Cidara Therapeutics, Inc. (CDTX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 was operationally strong (ANCHOR Phase 3 >50% enrolled, FDA Breakthrough Therapy designation, BARDA award) but financially heavy due to a $45.0M milestone expense, driving net loss to $83.233M and diluted EPS to $(3.10) .
• Collaboration revenue remained $0 and interest income rose with a larger cash balance; cash and investments were $476.5M at quarter-end, fully funding Phase 3 through completion .
• Management expanded the Phase 3 population to include generally healthy adults ≥65, more than doubling the initial U.S. target population potentially eligible to receive CD388; enrollment completion in the Northern Hemisphere is targeted by December and an interim analysis is planned for Q1 2026 .
• Versus Wall Street consensus, EPS and net income were materially worse than expected due to the milestone expense; revenue met estimates at $0. Bold catalyst path ahead: December enrollment completion, December 15 investor R&D day, and Q1 2026 interim analysis .

What Went Well and What Went Wrong

What Went Well

• FDA Breakthrough Therapy designation for CD388, recognizing preliminary clinical evidence of substantial improvement over existing options: “enhanced access to the FDA, including more frequent guidance, rolling data review, and eligibility for priority review” .
• Phase 3 ANCHOR study accelerated and expanded: “over 50 percent enrolled… on track to achieve 6,000 participants by December 2025,” and population expanded to include healthy adults ≥65, “more than doubles the target population” .
• BARDA award up to $339.2M (base $58.1M over 24 months) to onshore manufacturing and support development, strengthening supply chain readiness and pandemic preparedness .

What Went Wrong

• Large net loss driven by $45.0M acquired IPR&D milestone upon dosing first five subjects; Q3 net loss of $83.233M, EPS $(3.10), significantly worse vs consensus .
• Operating expenses surged: R&D $35.529M (+185% YoY; +43% QoQ) with ANCHOR initiation and manufacturing-related costs; G&A $8.099M (+63% YoY; +25% QoQ) mainly stock-based comp .
• CMC is gating to BLA timing (transition to single-vial commercial configuration and full process qualification), with management guiding toward a 2027 filing timeline, indicating longer path to commercialization .

Financial Results

Balance Sheet Progress

Consensus vs Actual (Q3 2025)

Values with asterisks retrieved from S&P Global.

KPIs and Program Metrics

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “All sites are now active, and the study is over 50% enrolled, on track to achieve target enrollment in the Northern Hemisphere by December.”
• “This change more than doubles the target population potentially eligible to receive CD388.” (on adding healthy adults ≥65)
• “The base period [BARDA]… will fund the onshoring of manufacturing to the United States… expanding our initial commercial supply chain.”
• “Based on our initial scale… around production of 5 million doses per year… transitioning… to a commercial configuration… single vial containing the full dose.”
• “Breakthrough Therapy designation… may accelerate development and regulatory timelines.”

Q&A Highlights

• Interim analysis mechanics: independent, blinded statistician will assess powering/event rate; company will only be told if sample size is sufficient or requires Southern Hemisphere enrollment; no efficacy data will be shared at interim .
• Inclusion of healthy ≥65: expected higher event potential but similar modeled placebo attack rate (~1.5%); aids faster enrollment; vaccination rates likely higher in this cohort .
• Manufacturing scale and BLA gating: WuXi initial capacity ~5M doses/year; transition to single-vial presentation and full process qualification are rate-limiting; integrated plan targeting a 2027 filing .
• Resistance risk: exposure-response modeling indicates inoculum effect; no evidence of resistance to date; sequencing ongoing .
• Market uptake: broad physician interest across high-risk and mild comorbid segments; more detail coming at Dec 15 R&D day .

Estimates Context

• EPS missed: Consensus $(1.30)* vs actual $(3.10); driven primarily by $45.0M acquired IPR&D milestone expense .
• Net income missed: Consensus $(29.883)M* vs actual $(83.233)M .
• Revenue met: $0.000* estimate vs $0.000 actual .
  Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

• Near-term catalysts: Northern Hemisphere enrollment completion by December, Dec 15 investor R&D day, Q1 2026 interim powering analysis—each can reset probability of success and timeline expectations .
• Regulatory momentum: Breakthrough Therapy plus Fast Track enhances dialogue and review speed; single-study BLA path clarifies strategy .
• Capacity build: Initial ~5M doses/year from WuXi, with BARDA-funded U.S. onshoring and future scale-up to meet broader demand; watch CMC milestones and single-vial transition (key to filing timeline) .
• Financial runway: $476.5M cash/investments funds Phase 3 through completion; expect Q4 $45.0M milestone cash outflow to Janssen .
• Estimate revisions: Street models should incorporate milestone-driven IPR&D, higher R&D cadence for Phase 3, and timing of BARDA option exercises; EPS/NI likely to remain loss-making through pivotal period .
• Label expansion potential: Inclusion of healthy ≥65 materially broadens initial TAM; physician interest suggests uptake beyond severe comorbid populations .
• Pandemic optionality: Ongoing H5N1 work and BARDA framework create contingency value; monitor EUA pathways and stockpiling discussions in a pandemic scenario .