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]

Core Insights - Tourmaline Bio (NASDAQ: TRML) is expected to have several catalysts in 2025 that could significantly enhance shareholder value [2]. Company Overview - Tourmaline Bio is involved in various programs aimed at generating substantial shareholder value [2]. Investment Analysis - The Biotech Analysis Central service provides in-depth analysis of pharmaceutical companies, including a library of over 600 articles and a model portfolio of small and mid-cap stocks [2].

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 ...

Phase 2 TRANQUILITY trial is evaluating the high-sensitivity C-reactive protein (hs-CRP)-lowering effect, safety, tolerability, and pharmacokinetics (PK) of quarterly and monthly subcutaneous administration of TOUR006 in patients with chronic kidney disease and elevated hs-CRP — Dosing regimens are informed by six previous Phase 1 and Phase 2 clinical studies in healthy volunteers and patients with inflammatory autoimmune disorders, as well as PK/PD modeling — Topline data is expected first half of 2025 — D ...

Mr. Robinson earned a B.S. in Management and an M.S. in Accounting from Boston College, and he is licensed as a Certified Public Accountant. NEW YORK, June 27, 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 the promotion of Ryan Robinson, CPA, to Chief Financial Officer and Treasurer, eff ...