UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________________________ FORM 10-Q _____________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-40693 RALLYBIO CORPORAT ...

Exhibit 99.1 Recent Business Highlights and Upcoming Milestones: RLYB116 Program • Rallybio is on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in the second quarter of 2025. Results from Cohort 1 (150 mg once weekly) and Cohort 2 (225 mg once weekly) are anticipated in the third and fourth quarter of 2025, respectively. Data from this study are expected to demonstrate complete and sustained complement inhibition with improved tolerability of RLY ...

Rallybio Corporation (RLYB) 2025 Conference May 07, 2025 12:00 PM ET Speaker0 BUCELL actually had like a commentary in New England Journal like last week or two weeks ago, which is interesting. Speaker1 I didn't see that on FNAIT or Yeah. I'll have to dig one out. I would say it's bit of a bad memory at the moment, so it's still post traumatic stress. Speaker0 Good afternoon, I guess, everybody. John Wallabin, senior analyst here at Citizens, and welcome to day one of our Life Sciences Conference. Pleased t ...

Shares of Rallybio Corporation (RLYB) tanked 41.2% on April 8 after the company announced its decision to stop the development of RLYB212 for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT).The company decided to stop the development of RLYB212 after pharmacokinetic (PK) data from a phase II study showed that treatment with the candidate failed to achieve predicted target concentrations of 6 ng/mL to 10, as well as the minimum target concentration required for efficacy of 3 ng/mL.Th ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________ FORM 10-K ____________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40693 ___________________________________ ...

Financial Performance - Revenue for Q4 2024 was $38 thousand, and total revenue for the year ended December 31, 2024, was $0.6 million, compared to no revenue in the same periods in 2023[12] - R&D expenses decreased to $7.4 million in Q4 2024 from $15.9 million in Q4 2023, and for the full year, R&D expenses were $41.5 million compared to $53.5 million in 2023[12] - G&A expenses were $4.3 million for Q4 2024, down from $5.2 million in Q4 2023, and totaled $19.6 million for the year compared to $25.4 million in 2023[12] - Net loss for Q4 2024 was $11.0 million, or $0.25 per share, compared to a net loss of $20.2 million, or $0.50 per share, in Q4 2023[13] - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $65.5 million, providing a runway into the second half of 2026[6] Clinical Development - RLYB212 Phase 2 trial dosing is underway, with key data readouts expected in Q2 and Q3 2025[6] - RLYB116 is on track to enter a confirmatory PK/PD study in Q2 2025, with data anticipated in the second half of 2025[6] - More than 14,300 pregnant women were screened in the FNAIT natural history study as of January 31, 2025[7] - The company plans to present interim data from the FNAIT natural history study in mid-2025[7] - REV102, an ENPP1 inhibitor, is advancing toward a Phase 1 study expected to start in 2026[12]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $299,000, compared to $0 for the same period in 2023, indicating a significant increase[17]. - The net loss for the three months ended September 30, 2024, was $11,466,000, compared to a net loss of $18,374,000 for the same period in 2023, showing a 37.5% improvement[17]. - The company reported a net loss of $11.5 million for the three months ended September 30, 2024, compared to a net loss of $18.4 million for the same period in 2023, reflecting a decrease of $6.9 million[115]. - Net loss for the nine months ended September 30, 2024, was $46.7 million, an improvement from a net loss of $54.3 million in 2023, a reduction of $7.6 million[122]. Expenses - Research and development expenses for the nine months ended September 30, 2024, were $34,122,000, down from $37,620,000 in the same period of 2023, reflecting a 6.6% decrease[17]. - The company reported a total operating expense of $49,486,000 for the nine months ended September 30, 2024, down from $57,820,000 in the same period of 2023, a reduction of 14.5%[17]. - General and administrative expenses were $4.1 million for the three months ended September 30, 2024, compared to $6.1 million in 2023, reflecting a decrease of $2.0 million[119]. - Research and development expenses for the three months ended September 30, 2024, were $8.2 million, down from $13.3 million in the same period in 2023, a reduction of $5.0 million[115]. Cash and Liquidity - Cash and cash equivalents as of September 30, 2024, were $25,320,000, an increase from $24,494,000 as of December 31, 2023[14]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $75.1 million, which is expected to fund operations for more than 12 months[24]. - The company expects existing cash resources to fund operations into the middle of 2026, assuming no significant changes in expenses[131]. - The company reported a net increase in cash and cash equivalents of $826,000 for the nine months ended September 30, 2024, compared to a decrease of $37.8 million in the same period of 2023[133]. Shareholder Equity and Stock - The total stockholders' equity as of September 30, 2024, was $70,818, an increase from $123,581 as of September 30, 2023[19]. - The weighted-average common shares outstanding increased to 44,593,221 for the three months ended September 30, 2024, compared to 40,531,497 for the same period in 2023[17]. - The Company had 41,487,586 shares of common stock issued and outstanding as of September 30, 2024, an increase from 37,829,565 shares as of December 31, 2023[46]. - The company issued 3,636,363 common shares upon completion of a securities purchase agreement, net of offering costs of $268[19]. Product Development and Clinical Trials - The company is heavily dependent on the success of its product candidates RLYB212 and RLYB116, which are currently in early-stage clinical development[9]. - The company plans to initiate a Phase 2 clinical trial of RLYB212 in the fourth quarter of 2024, following the completion of Phase 1 studies[23]. - RLYB212, an anti-HPA-1a antibody, is set to initiate a Phase 2 clinical trial in Q4 2024, following EMA and MHRA approval[83]. - RLYB116, a C5 inhibitor, showed a reduction in free C5 of greater than 99% within 24 hours at a 100 mg dose during the Phase 1 study[90]. Capital Requirements - The company anticipates requiring significant additional capital to fund operations and product development, which may lead to dilution for existing shareholders[9]. - The company expects to raise substantial additional capital to fund the development and commercialization of its product candidates, if approved[24]. - The company expects to finance operations through equity sales, debt financing, and collaborations, with no current credit facility or committed sources of capital[132]. Joint Ventures and Collaborations - The company funded $2.0 million for its 50% interest in the joint venture RE Ventures I, LLC for the nine months ended September 30, 2024, up from $1.5 million in the same period in 2023[62]. - The company recorded its allocable share of losses from the joint venture totaling $1.8 million for the nine months ended September 30, 2024, compared to $1.4 million for the same period in 2023[63]. - The company entered into a collaboration agreement with Johnson & Johnson, receiving an upfront payment of $0.5 million and is eligible for up to $0.7 million based on enrollment-related events[70][73]. Marketable Securities - As of September 30, 2024, the fair value of marketable securities was $68.698 million, compared to $101.963 million as of December 31, 2023, indicating a decrease of approximately 32.5%[41]. - The aggregate fair value of available-for-sale debt securities in an unrealized loss position was $2.0 million as of September 30, 2024, down from $40.0 million as of December 31, 2023[42]. Accounting and Reporting - The Company recognized revenue in accordance with ASC 606, reflecting the consideration expected to be received for goods and services[30]. - The company is currently evaluating the impact of recently issued accounting standards on its consolidated financial statements[36].

Revenue Performance - Revenue for Q3 2024 was $0.3 million, compared to no revenue in Q3 2023, attributed to a collaboration agreement with Johnson & Johnson[14] - Total revenue for the three months ended September 30, 2024, was $299,000, compared to $0 for the same period in 2023[21] Expenses - R&D expenses decreased to $8.2 million in Q3 2024 from $13.3 million in Q3 2023, primarily due to reduced development costs for RLYB116 and RLYB212[15] - G&A expenses were $4.1 million in Q3 2024, down from $6.1 million in Q3 2023, mainly due to lower payroll and consulting fees[16] - Total operating expenses decreased to $12,365,000 for the three months ended September 30, 2024, from $19,363,000 in the same period of 2023, representing a reduction of approximately 36.5%[21] - Research and development expenses for the three months ended September 30, 2024, were $8,240,000, compared to $13,288,000 for the same period in 2023, reflecting a decrease of approximately 38.5%[21] - General and administrative expenses were $4,125,000 for the three months ended September 30, 2024, down from $6,075,000 in the same period of 2023, a reduction of approximately 32.2%[21] Net Loss - Net loss for Q3 2024 was $11.5 million, or $0.26 per share, compared to a net loss of $18.4 million, or $0.45 per share, in Q3 2023[17] - Net loss for the three months ended September 30, 2024, was $11,466,000, compared to a net loss of $18,374,000 for the same period in 2023, indicating an improvement of approximately 37.5%[21] Cash and Assets - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled $75.1 million, providing a runway into mid-2026[17] - Cash, cash equivalents, and marketable securities totaled $75,139,000 as of September 30, 2024, down from $109,929,000 at the end of December 31, 2023[21] - Total assets decreased to $79,007,000 as of September 30, 2024, from $115,620,000 at December 31, 2023[21] - Total liabilities as of September 30, 2024, were $8,189,000, down from $9,436,000 at December 31, 2023[21] Clinical Trials and Research - RLYB212 Phase 2 trial is set to initiate screening in Q4 2024 after receiving CTA approvals from EMA and MHRA[3] - Over 13,000 pregnant women have been screened in the FNAIT natural history study as of November 1, 2024[4] - RLYB116 manufacturing enhancements completed in Q3 2024 are expected to improve tolerability[9] - More than 30,000 pregnancies annually in North America and major European countries are estimated to be at higher risk for FNAIT[8] Future Outlook - Rallybio aims to deliver multiple key value inflection points in 2025 through focused investments in its pipeline[2] - Weighted-average common shares outstanding increased to 44,593,221 for the three months ended September 30, 2024, compared to 40,531,497 for the same period in 2023[21] - The company reported a net unrealized gain on marketable securities of $240,000 for the three months ended September 30, 2024, compared to a gain of $64,000 for the same period in 2023[21]

Core Viewpoint - Rallybio Corporation (RLYB) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of earnings estimate revisions, which have shown a strong correlation with near-term stock price movements [4][6]. - For Rallybio, the increase in earnings estimates suggests an improvement in the company's underlying business, likely leading to a rise in stock price [5]. Earnings Estimate Revisions - For the fiscal year ending December 2024, Rallybio is expected to earn -$1.35 per share, reflecting a 26.6% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Rallybio has increased by 4.9%, indicating a positive trend in analyst expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, highlighting their potential for market-beating returns [9][10]. - The upgrade of Rallybio to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a favorable outlook for the stock in the near term [10].

Financial Performance - Total revenue for the three months ended June 30, 2024, was $299,000, compared to $0 for the same period in 2023[13]. - The company reported a comprehensive loss of $16,236,000 for the three months ended June 30, 2024[13]. - Net loss for the three months ended June 30, 2024, was $16,236,000, compared to a net loss of $18,630,000 for the same period in 2023[13]. - The net loss for the six months ended June 30, 2024, was $35,265 thousand, compared to a net loss of $35,948 thousand for the same period in 2023, representing a decrease of 1.9%[17]. - The company incurred net losses of $16.2 million and $35.3 million for the three and six months ended June 30, 2024, respectively[85]. Assets and Liabilities - As of June 30, 2024, total current assets decreased to $91.436 million from $114.789 million as of December 31, 2023, representing a decline of approximately 20.3%[11]. - Cash and cash equivalents decreased to $16.671 million from $24.494 million, a reduction of about 32.0%[11]. - Total liabilities rose to $12.414 million from $9.436 million, reflecting an increase of about 31.3%[11]. - The balance of stockholders' equity as of June 30, 2024, was $80,017,000, compared to $139,257,000 as of June 30, 2023[15]. - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $88.6 million, which is expected to fund operations for more than 12 months[20]. Research and Development - Research and development expenses for the three months ended June 30, 2024, were $12,946,000, a decrease from $13,130,000 in the previous quarter[13]. - Total research and development expenses for the six months ended June 30, 2024, were $25.9 million, an increase of $1.6 million from $24.3 million in the same period of 2023[106]. - RLYB212 and RLYB116 are heavily dependent on successful early-stage clinical development, with potential delays posing risks to the business[7]. - The company plans to initiate a Phase 2 clinical trial of RLYB212 in the fourth quarter of 2024, following the completion of Phase 1 studies for both RLYB212 and RLYB116[19]. - RLYB212 achieved proof-of-concept in the Phase 1b study, demonstrating a ≥ 90% reduction in mean platelet elimination half-life compared to placebo[70]. Capital and Financing - The company anticipates requiring significant additional capital to fund operations and product development, which may lead to dilution for existing shareholders[7]. - The company raised $5,405 thousand from the issuance of common stock from a securities purchase agreement during the six months ended June 30, 2024[17]. - The company raised approximately $6.6 million from the sale of 3,636,363 shares of common stock at $1.82 per share in April 2024, representing a 10% premium on the closing stock price[37]. - The company does not anticipate its current cash and marketable securities will be sufficient to fund product candidates through regulatory approval, indicating a need for substantial additional capital[20]. Operating Expenses - Total operating expenses for the three months ended June 30, 2024, were $17,334,000, compared to $20,083,000 for the same period in 2023[13]. - General and administrative expenses for the three months ended June 30, 2024, were $4,388,000, down from $6,953,000 in the previous quarter[13]. - Loss from operations improved to $(17.0) million in Q2 2024 from $(20.1) million in Q2 2023, an improvement of $3.0 million[97]. - General and administrative expenses decreased to $11.2 million for the six months ended June 30, 2024, down from $14.1 million in 2023, a reduction of $2.9 million[107]. Joint Ventures and Collaborations - The company entered into a Collaboration and License Agreement with Johnson & Johnson, receiving an upfront payment of $0.5 million and potential additional payments totaling up to $0.7 million[61]. - The carrying value of the investment in the joint venture as of June 30, 2024, was $0.6 million, reflecting the company's maximum exposure to risk[52]. - The company's allocable share of losses from the joint venture for the three months ended June 30, 2024, was $0.5 million, an increase from $0.2 million in the same period of 2023[52]. Market and Competition - The company faces significant competition from other biotechnology and pharmaceutical companies, which could adversely affect its operating results[8]. - The regulatory approval processes for product candidates are lengthy and unpredictable, posing a risk to the company's business if approvals are not obtained[7]. Stock and Shareholder Information - Weighted-average common shares outstanding for the three months ended June 30, 2024, were 44,128,059, compared to 40,363,902 for the same period in 2023[13]. - The total number of shares available for future issuance under the 2021 Employee Stock Purchase Plan (ESPP) was 834,589 as of June 30, 2024[49]. - The company had unrecognized share-based compensation expense related to unvested stock options of $11.1 million as of June 30, 2024, expected to be recognized over approximately 2.4 years[45].