Annual report pursuant to Section 13 and 15(d)

Significant Accounting Policies (Policies)

v3.20.4
Significant Accounting Policies (Policies)
12 Months Ended
Sep. 30, 2020
Significant Accounting Policies  
Basis of Presentation

Basis of Presentation

The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated during the consolidation process. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

Use of Estimates

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s consolidated financial statements relate to the valuation of share-based compensation, the valuation of licenses, the fair value of warrant liabilities and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. The Company assesses and updates estimates each period to reflect current information, such as the economic considerations related to the impact that the novel coronavirus disease (COVID-19) could have on our significant accounting estimates (See Part I, Item 1A- Risk Factors “Our operations may be adversely affected by the coronavirus outbreak, and we face risks that could impact our business” for further discussion of the effect of the COVID-19 pandemic on our operations). Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company's future results of operations will be affected.

Revision to Prior Year Financial Statements

Revision to Prior Year Financial Statements

During the course of preparing the annual report on Form 10-K for the years ended September 30, 2020, and 2019,           the Company identified an error in one of the Black-Scholes option pricing model assumptions, utilized in calculating the fair value of a stock option award granted during the year ended September 30, 2019, which resulted in an overstatement of share-based compensation expense for the year ended September 30, 2019.

The Company concluded that the error was not material to any prior annual period and the error had no impact to any prior interim period. Nevertheless, the Company has revised its historical financial statements to properly reflect the share-based compensation expense for the corrected fair value of options granted in the prior period.

The effect of the revisions to the financial statements is as follows:

Consolidated Balance Sheet

 

 

 

 

 

 

 

 

 

 

 

 

September 30, 2019

 

    

As Previously

    

 

 

    

 

 

 

 

Reported

 

Adjustments

 

As Adjusted

Stockholders’ equity

 

 

  

 

 

  

 

 

  

Additional paid-in capital

 

$

37,027,875

 

$

(826,117)

 

$

36,201,758

Accumulated deficit

 

 

(27,000,199)

 

 

826,117

 

 

(26,174,082)

Total stockholders’ equity

 

 

10,029,384

 

 

 —

 

 

10,029,384

Total liabilities and stockholders’ equity

 

$

12,531,397

 

$

 —

 

$

12,531,397

 

Consolidated Statement of Operations

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended September 30, 2019

 

    

As Previously

    

 

 

    

 

 

 

 

Reported

 

Adjustments

 

As Adjusted

Research and development expenses

 

$

4,273,318

 

$

(826,117)

 

$

3,447,201

Total operating expenses

 

 

26,336,407

 

 

(826,117)

 

 

25,510,290

Loss from operations

 

 

(26,336,407)

 

 

826,117

 

 

(25,510,290)

Net loss

 

$

(26,958,247)

 

$

826,117

 

$

(26,132,130)

Basic and diluted loss per common share

 

$

(3.26)

 

 

 

 

$

(3.16)

 

Consolidated Statement of Cash Flows

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended September 30, 2019

 

    

As Previously

    

 

 

    

 

 

 

 

Reported

 

Adjustments

 

As Adjusted

Cash flows from operating activities:

 

 

  

 

 

  

 

 

  

Net loss

 

$

(26,958,247)

 

$

826,117

 

$

(26,132,130)

Stock-based compensation

 

 

9,785,083

 

 

(826,117)

 

 

8,958,966

Net cash used in operating activities

 

 

(2,845,488)

 

 

 —

 

 

(2,845,488)

 

Concentration of Credit Risk

Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents. Cash and cash equivalents are maintained in accounts with financial institutions, which, at times may exceed the Federal depository insurance coverage of $250,000. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.

Fair Value Measurements

Fair Value Measurements

Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value:

Level 1- Quoted prices in active markets for identical assets or liabilities on the reporting date.

Level 2- Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3- Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models and fund manager estimates.

Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Management’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange.

The following tables present the Company’s fair value hierarchy for its warrant liabilities measured at fair value on a recurring basis at September 30, 2020 and 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements

 

 

as of September 30, 2020

 

    

(Level 1)

 

(Level 2)

 

(Level 3)

 

Total

Liabilities

 

 

  

 

  

 

  

 

 

  

Warrant liabilities

 

$

 —

 

 —

 

950,151

 

$

950,151

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Fair Value Measurements

 

 

as of September 30, 2019

 

    

(Level 1)

    

(Level 2)

    

(Level 3)

    

Total

Liabilities

 

 

  

 

  

 

  

 

 

  

Warrant liabilities

 

$

 —

 

 —

 

496,343

 

$

496,343

 

The following assumptions were used in determining the fair value of the warrant liabilities as of September 30, 2020 and 2019:

 

 

 

 

 

 

 

 

As of September 30, 

 

    

2020

    

2019

Remaining contractual term (years)

 

1.2 - 1.5

 

2.2 - 2.5

Common stock price volatility

 

91.1% - 96.1%

 

76.6%  - 78.4%

Risk-free interest rate

 

0.12% - 0.13%

 

1.6%  - 1.63%

Expected dividend yield

 

 —

 

 —

 

The change in fair value of the warrant liabilities for the years ended September 30, 2020 and 2019 is as follows:

 

 

 

 

 

 

    

Warrant liabilities

Fair value as of September 30, 2018

 

$

 —

Warrants issued in connection with license acquired- CMU

 

 

104,902

Warrants assumed in connection with acquisition of Ohr

 

 

470,093

Extinguishment of warrant liability related to the cashless exercise of warrants

 

 

(429,677)

Extinguishment of warrant liability related to warrants redeemed for cash

 

 

(141,864)

Change in fair value

 

 

492,889

Fair value as of September 30, 2019

 

 

496,343

Change in fair value

 

 

453,808

Fair value as of September 30, 2020

 

$

950,151

 

As of September 30, 2020 and 2019, the recorded values of cash and cash equivalents, accounts payable and the insurance note payable approximate fair value due to the short-term nature of the instruments.

Equipment

Equipment

Equipment is stated at cost less accumulated depreciation. Depreciation is provided on a straight-line basis over the estimated useful lives of the assets. The Company estimates useful lives as follows:

·

Laboratory equipment: five years

·

Office equipment: three years

Intangible Assets

Intangible Assets

Identifiable intangible assets includes clinical trial data acquired in the Ohr Acquisition. The intangible asset was amortized over its estimated useful life (approximately six months), which approximates the pattern in which the assets’ economic benefits were consumed. The fair value of the intangible asset was determined using actual and potential market transactions which are management’s best estimates of inputs and assumptions that a market participant would use. The estimates are based on assumptions that the Company believes to be reasonable, but such assumptions are subject to unpredictability and uncertainty.

For amortizable intangible assets, the Company performs an impairment analysis when circumstances suggest that the carrying values of those assets may not be recoverable. Recoverability of an asset to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted cash flows expected to be generated by the asset. If such asset is considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the asset exceeds its fair value. As of September 30, 2020 and 2019, the carrying value of the intangible asset was $0 and $0.1 million, respectively.

Impairment of Long-Lived Assets

Impairment of Long-Lived Assets

The Company reviews the carrying value of for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition.  In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group.  The factors that would be considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used and the effects of obsolescence, demand, competition and other economic factors.  Based on this assessment, there was no impairment at September 30, 2020 and 2019.

Investment

Investment

The Company’s investment consists of common and preferred shares of DepYmed, Inc.

Investments that the Company has the ability to exercise significant influence over are accounted for as equity method investments. Equity method investments are recorded at cost plus the proportional share of the issuer’s.

Investments that do not have a readily determinable fair value and qualify for the measurement alternative for equity investments provided in ASC 321, are accounted for at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investment of the same

Operating Leases

Operating Leases

Effective October 1, 2019, the Company determines if an arrangement is a lease at inception. Operating leases are included in operating right-of-use (“ROU”) assets and operating lease liabilities on the consolidated balance sheets. Prior to October 1, 2019, the Company recorded rent expense associated with its operating lease on a straight-line basis over the term of the lease.

Lease ROU assets and operating lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using the Company’s incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with a term of 12 months or less are not recognized on the Company’s consolidated balance sheet. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company accounts for lease and non-lease components as a single lease component for all its leases.

As of September 30, 2020, the Company’s leases had original terms of  12 months or less. The Company does not recognize ROU assets and lease liabilities that arise from leases with an original term of 12 months or less. Rather, the Company recognizes the lease expense on a straight-line basis over the term of the lease.

Research and Development

Research and Development

The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of:

·

salaries and related benefits for personnel in research and development functions, including stock-based compensation and benefits;

·

fees paid to consultants and contract research organizations for preclinical development work on our PATrOLTM platform and programs;

·

allocation of facility lease and maintenance costs;

·

depreciation of laboratory equipment and computers;

·

costs related to purchasing raw materials for and producing our product candidates;

·

costs related to compliance with regulatory requirements; and

·

license fees related to in-licensed technologies.

Research and Development Expense- Licenses Acquired

The Company evaluates whether acquired intangible assets are a business under applicable accounting standards.  Additionally, the Company evaluates whether the acquired assets have an alternative future use. Intangible assets that do not have alternative future use are considered acquired in-process research and development.  When the acquired in-process research and development assets are not part of a business combination, the value of the consideration paid is expensed on the acquisition date.  Future costs to develop these assets are recorded to research and development expense as they are incurred.

Stock-Based Compensation

Stock-Based Compensation

The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant-date fair value of the awards and actual forfeitures. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award.

The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The Company was historically a private company and lacked company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Additionally, due to an insufficient history with respect to stock option activity and post-vesting cancellations, the expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The mid-point between the weighted-average vesting term and the expiration date is used as the expected term under this method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

All stock-based compensation costs are recorded in general and administrative or research and development costs in the consolidated statements of operations based upon the underlying individual's role at the Company.

Income Taxes

Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized.

The Company also follows the provisions of accounting for uncertainty in income taxes which prescribes a model for the recognition and measurement of a tax position taken or expected to be taken in a tax return, and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. In accordance with this guidance, tax positions  must meet a more likely than not recognition threshold and measurement attribute for the financial statement recognition and measurement of tax position.

The Company’s policy is to account for income tax related interest and penalties in income tax expense in the accompanying consolidated statements of operations.

Net Loss Per Share

Net Loss Per Share

Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the dilutive effect, if any, from the potential exercise or conversion of securities, such as convertible debt, warrants and stock options that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive.

Recent Accounting Standards

Recent Accounting Standards

In February 2016, the FASB issued ASU 2016-2, Leases. The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The Company adopted this new lease standard on October 1, 2019 using a modified retrospective transition approach 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 adoption of the new lease standard did not have an impact on the Company’s consolidated financial statements as the Company did not have any leases with original terms longer than 12 months at the adoption date and as of September 30, 2020.

In December 2019, the FASB issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures.