Elevation Oncology(ELEV) - 2025 Q1 - Quarterly Results

Highlights Elevation Oncology reported Q1 2025 results, highlighting positive preclinical data for its HER3 ADC, EO-1022, with an IND filing expected in 2026, alongside exploring strategic alternatives and projecting a cash runway into the second half of 2026 after program discontinuation - Presented promising preclinical proof-of-concept data for its potentially differentiated HER3 ADC, EO-1022, at the AACR Annual Meeting[1][2][5] - Expects to file an Investigational New Drug (IND) application for EO-1022 in 2026[1][3] - The company is exploring a range of strategic alternatives to maximize shareholder value[2][4] - Cash runway is expected to fund operations into the second half of 2026[1][7] Business and Pipeline Updates The company strategically shifted its focus to developing the HER3 ADC, EO-1022, after discontinuing the EO-3021 program and reducing its workforce by 70%, with preclinical data for EO-1022 suggesting improved safety and potent anti-tumor activity - In March 2025, the company discontinued the development of EO-3021 and implemented an associated workforce reduction of approximately 70%[4] - The primary pipeline focus is now on EO-1022, a HER3 ADC for solid tumors, with an IND filing planned for 2026[3][11] - Preclinical data for EO-1022 showed high stability, a homogenous drug-to-antibody ratio (DAR) of 4, and minimal free payload, suggesting a potential for reduced toxicity and an improved safety profile[5] - EO-1022 demonstrated potent anti-tumor activity in in-vivo models with varying HER3 expression levels, including low-expressing cancer models[5] Financial Results and Outlook Elevation Oncology reported a Q1 2025 net loss of $14.2 million, up from $10.7 million in Q1 2024 due to restructuring charges, and projects a cash balance of $30-$35 million by Q2 2025, sufficient to fund operations into the second half of 2026 Financial Performance (Q1 2025) For Q1 2025, the company's net loss widened to $14.2 million ($0.24 per share) from $10.7 million ($0.21 per share) in Q1 2024, primarily due to increased R&D expenses for EO-1022 and $3.4 million in restructuring charges | Metric | Q1 2025 ($ thousands) | Q1 2024 ($ thousands) | Change | | :--- | :--- | :--- | :--- | | Research and development | 6,876 | 6,011 | +$865k | | General and administrative | 3,965 | 3,858 | +$107k | | Restructuring charges | 3,375 | — | +$3,375k | | Total operating expenses | 14,216 | 9,869 | +$4,347k | | Net loss | (14,211) | (10,707) | Worsened | | Net loss per share | (0.24) | (0.21) | Worsened | - The $0.9 million increase in R&D expenses was primarily due to a $1.3 million increase in costs for the preclinical development of EO-1022[8] - The company incurred $3.4 million in restructuring charges related to the workforce reduction and discontinuation of the EO-3021 program[10] Financial Position and Outlook As of March 31, 2025, Elevation Oncology held $80.7 million in cash and equivalents, and after a $32.3 million loan prepayment, projects a cash balance of $30-$35 million by June 30, 2025, expected to fund operations into the second half of 2026 | Selected Balance Sheet Data ($ thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | 80,659 | 93,184 | | Total assets | 82,223 | 95,626 | | Total stockholders' equity | 46,734 | 60,025 | - On May 2, 2025, the company voluntarily prepaid its $32.3 million loan (including principal, interest, fees, and expenses) with K2 HealthVentures[6] - The company projects its cash, cash equivalents, and marketable securities to be between $30 million and $35 million as of June 30, 2025[7] - The current cash position is expected to fund operations into the second half of 2026[7] About Elevation Oncology & EO-1022 Elevation Oncology is a clinical-stage company developing selective cancer therapies, with its lead candidate EO-1022, a next-generation HER3-targeting antibody-drug conjugate (ADC) constructed for enhanced efficacy and safety - EO-1022 is an ADC composed of the fully human IgG2 anti-HER3 antibody seribantumab, site-specifically conjugated to the MMAE payload with a drug-to-antibody ratio (DAR) of 4[11] - The company is leveraging its ADC expertise to develop therapies for solid tumors with significant unmet medical needs, with an IND for EO-1022 expected in 2026[12] Forward-Looking Statements This section contains standard "safe harbor" provisions, cautioning that statements regarding future events, including clinical development, regulatory submissions, cash runway, and strategic options, are subject to risks and uncertainties and are not guarantees of future performance - The press release includes forward-looking statements concerning clinical development activities, regulatory submission timing, potential benefits of product candidates, and the company's cash runway[13] - These statements are subject to significant risks and uncertainties, and actual results may differ materially from expectations, as detailed in SEC filings under "Risk Factors"[14]