ProtoKinetix, Inc. - Quarter Report: 2009 September (Form 10-Q)
U.
S. SECURITIES AND EXCHANGE C OMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended September 30, 2009
o
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period from ___________ to _____________
Commission
File Number: 0-32917
PROTOKINETIX,
INC.
Nevada
|
94-3355026
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
2225
Folkstone Way
West
Vancouver, British Columbia Canada V7S 2Y6
________________________________________________________________________
(Address
of principal executive offices, including zip code)
Registrant’s
telephone number, including area code:
|
(604)
926-6627
|
Securities
registered pursuant to Section 12(b) of the Act:
|
None
|
Securities
registered pursuant to Section 12(g) of the Act:
|
$.0000053 par value common
stock
|
Indicate
by check mark whether the registrant (1) filed all reports required to be
filed by Section 13 or 15(d) of the Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for the past 90
days. Yes x No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a small reporting
company.
Large
accelerated filer o Accelerated
filer o Non-accelerated
filer o Smaller
reporting company x
Indicate
by a check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act. Yeso No x
APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS
DURING THE PRECEDING FIVE YEARS
Check
whether the registrant filed all documents and reports required to be filed by
Section 12, 13, or 15(d) of the Exchange Act of 1934 after the distribution of
securities under a plan confirmed by a court. Yes o No o
APPLICABLE
ONLY TO CORPORATE ISSUERS
State the
number of shares outstanding of each of the issuer’s classes of common equity,
as of the latest practicable date:
68,156,433
common shares outstanding, $0.0000053 par value, at November 13,
2009.
PART I
ITEM
1.
|
FINANCIAL
STATEMENTS
|
PROTOKINETIX,
INC.
|
See Notes
to Financial Statements
PROTOKINETIX, INCORPORATED
(A
Development Stage Company)
BALANCE
SHEETS
(Unaudited)
ASSETS
|
September
30,
2009
|
December
31,
2008
|
||||||
Current
Assets
|
||||||||
Cash
|
$ | 25,831 | $ | 15,216 | ||||
Prepaid
expenses
|
275,209 | 242,006 | ||||||
Total
assets
|
$ | 301,040 | $ | 257,222 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
Current
Liabilities
|
||||||||
Accounts
payable
|
$ | 105,216 | $ | 78,349 | ||||
Short-term
loan
|
97,250 | 16,500 | ||||||
Convertible
note payable (Note 2.)
|
300,000 | 300,000 | ||||||
Total
current liabilities
|
502,466 | 394,849 | ||||||
Stockholders'
Equity (Deficit)
|
||||||||
Common
stock, $0.0000053 par value; 100,000,000 common shares authorized;
61,756,433 and 57,081,933 shares issued and outstanding for September 30,
2009 and December 31, 2008 respectively
|
335 | 308 | ||||||
Common
stock issuable; 600,000 December 31, 2008
|
- | 3 | ||||||
Additional
paid-in capital
|
21,519,984 | 20,997,912 | ||||||
Deficit
accumulated during the development stage
|
(21,721,745 | ) | (21,135,850 | ) | ||||
Total
shareholders’ equity (deficit)
|
(201,426 | ) | (137,627 | ) | ||||
Total
liabilities and stockholders’ equity (deficit)
|
$ | 301,040 | $ | 257,222 |
See Notes
to Financial Statements
PROTOKINETIX, INCORPORATED
(A
Development Stage Company)
STATEMENTS
OF OPERATIONS
For the
Three and Nine Months Ended September 30, 2009 and 2008, and for
the
Period
from December 23, 1999 (Date of Inception) to September 30, 2009
(Unaudited)
Three
Months
Ended
September
30,
2009
|
Three
Months
Ended
September
30,
2008
|
Nine
Months
Ended
September
30,
2009
|
Nine
Months
Ended
September
30,
2008
|
Cumulative
During
the
Development
Stage
|
||||||||||||||||
Revenues
|
$ | - | $ | - | $ | - | $ | - | $ | 2,000 | ||||||||||
General
and administrative expenses
|
||||||||||||||||||||
Licenses
|
- | - | - | - | 3,379,756 | |||||||||||||||
Professional
fees
|
3,861 | 42,156 | 27,275 | 139,167 | 3,388,839 | |||||||||||||||
Consulting
fees
|
229,687 | 223,750 | 400,207 | 616,343 | 11,481,314 | |||||||||||||||
Research
and development
|
1,338 | 87,275 | 20,153 | 389,501 | 2,222,863 | |||||||||||||||
General
and Administrative
|
39,102 | 73,026 | 120,260 | 220,596 | 1,105,345 | |||||||||||||||
Interest
|
6,000 | 6,000 | 18,000 | 18,000 | 102,162 | |||||||||||||||
279,988 | 432,207 | 585,895 | 1,383,607 | 21,680,279 | ||||||||||||||||
Loss
from continuing operations
|
(279,988 | ) | (432,207 | ) | (585,895 | ) | (1,383,607 | ) | (21,678,279 | ) | ||||||||||
Discontinued
Operations
|
||||||||||||||||||||
Loss
from operations of the discontinued segment
|
- | - | - | - | (43,466 | ) | ||||||||||||||
Net
loss
|
$ | (279,988 | ) | $ | (432,207 | ) | $ | (585,895 | ) | $ | (1,383,607 | ) | $ | (21,721,745 | ) | |||||
Net
Loss per Share (basic and diluted)
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.03 | ) | ||||||||
Weighted
average shares outstanding
|
61,169,096 | 52,520,628 | 58,976,121 | 51,292,277 |
See Notes to
Financial Statements
PROTOKINETIX, INCORPORATED
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT)
For the
Period from December 23, 1999 (Date of Inception) to September 30,
2009
(Unaudited)
Common
Stock
|
Common
Stock
|
Additional Paid-in Capital | Stock Subscriptions Receivable | Deficit Accumulated During the Development Stage | ||||||||||||||||||||||||||||
Shares
|
Amount
|
Issuable
Shares
|
Amount
|
Total
|
||||||||||||||||||||||||||||
Issuance
of common stock, December 1999
|
9,375,000 | $ | 50 | - | $ | - | $ | 4,950 | $ | - | $ | - | $ | 5,000 | ||||||||||||||||||
Net
loss for period
|
- | - | - | - | - | - | (35 | ) | (35 | ) | ||||||||||||||||||||||
Balance,
December 31, 2000
|
9,375,000 | 50 | - | - | 4,950 | - | (35 | ) | 4,965 | |||||||||||||||||||||||
Issuance
of common stock, April 2001
|
5,718,750 | 30 | - | - | 15,220 | - | - | 15,250 | ||||||||||||||||||||||||
Net
loss for year
|
- | - | - | - | - | - | (16,902 | ) | (16,902 | ) | ||||||||||||||||||||||
Balance,
December 31, 2001
|
15,093,750 | 80 | - | - | 20,170 | - | (16,937 | ) | 3,313 | |||||||||||||||||||||||
Net
loss for year
|
- | - | - | - | - | - | (14,878 | ) | (14,878 | ) | ||||||||||||||||||||||
Balance,
December 31, 2002
|
15,093,750 | 80 | - | - | 20,170 | - | (31,815 | ) | (11,565 | ) | ||||||||||||||||||||||
Issuance
of common stock for services:
|
||||||||||||||||||||||||||||||||
July
2003
|
2,125,000 | 11 | - | - | 424,989 | - | - | 425,000 | ||||||||||||||||||||||||
August
2003
|
300,000 | 2 | - | - | 14,998 | - | - | 15,000 | ||||||||||||||||||||||||
September
2003
|
1,000,000 | 5 | - | - | 49,995 | - | - | 50,000 | ||||||||||||||||||||||||
October
2003
|
1,550,000 | 8 | - | - | 619,992 | - | - | 620,000 | ||||||||||||||||||||||||
Issuance
of common stock for licensing rights
|
14,000,000 | 74 | - | - | 2,099,926 | - | - | 2,100,000 | ||||||||||||||||||||||||
Common
stock issuable for licensing rights
|
- | - | 2,000,000 | 11 | 299,989 | - | - | 300,000 | ||||||||||||||||||||||||
Shares
cancelled on September 30, 2003
|
(9,325,000 | ) | (49 | ) | - | - | 49 | - | - | - | ||||||||||||||||||||||
Net
loss for year
|
- | - | - | - | - | - | (3,662,745 | ) | (3,662,745 | ) | ||||||||||||||||||||||
Balance,
December 31, 2003
|
24,743,750 | 131 | 2,000,000 | 11 | 3,530,108 | (3,694,560 | ) | (164,310 | ) | |||||||||||||||||||||||
Issuance
of common stock for services:
|
||||||||||||||||||||||||||||||||
March
2004
|
1,652,300 | 9 | - | - | 991,371 | - | - | 991,380 | ||||||||||||||||||||||||
May
2004
|
500,000 | 3 | - | - | 514,997 | - | - | 515,000 | ||||||||||||||||||||||||
July
2004
|
159,756 | 1 | - | - | 119,694 | - | - | 119,695 | ||||||||||||||||||||||||
August
2004
|
100,000 | 1 | - | - | 70,999 | - | - | 71,000 | ||||||||||||||||||||||||
October
2004
|
732,400 | 4 | - | - | 479,996 | - | - | 480,000 | ||||||||||||||||||||||||
November
2004
|
650,000 | 4 | - | - | 454,996 | - | - | 455,000 | ||||||||||||||||||||||||
December
2004
|
255,000 | 1 | - | - | 164,425 | - | - | 164,426 | ||||||||||||||||||||||||
Common
stock issuable for AFGP license
|
- | - | 1,000,000 | 5 | 709,995 | - | - | 710,000 | ||||||||||||||||||||||||
Common
stock issuable for Recaf License
|
- | - | 400,000 | 2 | 223,998 | - | - | 224,000 | ||||||||||||||||||||||||
Warrants
granted (for 3,450,000 shares) for services, October 2004
|
- | - | - | - | 1,716,253 | - | - | 1,716,253 | ||||||||||||||||||||||||
Options
granted for services, October 2004
|
- | - | - | - | 212,734 | - | - | 212,734 | ||||||||||||||||||||||||
Stock
subscriptions receivable
|
- | - | 1,800,000 | 10 | 329,990 | (330,000 | ) | - | ||||||||||||||||||||||||
Warrants
exercised:
|
||||||||||||||||||||||||||||||||
August
2004
|
- | - | 50,000 | - | 15,000 | - | - | 15,000 | ||||||||||||||||||||||||
October
2004
|
- | - | 600,000 | 3 | 134,997 | - | - | 135,000 | ||||||||||||||||||||||||
December
2004
|
- | - | 1,000,000 | 5 | 224,995 | - | - | 225,000 | ||||||||||||||||||||||||
Options
exercised, December 2004
|
- | - | 100,000 | 1 | 29,999 | - | - | 30,000 | ||||||||||||||||||||||||
Net
loss for period
|
- | - | - | - | - | - | (6,368,030 | ) | (6,368,030 | ) | ||||||||||||||||||||||
Balance,
December 31, 2004
|
28,793,206 | $ | 154 | 6,950,000 | $ | 37 | $ | 9,924,547 | $ | (330,000 | ) | $ | (10,062,590 | ) | $ | (467,852 | ) |
See Notes to
Financial Statements
PROTOKINETIX,
INCORPORATED
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT)
(Continued)
For the
Period from December 23, 1999 (Date of Inception) to September 30,
2009
(Unaudited)
Common
Stock
|
Common
Stock
|
Deficit | ||||||||||||||||||||||||||||||
Shares
|
Amount
|
Issuable
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Stock
Subscriptions Receivable
|
Accumulated
During
the Development
Stage
|
Total
|
|||||||||||||||||||||||||
Issuance
of stock subscriptions receivable
|
- | $ | - | - | $ | - | $ | - | $ | 240,000 | $ | - | $ | 240,000 | ||||||||||||||||||
Issuance
of common stock for licensing rights
|
2,000,000 | 11 | (2,000,000 | ) | (11 | ) | - | - | - | - | ||||||||||||||||||||||
Issuance
of stock for warrants exercised
|
2,050,000 | 10 | (2,050,000 | ) | (10 | ) | - | - | - | - | ||||||||||||||||||||||
Options
exercised:
|
||||||||||||||||||||||||||||||||
February
2005
|
- | - | 35,000 | 1 | 10,499 | - | - | 10,500 | ||||||||||||||||||||||||
May
2005
|
200,000 | 1 | - | - | 59,999 | - | - | 60,000 | ||||||||||||||||||||||||
Note
payable conversion, February 2005
|
- | - | 285,832 | 1 | 85,749 | - | - | 85,750 | ||||||||||||||||||||||||
Issuance
of common stock for Note payable conversion:
|
||||||||||||||||||||||||||||||||
April
2005
|
285,832 | 1 | (285,832 | ) | (1 | ) | - | - | - | - | ||||||||||||||||||||||
May
2005
|
353,090 | 2 | - | - | 105,925 | - | - | 105,927 | ||||||||||||||||||||||||
Issuance
of common stock for AFGP license
|
1,000,000 | 5 | (1,000,000 | ) | (5 | ) | - | - | - | - | ||||||||||||||||||||||
Issuance
of common stock for stock subscriptions received
|
1,400,000 | 6 | (1,400,000 | ) | (6 | ) | - | 90,000 | 90,000 | |||||||||||||||||||||||
Issuance
of stock for options exercised
|
135,000 | 2 | (135,000 | ) | (2 | ) | - | - | - | - | ||||||||||||||||||||||
Issuance
of common stock for services:
|
||||||||||||||||||||||||||||||||
April
2005
|
30,000 | 1 | - | - | 14,999 | - | - | 15,000 | ||||||||||||||||||||||||
May
2005
|
3,075,000 | 15 | - | - | 3,320,985 | - | - | 3,321,000 | ||||||||||||||||||||||||
June
2005
|
50,000 | 1 | - | - | 50,499 | - | - | 50,500 | ||||||||||||||||||||||||
August
2005
|
(250,000 | ) | (1 | ) | - | - | (257,499 | ) | - | - | (257,500 | ) | ||||||||||||||||||||
August
2005
|
111,111 | 1 | (92,593 | ) | (1 | ) | 15,000 | - | - | 15,000 | ||||||||||||||||||||||
October
2005
|
36,233 | 1 | (36,233 | ) | (1 | ) | - | - | - | - | ||||||||||||||||||||||
November
2005
|
311,725 | 2 | (245,000 | ) | (1 | ) | 36,249 | - | - | 36,250 | ||||||||||||||||||||||
December
2005
|
1,220,000 | 8 | - | - | 756,392 | - | - | 756,400 | ||||||||||||||||||||||||
Common
stock issuable for services rendered:
|
||||||||||||||||||||||||||||||||
June
2005
|
- | - | 200,000 | 1 | 149,999 | - | - | 150,000 | ||||||||||||||||||||||||
August
2005
|
- | - | 36,233 | 1 | 21,739 | - | - | 21,740 | ||||||||||||||||||||||||
September
2005
|
- | - | 125,000 | 1 | 74,999 | - | - | 75,000 | ||||||||||||||||||||||||
September
2005 (Proteocell)
|
- | - | 100,000 | 1 | 57,999 | - | - | 58,000 | ||||||||||||||||||||||||
December
2005
|
- | - | 120,968 | 1 | 74,999 | - | - | 75,000 | ||||||||||||||||||||||||
Net
loss for the year
|
- | - | - | - | - | - | (4,826,540 | ) | (4,826,540 | ) | ||||||||||||||||||||||
Balance,
December 31, 2005
|
40,801,197 | $ | 220 | 608,375 | $ | 6 | $ | 14,503,079 | $ | - | $ | (14,889,130 | ) | $ | (385,825 | ) |
See Notes to
Financial Statements
PROTOKINETIX,
INCORPORATED
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT)
(Continued)
For the
Period from December 23, 1999 (Date of Inception) to September 30,
2009
(Unaudited)
Common
Stock
|
Common
Stock
|
Deficit | ||||||||||||||||||||||||||||||
Shares
|
Amount
|
Issuable
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Stock
Subscriptions Receivable
|
Accumulated
During
the Development
Stage
|
Total
|
|||||||||||||||||||||||||
February
2006 private placement (issued June 2006)
|
900,000 | $ | 5 | - | $ | - | $ | 352,142 | $ | - | $ | - | $ | 352,147 | ||||||||||||||||||
Warrants
granted from private placement (450,000)
|
- | - | - | - | 97,853 | - | - | 97,853 | ||||||||||||||||||||||||
Issuance
of common stock for Note payable conversion
|
529,279 | 3 | - | - | 158,780 | - | - | 158,783 | ||||||||||||||||||||||||
Issuance
of common stock for services:
|
||||||||||||||||||||||||||||||||
February/March
2006 services
|
- | - | 20,000 | 1 | 10,499 | - | - | 10,500 | ||||||||||||||||||||||||
March
2006
|
166,359 | 1 | (108,375 | ) | (1 | ) | 36,750 | - | - | 36,750 | ||||||||||||||||||||||
April
2006
|
(1,200,000 | ) | (6 | ) | - | - | 6 | - | - | - | ||||||||||||||||||||||
May
2006
|
1,266,278 | 7 | (70,000 | ) | (1 | ) | 792,750 | - | - | 792,756 | ||||||||||||||||||||||
June
2006
|
27,056 | - | 1,200,000 | 6 | 718,244 | - | - | 718,250 | ||||||||||||||||||||||||
July
2006
|
1,200,000 | 6 | (1,200,000 | ) | (6 | ) | - | - | - | - | ||||||||||||||||||||||
August
2006
|
100,000 | 1 | - | - | 64,999 | - | - | 65,000 | ||||||||||||||||||||||||
September
2006
|
369,984 | 2 | (50,000 | ) | - | 209,998 | - | - | 210,000 | |||||||||||||||||||||||
November
2006
|
100,000 | 1 | - | - | 48,999 | - | - | 49,000 | ||||||||||||||||||||||||
December
2006
|
7,000 | - | - | - | 3,010 | - | - | 3,010 | ||||||||||||||||||||||||
Warrants
issued (for 700,000 shares) for services
|
- | - | - | - | 58,658 | - | - | 58,658 | ||||||||||||||||||||||||
Net
loss for the period
|
- | - | - | - | - | - | (1,967,633 | ) | (1,967,633 | ) | ||||||||||||||||||||||
Balance,
December 31, 2006
|
44,267,153 | 240 | 400,000 | 5 | 17,055,767 | - | (16,856,763 | ) | 199,249 | |||||||||||||||||||||||
Issuance
of common stock for services:
|
||||||||||||||||||||||||||||||||
January
2007
|
218,834 | 1 | - | - | 119,999 | - | - | 120,000 | ||||||||||||||||||||||||
March
2007
|
104,652 | 1 | - | - | 44,999 | - | - | 45,000 | ||||||||||||||||||||||||
April
2007
|
187,500 | 1 | - | - | 74,999 | - | - | 75,000 | ||||||||||||||||||||||||
June
2007
|
112,500 | 1 | - | - | 44,999 | - | - | 45,000 | ||||||||||||||||||||||||
July
2007
|
291,812 | 2 | - | - | 112,998 | - | - | 113,000 | ||||||||||||||||||||||||
August
2007
|
860,000 | 5 | - | - | 257,995 | - | - | 258,000 | ||||||||||||||||||||||||
September
2007
|
1,516,275 | 8 | - | - | 457,492 | - | - | 457,500 | ||||||||||||||||||||||||
October
2007
|
250,000 | 1 | - | - | 37,499 | - | - | 37,500 | ||||||||||||||||||||||||
December
2007
|
535,716 | 1 | - | - | 74,999 | - | - | 75,000 | ||||||||||||||||||||||||
Warrants
issued for services
|
- | - | - | - | 825,476 | - | - | 825,476 | ||||||||||||||||||||||||
Cancellation
of issuable stock for Recaf License
|
- | - | (400,000 | ) | (5 | ) | - | - | - | (5 | ) | |||||||||||||||||||||
Warrant
exercised – December 2007
|
100,000 | 1 | - | - | 43,999 | - | - | 44,000 | ||||||||||||||||||||||||
Issuable
common stock from Private Placement
|
- | - | 1,190,000 | 6 | 172,494 | - | - | 175,500 | ||||||||||||||||||||||||
Net
loss for the year
|
- | - | - | - | - | - | (2,728,269 | ) | (2,728,269 | ) | ||||||||||||||||||||||
Balance,
December 31, 2007
|
48,444,442 | $ | 262 | 1,190,000 | $ | 6 | $ | 19,323,715 | $ | - | $ | (19,585,032 | ) | $ | (261,049 | ) |
See Notes to
Financial Statements
PROTOKINETIX,
INCORPORATED
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT)
(Continued)
For the
Period from December 23, 1999 (Date of Inception) to September 30,
2009
(Unaudited)
Common
Stock
|
Common
Stock
|
Deficit | ||||||||||||||||||||||||||||||
Shares
|
Amount
|
Issuable
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Stock
Subscriptions Receivable
|
Accumulated
During
the
Development
Stage
|
Total
|
|||||||||||||||||||||||||
Issuance
of common stock for services:
|
||||||||||||||||||||||||||||||||
March
2008
|
369,346 | $ | 2 | - | $ | - | $ | 133,867 | $ | - | $ | - | $ | 133,869 | ||||||||||||||||||
May
2008
|
395,170 | 2 | - | - | 137,723 | - | - | 137,725 | ||||||||||||||||||||||||
July
2008
|
2,405,170 | 13 | - | - | 577,226 | - | - | 577,239 | ||||||||||||||||||||||||
September
2008
|
186,430 | 1 | - | - | 42,878 | - | - | 42,879 | ||||||||||||||||||||||||
October
2008
|
250,000 | 1 | - | - | 49,999 | - | - | 50,000 | ||||||||||||||||||||||||
November
2008
|
1,018,375 | 5 | - | - | 153,495 | - | - | 153,500 | ||||||||||||||||||||||||
Issuance
of common stock for proceeds of $50,000 received in 2007
|
173,000 | 1 | - | - | (1 | ) | - | - | - | |||||||||||||||||||||||
Stock-based
compensation expense related to non-employee stock options
|
- | - | - | - | 82,214 | - | - | 82,214 | ||||||||||||||||||||||||
Warrants
exercised:
|
||||||||||||||||||||||||||||||||
September
2008
|
170,000 | 1 | - | - | 25,499 | - | - | 25,500 | ||||||||||||||||||||||||
November
2008
|
100,000 | 1 | - | - | 12,313 | - | - | 12,314 | ||||||||||||||||||||||||
December
2008
|
170,000 | 1 | - | - | 25,499 | - | - | 25,500 | ||||||||||||||||||||||||
Issuance
of common stock from Private Placement
|
3,400,000 | 18 | (1,190,000 | ) | (6 | ) | 337,488 | - | - | 337,500 | ||||||||||||||||||||||
Issuable
common stock to Directors
|
- | - | 600,000 | 3 | 95,997 | - | - | 96,000 | ||||||||||||||||||||||||
Net
loss for the year
|
- | - | - | - | - | - | (1,550,818 | ) | (1,550,818 | ) | ||||||||||||||||||||||
Balance,
December 31, 2008
|
57,081,933 | 308 | 600,000 | 3 | 20,997,912 | - | (21,135,850 | ) | (137,627 | ) | ||||||||||||||||||||||
Warrant
exercise proceeds
|
- | - | - | - | 2,686 | - | - | 2,686 | ||||||||||||||||||||||||
Issuance
of common stock for services:
|
||||||||||||||||||||||||||||||||
April
2009
|
1,200,000 | 6 | - | - | 131,994 | - | - | 132,000 | ||||||||||||||||||||||||
May
2009
|
500,000 | 3 | - | - | 49,997 | - | - | 50,000 | ||||||||||||||||||||||||
June
2009
|
300,000 | 3 | - | - | 26,997 | - | - | 27,000 | ||||||||||||||||||||||||
July
2009
|
1,324,500 | 8 | - | - | 235,402 | - | - | 235,410 | ||||||||||||||||||||||||
Issuance
of common stock from Private Placement – May 2009
|
250,000 | 1 | - | 24,999 | - | - | 25,000 | |||||||||||||||||||||||||
Issuance
of common stock from Private Placement – July 2009
|
500,000 | 3 | - | 49,997 | - | - | 50,000 | |||||||||||||||||||||||||
Issuance
of common stock to Directors
|
600,000 | 3 | (600,000 | ) | (3 | ) | - | - | - | - | ||||||||||||||||||||||
Net
loss for the period
|
- | - | - | - | - | - | ( 585,895 | ) | ( 585,895 | ) | ||||||||||||||||||||||
Balance,
September 30, 2009
|
61,756,433 | $ | 335 | - | $ | 3 | $ | 21,519,984 | - | (21,721,745 | ) | $ | (201,426 | ) |
See Notes to
Financial Statements
PROTOKINETIX, INCORPORATED
STATEMENTS
OF CASH FLOWS
For the
Nine Months Ended September 30, 2009 and 2008, and for the Period
from
December
23, 1999 (Date of Inception) to September 30, 2009
(Unaudited)
2009
|
2008
|
Cumulative
During the Development Stage
|
||||||||||
Cash
Flows from Operating Activities
|
||||||||||||
Net
loss for period
|
$ | (585,895 | ) | $ | (1,383,607 | ) | $ | (21,721,745 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities
|
||||||||||||
Amortization
and Depreciation expense
|
- | 426 | 3,388 | |||||||||
and
issuance of common stock for services and expenses
|
411,207 | 1,182,500 | 16,448,710 | |||||||||
Warrants
issued for consulting services
|
- | - | 2,602,833 | |||||||||
Stock
options issued for consulting services
|
- | - | 222,817 | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Prepaid
expenses
|
- | (103,750 | ) | - | ||||||||
Accounts
payable
|
26,867 | (58,385 | ) | 105,216 | ||||||||
Net
cash used in operating activities
|
(147,821 | ) | (362,816 | ) | (2,338,781 | ) | ||||||
Cash
Flows from Investing Activities
|
||||||||||||
Purchase
of computer equipment
|
- | - | (3,388 | ) | ||||||||
Net
cash used in investing activities
|
- | - | (3,388 | ) | ||||||||
Cash
Flows from Financing Activities
|
||||||||||||
Short-term
loan
|
80,750 | - | 97,250 | |||||||||
Warrants
exercised
|
2,686 | - | 815,000 | |||||||||
Stock
options exercised
|
- | 25,500 | 100,500 | |||||||||
Issuance
of common stock for cash
|
75,000 | 337,500 | 1,055,250 | |||||||||
Loan
proceeds
|
- | - | 300,000 | |||||||||
Net
cash provided by financing activities
|
158,436 | 363,000 | 2,368,000 | |||||||||
Net
change in cash
|
10,615 | 184 | 25,831 | |||||||||
Cash,
beginning of period
|
15,216 | 37,350 | - | |||||||||
Cash,
end of period
|
$ | 25,831 | $ | 37,534 | $ | 25,831 | ||||||
Cash
paid for interest
|
$ | 7,819 | $ | 18,000 | $ | 50,522 | ||||||
Cash
paid for income taxes
|
$ | - | $ | - | $ | - | ||||||
Supplementary
information - Non-cash Transactions:
|
||||||||||||
Note
payable converted to common stock
|
$ | - | $ | - | $ | 350,457 | ||||||
Common
stock for prepaid consulting services
|
153,475 | - | 275,209 |
See Notes to
Financial Statements
PROTOKINETIX, INCORPORATED
(A Development Stage
Company)
NOTES
TO FINANCIAL STATEMENTS
September
30, 2009
Note
1. Organization and Significant Accounting Policies
Organization
ProtoKinetix,
Incorporated (the "Company"), a development stage company, was incorporated
under the laws of the State of Nevada on December 23, 1999. The
Company is a medical research company whose mission is the advancement of human
health care.
In 2003,
the Company entered into an assignment of license agreement (the "Agreement")
with BioKinetix, Inc., an Alberta, Canada, corporation. The Agreement
provided the Company with an exclusive assignment of all of the rights (the
"Rights") that BioKinetix possessed relating to two proprietary technologies
that are being developed for the creation and commercialization of
"superantibodies," an enhancement of antibody technology that makes ordinary
antibodies much more lethal. In consideration, the Company's Board of
Directors authorized the Company to issue 16,000,000 shares of its common stock
to the shareholders of BioKinetix.
The
Company is also currently researching the benefits and feasibility of
proprietary synthesized Antifreeze Glycoproteins ("AFGP"). In
preliminary studies, AFGP has demonstrated an ability to protect and preserve
human cells at temperatures below freezing.
Interim Period Financial
Statements
The
unaudited financial statements included in this Form 10-Q are unaudited and have
been prepared in accordance with generally accepted accounting principles for
the three months ended September 30, 2009 and 2008 and the cumulative period
from December 23, 1999 to September 30, 2009 and with the instructions to Form
10-Q. Certain information and footnote disclosure normally included
in financial statements prepared in accordance with accounting principles
generally accepted in the United States have been condensed or omitted pursuant
to such SEC rules and regulations. The interim period financial
statements should be read together with the audited financial statements and
accompanying notes included in the Company's audited financial statements for
the years ended December 31, 2008 and 2007. In the opinion of the
Company, the unaudited financial statements contained herein contain all
adjustments (consisting of a normal recurring nature) necessary to present a
fair statement of the results of the interim periods presented.
Going
Concern
As shown
in the financial statements, the Company has not developed a commercially viable
product, has not generated any revenues to date and has incurred losses since
inception, resulting in a net accumulated deficit at September 30,
2009. These factors raise substantial doubt about the Company's
ability to continue as a going concern.
The
Company needs additional working capital to continue its medical research or to
be successful in any future business activities and continue to pay its
liabilities. Therefore, continuation of the Company as a going
concern is dependent upon obtaining the additional working capital necessary to
accomplish its objective. Management is presently engaged in seeking
additional working capital.
The
accompanying financial statements do not include any adjustments to the recorded
assets or liabilities that might be necessary should the Company fail in any of
the above objectives and is unable to operate for the coming year.
Fair Value
Measurement
Under
FASB ASC Topic 820, Fair Value Measurement and Disclosures, based on the
observability of the inputs used in the valuation techniques used to determine
the fair value of certain financial assets and liabilities, the company is
required to provide the following information according to the fair value
hierarchy. The fair value hierarchy ranks the quality and reliability
of the information used to determine fair values.
In
general, fair values determined by Level 1 inputs quoted prices (unadjusted) in
active markets for identical assets or liabilities. Fair value
determined by Level 2 inputs utilize observable inputs other Level 1 prices,
such as quoted prices for similar assets or liabilities, quoted prices in
markets that are not active or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of the
related assets or liabilities. Fair values determined by Level 3
inputs are observable data points for the asset or liability, and include
situations where there is little, if any, market activity for the asset or
liability.
The
following table presents information about the Company’s financial assets and
liabilities that have been measured at fair value as of September 30, 2009, and
indicates the fair value hierarchy of the valuation inputs utilized to determine
such fair values.
Description
|
Fair
Value at
September
30, 2009
|
Quoted
Prices in
Active
Markets
(Level
1)
|
Significant
Other
Observable
Inputs
(Level
2)
|
|||||||||
Assets:
|
||||||||||||
Cash
|
$ | 25,831 | $ | 25,831 | $ | - | ||||||
Assets
measured at fair value at September 30, 2009
|
$ | 25,831 | $ | 25,831 | $ | - | ||||||
Liabilities:
|
||||||||||||
Accounts
Payable
|
$ | 105,216 | $ | - | $ | 105,216 | ||||||
Short-Term
Loan
|
$ | 97,250 | $ | - | $ | 97,250 | ||||||
Convertible
Note Payable
|
$ | 300,000 | $ | - | $ | 300,000 | ||||||
Liabilities
measured at fair value at September 30, 2009
|
$ | 502,466 | $ | - | $ | 502,466 |
Use of
Estimates
Preparation
of financial statements in conformity with generally accepted accounting
principles in the United States of America requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and reported amounts of revenue and expenses during the reporting
period. Actual results could differ from those
estimates. The more significant accounting estimates inherent in the
preparation of the Company's financial statements include estimates as to
valuation of equity related instruments issued.
Earnings per
Share
Basic
loss per share is computed by dividing the net loss available to common
shareholders by the weighted average number of common shares outstanding in the
period. Diluted earnings per share takes into
consideration the weighted average common shares outstanding (computed under
basic earnings per share) and potentially dilutive securities. The
effect of debt convertible into common shares was not included in the
computation of diluted earnings per share for all periods presented because it
was anti-dilutive due to the Company's losses. Common stock issuable
is considered outstanding as of the original approval date for purposes of
earnings per share computations.
Stock Based
Compensation
The
Company accounts for stock based compensation which requires measurement of
compensation cost for all stock-based awards at fair value on the date of grant
and recognition of compensation over the service period for awards expected to
vest. The fair value of stock options is determined using the
Black-Scholes valuation model. Since the Company did not issue stock
options to employees during the periods ended September 30, 2009 or
2008. When the Company issues shares of common stock to employees and
others, the shares of common stock are valued based on the market price at the
date the shares of common stock are approved for issuance.
Note
2. Convertible Note Payable
On July
1, 2007, the Company executed a loan agreement under which the Company issued to
a corporation an 8% convertible promissory note in exchange for
$300,000. The noteholder has the right to demand payment of
outstanding principal and interest at any time with a 30-day grace
period. The note is due and payable no later than June 30, 2012, and
is convertible into shares of the Company's common stock at $0.25 per
share. No beneficial conversion feature was applicable to this
convertible note.
Note
3. Discontinued Operations
In 2003,
the Company signed the licensing agreement described in
Note 1. This agreement changed the Company's business plan to
that of a medical research company. Accordingly, the operating
results related to the Company's research prior to the licensing agreement have
been presented as discontinued operations in these financial statements for all
periods presented.
Note
4. Related Party Transactions
The
Company issued 600,000 shares to the directors for services performed in
2008.
Note
5. Subsequent Events
The
company issued 1,500,000 shares to Directors and Officers for services rendered
during 2009 and 5,100,000 shares to various consultants pursuant to consulting
agreements. Management has evaluated subsequent events and any
required disclosures through November 13, 2009, which is the date this quarterly
report on Form 10-Q was submitted for filing with the Securities and Exchange
Commission.
ITEM
2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OR PLAN OF
OPERATIONS
|
FORWARD-LOOKING
STATEMENTS
This
discussion and analysis in this Quarterly Report on Form 10-Q should be read in
conjunction with the accompanying Unaudited Financial Statements and related
notes for the nine months ended September 30, 2009 and 2008 and for the period
from December 23, 1999 to September 30, 2009. Our discussion and analysis of our
financial condition and results of operations are based upon our unaudited
financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of financial
statements in conformity with accounting principles generally accepted in the
United States of America requires us to make estimates and assumptions that
affect the reported amounts of assets and liabilities, disclosure of any
contingent liabilities at the financial statement date and reported amounts of
revenue and expenses during the reporting period. We review our estimates and
assumptions on an on-going basis. Our estimates are based on our historical
experience and other assumptions that we believe to be reasonable under the
circumstances. Actual results are likely to differ from those estimates under
different assumptions or conditions, but we do not believe such differences will
materially affect our financial position or results of operations. Our critical
accounting policies, the policies we believe are most important to the
presentation of our financial statements and require the most difficult,
subjective and complex judgments, are outlined below in ‘‘Critical Accounting
Policies,’’ and have not changed significantly.
In
addition, certain statements made in this report may constitute “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
These forward-looking statements involve known or unknown risks, uncertainties
and other factors that may cause the actual results, performance, or
achievements of the Company to be materially different from any future results,
performance or achievements expressed or implied by the forward-looking
statements. Specifically, but not limited to, 1) our ability to obtain
necessary regulatory approvals for our products; and 2) our ability to
increase revenues and operating income, is dependent upon our ability to develop
and sell our products, general economic conditions, and other factors. You can
identify forward-looking statements by terminology such as "may," "will,"
"should," "expects," "intends," "plans," "anticipates," "believes," "estimates,"
"predicts," "potential," "continues" or the negative of these terms or other
comparable terminology. We base these forward-looking statements on our
expectations and projections about future events, which we derive from the
information currently available to us. Such forward-looking
statements relate to future events or our future performance. Although we
believe that the expectations reflected-in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance
or achievements. Forward-looking statements are only
predictions. The forward-looking events discussed in this Quarterly
Report, the documents to which we refer you, and other statements made from time
to time by us or our representatives, may not occur, and actual events and
results may differ materially and are subject to risks, uncertainties, and
assumptions about us. For these statements, we claim the protection
of the “bespeaks caution” doctrine. The forward-looking statements
speak only as of the date hereof, and we expressly disclaim any obligation to
publicly release the results of any revisions to these forward-looking
statements to reflect events or circumstances after the date of this
filing.
Critical
Accounting Policies
Our
critical and significant accounting policies, including the assumptions and
judgments underlying them, are disclosed in the Notes to the Financial
Statements. These policies have been consistently applied in all
material respects and address such matters as revenue recognition and
depreciation methods. The preparation of the financial statements in
conformity with generally accepted accounting principles in the United States
requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of
revenues and expenses during the reported period. Actual results
could differ from those estimates. The accounting treatment of a
particular transaction is specifically dictated by accounting principles,
generally accepted in the United States of America, with no need for
management’s judgment in their application. There are also areas in
which management’s judgment in selecting any viable alternative would not
produce a materially different result. See our audited financial
statements and notes thereto which contain accounting policies and other
disclosures required by accounting principles, generally accepted in the United
States of America.
Important
Disclosures and Disclaimers.
Please
note that ProtoKinetix, Inc. (the "Company") is a research and product
development stage company that has not yet sold any products. The
Company had $0 in revenues for the Period ending September 30, 2009
Critical Accounting Policies
(cont’d…)
It
is important to understand that although the Company (as is discussed below) is
focused on various promising scientific and business development efforts, to
date, we have not yet marketed a product. Ongoing testing of the AAGP™ molecule
with three amino acids joined to a monosaccharide by a gemdifluride bond
continues to show that there is significant promise in the field of medicine of
preserving cells, tissue and organs from various stresses. The antiaging
properties and the protective effect of AAGP™ also is of significant interest to
the cosmetic and skin care industries. Tests have confirmed that the AAGP™
molecule improves the harvest of cells from cryopreservation by 30% to 120%. We
believe there is a market for AAGP™ to preserve cells, particularly various stem
cells, and we will continue testing with potential customers. At the same time
we are taking steps to improve the manufacturing process to reduce costs and
improve purity and biochemical activity.
Our
progress to date has been achieved notwithstanding the inherent risks relating
to the science, applications, market opportunities and commercial relationships.
The progress of the business has and will continue to be dependant on having
appropriate human and sufficient financial resources which have and will be
uncertain.
Overview
ProtoKinetix
owns the world-wide rights to a family of anti-aging glycoproteins, trademarked
as AAGPs™. In scientific tests AAGPs™ have demonstrated the ability to
enhance the health and extend the life of biologically sensitive cells which
have been subjected to severe stress conditions under laboratory controlled test
conditions. AAGPs™ are stable and non-toxic.
Since
2005, ProtoKinetix has primarily focused on scientific research, but the company
has recently been in the process of directing major efforts to the practical
side of commercial validation. The commercial applications for AAGPs™ in large
markets such as skincare/cosmetic products and targeted health care solutions
are numerous, and ProtoKinetix is currently working with researchers, business
leaders and advisors and commercial entities to bring AAGP™ to
market.
Native
AFGP Compound
AFGP
(Anti-Freeze Glycoprotein) is found in nature as a compound produced by some
fish, insects, reptiles, bacteria and plants that enable survival in freezing
temperatures.
One of
the many accomplishments from pioneering research of the U.S. Antarctic Program
was the discovery, in the early sixties, that fish living year-long in subzero
temperature are extremely resistant to freezing. The substances that
prevent these fish from freezing were isolated, characterized and designated as
antifreeze glycoproteins or AFGP. Various kinds of AFGP were isolated
from many species of fishes, and in some amphibians, plants and
insects. All of the AFGPs share a common characteristic that prevents
ice crystals from growing and connecting to each other. Research has
also confirmed a cell membrane stabilizing characteristics of native
AFGP.
There has
been much scientific research done in an attempt to synthetically replicate
AFGPs in research institutions because the protective properties of AFGPs could
have commercial applications, primarily in food and crop preservation at
freezing temperatures. The native antifreeze glycoproteins are very large
molecules that are often made up of a repeating series of smaller molecules,
glycoproteins. Glycoproteins are often very biologically active, but they are
inherently quite unstable. The oxygen-glycosidic link is readily cleaved by
glycosidases, resulting in a low bio-availability of these glycoconjugate based
molecules.
Scientific
research prior to AAGP has focused on building a stable and more efficient
compound with a strong bond.
AAGP™
– The Core Technology of ProtoKinetix
AAGP™
Invention
Dr.
Geraldine Castelot-Deliencourt, along with Dr. Jean-Charles Quirion at the
Research Institute of Organic Chemistry in Rouen, France, developed a patented
process to stabilize the oxygen-glycosidic bond in these sugar based molecules.
This patented process replaces the weaker oxygen bond with a C-F2 mimetic. The
resultant molecules are biologically active and stable over a pH range of 2 to
13. They are not broken down by glycosidases.
AAGP™ Toxicity
Tests
Tests
have shown cells that have been exposed to AAGP™ at low and high concentrations
have remained viable. A common viability test used on cell cultures using trypan
blue dye exclusion method has been used to show AAGP™ non-toxicity.
AAGP™ Invention
(cont’d…)
AAGP™ Stability
Tests
AAGP™
molecules have remained stable when subjected to three tests:
|
1.
|
pH
ranging from a strong acid level of 1.8 (stronger than stomach acid) to a
strong alkali level of 13.8. (the pH scale is calibrated from 1, highly
acidic, to 14, highly alkali);
|
|
2.
|
Enzymatic
action using protease, which targets the amino acid bonds, and
glycosidase, which targets the amino acid bonds, and glycosidase, which
targets the sugar molecules; and
|
|
3.
|
Temperatures
ranging from -196°C (cryopreservation) to +37°C (body
temperature).
|
Stress
Tests on 12 Different Cell Lines
Cell
lines are selected for their high level of sensitivity. Cell lines are also
selected for their potential role in adding value in medical applications,
enhancing health and extending life. All tests are designed to explore how cells
from different cell lines act biologically in the presence of AAGP™ when
subjected to health and life threatening inflammatory stress conditions
and agents.
Cell
Lines Tested
§ Stem cells
(human)
|
§ Adult skin
fibroblast cells
|
§ Whole blood
cells
|
§ Heart cells
(cardiac myocites)
|
§ Blood Platelet
cells
|
§ Liver cells
(hepatocites)
|
§ Heart
tissue
|
§ Embryonic skin
fibroblast cells
|
§ Hela (cancer)
cells
|
§ Islet cells
(pancreatic)
|
§ Kidney (KB and
vero) cells
|
§ Stem cells
(mouse)
|
Stress
Conditions and Agents
Temperature
|
§
|
temperatures
ranging from -80° C to +37°
|
UV-C
Radiation
|
§
|
harsh
sterilizing radiation
|
|
§
|
254
nanometer wavelength
|
Oxidation
|
§
|
hydrogen
peroxide (H2O20
|
|
§
|
powerful
oxidant
|
Starvation
|
§
|
serum
free culture media
|
|
§
|
food/growth/nutrients
factors (fetal bovine serum)
withheld
|
Inflammation
|
§
|
Interleukin
1 Beta, a standard agent for stimulating inflammation in cell
testing
|
|
§
|
All
of the above tests are also considered to cause
inflammation
|
Bio-Screening
Control Lab Testing
AAGP™
testing is conducted to international standards in outsourced research
laboratories in North America and Europe. All tests are designed to explore both
the safety and effectiveness of AAGP™ when challenged to enhance the health
and extend the life of cells.
Test
Results Summary
Cells
that were tested in the presence of AAGP™ had a higher survival and viability
rate than the controls. The overall effect of AAGP™ is to protect, preserve and
in some cases to repair. Anti-inflammatory effects appear to be at work,
although the mechanism and pathways of action are not yet
determined. AAGP™ appears to enhance heath and extend cell
life.
The test
results are considered preliminary. The limited number of samples and extent of
the tests are designed to investigate the potential attributes of AAGP™ and
should not be considered as statistically or scientifically conclusive.
Notwithstanding, we feel the results are sufficient to justify further tests by
commercial entities in health care.
AAGP™
Commercial Applications
The
extent of the value of the ProtoKinetix family of AAGPs™ is being investigated
by companies and the Company is targeting commercial entities specializing in
regenerative medicine, cellular and tissue therapies, organ transplantation,
trauma, blood product banking, anti- inflammation and cosmetics/skin
care.
Skincare
and Cosmetics
Industry
sources estimate that the skincare market in the USA, including both mass and
prestige, will reach $7.2 billion by 2010, driven in part by expected
double-digit growth of anti-aging products, which is likely to become the second
largest category behind hand & body lotions in the industry.
According
to the Johnson and Johnson 2003 Annual Report, the global skin care and
cosmetics market is already running easily in the tens of billions at some $43
billion dollars per year.
In the
skin care business it’s about healthier, younger looking skin. The two major
causes of dry, wrinkled, less elastic or even diseased skin are inflammation and
oxidation. The main culprits are the sun (UV rays and free radicals) and other
environmental and physiological stresses that also cause inflammation and
oxidation.
When
AAGP™ is combined with Coenzyme Q10 a powerful anti-oxidant effect is achieved
that not only protects but also seems to help the cells repair previously
existing damage. In vitro laboratory tests have shown the AAGP™ molecules can
protect in vitro skin cells from damage and death that would otherwise occur
from UV rays and free radicals. To the extent of the laboratory tests conducted,
AAGP™ appears to protect in vitro skin cells from cold temperatures, oxidation,
UV irradiation and pH variations.
Health
Care
Acute
medical problems are increasingly reliant on, and benefit from, solutions that
can deal with the fundamental factors of inflammation and oxidation. Both are
well-known causes of life-threatening conditions and diseases, and accelerated
aging. In addition many acute medical problems are benefiting from cell
therapies and transplantation of cells, tissues and time sensitive
organs.
Health
Care Applications of AAGP™ fall into two main categories: (i) harvesting,
storage and transplanting cells, tissues and organs; and (ii) treatments for
conditions and disease caused by stress factors, including UV radiation,
oxidation and inflammation. These are all areas that expand into many
sub-categories of existing and future health care solutions.
Intellectual
Property
Because
it is difficult and costly to protect our proprietary rights, we may not be able
to ensure their protection. Our commercial success will depend in part on
maintaining patent protection and trade secret protection for our products, as
well as successfully defending these patents against third-party challenges. We
will only be able to protect our technologies from unauthorized use by third
parties to the extent that valid and enforceable patents or trade secrets cover
them.
The
patent positions of pharmaceutical and biotechnology companies can be highly
uncertain and involve complex legal and factual questions for which important
legal principles remain unresolved. No consistent policy regarding the breadth
of claims allowed in pharmaceutical or biotechnology patents has emerged to date
in the United States. The patent situation outside the United States is even
more uncertain. Changes in either the patent laws or in interpretations of
patent laws in the United States and other countries may diminish the value of
our intellectual property. Accordingly, we cannot predict the breadth of claims
that may be allowed or enforced in our patents or in third-party
patents.
Patents
As of the
date of this Report, our development agents, including the parties we have
licensed AAGP™ technologies from, have applied to receive patents for
technologies we have licensed and continue to primarily base our research
efforts on. At present, we have engaged the patent law firm of Cabinet-Moutard
of Versaille, France, and have filed a number of international patent
applications. These patent applications include:
WO
2004/014928 A2 (19 February 2004)
PCT Int.
Appl. (2006), 87 pp. WO2006059227 A1 20060608 AN 2006:538719
Patent
application: Fr 03 May 2006, 06 03952
Consistent
with our agreements with the licensors of various technologies we license, we
have no finished commercial product or products, and have received no final
patents awards or FDA approvals for any product or diagnostic
procedures. We are focused on the research and development of one
primary compound known as AAGP™, which we have filed a trademark application
for.
Subject
to our available financial resources, our intellectual property strategy
is: (1) to pursue licenses, trade secrets, and know-how within our
primary research areas, and (2) to develop and acquire proprietary positions to
reagents and new platforms for the development of products related to these
technologies.
Trade
Secrets and Know-How
We have
developed a substantial body of trade secrets and know-how relating to the
development, use and manufacture of AAGP™, including but not limited to the
optimization of materials for efforts, and how to maximize sensitivity,
speed-to-result, specificity, stability, purity and
reproducibility.
Super
Antibody and Catalytic Antibody Platform Technologies
We
continue to own the rights to both the Super Antibody and the Catalytic Antibody
platform technologies. We plan to, as a secondary priority and subject to
available resources, search for a patentable receptor sites that exist on cancer
cells.
Competition
The
markets that we are focusing on are multi-billion dollar international
industries. They are intensely competitive. Many of our
competitors are substantially larger and have greater financial, research,
manufacturing, and marketing resources.
Industry
competition in general is based on the following:
|
§
|
Scientific
and technological capability;
|
|
§
|
Proprietary
know-how;
|
|
§
|
The
ability to develop and market products and
processes;
|
|
§
|
The
ability to obtain FDA or other required regulatory
approvals;
|
|
§
|
The
ability to manufacture products that meet applicable FDA requirements,
(i.e. FDA’s Quality System Regulations) see Governmental Regulation
section;
|
|
§
|
Access
to adequate capital;
|
|
§
|
The
ability to attract and retain qualified personnel;
and
|
|
§
|
The
availability of patent protection.
|
We
believe our scientific and technological capabilities are
significant.
Our
ability to develop our research is in large measure dependent on having
sufficient and additional resources and/or collaborative
relationships.
Our
access to capital is more challenging, relative to most of our
competitors. This is a competitive disadvantage. We
believe however that our access to capital may increase as we get closer to the
development of a commercially viable product.
We
believe that our research has enabled us to attract and retain qualified
consultants. Because of the greater financial resources of many of
our competitors, we may not be able to complete effectively for the same
individuals to the extent that a competitor uses its substantial resources to
attract any such individuals.
Employees
We
currently have no full time employees. We operate with a skeletal
management team headed by our Chief Executive Officer Ross Senior. In addition
to Mr. Senior, we receive advice and counsel from our Scientific Advisory
Board.
Governmental
Regulation
Our
AAGPs™ have commercial applications in markets and circumstances that fall under
government regulations ranging from none to limited to extensive.
Although
there is no such immediate need to make any regulatory filing in the United
States or other jurisdictions, we have limited or no experience with regard to
obtaining FDA or other required regulatory approvals. We intend to retain the
services of appropriately experiences consultants. For this reason, should our
research efforts continue to show promise, we will need to hire consultants to
assist the Company with such governmental regulations.
As we
continue to conduct research and testing programs, in collaboration with
commercial entities, to expand and confirm the potential medical applications of
AAGP™ in the a number of fields, including regenerative medicine, cell therapy,
blood products, transplants and skin care/cosmetics, we intend to utilize the
regulatory expertise of others, whether they are consultants or commercial
entities involved on collaborative development programs with the
Company.
The
following discussion relates to factors that may come into play when and if we
have a commercially viable product in an area which requires regulatory
approval. These products may be regulated by the European regulatory
agencies, FDA, U.S. Department of Agriculture, certain state and local agencies,
and/or comparable regulatory bodies in other countries (collectively, these
agencies shall be referred to as the "Agencies"). Government
regulation affects almost all aspects of development, production, and marketing,
including product testing, authorizations to market, labeling, promotion,
manufacturing, and record keeping. The FDA and U.S. Department of
Agriculture regulated products require some form of action by that agency before
they can be marketed in the United States, and, after approval or clearance, the
products must continue to comply with other FDA requirements applicable to
marketed products. Both before and after approval or clearance,
failure to comply with the FDA’s requirements can lead to significant penalties.
Our proposed AAGP™ products will require government regulatory approval as a
biologic agent. Such regulatory approval will be granted only after the
appropriate preclinical and clinical studies are conducted to confirm efficacy
and safety.
Every
company that manufactures biologic products or medical devices distributed in
the United States must comply with the FDA’s Quality System
Regulations. These regulations govern the manufacturing process,
including design, manufacture, testing, release, packaging, distribution,
documentation, and purchasing. Compliance with the Quality System
Regulations is required before the FDA will approve an application. These
requirements also apply to marketed products. Companies are also
subject to other post-market and general requirements, including compliance with
restrictions imposed on marketed products, compliance with promotional
standards, record keeping, and reporting of certain adverse reactions or
events. The FDA regularly inspects companies to determine compliance
with the Quality System Regulations and other post-approval
requirements. Failure to comply with statutory requirements and the
FDA’s regulations can lead to substantial penalties, including monetary
penalties, injunctions, product recalls, seizure of products, and criminal
prosecution.
The
Clinical Laboratory Improvement Act of 1988 prohibits laboratories from
performing in vitro tests for the purpose of providing information for the
diagnosis, prevention or treatment of any disease or impairment of, or the
assessment of, the health of human beings unless there is in effect for such
laboratories a certificate issued by the U.S. Department of Health and Human
Services applicable to the category of examination or procedure
performed. Although a certificate is not required, we consider the
applicability of the requirements of the Clinical Laboratory Improvement Act in
the potential design and development of its products.
We are
also subject to regulations in foreign countries governing products, human
clinical trials and marketing, and may need to obtain approval or evaluations by
international public health agencies, such as the World Health Organization, in
order to sell products in certain countries. Approval processes vary
from country to country, and the length of time required for approval or to
obtain other clearances may in some cases be longer than that required for U.S.
governmental approvals. The extent of potentially adverse
governmental regulation affecting ProtoKinetix that might arise from future
legislative or administrative action cannot be predicted.
Environmental
Laws
To date,
we have not encountered any costs relating to compliance with any environmental
laws.
Plan
of Operation
Our
current operations are centered around our relationships with various research
and development consultants who are conducting research on behalf of the company
at discrete and established laboratories in various parts of the world. We
intend to continue these efforts throughout 2009.
Recent
Developments
On
February 13, 2008, we appointed Mr. Edward D Martin, M.D. to the position of
Chairman of the Business Advisory Board.
Edward D. Martin,
M.D.
Edward D.
Martin, M.D., is the co-founder and Chairman of Martin, Blanck & Associates,
Inc., a consulting firm to the health care industry, government, and to major
health care information management and technology companies since March of 1998.
From July, 2000 through December, 2004, Dr. Martin was a Senior Vice President
and the Chief Medical Officer at Science Applications International Corporation
(SAIC) and continues to support SAIC on a part-time basis.
Dr.
Martin had a distinguished 30-year career in public service as a commissioned
officer in the United States Public Health Service, Department of Health and
Human Services (formerly Department of Health, Education and Welfare). His last
assignments were at the Department of Defense (DoD), where he served as the
Acting Assistant Secretary of Defense (Health Affairs), and, prior to this
appointment, as Principal Deputy Assistant Secretary of Defense (Health
Affairs).
Dr.
Martin arrived at the Pentagon in 1989 after 15 years of executive leadership
positions with the Public Health Service (PHS). He served as Chief of Staff for
C. Everett Koop, M.D., Surgeon General; Director, Bureau of Health Care Delivery
and Assistance; Acting Deputy Administrator, Health Resources and Services
Administration; and Director, Bureau of Community Health Services. Dr. Martin
was commissioned in the PHS in May 1975 and held the rank of Rear Admiral upon
his retirement in April 1998.
On March
5, 2008, we appointed Mr. Donald J. Weber to the Business Advisory
Board.
Mr. Donald J.
Weber
Mr. Weber
is the Chairman and founder of Logistics Health, Inc. (www.logisticshealth.com)
a major service provider for the United States Department of Defense, Homeland
Security and the Centers for Disease Control.
Previously,
Mr. Weber was President and founder of National Health Screenings, which focused
exclusively on health assessments and employee screening services. He built one
of the premier providers of pre-employment drug testing services and sold this
business to Pinkerton Services Group.
After a
transition period, he began devoting his time to building LHI into a world-class
leader in the field of military medical and dental readiness. After growing up
on a farm in rural Wisconsin, he joined the Marines and became a Vietnam veteran
who, among many awards, has received a purple heart and two bronze
stars.
In 2004,
Mr. Weber was named Wisconsin Entrepreneur of the Year by the Wisconsin
Entrepreneur’s Conference. This award is meant to recognize entrepreneurial
leaders who are instrumental in the development of the Wisconsin
economy.
On March
11, 2008, we appointed Mr. Randy Anderson as Vice President of Government
Affairs.
Mr. Randy
Anderson
Mr.
Anderson has been a long term governmental liaison specialist based in
Washington, D.C. Randy will be working very closely with our Washington, D.C.
team of business advisors. In this capacity, Mr. Anderson will be directing the
development of AAGP™ applications into the United States military and government
health care initiatives.
Recent Developments
(cont’d…)
On March
18, 2008, in order to accommodate our current growth and to take advantage of
our current opportunities, we opened an office in Washington, D.C. Our new
office will serve as a central hub to access the multiple government and
non-government health related agencies. Our Washington, D.C. office will enable
our business development team to accelerate strategic relationships required to
optimize the value of the many applications of AAGP™.
Sales
and Marketing
We are
not currently selling or marketing any products.
Results
of Operations for the nine months ended September 30, 2009 compared to September
30, 2008 are as follows:
We had $0
in net revenues for the period ending September 30, 2009.
Operating
expenses from continuing operations and net loss were $585,895 for the nine
month period ending September 30, 2009 compared to $1,383,607 for the nine
months ending September 30, 2008. These expenses were primarily
incurred for professional fees, consulting services related to the operations of
the Company's business, specifically, research and development related expenses,
and other general and administrative expenses. Significant changes
from the prior six month period include;
Professional
fees decreased by $111,892 from $139,167 to $27,275 primarily as a
result of discontinuing a contract with a legal firm requiring minimum quarterly
non refundable retainers.
Consulting
fees decreased by $216,136 from $616,343 to $400,207 as a result of completion
of agreements in 2008 that have not been renewed as at September 30,
2009
Research
and development costs decreased by $369,348 from $389,501 to $20,153 as a result
of completion of agreements in 2008 that have not been renewed as at September
30, 2009
Liquidity
and Capital Resources
At
September 30, 2009, we had $25,831 in cash and $301,040 in total current
assets. In the event that we need to raise additional
capital, there can be no assurance that we will be able to raise capital from
outside sources in sufficient amounts to fund our new business.
The
failure to secure adequate outside funding would have an adverse affect on our
plan of operation and results therefrom and a corresponding negative impact on
shareholder liquidity.
Inflation
Although
management expects that our operations will be influenced by general economic
conditions, we do not believe that inflation had a material effect on our
results of operations for the period ending September 30, 2009.
Going
Concern
The
accompanying financial statements have been prepared in conformity with
generally accepted accounting principles, which contemplate continuation of the
Company as a going concern. The history of losses and the inability
for the Company to make a profit from selling a good or service has raised
substantial doubt about our ability to continue as a going concern. In spite of
the fact that the current cash obligations of the Company are relatively
minimal, given the cash position of the Company, we have very little cash to
operate. We intend to fund the Company and attempt to meet corporate obligations
by selling common stock. However the Company's common stock is at a
low price and is not actively traded.
ITEM
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
As
defined by Rule 12b-2 of the Exchange Act, the Company is a smaller reporting
company, and as such, is not required to provide the information required under
this item
ITEM
4T.
|
CONTROLS
AND PROCEDURES
|
We
evaluated the effectiveness of the design and operation of our disclosure
controls and procedures as of the end of the period covered by this Quarterly
Report on Form 10-Q. Disclosure controls and procedures are designed to ensure
that information required to be disclosed in our reports filed under the
Exchange Act, such as this Quarterly Report on Form 10-Q is recorded, processed,
summarized and reported within the time periods specified by the SEC. Disclosure
controls are also designed to ensure that such information is accumulated and
communicated to our management, including the CEO and CFO, as appropriate, to
allow timely decisions regarding required disclosure.
Based on
the evaluation, our President and Chief Executive Officer, after evaluating the
effectiveness of our “disclosure controls and procedures” has concluded that, as
of September 30, 2009, our disclosure controls and procedures were not effective
due to the existence of several material weaknesses in our internal control over
financial reporting, as discussed below.
Material
Weaknesses Identified
In
connection with the preparation of our financial statements for the period ended
September 30, 2009 certain significant deficiencies in internal control became
evident to management that, in the aggregate, represent material weaknesses,
including,
Insufficient
segregation of duties in our finance and accounting functions due to limited
personnel. During the period ended September 30, 2009, the company used
outside services to perform all aspects of our financial reporting
process, including, but not limited to, access to the underlying accounting
records and systems, the ability to post and record journal entries and
responsibility for the preparation of the financial statements. This
creates a lack of review over the financial reporting process that would likely
result in a failure to detect errors in spreadsheets, calculations, or
assumptions used to compile the financial statements and related disclosures as
filed with the SEC. These control deficiencies could result in a material
misstatement to our interim or annual financial statements that would not be
prevented or detected.
Insufficient
corporate governance policies. Although we have a code of ethics which
provides broad guidelines for corporate governance, our corporate governance
activities and processes are not always formally documented. Specifically,
decisions made by the board to be carried out by management should be documented
and communicated on a timely basis to reduce the likelihood of any
misunderstandings regarding key decisions affecting our operations and
management.
Plan
for Remediation of Material Weaknesses
We intend
to take appropriate and reasonable steps to make the necessary improvements to
remediate these deficiencies.
We intend
to consider the results of our remediation efforts and related testing as part
of our year-end 2009 assessment of the effectiveness of our internal control
over financial reporting.
PART
II
ITEM
1.
|
LEGAL
PROCEEDINGS
|
We are
not party to any legal proceedings and to our knowledge, no such proceedings are
threatened or contemplated against us.
ITEM
1A.
|
RISK
FACTORS
|
Not
Applicable.
ITEM
2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
On
February 8, 2008, we issued 278,846 common shares to a consultant in connection
with a consulting agreement. These issuances were made in lieu of cash payments
for services rendered and were considered exempt transactions under Section 4(2)
of the Securities Act of 1933, as amended.
On March
20, 2008, we granted a total of 1,700,000 common shares and warrants to several
investors in connection with a private placement for a total sales price of
$255,000. These issuances were considered exempt transactions under Section 4(2)
of the Securities Act of 1933, as amended. These shares were issued
during the quarter ended June 30, 2008
On March
26, 2008, we issued 90,500 common shares to two consultants in connection with a
consulting agreement. These issuances were made in lieu of cash payments for
services rendered and were considered exempt transactions under Section 4(2) of
the Securities Act of 1933, as amended.
On May 6,
2008, we issued 308,500 common shares to two consultants in connection with a
consulting agreements. These issuances were made in lieu of cash payments for
services rendered and were considered exempt transactions under Regulation S
.
On May
21, 2008, we issued 86,670 common shares to two consultants in connection with a
consulting agreements. These issuances were made in lieu of cash payments for
services rendered and were considered exempt transactions under Regulation
S.
On May
21, 2008, we issued 173,000 common shares in connection with a settlement
agreements. These issuance was considered an exempt transaction under Regulation
S.
On June
30, 2008, our Board of Directors’ authorized the issuance of 2,850,000 common
shares to several consultants in connection to consulting agreements provide by
directors, officers and consultants. Those shares are in lieu of cash
payments. for services rendered.. We issued 2,250,000 of those common shares
during the quarter ending September 30, 2008 and were considered exempt
transactions under Regulation S.
On July
15, 2008, we issued 155,170 common shares to a consultant in connection with
consulting agreements. These issuances were made in lieu of cash payments for
services rendered and were considered exempt transactions under Regulation
S.
On
September 15, 2008, we issued 186,430 common shares to a consultant in
connection with consulting agreements. These issuances were made in
lieu of cash payments for services rendered and were considered exempt
transactions under Regulation S.
On
September 16, 2008, we issued 170,000 common shares pursuant to the exercise is
prior issued warrants. This issuance is considered an exempt
transaction under Regulation S.
On
October 8, 2008, we issued 250,000 common shares to a consultant in connection
with a consulting agreement. This issuance was made in lieu of cash
payments for services rendered and were considered exempt transactions under
Regulation S.
On
November 3, 2008, we issued 100,000 common shares pursuant to the exercise of
prior issued warrants. This issuance is considered an exempt
transaction under Regulation S.
On
November 17, 2008, we issued 18,375 common shares to a consultant in connection
with a consulting agreement. This issuance was made in lieu of cash
payments for services rendered and were considered exempt transactions under
Regulation S.
On
November 26, 2008, we issued 1,000,000 common shares to a consultant in
connection with a consulting agreement. This issuance was made in
lieu of cash payments for services rendered and were considered exempt
transactions under Regulation S.
On April
21, 2009, we issued 1,200,000 common shares to consultants in connection with
consulting agreements. These issuances were made in lieu of cash
payments for services rendered and were considered exempt transactions under
Regulation S.
On May
21, 2009, we issued 500,000 common shares to a consultant in connection with a
consulting agreement. These issuances were made in lieu of cash
payments for services rendered and were considered exempt transactions under
Regulation S.
On May
21, 2009, we issued a total of 250,000 common shares and warrants to an investor
in connection with a private placement for a total sales price of $25,000. These
issuances were considered exempt transactions under Section 4(2) of the
Securities Act of 1933, as amended.
On May
21, 2009, we issued 600,000 common shares to directors. These
issuances were made in lieu of cash payments for services rendered and were
considered exempt transactions under Regulation S.
On June
26, 2009, we issued 300,000 common shares to consultants in connection with
consulting agreements. These issuances were made in lieu of cash
payments for services rendered and were considered exempt transactions under
Regulation S.
On July
23, 2009, we issued 100,000 common shares to a consultant in connection with a
consulting agreement. These issuances were made in lieu of cash
payments for services rendered and were considered exempt transactions under
Regulation S.
On July
30, 2009, we issued a total of 500,000 common shares and warrants to an investor
in connection with a private placement for a total sales price of $50,000. These
issuances were considered exempt transactions under Section 4(2) of the
Securities Act of 1933, as amended.
On July
30, 2009, we issued 1,224,500 common shares to consultants in connection with
consulting agreements. These issuances were made in lieu of cash
payments for services rendered and were considered exempt transactions under
Regulation
Pursuant
to Item 3.02 of Form 8-K, because the Company is a small business issuer and all
of the above issuances, in the aggregate, equal less than 5% of the number of
common shares issued and outstanding (based on the number of issued and
outstanding shares identified in the Company's last periodic report), these
sales were not reported in a Form 8-K.
ITEM
3.
|
DEFAULT
UPON SENIOR SECURITIES
|
None
ITEM
4.
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY
HOLDERS
|
No
matters were submitted to our security holders for a vote during the quarter
ended September 30, 2009.
ITEM
5.
|
OTHER
INFORMATION
|
None
ITEM
6.
|
EXHIBITS
AND REPORTS ON FORM 8-K.
|
Ex. #
|
Description
|
|
Rule
13a-12(a)/15d-14(a) Certification of Chief Executive Officer and Chief
Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant
to Section 302 the Sarbanes-Oxley Act of 2002.
|
||
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
Signatures
In
accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the
registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Protokinetix,
Inc.
|
|
/s/
Ross L.
Senior
|
|
By: Ross
L. Senior
|
|
Its: President,
CEO and CFO
|
In
accordance with the requirements of the Exchange Act, this report has been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
Signatures
|
Title
|
Date
|
||||
/s/Ross L. Senior
|
Chief
Executive Officer, President, and
|
August
1, 2009
|
||||
Ross
L. Senior
|
Chief
Financial Officer
|
24