QUANTRX BIOMEDICAL CORP - Quarter Report: 2008 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT
OF
1934
|
For
the
quarterly period ended September 30, 2008
OR
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE
ACT OF 1934
|
For
the
transition period from _________ to _________
Commission
File No. 0-17119
QUANTRX
BIOMEDICAL CORPORATION
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
|
33-0202574
|
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
(I.R.S.
Employer
Identification
Number)
|
100
S.
Main Street, Suite 300, Doylestown, PA 18901
(Address
of Principal Executive Offices) (Zip Code)
(267)
880-1595
(Registrant’s
Telephone Number, Including Area Code)
Indicate
by check mark whether the registrant: (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act during the preceding
12 months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for the
past
90 days.
x
Yes o No
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). o Yes
x
No
The
number of shares outstanding of the issuer’s common stock as of November 12,
2008 was 42,853,880.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See the definitions of “large
accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule
12b-2 of the Exchange Act:
Large accelerated filer o | Accelerated filer o | ||
Non-accelerated filer o | Smaller reporting company x |
PART
I - FINANCIAL
INFORMATION
|
||
Financial
Statements
|
||
Consolidated
Balance Sheets as of September 30, 2008 (Unaudited) and December
31,
2007
|
4
|
|
Consolidated
Statements of Operations (Unaudited) for the three and nine months
ended
September 30, 2008 and 2007
|
5
|
|
Consolidated
Statements of Cash Flows (Unaudited) for the three and nine months
ended
September 30, 2008 and 2007
|
6
|
|
Condensed
Notes to (Unaudited) Consolidated Financial Statements
|
8
|
|
ITEM
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
29
|
ITEM
4T.
|
Controls
and Procedures
|
35
|
PART
II - OTHER INFORMATION
|
||
ITEM
1.
|
Legal
Proceedings
|
35
|
ITEM
2.
|
Unregistered
Sales of Equity Securities; and Use of Proceeds
|
35
|
ITEM
3.
|
Defaults
Upon Senior Securities
|
36
|
ITEM
4.
|
Submission
of Matters to a Vote of Security Holders
|
36
|
ITEM
5.
|
Other
Information
|
37
|
Exhibits
|
37
|
|
Signatures |
38
|
2
PART
I - FINANCIAL INFORMATION
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING INFORMATION
THIS
QUARTERLY REPORT ON FORM 10-Q, INCLUDING EXHIBITS HERETO, CONTAINS
FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE SECURITIES
ACT OF 1933, AS AMENDED, AND SECTION 21E OF THE SECURITIES EXCHANGE ACT OF
1934,
AS AMENDED. THESE FORWARD-LOOKING STATEMENTS ARE TYPICALLY IDENTIFIED BY THE
WORDS “ANTICIPATES,” “BELIEVES,” “EXPECTS,” “INTENDS,” “FORECASTS,” “PLANS,”
“ESTIMATES,” “MAY,” “FUTURE,” “STRATEGY,” OR WORDS OF SIMILAR MEANING. VARIOUS
FACTORS COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED
IN
THE FORWARD-LOOKING STATEMENTS; INCLUDING THOSE DESCRIBED IN “RISK FACTORS” IN
OUR ANNUAL REPORT ON FORM 10-KSB FOR THE YEAR ENDED DECEMBER 31, 2007. WE ASSUME
NO OBLIGATIONS TO UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT NEW
INFORMATION, ACTUAL RESULTS, CHANGES IN ASSUMPTIONS, OR CHANGES IN OTHER
FACTORS, EXCEPT AS REQUIRED BY LAW.
3
ITEM
1. Financial
Statements
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
BALANCE SHEETS
September
30,
2008
|
December
31,
2007
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$
|
253,738
|
$
|
213,332
|
||||
Accounts
receivable
|
35,535
|
80,758
|
||||||
Interest
receivable, net of allowance for bad debt of $14,000
|
—
|
—
|
||||||
Interest
receivable - related party
|
27,689
|
15,650
|
||||||
Inventories
|
69,397
|
37,313
|
||||||
Prepaid
expenses
|
141,273
|
227,022
|
||||||
Note
receivable, net of allowance for bad debt of $200,000
|
—
|
—
|
||||||
Note
receivable - related party
|
200,000
|
200,000
|
||||||
Deferred
finance costs, net
|
68,224
|
107,507
|
||||||
Deposits
|
143,963
|
4,448
|
||||||
Total
Current Assets
|
939,819
|
886,030
|
||||||
Investments
|
200,000
|
200,000
|
||||||
Property
and equipment, net
|
329,209
|
391,720
|
||||||
Intangible
assets, net
|
2,056,996
|
2,162,225
|
||||||
Security
deposits
|
10,667
|
10,667
|
||||||
Total
Assets
|
$
|
3,536,691
|
$
|
3,650,642
|
||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$
|
1,860,940
|
$
|
720,408
|
||||
Accrued
expenses
|
276,365
|
233,283
|
||||||
Deferred
revenue, current portion
|
66,667
|
—
|
||||||
Short-term
convertible notes payable, net of discount
|
2,002,402
|
795,476
|
||||||
Short-term
promissory notes payable, net of discount
|
1,346,242
|
—
|
||||||
Security
deposits
|
2,000
|
2,000
|
||||||
Loans
payable, current portion
|
8,524
|
10,882
|
||||||
Total
Current Liabilities
|
5,563,140
|
1,762,049
|
||||||
Deferred
revenue, long-term portion
|
8,782
|
—
|
||||||
Loans
payable, long-term portion
|
—
|
5,733
|
||||||
Notes
payable
|
44,000
|
44,000
|
||||||
Total
Liabilities
|
5,615,922
|
1,811,782
|
||||||
Commitments
and Contingencies
|
—
|
—
|
||||||
Minority
Interest
|
—
|
—
|
||||||
Stockholders’
Equity (Deficit):
|
||||||||
Preferred
stock - $0.01 par value, 25,000,000 authorized; no shares issued
and
outstanding
|
—
|
—
|
||||||
Common
stock - $0.01 par value; 75,000,000 authorized; 42,351,380 and 41,699,681
shares issued and outstanding
|
423,513
|
416,996
|
||||||
Additional
paid-in capital
|
41,111,537
|
38,810,086
|
||||||
Accumulated
deficit
|
(43,614,281)
|
(37,388,222)
|
||||||
Total
Stockholders’ Equity (Deficit)
|
(2,079,231)
|
1,838,860
|
||||||
Total
Liabilities and Stockholders’ Equity (Deficit)
|
$
|
3,536,691
|
$
|
3,650,642
|
The
accompanying condensed notes are an integral part of these interim
financial statements.
|
4
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
STATEMENTS OF OPERATIONS
Three
Months Ended
September 30, |
Nine
Months Ended
September 30, |
|||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
|||||||||
Revenues
|
$
|
216,526
|
$
|
85,518
|
$
|
469,786
|
$
|
256,169
|
||||
Costs
and Operating Expenses:
|
||||||||||||
Cost
of goods sold (excluding depreciation and amortization)
|
3,641
|
—
|
27,123
|
—
|
||||||||
Sales
and marketing
|
1,818
|
78,243
|
94,394
|
173,524
|
||||||||
General
and administrative
|
814,434
|
534,658
|
2,299,763
|
1,635,186
|
||||||||
Professional
fees
|
260,258
|
330,259
|
818,984
|
1,585,255
|
||||||||
Research
and development
|
508,815
|
462,740
|
1,738,304
|
1,464,873
|
||||||||
Amortization
|
44,901
|
44,209
|
134,544
|
88,666
|
||||||||
Depreciation
|
26,273
|
24,452
|
79,662
|
55,745
|
||||||||
Total
Costs and Operating Expenses
|
1,660,140
|
1,474,561
|
5,192,774
|
5,003,249
|
||||||||
Loss
from Operations
|
(1,443,614)
|
(1,389,043)
|
(4,722,988)
|
(4,747,080)
|
||||||||
Other
Income (Expense):
|
||||||||||||
Interest
and dividend income
|
4,211
|
12,070
|
16,508
|
66,681
|
||||||||
Interest
expense
|
(85,913)
|
(636)
|
(185,461)
|
(1,371)
|
||||||||
Bad
debt expense
|
—
|
—
|
—
|
(214,000)
|
||||||||
Rental
income
|
5,786
|
6,224
|
17,746
|
14,509
|
||||||||
Grant
income
|
—
|
—
|
—
|
14,000
|
||||||||
Amortization
of debt discount to interest expense
|
(462,096)
|
—
|
(808,637)
|
—
|
||||||||
Amortization
of deferred financing costs to interest expense
|
(170,264)
|
—
|
(249,633)
|
—
|
||||||||
Loss
on equity investee
|
—
|
—
|
—
|
(267,608)
|
||||||||
Loss
on extinguishment of debt
|
—
|
—
|
(439,445)
|
—
|
||||||||
Loss
on disposition of fixed assets
|
—
|
—
|
(1,787)
|
—
|
||||||||
Total
Other Income (Expense), Net
|
(708,276)
|
17,658
|
(1,650,709)
|
(387,789)
|
||||||||
Loss
Before Minority Interest and Taxes
|
(2,151,890)
|
(1,371,385)
|
(6,373,697)
|
(5,134,869)
|
||||||||
Minority
Interest
|
84,559
|
44,028
|
147,638
|
337,676
|
||||||||
Provision
for Income Taxes
|
—
|
—
|
—
|
—
|
||||||||
Net
Loss
|
$
|
(2,067,331)
|
$
|
(1,327,357)
|
$
|
(6,226,059)
|
$
|
(4,797,193)
|
||||
Basic
and Diluted Net Loss per Common Share
|
$
|
(0.05)
|
$
|
(0.03)
|
$
|
(0.15)
|
$
|
(0.12)
|
||||
Basic
and Diluted Weighted Average Shares Used in per Share
Calculation
|
42,183,242
|
41,263,039
|
41,938,312
|
40,265,924
|
||||||||
The
accompanying condensed notes are an integral part of these interim
financial statements.
|
5
QUANTRX
BIOMEDICAL CORPORATION
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Nine
Months Ended
September 30, |
||||||||
2008
|
2007
|
|||||||
(unaudited)
|
(unaudited)
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$
|
(6,226,059)
|
$
|
(4,797,193)
|
||||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||
Depreciation
and amortization
|
214,206
|
144,411
|
||||||
Interest
expense related to amortization of non-cash discount, non-cash beneficial
conversion feature and deferred financing costs
|
1,058,270
|
—
|
||||||
Bad
debt expense
|
—
|
214,000
|
||||||
Expenses
related to employee stock options
|
809,145
|
106,457
|
||||||
Expenses
related to stock options issued to non-employees
|
7,000
|
—
|
||||||
Expenses
related to common stock warrants issued
|
41,187
|
118,403
|
||||||
Non-cash
fair value of warrants and options issued for consulting
|
140,221
|
454,972
|
||||||
Non-cash
fair value of common stock and warrants issued for
interest
|
20,476
|
—
|
||||||
Loss
on extinguishment of debt
|
439,445
|
—
|
||||||
Loss
on disposition of fixed assets
|
1,787
|
—
|
||||||
Issuance
of convertible notes for accrued interest
|
103,123
|
—
|
||||||
Loss
on equity investee
|
—
|
267,608
|
||||||
Minority
interest
|
(147,638)
|
(337,676)
|
||||||
(Increase)
decrease in:
|
||||||||
Accounts
receivable
|
45,223
|
(57,531)
|
||||||
Interest
receivable
|
(12,040)
|
(17,673)
|
||||||
Inventories
|
(32,084)
|
—
|
||||||
Prepaid
expenses
|
85,750
|
114,572
|
||||||
Deposits
|
3,028
|
5,350
|
||||||
Increase
(decrease) in:
|
||||||||
Accounts
payable
|
893,369
|
(132,539)
|
||||||
Accrued
expenses
|
43,082
|
43,649
|
||||||
Security
deposits
|
—
|
2,000
|
||||||
Deferred
revenue
|
75,448
|
(62,500)
|
||||||
Net
Cash Used by Operating Activities
|
(2,437,061)
|
(3,933,690)
|
||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Cash
paid for purchases of fixed assets
|
(9,734)
|
(253,689)
|
||||||
Cash
paid for equity interest in FluoroPharma
|
—
|
(1,536,000)
|
||||||
Cash
obtained from equity interest in FluoroPharma
|
—
|
764,223
|
||||||
Payment
on note receivable from FluoroPharma
|
—
|
250,000
|
||||||
Issuance
of note receivable - related party
|
—
|
(300,000)
|
||||||
Cash
paid for deposit on asset acquisition
|
(25,000)
|
—
|
||||||
Cash
paid for licensing agreement
|
(20,000)
|
(15,000)
|
||||||
Cash
paid for capitalized website development costs
|
(600)
|
(29,700)
|
||||||
Net
Cash Used by Investing Activities
|
(55,334)
|
(1,120,166)
|
||||||
6
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from sale of common stock and warrants, net of issuance costs of
$157,504
|
—
|
3,374,996
|
||||||
Proceeds
from exercise of common stock warrants, net of placement fees of
$0 and
$16,429
|
169,189
|
567,777
|
||||||
Proceeds
from long-term note payable
|
—
|
44,000
|
||||||
Payments
on loan payable used to finance equipment purchase
|
(8,090)
|
(5,159)
|
||||||
Proceeds
from issuance of convertible notes, net of legal fees of
$7,500
|
992,500
|
—
|
||||||
Proceeds
from issuance of senior secured promissory notes
|
550,000
|
—
|
||||||
Proceeds
from issuance of promissory notes, net of issuance costs of
$57,500
|
942,500
|
—
|
||||||
Payments
of senior secured promissory notes
|
(100,000)
|
—
|
||||||
Payment
of payables related to fixed asset purchases
|
(13,298)
|
—
|
||||||
Net
Cash Provided by Financing Activities
|
2,532,801
|
3,981,614
|
||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
40,406
|
(1,072,242)
|
||||||
Cash
and Cash Equivalents, Beginning of Period
|
213,332
|
1,256,912
|
||||||
Cash
and Cash Equivalents, End of Period
|
$
|
253,738
|
$
|
184,670
|
||||
Supplemental
Cash Flow Disclosures:
|
||||||||
Interest
expense paid in cash
|
$
|
46,885
|
$
|
10,193
|
||||
Income
tax paid
|
$
|
—
|
$
|
—
|
||||
Supplemental
Disclosure of Non-Cash Activities Financing and Investing
Activities:
|
||||||||
Fair
value of warrants issued to placement agents for debt financing
costs
|
$
|
119,750
|
$
|
—
|
||||
Fair
value of warrants issued with convertible notes
|
122,036
|
—
|
||||||
Fair
value of beneficial conversion feature embedded in convertible
notes
|
647,760
|
—
|
||||||
Fair
value of common stock issued with senior secured promissory
notes
|
79,806
|
—
|
||||||
Fair
value of warrants issued with senior secured promissory
notes
|
58,050
|
—
|
||||||
Fair
value of common stock issued with promissory notes
|
132,827
|
—
|
||||||
Fair
value of warrants issued with promissory notes
|
108,159
|
—
|
||||||
Fair
value of warrants issued with common stock
|
—
|
1,243,087
|
||||||
Fair
value of warrants issued to placement agents for equity financing
costs
|
—
|
277,778
|
||||||
Increase
in payables related to purchase of fixed assets
|
9,203
|
—
|
||||||
Increase
in payables related to license acquisition
|
8,715
|
—
|
||||||
Increase
in payables for debt financing costs
|
125,000
|
—
|
||||||
Increase
in payables related to deposit on equipment purchase
|
117,543
|
—
|
||||||
Increase
in payables related to equipment purchase financing
|
—
|
24,377
|
||||||
The
accompanying condensed notes are an integral part of these interim financial
statements.
7
QUANTRX
BIOMEDICAL CORPORATION
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
Description
of Business and Basis of Presentation
QuantRx
Biomedical Corporation was incorporated on December 5, 1986, in the State of
Nevada. The Company’s principal business office is located at 100 South Main
Street, Suite 300, Doylestown, Pennsylvania. QuantRx also has a research and
development facility in Portland, Oregon.
QuantRx
is a broad-based diagnostics company focused on the development and
commercialization of innovative diagnostic products based on its patented
technology platforms for the worldwide healthcare industry. The Company’s
strategy is to commercialize its products through partners or distributors,
contracting the manufacturing to third party partners while maintaining control
over the manufacturing process.
The
interim consolidated financial statements are unaudited; however, in the opinion
of management, they include all adjustments (consisting only of normal recurring
adjustments) necessary for a fair statement of financial position and results
of
operations for the periods reported. The interim financial statements have
been
prepared pursuant to the rules and regulations of the SEC. Certain information
and footnote disclosures normally included in financial statements prepared
in
accordance with accounting principles generally accepted in the United States
of
America have been condensed or omitted pursuant to such rules and regulations,
although QuantRx believes that the disclosures included herein are adequate
to
make the information presented not misleading. Operating results for the periods
presented are not necessarily indicative of future results. These interim
financial statements should be read in conjunction with the financial statements
and notes to financial statements included in the Company’s Annual Report on
Form 10-KSB for the year ended December 31, 2007.
These
consolidated financial statements include the accounts of the Company and,
from
April 1, 2007, its majority-owned subsidiary, FluoroPharma, Inc. All significant
intercompany accounts and transactions have been eliminated in consolidation.
See Note 2 for additional information. When used in these notes, the terms
“Company,” “we,” “our,” “ours,” or “us” mean QuantRx Biomedical Corporation, a
Nevada corporation, and its subsidiary.
Management
Statement
The
Company has not generated sufficient revenues from operations to meet its
operating expenses. For this reason, the Company has historically financed
its
operations primarily through issuances of equity and the proceeds of debt
instruments. In the past, the Company has also provided for its cash needs
by
issuing common stock, options and warrants for certain operating costs,
including consulting and professional fees.
The
Company is currently negotiating additional funding, and has been successful
obtaining funding in the past; however, it is not known whether the Company
will
be successful in its current funding efforts due in part to current external
market conditions. Additionally, the Company is limited in its ability to issue
additional debt instruments, due to certain limitations contained in the senior
secured convertible notes and related agreements; however, the Company has
been
successful in obtaining all necessary waivers in the past.
8
While
the
Company believes that it will be able to obtain future financing on acceptable
terms, if it is not successful in obtaining debt or equity financing, or if
the
Company is not permitted to obtain such financing by the terms of its existing
agreements and financial instruments, the Company would need to expend
significant efforts to find other short- and long-term sources of capital to
meet its ongoing operating and business expenses. The Company is also focusing
on opportunities to increase net sales while seeking to manage operating
expenses in an attempt to preserve, as much as practical, its available cash
resources. If the Company is unable to raise sufficient long-term or short-term
capital resources on acceptable terms, the Company’s business, results of
operations, liquidity and financial condition would be materially and adversely
harmed.
The
Company believes that the successful growth and operation of its business is
dependent upon its ability to do any or all of the following:
·
|
obtain
adequate sources of debt or equity financing to pay operating expenses
and
fund long-term business operations;
|
·
|
manage
or control working capital requirements by reducing operating expenses;
|
·
|
develop
new and enhance existing relationships with product distributors
and other
points of distribution for the Company’s products;
and
|
·
|
seek
potential acquisitions that could be expected to generate positive
cash
flow for the Company upon acquisition, assuming appropriate financing
structures are available on acceptable terms in order to effect such
acquisitions.
|
There
can
be no assurance that the Company will be successful in achieving its long-term
plans as set forth above, or that such plans, if consummated, will enable the
Company to obtain profitable operations or continue in the long-term as a going
concern.
1.
|
Summary
of Significant Accounting
Policies
|
Accounting
for Share-Based
Payments
QuantRx
follows the provisions of Statement of Financial Accounting Standards (SFAS)
No. 123(R), “Share-Based Payments.” SFAS No. 123(R) establishes the
accounting for transactions in which an entity exchanges equity securities
for
services and requires companies to expense the estimated fair value of these
awards over the requisite service period. QuantRx uses the Black-Scholes method
in determining fair value. Accordingly, compensation cost has been recognized
using the fair value method and expected term accrual requirements as prescribed
in SFAS No. 123(R), which resulted in employee stock-based compensation expense
of $322,978 and $809,145 for the three and nine months ended September 30,
2008
(including $121,061 and $248,116 relating to subsidiary options), and $36,972
and $106,457, (including $4,459 and $8,971 relating to subsidiary options)
for
the three and nine months ended September 30, 2007, respectively.
9
Earnings
per Share
The
Company computes net income (loss) per common share in accordance with SFAS
No. 128, “Earnings per Share.” Net income (loss) per share is based upon
the weighted average number of outstanding common shares and the dilutive effect
of common stock equivalents, such as options and warrants to purchase common
stock, convertible preferred stock and convertible notes, if applicable, that
are outstanding. Basic and diluted earnings per share were the same at the
reporting dates of the accompanying financial statements, as including common
stock equivalents in the calculation of diluted earnings per share would have
been antidilutive.
As
of
September 30, 2008, the Company had common stock options of 2,344,750, common
stock warrants of 7,996,684, and convertible debt subject to conversion into
4,508,137 shares outstanding. The above options, warrants, and convertible
securities were deemed to be antidilutive for the three and nine months ended
September 30, 2008.
As
of
September 30, 2007, the Company had outstanding common stock options of
1,372,500 and common stock warrants of 6,757,383. The above options and warrants
were deemed to be antidilutive for the three and nine months ended September
30,
2007.
Fair
Value
Effective
January 1, 2008, the Company adopted SFAS No. 157, “Fair Value
Measurements.” In February 2008, the Financial Accounting Standards Board
(FASB) issued FASB Staff Position (FSP) No. FAS 157-2, “Effective Date of
FASB Statement No. 157,” which provides a one year deferral of the
effective date of SFAS No. 157 for non-financial assets and non-financial
liabilities, except those that are recognized or disclosed in the financial
statements at fair value at least annually. Therefore, the Company has adopted
the provisions of SFAS No. 157 with respect to its financial assets and
liabilities only. The adoption of SFAS No. 157 had no impact on the Company’s
consolidated results of operations or financial condition.
Effective
January 1, 2008, the Company adopted SFAS No. 159, “The Fair Value
Option for Financial Assets and Financial Liabilities.” SFAS No. 159 allows an
entity the irrevocable option to elect to measure specified financial assets
and
liabilities in their entirety at fair value on a contract-by-contract basis.
If
an entity elects the fair value option for an eligible item, changes in the
item’s fair value must be reported as unrealized gains and losses in earnings at
each subsequent reporting date. In adopting SFAS No. 159, we did not elect
the
fair value option for any of our financial assets or financial
liabilities.
Recent
Accounting Pronouncements
In
March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities - an amendment of FASB Statement
No. 133”.
This
statement changes the disclosure requirements for derivative instruments and
hedging activities. Entities are required to provide enhanced disclosures about
(a) how and why an entity uses derivative instruments, (b) how
derivative instruments and related hedged items are accounted for under SFAS
No.
133 and its related interpretations, and (c) how derivative instruments and
related hedged items affect an entity’s financial position, financial
performance and cash flows. SFAS
No.
161
is effective for fiscal years and interim periods beginning after
November 15, 2008, with early application permitted. The Company does not
expect the implementation of this
standard to have a material impact on its consolidated financial statements
at
this time.
10
In
June 2007, the FASB ratified the Emerging Issues Task Force (EITF)
consensus on EITF 07-3, “Accounting for Nonrefundable Advance Payments for
Goods or Services Received for Use in Future Research and Development
Activities.” EITF 07-3 provides that nonrefundable advance payments for goods or
services that will be used or rendered for future research and development
activities should be capitalized and deferred. Such amounts should be recognized
as an expense as the related goods are delivered or the related services are
performed or such time when an entity does not expect the goods to be delivered
or services to be performed. EITF 07-3 is effective for fiscal periods beginning
after December 15, 2007. The adoption of EITF 07-3 has not had a material
impact on the Company’s consolidated results of operations or financial
position.
Reclassifications
Certain
amounts from prior periods have been reclassified to conform to the current
period presentation. This reclassification has resulted in no changes to the
Company’s accumulated deficit or net losses presented.
Revenue
Recognition
The
Company recognizes revenue in accordance with the Securities and Exchange
Commission’s (SEC) Staff Accounting Bulletin Topic 13, “Revenue
Recognition” (Topic
13) and EITF 00-21, “Revenue Arrangements with Multiple Deliverables.”
Revenue is recognized when all of the following criteria are met:
(1) persuasive evidence of an arrangement exists; (2) delivery has
occurred or services have been rendered; (3) the seller’s price to the
buyer is fixed and determinable; and (4) collectibility is reasonably
assured.
Revenue
from licensing agreements is recognized based on the performance requirements
of
the agreement. Revenue is deferred for fees received before earned.
Nonrefundable upfront fees that are not contingent on any future performance
by
us are recognized as revenue when revenue recognition criteria under Topic
13
and EITF 00-21 are met and the license term commences. Nonrefundable upfront
fees, where we have an ongoing involvement or performance obligations, are
recorded as deferred revenue and recognized as revenue over the life of the
contract, the period of the performance obligation or the development period,
whichever is appropriate in light of the circumstances.
Payments
related to substantive, performance-based milestones in an agreement are
recognized as revenue upon the achievement of the milestones as specified in
the
underlying agreements when they represent the culmination of the earnings
process. Royalty revenue from licensed products will be recognized when earned
in accordance with the terms of the license agreements.
Use
of
Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires the use of estimates
and assumptions regarding certain types of assets, liabilities, revenues, and
expenses. Such estimates primarily relate to unsettled transactions and events
as of the date of the financial statements and fair valuations of share-based
payments. Actual results may differ from estimated amounts.
11
2.
|
Consolidation
of FluoroPharma, Inc.
|
In
March
2006, QuantRx purchased 1,096,170 shares of FluoroPharma common stock for a
total purchase price of $1,566,023. Contemporaneously, QuantRx negotiated the
purchase of an additional 300,000 shares from private investors for $429,000.
In
February 2007, QuantRx purchased an additional 200,000 shares from private
investors for $286,000. On April 13, 2007, QuantRx and FluoroPharma closed
the
transactions contemplated by a “stage 2” investment agreement. Under the
investment agreement, effective April 1, 2007, QuantRx purchased 627,058 shares
of common stock of FluoroPharma for $1,250,000, consisting of (i) cash payments
aggregating $741,178; and (ii) cancellation in full of two promissory notes
issued by FluoroPharma in favor of QuantRx, in the aggregate principal amount
of
$500,000, and with accrued and unpaid interest of $8,822, for a total of
$508,822. As a result of these equity purchases, QuantRx’s ownership in
FluoroPharma exceeded 50%, requiring QuantRx to consolidate FluoroPharma.
FluoroPharma, Inc. is a privately held molecular imaging company based in
Boston, Massachusetts, engaged in the discovery, development, and
commercialization of proprietary products for positron emission tomography.
The
investment in FluoroPharma is intended to strategically expand QuantRx’s
diagnostic platforms.
As
of
September 30, 2008, QuantRx owned approximately 57.78% of the issued and
outstanding capital stock of FluoroPharma. Effective April 1, 2007,
FluoroPharma’s results of operations have been included in the accompanying
consolidated financial statements.
The
aggregate investment in FluoroPharma of $2,281,023 as of the date of
consolidation, was accounted for in accordance with the equity method of
accounting. Since FluoroPharma’s liabilities exceeded assets on the investment
dates, each investment was recorded as equity method goodwill. In accordance
with SFAS No. 142, equity method goodwill is not amortized or tested for
impairment in accordance with this standard. QuantRx reviewed the equity method
goodwill in accordance with APB Opinion No. 18 under which QuantRx would have
recognized an impairment loss had there
been a
loss in the value of the equity method goodwill which was deemed to be other
than a temporary decline. No impairment was recognized through March 31,
2007.
QuantRx
did not account for the acquisition of FluoroPharma’s equity as a business
combination since FluoroPharma is a development-stage enterprise and did not
meet the definition of a business in accordance with SFAS No. 141, “Business
Combinations” and EITF 98-3, “Determining Whether a Nonmonetary Transaction
Involves Receipt of Productive Assets or of a Business.” As a result of the
consolidation and pursuant to Accounting Research Bulletin (ARB) No. 51,
“Consolidated Financial Statements,” effective April 1, 2007, QuantRx recognized
previously unrecognized equity method losses relating to its investment in
FluoroPharma of $829,648, attributable to 2006, as an adjustment to retained
earnings, and $267,608, attributable to 2007, in the second quarter of 2007.
These losses were previously unrecognized since APB No. 18 stipulated that
the
entire investment be treated as equity method goodwill with no equity method
loss recognition.
12
QuantRx’s
aggregate investment in the equity of FluoroPharma of $3,531,023 was reduced
at
April 1, 2007, by the $1,097,256 in previously unrecognized equity method losses
required to be recorded upon consolidation in accordance with ARB No. 51. The
remaining investment balance of $2,433,767 at April 1, 2007, has been allocated
upon consolidation based on fair value estimates as follows:
Cash
|
$
|
764,223
|
||
Prepaid
expenses
|
99,980
|
|||
Property
and equipment
|
62,802
|
|||
Intangible
assets
|
2,134,783
|
|||
Current
liabilities
|
(352,733
|
)
|
||
Minority
interests
|
(275,288
|
)
|
||
$
|
2,433,767
|
Acquired
intangibles primarily consist of licensed patent rights and technology licenses
and are estimated to have a weighted average life of 15 years. Amortization
expense related to these intangibles for the three and nine months ending
September 30, 2008, was $38,015 and $114,045, respectively, and was $38,015
and
$76,030 for the three and nine months ended September 30, 2007.
Minority
interests of $275,288 at April 1, 2007, resulted from the consolidation of
FluoroPharma reflecting the interests held by third parties of FluoroPharma.
Since acquisition, and as of September 30, 2008 and December 31, 2007, the
portion of FluoroPharma’s losses attributable to the minority interest have been
recorded, reducing the minority interest to zero.
In
the
first two quarters of 2008 and the third and fourth quarters of 2007, QuantRx
advanced an aggregate of $900,000 ($300,000 in 2008 and $600,000 in 2007) to
FluoroPharma through eight short-term convertible promissory notes.
Additionally, QuantRx advanced $457,100 as of September 30, 2008. These
advances, notes and accrued interest ($65,066 as of September 30, 2008 and
$14,252 as of December 31, 2007) were eliminated in consolidation.
Under
the
initial investment agreement with FluoroPharma, QuantRx has the option to
acquire additional shares of FluoroPharma through a series of staged
investments. Such staged investments will take the form of cash at increasing
valuations upon FluoroPharma’s achievement of certain milestones with respect to
the successful completion of Phase I and Phase II FDA trials for certain
compounds being developed by FluoroPharma. The final staged investment to wholly
acquire FluoroPharma will be settled in QuantRx’s common stock. Any subsequent
investment in FluoroPharma by QuantRx will be consummated pursuant to the terms
and subject to the conditions set forth in separate definitive agreements.
In
connection with the initial investment, QuantRx received an option to purchase
an additional 260,000 shares of FluoroPharma common stock at an exercise price
of $0.75. FluoroPharma has outstanding common stock equivalents which, if
exercised together with the Company’s option and convertible notes, would reduce
the Company’s ownership percentage to approximately 52.15%
on a
fully diluted and as converted basis as of September 30, 2008.
13
3.
|
Other Balance Sheet Information |
Components
of selected captions in the accompanying balance sheets consist of:
September
30,
2008
|
December
31,
2007
|
||||||
Prepaid
expenses:
|
|||||||
Prepaid
consulting
|
$
|
54,509
|
$
|
159,410
|
|||
Prepaid
consulting - related party
|
8,770
|
17,377
|
|||||
Prepaid
insurance
|
56,624
|
31,829
|
|||||
Prepaid
interest
|
10,238
|
—
|
|||||
Prepaid
rent
|
5,310
|
5,310
|
|||||
Other
|
5,822
|
13,096
|
|||||
Prepaid
expenses
|
$
|
141,273
|
$
|
227,022
|
|||
Deferred
financing costs:
|
|||||||
Deferred
financing costs
|
$
|
190,750
|
$
|
135,000
|
|||
Less:
accumulated amortization
|
(122,526
|
)
|
(27,493
|
)
|
|||
Deferred
financing costs, net
|
$
|
68,224
|
$
|
107,507
|
|||
Property
and equipment:
|
|||||||
Computers
and office furniture, fixtures and equipment
|
$
|
149,205
|
$
|
148,141
|
|||
Machinery
and equipment
|
268,768
|
252,681
|
|||||
Leasehold
improvements
|
92,233
|
92,233
|
|||||
Less:
accumulated depreciation
|
(180,997
|
)
|
(101,335
|
)
|
|||
Property
and equipment, net
|
$
|
329,209
|
$
|
391,720
|
|||
Accrued
expenses:
|
|||||||
Professional
fees
|
$
|
66,200
|
$
|
72,050
|
|||
Payroll
and related
|
107,250
|
—
|
|||||
Clinical
trials
|
—
|
110,833
|
|||||
Accrued
interest
|
25,215
|
—
|
|||||
Other
|
77,700
|
50,400
|
|||||
Accrued
expenses
|
$
|
276,365
|
$
|
233,283
|
|||
Short-term
convertible notes payable, net:
|
|||||||
Short-term
convertible notes payable
|
$
|
2,254,069
|
$
|
1,000,000
|
|||
Less:
discount for warrants and conversion feature, net
|
(251,667
|
)
|
(204,524
|
)
|
|||
Short-term
convertible notes payable, net
|
$
|
2,002,402
|
$
|
795,476
|
|||
Short-term
promissory notes payable, net:
|
|||||||
Secured
promissory notes payable
|
$
|
450,000
|
$
|
—
|
|||
Unsecured
promissory notes payable
|
1,000,000
|
—
|
|||||
Less:
discount for common stock and warrants, net
|
(103,758
|
)
|
—
|
||||
Short-term
promissory notes payable, net
|
$
|
1,346,242
|
$
|
—
|
14
4.
|
Notes
Receivable
|
Genomics
USA, Inc.
In
January 2007, QuantRx advanced $200,000 to Genomics USA, Inc. (GUSA) through
an
8% promissory note due April 8, 2007. The note is currently convertible at
QuantRx’s discretion into 10% of GUSA’s outstanding capital stock on a fully
diluted and as converted basis. QuantRx is continues to explore the possibility
of further investment, and has postponed settlement of the note during this
exploratory period, during which the note continues to accrue interest. QuantRx
accrued interest of $12,040, and $15,649 on this note for the nine months ended
September 30, 2008 and the year ended December 31, 2007, respectively. GUSA,
a
privately held Illinois corporation, is a technology company focused on the
development of Micro-Array Detection for DNA. This technology may strategically
expand QuantRx’s diagnostic platforms. See Note 5 for additional information on
GUSA.
Rockland
Technimed, Ltd.
In
April
2006, QuantRx advanced $200,000 to Rockland Technimed, Ltd. (Rockland) through
a
7% convertible promissory note due twelve months from the date of issuance.
Rockland, a privately held Delaware corporation, is a development stage company
focused on the research and development of tissue viability imaging diagnostics
using magnetic resonance imaging (MRI) scanners. QuantRx accrued interest of
$4,083 during the year ended December 31, 2007. The note is convertible at
QuantRx’s discretion into 20% of Rockland’s outstanding capital stock on a fully
diluted and as converted basis to satisfy the note and accrued interest. QuantRx
ceased accruing interest as of the maturity date and established an allowance
for bad debt in the amount equal to the principal balance and accrued interest,
$214,000, as the Company attempts to resolve this matter.
5.
|
Investments
|
Genomics
USA, Inc.
In
May
2006, QuantRx purchased 144,024 shares of GUSA common stock for $200,000. As
of
September 30, 2008, QuantRx owned approximately 10% of the issued and
outstanding capital stock of GUSA.
QuantRx
uses the cost method to account for this investment since QuantRx does not
control nor have the ability to exercise significant influence over operating
and financial policies. In accordance with the cost method, the investment
is
recorded at cost and impairment is considered in accordance with the Company’s
impairment policy. No impairment was recognized as of September 30,
2008.
15
6.
|
Intangible
Assets
|
Intangible
assets as of the balance sheet dates consisted of the
following:
September
30,
2008 |
December
31,
2007 |
||||||
Licensed
patents and patent rights
|
$
|
2,197,020
|
$
|
2,168,305
|
|||
Patents
|
82,008
|
82,008
|
|||||
Technology
license
|
22,517
|
22,517
|
|||||
Website
development
|
49,711
|
49,111
|
|||||
Less:
accumulated amortization
|
(294,260
|
)
|
(159,716
|
)
|
|||
Intangibles,
net
|
$
|
2,056,996
|
$
|
2,162,225
|
The
Company’s intangible assets are carried at the legal cost to obtain them.
Intangible assets are amortized using the straight line method over the
estimated useful life. Useful lives are as follows: licensed patents and patent
rights, eight to 15 years; patents, 17 years; technology license, five years;
and website development costs, three years. Amortization expense totaled $44,901
and $134,544 for the three and nine months ended September 30, 2008 and $44,209
and $88,666 for the three and nine months ended September 30, 2007,
respectively. Impairment will be considered in accordance with the Company’s
impairment policy. No impairment was recognized as of September 30,
2008.
7.
|
Deferred
Revenue
|
Synova
Healthcare, Inc.
On
July
7, 2006 (the effective date), QuantRx and Synova Healthcare, Inc. (Synova)
entered into a distribution agreement pursuant to which Synova would act as
the
exclusive distributor of specified hemorrhoid products of QuantRx in the United
States. The initial term of the agreement was to commence on the effective
date
and, unless sooner terminated as provided in the agreement, was to continue
in
effect for a period of five years following the month in which Synova made
its
first shipment of products to its initial customers. Management estimated the
effective term of the agreement to be six years from the effective date.
QuantRx
received an up-front, non-refundable payment of $500,000 upon execution of
the
distribution agreement, which was recorded as deferred revenue and was amortized
into revenue over the expected term of the agreement, which was six years.
QuantRx recognized revenue of $20,833 and $62,500 in the three and nine months
ended September 30, 2007. In December 2007, in accordance with the terms of
the
distribution agreement, QuantRx delivered notice of termination of the agreement
and recognized the remaining deferred revenue at that time.
CytoCore,
Inc.
On
May
19, 2008, QuantRx and CytoCore, Inc. (CytoCore) entered into a worldwide
distribution and supply agreement for specified PAD technology of QuantRx.
The
agreement specifies monthly license fees during CytoCore’s expected development
period and additional milestone payments based upon CytoCore’s achievement of
certain development and sales milestones.
16
QuantRx
received an up-front, non-refundable payment of $100,000 upon execution of
this
agreement, which was recorded as deferred revenue and is being amortized into
revenue over the expected development period of the agreement, which is
estimated as 18 months. QuantRx recognized revenue of $33,335 and $55,337 in
the
three and nine months ended September 30, 2008 related to this agreement.
8.
|
Portland
Development Commission
|
In
February 2007, QuantRx received a $44,000 loan from the Portland Development
Commission. The loan matures in 20 years and is interest free through March
1,
2010 and no payments are due until April 1, 2010. The terms of the promissory
note stipulate that the interest rate will accrue beginning in March 1, 2010
at
an annual rate between 1% and 8.5% based upon the level of compliance with
certain employment milestones beginning in 2008.
Additionally,
QuantRx received a $14,000 grant for qualified expenditures related to its
research facility. QuantRx satisfied the grant terms and recorded the grant
as
other income in the first quarter of 2007.
9.
|
Notes
Payable
|
2007
Convertible Notes
On
October 16, 2007, QuantRx completed a private placement of 10% senior secured
convertible notes (the “2007 Notes”) and warrants to purchase shares of
QuantRx’s common stock. In connection with the private placement, QuantRx issued
notes in the aggregate principal amount of $1,000,000 and warrants to purchase
250,000 shares of QuantRx’s common stock at an exercise price of $1.25 (relative
fair value of $134,454). Proceeds of the financing were used for general
corporate purposes. The notes and the warrants were offered only to certain
private accredited investors.
In
the
first quarter of 2008, the 2007 Notes were exchanged for 2008 Senior Secured
Convertible Notes (the “2008 Notes”) resulting in a loss on extinguishment, as
described below under “2008 Senior Secured Convertible Notes.”
The
2007
Notes were automatically convertible into shares of QuantRx common stock upon
completion of a “qualified” equity financing (or financings) with aggregate
gross proceeds of at least $3,000,000. Under the terms of the 2007 Notes,
holders would have been deemed to have tendered 115% of their aggregate
outstanding principal balance and accrued interest for purchase of securities
in
the qualified equity financing, entitling the holders to all rights afforded
to
purchasers in such financing (“contingent embedded conversion option”).
Alternatively, the 2007 Notes allowed the holders to convert their outstanding
principal and accrued interest into common stock at a price of $0.80 per common
share (“embedded conversion option”). Either conversion would have resulted in
the satisfaction of all of QuantRx’s obligations under the 2007 Notes.
In
accordance with APB Opinion No. 14, “Accounting for Convertible Debt and Debt
Issued with Stock Purchase Warrants,” QuantRx allocated $134,454 of the
principal amount of the 2007 Notes to the warrants as original issue discount,
which represented the relative fair value of the warrants at the date of
issuance.
17
The
conversion option embedded in the 2007 Notes described above was not considered
a derivative instrument and was not required to be bifurcated pursuant to the
scope exception in paragraph 11(a) of SFAS No. 133, “Accounting for Derivative
Instruments and Hedging Activities,” since it was indexed to QuantRx’s stock and
was classified as stockholders’ equity. Equity classification of the embedded
conversion option was met through the requirements of EITF 00-19, “Accounting
for Derivative Financial Instruments to, and Potentially Settled in, a Company’s
Own Stock,” paragraphs 12-32. QuantRx also concluded, pursuant to EITF 00-27,
“Application of Issue 98-5 to Certain Convertible Instruments,” that while the
embedded conversion option was not required to be bifurcated, the instruments
did contain a beneficial conversion feature, as the share prices on the dates
of
issuance exceeded the effective conversion price of the embedded conversion
option. QuantRx measured the intrinsic value of the embedded conversion option
($97,164) based upon the effective conversion price, which is defined by EITF
00-27 as the allocated proceeds divided by the number of shares to be received
on conversion. This amount was recorded as original issue discount.
The
contingent conversion option embedded in the 2007 Notes qualified as an embedded
contingent conversion option in accordance with EITF 98-5 and 00-27 since
execution was contingent upon a qualified equity financing and was not within
the control of QuantRx. The intrinsic value of the contingent embedded
conversion option was not recognized because the 2007 Notes were exchanged
and
satisfied in full.
In
connection with the 2007 Notes, certain warrants that were previously issued
to
the holders were modified by reducing their exercise price from $1.50 to $0.75.
The incremental fair value of this modification, accounted for in accordance
with SFAS No. 123(R), was $30,000, while the relative fair value was calculated
to be $25,210 and was recorded as additional original issue
discount.
In
association with the issuance of the 2007 Notes, QuantRx issued warrants to
purchase 100,000 shares of common stock at $1.10 per share valued at $65,000
to
the placement agent, and also incurred cash commissions of $70,000 in connection
with the private placement resulting in total deferred debt offering cost of
$135,000.
The
fair
value of the warrants issued to placement agents and the cash commissions have
been recorded as deferred financing costs. The total original issue discount
related to the warrants issued to the investors, the modified warrants and
the
beneficial conversion feature, and the deferred financing costs were being
amortized to interest expense over the original term of the 2007 Notes in
accordance with EITF 00-27, paragraph 19. Interest expense for 2008 through
the
date of extinguishment, including amortization of original issue discount and
deferred financing costs, related to the 2007 Notes was $29,832. The remaining
unamortized debt discount of $189,101 and deferred financing costs of $99,399
were included in the loss on extinguishment of debt in the first quarter of
2008
upon the exchange of the 2007 Notes into the 2008 Notes; see below.
2008
Senior Secured Convertible Notes
In
the first quarter of 2008, the Company completed a $2.16 million private
placement with certain accredited investors through the issuance of 10% senior
secured convertible notes (the “2008 Notes”) and warrants. In connection with
the private placement, QuantRx issued notes in the aggregate principal amount
of
$2,157,247 and warrants with a five-year term to purchase 250,000 shares of
QuantRx’s common stock at an exercise price of $1.25. The warrants provide for
full anti-dilution protection to the holders and allow for cashless exercise.
18
The
2008
Notes are automatically convertible into shares of QuantRx common stock upon
completion of a “qualified” equity financing (or financings) with aggregate
gross proceeds of at least $5,660,000 (amount to be reduced by the 2008 Notes,
up to a maximum of $2,250,000). Under the terms of the 2008 Notes, holders
will
be deemed to have tendered 115% of their aggregate outstanding principal balance
and accrued and unpaid interest for the purchase of securities in the qualified
equity financing, entitling the holders to all rights afforded to purchasers
in
such financing (“contingent embedded conversion option”). Alternatively, the
2008 Notes allow the holders to convert their outstanding principal and accrued
interest into common stock at a price of $0.50 per common share (“embedded
conversion option”). Either conversion would result in the satisfaction of all
of QuantRx’s obligations under the 2008 Notes.
In
the
event QuantRx does not complete a qualified financing and holders do not
voluntarily convert, QuantRx must repay the outstanding principal balance and
accrued and unpaid interest on January 23, 2009. Interest on the outstanding
principal amount of the 2008 Notes is payable quarterly in cash or, at the
holders’ option, in additional 10% senior secured convertible notes with a
principal amount equal to the calculated interest amount. QuantRx has the right
to prepay the 2008 Notes at 106% of face value and 100% of accrued interest
by
providing ten days notice. In connection with the financing QuantRx entered
into
1) a stock pledge agreement, pursuant to which QuantRx granted to the holders
a
continuing and perfected first priority security interest in certain equity
securities owned by QuantRx of two private companies and specified rights and
interests associated with the pledged shares, as well as 2) a patent, trademark
and copyright security agreement, pursuant to which QuantRx granted to the
holders a continuing and perfected first priority security interest in all
of
its owned or acquired patents, trademarks and copyrights and specified
intellectual property and related rights and interests associated therewith.
If
an event of default occurs under the 2008 Notes, the holders have agreed not
to
take any action with respect to the collateral for 120 days after the holders
provide QuantRx with notice of the holders’ proposed action. The stock pledge
agreement and the patent, trademark and copyright security agreement, and the
security interests created thereby, will terminate upon QuantRx’s satisfaction
in full of its payment obligations under the 2008 Notes. In connection with
the
2008 Notes, QuantRx may not issue any new indebtedness while at least 50% of
the
original principal amount of the notes remains outstanding without the consent
of holders of at least 75% of the principal amount of the then outstanding
notes.
In
connection with the financing and in accordance with the terms of the 2007
Notes, the holders representing $1,000,000 face value of QuantRx’s 2007 Notes
exchanged their notes at 115% of the outstanding principal and accrued and
unpaid interest as payment toward the purchase price of the 2008 Notes purchased
by such holders. Accordingly, the Company issued notes in the financing in
the
aggregate principal balance of $1,157,247 to the former holders upon their
surrender of the 2007 Notes. In the aggregate, the Company received gross cash
proceeds of $1,000,000 in connection with the issuance of the 2008 Notes.
QuantRx
used the net proceeds from the offering for product development, working capital
and general corporate purposes.
19
QuantRx
has determined that the terms of the 2008 Notes are “substantially different”,
as described in EITF Issue No. 96-19, “Debtor’s Accounting for a
Modification or Exchange of Debt Instruments”, from the terms of the 2007 Notes
based on the greater than 10% change in the present value of the cash flows
associated with the 2008 Notes and the 2007 Notes. As a result, the Company
recorded the 2008 Notes issued in exchange for the 2007 Notes at fair value
on
the date of issuance and recorded a loss on extinguishment of $439,445, which
includes $189,101 and $99,399 representing the remaining unamortized debt
discount and deferred finance costs related to the 2007 Notes, respectively.
In
accordance with EITF Issue No. 98-5, “Accounting for Convertible Securities
with Beneficial Conversion Features or Contingently Adjustable Conversion
Ratios”, the Company also remeasured the intrinsic value of the beneficial
conversion feature embedded in the 2007 Notes at the time of extinguishment
and
determined that it had no value as the closing stock price on the date of
extinguishment was less than the effective conversion price; therefore no
allocation of the reacquisition price for the repurchase of the beneficial
conversion feature embedded in the 2007 Notes was required. Additionally, there
were no warrants issued to the holders of the 2007 Notes related to their
exchange of 2007 Notes for 2008 Notes.
The
cash proceeds from the 2008 Notes of $1,000,000 were allocated between the
notes
and the warrants on a relative fair value basis in accordance with APB Opinion
No. 14, “Accounting for Convertible Debt and Debt Issued with Stock Purchase
Warrants.” QuantRx allocated $122,035 of the principal amount of $1,000,000 to
the warrants as original issue discount, which represented the relative fair
value of the warrants at the date of issuance.
Like
the
2007 Notes, the conversion option embedded in the 2008 Notes described above
is
not considered a derivative instrument and is not required to be bifurcated
pursuant to the scope exception in paragraph 11(a) of SFAS No. 133, “Accounting
for Derivative Instruments and Hedging Activities,” since it is indexed to
QuantRx’s stock and is classified as stockholders’ equity. Equity classification
of the embedded conversion option is met through the requirements of EITF 00-19,
“Accounting for Derivative Financial Instruments to, and Potentially Settled
in,
a Company’s Own Stock,” paragraphs 12-32. QuantRx also concluded, pursuant to
EITF 00-27, “Application of Issue 98-5 to Certain Convertible Instruments,” that
while the embedded conversion option is not required to be bifurcated, the
instruments do contain a beneficial conversion feature, as the share prices
on
the dates of issuance exceeded the effective conversion price of the embedded
conversion option. QuantRx measured the intrinsic value of the embedded
conversion option ($647,760) based upon the effective conversion price, which
is
defined by EITF 00-27 as the allocated proceeds divided by the number of shares
to be received on conversion. This amount was recorded as original issue
discount.
The
contingent conversion option embedded in the 2008 Notes qualifies as an embedded
contingent conversion option in accordance with EITF 98-5 and 00-27 since
execution is contingent upon a qualified equity financing and is not within
the
control of QuantRx. The intrinsic value of the contingent embedded conversion
option will not be recognized until and unless such financing occurs (the
triggering event); which will then enable QuantRx to measure the intrinsic
value
associated with the automatic conversion feature.
In
association with the issuance of the 2008 Notes, QuantRx issued warrants to
purchase 100,000 shares of common stock at $1.10 per share valued at $55,750
to
the placement agent, and also incurred cash commissions of $70,000 and legal
fees of $7,500 in connection with the private placement, resulting in total
deferred debt financing costs of $133,250.
20
The
fair
value of the warrants issued to placement agents and the cash commissions and
legal fees have been recorded as deferred financing costs. The total original
issue discount related to the warrants issued to the investors, the beneficial
conversion feature, and the deferred financing costs are being amortized to
interest expense over the term of the 2008 Notes in accordance with EITF 00-27,
paragraph 19. QuantRx recorded $291,679 and $752,962 in interest expense,
including amortization of original issue discount and deferred financing costs,
related to the 2008 Notes for the three and nine months ended September 30,
2008. As of September 30, 2008, the Company issued two 2008 Notes in the
aggregate amount of $96,822 pursuant to one holder’s election to receive
quarterly interest in the form of paid-in-kind notes.
2008
Short-term Secured Promissory Notes Payable
In
the
second quarter of 2008, the Company commenced a private placement to certain
accredited investors through the issuance of 8% senior secured promissory notes
(the “2008 Secured Promissory Notes”). The private placement closed in the third
quarter of 2008. In connection with the private placement, QuantRx issued notes
in the aggregate principal amount of $550,000, and an aggregate of 137,500
shares of common stock and warrants with a five-year term to purchase 137,500
shares of common stock warrants at a per share exercise price of $0.85. The
warrants provide for full anti-dilution protection to the holders and allow
for
cashless exercise. The 2008 Secured Promissory Notes were due on September
15,
2008, along with all accrued and unpaid interest. QuantRx used the net proceeds
from the offering for product development, working capital and general corporate
purposes.
In
connection with the financing QuantRx entered into 1) a stock pledge agreement,
pursuant to which QuantRx granted to the holders a continuing and perfected
first priority security interest in certain equity securities owned by QuantRx
of two private companies and specified rights and interests associated with
the
pledged shares, as well as 2) a patent, trademark and copyright security
agreement, pursuant to which QuantRx granted to the holders a continuing and
perfected first priority security interest in all of its owned or acquired
patents, trademarks and copyrights and specified intellectual property and
related rights and interests associated therewith. If an event of default occurs
under the 2008 Secured Promissory Notes, the holders have agreed not to take
any
action with respect to the collateral for 120 days after the holders provide
QuantRx with notice of the holders’ proposed action. The stock pledge agreement
and the patent, trademark and copyright security agreement, and the security
interests created thereby, will terminate upon QuantRx’s satisfaction in full of
its payment obligations under the 2008 Secured Promissory Notes.
The
cash proceeds from the 2008 Secured Promissory Notes of $550,000 were allocated
between the notes, common stock and warrants on a relative fair value basis.
QuantRx allocated $79,806 and $58,050 of the principal amount of $550,000 to
the
common stock and warrants as original issue discount, which represented the
relative fair values of each at the date of issuance.
In
association with the issuance of the 2008 Secured Promissory Notes, QuantRx
issued warrants to purchase 100,000 shares of common stock at $0.85 per share
valued at $64,000 to the placement agent, and also incurred cash commissions
of
$55,000 in connection with the private placement resulting in total deferred
debt offering cost of $119,000.
The
fair
value of the warrants issued to placement agents and the cash commissions have
been recorded as deferred financing costs. The total original issue discount
related to the common stock and warrants issued to the investors and the
deferred financing costs are being amortized to interest expense over the
original term of the 2008 Secured Promissory Notes in accordance with EITF
00-27, paragraph 19.
21
On
the
original maturity date, September 15, 2008, one note for $100,000 was settled
in
full and the Company negotiated monthly extensions of one to three months on
the
remaining notes. As a result of this negotiation, in consideration for each
month’s extensions, QuantRx will grant an aggregate of 22,500 shares of common
stock and warrants to purchase 22,500 shares of common stock with a five year
term for $0.85. At September 15, 2008, QuantRx granted an aggregate of 22,500
shares of common stock (fair value $11,475) and warrants to purchase 22,500
shares of common stock (fair value $9,000) which extended the maturity of the
remaining outstanding 2008 Secured Promissory Notes and related accrued interest
to October 15, 2008. The consideration for the extension was recognized as
prepaid interest and is being amortized over the extension period.
In
the
aggregate, QuantRx recorded $246,366 and $278,007 in interest expense, including
amortization of original issue discount, deferred financing costs and prepaid
interest, related to the 2008 Secured Promissory Notes for the three and nine
months ended September 30, 2008. See also Note 14, Subsequent Events.
2008
Short-term Unsecured Promissory Notes Payable
In
August
2008, the Company completed a private placement to certain accredited investors
through the issuance of 8% promissory notes (the “2008 Promissory Notes”). In
connection with the private placement, QuantRx issued notes in the aggregate
principal amount of $1,000,000, and an aggregate of 250,000 shares of common
stock and warrants with a five-year term to purchase 250,000 shares of common
stock at a per share exercise price of $0.85. The warrants provide for full
anti-dilution protection to the holders and allow for cashless exercise. The
2008 Promissory Notes are due on October 31, 2008, along with all accrued and
unpaid interest. QuantRx used the net proceeds from the offering for product
development, working capital and general corporate purposes.
The
net cash proceeds from the 2008 Promissory Notes were $942,500. QuantRx
allocated $132,827 and $108,159 of the principal amount of $1,000,000 to the
common stock and warrants as original issue discount, which represented the
relative fair values of each at the date of issuance.
In
association with the issuance of the 2008 Promissory Notes, QuantRx incurred
cash commissions and legal fees of $57,500, which were recorded as deferred
financing costs.
The
total
original issue discount related to the common stock and warrants issued to
the
investors and the deferred financing costs are being amortized to interest
expense over the term of the 2008 Promissory Notes in accordance with EITF
00-27, paragraph 19. QuantRx recorded $178,958 in interest expense, including
amortization of original issue discount and deferred financing costs, related
to
the 2008 Promissory Notes for the three and nine months ended September 30,
2008.
22
10.
|
Preferred
Stock
|
The
Company has authorized 25,000,000 shares of preferred stock, of which 9,750,000
are designated Series A convertible preferred stock, $0.01 par value. The
remaining 15,250,000 authorized preferred shares have not yet been designated
by
the Company. The Company had no issued and outstanding preferred stock at
September 30, 2008 or December 31, 2007.
11.
|
Common
Stock, Options and Warrants
|
On
September 15, 2008, the Company negotiated extensions on certain of the 2008
Secured Promissory Notes. In consideration for the first month’s extensions,
QuantRx granted an aggregate of 22,500 shares of common stock (fair value
$11,475) and 22,500 warrants to purchase common stock with a five year term
for
$0.85 (fair value $9,000).
In
August
2008, QuantRx completed a private placement of 8% promissory notes, common
stock, and warrants to purchase shares of QuantRx’s common stock. In connection
with the private placement, QuantRx issued 250,000 shares of common stock (with
a relative fair value of $132,827) and warrants with a five-year term to
purchase 250,000 shares of QuantRx’s common stock at an exercise price of $0.85
(with a relative fair value of $108,159). The notes, common stock and warrants
were offered only to certain private accredited investors.
On
August
18, 2008, the Company issued a warrant in consideration of a three month
consulting and investor relations services agreement. The warrant has a term
of
five years and represents the right to purchase 40,000 shares of common stock
at
an exercise price of $1.25. The fair value of this warrant was calculated to
be
$22,400 and will be expensed over the term of the agreement.
In
the
second and third quarters of 2008, QuantRx conducted a private placement of
8%
promissory notes, common stock and warrants to purchase shares of QuantRx’s
common stock. In connection with the private placement, QuantRx issued 137,500
shares of common stock (with a relative fair value of $79,806) along with
warrants with a five-year term to purchase 137,500 shares of QuantRx’s common
stock at an exercise price of $0.85 (with a relative fair value of $58,050).
The
notes, common stock and warrants were offered only to certain private accredited
investors. At the commencement of the financing, in June 2008, QuantRx issued
warrants for services to purchase 100,000 shares of common stock at $0.85 per
share valued at $64,000.
In
April
2008, QuantRx completed a limited warrant exercise inducement targeting large
warrant holders who have expressed an interest to participate. The inducement
was a reduction in the exercise price from $1.50 to $0.70 to a limited number
of
warrant holders who acquired the warrants in conjunction with prior common
stock
purchases. An aggregate of 241,699 common stock warrants were exercised and
exchanged for 241,699 shares of our common stock for total proceeds of $169,189.
In
April
2008, the Company issued common stock warrants with a five year term in
consideration of a financial advisory and investor relations consulting services
agreement. The warrant represents the right to purchase 200,000 shares of common
stock at an exercise price of $0.89 and vests ratably each month over a one
year
term. The fair value of the warrant was calculated to be $148,000 on grant
date,
and shall be remeasured during the vesting term as required. Consulting expense
related to the issuance of these warrants was $10,750 and $35,750 for the three
and nine months ended September 30, 2008.
23
In
April
2008, the Company issued common stock warrants with a five year term to purchase
25,000 shares of common stock at an exercise price of $1.35. The warrants were
issued as payment for technical advisory services related to medical
diagnostics. The fair value of these warrants was calculated to be $16,250,
and
will be expensed over a one year term. Consulting expense related to the
issuance of these warrants was $4,096 and $7,480 for the three and nine months
ended September 30, 2008.
In
the
first quarter of 2008, QuantRx completed a private placement of 10% senior
secured convertible notes and warrants to purchase shares of QuantRx’s common
stock. In connection with the private placement, QuantRx issued warrants with
a
five-year term to purchase 250,000 shares of QuantRx’s common stock at an
exercise price of $1.25. The notes and the warrants were offered only to certain
private accredited investors. In association with the issuance of these
convertible notes, QuantRx issued warrants for services to purchase 100,000
shares of common stock at $1.10 per share valued at $55,750.
On
October 16, 2007, QuantRx completed a private placement of 10% convertible
notes
and warrants to purchase shares of QuantRx’s common stock. In connection with
the private placement, QuantRx issued warrants with a five-year term to purchase
250,000 shares of QuantRx’s common stock at an exercise price of $1.25. The
notes and the warrants were offered only to certain private accredited
investors. In association with the issuance of these convertible notes, QuantRx
issued warrants for services to purchase 100,000 shares of common stock at
$1.10
per share valued at $65,000.
Throughout
2007, the Company issued an aggregate of 14,000 common stock warrants with
five-year terms and exercise prices equal to the market price on the dates
of
grant (varying between $0.61 to $1.15). These warrants were in consideration
of
business development consulting services. The fair value of these warrants
was
calculated to be $11,160, which was expensed in 2007.
In
the
third quarter of 2007, QuantRx initiated a limited warrant exercise inducement
targeting certain large warrant holders. The inducement was a reduction in
the
exercise price from $1.50 to $0.75 to a limited number of accredited investors
holding warrants acquired in conjunction with prior common stock purchases.
As a
result of this inducement, 751,001 common stock warrants were exercised and
exchanged for 751,001 shares of our common stock for aggregate gross proceeds
of
$563,251. In connection with the exercise of these warrants, QuantRx paid cash
commissions to Legend Merchant, Inc. of $16,429.
In
the
third quarter of 2007, 38,100 common stock warrants were exercised and exchanged
for 38,100 shares of our common stock resulting in proceeds to the Company
of
$20,955. The exercise price for these warrants was $0.55.
On
April
30, 2007, the Company issued a warrant in consideration of financial advisory
and public relations consulting services performed through April 30, 2007.
The
warrant has a term of five years and represents the right to purchase 30,000
shares of common stock at an exercise price of $1.20. The fair value of this
warrant was calculated to be $31,800 and was expensed in 2007.
24
On
April
16, 2007, the Company issued a warrant in consideration of a financial advisory
and investor relations consulting services agreement with an initial one year
term. The original agreement was modified June 20, 2007. The original warrant
had a term of five years and represented the right to purchase 350,000 shares
of
common stock at an exercise price of $1.35 and vested ratably each month over
the initial one year term. The fair value of the original warrant was calculated
to be $420,000. On June 20, 2007, the agreement was modified and the original
warrant was cancelled. The warrant issued upon modification of the agreement
has
the same terms as the originally issued warrant other than it represents the
right to purchase 150,000 shares of common stock at an exercise price of $0.95,
which was the closing price on the modification date. The fair value of the
modified warrant was calculated to be $126,000 on the modification date, and
was
remeasured during the vesting term as required. The final remeasurement of
the
fair value of these warrants on April 15, 2008 resulted in a reduction to
previously recorded consulting expense of $14,875 in the second quarter of
2008.
Consulting expense related to these warrants was $0 and $5,437 for the three
and
nine months ended September 30, 2008.
On
April
16, 2007, the Company issued common stock warrants with a five year term to
purchase 50,000 shares of common stock at an exercise price of $1.35. The
warrants were issued as payment for technical advisory services related to
medical diagnostics. The fair value of these warrants was calculated to be
$60,000, and was expensed over the initial year of the agreement. QuantRx
recorded $0 and $17,377 in consulting expense related to these warrants
in
the
three and nine months ended September 30, 2008, and $15,082 and $27,451 in
the
three and nine months ended September 30, 2007.
On
March
1, 2007, QuantRx completed a private placement of 3,532,500 shares of common
stock and warrants with a five-year term valued at $1,243,087 to purchase an
aggregate of 1,059,750 shares of common stock at $1.50 per share to accredited
investors for gross proceeds of $3,532,500 in cash. The Company issued warrants
with a seven-year term to purchase 194,250 shares of common stock at $1.00
per
share valued at $277,778, and paid cash commissions of $155,400 in connection
with the private placement to Legend Merchant Inc., and an additional $2,104
for
related legal services.
In
the
first quarter of 2007, QuantRx issued 200,000 common stock warrants with a
five-year term to purchase 200,000 shares of common stock at an exercise price
of $1.50. The warrants were issued pursuant to a financial advisory services
agreement, and the fair value of $250,000 for
these
warrants was expensed over the
service term of four months.
2007
Incentive and Non-Qualified Stock Option Plan
Pursuant
to SFAS 123(R), the fair value of options granted under the Company’s 2007
Incentive and Non-Qualified Stock Option Plan is recorded as compensation
expense over the vesting period, or, for performance based awards, the expected
service term. Total compensation cost related to QuantRx’s employee options was
$201,917 and $32,513 for the three months ended September 30, 2008 and 2007,
respectively, and $561,029 and $97,540 for the nine months ended September
30,
2008 and 2007, respectively. Compensation cost related to QuantRx’s non-employee
options was $833 and $7,000 for the three and nine months ended September 30,
2008. No options were granted in the nine months ended September 30, 2007.
25
In
the
first quarter of 2008, an aggregate of 528,000 qualified common stock options
were granted to employees and 25,000 non-qualified stock options were granted
to
certain consultants and issued from the Company’s 2007 Incentive and
Non-Qualified Stock Option Plan. The options were issued with an exercise price
of $0.80, and have a term of ten years. The options vest monthly over one year.
The fair value of these options is $420,280.
In
the
fourth quarter of 2007, 6,250 non-qualified common stock options were granted
to
a member of the board of directors and issued from the Company’s Incentive and
Non-Qualified Stock Option Plan. The options were issued with an exercise price
of $0.69, have a term of five years and vested immediately. The fair value
of
these options is $3,813.
In
the
fourth quarter of 2007, a total of 413,000 qualified common stock options were
granted to employees and issued from the Company’s Incentive and Non-Qualified
Stock Option Plan. The options were issued with an exercise price of $0.85,
and
have a term of ten years. The options vest monthly over one year. The fair
value
of these options is $342,790.
12.
|
Related
Party Transactions
|
In
August
2008, in connection with a debt financing, QuantRx incurred cash commissions
of
$50,000 to Burnham Hill Partners, of which a beneficial owner of more than
5% of
QuantRx common stock is a managing member. Burnham Hill Partners was the
placement agent for the debt financing. These commissions are outstanding as
of
September 30, 2008.
On
June
16, 2008, in connection with a debt financing, QuantRx issued warrants with
a
five-year term valued at $64,000 to purchase an aggregate of 100,000 shares
of
common stock at $0.85 per share to Burnham Hill Partners. Burnham Hill Partners
was the placement agent for the debt financing. Additionally, cash commissions
of $55,000 are due to Burnham Hill Partners for its role as placement agent
in
the transaction as of September 30, 2008.
In
the
first quarter of 2008, in connection with a debt financing, QuantRx issued
warrants with a five-year term valued at $55,750 to purchase an aggregate of
100,000 shares of common stock at $1.10 per share to Burnham Hill Partners.
Burnham Hill Partners was the placement agent for the debt financing.
Additionally, cash commissions of $70,000 are due to Burnham Hill Partners
for
its role as placement agent in the transaction as of September 30, 2008.
An
executive officer of our majority-owned subsidiary, who is also a beneficial
owner of approximately 25% of the subsidiary’s outstanding shares, was due
$20,000 for licensing fees related to patent license agreements, $84,037 for
advances to fund general operating expenses and $97,500 for accrued payroll
as
of September 30, 2008, of which $104,037 was included in accounts payable and
$97,500 was included in accrued expenses. At December 31, 2007, $20,155 was
included in accounts payable, of which $20,000 related to licensing
fees.
In
October 2007, in connection with a debt financing, QuantRx issued warrants
with
a five-year term valued at $65,000 to purchase an aggregate of 100,000 shares
of
common stock at $1.10 per share to Burnham Hill Partners. Burnham Hill Partners
was the placement agent for the debt financing. Additionally, cash commissions
of $70,000 were incurred for Burnham Hill Partners for its role as placement
agent in the transaction, of which $50,000 was paid in the third quarter of
2008, and $20,000 remains outstanding as of September 30, 2008.
26
On
March
9, 2007, the Company issued 200,000 common stock warrants with a five year
term
to purchase 200,000 shares of common stock at an exercise price of $1.50. The
warrants were issued as payment pursuant to a financial advisory services
agreement with Burnham Hill Partners. The fair value of these warrants was
calculated to be $250,000 and was expensed over the four month service term.
Additionally, cash compensation of $200,000 was paid pursuant to the terms
of
the agreement and was also expensed over the four month service term.
A
member
of the Company’s board of directors served as a consultant to the Company on
various business, strategic, and technical issues. Fees paid and expensed for
these services by the Company during the nine months ended September 30, 2008
were $20,000 and the three and nine months ended September 30, 2007 were $12,000
and $36,000, respectively.
13.
|
Commitments
and Contingencies
|
Operating
Leases
QuantRx
leases office space and research and development lab space under operating
leases
that expire at various times through 2011. Some of these leases
contain cancellation clauses, subject to a termination fee, and include
allocations for common expenses subject to future adjustment. Rent expense
related to operating leases
was approximately $30,689 and $90,689 for the three and nine months ended
September 30, 2008, and $29,945 and $89,039 for the three and nine months ended
September 30, 2007, respectively. In connection with some of these facility
leases,
the Company has made security deposits totaling $10,310, which are included
in
long-term assets in the balance sheet. Future minimum lease obligations,
inclusive of potential termination fees, for operating leases
as
of September 30, 2008 are estimated as follows:
Remainder
of 2008
|
$
|
31,356
|
||
2009
|
101,563
|
|||
2010
|
57,240
|
|||
2011
|
43,875
|
|||
Total
minimum payments
|
$
|
234,034
|
In
February 2007, the Company began subleasing research and development lab space
under the noncancellable operating leases. The sublease can be terminated upon
ninety days notice by either party, and a $2,000 security deposit is being
held
by QuantRx pursuant to the terms of the lease. Sublease income was $5,786 and
$17,746 for the three and nine months ended September 30, 2008 and $6,224 and
$14,509 for the three and nine months ended September 30, 2007, respectively,
and is recorded in other income.
Executive
Employment Contracts
The
Company has an employment contract with a key Company executive that provides
for the continuation of salary to the executive if terminated for reasons other
than cause, as defined in those agreements. At September 30, 2008, the future
employment contract commitment for such key executive based on this termination
clause was approximately $240,000.
27
14.
|
Subsequent
Events
|
2008
Senior Secured Convertible Notes
In
the
fourth quarter of 2008, the holder of aggregate principal $2,004,069 Senior
Secured Convertible Notes agreed to extend the maturity date from January 23,
2009 to July 31, 2009, and invested an additional $200,000 in a note with
substantially the same terms as the original Senior Secured Convertible Notes.
In connection with this note, the holder was issued 50,000 warrants (fair value
$40,000) with a term of five years and an exercise price of $0.55. Additionally,
in connection with the issuance, the exercise price on 437,500 previously issued
warrants was revised from $1.25 to $0.55, and 375,000 previously issued warrants
was revised to $0.75 to $0.55.
2008
Secured Promissory Notes
QuantRx
executed an extension with a holder of a $100,000 2008 Secured Promissory Note
as of October 15, 2008, extending the maturity date to September 15, 2009.
In
consideration for this extension, QuantRx granted 75,000 shares of common stock
with a fair value of $22,500, which will be expensed over the term of the
extension.
On
October 15, 2008, QuantRx executed the second stage of a three month extension
of 2008 Secured Promissory Notes with an aggregate principal of $150,000. In
consideration for this stage, QuantRx granted an aggregate of 7,500 shares
of
common stock (fair value $2,250) and warrants to purchase 7,500 shares of common
stock (fair value $1,650) with a five year term for $0.85; the fair values
of
which will be expensed over the term of these extensions. The third stage of
these extensions will extend maturities through December 15, 2008.
QuantRx
executed an extension with a holder of a $200,000 2008 Secured Promissory Note
as of October 15, 2008, extending the maturity dates as follows: $50,000 and
related accrued interest due October 31, 2008; $50,000 and related accrued
interest due November 30, 2008; $100,000 and related accrued interest due
December 31, 2008. In consideration for this extension, QuantRx granted 20,000
shares of common stock (fair value $6,000) and warrants to purchase 20,000
shares of common stock (fair value $4,400) with a five year term for $0.85;
the
fair values of which will be expensed over the term of the
extension.
2008
Promissory Notes
As
of
October 31, 2008, QuantRx settled a $500,000 2008 Promissory Note with the
issuance of a $607,890 8% unsecured promissory note which included additional
principal of $100,000 and accrued interest of $7,890. The maturity date is
April
30, 2009. In connection with the issuance of this note, QuantRx granted 200,000
shares of common stock with a fair value of $80,000, which will be expensed
over
the term of the extension.
QuantRx
executed an extension with a holder of a $500,000 2008 Promissory Note as of
October 31, 2008, extending the maturity date to January 31, 2009. In
consideration for this extension, QuantRx granted 200,000 shares of common
stock
with a fair value of $80,000 and revised the interest rate on the original
8%
note to 10% effective as of the origination date. The fair value of common
stock
granted in connection with this extension will be expensed over the term of
the
extension.
28
ITEM
2. Management's
Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion of our financial condition should be read in conjunction
with the financial statements and notes to financial statements included
elsewhere in this filing. The following discussion (as well as statements in
Item 1 above and elsewhere) contains forward-looking statements within the
meaning of the Private Securities Litigation Act of 1995 that involve risks
and
uncertainties. Some or all of the results anticipated by these forward-looking
statements may not occur. Forward-looking statements involve known and unknown
risks and uncertainties including, but not limited to, trends in the
biotechnology, healthcare, and pharmaceutical sectors of the economy;
competitive pressures and technological developments from domestic and foreign
genetic research and development organizations which may affect the nature
and
potential viability of our business strategy; and private or public sector
demand for products and services similar to what we plan to commercialize.
We
disclaim any intention or obligation to publicly announce the results of any
revisions to any of the forward-looking statements contained herein to reflect
future events or developments.
Unless
otherwise indicated or the context otherwise requires, all references in this
report to “we,” “our,” “ours,” “us,” the “Company” or similar terms refer to
QuantRx Biomedical Corporation, a Nevada corporation and its
subsidiary.
Overview
QuantRx
Biomedical Corporation was incorporated on December 5, 1986 in the State of
Nevada. The Company’s principal business office is located at 100 South Main
Street, Suite 300, Doylestown, Pennsylvania. QuantRx also has a research and
development facility in Portland, Oregon.
QuantRx
is a broad-based diagnostics company focused on the development and
commercialization of innovative diagnostic products based on its patented
technology platforms for the worldwide healthcare industry. The Company’s
strategy is to commercialize its products through partners or distributors,
contracting the manufacturing to third-party partners while maintaining control
over the manufacturing process.
The
Company's platforms include: (1) POC testing products based on QuantRx core
intellectual property related to lateral flow techniques; (2) through
FluoroPharma, molecular imaging agents for positron emission tomography (PET);
(3) through our affiliate, Genomics USA, Inc., genome-based diagnostic chips;
and (4) PAD miniform technology.
In
April
2007, QuantRx increased its ownership in FluoroPharma, Inc., a development-stage
molecular imaging company, to 57.78% of outstanding capital stock, resulting
in
its consolidation effective April 1, 2007. The investment in FluoroPharma is
intended to strategically expand QuantRx’s diagnostic platforms.
Consolidated
Results of Operations
Net
operating revenues for the three months ended September 30, 2008 and 2007 were
$216,526 and $85,518, respectively. Net operating revenues for the nine months
ended September 30, 2008 and 2007 were $469,786 and $256,169, respectively.
The
increase in revenues of $131,008 and $213,617 for the three and nine months
ended September 30, 2008 compared to the three and nine months ended September
30, 2007 is primarily due to increased revenues related to short-term research
and development agreements.
29
Sales
and
marketing expense for the three months ended September 30, 2008 and 2007 was
$1,818 and $78,243, respectively, and for the nine months ended September 30,
2008 and 2007, was $94,394 and $173,524, respectively. The decrease of $76,425
and $79,130 for the three and nine months ended September 30, 2008 compared
to
the three and nine months ended September 30, 2007 primarily relates to reduced
personnel and sales and marketing expenditures.
General
and administrative expense for the three months ended September 30, 2008 and
2007 was $814,434 and $534,658 respectively, and for the nine months ended
September 30, 2008 and 2007, was $2,299,763 and $1,635,186, respectively. The
increase of $279,776 for the three months ended September 30, 2008 as compared
to the three months ended September 30, 2007 reflects an increase in personnel
related expenses of $301,541, primarily due to increased stock based
compensation expenses; partially offset by reduced travel related expenses.
The
increase of $664,577 for the nine months ended September 30, 2008 as compared
to
the nine months ended September 30, 2007 reflects an increase in personnel
related expenses of $735,101, primarily due to increased stock based
compensation costs and the inclusion of our subsidiary’s personnel costs, offset
by the absence of a minimum royalty payment of $50,000 related to a licensing
agreement and reduced travel related expenses.
Professional
fees for the three months ended September 30, 2008 and 2007, were $260,258
and
$330,259, respectively, and for the nine months ended September 30, 2008 and
2007, were $818,984 and $1,585,255, respectively. Professional
fees include the costs of legal, consulting and auditing services provided
to
us. The decrease of $70,001 for the three months ended September 30, 2008 as
compared to the three months ended September 30, 2007 is primarily attributed
to
a decrease in consulting fees related to financial advisory and investor
relations services. The decrease of $766,271 for the nine months ended September
30, 2008 as compared to the nine months ended September 30, 2007 is primarily
attributed to a decrease in legal and consulting fees related to financial,
technical and investor relations services.
Research
and development expense for the three
months ended
September 30, 2008 and 2007, was $508,815 and $462,740, respectively, and for
the nine months ended September 30, 2008 and 2007, was $1,738,304 and
$1,464,873, respectively. The increase of $273,431 for the nine months ended
September 30, 2008 as compared to the nine months ended September 30, 2007
is
attributed to subsidiary research and
development expenses included as of April 1, 2007, the effective date of the
consolidation.
The
Company’s net loss for the three
months ended
September 30, 2008 and 2007 was $2,067,331 and $1,327,357, respectively, and
for
the nine months ended September 30, 2008 and 2007, was $6,226,059 and
$4,797,193, respectively. The increase in net loss of $739,974 for the three
months ended September 30, 2008 as compared to the three months ended September
30, 2007 is primarily due to an increase in interest expense (see Note 9 to
the
financial statements), including amortization of debt discount and deferred
finance costs of $717,637. The increase in net loss of $1,428,866 for the nine
months ended September 30, 2008 as compared to the nine months ended September
30, 2007 is primarily due to an increase in interest expense, including
amortization of debt discount and deferred finance costs of $1,242,360 and
a
$439,445 loss on extinguishment of convertible notes in the first quarter of
2008, offset by the absence of a bad debt expense of $214,000 in the second
quarter of 2008, as well as all the factors previously discussed.
30
Liquidity
and Capital Resources
As
of
September 30, 2008, QuantRx had cash and cash equivalents of $253,738, as
compared to cash and cash equivalents of $213,332 as of December 31, 2007.
The
net decrease in cash of $40,406 for the nine months ended September 30, 2008,
is
primarily attributed to net cash used for operating activities of $2,437,061,
offset by $992,500 in net proceeds from the issuance of 10% senior secured
convertible notes in the first quarter of 2008, proceeds of $550,000 from the
issuance of 8% senior secured promissory notes and net proceeds of $942,500
from
the issuance of 8% promissory notes (see Note 9 to the financial statements),
and proceeds of $169,189 from the exercise of common stock warrants. QuantRx
has
used its financing proceeds as well as its revenues to fund current operating
expenses and investments intended to strategically expand our platforms and
technologies.
The
Company has not generated sufficient revenues from operations to meet its
operating expenses. For this reason, the Company has historically financed
its
operations primarily through issuances of equity and the proceeds of debt
instruments. In the past, the Company has also provided for its cash needs
by
issuing common stock, options and warrants for certain operating costs,
including consulting and professional fees.
The
Company is currently negotiating additional funding, and has been successful
obtaining funding in the past; however, it is not known whether the Company
will
be successful in its current funding efforts due in part to current external
market conditions. Additionally, the Company is limited in its ability to issue
additional debt instruments, due to certain limitations contained in the senior
secured convertible notes and related agreements.
While
the
Company believes that it will be able to obtain future financing on acceptable
terms, if it is not successful in obtaining debt or equity financing, or if
the
Company is not permitted to obtain such financing by the terms of its existing
agreements and financial instruments, the Company would need to expend
significant efforts to find other short- and long-term sources of capital to
meet its ongoing operating and business expenses. The Company is also focusing
on opportunities to increase net sales while seeking to manage operating
expenses in an attempt to preserve as much as practical its available cash
resources. If the Company is unable to raise sufficient long-term or short-term
capital resources on acceptable terms, the Company’s business, results of
operations, liquidity and financial condition would be materially and adversely
harmed.
The
Company believes that the successful growth and operation of its business is
dependent upon its ability to do any or all of the following:
·
|
obtain
adequate sources of debt or equity financing to pay operating expenses
and
fund long-term business operations;
|
·
|
manage
or control working capital requirements by reducing operating expenses;
|
·
|
develop
new and enhance existing relationships with product distributors
and other
points of distribution for the Company’s products;
and
|
·
|
seek
potential acquisitions that could be expected to generate positive
cash
flow for the Company upon acquisition, assuming appropriate financing
structures are available on acceptable terms in order to effect such
acquisitions.
|
31
There
can
be no assurance that the Company will be successful in achieving its long-term
plans as set forth above, or that such plans, if consummated, will enable the
Company to obtain profitable operations or continue in the long-term as a going
concern.
Off-Balance
Sheet Arrangements
We
have
not entered into any transactions with unconsolidated entities in which we
have
financial guarantees, subordinated retained interests, derivative instruments
or
other contingent arrangements that expose us to material continuing risks,
contingent liabilities or any other obligations under a variable interest in
an
unconsolidated entity that provides us with financing, liquidity, market risk
or
credit risk support.
Critical
Accounting Policies
Revenue
Recognition
The
Company recognizes revenue in accordance with SEC Staff Accounting Bulletin
Topic 13 when persuasive evidence of an arrangement exists and delivery has
occurred, provided the fee is fixed or determinable and collection is probable.
The Company assesses whether the fee is fixed and determinable based on the
payment terms associated with the transaction. If a fee is based upon a variable
such as acceptance by the customer, the Company accounts for the fee as not
being fixed and determinable. In these cases, the Company defers revenue and
recognizes it when it becomes due and payable. Up-front engagement fees are
recorded as deferred revenue and amortized to income on a straight-line basis
over the term of the agreement, although the fee is due and payable at the
time
the agreement is signed or upon annual renewal. Payments related to substantive,
performance-based milestones in an agreement are recognized as revenue upon
the
achievement of the milestones as specified in the underlying agreement when
they
represent the culmination of the earnings process.
The
Company assesses the probability of collection based on a number of factors,
including past transaction history with the customer and the current financial
condition of the customer. If the Company determines that collection of a fee
is
not reasonably assured, revenue is deferred until the time collection becomes
reasonably assured. Significant management judgment and estimates must be made
and used in connection with the revenue recognized in any accounting period.
Material differences may result in the amount and timing of our revenue for
any
period if our management made different judgments or utilized different
estimates.
The
Company recognizes revenue from nonrefundable minimum royalty agreements from
distributors or resellers upon delivery of product to the distributor or
reseller, provided no significant obligations remain outstanding, the fee is
fixed and determinable, and collection is probable. Once minimum royalties
have
been received, additional royalties are recognized as revenue when earned based
on the distributor’s contractual reporting obligations. QuantRx is able to
recognize minimum royalty payments on an accrual basis, as they are specified
in
the contract. However, since the Company cannot forecast product sales by
licensees, royalty payments that are based on product sales by the licensees
are
not determinable until the licensee has completed their computation of the
royalties due and/or remitted their cash payment to us. Should information
on
licensee product sales become available so as to enable QuantRx to recognize
royalty revenue on an accrual basis, materially different revenues and results
of operations could occur.
32
Our
strategy includes entering into collaborative agreements with strategic partners
for the development, commercialization and distribution of our product
candidates. Such collaboration agreements may have multiple deliverables. We
evaluate multiple deliverable arrangements pursuant to Emerging Issues Task
Force (EITF) 00-21, “Revenue Arrangements with Multiple Deliverables.” Pursuant
to EITF 00-21, in arrangements with multiple deliverables where we have
continuing performance obligations, contract, milestone and license fees are
recognized as revenue together with any up-front payments over the term of
the
arrangement as performance obligations are completed, unless the deliverable
has
stand-alone value and there is objective, reliable evidence of fair value of
the
undelivered element in the arrangement. In the case of an arrangement where
it
is determined there is a single unit of accounting, all cash flows from the
arrangement are considered in the determination of all revenue to be recognized.
Cash received in advance of revenue recognition is recorded as deferred revenue.
Use
of Estimates
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect the reported amounts
of
assets and liabilities, revenues and expenses and related disclosures of
contingent assets and liabilities in the financial statements and accompanying
notes. The accounting policies discussed below are considered by management
to
be the most important to the Company’s financial condition and results of
operations, and require management to make its most difficult and subjective
judgments due to the inherent uncertainty associated with these matters. All
significant estimates and assumptions are developed based on the best
information available to us at the time made and are regularly reviewed and
adjusted when necessary. We believe that our estimates and assumptions are
reasonable under the circumstances; however, actual results may vary from these
estimates and assumptions. Additional information on significant accounting
principles is provided in Note 1 of the attached financial
statements.
Impairment
of Assets
We
assess
the impairment of long-lived assets, including our other intangible assets,
whenever events or changes in circumstances indicate that their carrying value
may not be recoverable in accordance with Statement of Financial Accounting
Standards (SFAS) No. 144, “Accounting for the Impairment or Disposal of
Long-Lived Assets.” The determination of related estimated useful lives and
whether or not these assets are impaired involves significant judgments, related
primarily to the future profitability and/or future value of the assets. Changes
in our strategic plan and/or market conditions could significantly impact these
judgments and could require adjustments to recorded asset balances. We hold
investments in companies having operations or technologies in areas which are
within or adjacent to our strategic focus when acquired, all of which are
privately held and whose values are difficult to determine. We record an
investment impairment charge if we believe an investment has experienced a
decline in value that is other than temporary. Future changes in our strategic
direction, adverse changes in market conditions or poor operating results of
underlying investments could result in losses or an inability to recover the
carrying value of the investments that may not be reflected in an investment’s
current carrying value, thereby possibly requiring an impairment charge in
the
future.
33
In
determining fair value of assets, QuantRx bases estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about carrying values of assets that are not readily apparent from
other sources. Actual fair value may differ from management estimates resulting
in potential impairments causing material changes to certain assets and results
of operations.
Share-based
Payments
We
grant
options to purchase our common stock to our employees and directors under our
stock option plan subject to the provisions of SFAS No. 123(R), “Share-Based
Payments.”
We
estimate the value of stock option awards on the date of grant using a
Black-Scholes pricing model (Black-Scholes model). The determination of the
fair
value of share-based payment awards on the date of grant using the Black-Scholes
model is affected by our stock price as well as assumptions regarding a number
of complex and subjective variables. These variables include, but are not
limited to, our expected stock price volatility over the term of the awards,
actual and projected employee stock option exercise behaviors, and risk-free
interest rate. If factors change and we employ different assumptions in the
application of SFAS No. 123(R) in future periods, the compensation expense
that we record under SFAS No. 123(R) may differ significantly from what we
have recorded in the current period.
We
account for share-based compensation awards granted to non-employees in
accordance with EITF No. 96-18, “Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services.” Under EITF 96-18, we determine the fair value of the
share-based compensation awards granted as either the fair value of the
consideration received or the fair value of the equity instruments issued,
whichever is more reliably measurable. If the fair value of the equity
instruments issued is used, it is measured using the stock price and other
measurement assumptions as of the earlier of either of (1) the date at
which a commitment for performance by the counterparty to earn the equity
instruments is reached or (2) the date at which the counterparty’s
performance is complete.
Estimates
of share-based compensation expenses are significant to our financial
statements, but these expenses are based on option valuation models and will
never result in the payment of cash by us.
The
above
listing is not intended to be a comprehensive list of all of our accounting
policies. In most cases, the accounting treatment of a particular transaction
is
specifically dictated by accounting principles generally accepted in the U.S.
34
ITEM
4T. Controls
and Procedures
(a) Evaluation
of Disclosure Controls and Procedures
The
Company maintains disclosure controls and procedures that are designed to ensure
that information required to be disclosed in our SEC reports is recorded,
processed, summarized and reported within the time periods specified in the
SEC’s rules and forms, and that such information is communicated to our
management including our Chief Executive Officer and Chief Financial Officer
as
appropriate. With the supervision and with the participation of our management,
including the Chief Executive Officer and Chief Financial Officer, we have
evaluated the effectiveness of our disclosure controls and procedures (as
defined under Exchange Act Rules 13a-15(e) and 15(d)-15(e)), as of the end
of the period covered by this report. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer have concluded that these
disclosure controls and procedures were effective as of September 30,
2008.
(b) Changes
in Internal Control over Financial Reporting
During
the period covered by this Quarterly Report on Form 10-Q, there were no changes
in our internal control over financial reporting that have materially affected,
or are reasonably likely to affect, our internal control over financial
reporting.
Given
the
inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that misstatements due to error or fraud will not
occur or that all control issues and instances of fraud, if any, will have
been
detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple
error or mistake. Further, the design of a control system must reflect the
fact
that there are resource constraints, and that the benefits of a control system
must be considered relative to its cost. The design of any system of controls
is
also based in part on certain assumptions regarding the likelihood of future
events, and there can be no assurance that any design will succeed in achieving
its stated goals under all potential future conditions.
PART
II - OTHER INFORMATION
ITEM
1. Legal
Proceedings.
As
of the
date hereof, the Company has no pending or threatened litigation.
ITEM
2. Unregistered
Sales of Equity Securities, and Use of Proceeds
On
August
18, 2008, the Company issued a warrant in consideration of a three month
consulting and investor relations services agreement. The warrant has a term
of
five years and represents the right to purchase 40,000 shares of common stock
at
an exercise price of $1.25.
In
August
2008, the Company completed a private placement of 8% promissory notes, common
stock, and warrants to purchase shares of QuantRx’s common stock. In connection
with the private placement, QuantRx issued 250,000 shares of common stock and
warrants with a five-year term to purchase 250,000 shares of QuantRx’s common
stock at an exercise price of $0.85.
35
On
September 15, 2008, the Company negotiated extensions on certain of the 2008
Secured Promissory Notes. In consideration for the first month’s extensions,
QuantRx granted an aggregate of 22,500 shares of common stock and 22,500
warrants to purchase common stock with a five year term for $0.85.
At
September 30, 2008 the Company issued a 10% senior secured convertible note
in
the amount of $49,272 pursuant to one holder’s election to receive quarterly
interest in the form of a paid-in-kind note. The note is currently convertible
into 98,543 shares of common stock.
On
October 15, 2008, the Company issued an aggregate of 7,500 shares of common
stock and warrants to purchase 7,500 shares of common stock with a five year
term for $0.85 pursuant to certain note extensions. See Note 14, Subsequent
Events.
On
October 15, 2008, the Company issued 75,000 shares of common stock pursuant
to
an extension on an outstanding note. See Note 14, Subsequent Events.
On
October 15, 2008, the Company issued 20,000 shares of common stock and warrants
to purchase 20,000 shares of common stock with a five year term for $0.85
pursuant to an extension on an outstanding note. See Note 14, Subsequent Events.
On
October 31, 2008, the Company issued 200,000 shares of common stock in
connection with the issuance of a promissory note. See Note 14, Subsequent
Events.
On
October 31, 2008, the Company issued 200,000 shares of common stock pursuant
to
an extension on an outstanding note. See Note 14, Subsequent Events.
In
the
fourth quarter of 2008, the Company issued 50,000 warrants with a term of five
years and an exercise price of $0.55 in connection with the issuance of a senior
secured convertible note. See Note 14, Subsequent Events.
There
were no additional sales of unregistered securities other than as reported
in
prior reports on Forms 10-KSB, 10-Q or 8-K.
The
issuances of the above securities were deemed to be exempt from registration
under the Securities Act of 1933, as amended (the “Securities Act”), in reliance
on Section 4(2) of the Securities Act or Regulation D promulgated under the
Securities Act, as transactions by an issuer not involving a public
offering.
ITEM
3. Defaults
on Senior Securities
None.
ITEM
4. Submission
of Matters to a Vote of Security Holders
None.
36
ITEM
5. Other
Information
None.
ITEM
6. Exhibits
Exhibit
|
Description
|
|
4.1
|
Form
of Promissory Bridge Note, dated August 2008 and maturing October
31,
2008, issued by QuantRx in favor of lender (incorporated
by reference to Exhibit 4.1 filed with Form 8-K on August 27,
2008).
|
|
4.2
|
Form
of Warrant to Purchase Shares of Common Stock of QuantRx, dated August
2008, issued by QuantRx in favor of lender. (incorporated
by reference to Exhibit 4.2 filed with Form 8-K on August 27,
2008).
|
|
10.1
|
Form
of Letter Loan Agreement, dated August 2008, between QuantRx and
lender
(incorporated
by reference to Exhibit 10.1 filed with Form 8-K on August 27,
2008).
|
|
31.1
|
|
Certification
of Chief Executive Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended.
|
31.2
|
|
Certification
of Chief Financial Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended.
|
32.1*
|
|
Certification
of Chief Executive Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350.
|
32.2*
|
|
Certification
of Chief Financial Officer required under Rule 13a-14(a) or Rule
15d-14(a)
of the Securities and Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350.
|
*The
certifications attached as Exhibits 32.1 and 32.2 accompany this Quarterly
Report on Form 10-Q pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
and shall not be deemed “filed” by QuantRx Biomedical Corporation for purposes
of Section 18 of the Exchange Act.
37
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act
of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
QuantRx
Biomedical Corporation
|
||
|
|
|
Date:
November 14, 2008
|
By: |
/s/
Walter Witoshkin
|
Walter
Witoshkin
|
||
Chairman
& CEO
|
Date:
November 14, 2008
|
By: |
/s/
Sasha Afanassiev
|
Sasha
Afanassiev
|
||
CFO,
Treasurer & VP of Finance
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