PetVivo Holdings, Inc. - Quarter Report: 2019 June (Form 10-Q)
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
Mark One
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2019
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______ to _______
Commission File No. 000-55167
PetVivo Holdings Inc.
(Name of small business issuer in its charter)
Nevada | 99-0363559 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S.
Employer Identification No.) |
5251 Edina Industrial Blvd.
Edina, Minnesota 55439
(Address of principal executive offices)
(952) 405-6216
(Issuer’s telephone number)
Securities registered pursuant to Section 12(b) of the Act: | Name of each exchange on which registered: | |
None |
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.001
(Title of Class)
Indicate by checkmark whether the issuer: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ]
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files. Yes [X] No [ ]
Indicate by check mark whether the registrant is a large accelerated filed, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
Large accelerated filer | [ ] | Accelerated filer | [ ] | |
Non-accelerated filer | [ ] | Smaller reporting company | [X] |
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X]
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the most practicable date:
Class | Outstanding as of June 30, 2019 | |
Common Stock, $0.001 | 22,074,667 |
PETVIVO HOLDINGS, INC.
FORM 10-Q
FOR THE PERIOD ENDED June 30, 2019
INDEX
Page | |||
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS | 3 | ||
PART I. FINANCIAL INFORMATION | 4 | ||
Item 1. | Financial Statements | 4 | |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 19 | |
Item 3. | Qualitative and Quantitative Disclosures About Market Risk | 24 | |
Item 4. | Controls and Procedures | 24 | |
PART II. OTHER INFORMATION | 26 | ||
Item 1. | Legal Proceedings | 26 | |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 26 | |
Item 3. | Defaults Upon Senior Securities | 26 | |
Item 4. | Mine Safety Disclosure | 26 | |
Item 5. | Other information | 26 | |
Item 6. | Exhibits | 27 | |
SIGNATURES | 28 |
2 |
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
Information included in this Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). This information may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of PetVivo Holdings Inc. (the “Company”), to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements. Forward-looking statements, which involve assumptions and describe future plans, strategies and expectations of the Company, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. These forward-looking statements are based on assumptions that may be incorrect, and there can be no assurance that these projections included in these forward-looking statements will come to pass. Actual results of the Company could differ materially from those expressed or implied by the forward-looking statements as a result of various factors. Except as required by applicable laws, the Company has no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.
3 |
PETVIVO HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2019 (Unaudited) | March 31, 2019 | |||||||
Assets: | ||||||||
Current Assets | ||||||||
Cash and cash equivalents | $ | 65,641 | $ | 6,460 | ||||
Accounts receivable | 450 | - | ||||||
Inventory | 12,495 | 12,495 | ||||||
Employee advance | 2,500 | 2,500 | ||||||
Investments - equity securities receivable | 1,500 | - | ||||||
Prepaid expenses | 45,484 | 34,327 | ||||||
Total Current Assets | 128,070 | 55,782 | ||||||
Property and Equipment: | ||||||||
Property and equipment | 148,798 | 149,802 | ||||||
Less: accumulated depreciation | (118,430 | ) | (112,453 | ) | ||||
Total Property and Equipment | 30,368 | 37,349 | ||||||
Other Assets: | ||||||||
Trademark and patents-net | 472,468 | 589,817 | ||||||
Operating lease right-of-use | 99,199 | - | ||||||
Security deposit | 8,201 | 8,201 | ||||||
Total Other Assets | 579,868 | 598,018 | ||||||
Total Assets | $ | 738,306 | $ | 691,149 | ||||
Liabilities and Stockholders’ Equity (Deficit) | ||||||||
Current Liabilities | ||||||||
Accounts payable and accrued expenses | $ | 849,668 | $ | 854,990 | ||||
Accrued expenses - related party | 578,098 | 576,393 | ||||||
Operating lease liability | 22,652 | - | ||||||
Notes payable and accrued interest | 10,303 | 18,831 | ||||||
Notes payable and accrued interest - related party | 75,941 | 85,752 | ||||||
Total Current Liabilities | 1,536,662 | 1,535,966 | ||||||
Other Liabilities: | ||||||||
Convertible notes payable | 280,000 | - | ||||||
Operating lease liability | 76,547 | - | ||||||
Total Other Liabilities | 356,547 | - | ||||||
Total Liabilities | $ | 1,893,209 | $ | 1,535,966 | ||||
Commitments and Contingencies | ||||||||
Stockholders’ Equity (Deficit): | ||||||||
Preferred stock, par value $0.001, 20,000,000 shares authorized 0 and 0 shares outstanding at June 30, 2019 and March 31, 2019, respectively | ||||||||
Common stock, par value $0.001, 250,000,000 shares authorized 22,074,667 and 22,074,667 shares outstanding at June 30, 2019 and March 31, 2019, respectively | 22,074 | 22,074 | ||||||
Common stock to be issued | 120,000 | 86,333 | ||||||
Additional Paid-In Capital | 51,709,822 | 51,552,688 | ||||||
Accumulated Deficit | (53,006,799 | ) | (52,505,912 | ) | ||||
Total Stockholders’ Deficit | (1,154,903 | ) | (844,817 | ) | ||||
Total Liabilities and Stockholders’ Deficit | $ | 738,306 | $ | 691,149 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4 |
PETVIVO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended | ||||||||
June 30, | June 30, | |||||||
2019 | 2018 | |||||||
Revenues | $ | - | $ | - | ||||
Cost of Sales | - | - | ||||||
Gross Profit | - | - | ||||||
Operating Expenses: | ||||||||
Sales and Marketing | 2,796 | - | ||||||
General and Administrative: | ||||||||
Depreciation and Amortization | 144,090 | 161,119 | ||||||
Other General and Administrative | 346,835 | 1,935,969 | ||||||
Total General and Administration | 490,925 | 2,097,088 | ||||||
Total Operating Expenses | 493,721 | 2,097,088 | ||||||
Operating Loss | $ | (493,721 | ) | $ | (2,097,088 | ) | ||
Other Income (Expense) | ||||||||
Gain on Sale of Asset | 450 | - | ||||||
Interest Expense | (7,616 | ) | (2,497 | ) | ||||
Total Other Expense | (7,166 | ) | (2,497 | ) | ||||
Net Loss before taxes | $ | (500,887 | ) | $ | (2,099,585 | ) | ||
Income Tax Provision | - | - | ||||||
Net Loss | (500,887 | ) | (2,099,585 | ) | ||||
Net Loss Per Share: | ||||||||
Basic and Diluted | $ | (0.02 | ) | $ | (0.11 | ) | ||
Weighted Average Common Shares Outstanding: | ||||||||
Basic and Diluted | 22,074,667 | 19,584,396 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5 |
PETVIVO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(UNAUDITED)
Three Months Ended June 30, 2019
Common Stock | Additional Paid-in | Accumulated | Common Stock to | |||||||||||||||||||||
Shares | Amount | Capital | Deficit | be Issued | Total | |||||||||||||||||||
Balance at March 31, 2019 | 22,074,667 | $ | 22,074 | $ | 51,552,688 | $ | (52,505,912 | ) | $ | 86,333 | $ | (844,817 | ) | |||||||||||
Stock-based compensation | - | - | 157,134 | - | 33,667 | 190,801 | ||||||||||||||||||
Net loss | - | - | - | (500,887 | ) | - | (500,887 | ) | ||||||||||||||||
Balance at June 30, 2019 | 22,074,667 | $ | 22,074 | $ | 51,709,822 | $ | (53,006,799 | ) | $ | 120,000 | $ | (1,154,903 | ) |
Three Months Ended June 30, 2018
Common Stock | Additional Paid-in | Accumulated | Common Stock to | |||||||||||||||||||||
Shares | Amount | Capital | Deficit | be Issued | Total | |||||||||||||||||||
Balance at March 31, 2018 | 18,279,075 | $ | 18,279 | $ | 47,257,557 | $ | (47,748,154 | ) | $ | 608,966 | $ | 136,648 | ||||||||||||
Common stock issued | 1,005,287 | 1,005 | 607,961 | - | (608,966 | ) | - | |||||||||||||||||
Common stock issued to replace shares to officer | 803,385 | 804 | 1,445,289 | - | - | 1,446,093 | ||||||||||||||||||
Stock-based compensation | - | - | 279,313 | - | 2,700 | 282,013 | ||||||||||||||||||
Stock granted for debt conversion | 95,462 | 95 | 95,367 | - | - | 95,462 | ||||||||||||||||||
Common stock sold | - | - | - | - | 93,892 | 93,892 | ||||||||||||||||||
Net loss | - | - | - | (2,099,585 | ) | - | (2,099,585 | ) | ||||||||||||||||
Balance at June 30, 2018 | 20,183,209 | $ | 20,183 | $ | 49,685,487 | $ | (49,847,739 | ) | $ | 96,592 | $ | (45,477 | ) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6 |
PETVIVO HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Three Months Ended | ||||||||
June 30, 2019 | June 30, 2018 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net Loss For The Period | $ | (500,887 | ) | $ | (2,099,585 | ) | ||
Adjustments to Reconcile Net Loss to Net Cash Used in | ||||||||
Operating Activities: | ||||||||
Stock-based compensation | 190,801 | 1,823,567 | ||||||
Depreciation and amortization | 144,090 | 161,119 | ||||||
Interest accrued on Convertible Notes Payable | 5,362 | - | ||||||
Interest accrued on Notes Payable - related party | 1,590 | - | ||||||
Interest accrued on Notes Payable | 471 | - | ||||||
Gain on sale of asset | (450 | ) | - | |||||
Changes in Operating Assets and Liabilities | ||||||||
Increase in inventory | - | (78,730 | ) | |||||
Increase in prepaid expenses and employee advances | (11,157 | ) | (6,547 | ) | ||||
Decrease in advances and receivables | - | 163 | ||||||
Decrease in accounts payable and accrued expense | (5,322 | ) | (49,774 | ) | ||||
Increase of accrued expenses - related party | 1,705 | 5,182 | ||||||
Net Cash Used In Operating Activities | (173,797 | ) | (244,605 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Decrease in security deposit | - | 1,999 | ||||||
Increase in investments - equity securities receivable | (1,500 | ) | - | |||||
Purchase of equipment | - | (23,181 | ) | |||||
Increase in patents and trademarks | (19,760 | ) | (32,612 | ) | ||||
Net Cash Used in Investing Activities | (21,260 | ) | (53,794 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Proceeds from stock sale | - | 93,893 | ||||||
Proceeds from convertible notes | 280,000 | - | ||||||
Repayments of convertible notes | (5,362 | ) | - | |||||
Repayments of notes payable | (9,000 | ) | - | |||||
Repayments of notes payable - related party | (11,400 | ) | - | |||||
Decrease in notes payable and accrued interest | - | (503 | ) | |||||
Net Cash Provided by Financing Activities | 254,238 | 93,390 | ||||||
Net Increase (Decrease) in Cash | 59,181 | (205,009 | ) | |||||
Cash at Beginning of Period | 6,460 | 237,335 | ||||||
Cash at End of Period | $ | 65,641 | $ | 32,326 | ||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||||||||
Cash Paid During The Period For: | ||||||||
Interest | $ | 7,676 | $ | 2,497 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7 |
PetVivo Holdings, Inc.
Notes to Financial Statements
June 30, 2019
(Unaudited)
NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ORGANIZATION
(A) Organization and Description
The Company is in the business of production, marketing and distribution of medical devices and biomaterials for the treatment of afflictions and diseases in animals, initially for dogs and horses. The Company’s operations are conducted from its headquarter facilities in suburban Minneapolis, Minnesota.
(B) Basis of Presentation
PetVivo Holdings, Inc. (the “Company”) was incorporated in Nevada under a former name in 2009 and entered its current business in 2014 through a stock exchange reverse merger with PetVivo, Inc., a Minnesota corporation. This merger resulted in Minnesota PetVivo becoming a wholly-owned subsidiary of the Company.
In April 2017, the Company acquired another Minnesota corporation, Gel-Del Technologies, Inc., through a statutory merger, which is also a wholly-owned subsidiary of the Company.
The accompanying condensed consolidated financial statements are unaudited. These unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and pursuant to the rules and regulations of the SEC. Certain information and note disclosures, which are included in annual financial statements, have been omitted pursuant to these rules and regulations. We believe the disclosures made in these interim unaudited financial statements are adequate to make the information not misleading.
Although these interim financial statements at June 30, 2019 and for the three months ended June 30, 2019 and 2018 are unaudited, in the opinion of our management, such statements include all adjustments (consisting of normal recurring entries) necessary to present fairly our financial position, results of operations and cash flows for the periods presented. The results for the three months ended June 30, 2019 are not necessarily indicative of the results to be expected for the year ended March 31, 2020 or for any future period.
These unaudited interim financial statements should be read and considered in conjunction with our audited financial statements and the notes thereto for the year ended March 31, 2019, included in our annual report on Form 10-K filed with the SEC.
(C) Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its two wholly-owned Minnesota corporations. All intercompany accounts have been eliminated upon consolidation.
(D) Use of Estimates
In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates. Significant estimates include estimated useful lives and potential impairment of property and equipment, estimate of fair value of share-based payments and derivative instruments and recorded debt discount, valuation of deferred tax assets and valuation of in-kind contribution of services and interest.
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(E) Cash and Cash Equivalents
The Company considers all highly-liquid, temporary cash investments with an original maturity of three months or less to be cash equivalents. At June 30, 2019, the Company had $65,641 in cash and no cash equivalents. At March 31, 2019, the Company had $6,460 in cash and no cash equivalents.
(F) Concentration-Risk
The Company maintains its cash with various financial institutions, which at times may exceed limits insured by the Federal Deposit Insurance Corporation (FDIC). At June 30, 2019, cash did not exceed the FDIC uninsured balances and management believes the Company is not exposed to any significant credit risk on cash.
(G) Property & Equipment
Property and equipment are recorded at cost less accumulated depreciation. Expenditures for major additions and betterments are capitalized. Maintenance and repairs are charged to operations as incurred. Depreciation is computed by the straight-line method (after taking into account their respective estimated residual values) over the asset’s estimated useful life of (3) years for equipment, (5) years for automobile, and (7) years for furniture and fixtures.
(H) Patents and Trademarks
The Company capitalizes direct costs for the maintenance and advancement of their patents and trademarks and amortizes these costs over the lesser of a useful life of 60 months or the life of the patent. We evaluate the recoverability of intangible assets periodically by taking into account events or circumstances that may warrant revised estimates of useful lives or that indicate the asset may be impaired.
(I) Loss Per Share
Basic loss per share is computed by dividing net loss by weighted average number of shares of common stock outstanding during each period. Diluted loss per share is computed by dividing net loss by the weighted average number of shares of common stock, common stock equivalents and potentially dilutive securities outstanding during the period.
The Company has 4,370,736 warrants outstanding as of June 30, 2019 with varying exercise prices ranging from $3.50 to $.30/share. The weighted average exercise price for these warrants is $.48/share. These warrants are excluded from the weighted average number of shares because they are considered anti-dilutive.
The Company has 4,243,236 warrants outstanding as of March 31, 2019 with varying exercise prices ranging from $3.50 to $.30/share. The weighted average exercise price for these warrants is $.50/share. These warrants are excluded from the weighted average number of shares because they are considered anti-dilutive.
The Company uses the guidance in ASC 260 to determine if-converted loss per share detailed in Note 14. ASC 260 states that convertible securities should be considered exercised at the later date of the first day of the reporting period’s quarter or the inception date of the debt instrument. Also, the if-converted method shall not be applied for the purposes of computing diluted EPS if the effect would be antidilutive.
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(J) Revenue Recognition
The Company will recognize revenue on arrangements in accordance with FASB ASC No. 606, “Revenue From Contracts With Customers”. Revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration we expect to receive in exchange for those products or services. The Company adopted the guidance on April 1, 2018 using the cumulative catch-up transition method. This change in accounting did not have any material effect on the Company’s financial statements.
(K) Research and Development
The Company expenses research and development costs as incurred.
(L) Fair Value of Financial Instruments
The Company applies the accounting guidance under FASB ASC 820-10, “Fair Value Measurements”, as well as certain related FASB staff positions. This guidance defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact business and considers assumptions that marketplace participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance.
The guidance also establishes a fair value hierarchy for measurements of fair value as follows:
● | Level 1 - quoted market prices in active markets for identical assets or liabilities. | |
● | Level 2 - inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |
● | Level 3 - unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The Company’s financial instruments consist of investments – equity securities receivable, notes payable and accrued interest, notes payable and accrued interest - related party, and convertible notes payable. The carrying amount of the Company’s financial instruments approximates their fair value as of June 30, 2019 and March 31, 2019, due to the short-term nature of these instruments and the Company’s borrowing rate of interest.
In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’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 valuation of the Company’s notes recorded at fair value is determined using Level 3 inputs, which consider (i) time value, (ii) current market and (iii) contractual prices.
The Company measured its investments – equity securities receivable at fair value at June 30, 2019, see Note 5 to the financial statements included in this Form 10-Q.
The Company had no assets and liabilities measured at fair value on a recurring basis at March 31, 2019.
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(M) Stock-Based Compensation - Non-Employees
Equity Instruments Issued to Parties Other Than Employees for Acquiring Goods or Services
The Company accounts for equity instruments issued to parties other than employees for acquiring goods or services under guidance of Sub-topic 505-50 of the FASB Accounting Standards Codification (“Sub-topic 505-50”).
Pursuant to ASC Section 505-50-30, all transactions in which goods or services are the consideration received for the issuance of equity instruments are accounted for based on the fair value of the consideration received or the fair value of the equity instrument issued, whichever is more reliably measurable. The measurement date used to determine the fair value of the equity instrument issued is the earlier of the date on which the performance is complete or the date on which it is probable that performance will occur. If the Company is a newly formed corporation or shares of the Company are thinly traded the use of share prices established in the Company’s most recent private placement memorandum (“PPM”), or weekly or monthly price observations would generally be more appropriate than the use of daily price observations as such shares could be artificially inflated due to a larger spread between the bid and asked quotes and lack of consistent trading in the market.
The fair value of share options and similar instruments is estimated on the date of grant using a Black-Scholes option-pricing valuation model. The ranges of assumptions for inputs are as follows:
● | Expected term of share options and similar instruments: Pursuant to Paragraph 718-10-50-2(f)(2)(i) of the FASB Accounting Standards Codification the expected term of share options and similar instruments represents the period of time the options and similar instruments are expected to be outstanding taking into consideration of the contractual term of the instruments and holder’s expected exercise behavior into the fair value (or calculated value) of the instruments. The Company uses historical data to estimate holder’s expected exercise behavior. If the Company is a newly formed corporation or shares of the Company are thinly traded the contractual term of the share options and similar instruments is used as the expected term of share options and similar instruments as the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. | |
● | Expected volatility of the entity’s shares and the method used to estimate it. Pursuant to ASC Paragraph 718-10-50-2(f)(2)(ii) a thinly-traded or nonpublic entity that uses the calculated value method shall disclose the reasons why it is not practicable for the Company to estimate the expected volatility of its share price, the appropriate industry sector index that it has selected, the reasons for selecting that particular index, and how it has calculated historical volatility using that index. The Company uses the average historical volatility of the comparable companies over the expected contractual life of the share options or similar instruments as its expected volatility. If shares of a company are thinly traded the use of weekly or monthly price observations would generally be more appropriate than the use of daily price observations as the volatility calculation using daily observations for such shares could be artificially inflated due to a larger spread between the bid and asked quotes and lack of consistent trading in the market. | |
● | Expected annual rate of quarterly dividends. An entity that uses a method that employs different dividend rates during the contractual term shall disclose the range of expected dividends used and the weighted-average expected dividends. The expected dividend yield is based on the Company’s current dividend yield as the best estimate of projected dividend yield for periods within the expected term of the share options and similar instruments. | |
● | Risk-free rate(s). An entity that uses a method that employs different risk-free rates shall disclose the range of risk-free rates used. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods within the expected term of the share options and similar instruments. |
Pursuant to Paragraphs 505-50-25-8 and 505-50-25-9, an entity may grant fully vested, non-forfeitable equity instruments that are exercisable by the grantee only after a specified period of time if the terms of the agreement provide for earlier exercisability if the grantee achieves specified performance conditions. Any measured cost of the transaction shall be recognized in the same period(s) and in the same manner as if the entity had paid cash for the goods or services or used cash rebates as a sales discount instead of paying with, or using, the equity instruments. A recognized asset, expense, or sales discount shall not be reversed if a share option and similar instrument that the counterparty has the right to exercise expires unexercised.
(N) Income Taxes
The Company accounts for income taxes under Accounting Standards Codification (ASC) Topic 740. Deferred tax assets and liabilities are determined based upon differences between financial reporting and tax bases of 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. 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.
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The Company accounts for income taxes under Accounting Standards Codification (ASC) Topic 740.
As required by ASC Topic 740, the Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company applied ASC Topic 740 to all tax positions for which the statute of limitations remained open. As a result of the implementation of ASC Topic 740, the Company did not recognize any change in the liability for unrecognized tax benefits.
The Company is not currently under examination by any federal or state jurisdiction.
The Company’s policy is to record tax-related interest and penalties as a component of operating expenses.
(O) Inventory
Inventories are recorded in accordance with ASC 330 and are stated at the lower of cost or net realizable value. We account for inventories using the first in first out (FIFO) methodology and capitalize costs on a project basis as they occur. The current marketed shelf life of our Kush inventory is 2 years. However, management reserves the right to review and adjust this as appropriate.
(P) Recently Issued and Adopted Accounting Pronouncements
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Topic 842 affects any entity that enters into a lease, with some specified scope exemptions. The guidance in this ASU supersedes Topic 840, Leases. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use (“ROU”) asset representing its right to use the underlying asset for the lease term. For public companies, the amendments in this ASU are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted ASU 2016-02 on April 1, 2019.
In January 2016, the FASB issued ASU No. 2016-01 Financial Instruments (Subtopic 825) to enhance the reporting model for financial instruments to provide users of financial statements with more decision-useful information. The amendments in this Update affect all entities that hold financial assets or owe financial liabilities. The amendments are meant to improve financial reporting by providing relevant information about an entity’s equity investments and reducing the number of items that are recognized in other comprehensive income since this Update requires equity securities to be measured at fair value with changes in the fair value recognized through net income. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company adopted ASU 2016-01 on April 1, 2018.
In August 2016, the FASB issued ASU No. 2016-15 Statement of Cashflows (Topic 230) to reduce diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The amendments in this Update apply to all entities, including both business entities and not-for-profit entities that are required to present a statement of cash flows under Topic 230. This Update addresses eight specific cash flow issues and their presentations in the statement of cash flows. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company adopted ASU 2016-15 on April 1, 2018.
All other newly issued accounting pronouncements but not yet effective have been deemed either immaterial or not applicable.
NOTE 2 - GOING CONCERN
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of the Company as a going concern.
The Company incurred net losses of $500,887 for the three-month period ended June 30, 2019 and had net cash used in operating activities of $173,797 for the same period. Additionally, the Company has an accumulated deficit of $53,006,799 and working capital deficit of $1,408,592 at June 30, 2019. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months after the date of issuance on these financial statements. In view of these matters, the Company’s ability to continue as a going concern is dependent upon the Company’s ability to achieve a level of profitability and/or to obtain adequate financing through the issuance of debt or equity in order to finance its operations.
Management intends to raise additional funds either through a private placement or public offering of its equity securities. Management believes that the actions presently being taken to further implement its business plan will enable the Company to continue as a going concern. While the Company believes in its viability to raise additional funds, there can be no assurances to that effect. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to further implement its business plan and raise additional funds.
These financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
NOTE 3 – INVENTORY
On November 1, 2018 the Company and its independent contract quality control organization discovered a possible contamination in vials produced from lots #1, #2 and #3 of three separate lots that were included in inventory. No vials derived from lots #2 and #3 have been distributed to customers. No evidence of contamination of vials distributed from lot #1 has been identified to date. No adverse events arising from use of product from lot #1 have been reported to the Company. The identified lots and vials were produced by the Company’s former third-party contract manufacturer. On November 5, 2018 we issued a formal Notice of Product Quarantine and Product Monitoring Period whereby we asked for any unused vials to be quarantined while the Company’s scientific team and third-party contract testing organization coordinated and performed testing on lots #1 and #2, and analyzed the events leading to this situation.
As of March 31, 2019, a reserve of approximately $67,000 in inventory has been taken in relation to this event due to the lack of sales when product was available leading to substantial doubt in the Company’s ability to obtain material sales if the product gets cleared for release, the amount of time it has taken the Company to analyze whether release of product is appropriate leaving little time before the product’s expiration date arrives, and the level of uncertainty as it relates to how pervasive any unidentified contamination may be in existing units of Kush in lots #1 and #2. Approximately $20,000 in inventory has been written off in relation to additional third-party product testing of lot #1 and approximately $5,000 in relation to lot #2. We also wrote-down the entirety of lot #3 in the amount of $5,166, which was a work-in-process when contamination was discovered.
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Total Inventory is broken out as follows:
June 30, 2019 | March 31, 2019 | |||||||
Finished Goods | $ | 67,310 | $ | 77,936 | ||||
Reserve for Obsolete Inventory | (67,310 | ) | (77,936 | ) | ||||
Work in Process | -0- | -0- | ||||||
Manufacturing Supplies | 3,127 | 3,127 | ||||||
Raw Materials | 9,368 | 9,368 | ||||||
Total Inventory | $ | 12,495 | $ | 12,495 |
NOTE 4 – LEASE AND COMMITMENTS
Rent expense for the three months ended June 30, 2019 and 2018 was $14,546 and $14,607, respectively.
On July 2nd, 2018 the Company gave its manufacturing contractor in Rochester, MN a 90-day notice to cancel the lease and agreement under which the Company was renting manufacturing and office space; the financial impact of this cannot be fully measured. Subsequently, the Company entered into an one-year agreement on July 13, 2018 with a 60-day notice of termination clause for 1,000 square feet of manufacturing and office space in White Bear Lake, MN.
The Company entered into an eighty-four-month lease for 3,577 square feet of newly constructed office, laboratory and warehouse space located in Edina, Minnesota on May 3, 2017. The base rent is $2,078 per month and the Company is responsible for its proportional share of common space expenses, property taxes, and building insurance. This lease is terminable by the landlord if damage causes the property to no longer be utilized as an integrated whole and by the Company if damage causes the facility to be unusable for a period of 45 days.
The following is a maturity analysis of the annual undiscounted cash flows of the operating lease liabilities as of June 30, 2019:
Year Ended March 31, | ||||
2020 | $ | 18,702 | ||
2021 | 24,936 | |||
2022 | 24,936 | |||
2023 | 24,936 | |||
2024 | 10,390 | |||
$ | 103,900 |
In compliance with ASC 842 the Company adopted new guidance in relation to lease accounting on April 1, 2019 whereby we recognized operating lease right-to-use assets and corresponding and equal operating lease liabilities. The planned future base rent lease payments total $103,900, which has been discounted to $101,269 using a the 52-week treasury bill coupon equivalent discount rate of 2.18% and a present value model. The Company only had one operating lease so that the weighted average remaining lease term and weighted average discount rate are approximately 4.2 years and 2.18%, respectively.
June 30, 2019 | ||||
Present value of future base rent lease payments | $ | 101,269 | ||
Base rent payments included in prepaid expenses | (2,070 | ) | ||
Present value of future base rent lease payments – net | 99,199 |
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As of June 30, 2019, the present value of future base rent lease payments – net is classified between current and non-current assets and liabilities as follows:
June 30, 2019 | ||||
Operating lease right-of-use current asset | $ | - | ||
Operating lease right-of-use other asset | 99,199 | |||
Total operating lease assets | 99,199 | |||
Operating lease current liability | 22,652 | |||
Operating lease other liability | 76,547 | |||
Total operating lease liabilities | $ | 99,199 |
Pursuant to a lease wherein our subsidiary, Gel-Del Technologies, Inc., was the lessee until the lease’s termination in 2017, the Company owes approximately $330,000 to the lessor as of the balance sheet date; this amount is included in accounts payable.
NOTE 5 – INVESTMENTS – EQUITY SECURITIES
On June 28, 2019, the Company entered into a purchase agreement with a third-party to purchase 1,500,000 shares of Emerald Organic Products, Inc. (OTC Pink: “EMOR”) common stock for consideration of $1,500. The Company applied guidance from ASU No. 2016-01 Financial Instruments – Overall – Recognition and Measurement of Financial Assets and Financial Liabilities and ASC 820 to arrive at a fair value at June 30, 2019 of $1,500. The Company took into account many factors when determining the stock’s fair value including, but not limited to, the nature and duration of the restriction on the stock, the extent to which potential buyers would be limited by the restriction, and qualitative and quantitative factors specific to both the instrument and the issuer.
NOTE 6 – PROPERTY AND EQUIPMENT
The components of property and equipment were as follows:
June 30, 2019 | March 31, 2019 | |||||||
Leasehold improvements | $ | 4,602 | $ | 4,602 | ||||
Furniture and office equipment | 10,130 | 10,130 | ||||||
Production equipment | 108,882 | 108,882 | ||||||
R&D equipment | 25,184 | 26,188 | ||||||
Total, at cost | 148,798 | 149,802 | ||||||
Accumulated depreciation | (118,430 | ) | (112,453 | ) | ||||
Total, net | $ | 30,368 | $ | 37,349 |
During the three months ended June 30, 2019 and 2018, depreciation expense was $6,981 and $1,652, respectively.
NOTE 7 – INTANGIBLE ASSETS
The components of intangible assets, all of which are finite-lived, were as follows:
June 30, 2019 | March 31, 2019 | |||||||
Patents | $ | 3,838,865 | $ | 3,820,374 | ||||
Trademarks | 24,098 | 22,829 | ||||||
Total, at cost | 3,862,963 | 3,843,203 | ||||||
Accumulated Amortization | (3,390,495 | ) | (3,253,386 | ) | ||||
Total, net | $ | 472,468 | $ | 589,817 |
During the three-month periods ended June 30, 2019 and 2018, amortization expense was $137,109 and $159,467, respectively.
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NOTE 8 – CONVERTIBLE NOTES AND NOTES PAYABLE
At June 30, 2019, the Company is obligated for several convertible notes payable in the total amount of $280,000. The Company entered into these convertible notes during the quarter ended June 30, 2019. All of these convertible notes mature during the quarter ended June 30, 2021, two years from their inception dates. These convertible notes accrue interest at a rate of 10%. Accrued interest is due and payable each calendar quarter in cash; during the quarter ended June 30, 2019, the Company paid out $5,362 in accrued interest to these convertible note holders. These convertible notes automatically convert into shares of common stock at a rate of $.65 per share at the earlier of the maturity date or an uplift to a national securities exchange (e.g. NASDAQ or New York Stock Exchange) provided that the Company’s stock price is at least $.78 at the time of the uplift. The convertible note holders have the right to convert their outstanding principal and interest into shares of the Company’s common stock at any time during their note’s term at $.65 per share.
At June 30, 2019 the Company is obligated for one note payable and accrued interest in the total amount of $10,303. The note terms dictate 12% simple interest, compounding daily based on a 365-day year, paid out 6 months from the date of the note and the issuance of a detachable warrant for purchase of half of the principal amount in shares exercisable at $1.00 per share for a 3-year term. All debt discount associated with the warrants issued in conjunction with this note was charged to interest expense as of the maturity date of the note in February of 2019. Upon maturity of the note we entered into a note amendment whereby instead of paying out the entire outstanding balance of principal and interest, we were to pay an initial installment of $5,000 and then monthly payments of $3,000 until the amended maturity date of September 30, 2019.
NOTE 9 – NOTES PAYABLE – RELATED PARTY
At June 30, 2019 and March 31, 2019 the Company was obligated for a related party note payable and accrued interest in the total amount of $75,941 and $85,752, respectively; the maturity date of this note is April 30, 2020. The related party note payable terms are accrual of interest at 8% annually with payments of $3,100 per month, which are applied to interest first, then principal. The terms also include a stipulation that if the Company receives additional financing during any 24-month period from the date of the note in the amount greater than $3,500,000, the Company will immediately pay the officer the principal amount of the note along with all interest due.
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NOTE 10 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES
At June 30, 2019 and March 31, 2019, the Company is obligated to pay $849,668 and $854,990, respectively, in accounts payable and accrued expenses. Of the total at June 30, 2019 of $849,668, $523,377 is made up of accounts payable, while the $326,291 in accrued expenses is made up of past employee’s accrued salaries and related payroll taxes payable. Of the total at March 31, 2019 of $854,990, $524,273 is made up of accounts payable, while the $330,717 in accrued expenses is made up of past employee’s accrued salaries and related payroll taxes payable. The Company has not paid the related payroll taxes, consisting primarily of Social Security and Medicare taxes. As a result, the Company has established an accrued liability for the unpaid salaries, along with related taxes of approximately $23,057 and $21,482 at June 30, 2019 and March 31, 2019, respectively.
NOTE 11 – ACCRUED EXPENSES – RELATED PARTY
At June 30, 2019, the Company is obligated to pay $578,098 in accrued expenses due to related parties. Of the total, $76,918 is made up of accounts payable, while $501,180 is made up of accrued salaries and payroll taxes payable.
At March 31, 2019, the Company was obligated to pay $576,393 in accrued expenses due to related parties. Of the total, $89,186 is made up of accounts payable, while $487,207 is made up of accrued salaries and payroll taxes payable.
NOTE 12 - COMMON STOCK AND WARRANTS
Common Stock
During the three-month period ended June 30, 2019 the Company did not issue any common stock.
Warrants
During the three-month period ended June 30, 2019, the Company granted warrants to purchase a total of 300,000 shares of common stock including:
i) warrants for 300,000 shares, valued at $119,954 using the Black-Scholes model, to three new Directors, Messrs. Scott Johnson, Gregory Cash, and James Martin, with 150,000 vested immediately and 150,000 vesting quarterly between August 2020 and May 2021, and exercisable over a five-year term at $.30/share.
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A summary of warrant activity for the year ending March 31, 2019 and three-month period ending June 30, 2019 is as follows:
Number of Warrants | Weighted- Average Exercise Price | Warrants Exercisable | Weighted- Average Exercisable Price | |||||||||||||
Outstanding, March 31, 2018 | 3,486,709 | .59 | 2,433,601 | .57 | ||||||||||||
Granted | 1,980,531 | .41 | ||||||||||||||
Exercised | 1,111,027 | .36 | ||||||||||||||
Expired | 12,977 | .30 | ||||||||||||||
Canceled | 100,000 | 1.00 | ||||||||||||||
Outstanding, March 31, 2019 | 4,243,236 | .50 | 3,372,261 | .49 | ||||||||||||
Granted | 300,000 | .30 | ||||||||||||||
Cancelled | 172,500 | .54 | ||||||||||||||
Outstanding, June 30, 2019 | 4,370,736 | .48 | 3,831,986 | .47 |
At June 30, 2019, the range of warrant prices for shares under warrants and the weighted-average remaining contractual life is as follows:
Warrants Outstanding | Warrants Exercisable | |||||||||||||||||||
Range of Warrant Exercise Price | Number of Warrants | Weighted- Average Exercise Price | Weighted- Average Remaining Contractual Life (Years) | Number of Warrants | Weighted- Average Exercise Price | |||||||||||||||
.30-.50 | 3,739,986 | .35 | 4.36 | 3,391,236 | .36 | |||||||||||||||
.51-1.00 | 517,500 | 1.00 | 3.39 | 327,500 | 1.00 | |||||||||||||||
1.01-3.50 | 113,250 | 2.35 | 2.08 | 113,250 | 2.35 | |||||||||||||||
Total | 4,370,736 | .48 | 4.19 | 3,831,986 | .47 |
For the three-month periods ended June 30, 2019 and 2018, the total stock-based compensation on all instruments was $157,134 and $279,311, respectively. It is expected that the Company will recognize expense after June 30, 2019 related to warrants issued, outstanding, and valued using the Black Scholes pricing model as of June 30, 2019 in the amount of approximately $488,000.
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NOTE 13 – INCOME TAXES
The following table presents the net deferred tax assets as of June 30, 2019 and March 31, 2019:
June 30, 2019 | March 31, 2019 | |||||||
Net operating loss carryforwards: | ||||||||
Federal | $ | (3,906,591 | ) | $ | (3,801,404 | ) | ||
State | (1,823,076 | ) | (1,773,989 | ) | ||||
Total net operating loss carryforwards | (5,729,666 | ) | (5,575,393 | ) | ||||
Total deferred tax assets | (5,729,666 | ) | (5,575,393 | ) | ||||
Valuation allowance | 5,729,666 | 5,575,393 | ||||||
Net deferred tax assets | $ | – | $ | – |
Current income taxes are based upon the year’s income taxable for federal and state tax reporting purposes. Deferred income taxes (benefits) are provided for certain income and expenses, which are recognized in different periods for tax and financial reporting purposes.
Deferred tax assets and liabilities are computed for differences between the financial statements and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the period in which the differences are expected to affect taxable income. The Company’s deferred income taxes arise from the temporary differences between financial statement and income tax recognition of net operating losses. These loss carryovers would be limited under the Internal Revenue Code should a significant change in ownership occur within a three-year period.
At June 30, 2019 and March 31, 2019, respectively, the Company had net operating loss carryforwards of approximately $18,600,000 and $18,100,000. The deferred tax assets arising from the net operating loss carryforwards are approximately $5,730,000 and $5,580,000 as of June 30, 2019 and March 31, 2019, respectively. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, the projected future taxable income and tax planning strategies in making this assessment. Based on management’s analysis, they concluded not to retain a deferred tax asset since it is uncertain whether the Company can utilize this asset in future periods. Therefore, they have established a full reserve against this asset. The net operating loss carryforwards, if not utilized, will begin to expire in 2021 for federal and Minnesota purposes.
Of the approximately $18,600,000 in net operating loss carryforwards, approximately $7,000,000 has been accumulated in our pre-merger operating subsidiary, Gel-Del Technologies, Inc. IRC 382 provides guidance around whether or not the Company is able to utilize the pre-merger Gel-Del Technologies, Inc. net operating loss of approximately $7,000,000. Management is currently analyzing whether or not these pre-merger dollars will be allowable if our deferred tax asset is ever realized.
A reconciliation of the expected tax computed at the U.S. statutory federal income tax rate to the total benefit for income taxes at June 30, 2019 and 2018 is as follows:
2019 | 2018 | |||||||
Expected tax at 21% and 9.8% | $ | (5,729,666 | ) | $ | (5,477,233 | ) | ||
Valuation allowance | 5,729,666 | 5,477,233 | ||||||
Provision for income taxes | $ | – | $ | – |
The Company’s continuing practice is to recognize interest and/or penalties related to income tax matters in income tax expense. As of June 30, 2019 and 2018, the Company had no accrued interest and penalties related to uncertain tax positions.
The Company is subject to taxation in the U.S. and Minnesota. Our tax years for 2016 and forward are subject to examination by tax authorities. The Company is not currently under examination by any tax authority.
Management has evaluated tax positions in accordance with FASB ASC 740, and has not identified any tax positions, other than those discussed above, that require disclosure.
NOTE 14 – LOSS PER SHARE
At June 30, 2019, the Company had $280,000 in convertible notes outstanding that mature in our fiscal quarter ended June 30, 2021; see Note 8 to these financial statements for more information on these convertible notes. If converted, the $280,000 in outstanding convertible notes would convert into 430,769 shares of common stock at a rate of $.65 per share. At June 30, 2019 our if-converted weighted average number of shares outstanding was 22,347,532. Our if-converted loss per share remains consistent with our actual loss per share at ($.02).
NOTE 15 – SUBSEQUENT EVENTS
On July 31, 2019, the Company entered into an exclusive license agreement with Emerald Organic Products, Inc. (“Emerald”) whereby PetVivo granted an exclusive license to Emerald to use PetVivo’s proprietary Technology in the formulation, manufacture and sale of Emerald’s nutritional supplements including its hemp-based CBD wellness products.
The Technology of PetVivo licensed to Emerald under the Agreement includes Patents and Know-how involved with protein-based active agent delivery systems and related carrier formulations for utilization in human nutritional supplement applications.
The Company’s CEO and President, John Lai, owns approximately 3% of Emerald’s outstanding common stock. The Company’s Secretary, John Dolan, owns approximately 2% of Emerald’s outstanding common stock.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
GENERAL
We were incorporated in Nevada in 2009 under a former name. In 2014, we entered our current business through a reverse merger with PetVivo Inc., a Minnesota corporation founded in 2013. From this merger, PetVivo Inc. became our wholly-owned subsidiary, and concurrently we changed our Nevada corporate name to PetVivo Holdings, Inc. Our common stock is publicly traded in the over-the-counter (OTC) market under the symbol “PETV.”
Minnesota PetVivo Inc.
On March 11, 2014, our Board of Directors authorized the execution of that certain securities exchange agreement dated March 11, 2014 (the “Securities Exchange Agreement”) with PetVivo Inc., a Minnesota corporation (“PetVivo”), and the shareholders of PetVivo. In accordance with the terms and provisions of the Securities Exchange Agreement, we acquired all of the issued and outstanding shares of stock of PetVivo, thus making PetVivo our wholly-owned subsidiary, in exchange for the issuance to the PetVivo shareholders of an aggregate 2,310,939,804 shares of our common stock as adjusted for a reverse stock split effective soon after this merger.
PetVivo was founded in 2013 by John Lai and John Dolan, and is based in suburban Minneapolis, Minnesota. PetVivo is a biomedical device company engaged in the business of acquiring/in-licensing and adapting human biomedical technology and products for commercial sale in the veterinary market to treat pets and other animals suffering from arthritis and other afflictions. PetVivo’s initial product, which is now being commercialized, is a medical device featuring the injections of patented gel-like, protein-based biomaterials into the afflicted body parts of pets and other animals suffering from osteoarthritis. PetVivo obtained the exclusive rights in a License Agreement for commercialization of Gel-Del technology for the treatment of pets and other animals.
Gel-Del Technologies Inc.
Gel-Del is a biomaterial and medical device development and manufacturing company with its offices in Edina, Minnesota, and was founded in 1999 by Dr. David B. Masters. Dr. Masters developed Gel-Del’s proprietary biomaterials that simulate a body’s cellular tissue and thus can be readily and effectively utilized to manufacture implantable therapeutic medical devices. The chief advantage of Gel-Del biomaterials is their enhanced biocompatibility with living tissues throughout the body. We are commercializing their technology in the veterinary field for the treatment of osteoarthritis. Gel-Del has also successfully completed a phase II clinical trial using their novel thermoplastic biomaterial as dermal filler for human cosmetic applications. Gel-Del’s core competencies are developing and manufacturing medical devices containing its proprietary thermoplastic protein-based biomaterials that mimic the body’s tissue to allow integration, tissue repair, and regeneration for long-term implantation. These biomaterials are produced using a patented and scalable self-assembly production process. The inherent thermoplastic properties of these biomaterials are then utilized to manufacture or coat implantable devices.
While working together relating to the Licensing Agreement, in 2014 our management and the management of Gel-Del determined to combine the two companies into one business entity producing, marketing and selling medical products based on Gel-Del technology for both humans and animals.
Gel-Del Merger
In November 2014 the respective Boards of Directors and executive officers of our company and of Gel-Del Technologies, Inc., a Minnesota corporation, (“Gel-Del”) entered into a merger agreement between our company and Gel-Del, subject to approval of our shareholders and Gel-Del shareholders. Shareholder approval of this merger was obtained from shareholders of Gel-Del in March 2015 and from our shareholders in April 2015, and concurrently we also appointed the directors of Gel-Del to our Board of Directors. We then controlled Gel-Del, combined all Gel-Del operations with ours, and were responsible to provide future funding for Gel-Del. Accordingly, we concluded that Gel-Del was a VIE entity for which we were the primary beneficiary and that for accounting purposes, we would consolidate our financial statements with those of Gel-Del with the assets and liabilities of Gel-Del stated at their fair value. We also determined the fair value of the Gel-Del assets and liabilities was based on the $4.02 per share trading price of our common stock at April 10, 2015, resulting in the total purchase consideration being $18,978,462.
We were unable to consummate this initial merger agreement with Gel-Del due primarily to a substantial public market decline in the value of our common stock during 2015-2016. In order to complete the Gel-Del merger, in early 2017 we agreed to provide Gel-Del an additional 31.3% of our common shares than was required in the initial merger agreement. Accordingly, our management and Gel-Del management revised the structure and terms of the Gel-Del merger to provide for the issuance of these additional shares to Gel-Del and to effect the transaction through a statutory triangular merger. The Gel-Del merger was then completed under Minnesota Statutes whereby Gel-Del and a wholly-owned subsidiary of ours (which was incorporated in Minnesota expressly for this transaction) completed the triangular merger (the “Merger”). Pursuant to the Merger, Gel-Del was the surviving entity and concurrently became our wholly-owned subsidiary, resulting in our obtaining full ownership of Gel-Del. Our primary reason to effect the Merger was to obtain 100% ownership and control of Gel-Del and its patented bioscience technology, including ownership of Gel-Del’s Cosmeta subsidiary. The effective date for the Merger was April 10, 2017 when the Merger was filed officially with the Secretary of State of Minnesota.
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Pursuant to the Merger, we issued a total of 5,450,000 shares of our common stock pro rata to the pre-merger shareholders of Gel-Del, resulting in each outstanding common share of Gel-Del being converted into 0.798 common share of the Company; .634 share was issued in relation to the merger and .164 share was issued pursuant to the License Agreement. The 5,450,000 shares represented approximately 30% of our total post-merger outstanding common shares and were valued at the closing price of our common shares on the effective date of the Merger of $0.40 per share, resulting in total consideration of $2,180,000. Incident to completion of the Merger, we also recorded an impairment loss of approximately $14,700,000 in order to account for the decline in our initial valuation of Gel-Del in 2015.
CURRENT BUSINESS OPERATIONS
We are an emerging biomedical device company focused on the licensing and commercialization of innovative medical devices and therapeutics for pets, based in Minneapolis, Minnesota. We operate in the $19 billion US veterinary care market that has grown at a CAGR of 4.8% over the past five years according to the American Pet Products Association. Despite the market size, veterinary clinics and hospitals have very few treatments and/or drugs for use in treating osteoarthritis in pets and other animals. Also, the role of pets in the family has greatly evolved in recent years. Many pet owners consider their pets an important member of the family. They are now willing to spend greater amounts of money on their pets to maintain their health and quality of life.
We intend to leverage investments already expended in the development of human therapeutics to commercialize treatments for pets in a capital and time-efficient way. A key component of this strategy is the accelerated timeline to revenues for veterinary medical devices, which enter the market earlier than the more-stringently regulated veterinary pharmaceuticals or human therapeutics.
We launched our lead product, Kush® in calendar Q2 2018. In Q4 2018 we issued a “Notice of Product Quarantine and Product Monitoring Period” notifying all product holders to suspend use of the product and place it in quarantine while the Company, through utilization of third-party testing vendors, perform additional testing of the product. Kush is a veterinarian-administered joint injection for the treatment of osteoarthritis and lameness in dogs and horses. The Kush device is made from natural components that are lubricious and cushioning to perform like cartilage for the treatment of pain and inflammation associated with osteoarthritis.
We believe that Kush is a superior treatment that safely improves joint function. The reparative Kush particles are lubricious, cushioning and long-lasting. The spongy, protein-based particles mimic the composition and protective function of cartilage (i.e., providing both a slippery cushion and healing scaffolding) and protect the joint as an artificial cartilage.
Using industry sources, we estimate osteoarthritis afflicts approximately 20 million owned dogs in the United States and the European Union, making canine osteoarthritis a $4 billion market opportunity if selling the product at $200 per canine unit; this does not factor in any contra-lateral usage of the product by veterinarians. See Johnston, Spencer A. “Osteoarthritis. Joint anatomy, physiology, and pathobiology.” The Veterinary clinics of North (1997):699-723;
http://www.humanesociety.org/issues/petoverpopulation/facts/pet_ownership_statistics.html;
and
http://www.americanpetproducts.org/press_industrytrends.asp.
In addition to being a treatment for osteoarthritis, the joint-cushioning and lubricity effects of Kush have shown an ability to treat equine lameness that is due to navicular disease (a problem associated with misalignment of joints and bones in the hoof and digits).
Based on a variety of industry sources we estimate that 1 million owned horses in the United Stated and European Union suffer from lameness and/or navicular disease each year, making the equine lameness and navicular disease market an annual opportunity worth $600 million if selling the product at $600 per equine unit; this does not factor in any contra-lateral usage of the product by veterinarians. See Kane, Albert J., Josie Traub-Dargatz, Willard C. Losinger, and Lindsey P. Garber; “The occurrence and causes of lameness and laminitis in the US horse population” Proc Am Assoc Equine Pract. San Antonio (2000): 277-80; Seitzinger, Ann Hillberg, J. L. Traub-Dargatz, A. J. Kane, C. A. Kopral, P. S. Morley, L. P. Garber, W. C. Losinger, and G. W. Hill. “A comparison of the economic costs of equine lameness, colic, and equine protozoal myeloencephalitis (EPM).” In Proceedings, pp. 1048-1050. 2000; and Kilby, E. R. 10 CHAPTER, The Demographics of the U.S. Equine Population, The State of the Animals IV: 2007.
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Osteoarthritis is a condition with degenerating cartilage, creating joint stiffness from mechanical stress resulting in inflammation and pain. The lameness caused by osteoarthritis worsens with time from the ongoing loss of protective cushion and lubricity (i.e., loss of slippery padding). There are currently very few, if any, treatments for osteoarthritis; some of which are palliative pain therapy and joint replacement. Non-steroidal, anti-inflammatory drugs (NSAIDs) are used to alleviate the pain and inflammation, but long-term use has been shown to cause gastric problems. NSAIDs do not treat the cartilage degeneration issue to halt or slow the progression of the osteoarthritis condition.
We believe that our treatment of osteoarthritis in canines using Kush is far superior to the current methodology of using NSAIDs. NSAIDs have many side effects, especially in canines, whereas the company’s treatment using Kush, to our knowledge, has not elicited any adverse side effects in dogs. Remarkably, Kush-treated dogs have shown an increase in activity even after they no longer are receiving pain medication.
No special training is required for the administration of the Kush device. The treatment is injected into synovial joint space using standard intra-articular injection technique and multiple joints can be treated simultaneously. Kush immediately treats effects of osteoarthritis with no special post-treatment requirements.
Historically, drug sales represent up to 30% of revenues at a typical veterinary practice (Veterinary Practice News). Revenues and margins at veterinary practices are being eroded because online, big-box and traditional pharmacies recently started filling veterinary prescriptions. Veterinary practices are looking for ways to replace the lost prescription revenues. Our treatments expand practice revenues and margins because they are veterinarian-administered. The Kush device is veterinarian-administered to expand practice revenues and margins. We believe that the increased revenues and margins provided by Kush will accelerate its adoption rate and propel it forward as the standard of care for canine and equine lameness related to or due to synovial joint issues.
We anticipate growing our product pipeline through the acquisition or in-licensing of additional proprietary products from human medical device companies specifically for use in pets. In addition to commercializing our own products in strategic market sectors and in view of the company’s vast proprietary product pipeline, the Company anticipates establishing strategic out-licensing partnerships to provide secondary revenues.
We plan to commercialize our products in the United States through distribution relationships supported by regional and national distributors and complemented by the use of digital marketing to educate and inform pet owners; and in Europe and rest of world through commercial partners.
Most veterinarians in the United States buy a majority of their equipment and supplies from one of four veterinary-product distributors. Combined, these four distributors deliver more than 85%, by revenue, of the products sold to companion animal veterinarians in the U.S. We plan to have our product distribution leverage the existing supply chain and veterinary clinic and clinician relationships already established by these large distributors. We plan to support this distribution channel with regional sales representatives. Our representatives will support our distributors and the veterinary clinics and hospitals. We will also target pet owners with product education and treatment awareness campaigns utilizing a variety of digital marketing tools. The unique nature and the anticipated benefits provided by our products are expected to generate significant consumer response.
Our biomaterials have been through a human trial and have been classified as a medical device. The FDA does not require submission of a 510(k) or formal pre-market approval for medical devices used in veterinary medicine.
RESULTS OF OPERATIONS
We are a development stage company with no history of commercial revenues, and we have incurred recurring substantial losses since inception. The following discussion should be read in conjunction with our unaudited financial statements and related notes included in this report.
Results of Operations for the Three Months Ended June 30, 2019 and 2018
Revenue – Revenue was $-0- for both three-month periods ended June 30, 2019 and June 30, 2018.
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Cost of Sales – Cost of sales was $-0- for both three-month periods ended June 30, 2019 and June 30, 2018.
Gross Profit – Gross profit was $-0- for both three-months periods ended June 30, 2019 and June 30, 2018.
Operating Expenses – Operating expenses for the three months ended June 30, 2019 were $493,721 compared to $2,097,088 for the three months ended June 30, 2018; the decrease of $1,603,367 was due primarily to common stock issuances to John Lai during the three months ended June 30, 2018 and the corresponding $1,446,093 in expense recognized pursuant to those transactions. Sales and marketing expenses increased from $-0- to $2,796 in the three-month periods ended June 30, 2018 and 2019, respectively. The majority of our operating expenses in both of these quarters were general and administrative expenses. During the three-month period ended June 30, 2019, operating expenses were primarily made up of $144,090 in depreciation and amortization and $190,801 in stock-based compensation. During the three-month period ended June 30, 2018, operating expenses were primarily made up of $161,119 in depreciation and amortization and approximately $1,700,000 in stock-based compensation.
Other Income (Expense) – Other Income (Expense) for the three months ended June 30, 2019 of ($7,166) is primarily due to interest accrued on outstanding notes payable, notes payable – related party, and convertible notes payable; this is partially offset by a $450 gain on sale of asset that was fully depreciated at the time of the sale. Other Income (Expense) for the three months ended June 30, 2018 of ($2,497) is made up of interest accrued on outstanding notes payable – related party.
Net Loss before Taxes and Net Loss – Our net loss for the three months ended June 30, 2019 was ($500,887), or ($.02) per share, compared to ($2,099,585), or ($.11) per share, for the three months ended June 30, 2018. The decreased loss of ($1,598,698) was attributable primarily to common stock issuances to John Lai during the three months ended June 30, 2018 and the corresponding $1,446,093 in expense recognized pursuant to those transactions. The weighted average number of shares outstanding during the three-month periods ended June 30, 2019 and June 30, 2018 were 22,074,667 and 19,584,396, respectively.
Liquidity and Capital Resources
Our financial position and future prospects depend significantly on our access to financing to fund our operations during our development stage. Much of our current cost structure is based on costs related to personnel and facilities, and not subject to material variability. In order to fund our operations and working capital needs, we historically have utilized loans from accredited investors and others, equity sales of common stock to accredited investors and others having pre-existing relationships with us, and substantial issuances of stock-based compensation to satisfy outstanding debt and pay for development, management, financial, professional and other services.
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As of June 30, 2019, our current assets were $128,070 including approximately $65,541 in cash, $450 in accounts receivable, $12,495 in inventory, $2,500 in employee advance, $1,500 in investment – equity securities receivable, and $45,484 in prepaid expenses. In comparison, our current liabilities as of that date were $1,536,662 consisting of $849,668 of accounts payable and accrued expenses, $578,098 of accrued expenses – related party, $22,652 in operating lease liability and $10,303 of notes payable and accrued interest and $75,941 in notes payable and accrued interest – related party. Our working capital deficiency as of June 30, 2019 was $1,408,592.
We will need to raise substantial additional capital through private or public offerings of our equity or debt securities, or a combination thereof, and we may have to use a material portion of any capital raised to repay past due debt obligations. To the extent any capital raised is insufficient to both satisfy operational working capital needs and meet any required debt payments, we will most likely need to either extend, refinance or convert to equity our outstanding indebtedness.
We currently have little cash to support our operations and projected commercial growth. Accordingly, we will require substantial additional financing to fund our operational working capital for at least the next 12 months. Financing may be sought by us from a number of sources such as private or public sales of our equity or convertible debt securities, and/or loans from affiliates, banks or other financial institutions. In the event we cannot obtain any such financing when needed on terms acceptable to us, if at all, our business would suffer substantially.
Liquidity represents the ability of a company to generate sufficient cash to provide for its immediate cash needs, which our continued losses have made it difficult for us to accomplish. Over the past several years; we have continued to incur substantial losses without any source of material revenues or liquid assets, which has caused a serious and harmful effect to our liquidity and a substantial strain on our ongoing business operations.
We have not generated any operating cash flows since we are a development stage company which has not yet realized any significant commercial revenues.
Net Cash Used in Operating Activities – We used ($173,797) of net cash in operating activities for the three months ended June 30, 2019 compared to using ($244,605) of net cash for the three months ended June 30, 2018. This decrease in cash used in operating activities was attributable primarily to a decrease in the amount spent on inventory of $78,730.
Net Cash Used in Investing Activities – We used ($21,260) of net cash in investing activities in the three months ended June 30, 2019, consisting of ($19,760) of costs capitalized to intangible assets. This is compared to ($53,794) net cash used in investing activities in the three months ended June 30, 2018, which was primarily due to ($32,612) of costs capitalized to intangible assets and ($23,181) in equipment purchases.
Net Cash Provided by Financing Activities – During the three months ended June 30, 2019, we were provided by financing activities with net cash of $254,238 consisting of $280,000 in proceeds from entering into convertible notes payable. In comparison, during the three months ended June 30, 2018, we were provided by financing activities with net cash of $93,390 including proceeds from sales of common stock of $93,893.
Inventory
Inventories are stated at cost, subject to the lower of cost or net realizable value. Cost includes materials, labor, and manufacturing overhead related to the purchase and production of inventories. Net realizable value is the estimated selling price less estimated costs of completion, disposal, and transportation. We regularly review inventory quantities on hand through an inventory count.
As of June 30, 2019, the Company’s inventory has a carrying value of $12,495 and is broken down into $67,310 of finished goods inventory, fully offset by a ($67,310) reserve for obsolete inventory, $3,127 of manufacturing supplies and $9,368 of raw materials.
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MATERIAL COMMITMENTS
Accrued Salary
We are indebted to related parties. At June 30, 2019, we are obligated for unpaid officer salaries and amounts payable to related parties of $578,098. This amount is included in accrued expenses – related party.
Notes Payable
As of June 30, 2019, we are obligated on the following notes:
1. | Third Parties – Principal | $ | 290,296 | |||
Third Parties – Interest | 7 | |||||
Third Parties – Total | 290,303 | |||||
2. | Related Parties – Principal | 75,429 | ||||
Related Parties – Interest | 512 | |||||
Related Parties – Total | 75,941 | |||||
Total | $ | 366,244 |
OFF-BALANCE SHEET ARRANGEMENTS
As of June 30, 2019, and as of the date of this Quarterly Report, we do not have any off balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
GOING CONCERN
The independent auditors’ report accompanying our March 31, 2019 Form 10-K and financial statements contains an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The financial statements have been prepared assuming that we will continue as a going concern, which contemplates that we will realize our assets and satisfy our liabilities and commitments in the ordinary course of business. We have suffered recurring losses from operations and have a working capital deficit. These factors raise substantial doubt about our ability to continue as a going concern.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable
ITEM 4. CONTROLS AND PROCEDURES
DISCLOSURE CONTROLS AND PROCEDURES
Evaluation of disclosure controls and procedures.
We maintain controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management including our principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosures.
Based upon their evaluation of those controls and procedures performed as of the end of the period covered by this report, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were not effective.
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Management’s report on internal control over financial reporting.
Our chief executive officer and our chief financial officer are responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and 15d-15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
● | Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; | |
● | Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and our directors; and | |
● | Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. |
Because of its inherent limitations, our internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of June 30, 2019. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control — Integrated Framework (revised 2013). This assessment included an evaluation of the design and procedures of our control over financial reporting.
● | Deficiencies in Segregation of Duties. Lack of proper segregation of functions, duties and responsibilities with respect to our cash and control over the disbursements related thereto due to our very limited staff, including our accounting personnel. | |
● | Deficiencies in the staffing of our financial accounting department. The number of qualified accounting personnel with experience in public company SEC reporting and GAAP is limited. | |
● | Limited checks and balances in processing cash and other transactions. |
As part of the preparation of this report, we have applied compensating procedures and processes as necessary to attempt to ensure the reliability of our financial reporting. Accordingly, management believes, based on its knowledge, that (1) this report does not contain any untrue statement of a material fact or omit to state a material face necessary to make the statements made not misleading with respect to the period covered by this report, and (2) the financial statements, and other financial information included in this report, fairly present in all material respects our financial condition, results of operations and cash flows for the years and periods then ended.
The existence of the material weaknesses in our internal control over financial reporting increases the risks that our financial statements may be misleading materially or even need to be restated. We are committed to improving our financial and oversight organization and procedures. During this fiscal year, we added three independent directors who have taken active roles in committees of the board of directors, and we added a fulltime, experienced CFO who is now responsible for helping to develop and implement our financial controls and procedures appropriate for the stage in which the Company is in.
Changes in internal control over financial reporting.
There were no significant changes in our internal control over financial reporting during the first quarter of our fiscal year ended March 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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AUDIT COMMITTEE
Our board of directors has established an audit committee consisting of three of our independent directors, Messrs James Martin (financial expert), Joseph Jasper, and David Deming. The audit committee’s primary function is to provide advice with respect to our financial matters and to assist our board of directors in fulfilling its oversight responsibilities regarding finance, accounting, and legal compliance. The audit committee’s primary duties and responsibilities are to: (i) serve as an independent and objective party to monitor our financial reporting process and internal control system; (ii) review and appraise the audit efforts of our independent accountants; (iii) evaluate our quarterly financial performance as well as its compliance with laws and regulations; (iv) oversee management’s establishment and enforcement of financial policies and business practices; and (v) provide an open avenue of communication among the independent accountants, management and our board of directors.
Management is not aware of any legal proceedings contemplated by any governmental authority or any other party involving our properties or the Company. As of the date of this Quarterly Report, no director, officer or affiliate is (i) a party adverse to us in any legal proceeding, or (ii) has an adverse interest to us in any legal proceedings. Management is not aware of any other legal proceedings pending or that have been threatened against our properties or the Company.
Not required
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
During the three months ended June 30, 2019, the Company did not sell or issue any common stock. During the three months ended June 30, 2019, the Company issued 300,000 warrants for purchase of common stock at $.30 per share for a term of 5 years to three directors for their service in that capacity.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not required.
ITEM 4. MINE SAFETY DISCLOSURES
Not required.
None
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The following exhibits are filed as part of this Quarterly Report.
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SIGNATURES
Pursuant to the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
August 19, 2019 | By: | /s/ John Lai |
John Lai | ||
Its: | CEO, President and Director (Principal Executive Officer) | |
August 19, 2019 | By: | /s/ John Carruth |
John Carruth | ||
Its: | Chief Financial Officer (Principal Financial and Accounting Officer) |
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