Financial Performance - Fractyl Health reported a net loss of $25.0 million for Q4 2024, compared to a net loss of $19.2 million in Q4 2023, reflecting a $12.2 million increase in operating expenses[12]. - Revenue for the three months ended December 31, 2024, was $3 million, a decrease from $7 million in the same period of 2023, while total revenue for the twelve months ended December 31, 2024, was $93 million compared to $120 million in 2023[24]. - Gross profit for the three months ended December 31, 2024, was $3 million, down from $5 million in the same period of 2023, with a total gross profit of $43 million for the twelve months ended December 31, 2024, unchanged from 2023[24]. - The net loss attributable to common stockholders for the three months ended December 31, 2024, was $24.97 million, compared to a loss of $23.51 million in the same period of 2023, with a total net loss of $70.43 million for the twelve months ended December 31, 2024, down from $94.27 million in 2023[24]. - The net loss per share attributable to common stockholders for the three months ended December 31, 2024, was $(0.52), compared to $(11.18) in the same period of 2023, with a total net loss per share of $(1.62) for the twelve months ended December 31, 2024, down from $(45.29) in 2023[24]. Operating Expenses - Total operating expenses for the three months ended December 31, 2024, increased to $25.2 million from $13 million in the same period of 2023, with total operating expenses for the twelve months reaching $93.6 million compared to $50.9 million in 2023[24]. - Research and development expenses for Q4 2024 were $20.3 million, up from $10.1 million in Q4 2023, primarily due to advancements in the REMAIN-1 clinical study[10]. - Selling, general and administrative expenses increased to $4.9 million in Q4 2024 from $2.8 million in Q4 2023, attributed to higher costs associated with being a publicly traded company[11]. - Research and development expenses for the three months ended December 31, 2024, were $20.28 million, significantly higher than $10.17 million in the same period of 2023, with total R&D expenses for the twelve months reaching $70.47 million compared to $38.04 million in 2023[24]. - Selling, general and administrative expenses for the three months ended December 31, 2024, were $4.93 million, up from $2.82 million in the same period of 2023, with total SG&A expenses for the twelve months at $23.1 million compared to $12.84 million in 2023[24]. Assets and Liabilities - Total assets increased to $108.1 million as of December 31, 2024, compared to $76.2 million in 2023, while total liabilities decreased to $79.7 million from $113.9 million[22]. - As of December 31, 2024, Fractyl had approximately $67.5 million in cash and cash equivalents, sufficient to fund operations through key clinical milestones into 2026[13]. Clinical Developments - The REMAIN-1 pivotal study has enrolled over 189 patients across 13 clinical sites within six months of initiation, indicating strong demand for weight maintenance solutions post-GLP-1 therapy[4]. - The company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes in H1 2025, with preliminary data expected in 2026 if authorized[7]. - A midpoint data analysis for the REMAIN-1 study is anticipated in Q2 2025, with full enrollment expected by summer 2025[5]. - Fractyl's strategic focus has shifted to prioritize the REMAIN-1 study and the Rejuva gene therapy platform, pausing investments in other Revita programs for type 2 diabetes[8]. Other Financial Metrics - Interest income for the three months ended December 31, 2024, was $726,000, an increase from $463,000 in the same period of 2023, with total interest income for the twelve months at $4.15 million compared to $1.26 million in 2023[24]. - The change in fair value of warrant liabilities resulted in a gain of $466,000 for the three months ended December 31, 2024, compared to a loss of $5.63 million in the same period of 2023, with a total gain of $17.91 million for the twelve months compared to a loss of $6.79 million in 2023[24]. - The weighted-average number of common shares outstanding for the three months ended December 31, 2024, was 48,445,979, compared to 2,102,410 in the same period of 2023, with a total of 43,541,527 shares for the twelve months compared to 2,081,328 in 2023[24].
Fractyl Health(GUTS) - 2024 Q4 - Annual Results