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 ...

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, effective June 25, 2024. Mr. Robinson most recently held the role of Vice President, Finance and Controller at Tourmaline, in addition to servin ...

A live webcast and replay will be posted under "Events and Presentations" in the News & Investors section of the Tourmaline Bio website at https://ir.tourmalinebio.com. NEW YORK, May 23, 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 i ...

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].

Exhibit 99.1 Tourmaline Bio Reports First Quarter 2024 Financial Results and Recent Business Highlights – Initiated Phase 2 TRANQUILITY trial in April 2024 following U.S. FDA clearance of Investigational New Drug application (IND) for clinical development program in Atherosclerotic Cardiovascular Disease (ASCVD) – – Expanded Thyroid Eye Disease (TED) clinical development plan, including accelerating the planned initiation of a pivotal Phase 3 trial into 2024 – – Completed underwritten follow-on public offer ...