MORRISVILLE, N.C. - Arrivo BioVentures (AIFF), a micro-cap biotechnology company with a market value of $20.07 million, has announced preliminary results from its SP-624-103 study, which is investigating the effects of the drug SP-624 on brain activity in healthy subjects. According to InvestingPro analysis, the company is currently trading below its Fair Value, despite facing significant financial challenges with negative EBITDA of $8.17 million in the last twelve months. The study's findings suggest that SP-624, which activates the SIRT6 enzyme, could potentially serve as a novel treatment for major depressive disorder (MDD), particularly in females.
The study is a double-blind, placebo-controlled trial with three cohorts. The first cohort included 12 healthy participants who were given a 20mg dose of SP-624 over a 15-day period. Using quantitative EEG and Firefly Neuroscience's brain network analytics technology, the researchers observed an increase in beta power and a decrease in delta power in the subjects' brains after a single dose of SP-624. These changes are associated with improved synaptic plasticity, neural connectivity, and cortical arousal, which could indicate the drug's potential to alleviate depressive symptoms.
Dr. Joel Raskin, Chief Medical (TASE:PMCN) Officer at Arrivo BioVentures, stated that the results could reflect SP-624's ability to normalize cortical activity and enhance cognitive processing, attention, and cortical arousal. These outcomes are considered promising for the treatment of neuropsychiatric diseases. InvestingPro data reveals the company is rapidly burning through cash, with a negative free cash flow of $5.51 million, highlighting the critical importance of successful clinical outcomes for the company's future.
The second cohort of the study, which is currently enrolling participants, will focus on patients diagnosed with MDD. The composition of the third cohort will be determined after the second cohort's completion.
Steve Butts, CEO of Arrivo, expressed confidence in the potential of SP-624 for treating MDD and other cognitive disorders based on the active drug evidence in the central nervous system presented by the study.
Arrivo BioVentures is known for developing medicines targeting the root causes of difficult-to-treat diseases, with a focus on achieving meaningful patient outcomes. The company has another clinical-stage pipeline candidate, RABI-767, for severe acute pancreatitis.
Firefly Neuroscience, which provided the brain analytics technology for the study, is a company specializing in AI-driven solutions that enhance brain health outcomes. Their technology, which has been FDA-cleared, aims to revolutionize diagnostic and treatment monitoring methods for various neurological and mental disorders.
This report is based on a press release statement from Arrivo BioVentures and does not include independent verification of the study's results. With the stock trading near its 52-week low of $2.31 and showing a 72% decline over the past six months, investors seeking deeper insights into Arrivo's financial health and growth potential can access additional analysis through InvestingPro, which offers 8 more exclusive ProTips and comprehensive financial metrics.
In other recent news, Firefly Neuroscience reported significant changes in its leadership and financial status, as well as several collaborations and a merger. Amid challenging market conditions, the company announced the termination of Mr. Olsen's role as CEO, with Greg Lipschitz appointed as the Interim Chief Executive Officer. Firefly Neuroscience also reported negative EBITDA of -$8.17 million in the last twelve months, indicating financial challenges. The company has also seen significant changes in its board, with the election of David DeCaprio, Jon Olsen, and Greg Lipschitz.
In addition, Firefly Neuroscience disclosed a merger with WaveDancer, Inc., which met Nasdaq's minimum stockholders' equity requirement and included a principal curtailment of $100,000 by WaveDancer. The company also announced collaborations with Bright Minds Biosciences Inc., Takeda Pharmaceutical Company (NYSE:TAK) Limited, and Novartis (SIX:NOVN), aiming to integrate its Brain Network Analytics (BNA™) technology into drug development processes.
These recent developments are part of Firefly Neuroscience's ongoing operations within the technology sector. The company's recent SEC filings and analyst reports from InvestingPro provide further details on these changes.
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