Tourmaline Bio Reports Second Quarter 2025 Financial Results and Recent Business Highlights
Tourmaline Bio (NASDAQ: TRML) reported Q2 2025 financial results and highlighted significant progress in its clinical programs. The company announced positive topline results from the Phase 2 TRANQUILITY trial of pacibekitug, demonstrating rapid and significant reductions in high-sensitivity C-reactive protein with quarterly dosing.
Key financial metrics include cash position of $256.4 million as of June 30, 2025, providing runway into H2 2027. Q2 2025 saw net loss of $23.1 million ($0.90 per share), with R&D expenses at $19.6 million and G&A expenses at $6.3 million.
The company plans to initiate a Phase 2 proof-of-concept trial in abdominal aortic aneurysm in H2 2025 and is preparing for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease. Additional TRANQUILITY trial data will be presented at the upcoming European Society of Cardiology Congress.
Tourmaline Bio (NASDAQ: TRML) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha evidenziato importanti progressi nei suoi programmi clinici. La società ha annunciato risultati topline positivi dallo studio di Fase 2 TRANQUILITY su pacibekitug, che mostrano riduzioni rapide e significative della proteina C-reattiva ad alta sensibilità con somministrazione trimestrale.
I principali indicatori finanziari includono una posizione di cassa di 256,4 milioni di dollari al 30 giugno 2025, che garantisce risorse fino alla seconda metà del 2027. Nel Q2 2025 la società ha registrato una perdita netta di 23,1 milioni di dollari (0,90 dollari per azione), con spese per R&S pari a 19,6 milioni e spese generali e amministrative di 6,3 milioni.
La società prevede di avviare uno studio di proof-of-concept di Fase 2 sull'aneurisma dell'aorta addominale nella seconda metà del 2025 e si sta preparando per uno studio di Fase 3 sugli esiti cardiovascolari nella malattia cardiovascolare aterosclerotica. Ulteriori dati dello studio TRANQUILITY saranno presentati al prossimo Congresso della Società Europea di Cardiologia.
Tourmaline Bio (NASDAQ: TRML) informó los resultados financieros del segundo trimestre de 2025 y destacó avances significativos en sus programas clínicos. La compañía anunció resultados topline positivos del ensayo de Fase 2 TRANQUILITY con pacibekitug, que demostraron reducciones rápidas y significativas de la proteína C reactiva ultrasensible con dosificación trimestral.
Los principales indicadores financieros incluyen una posición de efectivo de 256,4 millones de dólares al 30 de junio de 2025, que proporciona financiación hasta la segunda mitad de 2027. En el 2T 2025 se registró una pérdida neta de 23,1 millones de dólares (0,90 dólares por acción), con gastos de I+D de 19,6 millones y gastos generales y administrativos de 6,3 millones.
La compañía planea iniciar un ensayo de prueba de concepto de Fase 2 en aneurisma de la aorta abdominal en la segunda mitad de 2025 y se está preparando para un ensayo de Fase 3 sobre resultados cardiovasculares en enfermedad cardiovascular aterosclerótica. Datos adicionales del ensayo TRANQUILITY se presentarán en el próximo Congreso de la Sociedad Europea de Cardiología.
Tourmaline Bio (NASDAQ: TRML)은 2025년 2분기 재무 실적을 발표하고 임상 프로그램에서 중요한 진전을 강조했습니다. 회사는 pacibekitug의 2상 TRANQUILITY 시험에서 톱라인 긍정적 결과를 발표했으며, 분기별 투약으로 고감도 C-반응성 단백질(hs-CRP)이 빠르고 유의하게 감소함을 보여주었습니다.
주요 재무 지표로는 2025년 6월 30일 기준 현금 잔고 2억5,640만 달러로, 2027년 하반기까지 운영 자금이 확보되어 있습니다. 2025년 2분기 순손실은 2,310만 달러(주당 0.90달러)였으며, 연구개발비는 1,960만 달러, 일반관리비는 630만 달러였습니다.
회사는 2025년 하반기에 복부 대동맥류 대상 2상 개념증명 시험을 시작할 계획이며, 죽상동맥경화성 심혈관질환에서의 심혈관계 결과를 평가하는 3상 시험 준비도 진행 중입니다. TRANQUILITY 시험의 추가 데이터는 곧 있을 유럽심장학회(ESC) 학회에서 발표될 예정입니다.
Tourmaline Bio (NASDAQ: TRML) a publié ses résultats financiers du deuxième trimestre 2025 et a souligné des progrès significatifs dans ses programmes cliniques. La société a annoncé des résultats topline positifs de l'essai de phase 2 TRANQUILITY sur le pacibekitug, montrant des réductions rapides et significatives de la protéine C‑réactive ultrasensible avec des administrations trimestrielles.
Les principaux indicateurs financiers incluent une position de trésorerie de 256,4 millions de dollars au 30 juin 2025, assurant une visibilité financière jusqu'à la seconde moitié de 2027. Au 2T 2025, la société a enregistré une perte nette de 23,1 millions de dollars (0,90 $ par action), avec des dépenses de R&D de 19,6 millions et des frais généraux et administratifs de 6,3 millions.
La société prévoit de lancer un essai de preuve de concept (phase 2) sur l'anévrisme de l'aorte abdominale au second semestre 2025 et se prépare à un essai de phase 3 sur les résultats cardiovasculaires dans la maladie cardiovasculaire athéroscléreuse. Des données supplémentaires de TRANQUILITY seront présentées lors du prochain congrès de la Société Européenne de Cardiologie.
Tourmaline Bio (NASDAQ: TRML) veröffentlichte die Finanzergebnisse für das zweite Quartal 2025 und hob bedeutende Fortschritte in seinen klinischen Programmen hervor. Das Unternehmen meldete positive Topline-Ergebnisse der Phase-2-Studie TRANQUILITY zu pacibekitug, die bei vierteljährlicher Gabe schnelle und signifikante Senkungen des hochsensitiven C-reaktiven Proteins zeigten.
Wesentliche Finanzkennzahlen umfassen einen Barbestand von 256,4 Millionen US-Dollar zum 30. Juni 2025, der eine Finanzierung bis in die zweite Hälfte 2027 sicherstellt. Im 2. Quartal 2025 wurde ein Nettoverlust von 23,1 Millionen US-Dollar (0,90 US-Dollar je Aktie) ausgewiesen; F&E-Aufwendungen beliefen sich auf 19,6 Millionen und Verwaltungs- und allgemeine Aufwendungen auf 6,3 Millionen.
Das Unternehmen plant, in der zweiten Hälfte 2025 eine Phase-2-PoC-Studie zum abdominellen Aortenaneurysma zu starten und bereitet eine Phase-3-Studie zu kardiovaskulären Endpunkten bei atherosklerotischer Herz-Kreislauf-Erkrankung vor. Weitere TRANQUILITY-Daten werden auf dem kommenden Kongress der European Society of Cardiology präsentiert.
- Positive Phase 2 TRANQUILITY trial results showed >85% hs-CRP reductions with quarterly dosing
- Strong cash position of $256.4M providing runway into H2 2027
- First IL-6 inhibitor demonstrating deep hs-CRP reductions with quarterly dosing
- Safety profile comparable to placebo in TRANQUILITY trial
- Successful pre-IND interaction with FDA for AAA trial
- Increased net loss to $23.1M in Q2 2025 from $17.5M in Q2 2024
- R&D expenses increased 24.8% year-over-year to $19.6M
- Cash position decreased from $294.9M to $256.4M since December 2024
Insights
Tourmaline's pacibekitug shows quarterly dosing efficacy in inflammation with $256.4M cash providing runway through key data readouts until 2027.
Tourmaline Bio's Q2 update reveals significant clinical momentum for its lead candidate pacibekitug in cardiovascular inflammation. The Phase 2 TRANQUILITY trial demonstrated rapid, deep, and durable reductions in high-sensitivity C-reactive protein (hs-CRP) with quarterly subcutaneous dosing—a potential differentiator in the competitive IL-6 inhibitor landscape. Achieving >85% hs-CRP reduction with just a single dose in the quarterly arm is particularly noteworthy as this positions pacibekitug as the first IL-6 inhibitor to demonstrate efficacy with such an infrequent dosing schedule.
The safety profile appears promising with adverse events comparable to placebo, though the data cut-off was April 23, so longer-term safety data will be crucial. The company is strategically expanding its cardiovascular inflammation program on multiple fronts: planning a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD) while simultaneously preparing to initiate a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA) in H2 2025 following successful FDA alignment on trial design.
The company is also running a parallel program in Thyroid Eye Disease (TED) with the Phase 2b spiriTED trial, expecting topline data in early 2026. This dual-indication strategy creates multiple shots on goal and could significantly expand the commercial potential of pacibekitug. With $256.4M in cash (down from $294.9M at end of 2024), Tourmaline projects runway into H2 2027, sufficient to fund operations through critical data readouts in both indications. The quarterly net loss of $23.1M ($0.90 per share) versus $17.5M ($0.68 per share) in Q2 2024 reflects increased R&D investments as clinical programs advance.
Tourmaline's quarterly dosing advantage for pacibekitug with sufficient cash runway creates compelling clinical and commercial opportunity.
Tourmaline Bio's Q2 results highlight a potential best-in-class opportunity in the inflammation space. The standout achievement is pacibekitug's demonstrated efficacy with quarterly dosing—a potentially significant competitive advantage for chronic indications where patient convenience drives adherence and market share. The >85% reduction in hs-CRP with just a single dose in the quarterly arm represents a mechanistic validation that could translate across multiple inflammatory conditions.
The company's expansion into abdominal aortic aneurysm (AAA) represents a strategic move into an indication with limited treatment options and high unmet need. With FDA alignment on trial design including multi-modality imaging endpoints, this program could become a significant value driver if successful. The concurrent development in atherosclerotic cardiovascular disease (ASCVD)—a massive market—suggests management is building a comprehensive cardiovascular inflammation franchise.
Financially, Tourmaline's $256.4M cash position provides a projected runway into H2 2027, covering multiple value-inflection points including the TED data in early 2026 and likely interim data from the AAA program. The quarterly burn rate of approximately $19.3M (calculated from the $38.5M six-month reduction in cash) appears well-controlled given the two active clinical programs. While R&D expenses increased to $19.6M from $15.7M year-over-year, this reflects appropriate investment in clinical programs rather than concerning overhead growth. The G&A expense control (nearly flat at $6.3M vs $6.2M) demonstrates fiscal discipline. Overall, the financial picture supports Tourmaline's ability to execute its clinical strategy without near-term financing pressure.
– Reported positive topline results from the ongoing Phase 2 TRANQUILITY trial of pacibekitug in May 2025, demonstrating rapid, deep, and durable reductions in high-sensitivity C-reactive protein with quarterly dosing –
— Additional data from the ongoing Phase 2 TRANQUILITY trial to be presented at the European Society of Cardiology Congress in August 2025 –
– On track to initiate Phase 2 proof-of-concept trial in abdominal aortic aneurysm in the second half of 2025 –
– Planning underway for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease –
– Cash, cash equivalents, and investments of
NEW YORK, Aug. 13, 2025 (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 its financial results for the second quarter of 2025 and outlined recent business highlights.
“The second quarter of 2025 was a transformative period for Tourmaline, with our first data readout for pacibekitug,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “We are extremely pleased with the topline results from the ongoing Phase 2 TRANQUILITY trial, which have unlocked pacibekitug’s best-in-class potential by demonstrating the viability of quarterly subcutaneous administration. With these results in hand, we look forward to advancing pacibekitug into the next stage of development within cardiovascular inflammation, including the planned initiation of our Phase 2 proof-of-concept trial in abdominal aortic aneurysm in the second half of 2025.”
Cardiovascular Inflammation Highlights:
TRANQUILITY Topline Results
- On May 20, 2025, Tourmaline announced positive topline results from the ongoing Phase 2 TRANQUILITY trial, which evaluates quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease. The press release related to these topline results can be found here, and a replay of the related webcast can be accessed here.
- In the TRANQUILITY trial, rapid, deep, and durable reductions in hs-CRP through Day 90 were achieved across all pacibekitug arms with high statistical significance as compared to placebo (p<0.0001 for all arms).
- Based upon these results, pacibekitug is the first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing in a clinical trial, achieving >
85% hs-CRP reductions from baseline in the 50 mg quarterly arm after only a single dose. - The overall incidence rates of adverse events and serious adverse events in the pacibekitug groups of the TRANQUILITY trial were comparable to placebo through the data extract date of April 23, 2025. A more complete discussion of the safety data observed in the ongoing TRANQUILITY trial can be found in the topline results press release referenced above and available here.
Ongoing Development Activities
- The TRANQUILITY trial is the starting point of Tourmaline’s clinical development program for pacibekitug for the potential treatment of atherosclerotic cardiovascular disease (ASCVD) and other inflammation-driven cardiovascular diseases. Tourmaline continues to make progress in planning for a Phase 3 cardiovascular outcomes trial in ASCVD.
- Tourmaline completed a successful pre-IND interaction with the U.S. Food and Drug Administration in the second quarter of 2025 and has reached alignment with the agency on Tourmaline’s plans to conduct a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA), including the design of the study and the use of multi-modality imaging. Tourmaline remains on track to initiate this planned Phase 2 proof-of-concept trial in AAA in the second half of 2025.
Presentations and Publications
- At the European Society of Cardiology (ESC) Congress in Madrid, Spain, Tourmaline will present additional data related to the ongoing TRANQUILITY trial in a poster presentation entitled “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Ph2 Trial of Pacibekitug SC Quarterly or Monthly in Patients with Elevated hs-CRP and Chronic Kidney Disease: TRANQUILITY 90-Day Results”. This poster will be presented on August 31, 2025, by Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital, the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York, and Chair of Tourmaline’s Cardiovascular Scientific Advisory Board (for which he is compensated).
- Emil deGoma, MD, Tourmaline’s SVP of Medical Research, and John Walsh, MD, Tourmaline’s Vice President, Head of Medical Affairs, were contributing authors on a review manuscript entitled “Human Genetics Informing Drug Development in Cardiovascular Disease: Interleukin-6 Signaling as a Case Study” that was published in the August 2025 issue of Circulation: Genomic and Precision Medicine.
Thyroid Eye Disease (TED) Highlights:
- In May 2025, representatives from Tourmaline presented a poster entitled “Prevalence of Thyroid Eye Disease (TED) in the United States” at the Association for Research in Vision and Ophthalmology (ARVO) Annual Conference held in Salt Lake City, Utah.
- The Phase 2b spiriTED trial remains ongoing, and Tourmaline expects to report topline data from this trial in early 2026.
- Tourmaline expects to provide additional information on its future development plans in TED after review of data from the Phase 2b spiriTED trial.
Second Quarter 2025 Financial Results:
Cash Position
- Cash, cash equivalents, and investments were
$256.4 million as of June 30, 2025, as compared to$294.9 million as of December 31, 2024. Tourmaline anticipates that its current cash, cash equivalents, and investments will provide cash runway into the second half of 2027, funding its operations through key pacibekitug data readouts in cardiovascular inflammation and TED, as well as other pacibekitug development activities.
Operating Expenses
- Research and development expenses were
$19.6 million for the second quarter of 2025, as compared to$15.7 million for the second quarter of 2024. The increase in research and development expenses was primarily driven by increased clinical trial expenses directly related to the TRANQUILITY and spiriTED trials, increased routine toxicology study expenses, increased employee compensation costs attributable to additional headcount, and increased consulting expenses, partially offset by decreased chemistry, manufacturing, and controls expenses. - General and administrative expenses were
$6.3 million for the second quarter of 2025, as compared to$6.2 million for the second quarter of 2024. The slight increase in general and administrative expenses was primarily driven by increased employee compensation costs, partially offset by decreased consulting expenses.
Net Loss
- Net loss was
$23.1 million for the second quarter of 2025, resulting in a basic and diluted net loss per share of$0.90 . Net loss was$17.5 million for the second quarter of 2024, resulting in basic and diluted net loss per share of$0.68 . - The increase in both net loss and net loss per share was attributable to increased operating expenses and Tourmaline’s overall growth from 2024 to 2025.
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. For more information, please visit https://www.tourmalinebio.com/ and follow us on LinkedIn, X, and Bluesky.
About Pacibekitug:
Pacibekitug 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. Excluding ongoing trials, pacibekitug was previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future.
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, including pacibekitug’s best-in-class potential; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for pacibekitug, including reporting of data therefrom; the timing of Phase 3 clinical trial readiness; the timing and potential to expand pacibekitug into additional indications; 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 genetic evidence or modeling data indicating the therapeutic potential of IL-6 inhibition, or clinical evidence from other drug candidates targeting IL-6, will not be replicated 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 on 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 August 13, 2025 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.
| Tourmaline Bio, Inc. | |||||||||||||||
| Condensed Consolidated Statements of Operations (unaudited) | |||||||||||||||
| (amounts in thousands, except per share data) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 19,634 | $ | 15,734 | $ | 39,892 | $ | 27,110 | |||||||
| General and administrative | 6,340 | 6,237 | 12,313 | 12,378 | |||||||||||
| Total operating expenses | 25,974 | 21,971 | 52,205 | 39,488 | |||||||||||
| Loss from operations | (25,974 | ) | (21,971 | ) | (52,205 | ) | (39,488 | ) | |||||||
| Other income, net | 2,882 | 4,484 | 6,143 | 8,690 | |||||||||||
| Net loss | $ | (23,092 | ) | $ | (17,487 | ) | $ | (46,062 | ) | $ | (30,798 | ) | |||
| Net loss per share, basic and diluted | $ | (0.90 | ) | $ | (0.68 | ) | $ | (1.79 | ) | $ | (1.24 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 25,755 | 25,724 | 25,723 | 24,908 | |||||||||||
| Tourmaline Bio, Inc. | |||||
| Selected Condensed Consolidated Balance Sheet Data (unaudited) | |||||
| (amounts in thousands) | |||||
| June 30, | December 31, | ||||
| 2025 | 2024 | ||||
| Cash, cash equivalents and investments | $ | 256,418 | $ | 294,936 | |
| Working capital | $ | 239,006 | $ | 259,933 | |
| Total assets | $ | 269,295 | $ | 309,001 | |
| Total stockholders’ equity | $ | 259,192 | $ | 300,052 | |
Media Contact:
Scient PR
Sarah Mishek
SMishek@ScientPR.com
Investor Contact:
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com
FAQ
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