TED

• The pivotal spiriTED Phase 2b trial in TED is ongoing, and Tourmaline expects topline data from this trial in the second half of 2025.

• Tourmaline is on track to initiate a pivotal Phase 3 trial evaluating pacibekitug delivered subcutaneously every 8 weeks as first-line treatment for TED in the second half of 2024, with topline data expected in 2026.

Third Quarter 2024 Financial Results:

Cash Position

• Cash, cash equivalents and investments were $314.4 million as of September 30, 2024, as compared to $203.0 million as of December 31, 2023. Tourmaline anticipates that its current cash, cash equivalents and investments will provide cash runway into 2027, funding its operations through key pacibekitug data readouts in TED and cardiovascular disease and providing the opportunity to expand development efforts into additional indications.
  

Operating Expenses

• Research and development expenses were $19.3 million for the third quarter of 2024, as compared to $3.8 million for the third quarter of 2023. The increase in research and development expenses was primarily driven by employee compensation costs attributable to increased headcount, increased drug manufacturing expenses, and increased costs related to the spiriTED and TRANQUILITY clinical trials.

• General and administrative expenses were $5.1 million for the third quarter of 2024, as compared to $2.9 million for the third quarter of 2023. The increase in general and administrative expenses was primarily driven by employee compensation costs attributable to increased headcount, increased insurance expenses associated with being a public company, and increased professional service fees.

Net Loss

• Net loss was $20.2 million for the third quarter of 2024 and $5.6 million for the third quarter of 2023, resulting in basic and diluted net loss per share of $0.78 and $5.16, respectively.

• The increase in net loss was attributable to increased operating expenses and Tourmaline’s overall growth throughout 2023 and into 2024. The decrease in net loss per share was attributable to the issuance of additional shares of common stock in conjunction with Tourmaline’s reverse merger and private placement completed in October 2023 and the underwritten follow-on public offering completed by Tourmaline in January 2024.

About Tourmaline Bio:

Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is pacibekitug (also referred to as TOUR006). For more information, please visit https://www.tourmalinebio.com or follow us on LinkedIn or X.

About Pacibekitug:

Pacibekitug (also referred to as TOUR006) is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Pacibekitug has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is developing pacibekitug in thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD) as its first two indications, with additional diseases under consideration.

Cautionary Note Regarding Forward-Looking Statements:

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Tourmaline’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of pacibekitug; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for pacibekitug, including reporting of data therefrom; the timing and potential to expand pacibekitug into additional indications; the potential benefits and success of the CV SAB in shaping the strategic direction of Tourmaline’s cardiovascular program; Tourmaline’s market opportunities; and Tourmaline’s anticipated cash runway. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline’s current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline’s current or future product candidates; the risk that Tourmaline’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) on or about November 7, 2024 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact:
Scient PR
Sarah Mishek
[email protected]

Investor Contact:
Meru Advisors
Lee M. Stern
[email protected]