Financial Performance - Total current assets decreased from $357,103,000 as of December 31, 2024, to $290,828,000 as of September 30, 2025, a decline of approximately 18.5%[14] - Collaboration revenue for the three months ended September 30, 2025, was $2,054,000, compared to $0 for the same period in 2024, indicating a significant increase[15] - Net loss for the three months ended September 30, 2025, was $20,171,000, compared to a net loss of $23,407,000 for the same period in 2024, showing an improvement of approximately 9.4%[15] - The company reported a total comprehensive loss of $54,632,000 for the nine months ended September 30, 2025, compared to $49,925,000 for the same period in 2024, indicating an increase in overall losses[15] - The company reported a net loss of $54.7 million for the nine months ended September 30, 2025, compared to a net loss of $50.0 million for the same period in 2024[22] - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $20.2 million, compared to a net loss of $23.4 million for the same period in 2024, representing a decrease of approximately 13.5%[11] - For the nine months ended September 30, 2025, the net loss was $54.7 million, compared to $50.0 million for the same period in 2024, indicating an increase of approximately 9.4%[11] Expenses - Research and development expenses for the nine months ended September 30, 2025, rose to $49,466,000, up from $39,811,000 in 2024, reflecting a 24.5% increase[15] - Total operating expenses for the nine months ended September 30, 2025, were $70,274,000, compared to $52,832,000 in 2024, representing a 33.1% increase[15] - General and administrative expenses rose by $7.8 million, or 60%, from $13.0 million for the nine months ended September 30, 2024 to $20.8 million for the same period in 2025[162] - Research and development expenses increased by $9.7 million, or 24%, from $39.8 million for the nine months ended September 30, 2024 to $49.5 million for the same period in 2025[160] - Stock-based compensation expense increased to $8.97 million for the nine months ended September 30, 2025, from $4.26 million in the prior year[22] - Research and development expenses decreased by $1.5 million from $20.0 million for the three months ended September 30, 2024, to $18.5 million for the same period in 2025, primarily due to a $13.1 million reduction in azelaprag direct costs[154] - General and administrative expenses increased by $2.0 million from $4.7 million for the three months ended September 30, 2024, to $6.7 million for the same period in 2025, driven by increased legal fees and personnel-related expenses[155] Assets and Liabilities - Total liabilities decreased from $35,107,000 as of December 31, 2024, to $27,626,000 as of September 30, 2025, a reduction of about 21.1%[14] - Stockholders' equity decreased from $323,127,000 as of December 31, 2024, to $277,464,000 as of September 30, 2025, a decline of approximately 14.1%[14] - Cash and cash equivalents decreased from $354,349,000 as of December 31, 2024, to $215,573,000 as of September 30, 2025, a decline of approximately 39.2%[14] - The company had an accumulated deficit of $307.5 million as of September 30, 2025, up from $252.8 million as of December 31, 2024[28] - As of September 30, 2025, the company had $295.9 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $307.5 million[166] - The company has $4.1 million in non-cancellable lease obligations related to its Emeryville Lease, with $0.6 million due within the next 12 months[182] Revenue Recognition and Collaboration - The company has not generated any product revenue to date and anticipates incurring additional losses until it can generate significant sales[27] - The company recognized collaboration revenue of $5.9 million under the Novartis Agreement for the nine months ended September 30, 2025, with no revenue recognized in the same period of 2024[96] - The company entered into a collaboration agreement with Novartis, which includes potential payments of up to $550 million in future milestones[94] - The company evaluates collaboration agreements under ASC 606 and ASC 808 to determine the appropriate accounting treatment for multiple performance obligations[194] - The company recognizes revenue based on the satisfaction of performance obligations as outlined in ASC 606, impacting revenue recognition timing[186] Future Outlook and Plans - The company plans to finance its cash needs through equity offerings, debt financings, or other capital sources until it can generate substantial product revenues[30] - The company expects existing cash and marketable securities to fund operations through 2029, although this estimate is based on assumptions that may prove incorrect[177] - The company expects research and development expenses to continue to increase substantially as it progresses BGE-102 into additional clinical trials[137] - The company plans to file INDs for novel apelin receptor APJ agonists by the end of 2026[113] - The company expects to incur significant expenses related to developing commercialization capabilities for future product candidates if approved[120] Clinical Development - The lead product candidate, BGE-102, is being developed for obesity and cardiovascular risk factors, showing significant weight loss in preclinical models[24] - The first patient was dosed in the Phase 1 clinical trial for BGE-102 in August 2025, with initial data anticipated by year-end 2025[112] - The company discontinued its Phase 2 clinical trial for azelaprag in December 2024 due to liver transaminitis observed in some subjects[211] - The company has not completed any clinical trials beyond Phase 1b and has no products approved for commercial sale, making it difficult for investors to evaluate its business viability[208] - The transition from a research and development focus to supporting commercial activities has not been successfully demonstrated by the company[212] Capital and Funding - The company has raised approximately $559.2 million in gross proceeds since inception through various securities offerings[117] - The company has raised a total of $293.8 million from redeemable convertible preferred stock sales, $26.4 million from convertible notes, $238.3 million from common stock sales, and $0.7 million from stock option exercises as of September 30, 2025[210] - The company incurred net cash used in operating activities of $53.4 million for the nine months ended September 30, 2025, compared to $46.4 million for the same period in 2024[22] Risks and Challenges - The company has incurred significant operating losses since its inception and expects to continue incurring substantial losses for the foreseeable future[208] - The company requires substantial additional capital to finance operations and achieve its goals, with potential delays or reductions in research and development if capital is not raised[208] - The company faces unforeseen expenses and risks commonly experienced by biopharmaceutical companies[212] - The company is subject to risks related to securities litigation, which could divert management attention and incur significant costs[208]
Bioage Labs, Inc.(BIOA) - 2025 Q3 - Quarterly Report