Annovis Bio(US:ANVS)2025-11-12 21:16Financial Performance - The company reported a net loss of $7.263 million for the three months ended September 30, 2025, an improvement of $5.376 million compared to a net loss of $12.639 million in the same period of 2024[121]. - The company reported a net loss of $19.02 million for the nine months ended September 30, 2025, compared to a net loss of $18.73 million in 2024[128]. - Cash used in operating activities was $16.7 million for the nine months ended September 30, 2025, compared to $13.6 million in 2024, reflecting increased clinical trial expenses[140]. - Total operating expenses for the nine months ended September 30, 2025, were $19.99 million, slightly up from $19.96 million in 2024, with research and development expenses rising by $1.5 million[128]. Operating Expenses - Total operating expenses increased to $7.435 million in Q3 2025 from $4.388 million in Q3 2024, reflecting a rise of $3.047 million[121]. - Research and development expenses rose significantly to $6.291 million in Q3 2025, up by $3.601 million from $2.690 million in Q3 2024[121]. - General and administrative expenses decreased to $1.1 million for the three months ended September 30, 2025, down from $1.7 million in 2024, reflecting a $0.6 million reduction[124]. Capital and Funding - The company has an accumulated deficit of $153.9 million as of September 30, 2025, and expects to incur losses for the foreseeable future[117]. - The company plans to raise additional capital through public or private equity offerings, debt financings, and collaboration arrangements to fund operations and clinical trials[119]. - Cash provided by financing activities was $21.4 million for the nine months ended September 30, 2025, primarily from a public offering, compared to $20.5 million in 2024[142]. - The company completed a public offering in February 2025, raising gross proceeds of $21.0 million, with net proceeds of $19.3 million[136]. - As of September 30, 2025, the company had cash and cash equivalents totaling $15.3 million, which is not expected to be sufficient to fund operations for the next twelve months[135]. Clinical Trials and Research - The Phase 3 PD Study was completed on December 4, 2023, with topline efficacy data released on July 2, 2024, showing significant cognitive improvements in 12% of patients with pre-existing cognitive issues[109]. - The Phase 2/3 AD Study was completed on February 13, 2024, with topline efficacy data indicating statistically significant improvements in cognition for early AD patients[110]. - The company initiated a pivotal Phase 3 trial for early AD patients in February 2025, which includes a 6-month treatment period followed by an additional 12 months[112]. - The FDA has aligned with the company on a development path for buntanetap towards filing New Drug Applications (NDAs) for both short-term and long-term efficacy[111]. - The company believes it is the only one developing a drug that targets multiple neurotoxic proteins, potentially addressing significant unmet needs in the AD and PD markets[116]. Interest Income - Interest income increased to $0.2 million for the three months ended September 30, 2025, compared to $0.1 million in 2024, driven by higher cash balances from a public offering[125]. Future Outlook - The company expects elevated operating cash burn due to ongoing development costs associated with its active Phase 3 trial for AD[141].