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Deanne Eagle - Media Relations 917.837.5866 Susan Roush - Investor Relations 818.222.8330

Key Takeaway: Deanne Eagle - Media Relations 917.837.5866 Susan Roush - Investor Relations 818.222.8330 NEURALSTEM REPORTS FIRST QUARTER FINANCIAL AND PROVIDES BUSINESS AND CLINICAL UPDATE ROCKVILLE, Md., May 10, 2013 -- Neuralstem, Inc. (NYSE MKT: CUR) today reported its financial results

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Deanne Eagle - Media Relations 917.837.5866
Susan Roush - Investor Relations 818.222.8330
NEURALSTEM REPORTS FIRST QUARTER FINANCIAL
AND PROVIDES BUSINESS AND CLINICAL UPDATE
ROCKVILLE, Md., May 10, 2013 --
Neuralstem, Inc. (NYSE MKT: CUR) today reported its financial results for the three months ended March 31, 2013 and provided a
business and clinical update.
"The Company continues to progress
all of its clinical trial programs, in the U.S. and abroad, as we move into 2013. The FDA has approved our Phase II trial protocol
for NSI-566/ALS, which we expect to initiate this summer. The protocol calls for an aggressive dose escalation strategy and adds
a second trial center," said Karl Johe, PhD, Neuralstem's Chairman of the Board and Chief Scientific Officer. "We
welcome our esteemed collaborators at University of Michigan joining our collaborators at Emory. We look forward to receiving approvals
from both Institutional Review Boards in the near term and to commencing the trial, which has generous grant funding from the National
Institutes of Health and ALSA.
"Institutional Review Board approvals
are also expected during this summer for our NSI-566 chronic spinal cord injury trial, approved by the FDA in January. This trial
uses the same cells and procedure proven safe and well-tolerated in the ALS trial. The ALS data was presented at the American Association
of Neurological Surgeons Annual Meeting, in April," continued Dr. Johe. "The Phase I/chronic spinal cord injury trial
will treat a total of eight patients with T2-T12 complete paralysis. The trial centers will be announced as the IRB approvals are
Dr. Johe commented further, "Internationally,
the NSI-566 trial preparations are progressing well. We anticipate the Phase I/II ischemic stroke trial at BaYi Brain Hospital,
in Beijing, will commence this quarter, representing the first-in-human direct stereotactic injections into the brain of NSI-566.
The INDs for both acute spinal cord injury Phase I/II in Seoul and ALS Phase I/II in Mexico City are expected to be filed in June.
"Additionally, we were approved by
the FDA to treat the third and final cohort of the ongoing Phase Ib major depressive disorder trial with our lead neurogenic small
molecule compound, NSI-189. Dosing is proceeding well, and we expect to complete the trial in September," Dr. Johe concluded.
"This past quarter we were pleased
to grant licenses for our proprietary intraspinal cell therapy surgical devices and method, used in the Phase I NSI-566/ALS trial,
to Cedars-Sinai Medical Center. The licenses are specifically for academic research, enabling a new era of research and treatment
of spinal cord conditions and diseases," stated Richard Garr, Neuralstem President and CEO. "Additionally, we further
strengthened our substantial global IP portfolio to include five licensed patent grants in Europe for the floating cannula and
cell therapy method of use. Our newest U.S. patent covers the use of expanded spinal cord stem cells to treat ALS and joins past
patent claims covering methods of culturing and treating neurodegenerative conditions with our NSI-566 cells. In our neurogenic
small molecule program, we received one U.S. patent covering divisional compositions and methods of use, and 11 European patents
for method of discovering neurogenic agents.
"Finally, Dr. Johe and I would like
to thank our scientific and medical collaborators, and the patients and their families in the ALS community who believe in the
science, technology and promise of Neuralstem for appearing at the recent FDA hearing on ALS trials and being vocal with their
support" added Garr.
First Quarter Clinical Program and Business
In January, Neuralstem's lead cell
therapy candidate, NSI-566, was approved by the FDA to commence a Phase I trial to treat chronic spinal cord injury (cSI). This
open-label, multi-site study will enroll up to eight patients with thoracic spinal cord injuries (T2-T12) who have an American
Spinal Injury Association AIS-A level of impairment, between one and two years post injury. These patients exhibit no motor or
sensory function in the relevant segments at and below the injury, and are considered to be in complete paralysis.
Study patients will receive six injections in, or around, the injury site: the first four patients will receive 100,000 cells per
injection; the second four patients, 200,000 cells per injection. All NSI-566/cSCI patients will receive post-surgery physical
therapy, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six
months post-surgery for each patient. The primary objective of the study is to determine the safety and toxicity of NSI-566 for
the treatment of paralysis and related symptoms due to cSCI. The secondary objectives are to evaluate graft survival in
the transplant site by MRI, as well as the effectiveness of transient immunosuppression.
In January, Neuralstem received issuance
of U.S. Patent #8,362,262, Divisional Compositions and Methods of Use, part of the small molecule IP; additionally, issuance of
PCT Patent #2337517, Floating Cannula and Method of Use, which is exclusively licensed by Neuralstem, and validated in four European
countries: Germany, France, Italy and United Kingdom, for a total of five European patents.
In February, Neuralstem's NSI-566
Phase I Clinical Trial in ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) officially concluded, six months after
the final surgery at Emory University Hospital.
In February, Neuralstem
granted licenses to intellectual property surrounding its spinal cord delivery platform, floating cannula, and method for delivering
therapeutic agents to the spinal cord to Cedars-Sinai Medical Center, a nonprofit academic medical center in Los Angeles, CA, for
In March, Neuralstem
received issuance of EP Patent # 1576134, Method for Discovering Neurogenic Agents, which is part of the small molecule IP, and
granted in ten European countries: Belgium, Switzerland, Germany, France, United Kingdom, Ireland, Luxembourg, Netherlands and
Sweden, for a total of 11 European patents.
In March, Neuralstem
President and CEO Richard Garr was named the 15th most influential person in the stem field in Terrapinn's Total
BioPharma's "Top 50 Global Stem Cell Influencers."
In March, Neuralstem
secured $8 million in debt financing with Hercules Technology Growth Capital to fund the company's capital budget through
In April, Neuralstem
received FDA approval to commence the NSI-566 Phase II trial, for ALS, following the excellent safety and tolerability demonstrated
in Phase I. The Phase II dose escalation and safety trial to determine the maximum safe tolerated dose will expand to two centers,
Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan
Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution. The NSI-566/ALS
Phase II trial is designed to treat up to 15 ambulatory ALS patients, in five different dosing cohorts, advancing up to a maximum
of 40 direct injections and 400,000 cells per injection, based on safety. This compares to a maximum of 15 injections of 100,000
cells each, directly into the gray matter of the spinal cord, in the completed Phase I trial. The first 12 Phase II patients will
receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function;
the final three patients will receive both cervical and lumbar injections.
data on the intraspinal delivery method employed in the NSI-566/ALS Phase I trial was presented at the American Association of
Neurological Surgeons Annual Meeting. "Intraspinal Stem Cell Transplantation in ALS, A Phase I Trial: Cervical Microinjection
Safety Outcomes," presented by Jonathan Patrick Riley, MD, of the Department of Neurological Surgery at Emory University,
included data from all 18 procedures, in 15 patients, and showed the method of intraspinal cell delivery was found to be safe,
well-tolerated, and promising for other spinal cord conditions.
FDA approved Neuralstem to treat the third and final cohort in the ongoing Phase Ib NSI-189 trial in major depressive disorder
(MDD). Phase Ib is testing the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients in three
cohorts, and is expected to conclude in 3Q13. NSI-189, the lead compound in Neuralstem's neurogenic small molecule platform, is
a proprietary new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated
in MDD, as well as other diseases and conditions such as: traumatic brain injury, Alzheimer's disease, and post-traumatic
stress disorder (PTSD).
In April, Neuralstem
announced an initiative to investigate feasibility of a NSI-189 trial to treat cognitive and psychiatric impairment of former NFL
players from traumatic brain injury. These injuries can result in long-term and serious loss of cognitive function, depression,
a shorter life span and, as has been reported in some high-profile NFL cases, death by suicide.
In April, Neuralstem
received notice of allowance for patent application 12/404,841, which covers methods of treatment of ALS with expanded spinal cord
stem cells, including NSI-566.
First Quarter Financial Results
For the first quarter of 2013, the Company
reported a net loss of approximately $3,590,000 or $0.05 per share, compared with a net loss of approximately $2,453,000 or $0.05
Last updated: May 10, 2013