Rallybio(US:RLYB)2024-08-08 12:09Financial 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].