x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
41-2254389
|
|
(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification Number) |
Large accelerated filer
¨
|
Accelerated filer
¨
|
||
Non-accelerated filer
¨
|
Smaller reporting company
x
|
Page
|
|||||
Part I
|
Financial Information
|
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1
|
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2
|
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3
|
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9
|
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10
|
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23
|
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34
|
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34
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35
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35
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36
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36
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36
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36
|
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37
|
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As of
|
||||||||
June 30, 2013
|
December 31, 2012
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$ | 543,190 | $ | 402,823 | ||||
Accounts receivable
|
45,426 | 80,279 | ||||||
Inventories, net
|
162,425 | 203,389 | ||||||
Prepaid expenses and other current assets
|
81,447 | 62,833 | ||||||
Total current assets
|
832,488 | 749,324 | ||||||
PROPERTY AND EQUIPMENT, net
|
27,137 | 38,769 | ||||||
OTHER ASSETS
|
||||||||
Marketable securities, long-term
|
1,601,919 | 561,521 | ||||||
Intangibles, net
|
1,214,286 | 1,321,429 | ||||||
Notes receivable
|
18,000 | 18,000 | ||||||
Deposits
|
99,511 | 195,197 | ||||||
Total other assets
|
2,933,716 | 2,096,147 | ||||||
Total Assets
|
$ | 3,793,341 | $ | 2,884,240 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
CURRENT LIABILITIES
|
||||||||
Accounts payable and accrued expenses
|
$ | 2,688,784 | $ | 2,560,278 | ||||
Due to related party
|
— | 394,446 | ||||||
Dissenting stockholders payable
|
140,000 | 200,000 | ||||||
Notes payable, net
|
3,608,194 | 3,939,041 | ||||||
Convertible notes payable, net
|
4,565,137 | 4,627,695 | ||||||
Total current liabilities
|
11,002,115 | 11,721,460 | ||||||
LONG-TERM LIABILITIES
|
||||||||
Notes payable
|
200,000 | 700,000 | ||||||
Convertible notes payable, net
|
2,674,890 | 1,106,035 | ||||||
Total long-term liabilities
|
2,874,890 | 1,806,035 | ||||||
Total Liabilities
|
13,877,005 | 13,527,495 | ||||||
STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Preferred stock – par value $0.001 per share, 20,000,000 shares authorized, none issued and outstanding
|
— | — | ||||||
Common stock – par value $0.001 per share, 100,000,000 shares authorized, 23,493,454 and 24,878,436 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively (both excluding 47,178 shares held by stockholders who exercised dissenters’ rights).
|
23,493 | 24,878 | ||||||
Additional paid-in capital
|
32,022,311 | 25,361,863 | ||||||
Accumulated other comprehensive income
|
1,001,534 | (12,432 | ) | |||||
Deficit accumulated during the development stage
|
(43,131,002 | ) | (36,017,564 | ) | ||||
Total Stockholders’ Equity (Deficit)
|
(10,083,664 | ) | (10,643,255 | ) | ||||
Total Liabilities & Stockholders’ Equity (Deficit)
|
$ | 3,793,341 | $ | 2,884,240 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
From
December 20, 2000 (date of inception)
to June 30,
|
||||||||||||||||||
2013
|
2012
|
2013
|
2012
|
2013
|
||||||||||||||||
SALES
|
$ | 96,716 | $ | 109,312 | $ | 188,582 | $ | 263,039 | $ | 1,473,843 | ||||||||||
SALES RETURN & ALLOWANCE
|
(5,508 | ) | (2,196 | ) | (7,814 | ) | (10,756 | ) | (68,901 | ) | ||||||||||
REVENUES
|
91,208 | 107,116 | 180,768 | 252,283 | 1,404,942 | |||||||||||||||
COST OF GOODS SOLD
|
||||||||||||||||||||
Cost of goods sold
|
54,988 | 29,186 | 98,972 | 49,773 | 640,783 | |||||||||||||||
Scrapped inventory
|
— | — | — | — | 235,537 | |||||||||||||||
Total cost of goods sold
|
54,988 | 29,186 | 98,972 | 49,773 | 876,320 | |||||||||||||||
GROSS PROFIT
|
36,220 | 77,930 | 81,796 | 202,510 | 528,622 | |||||||||||||||
OPERATING EXPENSES
|
||||||||||||||||||||
Research and development
|
696,008 | 886,390 | 1,311,261 | 1,428,984 | 10,729,701 | |||||||||||||||
Selling
|
129,335 | 97,938 | 256,688 | 198,453 | 3,158,255 | |||||||||||||||
General and administrative
|
2,614,165 | 2,572,788 | 5,020,393 | 4,107,031 | 23,988,395 | |||||||||||||||
Transaction costs
|
— | — | — | — | 788,893 | |||||||||||||||
3,439,508 | 3,557,116 | 6,588,342 | 5,734,468 | 38,665,244 | ||||||||||||||||
LOSS FROM OPERATIONS
|
(3,403,288 | ) | (3,479,186 | ) | (6,506,546 | ) | (5,531,958 | ) | (38,136,622 | ) | ||||||||||
OTHER INCOME (EXPENSE)
|
||||||||||||||||||||
Realized gain on securities available-for-sale
|
— | 275,822 | — | 275,822 | 275,822 | |||||||||||||||
Gain on derecognition of liabilities
|
394,447 | — | 735,808 | — | 735,808 | |||||||||||||||
Interest income
|
5,081 | 7,535 | 10,722 | 14,612 | 164,098 | |||||||||||||||
Interest expense
|
(746,345 | ) | (998,898 | ) | (1,350,872 | ) | (1,892,396 | ) | (6,142,255 | ) | ||||||||||
(346,818 | ) | (715,541 | ) | (604,342 | ) | (1,601,962 | ) | (4,966,527 | ) | |||||||||||
LOSS BEFORE INCOME TAXES
|
$ | (3,750,105 | ) | $ | (4,194,727 | ) | $ | (7,110,888 | ) | $ | (7,133,920 | ) | $ | (43,103,149 | ) | |||||
INCOME TAXES
|
— | — | 2,550 | 5,800 | 27,853 | |||||||||||||||
NET LOSS
|
$ | (3,750,105 | ) | $ | (4,194,727 | ) | $ | (7,113,438 | ) | $ | (7,139,720 | ) | $ | (43,131,002 | ) | |||||
OTHER INCOME | ||||||||||||||||||||
Unrealized holding gain on securities available-for-sale, net of tax
|
348,627 | (424,335 | ) | 1,040,398 | (68,463 | ) | 1,036,013 | |||||||||||||
Unrealized foreign translation
|
(24,613 | ) | (36,179 | ) | (26,432 | ) | (34,530 | ) | (34,478 | ) | ||||||||||
COMPREHENSIVE LOSS
|
$ | (3,426,091 | ) | $ | (4,655,241 | ) | $ | (6,099,472 | ) | $ | (7,242,713 | ) | $ | (42,129,467 | ) | |||||
NET LOSS PER COMMON SHARE
|
$ | (0.15 | ) | $ | (0.17 | ) | $ | (0.28 | ) | $ | (0.29 | ) | ||||||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
|
25,281,873 | 24,395,239 | 25,086,033 | 24,394,350 |
Common stock – par value
$0.001 per share, 100,000,000 shares authorized |
Additional |
Accumulated
Other
|
Deficit Accumulated | |||||||||||||||||||||||||
Shares
|
Common stock
|
Gross $/Share
|
Paid-in Capital
|
Comprehensive Income
|
during Development Stage
|
Total
|
||||||||||||||||||||||
Balance, December 31, 2000 (1) (2)
|
12,531,125 | $ | 12,531 | $ | (2,931 | ) | $ | — | $ | — | $ | 9,600 | ||||||||||||||||
Net loss
|
— | — | — | — | (21,942 | ) | (21,942 | ) | ||||||||||||||||||||
Balance, December 31, 2001
|
12,531,125 | 12,531 | (2,931 | ) | — | (21,942 | ) | (12,342 | ) | |||||||||||||||||||
Net loss
|
— | — | — | — | (12,464 | ) | (12,464 | ) | ||||||||||||||||||||
Balance, December 31, 2002
|
12,531,125 | 12,531 | (2,931 | ) | — | (34,406 | ) | (24,806 | ) | |||||||||||||||||||
Constructive distribution of retained loss to Additional Paid-in Capital
|
— | — | (34,406 | ) | — | 34,406 | — | |||||||||||||||||||||
Common stock issued
|
737,125 | 737 | 0.34 | 249,263 | — | — | 250,000 | |||||||||||||||||||||
— | ||||||||||||||||||||||||||||
Net loss
|
— | — | — | — | (97,481 | ) | (97,481 | ) | ||||||||||||||||||||
Balance, December 31, 2003
|
13,268,250 | 13,268 | 211,926 | — | (97,481 | ) | 127,713 |
Common stock – par value
$0.001 per share, 100,000,000 shares authorized |
Additional |
Accumulated Other
|
Deficit Accumulated
|
|||||||||||||||||||||||||
Shares
|
Common Stock
|
Gross $/Share
|
Paid-in
Capital
|
Comprehensive
Income
|
during
Development Stage
|
Total
|
||||||||||||||||||||||
Balance, December 31, 2003
|
13,268,250 | $ | 13,268 | $ | 211,926 | $ | — | $ | (97,481 | ) | $ | 127,713 | ||||||||||||||||
Common stock issued
|
1,459,270 | 1,459 | 0.35 | 503,616 | — | — | 505,075 | |||||||||||||||||||||
Common stock issued
|
88,455 | 89 | 0.06 | 4,911 | — | — | 5,000 | |||||||||||||||||||||
Common stock issued
|
67,817 | 68 | 2.03 | 137,932 | — | — | 138,000 | |||||||||||||||||||||
Net loss
|
— | — | — | — | (624,936 | ) | (624,936 | ) | ||||||||||||||||||||
Balance, December 31, 2004
|
14,883,792 | 14,884 | 858,385 | — | (722,417 | ) | 150,852 | |||||||||||||||||||||
Common stock issued
|
398,549 | 399 | 2.03 | 327,886 | — | — | 328,285 | |||||||||||||||||||||
Net loss
|
— | — | — | — | (668,091 | ) | (668,091 | ) | ||||||||||||||||||||
Balance, December 31, 2005
|
15,282,341 | 15,283 | 1,186,271 | — | (1,390,508 | ) | (188,954 | ) | ||||||||||||||||||||
Common stock issued
|
523,388 | 523 | 2.03 | 824,517 | — | — | 825,040 | |||||||||||||||||||||
Net loss
|
— | — | — | — | (759,962 | ) | (759,962 | ) | ||||||||||||||||||||
Balance, December 31, 2006
|
15,805,729 | 15,806 | 2,010,788 | — | (2,150,470 | ) | (123,876 | ) | ||||||||||||||||||||
Common stock issued
|
1,344,162 | 1,344 | 2.03 | 2,732,516 | — | — | 2,733,860 | |||||||||||||||||||||
Net loss
|
— | — | — | — | (1,282,212 | ) | (1,282,212 | ) | ||||||||||||||||||||
Balance, December 31, 2007
|
17,149,891 | 17,150 | 4,743,304 | — | (3,432,682 | ) | 1,327,772 |
Common stock – par value
$0.001 per share, 100,000,000 shares authorized |
Additional
|
Accumulated Other
|
Deficit Accumulated
|
|||||||||||||||||||||||||
Shares
|
Common Stock
|
Gross $/Share
|
Paid-in Capital
|
Comprehensive Income | during Development Stage |
Total
|
||||||||||||||||||||||
Balance, December 31, 2007
|
17,149,891 | $ | 17,150 | $ | 4,743,304 | $ | — | $ | (3,432,682 | ) | $ | 1,327,772 | ||||||||||||||||
Common stock issued
|
1,226,959 | 1,227 | 2.03 | 3,389,464 | — | — | 3,390,691 | |||||||||||||||||||||
Net loss
|
— | — | — | — | (2,993,777 | ) | (2,993,777 | ) | ||||||||||||||||||||
Balance, December 31, 2008
|
18,376,850 | 18,377 | 8,132,768 | — | (6,426,459 | ) | 1,724,686 | |||||||||||||||||||||
Warrants issued
|
— | — | 160,000 | — | — | 160,000 | ||||||||||||||||||||||
Common stock issued, net of issuance cost of $160,000
|
854,446 | 854 | 2,078,071 | — | — | 2,078,925 | ||||||||||||||||||||||
Net loss
|
— | — | — | — | (2,567,807 | ) | (2,567,807 | ) | ||||||||||||||||||||
Balance, December 31, 2009
|
19,231,296 | 19,231 | 10,370,839 | — | (8,994,266 | ) | 1,395,804 | |||||||||||||||||||||
Warrants issued
|
— | — | 480,000 | — | — | 480,000 | ||||||||||||||||||||||
Common stock issued, net of issuance cost of $480,000
|
705,900 | 706 | 3.05 | 1,643,588 | — | — | 1,644,294 | |||||||||||||||||||||
Conversion of notes payable to common stock
|
427,857 | 428 | 3.05 | 1,305,572 | — | — | 1,306,000 | |||||||||||||||||||||
Unrealized gain on securities available for sale
|
— | — | — | 542,573 | — | 542,573 | ||||||||||||||||||||||
Net loss
|
— | — | — | — | (3,757,370 | ) | (3,757,370 | ) | ||||||||||||||||||||
Balance, December 31, 2010
|
20,365,053 | 20,365 | 13,799,999 | 542,573 | (12,751,636 | ) | 1,611,301 |
Common stock – par value
$0.001 per share, 100,000,000 shares authorized |
Additional |
Accumulated Other
|
Deficit Accumulated
|
|||||||||||||||||||||||||
Shares
|
Common Stock
|
Gross $/Share
|
Paid-in Capital
|
Comprehensive Income | during Development Stage |
Total
|
||||||||||||||||||||||
Balance, December 31, 2010
|
20,365,053 | $ | 20,365 | $ | 13,799,999 | $ | 542,573 | $ | (12,751,636 | ) | $ | 1,611,301 | ||||||||||||||||
Common stock issued, net of issuance cost
|
272,147 | 272 | 4.24 | 1,153,402 | — | — | 1,153,674 | |||||||||||||||||||||
Conversion of notes payable to common stock
|
36,514 | 37 | 3.05 | 109,993 | — | — | 110,030 | |||||||||||||||||||||
Shares issued to existing shell stockholders in the reorganization
|
3,750,000 | 3,750 | (3,750 | ) | — | — | — | |||||||||||||||||||||
Shares issued for stock option exercised
|
11,794 | 12 | 3.05 | 35,960 | — | — | 35,972 | |||||||||||||||||||||
Proceeds from exercise of warrants
|
4,718 | 5 | 3.05 | 14,395 | — | — | 14,400 | |||||||||||||||||||||
Stock options vested
|
— | — | 35,196 | — | — | 35,196 | ||||||||||||||||||||||
Cashless exercise of warrants
|
413 | — | — | — | — | — | ||||||||||||||||||||||
Common stock repurchased and cancelled from dissenting stockholders
|
(47,178 | ) | (47 | ) | 4.24 | (199,953 | ) | — | — | (200,000 | ) | |||||||||||||||||
Warrants issued as a payment of consulting fee
|
— | — | 1,053,150 | — | — | 1,053,150 | ||||||||||||||||||||||
Warrants issued in conjunction with convertible note
|
— | — | 864,773 | — | — | 864,773 | ||||||||||||||||||||||
Impact of beneficial conversion feature
|
— | — | 1,469,343 | — | — | 1,469,343 | ||||||||||||||||||||||
Unrealized loss on securities
|
— | — | — | (287,233 | ) | — | (287,233 | ) | ||||||||||||||||||||
Foreign currency translation effect
|
— | — | — | (2,927 | ) | — | (2,927 | ) | ||||||||||||||||||||
Net loss
|
— | — | — | — | (8,832,758 | ) | (8,832,758 | ) | ||||||||||||||||||||
Balance, December 31, 2011
|
24,393,461 | 24,394 | 18,332,508 | 252,413 | (21,584,394 | ) | (2,975,079 | ) |
Common stock – par value
$0.001 per share, 100,000,000 shares authorized |
Additional |
Accumulated Other
|
Deficit Accumulated
|
|||||||||||||||||||||||||
Shares
|
Common Stock
|
Gross $/Share
|
Paid-in
Capital
|
Comprehensive Income
|
during Development Stage |
Total
|
||||||||||||||||||||||
Balance, December 31, 2011
|
24,393,461 | $ | 24,394 | $ | 18,332,508 | $ | 252,413 | $ | (21,584,394 | ) | $ | (2,975,079 | ) | |||||||||||||||
Warrants issued in conjunction with convertible note
|
— | — | 175,961 | — | — | 175,961 | ||||||||||||||||||||||
Warrants issued in conjunction with promissory note
|
— | — | 1,485,835 | — | — | 1,485,835 | ||||||||||||||||||||||
Impact of beneficial conversion feature
|
— | — | 256,761 | — | — | 256,761 | ||||||||||||||||||||||
Discount on noninterest bearing convertible note
|
— | — | 25,562 | — | — | 25,562 | ||||||||||||||||||||||
Stock based compensation
|
— | — | 3,466,410 | — | — | 3,466,410 | ||||||||||||||||||||||
Stock issued as a payment of professional fee
|
12,787 | 12 | 3.60 | 46,021 | — | — | 46,033 | |||||||||||||||||||||
Stock issued for cash
|
472,188 | 472 | 3.33 | 1,572,805 | — | 1,573,277 | ||||||||||||||||||||||
Realized gain on securities
|
— | — | — | 24,490 | — | 24,490 | ||||||||||||||||||||||
Unrealized loss on securities
|
— | — | — | (284,215 | ) | — | (284,215 | ) | ||||||||||||||||||||
Foreign currency translation effect
|
— | — | — | (5,120 | ) | — | (5,120 | ) | ||||||||||||||||||||
Net loss
|
— | — | — | — | (14,433,170 | ) | (14,433,170 | ) | ||||||||||||||||||||
Balance, December 31, 2012
|
24,878,436 | 24,878 | 25,361,863 | (12,432 | ) | (36,017,564 | ) | (10,643,255 | ) |
Common stock – par value
$0.001 per share, 100,000,000 shares authorized |
Additional |
Accumulated Other
|
Deficit Accumulated
|
|||||||||||||||||||||||||
Shares
|
Common Stock
|
Gross $/Share
|
Paid-in
Capital
|
Comprehensive Income
|
during Development Stage |
Total
|
||||||||||||||||||||||
Balance, December 31, 2012
|
24,878,436 | $ | 24,878 | $ | 25,361,863 | $ | (12,432 | ) | $ | (36,017,564 | ) | $ | (10,643,255 | ) | ||||||||||||||
Impact of beneficial conversion feature
|
— | — | 225,714 | — | — | 225,714 | ||||||||||||||||||||||
Warrant issued in conjunction with convertible note
|
— | — | 116,831 | — | — | 116,831 | ||||||||||||||||||||||
Stock based compensation
|
— | — | 2,436,258 | — | — | 2,436,258 | ||||||||||||||||||||||
Stock issued as a payment of professional fee
|
28,333 | 28 | 3.60 | 101,971 | — | — | 101,999 | |||||||||||||||||||||
Stock issued for cash
|
299,056 | 299 | 3.60 | 1,076,301 | — | — | 1,076,600 | |||||||||||||||||||||
Stock issued for cash
|
27,000 | 27 | 3.30 | 89,073 | — | — | 89,100 | |||||||||||||||||||||
Conversion of notes payable to common stock
|
294,878 | 295 | 3.60 | 1,061,266 | — | — | 1,061,561 | |||||||||||||||||||||
Conversion of notes payable to common stock
|
470,000 | 470 | 3.30 | 1,550,530 | — | — | 1,551,000 | |||||||||||||||||||||
Stock cancelled
|
(2,504,249 | ) | (2,504 | ) | 2,504 | — | — | — | ||||||||||||||||||||
Unrealized gain on securities
|
— | — | — | 1,040,398 | — | 1,040,398 | ||||||||||||||||||||||
Foreign currency translation effect
|
— | — | — | (26,432 | ) | — | (26,432 | ) | ||||||||||||||||||||
Net loss
|
— | — | — | — | (7,113,438 | ) | (7,113,438 | ) | ||||||||||||||||||||
Balance, June 30, 2013
|
23,493,454 | $ | 23,493 | $ | 32,022,311 | $ | 1,001,534 | $ | (43,131,002 | ) | $ | (10,083,664 | ) |
A. | Product expiring within six (6) months of the expiration date printed on the package/container that is in the manufacturer’s original package/container and bears the original label. | |
B. | Expired product that is in the manufacturer’s original package/container and bears the manufacturer’s original label, provided, however, that expired product must be returned within 12 months of the expiration date printed on the package/container. | |
C. | Product shipped directly by the Company that is damaged in transit, subject to Free on Board (“FOB”) Destination, or material shipped in error by the Company. | |
D. | Product that is discontinued, withdrawn, or recalled. |
•
|
significantly lower performance relative to expected historical or projected future operating results;
|
|
•
|
market projections;
|
|
•
|
its ability to obtain patents, including continuation patents, on technology;
|
|
•
|
significant changes in its strategic business objectives and utilization of the assets;
|
|
•
|
significant negative industry or economic trends, including legal factors;
|
|
•
|
potential for strategic partnerships for the development of its patented technology; and
|
|
•
|
changing or implementation of rules regarding manufacture.
|
● |
Quoted prices for similar assets or liabilities in active markets;
|
|
● |
Quoted prices for identical or similar assets or liabilities in inactive markets;
|
|
● |
Inputs other than quoted prices that are observable for the asset or liability;
|
|
● |
Inputs that are derived principally from or corroborated by observable market data by correlation or other means.
|
June 30, 2013
|
December 31, 2012
|
|||||||
Equipment
|
$ | 121,319 | $ | 120,603 | ||||
Leasehold improvements
|
23,054 | 23,054 | ||||||
Furniture and fixtures
|
52,269 | 52,269 | ||||||
196,642 | 195,926 | |||||||
Less: accumulated depreciation
|
(169,505 | ) | (157,157 | ) | ||||
$ | 27,137 | $ | 38,769 |
June 30, 2013
|
December 31, 2012
|
|||||||
License fees and patent filing costs
|
$ | 2,250,000 | $ | 2,250,000 | ||||
Less: accumulated amortization
|
(1,035,714 | ) | (928,571 | ) | ||||
$ | 1,214,286 | $ | 1,321,429 |
Periods ending December 31
|
Amount
|
|||
2013
|
$ | 107,143 | ||
2014
|
214,286 | |||
2015
|
214,286 | |||
2016
|
214,286 | |||
2017
|
214,286 | |||
Thereafter
|
249,999 | |||
$ | 1,214,286 |
Accounts payable
|
June 30, 2013
|
December 31, 2012
|
||||||
Clinical trial management expenses
|
$ | 472,268 | $ | 527,868 | ||||
Legal expenses
|
377,157 | 609,823 | ||||||
Miscellaneous vendors
|
643,559 | 619,886 | ||||||
Subtotal
|
1,492,984 | 1,757,577 | ||||||
Accrued expenses
|
731,633 | 401,034 | ||||||
Accrued expenses (Deferred Salary)
|
464,167 | 401,667 | ||||||
Total accounts payable and accrued expenses
|
$ | 2,688,784 | $ | 2,560,278 |
Lender
|
Annual Interest Rate
|
Date of loan
|
Term of Loan
|
Loan Principal Outstanding
|
Conversion Price
|
Shares Underlying Principal as of June 30, 2013
|
||||||||||||||
Shigeru Matsuda (1)
|
6.50 | % |
1/12/2009
|
5 years
|
$ | 263,496 | $ | 3.05 | 86,392 | |||||||||||
Kazuo Murakami (1)
|
0.00 | % |
8/16/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
Makoto Murakami (1)
|
0.00 | % |
8/16/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
Nami Murakami (1)
|
0.00 | % |
8/16/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
M’s Support Co. Ltd. (1)
|
0.00 | % |
8/17/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
Yumiko Takemoto (1)
|
6.00 | % |
11/23/2010
|
5 years
|
$ | 2,000 | $ | 3.05 | 656 | |||||||||||
Mitsubishi UFJ Capital III, Limited Partnership (8)
|
10.00 | % |
3/14/2011
|
5 years
|
$ | 500,000 | $ | 3.05 | 163,809 | |||||||||||
Hiroshi Iguchi
|
8.00 | % |
2/20/2012
|
1 year (2)
|
$ | 133,333 | $ | 3.60 | 37,037 | |||||||||||
Yasushi Nagasaki (5)
|
10.00 | % |
6/29/2012
|
Due on Demand
|
$ | 388,800 | $ | 3.30 | 117,818 | |||||||||||
Yumiko Duchane
|
10.00 | % |
7/5/2012
|
1 year
|
$ | 30,000 | $ | 3.30 | 9,090 | |||||||||||
Andrew K. Wood (4)
|
10.00 | % |
7/8/2012
|
1 year
|
$ | 3,240 | $ | 3.30 | 981 | |||||||||||
Hiromi Saito
|
10.00 | % |
7/10/2012
|
1 year
|
$ | 25,000 | $ | 3.30 | 7,575 | |||||||||||
Suh Yung Min
|
10.00 | % |
7/11/2012
|
1 year
|
$ | 1,180,716 | $ | 3.30 | 357,792 | |||||||||||
Kiyohiro Sugashita
|
10.00 | % |
7/30/2012
|
1 year
|
$ | 6,600 | $ | 3.30 | 2,000 | |||||||||||
Yumiko Nakamura
|
10.00 | % |
8/9/2012
|
2 years
|
$ | 49,500 | $ | 3.30 | 15,000 | |||||||||||
Masayuki Makino
|
10.00 | % |
8/17/2012
|
1 year
|
$ | 6,600 | $ | 3.30 | 2,000 | |||||||||||
Hideki & Eiko Uehara (1)
|
10.00 | % |
9/7/2012
|
1 year
|
$ | 32,400 | $ | 3.60 | 9,000 | |||||||||||
Dennis Y. Teranishi
|
10.00 | % |
9/9/2012
|
1 year
|
$ | 116,640 | $ | 3.60 | 32,400 | |||||||||||
Paul Shitabata (1)
|
10.00 | % |
10/3/2012
|
1 year (2)
|
$ | 1,620,540 | $ | 3.60 | 450,150 | |||||||||||
Willis Lee (5)
|
10.00 | % |
10/5/2012
|
1 year
|
$ | 138,242 | $ | 3.60 | 38,400 | |||||||||||
Alison Brown
|
10.00 | % |
12/21/2012
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Yoshiko Takemoto
|
10.00 | % |
12/27/2012
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Sun Moo & Hyon Sil Lee
|
10.00 | % |
2/21/2013
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 |
Yukio Hasegawa (1)
|
10.00 | % |
2/15/2013
|
Due on Demand
|
$ | 144,000 | $ | 3.60 | 40,000 | |||||||||||
J. R. Downey
|
10.00 | % |
3/2/2013
|
1 year
|
$ | 162,005 | $ | 3.60 | 45,001 | |||||||||||
Shigenori Yoshida
|
10.00 | % |
3/12/2013
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Yoshiko & Yuki Takemoto
|
10.00 | % |
3/14/2013
|
2 years
|
$ | 420,511 | $ | 3.30 | 127,427 | |||||||||||
Wan Luen Pak Eric & Ho Shun Mei Grace
|
10.00 | % |
3/15/2013
|
2 years
|
$ | 125,000 | $ | 3.60 | 34,722 | |||||||||||
Wong Shuk Ching Judy
|
10.00 | % |
3/19/2013
|
2 years
|
$ | 200,000 | $ | 3.60 | 55,555 | |||||||||||
Yu Mei Lun Susan
|
10.00 | % |
4/2/2013
|
2 years
|
$ | 385,827 | $ | 3.60 | 107,174 | |||||||||||
Yoshiko and Yuki Takemoto
|
10.00 | % |
4/3/2013
|
2 years
|
$ | 227,200 | $ | 3.30 | 68,848 | |||||||||||
Yeung Yat Ming Barry and Ng Sur Ngan
|
10.00 | % |
4/25/2013
|
2 years
|
$ | 50,000 | $ | 3.60 | 13,888 | |||||||||||
Paul Terasaki (1) (7)
|
10.00 | % |
5/1/2013
|
1 year
|
$ | 550,000 | $ | 3.30 | 166,666 | |||||||||||
Wong Shuk Ching Judy
|
10.00 | % |
5/29/2013
|
2 years
|
$ | 200,257 | $ | 3.60 | 55,626 | |||||||||||
Alison Brown - Carvalho
|
10.00 | % |
6/20/2013
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Convertible Notes
|
$ | 7,537,907 | 2,208,599 | |||||||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
1/17/2012
|
Due on Demand
|
$ | 200,000 |
NA
|
|||||||||||||
Shigeru Matsuda (1)
|
11.00 | % |
2/15/2012
|
2 years (2)
|
$ | 833,335 |
NA
|
|||||||||||||
Hideki & Eiko Uehara (1)
|
11.00 | % |
2/15/2012
|
2 years (2)
|
$ | 133,333 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
6/14/2012
|
Due on Demand
|
$ | 200,000 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
6/21/2012
|
Due on Demand
|
$ | 100,000 |
NA
|
|||||||||||||
Cuc T. Tran
|
11.00 | % |
6/27/2012
|
1 year
|
$ | 10,000 |
NA
|
|||||||||||||
Yutaka Niihara (5)
|
10.00 | % |
12/5/2012
|
Due on Demand
|
$ | 940,189 |
NA
|
|||||||||||||
Lan T. Tran (5)
|
11.00 | % |
2/10/2012
|
2 years (2)
|
$ | 80,000 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
1/12/2013
|
Due on Demand
|
$ | 200,000 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
2/11/2013
|
Due on Demand
|
$ | 50,000 |
NA
|
|||||||||||||
Shigeru Matsuda (1)
|
10.00 | % |
5/29/2013
|
Due on Demand
|
$ | 1,008,200 |
NA
|
|||||||||||||
For Days Co., Ltd.
|
2.00 | % |
6/28/2013
|
2 years
|
$ | 200,000 |
NA
|
|||||||||||||
Non-Convertible Notes
|
$ | 3,955,057 | ||||||||||||||||||
Total, undiscounted (9)
|
$ | 11,492,964 |
(1)
|
Related party – Shareholder
|
|
(2)
|
Due on Demand
|
|
(3)
|
Director
|
|
(4)
|
Employee
|
|
(5)
|
Officer
|
|
(6)
|
Dr. Niihara is also the CEO and owner of Hope International Hospice, Inc.
|
|
(7)
|
Convertible into shares of the Company’s common stock at $3.30 per share or, if then publicly traded, at the average closing sale price per share for the three (3) trading days immediately preceding the exercise thereof, whichever is lower
|
|
(8)
|
Secured by the Company’s minority interest in CellSeed common stock (see Note 11 – Subsequent Events)
|
|
(9)
|
Total amount due on notes without discounts for fair market value of warrants issued and conversion features
|
From June 30, 2013
|
Payments by Year
|
|||
2013
|
$ | 7,581,167 | ||
2014
|
1,226,601 | |||
2015
|
2,185,196 | |||
2016
|
500,000 | |||
Total
|
$ | 11,492,964 |
Stock Price
|
$ | 3.60 | ||
Exercise Price
|
$ |
1.00 ~ 3.60
|
||
Term
|
2 ~ 10 years
|
|||
Risk-Free Rate
|
0.30 ~ 2.22
|
% | ||
Dividend Yield
|
0 | % | ||
Volatility
|
99.89 ~ 141.70
|
% |
Original Principal Loan Amount at June 30, 2013
|
Discount Amount at June 30, 2013
|
Carrying Amount at June 30, 2013
|
||||||||
$ | 11,492,964 | $ | (444,743 | ) | $ | 11,048,221 |
Six months ended June 30, 2013
|
||
Warrants outstanding, beginning of period
|
3,408,795
|
|
Granted
|
50,000
|
|
Exercised
|
—
|
|
Cancelled, forfeited and expired
|
—
|
|
Warrants outstanding, end of period
|
3,458,795
|
Outstanding
|
Exercisable
|
|||||||||||||||||||||
Exercise Price
|
Number of Warrants
|
Weighted Average Remaining Contractual Life (Years)
|
Weighted Average Exercise Price |
Total
|
Weighted Average Exercise Price
|
|||||||||||||||||
During 2013
|
||||||||||||||||||||||
$ | 3.30 | 50,000 | 4.84 | $ | 3.30 | 50,000 | $ | 3.30 | ||||||||||||||
During 2012
|
||||||||||||||||||||||
$ | 1.00 | 1,411,020 | 1.54 | $ | 1.00 | 911,020 | $ | 1.00 | ||||||||||||||
75% of FMV
|
56,573 | 1.74 |
75% of FMV
|
56,573 |
75% of FMV
|
|||||||||||||||||
$ | 2.50 | 1,000,000 | 2.16 | $ | 2.50 | 1,000,000 | $ | 2.50 | ||||||||||||||
During 2011
|
||||||||||||||||||||||
$ | 1.00 | 311,038 | 1.18 | $ | 1.00 | 311,038 | $ | 1.00 | ||||||||||||||
75% of FMV
|
331,670 | 1.18 |
75% of FMV
|
331,670 |
75% of FMV
|
|||||||||||||||||
$ | 3.05 | 5,898 | 1.73 | $ | 3.05 | 5,898 | $ | 3.05 | ||||||||||||||
During 2010
|
||||||||||||||||||||||
$ | 3.05 | 197,146 | 2.14 | $ | 3.05 | 197,146 | $ | 3.05 | ||||||||||||||
During 2009
|
||||||||||||||||||||||
$ | 3.05 | 95,450 | 1.28 | $ | 3.05 | 95,450 | $ | 3.05 |
Six Months ended June 30, 2013
|
Prior Plan
|
2011 Stock Incentive Option
|
||||||
Options outstanding, beginning of period
|
11,795 | 1,539,000 | ||||||
Granted
|
— | 3,250,000 | ||||||
Exercised
|
— | — | ||||||
Cancelled, forfeited and expired
|
— | — | ||||||
Options outstanding, end of period
|
11,795 | 4,789,000 |
2013
|
$ | 56,817 | ||
2014
|
46,912 | |||
2015
|
3,380 | |||
$ | 107,109 |
Country
|
Sales six months ended June 30, 2013
|
% of Total Revenue six months ended June 30, 2013
|
Sales six months ended June 30, 2012
|
% of Total Revenue six months ended June 30, 2012
|
||||||||||||
Japan
|
$ | 88,629 | 49 | % | $ | 142,725 | 57 | % | ||||||||
South Korea
|
$ | — | 0 | % | $ | 46,000 | 18 | % | ||||||||
Taiwan
|
$ | 3,480 | 2 | % | 0 | 0 | % |
Lender
|
Annual Interest Rate
|
Date of loan
|
Term of Loan
|
Loan Principal Outstanding
|
Conversion Price
|
Shares Underlying Principal as of June 30, 2013
|
||||||||||||
Andrew K. Wood
|
10.00 | % |
7/8//2013
|
1 Year
|
$ | 3,564 | $ | 3.30 | 1,080 | |||||||||
Hiromi Saito
|
10.00 | % |
7/10/2013
|
1 Year
|
$ | 27,500 | $ | 3.30 | 8,333 | |||||||||
Yung Min Suh
|
10.00 | % |
7/11/2013
|
1 Year
|
$ | 1,298,788 | $ | 3.30 | 393,572 |
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
From
December 20, 2000 (date of inception)
to June 30,
|
||||||||||||||||||
2013
|
2012
|
2013
|
2012
|
2013
|
||||||||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||||||||||
SALES
|
$ | 96,716 | $ | 109,312 | $ | 188,582 | $ | 263,039 | $ | 1,473,843 | ||||||||||
SALES RETURN & ALLOWANCE
|
(5,508 | ) | (2,196 | ) | (7,814 | ) | (10,756 | ) | (68,901 | ) | ||||||||||
REVENUES
|
91,208 | 107,116 | 180,768 | 252,283 | 1,404,942 | |||||||||||||||
COST OF GOODS SOLD
|
||||||||||||||||||||
Cost of goods sold
|
54,988 | 29,186 | 98,972 | 49,773 | 640,783 | |||||||||||||||
Scrapped inventory
|
— | — | — | — | 235,537 | |||||||||||||||
Total cost of goods sold
|
54,988 | 29,186 | 98,972 | 49,773 | 876,320 | |||||||||||||||
GROSS PROFIT
|
36,220 | 77,930 | 81,796 | 202,510 | 528,622 | |||||||||||||||
OPERATING EXPENSES
|
||||||||||||||||||||
Research and development
|
696,008 | 886,390 | 1,311,261 | 1,428,984 | 10,729,701 | |||||||||||||||
Selling
|
129,335 | 97,938 | 256,688 | 198,453 | 3,158,255 | |||||||||||||||
General and administrative
|
2,614,165 | 2,572,788 | 5,020,393 | 4,107,031 | 23,988,395 | |||||||||||||||
Transaction costs
|
— | — | — | — | 788,893 | |||||||||||||||
3,439,508 | 3,557,116 | 6,588,342 | 5,734,468 | 38,665,244 | ||||||||||||||||
LOSS FROM OPERATIONS
|
(3,403,288 | ) | (3,479,186 | ) | (6,506,546 | ) | (5,531,958 | ) | (38,136,622 | ) | ||||||||||
OTHER INCOME (EXPENSE)
|
||||||||||||||||||||
Realized gain on securities available-for-sale
|
— | 275,822 | — | 275,822 | 275,822 | |||||||||||||||
Gain on derecognition of liabilities
|
394,447 | — | 735,808 | — | 735,808 | |||||||||||||||
Interest income
|
5,081 | 7,535 | 10,722 | 14,612 | 164,098 | |||||||||||||||
Interest expense
|
(746,345 | ) | (998,898 | ) | 1,350,872 | (1,892,396 | ) | (6,142,255 | ) | |||||||||||
(346,818 | ) | (715,541 | ) | (604,342 | ) | (1,601,962 | ) | (4,966,527 | ) | |||||||||||
LOSS BEFORE INCOME TAXES
|
(3,750,105 | ) | (4,194,727 | ) | (7,110,888 | ) | (7,133,920 | ) | (43,103,149 | ) | ||||||||||
INCOME TAXES
|
— | — | 2,550 | 5,800 | 27,853 | |||||||||||||||
NET LOSS
|
$ | (3,750,105 | ) | $ | (4,194,727 | ) | $ | (7,113,438 | ) | $ | (7,139,720 | ) | $ | (43,131,002 | ) | |||||
NET LOSS PER COMMON SHARE
|
$ | (0.15 | ) | $ | (0.17 | ) | $ | (0.28 | ) | $ | (0.29 | ) | ||||||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
|
25,281,873 | 24,395,239 | 25,086,033 | 24,394,350 |
● |
as a result of increased payroll, expanded infrastructure and higher consulting, legal, accounting and investor relations costs, and director and officer insurance premiums associated with being a public company;
|
|
● |
to support research and development activities, which the Company expects to expand as development of our product candidate(s) continue; and
|
|
● |
to build a sales and marketing team before we receive regulatory approval of a product candidate in anticipation of commercial launch.
|
● |
as a result of increased payroll, expanded infrastructure and higher consulting, legal, accounting and investor relations costs, and director and officer insurance premiums associated with being a public company;
|
|
● |
to support research and development activities, which the Company expects to expand as development of our product candidate(s) continue; and
|
|
● |
to build a sales and marketing team before we receive regulatory approval of a product candidate in anticipation of commercial launch.
|
Lender
|
Annual Interest Rate
|
Date of loan
|
Term of Loan
|
Loan Principal Outstanding
|
Conversion Price
|
Shares Underlying Principal as of June 30, 2013
|
||||||||||||||
Shigeru Matsuda (1)
|
6.50 | % |
1/12/2009
|
5 years
|
$ | 263,496 | $ | 3.05 | 86,392 | |||||||||||
Kazuo Murakami (1)
|
0.00 | % |
8/16/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
Makoto Murakami (1)
|
0.00 | % |
8/16/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
Nami Murakami (1)
|
0.00 | % |
8/16/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
M’s Support Co. Ltd. (1)
|
0.00 | % |
8/17/2010
|
5 years
|
$ | 18,000 | $ | 3.05 | 5,898 | |||||||||||
Yumiko Takemoto (1)
|
6.00 | % |
11/23/2010
|
5 years
|
$ | 2,000 | $ | 3.05 | 656 | |||||||||||
Mitsubishi UFJ Capital III, Limited Partnership (8)
|
10.00 | % |
3/14/2011
|
5 years
|
$ | 500,000 | $ | 3.05 | 163,809 | |||||||||||
Hiroshi Iguchi
|
8.00 | % |
2/20/2012
|
1 year (2)
|
$ | 133,333 | $ | 3.60 | 37,037 | |||||||||||
Yasushi Nagasaki (5)
|
10.00 | % |
6/29/2012
|
Due on Demand
|
$ | 388,800 | $ | 3.30 | 117,818 | |||||||||||
Yumiko Duchane
|
10.00 | % |
7/5/2012
|
1 year
|
$ | 30,000 | $ | 3.30 | 9,090 | |||||||||||
Andrew K. Wood (4)
|
10.00 | % |
7/8/2012
|
1 year
|
$ | 3,240 | $ | 3.30 | 981 | |||||||||||
Hiromi Saito
|
10.00 | % |
7/10/2012
|
1 year
|
$ | 25,000 | $ | 3.30 | 7,575 | |||||||||||
Suh Yung Min
|
10.00 | % |
7/11/2012
|
1 year
|
$ | 1,180,716 | $ | 3.30 | 357,792 | |||||||||||
Kiyohiro Sugashita
|
10.00 | % |
7/30/2012
|
1 year
|
$ | 6,600 | $ | 3.30 | 2,000 | |||||||||||
Yumiko Nakamura
|
10.00 | % |
8/9/2012
|
2 years
|
$ | 49,500 | $ | 3.30 | 15,000 | |||||||||||
Masayuki Makino
|
10.00 | % |
8/17/2012
|
1 year
|
$ | 6,600 | $ | 3.30 | 2,000 | |||||||||||
Hideki & Eiko Uehara (1)
|
10.00 | % |
9/7/2012
|
1 year
|
$ | 32,400 | $ | 3.60 | 9,000 | |||||||||||
Dennis Y. Teranishi
|
10.00 | % |
9/9/2012
|
1 year
|
$ | 116,640 | $ | 3.60 | 32,400 | |||||||||||
Paul Shitabata (1)
|
10.00 | % |
10/3/2012
|
1 year (2)
|
$ | 1,620,540 | $ | 3.60 | 450,150 | |||||||||||
Willis Lee (5)
|
10.00 | % |
10/5/2012
|
1 year
|
$ | 138,242 | $ | 3.60 | 38,400 | |||||||||||
Alison Brown
|
10.00 | % |
12/21/2012
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Yoshiko Takemoto
|
10.00 | % |
12/27/2012
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Sun Moo & Hyon Sil Lee
|
10.00 | % |
2/21/2013
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Yukio Hasegawa (1)
|
10.00 | % |
2/15/2013
|
Due on Demand
|
$ | 144,000 | $ | 3.60 | 40,000 | |||||||||||
J. R. Downey
|
10.00 | % |
3/2/2013
|
1 year
|
$ | 162,005 | $ | 3.60 | 45,001 | |||||||||||
Shigenori Yoshida
|
10.00 | % |
3/12/2013
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Yoshiko & Yuki Takemoto
|
10.00 | % |
3/14/2013
|
2 years
|
$ | 420,511 | $ | 3.30 | 127,427 | |||||||||||
Wan Luen Pak Eric & Ho Shun Mei Grace
|
10.00 | % |
3/15/2013
|
2 years
|
$ | 125,000 | $ | 3.60 | 34,722 | |||||||||||
Wong Shuk Ching Judy
|
10.00 | % |
3/19/2013
|
2 years
|
$ | 200,000 | $ | 3.60 | 55,555 | |||||||||||
Yu Mei Lun Susan
|
10.00 | % |
4/2/2013
|
2 years
|
$ | 385,827 | $ | 3.60 | 107,174 | |||||||||||
Yoshiko and Yuki Takemoto
|
10.00 | % |
4/3/2013
|
2 years
|
$ | 227,200 | $ | 3.30 | 68,848 | |||||||||||
Yeung Yat Ming Barry and Ng Sur Ngan
|
10.00 | % |
4/25/2013
|
2 years
|
$ | 50,000 | $ | 3.60 | 13,888 | |||||||||||
Paul Terasaki (1) (7)
|
10.00 | % |
5/1/2013
|
1 year
|
$ | 550,000 | $ | 3.30 | 166,666 | |||||||||||
Wong Shuk Ching Judy
|
10.00 | % |
5/29/2013
|
2 years
|
$ | 200,257 | $ | 3.60 | 55,626 | |||||||||||
Alison Brown - Carvalho
|
10.00 | % |
6/20/2013
|
2 years
|
$ | 100,800 | $ | 3.60 | 28,000 | |||||||||||
Convertible Notes
|
$ | 7,537,907 | 2,208,599 | |||||||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
1/17/2012
|
Due on Demand
|
$ | 200,000 |
NA
|
|||||||||||||
Shigeru Matsuda (1)
|
11.00 | % |
2/15/2012
|
2 years (2)
|
$ | 833,335 |
NA
|
|||||||||||||
Hideki & Eiko Uehara (1)
|
11.00 | % |
2/15/2012
|
2 years (2)
|
$ | 133,333 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
6/14/2012
|
Due on Demand
|
$ | 200,000 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
6/21/2012
|
Due on Demand
|
$ | 100,000 |
NA
|
|||||||||||||
Cuc T. Tran
|
11.00 | % |
6/27/2012
|
1 year
|
$ | 10,000 |
NA
|
|||||||||||||
Yutaka Niihara (5)
|
10.00 | % |
12/5/2012
|
Due on Demand | $ | 940,189 |
NA
|
|||||||||||||
Lan T. Tran (5)
|
11.00 | % |
2/10/2012
|
2 years (2)
|
$ | 80,000 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
1/12/2013
|
Due on Demand
|
$ | 200,000 |
NA
|
|||||||||||||
Hope Int’l Hospice (6)
|
8.00 | % |
2/11/2013
|
Due on Demand
|
$ | 50,000 |
NA
|
|||||||||||||
Shigeru Matsuda (1)
|
10.00 | % |
5/29/2013
|
Due on Demand
|
$ | 1,008,200 | ||||||||||||||
For Days Co., Ltd.
|
2.00 | % |
6/28/2013
|
2 years
|
$ | 200,000 | ||||||||||||||
Non-Convertible Notes
|
$ | 3,955,057 | ||||||||||||||||||
Total, undiscounted (9)
|
$ | 11,492,964 |
(1)
|
Related party – Shareholder
|
|
(2)
|
Due on Demand
|
|
(3)
|
Related party – Director
|
|
(4)
|
Employee
|
|
(5)
|
Related party – Officer
|
|
(6)
|
Dr. Niihara is also the CEO and owner of Hope International Hospice, Inc.
|
|
(7)
|
Convertible into shares of the Company’s common stock at $3.30 per share or, if then publicly traded, at the average closing sale price per share for the three (3) trading days immediately preceding the exercise thereof, whichever is lower
|
|
(8)
|
Secured by the Company’s minority interest in CellSeed common stock (see Note 11 - Subsequent Events to the financial statements included in this Quarterly Report for additional information regarding this note)
|
|
(9)
|
Total amount due on notes without discounts for fair market value of warrants issued and conversion features
|
Lender
|
Annual Interest Rate
|
Date of Loan
|
Term of Loan
|
Loan Principal Amount
|
Conversion Price
|
Shares Underlying Original Principal Amount
|
||||||||||||
Andrew Wood
|
10.00 | % |
7/8/2013
|
1 year
|
3,564 | $ | 3.30 | 1,080 | ||||||||||
Hiromi Saito
|
10.00 | % |
7/10/2013
|
1 year
|
27,500 | $ | 3.30 | 8,333 | ||||||||||
Yung Min Suh
|
10.00 | % |
7/11/2013
|
1 year
|
1,298,788 | $ | 3.30 | 393,572 |
A. | Product expiring within six (6) months of the expiration date printed on the package/container that is in the manufacturer’s original package/container and bears the original label. | |
B. | Expired product that is in the manufacturer’s original package/container and bears the manufacturer’s original label, provided, however, that expired product must be returned within 12 months of the expiration date printed on the package/container. | |
C. | Product shipped directly by the Company that is damaged in transit, subject to Free on Board (“FOB”) Destination, or material shipped in error by the Company. | |
D. | Product that is discontinued, withdrawn, or recalled. |
Exhibit
Number
|
Description of Document
|
|
|
||
|
||
|
||
|
||
4.5 |
|
|
|
||
|
||
|
||
32.1
|
|
|
101.INS
|
XBRL Instance Document
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
*
|
This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
|
Emmaus Life Sciences, Inc.
|
||
Dated: August 14, 2013
|
/s/ Yutaka Niihara
|
|
By:
|
Yutaka Niihara, M.D., MPH
|
|
Its:
|
President and Chief Executive Officer
(principal executive officer and duly authorized officer)
|
|
/s/ Peter Ludlum
|
||
By:
|
Peter Ludlum
|
|
Its:
|
Chief Financial Officer
(principal financial and accounting officer)
|
Emmaus Life Sciences, Inc. | |
By: Yutaka Niihara, M.D., President and CEO
|
Conversion Date:
|
|||
Applicable Conversion Price:
|
|||
Signature:
|
|||
Name:
|
|||
Address:
|
|||
Amount to be converted:
|
$
|
||
Amount of Note unconverted:
|
$
|
|
|
Number of shares of Common Stock to be issued:
|
|||
Please issue the shares of Common Stock in the following name and to the following address:
|
|||
Address:
|
|||
Address:
|
|||
Phone Number:
|
Lender
|
Annual Interest Rate
|
Date of Loan
|
Term of Loan
|
Principal Loan Amount
|
Conversion Price
|
|||||||||
Yu Mei Lun Susan
|
10.00 | % |
4/2/2013
|
2 Years
|
$ | 385,827 | $ | 3.60 | ||||||
Alison Brown - Carvalho
|
10.00 | % |
6/20/2013
|
2 Years
|
$ | 100,800 | $ | 3.60 |
Emmaus Life Sciences, Inc. | |
By: Yutaka Niihara, M.D., President and CEO
|
Conversion Date:
|
|||
Applicable Conversion Price:
|
|||
Signature:
|
|||
Name:
|
|||
Address:
|
|||
Amount to be converted:
|
$
|
||
Amount of Note unconverted:
|
$
|
|
|
Number of shares of Common Stock to be issued:
|
|||
Please issue the shares of Common Stock in the following name and to the following address:
|
|||
Address:
|
|||
Address:
|
|||
Phone Number:
|
Emmaus Life Sciences, Inc. | |
By: Yutaka Niihara, MD, President and CEO
|
Conversion Date:
|
|||
Applicable Conversion Price:
|
|||
Signature:
|
|||
Name:
|
|||
Address:
|
|||
Amount to be converted:
|
$
|
||
Amount of Note unconverted:
|
$
|
||
Number of shares of Common Stock to be issued:
|
|||
Please issue the shares of Common Stock in the following name and to the following address:
|
|||
Address:
|
|||
Address:
|
|||
Phone Number:
|
Lender
|
Annual Interest Rate
|
Date of Loan
|
Term of Loan
|
Principal Loan Amount
|
Conversion Price
|
|||||||||||
Yeung Yat Ming Barry and Ng Sur Ngan
|
10 | % |
4/25/2013
|
2 Years Up To 3 Years
|
$ | 50,000 | $ | 3.60 | ||||||||
Wong Shuk Ching Judy
|
10 | % |
5/29/2013
|
2 Years Up To 3 Years
|
$ | 200,257 | $ | 3.60 |
Emmaus Life Sciences, Inc.
a Delaware corporation |
||
By: | ||
Yutaka Niihara, M.D., President and CEO
|
||
By: | ||
Name: | ||
Secretary |
Yutaka Niihara, M.D., an Individual
|
Lender’s Name: | Paul Terasaki Ph.D. | ||
Lender’s Address: |
|
||
Loan Amount:
|
USD $ |
550,000
|
Annual Interest at 10%
Per Annum on Loan Amount: |
$ | 55,000 |
Maturity Date: |
Conversion Date:
|
|||
Applicable Conversion Price:
|
|||
Signature:
|
|||
Name:
|
|||
Address:
|
|||
Amount to be converted:
|
$
|
||
Amount of Note unconverted:
|
$
|
||
Number of shares of Common Stock to be issued:
|
|||
Please issue the shares of Common Stock in the following name and to the following address:
|
|||
Address:
|
|||
Address:
|
|||
Phone Number:
|
Date of Issuance:
|
Void after:
|
May 1, 2013
|
May 1, 2018
|
EMMAUS LIFE SCIENCES, INC.
|
|||
By: |
|
||
Name: Yutaka Niihara MD, MPH
|
|||
Title: CEO
|
Date:
|
By:
|
|||
Name:
|
||||
Address:
|
||||
By: |
Lender’s Name: | For Days Co., Ltd. | ||
Lender’s Address: |
1-13-21. Kayana-ho
|
||
Nihonbashi, Chuo-ku | |||
Tokyo, Japan 103-0025 |
Principal Amount: | USD $ |
200,000.00
|
Quarterly Interest at 2% Per Annum on
Principal Amount: |
$ | 1,000.00 |
1.
|
I have reviewed this quarterly report on Form 10-Q of Emmaus Life Sciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: August 14, 2013
|
||
/s/
|
Yutaka Niihara
|
|
By:
|
Yutaka Niihara, M.D., MPH
|
|
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Emmaus Life Sciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: August 14, 2013
|
|
/s/ Peter Ludlum
|
|
Peter Ludlum
|
|
Chief Financial Officer
|
|
(Principal Financial Officer)
|
/s/ Yutaka Niihara
|
|
Yutaka Niihara, M.D., MPH
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
August 14, 2013
|
|
/s/ Peter Ludlum
|
|
Peter Ludlum
|
|
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
|
August 14, 2013
|