Tourmaline Bio Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Tourmaline Bio reported Q3 2024 financial results with a net loss of $20.2 million ($0.78 per share), compared to $5.6 million in Q3 2023. The company maintains a strong cash position of $314.4 million, providing runway into 2027. Research and development expenses increased to $19.3 million from $3.8 million year-over-year, while general and administrative expenses rose to $5.1 million from $2.9 million.
The company remains on track to report topline data from its Phase 2 TRANQUILITY trial in first half of 2025 and formed a Cardiovascular Scientific Advisory Board in October 2024. Additionally, Tourmaline expects topline data from the pivotal spiriTED Phase 2b trial in TED in second half of 2025.
Tourmaline Bio ha riportato i risultati finanziari del terzo trimestre 2024, con una perdita netta di 20,2 milioni di dollari (0,78 dollari per azione), rispetto a 5,6 milioni di dollari nel terzo trimestre del 2023. L'azienda mantiene una solida posizione di liquidità di 314,4 milioni di dollari, garantendo risorse fino al 2027. Le spese per ricerca e sviluppo sono aumentate a 19,3 milioni di dollari rispetto ai 3,8 milioni dell'anno precedente, mentre le spese generali e amministrative sono salite a 5,1 milioni di dollari dai 2,9 milioni.
L'azienda è in programma di riportare i dati iniziali del suo studio di Fase 2 TRANQUILITY nella prima metà del 2025 e ha costituito un Consiglio Scientifico Consultivo Cardiovascolare nel ottobre 2024. Inoltre, Tourmaline si aspetta di ricevere i dati iniziali dal trial pivotale spiriTED di Fase 2b nella sindrome di TED nella seconda metà del 2025.
Tourmaline Bio informó resultados financieros del tercer trimestre de 2024 con una pérdida neta de 20,2 millones de dólares (0,78 dólares por acción), en comparación con 5,6 millones de dólares en el tercer trimestre de 2023. La compañía mantiene una sólida posición de liquidez de 314,4 millones de dólares, lo que le proporciona recursos hasta 2027. Los gastos de investigación y desarrollo aumentaron a 19,3 millones de dólares desde 3,8 millones interanualmente, mientras que los gastos generales y administrativos subieron a 5,1 millones de dólares desde 2,9 millones.
La compañía sigue en camino de informar datos iniciales de su ensayo de Fase 2 TRANQUILITY en la primera mitad de 2025 y formó un Consejo Asesor Científico Cardiovascular en octubre de 2024. Además, Tourmaline espera datos iniciales del ensayo pivotal spiriTED de Fase 2b en TED en la segunda mitad de 2025.
투르말린 바이오는 2024년도 3분기 재무 결과를 발표하며 2020만 달러의 순손실(주당 0.78달러)을 기록했다고 밝혔습니다. 이는 2023년 3분기의 560만 달러와 비교됩니다. 회사는 3억 1440만 달러의 강력한 현금 보유를 유지하고 있으며, 이는 2027년까지의 자금을 보장합니다. 연구 및 개발 비용은 전년도 380만 달러에서 1930만 달러로 증가했으며, 일반 관리 비용은 290만 달러에서 510만 달러로 상승했습니다.
회사는 2025년 상반기에 TRANQUILITY 2상 시험의 초기 데이터를 보고할 예정이며, 2024년 10월에 심혈관 과학 자문 위원을 구성했습니다. 또한, 투르말린은 2025년 하반기에 TED에 대한 주요 spiriTED 2b 시험의 초기 데이터도 예상하고 있습니다.
Tourmaline Bio a annoncé ses résultats financiers pour le troisième trimestre 2024, avec une perte nette de 20,2 millions de dollars (0,78 dollar par action), contre 5,6 millions de dollars au troisième trimestre 2023. L'entreprise dispose d'une solide position de trésorerie de 314,4 millions de dollars, ce qui lui permet de financer ses activités jusqu'en 2027. Les dépenses de recherche et développement ont augmenté à 19,3 millions de dollars contre 3,8 millions l'année précédente, tandis que les frais généraux et administratifs sont passés de 2,9 millions à 5,1 millions de dollars.
L'entreprise est sur la bonne voie pour annoncer les données préliminaires de son essai de Phase 2 TRANQUILITY au cours de la première moitié de 2025 et a formé un Conseil scientifique consultatif en cardiologie en octobre 2024. De plus, Tourmaline s'attend à des données préliminaires de l'essai pivot spiriTED de Phase 2b sur le TED dans la deuxième moitié de 2025.
Tourmaline Bio berichtete über die Finanz Ergebnisse für das dritte Quartal 2024 mit einem Nettoverlust von 20,2 Millionen US-Dollar (0,78 US-Dollar pro Aktie), verglichen mit 5,6 Millionen US-Dollar im dritten Quartal 2023. Das Unternehmen hält eine starke Liquiditätsposition von 314,4 Millionen US-Dollar, die bis 2027 finanzielle Spielräume bietet. Die Forschungs- und Entwicklungskosten stiegen auf 19,3 Millionen US-Dollar, gegenüber 3,8 Millionen im Vorjahr, während die allgemeinen und administrativen Kosten auf 5,1 Millionen US-Dollar von 2,9 Millionen US-Dollar anstiegen.
Das Unternehmen bleibt auf Kurs, um in der ersten Hälfte von 2025 erste Daten aus der Phase 2 TRANQUILITY-Studie zu melden, und hat im Oktober 2024 einen wissenschaftlichen Beratungsausschuss für Herz-Kreislauf-Erkrankungen gegründet. Darüber hinaus erwartet Tourmaline in der zweiten Hälfte des Jahres 2025 erste Daten aus der entscheidenden spiriTED-Phase 2b-Studie zu TED.
- Strong cash position of $314.4 million providing runway into 2027
- Multiple clinical trial milestones expected in 2025
- Formation of strategic Cardiovascular Scientific Advisory Board
- Net loss increased to $20.2 million from $5.6 million year-over-year
- R&D expenses increased significantly to $19.3 million from $3.8 million
- G&A expenses rose to $5.1 million from $2.9 million
Insights
The Q3 financial results reveal significant operational expansion with
The robust cash position after January's follow-on offering provides strong operational flexibility through multiple clinical readouts. While spending has increased significantly, it's appropriately aligned with the advancement of two pivotal trials. The extended cash runway into 2027 significantly de-risks the company's ability to reach key clinical milestones without immediate financing needs.
The clinical development pipeline shows steady progress with two key programs: the TRANQUILITY trial for cardiovascular inflammation and the spiriTED Phase 2b study for Thyroid Eye Disease (TED). The formation of a specialized Cardiovascular Scientific Advisory Board strengthens the strategic positioning for future Phase 3 trials. The focus on IL-6 inhibition and high-sensitivity C-reactive protein as a biomarker demonstrates a well-defined mechanistic approach.
The planned initiation of a pivotal Phase 3 TED trial in H2 2024 alongside existing studies indicates confident program execution. Multiple data readouts scheduled throughout 2025-2026 provide several value-inflection points. The company's scientific approach is being validated through peer review at major medical conferences.
– On track to report topline data from Phase 2 TRANQUILITY trial in first half of 2025 –
– Assembled Cardiovascular Scientific Advisory Board (CV SAB), comprised of leading academic and industry experts, in October 2024 –
– Showcased poster presentations at the American Society of Preventive Cardiology Annual Congress in August 2024 and the 19th Annual Cardiometabolic Health Congress in October 2024 –
– Cash, cash equivalents and investments of
NEW YORK, Nov. 07, 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 its financial results for the third quarter of 2024 and outlined recent business highlights.
“We are proud of the continued momentum building at Tourmaline, highlighted by the formation of our Cardiovascular Scientific Advisory Board last month,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “Beyond the internal progress we have been making, we recognize the growing external enthusiasm around the potential for IL-6 inhibition in cardiovascular disease, including numerous publications outlining the importance of high-sensitivity C-reactive protein as an important biomarker for inflammatory risk. We look forward to continued execution throughout the remainder of 2024 as we approach key data readouts in 2025.”
Clinical Highlights and Upcoming Milestones:
Cardiovascular Inflammation
- At the American Society of Preventive Cardiology Annual Congress held in August 2024, Tourmaline presented a poster describing the rationale and design of the Phase 2 TRANQUILITY trial (Evaluating TOUR006 in Participants with Chronic Kidney Disease and Elevated hs-CRP: Rationale and Design of the TRANQUILITY Phase 2 Study).
- At the 19th Annual Cardiometabolic Health Congress held in October 2024, Tourmaline presented two posters (Utilization of High-Sensitivity C-Reactive Protein Testing in Primary and Secondary ASCVD Prevention and Effect of IL-6 Inhibition on Lipoprotein(a) Levels: A Systematic Review and Meta-Analysis).
- In October 2024, Tourmaline announced the formation of its CV SAB, comprised of academic and industry veterans with significant experience in cardiovascular medicine, clinical trial design and execution, and therapeutic innovation. Insights and guidance from the CV SAB are expected to be instrumental in shaping the strategic direction of Tourmaline’s cardiovascular program as the company prepares for Phase 3 clinical trial readiness in 2025, supporting efforts to redefine standards of care for high-risk cardiovascular disease patients.
- The Phase 2 TRANQUILITY trial, which evaluates quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease, is ongoing. Tourmaline continues to expect topline data from this trial in the first half of 2025.
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.
| Tourmaline Bio, Inc. Condensed Consolidated Statements of Operations (unaudited) (amounts in thousands, except per share data) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 19,330 | $ | 3,762 | $ | 46,440 | $ | 24,353 | |||||||
| General and administrative | 5,108 | 2,881 | 17,486 | 6,166 | |||||||||||
| Total operating expenses | 24,438 | 6,643 | 63,926 | 30,519 | |||||||||||
| Loss from operations | (24,438 | ) | (6,643 | ) | (63,926 | ) | (30,519 | ) | |||||||
| Other income, net | 4,261 | 1,052 | 12,951 | 1,297 | |||||||||||
| Net loss | $ | (20,177 | ) | $ | (5,591 | ) | $ | (50,975 | ) | $ | (29,222 | ) | |||
| Net loss per share, basic and diluted | $ | (0.78 | ) | $ | (5.16 | ) | $ | (2.02 | ) | $ | (29.40 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 25,767 | 1,084 | 25,197 | 994 | |||||||||||
| Tourmaline Bio, Inc. Selected Condensed Consolidated Balance Sheet Data (unaudited) (amounts in thousands) | |||||||
| September 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Cash, cash equivalents and investments | $ | 314,391 | $ | 202,951 | |||
| Working capital | $ | 286,501 | $ | 203,872 | |||
| Total assets | $ | 328,447 | $ | 210,295 | |||
| Total stockholders’ equity | $ | 321,068 | $ | 205,042 | |||
Media Contact:
Scient PR
Sarah Mishek
SMishek@ScientPR.com
Investor Contact:
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com
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