELLAR-001) will evaluate the safety and efficacy of durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in combination with Innate’s investigational first-in-class anti-C5aR monoclonal antibody, IPH5401, as a treatment for patients with selected solid tumors. Innate will sponsor the study with costs equally shared by both parties.

Next scientific publications:

Innate Pharma will present a broad range of preclinical and clinical data on on its development portfolio at the AACR 2018 Annual Meeting  being held April 14 – 18, 2018, in Chicago, Illinois. Abstracts will be available on the conference website on March 14 after 4:30 p.m. U.S. ET.

 

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 180 employees and is listed on Euronext Paris.

Learn more about Innate Pharma at www.innate-pharma.com.

 

Information about Innate Pharma shares:

ISIN code

Ticker code

FR0010331421

IPH

 

Disclaimer:

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.


 

For additional information, please contact:

Investors

 

Innate Pharma       

Markus Metzger / Jérôme Marino

Investor relations

Tel.: +33 (0)4 30 30 30 30

investors@innate-pharma.com

 

International Media

 

Consilium Strategic Communications

Mary-Jane Elliott / Jessica Hodgson

Tel.: +44 (0)20 3709 5700

InnatePharma@consilium-comms.com

 

French Media

 

ATCG Press

Marie Puvieux

Mob: +33 (0)6 10 54 36 72

presse@atcg-partners.com

 

 

[2] Phase II trial testing the efficacy of lirilumab as a single agent maintenance treatment in elderly patients with acute myeloid leukemia.

[3] 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).

 

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