Zero Candida Ltd (TSX-V:ZCT, OTCQB:ZCTFF) continued to advance its proprietary, tampon-like device being developed to treat vulvo-vaginal candidiasis (VVC) towards human use during the second quarter of 2025.
During the quarter, the company advanced validation and design refinements for its ZC–01 device and continued documentation and planning to support an anticipated De Novo FDA pathway, along with business-to-business and business-to-consumer strategies.
Zero Candida also reported ongoing discussions with major US hospitals and pharmaceutical companies, which management said reinforce clinical and commercial demand.
The company noted that tightening regulatory oversight on chemical-based health products, coupled with concerns over antifungal resistance and diagnostic gaps, highlights the potential importance of non-drug alternatives.
Its development timeline remains aligned with industry growth trends, with final preclinical results expected in the second quarter of 2026, laboratory validation studies in the third quarter of 2026, a pilot clinical trial in Israel in the fourth quarter of 2026, and US-targeted clinical trials in the third quarter of 2027.
CEO Eli Ben-Haroosh highlighted that the company laid the foundation for its regulatory and clinical strategy during Q2.
"Our discussions with leading hospitals and US pharmaceutical companies this past quarter reinforce both the clinical need and commercial potential of our technology,” Ben-Haroosh said.
“With regulators and policymakers calling for safer, less drug-reliant healthcare therapies that are cost-effective for patients, we are confident in our ability to deliver a solution for the hundreds of millions of women affected by VVC worldwide."
Zero Candida has not yet generated revenue as it continues to focus on device development and preclinical validation.
Operating expenses for Q2 were $0.31 million, primarily related to research and development and corporate activities, down from $0.35 million in the same period of 2024.
General and administrative expenses were $0.11 million, compared to $0.14 million in Q2 2024.
The company reported an operating loss of $0.31 million for the quarter, compared with $0.35 million a year earlier, and a net loss of $0.28 million, compared to $0.21 million in the same period of 2024.
As of June 30, the company held $0.46 million in cash and cash equivalents, up from $0.24 million at December 31, 2024.
Total assets were $2.77 million, with working capital of $1.53 million.
Zero Candida said these resources are sufficient to support ongoing development programs, regulatory activities, and corporate operations for at least the next 12 months.