Innate Pharma(IPHA)
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Innate Pharma S.A. (IPHA) First Half 2022 Financial Results and Business Update Transcript
2022-09-15 18:44
Summary of Innate Pharma S.A. First Half 2022 Financial Results and Business Update Company Overview - **Company**: Innate Pharma S.A. (NASDAQ: IPHA) - **Date of Call**: September 15, 2022 - **Participants**: CEO Mondher Mahjoubi, CFO Frédéric Lombard, and other executives Key Industry and Company Insights Strategic Priorities - **Three Key Priorities**: 1. **Near-term Value Creation**: Focus on lead asset lacutamab for T cell lymphoma with expected readouts in H2 2022 [6] 2. **Mid to Long-term Pipeline Development**: Emphasis on antibody engineering capabilities, particularly the ANKET platform [6] 3. **Sustainable Business Foundation**: Building partnerships across industry and academia, including ongoing collaborations with AstraZeneca [7] Pipeline Overview - **Lacutamab**: - First-in-class monoclonal antibody targeting KIR3DL2, with promising data from ongoing trials [10] - Fast Track designation in the U.S. and PRIME designation in the EU [11] - Enrollment on track for both Sézary syndrome and mycosis fungoides [11] - **Monalizumab**: - Licensed to AstraZeneca, currently in lung cancer trials [12] - Phase 3 trial PACIFIC9 initiated based on promising Phase 2 COAST data [13][14] - **Adenosine Pathway Assets**: - Progressing anti-CD39 (IPH5201) to Phase 2 in collaboration with AstraZeneca, with a $5 million milestone payment received [16] - Anti-CD73 (IPH5301) in an investigator-sponsored Phase 1 trial [16] Financial Highlights - **Cash Position**: €158.2 million as of June 30, 2022, providing a runway into H2 2024 [21][68] - **Revenue**: €45.6 million in H1 2022, up from €14.7 million in H1 2021, primarily from collaboration and licensing agreements [22] - **R&D Expenses**: Increased to €25 million, representing 67.3% of total operating expenses [22] Future Milestones - **Clinical Readouts**: Anticipated data from lacutamab trials and updates on the ANKET platform in the coming years [24] - **Partnership Strategy**: Open to collaborations for early-stage R&D and later-stage opportunities to maximize asset potential [58] Additional Important Insights - **Regained Rights**: Innate Pharma has regained rights to four preclinical molecules from AstraZeneca, which will be further developed [8][42] - **Market Potential**: Significant unmet medical need in peripheral T-cell lymphoma, with approximately 20,000 new diagnoses annually [57] - **Collaboration with AstraZeneca**: Despite setbacks, the partnership remains strong, with ongoing development of key assets [60][63] Conclusion - Innate Pharma is strategically positioned to leverage its innovative pipeline and partnerships to create value for patients and shareholders, with a strong financial foundation supporting its growth initiatives [68]
Innate Pharma(IPHA) - 2022 Q2 - Earnings Call Presentation
2022-09-15 14:03
Half Year 2022 Financial Results and Business Update September 15, 2022 PARIS: IPH.PA NASDAQ: IPHA © 2021 Innate Pharma. All rights reserved. Disclaimer on Forward-Looking Information and Risk Factors This document has been prepared by Innate Pharma S.A. (the "Company") solely for the purposes of a presentation to investors concerning the Company. This document is not to be reproduced by any person, nor to be distributed. This document contains forward-looking statements. The use of certain words, including ...
Innate Pharma(IPHA) - 2022 Q2 - Quarterly Report
2022-09-15 10:12
INNATE PHARMA SA HALF-YEAR FINANCIAL REPORT JUNE 30, 2022 INNATE PHARMA S.A. French société anonyme governed by an Executive Board and a Supervisory Boardé with a share capital of 3,995,355.70 euros composed of 79,893,019 ordinary shares, and 14,095 preferred shares with a nominal value of 0.05 euros each Registered office: 117, Avenue de Luminy, F-13009 Marseille, France Registered with the Company and Trade Register of Marseille under number 424 365 336 The following interim condensed consolidated financi ...
Innate Pharma(IPHA) - 2022 Q1 - Earnings Call Transcript
2022-05-14 15:08
Innate Pharma SA (NASDAQ:IPHA) Q1 2022 Earnings Conference Call May 10, 2022 8:00 AM ET Company Participants Henry Wheeler - VP and Head of IR Mondher Mahjoubi - Chairman of Executive Board and CEO Joyson Karakunnel - Executive VP and Chief Medical Officer Yannis Morel - Executive VP of Product Portfolio Strategy and Business Development and Member of Executive Board Conference Call Participants Daina Graybosch - SVB Leerink Olga Smolentseva - Bryan Garnier Jingming Chen - Evercore Arthur He - H.C. Wainwrig ...
Innate Pharma (IPHA) Investor Presentation - Slideshow
2022-04-08 16:49
Company Overview March 2022 PARIS: IPH.PA NASDAQ: IPHA © 2020 Innate Pharma. All rights reserved. Disclaimer on Forward-Looking Information and Risk Factors This document has been prepared by Innate Pharma S.A. (the "Company") solely for the purposes of a presentation to investors concerning the Company. This document is not to be reproduced by any person, nor to be distributed. This document contains forward-looking statements. The use of certain words, including "believe," "potential," "expect" and "will" ...
Innate Pharma(IPHA) - 2021 Q4 - Annual Report
2022-04-04 10:19
Financial Performance - Revenue for the year ended December 31, 2021, was €24,703 thousand, a significant decrease from €69,773 thousand in 2020, representing a decline of approximately 64.7%[34] - Operating income for 2021 was a loss of €47,825 thousand, compared to a profit of €1,079 thousand in 2020, indicating a substantial deterioration in operational performance[34] - Net income from continuing operations for 2021 was a loss of €45,478 thousand, compared to a loss of €829 thousand in 2020, reflecting a worsening financial position[34] - Total assets decreased from €401,361 thousand in 2019 to €267,496 thousand in 2021, a decline of approximately 33.3%[35] - Total shareholders' equity fell from €217,416 thousand in 2019 to €107,440 thousand in 2021, a decrease of about 50.7%[35] - The Company incurred net losses of €(52.8) million and €(64.0) million for the years ended December 31, 2021 and 2020, respectively, primarily due to research and development costs and selling, general, and administrative expenses[160] - As of December 31, 2021, the Company had cash, cash equivalents, short-term investments, and non-current financial assets totaling €159.7 million, which it believes will fund operations for the next twelve months[166] Product Development and Clinical Trials - The company is focusing on developing its proprietary and partnered product candidates in immuno-oncology, with several candidates currently in clinical trials[40] - Monalizumab, one of the key product candidates, is being evaluated in multiple Phase 1, 2, and 3 clinical trials under a co-development agreement with AstraZeneca[55] - The company intends to continue developing its clinical-stage product candidates, including lacutamab and avdoralimab, with ongoing trials in various cancer indications[55] - The most advanced product candidate, IPH6101, is currently in a phase 1 clinical trial, while two other trispecific antibodies are in preclinical stages, and IPH65 is moving towards an Investigational New Drug application[59] - Clinical trials are expensive and time-consuming, with potential delays that could impact the Company's ability to generate revenue and complete product development[61] - Patient enrollment for clinical trials is critical and may be hindered by factors such as limited patient populations for rare diseases, which could delay trial completion and regulatory approval[66] - The Company faces substantial risks related to the failure of product candidates' development, particularly due to their early stage in the pipeline, which could adversely impact its business and financial condition[57] - The Company is developing a broad pipeline of product candidates, including monalizumab, lacutamab, avdoralimab, IPH5201, and IPH5301, but may struggle to identify additional candidates due to various challenges[58] Regulatory and Compliance Challenges - The success of the company's product candidates is contingent upon obtaining positive results in clinical trials and regulatory approvals[41] - Regulatory approval processes are complex and can lead to delays or additional costs, impacting the Company's ability to commercialize its product candidates[73] - The Company has never submitted a product candidate for marketing approval in the United States or the European Union, which may limit its market entry opportunities[76] - The use of innovative technologies like the ANKET platform introduces additional risks in product candidate development, which could affect the overall pipeline[59] - Adverse side effects from product candidates could halt or delay clinical development and regulatory approval, impacting the Company's business prospects[67] - The Company expects to submit a Biologic License Application (BLA) to the FDA for marketing authorization of its product candidates[77] - Regulatory processes are complex and vary widely among countries, potentially delaying authorization and increasing costs[78] - A small percentage of drugs in development globally successfully complete the regulatory approval process, impacting the Company's financial condition[79] - Marketing authorization in one jurisdiction does not guarantee approval in others, which could limit market expansion[81] - The Company must obtain separate marketing approvals in jurisdictions outside the United States and Europe, which may involve additional testing and regulatory requirements[84] - The Company’s product candidates, if approved, will be subject to continuous regulatory review, which could lead to restrictions or withdrawal of marketing authorization[113] - The Company is subject to complex and changing regulatory requirements across multiple jurisdictions, which may impact its operations and financial condition[123] Market and Competitive Landscape - The Company may face competition from larger pharmaceutical companies with greater resources, which could affect its market position and profitability[71] - The company believes that pricing pressures will continue to increase, making it difficult to sell future product candidates at acceptable prices[104] - The company’s future growth depends on its ability to penetrate multiple markets, which will expose it to additional regulatory burdens and risks[111] - The company faces potential penalties from federal programs if commercial prices increase faster than the consumer price index, which may affect its pricing strategies[100] - Coverage and reimbursement from government authorities and third-party payors are critical for the successful commercialization of the Company's product candidates[91] Financial and Operational Risks - The Company may need to raise additional funding to complete the development and commercialization of its product candidates, which may not be available on acceptable terms[163] - The Company faces risks related to collaboration agreements, including potential termination or non-compliance by partners, which could adversely affect its business and financial condition[157] - The Company is subject to loan agreements that impose restrictions on its financial flexibility, which could limit its operational capabilities[169] - The Company has incurred operational losses since inception, except for the years 2016 and 2018, indicating ongoing financial challenges[160] - The Company relies on third-party manufacturers for all product candidates, which introduces risks related to quality, delivery times, and compliance with regulations[135] - Manufacturing issues have previously led to delays in clinical trials, such as the limitation on patient enrollment in the Phase 1 trial of lacutamab due to supply constraints[137] - The Company is dependent on a limited number of suppliers for key components, which poses risks if these suppliers fail to remain operational or compliant[141] Internal Controls and Governance - Innate Pharma's internal control over financial reporting has faced material weaknesses, which could affect the accuracy and timeliness of its financial reporting[191] - A material weakness in internal control was identified, which could lead to material misstatements in financial statements if not adequately addressed[195] - The Company has observed significant progress in improving the reliability of its internal control system, particularly in processing manual entries and handling complex transactions[194] Human Resources and Organizational Challenges - The Company had 214 employees as of December 31, 2021, and plans to recruit additional personnel to support its development and operational strategies[201] - The Company has experienced strong growth in headcount over the last five years, but rapid changes may lead to employee turnover and loss of expertise[197] - Employee misconduct poses a risk to Innate's business, potentially leading to regulatory sanctions and harm to its reputation[229] External Factors and Risks - The COVID-19 pandemic has had a significant impact on the Company's operations, including delays in clinical trials and potential disruptions in the supply chain[207] - The Company is exposed to risks related to cybersecurity, which could disrupt product development and operations[214] - The Company must comply with various environmental, health, and safety regulations, and failure to do so could result in fines and operational suspensions[222] - The Company has implemented fire prevention measures at its headquarters in Luminy, France, but remains at risk of forest fires that could cause financial losses and operational delays[218] Strategic Collaborations and Future Opportunities - The Company relies on collaboration agreements with AstraZeneca and Sanofi for the development of its product candidates, including monalizumab and IPH6101, and may seek additional collaborations[156] - The Company has established collaborations with academic and non-profit institutions to enhance research efforts, which may involve strategic transactions or joint ventures[176] - The Company may pursue acquisitions to grow its business, but there is no guarantee that expected benefits or synergies will be realized[231]
Innate Pharma(IPHA) - 2021 Q4 - Earnings Call Transcript
2022-03-24 18:35
Financial Data and Key Metrics Changes - Cash and cash equivalents amounted to €159.7 million as of December 31, 2021, including a state-guaranteed loan of €28.7 million received in December 2021 [31] - Revenue and other income totaled €24.7 million, primarily from collaboration and licensing agreements and governmental funding [33] - Operating expenses were €72.5 million, a 5% increase compared to 2020, with R&D expenses at €47 million, decreasing by 5% [34] Business Line Data and Key Metrics Changes - The lead proprietary product candidate, lacutamab, is in development for T-cell lymphoma, with significant progress in clinical trials [6][9] - The company initiated two trials in the larger indication of peripheral T-cell lymphoma [10] - Monalizumab, an anti-NKG2A, is involved in two ongoing Phase 3 trials in lung cancer and head and neck cancer [20][24] Market Data and Key Metrics Changes - The market for Sézary syndrome is niche, with about 100 to 200 new cases annually, while mycosis fungoides represents a larger opportunity with approximately 3,000 to 4,000 new patients each year [78] - The cutaneous T-cell lymphoma market is not large compared to peripheral T-cell lymphoma, which has nearly 20,000 new patients annually [78] Company Strategy and Development Direction - The company focuses on three key priorities: advancing lacutamab, leveraging antibody engineering capabilities, and building sustainable partnerships [6] - The ANKET platform is being developed to create a new class of tri- and tetra-specific molecules for cancer treatment [25][27] - The company aims to position itself for long-term value creation through strategic investments and partnerships [43] Management Comments on Operating Environment and Future Outlook - Management expects to report preliminary data from the TELLOMAK study for lacutamab in the second half of 2022 [40] - The company is optimistic about the development of the ANKET technology platform and its potential in the clinic [42] - There is a focus on advancing the adenosine pathway agents, with data from anti-CD39 expected in 2023 [41] Other Important Information - The company has a strong cash position, estimated to fund operations through at least 2023 [37] - The interim analysis for the INTERLINK study is expected in the second half of 2022 [69] Q&A Session Summary Question: Can you confirm the purpose of the new all-comers cohort in mycosis fungoides? - The all-comers cohort will evaluate an FFPE companion diagnostic approach and is integrated into the TELLOMAK study without delaying development [50] Question: What is the regulatory strategy for Sézary syndrome? - The initial strategy is a fast-to-market approach, with potential for a combined registration for both Sézary syndrome and mycosis fungoides [71] Question: What are the challenges and opportunities in developing tetra ANKET products? - The main opportunity lies in the safety of NK-cell engagers compared to T-cell engagers, while challenges include ensuring the safety profile translates into clinical benefits [78]
Innate Pharma(IPHA) - 2021 Q3 - Earnings Call Transcript
2021-11-16 18:24
Innate Pharma S.A. (NASDAQ:IPHA) Q3 2021 Results Earnings Conference Call November 16, 2021 8:00 AM ET Company Participants Mondher Mahjoubi - Chairman of Executive Board and Chief Executive Officer Joyson Karakunnel - Executive Vice President and Chief Medical Officer Yannis Morel - Executive Vice President, Product Portfolio Strategy and Business Development Conference Call Participants Yigal Nochomovitz - Citigroup Daina Graybosch - SVB Leerink Keyur Parekh - Goldman Sachs Olga Smolentseva - Bryan Garnie ...
Innate Pharma(IPHA) - 2021 Q3 - Earnings Call Presentation
2021-11-16 14:51
Third Quarter 2021 Business Update November 16, 2021 PARIS: IPH.PA NASDAQ: IPHA © 2021 Innate Pharma. All rights reserved. Disclaimer on Forward-Looking Information and Risk Factors This document has been prepared by Innate Pharma S.A. (the "Company") solely for the purposes of a presentation to investors concerning the Company. This document is not to be reproduced by any person, nor to be distributed. This document contains forward-looking statements. The use of certain words, including "believe," "potent ...
Innate Pharma(IPHA) - 2021 Q2 - Earnings Call Transcript
2021-09-15 18:16
Financial Data and Key Metrics Changes - Cash and cash equivalents amounted to €159.4 million as of June 30, 2021, down from €181.7 million at the end of Q1 2021, indicating a strong financial position to fund operations at least until 2022 [31] - Revenue and other income totaled €15.7 million, primarily from collaboration and licensing agreements, with no cash impact from this revenue [34] - Operating expenses for the first half of 2021 were €41.1 million, an 11% reduction from the first half of 2020, with R&D expenses decreasing to €21.8 million [35] Business Line Data and Key Metrics Changes - The lead asset, lacutamab, is in development for T cell lymphoma, with promising data from the Phase 2 TELLOMAK trial for Sézary syndrome and mycosis fungoides [10][15] - The company is advancing its multi-specific NK cell engager platform, ANKET, which has shown technological and efficacy breakthroughs [22][23] - The collaboration with AstraZeneca on monalizumab has generated $400 million in milestones to date, with ongoing trials in head and neck cancer and non-small cell lung cancer [27][28] Market Data and Key Metrics Changes - The company is targeting a niche market with approximately 8,000 patients with cutaneous T cell lymphoma, with a significant portion expressing KIR3DL2, which lacutamab targets [67] - The potential market for peripheral T cell lymphoma (PTCL) is larger, with over 18,000 new cases annually, indicating a compelling business case for lacutamab [68] Company Strategy and Development Direction - The strategy focuses on three core priorities: advancing lacutamab, leveraging antibody engineering capabilities for innovative molecules, and building sustainable partnerships [7][9] - The company aims to create near-term value through lacutamab while fueling long-term growth with its NK cell engager platform [8][9] - The development plan includes expanding lacutamab's use beyond Sézary syndrome to other T cell lymphomas, enhancing its market potential [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential for lacutamab to address significant unmet medical needs in T cell lymphomas [40][41] - The company anticipates reporting pivotal data for lacutamab in Sézary syndrome and mycosis fungoides in 2022, along with updates on the ANKET platform [42][43] Other Important Information - The company is efficiently managing resources and exploring strategic opportunities to enhance its impact [32] - The cash burn rate has decreased compared to the previous year, indicating improved financial management [86] Q&A Session Summary Question: Overlap in efficacy and read-through from concept to proof-of-concept study for monalizumab - Management noted that the NeoCOAST data is run by AstraZeneca, and they expect data in the second half of 2021 [51] Question: Percent improvement in ORR and PFS for monalizumab plus durvalumab - Management emphasized the importance of both ORR and PFS as key endpoints, with full data expected at ESMO [62] Question: Identifying Sézary syndrome and mycosis fungoides patients - Management explained that the strategy is to validate the mechanism of action in Sézary syndrome before expanding to mycosis fungoides and PTCL [66] Question: Differences between IPH5301 and AstraZeneca's asset - Management highlighted the superior enzymatic activity of their anti-CD73 compared to competitors, with plans to start clinical trials soon [80] Question: Financing options and cash runway - Management confirmed a robust cash position and ongoing monitoring of financial needs, with potential financing options being explored [89]