Company announces registered direct offering after revealing new data from Phase 2a trial of Lomecel-B in mild Alzheimer’s disease.
Shortly after releasing additional positive data from its Phase 2a Alzheimer’s trial, longevity biotech Longeveron (NASDAQ: LGVN) has announced plans to raise $2.36 million in a registered direct offering. The company said it has entered into a definitive agreement for the sale of 1,355,301 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules. The company says the funds raised will be used for “working capital and general corporate purposes.”
Longeveron, which develops cellular therapies for life-threatening and chronic aging-related conditions, recently revealed additional positive clinical data and imaging biomarker results from its Phase 2a trial, evaluating lead program Lomecel-B for the treatment of mild Alzheimer’s disease.
Lomacell-B is a “living cell product” made from specialized cells isolated from the bone marrow of young healthy adult donors. The investigational product is thought to have broad application in aging related diseases, with multiple potential mechanisms of action linked to anti-inflammatory, pro-vascular regenerative responses.
The new clinical data from the CLEAR MIND trial highlighted a dose-response improvement in cognitive function measures, with Lomecel-B demonstrating statistically significant improvements in the Montreal Cognitive Assessment (MOCA) and Mini-Mental State Examination (MMSE) compared to placebo. Caregiver ratings also documented an improved quality of life in patients treated with the product.
The MRI biomarker study also revealed promising results, showing that Lomecel-B countered the loss of brain volume in areas associated with Alzheimer’s disease. The drug was associated with reduced neuroinflammation, as assessed by Diffusion Tensor Imaging (DTI), and improved cerebral blood flow.
Specifically, Lomecel-B demonstrated a 49% reduction in whole brain volume loss and a statistically significant reduction in left hippocampal volume loss. The treatment group also exhibited a 20% and 33% reduction in left and right ventricular enlargement, respectively. The level of neuroinflammation measured by DTI was consistently lower in all Lomecel-B doses compared to the placebo.
“These new data support our initial results for CLEAR MIND that we announced in October and provide further validation of both the safety and therapeutic potential of Lomecel-B in the treatment of mild Alzheimer’s disease,” said Wa’el Hashad, CEO of Longeveron. “We believe these new data may provide evidence for Lomecel-B’s mechanism of action and add to the robust foundation we are building for its further investigation in Alzheimer’s disease as well as other indications.”
Longeveron plans to present the trial results at a “major medical meeting” in 2024.