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Innate Pharma(IPHA) - 2025 Q3 - Earnings Call Presentation
2025-11-13 13:00
Q3 2025 Business Update and Financial Results November 13 2025 This document contains data pertaining to the Company's potential markets and the industry and environment in which it operates. Some of this data comes from external sources that are recognized in the field or from Company's estimates based on such sources. This presentation discusses product candidates that are under clinical development, and which have not yet been approved for marketing by the U.S. Food and Drug Administration or the Europea ...
Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results
Businesswire· 2025-11-13 06:00
Core Insights - Innate Pharma reported strong execution across key programs, including FDA clearance for TELLOMAK-3, advancing lacutamab towards Phase 3 and potential accelerated approval in Sézary syndrome [2][13] - The company is on track for dose-escalation data from IPH4502 in the first half of 2026 and expects monalizumab PACIFIC-9 results in the second half of 2026 [2][5] - The cash position as of September 30, 2025, was €56.4 million, providing a runway until the end of Q3 2026 [5][17] Pipeline Highlights - Lacutamab is progressing towards Phase 3 initiation in H1 2026 after FDA clearance for the TELLOMAK-3 trial [5][13] - IPH4502, a Nectin-4 ADC, is in Phase 1 with enrollment progressing well and pharmacologically active dose reached [5][14] - Monalizumab PACIFIC-9 trial is ongoing, with data expected in H2 2026 [9][20] Financial Results - Revenues for the first nine months of 2025 were €2.3 million, down from €10.2 million in the same period in 2024 [18] - Financial liabilities amounted to €24.8 million as of September 30, 2025 [17] Corporate Update - The company is prioritizing investments in high-value clinical assets, including IPH4502, lacutamab, and monalizumab [3][20] - A redundancy plan is in place to streamline the organization, expected to be completed in the first half of 2026 [23]
Innate Pharma S.A. (IPHA) Analyst/Investor Day Transcript
Seeking Alpha· 2025-10-28 22:21
Core Perspective - The event focuses on the clinical and commercial outlook for lacutamab, highlighting its significance in the market [1][2]. Medical Perspective - The presentation will include insights from medical experts Pierluigi Porcu and Sonia Quaratino, discussing the landscape and future steps for lacutamab [2]. Commercial Perspective - Stéphanie Cornen from Innate and Chris Stuessy-Vidas from ZS Associates will present on the commercial opportunities for lacutamab, including new claims data that indicate a promising market potential [3].
Innate Pharma (NasdaqGS:IPHA) Update / Briefing Transcript
2025-10-28 13:00
Summary of Innate Pharma Update / Briefing (October 28, 2025) Company Overview - **Innate Pharma** is a biotechnology company with 26 years of experience, specializing in monoclonal antibody engineering and developing a clinical pipeline to address high unmet medical needs [3][4] Key Assets and Strategy - The company has refocused its strategy on three priority assets: 1. **Lacutamab**: An anti-KIR3DL2 antibody targeting cutaneous T cell lymphoma (CTCL) with breakthrough therapy designation from the FDA [6][7] 2. **Monalizumab**: In collaboration with AstraZeneca, currently in a Phase III study (PACIFIC-nine) with expected data in 2026 [8][9] 3. **IPH4502**: A novel antibody-drug conjugate (ADC) targeting NETIN4, with ongoing Phase I study and early clinical activity [10][12] Clinical Development and Regulatory Path - **Lacutamab**: - Targets CTCL, specifically mycosis fungoides and Sézary syndrome, with an accelerated path to approval agreed with the FDA [7][13] - A confirmatory Phase III study is planned to validate the indications and is expected to initiate in 2026 [17][73] - Anticipated regulatory milestones include: - Accelerated approval for Sézary syndrome in 2027 - Full approval for mycosis fungoides and Sézary syndrome in 2029 [81] - **Monalizumab**: - The PACIFIC-nine study has completed enrollment and passed a futility analysis, with significant potential financial milestones [9] - **IPH4502**: - Expected to provide early efficacy and safety data by the end of 2023 or early 2024 [12] Market Opportunity and Commercial Insights - The company has identified a significant commercial opportunity for lacutamab based on new claims data, indicating a larger market than previously estimated [17] - The CTCL market analysis conducted by ZS Associates highlights the prevalence and treatment patterns, emphasizing the need for effective therapies [85] Unmet Medical Needs in CTCL - CTCL, particularly Sézary syndrome and mycosis fungoides, presents significant unmet medical needs due to poor prognosis and limited effective therapies [21][46] - Current therapies often lack durable responses, leading to a need for continuous treatment and management of symptoms [47][49] - Lacutamab is positioned to address these needs with a favorable safety profile and potential for profound responses [71][72] Clinical Data Highlights - **TELEMAC Study**: Demonstrated rapid response rates and significant improvements in quality of life for patients with Sézary syndrome and mycosis fungoides [61][63] - Lacutamab showed a median time to global response of 2.8 months and a median duration of response of nearly 14 months in mycosis fungoides [63] Conclusion - Innate Pharma is strategically positioned to advance lacutamab through clinical trials and regulatory pathways, addressing significant unmet needs in the CTCL market while leveraging its expertise in monoclonal antibody development [4][73]
Innate Pharma to Host Analyst and Investor Event on Lacutamab on October 28, 2025
Businesswire· 2025-10-14 05:00
Core Insights - Innate Pharma SA is hosting an analyst and investor event focused on lacutamab, which has a potential path to Accelerated Approval based on long-term follow-up data from the Phase 2 TELLOMAK study [1] Company Overview - The event will provide clinical perspectives and market outlook for lacutamab, indicating the company's commitment to transparency and engagement with investors [1] Event Details - The event is scheduled for Tuesday, October 28, 2025, and will be held both in person and virtually, starting at 8:00 a.m. [1]
Innate Pharma(IPHA) - 2025 Q2 - Earnings Call Transcript
2025-09-17 13:02
Financial Data and Key Metrics Changes - For the first half of 2025, the company reported total revenue of EUR 4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [29] - Operating expenses reached EUR 30.3 million, with EUR 20.5 million in R&D and EUR 9.8 million in G&A expenses; R&D expenses decreased by 29% compared to the prior year [29] - As of June 30, 2025, the company had EUR 70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026 [29] Business Line Data and Key Metrics Changes - The company is focusing investments on three high-value clinical assets: IPH4502, lacutamab, and monalizumab, which are expected to create meaningful value [5][31] - IPH4502 is currently in phase one development, with enrollment on track to complete by the end of Q1 2026 [12] - Lacutamab has secured FDA breakthrough therapy designation and is preparing for phase III protocol submission [22][31] Market Data and Key Metrics Changes - The company identified approximately 1,000 Sézary syndrome patients in the U.S., with around 300 new cases each year, representing a significant market opportunity for lacutamab [25] - There are approximately 20,000 CTCL patients in the U.S., with an incidence of about 5,000 patients, suggesting a larger population than previously estimated [26] Company Strategy and Development Direction - The company has made a strategic decision to streamline its organization and focus on high-value clinical assets to drive forward programs that can make a significant difference [5][31] - The partnership with AstraZeneca for monalizumab is a significant value driver, with a total agreement worth up to $1.275 billion [28] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic refocus and the potential of the clinical pipeline to deliver value for patients and shareholders [31] - The restructuring plan is fully embedded into the cash runway, ensuring financial visibility until the end of Q3 2026 [54] Other Important Information - The Chief Scientific Officer responsibilities have been assumed by the COO following the departure of the CSO, who will continue to support the company as an advisor [6][7] Q&A Session Summary Question: What should we take away on the potential of targeting NK cells now that ANKET assets are not included in your prioritization today? - Management clarified that while NK cells are not the main priority, they are still working on NK cell programs and will base future decisions on clinical data [34][35] Question: Any commentary on where Sanofi is with the assets that they currently are developing? - Management indicated that Sanofi continues to progress the BCMA-targeted ANKET and expects updates in the near future [37] Question: Regarding the phase III start for lacutamab, should we still assume that unless you have a partner signed up ahead of the start of the study, it'll still be a wait and watch? - Management is actively working with investors and partners to keep options open for moving forward with lacutamab [38][39] Question: Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? - Management highlighted a focus on urothelial cancer patients who became refractory or resistant to PADCEV, with potential for accelerated market approval [40][41] Question: Can you provide an initial estimate of the investment requirements if you decide to go to trial without a partner? - Management refrained from providing specific cost estimates but indicated that it would be similar to standard oncology phase III trials [56]