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LA JOLLA, Calif. - MediciNova, Inc. (NASDAQ:MNOV), a clinical-stage biopharmaceutical company with a market capitalization of $62 million, reported Thursday that it is approaching the final stages of patient enrollment in two of its clinical trials for developmental compounds MN-166 (ibudilast) and MN-001 (tipelukast). According to InvestingPro analysis, the company maintains a strong balance sheet with more cash than debt, though it’s currently experiencing accelerated cash burn.
The company’s Phase 2/3 COMBAT-ALS trial now requires only single-digit patient enrollment to complete randomization. Simultaneously, MediciNova needs just two more patients to finalize enrollment in its Phase 2 trial evaluating MN-001 in patients with dyslipidemia and fatty liver disease due to type 2 diabetes. With a current share price of $1.26, InvestingPro analysis indicates the stock is currently undervalued, though investors should note that analysts don’t expect profitability this year.
"We are pleased to report continued strong progress in our core COMBAT-ALS program," said Dr. Yuichi Iwaki, MediciNova President and CEO, in the press release. He noted that the company is preparing for regulatory discussions with the FDA, with top-line data anticipated by the end of next year.
The COMBAT-ALS program is complemented by a large Expanded Access Program supported by a $22 million NIH grant that continues to enroll patients.
MN-166 is an oral small molecule compound that inhibits phosphodiesterase type-4 and inflammatory cytokines. It holds Orphan Drug Designation for ALS from both the U.S. FDA and EU EMA, and has received Fast Track Designation from the FDA for ALS treatment.
MN-001 is an oral compound that exerts anti-inflammatory and anti-fibrotic effects through several mechanisms, including leukotriene receptor antagonism and inhibition of phosphodiesterases. The compound has demonstrated ability to down-regulate genes that promote fibrosis and inflammation, and inhibit triglyceride synthesis in hepatocytes.
MediciNova is focusing its development activities on these two compounds for various neurological, fibrotic, and metabolic disorders with unmet medical needs. The company maintains a healthy current ratio of 17.66, indicating strong short-term liquidity. Unlock 5 additional key insights about MNOV’s financial health with an InvestingPro subscription, essential for making informed investment decisions in clinical-stage biotech companies.
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