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Innate Pharma (NasdaqGS:IPHA) 2025 Conference Transcript
2025-11-17 15:32
Summary of Innate Pharma Conference Call Company Overview - **Company**: Innate Pharma (NasdaqGS:IPHA) - **Industry**: Biotechnology, specifically focused on monoclonal antibodies and antibody-drug conjugates (ADCs) [3][4] Key Assets and Strategic Focus - **Current Assets**: Innate Pharma has eight assets in clinical development but is focusing on three key products: 1. **IPH4502**: Nectin-4 targeted ADC for solid tumors 2. **Lacutamab**: KIR3DL2 targeted antibody for cutaneous T-cell lymphoma (CTCL) 3. **Monalizumab**: NKG2A targeted antibody for stage III non-resectable non-small cell lung cancer (NSCLC) in collaboration with AstraZeneca [5][6] - **Organizational Changes**: The company downsized its workforce by 30% to allocate more resources towards advancing its clinical programs [6] Clinical Development Highlights Lacutamab - **Phase II Study**: Completed the TELLOMAK study for lacutamab, leading to a breakthrough therapy designation from the FDA for Sézary syndrome [7][21] - **Accelerated Approval Path**: The company has aligned with the FDA on a confirmatory phase III study for Sézary syndrome, which is expected to support a Biologics License Application (BLA) submission [7][8] - **Efficacy Data**: The phase II study showed an objective response rate of 42.9% and a progression-free survival (PFS) of 8.3 months in heavily pretreated patients [23] Monalizumab - **PACIFIC-9 Study**: Currently in a large randomized phase III study for NSCLC, with primary completion expected in June 2026. Positive results could yield $825 million in milestone payments [9][33] IPH4502 - **Differentiation**: IPH4502 is designed to target a broader range of Nectin-4 expressing tumors, including triple-negative breast cancer and prostate cancer. It utilizes an Exatecan payload, which has a different resistance profile compared to existing ADCs [10][12] - **Phase I Study**: Currently in phase I, with early signs of clinical activity observed at pharmacologically active doses [20][33] Market Potential and Commercial Strategy - **Sézary Syndrome**: Estimated 300 new patients annually in the U.S., with a potential market opportunity of up to $150 million [28][29] - **Mycosis Fungoides**: Approximately 3,000 new patients diagnosed each year, with a market potential of up to $500 million in the U.S. and Europe [29][30] - **Life Cycle Management**: Plans to expand the use of lacutamab to early-stage patients to improve quality of life and control symptoms [30] Upcoming Catalysts - **IPH4502 Data**: Expected data from the phase I study in early H1 next year [33] - **Lacutamab Phase III Initiation**: Anticipated to start in the first half of next year, leading to BLA submission for Sézary syndrome [34] - **PACIFIC-9 Results**: Primary endpoint results due in the second half of next year [34] Conclusion - Innate Pharma is strategically focusing on key assets with significant clinical and commercial potential, particularly in the treatment of rare cancers. The company is positioned for important upcoming milestones that could enhance its market presence and drive growth [34]
Innate Pharma(IPHA) - 2025 Q3 - Earnings Call Transcript
2025-11-13 14:00
Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of EUR 56.4 million, providing runway through the end of Q3 2026 to deliver on key milestones [26] Business Line Data and Key Metrics Changes - Lacutamab received FDA clearance to initiate the TELLOMAK III phase three trial in cutaneous T-cell lymphoma, with expectations for accelerated approval in Sézary syndrome based on robust phase two data [4][12] - IPH4502 is progressing well in its phase one trial, having reached a pharmacologically active dose and showing early signs of clinical activity [10][24] - Monalizumab is advancing in the PACIFIC-9 phase three trial, with top-line data expected in the second half of 2026 [11][24] Market Data and Key Metrics Changes - The annual incidence of Sézary syndrome is estimated at around 300 patients, with a prevalence of approximately 1,000 diagnosed patients in the U.S. [19] - For mycosis fungoides, approximately 3,000 new patients are diagnosed each year in the U.S., with one in four receiving systemic therapy [20] Company Strategy and Development Direction - The company is focusing investments on high-value clinical assets, including IPH4502, Lacutamab, and Monalizumab, while advancing next-generation ADC programs [6][24] - The development strategy for Lacutamab includes a stepwise approach starting with Sézary syndrome, followed by mycosis fungoides, and expanding to peripheral T-cell lymphoma [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory path for Lacutamab, indicating that the FDA has not requested additional substantial analyses beyond existing phase two data for accelerated approval [31] - There is growing momentum among KOLs for Lacutamab to become the preferred second-line option, with expectations that it may be used ahead of Mogamulizumab in mycosis fungoides [32][33] Other Important Information - The company is streamlining its organization to align with strategic objectives and ensure it remains fit for purpose [6] - The confirmatory phase three trial for Lacutamab is set to begin in the first half of 2026, with a potential BLA submission anticipated in early 2027 [12][31] Q&A Session Summary Question: What needs to be done for the potential Lacutamab commercial launch in Sézary syndrome? - The company aims to ensure Lacutamab is included in the NCCN guidelines prior to the BLA approval [27][28] Question: What can be expected from the upcoming data set for IPH4502? - The company hopes to present data from a cohort of patients in the Padcev resistance setting, with an interesting response rate and safety data [28][29] Question: Is the FDA looking for additional analyses for Lacutamab's accelerated approval? - The FDA has not indicated a need for further substantial analyses; the BLA approval will be based on existing TELLOMAK study data [31] Question: What are the expectations for the PACIFIC-9 study readout? - The company has good expectations based on previous studies, anticipating a positive outcome for the PACIFIC-9 study [40]
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 (NasdaqGS:IPHA) Earnings Call Presentation
2025-10-28 13:00
Lacutamab KOL Event Clinical perspectives and Commercial outlook New-York, October 28th, 2025 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 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" and similar expr ...
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(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 $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [29] - Operating expenses reached $30.3 million, with R&D expenses at $20.5 million, reflecting a 29% decrease compared to the prior year, while G&A expenses remained stable at $9.8 million [29] - As of June 30, 2025, the company had $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 and transform care [5][31] - IPH4502 is currently in phase one development, with enrollment progressing well and expected to complete by the end of Q1 2026 [12][15] - Lacutamab is close to finalizing the phase three protocol, with potential for accelerated approval in Sézary syndrome [16][21] 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 [24] - The total agreement for Monalizumab with AstraZeneca is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [28] Company Strategy and Development Direction - The company has made a strategic decision to streamline its organization and focus on high-value clinical assets, aligning its strategy, science, and investments [5][31] - The company is exploring partnerships and investor support to advance Lacutamab towards phase three, with a focus on maximizing value for both patients and shareholders [21][39] 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 [55] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a role as an advisor to the R&D Committee of the Board of Directors, ensuring continued collaboration [6] - The company is actively collecting additional market data for Lacutamab and plans to share insights at a focused investor event by the end of the year [26] Q&A Session Questions and Answers 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 [33][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 updates are expected soon [38] Question: Regarding the phase three 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 confirmed they are actively working with investors and partners to keep options open for advancing Lacutamab into phase three [39][40] Question: Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? - Management highlighted that IPH4502 could be effective in urothelial cancer patients who became refractory to enfortumab vedotin, with potential for accelerated market approval [41][42] Question: Can you provide an update on how enrollment has been progressing for IPH4502? - Management reported that enrollment is going extremely well, with plans to finish by Q1 2026 and a pool of data expected from 50-60 patients [46][48]
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 $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [28] - Operating expenses reached $30.3 million, with R&D expenses at $20.5 million, reflecting a 29% decrease compared to the prior year, while G&A expenses remained stable at $9.8 million [28] - As of June 30, 2025, the company had $70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026 [28] 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 [4][30] - IPH4502 is currently in phase one development, with enrollment progressing well and expected to complete by the end of Q1 2026 [11][14] - Lacutamab is close to completing the phase three protocol, with potential accelerated approval in Sézary syndrome anticipated by 2027 [21][25] 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 [24][25] - The total agreement with AstraZeneca for Monalizumab is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [27] 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 [4][30] - The company is actively working with investors and partners to secure funding for the phase three trial of Lacutamab, while also exploring options for IPH4502 [38][39] 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 [30] - The restructuring plan is fully embedded into the cash runway, ensuring financial visibility through the end of Q3 2026 [54] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a role as an advisor to the R&D Committee of the Board of Directors, ensuring continued collaboration [5] - The company is exploring the potential of IPH4502 in urothelial cancer patients who have become refractory to enfortumab vedotin, with a focus on addressing high unmet medical needs [41] 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 engagers and will base future decisions on clinical data [32][33] 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 updates are expected soon [37] Question: Regarding the phase three 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 confirmed they are actively working with investors and partners to keep options open for moving forward with Lacutamab [38] 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 are refractory to enfortumab vedotin, with potential for accelerated market approval [41] Question: Can you provide an initial estimate of the investment requirements if you decide to go to trial without a partner? - Management stated they would not normally communicate specific costs but indicated it would be similar to other oncology phase 3 trials [56]
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]
Innate Pharma(IPHA) - 2025 Q2 - Earnings Call Transcript
2025-09-17 13:00
Financial Data and Key Metrics Changes - For the first half of 2025, the company reported total revenue of $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [31] - Operating expenses reached $30.3 million, with R&D expenses at $20.5 million, reflecting a 29% decrease compared to the prior year, while G&A expenses remained stable at $9.8 million [31] - As of June 30, 2025, the company had $70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026 [31][33] 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 [6][33] - IPH4502 is currently in phase one development, with enrollment on track to complete by the end of Q1 2026 [13][15] - Lacutamab has received FDA breakthrough therapy designation and is preparing for a phase three trial, with a clear regulatory pathway for accelerated approval in Sézary syndrome [17][22] 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 [26] - The total agreement with AstraZeneca for Monalizumab is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [29] 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 [6][33] - The company is actively working to secure financing for Lacutamab's phase three trial and is exploring partnerships to maximize value for both patients and shareholders [22][28] Management's 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 [33] - The company is committed to advancing its ADC pipeline and expects to report preliminary safety and activity data for IPH4502 in the first half of 2026 [15][33] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a full-time academic role but will continue to support the company as an advisor [7] - The company is exploring the potential of IPH4502 in various tumor types with significant medical needs beyond urothelial cancer [12][15] 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 [36] 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 [40] Question: 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 till you get a partner? - Management confirmed they are actively working with investors and partners to keep options open for moving forward with Lacutamab [41] 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 to enfortumab vedotin, with potential for accelerated market approval [42] Question: How is enrollment progressing for IPH4502? - Management reported that enrollment is going extremely well, with plans to finish by Q1 2026 and a pool of data expected from 50-60 patients [48] Question: Does the new strategic focus mean the ANKET® assets will not be progressed irrespective of clinical data? - Management reiterated that decisions on ANKET® assets will be based on clinical data and market relevance [50]