Financial Performance - The company reported a net loss of $5.5 million for the three months ended March 31, 2025, compared to a net loss of $1.1 million for the same period in 2024, representing an increase in loss of $4.5 million[113]. - Total operating expenses for the three months ended March 31, 2025, were $6.3 million, a decrease of $1.5 million from $7.8 million in the same period of 2024[113]. - Cash used in operating activities was $8.1 million in Q1 2025, an increase of $1.1 million from $7.0 million in Q1 2024, primarily due to higher clinical trial expenses[126]. - The company has an accumulated deficit of $140.4 million as of March 31, 2025, and expects to incur losses for the foreseeable future[110]. - The company has not generated any revenue from product sales since inception and does not anticipate doing so in the foreseeable future[119]. Research and Development - Research and development expenses decreased by $1.5 million to $5.0 million for the three months ended March 31, 2025, down from $6.5 million in the same period of 2024[114]. - The pivotal Phase 3 AD trial is set to confirm symptomatic efficacy over a 6-month treatment period, followed by an additional 12 months to assess potential disease-modifying efficacy[105]. - 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 existing cognitive issues[102]. - The company is developing buntanetap, a drug designed to inhibit multiple neurotoxic proteins associated with neurodegeneration, with the potential to be the first drug to improve cognition in Alzheimer's disease and motor function in Parkinson's disease[107]. - The FDA has aligned with the company on a development path for buntanetap towards filing New Drug Applications for both short-term and long-term efficacy[104]. Capital and Financing - The company plans to raise additional capital to fund operations and clinical trials, as it does not have sufficient capital to meet obligations for the next 12 months[111]. - The February 2025 public offering generated gross proceeds of $21.0 million, with net proceeds of $19.3 million from the sale of 5.3 million units priced at $4.00 each[120]. - During Q1 2025, the company sold 0.1 million shares under an equity distribution agreement, raising gross proceeds of $0.5 million[122]. - Cash provided by financing activities was $19.8 million in Q1 2025, significantly higher than $4.4 million in Q1 2024, mainly from the ThinkEquity offering and ATM facility[128]. - Interest income increased to $188,000 for the three months ended March 31, 2025, compared to $44,000 in the same period of 2024, reflecting a $144,000 increase[113]. Cash Position - As of March 31, 2025, the company's cash and cash equivalents totaled $22.2 million, insufficient to fund operations for the next twelve months[119]. - Interest income for Q1 2025 was $0.2 million, up from $0.0 million in Q1 2024, attributed to increased cash balances from a public offering[117]. - Change in fair value of warrants showed a gain of $0.5 million in Q1 2025, down from a gain of $6.7 million in Q1 2024, due to fewer outstanding warrants and stock price changes[118]. - The company expects elevated operating cash burn in 2025 due to costs associated with completing a Phase 3 trial for Alzheimer's Disease[127]. Accounting Policies - There were no significant changes to critical accounting policies during the three-month period ended March 31, 2025[132].
Annovis Bio(ANVS) - 2025 Q1 - Quarterly Report