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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)
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
Operational KPIs (program)
Guidance Changes
Earnings Call Themes & Trends
Note: No Q2 2025 earnings call transcript was available via our document tools; themes below reflect press releases across quarters.
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 .