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Cidara Therapeutics, Inc. (CDTX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered a cleaner P&L (no IPR&D or collaboration revenue) and an EPS beat versus Street: diluted EPS was $(1.65) versus consensus $(1.815), aided by interest income and reversal of indirect tax liabilities; revenue was $0, in line with consensus .
  • Clinical momentum is the primary catalyst: Phase 2b NAVIGATE met primary and all secondary endpoints with dose-dependent protection of 76.1%, 61.3%, and 57.7%, with strong safety; End-of-Phase 2 FDA meeting is scheduled, breakthrough therapy designation has been requested, and BARDA funding proposal submitted .
  • Balance sheet significantly strengthened to fund Phase 3: cash, cash equivalents, and restricted cash were $516.9M at June 30, 2025 following a $402.5M upsized offering; CFO guided runway through completion of Phase 3 .
  • Management guided initiation of Phase 3 no later than spring 2026 (Southern Hemisphere), with operational readiness to start as early as this fall pending FDA alignment — a potential near-term stock catalyst on FDA minutes and trial start clarity .
  • Stock narrative likely pivots around regulatory milestones (FDA minutes, BTD decision), Phase 3 start timing, and BARDA outcome; positive efficacy versus historical vaccine effectiveness may support sentiment despite zero revenue .

What Went Well and What Went Wrong

What Went Well

  • Phase 2b NAVIGATE efficacy: single-dose CD388 conferred 76.1% (450mg), 61.3% (300mg), and 57.7% (150mg) protection over 24 weeks; clear dose response and favorable safety profile, a key de-risking event for Phase 3 .
  • Regulatory and funding positioning: End-of-Phase 2 meeting scheduled; breakthrough therapy designation requested; BARDA proposal submitted — collectively improving the probability of expedited development and non-dilutive support .
  • Capital strength: closed a $402.5M upsized offering; cash at quarter-end was $516.9M, with CFO stating funding is adequate through completion of the planned Phase 3 program .

Management quote:

  • “The highly compelling results of our Phase 2b NAVIGATE trial… put us in a position of strength to execute on our Phase 3 plan…” — Jeffrey Stein, Ph.D., CEO .

What Went Wrong

  • No revenue: collaboration revenue fell to $0 versus $0.3M in Q2 2024, reflecting prior termination of the Janssen collaboration, leaving the P&L fully dependent on financing and interest income .
  • Elevated R&D/OpEx: R&D rose to $24.8M (from $6.7M YoY) with G&A at $6.5M (from $4.7M YoY) as CD388 development ramped; while expected, it increases burn absent near-term revenue .
  • One-time tailwinds: EPS improvement included a $3.9M reversal of indirect tax liabilities — helpful but non-recurring and not indicative of ongoing operating leverage .

Financial Results

Income Statement and EPS vs Prior Periods and Estimates

MetricQ4 2024Q1 2025Q2 2025
Revenue ($USD Millions) - Actual$0.000 $0.000 $0.000
Revenue ($USD Millions) - Consensus*$0.240*$0.000*$0.000*
EPS (Diluted, $USD) - Actual$(5.38) $(1.66) $(1.65)
EPS (Diluted, $USD) - Consensus*$(3.85)*$(3.5725)*$(1.815)*

Values retrieved from S&P Global.*

Operating Expenses and Income

Metric ($USD Millions)Q2 2024Q1 2025Q2 2025
Acquired IPR&D$84.883 $0.000 $0.000
R&D$6.657 $24.600 $24.817
G&A$4.746 $6.179 $6.502
Reversal of Indirect Tax Liabilities$0.000 $(5.510) $(3.935)
Loss from Operations$(95.984) $(25.269) $(27.384)
Interest Income, net$1.774 $1.899 $1.666
Net Loss (Continuing Ops)$(94.210) $(23.480) $(25.718)
EPS (Continuing Ops, $)$(20.65) $(1.66) $(1.65)

Balance Sheet Snapshot

Metric ($USD Millions)Dec 31, 2024Mar 31, 2025Jun 30, 2025
Cash, Cash Equivalents & Restricted Cash$196.177 $174.489 $516.913
Total Assets$214.796 $191.727 $534.327
Total Liabilities$51.488 $50.045 $33.154
Stockholders’ Equity$163.308 $141.682 $501.173

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 3 Initiation TimingCD388 Influenza PreventionPotential to initiate Phase 3 during 2025–26 Northern Hemisphere season contingent on early efficacy analysis Initiate no later than spring 2026 (Southern Hemisphere); operationally prepared to start this fall pending FDA EOP2 outcomes Clarified timeline; optional earlier start; net effect: maintained optionality
Trial Population FocusPhase 3Broad prevention focus with Phase 3 dose selection pending NAVIGATE Initial focus on high-risk/co-morbid and immunocompromised patients Refined and prioritized high-need populations
Regulatory Milestones2025SAP changes and late-June topline from NAVIGATE EOP2 meeting scheduled; BTD requested; BARDA proposal submitted Advanced regulatory path and potential funding
Funding/Runway2025–2026Cash $174.5M at Q1; capital raises in 2024 Cash $516.9M; CFO indicates runway through Phase 3 completion Strengthened; extended runway
Index Inclusion/VisibilityMid-2025N/AAdded to Russell 2000/3000 in June 2025 Increased investor visibility

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 & Q1 2025)Current Period (Q2 2025)Trend
CD388 Efficacy & SafetyEnrollment complete; potential early efficacy analysis due to severe season; SAP changes under FDA discussion Statistically significant efficacy across all doses; placebo attack rate 2.8%; strong safety; p-values <0.001 / 0.0024 / 0.005 Strengthening (de-risked for Phase 3)
Regulatory PathPlanning Phase 3 design; alignment with FDA on SAP EOP2 meeting this month; BTD requested; Phase 3 initiation guidance clarified Advancing
Funding & RunwayCash $174.5M; prior raises in 2024 $402.5M offering; cash $516.9M; runway through Phase 3 per CFO Strengthened
BARDA/External SupportNot highlightedBARDA proposal submitted; potential EUA and orders in outbreak scenarios Emerging optionality
Commercial LandscapeN/ADownward pressure on vaccine businesses; CD388 strategy focuses on highest-risk segments with distinct value proposition Differentiated positioning

Management Commentary

  • CEO framing of strategic position: “The highly compelling results… put us in a position of strength to execute on our Phase 3 plan…” .
  • Efficacy significance: “Single doses of 450mg, 300mg and 150mg… confer seventy six, sixty one and fifty eight percent protection respectively… P values… <0.001, 0.0024 and 0.005” .
  • Regulatory plan: “EOP2 meeting… later this month… operationally prepared to start [Phase 3] this fall should this become an option…” .
  • CFO runway: “With the $500 plus million in cash on hand now, we believe we are adequately funded through the end of our Phase III program…” .
  • CBO commercial read-through: vaccine pricing pressure underscores CD388’s focused high-risk strategy .

Q&A Highlights

  • FDA alignment: Expectation of minimal changes from Type C to EOP2; will disclose details after FDA minutes, including design, dose, and timelines .
  • BARDA scope: Base period funding for onshoring manufacturing; option periods could fund additional clinical studies; EUA could enable orders in outbreak scenarios (e.g., H5N1) .
  • Attack rate assumptions: Despite higher-risk population, placebo attack rates in Phase 3 may be lower due to greater protection and vaccination; design anticipates this dynamic .
  • Redosing plan: Follow-up redosing study leveraging NAVIGATE participants; prior data show no substantial ADA concerns; timelines to be aligned post-EOP2 .
  • Scientific disclosures: Abstracts submitted to ISIRV and IDWeek; non-clinical ferret model efficacy against contemporary H5N1 accepted for oral presentation; PK/PD relationships to be presented .

Estimates Context

  • Q2 2025 EPS beat: Actual $(1.65) versus consensus $(1.815); in-line revenue ($0 vs $0). Q1 2025 also beat on EPS, while Q4 2024 missed (actual $(5.38) vs $(3.85); revenue $0 vs $0.240M). Drivers include interest income and tax liability reversals, plus the absence of IPR&D in 2025 versus 2024 .*
  • Post-quarter, consensus may refine operating loss expectations given one-time tax reversals and the ongoing R&D ramp for Phase 3; Street should focus on normalized OpEx trajectory and cash burn rate into trial start .*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Clinical de-risking: Statistically significant Phase 2b efficacy with favorable safety and dose response materially increases probability of Phase 3 success and regulatory traction .
  • Near-term catalysts: FDA EOP2 meeting minutes (design/timelines), breakthrough therapy decision, BARDA proposal outcome, and potential Phase 3 start as early as fall — each a stock-moving event .
  • Funding visibility: $516.9M cash post offering; CFO indicates runway through Phase 3, reducing financing overhang near term .
  • P&L optics: EPS beats aided by interest income and tax reversals; expect OpEx to track Phase 3 ramp; no revenue contribution near-term .
  • Strategic positioning: Focus on high-need populations where vaccines underperform supports potential differentiation and payer value once approved .
  • Index inclusion: Russell 2000/3000 addition broadens investor base and liquidity .
  • Trading stance: Watch FDA minutes and any Phase 3 start announcement; strong efficacy narrative supports upside skew, with timing risk tied to regulatory alignment and BARDA decision windows .

Appendix: Additional Q2 2025 Press Releases and Prior Quarter Context

  • Q2 2025 results PR: corporate updates, NAVIGATE data, cash, and conference call details .
  • Pre-announcement for Q2 earnings: call logistics .
  • External site recognition of NAVIGATE success (Segal Trials): reinforces efficacy and safety conclusions .
  • Q1 2025 PR/8-K: data cutoff, topline timing, SAP modifications, Q1 financials .
  • Q4/FY 2024 PR/8-K: enrollment complete; severe season enabling earlier analysis; financing history and FY P&L .