Cidara Therapeutics (CDTX -0.44%), a biotechnology company focused on the development of innovative therapies for infectious diseases and oncology, released its second-quarter 2025 earnings on August 7, 2025. The company reported GAAP earnings per share of $1.65. This result was significantly better than the analyst expectation of a $1.94 loss (GAAP EPS). There was no revenue (GAAP), aligning with forecasts due to the wind-down of a key collaboration earlier in the year. The quarter showcased major clinical advances for its flagship drug candidate and strong financial de-risking through a major equity raise. Overall, the period marked a pivotal step forward for Cidara, though it remains a pre-commercial biotech with no revenue-generating products.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(1.65) | $(1.94) | $(19.99) | 91.7 % |
| Revenue (GAAP) | $0 | $0 | $0.3 million | (100.0 %) |
| Research and Development Expenses | $24.8 million | $6.7 million | 270.1% | |
| General and Administrative Expenses | $6.5 million | $4.7 million | 38.3% | |
| Cash, Cash Equivalents and Restricted Cash | $516.9 million | $196.2 million(as of Dec 31, 2024) | 163.5 % |
Source: Analyst estimates for the quarter provided by FactSet.
Company Overview and Key Business Focus
Cidara Therapeutics is a clinical-stage biotechnology company developing drugs for infectious diseases and cancer. Its flagship program is CD388, a drug-Fc conjugate (DFC) designed to prevent influenza. DFCs are engineered molecules that combine targeted drug activity with extended lifespans in the body, aiming to offer protection for at-risk populations.
Recently, Cidara has prioritized advancing CD388 through critical clinical milestones while also developing its Cloudbreak platform. Cloudbreak is a drug discovery technology used to create DFCs with applications in both infectious disease and cancer. Strategic focus has shifted strongly toward realizing CD388's potential, underpinned by targeted funding and the divestiture of non-core products.
Second Quarter Highlights and Developments
The second quarter brought substantial progress for Cidara, highlighted by the Phase 2b results from its NAVIGATE trial for CD388. The influenza prevention drug met all primary and secondary endpoints in the Phase 2b NAVIGATE trial, demonstrating notable dose-related efficacy: 76.1% protection at the highest dose, 61.3% at the mid dose, and 57.7% at the lowest tested dose over the 24-week study period, with top-line results announced in June 2025. No meaningful safety issues were observed, and the drug was well-tolerated in the large study population.
The trial's positive results support a clear path to a pivotal Phase 3 trial. Cidara already submitted an “End of Phase 2” meeting request to the U.S. Food and Drug Administration (FDA) in June 2025. The planned Phase 3 study aims to launch by spring 2026 during the Southern Hemisphere flu season, focusing on high-risk and immunocompromised patients—segments with significant unmet medical need.
On the financial front, Cidara completed a $402.5 million equity offering. increasing its cash and restricted cash to $516.9 million as of June 30, 2025. This boost provides a long runway to fund upcoming clinical work for CD388. With no commercial product revenue after the end of its Janssen partnership in April 2024, GAAP revenue matched consensus of $0.
Research and development spending (GAAP) increased sharply to $24.8 million as Cidara accelerated clinical activities while general and administrative expenses (GAAP) grew to $6.5 million, reflecting expanded operations and the impact of stock-based compensation. The net loss (GAAP) shrank significantly compared to the same period in 2024, mainly due to the large one-time charge in 2024 related to reacquiring CD388. The company’s streamlining strategy continued, with the sale of all rezafungin assets completed in April 2024 and Cidara’s addition to the Russell 2000 and 3000 indexes, increasing the company's institutional profile.
Products and Pipeline Context
CD388, Cidara’s lead DFC, is developed for the prevention of influenza in both healthy and high-risk populations. A DFC is a type of engineered drug that links a disease-targeting molecule with an antibody fragment to extend its presence in the body. CD388 is designed to neutralize all major influenza strains, providing potential protection even for those with weakened immune systems who may not benefit from vaccines.
The Cloudbreak platform underlies Cidara’s broader ambitions. It creates DFCs for use in infectious disease and oncology. Recent developments under this platform include advancing CBO421, a DFC targeting the enzyme CD73 in solid tumors, which received regulatory clearance for human trials in July 2024. While much of the period’s focus and spending centered on CD388, Cloudbreak remains a key area for potential future pipeline diversification.
Looking Ahead: Outlook and Investor Considerations
Cidara did not issue financial guidance for future quarters. Management emphasized its preparedness to start the pivotal Phase 3 study for CD388, targeting a launch no later than spring 2026 in the Southern Hemisphere, pending FDA discussions. The goal is to provide enough data for future regulatory submissions and eventual commercialization, supported by the company’s expanded cash reserves.
Investors and observers should focus on progress toward Phase 3 trial start for CD388, ongoing regulatory interactions, and any clinical data updates around Cloudbreak-derived candidates. With no marketed products or recurring revenue, Cidara remains highly dependent on successful development and approval of its lead drug candidates. CDTX does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
