Aura Biosciences(US:AURA)2025-11-13 12:15Financial Performance - The company reported net losses of $80.6 million and $61.1 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $454.9 million as of September 30, 2025[103]. - The net loss for the three months ended September 30, 2025, was $26.1 million, compared to a net loss of $21.0 million for the same period in 2024, representing an increase in loss of $5.1 million[117]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $64.3 million, compared to $55.9 million for the same period in 2024[125]. - Total operating expenses for the three months ended September 30, 2025, were $27.9 million, compared to $23.2 million for the same period in 2024, reflecting an increase of $4.7 million[117]. - Research and development expenses increased to $22.2 million for the three months ended September 30, 2025, from $17.0 million for the same period in 2024, primarily due to ongoing clinical and CRO costs associated with the Phase 3 trial of bel-sar[118]. - For the nine months ended September 30, 2025, research and development expenses totaled $68.4 million, up from $51.0 million for the same period in 2024, an increase of $17.4 million[121]. - General and administrative expenses decreased to $5.7 million for the three months ended September 30, 2025, from $6.2 million for the same period in 2024, primarily due to reduced professional fees[119]. - Total other income for the three months ended September 30, 2025, was $1.8 million, down from $2.2 million for the same period in 2024, a decrease of $431,000[117]. Funding and Capital Requirements - The company has raised approximately $495.4 million in gross proceeds since inception through private placements and stock offerings[102]. - The company raised approximately $495.4 million in gross proceeds through the sale of equity and convertible preferred stock and warrants as of September 30, 2025[124]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $74.4 million, primarily from the 2025 Follow-On Offering[130]. - The company may need to raise additional funds through equity or debt financing, which could lead to dilution for existing stockholders[135]. - The company’s future capital requirements will depend on various factors, including the costs and timing of clinical trials and regulatory approvals[134]. - The company’s ability to raise additional funds may be adversely impacted by global economic conditions and market volatility[137]. Clinical Trials and Research - The ongoing Phase 3 CoMpass trial for bel-sar is expected to complete enrollment by 2026, with top-line data readout anticipated in Q4 2027[95]. - In a Phase 2 study, bel-sar achieved an 80% tumor control rate among Phase 3-eligible patients, with a post-treatment average growth rate of 0.011 mm/yr compared to 0.351 mm/yr prior to study entry[96]. - The company plans to initiate a Phase 2 trial for bel-sar in metastases to the choroid from breast and lung cancer, with early proof-of-concept data expected in 2026[97]. - The ongoing Phase 1b/2 trial for bel-sar in non-muscle invasive bladder cancer (NMIBC) will evaluate approximately 26 patients, with initial 3-month clinical data expected in mid-2026[100]. - The company anticipates significant increases in expenses and capital requirements as it advances clinical trials and seeks regulatory approvals[104]. - The company anticipates substantial increases in expenses related to ongoing research, development, and clinical trials for current and future product candidates[132]. Cash Position and Assets - As of September 30, 2025, the company had cash and cash equivalents of $161.9 million, expected to fund operations into the first half of 2027[107]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $161.9 million, expected to fund operations into the first half of 2027[133]. Lease and Commitments - The company has operating lease commitments totaling $25.187 million, with $3.38 million due within one year[139]. - The company entered into a 10-year office and laboratory lease in Boston, MA, which commenced on August 1, 2022[140]. Regulatory and Reporting Status - The company is classified as a smaller reporting company, with a market value of stock held by non-affiliates below $700 million[146]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company[147]. - The company has no long-term debt or finance leases, and its contracts with service providers are generally cancelable[141].