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.

Core Insights - Immunome's experimental drug successfully met the primary endpoint in a late-stage study targeting patients with a rare type of tumor [1] Company Summary - The company is advancing its drug development efforts in the oncology sector, focusing on rare tumor types [1]

Core Insights - Immunome, Inc. is set to host a conference call and webcast on December 15, 2025, to disclose topline results from the Phase 3 RINGSIDE trial of varegacestat, a gamma secretase inhibitor for desmoid tumors [1][2] Company Overview - Immunome is a clinical-stage targeted oncology company focused on developing first-in-class and best-in-class targeted cancer therapies [3] - The company has a portfolio that includes varegacestat, a late-clinical stage gamma secretase inhibitor, IM-1021, a clinical-stage ROR1 antibody-drug conjugate (ADC), and IM-3050, a FAP-targeted radiotherapy that has received IND clearance [3] - Immunome is also advancing a range of early-stage ADCs targeting undisclosed solid tumor indications [3]

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.

Immunome (NasdaqCM:IMNM) FY Conference December 03, 2025 09:00 AM ET Company ParticipantsClay Siegall - CEOConference Call ParticipantsBiren Amin - Senior Research AnalystBiren AminGreat. Welcome, everyone, to the Piper Sandler Healthcare Conference. My name is Biren Amin. I'd like to welcome our next company. We have Immunome and their CEO, Clay Siegall. Welcome, Clay. Maybe if you could, we could start off with just the company's focus on Varegacestat, as well as the ADC platform. If you could just maybe ...

Summary of Immunome FY Conference Call (November 11, 2025) Company Overview - **Company**: Immunome (NasdaqCM:IMNM) - **Focus**: Standalone pure-play cancer company specializing in targeted therapies, including antibody-based therapies, radioligands, and small molecules [1][1] Key Points on Varegacestat - **Asset**: Varegacestat, a gamma-secretase inhibitor, is nearing completion of phase three clinical trials for desmoid tumors [2][2] - **Market Opportunity**: The commercial opportunity in desmoid tumors is substantial, with approximately 1,650 new cases per year in the US and a prevalence of about 30,000 [9][15] - **Differentiation**: Varegacestat is expected to differentiate itself from Ogsivo (nirogacestat) due to better efficacy and dosing convenience (once daily vs. twice daily) [10][10][22][22] - **Phase 2 Data**: Phase 2 data indicated a significant improvement over nirogacestat, with a median tumor volume reduction that was 20-25% better [10][10] - **Regulatory Readiness**: The company is well-prepared for regulatory submission and product launch, with a strong team in place [14][14] Clinical Trial Insights - **Enrollment**: Enrollment for the phase 3 trial was completed in February 2024, with data expected to be released soon [11][11] - **Data Monitoring**: A Data Safety Monitoring Board (DSMB) has been overseeing the trial, ensuring safety and compliance [24][24] - **Comparison with Competitors**: The trial design and patient enrollment criteria are nearly identical to those used in SpringWorks' trial for nirogacestat, which is considered the gold standard [17][18] ADC Development - **ROR1 ADC**: Immunome is developing an antibody-drug conjugate (ADC) targeting ROR1, utilizing a proprietary payload (HC74) [27][27] - **Technology Differentiation**: The ADC aims to improve upon existing technologies by addressing common resistance pathways and enhancing permeability for better therapeutic activity [32][32][33][33] - **Future Pipeline**: The company plans to introduce additional ADCs in 2026 and 2027, with a focus on high internalization antibodies [34][34] Market Potential - **Revenue Potential**: A drug targeting 3,000 patients could generate over a billion dollars in revenue, with a significant number of treatable patients available in the US and Europe [15][15] - **Patient Compliance**: The once-daily dosing of Varegacestat is expected to improve patient compliance compared to competitors [10][10] Conclusion - Immunome is positioned to capitalize on the growing market for targeted cancer therapies, with a strong focus on developing innovative treatments that offer significant advantages over existing options. The upcoming data release for Varegacestat is highly anticipated and could be a pivotal moment for the company.

Pipeline Highlights - Varegacestat, an oral gamma secretase inhibitor for desmoid tumors, expects Phase 3 topline data before the end of 2025[9] - IM-1021, a ROR1 ADC, has shown objective responses in B-cell lymphoma patients at multiple dose levels[9] - IM-3050, a FAP radiotherapy, anticipates Phase 1 initiation in early 2026[9] - Three novel ADCs against solid tumor targets are undergoing IND-enabling studies to support 2026 INDs[9] HC74 Payload - HC74, a proprietary TOP1i ADC payload, is considered to have best-in-class potential[9] - HC74 demonstrates a lower efflux ratio of 10 compared to DXd's 79, potentially overcoming chemo-resistance[69] - HC74 ADC shows a payload loss of 18% at Day 7, compared to 36% for DXd ADC, indicating enhanced stability[75] Financial and Leadership - The company's cash runway is expected to extend into 2027[9] - The company's leadership team includes executives with experience at Seagen, where they grew revenue to over $2 billion in 2022, leading to a $43 billion acquisition[14] Varegacestat Market Potential - The estimated revenue for gamma secretase inhibitors (GSIs) in the US desmoid patient market is $356 million in 2025[20] - Phase 2 RINGSIDE Part A data showed a 64% response rate in the 1.2mg QD arm (n=14) and 55% overall (n=42)[27]

Financial Performance - Collaboration revenue for Q3 2025 was $0, a decrease of $2.9 million compared to $2.9 million in Q3 2024, as the collaboration agreement with AbbVie terminated in July 2025[115] - Total operating expenses for Q3 2025 were $60.1 million, an increase of $6.7 million from $53.4 million in Q3 2024[114] - The net loss for Q3 2025 was $57.5 million, compared to a net loss of $47.1 million in Q3 2024, reflecting an increase of $10.4 million[114] - Collaboration revenue increased by $0.6 million, from $6.3 million for the nine months ended September 30, 2024 to $6.9 million for the same period in 2025, driven by increased research and development activities allocated to AbbVie[122] - The net loss for the nine months ended September 30, 2025 was $142.5 million, compared to a net loss of $212.7 million for the same period in 2024, reflecting an improvement of $70.2 million[131] - Cash used in operating activities for the nine months ended September 30, 2025 was $143.0 million, compared to $68.7 million for the same period in 2024[135] Expenses - Research and development expenses increased by $12.0 million, from $37.2 million in Q3 2024 to $49.2 million in Q3 2025, driven by increased costs associated with various product candidates[117] - General and administrative expenses rose by $1.4 million, from $9.5 million in Q3 2024 to $10.9 million in Q3 2025, primarily due to increased personnel-related costs[118] - Research and development expenses rose by $44.9 million, from $81.7 million for the nine months ended September 30, 2024 to $126.5 million for the same period in 2025[124] - General and administrative expenses increased by $9.2 million, from $22.5 million for the nine months ended September 30, 2024 to $31.7 million for the same period in 2025, mainly due to higher personnel-related costs[127] - Share-based compensation expense totaled $6.7 million in Q3 2025, up from $4.9 million in Q3 2024, indicating a rise of $1.9 million[114] Clinical Development - Varegacestat demonstrated an objective response rate of 75% in evaluable patients and a median tumor volume reduction of 88% in the Phase 2 RINGSIDE study[99] - IM-3050 is designed to target FAP, which is expressed in 75% of solid tumors, and aims to deliver radioactive 177Lu directly to FAP-expressing cells[101] - The company has three clinical assets and three preclinical assets, with plans to submit IND applications for three solid tumor ADC candidates in 2026[96] - The Phase 1 trial for IM-1021 is ongoing, with initial data expected to be presented in 2026[100] Cash and Funding - As of September 30, 2025, the company had cash and cash equivalents of $272.6 million and an accumulated deficit of $658.3 million[131] - Cash provided by financing activities for the nine months ended September 30, 2025 was $207.6 million, consisting of gross proceeds from the 2025 Financing and the 2024 ATM Agreement[139] - The company expects expenses to increase substantially as it advances clinical development and seeks regulatory approval for its product candidates[141] - The company anticipates that existing cash and cash equivalents will be sufficient to fund current and planned operating expenses for at least 12 months from the filing date of the report[142] - Future funding requirements will depend on various factors including the costs of clinical trials and regulatory reviews[143] - The company expects to finance cash needs through equity offerings, debt financings, and collaborations due to extreme volatility in global credit and financial markets[144] Company Status and Compliance - As of June 30, 2025, the market value of common stock held by non-affiliates exceeded $700 million, leading to the company no longer qualifying as an emerging growth company effective December 31, 2025[150] - The company has no material non-cancelable purchase commitments, and expected cash requirements do not include potential contingent payments related to asset acquisitions[145] - The company may face challenges in raising additional funds through equity or debt financings, which could delay or limit research and development efforts[144] - The company qualifies as an emerging growth company under the JOBS Act, allowing it to take advantage of reduced disclosure requirements[148] - The company has elected not to "opt out" of the extended transition period for complying with new accounting standards, affecting comparability with other public companies[149] - The company will be subject to new disclosure and compliance requirements as it transitions out of emerging growth company status[150] - There have been no material changes in critical accounting policies and estimates from the previous fiscal year[146] - The company has not disclosed specific quantitative and qualitative disclosures about market risk as it is not required for smaller reporting companies[152]

Financial Performance - Immunome reported a net loss of $57.5 million for Q3 2025, compared to a net loss of $47.1 million in Q3 2024[10][16]. - The total operating expenses for Q3 2025 were $60.1 million, compared to $53.4 million in Q3 2024[16]. - The accumulated deficit as of September 30, 2025, was $658.3 million, up from $515.8 million at the end of 2024[14]. Cash Position - As of September 30, 2025, cash and cash equivalents totaled $272.6 million, with net proceeds of $44.9 million from equity offerings, expected to fund operations into 2027[10]. - Immunome's total assets increased to $299.4 million as of September 30, 2025, compared to $240.2 million at the end of 2024[14]. Research and Development - Research and development expenses for Q3 2025 were $49.2 million, including stock-based compensation costs of $2.9 million, while general and administrative expenses were $10.9 million, including stock-based compensation of $3.9 million[10]. - The company anticipates topline data for the Phase 3 RINGSIDE trial of varegacestat before the end of 2025, with a potential NDA submission if warranted[2][3]. - Objective responses have been observed in B-cell lymphoma patients treated with IM-1021, with initial data presentation planned for 2026[2][3]. - Immunome received IND clearance for IM-3050 in April 2025 and plans to initiate a Phase 1 study in early 2026[4]. - The company has three preclinical ADCs against solid tumor targets, IM-1617, IM-1340, and IM-1335, advancing towards 2026 IND submissions[5].

Core Insights - Immunome, Inc. is set to present at the 2nd Annual Guggenheim Healthcare Innovation Conference on November 11, 2025, at 8:30 a.m. ET [1] - The company focuses on developing first-in-class and best-in-class targeted cancer therapies, with a strong emphasis on innovative therapeutics [3] Company Overview - Immunome is a clinical-stage targeted oncology company dedicated to improving outcomes for cancer patients through advanced therapies [3] - The company has a diverse pipeline, including varegacestat in Phase 3 for desmoid tumors, IM-1021 in Phase 1 targeting ROR1, and IM-3050, a FAP-targeted radioligand that has received IND clearance [3] - Additional preclinical ADCs in the pipeline include IM-1617, IM-1335, and IM-1340, targeting undisclosed markers in various solid tumors [3] Recent Developments - Immunome recently presented preclinical data indicating that its proprietary ADC payload HC74 can overcome multiple mechanisms of ADC resistance, enhancing the efficacy of its therapies [5] - The company has granted inducement awards of stock options to new employees, totaling 69,000 shares on October 1, 2025, and 117,000 shares on September 2, 2025, under Nasdaq Listing Rule 5635(c)(4) [6][7]