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| Deanne Eagle - Media Relations | 917.837.5866 |
| Susan Roush - Investor Relations | 818.222.8330 |
NEURALSTEM REPORTS THIRD QUARTER FINANCIAL
AND PROVIDES BUSINESS AND CLINICAL UPDATE
ROCKVILLE, Md., November 12, 2013
-- Neuralstem, Inc. (NYSE MKT: CUR) today reported financial results for the three months and nine months ended September 30, 2013
and provided a business and clinical update.
reached several major milestones in the third quarter. We completed patient dosing in our Phase Ib trial to treat major
depressive disorder with NSI-189, our lead small molecule compound. We also commenced a multicenter Phase II cell therapy trial
with NSI-566 to treat ALS, and completed dosing of all patients in the first cohort," said Karl
Johe, PhD, Neuralstem's Chairman of the Board and Chief Scientific Officer. "The dose escalation trial
for NSI-189 advanced through three cohorts of eight depression patients each, with the final cohort receiving three daily doses
of 40 mg for 28 days. During the coming months we will be compiling the data from this Phase I study.
"We are particularly excited to have
begun our Phase II ALS dose escalation trial, treating the first cohort of three patients in the cervical region of the spinal
cord. We are currently treating the second of five cohorts and hope to transplant all 15 patients by the completion of the second
quarter of 2014," continued Dr. Johe. "We are pleased that principal investigator
Dr. Eva Feldman, added the University of Michigan Health System, where she is Director of Research of the ALS Clinic and Director
of the A. Alfred Taubman Medical Research Institute, as a second trial center. We are working towards adding a third site, Massachusetts
General, in the coming months. The Phase II trial protocol calls for increased dosing and a maximum
of 40 injections and up to 400,000 cells per injection, with a one-month observation period between
who is also the president of the American Neurological Association, recently presented complete Phase I NSI-566/ALS trial data
at the annual ANA meeting, which showed a clear slowing of disease progression or actual improvement for more than 700-to-approximately-850
days post-surgery, in six non-bulbar ALS patients who were treated early in the course of their disease. All patients in Phase
II are also ambulatory and within approximately two years of the onset of symptoms of the disease," said
Dr. Johe. "The results from the complete Phase I data will be made public after they are published in a peer-reviewed scientific
journal anticipated later this year.
"Looking ahead, our NSI-566/stroke
Phase I/II trial at BaYi Brain Hospital, in Beijing, is expected to be underway later in the fourth quarter. This trial will treat
with one-time intracerebral injections of cells directly into the ischemic stroke area," continued Dr. Johe. "The first
phase will determine the maximum safe dose in up to 18 patients, and is expected to be completed in seven or eight months. Phase
II will advance to a multicenter, randomized, controlled single-blind study with up to 100 patients, and is designed to evaluate
efficacy and safety for clinical proof-of-concept. Also, of note, we continue to make progress towards commencement of the FDA-approved
NSI-566/chronic spinal cord injury Phase I trial in the first quarter of 2014. This trial, which will treat eight patients with
T2-T12 complete paralysis, uses the same cells and methodology as our ALS trial.
"The recent publication of an animal
study by our collaborators at the University of California, Irvine, provided proof of principle for NSI-566 in the amelioration
of cognitive dysfunction induced by brain irradiation, a common treatment for brain cancer in humans. In the study, rats injected
with the cells two days after brain irradiation demonstrated a reduction in radiation-induced cognitive dysfunction. This is an
important validation for the ongoing NSI-566 preclinical program in multiple indications where loss of cognitive function is prevalent.
"We thank our shareholders for their
continued support; we begin the fourth quarter on solid financial footing, with cash on-hand to cover our corporate and clinical
budgets for the next two years," said Richard Garr, Neuralstem's President and CEO. "Dr. Johe and I extend our
deep appreciation to our patients, and their families and caregivers, for their continued support and dedication to our work in
ALS and other debilitating diseases and conditions of the central nervous system. We thank our team of world-class clinical collaborators
and investigators around the globe, innovators all, who we are proud to call our partners."
Third Quarter Clinical Program and Business
In August, the company completed dosing
of the NSI-189/major depressive disorder (MDD) Phase Ib trial. The trial of Neuralstem's lead neurogenic small molecule drug
was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effect of escalating doses of NSI-189
for 28 daily administrations in 24 depressed patients in three cohorts. Data is being compiled.
In August, University of California, Irvine
researchers published a paper in the scientific journal, CELL TRANSPLANTATION - THE REGENERATIVE MEDICINE JOURNAL, which
reported that NSI-566 reversed cognitive defect and improved cognitive function in rats that had received radiation to the brain.
"Transplantation of Human Fetal-Derived Neural Stem Cells Improves Cognitive Function Following Cranial Irradiation"
used an animal model of radiation treatment for brain cancer and showed that brain-irradiated rats that received NSI-566 transplants
had improved cognitive function, including improved hippocampal spatial memory, as assessed by two separate cognitive tasks.
In September, Neuralstem's NSI-566/ALS
Phase II dose escalation and safety trial commenced, with the first patient treated at Emory University Hospital and the second
patient treated at University of Michigan Health System. The multicenter trial is designed to treat up to 15 ambulatory ALS patients
in five different dosing cohorts. Patients in the first cohort received 10 injections of 200,000 cells per injection. In subsequent
cohorts, the dose will increase in both number of injections and cells per injection, advancing up to a maximum of 40 injections
and up to 400,000 cells per injection in the fifth cohort. The first 12 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.
This quarter, Neuralstem increased its
global IP portfolio to 49 issued and 59 pending patents. The company received issuance of Japan Patent # 5266297, and filed a new
patent application in South Korea, 10-2013-7020263, both related to the company's existing
stem cell technology. The company also filed a new U.S. patent application 61/844,165,
which covers methods of treating cognitive defects with spinal cord neural stem cells.
In September, the company raised aggregate
gross proceeds of $4,556,000 in a registered direct offering.
President and CEO Richard Garr presented at the Stem Cells & Regenerative Medicine Congress. NSI-566/ALS Phase I patient, Ted
Harada, also spoke about his experience with ALS and treatments at the congress.
In October, University of Michigan Health
System, the second center for the NSI-566/ALS Phase II dose escalation trial, treated its second patient. With one patient already
treated at Emory University Hospital, this represented the completion of the first of the trial's five cohorts in less than
In October, Dr. Eva Feldman, MD,
PhD, gave an update on the NSI-566/ALS trial at the annual American Neurological Association Meeting. Dr. Feldman is principal
investigator for Neuralstem's NSI-566/ALS trial, Director of the A. Alfred Taubman Medical Research Institute, Director of
Research of the ALS Clinic at the University of Michigan Health System, President of the American Neurological Association, and
an unpaid consultant to Neuralstem.
Third Quarter Financial Results
quarter of 2013, the Company reported a net loss of approximately $6,687,000 or $0.09 per share, compared with a net loss of approximately
$2,577,000 or $0.04 per share, for the comparable 2012 period. The increase in net loss was primarily due to non-cash charges of
approximately $1,945,000 related to the modification of certain stock purchase warrants, $678,000 related to the change in fair
value of the Company's derivative instruments and a $520,000 increase in share-based compensation coupled with a $377,000
increase in project and lab related expenses due to the ramping up of our clinical trial and research efforts and $449,000 of interest
expense related to the Company's long term debt.
ended September 30, 2013 the Company reported a net loss of approximately $16,529,000 or $0.23 per share, compared with a net loss
of approximately $7,407,000, or $0.14 per share for the comparable 2012 period. The increase in net loss was primarily due
to non-cash charges of approximately $5,017,000 related to the modification of certain stock purchase warrants, $860,000 related
to the change in fair value of the Company's derivative instruments and a $893,000 increase in share-based compensation coupled
with a $868,000 increase in research and development expenses due to an increase in headcount and the ramping up of our clinical
trial and research efforts and $936,000 of interest expense related to the Company's long term debt. In addition, the Company
recognized approximately $108,000 in revenue from third party licensing of certain intellectual properties in the first nine months
equivalents on hand was approximately $16,402,000 at September 30, 2013, compared with approximately $9,873,000 at September 30,
2012. The increase in our cash and cash equivalents of approximately $6,528,000, was primarily due to our raising approximately
$17.6 million through our March 2013 issuance of debt ($7.6 million), issuance of stock from exercise
of investor warrants ($5.8 million) and issuance of stock and warrants from our September equity offering ($4.2 million),
partially offset by cash used in operations