GUIDED THERAPEUTICS INC - Quarter Report: 2020 March (Form 10-Q)
UNITED
STATES SECURITIES AND
EXCHANGE
COMMISSION
Washington, D.C.
20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT 1934
For
the quarterly period ended March 31, 2020
Commission File No. 0-22179
GUIDED THERAPEUTICS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
|
58-2029543
|
(State
or other jurisdiction of incorporation or
organization)
|
(I.R.S.
Employer Identification No.)
|
5835
Peachtree Corners East, Suite B
Norcross, Georgia 30092
(Address of
principal executive offices) (Zip Code)
(770) 242-8723
(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 of
1934 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: Yes
☐ No ☒
Indicate by check
mark whether the registrant has submitted electronically, if any,
every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§ 232.405 of this chapter) during
the preceding 12 months (or for such shorter period that the
registrant was required to submit such files). Yes ☒ No
☐
Indicate by check
mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting
company or an emerging growth company. See definitions of
“large accelerated filer,” “accelerated
filer” and “smaller reporting company” and
“emerging growth company” in Rule 12b-2 of the Exchange
Act (Check one):
Large
Accelerated filer ☐
|
Accelerated filer
☐
|
Non-accelerated
filer ☐
|
Smaller
reporting company ☒
|
|
Emerging growth
company ☐
|
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised accounting standards provided pursuant to
Section 13 (a) of the Exchange Act. ☐
Indicate by check
mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act. Yes ☐ No ☒
As of
July 3, 2020, the registrant had 12,264,629 shares of common Stock,
$0.001 par value per share, outstanding.
GUIDED
THERAPEUTICS, INC. AND SUBSIDIARY
INDEX
3
|
|
|
|
3
|
|
|
|
3
|
|
|
|
5
|
|
|
|
6
|
|
|
|
7
|
|
|
|
8
|
|
|
|
33
|
|
|
|
40
|
|
|
|
40
|
|
|
|
41
|
|
|
|
41
|
|
|
|
41
|
|
|
|
41
|
|
|
|
41
|
|
|
|
41
|
|
|
|
42
|
|
|
|
2
PART I - FINANCIAL INFORMATION: ITEM
1. FINANCIAL STATEMENTS
GUIDED
THERAPEUTICS, INC. AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS (unaudited, in thousands)
ASSETS
|
March
31,
2020
|
December
31,
2019
|
CURRENT
ASSETS:
|
|
|
Cash
and cash equivalents
|
$21
|
$899
|
Accounts
receivable, net of allowance for doubtful accounts of $14 at March
31, 2020 and December 31, 2019, respectively
|
24
|
13
|
Other
receivable
|
100
|
-
|
Inventory,
net of reserves of $831 at March 31, 2020 and December 31, 2019,
respectively
|
57
|
48
|
Other
current assets
|
36
|
70
|
Total
current assets
|
238
|
1,030
|
NONCURRENT
ASSETS:
|
|
|
Lease
asset-right, net of amortization
|
109
|
132
|
Other
assets
|
17
|
18
|
Total
noncurrent assets
|
126
|
150
|
TOTAL
ASSETS
|
364
|
1,180
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
|
|
CURRENT
LIABILITIES:
|
|
|
Notes
payable in default, related parties
|
2
|
349
|
Notes
payable in default
|
297
|
427
|
Short-term
notes payable
|
19
|
380
|
Short-term
notes payable, related parties
|
-
|
646
|
Short-term
notes payable, related parties, past due
|
53
|
-
|
Convertible
notes , past due
|
1,890
|
-
|
Convertible
notes in default
|
740
|
2,915
|
Short-term
convertible notes payable
|
128
|
73
|
Short-term
convertible notes payable, related parties
|
-
|
513
|
Accounts
payable
|
2,841
|
2,897
|
Accounts
payable, related parties
|
125
|
136
|
Accrued
liabilities
|
2,928
|
3,235
|
Subscription
receivable
|
-
|
635
|
Current
portion of lease liability
|
99
|
103
|
Deferred
revenue
|
101
|
101
|
Total
current liabilities
|
9,223
|
12,410
|
LONG-TERM
LIABILITIES:
|
|
|
Warrants,
at fair value
|
1,797
|
5,092
|
Lease
liability
|
10
|
29
|
Long-term
convertible notes payable, net
|
102
|
15
|
Long-term
debt-related parties
|
577
|
569
|
Total
long-term liabilities
|
2,486
|
5,705
|
TOTAL
LIABILITIES
|
11,709
|
18,115
|
|
|
|
COMMITMENTS & CONTINGENCIES (Note 7)
|
|
|
3
STOCKHOLDERS’
DEFICIT:
|
|
|
Series C
convertible preferred stock, $.001 par value; 9.0 shares
authorized, 0.3 shares issued and outstanding as of March 31, 2020
and December 31, 2019. (Liquidation preference of $286 at March 31,
2020 and December 31, 2019).
|
105
|
105
|
Series C1
convertible preferred stock, $.001 par value; 20.3 shares
authorized, 1.0 shares issued and outstanding as of March 31, 2020
and December 31, 2019. (Liquidation preference of $1,049 at March
31, 2020 and December 31, 2019).
|
170
|
170
|
Series C2
convertible preferred stock, $.001 par value; 5.0 shares
authorized, 3.3 shares issued and outstanding as of March 31, 2020
and December 31, 2019. (Liquidation preference of $3,263 at March
31, 2020 and December 31, 2019).
|
531
|
531
|
Series D
convertible preferred stock, $.001 par value; 6.0 shares
authorized, 0.7 and nil shares issued and outstanding as of March
31, 2020 and December 31, 2019, respectively. (Liquidation
preference of $554 and nil at March 31, 2020 and December 31,
2019).
|
268
|
-
|
Common stock, $.001
par value; 3,000,000 shares authorized, 11,765 and 3,319 shares
issued and outstanding as of March 31, 2020 and December 31, 2019,
respectively
|
3,402
|
3,394
|
Additional
paid-in capital
|
121,150
|
118,552
|
Treasury
stock, at cost
|
(132)
|
(132)
|
(136,839)
|
(139,555)
|
|
TOTAL
STOCKHOLDERS’ DEFICIT
|
(11,345)
|
(16,935)
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
364
|
1,180
|
The
accompanying notes are an integral part of these consolidated
statements.
4
GUIDED THERAPEUTICS INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited,
in thousands)
|
FOR
THE THREE MONTHS
ENDED
MARCH 31,
|
|
|
2020
|
2019
|
REVENUE:
|
|
|
Sales
– devices and disposables, net
|
$-
|
$18
|
Cost
of goods sold
|
-
|
1
|
Gross profit
|
-
|
17
|
|
|
|
OPERATING
EXPENSES:
|
|
|
Research
and development
|
24
|
47
|
Sales
and marketing
|
34
|
45
|
General
and administrative
|
184
|
182
|
Total
operating expenses
|
242
|
274
|
|
|
|
Operating
loss
|
(242)
|
(257)
|
|
|
|
OTHER
INCOME (EXPENSE) :
|
|
|
Other
income
|
1
|
4
|
Interest
expense
|
(287)
|
(371)
|
Gain
from extinguishment of debt
|
28
|
-
|
Change
in fair value of warrants
|
3,228
|
409
|
Total
other income
|
2,970
|
42
|
|
|
|
INCOME
(LOSS) BEFORE INCOME TAXES
|
2,728
|
(215)
|
|
|
|
PROVISION
FOR INCOME TAXES
|
-
|
-
|
|
|
|
NET
INCOME (LOSS)
|
2,728
|
(215)
|
PREFERRED
STOCK DIVIDENDS
|
(12)
|
(9)
|
|
|
|
NET
INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$2,716
|
$(224)
|
|
|
|
NET
INCOME (LOSS) PER SHARE ATTRIBUTABLE TO COMMON
STOCKHOLDERS
|
|
|
BASIC
|
$0.542
|
$(0.069)
|
DILUTED
|
$0.041
|
$(0.069)
|
|
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING
|
|
|
BASIC
|
5,013
|
3,248
|
DILUTED
|
65,620
|
3,248
|
The
accompanying notes are an integral part of these consolidated
financial statements.
5
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR
THE THREE MONTHS ENDED MARCH 31, 2020 AND 2019 (In
Thousands)(Unaudited)
|
Preferred Stock
Series C
|
Preferred Stock
Series C1
|
Preferred Stock
Series C2
|
Preferred Stock
Series D
|
Common
Stock
|
Additional
Paid-In
|
Treasury
|
Accumulated
|
|
|||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Deficit
|
TOTAL
|
BALANCE, December
31, 2019
|
-
|
$105
|
1
|
$170
|
3
|
$531
|
-
|
$-
|
3,319
|
$3,394
|
$118,552
|
$(132)
|
$(139,555)
|
$(16,935)
|
Issuance of
preferred stock in financing
|
-
|
-
|
-
|
-
|
-
|
-
|
738
|
268
|
-
|
-
|
286
|
-
|
-
|
554
|
Conversion of debt
into common stock
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
6,957
|
7
|
2,068
|
-
|
-
|
2,075
|
Issuance of common
stock in financing
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1,476
|
1
|
177
|
-
|
-
|
178
|
Issuance of
warrants in financing
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
67
|
-
|
-
|
67
|
Issuance of common
stock for manufacturing agreements
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
13
|
-
|
-
|
-
|
-
|
-
|
Net
income
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
2,716
|
2,716
|
BALANCE,
March 31, 2020
|
-
|
$105
|
1
|
$170
|
3
|
$531
|
738
|
$268
|
11,765
|
$3,402
|
$121,150
|
$(132)
|
$(136,839)
|
$(11,345)
|
|
Preferred Stock
Series C
|
Preferred Stock
Series C1
|
Preferred Stock
Series C2
|
Common
Stock
|
Additional
Paid-In
|
Treasury
|
Accumulated
|
|
||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Deficit
|
TOTAL
|
BALANCE, December
31, 2018
|
-
|
$105
|
1
|
$170
|
3
|
$531
|
2,669
|
$2,877
|
$118,259
|
$(132)
|
$(137,634)
|
$(15,824)
|
Conversion of debt
into common stock
|
-
|
-
|
-
|
-
|
-
|
-
|
650
|
517
|
(484)
|
-
|
1
|
34
|
Stock-based
compensation
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
5
|
-
|
-
|
5
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(224)
|
(224)
|
BALANCE,
March 31, 2019
|
-
|
$105
|
1
|
$170
|
3
|
$531
|
3,319
|
$3,394
|
$117,780
|
$(132)
|
$(137,856)
|
$(16,009)
|
The
accompanying notes are an integral part of these consolidated
statements
6
GUIDED THERAPEUTICS INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(unaudited,
in thousands)
|
FOR
THE THREE MONTHS
ENDED
MARCH 31,
|
|
|
2020
|
2019
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
Net
income (loss)
|
$2,728
|
$(215)
|
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
|
|
Depreciation
|
-
|
5
|
Amortization
of debt issuance costs and discounts
|
94
|
14
|
Amortization
of beneficial conversion feature
|
19
|
37
|
Share-based
compensation
|
-
|
5
|
Change
in fair value of warrants
|
(3,228)
|
(409)
|
Gain
from extinguishment of debt
|
(28)
|
-
|
|
|
|
Changes
in operating assets and liabilities:
|
|
|
Accounts
receivable
|
(11)
|
-
|
Inventory
|
(9)
|
2
|
Other
current assets
|
34
|
33
|
Accounts
payable
|
(67)
|
(9)
|
Deferred
revenue
|
-
|
34
|
Accrued
liabilities
|
(62)
|
317
|
Total
adjustments
|
(3,258)
|
29
|
|
|
|
Net
cash used in operating activities
|
(530)
|
(186)
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
Proceeds
from debt financing, net of discounts and debt issuance
costs
|
-
|
230
|
Payments
made on notes payable
|
(451)
|
(38)
|
Proceeds
from the issuance of common stock
|
103
|
-
|
Net
cash (used in) provided by financing activities
|
(348)
|
192
|
|
|
|
NET
CHANGE IN CASH AND CASH EQUIVALENTS
|
(878)
|
6
|
CASH
AND CASH EQUIVALENTS, beginning of year
|
899
|
-
|
CASH
AND CASH EQUIVALENTS, end of period
|
$21
|
$6
|
SUPPLEMENTAL
SCHEDULE OF:
|
|
|
Cash paid
for:
|
|
|
Interest
|
$165
|
$-
|
NONCASH
INVESTING AND FINANCING ACTIVITIES:
|
|
|
Issuance
of common stock as debt repayment
|
$1,902
|
$33
|
Issuance
of common stock for accrued interest of debt repaid
|
$162
|
|
Dividends
on preferred stock
|
$12
|
$9
|
Subscription
receivable
|
$635
|
$-
|
Warrants
exchanged for fixed price warrants
|
$67
|
$-
|
Other
receivable
|
$100
|
$-
|
The
accompanying notes are an integral part of these consolidated
financial statements.
7
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1.
ORGANIZATION,
BACKGROUND, AND BASIS OF PRESENTATION
Guided
Therapeutics, Inc. (formerly SpectRx, Inc.), together with its
wholly owned subsidiary, InterScan, Inc. (formerly Guided
Therapeutics, Inc.), collectively referred to herein as the
“Company”, is a medical
technology company focused on developing innovative medical devices
that have the potential to improve healthcare. The Company’s
primary focus is the continued commercialization of its LuViva
non-invasive cervical cancer detection device and extension of its
cancer detection technology into other cancers, including
esophageal. The Company’s technology, including products in
research and development, primarily relates to biophotonics
technology for the non-invasive detection of
cancers.
Basis
of Presentation
All
information and footnote disclosures included in the consolidated
financial statements have been prepared in accordance with
accounting principles generally accepted in the United
States.
The
accompanying unaudited consolidated financial statements have been
prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”) for interim financial information
and with the instructions to Form 10-Q and Article 10 of Regulation
S-X. Accordingly, they do not include all of the information and
footnotes required by GAAP for complete financial statements.
Therefore, these financial statements should be read in conjunction
with our Annual Report on Form 10-K for the fiscal year ended
February 2, 2019 filed with the Securities and Exchange Commission
(“SEC”) pursuant to Section 13 or 15(d) under the
Securities Exchange Act of 1934. In the opinion of management, all
adjustments (consisting of normal recurring accruals and other
items) considered necessary for a fair presentation have been
included.
A 1:800
reverse stock split of all of the Company’s issued and
outstanding common stock was implemented on March 29, 2019. As a
result of the reverse stock split, every 800 shares of issued and
outstanding common stock were converted into 1 share of common
stock. All fractional shares created by the reverse stock split
were rounded to the nearest whole share. The number of authorized
shares of common stock did not change. The reverse stock split
decreased the Company’s issued and outstanding shares of
common stock from 2,652,309,322 shares to 3,319,469 shares as of
that date with rounding. See Note 4, Stockholders’ Deficit.
Unless otherwise specified, all per share amounts are reported on a
post-stock split basis, as of March 31, 2020 and December 31,
2019.
The
Company’s prospects must be considered in light of the
substantial risks, expenses and difficulties encountered by
entrants into the medical device industry. This industry is
characterized by an increasing number of participants, intense
competition and a high failure rate. The Company has experienced
net losses since its inception and, as of March 31, 2020, it had an
accumulated deficit of approximately $136.8 million. To date, the
Company has engaged primarily in research and development efforts
and the early stages of marketing its products. The Company may not
be successful in growing sales for its products. Moreover, required
regulatory clearances or approvals may not be obtained in a timely
manner, or at all. The Company’s products may not ever gain
market acceptance and the Company may not ever generate significant
revenues or achieve profitability. The development and
commercialization of the Company’s products requires
substantial development, regulatory, sales and marketing,
manufacturing and other expenditures. The Company expects operating
losses to continue for the foreseeable future as it continues to
expend substantial resources to complete development of its
products, obtain regulatory clearances or approvals, build its
marketing, sales, manufacturing and finance capabilities, and
conduct further research and development.
Certain
prior year amounts have been reclassified in order to conform to
the current year presentation.
Going
Concern
The
Company’s consolidated financial statements have been
prepared and presented on a basis assuming it will continue as a
going concern. The factors below raise substantial doubt about the
Company’s ability to continue as a going concern. The
financial statements do not include any adjustments that might be
necessary from the outcome of this uncertainty.
8
At
March 31, 2020, the Company had a negative working capital of
approximately $9.0 million, accumulated deficit of $136.8 million,
and net income of $2.7 million for the three months then ended (the
net income was the result of a $3.2 million change in fair value of
warrants gain that was recorded in the period). Stockholders’
deficit totaled approximately $11.3 million at March 31, 2020,
primarily due to recurring net losses from operations, deemed
dividends on warrants and preferred stock, offset by proceeds from
the exercise of options and warrants and proceeds from sales of
stock.
The
Company has taken steps to improve its going concern opinion,
including:
●
During the end of
2019 and beginning of 2020, the Company was able to raise $2.3
million in equity and debt investments;
●
The Company has
executed several exchange agreements that converted to
approximately $2.1 million of debt for equity, as well as eliminate
some existing debt;
●
The Company’s
has applied for an uplisting on the Over the Counter (OTC) bulletin
board from the pink sheets;
If
sufficient capital cannot be raised during 2020, the Company will
continue its plans of curtailing operations by reducing
discretionary spending and staffing levels and attempting to
operate by only pursuing activities for which it has external
financial support. However, there can be no assurance that such
external financial support will be sufficient to maintain even
limited operations or that the Company will be able to raise
additional funds on acceptable terms, or at all. In such a case,
the Company might be required to enter into unfavorable agreements
or, if that is not possible, be unable to continue operations, and
to the extent practicable, liquidate and/or file for bankruptcy
protection.
The
Company had warrants exercisable for approximately 27.2 million
shares of its common stock outstanding at March 31, 2020, with
exercise prices ranging between $0.04 and $1.82 per share.
Exercises of in the money warrants would generate a total of
approximately $1.3 million in cash, assuming full exercise,
although the Company cannot be assured that holders will exercise
any warrants. Management may obtain additional funds through the
public or private sale of debt or equity, and grants, if
available.
2. SIGNIFICANT
ACCOUNTING POLICIES
Use
of Estimates
The
preparation of financial statements 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 and disclosure of
contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those
estimates. Significant areas where estimates are used include the
allowance for doubtful accounts, inventory valuation and input
variables for Black-Scholes, Monte Carlo simulations and binomial
calculations. The Company uses the Monte Carlo simulations and
binomial calculations in the calculation of the fair value of the
warrant liabilities and the valuation of embedded conversion
options and freestanding warrants.
Principles
of Consolidation
The
accompanying consolidated financial statements include the accounts
of Guided Therapeutics, Inc. and its wholly owned subsidiary. All
intercompany transactions are eliminated.
Accounting
Standard Updates
Recently Adopted Accounting Pronouncements
In June
2016, the FASB issued ASU 2016-13, Financial Instruments - Credit
Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments. ASU 2016-13 requires that expected credit losses
relating to financial assets are measured on an amortized cost
basis and available-for-sale debt securities be recorded through an
allowance for credit losses. ASU 2016-13 limits the amount of
credit losses to be recognized for available-for-sale debt
securities to the amount by which carrying value exceeds fair value
and also requires the reversal of previously recognized credit
losses if fair value increases. The Company adopted the standard on
January 1, 2020. The adoption of ASU 2016-13 did not have a
material impact on the Company.
9
In
August 2018, the FASB issued Accounting Standards Update No.
2018-13, Fair Value Measurement (Topic 820): Disclosure
Framework—Changes to the Disclosure Requirements for Fair
Value Measurement, or ASU 2018-13. The amendments in ASU 2018-13
eliminate, add, and modify certain disclosure requirements for fair
value measurements. The amendments are effective for the
Company’s interim and annual reporting periods beginning
after December 15, 2019, with early adoption permitted for either
the entire ASU or only the provisions that eliminate or modify
requirements. The amendments with respect to changes in unrealized
gains and losses, the range and weighted average of significant
unobservable inputs used to develop Level 3 fair value
measurements, and the narrative description of measurement
uncertainty are to be applied prospectively. All other amendments
are to be applied retrospectively to all periods presented. The
adoption of ASU 2016-13 did not have a material impact on the
Company.
A
variety of proposed or otherwise potential accounting standards are
currently under consideration by standard-setting organizations and
certain regulatory agencies. Because of the tentative and
preliminary nature of such proposed standards, management has not
yet determined the effect, if any, that the implementation of such
proposed standards would have on the Company’s consolidated
financial statements.
Cash
Equivalents
The
Company considers all highly liquid investments with an original
maturity of three months or less when purchased to be a cash
equivalent.
Accounts
Receivable
The
Company performs periodic credit evaluations of its
distributors’ financial conditions and generally does not
require collateral. The Company reviews all outstanding accounts
receivable for collectability on a quarterly basis. An allowance
for doubtful accounts is recorded for any amounts deemed
uncollectable. Uncollectibility, is determined based on the
determination that a distributor will not be able to make payment
and the time frame has exceeded one year. The Company does not
accrue interest receivable on past due accounts
receivable.
Concentrations
of Credit Risk
The
Company, from time to time during the years covered by these
consolidated financial statements, may have bank balances in excess
of its insured limits. Management has deemed this a normal business
risk.
Inventory
Valuation
All
inventories are stated at lower of cost or net realizable value,
with cost determined substantially on a “first-in,
first-out” basis. Selling, general, and administrative
expenses are not inventoried, but are charged to expense when
incurred. At March 31, 2020 and December 31, 2019, our inventories
were as follows (in thousands):
|
March
31,
|
December
31,
|
|
2020
|
2019
|
Raw
materials
|
$783
|
$781
|
Work in
process
|
81
|
81
|
Finished
goods
|
24
|
17
|
Inventory
reserve
|
(831)
|
(831)
|
Total
|
$57
|
$48
|
The
company periodically reviews the value of items in inventory and
provides write-downs or write-offs of inventory based on its
assessment of market conditions. Write-downs and write-offs are
charged to cost of goods sold.
Property
and Equipment
Property and
equipment are recorded at cost. Depreciation is computed using the
straight-line method over estimated useful lives of three to seven
years. Leasehold improvements are amortized at the shorter of the
useful life of the asset or the remaining lease term. Depreciation
and amortization expense are included in general and administrative
expense on the statement of operations. Expenditures for repairs
and maintenance are expensed as incurred. Property and equipment
are summarized as follows at March 31, 2020 and December 31, 2019
(in thousands):
10
|
March
31,
|
December
31,
|
|
2020
|
2019
|
Equipment
|
$1,349
|
$1,349
|
Software
|
740
|
740
|
Furniture and
fixtures
|
124
|
124
|
Leasehold
Improvement
|
180
|
180
|
|
2,393
|
2,393
|
Less accumulated
depreciation and amortization
|
(2,393)
|
(2,393)
|
Total
|
$-
|
$-
|
Debt
Issuance Costs
Debt
issuance costs are capitalized and amortized over the term of the
associated debt. Debt issuance costs are presented in the balance
sheet as a direct deduction from the carrying amount of the debt
liability consistent with the debt discount.
Other
Assets
Other
assets primarily consist of a deposit for the corporate
office.
Patent
Costs (Principally Legal Fees)
Costs
incurred in filing, prosecuting, and maintaining patents are
recurring, and expensed as incurred. Maintaining patents are
expensed as incurred as the Company has not yet received U.S. FDA
approval and recovery of these costs is uncertain. Such costs
aggregated approximately $4,000 and $7,000 for the three months
ended March 31, 2020 and 2019,
respectively.
Leases
With the implementation of ASU 2016-02,
“Leases (Topic 842)”, the Company recorded a lease
asset-right and a lease liability. The implementation required the
analysis of certain criteria in determining its treatment. The
Company determined that its corporate office lease met those
criteria. The Company implemented the guidance using the
alternative transition method. Under this alternative, the
effective date would be the date of initial application. The
Company analyzed the lease at its effective date and calculated an
initial lease payment amount of $267,380 with a present value of
$213,000 using a 20% discount. As of March 31, 2020, the
balance of the lease asset – right and lease liability was
approximately $109,000.
The
cumulative effect of initially applying the new guidance had an
immaterial impact on the opening balance of retained earnings. The
Company elected the practical expedients permitted under the
transition guidance within the new standards, which allowed the
Company to carry forward the historical lease
classification.
Accrued Liabilities
Accrued
liabilities are summarized as follows (in thousands):
|
March
31,
2020
|
December
31,
2019
|
Compensation
|
$1,134
|
$1,123
|
Professional
fees
|
105
|
181
|
Interest
|
1,394
|
1,603
|
Warranty
|
2
|
2
|
Vacation
|
40
|
41
|
Preferred
dividends
|
132
|
120
|
Other accrued
expenses
|
121
|
165
|
Total
|
$2,928
|
$3,235
|
11
Subscription
receivables
Cash
received from investors for common stock shares that has not
completed processing is recorded as a liability to subscription
receivables. As of March 31, 2020, the Company did not have any
outstanding orders for common stock shares. As of December 31,
2019, the Company had reserved 1,270,000 common stock shares in
exchange for $635,000.
Revenue
Recognition
The
Company follows, ASC 606 Revenue from Contracts with Customers
establishes a single and comprehensive framework which sets out how
much revenue is to be recognized, and when. The core principle is
that a vendor should recognize revenue to depict the transfer of
promised goods or services to customers in an amount that reflects
the consideration to which the vendor expects to be entitled in
exchange for those goods or services. Revenue will now be
recognized by a vendor when control over the goods or services is
transferred to the customer. In contrast, Revenue based revenue
recognition around an analysis of the transfer of risks and
rewards; this now forms one of a number of criteria that are
assessed in determining whether control has been transferred. The
application of the core principle in ASC 606 is carried out in five
steps: Step 1 – Identify the contract with a customer: a
contract is defined as an agreement (including oral and implied),
between two or more parties, that creates enforceable rights and
obligations and sets out the criteria for each of those rights and
obligations. The contract needs to have commercial substance and it
is probable that the entity will collect the consideration to which
it will be entitled. Step 2 – Identify the performance
obligations in the contract: a performance obligation in a contract
is a promise (including implicit) to transfer a good or service to
the customer. Each performance obligation should be capable of
being distinct and is separately identifiable in the contract. Step
3 – Determine the transaction price: transaction price is the
amount of consideration that the entity can be entitled to, in
exchange for transferring the promised goods and services to a
customer, excluding amounts collected on behalf of third parties.
Step 4 – Allocate the transaction price to the performance
obligations in the contract: for a contract that has more than one
performance obligation, the entity will allocate the transaction
price to each performance obligation separately, in exchange for
satisfying each performance obligation. The acceptable methods of
allocating the transaction price include adjusted market assessment
approach, expected cost plus a margin approach, and, the residual
approach in limited circumstances. Discounts given should be
allocated proportionately to all performance obligations unless
certain criteria are met and reallocation of changes in standalone
selling prices after inception is not permitted. Step 5 –
Recognize revenue as and when the entity satisfies a performance
obligation: the entity should recognize revenue at a point in time,
except if it meets any of the three criteria, which will require
recognition of revenue over time: the entity’s performance
creates or enhances an asset controlled by the customer, the
customer simultaneously receives and consumes the benefit of the
entity’s performance as the entity performs, and the entity
does not create an asset that has an alternative use to the entity
and the entity has the right to be paid for performance to
date.
Revenue
by product line (in thousands):
|
Three
Months Ended March 31,
|
|
|
2020
|
2019
|
Devices
|
$-
|
$-
|
Disposables
|
-
|
2
|
Other
|
-
|
15
|
Warranty
|
-
|
1
|
Total
|
$-
|
$18
|
Revenue
by geographic location (in thousands):
|
Three
Months Ended March 31,
|
|
|
2020
|
2019
|
Asia
|
$-
|
$3
|
Europe
|
-
|
15
|
Total
|
$-
|
$18
|
Significant
Distributors
During
the three months ended March 31, 2020, all the Company did not have
any revenues. Accounts receivable, not reserved against, were from
one distributor and represents 100% of the balance as of March 31,
2020. During the three months ended March 31, 2019, revenues were
from two distributors and for extended warranties. Revenues from
these distributors totaled $18,000 for the period ended March 31,
2019. Accounts receivable, not reserved against, were from one
distributor and represents 100% of the balance for the period ended
March 31, 2019.
12
Deferred revenue
The
Company defers payments received as revenue until earned based on
the related contracts and applying ASC 606 as required. As of March
31, 2020, and December 31, 2019, the Company had $101,000 in
deferred revenue.
Research
and Development
Research and
development expenses consist of expenditures for research conducted
by the Company and payments made under contracts with consultants
or other outside parties and costs associated with internal and
contracted clinical trials. All research and development costs are
expensed as incurred.
Income
Taxes
The
Company uses the liability method of accounting for income taxes.
Under this method, deferred tax assets and liabilities are
determined based on differences between the financial reporting and
tax bases of assets and liabilities and are measured using the
enacted tax rates and laws that will be in effect when the
differences are expected to reverse. Management provides valuation
allowances against the deferred tax assets for amounts that are not
considered more likely than not to be realized.
The
Company has entered into an agreed upon payment plan with the IRS
for delinquent payroll taxes and also with the Georgia Department
of State. The Company is currently in process of setting up a
payment arrangement for its delinquent state income taxes with the
State of Georgia and the returns are currently under review by
state authorities. Although the Company has been experiencing
recurring losses, it is obligated to file tax returns for
compliance with IRS regulations and that of applicable state
jurisdictions. At December 31, 2019, the Company has approximately
$76 million of cumulative net operating losses, but it has not
filed its Federal tax returns, therefore this number may not be
accurate. Once the returns are filed, the net operating losses will
be eligible to be carried forward for tax purposes at federal and
applicable states level. A full valuation allowance has been
recorded related the deferred tax assets generated from the net
operating losses.
The
current corporate tax rates in the U.S. is 21%.
Uncertain
Tax Positions
The
Company assesses each income tax position is assessed using a
two-step process. A determination is first made as to whether it is
more likely than not that the income tax position will be
sustained, based upon technical merits, upon examination by the
taxing authorities. If the income tax position is expected to meet
the more likely than not criteria, the benefit recorded in the
financial statements equals the largest amount that is greater than
50% likely to be realized upon its ultimate settlement. At March
31, 2020 and December 31, 2019, there were no uncertain tax
positions.
Warrants
The
Company has issued warrants, which allow the warrant holder to
purchase one share of stock at a specified price for a specified
period of time. The Company records equity instruments including
warrants issued to non-employees based on the fair value at the
date of issue. The fair value of warrants classified as equity
instruments at the date of issuance is estimated using the
Black-Scholes Model. The fair value of warrants classified as
liabilities at the date of issuance is estimated using the Monte
Carlo Simulation or Binomial model.
Stock
Based Compensation
The
Company records compensation expense related to options granted to
employees and non-employees based on the fair value of the award.
Compensation cost is recorded as earned for all unvested stock
options outstanding at the beginning of the first year based upon
the grant date fair value estimates, and for compensation cost for
all share-based payments granted or modified subsequently based on
fair value estimates.
For
the three months ended March 31, 2020 and 2019, share-based
compensation for options attributable to employees, non-employees,
officers and Board members were approximately nil and $5,000,
respectively. These amounts have been included in the
Company’s statements of operations. Compensation costs for
stock options which vest over time are recognized over the vesting
period. As of March 31, 2020, and 2019 the Company had
approximately nil and $2,000 of unrecognized compensation costs
related to granted stock options that will be recognized over the
remaining vesting period of approximately one year,
respectively.
13
Beneficial
Conversion Features of Convertible Securities
Conversion options
that are not bifurcated as a derivative pursuant to ASC 815 and not
accounted for as a separate equity component under the cash
conversion guidance are evaluated to determine whether they are
beneficial to the investor at inception (a beneficial conversion
feature) or may become beneficial in the future due to potential
adjustments. The beneficial conversion feature guidance in ASC
470-20 applies to convertible stock as well as convertible debt
which are outside the scope of ASC 815. A beneficial conversion
feature is defined as a nondetachable conversion feature that is in
the money at the commitment date. The beneficial conversion feature
guidance requires recognition of the conversion option’s
in-the-money portion, the intrinsic value of the option, in equity,
with an offsetting reduction to the carrying amount of the
instrument. The resulting discount is amortized as a dividend over
either the life of the instrument, if a stated maturity date
exists, or to the earliest conversion date, if there is no stated
maturity date. If the earliest conversion date is immediately upon
issuance, the dividend must be recognized at inception. When there
is a subsequent change to the conversion ratio based on a future
occurrence, the new conversion price may trigger the recognition of
an additional beneficial conversion feature on
occurrence.
Derivatives
The
Company reviews the terms of convertible debt issued to determine
whether there are embedded derivative instruments, including
embedded conversion options, which are required to be bifurcated
and accounted for separately as derivative financial instruments.
In circumstances where the host instrument contains more than one
embedded derivative instrument, including the conversion option,
that is required to be bifurcated, the bifurcated derivative
instruments are accounted for as a single, compound derivative
instrument. Bifurcated embedded derivatives are initially recorded
at fair value and are then revalued at each reporting date with
changes in the fair value reported as non-operating income or
expense. When the equity or convertible debt instruments contain
embedded derivative instruments that are to be bifurcated and
accounted for as liabilities, the total proceeds received are first
allocated to the fair value of all the bifurcated derivative
instruments. The remaining proceeds, if any, are then allocated to
the host instruments themselves, usually resulting in those
instruments being recorded at a discount from their face value. The
discount from the face value of the convertible debt, together with
the stated interest on the instrument, is amortized over the life
of the instrument through periodic charges to interest
expense.
3.
FAIR VALUE OF FINANCIAL INSTRUMENTS
The
guidance for fair value measurements, ASC 820, Fair Value
Measurements and Disclosures, establishes the authoritative
definition of fair value, sets out a framework for measuring fair
value, and outlines the required disclosures regarding fair value
measurements. Fair value is the price that would be received to
sell an asset or paid to transfer a liability (an exit price) in
the principal or most advantageous market for the asset or
liability in an orderly transaction between market participants at
the measurement date. The Company uses a three-tier fair value
hierarchy based upon observable and non-observable inputs as
follow:
●
Level 1 –
Quoted market prices in active markets for identical assets and
liabilities;
●
Level 2 –
Inputs, other than level 1 inputs, either directly or indirectly
observable; and
●
Level 3 –
Unobservable inputs developed using internal estimates and
assumptions (there is little or no market date) which reflect those
that market participants would use.
The
Company records its derivative activities at fair value, which
consisted of warrants as of March 31, 2020. The fair value of the
warrants was estimated using the Binomial Simulation model. Gains
and losses from derivative contracts are included in net gain
(loss) from derivative contracts in the statement of operations.
The fair value of the Company’s derivative warrants is
classified as a Level 3 measurement, since unobservable inputs are
used in the valuation.
The
following table presents the fair value for those liabilities
measured on a recurring basis as of March 31, 2020 and December 31,
2019:
14
FAIR
VALUE MEASUREMENTS (In Thousands)
The
following is summary of items that the Company measures at fair
value on a recurring basis:
|
Fair
Value at March 31, 2020
|
|||
|
Level
1
|
Level
2
|
Level
3
|
Total
|
|
|
|
|
|
Warrants issued in
connection with Short-term loans
|
-
|
-
|
(30)
|
(30)
|
Warrants issued in
connection with Long-term loans
|
-
|
-
|
(871)
|
(871)
|
Warrants issued in
connection with Senior Secured Debt
|
-
|
-
|
(896)
|
(896)
|
Bifurcated
conversion option in connection with Auctus $700,000 loan on
December 17, 2019
|
-
|
-
|
-
|
-
|
Total
long-term liabilities at fair value
|
$-
|
$-
|
$(1,797)
|
$(1,797)
|
|
Fair
Value at December 31, 2019
|
|
||
|
Level
1
|
Level
2
|
Level
3
|
Total
|
|
|
|
|
|
Warrants issued in
connection with Distributor Debt
|
-
|
-
|
(114)
|
(114)
|
Warrants issued in
connection with Short-term loans
|
-
|
-
|
(83)
|
(83)
|
Warrants issued in
connection with Long-term loans
|
-
|
-
|
(893)
|
(893)
|
Warrants issued in
connection with Senior Secured Debt
|
-
|
-
|
(4,002)
|
(4,002)
|
Bifurcated
conversion option in connection with Auctus $700,000 loan on
December 17, 2019
|
-
|
-
|
-
|
-
|
Total
long-term liabilities at fair value
|
$-
|
$-
|
$(5,092)
|
$(5,092)
|
The
following is a summary of changes to Level 3 instruments during the
three months ended March 31, 2020:
|
Fair
Value Measurements Using Significant Unobservable Inputs (Level
3)
|
||||
|
Distributor Debt
|
Short-Term Loans
|
Senior Secured Debt
|
Long-Term Loans
|
Total
|
Balance,
December 31, 2019
|
$(114)
|
$(83)
|
$(4,002)
|
$(893)
|
$(5,092)
|
Warrants
exchanged for fixed price warrants
|
67
|
-
|
-
|
-
|
67
|
Change
in fair value during the year
|
47
|
53
|
3,106
|
22
|
3,228
|
Balance, March
31, 2020
|
$-
|
$(30)
|
$(896)
|
$(871)
|
$(1,797)
|
As of
March 31, 2020, the fair value of warrants was approximately $1.8 million. A net
change of approximately $3.2 million has been recorded to
the accompanying statement of operations for the three months ended
March 31, 2020.
4.
STOCKHOLDERS’ DEFICIT
Common
Stock
The
Company has authorized 3,000,000,000 shares of common stock with
$0.001 par value, of which 11,764,629 were issued and outstanding
as of March 31, 2020. As of December 31, 2019, there were
3,000,000,000 authorized shares of common stock, of which 3,319,469
were issued and outstanding.
15
For the
three months ended March 31, 2020, the Company issued 8,445,143
shares of common stock as listed below:
Exchange of Debt
for common stock shares and warrants
|
6,957,013
|
Shares issued for
manufacturing agreements
|
12,147
|
Investments
|
1,476,000
|
Issued during the
three months ended March 31, 2020
|
8,445,160
|
Summary
table of common stock share transactions:
Balance at December
31, 2019
|
3,319,469
|
Issued in
2020
|
8,445,160
|
Balance at March
31, 2020
|
11,764,629
|
Investments
During
January 2020, the Company received equity investments in the amount
of $103,000. These investors received a total of 206,000 common
stock shares and 206,000 warrants issued to purchase common stock
shares at a strike price of $0.25, 206,000 warrants to purchase
common stock shares at a strike price of $0.75 and 103 Series D
preferred stock (if the Investor elects to convert their Series D
preferred stock, each Series D preferred stock shares converts into
3,000 shares of the Company’s common stock shares). Of the
amount invested $38,000 was from related parties.
During
December 2019, the Company received equity investments in the
amount of $635,000. The $635,000 of investments were recorded as a
subscription liability in December 2019. The common stock shares
were issued in January 2020. These investors received a total of
1,270,000 common stock shares and 1,270,000 warrants to purchase
common stock shares at a strike price of $0.25, 1,270,000 warrants
issued to purchase common stock shares at a strike price of $0.75
and 635 Series D preferred stock (each Series D preferred stock
shares converts into 3,000 shares of the Company’s common
stock shares). Of the amount invested $350,000 was from related
parties.
Debt
Exchanges
On
January 8, 2020, the Company exchanged $2,064,366 in debt for
several equity instruments (noted below) that were determined to
have a total fair value of $2,065,548, resulting in a loss on
extinguishment of debt of $1,183 which is recorded in other income
(expense) on the accompanying consolidated statements of
operations. The Company also issued 6,957,013 warrants to purchase
common stock shares; with exercise prices of $0.25, $0.75 and
$0.20. In addition, one of the investors forgave approximately
$29,000 of debt, which was recorded as a gain for extinguishment of
debt.
The
following table summarizes the debt exchanges:
|
Total
Debt and Accrued Interest
|
Total
Debt
|
Total
Accrued Interest
|
Common
Stock Shares
|
Warrants
(Exercise $0.25)
|
Warrants
(Exercise $0.75)
|
Warrants
(Exercise $0.20)
|
|
|
|
|
|
|
|
|
Aquarius
|
$145,544
|
107,500
|
38,044
|
291,088
|
145,544
|
145,544
|
-
|
K2 Medical (Shenghuo)3
|
803,654
|
771,927
|
31,727
|
1,905,270
|
704,334
|
704,334
|
496,602
|
Mr.
Blumberg
|
305,320
|
292,290
|
13,030
|
1,167,630
|
119,656
|
119,656
|
928,318
|
Mr.
Case
|
179,291
|
150,000
|
29,291
|
896,456
|
-
|
-
|
896,456
|
Mr.
Grimm
|
51,050
|
50,000
|
1,050
|
255,548
|
-
|
-
|
255,548
|
Mr.
Gould
|
111,227
|
100,000
|
11,227
|
556,136
|
-
|
-
|
556,136
|
Mr.
Mamula
|
15,577
|
15,000
|
577
|
77,885
|
-
|
-
|
77,885
|
Dr. Imhoff2
|
400,417
|
363,480
|
36,937
|
1,699,255
|
100,944
|
100,944
|
1,497,367
|
Ms. Rosenstock1
|
50,000
|
50,000
|
-
|
100,000
|
50,000
|
50,000
|
-
|
Mr. James2
|
2,286
|
2,000
|
286
|
7,745
|
1,227
|
1,227
|
5,291
|
|
$2,064,366
|
$1,902,197
|
$162,169
|
6,957,013
|
1,121,705
|
1,121,705
|
4,713,603
|
1
Ms.
Rosenstock also forgave $28,986 in debt to the
Company.
2
Mr.
Imhoff and Mr. James are members of the board of directors and
therefore related parties.
3
The
Company’s COO and director, Mark Faupel, is a shareholder of
Shenghuo, and a former director, Richard Blumberg, is a managing
member of Shenghuo.
16
Preferred
Stock
The
Company has authorized 5,000,000 shares of preferred stock with a
$.001 par value. The board of directors has the authority to issue
these shares and to set dividends, voting and conversion rights,
redemption provisions, liquidation preferences, and other rights
and restrictions. The board of directors designated 525,000 shares
of preferred stock redeemable convertible preferred stock, none of
which remain outstanding, 33,000 shares of preferred stock as
Series B Preferred Stock, none of which remain outstanding, 9,000
shares of preferred stock as Series C Convertible Preferred Stock,
(the “Series C Preferred Stock”), of which 286 were
issued and outstanding at March 31, 2020 and December 31, 2019,
respectively and 20,250 shares of preferred stock as Series C1
Preferred Stock, of which 1,050 shares were issued and outstanding
at March 31, 2020 and December 31, 2019. In addition, some
holders separately agreed to exchange
each share of the Series C1 Preferred Stock held for one (1) share
of the Company’s newly created Series C2 Preferred Stock. In
total, for 3,262.25 shares of Series C1 Preferred Stock to be
surrendered, the Company issued 3,262.25 shares of Series C2
Preferred Stock. At March 31, 2020, shares of Series C2 had a conversion price of
$0.50 per share, such that each share of Series C preferred stock
would convert into approximately 2,000 shares of the
Company’s common stock.
The Company issued Series D Preferred Stock in
2020. The Company had authorized 6,000 Series D Preferred Stock. At
the end of 2019 and beginning of 2020, the Company had investments
of $738,000, of which $635,000 was received in December 2019 and
$103,000 was received in January 2020. that would provide each
investor one Series D Preferred Stock share for each $1,000
invested. And each Series D preferred stock converts into
3,000 shares of the Company’s common stock
shares.
Series C Convertible Preferred Stock
Pursuant to the
Series C certificate of designations, shares of Series C preferred
stock are convertible into common stock by their holder at any time
and may be mandatorily convertible upon the achievement of
specified average trading prices for the Company’s common
stock. At December 31, 2019, there were 286 shares outstanding with
a conversion price of $0.50 per share, such that each share of
Series C preferred stock would convert into approximately 2,000
shares of the Company’s common stock, subject to customary
adjustments, including for any accrued but unpaid dividends and
pursuant to certain anti-dilution provisions, as set forth in the
Series C certificate of designations. The conversion price will
automatically adjust downward to 80% of the then-current market
price of the Company’s common stock 15 trading days after any
reverse stock split of the Company’s common stock, and 5
trading days after any conversions of the Company’s
outstanding convertible debt.
Holders
of the Series C preferred stock are entitled to quarterly
cumulative dividends at an annual rate of 12.0% until 42 months
after the original issuance date (the “Dividend End
Date”), payable in cash or, subject to certain conditions,
the Company’s common stock. In addition, upon conversion of
the Series C preferred stock prior to the Dividend End Date, the
Company will also pay to the converting holder a “make-whole
payment” equal to the number of unpaid dividends through the
Dividend End Date on the converted shares. At December 31, 2019,
the “make-whole payment” for a converted share of
Series C preferred stock would convert to 200 shares of the
Company’s common stock. The Series C preferred stock
generally has no voting rights except as required by Delaware law.
Upon the Company’s liquidation or sale to or merger with
another corporation, each share will be entitled to a liquidation
preference of $1,000, plus any accrued but unpaid dividends. In
addition, the purchasers of the Series C preferred stock received,
on a pro rata basis, warrants exercisable to purchase an aggregate
of approximately 1 share of Company’s common stock. The
warrants contain anti-dilution adjustments in the event that the
Company issues shares of common stock, or securities exercisable or
convertible into shares of common stock, at prices below the
exercise price of such warrants. As a result of the anti-dilution
protection, the Company is required to account for the warrants as
a liability recorded at fair value each reporting period. At March
31, 2020, the exercise price per share was $512,000.
On May
23, 2016, an investor canceled certain of these warrants,
exercisable into 903 shares of common stock. The same investor also
transferred certain of these warrants, exercisable for 150 shares
of common stock, to two investors who also had participated in the
2015 Series C financing.
Series C1 Convertible Preferred Stock
Between
April 27, 2016 and May 3, 2016, the Company entered into various
agreements with certain holders of Series C preferred stock,
including directors John Imhoff and Mark Faupel, pursuant to which
those holders separately agreed to exchange each share of Series C
preferred stock held for 2.25 shares of the Company’s newly
created Series C1 Preferred Stock and 12 (9,600 pre-split) shares
of the Company’s common stock (the “Series C
Exchanges”). In connection with the Series C Exchanges, each
holder also agreed to roll over the $1,000 stated value per share
of the holder’s shares of Series C1 Preferred Stock into the
next qualifying financing undertaken by the Company on a
dollar-for-dollar basis and, except in the event of an additional
$50,000 cash investment in the Company by the holder, to execute a
customary “lockup” agreement in connection with the
financing. In total, for 1,916 shares of Series C preferred stock
surrendered, the Company issued 4,312 shares of Series C1 Preferred
Stock and 29 shares of common stock.
17
At
March 31, 2020, there were 1,050 shares outstanding with a
conversion price of $0.50 per share, such that each share of Series
C preferred stock would convert into approximately 381,098 shares
of the Company’s common stock.
On
August 31, 2018, 3,262.25 shares of Series C1 Preferred Stock were
surrendered, and the Company issued 3,262.25 shares of Series C2
Preferred Stock.
The
Series C1 preferred stock has terms that are substantially the same
as the Series C preferred stock, except that the Series C1
preferred stock does not pay dividends (unless and to the extent
declared on the common stock) or at-the-market “make-whole
payments” and, while it has the same anti-dilution
protections afforded the Series C preferred stock, it does not
automatically reset in connection with a reverse stock split or
conversion of our outstanding convertible debt.
Series C2 Convertible Preferred Stock
On August 31, 2018, the Company entered into
agreements with certain holders of the Company’s Series C1
Preferred Stock, including the chairman of the Company’s
board of directors, and the Chief Operating Officer and a director
of the Company pursuant to which those holders separately agreed to
exchange each share of the Series C1 Preferred Stock held for one
(1) share of the Company’s newly created Series C2 Preferred
Stock. In total, for 3,262.25 shares of Series C1 Preferred Stock
to be surrendered, the Company issued 3,262.25 shares of Series C2
Preferred Stock. At March 31, 2020, shares of Series C2 had a conversion price of
$0.50 per share, such that each share of Series C preferred stock
would convert into approximately 2,000 shares of the
Company’s common stock.
The
terms of the Series C2 Preferred Stock are substantially the same
as the Series C1 Preferred Stock, except that (i) shares of Series
C1 Preferred Stock may not be convertible into the Company’s
common stock by their holder for a period of 180 days following the
date of the filing of the Certificate of Designation (the
“Lock-Up Period”); (ii) the Series C2 Preferred Stock
has the right to vote as a single class with the Company’s
common stock on an as-converted basis, notwithstanding the Lock-Up
Period; and (iii) the Series C2 Preferred Stock will automatically
convert into that number of securities sold in the next Qualified
Financing (as defined in the Exchange Agreement) determined by
dividing the stated value ($1,000 per share) of such share of
Series C2 Preferred Stock by the purchase price of the securities
sold in the Qualified Financing.
Series D Convertible Preferred Stock
On January 8, 2020, the Company entered
into a Security Agreement with the Series D Investors (the
“Series D Security Agreement”) pursuant to which all
obligations under the Series D Certificate of Designation are
secured by all of the Company’s assets and personal
properties, with certain accredited investors, including
the Chief Executive Officer, Chief
Operating Officer and a director of the Company. In total, for
$738,000 the Company issued 738 shares of Series D Preferred Stock,
1,476,000 common stock shares, 1,476,000 common stock warrants,
exercisable at $0.25, and 1,476,000 common stock warrants,
exercisable $0.75. Each Series D Preferred Stock is convertible
into 3,000 common stock shares. The Series D Preferred Stock
will have cumulative dividends at the rate per share of 10% per
annum. The stated value and
liquidation preference on the Series D Preferred Stock is
$750.
Each
share of Series D Preferred is convertible, at any time for a
period of 5 years after issuance, into that number of shares of
Common Stock, determined by dividing the Stated Value by $0.25,
subject to certain adjustments set forth in the Series D
Certificate of Designation (the “Series D Conversion
Price”). The conversion of Series D Preferred is subject to a
4.99% beneficial ownership limitation, which may be increased to
9.99% at the election of the holder of the Series D Preferred. If
the average of the VWAPs (as defined in the Series D Certificate of
Designation) for any consecutive 5 trading day period
(“Measurement Period”) exceeds 200% of the then Series
D Conversion Price and the average daily trading volume of the
Common Stock on the primary trading market exceeds 1,000 shares per
trading day during the Measurement Period (subject to adjustments),
the Company may redeem the then outstanding Series D Preferred, for
cash in an amount equal to aggregate Stated Value then outstanding
plus accrued but unpaid dividends .
The
Series D Warrants may be exercised cashlessly if there is no
effective registration statement covering the Common Stock issuable
upon exercise of the Series D Warrants. The Series D Warrants
contain a 4.99% beneficial ownership blocker which may be increased
to 9.99% at the holder’s election.
On
January 8, 2020, the Company also entered into a Registration
Rights Agreement (the “Series D Registration Rights Agreement
“) with the Series D Investors pursuant to which the Company
agreed to file with the SEC, a registration statement on a Form S-3
(or on other appropriate form if a Form S-3 is not available)
covering the Common Stock issuable upon conversion of the Series D
Warrants within 90 days of the date of the Registration Rights
Agreement and cause such registration statement to be declared
effective within 120 days of the date of the Registration Rights
Agreement. All reasonable expenses related to such registration
shall be borne by the Company.
18
Warrants
The
following table summarizes transactions involving the
Company’s outstanding warrants to purchase common stock for
the three months ended March 31, 2020:
|
Warrants
(Underlying
Shares)
|
Outstanding,
January 1, 2020
|
46,016,840
|
Issuances
|
10,159,013
|
Cancelled /
Expired
|
(70)
|
Exchanged in debt
restructuring
|
(28,962,508)
|
Exercised
|
-
|
Outstanding, March
31, 2020
|
27,213,275
|
The
Company had the following shares reserved for the warrants as of
March 31, 2020:
Warrants(Underlying
Shares)
|
|
Exercise
Price
|
Expiration
Date
|
4,262
|
(1)
|
$1.824
per share
|
March
19, 2021
|
7,185,000
|
(2)
|
$0.20
per share
|
February 12,
2023
|
1,725,000
|
(3)
|
$0.04
per share
|
February 21,
2021
|
325,000
|
(4)
|
$0.18
per share
|
April
4, 2022
|
215,000
|
(5)
|
$0.25
per share
|
July 1,
2022
|
100,000
|
(6)
|
$0.25
per share
|
September 1,
2022
|
7,500,000
|
(7)
|
$0.20
per share
|
December 17,
2024
|
250,000
|
(8)
|
$0.16
per share
|
March
31, 2025
|
2,597,705
|
(9)
|
$0.25
per share
|
December 30,
2022
|
2,597,705
|
(10)
|
$0.75
per share
|
December 30,
2022
|
4,713,603
|
(11)
|
$0.20
per share
|
December 30,
2022
|
27,213,275*
|
|
|
|
* However, please refer to Footnote 10 - CONVERTIBLE DEBT in the
paragraph: Debt Restructuring for more information regarding our
warrants.
(1)
Issued
to investors for a loan in March 2018.
(2)
Exchanged in
January 2020 from amount issued as part of a February 2016 private
placement with senior secured debt holder
(3)
Issued
to a placement agent in conjunction with a February 2016 private
placement with senior secured debt holder
(4)
Issued
to investors for a loan in April 2019
(5)
Issued
to investors for a loan in July 2019
(6)
Issued
to investors for a loan in September 2019
(7)
Issued
to investors for a loan in December 2019
(8)
Issued
to investors for a loan in January 2020
(9)
Issued
to investors as part of Series D Preferred Stock Capital raise in
December 2020
(10)
Issued
to investors as part of Series D Preferred Stock Capital raise in
December 2020
(11)
Issued
to investors as part of Series D Preferred Stock Capital raise in
December 2020
Footnote (2) - On
January 16, 2020, the Company entered into an exchange agreement
with GPB. This exchange agreement canceled the existing outstanding
warrants, which were subject to anti-dilution and ratchet
provisions, to purchase 35,937,500 shares of common stock at an
exercise price of $0.04 per share and resulted in the issuance of
new warrants to purchase 7,185,000 share of common stock at a price
of $0.20 per share. The new warrants have fixed exercise prices of
$0.20; subject to the Company meeting the agreed upon terms of the
exchange agreement.
Warrant
to purchase 70 shares of common stock were not recorded as their
exercise price after considering reverse stock splits, were greater
than $60,000 and deemed to be immaterial for
disclosure
On
January 6, 2020, the Company entered into a finder’s fee
agreement. The finder will receive 5% cash and 5% warrants on all
funds it raises including bridge loans. The three-year common stock
share warrants will have an exercise price of $0.25. During 2019
and 2020, the finder helped the Company raise $300,000, therefore a
fee of $15,000 was paid and 60,000 warrants will be
issued.
19
On
January 22, 2020, the Company entered into a promotional agreement
with a consultant. The consultant will provide the Company investor
and public relations services. As compensation for these services,
the Company will issue a total of 5,000,000 common stock warrants
at a $0.25 strike price and expiring in three years, if the
following conditions occur: 1,250,000 common stock warrants, 6
months after the close of the Series D Preferred Stock units, if
the minimum common stock share price is a at least $0.50 based on a
30-day VWAP, with a two year term; 1,250,000 common stock warrants,
12 months after the close of the Series D Preferred Stock units, if
the minimum common stock share price is at least $0.75 based on a
30-day VWAP, with a one and half year term; 1,250,000 common stock
warrants, 18 months after the close of the Series D Preferred Stock
units, if the minimum common stock share price is a minimum of
$1.00 based on a 30-day VWAP, with a one year term; and 1,250,000
common stock warrants, 24 months after the close of the Series D
Preferred Stock units, if the minimum common stock share price is a
minimum of $1.25 based on a 30-day VWAP, with a one year term. The
consultant agrees to a 10.0% blocker at any single point in time it
cannot own 10.0% of the total common stock shares
outstanding.
5.
STOCK OPTIONS
The
Company’s 1995 Stock Plan (the “Plan”) has
expired pursuant to its terms, so zero shares remained available
for issuance at March 31, 2020 and December 31, 2019. The Plan
allowed for the issuance of incentive stock options, nonqualified
stock options, and stock purchase rights. The exercise price of
options was determined by the Company’s board of directors,
but incentive stock options were granted at an exercise price equal
to the fair market value of the Company’s common stock as of
the grant date. Options historically granted have generally become
exercisable over four years and expire ten years from the date of
grant.
Due to
the 1:800 reverse stock split of all of the Company’s issued
and outstanding common stock which was implemented on March 29,
2019, every 800 shares of issued and outstanding common stock were
converted into 1 share of common stock. This resulted in the number
of stock options outstanding to be zero.
6.
LITIGATION AND CLAIMS
From
time to time, the Company may be involved in various legal
proceedings and claims arising in the ordinary course of business.
Management believes that the dispositions of these matters,
individually or in the aggregate, are not expected to have a
material adverse effect on the Company’s financial condition.
However, depending on the amount and timing of such disposition, an
unfavorable resolution of some or all of these matters could
materially affect the future results of operations or cash flows in
a particular year.
As of
March 31, 2020, and December 31, 2019, there was no accrual
recorded for any potential losses related to pending
litigation.
7.
COMMITMENTS AND CONTINGENCIES
Operating
Leases
In
December 2009, the Company moved its offices, which comprise its
administrative, research and development, marketing and production
facilities to 5835 Peachtree Corners East, Suite B, Peachtree
Corners, Georgia 30092. The Company leased approximately 23,000
square feet under a lease that expired in June 2017. In July 2017,
the Company leased the offices on a month to month basis. On
February 23, 2018, the Company modified its lease to reduce its
occupancy to 12,835 square feet. The fixed monthly lease expense
will be: $13,859 each month for the period beginning January 1,
2018 and ending March 31, 2018; $8,022 each month for the period
beginning April 1, 2018 and ending March 31, 2019; $8,268 each
month for the period beginning April 1, 2019 and ending March 31,
2020; and $8,514 each month for the period beginning April 1, 2020
and ending March 31, 2021.
The
Company recognizes lease expense on a straight-line basis over the
estimated lease term and combine lease and non-lease components.
Future minimum rental payments at March 31, 2020 under
non-cancellable operating leases for office space and equipment are
as follows (in thousands):
Year
|
Amount
|
2020
|
90
|
2021
|
30
|
Total
|
120
|
Less:
Interest
|
11
|
Present value of
lease liability
|
109
|
20
Related
Party Contracts
On June
5, 2016, the Company entered into a license agreement with Shenghuo
Medical, LLC pursuant to which the Company granted Shenghuo an
exclusive license to manufacture, sell and distribute LuViva in
Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines,
Singapore, Thailand, and Vietnam. Shenghuo was already the
Company’s exclusive distributor in China, Macau and Hong
Kong, and the license extended to manufacturing in those countries
as well. Under the terms of the license agreement, once Shenghuo
was capable of manufacturing LuViva in accordance with ISO 13485
for medical devices, Shenghuo would pay the Company a royalty equal
to $2.00 or 20% of the distributor price (subject to a discount
under certain circumstances), whichever is higher, per disposable
distributed within Shenghuo’s exclusive territories. In
connection with the license grant, Shenghuo was to underwrite the
cost of securing approval of LuViva with Chinese Food and Drug
Administration. At its option, Shenghuo also would provide up to
$1.0 million in furtherance of the Company’s efforts to
secure regulatory approval for LuViva from the U.S. Food and Drug
Administration, in exchange for the right to receive payments equal
to 2% of the Company’s future sales in the United States, up
to an aggregate of $4.0 million. Pursuant to the license agreement,
Shenghuo had the option to have a designee appointed to the
Company’s board of directors (former director Richard
Blumberg was the designee).
On July
24, 2019, Shandong Yaohua Medical Instrument Corporation
(“SMI”), agreed to modify its existing agreement. Under
the terms of this modification, the Company agreed to grant (1)
exclusive manufacturing rights, excepting the disposable cervical
guides for the Republic of Turkey, and the final assembly rights
for Hungary, and (2) exclusive distribution and sales for LuViva in
jurisdictions, subject to the following terms and conditions.
First, SMI shall complete the payment for parts, per the purchase
order, for five additional LuViva devices. Second, in consideration
for the $885,144 that the Company received, SMI will receive 12,147
common stock shares. Third, SMI shall honor all existing purchase
orders it has executed to date with the Company, in order to
maintain jurisdiction sales and distribution rights. If SMI needs
to purchase cervical guides then it will do so at a cost including
labor, plus ten percent markup. The Company will provide 200
cervical guides at no cost for the clinical trials. Fourth, the
Company and SMI will make best efforts to sell devices after CFDA
approval. With an initial estimate of year one sales of 200 LuViva
devices; year two sales of 500 LuViva devices; year three sales of
1,000 LuViva devices; and year four sales of 1,250 LuViva devices.
Fifth, SMI shall pay for entire costs of securing approval of
LuViva with the Chinese FDA. Sixth, SMI shall arrange, at its sole
cost, for a manufacturer in China to build tooling to support
manufacture. In addition, SMI retains the right to manufacture for
China, Hong Kong, Macau and Taiwan, where SMI has distribution and
sales rights. For each single-use cervical guide sold by SMI in the
jurisdictions, SMI shall transfer funds to escrow agent at a rate
of $1.90 per device chip. If within 18 months of the
license’s effective date, SMI fails to achieve
commercialization of LuViva in China, SMI shall no longer have any
rights to manufacture, distribute or sell LuViva. Commercialization
is defined as: filing an application with the Chinese FDA for the
approval of LuViva; any assembly or manufacture of the devices or
disposables that begins in China; and purchase of at least 10
devices and disposables for clinical evaluations and regulatory use
and or sales in the jurisdictions. On March 5, 2020 the Company had
recorded an accrued liability for SMI of $692,335, which was
reclassified to additional paid in capital and 12,147 common stock
shares.
On
September 6, 2016, the Company entered into a royalty agreement
with one of its directors, John Imhoff, and another stockholder,
Dolores Maloof, pursuant to which the Company sold to them a
royalty of future sales of single-use cervical guides for LuViva.
Under the terms of the royalty agreement, and for consideration of
$50,000, the Company will pay them an aggregate perpetual royalty
initially equal to $0.10, and from and after October 2, 2016, equal
to $0.20, for each disposable that the Company sells (or that is
sold by a third party pursuant to a licensing arrangement with the
Company).
Contingencies
Based
on the current outbreak of the Coronavirus SARS-CoV-2, the pathogen
responsible for COVID-19, which has already had an impact on
financial markets, there could be additional repercussions to the
Company’s operating business, including but not limited to,
the sourcing of materials for product candidates, manufacture of
supplies for preclinical and/or clinical studies, delays in
clinical operations, which may include the availability or the
continued availability of patients for trials due to such things as
quarantines, conduct of patient monitoring and clinical trial data
retrieval at investigational study sites.
The
future impact of the outbreak is highly uncertain and cannot be
predicted, and the Company cannot provide any assurance that the
outbreak will not have a material adverse impact on the
Company’s operations or future results or filings with
regulatory health authorities. The extent of the impact to the
Company, if any, will depend on future developments, including
actions taken to contain the coronavirus.
21
8.
NOTES PAYABLE
Notes
Payable in Default
At
March 31, 2020 and December 31, 2019, the Company maintained notes
payable to both related and non-related parties totaling
approximately $299,000 and $776,000, respectively. These notes are
short term, straight-line amortizing notes. The notes carry annual
interest rates between 0% and 10% and have default rates as high a
20%. The Company is
accruing interest at the default rate of 18.0% on two of the loans.
As described in Note 4:
STOCKHOLDERS’ DEFICIT notes payable in default
outstanding had been exchanged for equity and cash as described in
the note.
As
described previously, the Company entered into an exchange
agreement with Dr. Imhoff. Based on this agreement the Company
exchanged $199,417 of short-term debt outstanding.
As
described previously, the Company entered into an exchange
agreement with Ms. Rosentstock. Based on this agreement the Company
exchanged $50,000 of short-term debt outstanding and forgave
$28,986.
On
February 8, 2019, a note payable in default to Aquarius as reported
in the Company’s Form 10-K report - Footnote 9: Notes payable – Note payable
in default, was exchanged for a note with a convertible
option. The balance on the note was $107,500 and accrued interest
was $38,044 for a total of $145,544 outstanding. As of March 31,
2020, the Company had entered into an exchange agreement with
Aquarius. Based on this agreement the Company exchanged $145,544 of
debt outstanding for: 291,088 common stock shares; 145,544 warrants
issued to purchase common stock shares at a strike price of $0.25;
and 145,544 warrants issued to purchase common stock shares at a
strike price of $0.75.
On July
1, 2019, the Company entered into a loan agreement with Accilent
Capital Management Inc / Rev Royalty Income and Growth Trust
(“Accilent”), providing for the purchase by Accilent of
an unsecured promissory note in the principal amount of $49,389
(CAD$ 65,500). The note was fully funded on July 9, 2019 (net of an
8% original issue discount and other expenses). The note bears an
interest rate of 16% and was due and payable on September 11, 2019.
Following maturity, demand, default, or judgment and until actual
payment in full, interest rate shall be paid at the rate of 19% per
annum. The Company issued 315,000 warrants at an exercise price of
$0.25 per warrant and exercisable within 3 years from issuance (the
“Initial Warrants”). As of March 31, 2020, the loan had
been paid off. As of December 31, 2019, $57,946 remained
outstanding, which included a fee of $4,951 and interest of
$4,606.
As
described previously, the Company entered into an exchange
agreement with Mr. Blumberg. Based on this agreement the Company
exchanged $70,320 of short-term debt outstanding.
As
described previously, the Company entered into an exchange
agreement with Mr. James. Based on this agreement the Company
exchanged $2,286 of short-term debt outstanding.
The
following table summarizes the Notes payable in default, including related
parties:
|
March
31,
2020
|
December
31,
2019
|
Dr.
Imhoff
|
$-
|
$199
|
Dr.
Cartwright
|
2
|
2
|
Ms.
Rosenstock
|
-
|
50
|
Mr.
Fowler
|
26
|
26
|
Mr.
Mermelstein
|
254
|
244
|
GPB
|
17
|
17
|
Aquarius
|
-
|
108
|
Accilent
|
-
|
58
|
Mr.
Blumberg
|
-
|
70
|
Mr.
James
|
-
|
2
|
Notes
payable in default
|
$299
|
$776
|
The
notes payable to related parties was $2,000 of the $299,000 balance
at March 31, 2020 and $349,000 of the $776,000 balance at December
31, 2019.
22
Short
Term Notes Payable
As
described previously, the Company entered into an exchange
agreement with Dr. Imhoff. Based on this agreement the Company
exchanged $167,000 of short-term debt outstanding.
The
Company issued promissory notes to Mr. Cartwright and Mr. Faupel,
in the amounts of approximately $48,000 and $5,000, respectively.
The notes were initially issued with 0% interest, however interest
increased to 6.0% interest 90 days after the Company received
$1,000,000 in financing proceeds.
On
August 22, 2018, the Company issued a promissory note to Mr. Case
for $150,000 in aggregate principal amount of a 6% promissory note
for an aggregate purchase price of $157,500 (representing a $7,500
original issue discount). As of March 31, 2020, the Company had
exchanged $179,291 of debt outstanding for: 896,456 common stock
shares; and 896,455 warrants issued to purchase common stock shares
at a strike price of $0.20. As of December 31, 2019, the Company
had not repaid the note and original issue discount of $157,500
($7,500 is recorded in accrued expenses).
As
described previously, the Company entered into an exchange
agreement with Mr. Mamula. Based on this agreement the Company
exchanged $15,577 of short-term debt outstanding.
On
September 19, 2018, the Company issued a promissory note to Mr.
Gould for $50,000 in aggregate principal amount of a 6% promissory
note for an aggregate purchase price of $52,500 (representing a
$2,500 original issue discount). As of March 31, 2020, the Company
had entered into an exchange agreement with Mr. Gould. Based on
this agreement the Company will exchange $111,227 of debt
outstanding for: 556,136 common stock shares; and 556,136 warrants
issued to purchase common stock shares at a strike price of $0.20.
As of December 31, 2019, the Company had not repaid the note and
original issue discount of $52,500 ($2,500 is recorded in accrued
expenses) and therefore the accrued interest rate increased to
12%.
On
February 15, 2019, the Company issued a promissory note to Mr.
Gould for $50,000 in aggregate principal amount of a 6% promissory
note for an aggregate purchase price of $52,500 (representing a
$2,500 original issue discount). As of March 31, 2020, this note
was exchanged as explained in the preceding paragraph. As of
December 31, 2019, the Company had not repaid the note and original
issue discount of $52,500 ($2,500 is recorded in accrued
expenses).
As
described previously, the Company entered into an exchange
agreement with K2 Medical. Based on this agreement the Company
exchanged $203,000 of short-term debt outstanding.
On
February 14, 2019, the Company entered into a Purchase and Sale
Agreement with Everest Business Funding for the sale of its
accounts receivable. The transaction provided the Company with
$48,735 after $1,265 in debt issuance costs (bank costs) for a
total purchase amount of $50,000, in which the Company would have
to repay $68,500. At a minimum the Company would need to pay
$535.16 per day or 20.0% of the future collected accounts
receivable or “receipts.” The effective interest rate
as calculated for this transaction is approximately 132.5%. As of
December 31, 2019, $60,105 had been paid, leaving a balance of
$8,016. As of March 31, 2020, $63,395 had been paid, leaving a
balance of $4,726.
In July
2019, the Company entered into a premium finance agreement to
finance its insurance policies totaling $142,000. The note requires
monthly payments of $14,459, including interest at 4.91% and
matures in April 2020. As of March 31, 2020, a balance of $14,459
remained. The balance due on insurance policies totaled $57,483 at
December 31, 2019.
As
described previously, the Company entered into an exchange
agreement with Mr. Blumberg. Based on this agreement the Company
exchanged $223,000 of short-term debt outstanding.
As
described previously, the Company entered into an exchange
agreement with Mr. Grimm. Based on this agreement the Company
exchanged $51,050 of short-term debt outstanding.
At
March 31, 2020 and December 31, 2019, the Company maintained short
term notes payable to both related and non-related parties totaling
$72,000 and $1,026,000, respectively. These notes are short term,
straight-line amortizing notes. The notes carry annual interest
rates between 5% and 19%.
23
The
following table summarizes the Short-term notes payable, including related
parties:
|
March
31,
2020
|
December
31,
2019
|
Dr.
Imhoff
|
$-
|
$167
|
Dr.
Cartwright
|
48
|
48
|
Dr.
Faupel
|
5
|
5
|
Mr.
Case
|
-
|
150
|
Mr.
Mamula
|
-
|
15
|
Mr.
Gould
|
-
|
100
|
K2
(Shenghuo)
|
-
|
203
|
Everest
|
5
|
8
|
Premium Finance
(insurance)
|
14
|
58
|
Mr.
Blumberg
|
-
|
223
|
Mr.
Grimm
|
-
|
49
|
Short-term
notes payable, including related parties
|
$72
|
$1,026
|
The
short-term notes payable past due to related parties was $53,000 of
the $72,000 balance at March 31, 2020 and $646,000 of the
$1,026,000 balance at December 31, 2019.
Troubled Debt Restructuring
The
debt extinguished for Notes Payable which closed on January 8,
2020, the Company exchanged $2,064,366 in debt for common stock
shares and warrants as described above that were determined to have
a total fair value of $2,065,548, resulting in a loss on
extinguishment of debt of $1,183 which is recorded in other income
(expense) on the accompanying consolidated statements of
operations. In addition, one of the investors forgave approximately
$29,000 of debt, which was recorded as a gain for extinguishment of
debt. This debt extinguished met the criteria for troubled debt.
The basic criteria are that the borrower is troubled, ie., they are
having financial difficulties, and a concession is granted by the
creditor. Due to the Company being in default on several of its
loans the debt is considered troubled debt. The troubled debt
restructuring for Notes Payable, had an immaterial effect on the
Company’s basic or diluted earnings per share calculation for
March 31, 2020 and 2019.
9.
SHORT-TERM CONVERTIBLE DEBT
Related
Party Convertible Note Payable – Short-Term
On June
5, 2016, the Company entered into a license agreement with a
distributor pursuant to which the Company granted the distributor
an exclusive license to manufacture, sell and distribute the
Company’s LuViva Advanced Cervical Cancer device and related
disposables in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar,
Philippines, Singapore, Thailand, and Vietnam. The distributor was
already the Company’s exclusive distributor in China, Macau
and Hong Kong, and the license will extend to manufacturing in
those countries as well.
As
partial consideration for, and as a condition to, the license, and
to further align the strategic interests of the parties, the
Company agreed to issue a convertible note to the distributor, in
exchange for an aggregate cash investment of $200,000. The note
will provide for a payment to the distributor of $240,000, due upon
consummation of any capital raising transaction by the Company
within 90 days and with net cash proceeds of at least $1.0 million.
As of March 31, 2020, the note had been exchanged for common stock
shares and warrants. This was part of the exchange made on January
8, 2020, for $790,544 of debt outstanding for: 1,905,270 common
stock shares issued on March 23, 2020; 496,602 warrants issued to
purchase common stock shares at a strike price of $0.20; 692,446
warrants issued to purchase common stock shares at a strike price
of $0.25; and 692,446 warrants issued to purchase common stock
shares at a strike price of $0.75. As of December 31, 2019, the
Company had a note due of $512,719.
Troubled Debt Restructuring
The
debt extinguished for Related Party Convertible Note Payable
– Short-Term, which closed on January 8, 2020, the Company
exchanged in part $512,719 in debt for several common stock shares
and warrants as described above. This debt extinguished met the
criteria for troubled debt. The basic criteria are that the
borrower is troubled, i.e., they are having financial difficulties,
and a concession is granted by the creditor. Due to the Company
being in default on several of its loans the debt is considered
troubled debt. See Note 8: Notes Payable, for total gain or loss
recorded in the period. The troubled debt restructuring for Notes
Payable, had an immaterial effect on the Company’s basic or
diluted earnings per share calculation for March 31, 2020 and
2019.
24
Convertible
Note Payable – Short-Term
On
March 31, 2020, we entered into a securities purchase agreement
with Auctus Fund, LLC for the issuance and sale to Auctus of
$112,750 in aggregate principal amount of a 12% convertible
promissory note. On March 31, 2020, we issued the note to Auctus
and issued 250,000 five-year common stock warrants at an exercise
price of $0.16. On April 3, 2020, we received net proceeds of
$100,000. The note matures on January 26, 2021 and accrues interest
at a rate of 12% per year. We may not prepay the note, in whole or
in part. After the 90th calendar day after
the issuance date, and ending on the later of maturity date and the
date of payment of the default amount, Auctus may convert the note,
at any time, in whole or in part, provided such conversion does not
provide Auctus with more than 4.99% of the outstanding common share
stock. The conversion may be made converted into shares of the our
common stock, at a conversion price equal to the lesser of: (i) the
lowest Trading Price during the twenty-five (25) trading day period
on the last trading prior to the issue date and (ii) the variable
conversion price (55% multiplied by the market price, market price
means the lowest trading price for the common stock during the
twenty-five (25) trading day period ending on the latest complete
trading day prior to the conversion date. Trading price is the
lowest trade price on the trading market as reported. The note
includes customary events of default provisions and a default
interest rate of 24% per year.
On May
15, 2019, the Company entered into a securities purchase agreement
with Eagle Equities, LLC, providing for the purchase by Eagle of a
convertible redeemable note in the principal amount of $57,750. The
note was fully funded on May 21, 2019, upon which the Company
received $45,000 of net proceeds (net of a 10% original issue
discount and other expenses). The note bears an interest rate of 8%
is due and payable on May 15, 2020. The note may be converted by
Eagle at any time after five months from issuance into shares of
the Company common stock (as determined in the notes) calculated at
the time of conversion. The conversion price of the notes will be
equal to 60% of the average of the two lowest closing bid prices of
the Company’s common stock shares as reported on OTC Markets
exchange, for the 20 prior trading days including the day upon
which the Company receives a notice of conversion. The notes may be
prepaid in accordance with the terms set forth in the notes. The
notes also contain certain representations, warranties, covenants
and events of default including if the Company are delinquent in
our periodic report filings with the SEC and increases in the
amount of the principal and interest rates under the notes in the
event of such defaults. In the event of default, at Eagle’s
option and in its sole discretion, Eagle may consider the notes
immediately due and payable. During 2020, Eagle provided a
forbearance to the Company on the default after a payment was made.
On May 15, 2019, the Company had recorded a $38,500 beneficial
conversion feature, $5,250 original issue discount and $7,500 of
debt issuance costs. As of December 31, 2019, the outstanding note
was for $25,651, which consisted of unamortized balance of $14,438
of a beneficial conversion feature, unamortized original issue
discount of $1,942, unamortized debt issuance costs of $2,774 and
interest of $1,166 included in accrued expenses on the accompanying
consolidated balance sheet. As of March 31, 2020, the outstanding
note was for $26,651, which consisted of unamortized balance of
$4,812 of a beneficial conversion feature, unamortized original
issue discount of $633, unamortized debt issuance costs of $904 and
interest of $2,317 included in accrued expenses on the accompanying
consolidated balance sheet
On May
15, 2019, the Company entered into a securities purchase agreement
with Adar Bays, LLC, providing for the purchase by Adar of a
convertible redeemable note in the principal amount of $57,750. The
note was fully funded on May 21, 2019, upon which the Company
received $45,000 of net proceeds (net of a 10% original issue
discount and other expenses). The note bears an interest rate of 8%
and are due and payable on May 15, 2020. The note may be converted
by Adar at any time after five months from issuance into shares of
the Company common stock (as determined in the notes) calculated at
the time of conversion. The conversion price of the notes will be
equal to 60% of the average of the two lowest closing bid prices of
the Company’s common stock shares as reported on OTC Markets
exchange, for the 20 prior trading days including the day upon
which the Company receives a notice of conversion. The notes may be
prepaid in accordance with the terms set forth in the notes. The
notes also contain certain representations, warranties, covenants
and events of default including if the Company are delinquent in
our periodic report filings with the SEC and increases in the
amount of the principal and interest rates under the notes in the
event of such defaults. In the event of default, at Adar’s
option and in its sole discretion, Adar may consider the notes
immediately due and payable. During 2020, Adar provided a
forbearance to the Company on the default after a payment was made.
On May 15, 2019, the Company had recorded a $38,500 beneficial
conversion feature, $5,250 original issue discount and $7,500 of
debt issuance costs. As of December 31, 2019, the note outstanding
increased to $84,780 as a default penalty of $27,030 was added to
the outstanding balance of the note, which consisted of unamortized
balance of $14,438 of a beneficial conversion feature, unamortized
original issue discount of $1,942, unamortized debt issuance costs
of $2,774 and interest of $3,190 included in accrued expenses on
the accompanying consolidated balance sheet. As of March 31, 2020,
the note outstanding decreased to $28,176 including a default
penalty of $27,030 that was added to the outstanding balance of the
note, which consisted of unamortized balance of $4,813 of a
beneficial conversion feature, unamortized original issue discount
of $633, unamortized debt issuance costs of $904 and interest of
$1,851 included in accrued expenses on the accompanying
consolidated balance sheet.
25
The
following table summarizes the Convertible notes payable:
|
March
31,
2020
|
December
31,
2019
|
Shenghuo
|
$-
|
$513
|
Auctus
|
113
|
-
|
Eagle
|
27
|
26
|
Adar
|
28
|
85
|
Debt discount and
issuance costs to be amortized
|
(30)
|
(9)
|
Debt discount
related to beneficial conversion
|
(10)
|
(29)
|
Convertible
notes payable
|
$128
|
$586
|
10.
CONVERTIBLE DEBT
Senior Secured Promissory Note
Effective
February 12, 2016, the Company entered into a securities purchase
agreement with GPB Debt Holdings II LLC (“GPB”) for the
issuance of a $1,437,500 senior secured convertible note for an
aggregate purchase price of $1,029,000 (representing an original
issue discount of $287,500 and debt issuance costs of $121,000). On
May 28, 2016, the balance of the note was increased by $87,500 for
a total principal balance of $1,525,000. On December 7, 2016, the
Company entered into an exchange agreement with GPB and as a result
the principal balance increased by a transfer $312,500 (see –
“Senior Secured Promissory Note”) for a total principal
balance of $1,837,500. In addition, GPB received warrants for 2,246
shares of the Company’s common stock. The Company allocated
proceeds totaling $359,555 to the fair value of the warrants at
issuance and recorded an additional discount on the debt. The
warrant is exercisable at any time, pending availability of
sufficient authorized but unissued shares of the Company’s
common stock, at an exercise price per share equal to the
conversion price of the convertible note, subject to certain
customary adjustments and anti-dilution provisions contained in the
warrant. The warrant has a five-year term. At December 31, 2019,
the common stock purchase warrant exercise price had been adjusted
to $0.04 and the number of common stock shares exchangeable for was
35,937,500.
As
of March 31, 2020, and as a result of the January 15, 2020 exchange
agreement, the common stock purchase warrant exercise price had
been adjusted to $0.20 and the number of common stock shares
exchangeable for was 7,185,000. This exchange is subject to the
Company meeting repayment conditions. Those conditions involved in
part the repayment of $450,000, $100,000 and $950,000 for the
completion of each Auctus financing tranche. The Company has
executed Tranche 1 and 2 and has paid GPB $550,000. In addition,
the Company would need to begin repaying $50,000, in repayment of
$1,500,000, each month, beginning on September 15, 2020 (if the
Company is not in default it may request an additional four-month
forbearance on that repayment.
The
convertible note required monthly interest payments at a rate of
17% per year and was due on February 12, 2018. Subject to resale
restrictions and the availability of sufficient authorized but
unissued shares of the Company’s common stock, the note is
convertible at a conversion price equal to 70% of the average
closing price per share for the five trading days prior to
issuance. In an event default the note will accrue interest at a
rate of 22%. Upon the occurrence of an event of default, the holder
may require the Company to redeem the convertible note at 120% of
the outstanding principal balance, but as of March 31, 2020 and
December 31, 2019, had not done so. The note is secured by a lien
on substantially all of the Company’s assets.
In
connection with the transaction, on February 12, 2016, the Company
and GPB entered into a four-year consulting agreement, pursuant to
which the investor will provide management consulting services to
the Company in exchange for a royalty payment, payable quarterly,
equal to 3.85% of the Company’s revenues from the sale of
products. As of March 31, 2020, and December 31, 2019, GPB had
earned approximately $32,000 and $31,000 in royalties that are
unpaid, respectively.
As
of March 31, 2020, the balance due on the convertible debt was
$1,889,556, consisting of principal of $1,542,530 and a prepayment
penalty of $347,026 and compared to December 31, 2019, where the
balance due on the convertible debt was $2,177,030 consisting of
principal of $1,830,000 and a prepayment penalty of $347,030.
Interest accrued on the note total $1,103,124 and $1,175,925 at
March 31, 2020 and December 31, 2019, respectively, and is included
in accrued expenses on the accompanying consolidated balance
sheet.
26
The
Company used a placement agent in connection with the transaction.
For its services, the placement agent received a cash placement fee
equal to 4% of the aggregate gross proceeds from the transaction
and a warrant to purchase shares of common stock equal to an
aggregate of 6% of the total number of shares underlying the
securities sold in the transaction, at an exercise price equal to,
and terms otherwise identical to, the warrant issued to the
investor. Finally, the Company agreed to reimburse the placement
agent for its reasonable out-of-pocket expenses.
Troubled Debt Restructuring
The
debt restructured for Convertible Debt, which closed on January 15,
2020, the Company restructured several re-payment plans as
described above and in addition cancelled warrants and issued new
warrants as part of the restructure. This debt restructure met the
criteria for troubled debt. The basic criteria are that the
borrower is troubled, i.e., they are having financial difficulties,
and a concession is granted by the creditor. Due to the Company
being in default on several of its loans the debt is considered
troubled debt. See Note 8: Notes Payable, for total gain or loss
recorded in the period. The troubled debt restructuring for
Convertible Debt, based on the reduction in warrants outstanding
would have an effect on the Company’s diluted earnings per
share calculation for March 31, 2020, but not on the basic earnings
per share calculation. The earnings per share value would have
adjusted from 0.041 to 0.029.
Secured Promissory Note.
Effective
September 10, 2014, the Company sold a secured promissory note to
an accredited investor, GHS Investments, LLC (“GHS”),
with an initial principal amount of $1,275,000, for a purchase
price of $570,000 (less an original issue discount of $560,000 and
debt issuance costs of $145,000). The note is secured by the
Company’s current and future accounts receivable and
inventory and accrued interest at a rate of 18% per year. The note
has subsequently been assigned to different credited investors and
the terms of the note were amended extend the maturity until August
31, 2016. The balance of this note was reduced by a transfer of
$306,863 as part of a debt restructuring that occurred on December
7, 2016 (see – “Senior Secured Promissory Note”).
The holder may convert the outstanding balance into shares of
common stock at a conversion price per share equal to 75% of the
lowest daily volume average price of common stock during the five
days prior to conversion. The balance due on the note was $150,025
and $148,223 at March 31, 2020 and December 31, 2019,
respectively.
Other
Convertible Debt in Default
Effective May 19,
2017, the Company entered into a securities purchase agreement with
GHS for the purchase of a $66,000 convertible promissory note for
the purchase of $60,000 in net proceeds (representing a 10%
original issue discount of $6,000). The accrued interest rate of 8%
per year until it matured in December 31, 2017. Beginning February
2018, the note is convertible, in whole or in part, at the
holder’s option, into shares of the Company’s stock at
a conversion price equal to 60% of the lowest trading price during
the 25 trading days prior to conversion. Upon the occurrence of an
event of default, the note will bear interest at a rate of 20% per
year and the holder of the note may require the Company to redeem
or convert the note at 150% of the outstanding principal balance.
At March 31, 2020 and December 31, 2019, the balance due on this
total was $83,094, including a default penalty of $37,926 and
accrued interest of $18,298, and $83,094 including a default
penalty of $37,926 and accrued interest of $16,641, respectively.
GHS converted $12,700 and $29,642 of principal and accrued interest
during the years ended December 31, 2019,
respectively.
Effective May 17,
2018, the Company entered into a securities purchase agreement with
GHS for the purchase of a convertible promissory note with a
principal of $9,250 for a purchase price of $7,500 (representing an
original issue discount of $750 and debt issuance costs of $1,000).
The note accrued interest at a rate of 8% per year until its
matured June 17, 2019. Beginning February 2018, the note is
convertible, in whole or in part, at the holder's option, into
shares of the Company's stock at a conversion price equal to 70% of
the lowest trading price during the 25 trading days prior to
conversion (if the note cannot be converted due to Depository Trust
Company freeze then rate decreases to 60%). Upon the occurrence of
an event of default, the note will bear interest at a rate of 20%
per year and the holder of the note may require the Company to
redeem or convert the note at 150% of the outstanding principal
balance. At March 31, 2020 and December 31, 2019, the balance due
on this total was $14,187, including a default penalty of $4,937,
and $14,187, including a default penalty of $4,937, respectively.
Interest accrued on the note totals $4,132 and $3,972 at March 31,
2020 and December 31, 2019, respectively, and is included in
accrued expenses on the accompanying consolidated balance
sheet.
Effective June 22,
2018, the Company entered into a securities purchase agreement with
GHS for the purchase of a $68,000 convertible promissory note for a
purchase price of $60,000 (representing an original issue discount
of $6,000 and debt issuance costs of $2,000). At issuance, the
Company recorded a $29,143 beneficial conversion feature, which was
fully amortized at December 31, 2019. The accrued interest at a
rate of 10% per year until it matured on June 22, 2019. Beginning
May 2019, the note is convertible, in whole or in part, at the
holder's option, into shares of the Company's stock at a conversion
price equal to 70% of the lowest trading price during the 25
trading days prior to conversion (if the note cannot be converted
due to Depository Trust Company freeze then rate decreases to 60%).
Upon the occurrence of an event of default, the note will bear
interest at a rate of 20% per year and the holder of the note may
require the Company to redeem or convert the note at 150% of the
outstanding principal balance. At March 31, 2020 and December 31,
2019, the balance due on this total was $103,285, including a
default penalty of $35,285, and $103,285, including a default
penalty of $35,285, respectively. Interest accrued on the note
totals $31,862 and $29,287 at March 31, 2020 and December 31, 2019,
respectively, and is included in accrued expenses on the
accompanying consolidated balance sheet.
27
Effective March 20,
2018, the Company entered into a securities purchase with Auctus
Fund, LLC ("Auctus") for the issuance of a $150,000 convertible
promissory note and warrants exercisable for 4,262 shares of the
Company's common stock. At issuance, the Company recorded a $97,685
beneficial conversion feature, which was fully amortized at
December 31, 2018. The warrants are exercisable at any time, at an
exercise price equal to $0.04 per share, subject to certain
customary adjustments and price-protection provisions contained in
the warrant. The warrants have a five-year term. The note accrued
interest at a rate of 12% per year until it matured in December
2018. Beginning December 2018, the note is convertible, in whole or
in part, at the holder's option, into shares of the Company's stock
at a conversion price equal to 60% of the lowest trading price
during the 20 trading days prior to conversion. Upon the occurrence
of an event of default, the note will bear interest at a rate of
24% per year and the holder of the note may require the Company to
redeem or convert the note at 150% of the outstanding principal
balance. At March 31, 2020 and December 31, 2019, the balance due
on this total was $192,267, including a default penalty of $70,931,
and 192,267, including a default penalty of $70,931, respectively.
Interest accrued on the note totals $57,293 and $45,629 at March
31, 2020 and December 31, 2019, respectively, and is included in
accrued expenses on the accompanying consolidated balance
sheet.
Auctus
converted nil and $14,236 of principal and accrued interested
during the three months and year ended March 31, 2020 and December
31, 2019, respectively.
Effective July 3,
2018, the Company entered into a securities purchase with Auctus
for the issuance of a $89,250 convertible promissory note. At
issuance, the Company recorded a $59,000 beneficial conversion
feature, which was fully amortized at December 31, 2019. The note
accrued interest at a rate of 12% per year until it matured in
April 2019. Beginning April 2019, the note is convertible, in whole
or in part, at the holder's option, into shares of the Company's
stock at a conversion price equal to 60% of the lowest trading
price during the 20 trading days prior to conversion. Upon the
occurrence of an event of default, the note will bear interest at a
rate of 24% per year and the holder of the note may require the
Company to redeem or convert the note at 150% of the outstanding
principal balance. At March 31, 2020 and December 31, 2019, the
balance due on this total was $90,641, including a default penalty
of $56,852, and $90,641, including a default penalty of $56,852,
respectively. Interest accrued on the note totals $21,935 and
$16,436 at March 31, 2020 and December 31, 2019, respectively, and
is included in accrued expenses on the accompanying consolidated
balance sheet.
Effective March 29,
2019, the Company entered into a securities purchase with Auctus
for the issuance of a $65,000 convertible promissory note. At
issuance, the Company recorded a $65,000 beneficial conversion
feature, which was fully amortized at December 31, 2019. The note
accrued interest at a rate of 12% until it matured in December
2019. Beginning December 2019, the note is convertible, in whole or
in part, at the holder's option, into shares of the Company's stock
at a conversion price equal to 50% of the lowest trading price
during the 25 trading days prior to conversion. Upon the occurrence
of an event of default, the note will bear interest at a rate of
24% per year and the holder of the note may require the Company to
redeem or convert the note at 150% of the outstanding principal
balance. At March 31, 2020 and December 31, 2019, the balance due
on this total was $106,210, including a default penalty of $41,210
and 106,210, including a default penalty of $41,210, respectively.
Interest accrued on the note totaled $6,585 and $142 at March 31,
2020 and December 31, 2019 and is included in accrued expenses on
the accompanying consolidated balance sheet.
The
following table summarizes the Convertible notes (including debt in
default):
|
|
March
31, 2020
|
|
December 31,
2019
|
GPB
|
|
$1,890
|
|
$2,177
|
GHS
|
$151
|
|
$149
|
|
|
83
|
|
83
|
|
|
14
|
|
14
|
|
|
103
|
351
|
103
|
349
|
Auctus
|
$192
|
|
$192
|
|
|
91
|
|
91
|
|
|
106
|
389
|
106
|
389
|
Convertible
notes (including debt in default)
|
|
$2,630
|
|
$2,915
|
The
convertible notes payable in default was $740,000 of the $2,630,000
balance at March 31, 2020 and the total balance of $2,915,000 at
December 31, 2019.
28
11.
LONG-TERM DEBT
Long-term
Debt – Related Parties
On July
24, 2019, Dr. Faupel and Mr. Cartwright agreed to an addendum to
the debt restructuring exchange agreement and to modify the terms
of the original exchange agreement. Under this modification Dr.
Faupel and Mr. Cartwright agreed to extend the note to be due in
full on the third anniversary of that agreement. The modification
also included simple interest at a 6% rate, with the principal and
accrued interest due in total at the date of maturity or September
4, 2021.
During
the quarter ended September 30, 2018, the Company entered into an
exchange agreement dated July 14, 2018, Dr Faupel, agreed to
exchange outstanding amounts due to him for loans, interest, bonus,
salary and vacation pay in the amount of $661,000 for a $207,000
promissory note dated September 4, 2018. As a result of the
exchange agreement, the Company recorded a gain for extinguishment
of debt of $199,000 and a capital contribution of $235,000 during
the year ended December 31, 2018. The resulting difference of
$20,000 was recorded to accrued interest. In the July 20, 2018
exchange agreement, Dr, Cartwright, agreed to exchange outstanding
amounts due to him for loans, interest, bonus, salary and vacation
pay in the amount of $1,621,000 for a $319,000 promissory note
dated September 4, 2018. As a result of the exchange agreement, the
Company recorded a gain for extinguishment of debt of $840,000 and
a capital contribution of $432,000 during the year ended December
31, 2018. The resulting difference of $30,000 was recorded to
accrued interest and elimination of debt.
Troubled Debt Restructuring
The
debt extinguished for Mr. Cartwright and Mr. Faupel meet the
criteria for troubled debt. The basic criteria are that the
borrower is troubled, i.e., they are having financial difficulties,
and a concession is granted by the creditor. Due to the Company
being in default on several of its loans the debt is considered
troubled debt. The troubled debt restructuring for Long-term Debt
– Related Parties, had an immaterial effect on the
Company’s basic or diluted earnings per share calculation for
March 31, 2020 and 2019 as the gain was recorded in
2018.
The
table below summarizes the detail of the exchange
agreement:
For Dr.
Faupel:
Salary
|
$134
|
Bonus
|
20
|
Vacation
|
95
|
Interest on
compensation
|
67
|
Loans to
Company
|
196
|
Interest on
loans
|
149
|
Total
outstanding prior to exchange
|
$661
|
Amount forgiven
during the quarter ended September 30, 2018
|
(454)
|
Promissory
note dated September 4, 2018
|
$207
|
Interest
accrued through December 31, 2019
|
17
|
Balance
outstanding at December 31, 2019
|
$224
|
Interest
accrued through March 31, 2020
|
4
|
Balance
outstanding at March 31, 2020
|
$228
|
For Dr.
Cartwright:
Salary
|
$337
|
Bonus
|
675
|
Interest on
compensation
|
59
|
Loans to
Company
|
528
|
Interest on
loans
|
22
|
Total
outstanding prior to exchange
|
$1,621
|
Amount
forgiven during the quarter ended September 30, 2018
|
(1,302)
|
Promissory
note dated September 4, 2018
|
$319
|
Interest
accrued through December 31, 2019
|
26
|
Balance
outstanding at December 31, 2019
|
$345
|
Interest
accrued through March 31, 2020
|
4
|
Balance
outstanding at March 31, 2020
|
$349
|
29
Future
debt obligations at March 31, 2020 for Long-term Debt –
Related Parties are as follows (in thousands):
Year
|
Amount
|
2020
|
-
|
2021
|
-
|
2022
|
200
|
2023
|
200
|
2024
|
177
|
Totals
|
577
|
Long-term
Convertible Notes Payable, net
On
December 17, 2019, the Company entered into a securities purchase
agreement and convertible note with Auctus. The convertible note
issued to Auctus will be for a total of $2.4 million. The first
tranche of $700,000 has been received and will have a maturity date
of December 17, 2021 and an interest rate of ten percent (10%). The
note may not be prepaid in whole or in part except as otherwise
explicitly allowed. Any amount of principal or interest on the note
which is not paid when due shall bear interest at the rate of the
lessor of 24% or the maximum permitted by law (the “default
interest”). The variable conversion prices shall equal the
lesser of: (i) the lowest trading price on the issue date, and (ii)
the variable conversion price. The variable conversion price shall
mean 95% multiplied by the market price (the market price means the
average of the five lowest trading prices during the period
beginning on the issue date and ending on the maturity date), minus
$0.04 per share, provided however that in no event shall the
variable conversion price be less than $0.15. If an event of
default under this note occurs and/or the note is not extinguished
in its entirety prior to December 17, 2020 the $0.15 price shall no
longer apply. In connection with the first tranche of $700,000, the
Company issued to 7,500,000 warrants to purchase common stock at an
exercise price of $0.20. The fair value of the warrants at the date
of issuance was $745,972 and was $635,000 allocated to the warrant
liability and a loss of $110,972 was recorded at the date of
issuance for the amount of the fair value in excess of the net
proceeds received of $635,000. The $700,000 proceeds were received
net of debt issuance costs of $65,000 (net proceeds of $635,000,
after administrative and legal expenses Company received $570,000).
The Company used $65,000 of the proceeds to make a partial payment
of the $89,250 convertible promissory note issued on July 3, 2018
to Auctus. On May 27, 2020, the second tranche of $400,000 was
received. The last tranche of $1.3 million will be received within
60 days of the S-1 registration statement becoming effective. The
conversion price of the notes will be at market value with a
minimum conversion amount of $0.15. The last two tranches will have
warrants attached. As of March 31, 2020, and December 31, 2019,
$700,000 remained outstanding and accrued interest of $20,417 and
$2,722, respectively. Further, as of March 31, 2020, and December
31, 2019, the Company had unamortized debt issuance costs of
$56,000 and $64,000, respectively and an unamortized debt discount
on warrants of $542,000, and $622,000, respectively and providing a
net balance of $102,000 and $15,000, respectively.
In
addition, the Company determined that the conversion option needed
to be bifurcated from the debt arrangement and will valued at fair
value each reporting period. The initial value at the date of
issuance deemed to be $0 due to the presence of the $0.15 floor
price.
Future
debt obligations at March 31, 2020 for Long-term Convertible Notes
Payable, net are as follows (in thousands):
Year
|
Amount
|
2020
|
-
|
2021
|
700
|
2022
|
-
|
2023
|
-
|
2024
|
-
|
Totals
|
700
|
12.
INCOME (LOSS) PER COMMON SHARE
Basic
net income (loss) per share attributable to common stockholders,
amounts are computed by dividing the net income (loss) plus
preferred stock dividends and deemed dividends on preferred stock
by the weighted average number of shares outstanding during the
year.
30
Diluted
net income (loss) per share attributable to common stockholders
amounts are computed by dividing the net income (loss) plus
preferred stock dividends, deemed dividends on preferred stock,
after-tax interest on convertible debt and convertible dividends by
the weighted average number of shares outstanding during the year,
plus Series C and Series D convertible preferred stock, convertible
debt, convertible preferred dividends and warrants convertible into
common stock shares.
The
following table sets forth pertinent data relating to the
computation of basic and diluted net loss per share attributable to
common shareholders.
In thousands
|
Three months ended March 31,
|
||
|
2020
|
2019
|
|
|
|
|
|
Net income (loss)
|
$2,716
|
$(224)
|
|
Basic weighted average number of shares outstanding
|
5,013
|
3,248
|
|
Net income (loss) per share (basic)
|
$0.542
|
$(0.069)
|
|
Diluted weighted average number of shares outstanding
|
65,620
|
3,248
|
|
Net income (loss) per share (diluted)
|
$0.0415
|
$(0.069)
|
|
|
|
|
|
Dilutive equity instruments (number of equivalent
units):
|
|
|
|
Stock options
|
-
|
-
|
|
Preferred stock
|
-
|
-
|
|
Convertible debt
|
59,282
|
37,898
|
|
Warrants
|
1,325
|
30,582
|
|
Total Dilutive instruments
|
60,607
|
68,480
|
|
13.
SUBSEQUENT EVENTS
On
April 23, 2020, the Company received $25,000 of equity investments.
These investors received a total of 50,000 common stock shares and
50,000 warrants issued to purchase common stock shares at a strike
price of $0.25, 50,000 warrants to purchase common stock shares at
a strike price of $0.75 and 50 Series D preferred stock (each
Series D preferred stock shares converts into 3,000 shares of the
Company’s common stock shares).
On May 4, 2020, the Company received a loan from
the Small Business Administration (SBA) pursuant to the Paycheck
Protection Program (PPP) as part of the Coronavirus Aid, Relief,
and Economic Security Act (CARES Act) in the amount of $50,184. The
loan bears interest at a rate of 1.00%, and matures in 24 months,
with the principal and interest payments being deferred until the
date of forgiveness with interest accruing, then converting to
monthly principal and interest payments, at the interest rate
provided herein, for the remaining eighteen (18) months. Lender
will apply each payment first to pay interest accrued to the day
Lender received the payment, then to bring principal current, and
will apply any remaining balance to reduce principal. Payments must
be made on the same day as the date of this Note in the months they
are due. Lendershall adjust payments at least annually as needed to
amortize principal over the remaining term of the Note. Under the
provisions of the PPP, the loan amounts will be forgiven as long
as: the loan proceeds are used to cover payroll costs, and most
mortgage interest, rent, and utility costs over a 24 week period
after the loan is made; and employee and compensation levels are
maintained. In addition, payroll costs are capped at $100,000 on an
annualized basis for each employee. Not more than 40% of the
forgiven amount may be for non-payroll
costs.
On May
20, 2020, the Company received a $70,000 loan from Mr.
Blumberg.
31
On May
22, 2020, the Company entered into an exchange agreement with
Auctus. Based on this agreement the Company exchanged three
outstanding notes, in the amounts of $150,000, $89,250, and $65,000
for a total amount $304,250 of debt outstanding for: $160,000 in
cash payments (payable in monthly payments of $20,000), convert a
portion of the notes pursuant to original terms of the notes into
500,000 restricted common stock shares (shares were issued on June
3, 2020); and 700,000 warrants issued to purchase common stock
shares at a strike price of $0.15.
On May
27, 2020, the Company received the second tranche in the amount of
$400,000, from the December 17, 2019, securities purchase agreement
and convertible note with Auctus. The net amount paid to the
Company was $313,000 This second tranche is part of the convertible
note issued to Auctus for a total of $2.4 million of which $700,000
has already been provided by Auctus. The notes maturity date is
December 17, 2021 and an interest rate of ten percent (10%). The
note may not be prepaid in whole or in part except as otherwise
explicitly allowed. Any amount of principal or interest on the note
which is not paid when due shall bear interest at the rate of the
lessor of 24% or the maximum permitted by law (the “default
interest”). The variable conversion prices shall equal the
lesser of: (i) the lowest trading price on the issue date, and (ii)
the variable conversion price. The variable conversion price shall
mean 95% multiplied by the market price (the market price means the
average of the five lowest trading prices during the period
beginning on the issue date and ending on the maturity date), minus
$0.04 per share, provided however that in no event shall the
variable conversion price be less than $0.15. If an event of
default under this note occurs and/or the note is not extinguished
in its entirety prior to December 17, 2020 the $0.15 price shall no
longer apply. The last tranche of $1.3 million will be received
within 60 days of the S-1 registration statement becoming
effective. The conversion price of the notes will be at market
value with a minimum conversion amount of $0.15. In addition, as
part of this transaction the Company was required to pay a 2.0% fee
to a registered broker-dealer.
On June
23, 2020, the Company entered into an exchange agreement with Mr.
Clavijo. Based on this agreement the Company exchanged outstanding
payables, in the amount of $135,213 of debt outstanding for:
$10,213 in cash; 500,000 restricted common stock shares; and
250,000 warrants issued to purchase common stock shares at a strike
price of $0.50.
During
June 2020, the Company received equity investments in the amount of
$1,177,500. These investors will receive 1,177.5 Series E Preferred
Stock (each Series E Preferred Stock share converts into 4,000
shares of the Company’s common stock shares). The Series E
Preferred Stock will have cumulative dividends at the rate per
share of 6% per annum. The stated value of the Series E Preferred
Stock is $1,000.
32
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Statements in this
report which express "belief," "anticipation" or "expectation," as
well as other statements which are not historical facts, are
forward-looking statements. These forward-looking statements are
subject to certain risks and uncertainties that could cause actual
results to differ materially from historical results or anticipated
results, including those that may be set forth under "Risk Factors"
below and elsewhere in this report, as well as in our annual report
on Form 10-K for the year ended December 31, 2019 and subsequently
filed quarterly reports on Form 10-Q. Examples of these
uncertainties and risks include, but are not limited
to:
●
access to
sufficient debt or equity capital to meet our operating and
financial needs;
●
the
extent of dilution of the holdings of our existing stockholders
upon the issuance, conversion or exercise of securities issued as
part of our capital raising efforts;
●
the
extent to which certain debt holders may call the notes to be
paid;
●
the
effectiveness and ultimate market acceptance of our products and
our ability to generate sufficient sales revenues to sustain our
growth and strategy plans;
●
whether
our products in development will prove safe, feasible and
effective;
●
whether
and when we or any potential strategic partners will obtain
required regulatory approvals in the markets in which we plan to
operate;
●
our
need to achieve manufacturing scale-up in a timely manner, and our
need to provide for the efficient manufacturing of sufficient
quantities of our products;
●
the
lack of immediate alternate sources of supply for some critical
components of our products;
●
our
ability to establish and protect the proprietary information on
which we base our products, including our patent and intellectual
property position;
●
the
need to fully develop the marketing, distribution, customer service
and technical support and other functions critical to the success
of our product lines;
●
the
dependence on potential strategic partners or outside investors for
funding, development assistance, clinical trials, distribution and
marketing of some of our products; and
●
other
risks and uncertainties described from time to time in our reports
filed with the SEC.
The
following discussion should be read in conjunction with our
financial statements and notes thereto included elsewhere in this
report.
OVERVIEW
We are
a medical technology company focused on developing innovative
medical devices that have the potential to improve healthcare. Our
primary focus is the sales and marketing of our LuViva®
Advanced Cervical Scan non-invasive cervical cancer detection
device. The underlying technology of LuViva primarily relates to
the use of biophotonics for the non-invasive detection of cancers.
LuViva is designed to identify cervical cancers and precancers
painlessly, non-invasively and at the point of care by scanning the
cervix with light, then analyzing the reflected and fluorescent
light.
LuViva
provides a less invasive and painless alternative to conventional
tests for cervical cancer screening and detection. Additionally,
LuViva improves patient well-being not only because it eliminates
pain, but also because it is convenient to use and provides rapid
results at the point of care. We focus on two primary applications
for LuViva: first, as a cancer screening tool in the developing
world, where infrastructure to support traditional cancer-screening
methods is limited or non-existent, and second, as a triage
following traditional screening in the developed world, where a
high number of false positive results cause a high rate of
unnecessary and ultimately costly follow-up tests.
We are
a Delaware corporation, originally incorporated in 1992 under the
name “SpectRx, Inc.,” and, on February 22, 2008,
changed our name to Guided Therapeutics, Inc. At the same time, we
renamed our wholly owned subsidiary, InterScan, which originally
had been incorporated as “Guided
Therapeutics.”
Since
our inception, we have raised capital through the public and
private sale of debt and equity, funding from collaborative
arrangements, and grants.
Our
prospects must be considered in light of the substantial risks,
expenses and difficulties encountered by entrants into the medical
device industry. This industry is characterized by an increasing
number of participants, intense competition and a high failure
rate. We have experienced operating losses since our inception and,
as of March 31, 2020 we have an accumulated deficit of
approximately $136.8 million. To date, we have engaged primarily in
research and development efforts and the early stages of marketing
our products. We do not have significant experience in
manufacturing, marketing or selling our products. We may not be
successful in growing sales for our products. Moreover, required
regulatory clearances or approvals may not be obtained in a timely
manner, or at all. Our products may not ever gain market acceptance
and we may not ever generate significant revenues or achieve
profitability. The development and commercialization of our
products requires substantial development, regulatory, sales and
marketing, manufacturing and other expenditures. We expect our
operating losses to continue for the foreseeable future as we
continue to expend substantial resources to complete
commercialization of our products, obtain regulatory clearances or
approvals, build our marketing, sales, manufacturing and finance
capabilities, and conduct further research and
development.
33
Our
product revenues to date have been limited. In 2019, the majority
of our revenues were from the sale of LuViva devices and
disposables. We expect that the majority of our revenue in 2020
will be derived from revenue from the sale of LuViva devices and
disposables.
Current Demand for LuViva
Based on discussions with our distributors, we expect to generate
purchase orders for approximately $1.0 to $2.0 million in LuViva
devices and disposables in 2020 and expect those purchase orders to
result in actual sales of $0.5 to $1.0 million in 2020,
representing what we view as current demand for our products. We
cannot be assured that we will generate all or any of these
additional purchase orders, or that existing orders will not be
canceled by the distributors or that parts to build product will be
available to meet demand, such that existing orders will result in
actual sales. Because we have a short history of sales of our
products, we cannot confidently predict future sales of our
products beyond this time frame and cannot be assured of any
particular amount of sales. Accordingly, we have not identified any
particular trends with regard to sales of our
products.
RECENT DEVELOPMENTS
A 1:800
reverse stock split of all of our issued and outstanding common
stock was implemented on March 29, 2019. As a result of the reverse
stock split, every 800 shares of issued and outstanding common
stock were converted into 1 share of common stock. All fractional
shares created by the reverse stock split were rounded to the
nearest whole share. The number of authorized shares of common
stock did not change. The number of authorized shares of common
stock did not change. The reverse stock split decreased the
Company’s issued and outstanding shares of common stock from
2,135,478,405 shares of Common Stock to 2,669,348 shares as of that
date.
CRITICAL
ACCOUNTING POLICIES
Our
material accounting policies, which we believe are the most
critical to investors understanding of our financial results and
condition, are discussed below. Because we are still early in our
enterprise development, the number of these policies requiring
explanation is limited. As we begin to generate increased revenue
from different sources, we expect that the number of applicable
policies and complexity of the judgments required will
increase.
Revenue
Recognition: ASC 606
Revenue from Contracts with Customers establishes a single and
comprehensive framework which sets out how much revenue is to be
recognized, and when. The core principle is that a vendor should
recognize revenue to depict the transfer of promised goods or
services to customers in an amount that reflects the consideration
to which the vendor expects to be entitled in exchange for those
goods or services. Revenue will now be recognized by a vendor when
control over the goods or services is transferred to the customer.
In contrast, Revenue based revenue recognition around an analysis
of the transfer of risks and rewards; this now forms one of a
number of criteria that are assessed in determining whether control
has been transferred. The application of the core principle in ASC
606 is carried out in five steps: Step 1 – Identify the
contract with a customer: a contract is defined as an agreement
(including oral and implied), between two or more parties, that
creates enforceable rights and obligations and sets out the
criteria for each of those rights and obligations. The contract
needs to have commercial substance and it is probable that the
entity will collect the consideration to which it will be entitled.
Step 2 – Identify the performance obligations in the
contract: a performance obligation in a contract is a promise
(including implicit) to transfer a good or service to the customer.
Each performance obligation should be capable of being distinct and
is separately identifiable in the contract. Step 3 –
Determine the transaction price: transaction price is the amount of
consideration that the entity can be entitled to, in exchange for
transferring the promised goods and services to a customer,
excluding amounts collected on behalf of third parties. Step 4
– Allocate the transaction price to the performance
obligations in the contract: for a contract that has more than one
performance obligation, the entity will allocate the transaction
price to each performance obligation separately, in exchange for
satisfying each performance obligation. The acceptable methods of
allocating the transaction price include adjusted market assessment
approach, expected cost plus a margin approach, and, the residual
approach in limited circumstances. Discounts given should be
allocated proportionately to all performance obligations unless
certain criteria are met and reallocation of changes in standalone
selling prices after inception is not permitted. Step 5 –
Recognize revenue as and when the entity satisfies a performance
obligation: the entity should recognize revenue at a point in time,
except if it meets any of the three criteria, which will require
recognition of revenue over time: the entity’s performance
creates or enhances an asset controlled by the customer, the
customer simultaneously receives and consumes the benefit of the
entity’s performance as the entity performs, and the entity
does not create an asset that has an alternative use to the entity
and the entity has the right to be paid for performance to
date.
34
Valuation of Deferred
Taxes: We account for
income taxes in accordance with the liability method. Under the
liability method, we recognize deferred assets and liabilities
based upon anticipated future tax consequences attributable to
differences between financial statement carrying amounts of assets
and liabilities and their respective tax bases. We establish a
valuation allowance to the extent that it is more likely than not
that deferred tax assets will not be utilized against future
taxable income.
Valuation of Equity Instruments
Granted to Employee, Service Providers and
Investors: On the date of
issuance, the instruments are recorded at their fair value as
determined using either the Black-Scholes valuation model or Monte
Carlo Simulation model.
Beneficial Conversion Features of Convertible
Securities: Conversion options that are not bifurcated as a
derivative pursuant to ASC 815 and not accounted for as a separate
equity component under the cash conversion guidance are evaluated
to determine whether they are beneficial to the investor at
inception (a beneficial conversion feature) or may become
beneficial in the future due to potential adjustments. The
beneficial conversion feature guidance in ASC 470-20 applies to
convertible stock as well as convertible debt which are outside the
scope of ASC 815. A beneficial conversion feature is defined as a
nondetachable conversion feature that is in the money at the
commitment date. The beneficial conversion feature guidance
requires recognition of the conversion option’s in-the-money
portion, the intrinsic value of the option, in equity, with an
offsetting reduction to the carrying amount of the instrument. The
resulting discount is amortized as a dividend over either the life
of the instrument, if a stated maturity date exists, or to the
earliest conversion date, if there is no stated maturity date. If
the earliest conversion date is immediately upon issuance, the
dividend must be recognized at inception. When there is a
subsequent change to the conversion ratio based on a future
occurrence, the new conversion price may trigger the recognition of
an additional beneficial conversion feature on
occurrence.
Allowance for Accounts
Receivable: We estimate
losses from the inability of our distributors to make required
payments and periodically review the payment history of each of our
distributors, as well as their financial condition, and revise our
reserves as a result.
Inventory
Valuation: All inventories
are stated at lower of cost or net realizable value, with cost
determined substantially on a “first-in, first-out”
basis. Selling, general, and administrative expenses are not
inventoried, but are charged to expense when
purchased.
RESULTS
OF OPERATIONS
COMPARISON
OF THE THREE MONTHS ENDED MARCH 31, 2020 AND 2019
Sales Revenue, Cost of
Sales and Gross Profit from Devices and Disposables:
Revenues from the sale of LuViva devices for the three months ended
March 31, 2020 and 2019 were approximately nil and $18,000,
respectively. Revenues for the three months ended March 31, 2020
were approximately, $18,000 or 100% lower when compared to the same
period in 2019, due to no sales activity in 2020. Related cost of
sales were approximately nil and $1,000 in the three months ended
March 31, 2020 and 2019, respectively. Cost of sales for the three
months ended March 31, 2020, were approximately, $1,000 or 100%
lower when compared to the same period in 2019, due to no sales
activity in 2020. This resulted in a gross profit of approximately
nil on the sales of devices and disposables for the three months
ended March 31, 2020 compared with a gross profit of approximately
$17,000 for the same period in 2019.
Research and Development
Expenses: Research and development expenses for the three
months ended March 31, 2020, decreased to approximately $24,000,
from approximately $47,000 to the same period in 2019. The decrease
of $23,000, or 48%, was primarily due to cost reduction plans in
research and development payroll expenses.
Sales and Marketing
Expenses: Sales and marketing expenses for the three months
ended March 31, 2020, decreased to approximately $34,000, compared
to $45,000 for the same period in 2018. The decrease, of
approximately $11,000, or 24% was primarily due to Company-wide
expense reduction and cost savings efforts.
General and Administrative
Expense: General and administrative expenses for the three
months ended March 31, 2020, increased to approximately $184,000,
compared to $182,000 for the same period in 2019. The increase of
approximately $2,000, or 1%, was primarily related to higher
compensation expenses incurred during the same period. For 2020,
general and administrative expenses consisted primarily of
professional fees, insurance, and paid and accrued compensation
costs.
35
Other Income: Other
income for the three months ended March 31, 2020, decreased to
approximately $1,000, compared to $4,000 for the same period in
2019. The decrease of approximately $3,000 or 74% was primarily a
result of lower refunds from prior years for insurance
policies.
Interest Expense:
Interest expense for the three months ended March 31, 2020
decreased to approximately $287,000, compared to $371,000 for the
same period in 2019. The decrease of approximately $84,000, or 23%,
was primarily related to amortization expense of and interest
recorded for the value of the beneficial conversion feature on
convertible debt outstanding and amortization of debt issuance
costs.
Gain from Extinguishment of
Debt: Gain from extinguishment of debt for the three months
ended March 31, 2020 increased to approximately $28,000, compared
to nil for the same period in 2019. The increase of approximately
$28,000, or 100%, was primarily related to debt that had been
eliminated from debt exchange agreements.
Fair Value of Warrants
Recovery/Expense: Fair value of warrants recovery for the
three months ended March 31, 2020, increased to approximately
$3,228,000 compared to fair value of warrants recovery of $409,000
for the same period in 2019. The increase of approximately
$2,819,000, or 689% was primarily due to a decrease in the number
of common stock warrants outstanding, the exchange of common stock
warrants for fixed price common stock warrants, the exchange of
debt and for favorable significant changes in warrant conversion
prices and increase in stock price in the three months ended March
31, 2020.
Net Income/Loss: Net
Income attributable to common stockholders increased to
approximately $2,716,000, or $0.542 and $0.042 per share, on a
fully diluted basis for the three months ended March 31, 2020, from
a net loss of $224,000, or $0.069 per share, for the same period in
2019. The decrease in the net loss of $2,940,000, or 1,312% was for
reasons outlined above. As stated previously, our net income for
the three months ended March 31, 2020, was primarily a result of
changes in the fair value of warrants, the decrease in the number
of common stock warrants outstanding, and the exchange of common
stock warrants for fixed price common stock warrants.
There
was no income tax benefit recorded for the three months ended March
31, 2020 or 2019, due to recurring net operating
losses.
LIQUIDITY
AND CAPITAL RESOURCES
Since
our inception, we have raised capital through the public and
private sale of debt and equity, funding from collaborative
arrangements, and grants. At March 31, 2020, we had cash of less
than $21,000 and a negative working capital of approximately
$9,000,000.
Our
major cash flows for the three months ended March 31, 2020
consisted of cash out-flows of $0.5 million from operations,
including approximately $2.7 million of net income, (as stated
previously, our net income for the three months ended March 31,
2020, was primarily a result of changes in the fair value of
warrants, the decrease in the number of common stock warrants
outstanding, and the exchange of common stock warrants for fixed
price common stock warrants), and a net change from financing
activities of $0.3 million; which primarily represented the
proceeds received from issuance of common stock and warrants, and
payments made on notes payable.
Capital resources for 2020
During
January 2020, we received equity investments in the amount of
$103,000. These investors received a total of 206,000 common stock
shares and 206,000 warrants issued to purchase common stock shares
at a strike price of $0.25, 206,000 warrants to purchase common
stock shares at a strike price of $0.75 and 103 Series D preferred
stock (each Series D preferred stock shares converts into 3,000
shares of the our common stock shares).
On
January 6, 2020, we entered into an exchange agreement with Jones
Day. We have not performed the initial terms of the exchange
agreement. We will exchange $1,744,768 of debt outstanding for:
$175,000, an unsecured promissory note in the amount of $550,000;
due 13 months form the date of issuance, that may be called at any
time prior to maturity upon a payment of $150,000; and an unsecured
promissory note in the principal amount of $444,768, bearing an
annualized interest rate of 6.0% and due in four equal annual
installments beginning on the second anniversary of the date of
issuance.
On
January 8, 2020, we exchanged $2,064,366 in debt for several equity
instruments (noted below) that were determined to have a total fair
value of $2,065,548, resulting in a loss on extinguishment of debt
of $1,183 which is recorded in other income (expense) on the
accompanying consolidated statements of operations. We also issued
6,957,013 warrants to purchase common stock shares; with exercise
prices of $0.25, $0.75 and $0.20.
36
The
following table summarizes the debt exchanges:
|
Total
Debt and Accrued Interest
|
Total
Debt
|
Total
Accrued Interest
|
Common
Stock Shares
|
Warrants
(Exercise $0.25)
|
Warrants
(Exercise $0.75)
|
Warrants
(Exercise $0.20)
|
|
|
|
|
|
|
|
|
Aquarius
|
$145,544
|
107,500
|
38,044
|
291,088
|
145,544
|
145,544
|
-
|
K2 Medical (Shenghuo)3
|
803,654
|
771,927
|
31,727
|
1,905,270
|
704,334
|
704,334
|
496,602
|
Mr.
Blumberg
|
305,320
|
292,290
|
13,030
|
1,167,630
|
119,656
|
119,656
|
928,318
|
Mr.
Case
|
179,291
|
150,000
|
29,291
|
896,456
|
-
|
-
|
896,456
|
Mr.
Grimm
|
51,050
|
50,000
|
1,050
|
255,548
|
-
|
-
|
255,548
|
Mr.
Gould
|
111,227
|
100,000
|
11,227
|
556,136
|
-
|
-
|
556,136
|
Mr.
Mamula
|
15,577
|
15,000
|
577
|
77,885
|
-
|
-
|
77,885
|
Dr. Imhoff2
|
400,417
|
363,480
|
36,937
|
1,699,255
|
100,944
|
100,944
|
1,497,367
|
Ms. Rosenstock1
|
50,000
|
50,000
|
-
|
100,000
|
50,000
|
50,000
|
-
|
Mr. James2
|
2,286
|
2,000
|
286
|
7,745
|
1,227
|
1,227
|
5,291
|
|
$2,064,366
|
$1,902,197
|
$162,169
|
6,957,013
|
1,121,705
|
1,121,705
|
4,713,603
|
1
Ms.
Rosenstock also forgave $28,986 in debt.
2
Mr.
Imhoff and Mr. James are members of the board of directors and
therefore related parties.
3
Our COO
and director, Mark Faupel, is a shareholder of Shenghuo, and a
former director, Richard Blumberg, is a managing member of
Shenghuo.
On
January 16, 2020, we entered into an exchange agreement with GPB.
This exchange agreement which has not been completed will call for
the exchange of $3,360,811 of debt outstanding as of December 12,
2019 for: cash of $1,500,000; 1,860,811 common stock shares;
7,185,000 warrants to purchase common stock shares at a strike
price of $0.20 for the 2016 warrants issued; 1,860,811 warrants to
purchase common stock shares at a strike price of $0.25; 3,721,622
warrants to purchase common stock shares at a strike price of
$0.75; and 2,791 series D preferred stock shares.
On
March 31, 2020, we entered into a securities purchase agreement
with Auctus Fund, LLC for the issuance and sale to Auctus of
$112,750 in aggregate principal amount of a 12% convertible
promissory note. On March 31, 2020, we issued the note to Auctus
and issued 250,000 five-year common stock warrants at an exercise
price of $0.16. On April 3, 2020, we received net proceeds of
$100,000. The note matures on January 26, 2021 and accrues interest
at a rate of 12% per year.
On
April 23, 2020, we received $25,000 of equity investments. These
investors received a total of 50,000 common stock shares and 50,000
warrants issued to purchase common stock shares at a strike price
of $0.25, 50,000 warrants to purchase common stock shares at a
strike price of $0.75 and 50 Series D preferred stock (each Series
D preferred stock shares converts into 3,000 shares of the our
common stock shares).
On May
4, 2020, we received a loan from the Small Business Administration
(SBA) pursuant to the Paycheck Protection Program (PPP) as part of
the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
in the amount of $50,184.
On May
20, 2020, the Company received a $70,000 loan from Mr.
Blumberg.
On May
22, 2020, we entered into an exchange agreement with Auctus. Based
on this agreement we exchanged three outstanding notes, in the
amounts of $150,000, $89,250, and $65,000 for a total amount
$304,250 of debt outstanding for: $160,000 in cash payments
(payable in monthly payments of $20,000), convert a portion of the
notes pursuant to original terms of the notes into 500,000
restricted common stock shares; and 700,000 warrants issued to
purchase common stock shares at a strike price of
$0.15.
On May
27, 2020, we received the second tranche in the amount of $400,000,
from the December 17, 2019, securities purchase agreement and
convertible note with Auctus. The net amount paid to us was
$313,000 This second tranche is part of the convertible note issued
to Auctus for a total of $2.4 million of which $700,000 has already
been provided by Auctus. The notes maturity date is December 17,
2021 and an interest rate of ten percent (10%).
37
On June
23, 2020, we entered into an exchange agreement with Mr. Clavijo.
Based on this agreement we exchanged outstanding payables, in the
amount of $135,213 of debt outstanding for: $10,213 in cash;
500,000 restricted common stock shares; and 250,000 warrants issued
to purchase common stock shares at a strike price of
$0.50.
During
June 2020, we received equity investments in the amount of
$1,177,500. These investors will receive 1,177.5 Series E Preferred
Stock (each Series E Preferred Stock share converts into 4,000
shares of our common stock shares). The Series E Preferred Stock
will have cumulative dividends at the rate per share of 6% per
annum. The stated value of the Series E Preferred Stock is
$1,000.
Capital resources for 2019
Auctus Note
On
December 17, 2019, we entered into a securities purchase agreement
and convertible note with Auctus. The convertible note issued to
Auctus will be for a total of $2.4 million. The first tranche of
$700,000 has been received and will have a maturity date of
December 17, 2021 and an interest rate of ten percent
(10%).
Series D Financing
During
December 2019 and January 2020, the Company received equity
investments in the amount of $738,000. These investors received a
total of 1,476,000 common stock shares and 1,476,000 warrants to
purchase common stock shares at a strike price of $0.25, 1,476,000
warrants to purchase common stock shares at a strike price of $0.75
and 738 Series D preferred stock shares (each Series D preferred
stock share converts into 3,000 shares of the Company’s
common stock shares). Of the amount invested $388,000 was from
related parties.
On
February 14, 2019, we entered into a Purchase and Sale Agreement
with Everest Business Funding for the sale of its accounts
receivable. The transaction provided us with $48,735 after $1,265
in debt issuance costs (bank costs) for a total purchase amount of
$50,000, in which we would have to repay $68,500. At a minimum we
would need to pay $535.16 per day or 20.0% of the future collected
accounts receivable or “receipts.” The effective
interest rate as calculated for this transaction is approximately
132.5%. As of December 31, 2019, $60,105 had been paid, leaving a
balance of $8,016. As of March 31, 2020, $63,395 had been paid,
leaving a balance of $4,726.
Effective March 29,
2019, we entered into a securities purchase with Auctus for the
issuance of a $65,000 convertible promissory note. At issuance, we
recorded a $65,000 beneficial conversion feature, which was fully
amortized at December 31, 2019. The note accrued interest at a rate
of 12% until it matured in December 2019. Beginning December 2019,
the note is convertible, in whole or in part, at the holder's
option, into shares of our stock at a conversion price equal to 50%
of the lowest trading price during the 25 trading days prior to
conversion. Upon the occurrence of an event of default, the note
will bear interest at a rate of 24% per year and the holder of the
note we may be required to redeem or convert the note at 150% of
the outstanding principal balance. At March 31, 2020 and December
31, 2019, the balance due on this total was $106,210, including a
default penalty of $41,210 and 106,210, including a default penalty
of $41,210, respectively. Interest accrued on the note totaled
$6,585 and $142 at March 31, 2020 and December 31, 2019 and is
included in accrued expenses on the accompanying consolidated
balance sheet.
On May
15, 2019, we entered into a securities purchase agreement with
Eagle Equities, LLC, providing for the purchase by Eagle of a
convertible redeemable note in the principal amount of $57,750. The
note was fully funded on May 21, 2019, upon which we received
$45,000 of net proceeds (net of a 10% original issue discount and
other expenses). The note bears an interest rate of 8% and are due
and payable on May 15, 2020. The note may be converted by Eagle at
any time after five months from issuance into shares of our common
stock (as determined in the notes) calculated at the time of
conversion. The conversion price of the notes will be equal to 60%
of the average of the two lowest closing bid prices of our common
stock shares as reported on OTC Markets exchange, for the 20 prior
trading days including the day upon which we receive a notice of
conversion. The notes may be prepaid in accordance with the terms
set forth in the notes. The notes also contain certain
representations, warranties, covenants and events of default
including if we are delinquent in our periodic report filings with
the SEC and increases in the amount of the principal and interest
rates under the notes in the event of such defaults. In the event
of default, at Eagle’s option and in its sole discretion,
Eagle may consider the notes immediately due and payable. As of
December 31, 2019, the outstanding note was for $25,651, which
consisted of unamortized balance of $14,438 of a beneficial
conversion feature, unamortized original issue discount of $1,942,
unamortized debt issuance costs of $2,774 and interest of $1,166
included in accrued expenses on the accompanying consolidated
balance sheet. As of March 31, 2020, the outstanding note was for
$26,651, which consisted of unamortized balance of $4,812 of a
beneficial conversion feature, unamortized original issue discount
of $633, unamortized debt issuance costs of $904 and interest of
$1,697 included in accrued expenses on the accompanying
consolidated balance sheet.
38
On May
15, 2019, we entered into a securities purchase agreement with Adar
Bays, LLC, providing for the purchase by Adar of a convertible
redeemable note in the principal amount of $57,750. The note was
fully funded on May 21, 2019, upon which we received $45,000 of net
proceeds (net of a 10% original issue discount and other expenses).
The note bears an interest rate of 8% and are due and payable on
May 15, 2020. The note may be converted by Adar at any time after
five months from issuance into shares of our common stock (as
determined in the notes) calculated at the time of conversion. The
conversion price of the notes will be equal to 60% of the average
of the two lowest closing bid prices of our common stock shares as
reported on OTC Markets exchange, for the 20 prior trading days
including the day upon which we receive a notice of conversion. The
notes may be prepaid in accordance with the terms set forth in the
notes. The notes also contain certain representations, warranties,
covenants and events of default including if we are delinquent in
our periodic report filings with the SEC and increases in the
amount of the principal and interest rates under the notes in the
event of such defaults. In the event of default, at Adar’s
option and in its sole discretion, Adar may consider the notes
immediately due and payable. In addition, we had recorded a $38,500
beneficial conversion feature, $5,250 original issue discount and
$7,500 of debt issuance costs. As of December 31, 2019, the note
outstanding increased to $84,780 as a default penalty of $27,030
was added to the outstanding balance of the note, which consisted
of unamortized balance of $14,438 of a beneficial conversion
feature, unamortized original issue discount of $1,942, unamortized
debt issuance costs of $2,774 and interest of $3,190 included in
accrued expenses on the accompanying consolidated balance sheet. As
of March 31, 2020, the note outstanding decreased to $28,176
including a default penalty of $27,030 that was added to the
outstanding balance of the note, which consisted of unamortized
balance of $4,813 of a beneficial conversion feature, unamortized
original issue discount of $633, unamortized debt issuance costs of
$904 and interest of $1,851 included in accrued expenses on the
accompanying consolidated balance sheet.
See
“—Recent Developments” for information regarding
capital-raising activities since December 31, 2019.
We will
be required to raise additional funds through public or private
financing, additional collaborative relationships or other
arrangements, as soon as possible. We cannot be certain that our
existing and available capital resources will be sufficient to
satisfy our funding requirements through 2020. We are evaluating
various options to further reduce our cash requirements to operate
at a reduced rate, as well as options to raise additional funds,
including loans.
Generally,
substantial capital will be required to develop our products,
including completing product testing and clinical trials, obtaining
all required U.S. and foreign regulatory approvals and clearances,
and commencing and scaling up manufacturing and marketing our
products. Any failure to obtain capital would have a material
adverse effect on our business, financial condition and results of
operations. Based on discussions with our distributors, we expect
to generate purchase orders for approximately $1.0 to $2.0 million
in LuViva devices and disposables in 2020 and expect those purchase
orders to result in actual sales of $0.5 to $1.0 million in 2020,
representing what we view as current demand for our products. We
cannot be assured that we will generate all or any of these
additional purchase orders, or that existing orders will not be
canceled by the distributors or that parts to build product will be
available to meet demand, such that existing orders will result in
actual sales. Because we have a short history of sales of our
products, we cannot confidently predict future sales of our
products beyond this time frame and cannot be assured of any
particular amount of sales. Accordingly, we have not identified any
particular trends with regard to sales of our
products.
Our
financial statements have been prepared and presented on a basis
assuming we will continue as a going concern. The above factors
raise substantial doubt about our ability to continue as a going
concern, as more fully discussed in Note 1 to the consolidated
financial statements contained herein and in the report of our
independent registered public accounting firm accompanying our
financial statements contained in our annual report on Form 10-K
for the year ended December 31, 2019.
Contingencies
Based
on the current outbreak of the Coronavirus SARS-CoV-2, the pathogen
responsible for COVID-19, which has already had an impact on
financial markets, there could be additional repercussions in our
operating business, including but not limited to, the sourcing of
materials for product candidates, manufacture of supplies for
preclinical and/or clinical studies, delays in clinical operations,
which may include the availability or the continued availability of
patients for trials due to such things as quarantines, conduct of
patient monitoring and clinical trial data retrieval at
investigational study sites.
The
future impact of the outbreak is highly uncertain and cannot be
predicted, and we cannot provide any assurance that the outbreak
will not have a material adverse impact on our operations or future
results or filings with regulatory health authorities. The extent
of the impact, if any, we will depend on future developments,
including actions taken to contain the coronavirus.
Off-Balance
Sheet Arrangements
We have
no material off-balance sheet arrangements, no special purpose
entities, and no activities that include non-exchange-traded
contracts accounted for at fair value.
39
ITEM 3. QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM 4. CONTROLS AND
PROCEDURES
Disclosure
Controls and Procedures
The
Company under the supervision and with the participation of
management, including the Chief Executive Officer (principal
executive officer) and the Chief Financial Officer (principal
financial officer), evaluated the effectiveness of our
“disclosure controls and procedures” (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of
1934 (the “Exchange Act”)) as of September 30, 2018.
The controls and system currently used by the Company to calculate
and record inventory is not operating effectively. Additionally,
the Company lacks the resources to properly research and account
for complex transactions. The combination of these controls
deficiencies has resulted in a material weakness in our internal
control over financial reporting.
Based
on that evaluation, the Chief Executive Officer and the Chief
Financial Officer concluded that our disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) were not effective as of March 31, 2020 to provide
reasonable assurance that (1) information required to be
disclosed by us in the reports we file or submit under the Exchange
Act is recorded, processed, summarized, and reported within the
time periods specified in the Securities and Exchange
Commission’s rules and forms, and (2) information
required to be disclosed by us in the reports we file or submit
under the Exchange Act is accumulated and communicated to our
management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate to allow timely decisions
regarding required disclosures.
The
effectiveness of any system of controls and procedures is subject
to certain limitations, and, as a result, there can be no assurance
that our controls and procedures will detect all errors or fraud. A
control system, no matter how well conceived and operated, can
provide only reasonable, not absolute, assurance that the
objectives of the control system will be attained.
Changes
in Internal Control over Financial Reporting
There
has been no change in our internal control over financial reporting
(as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act) during the quarter ended March 31, 2020 that has materially
affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
40
PART
II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From
time to time, the Company may be involved in various legal
proceedings and claims arising in the ordinary course of business.
Management believes that the disposition of these matters,
individually or in the aggregate, is not expected to have a
material adverse effect on the Company’s financial condition.
See Note 6 to the financial statements.
ITEM 1A. RISK FACTORS
Please
refer to Part I, Item 1A, “Risk Factors,” in our annual
report on Form 10-K for the year ended December 31, 2019, for
information regarding factors that could affect our results of
operations, financial condition and liquidity.
ITEM 2. UNREGISTERRED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS.
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not
applicable.
ITEM 4. EXHIBITS
Exhibit
Number
|
Exhibit
Description
|
|
|
31*
|
Rule
13a-14(a)/15d-14(a) Certification
|
32*
|
Section
1350 Certification
|
101.1*
|
XBRL
|
*Filed herewith
41
SIGNATURES
In
accordance with the requirements of the Exchange Act, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
|
GUIDED
THERAPEUTICS, INC.
|
|
|
|
|
|
|
Date:
July 6, 2020
|
By:
|
/s/
Gene S.
Cartwright
|
|
|
|
Gene S.
Cartwright
|
|
|
|
President, Chief
Executive Officer and Acting Chief
Financial Officer
|
|
42