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Cidara Therapeutics, Inc. (CDTX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was a non-revenue quarter with collaboration revenue $0.00 versus $0.97M in Q1 2024; diluted EPS was -$1.66, materially better than Wall Street consensus of -$3.57, driven in part by a $5.51M reversal of indirect tax liabilities and higher interest income; revenue was in line with a $0.00 consensus .*
  • R&D increased to $24.6M (vs. $5.9M YoY) as CD388 Phase 2b NAVIGATE trial costs ramped; G&A rose to $6.2M (vs. $3.6M YoY); net loss was $23.5M vs. $10.3M YoY .
  • Management set April 30 as NAVIGATE’s efficacy data cutoff and anticipates top-line in late June; discussions with FDA on statistical analysis plan could enable dose selection and statistical significance assessments by dose versus placebo .
  • Catalysts: May 22 R&D Day, late-June NAVIGATE top-line readout, and potential Phase 3 initiation in Spring 2026 (Southern Hemisphere); BARDA engagement noted for H5N1 preparedness .

What Went Well and What Went Wrong

What Went Well

  • “We have established April 30, 2025 as the data cutoff… We are expecting top-line results in late June… [and] opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA” .
  • Strong cash runway: cash, cash equivalents and restricted cash of $174.5M at March 31, 2025, following $105M financing in Nov-2024 and $240M raised in Apr-2024 to fund NAVIGATE .
  • CD388 scientific validation momentum: Nature Microbiology publication and multiple scientific presentations highlighting broad, universal antiviral potential and favorable safety in Phase 1/2a studies .

What Went Wrong

  • Revenue headwind: collaboration revenue fell to $0.00 (vs. $0.97M YoY) post-termination of the Janssen collaboration agreement in Apr-2024; revenue base remains de minimis .
  • Opex escalation: R&D rose to $24.6M and G&A to $6.2M YoY driven by NAVIGATE costs and personnel; while helped by a $5.51M indirect tax liability reversal, underlying burn rate remains elevated .
  • Net loss widened YoY to $23.5M vs. $10.3M, reflecting the transition to a single lead asset program without collaboration revenue offsets .

Financial Results

Quarter-over-Quarter and Trend Comparison

Metric ($USD)Q3 2024Q4 2024Q1 2025
Collaboration Revenue ($MM)$0.00 $0.00 $0.00
R&D Expense ($MM)$12.43 $46.87 $24.60
G&A Expense ($MM)$4.97 $7.31 $6.18
Reversal of Indirect Tax Liabilities ($MM)N/AN/A$(5.51)
Total Operating Expenses ($MM)$17.39 $54.18 $25.27
Net Loss ($MM)$(15.99) $(52.31) $(23.48)
Diluted EPS ($)$(2.45) $(5.37) $(1.66)
Cash, Cash Equivalents & Restricted Cash ($MM)$127.39 $196.18 $174.49

Year-over-Year vs Estimates

MetricQ1 2024Q1 2025 ActualQ1 2025 Consensus
Collaboration Revenue ($MM)$0.97 $0.00 $0.00*
Diluted EPS ($)$(2.28) $(1.66) $(3.57)*
Net Loss ($MM)$(10.33) $(23.48) N/A

Values marked with * retrieved from S&P Global. Q1 2025 EPS beat consensus by $1.91 per share; revenue was in-line.*

KPIs

KPIQ4 2024Q1 2025
Subjects Dosed in NAVIGATE (n)≥5,000 completed 5,041 subjects; efficacy data cutoff 4/30/2025
Top-line TimingPotential early analysis H1 2025 Late June 2025
FDA SAP Discussion StatusPotential mid-year assessment due to severe season Ongoing/held; update at May 22 R&D Day

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
NAVIGATE Top-line Data TimingQ2 2025“Potential early analysis H1 2025” “Late June 2025” Narrowed timing (refined)
Statistical Analysis Plan (SAP)Q2 2025Potential mid-year assessment FDA discussions held; update at May 22 R&D Day Process advanced (update pending)
Phase 3 Initiation2026Not specifiedSpring 2026 (Southern Hemisphere) contingent on Phase 2b/regulatory outcomes New timing disclosed
Financial Guidance (Revenue/EPS/Opex)FY/Q1 2025None providedNone provided Maintained “no formal guidance”

Earnings Call Themes & Trends

TopicQ3 2024 (Prior-2)Q4 2024 (Prior-1)Q1 2025 (Current)Trend
R&D Execution (CD388)First subjects dosed; safety/PK supportive of single dose per season Enrollment completed ≥5,000; severe season may enable early efficacy analysis Data cutoff set; top-line late June; PK timeline Sept; exposure-efficacy focus Increasing operational clarity; approaching readout
Regulatory Strategy (FDA, SAP)SAB strengthened; program alignment Mid-year efficacy possibility FDA SAP discussions held; update at R&D Day Advancing toward definitive Phase 3 design
Market Opportunity & PricingNot detailedFinancing/coverage expanded Target population >20M; pricing “meaningfully above” $180–$200 modeling Expanding addressable market; pricing confidence rising
Vaccine ComplementarityNot a focusNot a focusPositioning CD388 alongside vaccines; neuraminidase vs hemagglutinin Building combo narrative
H5N1 Preparedness (BARDA/WHO)Not a focusNot a focusBARDA discussions; WHO panel participation; broad activity including H5N1 Pandemic preparedness angle strengthening

Management Commentary

  • “The severity of the 2024–2025 flu season has provided an opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA… We believe CD388 is highly differentiated from vaccines and monoclonal antibodies…” — Jeffrey Stein, CEO .
  • “We plan to conduct our Phase III study in high-risk comorbid and immune-compromised patients… we expect to initiate a Phase III study in the spring of 2026 in the Southern Hemisphere.” — Jeffrey Stein .
  • “We definitely see upside beyond [~20M]… very confident in price points above [the $180–$200] number.” — Jim Beitel, CBO .
  • “Our primary endpoint is preventive efficacy… centrally confirmed influenza infection… nasopharyngeal PCR positivity… temperature ≥38°C and required symptom criteria.” — Nicole Davarpanah, CMO .

Q&A Highlights

  • FDA SAP status: Discussions have occurred; detailed update slated for May 22 R&D Day .
  • Population and pricing: Management signaled broader-than-previous high-risk segmentation and confidence in pricing above prior modeled ranges .
  • Positioning: CD388 potentially complementary to vaccines; different target (neuraminidase vs. hemagglutinin), aim to develop alongside vaccines .
  • Endpoint mechanics: Robust centrally confirmed infection criteria with PCR and symptom thresholds; not time-to-event; Kaplan–Meier not expected in top-line .
  • PK and exposure-response: Expect dose/exposure dependence; PK analysis to finalize around September due to long half-life and safety follow-up .

Estimates Context

  • Q1 2025 EPS: -$1.66 vs consensus -$3.57; beat by $1.91 per share. Q1 2025 revenue: $0.00 vs consensus $0.00; in-line. Estimate counts: EPS (4), revenue (6).*
  • Likely estimate revisions: Upward EPS revisions (less negative) post Q1 given opex credit and interest income; path of estimates will hinge on late-June top-line efficacy and FDA SAP outcomes.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Near-term catalyst density: May 22 R&D Day and late-June NAVIGATE top-line will drive stock narrative; FDA SAP update could enable statistically meaningful dose-level comparisons vs placebo .
  • Execution on trial and cash runway: ~$174.5M cash supports progression to Phase 3 planning; burn elevated but moderated versus Q4 peak opex; one-time tax liability reversal aided Q1 optics .
  • Commercial thesis sharpening: Management views >20M high-risk/comorbid segment with potential expansion and pricing “meaningfully above” earlier ranges, strengthening medium-term value proposition .
  • Strategic positioning: Complementarity with vaccines and pandemic preparedness (H5N1) expand optionality, including potential BARDA collaboration .
  • Risk anchors: No revenue base; program concentration in CD388; pivotal data readout and regulatory alignment are binary drivers; monitor PK/exposure-efficacy clarity and safety through September .
  • Trading lens: Expect pre-readout positioning; outcome-dependent re-rating—statistical significance by dose and robust preventive efficacy could materially de-risk Phase 3 and drive estimate/target upgrades .
  • Watch for guidance: No formal financial guidance; focus on operational milestones (top-line timing, Phase 3 start window) to gauge development velocity .