Neuralstem, Inc. reported its financial results for the three months and six months ended and provided clinical program and business highlights.
"The Company continued to make progress in our ongoing ALS cell therapy clinical trial in the second quarter of 2012," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer. "With FDA approval, we are currently transplanting a cohort of return patients that had previously received lumbar injections. Patients 16 and 17 have now received cervical injections."
Dr. Johe continued, "The second quarter also saw the Phase Ib commencement of the ongoing trial of our lead neurogenic small molecule compound, NSI-189, for the treatment of major depressive disorder (MDD). Phase Ib tests the safety of escalating doses for a 28-day cycle."
Cellular Therapy: NSI-566 Phase I Clinical Trial in ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) at Emory University Hospital
-In June, returning patient 16 received five injections in the cervical region, in addition to the ten he received previously in the lumbar region of the spine, for a total of 15 injections.
-In June, the Emory University Institutional Review Board approved the FDA-approved amendment to the trial protocol, permitting the return of three previously treated patients to the trial to receive additional dosing.
-In May, the FDA approved additional dosing of three patients from earlier cohorts for second treatments as the next, final cohort of patients, provided they met requirements at the scheduled time.
Neurogenic Small Molecule NSI-189: Phase I Clinical Trial in Major Depressive Disorder (MDD)
-In June, the first patient was dosed in the Phase Ib stage of the ongoing NSI-189/MDD trial. This phase tests the safety of NSI- 189 for 28 daily administrations in 24 patients with MDD.
-Subsequent Event: In July, the company extended the employment contracts of Dr. Karl Johe, Richard Garr, and Dr. Thomas Hazel for an additional 60 months.
In a release on August 10, the Company noted that for the second quarter of 2012, the Company reported a net loss of $2,376,381 or $0.04 per share, compared with a net loss of $3,648,725 or $0.08 per share, for the comparable 2011 period. The decrease in net loss was primarily due to a reduction in non-cash stock based compensation expense of approximately $730,000 coupled with decreases in employee bonuses and legal expenses and revenue recognized in the second quarter of 2012.
For the six months ended June 30, the Company reported a net loss of $4,829,162 or $0.09 per share, compared with a net loss of $6,750,527, or $0.14 per share for the comparable 2011 period. The decrease in net loss was primarily due to a reduction in non-cash stock based compensation expense of approximately $1,500,000 coupled with decreases in employee bonuses and legal expenses and revenue recognized in 2012 partially offset by gains in 2011 of approximately $250,000 related to a legal settlement and $162,000 related to the changes in the fair value of certain warrant obligations.
Cash and cash equivalents on hand at June 30, totaled $2,539,534, compared with $2,352,013 at December 31, 2011. The approximately $187,000 increase in cash and cash equivalents over the six months of 2012 was primarily due to approximately $4,900,000 of net proceeds from a registered direct financing in February 2012 largely offset by cash used in operations.
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