Quarterly report pursuant to Section 13 or 15(d)

Significant Accounting Policies (Policies)

v3.10.0.1
Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2018
Accounting Policies [Abstract]  
Substantial Doubt about Going Concern [Policy Text Block]
Going Concern
 
The Company has adopted the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic
205
-
40,
Presentation of Financial Statements - Going Concern
(“ASC
205
-
40”
). ASC
205
-
40
requires management to assess an entity's ability to continue as a going concern within
one
year of the date the financial statements are issued. In each reporting period (including interim periods), an entity is required to assess conditions known and reasonably knowable as of the financial statement issuance date to determine whether it is probable an entity will
not
meet its financial obligations within
one
year from the financial statement issuance date. Substantial doubt about an entity's ability to continue as a going concern exists when conditions and events, considered in the aggregate, indicate it is probable the entity will be unable to meet its financial obligations as they become due within
one
year after the date the financial statements are issued.
 
The Company is an early stage and emerging growth company and has
not
generated any revenues to date. As such, the Company is subject to all of the risks associated with early stage and emerging growth companies. Since inception, the Company has incurred losses and negative cash flows from operating activities. The Company does
not
expect to generate positive cash flows from operating activities in the near future.
 
For the
nine
months ended
September 30, 2018
and
2017,
the Company incurred net losses of
$6,895,374
 and
$5,765,340,
respectively, and had net cash flows used in operating activities of
$3,726,305
 and
$4,726,050,
respectively. At
September 30, 2018,
the Company had an accumulated deficit of
$39,391,713,
negative working capital of
$18,221,364
 and cash of
$197,975.
The Company does
not
expect to experience positive cash flows from operating activities in the near future, if at all. The Company anticipates incurring operating losses for the next several years as it completes the development of its products and seeks requested regulatory clearances to market such products. These factors raise substantial doubt about the Company's ability to continue as a going concern within
one
year after the date the financial statements are issued.
 
On
February 19, 2019,
the Company consummated its initial public offering (“IPO”). In the IPO, the Company sold a total of
2,172,591
shares of common stock at a purchase price of
$5.00
per share for gross proceeds of
$10,862,
298
and net proceeds of $
9,8
63
,
667.
Upon the closing of the IPO, all of the Company's convertible notes (and related accrued interest) of
$
11,832,768
were converted into
6,825,391
shares of the Company's common stock, accrued dividends of
$4,773,480
were converted into
954,696
shares of the Company's common stock, preferred stock, both A and B, were converted into
2,534,766
shares of the Company's common stock, and finally, restricted stock shares already vested and accelerated vesting represents
760,000
shares of the Company's common stock. Previously issued shares of the Company's common stock amounted to
1,365,556
that were either purchased or issued early in the Company's development stage. Total shares of common stock outstanding at the closing of the IPO amounted to
14,613,000.
The Company estimates its current cash resources, including the
$4,211,240
of net proceeds received during the
nine
months ended
September 30, 2018
from the issuance of convertible debt and the
$9,863,667
of net proceeds from the IPO is sufficient to fund its operations through
February 2020. 
Accordingly, the Company has sufficient cash resources to fund its anticipated operating losses for the next
twelve
months, However,
the Company
 cannot be certain that our planned levels of expenses will be achieved. If the Company's operating results fail to meet its expectations, it could be required to seek additional funding through private financings or other arrangements. In such event, adequate funds
may
not
be available when needed or
may
not
be available on favorable or commercially acceptable terms, which could have a negative effect on the Company's business and results of operations.
 
The Company’s ability to fund its operations is dependent upon management's plans, which include raising additional capital, obtaining regulatory clearance for its products currently under development, commercializing and generating revenues from products currently under development, and continuing to control expenses.
 
A failure to raise sufficient capital, generate sufficient product revenues, control expenditures and regulatory matters, among other factors, will adversely impact the Company’s ability to meet its financial obligations as they become due and payable and to achieve its intended business objectives and therefore raises substantial doubt of the Company's ability to continue as a going concern within
one
year after the date the financial statements are issued.
Basis of Accounting, Policy [Policy Text Block]
Basis of Presentation
 
The accompanying interim financial statements are unaudited. These unaudited interim financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission ("SEC") for interim financial information. Accordingly, they do
not
include all the information and footnotes required by U.S. Generally Accepted Accounting Principles ("GAAP") for complete financial statements. These unaudited interim financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended
December 31, 2017
as found in the Offering Circular on Form
1
-A. In the opinion of management, the unaudited interim financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of
September 30, 2018
and the results of operations for the
three
and
nine
months ended
September 30, 2018
and
2017.
The interim results of operations are
not
necessarily indicative of the results that
may
occur for the full fiscal year. The
December 31, 2017
balance sheet included herein was derived from the audited financial statements, but does
not
include all disclosures, including notes, required by GAAP for complete financial statements.
Use of Estimates, Policy [Policy Text Block]
Use of Estimates in Financial Statement Presentation
 
The preparation of these financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company's significant estimates and assumptions include stock-based compensation, depreciable lives of long-lived assets (including property and equipment and intangible assets), and the valuation allowance related to deferred taxes. Some of these judgments can be subjective and complex, and, consequently, actual results could differ from those estimates. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made. Actual results could differ from those estimates.
Cash and Cash Equivalents, Policy [Policy Text Block]
Cash and Cash Equivalents
 
The Company considers all highly liquid accounts with original maturities of
three
months or less to be cash equivalents. The Company participates in an insured cash sweep program through its bank that sweeps cash balances exceeding the FDIC insured limit of
$250,000
into multiple accounts. Periodically in the ordinary course of business, the Company
may
carry cash balances at financial institutions in excess of the insured limits of
$250,000.
Property, Plant and Equipment, Policy [Policy Text Block]
Property and Equipment
 
Property and equipment are stated at historical cost and depreciated on a straight-line basis over the estimated useful lives, generally
three
to
five
years. Leasehold improvements are depreciated over the shorter of the remaining lease term or useful lives of the assets. Upon disposition of the assets, the costs and related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Repairs and maintenance costs are included as expense in the accompanying statement of operations.
Goodwill and Intangible Assets, Intangible Assets, Policy [Policy Text Block]
Intangible Assets
 
Intangible assets include patents and trademarks. Patent related costs in connection with filing and prosecuting patent applications and patents filed by the Company are expensed as incurred, and are classified as research and development expenses. The Company does
not
amortize trademarks with indefinite useful lives; rather, such assets are required to be tested for impairment at least annually or sooner if events or changes in circumstances indicate that the asset
may
be impaired.
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]
Long-Lived Assets
 
The Company evaluates its long-lived assets, including equipment, for impairment whenever events or changes in circumstances indicate that the carrying value of these assets
may
not
be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset to the future undiscounted cash flows expected to result from the use of the asset and its eventual disposition. If the asset is considered impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired assets.
Deferred Rent [Policy Text Block]
Deferred Rent
 
Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required.
Debt, Policy [Policy Text Block]
Convertible Debt
 
When conversion terms related to convertible debt would be triggered by future events
not
controlled by the Company, the Company accounts for the conversion feature as contingent conversion options. Recognition of the intrinsic value of the conversion option is recognized only upon the occurrence of a triggering event.
Fair Value Measurement, Policy [Policy Text Block]
Fair Value Measurements
 
Fair value is defined as the price which would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A
three
-tier fair value hierarchy which prioritizes the inputs used in the valuation methodologies, as follows:
 
Level
1
Inputs
- Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.
 
Level
2
Inputs
- Inputs other than quoted prices included in Level
1
that are observable for the asset or liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are
not
active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means.
 
Level
3
Inputs
- Unobservable inputs for determining the fair values of assets or liabilities that reflect an entity’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities.
 
At
September 30, 2018
and
December 31, 2017,
the carrying amounts of the Company's financial instruments, including cash and accounts payable, approximate their respective fair value due to the short-term nature of these instruments.
 
At
September 30, 2018
and
December 31, 2017,
the Company does
not
have any assets or liabilities required to be measured at fair value in accordance with FASB ASC Topic
820,
Fair Value Measurement
.
Revenue from Contract with Customer [Policy Text Block]
Revenue Recognition
 
Prior to
January 1, 2017,
revenues were recognized when the
four
basic criteria for recognition were met: (
1
) persuasive evidence of an arrangement exists; (
2
) delivery has occurred or services have been rendered; (
3
) consideration is fixed or determinable; and (
4
) collectability is reasonably assured. The Company adopted new accounting guidance for revenue recognition effective
January 1, 2018
which did
not
have a material impact on the Company’s financial statements. Beginning from
January 1, 2018,
revenues are recognized when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services
Research and Development Expense, Policy [Policy Text Block]
Research and Development Expenses
 
Research and development expenses are recognized as incurred and include the costs related to the Company's various contract research service providers, suppliers, engineering studies, supplies, outsourced testing and consulting, clinical costs, and salaries and related costs of employees working directly on research activities.
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block]
Stock-Based Compensation
 
Stock-based compensation expense includes the estimated fair value of equity awards vested during the reporting period. The expense for equity awards vested during the reporting period is determined based upon the grant date fair value of the award and is recognized as expense over the applicable vesting period of the stock award using the straight-line method.
Income Tax, Policy [Policy Text Block]
Income Taxes
 
The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of reported assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than
not
that some portion or all of a deferred tax asset will
not
be realized. Tax rate changes are reflected in income during the period such changes are enacted. All of the Company's tax years remain subject to examination by the tax authorities.
 
Management has evaluated and concluded that there were
no
material uncertain tax positions requiring recognition in the Company's financial statement as of
September 30, 2018.
The Company does
not
expect any significant changes in the unrecognized tax benefits within
twelve
months of the reporting date.
 
The Company classified interest expense and any related penalties related to income tax uncertainties as a component of income tax expense.
No
interest or penalties have been recognized in
2018
and
2017.
Earnings Per Share, Policy [Policy Text Block]
Net Loss per Common Share
 
Basic net loss per common share are computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. As of
September 30, 2018
and
2017,
potentially dilutive securities included options to purchase
2,235,000
and
0
common shares, respectively, preferred stock convertible to
2,534,766
common shares, accrued preferred stock dividend convertible at a price determined by the Company's Board of Directors (the "Board") (the Company also had the option to pay the accrued preferred stock dividend in cash), unvested restricted stock of
227,500
and
405,000
shares, respectively, notes and accrued interest convertible to common shares upon a future financing and warrants to purchase
91,350
and
0
common shares, respectively. On
November 1, 2018,
the Company filed an amendment to Article
4
of the Company's Amended and Restated Certificate of Incorporation, whereby it increased the authorized shares of the Company's common stock to
19,000,000
shares of common stock,
$0.001
par value per share, and
2,534,766
shares of preferred stock,
$0.001
par value per share.
On
February 19, 2019,
the Company filed an amendment to the Company's Amended and Restated Certificate of Incorporation, whereby it, among other items, increased the authorized shares of the Company's common stock to
100,000,000
shares of common stock,
$0.001
par value per share, and eliminated the ability to issue preferred stock
JOBS Act Accounting Election [Policy Text Block]
JOBS Act Accounting Election
 
The Company is an emerging growth company ("EGC"), as defined in the Jumpstart Our Business Startups Act of
2012
(the “JOBS Act”). The JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected
not
to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This
may
make comparison of the Company’s financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.
Subsequent Events, Policy [Policy Text Block]
Subsequent Events
 
The Company’s management reviewed all material events through the date that the financial statements were issued for subsequent event disclosure consideration. See Note
8
for additional information.
New Accounting Pronouncements, Policy [Policy Text Block]
Recent Accounting Standards
 
In
February 2016,
the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU")
No.
2016
-
02,
Leases (Topic
842
)
("ASU
2016
-
02"
), which establishes a right-of-use (“ROU”) model requiring a lessee to recognize a ROU asset and a lease liability for all leases with terms greater-than
12
months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. This guidance is effective, for public EGC companies like the Company, for fiscal years beginning after
December 15, 2019
including interim periods within those fiscal years. A modified retrospective transition approach is required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact of this guidance on its financial position, results of operations, and cash flows.
 
In
June 2018,
the FASB issued ASU
No.
2018
-
07,
Compensation Stock Compensation (Topic
718
), Improvements to Non-employee Share-Based Payment Accounting. This ASU is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share based compensation. The guidance is effective for the Company for the fiscal year beginning
January 1, 2020.
While the exact impact of this standard is
not
known, the guidance is
not
expected to have a material impact on the Company’s financial statements, as non-employee stock compensation is nominal relative to the Company's total expenses for the
nine
months ended
September 30, 2018.
 
The Company does
not
believe that any other recently issued effective standards, or standards issued but
not
yet effective, if adopted, would have a material effect on the accompanying financial statements.