Rallybio(RLYB) - 2025 Q2 - Quarterly Report

Financial Performance - Total revenue for Q2 2025 was $212,000, a decrease of 29.1% compared to $299,000 in Q2 2024[18] - Net loss for Q2 2025 was $9,703,000, compared to a net loss of $16,236,000 in Q2 2024, representing a 40.5% improvement[18] - The company reported a comprehensive loss of $19,193,000 for the first half of 2025, compared to $35,351,000 in the same period of 2024[18] - The net loss for the three months ended June 30, 2025, was $9,703 thousand, a decrease from $16,236 thousand in the same period of 2024[54] - The company reported a net loss per common share of $0.22 for the three months ended June 30, 2025, compared to $0.37 in 2024[54] - Net loss for the six months ended June 30, 2025, was $19.1 million, compared to a net loss of $35.3 million for the same period in 2024, a reduction of $16.1 million[116] - The company has an accumulated deficit of $312.2 million as of June 30, 2025, primarily due to research and development costs[91] - The company incurred net losses of $9.7 million and $19.1 million for the three and six months ended June 30, 2025, respectively, compared to $16.2 million and $35.3 million for the same periods in 2024[159] Cash and Assets - Cash and cash equivalents decreased to $9,445,000 as of June 30, 2025, from $13,903,000 at the end of 2024, a decline of 32.4%[15] - Total assets decreased to $51,003,000 as of June 30, 2025, down 25.1% from $68,108,000 at the end of 2024[15] - Total stockholders' equity fell to $45,964,000 as of June 30, 2025, a decrease of 25.4% from $61,654,000 at the end of 2024[15] - The company had $36,304,000 in marketable securities as of June 30, 2025, down from $51,608,000 at the end of 2024, a decrease of 29.5%[15] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $45.7 million, expected to fund operations for over 12 months[26] - As of June 30, 2025, the company had $45.7 million in cash, cash equivalents, and marketable securities[128] - The company expects existing cash and marketable securities to fund operations into the middle of 2027[130] Research and Development - Research and development expenses for the first half of 2025 were $11,799,000, down 54.4% from $25,882,000 in the same period of 2024[18] - Research and development expenses for the three months ended June 30, 2025, were $6.1 million, down from $12.9 million in the same period in 2024, a reduction of $6.9 million[109] - The company has not generated any revenue from product sales since inception and continues to focus on research and development activities[86] - The company incurred restructuring charges of approximately $1.7 million due to a workforce reduction of about 40% of its positions[58] - The company discontinued the RLYB212 program in April 2025 due to insufficient pharmacokinetic data from the Phase 2 clinical trial[26] - The company initiated a confirmatory pharmacokinetic and pharmacodynamic study of RLYB116 in Q2 2025, with data expected in Q3 and Q4 2025[26] - RLYB116 demonstrated a reduction in free C5 greater than 99% within 24 hours at a 100 mg dose in the Phase 1 study, indicating strong efficacy[77] - The Company initiated a confirmatory PK/PD trial for RLYB116 in Q2 2025, evaluating weekly dosing of 150 mg and 225 mg[81] - RLYB332, a long-acting version of RLYB331, showed favorable tolerability and sustained pharmacodynamic effects in non-clinical studies[82] - The Phase 2 clinical trial for RLYB212 showed an inability to achieve predicted target concentrations, leading to the discontinuation of its development[181] - The company has invested a significant portion of its resources in the development of RLYB212 and RLYB116, with future success reliant on successful clinical trials and marketing approvals[177] Financing and Capital Requirements - The company raised approximately $182.5 million from equity financings prior to its IPO and received net proceeds of approximately $83.0 million from its IPO in August 2021[87] - In November 2022, the company completed a follow-on offering, raising approximately $54.8 million, with net proceeds of approximately $50.8 million after costs[88] - The company expects to incur significant additional operating losses as it advances its product candidates through clinical development[92] - The company expects to finance operations through equity sales, debt financing, and collaborations, with no current credit facility or committed capital sources[134] - Future capital requirements will depend on various factors, including clinical trial costs, regulatory requirements, and the development of additional product candidates[135] - The company will require significant additional capital to fund operations and may prioritize certain product candidates due to limited resources[162] - The company may raise additional capital through equity offerings, debt financings, or strategic alliances, but this could lead to dilution of stockholder ownership[165] Risks and Challenges - The company faces risks related to the commercialization of its product candidates, including competition and the need for effective marketing and distribution strategies[184] - Patient enrollment in clinical trials for rare diseases is challenging, which may lead to increased costs and delays in product development[194] - The lengthy and unpredictable marketing approval process by the FDA and EMA may significantly harm the company's ability to commercialize its product candidates[202] - The company has never obtained marketing approval for any product candidate, which could prevent it from generating revenues and achieving profitability[207] - Serious adverse events or undesirable side effects from product candidates could halt clinical development or delay marketing approval, impacting sales and market acceptance[198] - The company may struggle to identify eligible patients for its product candidates due to limited screening and diagnostic tests, potentially affecting revenue growth[211] - The risk of patient dropout during clinical trials could lead to increased costs and delays in product development[197] - Regulatory changes and legal challenges could create additional uncertainty and impact the company's operations and ability to obtain approvals[182] - The company must demonstrate safety and efficacy through extensive preclinical studies and clinical trials before obtaining marketing approvals from regulatory authorities[183] - The company is heavily dependent on the success of RLYB116, which is currently in early-stage clinical development, with no products generating revenue at this time[177] - The company may face challenges in transitioning from a research-focused entity to one capable of supporting commercial activities[171] - The potential for competition to render product candidates obsolete or less competitive is a significant concern for the company's future prospects[213]