ITEM
1. FINANCIAL STATEMENTS.
Condensed
Consolidated Financial Statements
Cardax,
Inc., and Subsidiary
March
31, 2019 and 2018
Contents
Cardax,
Inc., and Subsidiary
CONDENSED
CONSOLIDATED BALANCE SHEETS
As
of
|
|
March 31, 2019
|
|
|
December 31, 2018
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
73,355
|
|
|
$
|
243,753
|
|
Accounts receivable
|
|
|
185,295
|
|
|
|
157,082
|
|
Inventories
|
|
|
1,423,002
|
|
|
|
1,480,380
|
|
Deposits and other assets
|
|
|
119,066
|
|
|
|
119,066
|
|
Prepaid expenses
|
|
|
23,169
|
|
|
|
24,083
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
1,823,887
|
|
|
|
2,024,364
|
|
|
|
|
|
|
|
|
|
|
INTANGIBLE ASSETS, net
|
|
|
434,372
|
|
|
|
434,534
|
|
|
|
|
|
|
|
|
|
|
RIGHT TO USE LEASED ASSETS
|
|
|
30,813
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
|
2,289,072
|
|
|
$
|
2,458,898
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Accrued payroll and payroll related expenses, current portion
|
|
$
|
3,463,673
|
|
|
$
|
3,428,011
|
|
Accounts payable and accrued expenses
|
|
|
1,672,091
|
|
|
|
1,996,097
|
|
Fees payable to directors
|
|
|
418,546
|
|
|
|
418,546
|
|
Accrued separation costs, current portion
|
|
|
9,000
|
|
|
|
9,000
|
|
Lease liability, current portion
|
|
|
17,129
|
|
|
|
-
|
|
Employee settlement
|
|
|
50,000
|
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
5,630,439
|
|
|
|
5,901,654
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Long-term note payable
|
|
|
1,000,000
|
|
|
|
-
|
|
Accrued separation costs, less current portion
|
|
|
90,385
|
|
|
|
92,635
|
|
Lease liability, less current portion
|
|
|
13,684
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities
|
|
|
1,104,069
|
|
|
|
92,635
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
6,734,508
|
|
|
|
5,994,289
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’ DEFICIT
|
|
|
|
|
|
|
|
|
Preferred Stock - $0.001 par value; 50,000,000 shares authorized, 0 shares issued and outstanding as of March 31, 2019
and December 31, 2018, respectively
|
|
|
-
|
|
|
|
-
|
|
Common stock - $0.001 par value; 400,000,000 shares authorized, 134,686,596 and 133,888,573 shares issued and outstanding
as of March 31, 2019 and December 31, 2018, respectively
|
|
|
134,687
|
|
|
|
133,889
|
|
Additional paid-in-capital
|
|
|
58,498,615
|
|
|
|
58,274,038
|
|
Accumulated deficit
|
|
|
(63,078,738
|
)
|
|
|
(61,943,318
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders’ deficit
|
|
|
(4,445,436
|
)
|
|
|
(3,535,391
|
)
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
|
$
|
2,289,072
|
|
|
$
|
2,458,898
|
|
The
accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
Cardax,
Inc., and Subsidiary
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For
the three-months ended March 31,
|
|
2019
|
|
|
2018
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
REVENUES, net
|
|
$
|
164,972
|
|
|
$
|
313,310
|
|
|
|
|
|
|
|
|
|
|
COST OF GOODS SOLD
|
|
|
104,180
|
|
|
|
135,532
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT
|
|
|
60,792
|
|
|
|
177,778
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
Salaries and wages
|
|
|
404,809
|
|
|
|
418,218
|
|
Selling, general, and administrative expenses
|
|
|
291,569
|
|
|
|
426,867
|
|
Professional fees
|
|
|
241,368
|
|
|
|
181,889
|
|
Stock based compensation
|
|
|
180,375
|
|
|
|
129,625
|
|
Research and development
|
|
|
45,672
|
|
|
|
60,232
|
|
Depreciation and amortization
|
|
|
11,262
|
|
|
|
9,605
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
1,175,055
|
|
|
|
1,226,436
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(1,114,263
|
)
|
|
|
(1,048,658
|
)
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE):
|
|
|
|
|
|
|
|
|
Other income
|
|
|
-
|
|
|
|
556
|
|
Interest income
|
|
|
2
|
|
|
|
1,119
|
|
Interest expense
|
|
|
(21,159
|
)
|
|
|
(881
|
)
|
|
|
|
|
|
|
|
|
|
Total other (expense) income, net
|
|
|
(21,157
|
)
|
|
|
794
|
|
|
|
|
|
|
|
|
|
|
Loss before the provision for income taxes
|
|
|
(1,135,420
|
)
|
|
|
(1,047,864
|
)
|
|
|
|
|
|
|
|
|
|
PROVISION FOR INCOME TAXES
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$
|
(1,135,420
|
)
|
|
$
|
(1,047,864
|
)
|
|
|
|
|
|
|
|
|
|
NET LOSS PER SHARE
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
Diluted
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
|
|
|
|
|
|
|
|
|
SHARES USED IN CALCULATION OF NET LOSS PER SHARE
|
|
|
|
|
|
|
|
|
Basic
|
|
|
133,947,091
|
|
|
|
122,674,516
|
|
Diluted
|
|
|
133,947,091
|
|
|
|
122,674,516
|
|
The
accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
Cardax,
Inc., and Subsidiary
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDER DEFICIT
Three-months
ended March 31, 2018 and 2019
|
|
Common Stock
|
|
|
Additional
Paid-In-
|
|
|
Deferred
|
|
|
Accumulated
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Compensation
|
|
|
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2017
|
|
|
122,674,516
|
|
|
|
122,675
|
|
|
|
56,401,069
|
|
|
|
(10,125
|
)
|
|
|
(57,919,096
|
)
|
|
|
(1,405,477
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock grants to independent directors
|
|
|
185,184
|
|
|
|
185
|
|
|
|
49,815
|
|
|
|
-
|
|
|
|
-
|
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
10,125
|
|
|
|
-
|
|
|
|
10,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation - options
|
|
|
-
|
|
|
|
-
|
|
|
|
69,500
|
|
|
|
-
|
|
|
|
-
|
|
|
|
69,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,047,864
|
)
|
|
|
(1,047,864
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2018
|
|
|
122,859,700
|
|
|
$
|
122,860
|
|
|
$
|
56,520,384
|
|
|
$
|
-
|
|
|
$
|
(58,966,960
|
)
|
|
$
|
(2,323,716
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2018
|
|
|
133,888,573
|
|
|
$
|
133,889
|
|
|
$
|
58,274,038
|
|
|
$
|
-
|
|
|
$
|
(61,943,318
|
)
|
|
$
|
(3,535,391
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock grants to independent directors
|
|
|
460,525
|
|
|
|
461
|
|
|
|
87,039
|
|
|
|
-
|
|
|
|
-
|
|
|
|
87,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock grant to service providers
|
|
|
37,500
|
|
|
|
37
|
|
|
|
6,338
|
|
|
|
-
|
|
|
|
-
|
|
|
|
6,375
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation - options
|
|
|
-
|
|
|
|
-
|
|
|
|
86,500
|
|
|
|
-
|
|
|
|
-
|
|
|
|
86,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock issuances
|
|
|
299,998
|
|
|
|
300
|
|
|
|
44,700
|
|
|
|
-
|
|
|
|
-
|
|
|
|
45,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,135,420
|
)
|
|
|
(1,135,420
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2019
|
|
|
134,686,596
|
|
|
$
|
134,687
|
|
|
$
|
58,498,615
|
|
|
$
|
-
|
|
|
$
|
(63,078,738
|
)
|
|
$
|
(4,445,436
|
)
|
The
accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
Cardax,
Inc., and Subsidiary
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
For
the three-months ended March 31,
|
|
2019
|
|
|
2018
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,135,420
|
)
|
|
$
|
(1,047,864
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
11,262
|
|
|
|
9,605
|
|
Stock based compensation
|
|
|
180,375
|
|
|
|
129,625
|
|
Bad debt expense on note receivable and accrued interest
|
|
|
-
|
|
|
|
89,036
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
21,743
|
|
|
|
(86,043
|
)
|
Inventories
|
|
|
57,378
|
|
|
|
112,191
|
|
Deposits and other assets
|
|
|
-
|
|
|
|
(117,271
|
)
|
Prepaid expenses
|
|
|
914
|
|
|
|
990
|
|
Accrued payroll and payroll related expenses
|
|
|
35,662
|
|
|
|
32,926
|
|
Accounts payable and accrued expenses
|
|
|
(373,962
|
)
|
|
|
(61,491
|
)
|
Accrued separation costs
|
|
|
(2,250
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(1,204,298
|
)
|
|
|
(938,296
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Increase in intangible assets
|
|
|
(11,100
|
)
|
|
|
(5,238
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(11,100
|
)
|
|
|
(5,238
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock
|
|
|
45,000
|
|
|
|
-
|
|
Proceeds from the issuances of notes payable
|
|
|
1,000,000
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
1,045,000
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
NET DECREASE IN CASH
|
|
|
(170,398
|
)
|
|
|
(943,534
|
)
|
|
|
|
|
|
|
|
|
|
BEGINNING OF THE PERIOD
|
|
|
243,753
|
|
|
|
2,236,837
|
|
|
|
|
|
|
|
|
|
|
END OF THE PERIOD
|
|
$
|
73,355
|
|
|
$
|
1,293,303
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES:
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
10,967
|
|
|
$
|
881
|
|
Cash paid for income taxes
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Settlement of receivables with payables
|
|
$
|
49,956
|
|
|
$
|
-
|
|
Purchases of inventory in accounts payable
|
|
$
|
-
|
|
|
$
|
-
|
|
Right to use assets funded through leases
|
|
$
|
30,813
|
|
|
$
|
-
|
|
The
accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS
NOTE
1 – COMPANY BACKGROUND
The
Company’s predecessor, Cardax Pharmaceuticals, Inc. (“Holdings”), was incorporated in the State of Delaware
on March 23, 2006.
Cardax,
Inc. (the “Company”) (OTCQB:CDXI) is a biopharmaceutical company engaged in the development and commercialization
of dietary supplements for inflammatory health and pharmaceuticals for chronic diseases driven by inflammation and oxidative stress.
The Company’s first commercial product, ZanthoSyn®, is a physician recommended anti-inflammatory supplement for health
and longevity that provides astaxanthin with enhanced absorption and purity. The Company sells ZanthoSyn® primarily through
wholesale and e-commerce channels. The Company is also developing CDX-101 (astaxanthin pharmaceutical candidate) and CDX-301 (zeaxanthin
pharmaceutical candidate) for pharmaceutical applications. The safety and efficacy of the Company’s products have not been
directly evaluated in clinical trials or confirmed by the FDA.
Going
concern matters
The
accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying condensed consolidated
financial statements, the Company incurred net losses of $1,135,420 and $1,047,864 for the three-months ended March 31, 2019 and
2018, respectively. The Company has incurred losses since inception resulting in an accumulated deficit of $63,078,738 as of March
31, 2019, and has had negative cash flows from operating activities since inception. The Company expects that its marketing program
for ZanthoSyn® will continue to focus on outreach to physicians, healthcare professionals, retail personnel, and consumers,
and anticipates further losses in the development of its consumer business. The Company also plans to advance the research and
development of its pharmaceutical candidates and anticipates further losses in the development of its pharmaceutical business.
As a result of these and other factors, management has determined there is substantial doubt about the Company’s ability
to continue as a going concern.
During
the three-months ended March 31, 2019, the Company raised additional capital to carry out its business plan. As part of the Company’s
efforts, it raised an additional $45,000 in gross proceeds through a private unit offering and issued $1 million in debt. The
Company’s continued ability to raise additional capital through future equity and debt securities issuances is unknown.
Obtaining additional financing, the successful development of the Company’s contemplated plan of operations, and its transition,
ultimately, to profitable operations are necessary for the Company to continue operations. The ability to successfully resolve
these factors raises substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated
financial statements of the Company do not include any adjustments that may result from the outcome of these uncertainties.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Unaudited
interim financial information
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the rules and
regulations of the Securities and Exchange Commission (the “SEC”) for interim financial information. In the opinion
of the Company’s management, the accompanying condensed consolidated financial statements reflect all adjustments, consisting
of normal, recurring adjustments, considered necessary for a fair presentation of the results for the interim periods ended March
31, 2019 and 2018.
Although
management believes that the disclosures in these unaudited condensed consolidated financial statements are adequate to make the
information presented not misleading, certain information and footnote disclosures normally included in financial statements that
have been prepared in accordance U.S. GAAP have been condensed or omitted pursuant to the rules and regulations of the SEC.
These
unaudited interim consolidated financial statements should be read in conjunction with the consolidated financial statements and
the related notes included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2018, filed
with the SEC on March 28, 2019.
Revenue
from contracts with customers
In
May 2014, the Financial Accounting Standards Board (“FASB”) issued a new standard related to revenue recognition.
Under the standard, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects
the consideration the entity expects to receive in exchange for those goods or services. In addition, the standard requires disclosure
of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers.
The
Company adopted this standard effective January 1, 2018, using the retrospective method. As there was no impact on contracts that
were previously completed and no significant impact to contracts completed after adoption, there was no need to restate prior
results from operations.
The
Company recognizes revenues from its contracts with customers for its products through wholesale and e-commerce channels when
goods and services have been identified, the payment terms agreed to, the contract has commercial substance, both parties have
approved the contract, and it is probable that the Company will collect all substantial consideration.
The
following table presents our revenues disaggregated by revenue source and geographical location. Sales and usage-based taxes are
included as a component of revenues for the three-months ended:
|
|
|
|
|
March 31, 2019
|
|
|
March 31, 2018
|
|
Geographical area
|
|
Source
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
United States
|
|
|
Nutraceuticals
|
|
|
$
|
164,972
|
|
|
$
|
296,897
|
|
Hong Kong
|
|
|
Nutraceuticals
|
|
|
$
|
-
|
|
|
$
|
16,413
|
|
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)
Revenue
from contracts with customers (continued)
Sales
discounts, rebates, promotional amounts to vendors, and returns and allowances are recorded as a reduction to sales in the period
in which sales are recorded. The Company records shipping charges and sales tax gross in revenues and cost of goods sold. Sales
discounts and other adjustments are recorded at the time of sale.
Leases
In
February 2016, the FASB issued ASU No. 2016-02,
Leases
. This ASU requires management to recognize lease assets and lease
liabilities for all leases. ASU No. 2016-02 retains a distinction between finance leases and operating leases. The classification
criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria
for distinguishing between capital leases and operating leases in the previous lease guidance. The result of retaining a distinction
between finance leases and operating leases is that under the lessee accounting model, the effect of leases in the statement of
comprehensive income and the statement of cash flows is largely unchanged from previous U.S. GAAP. The guidance in ASU No. 2016-02
is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years.
The
Company applied the modified retrospective approach in adopting this standard. The modified retrospective approach includes a
number of optional practical expedients that the Company elected to apply; primarily the identification and classification of
leases that commenced before the effective date, initial direct costs for leases that commenced before the effective date, and
the ability to use hindsight in evaluating lessee options to extend or terminate a lease or to purchase the underlying asset.
As part of this adoption, the Company will, in effect, continue to account for leases that commence before the effective date
in accordance with previous U.S. GAAP unless the lease is modified, except that lessees are required to recognize a right-of-use
asset and a lease liability for all operating leases at each reporting date based on the present value of the remaining minimum
rental payments that were tracked and disclosed under previous U.S. GAAP. This adoption of this standard on January 1, 2019, resulted
in the Company recognizing a right-to-use asset and lease liability. The Company elected to not recognize any right-to-use assets
or liabilities for leases that are twelve months or less. Lease costs are recognized straight-line over the term of the lease.
The adoption of this standard did not impact retained earnings or cash flows of the Company.
Other
significant accounting policies
There
have been no other material changes to our significant accounting policies during the three-months ended March 31, 2019, as compared
to the significant accounting policies described in our Annual Report.
Reclassifications
The
Company has made certain reclassifications to conform its prior periods’ data to the current presentation, such as reclassifying
a separation agreement that has terms extending beyond one year. These reclassifications had no effect on the reported results
of operations or cash flows.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
3 – INVENTORIES
Inventories
consist of the following as of:
|
|
March
31, 2019
(Unaudited)
|
|
|
December 31, 2018
|
|
Finished goods
|
|
$
|
381,969
|
|
|
$
|
96,750
|
|
Raw materials
|
|
|
1,041,033
|
|
|
|
1,383,630
|
|
Total inventories
|
|
$
|
1,423,002
|
|
|
$
|
1,480,380
|
|
As
of March 31, 2019 and December 31, 2018, all raw materials were held at the manufacturer’s facility for future production.
NOTE
4 – INTANGIBLE ASSETS, net
Intangible
assets, net, consists of the following as of:
|
|
March 31, 2019
(Unaudited)
|
|
|
December 31, 2018
|
|
Patents
|
|
$
|
585,589
|
|
|
$
|
578,326
|
|
Less accumulated amortization
|
|
|
(303,774
|
)
|
|
|
(292,512
|
)
|
|
|
|
281,815
|
|
|
|
285,814
|
|
Patents pending
|
|
|
152,557
|
|
|
|
148,720
|
|
Total intangible assets, net
|
|
$
|
434,372
|
|
|
$
|
434,534
|
|
Patents
are amortized straight-line over a period of fifteen years. Amortization expense was $11,262 and $8,517 for the three-months ended
March 31, 2019 and 2018, respectively.
The
Company has capitalized costs for several patents that are still pending. In those instances, the Company has not recorded any
amortization. The Company will commence amortization when these patents are approved.
The
Company owns 28 issued patents, including 14 in the United States and 14 others in Europe, Canada, China, India, Japan,
and Hong Kong. These patents will expire beginning in 2023 through 2028, subject to any patent term extensions of the individual
patent. The Company has 1 patent application pending in the United States and 2 foreign patent applications pending in
Europe and Brazil.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
5 –ACCRUED SEPARATION COSTS
On
August 9, 2016, the Company entered into a separation agreement with an employee to pay $118,635 of accrued compensation over
nine-years. As of March 31, 2019, $99,385 remains outstanding of which $9,000 is due within one-year and is reflected as a current
liability.
NOTE
6 – LONG-TERM NOTE PAYABLE
On
January 11, 2019, the Company entered into a $1,000,000 revolving inventory financing facility with a lender. Use of proceeds
from this facility is limited to the purchase of inventory, including raw materials, intermediates, and finished goods, unless
otherwise waived by the lender. This facility accrues interest at the rate of 12% per annum, is unsecured, and matures in three
years from origination. This facility also requires monthly interest payments. As of March 31, 2019, the aggregate unpaid principal
amount under this facility was $1,000,000. The Company incurred interest charges of $19,973 during the three months ended March
31, 2019 and $10,192 of interest is accrued as of March 31, 2019 on this inventory financing facility.
NOTE
7 – STOCKHOLDERS’ DEFICIT
Self-directed
stock issuance 2019
During the three-months ended
March 31, 2019, the Company sold securities in a self-directed offering in the aggregate amount of $45,000 at $0.30 per unit.
Each $0.30 unit consisted of 2 shares of restricted common stock (299,998 shares) and a five-year warrant to purchase 1
share of restricted common stock (149,999 warrant shares) at $0.20 per share.
Warrant
exchange offering
In
June 2018, the Company commenced an offering to exchange outstanding warrants for shares of common stock under a Form S-4 Registration
Statement. These shares of common stock were issued to warrant holders in exchange for (i) their outstanding warrants to purchase
shares of common stock at $0.625 per share, and (ii) cash payment of $0.15 per share. This offering closed on July 27, 2018, and
resulted in an exchange of 9.6 million warrants and $1,440,043 in gross proceeds for 9,600,286 shares of common stock. Stock issuance
costs associated with this capital raise totaled $196,006, resulting in a net total of $1,244,037 raised in this offering.
Shares
outstanding
As
of March 31, 2019 and December 31, 2018, the Company had a total of 134,686,596 and 133,888,573 shares of common stock outstanding.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
8 – STOCK GRANTS
Director
stock grants
During
the three-months ended March 31, 2019 and 2018, the Company granted its independent directors an aggregate of 460,525 and 185,184,
respectively, shares of restricted common stock in the Company. These shares were fully vested upon issuance. The increase in
number of shares issued was due to the expansion of the Board of Directors by two members in June 2018. The expense recognized
for these grants based on the grant date fair value was $87,500 and $50,000 for the three-months ended March 31, 2019 and 2018,
respectively.
Consultant
stock grants
On April 10, 2017, the Company
granted a consultant 100,000 shares of restricted common stock valued at $0.23 per share. These shares were subject to a risk
of forfeiture and vested quarterly in arrears commencing on April 1, 2018. The Company recognized $5,750 in stock-based compensation
related to this grant during the three-months ended March 31, 2018.
On August 8, 2017, the Company
granted a consultant 100,000 shares of restricted common stock valued at $0.175 per share. These shares were subject to
a risk of forfeiture and vested 25% upon grant and quarterly in arrears thereafter commencing on September 1, 2017. The
Company recognized $4,375 in stock-based compensation related to this grant during the three-months ended March 31, 2018.
On
December 31, 2018, the Company granted consultants 112,500 shares of restricted common stock valued at $0.20 per share. These
shares were fully vested upon issuance. The Company recognized $22,500 in stock-based compensation related to these grants during
the year ended December 31, 2018.
On
March 31, 2019, the Company granted consultants 37,500 shares of restricted common stock valued at $0.17 per share. These shares
were fully vested upon issuance. The Company recognized $6,375 in stock-based compensation related to these grants during the
three-months ended March 31, 2019.
NOTE
9 – STOCK OPTION PLANS
On February 7, 2014, the Company
adopted the 2014 Equity Compensation Plan. Under this plan, the Company may issue options to purchase shares of common stock to
employees, directors, advisors, and consultants. The aggregate number of shares reserved under this plan upon adoption
was 30,420,148. On April 16, 2015, the majority stockholder of the Company approved an increase in the Company’s 2014 Equity
Compensation Plan by 15 million shares. On December 4, 2018, the stockholders of the Company approved an increase
in the Company’s 2014 Equity Compensation Plan by an additional 5 million shares, for a total of 50,420,148 shares
reserved under the plan.
Under
the terms of the 2014 Equity Compensation Plan and the 2006 Stock Incentive Plan (collectively, the “Plans”), incentive
stock options may be granted to employees at a price per share not less than 100% of the fair market value at date of grant. If
the incentive stock option is granted to a 10% stockholder, then the purchase or exercise price per share shall not be less than
110% of the fair market value per share of common stock on the grant date. Non-statutory stock options and restricted stock may
be granted to employees, directors, advisors, and consultants at a price per share, not less than 100% of the fair market value
at date of grant. Options granted are exercisable, unless specified differently in the grant documents, over a default term of
ten years from the date of grant and generally vest over a period of four years.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
9 – STOCK OPTION PLANS (continued)
A
summary of stock option activity is as follows:
|
|
Options
|
|
|
Weighted
average
exercise price
|
|
|
Weighted
average
remaining
contractual
term in years
|
|
|
Aggregate
intrinsic value
|
|
Outstanding January 1, 2018
|
|
|
38,213,427
|
|
|
$
|
0.41
|
|
|
|
5.23
|
|
|
$
|
562,456
|
|
Exercisable January 1, 2018
|
|
|
36,213,427
|
|
|
$
|
0.41
|
|
|
|
4.98
|
|
|
$
|
562,456
|
|
Canceled
|
|
|
(350,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
2,833,334
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(200,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding December 31, 2018
|
|
|
40,496,761
|
|
|
$
|
0.40
|
|
|
|
4.52
|
|
|
$
|
986,808
|
|
Exercisable December 31, 2018
|
|
|
37,157,179
|
|
|
$
|
0.41
|
|
|
|
4.10
|
|
|
$
|
966,808
|
|
Canceled
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding March 31, 2019
|
|
|
40,496,761
|
|
|
$
|
0.40
|
|
|
|
4.28
|
|
|
$
|
664,331
|
|
Exercisable March 31, 2019
|
|
|
37,559,261
|
|
|
$
|
0.41
|
|
|
|
3.90
|
|
|
$
|
660,435
|
|
The
aggregate intrinsic value in the table above is before applicable income taxes and represents the excess amount over the exercise
price option recipients would have received if all options had been exercised on March 31, 2019, based on a valuation of the Company’s
stock for that day.
A
summary of the Company’s non-vested options for the three-months ended March 31, 2019 and year ended December 31, 2018,
are presented below:
Non-vested at January 1, 2018
|
|
|
2,000,000
|
|
Granted
|
|
|
2,833,334
|
|
Vested
|
|
|
(1,143,752
|
)
|
Canceled
|
|
|
(350,000
|
|
Non-vested at December 31, 2018
|
|
|
3,339,582
|
|
Granted
|
|
|
-
|
|
Vested
|
|
|
(402,082
|
)
|
Canceled
|
|
|
-
|
|
Non-vested at March 31, 2019
|
|
|
2,937,500
|
|
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
9 – STOCK OPTION PLANS (continued)
The
Company estimates the fair value of stock options granted on each grant date using the Black-Scholes option valuation model and
recognizes an expense ratably over the requisite service period. The range of fair value assumptions related to options issued
were as follows for the:
|
|
Three-months
ended
March 31, 2019
|
|
|
Year
ended
December 31, 2018
|
|
Dividend
yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Risk-free
rate
|
|
|
2.38%
- 3.04
|
%
|
|
|
2.38%
- 3.04
|
%
|
Expected
volatility
|
|
|
214%
- 226
|
%
|
|
|
214%
- 226
|
%
|
Expected
term
|
|
|
3
- 7 years
|
|
|
|
3
- 7 years
|
|
The
expected volatility was calculated based on the historical volatility of the Company. The risk-free interest rate used was based
on the U.S. Treasury constant maturity rate in effect at the time of grant for the expected term of the stock options to be valued.
The expected dividend yield was zero, because the Company does not anticipate paying a dividend within the relevant timeframe.
Due to a lack of historical information needed to estimate the Company’s expected term, it was estimated using the simplified
method allowed.
The
Company records forfeitures as they occur and reverses compensation cost previously recognized, in the period the award is forfeited,
for an award that is forfeited before completion of the requisite service period.
Stock
option exercise
During
the year ended December 31, 2018, the Company issued 156,997 shares of common stock in connection with the cashless exercise of
stock options for 100,000, 50,000, and 50,000 shares of common stock exercisable at $0.06 per share with 43,003 shares of common
stock withheld with an aggregate fair market value equal to the aggregate exercise price.
Stock
based compensation
The
Company recognized stock-based compensation expense related to options during the:
|
|
Three-months
ended March 31
|
|
|
|
2019
|
|
|
2018
|
|
|
|
Amount
|
|
|
Amount
|
|
Service
provider compensation
|
|
$
|
44,375
|
|
|
$
|
9,375
|
|
Employee
compensation
|
|
|
42,125
|
|
|
|
60,125
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
86,500
|
|
|
$
|
69,500
|
|
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
10 – WARRANTS
The
following is a summary of the Company’s warrant activity:
|
|
Warrants
|
|
|
Weighted average exercise price
|
|
|
Weighted average remaining contractual term in years
|
|
|
Aggregate intrinsic value
|
|
Outstanding January 1, 2018
|
|
|
127,434,122
|
|
|
$
|
0.24
|
|
|
|
3.15
|
|
|
$
|
3,957,689
|
|
Exercisable January 1, 2018
|
|
|
127,434,122
|
|
|
$
|
0.24
|
|
|
|
3.15
|
|
|
$
|
3,957,689
|
|
Canceled
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
315,010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(9,600,286
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(101,984
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding December 31, 2018
|
|
|
118,046,862
|
|
|
$
|
0.20
|
|
|
|
2.32
|
|
|
$
|
7,848,637
|
|
Exercisable December 31, 2018
|
|
|
118,046,862
|
|
|
$
|
0.20
|
|
|
|
2.32
|
|
|
$
|
7,848,637
|
|
Canceled
|
|
|
(18,405,496
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
149,999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding March 31, 2019
|
|
|
99,791,365
|
|
|
$
|
0.13
|
|
|
|
2.49
|
|
|
$
|
5,005,222
|
|
Exercisable March 31, 2019
|
|
|
99,791,365
|
|
|
$
|
0.13
|
|
|
|
2.49
|
|
|
$
|
5,005,222
|
|
The
Company estimates the fair value of warrants granted on each grant date using the Black-Scholes option valuation model. The expected
volatility is calculated based on the historical volatility of the Company. The risk-free interest rate used is based on the U.S.
Treasury constant maturity rate in effect at the time of grant for the expected term of the warrants to be valued. The expected
dividend yield is zero, because the Company does not anticipate paying a dividend within the relevant timeframe. Due to a lack
of historical information needed to estimate the Company’s expected term, it is estimated using the simplified method allowed.
The
Company did not recognize any stock-based compensation expense related to warrants during the three-months ended March 31, 2019
and 2018.
Warrant
exchange offering
In
June 2018, the Company commenced an offering to exchange outstanding warrants for shares of common stock under a Form S-4 Registration
Statement. These shares of common stock were issued to warrant holders in exchange for (i) their outstanding warrants to purchase
shares of common stock at $0.625 per share, and (ii) cash payment of $0.15 per share. This offering closed on July 27, 2018, and
resulted in an exchange of 9.6 million warrants and $1,440,043 in gross proceeds for 9,600,286 shares of common stock. Stock issuance
costs associated with this capital raise totaled $196,006, resulting in a net total of $1,244,037 raised in this offering. As
part of this offering, warrants to purchase 315,010 shares of common stock at $0.21 per share were issued to investment bankers
for their services.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
10 – WARRANTS (continued)
Warrant
expiration
During
the three-months ended March 31, 2019, warrants to purchase an aggregate of 18,405,496 were canceled. During the year ended December
31, 2018, warrants to purchase an aggregate of 101,984 expired.
NOTE
11 – INCOME TAXES
The
Company accounts for income taxes using the asset and liability method. Under this method, deferred income tax assets and liabilities
are determined based upon the difference between the financial statement carrying amounts and the tax basis of assets and liabilities
and are measured using the enacted tax rate expected to apply to taxable income in the years in which the differences are expected
to be reversed.
The
effective tax rate for the three and three-months ended March 31, 2019 and 2018, differs from the statutory rate of 21% as a result
of state taxes (net of Federal benefit), permanent differences, and a reserve against deferred tax assets.
The
Company’s valuation allowance was primarily related to the operating losses. The valuation allowance is determined in accordance
with the provisions of ASC No. 740,
Income Taxes
, which requires an assessment of both negative and positive evidence when
measuring the need for a valuation allowance. Based on the available objective evidence and the Company’s history of losses,
management provides no assurance that the net deferred tax assets will be realized. As of March 31, 2019 and December 31, 2018,
the Company has applied a valuation allowance against its deferred tax assets net of the expected income from the reversal of
the deferred tax liabilities.
Recent
tax legislation
On
March 22, 2018, the Tax Cuts and Jobs Act (“TCJA”) was enacted into law, which significantly changes existing U.S.
tax law and includes numerous provisions that affect our business, such as reducing the U.S. federal statutory tax rate from 35%
to 21% effective January 1, 2018.
Uncertain
tax positions
The
Company is subject to taxation in the United States and two state jurisdictions. The preparation of tax returns requires management
to interpret the applicable tax laws and regulations in effect in such jurisdictions, which could affect the amount of tax paid
by the Company. Management, in consultation with its tax advisors, files its tax returns based on interpretations that are believed
to be reasonable under the circumstances. The income tax returns, however, are subject to routine reviews by the various taxing
authorities. As part of these reviews, a taxing authority may disagree with respect to the tax positions taken by management (“uncertain
tax positions”) and therefore may require the Company to pay additional taxes.
Management
evaluates the requirement for additional tax accruals, including interest and penalties, which the Company could incur as a result
of the ultimate resolution of its uncertain tax positions. Management reviews and updates the accrual for uncertain tax positions
as more definitive information becomes available from taxing authorities, completion of tax audits, expiration of statute of limitations,
or upon occurrence of other events.
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
11 – INCOME TAXES (continued)
Uncertain
tax positions (continued)
As
of March 31, 2019 and December 31, 2018, there was no liability for income tax associated with unrecognized tax benefits. The
Company recognizes accrued interest related to unrecognized tax benefits as well as any related penalties in interest income or
expense in its condensed consolidated statements of operations, which is consistent with the recognition of these items in prior
reporting periods.
The
federal and state income tax returns of the Company are subject to examination by the IRS and state taxing authorities, generally
for three years after they were filed.
NOTE
12 – BASIC AND DILUTED NET LOSS PER SHARE
The
following table sets forth the computation of the Company’s basic and diluted net loss per share for:
|
|
Three-months ended March 31, 2019
(Unaudited)
|
|
|
|
Net Loss (Numerator)
|
|
|
Shares (Denominator)
|
|
|
Per share
amount
|
|
Basic loss per share
|
|
$
|
(1,135,420
|
)
|
|
|
133,947,091
|
|
|
$
|
(0.01
|
)
|
Effect of dilutive securities—Common stock options and warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Diluted loss per share
|
|
$
|
(1,135,420
|
)
|
|
|
133,947,091
|
|
|
$
|
(0.01
|
)
|
|
|
Three-months
ended March 31, 2018
(Unaudited)
|
|
|
|
Net Loss (Numerator)
|
|
|
Shares (Denominator)
|
|
|
Per share
amount
|
|
Basic loss per share
|
|
$
|
(1,047,864
|
)
|
|
|
122,674,516
|
|
|
$
|
(0.01
|
)
|
Effect of dilutive securities—Common stock options and warrants
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Diluted loss per share
|
|
$
|
(1,047,864
|
)
|
|
|
122,674,516
|
|
|
$
|
(0.01
|
)
|
The
following outstanding shares of common stock equivalents were excluded from the computation of diluted net loss per share for
the periods presented because including them would have been antidilutive for the periods ended:
|
|
March 31, 2019
|
|
|
March 31, 2018
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Common stock options
|
|
|
40,496,761
|
|
|
|
38,696,761
|
|
Common stock warrants
|
|
|
99,791,365
|
|
|
|
127,434,122
|
|
Total common stock equivalents
|
|
|
140,288,126
|
|
|
|
166,130,883
|
|
Cardax,
Inc., and Subsidiary
NOTES
TO THE CONDENSED CONSOLIDATED
FINANCIAL
STATEMENTS (continued)
NOTE
13 – LEASES
Manoa
Innovation Center
The
Company entered into an automatically renewable month-to-month lease for office space on August 13, 2010. Under the terms of this
lease, the Company must provide a written notice 45 days prior to vacating the premises. Total rent expense under this agreement
as amended was $9,100 and $7,201 for the three-months ended March 31, 2019 and 2018, respectively.
Fleet
Lease
In
January 2018, the Company entered into a vehicle lease arrangement with a rental company for three vehicles. The terms of the
leases require monthly payments of $1,619 for three years. These leases convert to month-to-month leases in January 2021 unless
terminated. Total lease expense under this agreement was $5,959 and $3,730 for the three-months ended March 31, 2019 and
2018, respectively.
Right-to-use
leased asset and liability
As
a result of the adoption of ASU No. 2016-02,
Leases
, on January 1, 2019, the Company recognized a right-to-use leased asset
and liability for the Fleet Leases. The balance of this right-to-use asset and liability was $30,813 as of March 31, 2019.
NOTE
14 – SUBSEQUENT EVENTS
The
Company evaluated all material events through the date the financials were ready for issuance.
In April 2019, the Company sold
securities in a self-directed offering in the aggregate amount of $200,000 at $0.30 per unit. Each unit consisted of 2 shares
of restricted common stock (1,333,332 shares) and a five-year warrant to purchase 1 share of restricted common stock (666,666
warrant shares) at $0.20 per share.
On April 18, 2019, the Company
issued a convertible note payable in the amount $150,000. This note bears interest at 10% per annum and matures on December
31, 2019. This note and accrued interest may convert into shares of common stock at $0.12 per share any time
at the holder’s option or automatically upon maturity provided the 20-day volume weighted average price per share of the
Company’s common stock upon maturity is at least $0.12 per share. This note was also issued with a detachable warrant
to purchase 500,000 shares of stock at $0.20 per share.
***
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Explanatory
Note
Unless otherwise noted,
references in this Quarterly Report on Form 10-Q to “Cardax,” the “Company,” “we,”
“our,” or “us” means Cardax, Inc., the registrant, and, unless the context otherwise requires, together
with its wholly-owned subsidiary, Cardax Pharma, Inc., a Delaware corporation (“
Pharma
”), and Pharma’s
predecessor, Cardax Pharmaceuticals, Inc., a Delaware corporation (“
Holdings
”), which merged with and into
Cardax, Inc. on December 30, 2015.
Unless otherwise noted,
references in this Quarterly Report on Form 10-Q to our “product” or “products” includes
our dietary supplements, pharmaceutical candidates, and any of our other current or future products, product candidates, and technologies,
to the extent applicable.
Corporate
Overview and History
We
are devoting substantially all of our present efforts to establishing our business related to the development and commercialization
of dietary supplements and pharmaceuticals. Our first commercial product, ZanthoSyn®, is a physician recommended anti-inflammatory
supplement for health and longevity that features astaxanthin with optimal absorption and purity. The form of astaxanthin utilized
in ZanthoSyn® has demonstrated excellent safety in peer-reviewed published studies and is designated as GRAS (Generally Recognized
as Safe) according to FDA regulations. We sell ZanthoSyn® primarily through wholesale and e-commerce channels. We expect that
our marketing program will continue to focus on education of physicians, healthcare professionals, retail personnel, and consumers.
We are also developing CDX-101 (astaxanthin pharmaceutical candidate) and CDX-301 (zeaxanthin pharmaceutical candidate) for pharmaceutical
applications. The safety and efficacy of our products have not been directly evaluated in clinical trials or confirmed by the
FDA.
At
present we are not able to estimate if or when we will be able to generate sustained revenues. Our financial statements have been
prepared assuming that we will continue as a going concern; however, given our recurring losses from operations, our independent
registered public accounting firm has determined there is substantial doubt about our ability to continue as a going concern.
Subsequent
Events
In April 2019, we sold
securities in a self-directed offering in the aggregate amount of $200,000 at $0.30 per unit. Each unit consisted of 2 shares
of restricted common stock (1,333,332 shares) and a five-year warrant to purchase 1 share of restricted common stock (666,666
warrant shares) at $0.20 per share.
On April 18, 2019,
we issued a convertible note payable in the amount $150,000. This note bears interest at 10% per annum and matures on December
31, 2019. This note and accrued interest may convert into shares of common stock at $0.12 per share any time at the holder’s
option or automatically upon maturity provided the 20-day volume weighted average price per share of our common stock upon maturity
is at least $0.12 per share. This note was also issued with a detachable warrant to purchase 500,000 shares of stock at $0.20
per share.
Results
of Operations
Results
of Operations for the Three-Months Ended March 31, 2019 and 2018:
The
following table reflects our operating results for the three-months ended March 31, 2019 and 2018:
Operating Summary
|
|
Three-months ended
March 31, 2019
|
|
|
Three-months ended
March 31, 2018
|
|
Revenues
|
|
$
|
164,972
|
|
|
$
|
313,310
|
|
Cost of Goods Sold
|
|
|
(104,180
|
)
|
|
|
(135,532
|
)
|
Gross Profit
|
|
|
60,792
|
|
|
|
177,778
|
|
Operating Expenses
|
|
|
(1,175,055
|
)
|
|
|
(1,266,436
|
)
|
Net Operating Loss
|
|
|
(1,114,263
|
)
|
|
|
(1,048,658
|
)
|
Other (Loss) Income
|
|
|
(21,157
|
)
|
|
|
794
|
|
Net Loss
|
|
$
|
(1,135,420
|
)
|
|
$
|
(1,047,864
|
)
|
Operating
Summary for the Three-Months Ended March 31, 2019 and 2018
We sell
ZanthoSyn® primarily through wholesale and, to a lesser extent, e-commerce channels. We launched our e-commerce channel
in 2016 and began selling to GNC stores in 2017. ZanthoSyn® is currently available at over three thousand GNC corporate
stores in the United States. As a result, revenues were $164,972 and $313,310 for the three-months ended March 31, 2019 and
2018, respectively. The decrease in revenues for the three-months ended March 31, 2019 was primarily attributed to a
combination of (i) GNC selling through existing ZanthoSyn® inventory we sold to GNC during the prior year, which impacted
the timing and amounts of replenishment orders during the current period, and (ii) increased promotional activities at GNC
stores, which increased the sales discounts passed through to us during the current period. Cost of goods sold were
$104,180 and $135,32 for the three-months ended March 31, 2019 and 2018, respectively, and included costs of the
product, shipping and handling, sales taxes, merchant fees, and other costs incurred on the sale of goods. Gross profits were
$60,792 and $177,778 for the three-months ended March 31, 2019 and 2018, respectively, which represented gross profit margins
of 37% and 57%, respectively. The decrease in gross profit margin for the three-months ended March 31, 2019 was primarily
attributed to increased promotional activities at GNC stores, which increased the sales discounts passed through to us during
the current period.
Operating expenses were
$1,175,055 and $1,266,436, for the three-months ended March 31, 2019 and 2018, respectively. Operating expenses primarily consisted
of services provided to the Company, including payroll, consultation, and contract services, for research and development,
including our clinical trial and pharmaceutical development programs, sales and marketing, and administration. These expenses
were paid in accordance with agreements entered into with each employee or service provider. Included in operating expenses were
$180,375 and $129,625 in stock-based compensation for the three-months ended March 31, 2019 and 2018, respectively.
Other
income (expense) was $(21,157) and $794, for the three-months ended March 31, 2019 and 2018, respectively. For the three-months
ended March 31, 2019, other expense primarily consisted of interest expense of $21,429, which was offset by interest income of
$2. For the three-months ended March 31, 2018, other income primarily consisted of interest and other income of $1,675, which
was offset by interest expense of $881.
Liquidity
and Capital Resources
Since
our inception, we have sustained operating losses and have used cash raised by issuing securities in our operations. During the
three-months ended March 31, 2019 and 2018, we used cash in operating activities of $1,204,298 and $938,296, respectively, and
incurred net losses of $1,135,420 and $1,047,864, respectively.
We
require additional financing in order to continue to fund our operations and to pay existing and future liabilities and other
obligations.
We
intend to raise additional capital that would fund our operations for at least the next twelve months. We may continue to obtain
additional financing from investors through the private placement of our common stock and warrants to purchase our common stock.
Any financing transaction could also, or in the alternative, include the issuance of our debt or convertible debt securities.
There can be no assurance that a financing transaction would be available to us on terms and conditions that we determined are
acceptable.
We
cannot give any assurance that we will in the future be able to achieve a level of profitability from the sale of existing or
future products or otherwise to sustain our operations. These conditions raise substantial doubt about our ability to continue
as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects
on recoverability and reclassification of assets or the amounts and classification of liabilities that may result from the outcome
of this uncertainty.
Any
inability to obtain additional financing on acceptable terms will materially and adversely affect us, including requiring us to
significantly curtail or cease business operations altogether.
Our
working capital and capital requirements at any given time depend upon numerous factors, including, but not limited to:
|
●
|
revenues
from the sale of any products or licenses;
|
|
|
|
|
●
|
costs
of production, marketing and sales capabilities, or other operating expenses; and
|
|
|
|
|
●
|
costs
of research, development, and commercialization of our products and technologies.
|
We
have undertaken certain actions regarding the advancement of our pharmaceutical development program, the launch of a dietary supplement
clinical trial, and the continued sales and marketing of our commercial dietary supplement. We plan to fund such activities, including
compensation to service providers, with a combination of cash and equity payments. The amount of payments in cash and equity will
be determined by us from time to time.
On the basis of current
discussions with potential investors, investment banks, and others, management believes, consistent with its fundraising history,
that the Company should have sufficient sources of liquidity to satisfy its ongoing obligations, although no assurance
can be made that such financing will be available on acceptable terms, if at all. To the extent our cash and cash equivalents,
cash flow from operating activities, and proceeds from the revolving inventory financing facility are insufficient to fund our
future activities, including the development of our pharmaceutical candidates, we will need to raise additional funds through
private or public equity or debt financings or bank credit arrangements. We also may need to raise additional funds in the event
we determine to effect one or more acquisitions of, or investments in, businesses, services, or technologies. If additional funding
is required, we may not be able to effect equity or debt financing or obtain bank credit arrangements on terms acceptable to us
or at all.
The
following is a summary of our cash flows provided by (used in) operating, investing, and provided by financing activities during
the periods indicated: