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Immunome, Inc. (NASDAQ:IMNM) Targets Significant Growth with Public Offering
Financial Modeling Prep· 2025-12-16 03:07
Core Viewpoint - Immunome, Inc. is positioned for significant growth with a public offering aimed at raising $400 million to advance its cancer therapies, supported by a bullish price target from Leerink Partners of $40, indicating a potential increase of approximately 76.6% from its current price of $22.65 [1][2][5][6] Group 1: Public Offering - Immunome plans to initiate an underwritten public offering of its common stock, aiming to raise $400 million, with all shares offered directly by the company [2] - The offering is subject to market conditions and is expected to provide the necessary capital to advance its cancer therapy developments [2] Group 2: Stock Performance - The stock price of IMNM has increased by 15.74%, reaching a high of $25.30 today, marking the highest price over the past year [3] - The current market capitalization of IMNM is approximately $2.08 billion [3] - Today's trading volume for IMNM is 12.54 million shares, indicating strong investor interest [4] Group 3: Growth Potential - Leerink Partners has set a price target of $40 for IMNM, suggesting significant growth potential for the stock [1][6] - The strategic move to raise capital through a public offering aligns with the company's goal to advance its innovative cancer therapies, potentially driving future stock performance [5]
Why Immunome Stock Surged Today
The Motley Fool· 2025-12-15 22:43
Core Insights - Immunome's shares increased by over 15% following positive clinical results for varegacestat, a treatment for desmoid tumors [1] Group 1: Disease Overview - Desmoid tumors are diagnosed in 1,000 to 1,650 individuals annually in the U.S. and can cause significant physical and emotional distress due to their unpredictable nature and limited treatment options [3] Group 2: Clinical Trial Results - The phase 3 clinical trial for varegacestat achieved its primary endpoint, showing an 84% reduction in the risk of disease progression or death compared to placebo [4] - All key secondary endpoints were also met, including reductions in tumor volume and pain intensity [4] - Varegacestat was generally well tolerated, with common side effects including diarrhea, fatigue, rash, nausea, and cough [4] Group 3: Market and Future Plans - Based on the trial results, Immunome plans to submit a New Drug Application to the FDA in Q2 2026 [6] - The current market capitalization of Immunome is $1.8 billion, with a gross margin of 71.34% [6]
Kyverna Therapeutics, Immunome, Almonty Industries And Other Big Stocks Moving Higher On Monday - Almonty Indus (NASDAQ:ALM), AXT (NASDAQ:AXTI)
Benzinga· 2025-12-15 15:45
Group 1 - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 100 points on Monday [1] - Kyverna Therapeutics Inc shares surged 31% to $11.49 following the announcement of topline data from the KYSA-8 Phase 2 trial [2][3] - The KYSA-8 trial involved mivocabtagene autoleucel (miv-cel), a CAR T-cell therapy targeting stiff person syndrome [1] Group 2 - Other notable stock gains included Beneficient, which increased by 29.3% to $6.21, and Immunome Inc, which rose 25.5% to $24.56 after positive results from its Phase 3 trial [3] - Falcon's Beyond Global Inc gained 14% to $12.83, while XBP Global Holdings Inc surged 11.5% to $6.39 [3] - Almonty Industries Inc announced a voluntary withdrawal of its base shelf prospectus, leading to a 9.1% increase in its stock price to $7.38 [3]
Immunome (NasdaqCM:IMNM) Update / Briefing Transcript
2025-12-15 14:32
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's experimental drug meets main goal in late-stage study
Reuters· 2025-12-15 12:16
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]
Immunome to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors
Businesswire· 2025-12-14 21:00
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 (NasdaqCM:IMNM) FY Conference Transcript
2025-12-03 15:12
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 Transcript
2025-12-03 15:02
Summary of Immunome FY Conference Call - December 03, 2025 Company Overview - **Company**: Immunome (NasdaqCM:IMNM) - **Focus**: Targeted therapies for cancer, primarily through antibody-drug conjugates (ADCs), radioligands, and targeted small molecules like variegated statin [2][3] Key Points on Pipeline and Products Variegated Statin and AL102 - **AL102**: A small molecule inhibitor of gamma secretase in a Phase 3 study called RINGSIDE, targeting desmoid tumors, a type of cancer with no previously approved therapies [4] - **Objective**: To provide a better treatment option with a higher response rate and deeper tumor regression compared to existing therapies [5] - **Phase 3 Trial**: Expected to unblind data soon, with primary endpoint being progression-free survival (PFS) [6] - **Comparison with Nirogacestat**: Previous study showed 41% objective response rate (ORR) and 59% median tumor reduction; Immunome aims to exceed these results [8][9] Safety Profile - **Safety Monitoring**: No significant safety issues reported by the data safety monitoring board during the Phase 3 trial [13][14] - **Side Effects**: Expected side effects, but no major differentiations from Nirogacestat's profile noted in Phase II [14][15] Commercialization Plans - **Regulatory Submission**: Plans to submit for regulatory approval within four to five months post-data unblinding [17][18] - **Global Launch Strategy**: Plans to launch in the US, Canada, Europe, and use distributors in Latin America and the Middle East [19][20] ADC Pipeline IM1021 and ROR1 Targeting - **ROR1 ADC**: In early clinical development, targeting B-cell lymphoma; objective responses observed in Phase I trials [21][27] - **ADC Technology**: Development of ADC 3.0, addressing issues of resistance and deconjugation seen in previous ADC technologies [24][25] - **Differentiation from Competitors**: Aiming for higher response rates (50-70%) compared to Merck's ROR1 ADC, which has shown lower response rates [33][34] Future Development - **IND Plans**: Three INDs planned for 2026 and three for 2027, focusing on large solid tumor markets [27][28] Additional Insights - **Patient Considerations**: Emphasis on the need for rapid response in treatments for painful conditions like desmoid tumors [11][12] - **Market Positioning**: Aiming to differentiate products in a crowded market by demonstrating superior efficacy and safety profiles [34][35] This summary encapsulates the key points discussed during the Immunome FY Conference Call, highlighting the company's focus on innovative cancer therapies and strategic plans for product development and commercialization.
Immunome (NasdaqCM:IMNM) FY Conference Transcript
2025-11-11 14:32
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.
Immunome (NasdaqCM:IMNM) Earnings Call Presentation
2025-11-10 23:00
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]