Tourmaline Bio(TRML) - 2024 Q3 - Quarterly Report

Financial Performance - The company reported net losses of $51.0 million and $29.2 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $113.0 million as of September 30, 2024[97]. - The net loss for the three months ended September 30, 2024, was $20.2 million, an increase of $14.6 million from a net loss of $5.6 million in the same period of 2023[128]. - As of September 30, 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 to incur significant expenses and operating losses for the foreseeable future as it advances clinical development[136]. - The company has raised approximately $359.7 million in aggregate gross proceeds since inception[137]. Cash and Investments - The company has total cash, cash equivalents, and investments of $314.4 million as of September 30, 2024[96]. - As of September 30, 2024, the company had $314.4 million in cash, cash equivalents, and investments, with sufficient working capital expected to fund operations into 2027[138]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $56.4 million, an increase of $37.6 million compared to $18.7 million for the same period in 2023[148]. - Net cash used in investing activities for the nine months ended September 30, 2024, was $210.7 million, a significant increase from less than $0.1 million in the same period in 2023[149]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $161.4 million, compared to $88.6 million for the same period in 2023[150]. Research and Development - Research and development expenses for the three months ended September 30, 2024, increased by $15.6 million to $19.3 million compared to $3.8 million in the same period of 2023[129]. - For the nine months ended September 30, 2024, research and development expenses increased by $22.1 million to $46.4 million compared to $24.4 million in the same period of 2023[133]. - The company has reached alignment with the FDA on the ASCVD clinical development program, including a Phase 2 trial evaluating hs-CRP reduction[93]. - Pacibekitug, the company's lead product candidate, is currently being evaluated in a pivotal Phase 2b trial for thyroid eye disease (TED), with topline data expected in the second half of 2025[92]. - The company initiated a Phase 2 trial of pacibekitug in patients with chronic kidney disease and elevated hs-CRP in April 2024, with topline data expected in the first half of 2025[94]. Obligations and Future Funding - The company has an obligation to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones related to pacibekitug[105]. - The company may need to pay Pfizer up to $128.0 million upon achieving specific development and regulatory milestones and up to $525.0 million upon achieving specific sales milestones[146]. - Future funding requirements will depend on various factors, including the costs of clinical trials and regulatory reviews for product candidates[142]. - The company expects to seek additional capital through private or public equity or debt financings, which may dilute existing stockholders' ownership[141]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024, increased by $2.2 million to $5.1 million compared to $2.9 million in the same period of 2023[130]. - General and administrative expenses for the nine months ended September 30, 2024, increased by $11.3 million to $17.5 million compared to $6.2 million in the same period of 2023[134]. Business Strategy and Opportunities - The company is exploring additional indication opportunities for pacibekitug and evaluating new in-licensing and acquisition opportunities[95]. - The company remains an emerging growth company and a smaller reporting company, allowing it to take advantage of certain regulatory exemptions[156][158]. - The company is subject to risks associated with the development of new biopharmaceutical products, which may lead to unforeseen expenses and delays[140]. - Other income, net for the three months ended September 30, 2024, increased by $3.2 million to $4.3 million compared to $1.1 million in the same period of 2023[131].