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EMERYVILLE, Calif. - BioAge Labs, Inc. (NASDAQ:BIOA), a clinical-stage biotech company with a market capitalization of approximately $160 million, has dosed the first participant in a Phase 1 clinical trial of BGE-102, an orally available small molecule NLRP3 inhibitor being developed for obesity treatment, the company announced Friday. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn as it advances its clinical programs.
The randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants. The study includes a single ascending dose portion followed by a multiple ascending dose evaluation over 14 days.
BGE-102 represents a structurally novel class of NLRP3 inhibitors with high potency and brain penetration. In preclinical obesity models, BGE-102 achieved dose-dependent weight loss of up to 15% as a monotherapy, comparable to semaglutide. When combined with semaglutide, the compound produced approximately 25% weight reduction.
"This study was designed to deliver key data on safety, dosing, and activity," said Kristen Fortney, CEO and co-founder of BioAge. "By inhibiting NLRP3-driven inflammation, a core driver of metabolic dysfunction, BGE-102 has the potential to complement existing therapies like GLP-1 agonists to enhance weight loss." Despite the stock’s significant decline of over 75% in the past year, analysts maintain price targets ranging from $4 to $10, suggesting potential upside. InvestingPro subscribers can access detailed analysis and 7 additional ProTips about BIOA’s financial health and market position.
The company expects initial single ascending dose data by the end of 2025, with plans to advance BGE-102 into a proof-of-concept obesity study in 2026. Top-line data from the obesity study is anticipated by the end of 2026.
BioAge identified NLRP3 as a therapeutic target based on analysis of human aging cohorts, which showed reduced NLRP3 activity is associated with greater longevity, according to the company’s press release statement.
The compound has demonstrated a strong safety profile in GLP toxicology studies with no adverse findings reported. While the company maintains a healthy current ratio of 13.2, indicating strong short-term liquidity, InvestingPro’s comprehensive analysis shows the company faces profitability challenges with negative EBITDA of $91 million in the last twelve months. For deeper insights into BIOA’s financial health and growth prospects, investors can access the detailed Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, BioAge Labs, Inc. announced it will analyze over 17,000 samples from Norway’s HUNT Biobank in collaboration with Age Labs AS. This initiative aims to expand BioAge’s drug discovery platform focused on aging-related diseases. The company has secured exclusive access to the data generated from these samples. In addition, BioAge Labs has completed Investigational New Drug (IND)-enabling studies for its obesity drug, BGE-102, a small-molecule NLRP3 inhibitor. The company plans to submit an IND application by mid-2025 and anticipates initiating Phase 1 clinical trials by the end of the year. Jefferies analyst Roger Song has maintained a Hold rating on BioAge Labs with a $4.00 price target, noting the promising preclinical data of BGE-102. The drug has shown potential in obesity treatment, both as a standalone therapy and in combination with GLP-1 receptor agonists. These developments highlight BioAge Labs’ continued focus on aging-related drug discovery and clinical advancements.
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