Rallybio(RLYB) - 2024 Q1 - Quarterly Report

Financial Performance - The company experienced a net loss of $19.029 million for the three months ended March 31, 2024, compared to a net loss of$17.318 million for the same period in 2023, representing an increase in loss of 9.9%[20]. - The company reported total operating expenses of $19.787 million for Q1 2024, an increase of 7.7$18.374 million in Q1 2023[20]. - The company incurred a loss on investment in joint ventures of $685,000 in Q1 2024, compared to a loss of$563,000 in Q1 2023, marking a 21.7% increase in losses[20]. - The company reported a net loss of $19.0 million for the three months ended March 31, 2024, compared to a net loss of$17.3 million for the same period in 2023, representing an increase in loss of $1.7 million[97]. - The company has an accumulated deficit of$254.3 million as of March 31, 2024, reflecting significant operating losses since inception[83]. - The company has incurred substantial net operating losses (NOLs) and may face limitations on using these to offset future taxable income due to ownership changes[153]. Assets and Equity - As of March 31, 2024, the company reported total assets of $99.359 million, a decrease of 14.1$115.620 million as of December 31, 2023[18]. - Total stockholders' equity decreased to $89.157 million as of March 31, 2024, down from$106.184 million as of December 31, 2023, reflecting a decline of 16.1%[18]. - As of March 31, 2024, the fair value of marketable securities was $85,001 thousand, down from$101,963 thousand as of December 31, 2023, representing a decrease of approximately 16.6%[36]. - The aggregate fair value of available-for-sale debt securities in an unrealized loss position increased to $58.4 million as of March 31, 2024, compared to$40.0 million as of December 31, 2023[36]. - The company had cash, cash equivalents, and marketable securities totaling $94.2 million as of March 31, 2024, which is expected to fund operations for more than 12 months[29]. Research and Development - Research and development expenses increased to$12.936 million in Q1 2024, up 15.4% from $11.202 million in Q1 2023[20]. - The company plans to initiate a Phase 2 clinical trial of RLYB212 in the second half of 2024, following the completion of Phase 1 studies for both RLYB212 and RLYB116[28]. - RLYB116, a novel C5 inhibitor, demonstrated a greater than 99$54.8 million, with net proceeds of about 50.8 million after costs[81]. - The company sold 3,636,363 shares of common stock to Johnson & Johnson Innovation at a price of 1.82 per share, raising approximately $6.6 million in gross proceeds[61]. - The company expects existing cash and marketable securities to fund operations into mid-2026, although this is subject to various risks and uncertainties[108]. - The company requires significant additional capital for the development and potential commercialization of product candidates, which may be raised through various means including equity offerings and collaborations[144]. Clinical Trials and Regulatory Risks - The company’s lead product candidates, RLYB212 and RLYB116, are still in early clinical development and require successful completion of registrational trials for regulatory approval[169]. - The regulatory approval processes for product candidates are lengthy and unpredictable, potentially taking many years[185]. - The FDA may require additional clinical trials or impose restrictions on marketing approvals, impacting the company's ability to commercialize products[187]. - The company may face significant delays or inability to commercialize product candidates if it does not achieve timely regulatory approvals and successful clinical trials[159]. - The company may need to identify additional formulations or routes of administration for its product candidates, which could delay clinical trials and increase costs[157]. Market Competition and Challenges - The biotechnology and pharmaceutical industries are highly competitive, with many companies engaged in similar research and development, potentially impacting the company's market position[198]. - RLYB116 faces competition from established treatments such as Soliris and Ultomiris, which may affect its market entry and acceptance[199]. - The company has no product candidates approved for sale in any jurisdiction, including international markets, which poses a significant risk to market entry[205]. - The potential market opportunities for the company's product candidates may be smaller than anticipated due to the rarity of targeted diseases[193]. - The company has not commercialized any products and has never generated revenue from product sales[136].