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 September 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)
(801) 582-9583
(Issuers telephone number, including area code)
N/A
(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
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes o No þ
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 November 10, 2005, there were 107,679,724 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 September 30, 2005, (unaudited) and December 31, 2004
(audited)
Condensed Consolidated Statements of Operations for the nine-month periods ended September 30, 2005
(unaudited), September 30, 2004 (unaudited), three-month periods ended September 30, 2005
(unaudited), September 30, 2004 (unaudited) and from inception of the development stage on November
20, 1991 through September 30, 2005 (unaudited)
Condensed Consolidated Statements of Cash Flows for the nine-month periods ended September 30, 2005
(unaudited), September 30, 2004 (unaudited), and from inception of the development stage on
November 20, 1991 through September 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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September 30, |
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December 31, |
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2005 |
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2004 |
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ASSETS |
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CURRENT ASSETS |
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|
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|
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Cash |
|
$ |
1,256,939 |
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|
$ |
1,455,397 |
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Deposits |
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|
|
|
51,100 |
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|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
Total Current Assets |
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1,256,939 |
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|
1,506,497 |
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Note receivable |
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301,450 |
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Property and Equipment, Net |
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73,432 |
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TOTAL ASSETS |
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$ |
1,631,821 |
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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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$ |
2,658,393 |
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$ |
2,448,454 |
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Accrued interest payable |
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230,298 |
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|
415,262 |
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Notes payable |
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56,000 |
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|
336,717 |
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Convertible notes payable |
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193,200 |
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|
193,200 |
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Research and development obligation |
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602,900 |
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Total Current Liabilities |
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3,740,791 |
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|
3,393,633 |
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TOTAL LIABILITIES |
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|
3,740,791 |
|
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|
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) |
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1,570,109 |
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523,334 |
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Preferred stock undesignated, 49,958,000 shares authorized; none issued and outstanding |
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Common stock, no par value; 250,000,000 shares authorized; 107,679,724 and 105,653,335
shares issued and outstanding, respectively |
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15,283,407 |
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|
14,918,657 |
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Additional paid-in capital |
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|
6,302,017 |
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|
3,424,383 |
|
Deficit accumulated prior to the development stage |
|
|
(1,399,577 |
) |
|
|
(1,399,577 |
) |
Deficit accumulated during the development stage |
|
|
(23,864,926 |
) |
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|
(19,353,933 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Stockholders Deficit |
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|
(2,108,970 |
) |
|
|
(1,887,136 |
) |
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|
|
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TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT |
|
$ |
1,631,821 |
|
|
$ |
1,506,497 |
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|
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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 Nine |
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on November 20, 1991 |
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Months Ended |
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Months Ended |
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Through |
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September 30, |
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September 30, |
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September 30, |
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2005 |
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2004 |
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|
2005 |
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2004 |
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|
2005 |
|
REVENUES |
|
$ |
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|
$ |
|
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|
$ |
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|
$ |
|
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$ |
157,044 |
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COST OF GOODS SOLD |
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|
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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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|
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|
|
|
|
|
|
|
|
|
|
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|
142,480 |
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OPERATING EXPENSES |
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|
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General and administrative |
|
|
557,713 |
|
|
|
250,819 |
|
|
|
1,446,034 |
|
|
|
2,667,782 |
|
|
|
16,623,004 |
|
Research and development |
|
|
364,335 |
|
|
|
191,506 |
|
|
|
2,034,841 |
|
|
|
362,484 |
|
|
|
5,583,579 |
|
Inventory write-down |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,859 |
|
Impairment loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,709 |
|
License fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
1,001,500 |
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|
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|
|
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|
Total Expenses |
|
|
922,048 |
|
|
|
442,325 |
|
|
|
3,480,875 |
|
|
|
3,030,266 |
|
|
|
23,314,651 |
|
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|
|
|
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|
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|
|
|
|
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|
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|
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|
LOSS FROM OPERATIONS |
|
|
(922,048 |
) |
|
|
(442,325 |
) |
|
|
(3,480,875 |
) |
|
|
(3,030,266 |
) |
|
|
(23,172,171 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
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|
OTHER INCOME (EXPENSES) |
|
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|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2,674 |
|
|
|
854 |
|
|
|
17,584 |
|
|
|
3,980 |
|
|
|
47,155 |
|
Interest expense |
|
|
(7,591 |
) |
|
|
(27,497 |
) |
|
|
(30,726 |
) |
|
|
(114,221 |
) |
|
|
(1,148,163 |
) |
Foreign currency transaction gain (loss) |
|
|
(9,720 |
) |
|
|
|
|
|
|
51,080 |
|
|
|
|
|
|
|
51,080 |
|
Gain on forgiveness of debt |
|
|
|
|
|
|
|
|
|
|
196,353 |
|
|
|
|
|
|
|
1,431,889 |
|
Other income |
|
|
|
|
|
|
39 |
|
|
|
|
|
|
|
759 |
|
|
|
881,892 |
|
|
|
|
|
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|
|
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|
|
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|
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|
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|
|
|
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|
|
Total Other Income (Expenses) |
|
|
(14,637 |
) |
|
|
(26,604 |
) |
|
|
234,291 |
|
|
|
(109,482 |
) |
|
|
1,263,853 |
|
|
|
|
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|
|
|
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NET LOSS |
|
|
(936,685 |
) |
|
|
(468,929 |
) |
|
|
(3,246,584 |
) |
|
|
(3,139,748 |
) |
|
|
(21,908,318 |
) |
|
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|
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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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NET LOSS APPLICABLE TO
COMMON SHAREHOLDERS |
|
$ |
(936,685 |
) |
|
$ |
(468,929 |
) |
|
$ |
(4,510,993 |
) |
|
$ |
(3,139,748 |
) |
|
$ |
(23,864,926 |
) |
|
|
|
|
|
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BASIC AND DILUTED LOSS PER
COMMON SHARE |
|
$ |
(0.01 |
) |
|
$ |
|
|
|
$ |
(0.04 |
) |
|
$ |
(0.03 |
) |
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|
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WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING |
|
|
107,760,835 |
|
|
|
96,482,603 |
|
|
|
107,282,554 |
|
|
|
89,667,882 |
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|
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|
|
|
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|
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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|
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|
From Inception |
|
|
|
For the Nine |
|
|
of the |
|
|
|
Months Ended |
|
|
Development Stage |
|
|
|
September 30, |
|
|
on November 20, 1991 |
|
|
|
2005 |
|
|
2004 |
|
|
Through Sep. 30, 2005 |
|
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(3,246,584 |
) |
|
$ |
(3,139,748 |
) |
|
$ |
(21,908,318 |
) |
Adjustments to reconcile net loss to net cash used by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency transaction gain |
|
|
(51,080 |
) |
|
|
|
|
|
|
(51,080 |
) |
Gain on debt restructuring |
|
|
(196,353 |
) |
|
|
|
|
|
|
(1,431,889 |
) |
Common stock issued for services, expenses, and litigation |
|
|
18,750 |
|
|
|
66,500 |
|
|
|
4,286,467 |
|
Commitment for research and development obligation |
|
|
665,700 |
|
|
|
|
|
|
|
665,700 |
|
Depreciation |
|
|
4,613 |
|
|
|
|
|
|
|
104,884 |
|
Reduction of escrow receivable from
research and development |
|
|
|
|
|
|
|
|
|
|
272,700 |
|
Stock options and warrants granted for services |
|
|
|
|
|
|
1,675,000 |
|
|
|
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 receivable |
|
|
51,100 |
|
|
|
|
|
|
|
245,065 |
|
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 |
|
|
209,939 |
|
|
|
264,288 |
|
|
|
2,502,484 |
|
Increase in accrued expenses |
|
|
30,672 |
|
|
|
37,905 |
|
|
|
630,381 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Operating Activities |
|
|
(2,513,243 |
) |
|
|
(1,072,647 |
) |
|
|
(9,472,309 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Increase in deposits |
|
|
|
|
|
|
|
|
|
|
(51,100 |
) |
Purchase of equipment |
|
|
(78,045 |
) |
|
|
|
|
|
|
(210,229 |
) |
Issuance of note receivable |
|
|
(313,170 |
) |
|
|
|
|
|
|
(313,170 |
) |
Payments received on note receivable |
|
|
|
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Investing Activities |
|
|
(391,215 |
) |
|
|
|
|
|
|
(444,499 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, preferred stock and warrants for cash |
|
|
3,006,000 |
|
|
|
1,352,886 |
|
|
|
10,033,845 |
|
Contributed equity |
|
|
|
|
|
|
|
|
|
|
131,374 |
|
Proceeds from notes payable |
|
|
|
|
|
|
|
|
|
|
1,336,613 |
|
Payments on notes payable |
|
|
(300,000 |
) |
|
|
(270,000 |
) |
|
|
(801,287 |
) |
Proceeds from convertible notes payable |
|
|
|
|
|
|
|
|
|
|
571,702 |
|
Payments on convertible notes payable |
|
|
|
|
|
|
|
|
|
|
(98,500 |
) |
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Financing Activities |
|
|
2,706,000 |
|
|
|
1,082,886 |
|
|
|
11,173,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH |
|
|
(198,458 |
) |
|
|
10,239 |
|
|
|
1,256,939 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AT BEGINNING OF PERIOD |
|
|
1,455,397 |
|
|
|
424,216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AT END OF PERIOD |
|
$ |
1,256,939 |
|
|
$ |
434,455 |
|
|
$ |
1,256,939 |
|
|
|
|
|
|
|
|
|
|
|
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 Nine |
|
|
Months Ended |
|
|
September 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 Condensed Consolidated Financial Statements
The
accompanying unaudited condensed 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. 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended Sep. 30, |
|
|
Nine Months Ended Sep. 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss applicable to
common shareholders, as
reported |
|
$ |
(936,685 |
) |
|
$ |
(468,929 |
) |
|
$ |
(4,510,993 |
) |
|
$ |
(3,139,748 |
) |
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 |
|
$ |
(936,685 |
) |
|
$ |
(468,929 |
) |
|
$ |
(4,510,993 |
) |
|
$ |
(3,479,516 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share, as reported |
|
$ |
(0.01 |
) |
|
$ |
|
|
|
$ |
(0.04 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
8
Assumptions used to calculate the fair value 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
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 nine months ended September 30, 2005, the Company issued 2,026,389 shares of restricted
common stock, 104,167 of which were issued for services valued at $18,750 and 192,222 of which were
issued for cash totaling $346,000. In connection with the sales for cash, the Company also issued
warrants to purchase 192,222 shares of restricted common stock at $0.18 per share, expiring 3 years
from the date of issuance.
Preferred Stock and Warrants
During the nine months ended September 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 interest 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.
9
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, 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, $602,900 using the September 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 $1.62 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 September 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.
10
Transactions with Shareholder
On July 15, 2005, the Company entered into an agreement to grant a shareholder a non-interest
bearing loan in the amount of 500,000 (approximately $603,000 under current exchange rates) in
exchange for the transfer of certain patents in relation to Savetherapeutics AG, and the
performance of certain research activities. The loan is payable as follows, 100,000 upon
closing, 150,000 after signature of consent to the transfer of patents, and 250,000 after
performance and acceptance of certain research activities. As of September 30, 2005, the amount of
the loan was 250,000 (approximately $301,000 under current exchange rates). Settlement of the
loan shall take place by offsetting against profit claims, which accrue to the shareholder from his
stake in the Company.
Subsequent to the transfer of the industrial property rights and applications, the Company shall
grant to the aforementioned shareholder a 6% stake in MDI Oncology, Inc and to assign to him 6% of
the shares. The Company deemed these shares to have no value because it is a start-up company, and
its success is contingent on several different factors. The Company also entered into an
employment contract with the shareholder for a period of 24 months. The shareholder will receive a
fee of 120,000 per annum (approximately $145,000 using current exchange rates.)
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The
purpose of this section is to discuss and analyze our condensed consolidated financial condition,
liquidity and capital resources, and results of operations. This analysis should be read in
conjunction with the condensed 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. We further believe that MDI-P will be a safe
and effective treatment for cystic fibrosis. SaveCream is a 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
Investigational 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 preclinical
development.
We recently purchased SaveCream from a German biotechnology company. In a European Union study of
SaveCream used by over 100 women diagnosed with Stage 4 breast cancer, a significant number of
those women experienced a significant tumor reduction. This preliminary study showed an average
reduction in tumor size of fifty percent in two weeks. If these preliminary results are realized in
further clinical testing, this compound may be a useful neoadjuvant therapy for reducing tumor
size, increasing the potential for breast-saving surgery in place of mastectomy. We are in the
process of developing a global commercialization strategy for SaveCream.
11
Recent Events
SaveCream Asset Transfer. 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 from SaveCreams two inventors of the rights
to the underlying inventions. Each of those inventors has at least twice agreed with SaveT to
assign such rights and is contractually bound to do so. The fact that SaveT never followed through
and filed the assignment appears to be a mere oversight. One of the inventors, Alfred Schmidt, has
refused to cooperate to correct that oversight. We may need to initiate litigation against Mr.
Schmidt to extinguish his rights as a co-inventor. We have entered into an agreement with the
other inventor, Heinrich Wieland, pursuant to which he has provided us with the applicable
assignments, which we are in the process of filing with the appropriate patent offices. Should we
be unsuccessful in terminating Mr. Schmidts rights, he will remain a co-owner with us of the
patent rights. As a co-owner we would have the right to commercialize the inventions, but that
right would not be exclusive. Without exclusive rights to the inventions underlying SaveCream,
their value to us is much lower than it otherwise would be.
Cystic Fibrosis IND. We are continuing to prosecute our IND for cystic fibrosis with the FDA. At
the FDAs request, we have conducted a large animal model study intended to establish
pharmacological safety with relation to cardio and central nervous system toxicity as well as
genotoxicity for this IND. Should the FDA find the results of that study sufficient, we could 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 nine-month periods ended
September 30, 2005. As we continue to pursue preclinical and clinical testing of our
pharmaceuticals, we may not book significant revenues in the near future.
Operating Expenses and Operating Loss We incurred $364,335 in research and development expenses
for the quarter ended September 30, 2005. We incurred $191,506 in research and development expenses
for the same period of 2004. Our general and administrative expenses
were $557,713 during the
quarter ended September 30, 2005, as compared to $250,819 during the quarter ended September 30,
2004. As a result of the foregoing, we sustained an operating loss of
$922,048 for the quarter
ended September 30, 2005, as compared with an operating loss of
$442,325 for the same period of
2004.
For the nine months ended September 30, 2005 we incurred $2,034,841 in research and development
expenses, $1,345,000 of which related to our acquiring the patents and patent rights relating to
SaveCream. We incurred $362,484 in research and development expenses for the same period of 2004.
Our general and administrative expenses were $1,446,034 during the first nine months of 2005, as
compared to $2,667,782 during the nine-month period ended September 30, 2004, resulting in
operating losses of $3,480,875 through September 30, 2005 and
$3,030,266 for the same period of
2004.
Other Income/Expense and Net Loss We booked $2,674 in interest income and incurred interest
expenses of $7,591 for the quarter ended September 30, 2005, as compared with interest income of
$854 and $27,497 in interest expenses for the same period of 2004.
During the quarter ended September 30, 2005, we also booked a foreign
currency loss of $9,720. We had no foreign currency risk in 2004. In sum, our net loss applicable
to common shareholders for the third quarter
of 2005 was $936,685 or a loss of less than $0.01 per fully diluted share. For the quarter ended
September 30, 2004 we incurred a net loss applicable to common shareholders of $468,929, making a
loss of less than $0.01 per fully diluted share.
For the nine months ended September 30, 2005, we booked $17,584 in interest income and incurred
interest expense of $30,726, as compared with $3,980 of interest income and $114,221 of interest
expense for the comparable period of 2004. In addition, we recognized a preferred stock dividend of
$1,264,409 during the first nine 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
nine months of 2004. During the nine months ended September 30,
2005, we also booked a foreign currency gain of $51, 080. We had no
foreign currency risk in 2004. Our net loss applicable to common shareholders for the first nine months of
2005 was $4,510,993 or $0.04 per fully diluted share. Our net loss
for the first nine months of 2004 was
$3,139,748 or $0.03 per fully diluted share.
12
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 September 30, 2005, we had $1,256,939 in cash and had a working capital deficit of
$2,483,852. 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.
We have entered into fixed price contracts for all of the research services we expect will be
required in connection with our cystic fibrosis IND to meet the FDAs request for additional
preclinical information and for Phase I testing. We have budgeted for these costs and believe we
have sufficient funds to initiate this testing, however we may need to raise additional capital to
complete all of the necessary testing. Much of the preclinical testing requested by the FDA has
been completed with positive results. Our contracts for the additional outstanding testing require
completion of this work by December 31, 2005. In the interim, we are preparing a submission of the
existing data to the FDA in hopes of being permitted to proceed with Phase I testing pending the
outcome of the remaining preclinical work. We anticipate that we may be able to start Phase I
clinical trials on cystic fibrosis as early as Q1 of 2006.
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 believe we have insufficient capital to file our IND for HIV. In addition, once
an IND application for HIV is submitted, and assuming it is approved, we will need additional
capital to initiate Phase I clinical trials.
While our ability to obtain financing may improve in the event an IND application is approved and
we enter the clinic, 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.
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
13
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 September 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 September 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.
(filed as Exhibit 2.1 to the Companys Annual
Report on Form 10-KSB for the fiscal year ended
December 31, 2004, and incorporated herein by
reference). |
|
|
|
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). |
|
|
|
4.3
|
|
Certificate of Designations of Preferences and
Rights of Series A Convertible Preferred Stock
of Medical Discoveries, Inc. (filed as Exhibit
4.1 to Registration Statement No. 333-121635
filed on Form SB-2 on December 23, 2004, and
incorporated herein by reference). |
|
|
|
4.4
|
|
Amendment to Certificate of Designations of
Preferences and Rights of Series A Convertible
Preferred Stock of Medical Discoveries, Inc.
(filed as Exhibit 4.2 to Registration Statement
No. 333-121635 filed on Form SB-2 on December
23, 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). |
|
|
|
10.2
|
|
Subscription Agreement dated October 18, 2004
among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC, and Medical Discoveries,
Inc. (filed as Exhibit 10.2 to Amendment No. 2
to Registration Statement No. 333-121635 filed
on form SB-2 on June 2, 2005, and incorporated
herein by reference). |
|
|
|
10.3
|
|
Subscription 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 10.3 to Amendment No. 2 to Registration
Statement No. |
15
|
|
|
Number |
|
Exhibit |
|
|
333-121635 filed on form SB-2 on
June 2, 2005, and incorporated herein by
reference).
|
|
|
|
10.4
|
|
Employment Agreement dated March 1, 2005 between
Medical Discoveries, Inc. and Judy M. Robinett.
(filed as Exhibit 10.4 to Amendment No. 3 to
Registration Statement No. 333-121635 filed on
Form SB-2 on October 13, 2005, and incorporated
herein by reference). |
|
|
|
21
|
|
Subsidiaries.* |
|
|
|
31.1
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
|
31.2
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
|
|
|
32.2
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
16
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:
November 14, 2005 |
|
|
|
|
17
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.
(filed as Exhibit 2.1 to the Companys Annual
Report on Form 10-KSB for the fiscal year ended
December 31, 2004, and incorporated herein by
reference). |
|
|
|
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). |
|
|
|
4.3
|
|
Certificate of Designations of Preferences and
Rights of Series A Convertible Preferred Stock
of Medical Discoveries, Inc. (filed as Exhibit
4.1 to Registration Statement No. 333-121635
filed on Form SB-2 on December 23, 2004, and
incorporated herein by reference). |
|
|
|
4.4
|
|
Amendment to Certificate of Designations of
Preferences and Rights of Series A Convertible
Preferred Stock of Medical Discoveries, Inc.
(filed as Exhibit 4.2 to Registration Statement
No. 333-121635 filed on Form SB-2 on December
23, 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). |
|
|
|
10.2
|
|
Subscription Agreement dated October 18, 2004
among Monarch Pointe Fund, Ltd., Mercator
Advisory Group, LLC, and Medical Discoveries,
Inc. (filed as Exhibit 10.2 to Amendment No. 2
to Registration Statement No. 333-121635 filed
on form SB-2 on June 2, 2005, and incorporated
herein by reference). |
|
|
|
10.3
|
|
Subscription 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 10.3 to Amendment No. 2 to Registration
Statement No. 333-121635 filed on form SB-2 on
June 2, 2005, and incorporated herein by
reference). |
|
|
|
10.4
|
|
Employment Agreement dated March 1, 2005 between
Medical Discoveries, Inc. and Judy M. Robinett.
(filed as Exhibit 10.4 to Amendment No. 3 to
Registration Statement No. 333-121635 filed on
Form SB-2 on October 13, 2005, and incorporated
herein by reference). |
|
|
|
21
|
|
Subsidiaries.* |
18
|
|
|
Number |
|
Exhibit |
31.1
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
|
31.2
|
|
Rule 13a-14(a) Certification, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
|
|
|
32.2
|
|
Certification pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
19