Tourmaline Bio(TRML) - 2024 Q1 - Quarterly Report

Financial Performance - The company reported net losses of $13.3 million and $7.5 million for the three months ended March 31, 2024 and 2023, respectively, with an accumulated deficit of $75.4 million as of March 31, 2024[97]. - The net loss for the three months ended March 31, 2024, was $13.3 million, compared to a net loss of $7.5 million for the same period in 2023[130]. - As of March 31, 2024, the company has not generated any revenue since inception and does not expect to do so in the near future[116]. - The company expects significant increases in research and development and general and administrative costs as it advances clinical development and prepares for potential commercialization[133]. - The company has raised approximately $359.7 million in aggregate gross proceeds since inception, primarily through outside capital[134]. - Future capital requirements will necessitate additional funding through equity or debt financings, collaborations, or licensing arrangements[137]. - The company is unable to estimate exact capital requirements due to various uncertainties related to product development and commercialization[138]. Cash and Investments - The company has total cash, cash equivalents, and investments of $350.3 million as of March 31, 2024[96]. - As of March 31, 2024, the company had $350.3 million in cash, cash equivalents, and investments, which is expected to fund operations into 2027[135]. - Net cash used in operating activities for Q1 2024 was $14.9 million, an increase of $11.1 million compared to $3.8 million in Q1 2023[142]. - Net cash used in investing activities for Q1 2024 was $188.9 million, a significant increase from less than $0.1 million in Q1 2023, primarily due to investment purchases[143]. - Net cash provided by financing activities for Q1 2024 was $161.4 million, compared to no cash provided in Q1 2023, attributed to proceeds from the January 2024 Offering[144]. Product Development - TOUR006, the company's lead product candidate, is a fully human monoclonal antibody targeting interleukin-6 (IL-6), with the potential to establish new standards of care in autoimmune and inflammatory diseases[89]. - The pivotal Phase 2b trial for TOUR006 in thyroid eye disease (TED), named spiriTED, was initiated in September 2023, with topline data expected in 2025[92]. - The company expects to commence a pivotal Phase 3 trial of TOUR006 in first-line TED in the second half of 2024, with topline data anticipated in 2026[92]. - The FDA cleared the Investigational New Drug application for TOUR006 related to atherosclerotic cardiovascular disease (ASCVD) in March 2024, with a Phase 2 trial initiated in April 2024[94]. - The company plans to identify additional indication opportunities for TOUR006 and evaluate new in-licensing and acquisition opportunities for assets in immune and inflammatory diseases[95]. Expenses and Obligations - Research and development expenses increased by $5.2 million from $6.1 million for the three months ended March 31, 2023, to $11.4 million for the same period in 2024[131]. - General and administrative expenses rose by $4.8 million from $1.4 million for the three months ended March 31, 2023, to $6.1 million for the same period in 2024[132]. - The company may owe Pfizer up to $128.0 million upon achieving specific development and regulatory milestones, and up to $525.0 million upon achieving specific sales milestones[140]. - The company is obligated to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones related to TOUR006[106]. - The company has not included milestone or royalty payments under the Pfizer License Agreement due to the uncertainty of timing and amounts[146]. Company Classification - The company remains classified as an "emerging growth company" and a "smaller reporting company," with annual revenue below $100.0 million and market value of stock held by non-affiliates below $700.0 million[152]. - Future funding requirements will depend on the progress and costs associated with the development of TOUR006 and other product candidates[138].