Q2/10 Results, Neuralstem (NYSE Amex: CUR)
CUR reported a Q2/10 net loss of $4.9 M or $0.12 per share with a 42.5 M weighted average of common shares outstanding.
CUR reported no revenues for Q1/10 with R&D costs of $2.6 M and G&A costs $1.55 M. Net loss attributable to common stockholders for the first 6 months of FY10 was $11.7 M, or $0.29 per share. The increase was primarily attributable to increases in R&D and legal fees, and non-cash stock-based compensation expense, offset by a non-cash gain related back to the warrant accounting for Q1/09.
For the 6 months ended 6/30/10, cash used in operating activities totaled $4.9 M, an increase of $2.4 M compared to the 6 months of FY09, primarily attributable to increased research spending related to the beginning of clinical trials, the costs of completing preclinical trial studies for new indications, and increased legal fees.
During Q2/10, CUR received a total of $9.3 M from a registered direct placement. Cash, cash equivalents and short-term marketable securities at 6/30/10 totaled approximately $14 M.
Q2 Highlights:
- CUR announced that, after reviewing the safety data from the first cohort of 3 patients, the independent Safety Monitoring Board overseeing the ALS trial gave the approval to move to the 2nd cohort of 3 patients, which took place over the third quarter. The first cohort of 3 patients received only 5 injections each, unilaterally. The 2nd cohort of patients received 10 injections each, bilaterally, in the lower spinal cord. Subject to review of the 1st 2 cohorts and approval by the Safety Monitoring Board, the next part of the trial will move into earlier-stage ALS patients in October;
- In 6/10, the Principal Investigator (Dr. Eva Feldman) of CUR’s Phase I clinical trial to treat ALS with its spinal cord stem cells presented at the inaugural A. Alfred Taubman Forum on Improving Science and Technology Innovation;
- CUR announced that it will submit a clinical trial application in chronic spinal cord injury to the FDA as the first of planned additional FDA clinical trial submissions utilizing the company’s neural stem therapy platform. The company is on schedule to file an Investigational New Drug (IND) submission with the FDA in Q3/10. The Phase I clinical trial for chronic spinal cord injury is planned to be a multisite study;
- 4 CUR molecules have demonstrated neurogenic activity, the ability to stimulate neurogenesis of normal adult brain cells in the hippocampus. Neuralstem scientists have been developing this new class of drugs over the past 12 months. They are currently completing the pre-clinical pharmaceutical programs to submit INDs to the FDA for Phase I clinical trials for CUR’s neurogenic small molecule drug;
- The 1st Phase I trial of CUR’s small molecule compound is expected by early 2011, with an initial trial indication of major depression. CUR believes that its ability to screen against its proprietary cells provides a valuable and unique advantage for the discovery of novel compounds to central nervous system (CNS) diseases;
- CUR announced in June of 2010 that it commenced the formation of a wholly owned subsidiary, Neuralstem China (Suzhou Neuralstem Biopharmaceutical Company, Ltd.), with the intention of conducting stem cell clinical trials in the People’s Republic of China. CUR anticipates the formation to be completed during Q3/10;
- Additionally, CUR continues to support its Korean partner, CJ Cheil Jedang Corporation, as it moves to launch its first Asian markets clinical trial;
- CUR also continues to work on Huntington’s disease with its collaborators at Albert-Ludwigs-University in Freiburg, Germany.
