Tourmaline Bio(TRML) - 2024 Q2 - Quarterly Report

Financial Position and Cash Flow - Total cash, cash equivalents, and investments as of June 30, 2024, amounted to $334.4 million[86] - The January 2024 public offering resulted in net proceeds of $161.4 million after deducting underwriting discounts and offering costs[88] - As of June 30, 2024, the company had $334.4 million in cash, cash equivalents, and investments, which is expected to fund operating expenses and capital expenditures into 2027[125] - Net cash used in operating activities for the six months ended June 30, 2024 was $32.9 million, a $19.6 million increase compared to the same period in 2023[133] - Net cash used in investing activities for the six months ended June 30, 2024 was $199.0 million, primarily due to purchases of investments using proceeds from the January 2024 Offering[134] - Net cash provided by financing activities for the six months ended June 30, 2024 was $161.4 million, primarily from the January 2024 Offering[135] - The company has raised aggregate gross proceeds of approximately $359.7 million from outside capital, including Series A convertible preferred stock, Pre-Merger Financing Transaction, and the January 2024 Offering[125] Net Losses and Accumulated Deficit - Net losses for the six months ended June 30, 2024, were $30.8 million, compared to $23.6 million for the same period in 2023[87] - Accumulated deficit as of June 30, 2024, was $92.8 million[87] - Net loss increased by $1.4 million to $17.5 million for Q2 2024 compared to Q2 2023[115] - Net loss increased by $7.2 million to $30.8 million for the first six months of 2024 compared to the same period in 2023[119] - The company incurred net losses of $30.8 million and $23.6 million for the six months ended June 30, 2024 and 2023, respectively, with an accumulated deficit of $92.8 million as of June 30, 2024[125] Research and Development Expenses - Research and development expenses increased by $1.3 million to $15.7 million for Q2 2024 compared to Q2 2023[116] - Research and development expenses increased by $6.5 million to $27.1 million for the first six months of 2024 compared to the same period in 2023[120] - The company expects significant increases in research and development and general and administrative costs in the future[124] General and Administrative Expenses - General and administrative expenses increased by $4.3 million to $6.2 million for Q2 2024 compared to Q2 2023[118] - General and administrative expenses increased by $9.1 million to $12.4 million for the first six months of 2024 compared to the same period in 2023[122] - The company expects significant increases in research and development and general and administrative costs in the future[124] Clinical Trials and Product Development - The company initiated a Phase 2 trial of pacibekitug in patients with chronic kidney disease (CKD) and elevated high-sensitivity CRP (hs-CRP) in April 2024, with topline data expected in the first half of 2025[85] - The company expects to report topline data from the pivotal Phase 2b spiriTED trial in 2025 and commence a pivotal Phase 3 trial in the second half of 2024[83] - The company has identified thyroid eye disease (TED) as the beachhead indication for its FcRn+ strategy, with ongoing clinical trials[82] - Future funding requirements will depend on factors such as clinical trial costs, regulatory review costs, and commercialization expenses for pacibekitug and other product candidates[129] Revenue and Sales Milestones - No revenue generated since inception, with no expectation of near-term product sales[103] - The global sales of four anti-IL-6 or anti-IL-6R antibodies exceeded $3.5 billion in 2023[80] - The company has not generated any revenue from product sales and expects to require substantial additional capital for product development and commercialization[126] Obligations and Royalties - The company is obligated to pay Pfizer up to $128.0 million for development and regulatory milestones and up to $525.0 million for sales milestones[94] - The company is obligated to pay Lonza a royalty in the low-single digits on the Net Sales of products containing pacibekitug[99] - The company may be required to pay Pfizer up to $128.0 million for development and regulatory milestones and up to $525.0 million for sales milestones related to pacibekitug[131] Other Income and Future Funding - Other income, net increased by $8.4 million to $8.7 million for the first six months of 2024 compared to the same period in 2023[123] - The company will need additional capital to fund operations, potentially from equity or debt financings, collaborations, or licensing arrangements[124] Regulatory and Reporting Status - The company remains an emerging growth company and a smaller reporting company, with reduced disclosure obligations[143][144]