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Neuralstem Announces 2009 Financial Results, Provides Update

PRNewswire-FirstCall
ROCKVILLE, Md.
03/31/2010

Neuralstem, Inc. (NYSE Amex: CUR) today provided a financial and business update for the year ended December 31, 2009.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO )

"2009 was a pivotal year for Neuralstem as we made the transition into a clinical stage company," Neuralstem CEO and President, Richard Garr, stated. "The U.S. Food & Drug Administration approved the company's clinical trial to treat ALS (Amytrophic Lateral Sclerosis, or Lou Gehrig's disease) in September. The trial was approved by the Emory University Institutional Review Board in December, 2009, and the first patient dosed in January 2010."

Mr. Garr continued, "The company has also recently taken significant steps to strengthen our balance sheet. We have raised sufficient new capital to fund our research efforts through the first quarter 2011, and eliminated a large percent of certain long-term liabilities related to derivative accounting issues in warrants, which were exercised in the first quarter of 2010. "

  Business Highlights for 2009 and the Subsequent Weeks:
  --  In the first quarter of 2009, scientists at University Hospital
      Frieburg, Germany presented data at the Huntington's Disease
      Therapeutics Conference in France, entitled, 'Validation of Human
      Neural Stem Cell line in Rodent Model of Huntington's Disease,' which
      demonstrated robust survival of our cells, integration into the host
      brain, and early graft-mediated functional effect. This is a major
      milestone in the process of qualifying our cells into the hospital's
      existing human trial in Germany to treat Huntington's disease with our
      cells, as well as support our regulatory work in the U.S.
  --  In June, the company announced it received a notice of allowance from
      the U.S. Patent and Trademark Office (USPTO) for a patent on four new
      chemical entities that boost the generation of new neurons. Patent
      application 12/049,922, entitled "Use of Fused Nicotinamides to
      Promote Neurogenesis," claims four chemical entities and any
      pharmaceutical composition including them.  The compounds promote
      neurogenesis--the birth of new neurons in the adult brain. These four
      molecules with demonstrated neurogenic activity, are first-in-class
      compounds, were discovered entirely in-house and are owned by the
      company. These are the only drugs we are aware of with the
      demonstrated ability to stimulate neurogenesis of normal adult brain
      cells, which indicates that they are truly neurogenic.
  --  In September, the Company received notice of allowance from the United
      States Patent and Trademark Office (USPTO) for its patent entitled
      "Transplantation of Human Neural Cells for Treatment of
      Neurodegenerative Conditions," number 11/281,640.  The claims in this
      patent cover the manufacturing process of our future products from all
      regions of the human central nervous system (brain and spinal cord)
      through July of 2026."
  --  In September, the U.S. Food and Drug Administration (FDA) has approved
      Neuralstem's Investigational New Drug (IND) application to commence a
      Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou
      Gehrig's disease) with its spinal cord stem cells. Neuralstem is the
      first company to commence an FDA approved stem cell trial to treat
      ALS. The trial will study the safety of Neuralstem's cells and the
      surgical procedures and devices required for multiple injections of
      Neuralstem's cells directly into the grey matter of the spinal cord.
      The FDA's approval represents a significant step toward delivering
      regenerative medicine directly to damaged neural cells in humans. ALS
      affects roughly 30,000 people in the U.S., with about 7,000 new
      diagnoses per year. The clinical trial program is a major step toward
      achieving Neuralstem's goal of treating ALS, a fatal neurodegenerative
      disease for which currently there is no effective treatment or cure.
      While this trial aims to primarily establish safety and feasibility
      data in treating ALS patients, Neuralstem also hopes to be able to
      measure a slowing down of the ALS degenerative process. The trial will
      be administered by Dr. Eva L. Feldman, M.D., Ph.D., Director of the
      University of Michigan Health System ALS Clinic and the Program for
      Neurology Research & Discovery, and Dr. Jonathan Glass, Director of
      the Emory Neuromuscular Laboratory and Director of the Emory ALS
      Center.
  --  In December, the Phase I trial to treat Amyotrophic Lateral Sclerosis
      (ALS or Lou Gehrig's disease) with its spinal cord stem cells was
      approved by the Institutional Review Board (IRB) at Emory University
      in Atlanta, GA.
  --  In December, Neuralstem completed a $1.5 million private placement of
      646,551 common shares at $2.32, priced at a 30 percent premium over
      the market on the day of closing.
  --  In January, the first ALS patient was treated with our spinal cord
      stem cells the Emory ALS Center at Emory University, in Atlanta, GA. A
      total of up to 18 patients is planned to be treated in this first U.S.
      clinical trial to evaluate human neural stem cells for the treatment
      of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease).
  --  Neuralstem raised a total of $7.3 million since the beginning of the
      year from warrant exercises.
  --  In the first quarter, the Company converted, redeemed or modified more
      than 70% of the warrants outstanding at the beginning of the year
      which had price protection features. These changes removed the price
      protection features. In 2009 we were not able to account for these as
      equity and so treated as long term liabilities.  The Company expects
      these changes to significantly reduce its derivative liability.
  Results of Operations for the Year Ended December 31, 2009:
  --  The Company did not have revenues for the twelve months ended December
      31, 2009 and 2008, respectively.
  --  Net loss for 2009 was $10,364,363, or $0.30 per share, compared with a
      net loss of $11,830,798, or $0.37 per share, for 2008.  Net cash used
      in operating activities declined to $5,144,820 in 2009 from $6,860,039
      in 2008.
  --  Cash, cash equivalents and short term investments at December 31,
      2009, totaled $2,309,774, compared with $4,903,279 at December 31,
      2008. At March 16, 2010, the company had $7.8 million in cash.
  --  Research and development expenses for 2009 and 2008 were $5,346,904
      and $6,513,349, respectively. The decrease of $1,166,445 from 2008 to
      2009 was primarily attributable to the costs in 2008 of completing the
      application to the FDA to move our cell based products into clinical
      trials and a reduction in non-cash stock-based compensation expense.
  --  General and administrative expenses for 2009 and 2008 were $5,030,981
      and $5,252,863, respectively. The decrease of $221,882 from 2008 to
      2009 was primarily attributable to increased litigation expenses
      offset by expense decreases spread over a wide range of categories,
      including non-cash stock-based compensation expense, and reflects
      management's ongoing efforts to manage cash consumption.
  --  Non-operating income for 2009 was $102,186, compared with $1,175 in
      2008. The largest factors influencing the increase in 2009 were a net
      gain in the fair value of warrants accounted for as derivatives,
      offset by somewhat lower cash balances and a sharp drop in short term
      interest rates affecting interest income.
  About Neuralstem, Inc.

Neuralstem's patented technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. The Company is targeting major central nervous system diseases including: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury, Huntington's disease and ALS. Neuralstem's IND is under review with the FDA for ALS. ALS is a progressive, fatal neurodegenerative disease that affects nerve cells in the brain, leading to the degeneration and death of the motor neurons in the spinal cord that control muscle movement. ALS affects roughly 30,000 people in the U.S., with about 7,000 new diagnoses per year. Pre-clinical work has shown Neuralstem's cells to extend the life of rats with ALS (as reported the journal TRANSPLANTATION, in collaboration with Johns Hopkins University researchers), and also reversed paralysis in rats with Ischemic Spastic Paraplegia, (as reported in NEUROSCIENCE on June 29, 2007, in collaboration with researchers at University of California San Diego).

Cautionary Statement Regarding Forward Looking Information

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward- looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2009.

                       Neuralstem, Inc.
                        Balance Sheets
                                   December 31,      December 31,
                                       2009              2008
              ASSETS
  CURRENT ASSETS
  Cash and cash equivalents        $2,309,774        $4,903,279
  Prepaid expenses                    143,600           136,287
                                    ---------         ---------
  Total current assets              2,453,374         5,039,566
                                    ---------         ---------
  Property and equipment, net         196,755           163,930
  Intangible assets, net              301,560           212,265
  Other assets                         55,716            52,972
                                   ----------        ----------
  Total assets                     $3,007,405        $5,468,733
                                   ==========        ==========
           LIABILITIES AND
       STOCKHOLDERS' (DEFICIT)
              EQUITY
  CURRENT LIABILITIES
  Accounts payable and accrued 
   expenses                          $791,607          $547,950
  Accrued bonus expense               769,215           717,538
                                      -------           -------
  Total current liabilities         1,560,822         1,265,488
                                    ---------         ---------
  LONG-TERM LIABILITIES
  Fair value of warrant 
   obligations                      6,462,039                 -
                                    ---------         ---------
  Total liabilities                 8,022,861         1,265,488
                                    ---------         ---------
  STOCKHOLDERS'
   (DEFICIT) EQUITY
  Preferred stock, 7,000,000 shares
   authorized, zero shares issued and
   outstanding                              -                 -
  Common stock, $0.01 par value; 150
   million shares authorized,
   35,743,831 and 33,751,300 shares
   outstanding in 2009 and 2008,
   respectively                       357,438           337,513
  Additional paid-in capital       62,193,937        61,352,527
  Accumulated deficit             (67,566,831)      (57,486,795)
                                  -----------       -----------
  Total stockholders' (deficit)
   equity                          (5,015,456)        4,203,245
                                   ----------         ---------
  Total liabilities and 
   stockholders' (deficit)
   equity                          $3,007,405        $5,468,733
                                   ==========        ==========
                      Neuralstem, Inc.
                  Statements of Operations
                                               Years
                                         Ended December 31,
                                       2009              2008
                                       ----              ----
  Revenues                               $-                $-
                                        ---               ---
  Operating expenses:
  Research and development costs  5,346,904         6,513,349
  General, selling and 
   administrative expenses        5,030,981         5,252,863
  Depreciation and amortization      88,664            65,761
                                     ------            ------
       Total operating expenses  10,466,549        11,831,973
                                 ----------        ----------
  Operating loss                (10,466,549)      (11,831,973)
                                -----------       -----------
  Nonoperating (expense) income:
  Interest income                    19,614            39,806
  Interest expense                     (776)                -
  Warrant modification expense            -           (38,631)
  Gain from change in fair value of
   warrant obligations               83,348                 -
                                     ------             -----
       Total nonoperating income    102,186             1,175
                                    -------             -----
  Net loss attributable to
   common shareholders         $(10,364,363)     $(11,830,798)
                               ============      ============
  Net loss per share, basic 
   and diluted                       $(0.30)           $(0.37)
                                     ======            ======
  Weighted average common 
   shares outstanding, basic  
   and diluted                   34,280,882        32,114,365
                                 ==========        ==========

First Call Analyst:
FCMN Contact:

Photo: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO
AP Archive: http://photoarchive.ap.org/
PRN Photo Desk, photodesk@prnewswire.com

SOURCE: Neuralstem, Inc.

CONTACT: Richard Garr, President, +1-301-366-4960, or John Conron, Chief
Financial Officer, +1-301-633-7709, or Meg McElroy, Shareholder Relations,
+1-301-366-4960, all of Neuralstem, Inc.; or Deanne Eagle of Planet
Communications, Media, +1-917-837-5866, for Neuralstem, Inc.


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