Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on STEMCELLS INC. We currently have 3 research reports from 1 professional analysts.
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Critical juncture in spinal cord injury
05 Feb 16
StemCells has reached a critical juncture in its development program with a highly encouraging interim analysis of its Phase II PATHWAY study pointing to promising efficacy in cohort 1 of its human central nervous system stem cells (HuCNS-SC) in lead indication spinal cord injury (SCI). Given limited financial resources, StemCells is realigning operations to focus efforts on the internal funding for key pivotal Phase III SCI trials. New group leadership by way of a recently announced change in CEO comes on the heels of the current company reorganization.
Phase II trials underway
01 Sep 15
StemCells has announced transplantation of the first patient in a recently initiated Phase II trial, evaluating its human central nervous system stem cells (HuCNS-SC) as a treatment for dry age-related macular degeneration (AMD). Progression into the Phase II RADIANT trial was supported by the top-line results of its Phase I/II dose-ranging trial in dry AMD announced in June. Additionally, the company began dosing the first cohort in its Phase II PATHWAY study in cervical spinal cord injuries (CSI) earlier this year. At a price of $0.41, the shares offer considerable potential, currently trading significantly below our risk-adjusted fair value of $1.82 per share.
On the PATHWAY towards pivotal studies
08 Jun 15
StemCells is steadily progressing its pipeline of proprietary human central nervous system stem cells (HuCNS-SC), focusing on CNS disorders. Trials in its two lead indications, spinal cord injuries (SCI) and dry age-related macular degeneration (AMD) are now migrating from early and encouraging dose finding and initial efficacy to larger Phase II studies powered for proof of concept. Early findings are expected to begin feeding through in the current year. We believe StemCells' shares offer considerable value on a current price of $0.74, well below our risk-adjusted fair value calculation of $1.95 per share. Additionally, the company has recently filled its coffers with a successful share offering.
20 Apr 17
Although the last two months have seen a broadly neutral performance from the UK healthcare sector compared to a significantly more volatile 6 months prior, we continue to expect macro-events and increased geo-political risk to result in an overall neutral performance from the sector over the next period. However, company specific news is likely to drive a strong outperformance from selected mid-market companies. We retain our neutral sector stance whilst highlighting those we expect to outperform.
Positive top-line results in first iclaprim phase III clinical trial (REVIVE-1)
18 Apr 17
Motif Bio (LSE: MTFB, NASDAQ: MTFB), a late clinical stage antibiotic development company, announced positive results this morning in the first of its two iclaprim phase III clinical trials, REVIVE-1, comparing iclaprim to vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Iclaprim, a next-generation antibiotic targeting an underutilised mechanism of action which causes rapid killing of bacteria, is being developed for the treatment of serious and life threatening bacterial infections. On the key primary endpoint in the study, early clinical response at 48-72 hours after drug treatment began, 80.9% of patients on iclaprim achieved a positive response compared to 81.0% of patients on vancomycin, well within the 10% non-inferiority margin required by the FDA. Iclaprim was also shown to be safe and well-tolerated compared to vancomycin. With these positive results from REVIVE-1 we have increased the probability of success for the iclaprim development program from 65% to 75% raising our risk-adjusted NPV for Motif Bio to almost £240m or 122p per share (previously £210m and 107p per share).
N+1 Singer - Sinclair Pharma - EBITDA upgrade for 2017, but lower TP due to warranty claim and costs
19 Apr 17
We have updated product-level forecasts and included the £10m SVB debt facility and £5m warranty claim settlement with Alliance Pharma in our forecasts. The 6.3% upgrade to our FY2017 sales estimate (from £46.0m to £48.9m) brings expected EBITDA profitability forward by one year (to FY2017 from FY2018). We remain positive on the ongoing rollout of Silhouette Instalift® in particular and retain our Buy recommendation. However, higher expected sales & marketing costs and the warranty claim weigh on our valuation: we downgrade our target price from 42p to 37p.
Positive REVIVE-1 Phase III study data
18 Apr 17
Motif Bio (MTFB) has announced positive top-line results from REVIVE-1, its global Phase III study comparing iclaprim to vancomycin in patients with acute bacterial skin and skin structure infections (ABSSSI). Iclaprim achieved the primary endpoint of non inferiority when compared to vancomycin, in both the early time point and test of cure endpoint. Iclaprim offers clinical advantages over existing hospital antibiotics that include the avoidance of renal toxicity, fixed dosage regimen and early response indications. With data from REVIVE-2 due out in H2 2017 we maintain our 125p price target and Buy recommendation.