AVROBIO(AVRO)2024-08-14 20:11Clinical Trials - TX45 has advanced into Phase 2 clinical trial for patients with Group 2 PH-HFpEF, with the first site activated and screening open in August 2024[1] - The Phase 1a clinical trial results for TX45 in healthy volunteers are expected to be reported in September 2024[5] - The ongoing Phase 1b clinical trial results for TX45 are expected in mid-2025[11] - The company anticipates topline results from the Phase 2 clinical trial of TX45 in 2026[5] Financial Performance - The company reported a net loss of $12.7 million for Q2 2024, compared to a net loss of $10.5 million for Q2 2023[7] - Net loss for the three months ended June 30, 2024, was $12,671,000, compared to a net loss of $10,455,000 for the same period in 2023, indicating a year-over-year increase of 21.3%[19] - Comprehensive loss for the three months ended June 30, 2024, was $(12,679,000), compared to $(10,455,000) for the same period in 2023, representing an increase of 11.7%[19] Expenses - Research and development expenses for Q2 2024 were $7.1 million, a decrease from $8.8 million in Q2 2023[6] - General and administrative expenses increased to $4.3 million in Q2 2024 from $1.9 million in Q2 2023, primarily due to merger-related activities[7] - Total operating expenses for the three months ended June 30, 2024, were $11,421,000, compared to $10,631,000 for the same period in 2023, representing an increase of 7.4%[19] - Research and development expenses decreased to $7,074,000 for the three months ended June 30, 2024, from $8,766,000 in the same period of 2023, a reduction of 19.3%[19] - Interest expense decreased to $(28,000) for the three months ended June 30, 2024, from $(40,000) in the same period of 2023, a reduction of 30.0%[19] Cash and Assets - As of June 30, 2024, cash and cash equivalents were $185.1 million, expected to provide a cash runway into mid-2027[6] - Total assets as of June 30, 2024, were $19,390,000, compared to $39,399,000 as of December 31, 2023, showing a significant decrease of 50.8%[20] Equity and Shares - Total stockholders' equity (deficit) improved to $(166,367,000) as of June 30, 2024, from $(84,636,000) as of December 31, 2023, indicating a worsening of 96.5%[20] - Weighted-average common shares outstanding increased to 2,919,872 for the three months ended June 30, 2024, from 1,228,778 in the same period of 2023, an increase of 138.8%[19] Mergers and Acquisitions - The company completed a reverse merger with AVROBIO in June 2024, including a concurrent private placement of $130.7 million[3] Future Plans - The company plans to select a development candidate for its second program in Hereditary Hemorrhagic Telangiectasia (HHT) in the second half of 2024[5] Interest Income - Interest income increased to $318,000 for the three months ended June 30, 2024, compared to $224,000 for the same period in 2023, reflecting a growth of 42.0%[19] Liabilities - Change in fair value of SAFE liabilities was $(1,535,000) for the three months ended June 30, 2024, with no comparable figure for the same period in 2023[19]