UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-Q
X QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
--- OF THE SECURITIES EXCHANGE ACT OF 1934
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES ACT OF 1933
For Quarter Ended: November 30, 2009 Commission File Number 000-49908
----------------- ---------
CYTODYN, INC.
-------------
(Exact name of registrant as specified in its charter)
75-3056237 COLORADO
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(I.R.S. Employer Identification No.) State or other jurisdiction
of incorporation organization
1511 Third Street, Santa Fe, 87505
---------------------------------------- ----------
(Address of principal executive offices) (Zip code)
(Registrant's telephone number, including area code) (505) 988-5520
(Former address, changed since last report)
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 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 No X
--- ---
Indicate by check mark whether the registrant has submitted electronically and
posted on its corporate website, if any, every Interactive Data File required to
be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405
of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit and post such files). Yes No
--- ---
--------------------------------------------------------------------------------
Indicate by check mark whether the registrant is a large accelerated filer, and
an accelerated filer, a non-accelerated filer, or a smaller reporting company.
See Definition of "accelerated filer, large accelerated filer, and smaller
reporting company" in 12(b)2 of the Exchange Act (check one)
Large Accelerated Filer Accelerated Filer
--- ---
Non-accelerated Filer Smaller Reporting Company X
--- ---
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act): Yes No X
--- ---
On September 28, 2010, there were 20,451,796 shares outstanding of the
registrant's no par common stock.
TABLE OF CONTENTS
PAGE
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PART I FINANCIAL INFORMATION
---------------------
Item 1 Financial Statements
--------------------
Condensed Consolidated Balance Sheets as of November 30, 2009
(unaudited) and May 31, 2009 1
Condensed Consolidated Statement of Operations for the
Three and six months Ended November 30, 2009 and 2008, and
for the Period from October 28, 2003 to November 30 2009
(unaudited) 2
Condensed Consolidated Statement of Changes in Stockholders'
Deficit for the Period from October 28, 2003 to
November 30, 2009 (unaudited) 3
Condensed Consolidated Statement of Cash Flows for the six
Months Ended November 30, 2009 and 2008 and for the Period
from October 28, 2003 to November 30, 2009 (unaudited) 9
Notes to Condensed Consolidated Financial Statements (unaudited) 11
Item 2 Management's Discussion and Analysis of Financial Condition
-----------------------------------------------------------
and Results of Operations. 21
--------------------------
Item 3 Quantitative and Qualitative Disclosures About Market Risk 27
----------------------------------------------------------
Item 4T Controls and Procedures 27
-----------------------
PART II OTHER INFORMATION
-----------------
Item 1 Legal Proceedings 28
-----------------
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 28
-----------------------------------------------------------
Item 3 Defaults Upon Senior Securities 28
-------------------------------
Item 4 Reserved and removed 28
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Item 5 Other Information 28
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Item 6 Exhibits 28
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PART I
Item 1. Financial Statements
Cytodyn, Inc.
(A Development Stage Company)
Condensed Consolidated Balance Sheet
November 30, May 31,
2009 2009
(unaudited)
------------ ------------
Assets
Current Assets:
Cash $ 126,403 $ 265,520
Prepaid expenses 14,797 --
Prepaid license fees 7,500 7,500
------------ ------------
Total current assets 148,700 273,020
Furniture and equipment, net 3,082 1,963
Intangible assets, net -- 161
Other Assets 27,725 29,600
------------ ------------
$ 179,507 $ 304,744
============ ============
Liabilities and Shareholders' Deficit
Current liabilities:
Accounts payable $ 305,847 $ 269,870
Accrued liabilities 52,670 49,424
Short-term portion of legal accrual 25,000 25,000
Indebtedness to related parties - short-term portion 190,985 --
Short-term portion of notes payable 27,500 67,500
Accrued interest payable 34,000 80,329
------------ ------------
Total current liabilities 636,002 492,123
Long Term Liabilities
Accrued salaries - related party 229,500 229,500
Notes payable -- 70,500
Convertible notes payable, net 6,937 21,937
Indebtedness to related parties -- 190,985
------------ ------------
Total Liabilities 872,439 1,005,045
------------ ------------
Shareholders' deficit:
Series A Convertible preferred stock, no par value;
5,000,000 shares authorized, -0- and 100,000 shares
issued and outstanding At November 30, 2009 and
May 31, 2009, respectively -- 167,500
Series B Convertible stock preferred stock,
no par value; 400,000 shares authorized, 125,000 and
-0- shares issued and outstanding at November 30, 2009
and May 31, 2009, respectively 625,000 --
Treasury stock, at cost, 568,420 shares held (159,158) --
Additional paid-in capital - treasury stock 218,449
Common stock, no par value; 25,000,000 shares authorized,
19,139,315 issued and 18,570,895 outstanding
at November 30, 2009, respectively and 16,221,315
issued and outstanding at May 31, 2009 6,717,743 6,285,587
Prepaid stock services (108,433) --
Additional paid-in capital 3,178,849 2,994,153
Accumulated deficit on unrelated dormant operations (1,601,912) (1,601,912)
Deficit accumulated during development stage (9,563,470) (8,545,629)
------------ ------------
Total shareholders' deficit (692,932) (700,301)
------------ ------------
$ 179,507 $ 304,744
============ ============
See accompanying notes to condensed consolidated financial statements.
1
Cytodyn, Inc.
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
October 28,
2003
Three months ended, Six months ended, through
11/30/2009 11/30/2008 11/30/2009 11/30/2008 11/30/2009
------------ ------------ ------------ ------------ ------------
Operating expenses:
General and administrative $ 516,334 $ 402,786 $ 765,239 $ 660,483 $ 6,590,057
Amortization / depreciation 461 4,252 1,046 4,641 176,938
Research and development 160,878 195,000 167,368 460,000 1,587,296
Legal fees 10,848 43,840 30,407 73,194 721,181
------------ ------------ ------------ ------------ ------------
Total operating expenses 688,521 645,878 964,060 1,198,318 9,075,472
------------ ------------ ------------ ------------ ------------
Operating loss (688,521) (645,878) (964,060) (1,198,318) (9,075,472)
Interest income -- -- -- -- 1,627
Extinguishment of debt -- -- -- -- 337,342
Interest expense:
Interest on convertible debt -- -- (38,604) -- (734,863)
Interest on notes payable (6,091) (12,100) (15,177) (18,420) (92,104)
------------ ------------ ------------ ------------ ------------
Loss before income taxes (694,612) (657,978) (1,017,841) (1,216,738) (9,563,470)
Income tax provision -- -- -- -- --
------------ ------------ ------------ ------------ ------------
Net loss $ (694,612) $ (657,978) $ (1,017,841) $ (1,216,738) $ (9,563,470)
============ ============ ============ ============ ============
Basic and diluted loss per share $ (.04) $ (0.05) $ (.05) $ (0.09) $ (.87)
============ ============ ============ ============ ============
Basic and diluted weighted average
common shares outstanding 19,606,592 13,958,792 19,072,811 13,386,691 10,978,422
============ ============ ============ ============ ============
See accompanying notes to condensed consolidated financial statements
2
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Changes in Shareholders' Deficit
Period October 28, 2003 through November 30, 2009
(unaudited)
Preferred Stock Common Stock Treasury Stock
-------------------------- -------------------------- --------------------------
Shares Amount Shares Amount Shares Amount
----------- ----------- ----------- ----------- ----------- -----------
Balance at October 28, 2003,
following recapitalization -- -- 6,252,640 $ 1,425,334 -- --
February through April 2004,
sale of common stock less
offering costs of $54,000
($.30/share) -- -- 1,800,000 486,000 -- --
February 2004, shares issued
to former officer as payment
for working capital advance
($.30/share) -- -- 16,667 5,000 -- --
Net loss at year ended
May 31, 2004 -- -- -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2004 -- -- 8,069,307 1,916,334 -- --
July 2004, capital
contribution by an officer -- -- -- -- -- --
November 2004, common
stock warrants granted -- -- -- -- -- --
February 2005, capital
contribution by an officer -- -- -- -- -- --
Net loss at year ended
May 31, 2005 -- -- -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2005 -- -- 8,069,307 1,916,334 -- --
Deficit
Accumulated
Treasury Stock for Additional During
Stock Prepaid Paid-in Accumulated Development
APIC Services Capital Deficit Stage Total
----------- ----------- ----------- ----------- ----------- -----------
Balance at October 28, 2003,
following recapitalization -- -- $ 23,502 $(1,594,042) -- $ (145,206)
February through April 2004,
sale of common stock less
offering costs of $54,000
($.30/share) -- -- -- -- -- 486,000
February 2004, shares issued
to former officer as payment
for working capital advance
($.30/share) -- -- -- -- -- 5,000
Net loss at year ended
May 31, 2004 -- -- -- (7,870) (338,044) (345,914)
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2004 -- -- 23,502 (1,601,912) (338,044) (120)
July 2004, capital
contribution by an officer -- -- 512 -- -- 512
November 2004, common
stock warrants granted -- -- 11,928 -- -- 11,928
February 2005, capital
contribution by an officer --
-- 5,000 -- -- 5,000
Net loss at year ended
May 31, 2005 -- -- -- -- (777,083) (777,083)
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2005 -- -- 40,942 (1,601,912) (1,115,127) (759,763)
See accompanying notes to condensed consolidated financial statements
3
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Changes in Shareholders' Deficit
Period October 28, 2003 through November 30, 2009
(unaudited)
Preferred Stock Common Stock Treasury Stock
-------------------------- -------------------------- --------------------------
Shares Amount Shares Amount Shares Amount
----------- ----------- ----------- ----------- ----------- -----------
June through July 2005, sale
of common stock less
offering costs of $27,867
($.75/share) -- -- 289,890 189,550 -- --
August 2005, common shares
issued to extinguish
promissory notes payable and
related interest ($.75/share) -- -- 160,110 120,082 -- --
May 2006, common shares issued
to extinguish convertible debt -- -- 350,000 437,500 -- --
November 2005, 94,500 warrants
exercised ($.30/share) -- -- 94,500 28,350 -- --
January through April 2006,
common shares issued for
prepaid services -- -- 183,857 370,750 -- --
Amortization of prepaid
stock services -- -- -- -- -- --
January through June 2006,
warrants issued
with convertible debt -- -- -- -- -- --
January through May 2006,
beneficial conversion feature
of convertible debt -- -- -- -- -- --
March through May 2006, stock
options granted to consultants -- -- -- -- -- --
Deficit
Accumulated
Treasury Stock for Additional During
Stock Prepaid Paid-in Accumulated Development
APIC Services Capital Deficit Stage Total
----------- ----------- ----------- ----------- ----------- -----------
June through July 2005, sale
of common stock less
offering costs of $27,867
($.75/share) -- -- -- -- -- 189,550
August 2005, common shares
issued to extinguish
promissory notes payable and
related interest ($.75/share) -- -- -- -- -- 120,082
May 2006, common shares issued
to extinguish convertible debt -- -- -- -- -- 437,500
November 2005, 94,500 warrants
exercised ($.30/share) -- -- -- -- -- 28,350
January through April 2006,
common shares issued for
prepaid services -- (370,750) -- -- -- --
Amortization of prepaid
stock services -- 103,690 -- -- -- 103,690
January through June 2006,
warrants issued
with convertible debt -- -- 274,950 -- -- 274,950
January through May 2006,
beneficial conversion feature
of convertible debt -- -- 234,550 -- -- 234,550
March through May 2006, stock
options granted to consultants -- -- 687,726 -- -- 687,726
See accompanying notes to condensed consolidated financial statements
4
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Changes in Shareholders' Deficit
Period October 28, 2003 through November 30, 2009
(unaudited)
Preferred Stock Common Stock Treasury Stock
-------------------------- -------------------------- --------------------------
Shares Amount Shares Amount Shares Amount
----------- ----------- ----------- ----------- ----------- -----------
March 2006, stock options
issued to extinguish debt -- -- -- -- -- --
Net loss at year ended
May 31, 2006 -- -- -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2006 -- -- 9,147,664 3,062,566 -- --
Common stock issued to
extinguish convertible debt -- -- 119,600 149,500 -- --
Common stock issued for
AITI acquisition -- -- 2,000,000 934,399 -- --
Amortization of
prepaid stock services -- -- -- -- -- --
Common stock payable for
prepaid services -- -- -- -- -- --
Stock-based compensation -- -- -- -- -- --
Warrants issued with
convertible debt -- -- -- -- -- --
Common stock issued for
services -- -- 30,000 26,400 -- --
Preferred shares issued AGTI 100,000 167,500 -- -- -- --
Net loss, May 31, 2007 -- -- -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2007 100,000 167,500 11,297,264 4,172,865 -- --
Deficit
Accumulated
Treasury Stock for Additional During
Stock Prepaid Paid-in Accumulated Development
APIC Services Capital Deficit Stage Total
----------- ----------- ----------- ----------- ----------- -----------
March 2006, stock options
issued to extinguish debt -- -- 86,341 -- -- 86,341
Net loss at year ended
May 31, 2006 -- -- -- -- (2,053,944) (2,053,944)
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2006 -- (267,060) 1,324,509 (1,601,912) (3,169,071) (650,968)
Common stock issued to
extinguish convertible debt -- -- -- -- -- 149,500
Common stock issued for
AITI acquisition -- -- -- -- -- 934,399
Amortization of
prepaid stock services -- 267,060 -- -- -- 267,060
Common stock payable for
prepaid services -- (106,521) 120,000 -- -- 13,479
Stock-based compensation -- -- 535,984 -- -- 535,984
Warrants issued with
convertible debt -- -- 92,500 -- -- 92,500
Common stock issued for
services -- -- -- -- -- 26,400
Preferred shares issued AGTI -- -- -- -- -- 167,500
Net loss, May 31, 2007 -- -- -- -- (2,610,070) (2,610,070)
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2007 -- (106,521) 2,072,993 (1,601,912) (5,779,141) (1,074,216)
See accompanying notes to condensed consolidated financial statements
5
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Changes in Shareholders' Deficit
Period October 28, 2003 through November 30, 2009
(unaudited)
Preferred Stock Common Stock Treasury Stock
-------------------------- -------------------------- --------------------------
Shares Amount Shares Amount Shares Amount
----------- ----------- ----------- ----------- ----------- -----------
Amortization of prepaid
stock for services -- -- -- -- -- --
Stock based compensation -- -- -- -- -- --
Common stock issued to
extinguish convertible debt -- -- 750,000 75,000 -- --
Rescission of common
stock issued for services -- -- (142,857) (100,000) -- --
Original issue discount
convertible debt with
warrants -- -- -- -- -- --
Original issue discount
convertible debt with
beneficial conversion feature -- -- -- -- -- --
Stock issued for cash
($.50/share) -- -- 642,000 321,000 -- --
Net loss -- -- -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2008 100,000 $ 167,500 12,546,407 $ 4,468,865 -- --
Deficit
Accumulated
Treasury Stock for Additional During
Stock Prepaid Paid-in Accumulated Development
APIC Services Capital Deficit Stage Total
----------- ----------- ----------- ----------- ----------- -----------
Amortization of prepaid
stock for services -- 106,521 -- -- -- 106,521
Stock based compensation -- -- 461,602 -- -- 461,602
Common stock issued to
extinguish convertible debt -- -- -- -- -- 75,000
Rescission of common
stock issued for services -- -- -- -- -- (100,000)
Original issue discount
convertible debt with
warrants -- -- 3,662 -- -- 3,662
Original issue discount
convertible debt with
beneficial conversion feature -- -- 75,000 -- -- 75,000
Stock issued for cash
($.50/share) -- -- -- -- -- 321,000
Net loss -- -- -- -- (1,193,684) (1,193,684)
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2008 -- -- $ 2,613,257 $(1,601,912) $(6,972,825) $(1,325,115)
See accompanying notes to condensed consolidated financial statements
6
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Changes in Shareholders' Deficit
Period October 28, 2003 through November 30, 2009
(unaudited)
Preferred Stock Common Stock Treasury Stock
-------------------------- -------------------------- --------------------------
Shares Amount Shares Amount Shares Amount
----------- ----------- ----------- ----------- ----------- -----------
Stock issued for cash
($.50/share) -- -- 3,023,308 $ 1,511,654 -- --
Stock issued for services
($.50/share) -- -- 388,200 194,100 -- --
Stock issued for services
($.37/share) -- -- 150,000 55,500 -- --
Stock based compensation -- -- -- -- -- --
Stock issued in payment
Of accounts payable,
($.50/share) -- -- 98,000 49,000 -- --
Stock issued for services
($.42/share) -- -- 15,400 6,468 -- --
Capital contribution -- -- -- -- -- --
Net loss ended May 31, 2009 -- -- -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2009 100,000 $ 167,500 16,221,315 $ 6,285,587 -- --
Stock issued for cash
($.50/share) -- -- 236,400 118,200 -- --
Conversion of debt to
Common stock ($.45/share) -- -- 325,458 146,456 -- --
Deficit
Accumulated
Treasury Stock for Additional During
Stock Prepaid Paid-in Accumulated Development
APIC Services Capital Deficit Stage Total
----------- ----------- ----------- ----------- ----------- -----------
Stock issued for cash
($.50/share) -- -- -- -- -- $ 1,511,654
Stock issued for services
($.50/share) -- -- -- -- -- 194,100
Stock issued for services
($.37/share) -- -- -- -- -- 55,500
Stock based compensation -- -- 371,996 -- -- 371,996
Stock issued in payment
Of accounts payable,
($.50/share) -- -- -- -- -- 49,000
Stock issued for services
($.42/share) -- -- -- -- -- 6,468
Capital contribution -- -- 8,900 -- -- 8,900
Net loss ended May 31, 2009 -- -- -- -- (1,572,804) (1,572,804)
----------- ----------- ----------- ----------- ----------- -----------
Balance at May 31, 2009 -- -- $ 2,994,153 $(1,601,912) $(8,545,629) $ (700,301)
Stock issued for cash
($.50/share) -- -- -- -- -- 118,200
Conversion of debt to
Common stock ($.45/share) -- -- -- -- -- 146,456
See accompanying notes to condensed consolidated financial statements
7
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Changes in Shareholders' Deficit
Period October 28, 2003 through November 30, 2009
(unaudited)
Preferred Stock Common Stock Treasury Stock
-------------------------- -------------------------- --------------------------
Shares Amount Shares Amount Shares Amount
----------- ----------- ----------- ----------- ----------- -----------
Conversion of preferred
Stock to common stock (100,000) (167,500) 2,356,142 167,500 -- --
Stock-based compensation -- -- -- -- -- --
Original issue discount
Convertible debt with
Beneficial conversion Feature -- -- -- -- -- --
Repurchase of common stock
($.28/share) -- -- -- -- (1,200,000) (336,000)
Stock issued for cash
($.50/share) -- -- -- -- 550,000 154,000
Stock issued for services
($.69/share) -- -- -- -- 81,580 22,842
Amortization of prepaid
Stock for services -- -- -- -- -- --
Series B Convertible
Preferred stock issued
For cash ($5.00/share) 125,000 625,000 -- -- -- --
Net Loss, ended
November 30, 2009 -- -- -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Balance at November 30, 2009 125,000 $ 625,000 19,139,315 $ 6,717,743 (568,420) $ (159,158)
=========== =========== =========== =========== =========== ===========
Deficit
Accumulated
Treasury Stock for Additional During
Stock Prepaid Paid-in Accumulated Development
APIC Services Capital Deficit Stage Total
----------- ----------- ----------- ----------- ----------- -----------
Conversion of preferred
Stock to common stock -- -- -- -- -- --
Stock-based compensation -- -- 146,092 -- -- 146,092
Original issue discount
Convertible debt with
Beneficial conversion Feature -- -- 38,604 -- -- 38,604
Repurchase of common stock
($.28/share) -- -- -- -- -- (336,000)
Stock issued for cash
($.50/share) 123,000 -- -- -- -- 277,000
Stock issued for services
($.69/share) 95,449 (118,291) -- -- -- --
Amortization of prepaid
Stock for services -- 9,858 -- -- -- 9,858
Series B Convertible
Preferred stock issued
For cash ($5.00/share) -- -- -- -- -- 625,000
Net Loss, ended
November 30, 2009 -- -- -- -- (1,017,841) (1,017,841)
----------- ----------- ----------- ----------- ----------- -----------
Balance at November 30, 2009 $ 218,449 $ (108,433) $ 3,178,849 $(1,601,912) $(9,563,470) $ (692,932)
=========== =========== =========== =========== =========== ===========
See accompanying notes to condensed consolidated financial statements
8
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
(Unaudited)
October 28,
6 months ended 2003
-------------------------- through
11/30/2009 11/30/2008 11/30/2009
----------- ----------- -----------
Cash flows from operating activities
Net loss $(1,017,841) $(1,216,738) (9,563,470)
Adjustments to reconcile net loss to net cash
used by operating activities:
Amortization / depreciation 1,046 4,641 176,938
Extinguishment of debt -- -- (337,342)
Amortization of original issue discount 38,604 -- 717,202
Purchased in process research and development -- -- 274,399
Stock-based compensation 155,950 372,404 2,949,689
Changes in current assets and liabilities:
Accrued legal settlement -- -- 25,000
Prepaid expenses (14,797) 24,505 (22,297)
Other assets 1,875 138 (27,725)
Accounts payable, accrued
interest and accrued liabilities 13,850 32,452 691,973
----------- ----------- -----------
Net cash used in operating activities (821,313) (782,598) (5,115,633)
----------- ----------- -----------
Cash flows from investing activities:
Furniture and equipment purchases (2,004) (1,951) (14,719)
----------- ----------- -----------
Net cash used in investing activities (2,004) (1,951) (14,719)
----------- ----------- -----------
Cash flows from financing activities:
Capital contributions by president -- -- 14,412
Proceeds from notes payable to related parties -- -- 702,649
Payments on notes payable to related parties -- (34,543) (120,498)
Proceeds from notes payable issued to individuals -- -- 145,000
Payments on notes payable issued to individuals -- (7,000) (7,000)
Proceeds from convertible notes payable -- -- 686,000
Proceeds from the sale of common stock 118,200 781,000 2,708,271
Proceeds from Series B Preferred stock 625,000 -- 625,000
Purchase of treasury stock (336,000) -- (336,000)
Proceeds from issuance of treasury stock 277,000 -- 277,000
Payments for offering costs -- -- (81,867)
Proceeds from issuance of stock of AITI acquisition -- -- 512,200
Proceeds from issuance of stock of AGTI acquisition -- -- 100,000
Proceeds from exercise of warrants -- -- 28,350
----------- ----------- -----------
Net cash provided by financing activities 684,200 739,457 5,253,517
----------- ----------- -----------
Net change in cash (139,117) (45,092) 123,165
Cash, beginning of period 265,520 85,435 3,238
----------- ----------- -----------
Cash, end of period $ 126,403 $ 40,343 126,403
=========== =========== ===========
Supplemental disclosure of cash flow information:
Cash paid during the period for:
Income taxes $ -- $ -- --
=========== =========== ===========
Interest $ -- $ -- 3,036
=========== =========== ===========
9
CytoDyn, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
(Unaudited)
Six October 28,
months ended 2003
-------------------------- through
11/30/2009 11/30/2008 11/30/2009
----------- ----------- -----------
Non-cash investing and financing transactions:
Net assets acquired in exchange for common stock in
CytoDyn/Rexray business combination -- -- 7,542
=========== =========== ===========
Common stock issued to former officer to repay
working capital advance -- -- 5,000
=========== =========== ===========
Common stock issued for convertible debt -- -- 662,000
=========== =========== ===========
Common stock issued for debt 125,500 -- 245,582
=========== =========== ===========
Common stock issued for accrued interest payable 20,956 -- 20,956
=========== =========== ===========
Common stock issued on payment of accounts payable -- 49,000 49,000
=========== =========== ===========
Options to purchase common stock issued for debt -- -- 62,341
=========== =========== ===========
Original issue discount and intrinsic value of beneficial
conversion feature related to debt issued with warrants 38,604 -- 719,266
=========== =========== ===========
Common stock issued for preferred stock 167,500 -- 167,500
=========== =========== ===========
Treasury stock issued for prepaid services 118,291 -- 118,291
=========== =========== ===========
See accompanying notes to condensed consolidated financial statements
10
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
1 - Organization:
CytoDyn, Inc. (the "Company") was incorporated under the laws of Colorado on May
2, 2002 under the name Rexray Corporation ("Rexray"). In October 2003 we entered
into an Acquisition Agreement with CytoDyn of New Mexico, Inc., pursuant to
which we effected a one for two reverse split of our common stock, and amended
our articles of incorporation to change our name from Rexray Corporation to
CytoDyn, Inc. The acquisition was accounted for as a reverse merger and
recapitalization of the Company. Pursuant to the acquisition agreement, we were
assigned the patent license agreement dated July 1, 1994 between CytoDyn of New
Mexico and Allen D. Allen covering three United States patents along with
foreign counterpart patents which describe a method for treating HIV disease
with the use of monoclonal antibodies. We also acquired the trademarks, CytoDyn
and Cytolin, and a related trademark symbol. The license acquired gives us the
worldwide, exclusive right to develop, market, sell and profit from the HIV
therapies from the patents, technology and know-how invented by Mr. Allen. The
term of the license agreement is for the life of the patents. The original
expiration dates on the issued patents are 2013 to 2016. There is an automatic
extension of the expiration date on U.S. patents equal to the number of years
the drug under the patent is being studied in clinical trials. Typically this
provides another four to five years on the earliest claims. CytoDyn's counsel
expects its patents to be extended until 2017 to 2020 depending upon the
original date of the issued patents. As consideration for the intellectual
property and trademarks we paid CytoDyn of New Mexico $10,000 in cash and issued
5,362,640 post-split shares of common stock to CytoDyn of New Mexico.
The Company entered the development stage effective October 28, 2003 upon the
reverse merger and recapitalization of the Company and follows Financial
Standard Accounting Codification No. 915, Development Stage Entities.
Advanced Influenza Technologies, Inc. ("AITI") was incorporated under the laws
of Florida on June 9, 2006 pursuant to an acquisition during 2006.
Advanced Genetic Technologies, Inc. ("AGTI") was incorporated under the laws of
Florida on December 18, 2006 pursuant to an acquisition during 2006.
CytoDyn, Inc. discovered and is developing a class of therapeutic monoclonal
antibodies to address significant unmet medical needs in the areas of HIV and
AIDS.
11
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
2 - Summary of Significant Accounting Policies:
Basis of Presentation
The accompanying consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of
America (U.S. GAAP) and reflect all adjustments, consisting solely of normal
recurring adjustments, needed to fairly present the financial results for these
periods. The condensed consolidated financial statements and notes are presented
as permitted by Form 10-Q. Accordingly, certain information and note disclosures
normally included in financial statements prepared in accordance with accounting
principles generally accepted in the United States of America have been omitted.
The accompanying consolidated financial statements should be read in conjunction
with the financial statements for the years ended May 31, 2009 and 2008 and
notes thereto in the Company's annual report on Form 10-K for the year ended May
31, 2009, filed with the Securities and Exchange Commission on August 9, 2010.
Operating results for the three and six months ended November 30, 2009 and 2008
are not necessarily indicative of the results that may be expected for the
entire year. In the opinion of management, all adjustments consisting only of
normal recurring adjustments necessary for a fair statement of (a) the results
of operations for the three and six month periods ended November 30, 2009 and
2008 and the period October 28, 2003 through November 30 , 2009, (b) the
financial position at November 30, 2009, and (c) cash flows for the six month
periods ended November 30, 2009 and 2008 and the period October 28, 2003 through
November 30, 2009, have been made.
Principles of Consolidation
The consolidated financials statements include the accounts of CytoDyn, Inc. and
its wholly owned subsidiaries; AITI and AGTI. All intercompany transactions and
balances are eliminated in consolidation.
Going Concern
The accompanying financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. As shown in the accompanying
consolidated financial statements, the Company is currently in the development
stage with losses for all periods presented. As of September 28, 2010 these
factors, among others, raise substantial doubt about the Company's ability to
continue as a going concern.
The consolidated financial statements do not include any adjustments relating to
the recoverability of assets and classification of liabilities that might be
necessary should the Company be unable to continue as a going concern. The
Company's continuation as a going concern is dependent upon its ability to
obtain additional operating capital,
12
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
complete development of its medical treatment, obtain FDA approval, outsource
manufacturing of the treatment, and ultimately to attain profitability. The
Company intends to seek additional funding through equity offerings to fund its
business plan. There is no assurance that the Company will be successful in
these endeavors.
Use of Estimates
The preparation of the consolidated financial statements in accordance with
accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and the disclosure of contingent assets and
liabilities at the date of consolidated financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual results
could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid debt instruments with original
maturities of three months or less when acquired to be cash equivalents. The
Company had no cash equivalents as of November 30, 2009 or May 31, 2009. The
Company maintains its cash in bank deposit accounts, which at times, may exceed
federally insured limits. The Company has not experienced any losses in such
accounts.
Furniture, Equipment and Depreciation
Furniture and equipment are stated at cost. Depreciation is computed using the
straight-line method over the estimated useful lives of the related assets,
generally three to seven years. Maintenance and repairs are charged to expense
as incurred and major improvements or betterments are capitalized. Gains or
losses on sales or retirements are included in the consolidated statements of
operations in the year of disposition.
Impairment of Long-Lived Assets
The Company evaluates the carrying value of any long-lived assets under U.S.
GAAP, which requires impairment losses to be recorded on long-lived assets used
in operations when indicators of impairment are present and the undiscounted
future cash flows estimated to be generated by those assets are less than the
assets' carrying amount. If such assets are impaired, the impairment to be
recognized is measured by the amount by which the carrying amount of the assets
exceeds the fair value of the assets. Assets to be disposed of are reported at
the lower of the carrying value or fair value, less costs to sell. There were no
impairment charges for the three and six months ended November 30, 2009 and
2008, and for the period October 28, 2003 through November 30, 2009.
Research and Development
Research and development costs are expensed as incurred.
13
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
Financial Instruments
At November 30, 2009 and May 31, 2009, the carrying value of the Company's
financial instruments approximate fair value due to the short-term maturity of
the instruments. The Company's notes payable have market rates of interest, and
accordingly, the carrying values of the notes approximates the fair value.
Stock-Based Compensation
U.S GAAP requires companies to measure the cost of employee services received in
exchange for the award of equity instruments based on the fair value of the
award at the date of grant. The expense is to be recognized over the period
during which an employee is required to provide services in exchange for the
award (requisite service period). U.S. GAAP provides for two transition methods.
The "modified prospective" method requires that share-based compensation expense
be recorded for any employee options granted after the adoption date and for the
unvested portion of any employee options outstanding as of the adoption date.
The "modified retrospective" method requires that, beginning upon adoption, all
prior periods presented be restated to reflect the impact of share-based
compensation expense consistent with the pro forma disclosures previously
required under U.S. GAAP. The Company adopted the modified prospective method,
and as a result, was not required to restate its financial results for prior
periods. The Company accounts for common stock options, and common stock
warrants granted based on the fair market value of the instrument using the
Black-Scholes option pricing model utilizing certain weighted average
assumptions such as expected stock price volatility, term of the options and
warrants, risk-free interest rates, and expected dividend yield at the grant
date. The risk-free interest rate assumption is based upon observed interest
rates appropriate for the expected term of the stock options. The expected
volatility is based on the historical volatility of the Company's common stock
at consistent intervals. The Company has not paid any dividends on its common
stock since its inception and does not anticipate paying dividends on its common
stock in the foreseeable future. The computation of the expected option term is
based on the "simplified method" as the Company's stock options are "plain
vanilla" options and the Company has a limited history of exercise data. For
common stock options and warrants with graded vesting, the Company recognizes
the related compensation costs associated with these options and warrants on the
straight-line basis over the requisite service period.
U.S GAAP requires forfeitures to be estimated at the time of grant and revised,
if necessary, in subsequent periods if actual forfeitures differ from those
estimates. Based on limited historical experience of forfeitures, the Company
estimated future unvested option forfeitures at 0% as of November 30, 2009 and
2008.
14
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
Stock for Services
The Company issues common stock and common stock options to consultants for
various services. Costs for these transactions are measured at the fair value of
the consideration received or the fair value of the equity instruments issued,
whichever is more reliably measurable. The value of the common stock is measured
at the earlier of (i) the date at which a firm commitment for performance by the
counterparty to earn the equity instruments is reached or (ii) the date at which
the counterparty's performance is complete.
Earnings (Loss) per Common Share
Basic earnings (loss) per share is computed by dividing the net income or loss
by the weighted average number of common shares outstanding during the period.
Diluted earnings (loss) per share is computed by dividing net income (loss) by
the weighted average common shares and potentially dilutive common share
equivalents. The effects of potential common stock equivalents are not included
in computations when their effect is antidilutive. Because of the net loss for
the three and six month periods ended November 30, 2009 and 2008, the basic and
diluted weighted average shares outstanding are the same since including the
additional shares would have an antidilutive effect on the loss per share
calculation. Common stock option and warrants to purchase 5,094,176 and
3,326,222 shares of common stock were not included in the computation of basic
and diluted weighted average common shares outstanding for the three and six
months ended November 30, and 2008, respectively.
Reclassification
Certain prior period amounts have been reclassified to comply with current
period presentation.
3 - Recent Accounting Pronouncements:
Other recent accounting pronouncements issued by the FASB (including its EITF),
the AICPA, and the SEC did not or are not believed by management to have a
material impact on the Company's present or future consolidated financial
statements.
15
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
4 - Convertible instruments:
In July 2009, the Company amended certain promissory notes into convertible
notes that can be converted into shares of common stock. The notes had a fixed
conversion price of $.45 per share. During the six months ended November 30,
2009, $146,456 in notes and accrued interest converted into 325,458 shares of
common stock. At the commitment date, the conversion option associated with the
notes was deemed to have a beneficial conversion feature (BCF), and the Company
recorded a BCF of $38,604 as a debt discount and corresponding increase to
additional paid-in capital. For the three and six months ended November 30,
2009, the Company recorded $-0- and $38,604 in interest expense as the debt
discount was fully amortized upon the conversion of the notes into common stock.
In June, 2009, an investor converted 100,000 shares of Series A Preferred stock
into 2,356,142 shares of restricted common stock. At the commitment date, there
was no beneficial conversion feature associated with the convertible preferred
stock, and accordingly, no constructive dividend was recorded by the Company.
During the three months ended November 30, 2009 the Company issued 125,000
shares of Series B Convertible Preferred Stock (Series B) at $5.00 per share for
cash proceeds totaling $625,000. The Series B is convertible into ten shares of
the Company's common stock including any accrued dividend, with an effective
fixed conversion price of $.50 per share. The holders of the Series B can only
convert their shares to common shares provided the Company has sufficient
authorized common shares at the time of conversion. Accordingly, the conversion
option is contingent upon the Company increasing their authorized common shares,
which occurred April 2010. The Series B has liquidation preferences over the
common share holders at $5.00 per share plus any accrued dividends. Dividends
are payable to the Series B holders when declared by the board of directors at
$.25 per share. The Series B holders have no voting rights.
5 - Equity:
The Company has one stock-based equity plan at November 30, 2009. The 2005 Stock
Incentive Plan as amended (the "Plan") was authorized to issue options and
warrants to purchase up to 2,800,000 shares of the Company's common stock. As of
November 30, 2009 the Company had 448,878 shares available for future stock
option grants under the plan. See Note 8.
The estimated fair value of options and warrants is determined using the
Black-Scholes option valuation model with the following weighted-average
assumption for the periods ended November 30, 2009 and 2008:
2009 2008
------------------- -------------------
Risk free rate -- 2.56% - 2.84%
Dividend Yield -- 0.00
Volatility -- 124.00% - 156.00%
Expected term -- 3.0 years
During the six months ended November 30, 2009 the Company granted 118,200
warrants with an exercise price of $1.00, immediate vesting, and expiration date
of five years from the date of grant. The warrants were issued in conjunction
with the issuance of common stock to certain investors pursuant to a private
placement, which entitled the investors to one common stock warrant for each
dollar of common stock purchased. Accordingly, these warrants were not valued in
the above Black-Scholes model.
16
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
Net cash proceeds from the exercise of stock options and warrants were $0 for
the three and six months ending November 30, 2009 and 2008, respectively.
Compensation expense related to stock options and warrants was approximately
$68,000, and $85,000 for the three months ended November 30, 2009 and 2008,
respectively, and $146,000 and $205,000 for the six months ended November 30,
2009 and 2008, respectively.
The grant date fair value of options vested during the six month periods ended
November 30, 2009 and 2008 was approximately $140,000 and $201,000,
respectively. The weighted average grant date fair value of options and warrants
granted during the six month periods ended November 30, 2009 and 2008 was $-0-
and $.30, respectively. As of November 30, 2009 there was approximately $155,000
of unrecognized compensation costs related to share-based payments for unvested
options, which is expected to be recognized over a weighted average period of
..49 years.
The following table represents stock option and warrant activity as of and for
the six months ended November 30, 2009:
Weighted Average
Average Remaining Aggregate
Number of Exercise Contractual Intrinsic
Shares Price Life Value
--------- -------- ----------- ---------
Options and warrants
outstanding - May 31, 2009 4,975,976 $1.18 5.37 $ 164,500
Granted 118,200 $1.00
Exercised --
Forfeited/expired/cancelled --
Options and warrants
outstanding - November 30 2009 5,094,176 $1.18 4.85 $ 179,180
Outstanding exercisable
- November 30, 2009 4,930,606 $1.19 4.76 $ 179,180
During the three months ended November 30, 2009, the Company acquired $1,200,000
shares of common stock at $.28 per share. The shares were included at cost as
part of the Company's treasury stock as of November 30, 2009. During the three
months ended November 30, 2009, the Company reissued 550,000 treasury shares at
$.50 per share, and realized cash proceeds of $277,000.
Additionally, during the three months ended November 30, 2009, the Company
reissued 81,500 shares of treasury stock for certain consulting services at $.69
per share, which represented the fair market value of the Company's common stock
at the commitment date. The prepaid stock services are amortized over the life
of the consulting agreement, and during three months ended November 30, 2009,
the Company recognized approximately $10,000 in consulting expense related to
this consulting agreement.
17
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
6 - Commitments and Contingencies:
Related to certain litigation whereby the Company was both a defendant and a
plaintiff, the Company entered into a settlement agreement in December 2008. As
part of the settlement agreement, the Company agreed to pay $50,000 in January
2009 and $25,000 on or before January 14, 2010 to the plaintiff. The Company
paid the $50,000 in January 2009. The remaining $25,000 was unsecured and
accrued interest at 10.0 percent per annum. The Company paid $27,500 in January
2010. As of November 30, 2009, the Company has an accrual of $25,000 related to
this settlement agreement.
7 - Related Party Transactions:
A director provided legal services to the Company over the past several years.
As of August 31, 2009, the Company owed the director $40,985 and it is included
in the accompanying consolidated financial statements as "indebtedness to
related parties" as of November 30, 2009. As of November 30, 2009 no
arrangements had been made for the Company to repay the balance of this
obligation. The amount has been classified as short-term, as the amount is
payable on demand. The Company anticipates that the director will continue to
provide legal services in the future.
In May and July 2007, the Company issued $150,000 in promissory notes with a
stated interest rate of 14%, and a maturity date of six months from the issuance
date. The notes were originally issued to an unrelated third-party, who
subsequently became director of the Company during 2008. Accordingly, the notes
are classified as related party notes as of November 30, 2009. The notes have no
stated maturity, and are essentially payable upon demand. Accordingly, the
Company has Classified the balance as short-term obligation as of November 30,
2009.
18
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
8 - Subsequent Events:
In September 2009, the Company entered into an agreement with Massachusetts
General Hospital (MGH) to provide financial support for the purpose of
conducting an ex-vivo study of the Company's lead drug, Cytolin(R). This study
is intended as a prelude to an in-vivo study. Costs are estimated at
approximately $550,000 of which 50%, or $275,000, was paid to Massachusetts
General Hospital by March 2010. During 2009 the Company agreed to provide an
additional $204,000 to Massachusetts General Hospital for the current clinical
trial of Cytolin(R). Additionally, per the agreement with MGH, the Company is
obligated to pay an additional $137,000 by October 21, 2010. This amount is
included in the cost above. This will enable the Principal Investigator to hire
additional personnel in order to ensure that key data from the study will be
available by December 31, 2010.
In January 2010, the Company approved the grant of 2,177,238 stock options to
employees and consultants. The options have an exercise price of $1.95, expire
ten years from grant, and vest over three years. The grant is contingent upon
the shareholder approval of of the increase in the authorized common shares from
25 to 100 million shares as discussed below.
In September 2009, the Company's Board of Directors approved a Private Placement
to sell up to 400,000 shares of the Company's Series B Convertible Preferred
Stock, no par value. This offering was only available to accredited investors as
defined under the 1933 Securities Act ("The Act"). The offering commenced on or
about September 23, 2009 and was completed on March 29, 2010. All 400,000 shares
were sold and the gross proceeds from the sale were $2,000,000. Each share of
Series B Convertible Preferred Stock will receive a 5% annual dividend and is
convertible into ten (10) shares of Common Stock. The conversion option is
contingent upon shareholder approval of the increase in the authorized common
shares from 25 to 100 million shares as discussed below.
19
CYTODYN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF November 30, 2009
(UNAUDITED)
In October 2009, the Company's Board of Directors approved a Private Placement
to sell up to 2,000,000 shares of the Company's common stock, no par value, at a
price of $.50 per share. The offering commenced on or about November 2009 and
was completed on March 29, 2010. All 2,000,000 shares were sold for proceeds
totaling $1,000,000.
In May 2010, the Company purchased 200,000 shares of common stock at $.50 per
share.
In February 2010, the Company negotiated a contract with Vista Biologicals
Corporation to manufacture a humanized version of the Company's lead product,
Cytolin(R) at a cost of $229,500, which will be paid over twelve (12) months
beginning in March 2010.
In April 2010, the Board issued 200,000 warrants to purchase the Company's
common stock to Eware and Evolution Holdings, LLC with an exercise price of
$2.00 per share. The warrants expire September 12, 2010.
In April 2010, the Board authorized the conversion of promissory notes totaling
$9,000 into common stock at $.45 per share.
On April 24, 2010 the Company's shareholders approved an amendment to the
Company's Articles of Incorporation increasing the number of authorized shares
of common stock from 25,000,000 to 100,000,000 shares effective as of April 29,
2010. The shareholders also approved to increase the number of shares available
in the Company's Stock Option and Incentive plan from 2,000,000 to 5,000,000.
In January 2010, two of the Company's executives forgave approximately $230,000
in accrued salaries that are included as "Accrued salaries - related party" at
May 31, 2009.
In August 2010, the Company renewed the office lease for $1,650 per month for
one year.
In August 2010 the Company's Board of Directors approved a private placement
offering to sell 2,000,000 shares of the Company's no par common stock to
accredited investors at $1.00 per share. The Company has raised approximately
$116,000 in cash related to this private placement.
20
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations.
The following discussion and analysis should be read in conjunction with our
condensed consolidated financial statements and the related notes thereto
included in this Quarterly Report on Form 10-Q. The discussion and analysis
contains 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 (Exchange Act). These forward-looking statements are
based on our current expectations and entail various risks and uncertainties.
Our actual results could differ materially from those projected in the
forward-looking statements as a result of various factors including those set
forth in "Risk Factors" of the Company's May 31, 2009 Form 10-K.
Background of our Company
CytoDyn, Inc. discovered and is developing a class of therapeutic monoclonal
antibodies to address significant unmet medical needs in the area of HIV/AIDS.
CytoDyn, Inc. has sponsored a research grant to Massachusetts General Hospital
in Boston, Massachusetts, to design and sponsor clinical trials in addition to
conducting those trials on our lead product Cytolin(R), an immune therapy
intended to treat early HIV infection. Although CytoDyn, Inc. will retain all of
its intellectual property rights and will have access to the study data, the
data will be owned by Massachusetts General Hospital (MGH). A chief benefit for
CytoDyn, Inc. is that the Company will not have to deal directly with the FDA.
Moreover, the high costs and long delays associated with the FDA's oversight of
clinical trials may be significantly reduced in the case of clinical trials
designed and sponsored by a leading teaching hospital.
The FDA licenses medicinal products for sale in interstate commerce under a
particular label. Only if they receive data supporting that label and only if
some company asks them to do so. CytoDyn may or may not be the company that
requests a license to market Cytolin(R) under a label. Under our current
thinking we hope to enter into a strategic alliance after the next two studies
under which a larger pharmaceutical marketing company will seek a license from
the FDA to market Cytolin(R) and under a license from us to use our intellectual
property in that manner. However there is no guarantee that we will wind up
pursuing this strategy.
21
We negotiated with a contract manufacturer Vista Biologicals Corporation to
manufacture GMP product for the current clinical trial of Cytolin(R) at a cost
of $565,000, all of which was paid by September 2008. The initial clinical trial
is being conducted by Massachusetts General Hospital will cost the Company
approximately $550,000 of which $275,000 was paid by March 18, 2010. Per our
agreement the Company owes another $137,500 to MGH by October 21, 2010. The
Company has the funds available to satisfy this payment due.
We negotiated a contract with manufacturer Vista Biologicals Corporation to
manufacture a humanized version of the company's lead product, Cytolin(R) at a
cost of $229,500, which will be paid over twelve (12) months beginning in March
2010. $47,500 was paid by May 2010. Although a murine (mouse) version of
Cytolin(R) was used for previous human experience that included some 200
patients successfully treated for up to two years, as well as an encouraging
Phase I(b)/II(a) study, the Company believes that a fully-humanized version is
necessary for the clinical trial that is expected to follow the current one.
The Company expects to have its proprietary, fully-humanized version of
Cytolin(R) ready for bulk manufacturing in 2010 in time for a possible follow-up
clinical trial.
Human subjects have been recruited for the initial study conducted by
Massachusetts General Hospital from the clinic of the Principal Investigator,
Dr. Eric Rosenberg. The study protocol calls for 10 adults with early HIV
infection and 10 healthy control subjects. The enrollment was closed as of July
23, 2010 therefore we expect the study to be completed by January 2011.
We registered a clinical trial of Cytolin(R) with the government's website at
www.clinicaltrials.gov, ID NCT01048372. The public has online access to this
federal database, which describes the key elements of clinical trials and their
status. To peruse the continually updated public record for the study of
Cytolin(R) on the government's website, enter "Cytolin" as search terms (case
sensitive).
Subsequently, CytoDyn, Inc. may fund a follow-up clinical trial at Massachusetts
General Hospital using venture capital or, at that time, may enter into a
strategic alliance for completion of research and the subsequent marketing of
Cytolin(R) if approved. In the former case, CytoDyn, Inc. will need to provide a
new batch of humanized product, which we estimate will cost on the order of
another half million dollars. The Company is conducting a private placement of
common shares to secure the capital needed for the follow-up study. We cannot
estimate what the hospital's research grant will be at this time until the
hospital has provided those estimates.
There are many factors that can delay clinical trial benchmarks. However, the
Company hopes to receive the results and analysis of the upcoming clinical trial
during 2010.
22
=============================================================================
Benchmark Some Factors That Can Cause Delays+
=============================================================================
Manufacturing Delays
Documentation Delays
Patient Outreach IRB Delays
Delays in Regulatory Review or Approval
Force Majeure
=============================================================================
Fill and Finish Delays
Dose First Patient Slower Than Expected Patient Enrollment
Force Majeure
=============================================================================
Slower Than Expected Patient Enrollment
Lock Database - Begin Clinical Hold
Statistical Analysis Laboratory Error
Protocol Deviation
Force Majeure
=============================================================================
Additional Stratification Required
Release Final Report Computer Hardware or Software
Malfunction
Force Majeure
=============================================================================
+There are other factors, known and unknown, such as unexpected financial
hardships, that can cause delays.
Clinical Trials Process - Described below is the traditional drug development
track. Under the Company's current business plan, much of this initial work will
be sponsored and conducted by the MGH, eliminating the need for CytoDyn to deal
directly with the FDA. Traditionally, the Company would enter into a strategic
alliance with a larger pharmaceutical company after development has progressed
to a certain point. While there can be no guarantee that this will occur in our
case, if it does, then our larger partner would usually be responsible for
dealing with the FDA.
Phase I
-------
Phase I includes the initial introduction of an investigational new drug or
biologic into humans. These studies are closely monitored and may be conducted
in patients, but are usually conducted in a small number of healthy volunteer
subjects. These studies are designed to determine the metabolic and
pharmacologic actions of the investigational product in humans, the side effects
associated with increasing doses, and, if possible, to gain early evidence on
effectiveness. During Phase I, sufficient information about the investigational
product's pharmacokinetics and pharmacological effects are obtained to permit
the design of well-controlled, scientifically valid, Phase II studies.
Phase II
--------
Phase II includes the early controlled clinical studies conducted to obtain some
preliminary data on the effectiveness of the drug for a particular indication or
indications in patients with the disease or condition. This phase of testing
also helps determine the common short-term side effects and risks associated
with the drug. Phase II studies are typically well-controlled, closely
monitored, and conducted in a relatively small number of patients, usually
involving several hundred people. Depending upon need, a new drug may be
licensed for interstate marketing after Phase II if it is a "pivotal" study.
Phase III
---------
Phase III studies are expanded controlled clinical studies. They are performed
after preliminary evidence suggesting effectiveness of the drug has been
obtained in Phase II, and are intended to gather the additional information
about effectiveness and safety that is needed to evaluate the overall
benefit/risk relationship of the drug. Phase III studies also provide an
adequate basis for extrapolating the results to the general population and
transmitting that information in the physician labeling. Phase III studies
usually include several hundred to several thousand people.
23
Patents
-------
We have a License Agreement with Allen D. Allen, our President and CEO that
gives us the exclusive right to develop, market, sell and profit from his
technology worldwide. This includes issued U.S. patents 5,424,066; 5,651,970 and
6,534,057, foreign counterparts, as well as European Patents No. 94 912826.8 and
04101437.4. Hong Kong, Australian and Canadian patents have been obtained as
well. The original expiration dates of the U.S. patents are 2013 to 2016. There
is an automatic extension of the expiration date on U.S. patents equal to the
number of years the drug under the patent is being studied in clinical trials.
Typically this provides another four to five years on the earliest claims.
CytoDyn's counsel expects its patents to be extended until 2017 to 2020
depending upon the original date of the issued patents. We estimate the costs
associated with these issued patents to be approximately $100,000 per year. We
may file additional patents during the current fiscal year if our research and
development efforts warrant them, but we do not have any such potential patents
identified at this time.
Going Concern
We will require additional funding in order to continue with research and
development efforts.
The accompanying financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. As shown in the accompanying
financial statements, the Company is currently in the development stage with
losses for all periods presented. As of September 28, 2010 these factors, among
others, raise substantial doubt about the Company's ability to continue as a
going concern.
The financial statements do not include any adjustments relating to the
recoverability and classification of liabilities that might be necessary should
the Company be unable to continue as a going concern. The Company's continuation
as a going concern is dependent upon its ability to obtain additional operating
capital, complete development of its medical treatments, obtain FDA approval,
outsource manufacturing of the treatments, and ultimately to attain
profitability. The Company intends to seek additional funding through equity
offerings or licensing agreements to fund its business plan. There is no
assurance that the Company will be successful in these endeavors.
24
Results of Operations
---------------------
Results of Operations for the three months ended November 30, 2009 and 2008 are
as follows:
For the three months ended November 30, 2009 and 2008 we had no activities that
produced revenues from operations.
For the three months ended November 30, 2009, we had a net loss of $(694,612)
compared to a net loss of $(657,978) for the corresponding period in 2008. For
the three months ended November 30, 2009 and 2008, we incurred operating
expenses of $(688,521) and $(645,878) consisting primarily of, consulting
expense, stock-based compensation, legal fees, and salaries.
The increase in operating expenses of $42,643 from the three month period
November 30, 2009 compared to the three months ended November 30, 2008 related
primarily to decreases in research and development, offset by increases in
salaries and consulting included in general and administrative expenses.
Research and development expenses are associated with the development of our
lead product Cytolin (R). As discussed above in our background, we negotiated a
contract with a manufacturer in September 2008 to manufacture product that will
be used in clinical trials going forward. This resulted in significant expense
for the three months ended November 30, 2008. However, going forward we expect
to have significant increases in research and development expenses as our
clinical trials for Cytolin (R) move forward as discussed above.
Results of Operations for the six months ended November 30, 2009 and 2008 are as
follows:
For the six months ended November 30, 2009 and 2008 we had no activities that
produced revenues from operations.
For the six months ended November 30, 2009, we had a net loss of $(1,017,841)
compared to a net loss of $(1,216,738) for the corresponding period in 2008. For
the six months ended November 30, 2009 and 2008, we incurred operating expenses
of $(964,060) and $(1,198,318) consisting primarily of, consulting expense,
stock-based compensation, legal fees, research and development and salaries.
The decrease in operating expenses of $234,258 from the six month period
November 30, 2009 compared to the six months ended November 30, 2008 related
primarily to a decrease in research and development expenses of approximately
$263,000, offset by increases in general and administrative expenses related to
salaries and consulting expenses. Research and development expenses are
associated with the development of our lead product Cytolin (R). As discussed
above in our background, we negotiated a contract with a manufacturer in
September 2008 to manufacture product that will be used in clinical trials going
forward. This resulted in significant expense for the six months ended November
30, 2008. However, going forward we expect to have significant increases in
research and development expenses as our clinical trials for Cytolin (R) move
forward as discussed above.
25
Liquidity and Capital Resources
As shown in the accompanying Financial Statements, for the six months ended
November 30, 2009 and 2008, and since October 28, 2003 through November 30, 2009
the Company has had net losses of $(1,017,841) and $(1,216,738) and
$(9,563,470), respectively. As of November 30, 2009, the Company has not emerged
from the development stage. In view of these matters, the Company's ability to
continue as a going concern is dependent upon the Company's ability to begin
operations and to achieve a level of profitability. Since inception, the Company
has financed its activities principally from the sale of public equity
securities and proceeds from notes payable. The Company intends on financing its
future development activities and its working capital needs largely from the
sale of public equity securities with some additional funding from other
traditional financing sources.
As previously mentioned, since October 28, 2003, we have financed our operations
largely from the sale of common and preferred stock and proceeds from notes
payable. From October 28, 2003 through November 30, 2009 we raised cash of
approximately $3,333,000 (net of offering costs) in common and preferred stock
financings and approximately $1,534,000 through the issuance notes payable.
Since October 28, 2003 through November 30, 2009, we have incurred $1,587,000 of
research and development costs and approximately $9,075,000 in operating
expenses.
We have incurred significant net losses and negative cash flows from operations
since our inception. As of November 30, 2009, we had an accumulated deficit of
approximately $(11,165,000) and a working capital deficit of approximately
$(487,000).
We anticipate that cash used in product development and operations, especially
in the marketing, production and sale of our products will increase
significantly in the future.
In October 2009, the Company's Board of Directors approved a Private Placement
to Sell up to 2,000,000 shares of the Company's common stock, no par value, at a
price of $.50 per share. The offering commenced on or about November 2009 and
was completed on March 29, 2010. All 2,000,000 shares were sold for proceeds
totaling $1,000,000.
In September 2009, the Company authorized the raise of $2,000,000 through a
Private Placement Offering of preferred shares. The Company amended its articles
and designated 400,000 preferred shares Series B to be sold at $5.00 per share.
The preferred shares are convertible into common shares at $.50 per share or 10
shares of common for every preferred share issued. The Company raised $2,000,000
of cash related to this private placement.
26
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not applicable
Item 4T. Controls and Procedures
The Company's Chief Executive Officer and Chief Financial Officer have evaluated
the effectiveness of the Company's disclosure controls and procedures (as
defined in Rule 13a-15(e) and 15d015(e) under the Exchange Act) as of the six
month period ending November 30, 2009 covered by this quarterly report on Form
10Q. Based upon such evaluation, the Chief Executive Officer and Chief Financial
Officer have concluded that, as of the end of such period, the Company's
disclosure controls and procedures were not effective as required under Rules
13a015(e) and 15d-15(e) under the Exchange Act. This conclusion by the Company's
Chief Executive Officer and Chief Financial Officer does not relate to reporting
periods after November 30, 2009.
Changes in Control Over Financial Reporting
No change in the Company's internal control over financial reporting occurred
during the quarter ended November 30, 2009, that materially affected, or is
reasonably likely to materially affect, the Company's internal control over
financial reporting.
27
Part II
Item 1. Legal Proceedings
None
Item 2. Unregistered Sales of Equity and Use of Proceeds
During the three months ended November 30, 2009, the Company acquired $1,200,000
shares of common stock at $.28 per share. The shares were included at cost as
part of the Company's treasury stock as of November 30, 2009. During the three
months ended November 30, 2009, the Company reissued 550,000 treasury shares at
$.50 per share, and realized cash proceeds of $277,000. Additionally, during the
three months ended November 30, 2009, the Company reissued 81,500 shares of
treasury stock for certain consulting services at $.69 per share. These shares
were sold pursuant to an exemption under Regulation D Rule 506 of the Securities
Act.
During the three months ended November 30, 2009 the Company issued 125,000
shares of Series B Convertible Preferred Stock (Series B) at $5.00 per share for
cash proceeds totaling $625,000. The Series B is convertible into ten shares of
the Company's common stock, with an effective fixed conversion price of $.50 per
share. These shares were sold pursuant to an exemption under Regulation D Rule
506 of the Securities Act.
Item 3. Defaults Upon Senior Securities
None
Item 4. Reserved and removed
None
Item 5. Other Information
None
Item 6. Exhibits and Reports on Form 8-K.
(a) Exhibits:
1. 31.1: Certification by the CEO
2. 31.2: Certification by the CFO
3. 32.1: Certification Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 - CEO
4. 32.2: Certification Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 - CFO
SIGNATURES
CYTODYN, INC.
Registrant)
DATE: September 28, 2010 BY: /s/ Allen D. Allen
----------------------- -----------------------------
Allen D. Allen
President and CEO
28