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Tourmaline Bio, Inc. (TRML)·Q2 2025 Earnings Summary

Executive Summary

  • Reported positive topline TRANQUILITY results confirming deep hs-CRP reductions with quarterly subcutaneous dosing of pacibekitug; notably, the 50 mg quarterly arm achieved >85% hs-CRP reduction after a single dose, positioning pacibekitug with best-in-class potential in IL-6 inhibition .
  • Q2 financials: Net loss was $23.1M ($0.90 per share) versus $17.5M ($0.68) in Q2 2024; R&D rose to $19.6M and G&A was $6.3M, reflecting higher clinical and headcount costs; Other income was $2.9M .
  • Cash, cash equivalents, and investments of $256.4M as of June 30, 2025, with guided runway into H2 2027; working capital $239.0M, total assets $269.3M, equity $259.2M .
  • Advancement catalysts: completed pre-IND interaction and alignment with FDA on Phase 2 AAA trial design (initiation H2 2025) and planning underway for a Phase 3 ASCVD outcomes trial; ESC poster presentation of TRANQUILITY 90-day results on Aug 31, 2025 .
  • TED timing shift: spiriTED Phase 2b topline moved from H2 2025 to early 2026, a modest delay to the ophthalmology program cadence .

What Went Well and What Went Wrong

What Went Well

  • Best-in-class profile reinforced: “We are extremely pleased with the topline results from the ongoing Phase 2 TRANQUILITY trial… demonstrating the viability of quarterly subcutaneous administration,” underscoring deep, durable hs-CRP reductions and quarterly dosing convenience .
  • Clinical/regulatory momentum: Completed pre-IND interaction and achieved FDA alignment on Phase 2 AAA trial design using multi-modality imaging; on track to initiate in H2 2025 .
  • Strategic visibility and peer validation: Additional TRANQUILITY data to be presented at ESC; publication and scientific engagement bolstered credibility (Circulation: Genomic and Precision Medicine review) .

What Went Wrong

  • Operating cost intensity: R&D increased year over year (Q2 2025: $19.6M vs $15.7M), driven by TRANQUILITY and spiriTED trials, toxicology, headcount, and consulting; G&A slightly up to $6.3M (employee comp) .
  • Wider losses: Net loss expanded to $23.1M and EPS to $(0.90) (from $17.5M and $(0.68) in Q2 2024), reflecting program scale-up and overall growth .
  • TED timeline slippage: spiriTED Phase 2b topline moved to early 2026 from earlier expectations of H2 2025, potentially deferring TED-related optionality and catalysts .

Financial Results

Income Statement (GAAP)

Metric ($USD Thousands)Q4 2024Q1 2025Q2 2025
Research and development$20,545 $20,258 $19,634
General and administrative$5,261 $5,973 $6,340
Total operating expenses$25,806 $26,231 $25,974
Loss from operations$(25,806) $(26,231) $(25,974)
Other income, net$3,571 $3,261 $2,882
Net loss$(22,235) $(22,970) $(23,092)
Net loss per share, basic & diluted ($)$(0.86) $(0.89) $(0.90)
Weighted avg shares outstanding (thousands)25,796 25,692 25,755

Notes: The company did not report product revenue or margin measures; operating results reflect R&D-focused stage with other income driven by interest/marketable securities .

Balance Sheet Highlights

Metric ($USD Thousands)Q4 2024Q1 2025Q2 2025
Cash, cash equivalents & investments$294,936 $275,306 $256,418
Working capital$259,933 $250,522 $239,006
Total assets$309,001 $287,498 $269,295
Total stockholders’ equity$300,052 $279,863 $259,192

Operational KPIs (program)

KPIQ4 2024Q1 2025Q2 2025
TRANQUILITY enrollmentOver-enrolled to 143 participants 143 participants confirmed Topline data reported; deep hs-CRP reductions, quarterly dosing viability
hs-CRP reduction (50 mg quarterly arm)n/an/a>85% reduction after single dose
AAA program statusn/aIndication nominated; further details post-topline Pre-IND complete; FDA alignment; Phase 2 POC initiation H2 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti-yearInto H2 2027 (Dec 31, 2024 basis) Into H2 2027 (Jun 30, 2025 basis) Maintained
TRANQUILITY topline timingQ2 2025On track for Q2 2025 readout Reported May 20, 2025; ESC poster Aug 31, 2025 Achieved; added presentation timing
AAA Phase 2 POC initiationH2 2025Details to be provided post-topline On track to initiate H2 2025; FDA alignment on design Raised specificity; timeline affirmed
ASCVD Phase 3 outcomes trialPlanningIf TRANQUILITY successful, Phase 3-ready Planning underway for outcomes trial Advanced to active planning
TED spiriTED toplineProgram milestoneH2 2025 expected Early 2026 Lowered (delayed)

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available via our document tools; themes below reflect press releases across quarters.

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Cardiovascular inflammation strategyOver-enrollment; Phase 3-ready ambition if TRANQUILITY successful Positive topline with quarterly dosing; Phase 3 outcomes planning underway Strengthening (data-driven momentum)
Regulatory interactionsn/aPre-IND complete; FDA alignment on AAA Phase 2 design Progressing
R&D executionTrial over-enrollment; on-track topline Topline achieved; ESC presentation scheduled Advancing
TED program cadenceH2 2025 topline expected Early 2026 topline timing Moderating (delay)
Balance sheet discipline$294.9M cash (YE 2024); runway into H2 2027 $256.4M cash; runway into H2 2027 maintained Stable runway, cash drawdown from operations

Management Commentary

  • “The second quarter of 2025 was a transformative period for Tourmaline with our first data readout for pacibekitug… quarterly subcutaneous administration” — Sandeep Kulkarni, MD, CEO .
  • “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” .
  • “Tourmaline completed a successful pre-IND interaction… reached alignment with [FDA] on… Phase 2 proof-of-concept trial in AAA… remains on track to initiate… in the second half of 2025” .
  • “Planning underway for a Phase 3 cardiovascular outcomes trial in ASCVD” .

Q&A Highlights

  • No Q2 2025 earnings call transcript was located in our document catalog; Q&A themes could not be validated. The company’s updates were communicated via the 8-K press release and IR materials .

Estimates Context

  • Wall Street consensus (S&P Global) for Q2 2025 EPS and revenue was unavailable in our S&P Global data pull for TRML; coverage appears limited for this pre-commercial biotech. Where estimates are not available, we cannot quantify beats/misses versus consensus [GetEstimates: Q2 2025 returned no data].
  • Given the lack of product revenue and GAAP-only reporting, near-term estimate updates are more likely to center on R&D spending cadence and cash runway rather than top-line metrics .

Key Takeaways for Investors

  • The quarterly dosing validation with >85% hs-CRP reduction is a meaningful differentiator for pacibekitug in IL-6–mediated cardiovascular inflammation and a potential stock narrative driver as more data are shared at ESC .
  • Regulatory path clarity in AAA (pre-IND complete, FDA design alignment) and the move to Phase 3 outcomes planning in ASCVD increase program visibility and could compress timelines to pivotal evaluation, contingent on ongoing data .
  • Operating expense intensity continues as programs scale, widening net losses; however, a $256.4M cash balance and runway into H2 2027 mitigate financing risk in the near-to-medium term .
  • TED program delay to early 2026 shifts ophthalmology catalysts out; investor focus likely consolidates on cardiovascular readouts and ASCVD/AAA development milestones in H2 2025–2026 .
  • With limited sell-side consensus visibility, monitor company-reported R&D and G&A trajectories, cash burn, and milestone execution (ESC presentation, AAA Phase 2 initiation) for near-term trading implications .
  • Any future disclosures of safety and efficacy detail from TRANQUILITY (beyond topline) and early AAA signal could re-rate the probability of success assumptions embedded in the cardiovascular thesis .
  • Maintain awareness of macro and regulatory risks acknowledged in forward-looking statements; program advancement remains data-dependent and subject to clinical and regulatory execution .