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biomanbaba

11/25/13 3:19 PM

#1574 RE: peterus #1573

Aegis Capital analyst remarks posted today


Neuralstem, Inc.
Rating: Buy
Upcoming Catalysts: Raising Price Target
Investment Highlights:
¦ Significant Milestones Ahead - Raising Price Target. In our view,
Neuralstem is entering a critical period in its history, with potentially
imminent initiation of dosing in a proof-of-concept Phase 1 / 2 trial of its
lead stem cell-based therapeutic product candidate, NSI-566, in spinal cord
injury (SCI). We also note that the company is slated to report data from
the Phase 1b trial of its small molecule agent, NSI-189, within the coming
weeks and should report data with NSI-566 in a Phase 2 trial enrolling
patients with amyotrophic lateral sclerosis (ALS) by mid-2014. If this ALS
data shows activity of the drug in maintaining and / or improving forced
vital capacity, a measure of breathing capability in these patients, we believe
that NSI-566 could qualify for accelerated approval. In anticipation of these
clinical catalysts, we reiterate our Buy rating and raise our 12-month price
target from $4.00 to $4.50 per share on CUR.
¦ Solid Financial Position. Neuralstem ended the third quarter of 2013 with
$16.4mm in cash and equivalents. We note that the company's operational
burn rate through the next nine months is likely to be relatively low, since
most of its clinical development initiatives are likely to receive substantial
non-dilutive funding from academic institutions. Accordingly, we believe that
Neuralstem should be able to fund operations with existing capital for the
next several quarters. Investors should note that the firm has 18.6mm in-themoney
warrants that could accrue over $30mm to the company if exercised.
We would anticipate that, if warrant exercises were to continue as envisaged,
Neuralstem should comfortably be able to fund operations into late 2015.
¦ Additional Clinical Initiatives Under Way Ex-U.S. We expect Neuralstem
to begin testing of NSI-566 in ALS patients in a Phase 1/2 study in Mexico
early in 2014, after filing its IND by the end of the year. Also, the firm is slated
to start a Phase 1/2 study of NSI-566 in ischemic stroke patients in China.
This study is being conducted at the Bayi Brain Hospital and is designed to
enroll up to 18 patients in a dose-escalation study. There are about 1.75mm
stroke patients in China. If successful, this Phase 1/2 trial could pave the way
for a larger, 100-patient Phase 2 study. The firm also plans to file another IND
to begin a Phase 1 acute SCI trial in South Korea before the end of 2013.