Zacks Small Cap Analysis – MNOV: A number of Abstracts Introduced at 92nd EAS Congress… – Nexus Vista

By David Bautz, PhD

NASDAQ:MNOV

READ THE FULL MNOV RESEARCH REPORT

Enterprise Replace

Abstracts Concerning MN-001 and MN-002 Introduced at 92nd EAS Congress

On Might 28, 2024, MediciNova (NASDAQ:MNOV) introduced that two abstracts relating to MN-001 (tipelukast) and MN-002 have been introduced as posters on the 92nd European Atherosclerosis Society (EAS) 2024 Congress. The poster on MN-001 pertained to the goals and design of the continuing Part 2 scientific trial enrolling sufferers with Kind 2 diabetes, dyslipidemia, and NAFLD. The poster on MN-002 pertained to the mechanism of motion of MN-001/MN-002 in lipid metabolism, notably the results on ldl cholesterol efflux capability.

As of April 25, 2024, 33 sufferers have been enrolled within the Part 2 trial of MN-001, with 19 sufferers at the moment randomized and 14 sufferers having accomplished the examine. Up to now, three topics have reported severe opposed occasions, nonetheless they have been all thought-about “unlikely associated” or “unrelated” to review drug.

For MN-002, the goals of that examine have been to guage each MN-001 and its main lively metabolite MN-002 on ldl cholesterol efflux capability in THP-1 macrophages and the impact of each compounds on ABCA1 and ABCG1 mRNA expression. The outcomes confirmed that MN-002:

•   Elevated each ApoA1-mediated and HDL-mediated ldl cholesterol efflux capability in comparison with management

•   Elevated ABCA1 and ABCG1 protein ranges in a dose-dependent method

•   Elevated ABCA1/ABCG1/LXR-alpha mRNA ranges

•   Elevated ABCA1 protein ranges impartial of a PKA signaling pathway inhibitor

Part 1b/2a Outcomes for MN-166 in GBM Introduced at ASCO 2024

On June 3, 2024, MediciNova, Inc. (MNOV) introduced that an summary relating to outcomes for the Part 1b/2a scientific trial of MN-166 (ibudilast) in glioblastoma (GBM) was introduced on the American Society of Medical Oncology (ASCO) 2024 Annual Assembly.

The Part 1b/2a trial is a two-part examine happening at Dana-Farber Most cancers Institute; Half 1 of the trial evaluated the protection and tolerability of MN-166 together with temozolomide (TMZ) and decided the optimum dose of MN-166 to make use of in Half 2 of the examine. Half 2 evaluated the efficacy of MN-166 and TMZ as measured by the proportion of topics who’re progression-free at 6 months. Extra end result measures included total survival, response price, and median six-month progression-free survival. A complete of 62 sufferers have been enrolled into the trial; 36 with newly identified GBM and 26 with recurrent GBM.

The info from the trial confirmed that the mixture of TMZ and MN-166 was secure and well-tolerated. There have been no sudden opposed occasions in both new GBM or recurrent GBM sufferers. Essentially the most generally reported opposed occasions have been lymphopenia, leukopenia, thrombocytopenia, and neutropenia. Development-free survival at 6 months (PFS6) was 44% (new GBM) and 31% (recurrent GBM), with the PFS6 in recurrent GBM being increased than historic controls. Neither median PFS (8.7 months for brand new GBM and a pair of.4 months for recurrent GBM) or median total survival (21 months in new GBM and eight.6 months in recurrent GBM) have been increased than historic information.

Beforehand revealed preclinical information confirmed improved survival in animal fashions of GBM when MN-166 was utilized in mixture with PD-1 or PD-L1 antibody remedy in comparison with both remedy alone. Given these outcomes, future scientific research could consider MN-166 together with both anti-PD-1 and/or anti-PD-L1.

Mental Property Replace for MN-166

MediciNova has lately introduced a number of Notices of Allowance for brand new patents relating to MN166:

•   In March 2024, the corporate introduced a Discover of Allowance from the Japanese Patent Workplace for a pending patent utility that covers MN-166 for the remedy of macular harm related to progressive a number of sclerosis (MS). The allowed claims cowl using MN-166 for treating macular harm related to progressive MS and for lowering macular quantity loss related to progressive MS. The allowed claims cowl each main progressive MS and secondary progressive MS.

•   In Might 2024, the corporate introduced it acquired notification from the U.S. Patent and Trademark Workplace (USPTO) for a brand new patent that covers extended-release oral formulations of MN-166.

•   In Might 2024, the corporate introduced it acquired notification from the USPTO for a pending patent utility that covers MN-166 for the remedy of chlorine-induced acute respiratory misery syndrome (ARDS). The allowed claims cowl using MN-166 as a monotherapy or together remedy for treating chlorine-induced ARDS.

Monetary Replace

On Might 9, 2024, MediciNova filed Kind 10-Q with monetary outcomes for the primary quarter of 2024. As anticipated, the corporate didn’t report any revenues within the first quarter of 2024. R&D bills within the first quarter of 2024 have been $1.8 million in comparison with $1.5 million within the first quarter of 2023. The rise was primarily resulting from a rise in MN-166 manufacturing bills. G&A bills within the first quarter of 2024 have been $1.4 million in comparison with $1.5 million within the first quarter of 2023. The lower was primarily resulting from a lower in performance-based inventory possibility expense.

Web money utilized in working actions was $3.9 million for the primary quarter of 2024. MediciNova exited the primary quarter of 2024 with roughly $47.1 million in money and money equivalents. We estimate the corporate has enough capital to fund operations no less than by way of the tip of 2024. As of Might 7, 2024, the corporate had roughly 49.0 million shares excellent and when factoring in inventory choices a completely diluted share depend of roughly 57.6 million.

Conclusion

Whereas the mixture of MN-166 and TMZ was secure and effectively tolerated in GBM sufferers, it didn’t positively impression total survival in both new GBM or recurrent GBM sufferers. Primarily based on these outcomes we have now eliminated the GBM indication from our mannequin, which has decreased our valuation to $26 per share.

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