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Wednesday, October 21, 2020

Neuralstem, Inc. (NASDAQ:CUR) Breaks Higher as Phase 2 Comes Together

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Neuralstem, Inc. (NASDAQ:CUR) is a micro-cap stock that has started to engage some focus among traders and investors as prices get a little traction in bounce mode. The stock just broke out of its trading range in reaction to an announcement of the completion of subject enrollment in its Phase 2 clinical trial of NSI-189 for the treatment of major depressive disorder (MDD). According to the release, NSI-189 is a new chemical entity and the lead compound in Neuralstem’s neurogenic small molecule program.  Enrollment was completed ahead of schedule and data are expected in 3Q 2017.

We’ve witnessed 21% during the past week in terms of shareholder gains in the name. This is emblematic of the stock. CUR has evidenced sudden upward volatility on many prior occasions. In addition, the company has witnessed a pop in interest, as transaction volume levels have recently pushed 390% over the long run average.

Neuralstem, Inc. (NASDAQ:CUR) promulgates itself as a biotechnology company focused on stem cell and small molecule treatment therapies for psychopathologies and nervous system disorders.

Neuralstem’s patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.

Neuralstem’s technology enables the generation of small molecule compounds by screening hippocampal stem cell lines with its proprietary systematic chemical screening process. The screening process has led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brain’s capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.

The company has completed Phase 1a and 1b trials evaluating NSI-189, a novel neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a Phase 2 efficacy study for MDD.

Neuralstem’s stem cell therapy product candidate, NSI-566, is a spinal cord-derived neural stem cell line. Neuralstem is currently evaluating NSI-566 in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

Neuralstem is conducting a Phase 1 safety study for the treatment of paralysis from chronic motor stroke at the BaYi Brain Hospital in Beijing, China. In addition, NSI-566 was evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS.  Subjects from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits.

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“Completing the last subject enrolled in the Phase 2 study with NSI-189 for the treatment of MDD earlier than expected is a significant clinical development milestone for Neuralstem,” said Rich Daly, Chairman and CEO, Neuralstem.  “We now expect results from the Phase 2 study in the 3Q of 2017, and results from the subsequent, 6-month observational study to assess NSI-189’s durability effect will be available in the first half of 2018. We are thankful to the individuals and physicians who are participating in these studies and helping us to move closer to potentially bringing this new category of treatment forward.”

The double-blind, placebo-controlled Phase 2 study randomized 220 subjects to one of three oral treatment groups:  placebo, 40 mg once daily (QD), 40 mg twice daily (BID). The primary efficacy endpoint is a reduction in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).  Secondary endpoints encompass additional clinical outcomes including objective cognition improvement measures.

The trial is evaluating subjects over a 12-week dosing period with an observational follow-up period of six months to assess NSI-189’s potential for durability of benefits after the cessation of therapy.  The trial is being conducted in 12 select MDD trial sites across the United States.

“Our goal is to improve the success rate in the treatment of major depressive disorder, and fulfill the unmet medical need for effective and well-tolerated therapies that work differently from antidepressants that are currently available,” said Maurizio Fava, MD, Slater Family Professor of Psychiatry at Harvard Medical School, Massachusetts General Hospital and principal investigator.  “The Phase 1 data have shown that NSI-189’s biological mechanism of action may provide an alternative for the treatment of MDD, with the potential for cognitive benefits and durability effects beyond the course of treatment.”

At this time, carrying a capital value in the market of $41.7M, CUR has a significant war chest ($5.7M) of cash on the books, which is balanced by about $4.8M in total current liabilities. CUR is pulling in trailing 12-month revenues of $10K. You can bet we will update this one again as new information comes into view. For continuing coverage on shares of $CUR stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!

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