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Tourmaline Bio, Inc. (TRML)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was an execution quarter ahead of the TRANQUILITY Phase 2 topline readout: net loss was $23.0M (EPS $(0.89)), with cash, cash equivalents and investments of $275.3M, supporting runway into 2H 2027 .
  • R&D spending rose 78% YoY to $20.3M on higher TRANQUILITY and spiriTED trial activity (G&A was $6.0M, roughly flat YoY), driving the larger loss as management scaled programs .
  • The company remains pre-revenue; Wall Street EPS/revenue consensus for Q1 2025 was not available from S&P Global for TRML (no estimates returned)* .
  • Subsequent update: on May 20, management announced positive TRANQUILITY topline (deep hs-CRP reductions with quarterly dosing), and outlined plans to advance toward a Phase 3 CV outcomes trial in ASCVD and a Phase 2 PoC in AAA in 2H 2025—key stock catalysts for the near term .

*Values retrieved from S&P Global.

What Went Well and What Went Wrong

  • What Went Well

    • TRANQUILITY timing stayed intact into Q2 2025; management reinforced conviction in IL‑6/hs‑CRP biology and pacibekitug’s positioning: “We continue to see growing evidence and enthusiasm…” (CEO) .
    • Cash runway remained robust: $275.3M at 3/31/25 with guidance for funding into 2H 2027, supporting multiple readouts and development steps .
    • Scientific momentum: multiple publications and presentations across cardiovascular inflammation and TED (AHA ATVB paper on AAA genetics; NANOS claims analysis; Frontiers in Ophthalmology review) .
  • What Went Wrong

    • Losses widened as clinical activity ramped: net loss rose to $23.0M (from $13.3M YoY) on higher R&D tied to TRANQUILITY and spiriTED, routine tox studies, and headcount .
    • No topline data in the quarter; investor focus remained on upcoming TRANQUILITY readout for validation and derisking .
    • Company remains pre-revenue with continued reliance on external capital and third-party manufacturing relationships to fund development .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($M)$0.0 (pre‑revenue) $0.0 (pre‑revenue) $0.0 (pre‑revenue)
Net Loss ($M)$(20.177) $(22.235) $(22.970)
Diluted EPS ($)$(0.78) $(0.86) $(0.89)
R&D Expense ($M)$19.330 $20.545 $20.258
G&A Expense ($M)$5.108 $5.261 $5.973
Total Operating Expenses ($M)$24.438 $25.806 $26.231
Cash, Cash Equivalents & Investments ($M, period-end)$314.391 $294.936 $275.306

KPIs and Balance Sheet

KPIQ3 2024Q4 2024Q1 2025
Working Capital ($M)$286.501 $259.933 $250.522
Total Assets ($M)$328.447 $309.001 $287.498
Stockholders’ Equity ($M)$321.068 $300.052 $279.863

Notes:

  • YoY operating expense growth was primarily due to clinical trial costs for TRANQUILITY and spiriTED, higher headcount, and routine tox studies; G&A modestly decreased YoY on lower consulting despite higher payroll .
  • Single operating segment: pacibekitug program .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
TRANQUILITY topline timingQ2 2025“On track for Q2 2025” (Q4 release) “On track for Q2 2025; details on CV plan with topline” Maintained
AAA Phase 2 PoC next steps2H 2025 (post-topline)Details after TRANQUILITY topline Additional details with TRANQUILITY topline; PoC planning underway (affirmed subsequently) Maintained/clarified
TED spiriTED topline timing2H 20252H 2025 2H 2025 Maintained
Cash runwayMulti-yearInto 2H 2027 Into 2H 2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
IL‑6/Inflammation in CV diseaseFormation of CV SAB; ongoing validation; on track for TRANQUILITY 1H25 Reinforced evidence and enthusiasm; maintained Q2 2025 timing Consistent, building
TRANQUILITY enrollment/readoutOver-enrolled to 143; Q2 2025 topline On track; plan to outline CV development with topline Execution maintained
AAA programIndication nominated; details after TRANQUILITY Will provide PoC design details with TRANQUILITY topline Steady progression
TED (spiriTED)Pivotal Phase 2b ongoing; 2H 2025 topline Phase 2b ongoing; 2H 2025 topline Steady
Liquidity/runwayCash $314.4M (Q3), $294.9M (Q4); runway into 2H 2027 Cash $275.3M; runway into 2H 2027 Strong runway despite spend

Management Commentary

  • CEO strategic message: “We continue to see growing evidence and enthusiasm for the potential of addressing IL‑6‑driven cardiovascular inflammation… We look forward to the expected presentation of topline data from our Phase 2 TRANQUILITY trial… This readout has the potential to advance pacibekitug into the next stage of development within atherosclerotic cardiovascular disease, abdominal aortic aneurysm, and potentially other cardiovascular diseases.” (Sandeep Kulkarni, MD) .
  • Subsequent topline quote (May 20): “We are thrilled with the data… All active arms achieved rapid, deep, and durable reductions in hs‑CRP… this is the first time that pacibekitug or any IL‑6 inhibitor has been tested… with quarterly dosing.” (CEO) .
  • External validation: “Based upon these results, pacibekitug merits testing in future Phase 3 trials for cardiovascular risk reduction.” (Deepak L. Bhatt, MD, MPH, MBA; Chair of CV SAB) .

Q&A Highlights

  • A Q1 2025 earnings call transcript was not available in our document set; management commentary reflected in the quarter’s 8‑K/press release and 10‑Q. A separate May 20 TRANQUILITY webcast occurred; no transcript was available in our dataset, but slides and detailed topline metrics were furnished in 8‑K exhibits .

Estimates Context

  • S&P Global consensus for TRML EPS and revenue for Q1 2025 was not available (no estimate values returned). As a pre‑revenue biotech, comparisons to Street revenue/EPS were not feasible for the period.*

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Balance sheet provides multi‑year runway (into 2H 2027) to drive value creation across CV inflammation and TED, mitigating financing overhang ahead of pivotal development steps .
  • Operating expense growth is purposeful and tied to clinical execution (TRANQUILITY, spiriTED, tox), with spend discipline in G&A; expect continued R&D intensity as programs advance .
  • Near‑term trading catalyst was the TRANQUILITY topline announced May 20 (deep hs‑CRP reductions with quarterly dosing), which supports Phase 3 readiness in ASCVD and a Phase 2 PoC in AAA in 2H 2025 .
  • Program narrative is consolidating around IL‑6 biology and adherence‑friendly quarterly dosing, a potential differentiator vs. monthly competitors in CV inflammation .
  • TED program offers a second path; 2H 2025 topline remains an important readout for validating broader anti‑IL‑6 potential in autoantibody‑driven disease .
  • Risks remain typical of late‑stage biotech (clinical, regulatory, manufacturing dependence, capital markets), but recent execution (over‑enrollment, on‑time topline) and SAB depth are positive mitigants .
  • Position sizing should reflect binary clinical events and timeline clustering (ASCVD Phase 3 planning, AAA PoC start, spiriTED topline), which can drive volatility around data and regulatory milestones .

Supporting detail:

  • Q1 2025 P&L and cash metrics ; pre‑revenue status ; R&D/G&A drivers .
  • Prior quarter comps for trend analysis .
  • TRANQUILITY topline and forward plans .