e10qsb
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-QSB
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2005
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o |
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT |
For the transition period from to
Commission file number 0-12627
MEDICAL DISCOVERIES, INC.
(Exact name of Small Business Issuer as specified in its charter)
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Utah
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87-0407858 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
1388 S. Foothill Drive, #266, Salt Lake City, Utah 84108
(Address of principal executive offices)
(Issuers telephone number, including area code)
(Former name, former address and former fiscal year, if 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 þ No o
APPLICABLE ONLY TO CORPORATE ISSUERS:
State the number of shares outstanding of each of the issuers classes of common equity, as of the
latest practicable date: As of August 10, 2005, there were 107,829,724 shares of the issuers
Common Stock and 42,000 shares of the issuers Series A Preferred Stock outstanding.
Transitional Small Business Disclosure Format (check one): Yes o No þ
PART I
FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
The following financial statements are filed with this report:
Condensed Consolidated Balance Sheets as of June 30, 2005, (unaudited) and December 31, 2004
(audited)
Condensed Consolidated Statements of Operations for the six-month periods ended June 30, 2005
(unaudited), June 30, 2004 (unaudited), three-month periods ended June 30, 2005 (unaudited), June
30, 2004 (unaudited) and from inception of the development stage on November 20, 1991 through June
30, 2005 (unaudited)
Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, 2005
(unaudited), June 30, 2004 (unaudited), and from inception of the development stage on November 20,
1991 through June 30, 2005 (unaudited)
Notes to Unaudited Condensed Consolidated Financial Statements
- 3 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Balance Sheets
(Unaudited)
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June 30, |
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December 31, |
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2005 |
|
2004 |
ASSETS |
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CURRENT ASSETS |
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|
|
|
|
|
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|
|
|
|
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|
|
|
|
Cash |
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$ |
2,424,197 |
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|
$ |
1,455,397 |
|
Deposits |
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|
51,100 |
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|
|
51,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current Assets |
|
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2,475,297 |
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|
|
1,506,497 |
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|
|
|
|
|
|
|
|
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|
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Property and Equipment, Net |
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|
67,621 |
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TOTAL ASSETS |
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$ |
2,542,918 |
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|
$ |
1,506,497 |
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LIABILITIES AND STOCKHOLDERS DEFICIT |
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CURRENT LIABILITIES |
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Accounts payable |
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$ |
2,611,343 |
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$ |
2,448,454 |
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Accrued interest payable |
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|
222,760 |
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|
415,262 |
|
Notes payable |
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|
56,000 |
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|
336,717 |
|
Convertible notes payable |
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|
193,200 |
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|
|
193,200 |
|
Research and development obligation |
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|
604,900 |
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|
|
|
|
|
|
|
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|
|
|
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|
|
|
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|
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Total Current Liabilities |
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|
3,688,203 |
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|
3,393,633 |
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|
|
|
|
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|
|
|
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TOTAL LIABILITIES |
|
|
3,688,203 |
|
|
|
3,393,633 |
|
|
|
|
|
|
|
|
|
|
|
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STOCKHOLDERS DEFICIT |
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Preferred stock, Series A, convertible; no par value; 42,000 shares
authorized; 42,000 and
12,000 shares issued and outstanding, respectively; (aggregate
liquidation preference of
$4,200,000 and $1,200,000, respectively) |
|
|
1,570,109 |
|
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|
523,334 |
|
Common stock, no par value; 250,000,000 shares authorized; 107,829,724
and 105,653,335
shares issued and outstanding, respectively |
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|
15,310,407 |
|
|
|
14,918,657 |
|
Additional paid-in capital |
|
|
6,302,017 |
|
|
|
3,424,383 |
|
Deficit accumulated prior to the development stage |
|
|
(1,399,577 |
) |
|
|
(1,399,577 |
) |
Deficit accumulated during the development stage |
|
|
(22,928,241 |
) |
|
|
(19,353,933 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Stockholders Deficit |
|
|
(1,145,285 |
) |
|
|
(1,887,136 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT |
|
$ |
2,542,918 |
|
|
$ |
1,506,497 |
|
|
|
|
|
|
|
|
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|
See notes to unaudited condensed consolidated financial statements
- 4 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
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From Inception |
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of the |
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Development Stage |
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For the Three |
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For the Six |
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on November 20, 1991 |
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Months Ended |
|
Months Ended |
|
Through |
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|
June 30, |
|
June 30, |
|
June 30, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
2005 |
REVENUES |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
157,044 |
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|
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COST OF GOODS SOLD |
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|
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|
|
|
|
|
|
|
|
|
|
14,564 |
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
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|
GROSS PROFIT |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
142,480 |
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|
|
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|
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|
OPERATING EXPENSES |
|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
636,325 |
|
|
|
369,270 |
|
|
|
888,321 |
|
|
|
2,416,963 |
|
|
|
16,065,291 |
|
Research and development |
|
|
118,520 |
|
|
|
132,335 |
|
|
|
1,670,506 |
|
|
|
170,978 |
|
|
|
5,219,244 |
|
Inventory write-down |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,859 |
|
Impairment loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,709 |
|
License fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,001,500 |
|
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|
|
|
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|
|
|
|
|
|
|
|
|
Total Expenses |
|
|
754,845 |
|
|
|
501,605 |
|
|
|
2,558,827 |
|
|
|
2,587,941 |
|
|
|
22,392,603 |
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
LOSS FROM OPERATIONS |
|
|
(754,845 |
) |
|
|
(501,605 |
) |
|
|
(2,558,827 |
) |
|
|
(2,587,941 |
) |
|
|
(22,250,123 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSES) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
9,346 |
|
|
|
1,426 |
|
|
|
14,910 |
|
|
|
3,126 |
|
|
|
44,481 |
|
Interest expense |
|
|
(7,237 |
) |
|
|
(33,048 |
) |
|
|
(23,135 |
) |
|
|
(86,724 |
) |
|
|
(1,140,572 |
) |
Foreign
currency transaction gain |
|
|
40,900 |
|
|
|
|
|
|
|
60,800 |
|
|
|
|
|
|
|
60,800 |
|
Gain on forgiveness of debt |
|
|
196,353 |
|
|
|
|
|
|
|
196,353 |
|
|
|
|
|
|
|
1,431,889 |
|
Other income |
|
|
|
|
|
|
720 |
|
|
|
|
|
|
|
720 |
|
|
|
881,892 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
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|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
Total Other Income
(Expenses) |
|
|
239,362 |
|
|
|
(30,902 |
) |
|
|
248,928 |
|
|
|
(82,878 |
) |
|
|
1,278,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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|
|
|
|
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|
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|
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|
NET LOSS |
|
|
(515,483 |
) |
|
|
(532,507 |
) |
|
|
(2,309,899 |
) |
|
|
(2,670,819 |
) |
|
|
(20,971,633 |
) |
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividend from
beneficial conversion
feature |
|
|
|
|
|
|
|
|
|
|
(1,264,409 |
) |
|
|
|
|
|
|
(1,956,608 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
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|
|
|
|
|
|
|
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|
|
NET LOSS APPLICABLE TO
COMMON SHAREHOLDERS |
|
$ |
(515,483 |
) |
|
$ |
(532,507 |
) |
|
$ |
(3,574,308 |
) |
|
$ |
(2,670,819 |
) |
|
$ |
(22,928,241 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
|
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|
|
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BASIC AND DILUTED LOSS PER
COMMON SHARE |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
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|
|
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING |
|
|
107,580,033 |
|
|
|
92,393,559 |
|
|
|
107,043,413 |
|
|
|
88,478,847 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to unaudited condensed consolidated financial statements
- 5 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
From Inception |
|
|
For the Six |
|
of the |
|
|
Months Ended |
|
Development Stage |
|
|
June 30, |
|
on November 20, 1991 |
|
|
2005 |
|
2004 |
|
Through June 30, 2005 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(2,309,899 |
) |
|
$ |
(2,670,819 |
) |
|
$ |
(20,971,633 |
) |
Adjustments to reconcile net loss to net cash used by
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency transaction gain |
|
|
(60,800 |
) |
|
|
|
|
|
|
(60,800 |
) |
Gain on debt restructuring |
|
|
(196,353 |
) |
|
|
|
|
|
|
(1,431,889 |
) |
Common stock issued for services, expenses, and litigation |
|
|
18,750 |
|
|
|
1,750,954 |
|
|
|
4,286,467 |
|
Commitment for research and development obligation |
|
|
665,700 |
|
|
|
|
|
|
|
665,700 |
|
Depreciation |
|
|
870 |
|
|
|
|
|
|
|
101,141 |
|
Reduction of escrow receivable from
research and development |
|
|
|
|
|
|
|
|
|
|
272,700 |
|
Stock options and warrants granted for services |
|
|
|
|
|
|
|
|
|
|
4,811,253 |
|
Reduction of legal costs |
|
|
|
|
|
|
|
|
|
|
(130,000 |
) |
Write-off of subscriptions receivable |
|
|
|
|
|
|
|
|
|
|
112,500 |
|
Impairment of loss on assets |
|
|
|
|
|
|
|
|
|
|
9,709 |
|
Loss on disposal of equipment |
|
|
|
|
|
|
|
|
|
|
30,364 |
|
Write-off of accounts receivable |
|
|
|
|
|
|
|
|
|
|
193,965 |
|
Note payable issued for litigation |
|
|
|
|
|
|
|
|
|
|
385,000 |
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in accounts receivable |
|
|
|
|
|
|
|
|
|
|
(7,529 |
) |
Decrease in prepaid expenses |
|
|
|
|
|
|
11,331 |
|
|
|
|
|
Decrease in deferred charges |
|
|
|
|
|
|
12,077 |
|
|
|
|
|
Increase in accounts payable |
|
|
162,889 |
|
|
|
293,150 |
|
|
|
2,455,434 |
|
Increase in accrued expenses |
|
|
23,134 |
|
|
|
2,516 |
|
|
|
622,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Operating Activities |
|
|
(1,695,709 |
) |
|
|
(600,791 |
) |
|
|
(8,654,775 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Increase in deposits |
|
|
|
|
|
|
|
|
|
|
(51,100 |
) |
Purchase of equipment |
|
|
(68,491 |
) |
|
|
|
|
|
|
(200,675 |
) |
Payments received on note receivable |
|
|
|
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Investing Activities |
|
|
(68,491 |
) |
|
|
|
|
|
|
(121,775 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, preferred stock and warrants for
cash |
|
|
3,033,000 |
|
|
|
718,504 |
|
|
|
10,060,845 |
|
Contributed equity |
|
|
|
|
|
|
|
|
|
|
131,374 |
|
Proceeds from notes payable |
|
|
|
|
|
|
|
|
|
|
1,336,613 |
|
Payments on notes payable |
|
|
(300,000 |
) |
|
|
(195,000 |
) |
|
|
(801,287 |
) |
Proceeds from convertible notes payable |
|
|
|
|
|
|
|
|
|
|
571,702 |
|
Payments on convertible notes payable |
|
|
|
|
|
|
|
|
|
|
(98,500 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Financing Activities |
|
|
2,733,000 |
|
|
|
523,504 |
|
|
|
11,200,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE IN CASH |
|
|
968,800 |
|
|
|
(77,287 |
) |
|
|
2,424,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AT BEGINNING OF PERIOD |
|
|
1,455,397 |
|
|
|
424,216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AT END OF PERIOD |
|
$ |
2,424,197 |
|
|
$ |
346,929 |
|
|
$ |
2,424,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to unaudited condensed consolidated financial statements
- 6 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Statements of Cash Flows (Continued)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the Six |
|
|
Months Ended |
|
|
June 30, |
|
|
2005 |
|
2004 |
SUPPLEMENTAL DISCLOSURES OF
CASH FLOW INFORMATION |
|
|
|
|
|
|
|
|
Preferred stock dividend as part of beneficial
conversion feature |
|
$ |
1,264,409 |
|
|
$ |
|
|
Retirement of notes payable with common stock |
|
$ |
|
|
|
$ |
175,000 |
|
See notes to unaudited condensed consolidated financial statements
- 7 -
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to the Unaudited Condensed Consolidated Financial Statements
Note 1 Basis of Presentation
Unaudited Interim Consolidated Financial Statements
The accompanying unaudited consolidated financial statements have been prepared by the Company
pursuant to the rules and regulations of the Securities and Exchange Commission. Certain
information and footnote disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles have been condensed or omitted pursuant to
such rules and regulations. In the opinion of management, all adjustments and disclosures necessary
for a fair presentation of these financial statements have been included. These financial
statements should be read in conjunction with the financial statements and notes thereto included
in the Companys 2004 Annual Report on Form 10-KSB for the year ended December 31, 2004, as filed
with the Securities and Exchange Commission. Certain reclassifications and other corrections for
rounding have been made in prior-period financial statements to conform to the current-period
presentation. The consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries. All significant inter-company transactions and balances have been
eliminated in consolidation.
Stock Based Compensation
The Company accounts for its stock options under Accounting Principles Board (APB) Opinion No. 25
using the intrinsic value method. The Company has elected not to adopt the provisions of Statement
of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (FAS 123). In
accordance with Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure, pro-forma net income, stock-based compensation expense,
and earnings per share using the fair value method are stated as follows:
- 8 -
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net loss applicable to
common shareholders, as
reported |
|
$ |
(515,483 |
) |
|
$ |
(532,507 |
) |
|
$ |
(3,574,308 |
) |
|
$ |
(2,670,819 |
) |
Add: Stock-based employee
compensation expense
included in reported net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,577,000 |
|
Deduct: Total stock based
employee compensation
expense determined under
fair value based method for
all awards |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,916,768 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss applicable
to common shareholders |
|
$ |
(515,483 |
) |
|
$ |
(532,507 |
) |
|
$ |
(3,574,308 |
) |
|
$ |
(3,010,587 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share, as reported |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share, pro forma |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumptions used to calculate the income statement impact of stock options granted as if the
Company had adopted FAS 123 were as follows:
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
Expected dividend yield |
|
|
N/A |
|
|
|
|
|
Risk free interest rate |
|
|
N/A |
|
|
|
3.8 |
% |
Expected volatility |
|
|
N/A |
|
|
|
220 |
% |
Expected life |
|
|
N/A |
|
|
7 years |
Weighted
average fair value per share |
|
|
N/A |
|
|
$ |
0.10 |
|
Loss Per Common Share
Loss per share is computed by dividing net loss applicable to common shareholders by the
weighted-average number of shares outstanding. Potential common shares from convertible notes
payable, warrants and stock options have not been included as they are anti-dilutive.
Note 2 Going Concern Considerations
The Companys recurring losses from development-stage activities in current and prior years raise
substantial doubt about the Companys ability to continue as a going concern. The financial
statements do not include any adjustments to reflect the possible effects on the recoverability and
classification of assets or amounts and classifications of liabilities that may result from the
possible inability of the Company to continue as a going concern. The Company is attempting to
raise additional capital to fund research and development costs until it is able to consistently
- 9 -
generate revenues and sustain profitable operations. However, there can be no assurance that these
plans will be successful.
Note 3 Issuance of Common Stock, Preferred Stock, and Warrants
Common Stock
During the six months ended June 30, 2005, the Company issued 2,176,389 shares of restricted common
stock, 104,167 of which were issued for services valued at $18,750 and 2,072,222 of which were
issued for cash totaling $373,000. In connection with the sales for cash, the Company also issued
warrants to purchase 2,072,222 shares of restricted common stock at $0.18 per share, expiring 3
years from the date of issuance.
Preferred Stock and Warrants
During the six months ended June 30, 2005, the Company issued 30,000 shares of Series A Convertible
Preferred Stock and warrants to purchase 22,877,478 shares of common stock for a total offering
price of $3.0 million. The Company incurred $340,000 of offering costs and issued to the placement
agent warrants to purchase 1,220,132 shares of common stock exercisable at $0.1967 per share which
are exercisable for a period of three years. The Company valued these warrants at $213,889 ($0.18
per share) using a Black Scholes option pricing model with the following assumptions: risk free
rate 2.82%, volatility of 203% and an expected life of three years.
Each share of Preferred Stock entitles the holder to convert the share of Preferred Stock into the
number of shares of common stock resulting from multiplying $100 by the conversion price. The
conversion price is 85% of the average of the lowest three intra-day trading prices for the
Companys common stock during the 10 trading days immediately preceding the conversion date, but
the conversion price may not exceed $0.1967. The warrants are subject to equitable adjustment in
connection with a stock split, stock dividend or similar transaction. The warrants entitle the
holder to purchase up to 22,877,478 shares of common stock of the Company on or before the third
anniversary of the issuance date of the warrants at $0.1967 per share.
The Company has allocated the proceeds from the issuance of the Series A Convertible Preferred
Stock and warrants, based on their relative fair values on the date of issuance which are as
follows: $3,000,000 to the Series A Convertible Preferred and $4,010,422 to the warrants. The
warrants were valued using the Black Scholes Pricing model using the following assumptions:
volatility of 203%, risk-free interest rate of 2.82% and a term of three years. The allocation of
the net proceeds resulted in $1,046,775 being allocated to the Series A Convertible Preferred Stock
and $1,399,336 being allocated to the warrants. The Company recognized a beneficial conversion
dividend of $1,264,409 on the date of issuance equal to the value allocated to the Series A
Convertible Preferred Stock (before offering costs). The actual amount of the beneficial conversion
was $4,037,917 but the dividend is limited to the amount of gross proceeds allocated to the Series
A Convertible Preferred Stock.
The Series A Convertible Preferred Stock has no voting rights. In the event of liquidation, the
holders are entitled to a liquidating distribution of $100 per share. The number of shares of
common stock subject to the warrants and the exercise price are subject to equitable adjustment in
connection with a stock split, stock dividend or similar transaction. The Company also entered into
a Registration Rights Agreement with the investors requiring the Company to file a registration
statement with the Securities and Exchange Commission registering the shares of common stock
issuable upon conversion of the Preferred Stock and exercise of the warrants.
Note 4
Other Significant Events
SaveCream Asset Purchase
On March 16, 2005, the Company completed the purchase of the intellectual property assets (the
Assets) of Savetherapeutics AG, a German corporation in liquidation in Hamburg, Germany
(SaveT). The Assets consist primarily of patents, patent applications, pre-clinical study data
and clinical trial data concerning SaveCream,
- 10 -
SaveTs developmental-stage topical aromatase inhibitor treatment for breast cancer. SaveCream
never generated revenues for SaveT. The Companys analysis as to whether the intellectual property
purchased constituted a business resulted in the conclusion that no such business had been
acquired.
The purchase price of the Assets was negotiated to be 2,350,000 (approximately $2.8 million under
current exchange rates), payable as follows: 500,000 at closing, 500,000 (approximately $665,700
on the date of transaction, $604,900 using the June 30, 2005 exchange rates) upon conclusion of
certain pending transfers of patent and patent application rights from SaveTs inventors to the
Company, and the remaining 1,350,000 (approximately $1.74 million at current exchange rates) upon
successful commercialization of the Assets. The Companys source of funds for the acquisition was a
$3 million investment in the Companys Series A Preferred Stock by an unrelated third party, as
described in Note 3.
SaveT inventors have yet to assign the patent and application rights to the Company, management has
deemed the assignment of the rights to be reasonably likely because the inventors are contractually
bound to execute and deliver the assignments; therefore, the Company has recorded the second
500,000 payment as a current liability in these financial statements. At present it is
undeterminable whether the intellectual property will ever be commercialized; therefore, the final
1,350,000 under this acquisition has not been accrued as a liability as of June 30, 2005. The
Company determined the intellectual property purchased should be expensed as research and
development costs
Formation of MDI Oncology, Inc.
On March 22, 2005, the Company formed MDI Oncology, Inc., a Delaware Corporation, as a wholly-owned
subsidiary for the purpose of acquiring and operating the assets and associated business ventures
associated with the SaveCream purchase.
Settlement of Debt
On April 1, 2005, the Company negotiated a settlement regarding notes payable totaling $280,717 and
accrued interest of $215,636, by payment of $300,000 in cash. The Company recognized a gain on
settlement of debt totaling $196,353.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The purpose of this section is to discuss and analyze our consolidated financial condition,
liquidity and capital resources, and results of operations. This analysis should be read in
conjunction with the consolidated financial statements and notes thereto at pages 3 through 11 and
Managements Discussion and Analysis of Financial Condition and Results of Operations contained in
our Annual Report on Form 10-KSB for the year ended December 31, 2004 (the 2004 10-KSB).
This section contains certain forward-looking statements that involve risks and uncertainties,
including statements regarding our plans, objectives, goals, strategies and financial performance.
Our actual results could differ materially from the results anticipated in these forward-looking
statements as a result of factors set forth under Cautionary Statement for Forward-Looking
Information and Factors Affecting Future Results below and elsewhere in this report.
Overview
We are a developmental-stage bio-pharmaceutical company engaged in the research, validation,
development and ultimate commercialization of two drugs: MDI-P and SaveCream. MDI-P is an
anti-infective drug that we believe will be a safe and effective treatment for bacterial
infections, viral infections and fungal infections. SaveCream is a
- 11 -
breast cancer medication that is applied topically to reduce breast cancer tumors. Both of these
drugs are still in development and have not been approved by the U.S. Food and Drug Administration
(FDA).
Our initial target indications for MDI-P are Cystic Fibrosis and HIV. We have filed an
Investigatory New Drug application (IND) with the FDA seeking permission to begin Phase I human
clinical trials of MDI-P as a treatment for Cystic Fibrosis. The FDA has responded to our IND and
we are hopeful that we can satisfactorily answer the FDAs questions and satisfy the FDAs
follow-up requests for further animal testing, resulting in the FDA approving the application. If
the FDA approves that IND, we will begin human trials at St. Lukes Regional Medical Center in
Boise, Idaho using a protocol designed by Dr. Henry Thompson. If our Phase I IND for Cystic
Fibrosis is successful, we intend to file an IND for Phase I testing of MDI-P as a treatment for
HIV at Harvard School of Medicine using a protocol designed by Dr. Bruce Dezube. We also expect to
add additional indications for the use of MDI-P in the future as we further our pre-clinical
development.
We recently purchased the intellectual property for SaveCream from the liquidation estate of a
defunct German biotechnology company. In a European Union study of SaveCream used by over 100 women
diagnosed with breast cancer, a significant number of those women experienced a significant tumor
reduction. This study, while preliminary, indicates that SaveCream may be substantially more
effective and faster acting than similar drugs already on the market. We are in the process of
developing a global commercialization strategy for SaveCream.
To date, we have not generated significant revenues from operations or realized a profit. Through
June 30, 2005, we had incurred a cumulative net loss since inception of $22,928,241.
Recent Events
SaveCream Asset Purchase. We are in the process of developing a commercialization plan for
SaveCream and of integrating the SaveCream assets into MDI. Specifically, we are working to
complete the transfer of patents and patent applications to MDIs subsidiary designated for
developing SaveCream. As we previously reported, at the time we purchased SaveCream and the other
intellectual property assets from Savetherapeutics A.G. (SaveT), SaveT had not yet obtained and
filed with the appropriate patent offices assignments of the various inventors rights to the
underlying inventions. Each of those inventors has agreed and is contractually bound to assign such
rights. We are currently in the process of securing the applicable assignments. However, we may
need to initiate litigation against the inventors to secure such assignments.
Cystic Fibrosis IND. We are continuing to prosecute our IND for cystic fibrosis with the FDA. We
have agreed with the FDA on a large animal model protocol to establish pharmacological safety with
relation to cardio and central nervous system toxicity as well as genotoxicity for this IND. We
expect to begin that phase of testing in Q3 of this year and to start Phase I clinical trials on
cystic fibrosis in Q1 of 2006, subject to FDA approval.
Results of Operations
Revenues and Gross Profit We did not book any revenue for the three or six-month periods ended
June 30, 2005 or June 30, 2004. As we continue to pursue pre-clinical and clinical testing of our
pharmaceuticals, we may not book significant revenues in the near future.
Operating
Expenses and Operating Loss We incurred $118,520 in research and development expenses
for the quarter ended June 30, 2005. We incurred $132,335 in research and development expenses for
the same period of 2004. Our general and administrative expenses were $636,325 during the quarter
ended June 30, 2005, as compared to $369,270 during the quarter ended June 30, 2004. As a result of
the foregoing, we sustained an operating loss of $754,845 for the quarter ended June 30, 2005, as
compared with an operating loss of $501,605 for the same period of 2004.
For the six months ended June 30, 2005 we incurred $1,670,506 in research and development expenses,
$1,345,000 of which related to our acquiring the patents and patent rights relating to SaveCream.
We incurred $170,978 in research and development expenses for the same period of 2004. Our general
and administrative expenses were
- 12 -
$888,321 during the first six months of 2005, as compared to $2,416,963 during the six-month period
ended June 30, 2004, resulting in operating losses of $2,558,827 through June 30, 2005 and
$2,587,941 for the same period of 2004.
Other Income/Expense and Net Loss We booked $9,346 in interest income and incurred interest
expenses of $7,237 for the quarter ended June 30, 2005, as compared with interest income of $1,426
and $33,048 in interest expenses for the same period of 2004. The decrease in interest expense is a
result of our successful efforts to convert high-interest debt to equity. We also recorded
$196,353 as Gain on Forgiveness of Debt during the quarter ended June 30, 2005, which resulted from
a negotiated settlement of certain notes payable. In sum, our net loss applicable to common
shareholders for the second quarter of 2005 was $515,483 or a loss of less than $0.01 per fully
diluted share. For the quarter ended June 30, 2004 we incurred a net loss applicable to common
shareholders of $532,507, making a loss of $0.01 per fully diluted share.
For the six months ended June 30, 2005, we booked $14,910 in interest income and incurred interest
expense of $23,135, as compared with $3,126 of interest income and $86,724 of interest expense for
the comparable period of 2004. In addition, we recognized a preferred stock dividend of $1,264,409
during the first six months as a result of the beneficial conversion feature of the preferred
shares issued during the period. There was no such dividend recognized during the first half of
2004. Our net loss applicable to common shareholders for the first half of 2005 was $3,574,308 or
$0.03 per fully diluted share. Our net loss for the first half of 2004 was $2,670,819 or $0.03 per
fully diluted share.
Future
Expectations We may operate at a loss for several more years while we continue to
research, gain regulatory approval of, and commercialize our technologies. We will spend more in
the remainder of the 2005 fiscal year in research and development expenses than we did over the
prior year as we continue to implement our commercialization strategy. Similarly, we expect our
general and administrative expenses to continue to increase for the remainder of 2005 as we
continue to expand the scope of our operations. As a result, we expect to sustain a greater net
loss in 2005 than we have in recent years.
Liquidity and Capital Resources
As of June 30, 2005, we had $2,424,197 in cash and had a working capital deficit of $1,212,906.
Since our inception, we have financed our operations primarily through private sales of equity and
the issuance of convertible and non-convertible notes. We continue to require significant
supplementary funding to continue to develop, research, and seek regulatory approval of our
technologies. We do not currently generate any cash from operations and have no credit facilities
in place or available. Currently, we are funding operations through private issuances of equity.
During the six months ended June 30, 2005, we issued 30,000 shares of our Series A Preferred Stock
to an unrelated third-party in exchange for $3 million in cash, less offering costs of $250,000.
We intend to use this cash for additional research and development, including making the second
installment on our purchase of the SaveCream assets.
We believe we have sufficient capital on hand to complete Phase I clinical trials for Cystic
Fibrosis once the FDA approves our IND. We also believe we have sufficient capital to file our IND
for HIV.
Once an IND application for HIV is submitted, and assuming it is approved, we will need additional
capital to initiate Phase I clinical trials. We estimate the cost to complete Phase I and Phase II
clinical trials to be several million dollars per indication and the cost to complete Phase III
testing and obtain approval of an NDA to be in the tens of millions of dollars per indication.
While our ability to obtain financing may improve in the event our IND application is approved, we
cannot give assurances that we will have access to the significant capital required to take a drug
through regulatory approvals and to market. We may seek a partner in the global pharmaceutical
industry to help us co-develop, license, or even purchase some or all of our technologies.
- 13 -
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements as defined in Item 303(c) of Regulation S-B.
Cautionary Statement for Forward Looking Information
Certain information set forth in this report contains forward-looking statements within the
meaning of federal securities laws. Forward looking statements include statements concerning our
plans, objectives, goals, strategies, future events, future revenues or performance, capital
expenditures, and financing needs and other information that is not historical information. When
used in this report, the words estimates, expects, anticipates, forecasts, plans,
intends, believes and variations of such words or similar expressions are intended to identify
forward-looking statements. Additional forward-looking statements may be made by us from time to
time. All such subsequent forward-looking statements, whether written or oral and whether made by
us or on our behalf, are also expressly qualified by these cautionary statements.
Our forward-looking statements are based upon our current expectations and various assumptions. Our
expectations, beliefs and projections are expressed in good faith and are believed by us to have a
reasonable basis, including without limitation, our examination of historical operating trends,
data contained in our records and other data available from third parties, but there can be no
assurance that our expectations, beliefs and projections will result or be achieved or
accomplished. Our forward-looking statements apply only as of the date made. We undertake no
obligation to publicly update or revise forward-looking statements which may be made to reflect
events or circumstances after the date made or to reflect the occurrence of unanticipated events.
There are a number of risks and uncertainties that could cause actual results to differ materially
from those set forth in, contemplated by or underlying the forward-looking statements contained in
this report. Those risks and uncertainties include, but are not limited to, our lack of significant
operating revenues and lack of profit to date, our need for substantial and immediate additional
capital, the fact that we may dilute existing shareholders through additional stock issuances, the
extensive governmental regulation to which we are subject, the fact that our technologies remain
unproven, the intense competition we face from other companies and other products, and our reliance
upon potentially inadequate intellectual property. Those risks and certain other uncertainties are
discussed in more detail in the 2004 10-KSB. There may also be other factors, including those
discussed elsewhere in this report, that may cause our actual results to differ from the
forward-looking statements. Any forward-looking statements made by us or on our behalf should be
considered in light of these factors.
ITEM 3. CONTROLS AND PROCEDURES
(a) Under the supervision and with the participation of our management, including our principal
executive officer and principal financial officer, we conducted an evaluation of our disclosure
controls and procedures, as such term is defined under Rule 13a-14(c) promulgated under the
Securities Exchange Act of 1934, as amended (the Exchange Act), as of June 30, 2005. Based on
this evaluation, our principal executive officer and principal financial officer concluded that our
disclosure controls and procedures were effective as of June 30, 2005.
(b) There have been no significant changes (including corrective actions with regard to significant
deficiencies or material weaknesses) in our internal controls or in other factors that could
significantly affect these controls subsequent to the date of the evaluation referenced in
paragraph (a) above.
- 14 -
PART II
OTHER INFORMATION
ITEM 6. EXHIBITS
The following documents are furnished as exhibits to this Form 10-QSB. Exhibits marked with an
asterisk are filed herewith. The remainder of the exhibits previously have been filed with the
Commission and are incorporated herein by reference.
|
|
|
Number |
|
Exhibit |
2.1
|
|
Sale and Purchase Agreement between Attorney
Hinnerk-Joachim Müller as liquidator of
Savetherapeutics AG i.L. and Medical
Discoveries, Inc. regarding the purchase of the
essential assets of Savetherapeutics AG i.L.
(Exhibits referenced therein will be provided
upon request.) |
|
|
|
3.1
|
|
Amended and Restated Articles of Incorporation
of the Company (filed as Exhibit 3.1 to the
Companys Annual Report on Form 10-KSB for the
fiscal year ended December 31, 1994, and
incorporated herein by reference). |
|
|
|
3.2
|
|
Amended Bylaws of the Company (filed as Exhibit
3.2 to the Companys Annual Report on Form
10-KSB for the fiscal year ended December 31,
1994, and incorporated herein by reference). |
|
|
|
4.1
|
|
Registration Rights Agreement dated October 18,
2004 among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC and Medical Discoveries,
Inc. (filed as Exhibit 4.1 to the Companys Annual Report on
Form 10-KSB for the fiscal year ended December 31, 2004,
and incorporated herein by reference). |
|
|
|
4.2
|
|
Registration Rights Agreement dated December 3,
2004 among Mercator Momentum Fund, LP, Mercator
Momentum Fund III, LP, Mercator Advisory Group,
LLC and Medical Discoveries, Inc. (filed as Exhibit 4.2 to the
Companys Annual Report on Form 10-KSB for the fiscal year
ended December 31, 2004, and incorporated herein by reference). |
|
|
|
10.1
|
|
2002 Stock Incentive Plan adopted by the Board
of Directors as of July 11, 2002 (filed as
Exhibit 10.5 to the Companys Quarterly Report
on Form 10-QSB for the quarter ended June 30,
2002, and incorporated herein by reference). |
|
|
|
21
|
|
Subsidiaries.* |
|
|
|
31
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
|
32
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
- 15 -
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
|
MEDICAL DISCOVERIES, INC. |
|
|
|
|
|
|
|
|
|
/S/ JUDY M. ROBINETT
|
|
|
|
|
Judy M. Robinett |
|
|
|
|
President and Chief Executive Officer |
|
|
Date: August 12, 2005
- 16 -
INDEX TO EXHIBITS
|
|
|
Number |
|
Exhibit |
2.1
|
|
Sale and Purchase Agreement between Attorney
Hinnerk-Joachim Müller as liquidator of
Savetherapeutics AG i.L. and Medical
Discoveries, Inc. regarding the purchase of the
essential assets of Savetherapeutics AG i.L.
(Exhibits referenced therein will be provided
upon request.) |
|
|
|
3.1
|
|
Amended and Restated Articles of Incorporation
of the Company (filed as Exhibit 3.1 to the
Companys Annual Report on Form 10-KSB for the
fiscal year ended December 31, 1994, and
incorporated herein by reference). |
|
|
|
3.2
|
|
Amended Bylaws of the Company (filed as Exhibit
3.2 to the Companys Annual Report on Form
10-KSB for the fiscal year ended December 31,
1994, and incorporated herein by reference). |
|
|
|
4.1
|
|
Registration Rights Agreement dated October 18,
2004 among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC and Medical Discoveries,
Inc. (filed as Exhibit 4.1 to the Companys Annual Report on
Form 10-KSB for the fiscal year ended December 31, 2004,
and incorporated herein by reference). |
|
|
|
4.2
|
|
Registration Rights Agreement dated December 3,
2004 among Mercator Momentum Fund, LP, Mercator
Momentum Fund III, LP, Mercator Advisory Group,
LLC and Medical Discoveries, Inc. (filed as Exhibit 4.2 to the
Companys Annual Report on Form 10-KSB for the fiscal year
ended December 31, 2004, and incorporated herein by reference). |
|
|
|
10.1
|
|
2002 Stock Incentive Plan adopted by the Board
of Directors as of July 11, 2002 (filed as
Exhibit 10.5 to the Companys Quarterly Report
on Form 10-QSB for the quarter ended June 30,
2002, and incorporated herein by reference). |
|
|
|
21
|
|
Subsidiaries.* |
|
|
|
31
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
|
32
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
- 17 -