Item 1. Financial Statements
Item
1. Financial Statements.
VIVOS INC
BALANCE SHEETS
SEPTEMBER 30, 2020 (UNAUDITED) AND DECEMBER 31, 2019
SEPTEMBER 30,
DECEMBER 31,
2020
2019
(UNAUDITED)
ASSETS
Current Assets:
Cash
$ 14,934
$ 20,381
Prepaid expenses
42,969
23,492
Total Current Assets
57,903
43,873
TOTAL ASSETS
$ 57,903
$ 43,873
LIABILITIES AND STOCKHOLDERS’ DEFICIT
LIABILITIES
Current Liabilities:
Accounts payable and accrued expenses
$ 377,483
$ 511,817
Related party accounts payable
32,110
32,110
Accrued interest payable
94,577
93,249
Payroll liabilities payable
130,000
100,000
Convertible notes payable, related party, net
-
14,500
Convertible notes payable, net
56,966
434,886
Promissory notes payable, net of discount
-
100,000
Related party promissory note
237,000
237,000
Total Current Liabilities
928,136
1,523,562
Total Liabilities
928,136
1,523,562
Commitments and contingencies
-
-
STOCKHOLDERS’ DEFICIT
Preferred stock, par value, $0.001, 20,000,000 shares authorized, Series A
Convertible Preferred, 5,000,000 shares authorized, 2,552,642 shares issued and outstanding, respectively
2,553
2,553
Additional paid in capital - Series A Convertible preferred stock
8,870,626
8,870,626
Series B Convertible Preferred, 5,000,000 shares authorized, 1,013,245 and
1,113,245 shares issued and outstanding, respectively
1,013
1,113
Additional paid in capital - Series B Convertible preferred stock
615,295
665,195
Series C Convertible Preferred, 5,000,000 shares authorized, 385,302 and
821,292 shares issued and outstanding, respectively
385
821
Additional paid in capital - Series C Convertible preferred stock
500,507
674,457
Common stock, par value, $0.001, 950,000,000 shares authorized, 234,700,228
and 184,845,821 issued and outstanding, respectively
234,700
184,846
Additional paid in capital - common stock
63,160,706
61,721,809
Shares to be issued
-
-
Accumulated deficit
(74,256,018 )
(73,601,109 )
Total Stockholders’ Deficit
(870,233 )
(1,479,689 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
$ 57,903
$ 43,873
The
accompanying notes are an integral part of these financial statements.
1
VIVOS INC
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
FOR THE NINE AND THREE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019
NINE MONTHS ENDED
THREE MONTHS ENDED
SEPTEMBER 30,
SEPTEMBER 30,
SEPTEMBER 30,
SEPTEMBER 30,
2020
2019
2020
2019
Consulting revenues, net
$ 7,000
$ 8,000
$ 7,000
$ 8,000
OPERATING EXPENSES
Professional fees
170,771
356,248
59,502
87,075
Stock based compensation
2,176
463,917
-
457,949
Payroll expenses
94,029
90,000
34,029
30,000
Research and development
31,809
62,194
14,383
18,492
General and administrative expenses
85,482
41,067
27,526
21,691
Total Operating Expenses
384,267
1,013,426
135,440
615,207
OPERATING LOSS
(377,267 )
(1,005,426 )
(128,440 )
(607,207 )
NON-OPERATING INCOME (EXPENSE)
Interest expense
(280,642 )
(134,739 )
(7,151 )
(96,271 )
Other income
3,000
34,106
-
34,106
Total Non-Operating Income (Expenses)
(277,642 )
(100,633 )
(7,151 )
(62,165 )
NET LOSS BEFORE PROVISION FOR INCOME TAXES
(654,909 )
(1,106,059 )
(135,591 )
(669,372 )
Provision for income taxes
-
-
-
-
NET LOSS
$ (654,909 )
$ (1,106,059 )
$ (135,591 )
$ (669,372 )
Net loss per share - basic and diluted
$ (0.00 )
$ (0.01 )
$ (0.00 )
$ (0.00 )
Weighted average common shares outstanding - basic
213,424,420
172,437,108
234,418,486
177,835,282
The
accompanying notes are an integral part of these financial statements.
2
VIVOS
INC
STATEMENT
OF CHANGES IN STOCKHOLDERS' DEFICIT
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2020 (UNAUDITED) AND DECEMBER 31, 2019
Additional
Additional
Additional
Paid-In
Paid-In
Paid-In
Additional
Series
A Preferred
Capital
-
Series A
Series
B Preferred
Capital
-
Series B
Series
C Preferred
Capital
-
Series C
Common
Stock
Paid-In
Capital -
Shares
to be
Accumulated
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Preferred
Shares
Amount
Common
Issued
Deficit
Total
Balance
- December 31, 2018
2,552,642
$ 2,553
$ 8,870,626
3,305,755
$ 3,306
$ 1,876,768
-
$ -
$ -
163,445,736
$ 163,446
$ 60,132,139
$ -
$ (71,991,012 )
$ (942,174 )
Stock
issued for:
Cash
-
-
-
100,000
100
49,900
-
-
-
1,250,000
1,250
48,750
-
-
100,000
Conversion
of preferred stock into common stock
-
-
-
(524,218 )
(525 )
(209,163 )
-
-
-
6,552,725
6,553
203,135
-
-
-
Conversion
of Series B Preferred into Series C Preferred
-
-
-
(821,292 )
(821 )
(674,457 )
821,292
821
674,457
-
-
-
-
-
-
Warrants
issued with notes payable (discount)
-
-
-
-
-
-
-
-
-
-
-
28,721
-
-
28,721
Options
and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
3,792
-
-
3,792
Net
loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
(236,382 )
(236,382 )
Balance
- March 31, 2019
2,552,642
2,553
8,870,626
2,060,245
2,060
1,043,048
821,292
821
674,457
171,248,461
171,249
60,416,537
-
(72,227,394 )
(1,046,043 )
Conversion
of preferred stock into common stock
-
-
-
(517,000 )
(517 )
(206,283 )
-
-
-
6,462,500
6,462
200,338
-
-
-
Adjustment
for fractional shares in reverse split
-
-
-
-
-
-
-
-
-
(140 )
-
-
-
-
-
Warrants
issued with notes payable (discount)
-
-
-
-
-
-
-
-
-
-
-
12,592
-
-
12,592
Options
and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
2,176
-
-
2,176
Net
loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
(200,305 )
(200,305 )
Balance
- June 30, 2019
2,552,642
2,553
8,870,626
1,543,245
1,543
836,765
821,292
821
674,457
177,710,821
177,711
60,631,643
-
(72,427,699 )
(1,231,580 )
Stock
issued for:
Accounts
payable
-
-
-
-
-
-
-
-
-
562,500
563
21,937
-
-
22,500
Services
-
-
-
-
-
-
-
-
-
312,500
312
12,188
-
-
12,500
Warrants
issued with notes payable (discount)
-
-
-
-
-
-
-
-
-
-
-
95,437
-
-
95,437
Warrants
issued for extension of notes payable
-
-
-
-
-
-
-
-
-
-
-
25,656
-
-
25,656
Options
issued for settlement of accounts payable
-
-
-
-
-
-
-
-
-
-
-
33,829
-
-
33,829
Options
and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
457,949
-
-
457,949
BCF
recognized on convertible notes
-
-
-
-
-
-
-
-
-
-
-
59,957
-
-
59,957
Net
loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
(669,372 )
(669,372 )
Balance
- September 30, 2019
2,552,642
2,553
8,870,626
1,543,245
1,543
836,765
821,292
821
674,457
178,585,821
178,586
61,338,596
-
(73,097,071 )
(1,193,124 )
Stock
issued for:
Accounts
payable
-
-
-
-
-
-
-
-
-
500,000
500
20,900
-
-
21,400
Conversion
of preferred stock into common stock
-
-
-
(430,000 )
(430 )
(171,570 )
-
-
-
5,375,000
5,375
166,625
-
-
-
Conversion
of restricted stock units into common stock
-
-
-
-
-
-
-
-
-
385,000
385
(385 )
-
-
-
Warrants
issued with notes payable (discount)
-
-
-
-
-
-
-
-
-
-
-
14,299
-
-
14,299
Warrants
issued in settlement of litgation
-
-
-
-
-
-
-
-
-
-
-
18,500
-
-
18,500
Options
issued for settlement of payables
-
-
-
-
-
-
-
-
-
-
-
14,812
-
-
14,812
Options
and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
148,462
-
-
148,462
Net
loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
(504,038 )
(504,038 )
Balance
- December 31, 2019
2,552,642
2,553
8,870,626
1,113,245
1,113
665,195
821,292
821
674,457
184,845,821
184,846
61,721,809
-
(73,601,109 )
(1,479,689 )
Stock
issued for:
Cash
-
-
-
-
-
-
-
-
-
-
-
-
6,870
-
6,870
Note
conversions
-
-
-
-
-
-
-
-
-
-
-
-
526,113
-
526,113
Redemption
of preferred stock in convertible note agreement
-
-
-
(100,000 )
(100 )
(49,900 )
-
-
-
-
-
-
-
-
(50,000 )
Conversion
of preferred stock into common stock
-
-
-
-
-
-
(435,990 )
(436 )
(173,950 )
5,449,875
5,449
168,937
-
-
-
Warrants
issued with notes payable (discount)
-
-
-
-
-
-
-
-
-
-
-
28,482
-
-
28,482
Options
and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
77,883
-
-
77,883
Share
adjustmnet
-
-
-
-
-
-
-
-
-
(62 )
-
-
-
-
-
Net
loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
(360,231 )
(360,231 )
Balance
- March 31, 2020
2,552,642
2,553
8,870,626
1,013,245
1,013
615,295
385,302
385
500,507
190,295,634
190,295
61,997,111
532,983
(73,961,340 )
(1,250,572 )
Stock
issued for:
Cash
-
-
-
-
-
-
-
-
-
18,440,000
18,440
479,440
(6,870 )
-
491,010
Note
conversions/settlements
-
-
-
-
-
-
-
-
-
24,112,742
24,113
626,931
(526,113 )
-
124,931
Warrants
purchased for cash
-
-
-
-
-
-
-
-
-
-
-
6,900
-
-
6,900
Options
and warrants issued for services
-
-
-
-
-
-
-
-
-
-
-
2,176
-
-
2,176
Net
loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
(159,087 )
(159,087 )
Balance
- June 30, 2020
2,552,642
$ 2,553
$ 8,870,626
1,013,245
$ 1,013
$ 615,295
385,302
$ 385
$ 500,507
232,848,376
$ 232,848
$ 63,112,558
$ -
$ (74,120,427 )
$ (784,642 )
Stock
issued for:
Note
conversions/settlements
-
-
-
-
-
-
-
-
-
1,851,852
1,852
48,148
-
-
50,000
Net
loss for the period
-
-
-
-
-
-
-
-
-
-
-
-
-
(135,591 )
(135,591 )
Balance
- September 30, 2020
2,552,642
$ 2,553
$ 8,870,626
1,013,245
$ 1,013
$ 615,295
385,302
$ 385
$ 500,507
234,700,228
$ 234,700
$ 63,160,706
$ -
$ (74,256,018 )
$ (870,233 )
The
accompanying notes are an integral part of these financial statements.
3
VIVOS
INC
STATEMENTS
OF CASH FLOWS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019 (UNAUDITED)
2020
2019
CASH FLOW FROM OPERTING ACTIVIITES
Net loss
$ (654,909 )
$ (1,106,059 )
Adjustments to reconcile net loss to net cash used in operating activities
Amortization of convertible debt discount
53,527
66,969
Amortization of BCF discount
6,187
16,327
Common stock issued for services
-
12,500
Stock options and warrants for services
2,176
489,573
Forgiveness of debt
-
(34,106 )
Warrants issued for interest expense
77,883
-
Exchange premium in conversion of notes
98,508
-
Changes in assets and liabilities
Prepaid expenses and other assets
(19,477 )
(27,528 )
Accounts payable and accrued expenses
(134,334 )
(101,620 )
Accounts payable and accrued expenses from related party
-
15,100
Payroll liabilities
30,000
68,549
Accrued interest
30,212
16,339
Total adjustments
144,682
522,103
Net cash used in operating activities
(510,227 )
(583,956 )
CASH FLOWS FROM FINANCING ACTIVITES
Proceeds from related party notes payable
-
187,000
Redemption of preferred stock
(50,000 )
-
Proceeds from sale of preferred stock
-
50,000
Proceeds from sale of common stock
-
50,000
Proceeds from sale of common stock and warrants
504,780
-
Proceeds from convertible debt
100,000
-
Proceeds from promnissory notes
-
450,000
Payment of notes payable
(50,000 )
-
Net cash provided by financing activities
504,780
737,000
NET INCREASE (DECREASE) IN CASH
(5,447 )
153,044
CASH - BEGINNING OF PERIOD
20,381
5,494
CASH - END OF PERIOD
$ 14,934
$ 158,538
CASH PAID DURING THE PERIOD FOR:
Interest expense
$ 13,442
$ 4,000
Income taxes
$ -
$ -
SUPPLEMENTAL INFORMATION - NON-CASH INVESTING AND FINANCING ACTIVITIES:
Conversion of preferred stock into common stock
$ 174,386
$ 416,487
Conversion of convertible preferred B into convertible preferred C
$ -
$ 675,278
Recognition of debt discount at inception of notes payable
$ 28,482
$ 136,750
Conversion of notes payable and accrued interest into common stock
$ 701,044
$ -
Recognition of BCF discount at inception of notes payable
$ -
$ 59,957
Common stock issued in settlement of accounts payable
$ -
$ 22,500
Stock options issued in settlement of accounts payable
$ -
$ 33,829
Reclassification of notes payable and accrued interest into common stock
$ -
$ 15,000
The
accompanying notes are an integral part of these financial statements.
4
Vivos
Inc.
Notes
to Condensed Financial Statements
(Unaudited)
NOTE
1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
The
accompanying condensed financial statements of Vivos Inc. (the “ Company ”) have been prepared without audit,
pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and disclosures required
by accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations.
These condensed financial statements reflect all adjustments that, in the opinion of management, are necessary to present fairly
the results of operations of the Company for the period presented. The results of operations for the six months ended June 30,
2020, are not necessarily indicative of the results that may be expected for any future period or the fiscal year ending December
31, 2020 and should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31,
2019, filed with the Securities and Exchange Commission on April 28, 2020.
Effective
June 28, 2019, FINRA approved the Company’s reverse 1 for 8 stock-split. The reverse stock split will enable the Company
to issue additional shares now that there is availability to do so. All share and per-share figures herein have been restated
to take effect for this reverse stock-split.
In
April of 2017, the Company filed a Certificate of Merger with the Delaware Division of Corporations in order to merge the Company’s
wholly-owned subsidiary, IsoPet Solutions Corporation, with and into the Company. The Company therefore no longer prepares Consolidated
Financial Statements.
The
Company is a radiation oncology medical device company engaged in the development of its yttrium-90 based brachytherapy device
RadioGel™ for the treatment of non-resectable tumors. A prominent team of radiochemists, scientists and engineers, collaborating
with strategic partners, including national laboratories, universities and private corporations, lead the Company’s development
efforts. The Company’s overall vision is to globally empower physicians, medical researchers and patients by providing them
with new isotope technologies that offer safe and effective treatments for cancer.
The
Company’s current focus is on the development of its RadioGel™ device. RadioGel™ is an injectable particle-gel,
for brachytherapy radiation treatment of cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or
a substance that is liquid at room temperature and then gels when reaching body temperature after injection into a tumor. In the
gel are small, one micron, yttrium-90 phosphate particles (“ Y-90 ”). Once injected, these inert particles are
locked in place inside the tumor by the gel, delivering a very high local radiation dose. The radiation is beta, consisting of
high-speed electrons. These electrons only travel a short distance so the device can deliver high radiation to the tumor with
minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment without the risk of radiation
exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactively drops to 5% of its original value after
ten days.
5
The
Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle
Memorial Institute (“ Battelle ”) at Pacific Northwest National Laboratory, a leading research institute for
government and commercial customers. Battelle has granted the Company an exclusive license to patents covering the manufacturing,
processing and applications of RadioGel™ (the “ Battelle License ”). Other intellectual property protection
includes proprietary production processes and trademark protection in 17 countries. The Company plans to continue efforts to develop
new refinements on the production process, and the product and application hardware, as a basis for future patents.
The
Company is currently focusing on obtaining approval from the Food and Drug Administration ( “FDA” ) to market
and sell RadioGel™ as a Class II medical device. The Company first requested FDA approval of RadioGel™ in June 2013,
at which time the FDA classified RadioGel™ as a medical device. The Company then followed with a 510(k) submission which
the FDA responded, in turn, with a request for a physician letter of substantial equivalence and a reformatted 510(k) summary,
which the Company provided in January 2014.
In
February 2014, the FDA ruled the device as not substantially equivalent due to a lack of a predicate device and it was therefore
classified as a Class III device. Class III devices are generally the highest risk devices and are therefore subject to the highest
level of regulatory review, control and oversight. Class III devices must typically be approved by the FDA before they are marketed.
Class II devices represent lower risk devices than Class III and require fewer regulatory controls to provide reasonable assurance
of the device’s safety and effectiveness. In contrast, Class I devices are deemed to be lower risk than Class II or III
and are therefore subject to the least regulatory controls.
The
Company is currently developing test plans to address issues raised by the FDA in connection with the Company’s previous
submissions regarding RadioGel™, including developing specific test plans and specific indication of use. The Company intends
to request that the FDA grant approval to re-apply for de novo classification of RadioGel™, which would reclassify
the device from a Class III device to a Class II device, further simplifying the path to FDA approval. In the event the FDA denies
the Company’s application and subsequently determines during the de novo review that RadioGel™ cannot be classified
as a Class I or Class I1 device, the Company will then need to submit a pre-market approval application to obtain the necessary
regulatory approval as a Class III device. See also Business – Regulatory History in Part I of the Annual Report
on Form 10-K (“ Annual Report ”) filed April 28, 2020 for a discussion regarding the Company’s application
for FDA approval of RadioGel™.
IsoPet
Solutions
The
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement
of university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the
technology in private clinics. The Company has worked with three different university veterinarian hospitals on IsoPet® testing
and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which are incorporated
in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University demonstrated
the CT and PET-CT imaging of IsoPet®. A contract was signed with University of Missouri to treat canine sarcomas and equine
sarcoids starting in November 2017.
The
dogs were treated for canine soft tissue sarcoma. Response evaluation criteria in solid tumors (“ RECIST ”) is
a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress)
during treatment. The criteria were published by an international collaboration including the European Organisation for Research
and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical
Trials Group.
The
testing at the University of Missouri met its objective to demonstrate the safety of IsoPet®. Using its advanced CT and PET
equipment it was able to demonstrate that the dose calculations were accurate and that the injections perfused into the cell interstices
and did not stay concentrated in a bolus. This results in a more homogeneous dose distribution. There was insignificant spread
of Y-90 outside the points of injection demonstrating the effectiveness of the particles and the gel to localize the radiation
with no spreading to the blood or other organs nor to urine or fecal material. This confirms that IsoPet® is safe for same
day therapy.
6
The
effectiveness of IsoPet® for life extension was not the prime objective, but it resulted in valuable insights. Of the cases
one is still cancer-free but the others eventually recurred since there was not a strong focus on treating the margins. The University
of Missouri has agreed to become a regional center to administer IsoPet® therapy and will incorporate the improvements suggested
by the testing program.
The
Company anticipates that future profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®)
and related services, and from licensing to private medical and veterinary clinics in the U.S. and internationally. The Company
intends to report the results from the IsoPet® Solutions division as a separate operating segment in accordance with GAAP.
Commencing
in July 2019, the Company recognized its first commercial sale of IsoPet®. A doctor
brought his cat with a re-occurrent spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy,
but now the tumor was growing rapidly. He was given a high dose of 400Gy with heavy therapy at the margins. This sale met the
revenue recognition requirements under ASC 606 as the performance obligation was satisfied. The Company completed sales for an
additional four animals that received the IsoPet® during 2019.
Our
plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s efforts
in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell
RadioGel™ as a Class II medical device. RadioGel™ is an injectable particle-gel for brachytherapy radiation treatment
of cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
and then gels when reaching body temperature after injection into a tumor. In the gel are small, one micron, yttrium-90 phosphate
particles (“ Y-90 ”). Once injected, these inert particles are locked in place inside the tumor by the gel, delivering
a very high local radiation dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short
distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients
can go home immediately following treatment without the risk of radiation exposure to family members. Since Y-90 has a half-life
of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
The
Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle
Memorial Institute (“ Battelle ”) at Pacific Northwest National Laboratory, a leading research institute for
government and commercial customers. Battelle has granted the Company an exclusive license to patents covering the manufacturing,
processing and applications of RadioGel™ (the “ Battelle License ”). This exclusive license is to terminate
upon the expiration of the last patent included in this agreement (January 2022). Other intellectual property protection includes
proprietary production processes and trademark protection in 17 countries. The Company plans to continue efforts to develop new
refinements on the production process, and the product and application hardware, as a basis for future patents.
Use
of Estimates
The
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities
at the date of financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates the
Company considers include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual
results could differ from those estimates.
Financial
Statement Reclassification
Certain
account balances from prior periods have been reclassified in these financial statements so as to conform to current period classifications.
Cash
Equivalents
For
the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original
maturity of three months or less to be cash equivalents.
7
Inventory
Inventory
is reported at the lower of cost or market, determined using the first-in, first-out basis, or net realizable value. All inventories
consisted of finished goods. The Company has no inventory for the nine-months ended September 30, 2020 and for the year ended
December 31, 2019.
Fair
Value of Financial Instruments
Fair
value of financial instruments requires disclosure of the fair value information, whether or not recognized in the balance sheet,
where it is practicable to estimate that value. As of September 30, 2020 and December 31, 2019, the balances reported for cash,
prepaid expenses, accounts receivable, accounts payable, and accrued expenses, approximate the fair value because of their short
maturities.
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. Accounting Standards Codification (“ ASC ”) Topic 820 established
a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority
to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority
to unobservable inputs (level 3 measurements). These tiers include:
Level
1, defined as observable inputs such as quoted prices for identical instruments in active markets;
Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not
active; and
Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are
unobservable.
The
Company measures certain financial instruments including options and warrants issued during the period at fair value on a recurring
basis.
Derivative
Liabilities and Beneficial Conversion Feature
The
Company evaluates its convertible debt, options, warrants or other contracts, if any, to determine if those contracts or embedded
components of those contracts qualify as derivatives to be separately accounted for in accordance with ASC Topic 815, Accounting
for Derivative Instruments and Hedging Activities (“ ASC 815 ”) as well as related interpretations of this standard
and Accounting Standards Update 2017-11, which was adopted by the Company effective January 1, 2018. In accordance with this standard,
derivative instruments are recognized as either assets or liabilities in the balance sheet and are measured at fair values with
gains or losses recognized in earnings. Embedded derivatives that are not clearly and closely related to the host contract are
bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings.
The
result of this accounting treatment is that the fair value of the derivative instrument is marked-to-market each balance sheet
date and with the change in fair value recognized in the statement of operations as other income or expense.
Upon
conversion, exercise or cancellation of a derivative instrument, the instrument is marked to fair value at the date of conversion,
exercise or cancellation than that the related fair value is removed from the books. Gains or losses on debt extinguishment are
recognized in the statement of operations upon conversion, exercise or cancellation of a derivative instrument after any shares
issued in such a transaction are recorded at market value.
The
classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is
re-assessed at the end of each reporting period. Equity instruments that are initially classified as equity that become subject
to reclassification are reclassified to liability at the fair value of the instrument on the reclassification date. Instruments
that become a derivative after inception are recognized as a derivative on the date they become a derivative with the offsetting
entry recorded in earnings.
8
The
Company determines the fair value of derivative instruments and hybrid instruments, considering all of the rights and obligations
of each instrument, based on available market data using a binomial model, adjusted for the effect of dilution, because it embodies
all of the requisite assumptions (including trading volatility, estimated terms, dilution and risk-free rates) necessary to fair
value these instruments. For instruments in default with no remaining time to maturity the Company uses a one-year term for their
years to maturity estimate unless a sooner conversion date can be estimated or is known. Estimating fair values of derivative
financial instruments requires the development of significant and subjective estimates that may, and are likely to, change over
the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques
(such as Black-Scholes model) are highly volatile and sensitive to changes in the trading market price of our common stock.
The
Company accounts for the beneficial conversion feature on its convertible instruments in accordance with ASC 470-20. The Beneficial
Conversion Feature (“BCF”) is normally characterized as the convertible portion or feature that provides a rate of
conversion that is below market value or in the money when issued. The Company records a BCF when these criteria exist, when issued.
BCFs that are contingent upon the occurrence of a future event are recorded when the contingency is resolved.
To
determine the effective conversion price, the Company first allocates the proceeds received to the convertible instrument, and
then use those allocated proceeds to determine the effective conversion price. The intrinsic value of the conversion option should
be measured using the effective conversion price for the convertible instrument on the proceeds allocated to that instrument.
The
accounting for a BCF requires that the BCF be recognized by allocating the intrinsic value of the conversion option to additional
paid in capital, resulting in a discount to the convertible instrument. This discount should be accreted from the date on which
the BCF is first recognized through the earliest conversion date for instruments that do not have a stated redemption date.
Fixed
Assets
Fixed
assets are carried at the lower of cost or net realizable value. Production equipment with a cost of $2,500 or greater and other
fixed assets with a cost of $1,500 or greater are capitalized. Major betterments that extend the useful lives of assets are also
capitalized. Normal maintenance and repairs are charged to expense as incurred. When assets are sold or otherwise disposed of,
the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized in operations.
Depreciation
is computed using the straight-line method over the following estimated useful lives:
Production
equipment:
3
to 7 years
Office
equipment:
2
to 5 years
Furniture
and fixtures:
2
to 5 years
Leasehold
improvements and capital lease assets are amortized over the shorter of the life of the lease or the estimated life of the asset.
Management
of the Company reviews the net carrying value of all of its equipment on an asset by asset basis whenever events or changes in
circumstances indicate that its carrying amount may not be recoverable. These reviews consider the net realizable value of each
asset, as measured in accordance with the preceding paragraph, to determine whether impairment in value has occurred, and the
need for any asset impairment write-down.
License
Fees
License
fees are stated at cost, less accumulated amortization. Amortization of license fees is computed using the straight-line method
over the estimated economic useful life of the assets.
9
Effective
March 2012, the Company entered into an exclusive license agreement with Battelle Memorial Institute regarding the use of its
patented RadioGel™ technology. This license agreement originally called for a $17,500 nonrefundable license fee and a royalty
based on a percent of gross sales for licensed products sold; the license agreement also contains a minimum royalty amount to
be paid each year starting with 2013. The license agreement was most recently amended on December 20, 2018, and pursuant to the
amendment the maintenance fee schedule was updated for minimum royalties, as well as the increase in royalties from one percent
(1%) to two percent (2%), then on October 8, 2019 to reduce the fee back to one percent (1%).
Future
minimum royalties for the years ended December 31 are noted below:
Minimum
Royalties per
Calendar Year
Calendar Year
2020
$ 10,000
2021
10,000
2022
4,000
Total
$ 24,000
The
Company periodically reviews the carrying values of capitalized license fees and any impairments are recognized when the expected
future operating cash flows to be derived from such assets are less than their carrying value.
The
2020 fee was paid in January 2020.
Patents
and Intellectual Property
While
patents are being developed or pending, they are not being amortized. Management has determined that the economic life of the
patents to be ten years and amortization, over such 10-year period and on a straight-line basis will begin once the patents have
been issued and the Company begins utilization of the patents through production and sales, resulting in revenues.
The
Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis. Several
factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent
operating results and projected and expected undiscounted future cash flows.
There
have been no such capitalized costs in the nine-months ended June 30, 2020 and 2019, respectively. However, a patent was filed
on July 1, 2019 (No. 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company based on the Company’s
proprietary particle manufacturing process. The timing of this filing was important given the Company’s plans to make IsoPet®
commercially available, which it did on or about July 9, 2019. This additional patent protection will strengthen the Company’s
competitive position. It is the Company’s intention to further extend this patent protection to several key countries within
one year, as permitted under international patent laws and treaties.
Revenue
Recognition
In
May 2014, the Financial Accounting Standards Board (“F ASB ”) issued Accounting Standard Update (“ ASU ”)
No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue
recognition to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step
model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers
at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.
The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method.
Under
ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to preform respective
obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for
the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration
is probable. The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.
10
The
Company recognized revenue as they (i) identified the contracts with ach customer; (ii) identified the performance obligation
in each contract; (iii) determined the transaction price in each contract; (iv) were able to allocate the transaction price to
the performance obligations in the contract; and (v) recognized revenue upon the satisfaction of the performance obligation. Upon
the sales of the product to complete the procedures on the animals, the Company recognized revenue as that was considered the
performance obligation.
All
revenue generated during the nine months ended September 30, 2020 and year ended December 31, 2019 related to sales of product.
Loss
Per Share
The
Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted
earnings per share. Basic loss per share is computed by dividing loss available to common stockholders (the numerator) by the
weighted-average number of common shares outstanding (the denominator) for the period, and does not include the impact of any
potentially dilutive common stock equivalents since the impact would be anti-dilutive. The computation of diluted earnings per
share is similar to basic earnings per share, except that the denominator is increased to include the number of additional common
shares that would have been outstanding if potentially dilutive common shares had been issued. For the given periods of loss,
of the periods ended in the nine months ended September 30, 2020 and 2019, the basic earnings per share equals the diluted earnings
per share.
The
following represent common stock equivalents that could be dilutive in the future as of September 30, 2020 and December 31, 2019,
which include the following:
September 30, 2020
December 31, 2019
Convertible debt
2,419
10,914,782
Preferred stock
20,672,640
27,372,515
Common stock options
34,524,580
34,524,580
Common stock warrants
43,956,847
31,286,847
Total potential dilutive securities
99,156,486
104,098,724
Research
and Development Costs
Research
and developments costs, including salaries, research materials, administrative expenses and contractor fees, are charged to operations
as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part
of fixed assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research
and development is classified as research and development expense in the year computed.
The
Company incurred $31,809 and $62,194 research and development costs for the nine months ended September 30, 2020, and 2019, respectively,
all of which were recorded in the Company’s operating expenses noted on the statements of operations for the nine months
then ended.
Advertising
and Marketing Costs
Advertising
and marketing costs are expensed as incurred except for the cost of tradeshows which are deferred until the tradeshow occurs.
During the nine months ended September 30, 2020 and 2019, the Company incurred $6,182 and $0, respectively, in advertising and
marketing costs.
Shipping
and Handling Costs
Shipping
and handling costs are expensed as incurred and included in cost of materials.
11
Contingencies
In
the ordinary course of business, the Company is involved in legal proceedings involving contractual and employment relationships,
product liability claims, patent rights, and a variety of other matters. The Company records contingent liabilities resulting
from asserted and unasserted claims against it, when it is probable that a liability has been incurred and the amount of the loss
is reasonably estimable. The Company discloses contingent liabilities when there is a reasonable possibility that the ultimate
loss will exceed the recorded liability. Estimated probable losses require analysis of multiple factors, in some cases including
judgments about the potential actions of third-party claimants and courts. Therefore, actual losses in any future period are inherently
uncertain. The Company has entered into various agreements that require them to pay certain fees to consultants and/or employees
that have been fully accrued for as of September 30, 2020 and December 31, 2019.
Income
Taxes
To
address accounting for uncertainty in tax positions, the Company clarifies the accounting for income taxes by prescribing a minimum
recognition threshold that a tax position is required to meet before being recognized in the financial statements. The Company
also provides guidance on de-recognition, measurement, classification, interest, and penalties, accounting in interim periods,
disclosure and transition.
The
Company files income tax returns in the U.S. federal jurisdiction. The Company did not have any tax expense for the nine months
ended September 30, 2020 and 2019. The Company did not have any deferred tax liability or asset on its balance sheet on September
30, 2020 and December 31, 2019.
Interest
costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs,
respectively, in the Company’s financial statements. For the nine months ended September 30, 2020 and 2019, the Company
did not recognize any interest or penalty expense related to income taxes. The Company believes that it is not reasonably possible
for the amounts of unrecognized tax benefits to significantly increase or decrease within the next twelve months.
Stock-Based
Compensation
The
Company recognizes compensation costs to employees under FASB ASC Topic 718, Compensation – Stock Compensation. Under FASB
ASC Topic. 718, companies are required to measure the compensation costs of share-based compensation arrangements based on the
grant-date fair value and recognize the costs in the financial statements over the period during which employees are required
to provide services. Share based compensation arrangements include stock options, restricted share plans, performance-based awards,
share appreciation rights and employee share purchase plans. As such, compensation cost is measured on the date of grant at their
fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant.
In
May 2017, the FASB issued ASU 2017-09, “Compensation - Stock Compensation.” The update provides guidance about which
changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in ASC Topic
718. An entity shall account for the effects of a modification described in ASC paragraphs 718-20-35-3 through 35-9, unless all
the following are met: (1) The fair value of the modified award is the same as the fair value of the original award immediately
before the original award is modified; (2) The vesting conditions of the modified award are the same as the vesting conditions
of the original award immediately before the original award is modified; and (3) The classification of the modified award as an
equity instrument or a liability instrument is the same as the classification of the original award immediately before the original
award is modified. The provisions of this update become effective for annual periods and interim periods within those annual periods
beginning after December 15, 2017. The Company’s adoption of this guidance on January 1, 2018 did not have a material impact
on the Company’s results of operations, financial position and related disclosures.
12
In
June 2018, the FASB issued ASU No. 2018-07 “Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based
Payment Accounting.” These amendments expand the scope of Topic 718, Compensation - Stock Compensation (which currently
only includes share-based payments to employees) to include share-based payments issued to nonemployees for goods or services.
Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. The ASU supersedes
Subtopic 505-50, Equity - Equity-Based Payments to Non-Employees. The guidance is effective for public companies for fiscal years,
and interim fiscal periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted, but no earlier
than a company’s adoption date of Topic 606, Revenue from Contracts with Customers. The adoption of this standard did not
have a material impact on its financial statements. The Company has determined that no amounts had to be revalued upon adoption
of this amendment.
Recent
Accounting Pronouncements
In
August, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own
Equity (Subtopic 815-40), Accounting for Convertible Instruments and Contract’s in an Entity’s Own Equity. The ASU
simplifies accounting for convertible instruments by removing major separation models required under current GAAP. Consequently,
more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion
features. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope
exception, which will permit more equity contracts to qualify for it. The ASU simplifies the diluted net income per share calculation
in certain areas. The ASU is effective for annual and interim periods beginning after December 31, 2021, and early adoption is
permitted for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. The Company is currently
evaluating the impact that this new guidance will have on its financial statements.
The
Company does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial
condition, results of operations, cash flows or disclosures.
NOTE
2: GOING CONCERN
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and
satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company has
suffered recurring losses and used significant cash in support of its operating activities and the Company’s cash position
is not sufficient to support the Company’s operations. Research and development of the Company’s brachytherapy product
line has been funded with proceeds from the sale of equity and debt securities as well as a series of grants. The Company requires
funding of approximately $1.5 to $2.0 million annually to maintain current operating activities.
The
Company’s stock offering under Regulation A+ was qualified by the Securities and Exchange Commission (“SEC”)
on June 3, 2020 and have issued the first tranche of shares under the Regulation A+ on June 10, 2020. The intent is to raise up
to $4,050,000 over the next 12-18 months, which may be completed in separate closings.
The
Company intends to use the proceeds generated from the sale of shares under Regulation A+ as follows:
For
the animal therapy market:
●
Fund
the effort to communicate the benefits of IsoPet ® to the veterinary community and the pet parents.
●
Conduct
additional clinical studies to generate more data for the veterinary community
●
Subsidize
some IsoPet ® therapies, if necessary, to ensure that all viable candidates are treated.
●
Assist
a new regional clinic with their license and certification training.
For
the human market:
●
Enhance
the pedigree of the Quality Management System.
●
Complete
the pre-clinical testing that has been previously defined and report the bulk of the results to the FDA in a pre-submission
meeting.
●
Use
the feedback from that meeting to write the IDE (Investigational Device Exemption), which is required to initiate clinical
trials.
13
The
Company received $497,880 which were deposited into the Company’s accounts between April and June 2020. Following the clearance
of the Regulation A+ offering by the SEC on June 3, 2020, the common shares for these proceeds were issued. In addition, the Company
exchanged their outstanding convertible notes payable of $525,000, $27,536 in accrued interest and $98,508 in an exchange premium
stipulated in the note agreements into shares of common stock through September 30, 2020.
Over
the next 12 to 24 months, the Company believes it will cost approximately $5.0 million to $10.0 million to: (1) fund the FDA approval
process and initial deployment of the brachytherapy products, and (2) initiate regulatory approval processes outside of the United
States. The continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional
resources and personnel. The principal variables in the timing and amount of spending for the brachytherapy products in the next
12 to 24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III
devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the
principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals
and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of
those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic
transactions such as licensing and partnership agreements or additional capital raises.
Following
receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships
to facilitate its global commercialization strategy.
In
the longer-term, subject to the Company receiving adequate funding, regulatory approval for RadioGel™ and other brachytherapy
products, and thereafter being able to successfully commercialize its brachytherapy products, the Company intends to consider
resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment
of cancer and other illnesses.
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has
expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue,
nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company
will be required to delay the implementation of its business strategy and may not be able to continue operations.
The
Company has been impacted from the effects of COVID-19. The Company’s headquarters are in Northeast Washington however there
focus of the animal therapy market has been the Northwestern sector of the United States, the initial epicenter of the COVID-19
outbreak in the United States. In addition to a slow down in the marketing of the services, the volatility of the stock market
has contributed to a lack of funds that ordinarily may have been available to the Company. The Company is hopeful that by the
end of 2020 into the first quarter of 2021, they will be allowed to continue their marketing to the animal therapy market and
attempt to increase the exposure to their product and generate revenue accordingly.
The
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern
is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
to the cost structure. There is no assurance that the Company will be successful in its efforts to raise additional working capital
or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of
this uncertainty.
As
of September 30, 2020, the Company has $14,934 cash on hand. There are currently commitments to vendors for products and services
purchased that will necessitate liquidation of the Company if it is unable to raise additional capital. The current level of cash
is not enough to cover the fixed and variable obligations of the Company. The Company was able to execute the following transactions
to improve their balance sheet and decrease the liabilities incurred and increase their cash flow:
14
●
In
November 2019, the Company had its Regulation A+ initially qualified by the SEC for an offering up to 150 million shares of
common stock. On April 30, 2020, the Company filed a post-effective Amendment, which was qualified by the SEC on June 3, 2020.
●
During
the Company’s second and third fiscal quarters, the Company secured approximately $300,000 in convertible promissory
notes, which have subsequently been converted into shares of common stock and raised approximately $500,000 from the sales
of common stock under the Regulation A+..
●
The
Company recognized initial sales of IsoPet ® .
Assuming
the Company is successful in the Company’s sales/development effort, it believes that it will be able to raise additional
funds through strategic agreements or the sale of the Company’s stock to either current or new stockholders. There is no
guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
The
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern
is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
to the cost structure. There is no assurance that the Company will be successful in its efforts to raise additional working capital
or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of
this uncertainty.
NOTE
3: FIXED ASSETS
Fixed
assets consist of the following at September 30, 2020 (unaudited) and December 31, 2019:
September
30, 2020
December
31, 2019
Production
equipment
$ -
$ -
Less
accumulated depreciation
(- )
(- )
$ -
$ -
There
is no depreciation expense for the above fixed assets for the nine months ended September 30, 2020 and 2019, respectively. In
June 2019, the Company sold the one piece of equipment still held for $0. The basis of this piece of equipment was also $0, resulting
in no gain or loss on the sale.
NOTE
4: RELATED PARTY TRANSACTIONS
Related
Party Convertible Notes Payable
As
of September 30, 2020 and December 31, 2019, the Company had the following related party convertible notes outstanding:
September 30, 2020
December 31, 2019
Principal
Accrued
Interest
Principal
Accrued
Interest
September 2019 $15,000 Note, 8% interest, due January 2020
$ -
$ -
$ 15,000
$ 321
Other related party notes
-
1,054
-
1,054
March 2017 $332,195 Note, 10% interest, due May 2017
-
-
-
-
Total Convertible Notes Payable, Net
$ -
$ 1,054
$ 15,000
$ 1,375
Less: Debt Discount
-
-
(500 )
-
$ -
$ 1,054
$ 14,500
$ 1,375
15
In
March 2017, the Company combined Outstanding Notes owed to a director and major stockholder, along with $51,576 of accrued interest
payable, into one promissory note (the “ Related Party Note ”). The Related Party Note accrues interest at a
rate of 10% and was due and payable on December 31, 2017. The note holder agreed to an extension of the due date until May 9,
2018. On August 9, 2018 the Company entered into a Path Forward and Restructuring Agreement whereby this Convertible Note would
convert at a conversion price of $0.032 per share concurrently with a funding of at least $500,000 (the “ Qualified Financing ”).
The Qualified Financing occurred on October 10, 2018 at which time this note was fully converted into 6,250,000 shares of Company
common stock, 385,302 Series B Convertible Preferred shares of the Company, and 5,533,138 warrants that are exercisable into common
shares with an exercise price of $0.08. The Company valued this transaction at a price of $0.104 per share as the conversion occurred
October 19, 2018 upon board approval.
The
Company has outstanding accrued interest in the amount of $1,054 from old related party notes that the principal had been paid
off in full.
The
Company from time to time receives non-interest bearing advancers from its Chief Executive Officer that are due on demand. During
the year ended December 31, 2019, the Company received $20,000 in advances and repaid $5,000 of these and had $15,000 outstanding
at September 24, 2019. On September 24, 2019, these advances were converted into a convertible note at 8% interest which matures
January 15, 2020. Interest on this note for the period ended December 31, 2019 amounted to $321, and this amount is accrued at
December 31, 2019. The Chief Executive Officer received 150,000 warrants when the advances were converted into this convertible
note payable. The Company recognized a discount on the convertible note of $3,721 as a result of the warrants which are being
amortized over the life of the note through January 15, 2020. The Company is in default of this note. As a result of the default,
the interest rate charged was changed to 12.5% through conversion of this note in April 2020.
Interest
expense for the nine months ended September 30, 2020 and 2019 on the related party convertible notes payable amounted to $298
and $0, respectively.
Related
Party Notes Payable
As
of September 30, 2020 and December 31, 2019, the Company had the following related party notes outstanding:
September 30, 2020
December 31, 2019
Principal
Accrued
Interest
Principal
Accrued
Interest
January 2019 $60,000 Note, 8% interest, due January 2020
$ 60,000
$ 8,065
$ 60,000
$ 4,472
March 2019 $48,000 Note, 8% interest, due March 2020
48,000
5,802
48,000
2,927
April 2019 $29,000 Note, 8% interest, due April 2020
29,000
3,296
29,000
1,559
July 2019 $50,000 Note 8% interest, due July 2020
50,000
4,951
50,000
1,956
November 2019 $50,000 Note 8% interest, due November 2020
50,000
3,388
50,000
393
Total Related Party Notes Payable, Net
$ 237,000
$ 25,502
$ 237,000
$ 11,307
On
January 24, 2019 the Company entered into a note payable with a trust related to one of the Company’s directors in the amount
of $60,000. The note is for a one-year period which was to mature January 24, 2020 and bears interest at an annual rate of 8.00%.
The Company is in default of this note.
16
On
March 27, 2019 the Company entered into a note payable with a trust related to one of our directors in the amount of $48,000.
The note is for a one-year period maturing March 27, 2020 and bears interest at an annual rate of 8%. The Company is in default
of this note. On April 29, 2019 the Company entered into a note payable with a trust related to one of our directors in the amount
of $29,000. The Company is in default of this note. On July 5, 2019 the Company entered into a note payable with a trust related
to one of our directors in the amount of $50,000. The note is for a one-year period maturing July 5, 2020 and bears interest at
an annual rate of 8%. On November 25, 2019 the Company entered into a note payable with a trust related to one of our directors
in the amount of $50,000. The note is for a one-year period maturing November 25, 2020 and bears interest at an annual rate of
8%. Interest expense for these notes for the nine months ended September 30, 2020 and 2019 was $14,194 and $7,155, respectively
and accrued interest at September 30, 2020 is $25,502.
The
Company borrowed $87,000 in the nine months ended September 30, 2020 from its CEO and repaid these amounts in full.
Related
Party Payables
The
Company periodically receives advances for operating funds from related parties or has related parties make payments on the Company’s
behalf. As a result of these activities the Company had related party payables of $32,110 and $32,110 as of September 30, 2020
and December 31, 2019, respectively.
Preferred
and Common Shares Issued to Officers and Directors
The
Company’s Chairman converted the Series B Convertible Preferred Shares into Series C Convertible Preferred Shares and as
of April 2020, the 385,302 shares that are issued in the Series C Convertible Preferred Stock are all to the Chairman.
In
April 2020, effective March 31, 2020, the Company converted the $15,000 convertible note payable along with $619 in accrued interest
and an exchange premium of $3,124 into 694,178 shares of common stock. This was part of the Regulation A+. These shares were issued
on June 10, 2020 following the qualification of the Regulation A+.
17
NOTE
5: CONVERTIBLE NOTES PAYABLE
As
of September 30, 2020 and December 31, 2019, the Company had the following convertible notes outstanding:
September 30, 2020
December 31, 2019
Principal
Accrued Interest
Principal
Accrued Interest
July and August 2012 $1,060,000 Notes convertible into common stock at $4.60 per share, 12% interest, due December 2013 and January 2014
$ 45,000
$ 44,031
$ 45,000
39,998
May through October 2015 $605,000 Notes convertible into preferred stock at $1 per share, 8-10% interest, due September 30, 2015
-
17,341
-
17,341
October through December 2015 $613,000 Notes convertible into preferred stock at $1 per share, 8% interest, due June 30, 2016, net of debt discount of $0 and $560,913, respectively
-
5,953
-
5,953
January through March 2016 $345,000 Notes convertible into preferred stock at $1 per share, 8% interest, due June 30, 2016
-
696
-
696
May 2019 $60,000 Note convertible into common shares at $0.04 per share, 8% interest, due October 30, 2019
-
-
60,000
3,264
July 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
-
50,000
1,880
September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
-
50,000
1,235
September 2019 $38,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
-
38,000
939
September 2019 $25,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
-
25,000
612
September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
-
50,000
1,213
September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
-
50,000
1,202
September 2019 $37,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
-
-
37,000
833
December 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due March 31, 2020
-
-
50,000
-
January 2020 $100,000 Note convertible into common shares at $0,04 per share, 8% interest, due March 31, 2020
-
-
-
-
Penalties on notes in default
11,966
-
10,618
-
Total Convertible Notes Payable, Net
$ 56,966
$ 68,021
$ 465,618
$ 75,166
Less: BCF Discount
(- )
-
(6,187 )
-
Less: Debt Discount
(- )
-
(24,545 )
-
$ 56,966
$ 68,021
$ 434,886
$ 75,166
Interest
expense for the nine months ended September 30, 2020 and 2019 on the convertible notes payable amounted to $19,783 and $7,509,
respectively.
The
May 2017 notes totaling $3,136,506, $2,419,240 after debt discounts, had a December 2017 due date which was extended to May 2018.
The
Company entered into a $50,000 convertible promissory note dated May 31, 2019, that was to mature October 30, 2019. The convertible
promissory note bears interest at a rate of 8%, The convertible promissory note is convertible into shares of common stock at
a price of $0.032 per share. Upon the closing of an equity financing pursuant to an effective registration statement with gross
proceeds to the Company totaling at least $250,000 exclusive of any exchanges (“Qualified Financing”), the outstanding
principal amount of this convertible promissory note together with all accrued and unpaid interest shall be exchanged into such
securities as are issued in the Qualified Financing at a rate of 1.20. Upon an exchange, the Payee shall be granted all rights
afforded to an investor in the Qualified Financing. The $10,000 contingent exchange amount is classified as original issue discount
and will be amortized over the life of the convertible promissory note. The convertible promissory noteholder received 625,000
warrants at an exercise price of $0.04 per share, that have a term of two years. The warrants were valued at $12,592 and represent
a debt discount, which were amortized over the life of the convertible promissory note.
18
The
Company entered into $300,000 in convertible promissory notes in July and September 2019, that were to mature January 15, 2020.
The convertible promissory notes bear interest at a rate of 8%, The convertible promissory notes are convertible into shares of
common stock at a price of $0.04 per share. Upon the closing of an equity financing pursuant to an effective registration statement
with gross proceeds to the Company totaling at least $250,000 exclusive of any exchanges (“Qualified Financing”),
the outstanding principal amount of this convertible promissory notes together with all accrued and unpaid interest shall be exchanged
into such securities as are issued in the Qualified Financing at a rate of 1.20. Upon an exchange, the Payee shall be granted
all rights afforded to an investor in the Qualified Financing. The convertible promissory noteholders received 3,000,000 warrants
at an exercise price ranging between $0.06 and $0.08 per share (amended to $0.045 per share), that have a term of two years. The
warrants were valued at $91,716 and represent a debt discount, which will be amortized over the life of the convertible promissory
notes. In addition, the Company recognized a beneficial conversion feature discount to the notes of $59,957 that is being amortized
over the life of the notes. For the nine months ended September 30, 2020 and 2019, the Company recognized $6,187 and $0, in amortization
of the BCF discount.
Prior
to the conversion of these notes, the Company was in default of these notes. As a result of the default, the interest rate charged
was changed to 12.5% up through the conversion of these notes.
The
Company entered into $50,000 in a convertible promissory note on December 31, 2019, that matures March 31, 2020. The convertible
promissory notes bear interest at a rate of 8%, The convertible promissory note is convertible into shares of common stock at
a price of $0.04 per share. Upon the closing of an equity financing pursuant to an effective registration statement with gross
proceeds to the Company totaling at least $250,000 exclusive of any exchanges (“Qualified Financing”), the outstanding
principal amount of this convertible promissory notes together with all accrued and unpaid interest shall be exchanged into such
securities as are issued in the Qualified Financing at a rate of 1.20. Upon an exchange, the Payee shall be granted all rights
afforded to an investor in the Qualified Financing. The convertible promissory noteholders received 625,000 warrants at an exercise
price of $0.06 per share (amended to $0.045 per share), that have a term of two years. The warrants were valued at $14,299 and
represent a debt discount, which will be amortized over the life of the convertible promissory note. This note was converted effective
March 31, 2020. These shares were issued on June 10, 2020 following the qualification of the Regulation A+.
The
Company issued a convertible note in January 2020 in the amount of $100,000 to an accredited investor. The note bears interest
at 8% per annum and was to mature March 31, 2020. The Company granted 1,250,000 warrants with an exercise price of $0.06 per share
and a term of two years with this note and amended 1,312,500 previously issued warrants held by the investor to provide for a
$.06 exercise price and an expiration date of March 31, 2022, the note was converted in June 2020.
NOTE
6: PROMISSORY NOTES PAYABLE
As
of September 30, 2020 and December 31, 2019, the Company had the following promissory notes outstanding:
September 30, 2020
December 31, 2019
Principal
(net)
Accrued
Interest
Principal
(net)
Accrued
Interest
February 2019, two promissory notes for $50,000 each (total of $100,000), maturing August 2019, extended to February 2020, at 8.00% interest (originally) and now 15% interest and extended to August 20, 2020
$ -
$ -
$ 100,000
5,410
Debt discount
(- )
-
-
-
Total Promissory Notes Payable, Net
$ -
$ -
$ 100,000
$ 5,410
The
Company issued two separate promissory notes on February 20, 2019 at $50,000 each (total of $100,000) that were to mature on August
20, 2019 and accrued interest at 8.00% per annum. In connection with the promissory notes, the Company issued warrants to purchase
1,250,000 shares of common stock. The Company recorded the relative fair value of the warrants as a debt discount of $28,721 and
amortized the discount over the life of the note (6 months). Amortization of debt discount for the year ended December 31, 2019
was $28,721 and is recorded as interest expense on the statement of operations for the year ended December 31, 2019.
19
On
August 20, 2019, the two noteholders agreed to extend these notes another six-months to February 20, 2020, then amended again
for six-months and the notes now mature August 20, 2020. In consideration for the extension, the note holders received 750,000
warrants (375,000 each) and the interest rate on the notes increased from 8% to 15% per annum. The interest expense on these notes
for the nine months ended September 30, 2020 and 2019 amounted to $8,032 and $5,640, and $0 is accrued for as of September 30,
2020.
The
Company repaid $50,00 of these notes plus $13,442 in accrued interest, and settled the remaining $50,000 into 1,851,852 shares
of common stock effective July 14, 2020.
NOTE
7: STOCKHOLDERS’ DEFICIT
Common
Stock
The
Company has 950,000,000 shares of common stock authorized, with a par value of $0.001, and as of September 30, 2020 and December
31, 2019, the Company has 234,700,228 and 184,845,821 shares issued and outstanding, respectively.
On
March 28, 2019, the Company’s board of directors approved a reverse 1-for-8 stock split, and a decrease in the authorized
shares from 2,000,000,000 to 950,000,000. The reverse stock split went effective by FINRA on June 28, 2019.
Preferred
Stock
As
of September 30, 2020 and December 31, 2019, the Company has 20,000,000 shares of Preferred stock authorized with a par value
of $0.001. The Company’s Board of Directors is authorized to provide for the issuance of shares of preferred stock in one
or more series, fix or alter the designations, preferences, rights, qualifications, limitations or restrictions of the shares
of each series, including the dividend rights, dividend rates, conversion rights, voting rights, term of redemption including
sinking fund provisions, redemption price or prices, liquidation preferences and the number of shares constituting any series
or designations of such series without further vote or action by the shareholders. The issuance of preferred stock may have the
effect of delaying, deferring or preventing a change in control of management without further action by the shareholders and may
adversely affect the voting and other rights of the holders of common stock. The issuance of preferred stock with voting and conversion
rights may adversely affect the voting power of the holders of common stock, including the loss of voting control to others.
On
October 8, 2018 the Company created out of the shares of Preferred Stock, par value $0.001 per share, of the Company, as authorized
in Article IV of the Company’s Certificate of Incorporation, a series of Preferred Stock of the Company, to be named “Series
B Convertible Preferred Stock,” consisting of Five Million (5,000,000) shares.
On
March 27, 2019 the Company created out of the shares of Preferred Stock, par value $0.001 per share, of the Company, as authorized
in Article IV of the Company’s Certificate of Incorporation, a series of Preferred Stock of the Company, to be named “Series
C Convertible Preferred Stock,” consisting of Five Million (5,000,000) shares.
Series
A Convertible Preferred Stock (“Series A Convertible Preferred”)
In
June 2015, the Series A Certificate of Designation was filed with the Delaware Secretary of State to designate 2.5 million shares
of our preferred stock as Series A Convertible Preferred. Effective March 31, 2016, the Company amended the Certificate of Designations,
Preferences and Rights of Series A Convertible Preferred of the Registrant, increasing the maximum number of shares of Series
A Convertible Preferred from 2,500,000 shares to 5,000,000 shares. The following summarizes the current rights and preferences
of the Series A Convertible Preferred:
Liquidation
Preference . The Series A Convertible Preferred has a liquidation preference of $5.00 per share.
Dividends .
Shares of Series A Convertible Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series A Certificate of Designation, each share of Series A Convertible Preferred
is convertible, at the option of the holder, into that number of shares of common stock (the “ Series A Conversion Shares ”)
equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series A Certificate
of Designation), currently $4.00.
20
In
the event the Company completes an equity or equity-based public offering, registered with the SEC, resulting in gross proceeds
to the Company totaling at least $5.0 million, all issued and outstanding shares of Series A Convertible Preferred at that time
will automatically convert into Series A Conversion Shares.
Redemption .
Subject to certain conditions set forth in the Series A Certificate of Designation, in the event of a Change of Control (defined
in the Series A Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders
of the Series A Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the
Company representing more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option,
will have the right to redeem all or a portion of the outstanding Series A Convertible Preferred in cash at a price per share
of Series A Convertible Preferred equal to 100% of the Liquidation Preference.
Voting
Rights . Holders of Series A Convertible Preferred are entitled to vote on all matters, together with the holders of common
stock, and have the equivalent of five (5) votes for every Series A Conversion Share issuable upon conversion of such holder’s
outstanding shares of Series A Convertible Preferred. However, the Series A Conversion Shares, when issued, will have all the
same voting rights as other issued and outstanding common stock of the Company, and none of the rights of the Series A Convertible
Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series A Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the
Company an amount equal to the liquidation preference of the Series A Convertible Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts,
then the entire assets to be distributed to the holders of the Series A Convertible Preferred shall be ratably distributed among
the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were
paid in full.
Certain
Price and Share Adjustments .
a)
Stock Dividends and Stock Splits . If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
payable in shares of common stock on shares of common stock or any other common stock equivalents; (ii) subdivides outstanding
shares of common stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding
shares of common stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the common
stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization . If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series
A Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the number of
shares of common stock issuable upon conversion of one share of Series A Convertible Preferred prior to any such merger or reorganization
would have been entitled to receive pursuant to such transaction.
Series
B Convertible Preferred Stock (“Series B Convertible Preferred”)
In
October 2018, the Series B Certificate of Designation was filed with the Delaware Secretary of State to designate 5.0 million
shares of our preferred stock as Series B Convertible Preferred. The following summarizes the current rights and preferences of
the Series B Convertible Preferred:
Liquidation
Preference . The Series B Convertible Preferred has a liquidation preference of $1.00 per share.
Dividends .
Shares of Series B Convertible Preferred do not have any separate dividend rights.
21
Conversion .
Subject to certain limitations set forth in the Series B Certificate of Designation, each share of Series B Convertible Preferred
is convertible, at the option of the holder, into that number of shares of common stock (the “ Series B Conversion Shares ”)
equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series B Certificate
of Designation), currently $0.08.
Redemption .
Subject to certain conditions set forth in the Series B Certificate of Designation, in the event of a Change of Control (defined
in the Series B Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders
of the Series B Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the
Company representing more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option,
will have the right to redeem all or a portion of the outstanding Series B Convertible Preferred in cash at a price per share
of Series B Convertible Preferred equal to 100% of the Liquidation Preference.
Voting
Rights . Holders of Series B Convertible Preferred are entitled to vote on all matters, together with the holders of common
stock, and have the equivalent of two (2) votes for every Series B Conversion Share issuable upon conversion of such holder’s
outstanding shares of Series B Convertible Preferred. However, the Series B Conversion Shares, when issued, will have all the
same voting rights as other issued and outstanding common stock of the Company, and none of the rights of the Series A Convertible
Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series B Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the
Company an amount equal to the liquidation preference of the Series B Convertible Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts,
then the entire assets to be distributed to the holders of the Series B Convertible Preferred shall be ratably distributed among
the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were
paid in full.
Certain
Price and Share Adjustments .
a)
Stock Dividends and Stock Splits . If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
payable in shares of common stock on shares of common stock or any other common stock equivalents; (ii) subdivides outstanding
shares of common stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding
shares of common stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the common
stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization . If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series
B Convertible Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the
number of shares of common stock issuable upon conversion of one share of Series B Convertible Preferred prior to any such merger
or reorganization would have been entitled to receive pursuant to such transaction.
Series
C Convertible Preferred Stock (“Series C Convertible Preferred”)
In
March 2019, the Series C Certificate of Designation was filed with the Delaware Secretary of State to designate 5.0 million shares
of our preferred stock as Series C Convertible Preferred. The following summarizes the current rights and preferences of the Series
C Convertible Preferred:
Liquidation
Preference . The Series C Convertible Preferred has a liquidation preference of $1.00 per share.
Dividends .
Shares of Series C Convertible Preferred do not have any separate dividend rights.
Conversion .
Subject to certain limitations set forth in the Series C Certificate of Designation, each share of Series C Convertible Preferred
is convertible, at the option of the holder, into that number of shares of common stock (the “ Series C Conversion Shares ”)
equal to the liquidation preference thereof, divided by Conversion Price (as such term is defined in the Series C Certificate
of Designation), currently $0.08.
22
The
Series C Convertible Preferred will only be convertible at any time after the date that the Company shall have amended its Certificate
of Incorporation to increase the number of shares of common stock authorized for issuance thereunder or effect a reverse stock
split of the outstanding shares of common stock by a sufficient amount to permit the conversion of all Series C Convertible Preferred
into shares of common stock (“ Authorized Share Approval ”) (such date, the “ Initial Convertibility
Date ”), each share of Series C Convertible Preferred shall be convertible into validly issued, fully paid and non-assessable
shares of Common Stock on the terms and conditions set forth in the Series C Certificate of Designation under the definition “ Conversion
Rights ”.
Redemption .
Subject to certain conditions set forth in the Series C Certificate of Designation, in the event of a Change of Control (defined
in the Series C Certificate of Designation as the time at which as a third party not affiliated with the Company or any holders
of the Series C Convertible Preferred shall have acquired, in one or a series of related transactions, equity securities of the
Company representing more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option,
will have the right to redeem all or a portion of the outstanding Series B Convertible Preferred in cash at a price per share
of Series C Convertible Preferred equal to 100% of the Liquidation Preference.
Voting
Rights . Holders of Series C Convertible Preferred are entitled to vote on all matters, together with the holders of common
stock, and have the equivalent of thirty-two (32) votes for every Series C Conversion Share issuable upon conversion of such holder’s
outstanding shares of Series C Convertible Preferred. However, the Series C Conversion Shares, when issued, will have all the
same voting rights as other issued and outstanding common stock of the Company, and none of the rights of the Series C Convertible
Preferred.
Liquidation .
Upon any liquidation, dissolution, or winding-up of the Company, whether voluntary or involuntary (a “ Liquidation ”),
the holders of Series C Convertible Preferred shall be entitled to receive out of the assets, whether capital or surplus, of the
Company an amount equal to the liquidation preference of the Series C Convertible Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if the assets of the Company is insufficient to pay in full such amounts,
then the entire assets to be distributed to the holders of the Series C Convertible Preferred shall be ratably distributed among
the holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were
paid in full.
Certain
Price and Share Adjustments .
a)
Stock Dividends and Stock Splits . If the Company (i) pays a stock dividend or otherwise makes a distribution or distributions
payable in shares of common stock on shares of common stock or any other common stock equivalents; (ii) subdivides outstanding
shares of common stock into a larger number of shares; (iii) combines (including by way of a reverse stock split) outstanding
shares of common stock into a smaller number of shares; or (iv) issues, in the event of a reclassification of shares of the common
stock, any shares of capital stock of the Company, then the conversion price shall be adjusted accordingly.
b)
Merger or Reorganization . If the Company is involved in any reorganization, recapitalization, reclassification, consolidation
or merger in which the Common Stock is converted into or exchanged for securities, cash or other property than each share of Series
C Convertible Preferred shall be convertible into the kind and amount of securities, cash or other property that a holder of the
number of shares of common stock issuable upon conversion of one share of Series C Convertible Preferred prior to any such merger
or reorganization would have been entitled to receive pursuant to such transaction.
Common
and Preferred Stock Issuances - 2020
The
Company in January 2020 paid $50,000 to redeem 100,000 shares of Series B Convertible Preferred Stock. The redemption price was
agreed to by the investor.
In
January 2020, the Company converted 435,990 shares of Series C Convertible Preferred stock into 5,449,875 shares of common stock.
23
In
March through June 2020, the Company entered into agreements to issue 18,440,000 shares of common stock conditioned upon the qualification
of the offer and sale of such shares under Regulation A+ for $497,880. Additionally, the Company agreed to issue 9,220,000 warrants
with a term of two years and an exercise price of $.045 for a purchase price of $8,143. These shares were issued in June 2020
and July 2020 following the qualification of the Regulation A+.
In
March through June 2020, certain holders of convertible promissory notes entered into agreements to exchange certain notes totaling
$651,044, including $525,000 in principal amount, $27,536 in accrued interest and an exchange premium as provided for in the note
agreements of $98,508 into 21,770,668 shares of common stock effective upon the qualification of the offer and sale of such shares
under Regulation A+. In connection with the holder’s agreement to enter into the exchange, the Company intends to issue
2,200,000 warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants
to provide for a $.045 exercise price and an expiration date of March 31, 2022. These shares were issued on June 10, 2020 following
the qualification of the Regulation A+.
During
the three months ended September 30, 2020, the Company issued 1,851,852 shares of common stock to settle $50,000 in promissory
notes.
Common
and Preferred Stock Issuances - 2019
In
January 2019, the Company received $100,000 in gross proceeds resulting from the issuance to accredited investors of 1,250,000
shares of common stock, 100,000 shares of Series B Convertible Preferred and warrants to purchase 1,250,000 shares of common stock.
The
Company issued 13,015,225 shares of common stock in consideration for the conversion of 1,041,218 shares of Series B Convertible
Preferred.
The
Company issued 821,292 shares of Series C Convertible Preferred in exchange for 821,292 shares of Series B Convertible Preferred.
The
Company issued 562,500 shares of common stock in a settlement of accounts payable valued at $22,500.
The
Company issued 312,500 shares of common stock for services rendered in connection with the raising of debt instruments valued
at $12,500.
NOTE
8: COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS
Common
Stock Options
The
Company recognizes in the financial statements compensation related to all stock-based awards, including stock options and warrants,
based on their estimated grant-date fair value. The Company has estimated expected forfeitures and is recognizing compensation
expense only for those awards expected to vest. All compensation is recognized by the time the award vests.
The
following schedule summarizes the changes in the Company’s stock options:
Weighted
Weighted
Options Outstanding
Average
Average
Number
Exercise
Remaining
Aggregate
Exercise
Of
Price
Contractual
Intrinsic
Price
Shares
Per Share
Life
Value
Per Share
Balance at December 31, 2019
34,524,580
$ 0.024-120.00
6.49 years
$ 277,973
$ 0.08
Options granted
-
$ -
-
$ -
Options exercised
-
$ -
-
$ -
Options expired
(- )
$ -
-
$ -
Balance at September 30, 2020
34,524,580
$ 0.024-120.00
5.73 years
$ 64,148
$ 0.08
Exercisable at September 30, 2020
34,428,955
$ 0.024-120.00
5.73 years
$ 63,861
$ 0.08
24
In
June 2019, the Company issued 382,500 stock options to consultants that vest through June 30, 2020. The grant date of these options
was June 17, 2019, the date of board approval. On June 21, 2019, 46,250 stock options expired that were issued June 21, 2016.
There was $6,529 expensed in 2019 and $2,176 remaining to be expensed through June 30, 2020 for these options.
The
Company has granted 21,000,000 stock options under the Company’s 2015 Omnibus Securities and Incentive Plan to Dr. Korenko.
The granting of the stock options occurs 10 days after the approval of the Company’s recent 1 for 8 reverse stock split
that occurred on June 28, 2018. The vesting of the options are as follows: (i) 50% vested in equal amounts at the end of each
of the two successive calendar quarters (25% for each of the quarters September 30, 2019, and December 31, 2019); (ii) 25% upon
the Company filing a patent (completed on July 1, 2019); and (iii) 25% upon the first commercial sale of IsoPet ® .
The first commercial sale occurred in July 2019. The value of these options in the aggregate is $585,144.
In
September 2019, the Company granted 1,000,000 stock options in a settlement agreement for past due legal fees. The options have
a ten-year life and vest immediately. These options were valued at $33,829 which offset accounts payable. The Company recognized
a gain of $34,106 on this transaction which is included in the net (gain) loss on debt extinguishment in the statement of operations
for the year ended December 31, 2019.
In
September 2019, the Company granted 500,000 stock options to a consultant for services rendered. The options have a ten-year life
and vest immediately. These options were valued at $16,915.
In
December 2019, the Company granted 370,309 stock options to consultants for accounts payable. The options have a ten-year life
and vest immediately. These options were valued at $14,812.
During
the nine months ended September 30, 2020 and 2019, the Company recognized $2,176 and $460,125, respectively, worth of stock based
compensation related to the vesting of it stock options.
Common
Stock Warrants
The
following schedule summarizes the changes in the Company’s stock warrants:
Warrants Outstanding
Weighted Average
Weighted Average
Number
Of
Shares
Exercise
Price
Per Share
Remaining Contractual
Life
Aggregate Intrinsic
Value
Exercise
Price
Per Share
Balance at December 31, 2019
31,286,847
$ 0.04-80.00
0.97 years
$ -
$ 0.10
Warrants granted
12,670,000
$ 0.045-0.06
-
$ -
Warrants exercised
-
$ -
-
$
Warrants expired/cancelled
-
$ -
-
$
Balance at September 30, 2020
43,956,847
$ 0.04-80.00
0.34 years
$ -
$ 0.10
Exercisable at September 30, 2020
43,956,847
$ 0.04-80.00
0.34 years
$ -
$ 0.10
25
For
the year ended December 31, 2019, the Company granted 1,250,000 warrants in the issuance of common and preferred shares issued
for cash to accredited investors, 5,650,000 warrants in the issuance of promissory notes (recorded as a debt discount valued at
$151,048), 750,000 warrants for the extension of promissory notes, recorded as interest expense valued at $25,656, 500,000 warrants
for settlement of accounts payable valued at $18,500 (see Note 9) and 84,375 warrants issued for consulting services valued at
$3,792.
The
Company issued a convertible note in the amount of $100,000 to an accredited investor. The note bears interest at 8% per annum
and matures March 31, 2020. The Company granted 1,250,000 warrants with an exercise price of $0.06 per share and a term of two
years with this note and amended 1,312,500 previously issued warrants held by the investor to provide for a $.06 exercise price
and an expiration date of March 31, 2022.
In
March through June 2020, the Company entered into agreements to issue 18,440,000 shares of common stock conditioned upon the qualification
of the offer and sale of such shares under Regulation A+ for $497,880. Additionally, the Company agreed to issue 9,220,000 warrants
with a term of two years and an exercise price of $.045 for a purchase price of $8,143. These shares were issued in June 2020
and July 2020 following the qualification of the Regulation A+.
In
March through June 2020, certain holders of convertible promissory notes entered into agreements to exchange certain notes totaling
$651,044, including $525,000 in principal amount, $27,536 in accrued interest and an exchange premium as provided for in the note
agreements of $98,508 into 21,770,668 shares of common stock effective upon the qualification of the offer and sale of such shares
under Regulation A+. In connection with the holder’s agreement to enter into the exchange, the Company intends to issue
2,200,000 warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants
to provide for a $.045 exercise price and an expiration date of March 31, 2022. These shares were issued on June 10, 2020 following
the qualification of the Regulation A+.
Restricted
Stock Units
The
following schedule summarizes the changes in the Company’s restricted stock units:
Weighted
Number
Average
Of
Grant Date
Shares
Fair Value
Balance at December 31, 2019
262,500
$ 0.59
RSU’s granted
-
$ -
RSU’s vested
-
$ -
RSU’s forfeited
-
$ -
Balance at September 30, 2020
262,500
$ 0.59
During
the nine months ended September 30. 2020 and 2019, the Company recognized $0 and $0 worth of expense related to the vesting of
its RSU’s. As of September 30, 2020, the Company had $155,400 worth of expense yet to be recognized for RSU’s not
yet vested.
26
NOTE
9: LEGAL MATTERS
The
Company may, from time to time, be involved in various legal proceedings incidental to the conduct of our business. Historically,
the outcome of all such legal proceedings has not, in the aggregate, had a material adverse effect on our business, financial
condition, results of operations or liquidity. Other than as set forth below, there are no additional material pending or threatened
legal proceedings at this time.
On
January 28, 2019, James Katzaroff, (“ Plaintiff ”) the Company’s former Chief Executive Officer filed a
lawsuit in the Superior Court in the State of Washington in and for the County of Benton against the Company and its current and
former directors, alleging a default of the Separation Agreement and General Release (“ Release ”) that the Company
entered into with Plaintiff on July 21, 2017 (the “ Complaint ”). The Company has made required payments under
the Release.
On
November 25, 2019, the Company and its current and former directors entered into a Settlement Agreement with the Plaintiff. Under
the terms of the Settlement Agreement, the Company has agreed to issue 500,000 shares of common stock and 500,000 warrants to
the Plaintiff, make an initial payment of $33,503 by December 4, 2019 and beginning on December 16, 2019, the Company will make
payments of $10,000 per month for 10 months in full satisfaction of the Separation Agreement and General Release originally entered
into on July 21, 2017. The Company has paid this liability in full as of September 11, 2020.
NOTE
10: COMMITMENT
On
June 4, 2019, the Company entered into an Executive Employment Agreement (“Employment Agreement”) with Dr. Michael
K. Korenko, the Company’s Chief Executive Officer. The employment term under the Employment Agreement commenced with an
effective date of June 11, 2019 and expires on December 31, 2020, and December 31 of each successive year if the Employment Agreement
is extended, unless terminated earlier as set forth in the Employment Agreement.
Under
the terms of the Employment Agreement, the Company shall pay to Dr. Korenko a base compensation of $180,000. Of this amount, $120,000
is booked in monthly intervals and the remaining balance is only paid upon the Company achieving a cash balance that exceeds $1,000,000.
The Company has elected to record the compensation as $120,000, and upon achieving the milestone of $1,000,000 in cash balances,
will record the deferred compensation at that time.
NOTE
11: SUBSEQUENT EVENTS
Management
has evaluated subsequent events, in accordance with FASB ASC Topic 855, “Subsequent Events”, through the date which
the financial statements were available to be issued and there are no material subsequent events to report.
27
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Except
for statements of historical fact, certain information described in this Form 10-Q report contains “forward-looking statements”
that involve substantial risks and uncertainties. You can identify these statements by forward-looking words such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “intend,” “may,”
“should,” “will,” “would” or similar words. The statements that contain these or similar words
should be read carefully because these statements discuss the Company’s future expectations, including its expectations
of its future results of operations or financial position, or state other “forward-looking” information. Vivos Inc.
believes that it is important to communicate its future expectations to its investors. However, there may be events in the future
that the Company is not able to accurately predict or to control. Further, the Company urges you to be cautious of the forward-looking
statements which are contained in this Form 10-Q report because they involve risks, uncertainties and other factors affecting
its operations, market growth, service, products and licenses. The risk factors in the section captioned “Risk Factors”
in Item 1A of the Company’s previously filed Form 10-K, as well as other cautionary language in this Form 10-Q report, describe
such risks, uncertainties and events that may cause the Company’s actual results and achievements, whether expressed or
implied, to differ materially from the expectations the Company describes in its forward-looking statements. The occurrence of
any of the events described as risk factors could have a material adverse effect on the Company’s business, results of operations
and financial position.
General
Statement of Business
Vivos
Inc. (the “ Company ” or “ we ”) was incorporated under the laws of Delaware on December 23,
1994 as Savage Mountain Sports Corporation (“ SMSC ”). On December 28, 2017, the Company changed its name from
Advanced Medical Isotope Corp. to Vivos Inc.
On
June 25, 2019, the Company amended their Certificate of Incorporation amending their authorized common shares to 950,000,000 from
2,000,000,000 shares. In addition, the 1 for 8 reverse stock-split was effective on June 28, 2019. The reverse stock-split reduced
the number of common shares issued and outstanding from 1,421,687,688 to 177,710,961 shares. The par value for the common shares
remained $0.001 per share, The Company did not amend their preferred stock which is 20,000,000 shares of preferred stock authorized,
$0.001 par value per share.
Our
principal place of business is located at 719 Jadwin Avenue, Richland, Washington 99352. Our telephone number is (509) 736-4000.
Our corporate website address is http://www.radiogel.com. Our common stock is currently listed for quotation on the OTCQB Marketplace
under the symbol “RDGL.”
Overview
The
Company is a radiation oncology medical device company engaged in the development of its yttrium-90 based brachytherapy device,
RadioGel™, for the treatment of non-resectable tumors. A prominent team of radiochemists, scientists and engineers, collaborating
with strategic partners, including national laboratories, universities and private corporations, lead the Company’s development
efforts. The Company’s overall vision is to globally empower physicians, medical researchers and patients by providing them
with new isotope technologies that offer safe and effective treatments for cancer.
In
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified
as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company
believes that the device classification obtained from the Food and Drug Administration (“ FDA ”) Center for Veterinary
Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers,
including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional
regulatory approvals are necessary for the use of IsoPet ® for the treatment of solid tumors in animals. The FDA
does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring
that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
Based
on the FDA’s recommendation, RadioGel TM will be marketed as “IsoPet ® ” for use by veterinarians
to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet ® ”
name. IsoPet ® and RadioGel TM are used synonymously throughout this document. The only distinction between
IsoPet ® and RadioGel TM is the FDA’s recommendation that we use “IsoPet®” for veterinarian
usage, and reserve “RadioGel TM” for human therapy. Based on these developments, the Company has shifted
its primary focus to the development and marketing of Isopet® for animal therapy, through the Company’s IsoPet®
Solutions division.
The
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement
of university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the
technology in private clinics. The Company has worked with three different university veterinarian hospitals on IsoPet® testing
and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which are incorporated
in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University demonstrated
the CT and PET-CT imaging of IsoPet®. A contract was signed with University of Missouri to treat canine sarcomas and equine
sarcoids starting in November 2017.
28
The
dogs were treated for canine soft tissue sarcoma. Response evaluation criteria in solid tumors (“ RECIST ”) is
a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress)
during treatment. The criteria were published by an international collaboration including the European Organisation for Research
and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical
Trials Group.
The
testing at the University of Missouri met its objective to demonstrate the safety of IsoPet®. Using its advanced CT and PET
equipment it was able to demonstrate that the dose calculations were accurate and that the injections perfused into the cell interstices
and did not stay concentrated in a bolus. This results in a more homogeneous dose distribution. There was insignificant spread
of Y-90 outside the points of injection demonstrating the effectiveness of the particles and the gel to localize the radiation
with no spreading to the blood or other organs nor to urine or fecal material. This confirms that IsoPet® is safe for same
day therapy.
The
effectiveness of IsoPet® for life extension was not the prime objective, but it resulted in valuable insights. Of the cases
one is still cancer-free but the others eventually recurred since there was not a strong focus on treating the margins. The University
of Missouri has agreed to become a regional center to administer IsoPet® therapy and will incorporate the improvements suggested
by the testing program.
The
Company anticipates that future profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®)
and related services, and from licensing to private medical and veterinary clinics in the U.S. and internationally. The Company
intends to report the results from the IsoPet® Solutions division as a separate operating segment in accordance with GAAP.
Commencing
in July 2019, the Company recognized its first commercial sale of IsoPet®. A doctor
brought his cat with a re-occurrent spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy,
but now the tumor was growing rapidly. He was given a high dose of 400Gy with heavy therapy at the margins. This sale met the
revenue recognition requirements under ASC 606 as the performance obligation was satisfied. The Company completed sales for an
additional four animals that received the IsoPet® during 2019.
Our
plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s efforts
in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell
RadioGel™ as a Class II medical device. RadioGel™ is an injectable particle-gel for brachytherapy radiation treatment
of cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature
and then gels when reaching body temperature after injection into a tumor. In the gel are small, one micron, yttrium-90 phosphate
particles (“ Y-90 ”). Once injected, these inert particles are locked in place inside the tumor by the gel, delivering
a very high local radiation dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short
distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients
can go home immediately following treatment without the risk of radiation exposure to family members. Since Y-90 has a half-life
of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
The
Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle
Memorial Institute (“ Battelle ”) at Pacific Northwest National Laboratory, a leading research institute for
government and commercial customers. Battelle has granted the Company an exclusive license to patents covering the manufacturing,
processing and applications of RadioGel™ (the “ Battelle License ”). This exclusive license is to terminate
upon the expiration of the last patent included in this agreement (January 2022). Other intellectual property protection includes
proprietary production processes and trademark protection in 17 countries. The Company plans to continue efforts to develop new
refinements on the production process, and the product and application hardware, as a basis for future patents.
29
Vista
Veterinary Hospital
Vista
Veterinary Hospital (“ Vista ”) was selected as the pilot private clinic to initiate commercial sales of IsoPet ® .
It is good management practice to implement and learn from a pilot program before spreading to regional clinics across the country.
Vista is located in the Tri-Cities Washington area which is convenient for interactions with key personnel of Vista Inc. The pilot
is being used to
●
Refine
the Memorandum of Understanding to define all the germane interfaces, roles and liabilities between Vista Inc and the private
clinics, including the pilot responsivity to document and share the key aspects of all therapies with the Company;
●
Create
and implement proprietary certification training packages;
●
Amend
the production center radioactive material license at IsoTherapeutics, the Company’s IsoPet ® production
center, to allow distribution for commercial applications;
●
Work
with the pilot program to obtain a radioactive material licensing in an NRC agreement state;
●
Create
equipment and supplies list;
●
Create
and post regulatory signage;
●
Explore
different IsoPet ® pricing options;
●
Evaluate
different approaches to obtain patients;
●
Optimize
patient scheduling practices to reduce cost to the pet owners; and
●
Develop
communication material and a liability document for the pet owners.
Vista
Veterinary Hospital has done well on two audits by the Washington State Department of Health. The Company is working closely with
the Washington State Department of Health to refine and improve the radioactive material license. The Company has added several
detailed procedures, which will benefit future regional clinics. In addition, a second veterinarian has completed all the preliminary
requirements to become certified. All that remains is to demonstrate proficiency in three therapies.
The
testing at the universities and at Vista Veterinary Hospital have demonstrated that IsoPet ® is effective on killing
cancer tissue in close proximity to the injections. It is most effective in early cases before the cancer has begun to spread.
Later stage cancers are more difficult to treat since the tendrils from the primary cancer site are not well defined and therefore
can lead to recurrence.
There
have been 36 expressions of interest in IsoPet ® therapy from across the United States, but only four of these were
treated and they were very advanced cases. The reasons are instructive. Most of the cases were for so advanced that the pet parents
found out about IsoPet ® on the Internet as a last hope. Several others were internal cancers that could not be
reached, for example deep in the throat. Four cases were treatable, but the pets weighed more than 20 pounds and the pet parents
were not willing to fly them in the “Safe Cargo” holds. Those patients would have been treated by regional clinics
once we implement that strategy. Three cases were mast cell cancers. The Company is confident that those tumors could have been
treated, but once killed they release mast cells in a process called granulation. This could cause a shock to the animal’s
system. The Company will focus one of our clinical studies on the optimum approach for those therapies.
Vista
Veterinary Hospital accepted four advanced cancer cases. The first cat was terminally ill and had previously had external beam,
surgery and chemotherapy. The facial tumor was treated with 400 Gy and the biopsy confirmed that the cancer was killed. In about
seven months the cancer returned in the throat and could not be treated so the cat had to be put down. Dr. Buader, the veterinarian
pet parent, was still elated about the life extension and is asking us to use him as a reference. Two other cases were also very
advanced with multiple tumors and they recurred since they had already spread before therapy.
The
Company’s efforts are now to obtain more early stage cancer patients. The biggest obstacle is to convince the veterinarians
of the pet parents to agree with IsoPet ® therapy rather than using a more traditional method such as surgery. This
is a slow process due to the conservative nature of the veterinarian professions. This is the prime motivation to continue with
additional clinical trials and to publish the results.
30
Regulatory
History
Human
Therapy
RadioGel™
has a long regulatory history with the Food and Drug Administration (“ FDA ”). Initially, the Company submitted
a presubmission (Q130140) to obtain FDA feedback about the proposed product. The FDA requested that the Company file a request
for designation with the Office of Combination Products (RFD130051), which led to the determination that RadioGel™ is a
device for human therapy for non-resectable cancers, which must be reviewed and ultimately regulated by the Center for Devices
and Radiological Health (“ CDRH ”). The Company then submitted a 510(k) notice for RadioGel™ (K133368),
which was found Not Substantially Equivalent due to the lack of a suitable predicate, and RadioGel™ was assigned to the
Class III product code NAW (microspheres). Class III products or devices are generally the highest risk devices and are therefore
subject to the highest level of regulatory review, control and oversight. Class III products or devices must typically be approved
by FDA before they are marketed. Class II devices represent lower risk products or devices than Class III and require fewer regulatory
controls to provide reasonable assurance of the product’s or device’s safety and effectiveness. In contrast, Class
I products and devices are deemed to be lower risk than Class I or II, and are therefore subject to the least regulatory controls.
A
pre-submission meeting (Q140496) was held with the FDA on June 17, 2014, during which the FDA maintained that RadioGel™
should be considered a Class III device and therefore subject to pre-market approval. On December 29, 2014, the Company submitted
a de novo petition for RadioGel™ (DEN140043). The de novo petition was denied by the FDA on June 1, 2015,
with the FDA providing numerous comments and questions. On September 29, 2015, the Company submitted a follow-up pre-submission
informational meeting request with the FDA (Q151569). This meeting took place on November 9, 2015, at which time the FDA indicated
acceptance of the Company’s applied dosimetry methods and clarified the FDA’s outstanding questions regarding RadioGel™.
Following the November 2015 pre-submission meeting, the Company prepared a new pre-submission package to obtain FDA feedback on
the proposed testing methods, intended to address the concerns raised by the FDA staff and to address the suitability of RadioGel™
for de novo reclassification. This pre-submission package was presented to the FDA in a meeting on August 29, 2017. During
the August 2017 meeting, the FDA clarified their position on the remaining pre-clinical testing needed for RadioGel™. Specifically,
the FDA addressed proposed dosimetry calculating techniques, dosimetry distribution between injections, hydrogel viscoelastic
properties, and the details of the Company’s proposed animal testing.
The
Company believes that its submissions to the FDA to date have addressed all the FDA staff’s feedback over the past four
years. Of particular importance, the Company has provided corresponding supporting data for proposed future testing of RadioGel™
to address any remaining questions raised by the FDA. We believe, although no assurances can be given, that the clinical testing
modifications presented to the FDA in August 2017 will result in a de novo reclassification for RadioGel™ by the
FDA. In addition, in previous FDA submittals, the Company proposed applying RadioGel™ for a very broad range of cancer therapies,
referred to as Indication for Use. The FDA requested that the Company reduce its Indications for Use. To comply with that request,
the Company expanded its Medical Advisory Board (“ MAB ”) and engaged doctors from respected hospitals who have
evaluated the candidate cancer therapies based on three criteria: (1) potential for FDA approval and successful therapy;
(2) notable advantage over current therapies; and (3) probability of wide-spread acceptance by the medical community.
The
MAB selected eighteen applications for RadioGel™, each of which meet the criteria described above. This large number confirms
the wide applicability of the device and defines the path for future business growth. The Company’s application establishes
a single Indication for Use - treatment of basal cell and squamous cell skin cancers. We anticipate that this initial application
will facilitate each subsequent application for additional Indications for Use, and the testing for many of the subsequent applications
could be conducted in parallel, depending on available resources.
Results
of Operations
Comparison
of the Nine Months Ended September 30, 2020 and 2019
The
following table sets forth information from our statements of operations for the nine months ended September 30, 2020 and 2019:
Nine Months Ended
September 30, 2020
Nine Months Ended
September 30, 2019
Revenues
$ 7,000
$ 8,000
Operating expenses
(384,267 )
(1,013,426 )
Operating loss
(377,267 )
(1,005,426 )
Non-operating income (expense):
Other income
3,000
34,106
Interest expense
(280,642 )
(134,739 )
Net loss
$ (654,909 )
$ (1,106,059 )
31
Revenue
Revenue
was $7,000 and $8,000 for the nine months ended September 30, 2020 and 2019, respectively.
Operating
Expenses
Operating
expenses for the nine months ended September 30, 2020 and 2019, respectively consists of the following:
Nine months ended
September 30, 2020
Nine months ended
September 30, 2019
Professional fees
$ 170,771
$ 356,248
Stock based compensation
2,176
463,917
Payroll expenses
94,029
90,000
Research and development
31,809
62,194
General and administrative expenses
85,482
41,067
Total operating expenses
$ 384,267
$ 1,013,426
Operating
expenses for the nine months ended September 30, 2020 and 2019 was $384,267 and $1,013,426, respectively. The decrease in operating
expenses from 2019 to 2020 can be attributed to the decrease in professional fees ($170,771 for the nine months ended September
30, 2020 versus $356,248 for the nine months ended September 30, 2020) as the Company utilized less services due to cash flow
constraints; the decrease in stock based compensation ($2,176 for the nine months ended September 30, 2020 versus $463,917 for
the nine months ended September 30, 2019) and the increase in general and administrative expense ($41,067 for the nine months
ended September 30, 2019 versus $85,482 for the nine months ended September 30, 2020) as the Company continued to incur reasonable
administrative costs to run the Company.
Non-Operating
Income (Expense)
Non-operating
income (expense) for the nine months ended September 30, 2020 and 2019 consists of the following:
Nine months ended
September 30, 2020
Nine months ended
September 30, 2019
Interest expense
$ (280,642 )
$ (134,739 )
Other income
3,000
34,106
Non-operating income (expense)
$ (277,642 )
$ (100,633 )
Non-operating
income (expense) for the nine months ended September 30, 2020 varied from the nine months ended September 30, 2019 primarily due
to an increase in interest expense from as a result of the debt increase from 2019 to 2020 prior to conversion of this debt. The
majority of the interest recorded by the Company consists of amortization of debt discount, BCF discount and the exchange premium
resulting in additional shares to the noteholders on conversion.
Net
Loss
Our
net loss for the nine months ended September 30, 2020 and 2019 was $(654,909) and $(1,106,059), respectively.
32
Comparison
of the Three Months Ended September 30, 2020 and 2019
The
following table sets forth information from our statements of operations for the three months ended September 30, 2020 and 2019:
Three Months Ended
September 30, 2020
Three Months Ended
September 30, 2019
Revenues
$ 7,000
$ 8,000
Operating expenses
(135,440 )
(615,207 )
Operating loss
(128,440 )
(607,207 )
Non-operating income (expense):
Other income
-
34,106
Interest expense
(7,151 )
(96,271 )
Net loss
$ (135,591 )
$ (669,372 )
Revenue
Revenue
was $7,000 and $8,000 for the three months ended September 30, 2020 and 2019, respectively.
Operating
Expenses
Operating
expenses for the three months ended September 30, 2020 and 2019, respectively consists of the following:
Three months ended
September 30, 2020
Three months ended
September 30, 2019
Professional fees
$ 59,502
$ 87,075
Stock based compensation
-
457,949
Payroll expenses
34,029
30,000
Research and development
14,383
18,492
General and administrative expenses
27,526
21,691
Total operating expenses
$ 135,440
$ 615,207
Operating
expenses for the three months ended September 30, 2020 and 2019 was $135,440 and $615,207, respectively. The decrease in operating
expenses from 2019 to 2020 can be attributed to the decrease in professional fees ($59,502 for the three months ended September
30, 2020 versus $87,075 for the three months ended September 30, 2019) as the Company utilized less services due to cash flow
constraints; the decrease in stock based compensation ($0 in the three months ended September 30, 2020 versus $457,949 for the
three months ended September 30, 2020) and the increase in general and administrative expense ($21,691 for the three months ended
September 30, 2019 versus $27,526 for the three months ended September 30, 2020) as the Company continued to incur reasonable
administrative costs to run the Company.
Non-Operating
Income (Expense)
Non-operating
income (expense) for the three months ended September 30, 2020 and 2019 consists of the following:
Three months ended
September 30, 2020
Three months ended
September 30, 2019
Interest expense
$ (7,151 )
$ (96,271 )
Other income
-
34,106
Non-operating income (expense)
$ (7,151 )
$ (62,165 )
Non-operating
income (expense) for the three months ended September 30, 2020 varied from the three months ended September 30, 2019 primarily
due to an increase in interest expense from as a result of the debt increase from 2019 to 2020 prior to conversion of this debt.
The majority of the interest recorded by the Company consists of amortization of debt discount, BCF discount and the exchange
premium resulting in additional shares to the noteholders on conversion.
33
Net
Loss
Our
net loss for the three months ended September 30, 2020 and 2019 was $(135,591) and $(669,372), respectively.
Liquidity
and Capital Resources
At
September 30, 2020, the Company had a working capital deficit of $870,233 as compared to $1,479,689 at December 31, 2019. During
the nine months ended September 30, 2020 the Company experienced negative cash flow from operations of $510,227 and it received
$0 for investing activities while adding $504,780 of cash flows from financing activities. As of September 30, 2020, the Company
had no commitments for capital expenditures.
Cash
used in operating activities was primarily a result of the Company’s net loss, and the adjustments to reconcile the net
loss to net cash which included the amortization of discounts as well as expense related to the warrants granted to note holders
and the exchange premium recognized for the conversion of notes. Additionally there were increases in accrued payroll and accrued
interest. The Company had no investing activities for the nine-month periods ended September 30, 2020 and 2019, respectively.
In the nine months ended September 30, 2020 and 2019, the Company had cash provided by financing activities of $504,780 and $737,000,
respectively. These activities were the result of proceeds received from notes payable (both related and unrelated parties) as
well as from sales of common stock and preferred stock.
The
Company has generated material operating losses since inception. The Company had a net loss of $654,909 for the nine months ended
September 30, 2020, and a net loss of $1,106,059 for the nine months ended September 30, 2019. The Company expects to continue
to experience net operating losses. Historically, the Company has relied upon investor funds to maintain its operations and develop
the Company’s business.
The
Company received $497,880 which were deposited into the Company’s accounts between April and June 2020. Following the clearance
of the Regulation A+ offering by the SEC on June 3, 2020, the common shares for these proceeds were issued. In addition, the Company
exchanged their outstanding convertible notes payable of $525,000, $27,536 in accrued interest and $98,508 in an exchange premium
stipulated in the note agreements into shares of common stock through September 30, 2020, and repaid $50,000 in promissory notes
payable.
Over
the next 12 to 24 months, the Company believes it will cost approximately $5.0 million to $10.0 million to: (1) fund the FDA approval
process and initial deployment of the brachytherapy products, and (2) initiate regulatory approval processes outside of the United
States. The continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional
resources and personnel. The principal variables in the timing and amount of spending for the brachytherapy products in the next
12 to 24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III
devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the
principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals
and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of
those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic
transactions such as licensing and partnership agreements or additional capital raises.
Following
receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships
to facilitate its global commercialization strategy.
In
the longer-term, subject to the Company receiving adequate funding, regulatory approval for RadioGel™ and other brachytherapy
products, and thereafter being able to successfully commercialize its brachytherapy products, the Company intends to consider
resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment
of cancer and other illnesses.
34
Based
on the Company’s financial history since inception, the Company’s independent registered public accounting firm has
expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue,
nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company
will be required to delay the implementation of its business strategy and may not be able to continue operations.
The
Company has been impacted from the effects of COVID-19. The Company’s headquarters are in Northeast Washington however there
focus of the animal therapy market has been the Northwestern sector of the United States, the initial epicenter of the COVID-19
outbreak in the United States. In addition to a slow down in the marketing of the services, the volatility of the stock market
has contributed to a lack of funds that ordinarily may have been available to the Company. The Company is hopeful that by the
end of the third quarter of 2020, they will be allowed to continue their marketing to the animal therapy market and attempt to
increase the exposure to their product and generate revenue accordingly.
The
financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern
is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
to the cost structure. There is no assurance that the Company will be successful in its efforts to raise additional working capital
or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of
this uncertainty.
Accounting
Policies and Estimates
The
preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the
United States of America requires management to make estimates and assumptions that affect the amounts reported in the unaudited
condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and
on various other assumptions that are believed to be reasonable under the circumstances. Actual results could differ from these
estimates under different assumptions or conditions. During the period ended September 30, 2020, we believe there have been no
significant changes to the items disclosed as significant accounting policies in management’s notes to the financial statements
in our annual report on Form 10-K for the year ended December 31, 2019, filed on April 28, 2020.
Off-Balance
Sheet Arrangements
The
Company does not have any off-balance sheet arrangements that are reasonably likely to have a current or future effect on the
Company’s financial condition, revenues, results of operations, liquidity or capital expenditures.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
This
item is not applicable to us because we are a smaller reporting company as defined by Rule 12b-2 under the Securities Exchange
Act of 1934.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.