Financial Performance - As of March 31, 2025, the total assets of BioAge Labs, Inc. were $343.8 million, a decrease from $358.2 million as of December 31, 2024[14]. - The company reported collaboration revenue of $1.45 million for the three months ended March 31, 2025, compared to no revenue in the same period of 2024[15]. - Total operating expenses increased to $17.9 million for the first quarter of 2025, up from $12.8 million in the same quarter of 2024, primarily driven by higher research and development costs[15]. - The net loss for the first quarter of 2025 was $12.93 million, slightly lower than the net loss of $12.99 million in the same period of 2024[15]. - Cash and cash equivalents at the end of the first quarter of 2025 were $257.5 million, down from $354.3 million at the end of 2024[20]. - The accumulated deficit increased to $265.7 million as of March 31, 2025, compared to $252.8 million at the end of 2024[25]. - The company incurred net cash used in operating activities of $17.36 million for the first quarter of 2025, compared to $15.67 million in the same period of 2024[20]. - The company reported a net loss of $12.9 million for the three months ended March 31, 2025, compared to a net loss of $13.0 million for the same period in 2024[115]. - The company has incurred significant operating losses since its inception, with net losses of $12.9 million and $13.0 million for the three months ended March 31, 2025 and 2024, respectively, resulting in an accumulated deficit of $265.7 million as of March 31, 2025[196]. Cash and Funding - The company had cash, cash equivalents, and marketable securities totaling $335.1 million as of March 31, 2025, sufficient to fund planned operations for at least one year[25]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources, which may dilute existing stockholders' ownership interests[27]. - The company has raised approximately $559.2 million in gross proceeds since its inception in 2015 through various securities[114]. - Existing cash, cash equivalents, and marketable securities are estimated to be sufficient to fund operations and capital expenses through 2029, although this is based on assumptions that may prove incorrect[159]. - The company has no committed sources of capital and may need to finance cash needs through equity offerings or debt financings, which could dilute existing stockholders' interests[162]. - The company has not yet demonstrated the ability to successfully complete clinical trials or obtain regulatory approvals, which poses significant risks to its business[194]. - Failure to raise adequate capital could significantly harm the company's business, financial condition, and prospects, potentially leading to delays or reductions in research programs[205]. Research and Development - Research and development expenses increased by $1.8 million, from $9.3 million in Q1 2024 to $11.1 million in Q1 2025, primarily due to a $2.7 million increase in direct costs related to other programs[146]. - The company expects to continue incurring net operating losses and anticipates significant increases in research and development expenses, general and administrative expenses, and capital expenditures[115]. - The company expects to incur substantial additional capital expenses as it advances its product candidates, particularly BGE-102, through preclinical and clinical development[201]. - The company plans to submit an IND for BGE-102 in mid-2025 and initiate a Phase 1 clinical trial in the second half of 2025[109]. - The company has terminated the development of azelaprag for obesity in January 2025 due to safety concerns but is advancing a new lead program, BGE-102, a small molecule NLRP3 inhibitor[108][109]. - Research and development expenses are expected to continue increasing substantially as the company progresses BGE-102 and other product candidates toward clinical trials[133]. Collaboration and Revenue Recognition - The company entered into a collaboration agreement with Novartis, which includes potential payments of up to $550 million in research and development milestones[124]. - The company recorded collaboration revenue of $1.5 million under the Novartis Agreement for the three months ended March 31, 2025, with no revenue recognized in the same period of 2024[95]. - Deferred revenue related to the Novartis Agreement was $11.4 million as of March 31, 2025[125]. - The Company evaluates collaboration agreements under ASC 606, which may include upfront license fees, research funding, and milestone payments[45]. - The Company recognizes revenue when performance obligations are satisfied, with deferred revenue classified within current liabilities if expected to be recognized within 12 months[41]. Risks and Challenges - The Company faces risks associated with the biotechnology industry, including regulatory approval uncertainties and dependence on third parties[36]. - The company has not generated any product revenue to date and anticipates incurring additional losses until significant sales can be generated from its products in development[24]. - The company is highly dependent on the successful development and commercialization of its lead product candidate, BGE-102, which is still in early development stages[207]. - Successful commercialization of BGE-102 will depend on various factors, including regulatory approvals and effective marketing strategies[208]. - The company must prioritize development of certain product candidates due to limited resources, which may impact its commercial success[210]. - The company anticipates continued significant losses for the foreseeable future and may never achieve or sustain profitability[196]. Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting, although it has remediated these issues[197]. - The company does not expect the recent FASB updates on income tax disclosures and expense disaggregation to have a material impact on its consolidated financial statements[49][50]. - The company has no unrecognized tax benefits that would reduce its effective tax rate if recognized[101]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700.0 million and annual revenue below $100.0 million[181].
Bioage Labs, Inc.(BIOA) - 2025 Q1 - Quarterly Report