TIDMMEDG TIDMMEDU

RNS Number : 4925S

Medgenics Inc

07 November 2013

 
 Press Release   7 November 2013 
 

Medgenics Reports Third Quarter Financial Results

Business Update Conference Call Scheduled for Tomorrow at 8:30 a.m. Eastern time

Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) ("the Company"), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today reported financial results for the three and nine months ended September 30, 2013 and the filing with the U.S. Securities and Exchange Commission (SEC) of the Company's Quarterly Report on Form 10-Q. The Form 10-Q includes unaudited interim consolidated financial statements containing the information presented below, as well as additional information regarding the Company. The Form 10-Q is available at www.sec.gov and at www.medgenics.com.

Highlights of the third quarter and recent weeks include:

-- Appointed a new leadership team including President and CEO Michael Cola, formerly with Shire and Safeguard Scientifics; CFO John Leaman, formerly with Shire and McKinsey; and Global Head of R&D Garry Neil, formerly with Johnson & Johnson; also announced the retirement of founder and former CEO Andrew L. Pearlman, Ph.D.

-- Appointed biopharmaceutical industry veteran Wilbur H. (Bill) Gantz to the Company's Board of Directors

-- Reported new, positive data on the Company's second-generation viral vectors in a poster presentation at the European Society of Gene and Cell Therapy Congress

Management Commentary

"It was with great pleasure that the new executive team joined Medgenics in mid-September. We are excited to be building upon the Company's strong scientific and technological foundation, and are refining new strategic initiatives to advance the clinical development program in carefully selected specialty and orphan indications," stated Michael Cola, President and Chief Executive Officer of Medgenics. "Our Board of Directors, enhanced by the recent addition of Bill Gantz, is comprised of an impressive team of industry leaders. We are delighted to be working together to implement our shared vision for the future of Medgenics."

"The Company achieved a significant milestone with the recent presentation of new, positive data on our second-generation viral vectors that optimize the Biopump platform through a number of enhancements to our protein expression technology and processing methods, as well as improvements in patient administration. In vitro and in vivo models of the second-generation viral vectors showed potential to substantially increase the duration and levels of the protein secretion of the Biopump along with enhanced surgical techniques. These advances can be clinically meaningful, particularly for patients on chronic protein therapy. Based on these results, we believe that all clinical programs, including the proposed EPODURE trial in the U.S., could benefit from the potentially improved performance from a second-generation vector. Our plan is to use Biopumps utilizing these vectors in clinical trials expected to commence in the first half of 2014," commented Garry Neil, M.D., Global Head of R&D for Medgenics.

Third Quarter Financial Results

Gross research and development (R&D) expense for the third quarter of 2013 increased to $2.45 million from $1.89 million for same period in 2012. Net R&D expense for the third quarter of 2013 was $2.34 million compared with net R&D expense of $1.61 million for the prior-year third quarter. The increase in net R&D expense was due mainly to higher headcount and an increase in clinical activities.

General and administrative expense for the three months ended September 30, 2013 was $2.56 million, up from $1.47 million for the same period in 2012 primarily due to increases in general and administrative personnel, directors' equity compensation and professional fees.

Financial expense for the quarter ended September 30, 2013 increased to $1.26 million from nil for the same period in 2012, mainly due to the change in valuation of the warrant liability.

Financial income for the quarter ended September 30, 2013 declined to $0.02 million from $0.06 million for the same period in 2012, primarily due to the change in valuation of the warrant liability.

For the third quarter of 2013 the Company reported a net loss of $6.14 million or $0.33 per share, compared with a net loss of $3.03 million or $0.25 per share for the third quarter of 2012.

Nine Month Financial Results

Gross R&D expense for the first nine months of 2013 increased to $6.56 million from $5.13 million for same period in 2012 due to an increase in R&D personnel and clinical activities. Net R&D expense for the first nine months of 2013 was $5.23 million compared with net R&D expense of $3.36 million for the first nine months of 2012. The increase in net R&D expense was due to a reduction in participation by the OCS, $1.33 million in the 2013 period versus $1.77 million in the 2012 period, and the increase in the gross R&D expense as explained above.

General and administrative expense for the nine months ended September 30, 2013 of $6.70 million increased from $5.60 million in the prior-year period primarily due to increases in general and administrative personnel, directors' equity compensation and professional fees.

Financial expense for the nine months ended September 30, 2013 of $0.02 million decreased from $3.72 million for the same period in 2012, primarily due to the change in valuation of the warrant liability.

Financial income for the nine months ended September 30, 2013 increased by an insignificant amount compared to the same period in 2012.

For the nine months ended September 30, 2013, the Company reported a net loss of $11.92 million or $0.68 per share, compared with a net loss of $12.69 million or $1.20 per share in the comparable 2012 period.

The Company ended the third quarter of 2013 with cash and cash equivalents of $26.79 million, compared with $6.43 million as of December 31, 2012. The Company used $8.36 million in net cash to fund operating activities during the first nine months of 2013, compared with $5.87 million in the first nine months of 2012.

Conference Call

Medgenics management will host a Business Update conference call to discuss the Company's progress and to answer questions tomorrow, Friday, November 8, 2013 beginning at 8:30 a.m. Eastern time. Shareholders and other interested parties may participate in the call by dialing 877-664-6134 (from within the U.S.) or 702-495-1913 (from outside the U.S.) or 1-809-457-877 (toll-free from Israel) and entering passcode 94707205. The call will also be broadcast live on the Company's website at www.medgenics.com.

A replay of the conference call will be accessible two hours after its completion through November 14, 2013, by dialing 855-859-2056 (domestic) or 404-537-3406 (international) and referencing conference ID number 94707205. The call will also be archived for 90 days on the Company's website at www.medgenics.com.

About Medgenics

Medgenics is developing and commercializing Biopump(TM), a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia, hepatitis, among others. For more information, please visit www.medgenics.com.

Forward-looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend, " "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

Contacts:

 
 Medgenics, Inc. 
  John Leaman, CFO 
  john.leaman@medgenics.com 
 LHA 
  Anne Marie Fields, 
  afields@lhai.com 
  @LHA_IR_PR                                    212-838-3777 
 Abchurch Communications 
  Joanne Shears / Jamie Hooper / Harriet 
  Rae 
  harriet.rae@abchurch-group.com            +44 207 398 7718 
 Oriel Securities (NOMAD & Joint 
  Broker) 
  Jonathan Senior / Giles Balleny           +44 207 710 7617 
 SVS Securities plc (Joint Broker) 
  Alex Brearley                             +44 203 700 0100 
 

Tables to Follow

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 
                                                            September   December 
                                                               30,         31, 
                                                              2013        2012 
                                                           -----------  --------- 
                                                           (Unaudited) 
                                                           ----------- 
 
ASSETS 
 
CURRENT ASSETS: 
 
 Cash and cash equivalents                                    $ 26,791    $ 6,431 
 Accounts receivable and prepaid expenses                        1,009        539 
                                                           -----------  --------- 
 
Total current assets                                            27,800      6,970 
                                                           -----------  --------- 
 
LONG-TERM ASSETS: 
 
Restricted lease deposits                                           46         62 
Severance pay fund                                                  93        283 
Property and equipment, net                                        381        352 
 
Total long-term assets                                             520        697 
                                                           -----------  --------- 
 
DEFERRED ISSUANCE EXPENSES                                           -         40 
                                                           -----------  --------- 
 
 Total assets                                                 $ 28,320    $ 7,707 
 LIABILITIES AND STOCKHOLDERS' EQUITY 
 
 CURRENT LIABILITIES: 
 
 Trade payables                                                $ 1,546      $ 877 
 Other accounts payable and accrued expenses                     2,042      1,473 
                                                           -----------  --------- 
 
 Total current liabilities                                       3,588      2,350 
                                                           -----------  --------- 
 
 LONG-TERM LIABILITIES: 
 
 Accrued severance pay                                             873      1,492 
 Liability in respect of warrants                                1,911      1,931 
                                                           -----------  --------- 
 
 Total long-term liabilities                                     2,784      3,423 
                                                           -----------  --------- 
 
 Total liabilities                                               6,372      5,773 
                                                           -----------  --------- 
 
 STOCKHOLDERS' EQUITY: 
 
 Common stock - $ 0.0001 par value; 
  100,000,000 shares authorized;18,481,308 and 
  12,307,808 shares issued and outstanding at 
  September 30, 2013 and December 31, 2012, respectively             2          1 
 Additional paid-in capital                                     98,443     66,509 
 Deficit accumulated during the development 
  stage                                                       (76,497)   (64,576) 
                                                           -----------  --------- 
 
 Total stockholders' equity                                     21,948      1,934 
                                                           -----------  --------- 
 
 Total liabilities and stockholders' equity                   $ 28,320    $ 7,707 
                                                           ===========  ========= 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)

 
                                Nine months ended                Three months             Period from 
                                   September 30,                     ended                   January 
                                                                 September 30,              27, 2000 
                                                                                           (inception) 
                                                                                             through 
                                                                                            September 
                                                                                               30, 
                             2013            2012          2013              2012             2013 
                                                           Unaudited 
 
 Research and 
  development 
  expenses                     $ 6,556       $ 5,125        $ 2,452              $ 1,894      $ 44,185 
 
  Less - 
   Participation 
   by 
   the Office of 
   the Chief 
   Scientist                   (1,327)       (1,769)          (109)                (283)       (8,376) 
  U.S. Government 
   grant                             -             -              -                    -         (244) 
  Participation by 
   third 
   party                             -             -              -                    -       (1,067) 
                        --------------   -----------   ------------    -----------------   ----------- 
 
 Research and 
  development 
  expenses, net                  5,229         3,356          2,343                1,611        34,498 
 
 General and 
  administrative 
  expenses                       6,695         5,603          2,561                1,470        40,290 
 
 Other income: 
 Excess amount of 
  participation 
  in research and 
  development 
  from third party                   -             -              -                    -       (2,904) 
                        --------------   -----------   ------------    -----------------   ----------- 
 
 Operating loss               (11,924)       (8,959)        (4,904)              (3,081)      (71,884) 
 
 Financial 
  expenses                        (21)       (3,721)        (1,260)                    -       (5,311) 
 Financial income                   29             4             21                   55           369 
                        --------------   -----------   ------------    -----------------   ----------- 
 
 Loss before taxes 
  on income                   (11,916)      (12,676)        (6,143)              (3,026)      (76,826) 
 
 Taxes on income                     5             9              -                    1           100 
                        --------------   -----------   ------------    -----------------   ----------- 
 
 Loss                        $(11,921)    $ (12,685)       $(6,143)            $ (3,027)    $ (76,926) 
                        ==============   ===========   ============    =================   =========== 
 
 Basic and diluted 
  loss 
  per share                   $ (0.68)      $ (1.20)       $ (0.33)             $ (0.25) 
                        ==============   ===========   ============    ================= 
 
 Weighted average 
  number 
  of shares of 
  Common stock 
  used in 
  computing basic 
  loss per share            17,435,235    10,604,924       18,410,951         12,013,153 
                    ==================   ===========   ==============      ============= 
 
 Weighted average 
  number 
  of shares of 
  Common stock 
  used in 
  computing 
  diluted 
  loss per share            17,468,255    10,604,924      18,410,951          12,013,153 
                    ==================   ===========   =============   ================= 
 
 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

U.S. dollars in thousands (except share and per share data)

 
                                                                     Deficit 
                                                                    accumulated 
                                                       Additional   during the         Total 
                                                         paid-in    development    stockholders' 
                                      Common stock       capital       stage          equity 
                                   ------------------  ----------  ------------  --------------- 
                                     Shares    Amount 
                                   ----------  ------ 
 
Balance as of December 
 31, 2011                           9,722,725     $ 1    $ 52,501    $ (49,505)          $ 2,997 
 
Stock based compensation 
 related to issuance of 
 restricted common stock               35,000     (*)          55             -               55 
Issuance of Common stock 
 to consultants at $ 4.84 
 and $ 8.79 per share                  30,000     (*)         204             -              204 
Issuance of Common stock 
 and warrants at $4.90 per 
 unit of one share and 0.75 
 warrant                            1,944,734     (*)       8,407             -            8,407 
Exercise of options and 
 warrants                             504,111     (*)       2,263             -            2,263 
Stock based compensation 
 related to options and 
 warrants granted to consultants 
 and employees                              -       -       1,973             -            1,973 
Loss                                        -       -           -      (12,685)         (12,685) 
                                   ----------  ------  ----------  ------------  --------------- 
 
Balance as of September 
 30, 2012 (unaudited)              12,236,570     $ 1    $ 65,403    $ (62,190)          $ 3,214 
                                   ==========  ======  ==========  ============  =============== 
 
   (*)         Represents an amount lower than $ 1. 

The accompanying notes are an integral part of the interim consolidated financial statements.

STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

U.S. dollars in thousands (except share and per share data)

 
                                                                      Deficit 
                                                                     accumulated 
                                                        Additional   during the       Total 
                                                          paid-in    development   stockholders' 
                                       Common stock       capital       stage         equity 
                                    ------------------  ----------  ------------  -------------- 
                                      Shares    Amount 
                                    ----------  ------ 
 
 Balance as of December 31, 
  2012                              12,307,808     $ 1    $ 66,509    $ (64,576)         $ 1,934 
 
 Issuance of Common stock 
  and warrants at $ 5.24 per 
  share and $ 0.01 per warrant       6,070,000       1      28,820             -          28,821 
 Stock based compensation 
  related to Common stock 
  to consultants at $ 7.25 
  per share (**)                        55,000     (*)         594             -             594 
 Issuance and vesting of 
  restricted common stock               45,000     (*)         331             -             331 
 Exercise of warrants and 
  options                                3,500     (*)          13             -              13 
 Stock based compensation 
  related to options and warrants 
  granted to consultants and 
  employees                                  -       -       2,176             -           2,176 
 Loss                                        -       -                  (11,921)        (11,921) 
                                    ----------  ------  ----------  ------------  -------------- 
 
 Balance as of September 
  30, 2013 (unaudited)              18,481,308     $ 2    $ 98,443    $ (76,497)        $ 21,948 
                                    ==========  ======  ==========  ============  ============== 
 
   (*)         Represents an amount lower than $ 1. 

(**) Includes stock based compensation for an additional 25,000 shares which were approved, but not issued, as of September 30, 2013.

The accompanying notes are an integral part of the interim consolidated financial statements.

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 
                                                                          Period from 
                                                                          January 27, 
                                                                        2000 (inception) 
                                                 Nine months ended          through 
                                                    September 30,        September 30, 
                                               ---------------------- 
                                                  2013        2012           2013 
                                               ----------  ----------  ----------------- 
                                                               Unaudited 
                                               ----------------------------------------- 
 
CASH FLOWS FROM OPERATING ACTIVITIES: 
 
 Loss                                          $ (11,921)  $ (12,685)         $ (76,926) 
 
Adjustments to reconcile loss to net 
 cash used in operating activities: 
 
Depreciation                                          130         108              1,356 
Loss from disposal of property and equipment            -           -                330 
Stock based compensation to employees 
 and consultants                                    3,101       2,232             13,286 
Interest and amortization of beneficial 
 conversion feature of convertible note                 -           -                759 
Change in fair value of convertible 
 debentures and warrants                             (20)       3,632              3,958 
Accrued severance pay, net                          (429)         237                780 
Exchange differences on a restricted 
 lease deposit and on long term loan                    1         (2)                  2 
 
Changes in operating assets and liabilities: 
Accounts receivable and prepaid expenses            (447)         503            (1,026) 
Trade payables                                        669       (133)              2,150 
Other accounts payable and accrued expenses           569         239              2,589 
Restricted lease deposit                              (8)         (5)               (68) 
 
Net cash used in operating activities             (8,355)     (5,874)           (52,810) 
                                               ----------  ----------  ----------------- 
 
CASH FLOWS FROM INVESTING ACTIVITIES: 
 
Purchase of property and equipment                  (159)        (54)            (2,241) 
Proceeds from disposal of property and 
 equipment                                              -           -                173 
 
Net cash used in investing activities             $ (159)      $ (54)          $ (2,068) 
                                               ----------  ----------  ----------------- 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 
                                                                       Period from 
                                                                       January 27, 
                                                                     2000 (inception) 
                                                                         through 
                                                Nine months ended       September 
                                                  September 30,            30, 
                                               ------------------- 
                                                  2013      2012          2013 
                                               ----------  -------  ----------------- 
                                                             Unaudited 
                                               -------------------------------------- 
CASH FLOWS FROM FINANCING ACTIVITIES: 
 
Proceeds from issuance of shares and 
 warrants, net                                   $ 28,861  $ 8,407           $ 71,769 
Proceeds from exercise of options and 
 warrants, net                                         13    1,525              2,735 
Repayment of a long-term loan                           -        -               (73) 
Proceeds from long-term loan                            -        -                 70 
Issuance of a convertible debenture 
 and warrants                                           -        -              7,168 
 
Net cash provided by financing activities          28,874    9,932             81,669 
                                               ----------  -------  ----------------- 
 
Increase in cash and cash equivalents              20,360    4,004             26,791 
 
Balance of cash and cash equivalents 
 at the beginning of the period                     6,431    4,995                  - 
                                               ----------  -------  ----------------- 
 
Balance of cash and cash equivalents 
 at the end of the period                        $ 26,791  $ 8,999           $ 26,791 
                                               ==========  =======  ================= 
 
Supplemental disclosure of cash flow 
 information: 
 
Cash paid during the period for: 
 
Interest                                              $ -      $ -              $ 242 
                                               ==========  =======  ================= 
 
Taxes                                                 $ 5     $ 40              $ 153 
                                               ==========  =======  ================= 
 
Supplemental disclosure of non-cash 
 flow information: 
 
Issuance expenses paid with Common stock              $ -      $ -              $ 310 
                                               ==========  =======  ================= 
 
Issuance of Common stock upon conversion 
 of a convertible debenture                           $ -      $ -            $ 8,430 
                                               ==========  =======  ================= 
 
Classification of liability in respect 
 of warrants into equity due to the exercise 
 of warrants                                          $ -    $ 738            $ 2,014 
                                               ==========  =======  ================= 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

   NOTE 1:-           GENERAL 

a. Medgenics, Inc. (the "Company") was incorporated in January 2000 in Delaware. The Company has a wholly-owned subsidiary, Medgenics Medical Israel Ltd. (formerly Biogenics Ltd.) (the "Subsidiary"), which was incorporated in Israel in March 2000. The Company and the Subsidiary are engaged in the research and development of products in the field of biotechnology and associated medical equipment and are thus considered development stage companies as defined in Accounting Standards Codification ("ASC") topic number 915, "Development Stage Entities" ("ASC 915").

The Company's Common stock is traded on the NYSE MKT (formerly NYSE Amex) and on the AIM market of the London Stock Exchange ("AIM").

b. The Company and the Subsidiary are in the development stage. As reflected in the accompanying financial statements, the Company incurred a loss for the nine month period ended September 30, 2013 of $ 11,921 and had a negative cash flow from operating activities of $ 8,355 during the nine month period ended September 30, 2013. The accumulated deficit as of September 30, 2013 is $ 76,497. The Company and the Subsidiary have not yet generated revenues from product sale. The Company previously generated income from partnering on development programs and expects to expand its partnering activity. Management's plans also include seeking additional investments and commercial agreements to continue the operations of the Company and the Subsidiary.

The Company believes that the net proceeds of the underwritten public offering in February 2013, plus its existing cash and cash equivalents, should be sufficient to meet its operating and capital requirements through 2014.

c. In May 2013, the Subsidiary received approval for an additional Research and Development program from the Office of the Chief Scientist in Israel ("OCS") for the period December 2012 through November 2013. The approval allows for a grant of up to approximately $ 2,000 based on research and development expenses, not funded by others, of up to $ 3,660. As of September 30, 2013, $909 has been received and $664 recorded as grants receivable. In October 2013, subsequent to the balance sheet date, an additional $348 has been received.

   NOTE 2:-           SIGNIFICANT ACCOUNTING POLICIES 

The accompanying unaudited interim financial statements of the Company, have been prepared in accordance with accounting principles generally accepted in the United States of America and the rules of the Securities and Exchange Commission ("SEC") and should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2012 ("2012 Form 10-K") as filed with the SEC. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that would substantially duplicate the disclosure contained in the audited financial statements for the most recent fiscal year, as reported in the 2012 Form 10-K, have been omitted.

   NOTE 3:-           STOCKHOLDERS' EQUITY 
   a.                         General: 

In March 2013, the Compensation Committee of the Company's Board of Directors approved an amendment to the stock incentive plan increasing the number of shares of Common stock authorized for issuance there under to a total of 3,855,802 shares of Common stock, subject to stockholder approval. The Company's stockholders approved the amendment at the Company's annual meeting of stockholders on April 30, 2013.

   b.                         Issuance of shares and warrants to investors: 

In February 2013, the Company closed an underwritten public offering of 5,600,000 shares of Common stock and Series 2013-A warrants to purchase up to an aggregate of 2,800,000 shares of Common stock. The shares and the warrants were sold together as a fixed combination at a price to the public of $ 5.25 per fixed combination. Each combination consisted of one share of Common stock and a warrant to purchase one-half of a share of Common stock at an exercise price of $6.78 per share. In March 2013, the underwriters exercised their overallotment option and purchased an additional 420,000 shares of Common stock at $5.24 per share and an additional 840,000 warrants at $ 0.01 per warrant. Gross proceeds were $ 31,871 or approximately $ 28,821 in net proceeds after deducting underwriting discounts and commissions of $ 2,550 and other offering costs of approximately $ 500.

   c.            Issuance of stock options, warrants and restricted shares to employees and directors: 

1. A summary of the Company's activity for restricted shares granted to employees and directors is as follows:

 
                                                   Nine months 
                                                       ended 
                                                   September 30, 
             Restricted shares                         2013 
--------------------------------------------      -------------- 
 
Number of restricted shares as of December 
 31, 2012                                             60,357 
 
Vested                                               (35,000) 
Granted                                               45,000 
                                                  -------------- 
 
Number of restricted shares as of September 
 30, 2013                                             70,357 
                                                  ============== 
 

2. A summary of the Company's activity for options and warrants granted to employees and directors is as follows:

 
                                                      Nine months ended 
                                                       September 30, 2013 
                           ----------------------------------------------------------- 
                                                            Weighted 
                               Number        Weighted        average 
                                  of          average       remaining      Aggregate 
                               options        exercise     contractual     intrinsic 
                             and warrants      price      terms (years)   value price 
                           ---------------  -----------  --------------  ------------- 
 
Outstanding at December 
 31, 2012                        2,656,587       $ 6.04 
 
Granted                          4,160,000       $ 4.49 
 
Expired/Forfeited                 (34,994)       $ 5.56 
 
Exercised                          (3,500)       $ 3.64 
                           ---------------  ----------- 
 
Outstanding at September 
 30, 2013                        6,778,093       $ 5.09          $ 7.37       $ 21,264 
                           ===============  ===========  ==============  ============= 
 
Vested and expected 
 to vest at September 
 30, 2013                        6,546,700       $ 5.10          $ 7.31       $ 20,544 
                           ===============  ===========  ==============  ============= 
 
Exercisable at September 
 30, 2013                        2,150,224       $ 5.48          $ 3.46        $ 6,881 
                           ===============  ===========  ==============  ============= 
 
 

The aggregate intrinsic value represents the total intrinsic value (the difference between the Company's Common share fair value as of September 30, 2013 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2013.

Calculation of aggregate intrinsic value is based on the share price of the Company's Common stock as reported on the NYSE MKT as of September 30, 2013 ($7.80 per share).

As of September 30, 2013, there was $9,879 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to employees and directors. That cost is expected to be recognized over a weighted-average period of 2.2 years.

In September 2013, upon the resignation of our former CEO, the Company caused his unvested options to become fully vested as of his separation date (September 13, 2013), and all options vested as of the separation date will be exercisable through the one-year anniversary of his separation date. The Company recorded an additional expense in the amount of $120 during the quarter.

   d.                 Issuance of shares, stock options and warrants to consultants: 

1. In January 2013, the Company issued a total of 55,000 shares of Common stock to two consultants. Total compensation, measured as the grant date fair market value of the stock, amounted to $ 494 and was recorded as an operating expense in the Statement of Operations. As part of the agreement with the consultant, the Company has an obligation to issue an additional 25,000 shares for services received during the nine month period ended September 30, 2013.

2. A summary of the Company's activity for warrants and options granted to consultants is as follows:

 
                                               Nine months ended 
                                               September 30, 2013 
                             ------------------------------------------------------ 
                                                          Weighted 
                                Number      Weighted       average 
                                   of        average      remaining     Aggregate 
                                options      exercise    contractual     intrinsic 
                              and warrants    price     terms (years)   value price 
                             -------------  ---------  --------------  ------------ 
 
Outstanding at December31, 
 2012                              521,904     $ 7.29 
 
Granted                            125,000     $ 4.01 
 
  Expired/Forfeited               (25,000)     $ 7.56 
 
 
Outstanding at September 
 30, 2013                          621,904     $ 6.61            4.28       $ 1,083 
                             =============  =========  ==============  ============ 
 
Exercisable at September 
 30, 2013                          561,907     $ 6.57            3.84       $ 1,010 
                             =============  =========  ==============  ============ 
 

The aggregate intrinsic value represents the total intrinsic value (the difference between the Company's Common share fair value as of September 30, 2013 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on September 30, 2013.

As of September 30, 2013, there was $467 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to consultants. That cost is expected to be recognized over a weighted-average period of 1.3 years.

Calculation of aggregate intrinsic value is based on the share price of the Company's Common stock as reported on the NYSE MKT as of September 30, 2013 ($7.80 per share).

   e.                 Compensation expenses: 

Compensation expense related to shares, warrants and options granted to employees, directors and consultants was recorded in the statement of operations in the following line items:

 
                                Nine months ended     Three months ended 
                                  September 30,          September 30, 
                                 2013       2012        2013       2012 
 
 Research and development 
  expenses                        $ 221      $ 193        $ 155      $ 95 
 General and administrative 
  expenses                        2,880      2,039          869       190 
 
                                $ 3,101    $ 2,232      $ 1,024     $ 285 
 
   f.                  Summary of options and warrants: 

A summary of all the options and warrants outstanding as of September 30, 2013 is presented in the following table:

 
                                                              As of September 30, 2013 
                                         ------------------------------------------------------------------- 
                                                                                 Weighted 
                                                                                  Average 
                                                                                 Remaining 
                             Exercise    Options and  Options and               Contractual 
                             Price per    Warrants     Warrants                  Terms (in 
    Options / Warrants       Share ($)   Outstanding  Exercisable                  years) 
--------------------------  -----------  -----------  -----------  ------------------------------------- 
 
Options: 
Granted to Employees and 
 Directors                    2.49-3.14      499,806      354,556       4.3                          6.0 
                              3.64-4.99    3,653,629      117,915       9.5                          9.0 
 
                              5.13-7.25      632,967       35,740       9.6                         4.4 
                             8.19-14.50    1,109,451      759,773       4.4                          4.4 
                                         -----------  ----------- 
                                           5,895,853    1,267,984 
                                         -----------  ----------- 
 
Granted to Consultants 
                              4.20-5.14       34,634       24,447       4.3 
                              6.65-8.19      119,916       73,870       7.8 
                                  14.50        5,646        1,882       8.8 
                                             160,196      100,199 
                                         -----------   ---------- 
 
Total Options                              6,056,049    1,368,183 
                                         -----------   ---------- 
 
 
 
Warrants: 
Granted to Employees 
 and Directors                      2.49               882,240              882,240       2.5 
                                               ---------------        ------------- 
 
Granted to Consultants         3.19-4.01               161,370              161,370       3.9 
                                    4.99                31,635               31,635       4.1 
                                    5.50                67,230               67,230       0.2 
                              9.17-11.16               201,473              201,473       3.7 
                                                       461,708              461,708 
                                               ---------------        ------------- 
 
Granted to Investors 
                                  0.0002                35,922               35,922       2.5 
                                    2.49                22,950               22,950       2.5 
                               4.54-6.00             3,233,521            3,233,521       2.5 
                               6.78-8.34             4,678,550            4,678,550       4.2 
                                                     7,970,943            7,970,943 
                                               ---------------    ----------------- 
 
Total Warrants                                       9,314,891            9,314,891 
                                                   -----------    ----------------- 
 
 Total Option and Warrants                          15,370,940           10,683,074 
                                           ===================        ============= 
 
 
   NOTE 4:-              CONTINGENCIES 

In September 2013, three executives joined the Company. Per their employment agreements, if terminated without cause, these executives will be entitled to severance pay in the aggregate amount of $2,975.

   NOTE 5:-              FAIR VALUE MEASURMENTS 

The Company classified certain warrants with down-round protection issued to the purchasers of convertible debentures in 2010 as a liability at their fair value according to ASC 815-40-15-7I. The liability in respect of these warrants is remeasured at each reporting period until exercised or expired. Changes in the fair value of these warrants are reported in the statements of operations as financial income or expense.

The fair value of these warrants was estimated at September 30, 2013 and December 31, 2012 using the Binomial pricing model with the following assumptions:

 
                                     September       December 
                                        30,             31, 
                                        2013           2012 
                                    ----------      --------- 
 
 Dividend yield                         0%              0% 
 Expected volatility                   81.6%          78.1% 
 Risk-free interest rate               0.3%            0.3% 
 Contractual life (in years)            2.0            2.7 
 

The changes in level 3 liabilities measured at fair value on a recurring basis:

 
                                                      Fair value 
                                                      of liability 
                                                       in respect 
                                                      of warrants 
                                                     ------------- 
 
Balance as of December 31, 2011                              $ 478 
 
Classification of liability in respect of warrants 
 into equity due to the exercise of warrants                 (883) 
Change in the fair value of liability in respect 
 of warrants                                                 2,336 
                                                     ------------- 
 
Balance as of December 31, 2012                              1,931 
 
Change in the fair value of liability in respect 
 of warrants                                                  (20) 
                                                     ------------- 
 
Balance as of September 30, 2013 (unaudited)               $ 1,911 
                                                     ============= 
 

-Ends-

This information is provided by RNS

The company news service from the London Stock Exchange

END

QRTNKODBQBDDNDK

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