Core Viewpoint - SELLAS Life Sciences Group, Inc. is advancing its Phase 3 REGAL trial for GPS as a potential maintenance therapy in patients with acute myeloid leukemia (AML) after second complete remission, with the trial currently reporting 72 events as of December 26, 2025, and awaiting the 80 events needed for final analysis [1][3][7] Group 1: Trial Update - The Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 REGAL trial continue without modification, with expectations that the required 80 events (deaths) for final analysis would occur before year-end [2] - As of December 26, 2025, the trial has recorded 72 events, and SELLAS remains blinded to all efficacy and survival data outcomes, meaning this update does not affect future statistical analyses [3][7] - The final analysis is event-driven, and the company will announce when the 80th event occurs [3][7] Group 2: Company Commitment and Expert Insights - The CEO of SELLAS expressed appreciation for the dedication of participants in the REGAL trial, noting that survival times appear longer than expected, which may increase the probability of a successful study [4] - Dr. Yair Levy, a member of the REGAL Steering Committee, highlighted the significance of the REGAL study in evaluating GPS for AML patients who cannot undergo transplant, with an expected median overall survival of around eight months for current treatments [4] - The company is committed to advancing breakthrough therapies like GPS that have the potential to significantly improve patient outcomes in AML [4] Group 3: About the REGAL Trial - The REGAL trial (NCT04229979) is a Phase 3 randomized registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy [5] - The primary endpoint of the trial is overall survival, and the IDMC is responsible for monitoring patient safety and efficacy data [5] Group 4: About SELLAS Life Sciences - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapeutics for various cancer indications, with its lead product candidate GPS targeting the WT1 protein present in multiple tumor types [6] - The company is also developing SLS009, a differentiated small molecule CDK9 inhibitor, which has shown a high response rate in AML patients with unfavorable prognostic factors [8]

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Core Insights - SELLAS Life Sciences Group, Inc. reported positive developments in its clinical programs, particularly for SLS009 and GPS, with significant upcoming milestones and a strong financial position [1][2][3] Financial Performance - As of September 30, 2025, the company had cash and cash equivalents totaling approximately $44.3 million, with an additional $29.1 million received from warrant exercises in October 2025 [1][11] - Research and development expenses for Q3 2025 were $4.2 million, a decrease from $4.4 million in Q3 2024, primarily due to reduced clinical trial expenses [8] - General and administrative expenses for Q3 2025 were $2.9 million, slightly down from $3.0 million in Q3 2024, attributed to lower professional fees [9] - The net loss for Q3 2025 was $6.8 million, or a loss per share of $0.06, compared to a net loss of $7.1 million, or $0.10 per share, in Q3 2024 [10][16] Clinical Developments - The Phase 3 REGAL trial of GPS is progressing as planned, with a final analysis expected by year-end 2025 after reaching 80 events [3] - Positive Phase 2 data for SLS009 in relapsed/refractory AML has been accepted for presentation at the ASH Annual Meeting in December 2025, with plans for an 80-patient trial in newly diagnosed AML patients expected to start in Q1 2026 [4][6] - Preclinical data presented at ESMO 2025 showed significant survival benefits of SLS009 in T-cell prolymphocytic leukemia (T-PLL), supporting its potential across various hematologic malignancies [5] Corporate Events - A virtual R&D Day was held on October 29, 2025, showcasing the company's ongoing clinical trials and receiving positive feedback from key opinion leaders [6] - The company raised approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025, enhancing its financial foundation [7]

Company Overview - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [2] - The lead product candidate, GPS, targets the WT1 protein found in multiple tumor types and has potential as both a monotherapy and in combination with other therapies [2] - The company is also developing SLS009 (tambiciclib), a differentiated small molecule CDK9 inhibitor, which shows a high response rate in AML patients with unfavorable prognostic factors [2] Event Participation - Dr. Angelos Stergiou, President and CEO of SELLAS, will participate in the J.P. Morgan U.S. Opportunities Forum on November 12, 2025 [1] - The event will take place at the Kimpton EPIC Hotel in Miami, Florida, and will consist of 1x1 investor meetings [2]

Financial Data and Key Metrics Changes - The company reported approximately $193 million in cash, bolstered by a recent $75 million capital raise, which is expected to support operations into the second half of 2026 [41][42][44] - The stock price fluctuated, dropping to $4 before recovering to around $8, influencing the decision to raise funds earlier than initially planned [42][43] Business Line Data and Key Metrics Changes - The lead combination therapy ofatumumab plus defecanib received accelerated approval from the FDA for low-grade serous ovarian cancer, indicating a significant milestone for the company [1][5] - The company is actively working on the launch of the approved therapy, with initial orders and positive feedback from the physician community [10][12] Market Data and Key Metrics Changes - Approximately 80% of patients are already being tested for KRAS mutations, which is crucial for the therapy's application, indicating a well-established testing framework in the market [21][22] - The company is planning to pursue approvals in international markets, with Japan being the next target due to a relatively straightforward approval process [23][24] Company Strategy and Development Direction - The company aims to remove barriers to access for its therapies by proactively engaging with payers and large group purchasing organizations [12][14] - Future investments will focus on larger programs contingent on positive results, while the current funding supports the launch of the LGSOC business [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of the therapy, noting that it has gone as well or better than expected, with significant interest from healthcare providers [9][10] - The company is preparing for an upcoming ASCO conference to report data on its frontline pancreatic cancer study, which is anticipated to be a key event for the company [6][28] Other Important Information - The company is developing a companion diagnostic for the therapy, which is a post-marketing commitment but is not required for the initial launch [18][22] - The company is also exploring additional indications beyond ovarian cancer, including lung and pancreatic cancers, with promising preclinical data [26][27] Q&A Session Summary Question: What are the next steps for commercialization? - The company aims to see a good trajectory on uptake by the end of the year and is working to remove barriers with payers and large systems [12][14] Question: How important is the companion diagnostic for the drug? - The companion diagnostic is necessary for regulatory compliance, but a significant proportion of patients are already being tested for KRAS mutations [18][21] Question: What are the plans for international markets? - The company is focusing on Japan for the next approval and is also engaging with European regulators for potential orphan drug designation [23][24] Question: What is the company's cash position and runway? - The company has approximately $193 million in cash, which is expected to support operations and the launch of its therapies into 2026 [41][42][44]

Core Insights - SELLAS Life Sciences Group, Inc. announced positive overall survival data from the ongoing Phase 2 trial of SLS009 in relapsed/refractory acute myeloid leukemia (AML), demonstrating a median overall survival (mOS) of 8.9 months in AML-Myelodysplasia-Related Changes (AML-MRC) and 8.8 months in all relapsed or refractory patients, significantly exceeding historical benchmarks [1][3][6] - The company reported a cash position of approximately $28.4 million as of March 31, 2025, with an additional $4.0 million received from warrant exercises in April 2025 [1][12] Clinical Developments - The Phase 2 trial of SLS009 showed a 67% overall response rate (ORR) in patients with AML-MRC and 46% in all evaluable patients, surpassing the targeted 20% ORR [3] - Preclinical data presented at the 2025 AACR Conference indicated that SLS009 can induce apoptosis in TP53 mutated AML by targeting proteins like MCL-1 and survivin, achieving up to 97% reduction in TP53-mutated leukemia cell populations [4] - Promising preclinical efficacy of SLS009 in ASXL1 mutated colorectal cancer will be showcased at ASCO 2025 [5] Financial Performance - Research and development expenses for Q1 2025 were $3.2 million, down from $5.1 million in Q1 2024, primarily due to reduced clinical trial expenses [10] - General and administrative expenses decreased to $2.9 million in Q1 2025 from $4.5 million in Q1 2024, attributed to lower personnel-related expenses and professional fees [11] - The net loss for Q1 2025 was $5.8 million, or $0.07 per share, compared to a net loss of $9.6 million, or $0.21 per share, in Q1 2024 [12][17] Corporate Updates - The interim analysis of the Phase 3 REGAL trial of Galinpepimut-S (GPS) in AML indicated preliminary signals of effectiveness, with fewer than 50% of enrolled patients confirmed deceased after a median follow-up of 13.5 months [6] - A Phase 2a trial of SLS009 in combination with zanubrutinib in DLBCL showed an ORR of 67%, with one complete response and three partial responses among responders [7] - The company raised $25 million from a registered direct offering to strengthen its financial position for working capital and potential acquisitions [9]

Core Insights - Elevation Oncology is advancing its Claudin 18.2 ADC program, EO-3021, for advanced gastric/gastroesophageal junction cancer, with initial data from combination cohorts expected in Q4 2025 or Q1 2026 [1][2] - The company has implemented prospective Claudin 18.2 testing in its ongoing Phase 1 trial to better identify patients likely to benefit from EO-3021 [2][3] - Financial results for the year ended December 31, 2024, show an increase in cash reserves and R&D expenses, reflecting ongoing investment in clinical trials [5][6][14] Clinical Development - EO-3021 is currently being evaluated in combination with dostarlimab and ramucirumab in Phase 1 clinical trials [1][3] - Preclinical data presented at ESMO-IO 2024 demonstrated superior tumor growth inhibition when EO-3021 was combined with either a PD-1 inhibitor or a VEGFR2 inhibitor [3] - The company plans to file an Investigational New Drug (IND) application for its HER3 ADC, EO-1022, in 2026 [1][4][11] Financial Performance - As of December 31, 2024, Elevation Oncology reported cash, cash equivalents, and marketable securities totaling $93.2 million, up from $83.1 million in 2023 [5][14] - R&D expenses for Q4 2024 were $6.6 million, an increase from $4.7 million in Q4 2023, driven by clinical trial costs [6][13] - The net loss for Q4 2024 was $10.4 million, compared to $7.9 million in Q4 2023 [8][13] Upcoming Milestones - The company expects to report additional safety and efficacy data from the EO-3021 monotherapy trial in Q2 2025 [11] - Initial data from the combination cohorts of the EO-3021 trial is anticipated in Q4 2025 or Q1 2026 [1][11] - Preclinical data for EO-1022 will be presented at the AACR Annual Meeting in 2025 [1][11]