Neuralstem Wins Patent Infringement Case Vs. StemCell, Inc.; Moves Forward In Spinal Cord Injury
Jason Napodano, CFA • 34 Comments
Jason Napodano, CFA • 34 Comments
Wed, Nov. 30, 4:16 PM| Wed, Nov. 30, 4:16 PM | 13 Comments
Tue, Nov. 8, 7:39 AM
Thu, Aug. 11, 4:44 PM
Fri, May 20, 9:07 AM
- With the aim reducing operating expenses while advancing NSI-189 in major depressive disorder (MDD) and pursuing collaborations for NSI-566, Neuralstem (NASDAQ:CUR) cuts its workforce by an undisclosed amount.
- As of March 31, the company had $7.6M in quick assets. Operations consumed ~$3.5M in cash in Q1 so the runway is short.
Thu, May 12, 10:43 AM
- Neuralstem's (CUR -2.2%) Phase 2 study of NSI-189 in patients with major depressive disorder (MDD) is now underway. The primary endpoint of the 220-subject trial is the effect on depression as measured by the Montgomery-Asberg Depression Rating Scale over a 12-week period. Top-line results should be available in H2 2017.
- Results from a 24-subject Phase 1b study were mixed. The treatment group met one efficacy endpoint but fell short on another.
- According to the company, small molecule NSI-189 stimulates neurogenesis, synaptogenesis and increases hippocampal volume, all of which play a role in reversing depression, enhancing cognition and promoting the growth of new nerve tissue.
- Previously: Neuralstem off 26% after JPM16 presentation fails to excite investors (Jan. 13)
Mon, May 9, 8:19 AM
- Neuralstem (NASDAQ:CUR): Q1 EPS of -$0.07 misses by $0.01.
- Revenue of $2.5K (-14.4% Y/Y)
Mon, May 2, 4:13 PM
- Thinly traded nano cap Neuralstem (NASDAQ:CUR) slumps 15% after hours on increased volume in response to its announcement that it intends to execute a public offering of common stock and warrants. Prices, volumes and terms have yet to be announced.
- Update: The offering is 20M shares of common stock at $0.40 per share and five-year, immediately exercisable warrants to purchase 20M shares of common at $0.40. The stock and warrants are immediately separable and will be issued separately. Closing date is May 6. Net proceeds will fund regulatory, preclinical and clinical activities and general corporate purposes. Shares are down 40% premarket.
Mon, Mar. 14, 4:29 PM
- Neuralstem (NASDAQ:CUR): FY15 EPS of -$0.23 beats by $0.02.
- Revenue of $0.01M (-50.0% Y/Y) in-line.
Tue, Feb. 16, 1:05 PM
- Neuralstem (CUR +14.5%) appoints Richard Daly as President & CEO effective February 15, succeeding co-founder Richard Garr, J.D., who will continue to serve on the board.
- Mr. Daly joins the company from healthcare commercial performance acceleration firm Ravine Rock Partners, LLC, where he was Managing Director.
Wed, Jan. 13, 1:37 PM
- Thinly traded nano cap Neuralstem (CUR -25.5%) slumps on more than triple normal volume in apparent response to the company's presentation yesterday at JPM16 that highlighted small molecule NSI-189, under development for the treatment of major depressive disorder (MDD).
- Results from a small 24-subject Phase 1b study showed a treatment effect across three dose cohorts (40 mg once/day, 2x/day and 3x/day). Patients were treated for 28 days and then followed for up to 84 days. The combined treatment group showed a statistically significant improvement versus placebo in one metric, Symptoms of Depression Questionnaire at Day 28 (p=0.02) and Day 84 (p=0.03), but fell short on another, the Montgomery and Asberg Depression Rating Scale (Day 28: p=0.09; Day 84: p=0.19). NSI-189's effect on cognitive function was also statistically better than placebo.
- The company intends to start a Phase 2 study in MDD shortly. Results will not be available, though, until H2 2017.
Wed, Jan. 13, 12:43 PM
Nov. 9, 2015, 10:36 AM
- Neuralstem (CUR -0.9%) Q3 results: Revenues: $2.5K (-50.0%); R&D Expense: $3.4M (+61.9%); SG&A: $1.8M (-10.0%); Operating Loss: ($5.2M) (-26.8%); Net Loss: ($5.6M) (-24.4%); Loss Per Share: ($0.06) (-20.0%); Quick Assets: $18.1M (-34.2%).
- No guidance given.
Nov. 9, 2015, 9:22 AM
- Neuralstem (NASDAQ:CUR): Q3 EPS of -$0.06 beats by $0.01.
- Revenue of $2.5K (-50.0% Y/Y).
Sep. 29, 2015, 10:06 AM
- Phase 2 and combined Phase 1 and 2 data presented at the American Neurological Association Annual Meeting by the principal investigator of Neuralstem's (CUR -4.7%) NSI-566 in amyotrophic lateral sclerosis (ALS) patients showed that treatment with escalating doses of NSI-566 (maximum tolerated dose of 16M cells via 20 bilateral injections) did not "accelerate disease progression."
- The positive spin on the results continued with a calculation of the 95% confidence interval around the slopes of decline on ALSFRSr scores, forced vital capacity (FVC) and grip strength of the ProAct historical database subjects. Participants in the NSI-566 studies were then assessed whether they fell inside or outside the confidence intervals.
- 73% of the Phase 2 patients and 79% of the combined Phase 1&2 patients fell above the upper limit on ALSFRSr score. This means that most of the patients continued to deteriorate but not as rapidly as others.
- 50% of Phase 1&2 participants and 40% of the Phase 2 subjects fell above the upper limit on FVC. This also means that 50% and 60%, respectively, fell below the upper limit showing that the majority of patients continued to deteriorate unabated.
- 67% of the Phase 1&2 and 60% of the Phase 2 patients fell above the upper limit on grip strength control. Again, this shows that all patients continued to deteriorate, some not as rapidly as others.
- The company intends to advance NSI-566 to a registration-directed trial in 2016.
Aug. 10, 2015, 4:58 PM
- Neuralstem (NASDAQ:CUR): Q2 EPS of -$0.06 in-line.
Jul. 23, 2015, 9:15 AM