Acrivon Therapeutics(ACRV) - 2024 Q3 - Quarterly Results

Clinical Trials and Research - Acrivon reported a confirmed overall response rate (ORR) of 62.5% (95% CI, 30.4-86.5) in patients with high-grade endometrial cancer from the ongoing Phase 2b study of ACR-368[1][2][4]. - The company completed planned enrollment of the first dose-escalation cohort in the Phase 1 study of ACR-2316, which was initiated 15 months after the initial lead discovery[1][9]. - ACR-368 is positioned as a potential first approval opportunity in the second-line treatment of endometrial cancer, with ongoing evaluations for front-line setting options[5][6]. - The Phase 1 trial of ACR-2316 aims to establish safety, tolerability, and pharmacokinetic profiles, with dose optimization guided by FDA's Project Optimus[6][7]. - Acrivon anticipates providing updates from the Phase 2b trial of ACR-368 in the first half of 2025 and initial data from the Phase 1 study of ACR-2316 in the second half of 2025[7]. Financial Performance - Research and development expenses for Q3 2024 were $18.9 million, up from $10.3 million in Q3 2023, primarily due to the development of ACR-368 and the initiation of the ACR-2316 clinical trial[8][9]. - The net loss for Q3 2024 was $22.4 million, compared to a net loss of $14.5 million for the same period in 2023[8]. - Total operating expenses for Q3 2024 were $25,140,000, up 55.7% from $16,137,000 in Q3 2023[16]. - Research and development expenses increased to $18,864,000 in Q3 2024, compared to $10,267,000 in Q3 2023, reflecting a 83.6% rise[16]. - Net loss for Q3 2024 was $22,441,000, compared to a net loss of $14,466,000 in Q3 2023, representing a 55.2% increase in losses[16]. - Comprehensive loss for Q3 2024 was $21,640,000, compared to $14,341,000 in Q3 2023, reflecting a 51.1% increase[16]. Cash and Assets - As of September 30, 2024, Acrivon had cash, cash equivalents, and marketable securities totaling $202.8 million, expected to fund operations into the second half of 2026[1][10]. - Cash and cash equivalents increased to $43,415,000 as of September 30, 2024, from $36,015,000 at the end of 2023, showing a 9.9% growth[17]. - Total assets rose to $214,684,000 as of September 30, 2024, up from $138,265,000 at the end of 2023, indicating a 55.2% increase[17]. - Stockholders' equity increased significantly to $196,892,000 as of September 30, 2024, compared to $121,195,000 at the end of 2023, a growth of 62.3%[17]. Market Context - Approximately 30,000 new cases of high-grade endometrial cancer are diagnosed annually in the U.S., with about 90% of these patients progressing to second-line treatment[3][5]. - Interest income for Q3 2024 was $2,698,000, up from $1,768,000 in Q3 2023, marking a 52.5% increase[16]. - Weighted-average common stock outstanding increased to 38,105,131 shares in Q3 2024 from 22,081,162 shares in Q3 2023, a rise of 72.7%[16]. - Other comprehensive income for Q3 2024 included an unrealized gain of $801,000, compared to a gain of $125,000 in Q3 2023[16].