Quarterly report pursuant to Section 13 or 15(d)

Significant Accounting Policies (Policies)

v3.19.2
Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2019
Accounting Policies [Abstract]  
Initial Public Offering, Policy [Policy Text Block]
Initial Public Offering
 
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 $10,862,955 and net proceeds of approximately $9,700,000. In connection with the closing of the IPO, the Company's convertible notes (and related accrued interest) of $11,784,987 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, and preferred stock, both Series A and Series B, was converted into 2,534,766 shares of the Company's common stock. In addition, 127,500 shares of unvested restricted grants were immediately vested upon the completion of the IPO. Total shares of common stock outstanding at the closing of the IPO amounted to 14,613,000. Upon the closing of the IPO, certain notes were to be automatically converted according to their terms into the Company’s common stock to the extent and provided that certain holders of these notes are not permitted to convert such notes to the extent that the holders or any of its affiliates would beneficially own in excess of 4.99% of the Company’s common stock after such conversion. Due to this 4.99% limitation, principal representing $47,781 of these notes remained outstanding and will be converted into 273,034 shares of our common stock at such time when the conversion will not result in the holders and any of its affiliates to own more than 4.99% of our outstanding common shares. The maturity date of these notes is automatically extended until such date the notes are fully converted and these notes cease to accrue interest and are not repayable in cash.
Private Investment in Public Equity Offering [Policy Text Block]
Private Investment in Public Equity Offering
 
On June 16, 2019, the Company entered into a private investment in public equity ("PIPE") offering with certain institutional and accredited investors for the sale by the Company in a private placement of 675,000 units (each a “Unit”), each Unit consisting of (i) one share of the Company’s common stock, and (ii)
0.7 of a warrant to purchase one share of common stock
(each a “Warrant”). The offering price of the Units was $14.00 per Unit. The Warrants included in the Units are exercisable at a price of $16.00 per share commencing on the date of issuance and will expire five years from the effective date of the registration statement pursuant to which the resale of the shares of common stock underlying the Warrants are registered. The Company estimates that the net proceeds from the sale of the Units was approximately $8,600,000 after deducting the placement agent fees and estimated offering expenses payable by the Company.
Substantial Doubt about Going Concern [Policy Text Block]
Going Concern
 
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.
 
For the three and
six months ended June 30, 2019 and 2018
, the Company incurred net losses of $2,973,534 and $2,565,089, respectively, and $6,181,879 and $3,916,754, respectively, and for the six months ended June 30, 2019 and 2018, had net cash flows used in operating activities of $6,353,747 and $2,797,746, respectively. At
June 30, 2019
, the Company had an accumulated deficit of $48,473,373, working capital of $9,685,766 and cash of $11,387,168. 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. The accompanying financial statements have been prepared on a going concern basis and do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
 
The Company’s cash on hand of $11,387,168 as of
June 30, 2019
is sufficient to fund its operations into but not beyond May 2020 as the Company's recent PIPE offering has allowed us to commercialize at a faster pace. The Company also believes it will need to raise additional capital in order to continue to execute its business plan, including obtaining additional regulatory clearance for its products currently under development and commercializing and generating revenues from products under development. There is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company. A failure to raise sufficient capital 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. If the Company is unable to raise sufficient additional funds, it will have to scale back its operations.
Basis of Accounting, Policy [Policy Text Block]
Basis of Presentation
 
The accompanying condensed 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 condensed interim financial statements should be read in conjunction with the audited financial statements and accompanying notes as found in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2018
 filed with the SEC on March 29, 2019. In the opinion of management, the unaudited condensed interim financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The
December 31, 2018
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.
 
Subsequent to the issuance of the Company’s Form 10-Q for the quarterly period ended March 31, 2019, the Company identified a transposition error in the beginning and ending balance of the accumulated deficit and total stockholders' equity presented in the Condensed Statement of Changes in Stockholders’ Equity for the quarterly period ended March 31, 2018. The December 31, 2017 balances were erroneously reported as $31,356,339 and $10,320,595, respectively, and have been corrected in the accompanying Condensed Statement of Changes in Stockholders' Equity as of December 31, 2017, which reports balances of $31,536,339 and $10,500,595, respectively. In addition, the March 31, 2018 balances were erroneously reported as $33,028,004 and $11,846,707, respectively, and have been corrected in the accompanying Condensed Statement of Changes in Stockholders’ Equity for the quarterly period ended March 31, 2018, which reports balances of $33,208,004 and $12,026,707, respectively.
Segment Reporting, Policy [Policy Text Block]
Segments
 
The Company operates in one reportable segment based on management’s view of its business for purposes of evaluating performance and making operating decisions.
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 expenses during the reporting period. The Company's significant estimates and assumptions include valuation of equity related instruments, estimates of work performed by outside consultants, 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, Cash Equivalents and Restricted Cash
 
The Company considers all highly liquid accounts with original maturities of
three
months or less to be cash equivalents or restricted cash. 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.
 
Restricted cash consists of amounts held in deposit with the Company’s bank to collateralize a letter of credit which supports the Company's obligations to pay or perform according to the requirements of an underlying agreement with a certain vendor. Such letter of credit has an initial term of
one
year, renews automatically and can only be modified or canceled with the approval of the beneficiary. As of
June 30, 2019,
the letter of credit was
not
used.
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 trademarks. At
June 30, 2019
and
December 31, 2018
, the Company had trademarks of
$89,409
and
$84,942,
respectively. 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. Amortization expense for each of the
three
months ended
June 30, 2019
and
2018
was
$0,
and for the
six
months ended
June 30, 2019
and
2018
 was
$0
and
$376,
respectively.
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]
Long-Lived Assets
 
The Company evaluates its long-lived assets, including equipment and intangible assets, 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 differ from 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
June 30, 2019
and
December 31, 2018
, the carrying amounts of the Company's financial instruments, including cash and cash equivalents, restricted cash and accounts payable, approximate their respective fair value due to the short-term nature of these instruments.
 
At
June 30, 2019
and
December 31, 2018
, the Company does
not
have any assets or liabilities required to be measured at fair value on a recurring basis.
Deferred Direct Issuance Costs, Offering, Policy [Policy Text Block]
Deferred Direct IPO Issuance Costs – Offering
 
The Company had capitalized offering costs of
$276,560,
consisting of legal, accounting and other fees and costs related to the IPO, which were reclassified to additional paid-in capital as a reduction of the proceeds upon the closing of the IPO in
February 2019.
Warrants [Policy Text Block]
Warrants to Purchase Common Stock
 
The Company issued warrants to purchase shares of common stock related to bridge notes issued prior to its IPO and as part of underwriter compensation in
2019
 and
2018.
The Company accounted for such warrants in accordance with Accounting Standards Codification (ASC) Topic
480
-
10,
Distinguishing Liabilities from Equity
, which identifies
three
categories of freestanding financial instruments that are required to be accounted for as a liability. Based on this guidance, the Company determined, for each issuance, that its warrants did
not
need to be accounted for as a liability. Accordingly, the warrants were classified as equity and are
not
subject to remeasurement at each balance sheet date. In addition, the Company accounts for issuance costs of warrants issued with debt instruments in accordance with ASC
470
-
20,
Debt with Conversion and Other Options
, which states proceeds from the sale of a debt instrument with stock purchase warrants (detachable call options) are allocated to elements based on the relative fair values of the debt instrument without the warrants and of the warrants themselves at time of issuance. The portion of the proceeds so allocated to the warrants are accounted for as paid-in capital. The remainder of the proceeds are allocated to the debt instrument, which
may
result in a discount or premium. Accordingly, there was
no
liability under the payment arrangement requiring disclosure or recognition.
 
On
July 1, 2019,
the Company filed a Registration Statement on Form S-
1
to register for resale the common stock underlying the units sold with the Company's PIPE offering.
Related registration rights agreements were accounted for in accordance with Topic ASC Topic
450
-
20,
Loss Contingencies
, which requires measurement of the contingent liability when an entity would be required to deliver shares under a registration payment arrangement, the transfer of consideration is probable and the number of shares to be delivered can be reasonably estimated.
 
The fair value of warrants is estimated using the Black-Scholes option pricing model, based on the market value of the underlying common stock at the measurement dates, the contractual terms of the warrants, risk-free interest rates and expected volatility of the price of the underlying common stock.  There are
no
expected dividends.
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, patent costs and salaries and related costs of employees working directly on research activities.
Share-based Payment Arrangement [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 either the straight-line method or the accelerated method, depending on the vesting structure, and is included in general and administrative expenses.
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. The Company's tax years ending
December 31, 2016
and thereafter remain subject to examination by the tax authorities.
 
In assessing the realization of deferred tax assets, management considers whether it is more likely than
not
that some portion or all of deferred assets will
not
be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company has recorded a full valuation allowance against its net total deferred tax assets as of 
June 30, 2019
and
December 31, 2018
because management determined that it is
not
more-likely-than
not
that those assets will be realized. Accordingly, there was
no
income tax benefit for all periods presented.
Management has evaluated and concluded that there were
no
material uncertain tax positions requiring recognition in the Company's financial statement as of
June 30, 2019
. The Company does
not
expect any significant changes in the unrecognized tax benefits within
twelve
months of the reporting date.
The Company classifies 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 for the
three
and
six
months ended
June 30, 2019
and
2018
.
Earnings Per Share, Policy [Policy Text Block]
Net Loss per Common Share
 
Basic net loss per common share is 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. The Company's unvested stock awards that contain non-forfeitable rights to dividends or dividend equivalents, whether paid or unpaid, are considered participating securities and are contemplated in the computations of basic and diluted earnings or loss per share. These securities do
not
participate in losses and accordingly
no
such allocation has been made in the periods presented. 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 
June 30, 2019
, potentially dilutive securities included options to purchase
2,824,550
common shares, warrants to purchase
1,380,833
common shares, unvested restricted stock of
183,332
shares and
273,034
common shares convertible notes payable
not
converted at the Company's IPO in
February 2019
due to the holders beneficially owning in excess of
4.99%
of the Company’s common stock after such conversion. 
 
As of 
June 30, 2018
, potentially dilutive securities included options to purchase
2,235,000
common shares, preferred stock convertible to
2,534,766
common shares, warrants to purchase
91,350
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
shares, respectively, and notes and accrued interest convertible to common shares upon a future financing.
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-EGCs 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 EGC, 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 EGC nor an EGC 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
7
 for additional information.
New Accounting Pronouncements, Policy [Policy Text Block]
Recent Accounting Standards
 
In
February 2016,
the FASB issued Accounting Standards Update ("ASU")
No.
2016
-
02,
“Leases (Topic
842
)”
, 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 currently effective, for public EGC companies like the Company, for fiscal years beginning after
December 15, 2020
and
may
include interim periods within those fiscal years. The modified retrospective transition approach applies to 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 has the option to instead apply the provisions at the effective date without adjusting the comparative periods presented. 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.”
Under legacy guidance, the accounting for non-employee share-based payments differs from that applied to employee awards, particularly with regard to the measurement date and the impact of performance conditions. ASU
No.
2018
-
07
provides that existing employee guidance will apply to non-employee share-based transactions (as long as the transaction is
not
effectively a form of financing), with the exception of specific guidance related to the attributions of compensation cost. The cost of non-employee awards will continue to be recorded as if the grantor had paid cash for the goods or services. In addition, the contractual term will be able to be used in lieu of an expected term in the option-pricing model for non-employee awards. The Company adopted the standard as of
January 1, 2019
and it did
not
have an impact on the Company's financial statements, as non-employee stock compensation is nominal relative to the Company's total expenses for the
three
and
six
months ended
June 30, 2019
.
 
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.