Filed Pursuant to Rule 424(b)(3)
Registration Statement No. 333-179331
Prospectus Supplement No. 6
(to Prospectus dated July 19, 2012, as supplemented by Prospectus Supplement No. 1 dated August 16, 2013, Prospectus Supplement No. 2 dated August 16, 2013, Prospectus Supplement No. 3 dated August 16, 2013, Prospectus Supplement No. 4 dated August 16, 2013 and Prospectus Supplement No. 5 dated August 16, 2013)
BRAINSTORM CELL THERAPEUTICS INC.
19,818,972 Shares of Common Stock
Warrants to Purchase 14,864,229 Shares of Common Stock
and
14,864,229 Shares of Common Stock Underlying Warrants
This prospectus supplement, together with the prospectus listed above, is to be used by certain holders of the above-referenced securities or by their pledgees, donees, transferees or other successors-in-interest in connection with the offer and sale of such securities.
This prospectus supplement updates and should be read in conjunction with the prospectus dated July 19, 2012 (as supplemented to date), which is to be delivered with this prospectus supplement. Such documents contain information that should be considered when making your investment decision. To the extent there is a discrepancy between the information contained herein and the information in the prospectus, the information contained herein supersedes and replaces such conflicting information.
This prospectus supplement consists of Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “Commission”) on November 14, 2013 (the “Form 10-Q”).
Our common stock is traded on the OTCQB Marketplace, operated by OTC Markets Group, under the symbol “BCLI”. On November 12, 2013, the last reported sales price for our common stock was $0.18 per share. We do not intend to list the warrants on any securities exchange or other trading market and we do not expect that a public trading market will develop for the warrants.
Investing in the Company’s securities involves risks. See “Risk Factors” beginning on page 4 of the Prospectus, as supplemented or amended by the prospectus supplements filed to date, to read about factors you should consider.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this Prospectus Supplement No. 6 is November 14, 2013
Delaware | 20-8133057 |
(State or other jurisdiction of | (I.R.S. Employer |
incorporation or organization) | Identification No.) |
Large accelerated filer ¨ | Accelerated filer ¨ | ||
Non-accelerated filer ¨ (Do not check if a smaller reporting company) | Smaller reporting company x |
| Page |
| Number |
PART I | |
| |
Item 1. Financial Statements | 3 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 34 |
Item 3. Quantitative and Qualitative Disclosures About Market Risk | 41 |
Item 4. Controls and Procedures | 41 |
| |
PART II | |
| |
Item 1. Legal Proceedings | 42 |
Item 1A. Risk Factors | 42 |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 43 |
Item 5. Other Information | 43 |
Item 6. Exhibits | 43 |
3 | ||
| Page |
| |
Consolidated Balance Sheets | 5 |
| |
Consolidated Statements of Operations | 6 |
| |
Statements of Changes in Stockholders' Equity (Deficiency) | 7-15 |
| |
Consolidated Statements of Cash Flows | 16-17 |
| |
Notes to Consolidated Financial Statements | 18 - 33 |
4 | ||
| | September 30, | | December 31, | |
| | 2013 | | 2012 | |
| | Unaudited | | Audited | |
ASSETS | | | | | |
| | | | | |
Current Assets: | | | | | |
Cash and cash equivalents | | 329 | | 1,317 | |
Short-term deposit | | 4,786 | | 2,769 | |
Account receivable | | 502 | | 742 | |
Prepaid expenses | | 55 | | 46 | |
Total current assets | | 5,672 | | 4,874 | |
| | | | | |
Long-Term Assets: | | | | | |
Prepaid expenses | | 28 | | 17 | |
Severance payment fund | | 245 | | 172 | |
Total long-term assets | | 273 | | 189 | |
| | | | | |
Property and Equipment, Net | | 267 | | 247 | |
| | | | | |
Total assets | | 6,212 | | 5,310 | |
| | | | | |
LIABILITIES AND STOCKHOLDERS' EQUITY | | | | | |
| | | | | |
Current Liabilities: | | | | | |
Trade payables | | 446 | | 358 | |
Accrued expenses | | 710 | | 605 | |
Other accounts payable | | 230 | | 176 | |
Total current liabilities | | 1,386 | | 1,139 | |
| | | | | |
Accrued Severance Pay | | 291 | | 189 | |
| | | | | |
Total liabilities | | 1,677 | | 1,328 | |
| | | | | |
Stockholders' Equity: | | | | | |
Stock capital: (Note 6) | | 8 | | 7 | |
Common stock of $0.00005 par value - Authorized: 800,000,000 shares at September 30, 2013 and December 31, 2012; Issued and outstanding: 176,243,587 and 150,085,035 shares at September 30, 2013 and December 31, 2012 respectively. | | | | | |
Additional paid-in-capital | | 55,717 | | 51,483 | |
Deficit accumulated during the development stage | | (51,190) | | (47,508) | |
Total stockholders' equity | | 4,535 | | 3,982 | |
| | | | | |
Total liabilities and stockholders' equity | | 6,212 | | 5,310 | |
5 | ||
| | | | | | | | | | | | | | Period from | | |
| | | | | | | | | | | | | | September 22, | | |
| | | | | | | | | | | | | | 2000 (inception | | |
| | Nine months ended | | Three months ended | | date) through | | |||||||||
| | September 30, | | September 30, | | September 30, | | |||||||||
| | 2013 | | 2012 | | 2013 | | 2012 | | 2013 | | |||||
| | Unaudited | | Unaudited | | Unaudited | | |||||||||
| | | | | | | | | | | | | | | | |
Operating costs and expenses: | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Research and development, net | | $ | 2,068 | | $ | 1,486 | | $ | 804 | | $ | 732 | | $ | 28,257 | |
General and administrative | | | 1,574 | | | 1,397 | | | 272 | | | 440 | | | 20,325 | |
| | | | | | | | | | | | | | | | |
Total operating costs and expenses | | | 3,642 | | | 2,883 | | | 1,076 | | | 1,172 | | | 48,582 | |
| | | | | | | | | | | | | | | | |
Financial expenses (income), net | | | 21 | | | (37) | | | 5 | | | (22) | | | 2,475 | |
Other income | | | - | | | - | | | - | | | - | | | (132) | |
| | | | | | | | | | | | | | | | |
Operating loss | | | 3,663 | | | 2,846 | | | 1,081 | | | 1,150 | | | 50,925 | |
| | | | | | | | | | | | | | | | |
Taxes on income | | | 19 | | | 5 | | | 1 | | | - | | | 101 | |
| | | | | | | | | | | | | | | | |
Loss from continuing operations | | | 3,682 | | | 2,851 | | | 1,082 | | | 1,150 | | | 51,026 | |
| | | | | | | | | | | | | | | | |
Net loss from discontinued operations | | | - | | | - | | | - | | | - | | | 164 | |
| | | | | | | | | | | | | | | | |
Net loss | | $ | 3,682 | | $ | 2,851 | | $ | 1,082 | | $ | 1,150 | | $ | 51,190 | |
Basic and diluted net loss per share from continuing operations | | $ | 0.02 | | $ | 0.02 | | $ | 0.01 | | $ | 0.01 | | | | |
| | | | | | | | | | | | | | | | |
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | | | 152,094,266 | | | 133,403,123 | | | 164,223,127 | | | 145,407,840 | | | | |
6 | ||
| | | | | | | | | | | | | Deficit accumulated | | Total | | ||
| | Common stock | | Additional paid-in | | Deferred Stock - based | | during the development | | stockholders' equity | | |||||||
| | Number | | Amount | | capital | | compensation | | stage | | (deficiency) | | |||||
| | | | | | | | | | | | | | | | | | |
Balance as of September 22, 2000 (date of inception) (unaudited) | | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | |
| | | | | | | | | | | | | | | | | | |
Stock issued on September 22, 2000 for cash at $0.00188 per share | | 8,500,000 | | | 1 | | | 16 | | | - | | | - | | | 17 | |
Stock issued on March 31, 2001 for cash at $0.0375 per share | | 1,600,000 | | * | - | | | 60 | | | - | | | - | | | 60 | |
Contribution of capital | | - | | | - | | | 8 | | | - | | | - | | | 8 | |
Net loss | | - | | | - | | | - | | | - | | | (17) | | | (17) | |
| | | | | | | | | | | | | | | | | | |
Balance as of March 31, 2001 (unaudited) | | 10,100,000 | | | 1 | | | 84 | | | - | | | (17) | | | 68 | |
| | | | | | | | | | | | | | | | | | |
Contribution of capital | | - | | | - | | | 11 | | | - | | | - | | | 11 | |
Net loss | | - | | | - | | | - | | | - | | | (26) | | | (26) | |
Balance as of March 31, 2002 (unaudited) | | 10,100,000 | | | 1 | | | 95 | | | - | | | (43) | | | 53 | |
| | | | | | | | | | | | | | | | | | |
Contribution of capital | | - | | | - | | | 15 | | | - | | | - | | | 15 | |
Net loss | | - | | | - | | | - | | | - | | | (47) | | | (47) | |
Balance as of March 31, 2003 (unaudited) | | 10,100,000 | | | 1 | | | 110 | | | - | | | (90) | | | 21 | |
| | | | | | | | | | | | | | | | | | |
2-for-1 stock split | | 10,100,000 | | * | - | | | - | | | - | | | - | | | - | |
Stock issued on August 31, 2003 to purchase mineral option at $0.065 per share | | 100,000 | | * | - | | | 6 | | | - | | | - | | | 6 | |
Cancellation of shares granted to Company's President | | (10,062,000) | | * | - | | * | - | | | - | | | - | | | - | |
Contribution of capital | | - | | * | - | | | 15 | | | - | | | - | | | 15 | |
Net loss | | - | | | - | | | - | | | - | | | (73) | | | (73) | |
Balance as of March 31, 2004 (unaudited) | | 10,238,000 | | $ | 1 | | $ | 131 | | $ | - | | $ | (163) | | $ | (31) | |
7 | ||
| | | | | | | Additional | | Deferred | | Deficit accumulated during the | | Total stockholders' | | ||||
| Common stock | | paid-in | | Stock - based | | development | | equity | | ||||||||
| Number | | Amount | | capital | | compensation | | stage | | (deficiency) | | ||||||
| | | | | | | | | | | | | | | | | | |
Balance as of March 31, 2004 | | 10,238,000 | | $ | 1 | | $ | 131 | | $ | - | | $ | (163) | | $ | (31) | |
| | | | | | | | | | | | | | | | | | |
Stock issued on June 24, 2004 for private placement at $0.01 per share, net of $25,000 issuance expenses | | 8,510,000 | | * | - | | | 60 | | | - | | | - | | | 60 | |
Contribution capital | | - | | | - | | | 7 | | | - | | | - | | | 7 | |
Stock issued in 2004 for private placement at $0.75 per unit | | 1,894,808 | | * | - | | | 1,418 | | | - | | | - | | | 1,418 | |
Cancellation of shares granted to service providers | | (1,800,000) | | * | - | | | | | | - | | | - | | | - | |
Deferred stock-based compensation related to options granted to employees | | - | | | - | | | 5,979 | | | (5,979) | | | - | | | - | |
Amortization of deferred stock-based compensation related to shares and options granted to employees | | - | | | - | | | - | | | 584 | | | - | | | 584 | |
Compensation related to shares and options granted to service providers | | 2,025,000 | | * | - | | | 17,506 | | | - | | | - | | | 17,506 | |
Net loss | | - | | | - | | | - | | | - | | | (18,840) | | | (18,840) | |
| | | | | | | | | | | | | | | | | | |
Balance as of March 31, 2005 | | 20,867,808 | | $ | 1 | | $ | 25,101 | | $ | (5,395) | | $ | (19,003) | | $ | 704 | |
8 | ||
| | | | | | | | | | | | | Deficit accumulated | | Total | | ||
| | | | | | | Additional | | Deferred | | during the | | stockholders' | | ||||
| | Common stock | | paid-in | | Stock - based | | development | | equity | | |||||||
| | Number | | Amount | | capital | | compensation | | stage | | (deficiency) | | |||||
Balance as of March 31, 2005 | | 20,867,808 | | $ | 1 | | $ | 25,101 | | $ | (5,395) | | $ | (19,003) | | $ | 704 | |
Stock issued on May 12, 2005 for private placement at $0.8 per share | | 186,875 | | * | - | | | 149 | | | - | | | - | | | 149 | |
Stock issued on July 27, 2005 for private placement at $0.6 per share | | 165,000 | | * | - | | | 99 | | | - | | | - | | | 99 | |
Stock issued on September 30, 2005 for private placement at $0.8 per share | | 312,500 | | * | - | | | 225 | | | - | | | - | | | 225 | |
Stock issued on December 7, 2005 for private placement at $0.8 per share | | 187,500 | | * | - | | | 135 | | | - | | | - | | | 135 | |
Forfeiture of options granted to employees | | - | | | - | | | (3,363) | | | 3,363 | | | - | | | - | |
Deferred stock-based compensation related to shares and options granted to directors and employees | | 200,000 | | * | - | | | 486 | | | (486) | | | - | | | - | |
Amortization of deferred stock-based compensation related to options and shares granted to employees and directors | | - | | | - | | | 51 | | | 1,123 | | | - | | | 1,174 | |
Stock-based compensation related to options and shares granted to service providers | | 934,904 | | * | - | | | 662 | | | - | | | - | | | 662 | |
Reclassification due to application of ASC 815-40-25 (formerly EITF 00-19) | | - | | | - | | | (7,906) | | | | | | | | | (7,906) | |
Beneficial conversion feature related to a convertible bridge loan | | - | | | - | | | 164 | | | - | | | - | | | 164 | |
Net loss | | - | | | - | | | - | | | - | | | (3,317) | | | (3,317) | |
Balance as of March 31, 2006 | | 22,854,587 | | $ | 1 | | $ | 15,803 | | $ | (1,395) | | $ | (22,320) | | $ | (7,911) | |
Elimination of deferred stock compensation due to implementation of ASC 718-10 (formerly SFAS 123(R)) | | - | | | - | | | (1,395) | | | 1,395 | | | - | | | - | |
Stock-based compensation related to shares and options granted to directors and employees | | 200,000 | | * | - | | | 1,168 | | | - | | | - | | | 1,168 | |
Reclassification due to application of ASC 815-40-25 (formerly EITF 00-19) | | - | | | - | | | 7,191 | | | - | | | - | | | 7,191 | |
Stock-based compensation related to options and shares granted to service providers | | 1,147,225 | | | - | | | 453 | | | - | | | - | | | 453 | |
Warrants issued to convertible note holder | | - | | | - | | | 11 | | | - | | | - | | | 11 | |
Warrants issued to loan holder | | - | | | - | | | 110 | | | - | | | - | | | 110 | |
Beneficial conversion feature related to convertible bridge loans | | - | | | - | | | 1,086 | | | - | | | - | | | 1,086 | |
Net loss | | - | | | - | | | - | | | - | | | (3,924) | | | (3,924) | |
Balance as of December 31, 2006 | | 24,201,812 | | $ | 1 | | $ | 24,427 | | $ | - | | $ | (26,244) | | $ | (1,816) | |
9 | ||
| | | | | | | | | | | | | Deficit accumulated | | Total | | ||
| | | | | | | Additional | | Deferred | | during the | | stockholders' | | ||||
| | Common stock | | paid-in | | Stock - based | | development | | equity | | |||||||
| | Number | | Capital | | compensation | | stage | | stage | | (deficiency) | | |||||
Balance as of December 31, 2006 | | 24,201,812 | | $ | 1 | | $ | 24,427 | | $ | - | | $ | (26,244) | | $ | (1,816) | |
Stock-based compensation related to options and shares granted to service providers | | 544,095 | | | | | | 1,446 | | | - | | | - | | | 1,446 | |
Warrants issued to convertible note holder | | - | | | - | | | 109 | | | - | | | - | | | 109 | |
Stock-based compensation related to shares and options granted to directors and employees | | 200,000 | | * | - | | | 1,232 | | | - | | | - | | | 1,232 | |
Beneficial conversion feature related to convertible loans | | - | | | - | | | 407 | | | - | | | - | | | 407 | |
Conversion of convertible loans | | 725,881 | | * | - | | | 224 | | | - | | | - | | | 224 | |
Exercise of warrants | | 3,832,621 | | * | - | | | 214 | | | - | | | - | | | 214 | |
Stock issued for private placement at $0.1818 per unit, net of finder's fee | | 11,500,000 | | | 1 | | | 1,999 | | | - | | | - | | | 2,000 | |
Net loss | | - | | | - | | | - | | | - | | | (6,244) | | | (6,244) | |
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2007 | | 41,004,409 | | $ | 2 | | $ | 30,058 | | $ | - | | $ | (32,488) | | $ | (2,428) | |
Stock-based compensation related to options and stock granted to service providers | | 90,000 | | | - | | | 33 | | | - | | | - | | | 33 | |
Stock-based compensation related to stock and options granted to directors and employees | | - | | | - | | | 731 | | | - | | | - | | | 731 | |
Conversion of convertible loans | | 3,644,610 | | * | - | | | 1,276 | | | - | | | - | | | 1,276 | |
Exercise of warrants | | 1,860,000 | | * | - | | | - | | | - | | | - | | | - | |
Exercise of options | | 17,399 | | * | - | | | 3 | | | - | | | - | | | 3 | |
Stock issued for private placement at $0.1818 per unit, net of finder's fee | | 8,625,000 | | | 1 | | | 1,499 | | | - | | | - | | | 1,500 | |
Subscription of shares for private placement at $0.1818 per unit | | - | | | - | | | 281 | | | - | | | - | | | 281 | |
Net loss | | - | | | - | | | - | | | - | | | (3,472) | | | (3,472) | |
Balance as of December 31, 2008 | | 55,241,418 | | $ | 3 | | $ | 33,881 | | $ | - | | $ | (35,960) | | $ | (2,076) | |
10 | ||
| | Common stock | | Additional paid-in | | Deferred stock - based | | Deficit accumulated during the development | | Total stockholders' equity | | |||||||
| | Number | | | Amount | | capital | | compensation | | stage | | (deficiency) | | ||||
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2008 | | 55,241,418 | | $ | 3 | | $ | 33,881 | | $ | - | | $ | (35,960) | | $ | (2,076) | |
| | | | | | | | | | | | | | | | | | |
Stock-based compensation related to options and stock granted to service providers | | 5,284,284 | | * | | | | 775 | | | - | | | - | | | 775 | |
Stock-based compensation related to stock and options granted to directors and employees | | - | | | - | | | 409 | | | - | | | - | | | 409 | |
Conversion of convertible loans | | 2,500,000 | | * | | | | 200 | | | - | | | - | | | 200 | |
Exercise of warrants | | 3,366,783 | | * | | | | - | | | - | | | - | | | - | |
Stock issued for amendment of private placement | | 9,916,667 | | | 1 | | | - | | | - | | | - | | | 1 | |
Subscription of shares | | - | | | - | | | 729 | | | - | | | - | | | 729 | |
Net loss | | - | | | - | | | - | | | - | | $ | (1,781) | | | (1,781) | |
Balance as of December 31, 2009 | | 76,309,152 | | $ | 4 | | $ | 35,994 | | $ | - | | $ | (37,741) | | $ | (1,743) | |
11 | ||
| | | | | | | | | | | | | Deficit | | | | | |
| | | | | | | | | | | | | accumulated | | Total | | ||
| | Common stock | | Additional paid-in | | Deferred Stock - based | | during the development | | stockholders' equity | | |||||||
| | Number | | Amount | | capital | | compensation | | stage | | (deficiency) | | |||||
Balance as of December 31, 2009 | | 76,309,152 | | $ | 4 | | $ | 35,994 | | $ | - | | $ | (37,741) | | $ | (1,743) | |
Stock-based compensation related to options and stock granted to service providers | | 443,333 | | * | - | | | 96 | | | - | | | - | | | 96 | |
Stock-based compensation related to stock and options granted to directors and employees | | 466,667 | | * | - | | | 388 | | | - | | | - | | | 388 | |
Stock issued for amendment of private placement | | 7,250,000 | | | 1 | | | 1,750 | | | - | | | - | | | 1,751 | |
Conversion of convertible note | | 402,385 | | * | - | | | 135 | | | - | | | - | | | 135 | |
Conversion of convertible loans | | 1,016,109 | | * | - | | | 189 | | | - | | | - | | | 189 | |
Issuance of shares | | 2,475,000 | | | | | | 400 | | | | | | | | | 400 | |
Exercise of options | | 1,540,885 | | * | - | | | 77 | | | - | | | - | | | 77 | |
Exercise of warrants | | 3,929,446 | | * | - | | | 11 | | | - | | | - | | | 11 | |
Subscription of shares for private placement at $0.12 per unit | | | | | - | | | 455 | | | - | | | - | | | 455 | |
Conversion of trade payable to stock | | | | | - | | | 201 | | | - | | | - | | | 201 | |
Issuance of shares on account of previously subscribed shares | | 2,000,001 | | * | - | | | - | | | - | | | - | | | - | |
Net loss | | | | | | | | | | | | | | (2,419) | | | (2,419) | |
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2010 | | 95,832,978 | | $ | 5 | | $ | 39,696 | | $ | - | | $ | (40,160) | | $ | (459) | |
12 | ||
| | | | | | | | | | | | | Deficit | | | | | |
| | | | | | | | | | | | | Accumulated | | Total | | ||
| | Common stock | | Additional paid-in | | Deferred Stock - based | | during the development | | stockholders' equity | | |||||||
| | Number | | Amount | | capital | | compensation | | Stage | | (deficiency) | | |||||
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2010 | | 95,832,978 | | $ | 5 | | $ | 39,696 | | $ | - | | $ | (40,160) | | $ | (459) | |
| | | | | | | | | | | | | | | | | | |
Stock-based compensation related to options and stock granted to service providers | | 474,203 | | | - | | | 449 | | | - | | | - | | | 449 | |
Stock-based compensation related to stock and options granted to directors and employees | | 2,025,040 | | | - | | | 1,135 | | | - | | | - | | | 1,135 | |
Conversion of convertible note | | 755,594 | | | - | | | 140 | | | - | | | - | | | 140 | |
Exercise of options | | 1,648,728 | | | - | | | 243 | | | - | | | - | | | 243 | |
Exercise of warrants | | 1,046,834 | | | - | | | 272 | | | - | | | - | | | 272 | |
Issuance of shares for private placement | | 14,160,933 | | | 1 | | | 3,601 | | | - | | | - | | | 3,602 | |
Issuance of shares on account of previously subscribed shares | | 10,499,999 | | | - | | | 24 | | | - | | | - | | | 24 | |
Net loss | | - | | | - | | | - | | | - | | | (3,918) | | | (3,918) | |
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2011 | | 126,444,309 | | $ | 6 | | $ | 45,560 | | $ | - | | $ | (44,078) | | $ | 1,488 | |
13 | ||
| | | | | | | | | | | | | Deficit | | | | | |
| | | | | | | | | | | | | accumulated | | | | | |
| | | | | | | Additional | | Deferred | | during the | | Total | | ||||
| | Common stock | | paid-in | | Stock - based | | development | | stockholders' | | |||||||
| | Number | | Amount | | capital | | compensation | | stage | | equity | | |||||
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2011 | | 126,444,309 | | $ | 6 | | $ | 45,560 | | $ | - | | $ | (44,078) | | $ | 1,488 | |
| | | | | | | | | | | | | | | | | | |
Stock-based compensation related to options and stock granted to service providers | | 794,423 | | | - | | | 195 | | | - | | | - | | | 195 | |
Stock-based compensation related to stock and options granted to directors and employees | | 885,000 | | | - | | | 560 | | | - | | | - | | | 560 | |
Exercise of options | | 1,182,606 | | * | | | | 137 | | | - | | | - | | | 137 | |
Exercise of warrants | | 959,729 | | * | | | | 9 | | | - | | | - | | | 9 | |
Issuance of shares for private placement | | 19,818,968 | | | 1 | | | 5,022 | | | | | | - | | | 5,023 | |
Net loss | | - | | | - | | | - | | | - | | | (3,430) | | | (3,430) | |
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2012 | | 150,085,035 | | $ | 7 | | $ | 51,483 | | $ | - | | $ | (47,508) | | $ | 3,982 | |
14 | ||
| | | | | | | | | | | | | Deficit | | | | | |
| | | | | | | | | | | | | accumulated | | | | | |
| | | | | | | Additional | | Deferred | | during the | | Total | | ||||
| | Common stock | | paid-in | | Stock - based | | development | | stockholders' | | |||||||
| | Number | | Amount | | capital | | compensation | | stage | | equity | | |||||
| | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2012 | | 150,085,035 | | $ | 7 | | $ | 51,483 | | $ | - | | $ | (47,508) | | $ | 3,982 | |
| | | | | | | | | | | | | | | | | | |
Stock-based compensation related to options and stock granted to service providers | | 809,696 | | | | | | 183 | | | - | | | - | | | 183 | |
Stock-based compensation related to stock and options granted to directors and employees | | 760,000 | | | | | | 439 | | | - | | | - | | | 439 | |
Issuance of shares for public offering | | 23,529,411 | | | 1 | | | 3,325 | | | - | | | - | | | 3,326 | |
Issuance of shares for private placement | | 833,334 | | | - | | | 250 | | | - | | | - | | | 250 | |
Conversion of convertible loans | | 126,111 | | | - | | | 30 | | | - | | | - | | | 30 | |
Exercise of options | | 100,000 | | | - | | | 7 | | | - | | | - | | | 7 | |
Net loss | | - | | | - | | | - | | | - | | | (3,682) | | | (3,682) | |
| | | | | | | | | | | | | | | | | | |
Balance as of September 30, 2013 | | 176,243,587 | | | 8 | | | 55,717 | | | - | | | (51,190) | | | 4,535 | |
15 | ||
| | | | | | | | | | | | | | Period from | | |
| | | | | | | | | | | | | | September 22, | | |
| | | | | | | | | | | | | | 2000 (inception | | |
| | Nine months ended | | Three months ended | | date) through | | |||||||||
| | September 30, | | September 30, | | September 30, | | |||||||||
| | 2013 | | 2012 | | 2013 | | 2012 | | 2013(*) | | |||||
| | Unaudited | | Unaudited | | Unaudited | | |||||||||
| | | | | | | | | | | | | | | | |
Cash flows from operating activities: | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Net loss | | $ | (3,682) | | $ | (2,851) | | $ | (1,082) | | $ | (1,150) | | $ | (51,190) | |
Less - loss for the period from discontinued operations | | | - | | | - | | | - | | | - | | | 164 | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | | | | | | | | | |
Depreciation and amortization of deferred charges | | | 77 | | | 116 | | | 27 | | | 40 | | | 1,235 | |
Severance pay, net | | | 29 | | | 6 | | | 22 | | | 5 | | | 46 | |
Accrued interest on loans | | | - | | | - | | | - | | | - | | | 451 | |
Amortization of discount on short-term loans | | | - | | | - | | | - | | | - | | | 1,864 | |
Change in fair value of options and warrants | | | - | | | - | | | - | | | - | | | (795) | |
Expenses related to shares and options granted to service providers | | | 213 | | | 46 | | | 11 | | | 38 | | | 21,894 | |
Amortization of deferred stock-based compensation related to options granted to employees | | | 439 | | | 440 | | | (75) | | | 127 | | | 7,820 | |
Decrease (increase) in accounts receivable and prepaid expenses | | | 231 | | | (121) | | | 198 | | | 56 | | | (557) | |
Increase (decrease) in trade payables and convertible note | | | 88 | | | (50) | | | 73 | | | (321) | | | 919 | |
Increase in other accounts payable and accrued expenses | | | 159 | | | 175 | | | 113 | | | 131 | | | 1,446 | |
Erosion of restricted cash | | | - | | | - | | | - | | | - | | | (6) | |
| | | | | | | | | | | | | | | | |
Net cash used in continuing operating activities | | | (2,446) | | | (2,239) | | | (713) | | | (1,074) | | | (16,709) | |
| | | | | | | | | | | | | | | | |
Net cash used in discontinued operating activities | | | - | | | - | | | - | | | - | | | (23) | |
| | | | | | | | | | | | | | | | |
Total net cash used in operating activities | | $ | (2,446) | | $ | (2,239) | | $ | (713) | | $ | (1,074) | | $ | (16,732) | |
16 | ||
| | | | | | | | | | | | | | Period from | | |
| | | | | | | | | | | | | | September 22, | | |
| | | | | | | | | | | | | | 2000 (inception | | |
| | Nine months ended | | Three months ended | | date) through | | |||||||||
| | September 30, | | September 30, | | September 30, | | |||||||||
| | 2013 | | 2012 | | 2013 | | 2012 | | 2013 | | |||||
| | Unaudited | | Unaudited | | Unaudited | | |||||||||
| | | | | | | | | | | | | | | | |
Cash flows from investing activities: | | | | | | | | | | | | | | | | |
Purchase of property and equipment | | | (97) | | | (75) | | | (31) | | | (14) | | | (1,320) | |
Restricted cash | | | - | | | - | | | - | | | - | | | 6 | |
Changes in short-term deposit | | | (2,017) | | | - | | | (3,006) | | | - | | | (4,786) | |
Investment in lease deposit | | | (11) | | | - | | | (2) | | | - | | | (28) | |
Net cash used in continuing investing activities | | | (2,125) | | | (75) | | | (3,039) | | | (14) | | | (6,128) | |
Net cash used in discontinued investing activities | | | - | | | - | | | - | | | - | | | (16) | |
| | | | | | | | | | | | | | | | |
Total net cash used in investing activities | | $ | (2,125) | | $ | (75) | | $ | (3,039) | | $ | (14) | | $ | (6,144) | |
| | | | | | | | | | | | | | | | |
Cash flows from financing activities: | | | | | | | | | | | | | | | | |
Proceeds from issuance of Common stock, net | | | 3,576 | | | 5,028 | | | 3,326 | | | 5,028 | | | 20,918 | |
Proceeds from loans, notes and issuance of warrants, net | | | - | | | - | | | - | | | - | | | 2,061 | |
Proceeds from exercise of warrants and options | | | 7 | | | 146 | | | - | | | - | | | 784 | |
Repayment of short-term loans | | | - | | | - | | | - | | | - | | | (601) | |
| | | | | | | | | | | | | | | | |
Net cash provided by continuing financing activities | | | 3,583 | | | 5,174 | | | 3,326 | | | 5,028 | | | 23,162 | |
Net cash provided by discontinued financing activities | | | - | | | - | | | - | | | - | | | 43 | |
Total net cash provided by financing activities | | $ | 3,583 | | $ | 5,174 | | $ | 3,326 | | $ | 5,028 | | $ | 23,205 | |
| | | | | | | | | | | | | | | | |
Increase (decrease) in cash and cash equivalents | | | (988) | | | 2,860 | | | (426) | | | 3,940 | | | 329 | |
Cash and cash equivalents at the beginning of the period | | | 1,317 | | | 1,923 | | | 755 | | | 843 | | | - | |
| | | | | | | | | | | | | | | | |
Cash and cash equivalents at end of the period | | $ | 329 | | $ | 4,783 | | $ | 329 | | $ | 4,783 | | $ | 329 | |
17 | ||
| A. | Brainstorm Cell Therapeutics Inc. (formerly: Golden Hand Resources Inc. - the "Company") was incorporated in the State of Washington on September 22, 2000. |
| | |
| B. | On May 21, 2004, the former major stockholders of the Company entered into a purchase agreement with a group of private investors, who purchased from the former major stockholders 6,880,000 shares of the then issued and outstanding 10,238,000 shares of Common Stock. |
| | |
| C. | On July 8, 2004, the Company entered into a licensing agreement with Ramot of Tel Aviv University Ltd. ("Ramot"), to acquire certain stem cell technology (see Note 4). Subsequent to this agreement, the Company decided to focus on the development of novel cell therapies for neurodegenerative diseases based on the acquired technology and research to be conducted and funded by the Company. |
| | |
| | Following the licensing agreement dated July 8, 2004, the management of the Company decided to abandon all old activities related to the sale of the digital data recorder product. The discontinuation of this activity was accounted for under the provision of Statement of Financial Accounting Standard ASC 360-10, "Accounting for the Impairment or Disposal of Long-Lived Assets". |
| | |
| D. | On October 25, 2004, the Company formed a wholly-owned subsidiary in Israel, Brainstorm Cell Therapeutics Ltd. ("BCT"). |
| | |
| E. | On November 18, 2004, the Company changed its name from Golden Hand Resources Inc. to Brainstorm Cell Therapeutics Inc. to better reflect its new line of business in the development of novel cell therapies for neurodegenerative diseases. BCT, as defined above, owns all operational property and equipment. |
| | |
| | The Common Stock is registered and publicly traded on the OTC Markets Group service of the National Association of Securities Dealers, Inc. under the symbol BCLI. |
| F. | On September 17, 2006, the Company changed the Company's fiscal year-end from March 31 to December 31. |
| | |
| G. | In December 2006, the Company changed its state of incorporation from Washington to Delaware. |
| | |
| H. | Since its inception, the Company has devoted substantially all of its efforts to research and development, recruiting management and technical staff, acquiring assets and raising capital. In addition, the Company has not generated revenues. Accordingly, the Company is considered to be in the development stage, as defined in "Accounting and reporting by development Stage Enterprises" ASC 915-10. |
| | |
| I. | In October 2010, the Israeli Ministry of Health (“MOH”) granted clearance for a Phase I/II clinical trial using the Company’s autologous NurOwn stem cell therapy in patients with amyotrophic lateral sclerosis (”ALS”), subject to some additional process specifications as well as completion of the sterility validation study for tests performed. |
| | |
| | On February 23, 2011, the Company submitted, to the MOH, all the required documents. Following approval of the MOH, a Phase I/II clinical study for ALS patients using the Company’s autologous NurOwn stem cell therapy (the “Clinical Trial”) was initiated in June 2011. |
| | |
| J. | In February 2011, the U.S. Food and Drug Administration (“FDA”) granted orphan drug designation to the Company’s NurOwn autologous adult stem cell product for the treatment of ALS. |
18 | ||
NOTE 1 - | GENERAL (Cont.): |
| K. | On February 19, 2013, Brainstorm Ltd established a wholly-owned subsidiary, Brainstorm Cell Therapeutics UK Ltd. (“Brainstorm UK”). Brainstorm UK will act on behalf of the parent Company in the EU. |
| L. | On February 21, 2013, Brainstorm UK filed a request for Orphan Medicinal Product Designation by the European Medicine Agency (EMA) for its Autologous Bone Marrow derived Mesenchyme Stromal cells Secreting Neurotropic factors (MSC-NTF, NurOwn). |
| M. | On April 8, 2013, the Company entered into an agreement with Dana-Farber Cancer Institute (“Dana-Farber”) to provide cGMP-compliant clean room facilities for production of the Company’s NurOwn stem cell candidate during its upcoming Phase II ALS trial in the United States. The Company’s Phase II trial, to be launched in the second half of 2013 pending FDA approval, will be conducted at Massachusetts General Hospital (“MGH”), the University of Massachusetts (“UMass”) Hospital and the Mayo Clinic. The Connell and O'Reilly Cell Manipulation Core Facility at Dana-Farber will produce NurOwn for the MGH and UMass Hospital clinical sites. |
| N. | On April 18, 2013, the stockholders of the Company authorized the Board of Directors of the Company, in its discretion, should it deem it to be appropriate and in the best interests of the Company and its stockholders, to amend the Company’s Certificate of Incorporation to effect a reverse stock split of the Company’s issued and outstanding shares of common stock by a ratio of between 1-for-10 and 1-for-20, inclusive, without further approval or authorization of the Company’s stockholders. |
| O. | On July 17, 2013, the European Commission granted Orphan Drug Designation to the Company’s NurOwn autologous adult stem cell product for the treatment of ALS. |
| P. | On September 27, 2013, the Company recently completed treatment of the 12 patients in its ALS Phase IIa dose-escalating clinical trial with the Company’s NurOwn technology. The complete and final statistical analysis of the data is expected to be available after 6 months of follow up with the patients. The Company has been informed that one patient in the study expired due to a medical condition unrelated to the Clinical Trial. |
| The Clinical Trial is being performed at Hadassah Medical Center in Jerusalem, Israel, under the direction of Prof. Dimitrios Karussis, M.D., Ph.D., head of Hadassah's Multiple Sclerosis Center and a member of the International Steering Committees for Bone Marrow and Mesenchymal Stem Cells Transplantation in Multiple Sclerosis (MS). The study is designed to establish the safety and preliminary efficacy of NurOwn at increasing dosages. |
| GOING CONCERN: |
| |
| As reflected in the accompanying financial statements, the Company’s operations for the nine months ended September 30, 2013, resulted in a net loss of $3,682. The Company’s balance sheet reflects an accumulated deficit of $51,190. These conditions, together with the fact that the Company is a development stage Company and has no revenues nor are revenues expected in the near future, raise substantial doubt about the Company's ability to continue to operate as a going concern. The Company’s ability to continue operating as a “going concern” is dependent on several factors, among them is its ability to raise sufficient additional working capital. |
| |
| In 2009, the Company decided to focus only on the effort to commence clinical trials for ALS and such trials did commence in 2011. |
| |
| In July 2012, the Company raised $5.7 million, gross, in a public offering (See Note 6B (i)). In August 2013, the Company raised $4 million, gross, in a public offering (See Note 6B(j)). However, there can be no assurance that additional funds will be available on terms acceptable to the Company, or at all. |
| |
| These financial statements do not include any adjustments relating to the recoverability and classification of assets, carrying amounts or the amount and classification of liabilities that may be required should the Company be unable to continue as a going concern. |
19 | ||
NOTE 2 - | SIGNIFICANT ACCOUNTING POLICIES |
| |
| The significant accounting policies applied in the annual financial statements of the Company as of December 31, 2012 are applied consistently in these financial statements. |
NOTE 3 - | UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| |
| The accompanying unaudited interim financial statements have been prepared in a condensed format and include the consolidated financial operations of the Company and its wholly-owned subsidiary as of September 30, 2013 and for the three months then ended, in accordance with accounting principles generally accepted in the United States relating to the preparation of financial statements for interim periods. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the nine months ended September 30, 2013, are not necessarily indicative of the results that may be expected for the year ended December 31, 2013. |
NOTE 4 - | RESEARCH AND LICENSE AGREEMENT |
| |
| The Company has a Research and License Agreement, as amended and restated, with Ramot. The Company obtained a waiver and release from Ramot pursuant to which Ramot agreed to an amended payment schedule regarding the Company's payment obligations under the Research and License Agreement and waived all claims against the Company resulting from the Company's previous defaults and non-payment under the Research and License Agreement. The waiver and release amended and restated the original payment schedule under the original agreement providing for payments during the initial research period and additional payments for any extended research period. |
| |
| As of December 24, 2009, the Company had paid to Ramot $400 but did not make payments totaling $240 for the initial research period and payments totaling $380 for the extended research period. |
| |
| On December 24, 2009, the Company and Ramot entered into a settlement agreement which amended the Research and License Agreement, as amended and restated pursuant to which, among other things, the following matters were agreed upon: |
| a) | Ramot released the Company from its obligation to fund the extended research period in the total amount of $1,140. Therefore, the Company reversed an amount in 2009, equal to $760, from it research and development expenses that were previously expensed. |
| b) | Past due amounts of $240 for the initial research period plus interest of $32 owed by the Company to Ramot was converted into 1,120,000 shares of common stock on December 30, 2009. Ramot was required to deposit the shares with a broker and only sell the shares in the open market after 185 days from the issuance date. |
| c) | In the event that the total proceeds generated by sales of the shares on December 31, 2010, together with the March 31, 2010 payment, were less than $240 on or prior to December 31, 2010, then on such date the Company would pay to Ramot the difference between the proceeds that Ramot has received from sales of the shares up to such date together with the September Payment (if any) that has been transferred to Ramot up to such date, and $240. Related compensation in the amount of $51 was recorded as research and development expenses. |
| In January 2011, Ramot sold an additional 167,530 shares of Common Stock of the Company, for $35, which finalized the sale of the 1,120,000 Common Stock of the Company granted to Ramot for $235. In February 2011, the Company paid the remaining $5 and finalized the balance due to Ramot according to the settlement agreement between the parties dated December 24, 2009. |
20 | ||
NOTE 4 - | RESEARCH AND LICENSE AGREEMENT (Cont.) |
| The Company is to pay Ramot royalties on Net Sales on a Licensed Product by Licensed Product and jurisdiction by jurisdiction basis as follow: |
| a) | So long as the making, producing, manufacturing, using, marketing, selling, importing or exporting of such Licensed Product is covered by a Valid Claim or is covered by Orphan Drug Status in such jurisdiction 5% of all Net Sales. |
| b) | In the event the making, producing, manufacturing, using, marketing, selling, importing or exporting of such Licensed Product is not covered by a Valid Claim and not covered by Orphan Drug status in such jurisdiction 3% of all Net Sales until the expiration of 15 years from the date of the First Commercial Sale of such Licensed Product in such jurisdiction. |
NOTE 5 - | CONSULTING AGREEMENTS |
| A. | On July 8, 2004, the Company entered into two consulting agreements with Prof. Eldad Melamed and Dr. Daniel Offen (together, the "Consultants"), under which the Consultants provide the Company scientific and medical consulting services in consideration for a monthly payment of $6 each. In addition, the Company granted each of the Consultants, a fully vested warrant to purchase 1,097,215 shares of Common Stock at an exercise price of $0.01 per share. The warrants issued pursuant to the agreement were issued to the Consultants effective as of November 4, 2004. Each of the warrants is exercisable for a seven-year period beginning on November 4, 2005. As of September 2010, all the above warrants had been exercised. In June 2012 an amendment was signed with Dr. Daniel Offen, according to which the company pays Daniel Offen a monthly payment of $6, out of which $3 in cash and $3 by grant of Company stock. |
| B. | On December 16, 2010, the Company approved a grant of 1,100,000 shares of the Company's Common Stock to the two Consultants, for services rendered through December 31, 2010. Related compensation in the amount of $220 was recorded as research and development expense. A sum of $487 was cancelled concurrently with the issuance of the 1,100,000 shares of Common Stock of the Company. |
| C. | On June 27, 2011, the Company approved an additional grant of 400,000 shares of the Company's Common Stock to Prof. Daniel Offen, for services rendered through December 31, 2009. Related compensation in the amount of $192 was recorded as research and development expense. |
| | |
| D. | On August 1, 2012, the Company approved an additional grant of 623,077 shares of the Company's Common Stock to the Consultants, for services rendered from January 1, 2011 through June 30, 2012. Related compensation in the amount of $162 was recorded as research and development expense. |
| | |
| E. | On January 16, 2013, the Company granted the Consultants an aggregate of 216,000 shares of Common Stock for their services from January 1, 2012 through December 31, 2012. Related compensation in the amount of $54 was recorded as research and development expense. |
21 | ||
22 | ||
23 | ||
24 | ||
25 | ||
26 | ||
| | For the nine months ended | | ||||
| | September 30, 2013 | | ||||
| | | | Weighted average | | Aggregate | |
| | Amount of | | exercise | | intrinsic | |
| | options | | price | | value | |
| | | | $ | | $ | |
| | | | | | | |
Outstanding at beginning of period | | 4,751,665 | | 0.1803 | | | |
Granted | | 4,626,666 | | 0.2656 | | | |
Exercised | | - | | - | | | |
Cancelled | | (4,006,667) | | 0.2898 | | | |
| | | | | | | |
Outstanding at end of period | | 5,371,664 | | 0.1721 | | 96,166 | |
| | | | | | | |
Vested and expected-to-vest at end of period | | 4,943,609 | | 0.1764 | | 67,341 | |
27 | ||
28 | ||
| | Number of | | | | | | | | | | | | |
| | warrants | | | | | | | | Exercise | | Warrants | | Exercisable |
Issuance date | | issued | | Exercised | | Forfeited | | Outstanding | | Price $ | | exercisable | | through |
| | | | | | | | | | | | | | |
November-December 2004 | | 14,600,845 | | 14,396,010 | | 204,835 | | - | | 0.00005 - 0.01 | | - | | - |
February-December 2005 | | 3,058,471 | | 173,000 | | 2,548,308 | | 337,163 | | 0.15 - 2.5 | | 337,163 | | Jun - Dec 2015 |
February-December 2006 | | 1,686,355 | | 727,696 | | 478,659 | | 480,000 | | 0.005 1.5 | | 480,000 | | Feb - May 2016 |
March 2007 | | 14,803,300 | | | | 1,003,300 | | 13,800,000 | | 0.15 - 0.47 | | 13,800,000 | | May 2015 Oct 2017 |
April 2008 | | 9,175,000 | | | | | | 9,175,000 | | 0.15 - 0.29 | | 9,175,000 | | May 2015 Sep 2018 |
Apr-Oct 2009 | | 4,937,500 | | 100,000 | | | | 4,837,500 | | 0.067 0.29 | | 4,837,500 | | May 2015 Oct 2019 |
January 2010 | | 1,250,000 | | | | 1,250,000 | | - | | 0.5 | | - | | - |
February 2010 | | 125,000 | | 125,000 | | | | - | | 0.01 | | - | | - |
February 2010 | | 3,000,000 | | | | 3,000,000 | | - | | 0.5 | | - | | - |
February 2010 | | 1,500,000 | | | | | | 1,500,000 | | 0.001 | | 1,000,000 | | Feb 2020 |
April 2010 | | 33,334 | | | | | | 33,334 | | 0.00005 | | 33,334 | | Apr 2020 |
January 2011 | | 4,537,500 | | | | | | 4,537,500 | | 0.29 | | 4,537,500 | | May 2015 |
February 2011 | | 641,026 | | | | 641,026 | | - | | 0.39 | | - | | - |
February 2011 | | 6,407,500 | | 946,834 | | 5,460,666 | | - | | 0.28 | | - | | - |
February 2011 | | 12,815,000 | | | | 12,815,000 | | - | | 0.5 | | - | | - |
April 2011 | | 33,334 | | | | | | 33,334 | | 0.01 | | 33,334 | | Apr 2021 |
April 2012 | | 33,334 | | | | | | 33,334 | | 0.01 | | 33,334 | | Apr 2022 |
July 2012 | | 493,966 | | | | | | 493,966 | | 0.348 | | 493,966 | | Jul 2014 |
July 2012 | | 232,758 | | | | | | 232,758 | | 0.29 | | 232,758 | | Jan 2015 |
July 2012 | | 14,864,228 | | | | | | 14,864,228 | | 0.29 | | 14,864,228 | | Jan 2015 |
Feb 2013 | | 833,334 | | | | | | 833,334 | | 0.5 | | 833,334 | | Oct 2015 |
April 2013 | | 33,334 | | | | | | 33,334 | | 0.00005 | | 13,889 | | April 2023 |
August 2013 | | 17,647,058 | | | | | | 17,647,058 | | 0.25 | | 17,647,058 | | August 2016 |
| | 112,742,177 | | 16,468,540 | | 27,401,794 | | 68,871,843 | | | | 68,352,398 | | |
29 | ||
30 | ||
31 | ||
32 | ||
| | | | | | | | | | Period from | |
| | | | | | | | | | September 22, | |
| | | | | | | | | | 2000 (inception | |
| | Nine months ended | | Three months ended | | date) through | | ||||
| | September 30, | | September 30, | | September 30, | | ||||
| | 2013 | | 2012 | | 2013 | | 2012 | | 2013 | |
| | Unaudited | | Unaudited | | Unaudited | | ||||
| | | | | | | | | | | |
Research and development | | 101 | | 44 | | 7 | | 19 | | 17,867 | |
General and administrative | | 521 | | 441 | | (71) | | 145 | | 11,179 | |
Financial expenses, net | | - | | - | | - | | - | | 248 | |
Total stock-based compensation expense | | 622 | | 485 | | (64) | | 164 | | 29,294 | |
33 | ||
34 | ||
35 | ||
· | Bone marrow aspiration from patient; |
36 | ||
· | Isolation and expansion of the mesenchymal stem cells; |
· | Differentiation of the expanded stem cells into neurotrophic-factor secreting (MSC-NTF) cells; and |
· | Autologous transplantation into the patient’s spinal cord or muscle tissue. |
· | Protection of existing motor neurons; |
· | Promotion of motor neuron growth; and |
· | Re-establishment of nerve-muscle interaction. |
37 | ||
38 | ||
39 | ||
· | our ability to obtain funding from third parties, including any future collaborative partners; |
· | the scope, rate of progress and cost of our clinical trials and other research and development programs; |
· | the time and costs required to gain regulatory approvals; |
· | the terms and timing of any collaborative, licensing and other arrangements that we may establish; |
· | the costs of filing, prosecuting, defending and enforcing patents, patent applications, patent claims, trademarks and other intellectual property rights; |
40 | ||
· | the effect of competition and market developments; and |
· | future pre-clinical and clinical trial results. |
41 | ||
42 | ||
43 | ||
| BRAINSTORM CELL THERAPEUTICS INC. | |
| | |
November 14, 2013 | By: | /s/ Chaim Lebovits |
| | Name: Chaim Lebovits |
| | Title: President (Principal Executive Officer) |
November 14, 2013 | By: | /s/ Liat Sossover |
| | Name: Liat Sossover |
| | Title: Chief Financial Officer (Principal |
| | Financial Officer) |
44 | ||
Exhibit | | |
Number | | Description |
31.1 | | Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| | |
31.2 | | Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| | |
32.1 | | Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| | |
32.2 | | Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| | |
4.1 | | Form of Warrant, incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed August 13, 2013 (File No. 000-54365). |
| | |
10.1 | | Underwriting Agreement dated as of August 13, 2013 by and between Brainstorm Cell Therapeutics Inc., Roth Capital Partners, LLC and Maxim Group LLC, incorporated by reference to Exhibit 1.1 of the Company’s Current Report on Form 8-K filed August 13, 2013 (File No. 000-54365). |
| | |
10.2 | | Amendment to Employment Agreement, dated September 5, 2011, by and between Brainstorm Cell Therapeutics Ltd. and Adrian Harel, incorporated by reference to Exhibit 10.39 of the amendment to the Company’s Registration Statement on Form S-1 filed on July 9, 2013 (File No. 333-186516). |
45 | ||