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].

Financial Performance - Cash, cash equivalents, and investments totaled $314.4 million as of September 30, 2024, up from $203.0 million as of December 31, 2023, providing a cash runway into 2027[7] - Net loss for Q3 2024 was $20.2 million, compared to a net loss of $5.6 million for Q3 2023, resulting in a basic and diluted net loss per share of $0.78[10] - Total operating expenses for Q3 2024 were $24.4 million, compared to $6.6 million for Q3 2023[15] - Tourmaline's total assets increased to $328.4 million as of September 30, 2024, up from $210.3 million as of December 31, 2023[16] Research and Development - Research and development expenses increased to $19.3 million for Q3 2024, compared to $3.8 million for Q3 2023, primarily due to higher employee compensation and clinical trial costs[8] - The Phase 2 TRANQUILITY trial is ongoing, with topline data expected in the first half of 2025[5] - Tourmaline is on track to initiate a pivotal Phase 3 trial for pacibekitug in thyroid eye disease (TED) in the second half of 2024, with topline data anticipated in 2026[6] Administrative and Operational Developments - General and administrative expenses rose to $5.1 million for Q3 2024, up from $2.9 million for Q3 2023, driven by increased headcount and professional service fees[9] - The company formed a Cardiovascular Scientific Advisory Board in October 2024 to guide its cardiovascular program[4] - Tourmaline showcased research at two major cardiology congresses in 2024, highlighting its focus on cardiovascular inflammation[3]

Core Insights - Tourmaline Bio, Inc. is progressing towards reporting topline data from its Phase 2 TRANQUILITY trial in the first half of 2025, focusing on cardiovascular inflammation and chronic kidney disease [1][3] - The company has established a Cardiovascular Scientific Advisory Board to guide its cardiovascular program, which is expected to enhance its strategic direction as it prepares for Phase 3 clinical trials [2][3] - Tourmaline's financial position is strong, with cash, cash equivalents, and investments totaling $314.4 million as of September 30, 2024, providing a cash runway into 2027 [5][13] Clinical Developments - The Phase 2 TRANQUILITY trial is evaluating the efficacy of pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease, with topline data expected in early 2025 [3] - The pivotal spiriTED Phase 2b trial is ongoing, with topline data anticipated in the second half of 2025, and a Phase 3 trial for TED is set to begin in late 2024 [4] Financial Performance - For Q3 2024, research and development expenses increased to $19.3 million from $3.8 million in Q3 2023, driven by higher employee compensation and clinical trial costs [6] - General and administrative expenses rose to $5.1 million in Q3 2024 from $2.9 million in Q3 2023, reflecting increased headcount and professional service fees [6] - The net loss for Q3 2024 was $20.2 million, compared to $5.6 million in Q3 2023, with a basic and diluted net loss per share of $0.78 [7][12]

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

NEW YORK, Oct. 11, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced that it expects to present two posters at the upcoming 19th Annual Cardiometabolic Health Congress (CMHC), taking place October 17-19, 2024, in Boston, MA. These posters highlight Tourmaline's ongoing commitment to further ...

– Tourmaline assembles leading experts to support the development of pacibekitug for cardiovascular diseases – – Cardiovascular Scientific Advisory Board expected to provide strategic guidance as Tourmaline advances pacibekitug towards potential Phase 3 clinical trial readiness in 2025 for the treatment of cardiovascular diseases – NEW YORK, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to d ...

NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced that Sandeep Kulkarni, CEO, is expected to participate in the following investor conferences: H.C. Wainwright 26th Annual Global Investor Conference, New York Fireside Chat Monday, September 9, 2024 at 12:00 pm ET Cantor G ...

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]

Financial Position and Cash Runway - Cash, cash equivalents, and investments totaled $334.4 million as of June 30, 2024, providing a cash runway into 2027[7][15] - Total assets increased to $344.79 million as of June 30, 2024, compared to $210.30 million as of December 31, 2023[15] Operating Expenses and Net Loss - Research and development expenses increased to $15.7 million in Q2 2024, up from $14.5 million in Q2 2023, driven by employee compensation and clinical trial costs[8] - General and administrative expenses rose to $6.2 million in Q2 2024, compared to $1.9 million in Q2 2023, due to increased headcount and consulting expenses[9] - Net loss for Q2 2024 was $17.5 million, compared to $16.1 million in Q2 2023, with basic and diluted net loss per share of $0.68 and $16.29, respectively[10] - Total operating expenses for Q2 2024 were $21.97 million, up from $16.37 million in Q2 2023[14] Clinical Trials and Development Progress - The first patient was dosed in May 2024 in the Phase 2 TRANQUILITY trial evaluating pacibekitug for cardiovascular diseases[1][4] - Tourmaline is on track to initiate a pivotal Phase 3 trial for pacibekitug in Thyroid Eye Disease (TED) in the second half of 2024, with topline data expected in 2026[3] - Topline data from the Phase 2 TRANQUILITY trial is expected in the first half of 2025, potentially positioning the company for Phase 3 readiness in cardiovascular diseases[4][5] Corporate and Market Recognition - Tourmaline was added to the Russell 2000® and Russell 3000® Indexes in June 2024[6]

– First patient dosed in May 2024 in Phase 2 TRANQUILITY trial evaluating pacibekitug (TOUR006) in patients with high cardiovascular risk – – On track to initiate a pivotal Phase 3 trial evaluating pacibekitug delivered subcutaneously every 8 weeks as first-line treatment for Thyroid Eye Disease (TED) in the second half of 2024 – – Added to the Russell 2000® Index and the broad-market Russell 3000® Index in June 2024 – – Cash, cash equivalents and investments of $334.4 million as of June 30, 2024, providing ...