Immunome (NasdaqCM:IMNM) FY Conference Summary Company Overview - **Company**: Immunome - **Event**: 44th J.P. Morgan Healthcare Conference - **Date**: January 14, 2026 Core Industry Focus - **Industry**: Biotechnology, specifically in targeted oncology therapies Key Points and Arguments AL102 Development - **Drug Description**: AL102 is an oral gamma-secretase inhibitor for treating desmoid tumors, administered once daily [4][5] - **Clinical Progress**: Positive top-line data reported in December, with plans to submit a New Drug Application (NDA) in Q2 2026 [5][8] - **Efficacy Data**: - Hazard ratio of 0.16, indicating strong efficacy [8] - Objective response rate of 56% based on strict FDA criteria [8][16] - Median tumor reduction of 83% [8][16] - **Patient Population**: Approximately 10,000-11,000 patients in the U.S. actively managed for desmoid tumors annually [10][17] Competitive Landscape - **Comparison with Nirogacestat**: AL102 is positioned as a better option due to superior pharmacokinetics and a more user-friendly dosing schedule [11][12][47] - **Historical Context**: Previous treatments had lower response rates (20% pre-2018, 33% with Sorafenib in 2018, and 41% with Nirogacestat in 2023) [16] ADC Program - **ROR1 ADC (IM-1021)**: - Focus on liquid tumors, particularly B-cell lymphomas [22][26] - Development of a diagnostic tool for ROR1 to enhance treatment targeting [22] - Objective responses observed in early trials, with plans for further expansion [23][26] - **HC74 Platform**: A new ADC technology that improves therapeutic index and overcomes resistance mechanisms [27][30] Radioligand Development - **FAP Targeting**: A radioligand targeting fibroblast activation protein (FAP), which binds to 75% of solid tumors [35][36] - **Clinical Trials**: FDA clearance obtained, with trials expected to start soon [36][39] Financial Position - **Cash Position**: Sufficient funding to extend operations into 2028 [6] Future Outlook - **Upcoming Submissions**: Plans to submit three INDs for solid tumor ADCs and the FAP radioligand within the year [39][64] - **Investor Expectations**: Anticipation of FDA approval for AL102 and significant clinical data releases by the end of 2026 [63][64] Additional Important Information - **Safety Profile**: AL102 has a generally well-tolerated safety profile, with common adverse events being manageable [15] - **Market Strategy**: Focus on making AL102 accessible to the 10-11,000 patients actively managed for desmoid tumors, leveraging a modest sales force [18] This summary encapsulates the critical insights from the Immunome conference, highlighting the company's innovative approaches in oncology and its strategic positioning in the biotechnology sector.

Summary of Immunome's Conference Call on AL102 Phase 3 Results Company and Industry Overview - **Company**: Immunome - **Industry**: Oncology, specifically focusing on desmoid tumors Key Points and Arguments 1. **Positive Phase 3 Results**: The top-line results from the AL102 Ringside phase 3 clinical trial for desmoid tumors were reported as positive, indicating the potential for AL102 to be a best-in-class treatment [4][5][6] 2. **Primary and Secondary Endpoints**: The trial met all primary and secondary endpoints, including: - Progression-Free Survival (PFS) hazard ratio of 0.16, indicating a significant reduction in disease progression risk compared to placebo [5][10] - Confirmed Objective Response Rate (ORR) of 56%, the highest reported in randomized trials for desmoid tumors [5][11] - Median tumor volume reduction of 83%, with placebo showing an 11% increase [5][12] 3. **Safety Profile**: AL102 was generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor (GSI) class. Common adverse events included diarrhea, fatigue, and rash, primarily grade one or two [5][13] 4. **Ovarian Toxicity**: Notably, 55.6% of women of childbearing potential experienced ovarian toxicity, which is a known side effect of GSIs. This rate is lower than the up to 75% reported in the GSI class [13][14] 5. **Regulatory Plans**: Immunome plans to meet with the FDA in early 2026 to review the trial results and aims to submit a New Drug Application (NDA) in the second quarter of 2026 [6][14] 6. **Commercial Strategy**: The company is focused on a three-pillar strategy (start, support, scale) to drive adoption of AL102 upon approval, targeting approximately 11,000 actively managed desmoid tumor patients in the U.S. [25][26] 7. **Market Dynamics**: There are about 85 specialty sarcoma centers in the U.S. that treat desmoid tumors, which will facilitate efficient engagement and rapid uptake of AL102 [26][27] 8. **Future Studies**: Additional studies are planned to explore AL102's efficacy in treating other tumors and to better understand its impact on patients with functional impairments [14][61] Other Important Insights 1. **Patient Impact**: Desmoid tumors significantly affect the quality of life, often leading to debilitating pain and loss of function, particularly in younger patients [17][18] 2. **Treatment Landscape Evolution**: The treatment approach for desmoid tumors has shifted from surgery to active surveillance and systemic therapy, with GSIs emerging as a viable option [19][20] 3. **Clinical Experience**: The call featured insights from Dr. Mrinal Gounder, an expert in desmoid tumors, who emphasized the potential of AL102 to become a standard of care based on its clinical profile [20][23] 4. **Payer Coverage**: The expectation is for over 90% payer coverage at launch, supported by the familiarity of key opinion leaders (KOLs) with AL102 [27][28] 5. **Pricing Strategy**: While specific pricing details were not disclosed, the company plans to engage with payers and doctors to determine an appropriate price for AL102 [72] This summary encapsulates the critical aspects of Immunome's conference call regarding the promising results of AL102 for desmoid tumors, highlighting its potential impact on patient care and the company's strategic plans moving forward.

Immunome FY Conference Summary Company Overview - **Company**: Immunome (NasdaqCM:IMNM) - **Date of Conference**: December 03, 2025 Key Accomplishments in 2025 - Immunome focused on executing its clinical trials and IND-enabling work for ADCs, particularly AL102 and IM1021, with top-line data expected by the end of 2025 [3][4] - The company filed an IND for IM1021 at the end of 2024 and is preparing for a potential NDA submission and commercial launch [4] Product Differentiation and Clinical Data - **AL102**: Expected to show a higher objective response rate compared to Ogsiveo (41% response rate) with a phase 2 data showing a 64% response rate [5][6] - Tumor volume reduction for AL102 was reported at a median of 88%, significantly higher than Ogsiveo's 59% [6][7] - The company emphasizes the importance of secondary endpoints like tumor volume reduction and T2-weighted imaging, which may not be as well-known but are crucial for understanding treatment benefits [8][9] Market Opportunity - The desmoid tumor market is still developing, with approximately 1,600 new diagnoses annually, but patients often live with the disease for many years, indicating a larger prevalence pool [14] - Ogsiveo has treated around 1,000 patients, suggesting significant room for growth and market displacement, particularly for patients currently under active surveillance [15] ADC Platform and Innovation - Immunome's ADC platform utilizes a topo I inhibitor (HC-74) with a broader therapeutic index compared to competitors [16][17] - The platform aims to overcome resistance seen in other ADCs, particularly in patients with high expression of efflux transporters [17][18] - The lead ADC, IM-1021, targets ROR1 and is differentiated from Merck's ROR1 asset by a better safety profile, allowing for higher dosing [19][20] Future Developments - Multiple additional INDs are expected throughout 2026, including IM-1617, IM-1340, and IM-1335, all targeting solid tumors [21][22] - A successful outcome for IM1021 could validate the platform's capabilities, influencing the perception of other assets [22] Conclusion - Immunome is positioned for significant advancements in the desmoid tumor market and ADC development, with a focus on clinical efficacy and safety. The upcoming data releases and IND filings will be critical for the company's growth trajectory and market positioning.