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Corvus Pharmaceuticals(CRVS) - 2025 Q4 - Earnings Call Transcript
2026-03-12 21:32
Financial Data and Key Metrics Changes - Research and development (R&D) expenses in Q4 2025 totaled $9.9 million, up from $6 million in Q4 2024, with full-year R&D expenses reaching $33.7 million compared to $19.4 million in 2024, primarily due to higher clinical trial and manufacturing costs for soquelitinib and increased personnel costs [4] - The net loss for Q4 2025 was $12.3 million, slightly higher than the net loss of $12.1 million in Q4 2024, with total stock compensation expense increasing to $1.6 million from $0.8 million in the same period [5] - As of December 31, 2025, cash equivalents and marketable securities totaled $56.8 million, up from $52 million at the end of 2024, with pro forma cash including recent financing reaching approximately $246 million, extending the cash runway into Q2 2028 [6][7] Business Line Data and Key Metrics Changes - Significant progress was made in the development of soquelitinib, with promising results from clinical trials in peripheral T-cell lymphoma and atopic dermatitis, indicating its potential as a leading therapy for these conditions [8][9] - The phase I trial results for soquelitinib showed a mean percent reduction in EASI of 72% versus 40% for placebo, with 75% of patients achieving EASI 75 [12] Market Data and Key Metrics Changes - The company is entering 2026 with ongoing enrollment in its phase III PTCL trial and a recently initiated phase II atopic dermatitis trial, with plans to expand into mid-stage trials for other inflammatory diseases later in the year [9][10] - Market research indicates that soquelitinib's profile could significantly advance treatment options for patients with atopic dermatitis, with a unique mechanism of action and favorable safety profile [11][22] Company Strategy and Development Direction - The company aims to leverage the unique mechanism of action of soquelitinib to address multiple inflammatory diseases and cancers, with ongoing trials and data presentations planned for 2026 [9][28] - The strategy includes expanding into additional indications such as hidradenitis suppurativa and asthma, with a focus on the drug's durability and efficacy in patients who have failed prior therapies [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of soquelitinib, highlighting its promising clinical data and the opportunity to unlock its full potential in various immune inflammatory diseases [28] - The company is optimistic about the upcoming data readouts from ongoing trials, which are expected to provide further insights into the drug's efficacy and safety [9][34] Other Important Information - The company plans to present additional data from its phase I clinical trials at upcoming medical meetings, emphasizing the importance of biomarker results and the drug's mechanism of action [23][24] - Collaboration with Angel Pharmaceuticals for a phase Ib/II trial in China is ongoing, with initial data expected later this year [24] Q&A Session Summary Question: Regarding the upcoming data readouts for PTCL and the China study - Management anticipates initial data from Angel Pharmaceuticals' trial later this year, with further data expected in mid-2027 from the phase II study [32][34] Question: Expectations for the SID meeting presentation - Management indicated that the presentation will focus on durability and new biomarkers related to soquelitinib's mechanism of action [38][39] Question: Efficacy benchmarks for the phase II trial in hidradenitis suppurativa - Management expects efficacy to be comparable or better than existing biologics, with ongoing assessments to determine optimal dosing [42] Question: Insights on the ALPS trial and its implications for other indications - Management noted that while ALPS results are promising, they do not directly predict outcomes for other diseases but indicate the drug's potential in managing aberrant autoinflammatory responses [68] Question: Durability of response in the phase II trial - The phase II trial includes a follow-up period of 90 days post-treatment, although the primary endpoint focuses on EASI scores at 12 weeks [94][96] Question: Target populations for the upcoming asthma study - Management is considering a broad patient population for the asthma study, without restricting to specific subtypes, and is still finalizing the study protocol [100]
Corvus Pharmaceuticals(CRVS) - 2025 Q4 - Earnings Call Transcript
2026-03-12 21:32
Financial Data and Key Metrics Changes - Research and development (R&D) expenses in Q4 2025 totaled $9.9 million, up from $6 million in Q4 2024. For the full year 2025, R&D expenses were $33.7 million compared to $19.4 million in 2024, primarily due to higher clinical trial and manufacturing costs associated with soquelitinib and increased personnel costs [4][5] - The net loss for Q4 2025 was $12.3 million, slightly higher than the net loss of $12.1 million in Q4 2024. Non-cash losses included $0.7 million in Q4 2025 and $2.2 million in Q4 2024 from equity method investments [5] - As of December 31, 2025, cash equivalents and marketable securities totaled $56.8 million, an increase from $52 million at the end of 2024. Following a public offering, pro forma cash was approximately $246 million, extending the cash runway into Q2 2028 [6][7] Business Line Data and Key Metrics Changes - Significant progress was made in the development of soquelitinib, with promising results from clinical trials in peripheral T-cell lymphoma and atopic dermatitis. The company is entering 2026 with ongoing enrollment in a phase 3 PTCL trial and a newly initiated phase 2 atopic dermatitis trial [8][9] - The phase 1 trial results for soquelitinib showed a mean percent reduction in EASI of 72% versus 40% for placebo, with 75% of patients achieving EASI 75 [12][13] Market Data and Key Metrics Changes - The company is focusing on expanding soquelitinib's application in various inflammatory diseases, including hidradenitis suppurativa and asthma, with plans to initiate trials later in 2026 [9][26] - The market research indicates that soquelitinib's profile could significantly advance treatment options for patients with atopic dermatitis, particularly due to its oral administration and novel mechanism of action [11][21] Company Strategy and Development Direction - The company aims to leverage the unique mechanism of action of soquelitinib to address multiple inflammatory diseases and cancers, with a strong focus on clinical data and biomarker analysis to support its therapeutic potential [21][27] - The strategy includes expanding into mid-stage trials for other inflammatory diseases and maintaining a robust pipeline for soquelitinib, which is expected to be a leading option for treating moderate to severe atopic dermatitis [9][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of soquelitinib, highlighting its safety profile and efficacy in patients who have failed prior therapies. The company anticipates significant data readouts in 2026 that will inform future development [9][27] - The management team emphasized the importance of ongoing clinical trials and the potential for soquelitinib to provide durable responses in patients, which could change treatment paradigms in inflammatory diseases [27][98] Other Important Information - The company plans to present additional data from the phase 1 clinical trial at the Society for Investigative Dermatology annual meeting, focusing on biomarker results and durability of response [22] - The phase 2 trial in atopic dermatitis will enroll 200 patients, with results expected in mid-2027, while the PTCL trial will have an interim analysis later this year [24][25] Q&A Session Summary Question: Regarding the upcoming data readouts for PTCL and the China study - Management anticipates initial data from Angel Pharmaceuticals' trial later this year, with further data expected in 2027. The PTCL trial will have an interim review later this year [32][34] Question: Expectations for the SID meeting presentation - Management indicated that the durability of response and new biomarkers will be key focuses of the presentation [38][39] Question: Efficacy benchmarks for the phase 2 trial in hidradenitis suppurativa - Management expects efficacy to be comparable or better than existing biologics in the market [42] Question: Updates on the phase 2 trial in atopic dermatitis - The phase 2 trial is blinded and randomized, with no interim data expected until completion. However, updates from the Angel trial will provide interim insights [52][53] Question: Insights on the ALPS trial and its implications - Management noted that while ALPS results are promising, they do not directly predict outcomes for other indications but indicate the drug's activity in autoimmune responses [70][71] Question: Durability of response in the phase 2 trial - The phase 2 trial includes a follow-up period of 90 days post-treatment, but the primary endpoint will focus on EASI scores at 12 weeks [96][99] Question: Asthma trial design considerations - Management is considering a broad patient population for the asthma trial, without restricting to TH2 high patients, and is still finalizing the protocol [100][102]
Corvus Pharmaceuticals(CRVS) - 2025 Q4 - Earnings Call Transcript
2026-03-12 21:30
Financial Data and Key Metrics Changes - Research and development (R&D) expenses in Q4 2025 totaled $9.9 million, up from $6 million in Q4 2024, with full-year R&D expenses reaching $33.7 million compared to $19.4 million in 2024, primarily due to higher clinical trial and manufacturing costs for soquelitinib and increased personnel costs [4] - Net loss for Q4 2025 was $12.3 million, slightly higher than the net loss of $12.1 million in Q4 2024, with total stock compensation expense increasing to $1.6 million from $0.8 million in the same period [5] - As of December 31, 2025, cash equivalents and marketable securities totaled $56.8 million, up from $52 million at the end of 2024, with pro forma cash including net proceeds from a public offering amounting to approximately $246 million, extending the cash runway into Q2 2028 [6] Business Line Data and Key Metrics Changes - Significant progress was made in the development of soquelitinib, with ongoing enrollment in the phase 3 trial for peripheral T-cell lymphoma (PTCL) and a recently initiated phase 2 trial for atopic dermatitis [9] - The phase 1 trial results for soquelitinib in atopic dermatitis showed a mean percent reduction in EASI of 72% compared to 40% for placebo, with 75% of patients achieving EASI 75 [12] Market Data and Key Metrics Changes - The company is entering 2026 with strong investor interest, highlighted by a $200 million financing, reflecting confidence in the potential of soquelitinib and ITK inhibition [8] - The phase 1 trial data presented at the ASH annual meeting indicated that soquelitinib could be a leading therapy for atopic dermatitis and other inflammatory diseases, with a favorable comparison to existing treatments [25] Company Strategy and Development Direction - The company plans to expand its clinical trials for soquelitinib into mid-stage trials for other inflammatory diseases such as hidradenitis suppurativa and asthma later in the year [9] - The strategy focuses on leveraging the unique mechanism of action of soquelitinib to address multiple inflammatory diseases, with ongoing research into its safety and efficacy [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of soquelitinib across various indications, emphasizing the drug's unique properties and the promising clinical data supporting its use [27] - The company is optimistic about the upcoming data readouts from ongoing trials, which are expected to provide further insights into the drug's efficacy and safety [33] Other Important Information - The company is collaborating with Angel Pharmaceuticals for a phase 1b/2 trial in China, which is expected to provide additional data on soquelitinib's efficacy in atopic dermatitis [21] - The phase 2 trial for atopic dermatitis is set to enroll 200 patients, with results anticipated in mid-2027 [24] Q&A Session Summary Question: Regarding the upcoming data readouts for PTCL and the China study - Management indicated that initial data from Angel Pharmaceuticals' trial will be available later this year, with further data expected in 2027 [31][33] Question: Expectations for the SID meeting presentation - Management highlighted that the presentation will focus on durability and new biomarkers related to soquelitinib's mechanism of action [37] Question: Insights on the phase 2 trial in hidradenitis suppurativa - Management stated that they expect efficacy to be comparable or better than existing biologics, with ongoing assessments to determine optimal dosing [40] Question: Comments on the ALPS trial and its implications - Management noted that while results from the ALPS trial are promising, they do not directly predict outcomes for other autoimmune diseases [68] Question: Enrollment dynamics in the PTCL trial - Management confirmed that the trial is progressing well, with patients being randomized to receive either soquelitinib or standard care options [72][75] Question: Durability of response in the phase 2 trial - Management confirmed that the phase 2 trial includes a follow-up period to assess durability, although the primary endpoint remains the EASI score at 12 weeks [93]
Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-03-12 20:01
Core Insights - Corvus Pharmaceuticals announced positive safety and efficacy results from cohort 4 of the Phase 1 trial for soquelitinib in atopic dermatitis, indicating its potential as a new treatment option for patients with immune diseases [1][3][4] - The company initiated a Phase 2 trial for soquelitinib in atopic dermatitis, aiming to enroll approximately 200 patients who have failed prior therapies [4][5] Business Update and Strategy - Corvus completed a public offering, raising net proceeds of $189 million, which extends its cash runway into the second quarter of 2028 [2][8] - The company is focusing on ongoing enrollment in a Phase 3 trial for peripheral T cell lymphoma (PTCL) and has plans to initiate two additional Phase 2 trials in asthma and hidradenitis suppurativa later this year [3][4] Efficacy and Safety Highlights - In cohort 4, 75% of patients achieved EASI 75, 25% achieved EASI 90, and 33% achieved IGA 0/1, compared to 20%, 0%, and 0% in the placebo group [4] - No new safety signals were observed, and no severe adverse events were reported across over 150 patients treated with soquelitinib [4][11] Financial Results - As of December 31, 2025, Corvus reported cash, cash equivalents, and marketable securities of $56.8 million, an increase from $52.0 million in 2024 [8][23] - Research and development expenses for the year totaled $33.7 million, up from $19.4 million in 2024, primarily due to higher clinical trial costs [9][21] Clinical Trials and Collaborations - Corvus is conducting a Phase 2 clinical trial for Autoimmune Lymphoproliferative Syndrome (ALPS) in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), aiming to enroll up to 30 patients [6] - The company is also advancing its next-generation ITK inhibitor preclinical candidates for specific immunology and oncology indications [5][13]
Corvus Pharmaceuticals (NasdaqGM:CRVS) FY Conference Transcript
2026-02-26 20:42
Corvus Pharmaceuticals Conference Call Summary Company Overview - **Company**: Corvus Pharmaceuticals (NasdaqGM:CRVS) - **Focus**: Development of first-in-class immune modulators for oncology and immune-mediated diseases, particularly atopic dermatitis and peripheral T-cell lymphoma [2][3] Key Product: Soquelitinib - **Description**: A novel oral therapy targeting interleukin-2-inducible T-cell kinase (ITK), showing promise in treating atopic dermatitis and other immune diseases [2][3] - **Current Trials**: - Phase 3 trial for peripheral T-cell lymphoma ongoing, with interim analysis expected by year-end 2026 [3][4] - Phase 2 trial for atopic dermatitis to start soon, with data expected in approximately 18 months [4] - Two additional Phase 2 proof-of-concept studies in asthma and hidradenitis suppurativa (HS) planned for this year [4] Clinical Trial Results - **Efficacy in Atopic Dermatitis**: - 75% of patients achieved EASI-75, 25% achieved EASI-90, and 33% achieved IGA 0/1 after 8 weeks of treatment [11][24] - Mean EASI score reduction of 72% compared to 40% in placebo [24] - Durability of response observed, with continued reductions in EASI scores even after treatment cessation [11][20] - **Patient Population**: Included patients who had failed prior systemic therapies, demonstrating efficacy in a typically excluded population [31][32] Safety Profile - **Safety Observations**: No new safety signals reported in the extended 8-week treatment duration; adverse events (AEs) were similar between active and placebo groups [32][33] - **Specific AEs**: No significant lab abnormalities or infections reported; no injection site reactions due to the oral administration of soquelitinib [33] Market Opportunity - **Atopic Dermatitis Market**: - Affects approximately 30 million patients in the G7, with the market projected to grow from $12 billion in 2023 to $28 billion by 2030 [37] - Significant unmet need for oral therapies, as only about 10% of eligible patients are currently receiving advanced treatments [37] - **Commercial Potential**: The immune-mediated (IM) market is expected to reach $170 billion by 2030, with oral agents representing a small fraction of this potential [10] Competitive Advantage - **Mechanism of Action**: Soquelitinib modulates multiple inflammatory pathways, differentiating it from other therapies that typically target single cytokines [8][9] - **Intellectual Property**: Strong IP protection for soquelitinib, with composition of matter protection extending through 2037 [3] Upcoming Milestones - **Future Trials**: Phase 2 trial for atopic dermatitis to enroll 200 patients, with results expected in 2026 [36] - **Data Presentations**: Upcoming presentations at AAD and SID meetings to share further data [45] Conclusion - **Overall Assessment**: Soquelitinib is positioned as a promising first-in-class therapy with a favorable safety profile and significant efficacy in treating atopic dermatitis and other immune diseases, supported by a strong clinical pipeline and market potential [45]
Corvus Pharmaceuticals to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference
Globenewswire· 2026-02-23 21:01
Core Viewpoint - Corvus Pharmaceuticals is actively engaging with investors through one-on-one meetings and a corporate presentation at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, highlighting its focus on immunotherapy and clinical development [1][2]. Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in ITK inhibition as a novel approach to immunotherapy for various immune diseases and cancers [3]. - The company's lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK, currently undergoing a registration Phase 3 clinical trial for relapsed/refractory PTCL and a Phase 1 clinical trial for atopic dermatitis [3]. Upcoming Events - The corporate presentation will take place virtually on February 26, 2026, at 2:40 PM ET, with a live webcast available for 90 days post-event [1][2].
Corvus Pharmaceuticals Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2026-01-20 21:01
Core Viewpoint - Corvus Pharmaceuticals has initiated an underwritten public offering of $150 million in common stock and pre-funded warrants, with an additional option for underwriters to purchase up to $22.5 million more [1][2]. Group 1: Offering Details - The public offering consists of $150 million in shares of common stock and pre-funded warrants, all offered by Corvus Pharmaceuticals [1]. - The underwriters have a 30-day option to purchase an additional $22.5 million in shares at the public offering price [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1]. Group 2: Use of Proceeds - The net proceeds from the offering are expected to be used for working capital and general corporate purposes, including capital expenditures and research and development [2]. - Specific clinical trials funded by the proceeds include Phase 3 for T cell lymphoma and Phase 2 for atopic dermatitis, hidradenitis suppurativa, and asthma [2]. Group 3: Underwriters - Jefferies and Goldman Sachs & Co. LLC are the lead book-running managers for the offering, with Mizuho as the bookrunner and Ladenburg Thalmann as a co-manager [3]. Group 4: Regulatory Information - A shelf registration statement on Form S-3 was declared effective by the SEC on August 15, 2024, allowing the sale of these securities [4]. - A preliminary prospectus supplement will be filed with the SEC on January 20, 2026, and will be available on the SEC's website [4].
Corvus Pharmaceuticals (NasdaqGM:CRVS) Update / briefing Transcript
2026-01-20 14:02
Corvus Pharmaceuticals Conference Call Summary Company Overview - **Company**: Corvus Pharmaceuticals (NasdaqGM:CRVS) - **Date**: January 20, 2026 - **Key Executives Present**: Dr. Richard Miller (CEO), Leif Lea (CFO), Jeff Arcara (CBO), Dr. Ben Jones (SVP, Pharmaceutical Development), Dr. Suresh Mahabhashyam (VP, Clinical Development) [2][3] Core Industry and Product Focus - **Industry**: Pharmaceuticals, specifically focusing on immune diseases and atopic dermatitis - **Product**: Socalitinib, a first-in-class oral drug targeting interleukin-2 inducible T-cell kinase (ITK) [4][39] Key Findings and Data from Clinical Trials - **Phase I Clinical Trial Results**: - Socalitinib shows potential as a leading therapy for atopic dermatitis, achieving significant clinical results [5][6] - Efficacy metrics: - EASI 75: 75% of patients - EASI 90: 25% of patients - IGA 0/1: 33% of patients - Mean percent reduction in EASI score: 72% at eight weeks [6][24] - Responses are durable, with continued reduction in EASI scores post-treatment [6][21] - **Cohort 4 Specifics**: - 24 patients enrolled with a one-to-one randomization of active versus placebo - Treatment duration extended to eight weeks, confirming positive results from earlier cohorts [18][24] - EASI score reduction: 72% for Socalitinib vs. 40% for placebo, p-value of 0.035 [24][26] - **Prior Systemic Therapy**: - 35% of all patients had prior therapies, with 50% in cohort 4 - Socalitinib demonstrated efficacy in patients with prior systemic therapy, indicating no resistance [27][30] Mechanism of Action - Socalitinib selectively inhibits ITK, leading to a rebalancing of the immune system without causing immunosuppression [9][10] - Induction of T regulatory cells (Tregs) contributes to durable suppression of inflammation [21][30] Market Opportunity - Over 3 million patients with moderate to severe atopic dermatitis, with a significant unmet need for safe and effective oral therapies [15][38] - The market for atopic dermatitis is projected to grow to $170 billion by 2030, with oral agents expected to gain a larger share [38] Future Plans - Initiation of a phase 2 randomized placebo-controlled trial in atopic dermatitis, planned to enroll 200 patients [37][39] - Exploration of Socalitinib's efficacy in other immune diseases, including hidradenitis suppurativa and asthma [39] Safety Profile - No new safety signals observed in cohort 4; adverse events (AEs) were similar between active and placebo groups [31][55] - Historical data from lymphoma studies indicate a strong safety profile, with no patients discontinuing due to safety concerns [54][55] Conclusion - Socalitinib is positioned as a promising treatment for atopic dermatitis and potentially other immune diseases, with a strong clinical efficacy and safety profile [39][40]
Corvus Pharmaceuticals Announces Positive Data from Cohort 4 Confirming Results for Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
Globenewswire· 2026-01-20 12:00
Core Insights - Corvus Pharmaceuticals announced positive results from cohort 4 of the Phase 1 clinical trial for soquelitinib, showing favorable safety and efficacy in patients with moderate to severe atopic dermatitis [1][2][3] - The company plans to initiate a Phase 2 trial in Q1 2026, targeting patients who have failed prior therapies [1][22] Efficacy Results - In cohort 4, 75% of soquelitinib patients achieved EASI 75, 25% achieved EASI 90, and 33% achieved IGA 0/1, compared to placebo results of 20%, 0%, and 0% respectively [1][7] - The mean percent reduction in EASI for soquelitinib patients was 72% at day 56, compared to 40% for placebo [5] - Continuous improvement in response was observed from day 28 to day 56, with a statistically significant difference (p=0.035) [9] Safety Profile - No new safety signals were reported; adverse events occurred in 41.7% of soquelitinib patients and 50% of placebo patients, all classified as Grade 1-2 [21] - No severe or serious adverse events were reported during the trial [21] Patient Demographics - Cohort 4 included 12 patients treated with soquelitinib and 12 placebo patients, with 10 evaluable at day 56 [3][4] - 50% of cohort 4 patients had received prior systemic therapies, consistent with the overall cohort data where 35% had prior treatments [3][13] Mechanism of Action - Soquelitinib is believed to act through ITK inhibition, which regulates multiple T cell functional pathways, showing potential for a wide range of inflammatory and immune diseases [1][2][25] - Biomarker data indicated reductions in serum IL-4 and IL-5 cytokines, supporting the drug's mechanism of action [18][19] Future Plans - The upcoming Phase 2 trial will enroll approximately 200 patients and will evaluate different dosing regimens of soquelitinib [22] - The trial aims to further assess the efficacy and safety of soquelitinib in a larger patient population [2][22]
Corvus Pharmaceuticals Presents Final Data from Soquelitinib Phase 1/1b T Cell Lymphoma Trial
Globenewswire· 2025-12-08 15:30
Core Insights - Corvus Pharmaceuticals presented final data from its Phase 1/1b trial of soquelitinib for T cell lymphoma, showing promising median progression-free survival (PFS) of 6.2 months and median overall survival (OS) of 28.1 months, indicating potential as a new treatment option [1][2][5] Group 1: Clinical Trial Results - The Phase 1 trial enrolled 75 patients with various T cell lymphomas, with a median of 3 prior therapies, and only 31% achieving an objective response to their last therapy [2][4] - In the 200 mg twice-daily cohort, 6 patients achieved complete responses, with an objective response rate of 37.5% among those with 1 to 3 prior therapies [4] - The trial demonstrated no dose-limiting toxicities or significant adverse events, indicating a favorable safety profile for soquelitinib [4] Group 2: Mechanism of Action - Soquelitinib operates through ITK inhibition, affecting T cell receptor signaling and promoting Th1 differentiation while blocking Th2 and Th17 pathways [3][8] - Biomarker studies showed an increase in Th1 cells and a reduction in IL-5, supporting the drug's immunological effects [9] Group 3: Future Development Plans - The company is advancing soquelitinib into a registration Phase 3 trial for relapsed/refractory peripheral T cell lymphoma (PTCL), with plans to enroll 150 patients [5][11] - Corvus is also exploring soquelitinib's potential in atopic dermatitis and other immune and inflammatory diseases, with additional data expected in early 2026 [5][7]