Rallybio(RLYB) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Overview Rallybio reported its Q2 2025 financial results, highlighting the advancement of its lead program RLYB116, the strategic divestiture of REV102, and an extended cash runway into mid-2027 Executive Summary Rallybio reported its Q2 2025 financial results, highlighting the advancement of its lead program RLYB116, the strategic divestiture of REV102, and an extended cash runway into mid-2027 - Data readouts from Cohort 1 and Cohort 2 of RLYB116 confirmatory PK/PD study are on track for 3Q and 4Q 2025, respectively[2] - Sold interest in REV102 to Recursion Pharmaceuticals for up to $25 million, including an upfront equity payment of $7.5 million[2] - Cash runway extended into mid-2027[2] Q2 2025 Key Financial Highlights (in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net Loss | $(9.7) | $(16.2) | Improved by $6.5 | | Net Loss Per Common Share | $(0.22) | $(0.37) | Improved by $0.15 | CEO Commentary CEO Stephen Uden highlighted the significant progress of RLYB116 into a confirmatory PK/PD study and the strategic importance of the REV102 divestiture for disciplined portfolio management and balance sheet strengthening - Advanced lead program RLYB116 into a confirmatory PK/PD study, reflecting strong science and team dedication[3] - Strategic divestiture of a preclinical asset (REV102) underscores commitment to disciplined portfolio management, sharpening focus and strengthening the balance sheet[3] - Topline data from RLYB116 Cohort 1 and Cohort 2 expected in 3Q and 4Q 2025, respectively[3] Recent Business Highlights and Upcoming Milestones Rallybio achieved significant program milestones, including advancing RLYB116, divesting REV102, and evaluating RLYB332, while discontinuing RLYB212 Corporate Updates Rallybio announced the sale of its interest in REV102 to Recursion Pharmaceuticals, securing an upfront equity payment and potential future milestones and royalties, which significantly extends the company's cash runway - Entered into a definitive agreement in July 2025 to sell interest in REV102 to Recursion Pharmaceuticals for up to $25.0 million[4] - Upfront equity payment of $7.5 million extends Rallybio's cash runway into mid-2027[4] - Eligible for contingent equity payment of $12.5 million upon initiation of additional preclinical studies and a $5.0 million cash milestone upon initiation of dosing in a Phase 1 clinical study[4] - Also eligible to receive low single-digit royalties on future net sales and potential payments if Recursion sells the REV102 program[4] RLYB116 Program The RLYB116 program initiated dosing in its confirmatory PK/PD study in June 2025, with data expected later in the year, and has identified immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS) as initial indications - Dosing initiated in RLYB116 confirmatory clinical PK/PD study in June 2025[5] - Results from Cohort 1 and Cohort 2 anticipated in 3Q and 4Q 2025, expected to demonstrate complete and sustained complement inhibition and improved tolerability[5] - Initial indication focus for RLYB116 will be immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS)[5] RLYB332 Program Rallybio is evaluating future development plans for RLYB332, a long-acting anti-matriptase-2 antibody, which has shown superior preclinical data for treating iron overload diseases - Continues to evaluate plans for future development of RLYB332, a long-acting, monoclonal anti-matriptase-2 antibody[6] - Potential to be a best-in-class treatment for diseases of iron overload[6] - Preclinical data demonstrated superior impact on PD parameters (serum iron, UIBC, TSAT) relative to comparator molecules[6] RLYB212 Program The RLYB212 program for preventing FNAIT was discontinued in April 2025 due to pharmacokinetic data from the Phase 2 trial indicating the dose regimen's inability to achieve target concentrations required for efficacy - Discontinuation of the RLYB212 program in April 2025 for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT)[7] - Decision based on PK data from Phase 2 clinical trial showing inability of dose regimen to achieve predicted target concentrations and minimum target concentration for efficacy[7] - Safety follow-up of the sentinel participant in the Phase 2 trial will continue[7] Second Quarter 2025 Financial Results Rallybio reported a significant reduction in net loss for Q2 2025, driven by lower operating expenses, and maintained a cash position supporting operations into mid-2027 Key Financial Highlights Rallybio reported a decrease in revenue and a significant reduction in net loss for Q2 2025 compared to Q2 2024, primarily driven by lower R&D and G&A expenses, partially offset by workforce reduction costs. The company's cash position was $45.7 million as of June 30, 2025, with a projected runway into mid-2027 Selected Financial Results (Q2 2025 vs. Q2 2024) (in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | Primary Reason for Change | | :----- | :--------------------- | :--------------------- | :----------- | :------------------------ | | Revenue | $212 | $299 | $(87) | Decrease related to collaboration agreement with Johnson & Johnson in Q2 2024 | | R&D Expenses | $6,074 | $12,946 | $(6,872) | Decrease in development costs for RLYB212, RLYB116, and other candidates, offset by increased payroll due to workforce reduction | | G&A Expenses | $4,195 | $4,388 | $(193) | Decrease in professional fees and other G&A, offset by increased payroll due to workforce reduction | | Net Loss | $(9,703) | $(16,236) | $(6,533) | Improved due to lower R&D and G&A expenses | | Net Loss Per Common Share | $(0.22) | $(0.37) | $(0.15) | Improved | - Cash, cash equivalents, and marketable securities were $45.7 million as of June 30, 2025[10] - Funds, combined with the upfront payment from REV102 sale, are expected to support operations into mid-2027[10] About Rallybio Rallybio is a clinical-stage biotechnology company focused on developing transformative therapies for severe and rare diseases, with a pipeline in complement dysregulation and hematology Company Overview and Pipeline Rallybio is a clinical-stage biotechnology company dedicated to developing transformative therapies for severe and rare diseases, with a pipeline focused on complement dysregulation and hematology, including its lead program RLYB116 - Clinical-stage biotechnology company focused on developing and commercializing life-transforming therapies for patients with severe and rare diseases[9] - Pipeline addresses unmet medical needs in complement dysregulation and hematology[9] - Lead program RLYB116 is a differentiated C5 inhibitor for diseases of complement dysregulation, initially focusing on immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS)[9] - Pipeline also includes RLYB332, a preclinical long-acting matriptase-2 antibody for iron overload[9] Forward-Looking Statements This section provides a cautionary statement regarding forward-looking statements, outlining inherent risks and uncertainties that could cause actual results to differ materially Disclaimer and Risk Factors This section serves as a cautionary statement, indicating that the press release contains forward-looking statements based on management's current expectations, which are subject to various known and unknown risks, uncertainties, and assumptions, and are not guaranteed to occur - Press release contains forward-looking statements based on management's beliefs and assumptions, subject to known and unknown risks, uncertainties, and assumptions[11] - Forward-looking statements include timing of RLYB116 data, potential commercial opportunity, future payments from REV102 sale, and cash runway[11] - Risks include ability to conduct clinical trials, sufficiency of cash resources, ability to raise capital, strategic partnerships, competition, and SEC filings[11] - Company is not obligated to publicly update or revise any forward-looking statements unless required by applicable law[11] Financial Tables This section presents the unaudited condensed consolidated financial statements, including statements of operations and balance sheets, for the specified periods Condensed Consolidated Statements of Operations and Comprehensive Loss Presents the unaudited consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024, detailing revenue, operating expenses, other income, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | (in thousands, except share and per share amounts) | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | | :----------------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Collaboration and license revenue | $212 | $299 | $424 | $299 | | Total revenue | $212 | $299 | $424 | $299 | | Research and development | $6,074 | $12,946 | $11,799 | $25,882 | | General and administrative | $4,195 | $4,388 | $8,352 | $11,239 | | Total operating expenses | $10,269 | $17,334 | $20,151 | $37,121 | | Loss from operations | $(10,057) | $(17,035) | $(19,727) | $(36,822) | | Interest income | $523 | $1,143 | $1,167 | $2,419 | | Other income | $118 | $143 | $292 | $310 | | Total other income, net | $641 | $1,286 | $1,459 | $2,729 | | Loss before equity in losses of joint venture | $(9,416) | $(15,749) | $(18,268) | $(34,093) | | Loss on investment in joint venture | $287 | $487 | $874 | $1,172 | | Net loss | $(9,703) | $(16,236) | $(19,142) | $(35,265) | | Net loss per common share, basic and diluted | $(0.22) | $(0.37) | $(0.43) | $(0.83) | | Weighted-average common shares outstanding, basic and diluted | 44,841,140 | 44,128,059 | 44,808,055 | 42,450,837 | | Net unrealized loss on marketable securities | $(30) | — | $(51) | $(86) | | Other comprehensive loss | $(30) | — | $(51) | $(86) | | Comprehensive loss | $(9,733) | $(16,236) | $(19,193) | $(35,351) | Condensed Consolidated Balance Sheets Presents the unaudited condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (Unaudited) | (in thousands) | JUNE 30, 2025 | DECEMBER 31, 2024 | | :------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | $45,749 | $65,511 | | Total assets | $51,003 | $68,108 | | Total liabilities | $5,039 | $6,454 | | Total stockholders' equity | $45,964 | $61,654 | Contacts This section provides contact information for investor relations and media inquiries for Rallybio Corporation Investor and Media Contacts Provides contact information for investor relations and media inquiries for Rallybio Corporation - Investor Contacts: Samantha Tracy (Rallybio Corporation) and Kevin Lui (Precision AQ)[15] - Media Contact: media@rallybio.com[15]