þ
|
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
|
|
For
the quarterly period ended September 30, 2006
|
|
|
|
o
|
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
|
|
For
the transition period from
to
|
|
|
|
Utah
|
|
87-0407858
|
(State
or other jurisdiction of incorporation
or organization)
|
|
(I.R.S.
Employer Identification
No.)
|
PART
I
|
|
FINANCIAL
INFORMATION
|
|
ITEM 1. FINANCIAL STATEMENTS |
3
|
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
12
|
ITEM 3. CONTROLS AND PROCEDURES |
16
|
|
|
PART
II OTHER INFORMATION
|
|
ITEM 6. EXHIBITS |
17
|
SIGNATURES
|
18
|
INDEX
TO EXHIBITS
|
|
EXHIBIT
31.1
|
|
EXHIBIT
31.2
|
|
EXHIBIT
32.1
|
|
EXHIBIT
32.2
|
ASSETS
|
|||||||
September
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
CURRENT
ASSETS
|
|||||||
Cash
|
$
|
103,744
|
$
|
654,438
|
|||
Receivables
|
225,000
|
-
|
|||||
Total
Current Assets
|
328,744
|
654,438
|
|||||
Note
receivable, net of allowance of $169,475
|
150,000
|
296,050
|
|||||
Property
and Equipment, net
|
66,707
|
80,635
|
|||||
TOTAL
ASSETS
|
$
|
545,451
|
$
|
1,031,123
|
|||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
2,165,193
|
$
|
2,608,783
|
|||
Accrued
interest payable
|
260,202
|
237,836
|
|||||
Notes
payable
|
56,000
|
56,000
|
|||||
Convertible
notes payable
|
193,200
|
193,200
|
|||||
Research
and development obligation
|
2,347,095
|
592,100
|
|||||
Financial
instrument
|
1,139,245
|
2,859,596
|
|||||
Total
Current Liabilities
|
6,160,935
|
6,547,515
|
|||||
NOTE
PAYABLE
|
90,000
|
-
|
|||||
TOTAL
LIABILITIES
|
6,250,935
|
6,547,515
|
|||||
STOCKHOLDERS'
DEFICIT
|
|||||||
Preferred
Stock - undesignated, Series A, convertible; no par value; 50,000
shares
|
|||||||
authorized;
34,420 and 42,000 shares issued and outstanding,
respectively;
|
|||||||
(aggregate
liquidation preference of $3,442,000 and $4,200,000,
respectively)
|
514,612
|
523,334
|
|||||
Common
stock, no par value; 250,000,000 shares authorized; 117,922,148 and
|
|||||||
107,679,724
shares issued and outstanding, respectively
|
15,220,617
|
15,211,895
|
|||||
Additional
paid-in capital
|
1,056,020
|
988,670
|
|||||
Deficit
accumulated prior to the development stage
|
(1,399,577
|
)
|
(1,399,577
|
)
|
|||
Deficit
accumulated during the development stage
|
(21,097,156
|
)
|
(20,840,714
|
)
|
|||
Total
Stockholders' Deficit
|
(5,705,484
|
)
|
(5,516,392
|
)
|
|||
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$
|
545,451
|
$
|
1,031,123
|
|||
|
From
Inception
of
the
Development
Stage on |
|||||||||||||||
For
the Three Months
Ended September 30,
|
For
the Nine Months
Ended September 30,
|
November
20, 1991 Through |
||||||||||||||
2006
|
2005
|
2006
|
2005
|
September
30, 2006
|
||||||||||||
REVENUES
|
$
|
800,000
|
$
|
-
|
$
|
800,000
|
$
|
-
|
$
|
957,044
|
||||||
COST
OF GOODS SOLD
|
-
|
-
|
-
|
-
|
14,564
|
|||||||||||
GROSS
PROFIT
|
800,000
|
-
|
800,000
|
-
|
942,480
|
|||||||||||
OPERATING
EXPENSES
|
||||||||||||||||
General
and administrative
|
618,359
|
557,713
|
1,349,825
|
1,446,034
|
18,404,822
|
|||||||||||
Research
and development
|
1,667,080
|
364,335
|
1,994,322
|
2,034,841
|
7,715,521
|
|||||||||||
Inventory
write-down
|
-
|
-
|
-
|
-
|
96,859
|
|||||||||||
Impairment
loss
|
-
|
-
|
-
|
-
|
9,709
|
|||||||||||
License
fees
|
-
|
-
|
-
|
-
|
1,001,500
|
|||||||||||
Total
Expenses
|
2,285,439
|
922,048
|
3,344,147
|
3,480,875
|
27,228,411
|
|||||||||||
LOSS
FROM OPERATIONS
|
(1,485,439
|
)
|
(922,048
|
)
|
(2,544,147
|
)
|
(3,480,875
|
)
|
(26,285,931
|
)
|
||||||
OTHER
INCOME (EXPENSES)
|
||||||||||||||||
Unrealized
gain (loss) on financial instrument
|
840,271
|
(200,673
|
)
|
1,720,351
|
1,790,242
|
4,020,542
|
||||||||||
Interest
income
|
519
|
2,674
|
2,295
|
17,584
|
57,593
|
|||||||||||
Interest
expense
|
(7,538
|
)
|
(7,591
|
)
|
(22,382
|
)
|
(30,726
|
)
|
(1,178,083
|
)
|
||||||
Foreign
currency transaction gain (loss)
|
2,300
|
(9,720
|
)
|
(21,125
|
)
|
51,080
|
35,355
|
|||||||||
Gain
on debt restructuring
|
2,709
|
-
|
607,761
|
196,353
|
2,039,650
|
|||||||||||
Other
income
|
22
|
-
|
805
|
-
|
905,917
|
|||||||||||
Total
Other Income (Expenses)
|
838,283
|
(215,310
|
)
|
2,287,705
|
2,024,533
|
5,880,974
|
||||||||||
NET
LOSS
|
(647,156
|
)
|
(1,137,358
|
)
|
(256,442
|
)
|
(1,456,342
|
)
|
(20,404,957
|
)
|
||||||
Preferred
stock dividend from
|
||||||||||||||||
beneficial
conversion feature
|
-
|
-
|
-
|
-
|
(692,199
|
)
|
||||||||||
NET
LOSS APPLICABLE TO
|
||||||||||||||||
COMMON
SHAREHOLDERS
|
$
|
(647,156
|
)
|
$
|
(1,137,358
|
)
|
$
|
(256,442
|
)
|
$
|
(1,456,342
|
)
|
$
|
(21,097,156
|
)
|
|
BASIC
AND DILUTED LOSS PER SHARE
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
$
|
(0.01
|
)
|
||||
WEIGHTED
AVERAGE NUMBER OF
|
||||||||||||||||
SHARES
OUTSTANDING
|
117,922,148
|
107,760,835
|
112,382,132
|
107,282,554
|
||||||||||||
From
Inception
|
||||||||||
|
of
the
|
|||||||||
|
Development
Stage
|
|||||||||
Nine
Months
Ended September 30,
|
on
November 20, 1991
|
|||||||||
2006
|
2005
|
Through
Sept. 30, 2006
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(256,442
|
)
|
$
|
(1,456,342
|
)
|
$
|
(20,404,957
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||
Foreign
currency transaction (gain) loss
|
21,125
|
(51,080
|
)
|
(35,355
|
)
|
|||||
Bad
debt expense
|
167,175
|
-
|
167,175
|
|||||||
Gain
on debt restructuring
|
(607,761
|
)
|
(196,353
|
)
|
(2,039,650
|
)
|
||||
Common
stock issued for services, expenses, and litigation
|
-
|
18,750
|
4,267,717
|
|||||||
Commitment
for research and development obligation
|
1,712,745
|
665,700
|
2,378,445
|
|||||||
Depreciation
|
13,928
|
4,613
|
122,714
|
|||||||
Reduction
of escrow receivable from research and development
|
-
|
-
|
272,700
|
|||||||
Unrealized
gain on financial instrument
|
(1,720,351
|
)
|
(1,790,242
|
)
|
(4,020,542
|
)
|
||||
Stock
options and warrants granted for services
|
67,350
|
-
|
4,878,603
|
|||||||
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
|
-
|
51,100
|
30,364
|
|||||||
Write-off
of accounts receivable
|
-
|
-
|
245,065
|
|||||||
Note
payable issued for litigation
|
-
|
-
|
385,000
|
|||||||
Changes
in operating assets and liabilities
|
||||||||||
Increase
in receivables
|
(225,000
|
)
|
-
|
(232,529
|
)
|
|||||
Increase
in accounts payable
|
254,171
|
209,939
|
2,718,357
|
|||||||
Increase
in accrued interest payable
|
22,366
|
30,672
|
660,285
|
|||||||
Net
Cash Used by Operating Activities
|
(550,694
|
)
|
(2,513,243
|
)
|
(10,614,399
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Increase
in deposits
|
-
|
-
|
(51,100
|
)
|
||||||
Purchase
of equipment
|
-
|
(78,045
|
)
|
(221,334
|
)
|
|||||
Issuance
of notes receivable
|
-
|
(313,170
|
)
|
(313,170
|
)
|
|||||
Payments
received on notes receivable
|
-
|
-
|
130,000
|
|||||||
Net
Cash Used by Investing Activities
|
-
|
(391,215
|
)
|
(455,604
|
)
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||||
Issuance
of common stock, preferred stock and warrants for
cash
|
-
|
3,006,000
|
10,033,845
|
|||||||
Contributed
equity
|
-
|
-
|
131,374
|
|||||||
Proceeds
from notes payable
|
-
|
-
|
1,336,613
|
|||||||
Payments
on notes payable
|
-
|
(300,000
|
)
|
(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
|
11,173,747
|
|||||||
NET
INCREASE (DECREASE) IN CASH
|
(550,694
|
)
|
(198,458
|
)
|
103,744
|
|||||
CASH
AT BEGINNING OF PERIOD
|
654,438
|
1,455,397
|
-
|
|||||||
CASH
AT END OF PERIOD
|
$
|
103,744
|
$
|
1,256,939
|
$
|
103,744
|
||||
|
|||||||
|
|||||||
For
the Nine Months
Ended September
30,
|
|||||||
2006
|
2005
|
||||||
SUPPLEMENTAL
DISCLOSURES OF
|
|||||||
CASH
FLOW INFORMATION
|
|||||||
Initial
valuation of financial instrument
|
$
|
-
|
$
|
6,279,829
|
|||
Conversion
of preferred stock to common stock
|
$
|
8,722
|
$
|
-
|
|
|||||||
Potential
Common Shares as of September 30,
|
|||||||
2006
|
2005
|
||||||
Convertible
notes
|
$
|
128,671
|
$
|
128,671
|
|||
Convertible
preferred stock
|
62,018,018
|
38,244,444
|
|||||
Warrants
|
40,923,861
|
40,923,861
|
|||||
Stock
options
|
19,983,000
|
19,483,000
|
|||||
Total
potential common shares
|
$
|
123,053,550
|
$
|
98,779,976
|
|||
|
|
|
|
|
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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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).
|
||
|
10
|
.5
|
|
Definitive
Master Agreement, dated as of July 29, 2006, by and between MDI Oncology,
Inc. and Eucodis Forschungs und Entwicklungs GmbH (filed as Exhibit
10.1
to the Company’s Current Report on Form 8-K filed August 3, 2006, and
incorporated herein by reference).
|
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.*
|
*
|
Filed
herewith.
|
MEDICAL
DISCOVERIES, INC.
|
||
|
|
|
Date: November 14, 2006 | By: | /s/ JUDY M. ROBINETT |
Judy
M. Robinett
|
||
President
and Chief Executive Officer
|
|
|
|
|
|
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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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).
|
||
|
10
|
.5
|
|
Definitive
Master Agreement, dated as of July 29, 2006, by and between MDI Oncology,
Inc. and Eucodis Forschungs und Entwicklungs GmbH (filed as Exhibit
10.1
to the Company’s Current Report on Form 8-K filed August 3, 2006, and
incorporated herein by reference).
|
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.*
|
*
|
Filed
herewith.
|