Tue, May 31, 12:50 PM
Tue, May 31, 11:00 AM
Tue, May 31, 11:00 AM
- Thinly traded nano cap StemCells (STEM -81.9%) craters on almost a 20x surge in volume in response to its announcement that it has terminated its Phase 2 Pathway Study, assessing its HuCNS-SC human neural stem cells in spinal cord injury, due to lack of demonstrated effect, specifically a declining trend in the magnitude of treatment effect in both strength and function at month 12. An analysis by the Data Monitoring Committee showed the study was unlikely to achieve its primary efficacy endpoint.
- Bullish expectations stoked a brief rally several weeks ago after the company reported positive interim results from six patients.
- Previously: Bullish investors stoke buying in StemCells ahead of Pathway study data release; shares up 22% (May 11)
Tue, May 31, 9:15 AM
Wed, May 11, 12:49 PM
Wed, May 11, 11:11 AM
- Thinly traded nano cap StemCells (STEM +22.1%) jumps on a 7x surge in volume in early trading. Shares have rallied over 40% since yesterday when the company announced that it will release top-line 12-month data from Cohort 1 in its Pathway Study during its upcoming Q1 earnings call.
- The Phase 2 Pathway Study is assessing its HuCNS-SC human neural stem cells for the treatment of chronic cervical spinal cord injury. Last month, interim six-month data presented at the American Spinal Injury Association meeting showed five of six patients experienced improved muscle strength while four demonstrated improved dexterity.
- Separately, the company executed a 1:12 reverse split of its common stock on May 9 in order to regain compliance with Nasdaq listing requirements.
- Previously: Mid-stage study in cervical spine injury shows encouraging results for StemCells' HuCNS-SC; shares up 21% premarket (April 18)
Mon, Apr. 18, 8:38 AM
- Nano cap StemCells (NASDAQ:STEM) is up 21% premarket on light volume in response to its announcement of positive interim data from a Phase 2 study, Pathway, assessing its HuCNS-SC human neural stem cells for the treatment of chronic cervical spinal cord injury. The results were presented at the 2016 American Spinal Injury Association annual meeting in Philadelphia.
- At month six, five of six patients in Cohort I showed an improvement in muscle strength while four of the five demonstrated improved performance on functional tests assessing dexterity and fine motor skills. Also, four of the six showed improvement in the level of cord injury as measured by standards called ISNCSCI. Twelve-month data on the first open-label cohort will be released later this quarter.
- The company has currently enrolled and randomized 19 of the 40 total subjects in the statistically powered, single-blind Cohort II. Enrollment should be completed in September with final results expected in 2017.
- Read now Treacherous Road Ahead For StemCells Investors
Thu, Mar. 24, 9:55 AM
- StemCells (STEM -2.8%) Q4 results: Revenues: $28M (-96.8%); R&D Expense: $5.9M (-10.6%); SG&A: $2.3M (-42.5%); Operating Loss: ($8.5M) (+12.4%); Net Loss: ($9M) (+10.9%); Loss Per Share: ($0.08) (+46.7%); Non-GAAP Loss Per Share: ($0.07) (+50.0%).
- FY2015 results: Revenues: $0.1M (-90.0%); R&D Expense: $27.1M (+26.0%); SG&A: $9.3M (-10.6%); Operating Loss: ($36.7M) (-18.8%); Net Loss: ($36.4M) (-12.7%); Loss Per Share: ($0.38) (+26.9%); Non-GAAP Loss Per Share: ($0.33) (-31.3%); Quick Assets: $12.1M (-51.6%).
- No guidance given.
Wed, Mar. 23, 4:13 PM
Wed, Mar. 9, 11:03 AM
- StemCells (STEM -33.3%) is down on a 16x surge in volume in response to its announcement of the pricing of its public offering of common stock and warrants.
- The offering appears to be units, with each unit comprised of one share of common stock at $0.30 per share, a two-year Series A warrant to purchase 1/2 a share of common at $0.30 and a five-year Series B warrant to purchase 3/4 of a share of common at $0.42. Gross proceeds are expected to be ~$8.1M which implies a 27M-share offering.
- Underwriters over-allotment is an additional ~4M shares of stock and/or warrants to purchase up to ~5M shares of stock.
- Net proceeds will fund general corporate purposes, including working capital, capex and R&D. Closing date is March 14.
Fri, Jan. 15, 7:33 AM
- In a regulatory filing, StemCells (NASDAQ:STEM) discloses that it has promoted President & COO Dr. Ian Massey to President & CEO succeeding Martin McGlynn, who will resign effective January 17. Dr. Massey, who has been with the firm since March 2015, joined the company from BioTie Therapies where he was COO and President of U.S. Operations.
Dec. 23, 2015, 10:26 AM
- Buoyed by encouraging clinical results, StemCells (STEM -11.3%) announces a strategic realignment to fully focus its resources on its proprietary HuCNS-SC platform for the treatment of spinal cord injury (SCI).
- The plan, expected to trim $20M in costs over the next two years, includes the suspension of the Phase 2 Radiant study in geographic atrophy of age-related macular degeneration while the company seeks a development partner. It also includes a 25% workforce reduction that will be completed by the end of January. StemCells will book a $400K charge in Q1 for one-time employee termination costs.
- The freed-up funds will allow it to accelerate the completion of the ongoing Phase 2 Pathway Study and the commencement of a Phase 3 trial in SCI.
Nov. 18, 2015, 4:55 PM
- In a webcast this afternoon, StemCells (NASDAQ:STEM) presented six-month interim results from the first cohort in its Phase 2 proof-of-concept Pathway Study evaluating its HuCNS-SC platform (purified human neural stem cells) in cervical spinal cord injury, an open-label dose escalation arm used to determine the cell dose for the second cohort of the trial. Final results from this cohort are expected in Q2 2016.
- Dose escalation from 15M to 30M to 40M cells. Dose of 40M cells was well tolerated and will be the dose for the second cohort. Safety profile is acceptable. Five of six patients in the first cohort showed improved upper extremity muscle strength and four showed improved function in dexterity.
- The second cohort, expected to be 40 participants with complete loss of motor function below the point of injury, will be a randomized, single-blind study statistically powered to show efficacy. Final results from the study are expected in 2017.
- Shares are up 19% after hours on robust volume.
Nov. 2, 2015, 4:40 PM
- StemCells (NASDAQ:STEM): Q3 EPS of -$0.09 in-line.
- Revenue of $37K (-54.9% Y/Y)
Aug. 6, 2015, 4:41 PM
- StemCells (NASDAQ:STEM): Q2 EPS of -$0.08 beats by $0.01.
- Revenue of $0.03M (+50.0% Y/Y) in-line.
- Shares -2.62%.
Jul. 20, 2015, 10:37 AM
- The first geographic atrophy (GA) patient has been transplanted with StemCells' (STEM +2%) proprietary HuCNS-SC neural stem cells in its Phase 2 clinical trial in dry age-related macular degeneration. GA is the most advanced form of the condition.
- The primary endpoint of the 63-subject proof-of-concept study, called RADIANT, is the change in GA area as measured by fundus autofluorescence at month 12. The estimated completion date of the trial is December 2017.
- Age-related macular degeneration is characterized by the loss of photoreceptors (rods and cones) from the central part of the retina (macula). It typically manifests in older people and is the leading cause of severe vision loss and legal blindness in adults over the age of 55.
StemCells, Inc. engages in the research, development and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The company is focused on developing and commercializing stem and progenitor cells as the basis for novel therapeutics and therapies;... More
Country: United States
Other News & PR