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.

Financial Data and Key Metrics Changes - The company's net loss for Q1 2025 was $37 million, or $0.86 per share, compared to a net loss of $21.6 million, or $0.64 per share for Q1 2024 [20] - Non-GAAP adjusted net loss was $34.7 million, or $0.81 per share for Q1 2025, compared to a non-GAAP adjusted net loss of $19.9 million, or $0.59 per share for Q1 2024 [20] - Research and development expenses increased to $32.2 million for Q1 2025 from $20.6 million in Q1 2024, with a significant portion attributed to clinical trial activities [20][21] - General and administrative expenses rose to $3.9 million for Q1 2025 from $1.8 million in Q1 2024 [21] - Net cash used in operating activities was $35.9 million for Q1 2025, compared to $17.1 million for Q1 2024 [22] - The company ended the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments [22] Business Line Data and Key Metrics Changes - The company is focused on three clinical programs, with significant revenue potential if regulatory approvals are obtained [7][8] - The Phase III VICTORIA-one trial is designed to evaluate gadotelisib in combination with fulvestrant for advanced breast cancer patients [9] - The VICTORIA-two trial is a global Phase III study evaluating gadotelisib as a first-line treatment for HR positive, HER2 negative advanced breast cancer [15][16] - The Phase 1B2 trial is assessing gadotelisib in combination with darolutamide for metastatic castration-resistant prostate cancer [17] Market Data and Key Metrics Changes - The company estimates that nearly 200,000 late-stage cancer patients globally would be eligible for treatment with gadotelisib if approved [8] - The peak revenue potential for the second-line indication of gadotelisib could exceed $2 billion with just 40% market penetration [15] Company Strategy and Development Direction - The company aims to transition to a commercial stage company following potential FDA approvals for its clinical programs [10] - The focus is on developing effective therapies for advanced breast cancer patients resistant to endocrine therapy, addressing a significant unmet need in the market [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical data readouts, with top-line data expected from the VICTORIA-one trial in Q3 2025 [7][10] - The company recognizes the importance of demonstrating clinically meaningful results in terms of progression-free survival (PFS) to gain market acceptance [12][14] Other Important Information - The company is collaborating with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gadotelisib in endometrial cancer [18] - The company expects its current cash reserves to fund clinical development activities through 2026 [22] Q&A Session Summary Question: Timing for VICTORIA-one data readout - Management expects to lock the database in June and report results in Q3 2025, with no anticipated delays [27][28][30] Question: Impact of SERNA6 on second-line setting - Management believes SERNA6 will not affect their patient population as it pertains to first-line CDK4/6 patients [36][37] Question: Minimum HR for wild type update - Management indicated that an incremental three months in PFS would be considered clinically meaningful, but specifics will not be disclosed until data is available [39][40] Question: Change in timing for wild type readout - Management clarified that variability in event distribution among trial arms influenced the timing, but they remain confident in the Q4 timeline for the PIK3CA mutant population [43][44] Question: Prior proof of concept data for prostate cancer - Management discussed the encouraging non-clinical data supporting the efficacy of gadotelisib compared to single-node inhibitors [47][49]