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Monday, 06/02/2014 4:25:31 PM

Monday, June 02, 2014 4:25:31 PM

Post# of 3108
Aegis Capital price target is $21.00

I can't give a link since it came in my email and the web address includes my email address. But, here's a quote from the report:

NeoStem Phase 3 Vaccine Showcased At ASCO


•Five-Year Survival Metrics Prove Promising. In the wake of Neostem's acquisition of the privately-held firm California Stem Cell, Inc. (CSC), which established Neostem's platform in cancer immunotherapy, five-year survival data with CSC's lead drug candidate, melapuldencel-T, were showcased in a poster presentation at the American Society for Clinical Oncology (ASCO) meeting in Chicago, IL yesterday. The two-year survival rate on melapuldencel-T was 72% in an open-label, single-arm study, while the five-year survival rate was 50%. We note that the remainder of this year is likely to be eventful for Neostem, with a Phase 3 melanoma trial for the CSC lead product candidate, melapuldencel-T, slated to begin enrollment before the end of the year and with the PreSERVE Phase 2 trial of AMR-001 slated to report top-line results in the third quarter of 2014. We reiterate our Buy rating and 12-month price target of $21.00 per share on NBS.
•PreSERVE Trial Remains Key Near-Term Value Driver. Neostem closed enrollment in the ongoing "PreSERVE" Phase 2 trial of AMR-001 in late 2013, with top-line data expected by August 2014. This study enrolled 160 subjects with left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI), a severe form of heart attack. We were enthused about the completion of enrollment, given the lengthy period of time that this trial has taken to accrue the requisite number of patients, and remain confident that the AMR-001 Phase 2 study has a high likelihood of success. Positive data could pave the way for a transformative licensing agreement or partnership.
•Melapuldencel-T Makes Neostem A Phase 3 Firm. The acquisition of the CSC asset vaults Neostem into the domain of companies with pivotal-stage assets in development. In our view, the mechanism of action for melapuldencel-T may have intriguing benefit potential in melanoma, a deadly skin cancer estimated to afflict 120,000 individuals annually in the U.S. Neostem aims to begin Phase 3 testing before the end of 2014 under a Special Protocol Assessment (SPA) from the FDA. If positive, data from this trial could be sufficient to support filing for approval.
•Subset Analysis. The poster data included subset analysis on patients who either had no evidence of disease (NED) or who still had evidence of disease after prior treatment with one or more standard therapies. Patients who were not NED at the start of vaccine therapy had median overall survival of 38.8 months vs. 14.7 months, with a five-year overall survival rate of 33% vs. 20% (hazard ratio 0.65; p-value 0.025).






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