Rallybio(RLYB) - 2025 Q1 - Quarterly Results

Rallybio Q1 2025 Financial Results and Business Update Business Highlights and Pipeline Update Rallybio provides updates on its clinical and preclinical programs, including progress on RLYB116 and REV102, and the discontinuation of RLYB212, while evaluating RLYB332 development RLYB116 Program The company is on track to start a confirmatory PK/PD study for RLYB116, a C5 inhibitor for complement-driven diseases, in Q2 2025, with data readouts expected in the second half of 2025 - A confirmatory pharmacokinetic/pharmacodynamic (PK/PD) study for RLYB116 is set to begin dosing in the second quarter of 2025[4] - Data readouts are anticipated in Q3 2025 for Cohort 1 (150 mg) and Q4 2025 for Cohort 2 (225 mg)[4] - The study aims to demonstrate RLYB116's potential for complete and sustained complement inhibition with improved tolerability, positioning it as a potential best-in-class therapeutic for complement-driven diseases[3][4] REV102 Program IND-enabling studies are underway for REV102, an ENPP1 inhibitor for hypophosphatasia (HPP), developed with Recursion Pharmaceuticals, with a Phase 1 study planned for the second half of 2026 - Investigational new drug application (IND)-enabling studies are underway for REV102, an ENPP1 inhibitor for treating hypophosphatasia (HPP)[7] - A Phase 1 study is expected to be initiated in the second half of 2026, supported by the ongoing studies[7] - Data from a preclinical model of later-onset HPP is expected to be presented in the second half of 2025[7] RLYB332 Program Rallybio is assessing future development for RLYB332, a long-acting antibody for iron overload diseases, with preclinical data showing superior impact on key parameters compared to other molecules - Rallybio continues to evaluate development plans for RLYB332, a long-acting monoclonal antibody for diseases of iron overload[6] - Preclinical data has shown RLYB332 has a superior impact on pharmacodynamic (PD) parameters like serum iron and transferrin saturation (TSAT) compared to comparator molecules[6] RLYB212 Program In April 2025, Rallybio discontinued the RLYB212 program for preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT) due to Phase 2 PK data indicating the dose regimen failed to achieve required target concentrations for efficacy - The RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) was discontinued in April 2025[8] - The decision was based on Phase 2 clinical trial PK data showing the dose regimen was unable to achieve the minimum target concentration required for efficacy[8] Corporate Update Rallybio is implementing a 40% workforce reduction, affecting nine positions, to be completed by the end of Q2 2025, resulting in approximately $1.7 million in charges for severance and benefits - A 40% workforce reduction, representing nine positions, will be substantially complete by the end of Q2 2025[9] - The company estimates the reduction will result in aggregate charges of approximately $1.7 million, primarily for one-time employee severance and benefit costs[9] First Quarter 2025 Financial Results For Q1 2025, Rallybio reported a net loss of $9.4 million, a significant reduction from the $19.0 million loss in Q1 2024, driven by lower expenses and collaboration revenue, ending the quarter with $54.5 million in cash, providing a runway into H1 2027 Q1 2025 Financial Highlights (in millions) | Metric | Q1 2025 (USD) | Q1 2024 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | Revenue | $0.2 | $0 | +$0.2 | | R&D Expenses | $5.7 | $12.9 | -55.8% | | G&A Expenses | $4.2 | $6.9 | -39.4% | | Net Loss | $9.4 | $19.0 | -50.5% | | Net Loss Per Share | $0.21 | $0.47 | -55.3% | - Cash, cash equivalents, and marketable securities were $54.5 million as of March 31, 2025[12] - The current cash position is expected to fund operations into the first half of 2027[12] - The decrease in operating expenses was primarily due to lower development costs for RLYB212 and RLYB116, and reduced payroll costs following a workforce reduction in Q1 2024[12] Financial Tables The financial tables provide detailed, unaudited condensed consolidated statements of operations and balance sheets for the period ended March 31, 2025, compared to prior periods Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, Rallybio reported total revenues of $0.212 million and a net loss of $9.439 million, or $0.21 per share, compared to no revenue and a net loss of $19.029 million, or $0.47 per share, in the prior-year period Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) | | For the Three Months Ended March 31, | | | :--- | :---: | :---: | | | 2025 | 2024 | | Collaboration and license revenue | $212 | $— | | Total revenue | $212 | $— | | Research and development | $5,725 | $12,936 | | General and administrative | $4,157 | $6,851 | | Total operating expenses | $9,882 | $19,787 | | Loss from operations | ($9,670) | ($19,787) | | Net loss | ($9,439) | ($19,029) | | Net loss per common share | ($0.21) | ($0.47) | Condensed Consolidated Balance Sheets As of March 31, 2025, Rallybio had $54.5 million in cash, cash equivalents, and marketable securities, with total assets of $58.0 million and total stockholders' equity of $54.1 million, compared to $65.5 million in cash and equivalents at the end of 2024 Condensed Consolidated Balance Sheet Highlights (Unaudited) (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :---: | :---: | | Cash, cash equivalents and marketable securities | $54,495 | $65,511 | | Total assets | $57,983 | $68,108 | | Total liabilities | $3,910 | $6,454 | | Total stockholders' equity | $54,073 | $61,654 |