On March 24, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2021 (Press release, Innate Pharma, MAR 24, 2022, View Source [SID1234610844]). The consolidated financial statements are attached to this press release.
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"Throughout 2021, we made key progress across our portfolio – announcing promising data with our proprietary pipeline as well as the start of a new pivotal study by our partner AstraZeneca with our most advanced pipeline asset, monalizumab. Highlights from our pipeline included the encouraging lacutamab data in a subtype of cutaneous T-cell lymphoma, mycosis fungoides (MF), and the initiation of trials of the product in the broader indications of peripheral T-cell lymphomas (PTCL). We also showed further validation with our multi-specific NK cell engager platform, ANKETTM, including the start of a Phase 1 trial with Sanofi," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The value in Innate is the strength and depth of our core R&D efforts, as we look to progress our pipeline in house, or with partnerships. We look forward to new milestones in the coming year including readouts from the lacutamab program, further progress in our early-stage R&D activities in ANKETTM and the adenosine franchise and not least in continued development of monalizumab."
Webcast and conference call will be held today at 2:00pm CET (9:00am EDT)
Access to live webcast:
View Source
Participants may also join via telephone using the dial-in details below:
France: 0805 620 704
United States: 1 844 200 6205 / 1 646 904 5544
United Kingdom: 44 208 0682 558 / 44 808 189 648
All other locations: +1 929 526 1599
Access code: 834852
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.
Pipeline highlights:
Lacutamab (IPH4102, anti-KIR3DL2 antibody):
The Company announces the opening of a new mycosis fungoides (MF) all-comers cohort in the TELLOMAK study. The all-comers cohort will recruit both KIR3DL2 expressors and non-expressors to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay as a companion diagnostic. The KIR3DL2 non-expressing Cohort 3 has been closed to recruitment. As per the Simon 2-stage design, the number of responses to move to stage 2 was not reached, as such, recruitment into this cohort is stopped. Cohort 3 included KIR3DL2 non-expressing patients assigned via a KIR3DL2 immunohistochemistry assay for use on frozen biopsy samples and as a tool for stratification.
In June 2021, the Company announced preliminary data from its Phase 2 TELLOMAK trial, in which lacutamab demonstrated a 35% overall global response rate in patients with 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 16th International Conference on Malignant Lymphoma (16-ICML).
Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are ongoing:
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) 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):
In December 2021, the Company announced that the first patient was dosed in a Phase 1/2 clinical trial by Sanofi, evaluating IPH6101/SAR443579, the first NKp46/CD16‑based NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS). The purpose of the dose escalation and dose expansion study, which is sponsored by Sanofi, is to evaluate the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of IPH6101/SAR443579, Innate’s lead ANKETTM asset, in various CD123-expressing hematological malignancies. The start of the trial has triggered a milestone payment from Sanofi to Innate.
In November 2021, Innate Pharma in collaboration with Sanofi, presented preclinical data from Innate’s proprietary, multi-specific NK cell engager platform, ANKETTM, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Data on IPH6101/SAR443579, using Innate’s proprietary multi-specific antibody format (Gauthier et al. Cell 2019) that targets CD123 on acute myeloid leukemia (AML) cells and co-engages NKp46 and CD16a on NK cells was presented. In preclinical studies, IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells. In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor systemic cytokine release in comparison to T-cell engagers. As expected, it also had a favorable safety profile.
In June 2021, the Company presented new data on its ANKETTM platform, at the Federation of Clinical Immunology Societies meeting. Specifically, Innate shared data from its tetra-specific ANKETTM 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 ANKETTM 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 ANKETTM 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. ANKETTM also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates.
In January 2021, it was announced that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. The decision triggered a €7 million milestone payment from Sanofi to Innate. In addition, in January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.
IPH64, the other drug candidate of the research collaboration with Sanofi is progressing and the Company look forward to updates on this asset.
The Company’s proprietary tetra-specific ANKETTM IPH65 is progressing to IND enabling studies.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
In March 2022, the Phase 2 NeoCOAST study assessing the safety and efficacy of neoadjuvant durvalumab in combination with chemotherapy and oleclumab or monalizumab and adjuvant treatment in participants with resectable, early-stage non-small cell lung cancer (NSCLC) has been accepted for an oral presentation on 11 April 2022 at the Annual Meeting 2022 of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
In February 2022, AstraZeneca initiated a Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (anti-PD-L1) in combination with monalizumab (anti-NKG2A) 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).
In December 2021, the Company presented data from the Phase 2 expansion cohort (‘cohort 3’), exploring the triplet combination of monalizumab, cetuximab and durvalumab in the first-line treatment of patients with recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2021. After a median follow-up of 16.3 months, preliminary data suggest anti-tumor activity in the triplet of monalizumab, cetuximab and durvalumab in first-line treatment of R/M HNSCC. As of August 1, 2021, 40 patients were enrolled. Thirteen patients had a confirmed response with a 32.5% overall response rate (95% confidence interval (CI): 20-48), including three complete responses. Seven out of 13 responders were still on treatment. Median duration of response was not yet reached (95% CI: 7.1-not available). The survival rate at 12 months was 58.6% (95% CI: 45-77) and the median overall survival was 15 months (95% CI: 11.4 – not available).
In September 2021, AstraZeneca commenced a Phase 2 clinical study, NeoCOAST-2, that includes a treatment arm with durvalumab in combination with chemotherapy and monalizumab in resectable, early-stage NSCLC.
In September 2021, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III NSCLC at the ESMO (Free ESMO Whitepaper) Congress. The presentation highlighted progression-free survival (PFS) and overall response rate (ORR) results for durvalumab in combination with monalizumab, Innate’s lead partnered asset, and oleclumab, AstraZeneca’s anti-CD73 monoclonal antibody. After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC patients following chemoradiation therapy. The results also showed an increase in the primary endpoint of confirmed ORR for durvalumab plus monalizumab over durvalumab alone (36% vs. 18%).
IPH5201 (anti-CD39), partnered with AstraZeneca:
AstraZeneca is conducting a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab (anti-PD-L1). The data is expected to be presented in 2023. Innate is in discussions with AstraZeneca on potential next steps for this program.
IPH5301 (anti-CD73):
In March 2022, The Institut Paoli-Calmettes announced that the first patient had been dosed in the investigator-sponsored Phase 1 trial of IPH5301 (CHANCES). 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.
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. Data in bullous pemphigoid is now expected in 2024.
Corporate Update:
In February 2022, Mrs Tracy Rossin, VP, Global Head of Communications, decided to pursue another opportunity outside the Company. Mr Henry Wheeler, Vice President of Investor Relations, who joined Innate in June 2021 is now responsible for Investor Relations and Communications.
In January 2022, Mr Nicola Beltraminelli PhD was appointed as Vice President, Chief Development Officer of Innate responsible for non-clinical development. Mrs Frederique Brune, Vice President Development CMC and Supply Chain decided to pursue another opportunity outside the company. Mr Beltraminelli brings more than 20 years of biotech experience to the role, and specifically in the development of biologic products from early discovery to GMP manufacture. Most recently, Mr Beltraminelli served as Chief Technical Officer at Lysogene, where he led the CMC activities for two late-stage assets.
In January 2022, Innate Pharma announced that it had obtained €28.7M in non-dilutive financing in the form of State Guaranteed Loans from Société Générale and BNP Paribas. The two agreements were signed and funds received in December 2021.
In November 2021, Jen Butler, Head of Global Commercial and US General Manager left her position at the Company.
In June 2021, Bpifrance informed Innate that its permanent representative at Innate’s Supervisory Board, Mrs Maïlys Ferrere will be replaced by Mr Olivier Martinez, Senior Investment Director in the Life 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 by Marcus 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.
Frederic Lombard was appointed as Chief Financial Officer on April 1, 2021. Mr Lombard has more than 20 years of financial experience in the pharmaceutical industry, holding senior finance roles at Ipsen, AstraZeneca and Novartis. Laure-Hélène Mercier, Executive Vice President, Chief Financial Officer and member of the Executive Board, decided to step down from her position, after leading the Company through more than 14 years of growth, including an initial public offering in the US. She left the Company on January 2022.
Financial highlights for 2021:
The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2021 are as follows:
Cash, cash equivalents, short-term investments and financial assets amounting to €159.7 million2 (€m) as of December 31, 2021 (€190.6m as of December 31, 2020), including non-current financial instruments amounting to €39.9m (€38.9m as of December 31, 2020).
As of December 31, 2021, financial liabilities amount to €44.3m (€19.1m as of December 31, 2020). This change is mainly linked to proceeds relating to State-Guaranteed Loans (Prêts Garantis par l’Etat "PGE") of €28.7m from Société Générale (€20.0m) and BNP Paribas (€8.7m) collected by the Company on December 2021.
Revenue and other income from continuing operations3 amounted to €24.7m in 2021 (2020: €69.8m, -64.6%). It mainly comprises revenue from collaboration and licensing agreements (€12.1m in 2021 vs €56.2m in 2020, -78.4%), and research tax credit (€10.3m in 2021 vs €13.1m in 2020, -21.2%):
Revenue from collaboration and licensing agreement with AstraZeneca amounted to €9.1m in 2021 (€49.0m in 2020, -81.4%) and mainly resulted from (i) the spreading of the upfront and opt-in payments received from AstraZeneca and (ii) the invoicing to AstraZeneca of certain fees for the work performed by Innate for the partnered programs. The variation between the two periods is notably explained by the (i) decrease in direct monalizumab research and development costs over the period, in connection with the Phase 1 & 2 trials maturity, and (ii) the absence of revenue relating to IPH5201 in 2021, the Company having fulfilled all of its commitments on preclinical work related to the start of Phase 1 as of December 31,2020.
Revenue of €3.0m from Sanofi following the initiation of a GLP-tox Study and the launching of the first Phase 1 clinical trial in humans in relapsed of refractory AML with IPH6101/SAR443579, respectively in January and December 2021.
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).
Operating expenses from continuing operations amounted to €72.5m in 2021 (2020: €68.7m, +5.6%):
General and administrative (G&A) expenses from continuing activities amounted to €25.5m in 2021 (2020: €19.0m, +34.4% 4). This increase results cumulatively from (i) an increase in wages mainly resulting from restructuring costs and higher annual bonuses level in 2021, (ii) an increase in non-scientific advisory fees and (iii) an increase in other general and administrative expenses.
Research and development (R&D) expenses from continuing activities amounted to €47.0m in 2021 (2020: €49.7m, -5.4%). This variation mainly results from a (i) decrease in depreciation and amortization of intangible assets acquired by the Company (IPH5201, fully amortized since December 2020, and monalizumab) partly offset by (ii) an increase in direct research and development expenses (clinical and non-clinical).
A net financial income of €2.3m in 2021 (2020: €1.9m loss).
A net loss from Lumoxiti discontinued operations of €7.3m in 2021 (2020 : net loss of €63.2m, -88.4%) mainly resulting from the Settlement Amount of $6.2m5 (€5.5m as of December 31, 2021) to be paid to AstraZeneca on April 30, 2022, as part of the Termination and Transition agreement effective as of June 30, 2021. The net loss in 2020 mainly resulted from the full impairment of Lumoxiti rights following the Company decision to return the marketing rights of Lumoxiti in the United States and in Europe to AstraZeneca.
A net loss of €52.8m in 2021 (2020: net loss of €64.0m).