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Neuralstem Inc.


Neuralstem Inc. is focused on developing and commercializing treatments for central nervous system diseases based on transplanting human neural stem cells and small molecule drugs. The company has developed and maintains a portfolio of patents and patent applications that form the base of its research and development efforts in neural stem cell research, small molecule research and related technologies. Neuralstem has also developed and patented a series of small molecule compounds (low molecular weight organic compounds) that can efficiently cross the blood/brain barrier.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Jason Napodano, Seeking Alpha (10/15/14) "For the purpose of our financial model, we assume that if Neuralstem Inc.'s NSI-566 works, regardless of the entry criteria for the Phase 1 trial, neurosurgeons will use it in all patients and all areas of injury. . .as for the price of the surgery, we believe $150K is realistic. . .if we apply these data in a detailed epidemiology and pricing model, with 5% U.S. market share, NSI-566 is a potential $500M drug."

Reni Benjamin, H.C. Wainwright & Co. (10/13/14) "Last Thursday, Neuralstem Inc. announced that the first of four chronic spinal cord injury patients in a Phase 1 trial of NSI-566 was recently treated at the University of California, San Diego School of Medicine. . .we view the forward progress of the trial as welcome news for investors; it marks a foray into an indication area with a potentially addressable patient population nearly 10 times that of amyotrophic lateral sclerosis."

Ram Selvaraju, Aegis Capital (10/9/14) "This morning, Neuralstem Inc. announced that the first patient was treated last week in the firm's Phase 1 trial testing NSI-566. . .we are encouraged to see the initiation of this important clinical program, and believe that preclinical evidence of NSI-566 therapeutic efficacy is particularly strong in the context of spinal cord injury."

Reni Benjamin, H.C. Wainwright & Co. (9/23/14) "Dr. Glass of Emory University presented positive long-term follow-up data of a subset of patients from the Phase 1 trial of NSI-566 testing Neuralstem Inc.'s human neural stem cells in Amyotrophic Lateral Sclerosis (ALS). . .together, the data continue to suggest that NSI-566 treatment can slow the progression of the disease for over three years in ambulatory patients given bilateral injections of NSI-566 cells in the lumbar and cervical spine. . .if the above results are successfully replicated in the ongoing Phase 2 trial in ALS, we believe NSI-566 could represent a treatment capable of producing long lasting and durable responses in this progressive and invariably fatal neurological disease."

Larry Smith, SmithOnStocks (9/23/14) "The key investigators for the treatment of amyotrophic lateral sclerosis (ALS) with Neuralstem Inc.'s NSI-566 neural stem cells have been extremely positive in public statements; they are Dr. Eva Feldman, the lead investigator for the trial, and Dr. Jonathan Glass. Feldman is professor of medicine at the University of Michigan Health Care System and past president of the American Neurological Association; Glass is director of the Emory ALS Center at Emory University."

more comments

Reni Benjamin, H.C. Wainwright & Co. (9/8/14) "We are initiating coverage on Neuralstem Inc. . .the major investment pros are: a lead product that potentially addresses unmet global medical needs, orphan drug status in amyotrophic lateral sclerosis, a pipeline with multiple products in various stages of early clinical development and an excellent safety profile based on multiple Phase 1 and 2 studies."

The Life Sciences Report Interview with Raghuram Selvaraju (8/13/14) "Neuralstem Inc. has been in the process of running a Phase 2 proof-of-concept study in amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease. It's an orphan disease. There is no effective therapy, and after diagnosis, patients typically die within three to six years.

Neuralstem's stem cell-based solution, NSI-566 (human fetal spinal cord-derived stem cells), has been widely anticipated. The Phase 1/2 data, published in the peer-reviewed journal Annals of Neurology, showed anecdotal evidence of efficacy, which was encouraging. If these Phase 2 data, expected from all cohorts in early 2015, show signs of the same kind of efficacy, that would go a long way toward convincing the FDA that NSI-566 should receive breakthrough therapy designation. NSI-566 could then be fast-tracked toward approval. . ." More >

Ram Selvaraju, Aegis Capital (8/8/14) "Neuralstem Inc. reported financial results for Q2/14, ending the period with $30.2M in cash. We expect this to be sufficient to fund operations through 2015. . .the company essentially delivered an in line quarter."

Jason Napodano, Zacks Small-Cap Research (8/8/14) "Neuralstem Inc. exited Q2/14 ending June 30, 2014 with $30.2M in cash and investments. Based on the current quarterly burn rate, less debt repayments, we believe this is enough cash to fund operations into the middle of 2016." -Zacks Small-Cap Research

Ram Selvaraju, Aegis Capital (8/4/14) "This morning, Neuralstem Inc. announced that the final patient had been treated in its Phase 2 study of NSI-566, a novel stem cell-based therapeutic agent, assessing individuals with amyotrophic lateral sclerosis. . .the trial will continue until six months past the final surgery, at which point the data will be evaluated. In anticipation of favorable efficacy results from this Phase 2 trial of NSI-566, we reiterate our Buy rating and 12-month price target of $7/share."

Jason Napodano, Zacks Small-Cap Research (6/25/14) "Data from Neuralstem Inc.'s Phase 1b, randomized, double-blind, placebo-controlled, multiple-dose escalation study evaluating the effects of NSI-189 in patients with major depressive disorder was presented via an oral presentation and poster at two major neuropharmacology meetings earlier this month. . .in terms of a Phase 1b study, [data] looks very good. Safety was confirmed and there are clear trends toward efficacy. . .we continue to be optimistic on the future of Neuralstem."

Ram Selvaraju, Aegis Capital (6/25/14) "We are raising our price objective on Neuralstem Inc. in the wake of favorable safety and efficacy data. . .these data validate the company's hypothesis that NSI-189 has activity as both a cognitive function enhancer and an antidepressant. . .we reiterate our Buy rating and raise our 12-month price target from $6 to $7/per share."

Ram Selvaraju, Aegis Capital (5/27/14) "Neuralstem Inc.'s proprietary small molecule drug candidate, NSI-189, performed favorably in a Phase 1b trial that enrolled individuals suffering from major depression, showing no serious adverse events and provoking clinically meaningful changes in validated outcome measures of efficacy, including in particular the Montgomery-Asberg depression rating scale and the symptoms of depression questionnaire. In the wake of this positive data, and in anticipation of favorable efficacy results from the ongoing Phase 2 trial of NSI-566, Neuralstem's proprietary stem cell-based therapeutic product, in ALS patients, we reiterate our Buy rating and raise our 12-month price target from $4.50 to $6/share."

The Life Sciences Report Interview with Raghuram Selvaraju (4/22/14) "In the case of Neuralstem Inc., we've seen the company go from strength to strength. It has put out a great deal of favorable preclinical data recently in animal models. The company plans to begin dosing in a Phase 1/2 study assessing its proprietary NSI-566 (human fetal spinal cord-derived stem cells) in the context of spinal cord injury (SCI), an indication in which it recently received formal clearance from the FDA to begin treating patients. It has a Phase 2 study ongoing with NSI-566 in amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, which is slated to wrap up patient dosing about the middle of this year, and could potentially report initial efficacy data late in H2/14. . . if this drug is able to regenerate patients' ability to breathe, clearly that would be grounds for accelerated approval—and that would obviously be grounds for a substantial influx of interest in Neuralstem's stock. . .

The initiation of patient dosing in spinal cord injury is a very substantial matter, since spinal cord injury is a complete greenfield opportunity. Nothing currently approved does anything meaningful for these patients. Any impact from the Phase 2 ALS study would be grounds for the company to go to the FDA and ask for accelerated approval, conditional or otherwise." More >

Jason Napodano, Seeking Alpha (4/21/14) "Recently published data on Neuralstem Inc.'s NSI-566 from a Phase 1 study [in amyotrophic lateral sclerosis (ALS)] demonstrates clear signs of efficacy in a select patient population. . .we believe NSI-566 is a $2+ billion drug in ALS. . .all eyes have now turned to the ongoing Phase 2 study. . .preclinical data testing NSI-566 in spinal cord injury (SCI) is encouraging, and although the Phase 1 trial has yet to even enroll one patient, we view this as another incremental $500M to $2B+ global opportunity. . .NSI-566 in ALS and SCI alone make Neuralstem an attractive investment."

Larry Smith, Smith on Stocks (3/17/14) "The final results of the phase 1 trial of Neuralstem Inc.'s NSI-566 spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) were just published in the peer-reviewed journal Annals of Neurology. The market has responded very positively to the data with the stock up about 15% to $4.48. . .I see the commercial opportunity for the NSI-566 spinal cord stem cells as being extraordinary if they are successful in phase 3 trials."

Jason Napodano, Zacks Small-Cap Research (3/11/14) "Neuralstem Inc. recently reported financial results for Q4/13 and FY/13. The company continues on track with development of its lead compounds and has raised significant amounts of cash recently to shore up the balance sheet as it moves these drugs forward in the clinic. We continue to be positive on the Neuralstem story, especially with the recent financing deals that includes a $20M."

J. Kenser, Seeking Alpha (2/28/14) "Neuralstem Inc.'s phase 1 intraspinal cord injections of neural stem cells has shown remarkable early results. . .we now have positive confirmation that the company's phase 2 trial is showing some early positive results as well. . .overall, I believe that the reward that it offers to investors here far outweighs the risk."

Jason Napodano, Seeking Alpha (2/17/14) "The overall conclusion of Neuralstem Inc.'s phase 1 study of NSI-566 in amyotrophic lateral sclerosis is that human spinal cord stem cells can be safely transplanted into both lumbar and cervical spinal cord segments and there appears to be preliminary evidence of stem cell biological activity in some of the patients. . .there is a lot to be encouraged by from the data collected in the phase 1 trial."

Josh Levine, MicroCap Investor (2/6/14) "Neuralstem Inc.'s CEO Richard Garr will present clinical updates on several of the company's ongoing programs next Tuesday (Feb. 11) at the 16th Annual BIO CEO & Investor Conference 2014. . .these and other events and news in the near term will serve as catalysts and likely drive the share price higher. If you don't yet own Neuralstem or are considering adding to your position, it is an opportune time."

JMY Investments, Seeking Alpha (1/31/14) "Neuralstem Inc.'s phase 2 trial for amyotrophic lateral sclerosis (ALS) started in September 2013. The phase 1 safety trial revealed strong signs of efficacy in some of the patients. . .U.S. Food and Drug Administration breakthrough status is the latest buzzword thrown around with a number of biotechs these days, but I truly believe the company's ALS therapy has a strong chance of obtaining it."

Larry Smith, Seeking Alpha (1/28/14) "Neuralstem Inc.'s clinical trial programs and accompanying results for its two key drugs, the neural stem cell product NSI-566 and its small molecule drug NSI-189, are picking up a good deal of momentum. This year holds the promise for several events that could meaningfully impact the stock. . .Neuralstem has applied for breakthrough drug status for NSI-566 from the FDA; if this is approved it could provide significant validation of the use of NSI-566 in ALS. . .I don't know whether FDA will give NSI-566 this designation. . .but we should know one way or another in 2014."

Jason Napodano, Zacks Small-Cap Research (1/22/14) "Neuralstem Inc. is firing on all cylinders in terms of both moving the product candidates forward in clinical trials and executing on its business model. . .earlier in the year, the company was able to secure $20M in a registered direct offering with a small group of institutional investors. It was an impressive transaction because Neuralstem closed the deal without having to solicit interest via a public offering (meaning no calling around asking for money) and the shares were placed into all institutional accounts (no retail accounts or brokers involved). Really good stuff!"

Larry Smith, Smith on Stocks (1/8/14) "There are lots of events that can move Neuralstem Inc.'s stock in 2014, and my base case is that this will create a great deal of interest and excitement. . .based on fully diluted shares of 119.2M and the current price of $3.30, the current market capitalization is $393M. I think that there is room for expansion if the news flow is positive, as I think it will be."

Red Bull, Seeking Alpha (1/6/14) "We believe Neuralstem Inc. has potential to continue to accumulate rapid gains for investors as the amyotrophic lateral sclerosis (ALS) trials move closer to producing data. If the company indeed has a treatment for a multibillion dollar market, the recent stock offering should be welcome by investors because those funds can help it position itself as the only significant player in a very large ALS market and further develop one of the most exciting pipelines in the biotech sector."

Jason Napodano, Seeking Alpha (12/26/13) "We believe Neuralstem Inc. has a number of catalysts on the near-term horizon that will drive the shares significantly higher. These include: 1.) Initial top-line data from the first and second cohorts of the phase 2 amyotrophic lateral sclerosis (ALS) trial in Q1/14, 2.) Completing patient enrollment and procedures in the phase 2 ALS trial by the end of the first quarter 2014, 3.) Filing an investigational new drug application to begin the phase 2 ALS trial in Mexico, 4.) Enroll the first patient in the phase 1 spinal cord injury trial in early 2014 and 5.) Phase 1b data from small molecule NSI-189 in the next few weeks. But the biggest catalyst for the company is the potential for the FDA to award the new breakthrough therapy designation (BTD) to NSI-566. . .we believe Neuralstem will seek BTD on NSI-566 and be granted the designation during the second half of the year."

The Life Sciences Report Interview with Reni Benjamin (12/12/13) "A company we believe is making significant strides in the regenerative medicine space is Neuralstem Inc. The company is in a phase 2 trial for Lou Gehrig's disease (amyotrophic lateral sclerosis/ALS). Some very promising anecdotal evidence has been reported from patients participating in the trial. Several universities are currently involved in the study, including Emory University, and we believe the readout for the ongoing trial could generate some significant interest for the company in 2014." More >

Carl Cachia, Seeking Alpha (12/8/13) "Neuralstem Inc. is my favorite biotech going into 2014. . .I expect multiyear highs in 2014 as results of the study continue to be presented. . .the company has grown significantly in 2013 and I believe the future is even more exciting. . .it has very strong cash position. . .the $16M cash on hand will be enough to cover expenses for the next two years."

Ram Selvaraju, Aegis Capital (11/25/13) "Neuralstem Inc. is entering a critical period in its history, with potentially imminent initiation of dosing in a proof-of-concept phase 1/2 trial of its lead stem cell-based therapeutic product candidate, NSI-566, in spinal cord injury. We also note that the company is slated to report data from the phase 1b trial of its small molecule agent, NSI-189, within the coming weeks. . .in anticipation of these clinical catalysts, we reiterate our Buy rating and raise our 12-month price target from $4 to $4.50/share."

Jason Kolbert, Maxim Group (11/18/13) "Neuralstem Inc. is also using allogeneic fetal neural stem cells in a phase 1/2 trial in China, which the company now expects to commence in Q4/13."

Smith on Stocks, Seeking Alpha (9/19/13) "Neuralstem Inc.'s stock has appreciated significantly over the past year and has been extremely strong in the month of September. . .the announcement that the first patient had been dosed in the phase 2 study on Sept. 10 was an important event. . .there are several other phase 1 trials that are about to begin or are in the planning stage in which the same neural stem cells will be transplanted. . .the primary goal of phase 2 trial is identify the maximum safely tolerated dose. The company hopes to transplant all of the patients in the trial by the completion of Q2/14."

Red Bull, Seeking Alpha (9/9/13) "Neuralstem Inc. is working on breakthrough stem cell treatments that would give it access to billion dollar markets, perhaps sooner than many anticipate. The highlight. . .is NSI-566 being tested for ALS patients who have already started in phase 2 trials, though the company has not yet announced this important milestone to the public. . .Neuralstem has been granted orphan drug status by the FDA for the treatment of ALS with its human spinal cord derived neural stem cells (NSI-566). . .I anticipate Neuralstem to gain momentum for the remainder of 2013 and to demonstrate gains in the coming months."

Stock Investor, Seeking Alpha (9/8/13) "Neuralstem Inc. continues to roll out positive news on its spinal cord pipeline; it also has a possible funding deal coming funded by the National Football League. Developments on these could help the stock move nicely higher in the coming year."

The Life Sciences Report Interview with Michael Berry (8/22/13) "Neuralstem now has tenbagger discovery potential. The company is advancing on several stem cell fronts. There seem to be indications of efficacy and safety of the company's therapies in several applications, including ALS, ischemic and chronic stroke, and possibly major depressive disorder. These quality-of-life markets are huge, multibillion-dollar and global, and Neuralstem has little or no competition in these markets at present. The company has clinical research studies underway in China and Korea, and may move aggressively into Mexico.

"Neuralstem has two stem cell therapies, NSI-189 (in a phase 1 trial for major depressive disorder) and NSI 566. It has patented NSI-566 for regenerative treatment of ALS. The original research base has spawned such a powerful array of therapeutic approaches that larger pharmas will certainly begin to take the company seriously once its clinical trials advance further. . .if management can carry off the huge clinical trial load, then Neuralstem is a much more valuable wealth creator. The company is clearly a mature discovery investment. We own it. It ranked highly on all 10 factors in our Discovery software. The company is well underway to derisking its stem cell technologies and we would be buyers on any market weakness. Finally, there are lots of catalysts in the near future for Neuralstem investors." More >

Ram Selvaraju, Aegis Capital (8/16/13) "Neuralstem Inc. reported financial results for Q2/13. The firm closed the quarter with $11.2M in cash and equivalents, which we anticipate to be sufficient to fund operations well into 2014. . .the company is expected to begin dosing of its proprietary neural stem cell line therapeutic, NSI-566, in a phase 2 trial enrolling patients with amyotrophic lateral sclerosis. . .this could represent a substantial value driver in the future if NSI-566 is able to demonstrate meaningful clinical benefit. . .Neuralstem should start dosing with NSI-566 in a proof-of-concept spinal cord injury trial within the next couple of months as well."

Jason Napodano, Seeking Alpha (8/12/13) "We continue to be optimistic on the Neuralstem Inc. story; NSI-566 is currently being studied in amyotrophic lateral sclerosis, spinal cord injury and ischemic stroke, all significant unmet medical needs and enormous market opportunities. The company is well funded with several clinical catalysts on the horizon for NSI-566 and NSI-189."

The Life Sciences Report Interview with Jason Napodano (8/1/13) "Everybody knows Neuralstem Inc. as the company treating amyotrophic lateral sclerosis (ALS) patients with neural stem cells, directly injecting them into the spinal cord. It has just gotten an approval to use those same exact cells in a spinal cord injury trial. The lesser known part of the story is Neuralstem's phase 1 small molecule program with NSI-189, which is addressing a completely new mechanism of action for depression and other neurological disorders. What excites me is that new discoveries of mechanisms of action and new targets for central nervous system (CNS) disease don't come around very often. The fact that the company is working on something new in CNS, and also has interesting animal data with preclinical proof of concept, leads me to believe that if Neuralstem can show that this molecule is safe and if there are some signs of efficacy, there is going to be a lot of interest from big pharma. I don't want to oversell this, but if this NSI-189 molecule hits, it could be a tenbagger for the company." More >

The Life Sciences Report Interview with Ram Selvaraju (7/18/13) "We continue to like Neuralstem Inc., the only company we cover in the stem cell space that is focused on the neurodegenerative disease domain. We like it because of the company's high-quality science. Neuralstem is developing two different programs simultaneously. One is a neural stem cell-based solution called NSI-566 (human fetal neural tissue-derived stem cells), for the treatment of various neurodegenerative diseases, particularly amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). ALS is relatively rare but is incurable; patients usually die within 3–5 years of diagnosis. The company is also going after spinal cord injury (SCI), which is a significant unmet need. Millions of people are living in the U.S. with SCI, or are chronically paralyzed. There are no available, effective therapies currently. Neuralstem has other possible indications with this technology as well.

"Neuralstem also has a small molecule, NSI-189, which is aimed at the treatment of major depression. This small molecule is very interesting because it could have the ability to enhance cognitive performance in non-depressed or healthy people. Animal studies have shown that this drug selectively enhances neurogenesis in the hippocampus, which is the part of the brain used for learning and memory. For all these reasons we believe Neuralstem is very interesting, with a rich calendar of catalysts over the remainder of 2013 and into H1/14. It is moving into phase 2b for ALS with the neural stem cell solution. We anticipate that study will begin in the U.S. in H2/13. It is also starting a phase 2a clinical study in the same indication in Mexico. We anticipate that the company will start a phase 1/2 study in SCI in the U.S. imminently. . .we believe Neuralstem is one of the best stories in the stem cell arena. It's appealing because it has been able to generate attractive, promising, scientific and preclinical data even while focusing on very difficult-to-treat neurodegenerative conditions. . .it is very undervalued, and we think there is significant upside potential." More >

Josh Levine, MicroCap Investor (6/20/13) "Neuralstem Inc.'s upcoming phase 2 trial is expected to take place at three centers: Emory, Michigan and Massachusetts General. . .importantly, the U.S. Food and Drug Administration has approved a trial designed to considerably increase both the dose escalation throughout the trial and the pace of the treatments. . .the company hopes to complete the phase 2 trial in just 18 months at multiple world class centers. That's momentum, folks."

Jason Napodano, Seeking Alpha (6/19/13) "Most investors know Neuralstem Inc. as a leader in cell therapy and regenerative medicine. . .management has noted being in partnership discussions with interested parties on NSI-189, with a goal of closing a deal after the data have been released. We expect that upfront payment from such a deal, along with milestones on the development of NSI-189 will help fund the next wave of clinical studies with HSSC therapy NSI-566 ALS or SCI: This is a unique opportunity that many of Neuralstem's competitors are lacking—the ability to self-fund a potentially revolutionary breakthrough in stem cell technology through the advancement of a traditional small molecule platform. In our eyes, that makes Neuralstem an intriguing long-term investment."

Jason Napodano, PropThink (5/30/13) "Neuralstem Inc. announced the publication of preclinical data in the journal of Stem Cell Research & Therapy, demonstrating that rats transplanted with its spinal cord derived human neural stem cells, NSI-566, three days after a spinal cord injury at lumbar 3, showed improvement along several measures of motor function and a reduction of spasticity. . .simply based on the size of the market, the lack of any real breakthroughs in treatment for patients with chronic injury and the ability to command premium pricing, a product like NSI-566 has billion dollar potential in spinal cord injury alone."

Brian Wilson, Seeking Alpha (5/22/13) "Neuralstem Inc. has been in a strong uptrend since the company finally received approval from the FDA on April 17 to commence a phase 2 clinical trial in 18 patients with ALS using its line of spinal-cord derived stem cells NSI-566; these proprietary stem cells can be differentiated into neurons, which can (in theory) replace the dying cells in a patient with a neurodegenerative disease. . .the upcoming phase 2 trial. . .should be watched closely since it will demonstrate. . .whether or not the company can replicate the implied efficacy in the phase 1 studies with NSI-566."

Larry Smith, Seeking Alpha (5/21/13) "An encouraging update on the phase 1 trial of Neuralstem Inc.'s neural stem cells in ALS was just presented. . .the these results are an extremely encouraging signal of efficacy. . .I just don't think these results can be ignored. I think that this is going to create a buzz in the ALS community and I also think it will create a buzz in the investment community."

Ram Selvaraju, Aegis Capital (5/20/13) "In the coming months, Neuralstem Inc. is expected to begin dosing of its proprietary neural stem cell line therapeutic, NSI-566, in a phase 2 trial enrolling patients with amyotrophic lateral sclerosis (ALS). . .this is a significant step forward for the company and could represent a substantial value driver in the future if NSI-566 is able to demonstrate meaningful clinical benefit in the ALS patients to be enrolled in this study."

Jason Napodano, Zacks Investment Research (5/13/13) "We continue to be optimistic on the Neuralstem Inc. story; NSI-566 is currently being studied in amyotrophic lateral sclerosis, spinal cord injury and ischemic stroke, all significant unmet medical needs and enormous market opportunities. The company is well-funded, with several clinical catalysts on the horizon for NSI-566 and NSI-189; our rating is Outperform with a $2.50 price target." -Zacks Investment Research

Larry Smith, Seeking Alpha (5/7/13) "I am continuing to recommend purchase of Neuralstem Inc. The company has completed its first trial in humans, a 15-patient phase 1 trial in amyotrophic lateral sclerosis. Results of this trial have indicated that the surgical procedure used to implant the cells and the cells themselves are safe, which is the critical first step."

Ram Selvaraju, Aegis Capital (4/17/13) "Neuralstem Inc. received approval from the FDA to begin phase 2 testing of its neural stem cell line therapeutic, designated NSI-566, in patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. . .this is a significant step forward for the company and could represent a substantial value driver in the future if NSI-566 is able to demonstrate meaningful clinical benefit. . .as a result of the excellent safety and tolerability demonstrated in phase 1 testing, Neuralstem will now be able to proceed more aggressively in phase 2 development."

Jason Napodano, Zacks Small-Cap Research (3/15/13) "We continue to be positive on the Neuralstem Inc. story. We believe the company's dual-technology platform focused on cell therapy and traditional pharmaceutical products provides investors with the best of both worlds: An early-stage investment in a potentially revolutionary pipeline in regenerative medicine and an attractive and undervalued small-molecule pipeline we think is sure to attract interest from larger pharmaceutical partners given the novel mechanism of action and broad application potential into multiple indications."

The Life Sciences Report interview with Ram Selvaraju (2/14/13) "Neuralstem Inc. has gone from strength to strength recently. It had a phenomenal year in 2012. One of the watershed events for the company was the publication of a landmark Cell paper discussing its technology platform and its lead cell therapy candidate, NSI-566 (human spinal cord stem cells), which demonstrated the ability to completely regrow damaged spinal cords in rats. This has never been seen before. On top of that, the company reported additional safety and anecdotal efficacy data from an ongoing phase 1/2 study in amyotrophic lateral sclerosis (ALS), which it is also addressing with its NSI-566 cell line. ALS is a massive unmet need. . .if Neuralstem's cells turn out to have even a minor impact on functional independence or motor function in the context of ALS patients, it could very easily be fast-tracked toward approval, even if the patient data set is relatively small. The company finished an 18-patient phase 1/2 study in ALS, and now it wants to go to the FDA and potentially get approval to start a pivotal phase 3 study with 50–60 patients. Potentially, this trial could kick off well before the end of this year.

"Finally, and perhaps most exciting, is that the company announced on Jan. 14 that it had received approval from the FDA to begin a phase 1 trial using its NSI-566 cells in the context of spinal cord injury. . .it is very encouraging that the FDA gave Neuralstem such timely approval to start this trial. The company could potentially generate efficacy data in spinal cord injury by the end of this year. If that turns out to be successful, we think Neuralstem could apply for rapid access to the market because there is currently nothing out there to help spinal cord injury patients." More >

Ram Selvaraju, Aegis Capital (1/14/13) "Neuralstem Inc. has received FDA approval to move into spinal cord injury (SCI); we are raising our 12-month price target from $3.50 to $4/share. . .we believe that, if there is any improvement in patients given cervical injections, NSI-566 could rapidly progress into phase 2 testing and could eventually be fast-tracked toward approval in ALS. . .the FDA has given its approval for Neuralstem to begin a study in eight chronic SCI patients, 1–2 years post-injury, who have injuries at the thoracic level of the spinal cord. . .Neuralstem could obtain a fast-tracked approval for the stem cells it is implanting if more than one of the patients enrolled in the chronic SCI trial shows significant functional improvement."

The Life Sciences Report Interview with Josh Levine (1/3/13) "Neuralstem Inc. has a very compelling technology platform. The company is in the stem cells space, but unlike other stem cell companies it has a unique approach in a number of ways. One important thing I'll say right away is that Neuralstem gets over the ethical barrier because it has created an entire bank of proprietary neural stem cells by isolating stem cells from the brains and spinal cords of aborted fetuses. Based on its successful phase 1 trial for amyotrophic lateral sclerosis (ALS), the company's hope is that cells injected into the spinal cords of patients will provide support, perhaps by releasing growth factors, and prevent motor neurons from dying. . .if it can halt ALS in its tracks or slow it down, it would be an enormous success." More >

The Life Sciences Report Interview with Jason Napodano (12/13/12) "Neuralstem Inc. is very interesting because it is trying to do something that's never been done before. That is what attracted me to the stock. It's still early stage compared to most of what we go after at Zacks. It has two phase 1 assets, which tend to be too early in development for investors, but the company was worth digging into and initiating coverage on. Neuralstem is taking human neuronal stem cells and injecting them directly into the spinal cord to improve outcomes in patients with amyotrophic lateral sclerosis (ALS), a highly debilitating and always fatal disease for which there is no cure.

The phase 1 study is, of course, primarily about safety, but the data generated so far represents a pretty big milestone because no one has ever done this kind of work before. Just the fact that the company has developed a device and system to perform that procedure safely creates a platform for additional applications in the future, potentially in multiple sclerosis (MS) and spinal cord injury. We know it is still very early stage, but it is interesting. If Neuralstem can develop a therapy for ALS, it would be sitting on a blockbuster." More >

Ram Selvaraju, Aegis Capital (12/10/12) "We have been encouraged by Neuralstem Inc.'s recent progress in the clinical development of both its stem cell platform, designated NSI-566, and its small molecule program, designated NSI-189. Complete phase 1/2 data from the company's amyotrophic lateral sclerosis study of its proprietary stem cells is expected to be available in February 2013. . .Neuralstem is slated to complete dosing in a phase 1 study of NSI-189 by the end of 2012 and report results in Q1/13; in anticipation of these upcoming catalysts, we reiterate our Buy rating."

The Life Sciences Report Interview with Michael Berry (11/20/12) "Neuralstem Inc. has had quite a bit of success. I've been with this company for six or seven years. It has a bank of stem cells that it created from a single source. It has teamed up with foremost stem cell researcher Dr. Eva Feldman, a neurologist from the University of Michigan Medical School. The company has been transplanting stem cells to deal with a number of conditions—from ischemic paraplegia to chronic stroke to spinal cord injuries, like those we see in football and other sports. More recently, the company has had pretty good success in the clinic at Emory University on ALS (Lou Gehrig's disease). . .it has made significant strides over the past few months." More >

The Life Sciences Report Interview with Raghuram Selvaraju (11/1/12) "This little company, Neuralstem Inc., was demonstrating that implantation of its neural stem cells into a rat's spinal cord could generate axonal tracts—nerve fibers—along the entire length of the spinal cord, from head to tail. Before implantation, the spinal cords of these animals had been completely severed through a crush operation. When the company showed me these results, I was extremely impressed. . .the science underlying Neuralstem, in my opinion, is truly world class. . .I believe it is a worthwhile investment opportunity for the risk-tolerant biotech investor. The science is of high quality. . .
The company also has a potential ace up its sleeve. Its small molecule program focuses on disease indications that are less chronic in nature and in which activity could be observed in a much shorter period of time. Its lead small molecule candidate, NSI-189, is being developed for treatment of major depressive disorder. We could see efficacy data early next year. In the future, we could see the molecule being applied to enhancement of cognitive function in healthy people." More >

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