Rallybio(US:RLYB)2024-11-07 21:08Financial 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].