UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 

 

For the quarterly period ended June 30, 2020

 

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission file number: 333-216054

 

AVRA MEDICAL ROBOTICS, INC.

(Exact name of registrant as specified in its charter)

 

Florida   47-3478854
(State or Other Jurisdiction of   (I.R.S. Employer
Incorporation or Organization)   Identification No.)

 

3259 Progress Drive, Suite 112A, Orlando, FL 32826

(Address of Principal Executive Offices)

 

(407) 956-2250

(Registrant’s telephone number, including area code)

 

 

(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which
registered
None   N/A   N/A

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files.) Yes ☐  No ☒

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “accelerated filer”, “large accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer Accelerated Filer
Non-Accelerated Filer Smaller reporting company
Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐   No ☒

 

There were 37,808,805 shares of common stock, $0.0001 par value, of the Registrant issued and outstanding as of July 15, 2022.

 

 

 

 

 

TABLE OF CONTENTS

 

    Page
     
PART I – FINANCIAL INFORMATION 1
     
Item 1. Financial Statements 1
     
  Condensed Balance Sheets as of June 30, 2020 and December 31, 2019 (unaudited) 1
     
  Condensed Statements of Operations for the three and six months ended June 30, 2020 and June 30, 2019 (unaudited) 2
     
  Condensed Statement of Stockholders’ (Deficit) for the three and six months ended June 30, 2020 and June 30, 2019 (unaudited) 3
     
  Condensed Statements of Cash Flows for the six months ended June 30, 2020 and June 30, 2019 (unaudited) 4
     
  Notes to Condensed Financial Statements (unaudited) 5
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 17
     
Item 3. Quantitative Disclosures About Market Risks 22
     
Item 4. Controls and Procedures 22
     
PART II - OTHER INFORMATION 23
     
Item 1. Legal Proceedings 23
     
Item 1A. Risk Factors 23
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 23
     
Item 3. Defaults Upon Senior Securities 23
     
Item 4. Mine Safety Disclosures 23
     
Item 5. Other Information 23
     
Item 6. Exhibits 24
     
SIGNATURES 25

 

i

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

AVRA MEDICAL ROBOTICS, INC.

CONDENSED BALANCE SHEETS

(Unaudited)

 

   June 30,
2020
   December 31,
2019
 
         
ASSETS        
CURRENT ASSETS:        
Cash and cash equivalents  $5,416   $28,474 
Other prepaid expenses and deposit   2,290    6,290 
Total Current Assets   7,706    34,764 
           
EQUIPMENT:          
Equipment   98,592    119,592 
Accumulated depreciation   (47,670)   (34,954)
Total Equipment, net   50,922    84,638 
           
OTHER ASSETS:          
Website   36,122    36,122 
Accumulated amortization   (29,000)   (23,000)
Total Other Assets, net   7,122    13,122 
           
TOTAL ASSETS  $65,750   $132,524 
           
LIABILITIES AND STOCKHOLDERS’ DEFICIT CURRENT LIABILITIES:          
Accounts payable  $129,232   $141,417 
Accrued compensation   
 
    
 
 
Accrued expenses   732,030    596,865 
Notes payable - related party   380,000    367,500 
Promissory notes   25,000    90,000 
Total Current Liabilities   1,266,262    1,195,782 
           
LONG-TERM LIABILITIES:          
Note payable SBA   4,630    - 
Total Long-term Liabilities   4,630    - 
           
STOCKHOLDERS’ DEFICIT:          
Preferred stock, 5,000,000 shares authorized, $.0001 par value, none issued or outstanding   -    - 
Common stock, 100,000,000 shares authorized, $.0001 par value, 22,992,752 and 21,857,218 issued and outstanding at June 30, 2020 and December 31, 2019 respectively   2,299    2,186 
Common stock liability, 372,141 and 128,909 shares, $.0001 par value at June 30, 2020 and December 31, 2019, respectively   157,208    254,564 
Additional paid-in capital   5,031,733    4,549,058 
Accumulated deficit   (6,396,382)   (5,869,066)
Total Stockholders’ Deficit   (1,205,142)   (1,063,258)
           
TOTAL LIABILITIES AND  STOCKHOLDERS’ DEFICIT  $65,750   $132,524 

 

See accompanying notes to unaudited Condensed Financial Statements.

 

1

 

AVRA MEDICAL ROBOTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

   FOR THE THREE MONTHS   FOR THE SIX MONTHS 
   ENDED JUNE 30,   ENDED JUNE 30, 
   2020   2019   2020   2019 
                 
Revenues  $-   $-   $-   $- 
                     
OPERATING EXPENSES:                    
Research and Development   -    27,812    2,000    51,874 
Compensation Expense   
 
    
 
    
 
    
 
 
General and Administrative   219,988    504,696    524,659    874,963 
Total Operating Expenses   219,988    532,508    526,659    926,837 
                     
OTHER INCOME AND (EXPENSES)                    
Interest Earned   -    1    -    5 
Interest Expense   (313)   (6,493)   (657)   (7,649)
Total Other Income and (Expenses), net   (313)   (6,492)   (657)   (7,644)
                     
Loss before Income Taxes   (220,301)   (539,000)   (527,316)   (934,481)
                     
Provision for Income Taxes   -    -    -    - 
                     
NET LOSS  $(220,301)  $(539,000)  $(527,316)  $(934,481)
                     
Loss per common share - basic and diluted   (0.01)   (0.03)   (0.02)   (0.04)
                     
Weighted average common shares outstanding - basic and diluted   22,992,752    21,427,546    22,984,643    21,273,957 

 

See accompanying notes to unaudited Condensed Financial Statements.

 

2

 

AVRA MEDICAL ROBOTICS

CONDENSED STATEMENT OF STOCKHOLDERS’ DEFICIT

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2019

(Unaudited)

 

  

Common Stock

   Common Stock to be Issued  Additional   Accumulated   Total Stockholders’ 
   Number   Amount   Number   Amount   Paid - In Capital   Deficit   Deficit 
                             
BALANCE AT DECEMBER 31, 2019   21,857,218   $2,186    128,909   $254,564   $4,549,038   $(5,869,066)  $(1,063,278)
         
 
                          
Stock based compensation expense   -    -    -    -    126,059    -    126,059 
Conversion of debt to equity   1,013,334    101    -    -    119,899    -    120,000 
Stock issued for services   122,200    12    -    -    203,832    -    203,844 
Common stock issuable for services             (13,901)   (170,938)   -    -    (170,938)
Net loss   -    -    -    -    -    (307,015)   (307,015)
         
 
                          
BALANCE AT MARCH 31, 2020   22,992,752    2,299    115,008    83,626    4,998,828    (6,176,081)   (1,091,328)
         
 
                          
Stock based compensation expense   -    -    -    -    32,905    -    32,905 
Common stock issuable for services             257,133    73,582    -    -    73,582 
Net loss   -    -    -    -    -    (220,301)   (220,301)
         
 
                          
BALANCE AS AT JUNE 30, 2020   22,992,752   $2,299    372,141   $157,208   $5,031,733   $(6,396,382)  $(1,205,142)
                                    
                                    
BALANCE AT DECEMBER 31, 2018   21,007,446   $2,101    

65,050

   $81,312   $2,176,643   $(2,483,093)  $(223,037)
         
 
                          
Stock based compensation expense   -    -    -    -    48,372    -    48,372 
Stock issued for services   115,050    11    -    -    143,801    -    143,812 
Stock warrants   -    -    -    -    16,221    -    16,221 
Common stock issuable for services             

170,556

    23,202    -    -    23,202 
Net (loss) - 3 months ended March 31, 2019   -    -    -    -    -    (395,481)   (395,481)
         
 
                          
BALANCE AT MARCH 31, 2019   21,122,496    2,112    235,606    104,514    2,385,037    (2,878,574)   (386,911)
              
 
    
 
                
Exercise of stock options   210,000    21    -    -    39,464    -    39,485 
Stock issued for services   95,050    10    -    -    143,913    -    143,923 
Stock based compensation expense   -    -    -    -    13,414    -    13,414 
Common stock issuable for services             (158,334)   55,220    -    -    55,220 
Net (loss) - 3 months ended June 30, 2019   -    -    -    -    -    (539,000)   (539,000)
         
 
                          
BALANCE AS AT JUNE 30, 2019   21,427,546   $2,143    77,272   $159,734   $2,581,828   $(3,417,574)  $(673,869)

 

See accompanying notes to unaudited Condensed Financial Statements.

 

3

 

AVRA MEDICAL ROBOTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

  

For the Six Months Ended

June 30,

 
   2020   2019 
       As Adjusted 
CASH FLOWS OPERATING ACTIVITIES:        
Net loss  $(527,316)  $(934,481)
Adjustments to reconcile net loss to net          
cash used in operating activities:          
Depreciation and amortization expense   18,716    17,046 
Stock compensation expense   285,432    432,700 
Non-cash interest   
-
    6,307 
Changes in operating assets and liabilities:          
Prepaid expenses   4,000    (460)
Accounts payable and accrued expenses   147,980    333,768 
Net Cash Used in Operating Activities   (71,188)   (145,120)
           
INVESTING ACTIVITIES:          
Website costs   
-
    
-
 
Equipment acquisition   (4,000)   (75,000)
Net Cash Used in Investing Activities   (4,000)   (75,000)
           
FINANCING ACTIVITIES:          
Proceeds from exercise of stock options   
-
    21,000 
Proceeds from related party   112,500    107,500 
Proceeds from promissory notes   (65,000)   95,000 
Proceeds from SBA   4,630    
-
 
Net Cash Provided by Financing Activities   52,130    223,500 
           
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS   (23,058)   3,380 
           
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD   28,474    35,716 
           
CASH AND CASH EQUIVALENTS - END OF PERIOD  $5,416   $39,096 
           
Supplemental information of non-cash investing and financing activities:          
Non-cash investing activities:          
Cash paid for interest  $657   $1,342 
Cash paid for income taxes  $
-
   $
-
 
           
Non-cash financing activities:          
Equipment acquisition included in accounts payable  $
-
   $
-
 
Related party note payable converted to common stock  $100,000   $
-
 
Promissory note converted into common stock  $20,000   $
-
 
Reduction of account payable and equipment  $25,000   $
-
 

 

See accompanying notes to unaudited Condensed Financial Statements.

 

4

 

AVRA MEDICAL ROBOTICS, INC.

NOTES TO FINANCIAL STATEMENTS

 

NOTE 1 – COMPANY AND BASIS OF PRESENTATION

 

Organization

 

AVRA Medical Robotics, Inc. (the “Company” or “AVRA”) was incorporated as AVRA Surgical Microsystems, Inc. in the State of Florida on February 4, 2015. Effective November 5, 2015, the Company’s corporate name was changed to AVRA Medical Robotics, Inc. The Company was established to develop advanced medical surgical devices. The Company is structured to invest in four principal areas – surgical robotic systems, surgical tools, implantable devices and surgical robotic training.

 

The significant accounting policies of AVRA were described in Note 1 to the audited financial statements included in the Company’s 2019 Annual Report on Form 10-K (“2019 Form 10-K”). There have been no significant changes in the Company’s significant accounting policies for the three and six months ended June 30, 2020.

 

Basis of Presentation

 

The accompanying unaudited condensed financial statements of the Company have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the Securities and Exchange Commission.  Therefore, they do not include all information and footnotes normally included in annual consolidated financial statements and should be read in conjunction with the consolidated financial statements and notes thereto included in the 2019 Form 10-K for the year ended December 31, 2019. In the opinion of the Company’s management, the accompanying unaudited condensed financial statements contain all the adjustments necessary (consisting only of normal recurring accruals) to present the financial position of the Company as of June 30, 2020 and the results of operations and cash flows for the periods presented. The results of operations for the three and six months ended June 30, 2020 are not necessarily indicative of the operating results for the full fiscal year or any future period.

 

Going Concern

 

The accompanying financial statements have been prepared assuming the continuation of the Company as a going concern. At June 30, 2020, the Company’s stockholders’ deficit was $1,205,142 which raises substantial doubt about the Company. The Company has not yet established an ongoing source of revenues sufficient to cover its operating costs and is dependent on debt and equity financing to fund its operations. Management of the Company is making efforts to raise additional funding until a registration statement relating to an equity funding facility is in effect. While management of the Company believes that it will be successful in its capital formation and planned operating activities, there can be no assurance that the Company will be able to raise additional equity capital, or be successful in the development and commercialization of the products it develops or initiates collaboration agreements thereon. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern.

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses. The Company regularly evaluates 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 revenues and expenses during the reporting period. Actual results could differ from those estimates made by management.

 

5

 

Cash and Cash Equivalents

 

The Company considers all cash on hand, cash accounts not subject to withdrawal restrictions or penalties, and all highly liquid debt instruments purchased with a maturity of three months or less to be cash and cash equivalents.

 

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash. The Company maintains its principal cash balance in a financial institution. These balances are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. At June 30, 2020 and 2019, $0 were in excess of the FDIC insured limit.

 

Revenue Recognition

 

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606). The ASU and all subsequently issued clarifying ASUs replaced most existing revenue recognition guidance in U.S. GAAP. The ASU also required expanded disclosures relating to the nature amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The Company adopted the new standard effective January 1, 2018, the first day of the Company’s fiscal year. For these reasons, the adoption of this ASU did not have a significant impact on the Company’s financial statements

 

Effective January 1, 2018, the Company adopted guidance issued by the FASB regarding recognizing revenue from contracts with customers. The revenue recognition policies as enumerated below reflect the Company’s accounting policies effective January 1, 2018, which did not have a materially different financial statement result than what the results would have been under the previous accounting policies for revenue recognition.

 

Equipment

  

Equipment is recorded at cost and depreciated using the straight-line method at rates determined to estimate the useful lives of the assets. The annual rates used in calculating depreciation is as follows:

 

Equipment -5 years straight-line

 

Intangibles

 

Intangible assets continue to be subject to amortization, and any impairment is determined in accordance with ASC 360, “Property, Plant, and Equipment,” intangible assets are stated at historical cost and amortized over their estimated useful lives. The Company uses a straight-line method of amortization, unless a method that better reflects the pattern in which the economic benefits of the intangible asset are consumed or otherwise used up can be reliably determined

 

The Company purchased existing Intellectual Property from the University of Central Florida. Management regularly assesses the carrying value of the intellectual property to determine if there has been any diminution of value.

 

Website

 

Website is recorded at cost and amortized using the straight-line method over its estimated life of 3 years.

 

Long-lived Assets

 

In accordance with ASC 360, “Property Plant and Equipment”, the Company tests long-lived assets or asset groups for recoverability when events or changes in circumstances indicate that their carrying amount may not be recoverable. Circumstances which could trigger a review include, but are not limited to : significant decreases in the market price of the asset; significant adverse changes in the business climate or legal factors; accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of the asset; current cash flow or operating losses combined with a history of losses or a forecast of continuing losses associated with the use of the asset and current expectation that the asset will more than likely not be sold or disposed significantly before the end of its estimated useful life. Recoverability is assessed based on the carrying amount of the asset and its fair value which is generally determined based on the sum of the discounted cash flows expected to result from the use and the eventual disposal of the asset, as well as specific appraisal in certain circumstances. An impairment loss is recognized when the carrying amount is not recoverable and exceeds fair value.

 

6

 

Stock Compensation Expense

 

The Company accounts for equity instruments issued in exchange for the receipt of goods or services from other than employees in accordance with Accounting Standards Codification (“ASC”) Topic 505, “Equity.” Costs are measured at the estimated fair market value of the consideration received or the estimated fair value of the equity instruments issued, whichever is more reliably measurable. The value of equity instruments issued for consideration other than employee services is determined on the earlier of a performance commitment or completion of performance by the provider of goods or services as defined by ASC Topic 505.

 

Income Taxes

 

The Company accounts for income taxes pursuant to ASC Topic 740 “Income Taxes.” Under ASC Topic 740, deferred tax assets and liabilities are determined based on temporary differences between the bases of certain assets and liabilities for income tax and financial reporting purposes. The deferred tax assets and liabilities are classified according to the financial statement classification of the assets and liabilities generating the differences. A valuation allowance is recorded when it is more likely than not that some or all of the deferred tax assets will not be realized.

 

The Company applies the provisions of ASC Topic 740-10-05 “Accounting for Uncertainty in Income Taxes.” The ASC clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. The ASC prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The ASC provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.

 

Basic and Diluted Loss per Share

 

In accordance with ASC Topic 260 “Earnings Per Share, basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted loss per common share gives effect to dilutive convertible securities, options, warrants and other potential common stock outstanding during the period, only in periods in which such effect is dilutive. The Company has stock options, warrants, and convertible promissory notes that may be converted to outstanding potential common shares.

 

Research and Development Costs

 

In accordance with ASC Topic 730 “Research and Development”, with the exception of intellectual property that is purchased from another enterprise and have alternative future use, research and development expenses are charged to operations as incurred.

 

Fair Value of Financial Instruments

 

Our financial instruments consist principally of accounts receivable, amounts due to related parties and promissory notes payable. The carrying amounts of cash and cash equivalents and promissory notes approximate fair value because of the short-term nature of these items.

 

7

 

Recent Accounting Pronouncements

 

Compensation- Stock Compensation

 

In May 2017, the FASB issued ASU 2017-09, “Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting,” that provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The new guidance became effective for the Company on January 1, 2018 and was applied on a prospective basis, as required. The adoption of this standard did not have an impact on the financial statements or the related disclosures.

 

Leases

 

In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). The FASB issued ASU 2016-02 to increase transparency and comparability among organizations recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Under ASU 2016-02, lessors will account for leases using an approach that is substantially equivalent to existing GAAP for sales-type leases, direct financing leases and operating leases. Unlike current guidance, however, a lease with collectability uncertainties may be classified as a sales-type lease. If collectability of lease payments, plus any amount necessary to satisfy a lessee residual value guarantee, is not probable, lease payments received will be recognized as a deposit liability and the underlying assets will not be derecognized until collectability of the remaining amounts becomes probable. ASU 2016-02 is effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted, and must be adopted using a modified retrospective transition. The Company did not adopt the standard effective January 1, 2019, utilizing the lessor practical expedient. On November 15, 2019, the FASB issued ASU 2019-10 which amended the effective dates for ASC 842, to give implementation relief. Under the FASB’s new framework, two “buckets” were defined, bucket 1 includes public companies that are SEC filers but excludes “Small Reporting Companies” (SRC’s). Bucket 2 includes all other entities, including SRC’s. Bucket 2 entities have to apply ASC 842 for fiscal years beginning after December 15, 2020, and interim periods within fiscal years beginning after December 15, 2021.

 

NOTE 3 – NOTES PAYABLE – RELATED PARTY

 

On December 31, 2018, the Company borrowed $15,000 under a non-interest bearing promissory note from a related party. The note matured on December 31, 2019 and was extended to December 31, 2020.

 

On February 6, 2019, the Company borrowed from its CEO, $17,500 under a non-interest bearing promissory note which matures on February 6, 2020 and was extended to December 31, 2020.

 

On May 8, 2019, the Company borrowed from its CEO, $25,000 under a non-interest bearing promissory note which matures on May 8, 2020 and was extended to December 31, 2020.

 

On May 29, 2019, the Company borrowed from its CEO, $25,000 under a non-interest bearing promissory note which matures on May 29, 2020 and was extended to December 31, 2020.

 

On June 26, 2019, the Company borrowed from its CEO, $40,000 under a non-interest bearing promissory note which matures on June 26, 2020 and was extended to December 31, 2020.

 

On July 19, 2019, the Company borrowed from its CEO, $50,000 under a non-interest bearing promissory note which matures on July 19, 2020 and was extended to December 31, 2020.

 

On October 11, 2019, the Company borrowed from its CEO, $30,000 under a non-interest bearing promissory note which matures on March 11, 2020 and was extended to December 31, 2020.

 

8

 

On November 14, 2019, the Company borrowed from its CEO, $7,000 under a non-interest bearing promissory note which matures on November 14, 2020 and was extended to December 31, 2020.

 

On March 1, 2020, the Company entered into a promissory notes totaling $194,500 for the above notes, as an incentive to its CEO for entering into this agreement, issued option to purchase 389,000 restricted common shares of the Company at $0.25 per share. The option will be fully vested as of March 1, 2020.

 

On August 26, 2019, the Company borrowed from its CEO, $100,000 under a non-interest bearing promissory note which matures on December 26, 2019.

On December 3, 2019, the Company borrowed from its CEO, $3,000 under a non-interest bearing promissory note which matures on December 3, 2020.

 

On December 6, 2019, the Company borrowed from its CEO, $30,000 under a non-interest bearing promissory note which matures on December 6, 2020.

 

On December 30, 2019, the Company borrowed from its CEO, $25,000 under a non-interest bearing promissory note which matures on December 30, 2020.

 

On January 3, 2020, the Company borrowed from its CEO, $95,000 under a non-interest bearing promissory note which matures on January 3, 2021.

 

On January 5, 2020, the related party exercised his option and converted his note of $100,000 into 1,000,000 shares at $0.10 per share.

 

On March 31, 2020, the Company borrowed from its CEO, $6,000 under a non-interest bearing promissory note which matures on December 31, 2020.

 

On May 4, 2020, the Company borrowed from its CEO, $2,500 under a non-interest bearing promissory note which matures on December 31, 2020.

 

On June 1, 2020, the Company borrowed from its CEO, $4,000 under a non-interest bearing promissory note which matures on December 31, 2020.

 

On June 30, 2020, the Company borrowed from its CEO, $5,000 under a non-interest bearing promissory note which matures on December 31, 2020.

 

NOTE 4 – PROMISSORY NOTES

 

On December 31, 2018, the Company borrowed an additional $15,000, with interest payable annually at 4%, maturing on December 31, 2019. This note was paid in full on January 7, 2020.

 

During January 2019, the Company borrowed $20,000 under a non-interest bearing promissory note which matures on December 31, 2019, this amount was converted to 13,334 shares of common stock in 2020.

 

On March 11, 2019, the Company borrowed $25,000 under a promissory note bearing an annual interest rate of 5% and which matures on September 11, 2019. The loan includes a warrant to purchase 12,500 common shares at a strike price of $1.25 per share. The warrant expires in 3 years. This note was paid in full on January 16, 2020.

 

On March 14, 2019, the Company borrowed $25,000 under a promissory note bearing an annual interest rate of 5% and which matures on September 14, 2019 and was extended until December 31, 2020. The loan includes a warrant to purchase 12,500 common shares at a strike price of $1.25 per share. The warrant expires in 3 years.

 

On March 29, 2019, the Company borrowed $25,000 under a promissory note bearing an annual interest rate of 5% and which matures on September 29, 2019. The loan includes a warrant to purchase 12,500 common shares at a strike price of $1.25 per share. The warrant expires in 3 years. This note was paid in full on January 21, 2020.

 

During the three and six months ended June 30, 2020, 37,500 warrants were valued at $51,740 and expensed as stock compensation.

 

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NOTE 5– INCOME TAXES

 

The Company’s deferred tax assets at June 30, 2020 consist of net operating loss carry forwards of $3,443,145. Using a new federal statutory tax rate of 21%, the valuation allowance balance as of June 30, 2019 total of $723,060. The increase in the valuation allowance balance for the six months ended June 30, 2020 of $50,489 is entirely attributable to the net operating loss.

 

Due to the uncertainty of their realization, no income tax benefits have been recorded by the Company for these loss carry forwards as valuation allowances have been established for any such benefits. The increase in the valuation allowance was the result of increases in the net operating losses discussed above. Therefore, the Company’s provision for income taxes is $-0- for the six months ended June 30, 2020 and 2019.

At June 30, 2020 and December 31, 2019, the Company had no material unrecognized tax benefits and no adjustments to liabilities or operations were required. The Company does not expect that its unrecognized tax benefits will materially increase within the next twelve months. The Company recognizes interest and penalties related to uncertain tax positions in general and administrative expense. At June 30, 2020 and December 31, 2019, the Company has not recorded any provisions for accrued interest and penalties related to uncertain tax positions.

 

The Company files U.S. federal and state income tax returns in jurisdictions with varying statutes of limitations.

 

NOTE 6 – STOCKHOLDERS’ DEFICIT

 

The Company is authorized to issue up to 100,000,000 shares of common stock, $0.0001 par value per share plus 5,000,000 shares of preferred stock, par value $0.0001. On February 1, 2016 subscriptions were issued for 5,899,600 shares of common stock at $0.0001 per share (total $590). In February 2017, the Company raised an additional $135,000 from a private offering of 135,000 shares of common stock at a price of $1.00 per share made to three investors.

 

On September 30, 2017, the Company raised an additional $542,260, from a private offering of 433,808 shares of common stock at a price of $1.25 per share.

 

Effective April 1, 2017, the Company entered into Conversion Agreements with its Chairman/CEO and the Chief Financial Officer whereby each agreed to convert the amounts owing to them as of March 31, 2017 as compensation into common stock of the Company at a price of $2.00 per share. Furthermore, the Chief Financial Officer has agreed to convert any future amounts due as compensation per his Employment Agreement effective through August 1, 2017, into shares of common stock at $2.00 per share as such amounts are earned, and the Chairman/CEO has agreed to convert any future amounts in excess of $2,500 per month due as compensation through July 1, 2017, per his Employment Agreement, into shares of common stock at $2.00 per share as such amounts are earned. On April 1, 2017, 57,438 shares were issued under the agreement to convert compensation due to the Chairman/CEO and Chief Financial Officer. Both agreements were renewed upon their respective expirations. As of July 1, 2017, the Chairman/CEO agreed to convert any future amounts in excess of $2,500 per month due as compensation through December 31, 2017, per his Employment Agreement, into shares of common stock at $2.00 per share, as such amounts are earned. As of August 1, 2017, the Chief Financial Officer agreed to convert all cash payments due to the employee per his Employment Agreement, into shares of common stock using a price of $2.00 per share, as such amounts are earned.

 

On September 30, 2017, the Chairman/CEO and the Chief Financial Officer converted $117,000 of compensation owed into 58,500 common shares.

 

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In addition, on September 30, 2017, the promissory notes of $480,000 were converted into 960,000 shares of common stock (see Note 5). The interest due on the promissory note was exchanged for Warrants to purchase 144,000 common shares at $1.25. The Warrants expire on the third-year anniversary.

 

On February 23, 2018, the board of directors of AVRA authorized the issuance of an aggregate of 218,000 shares of AVRA’s common stock (the “Shares”) as follows:

 

150,000 Shares at a value of $1.25 per Share, to six consultants and service providers for services rendered through December 31, 2017;

 

35,000 Shares, at a value of $1.25 per Share, to Farhan Taghizadeh, M.D., AVRA’s Chief Medical Officer, for services rendered during the period September 1, 2017 to December 31, 2017; and

 

19,500 and 13,500 Shares, at a value of $2.00 per Share, to Barry F. Cohen and A. Christian Schauer, our Chief Executive Officer and its former Chief Financial Officer, respectively, pursuant to Conversion Agreements with each of such officers, under which they converted all December 31, 2017 accrued but unpaid compensation due them under their respective employment agreements with the Company into the Shares.

 

On August 13, 2018 the Company sold 16,000 shares of its common stock for $20,000.

 

On October 4, 2018, the Board of Directors adopted the following resolutions and took the following actions by unanimous written consent in lieu of a meeting in accordance with the applicable provisions of the Florida business Corporation Act:

 

128,300 shares of restricted common stock required to be issued, to six consultants and service providers for services rendered through September 30, 2018; and

 

400 shares of restricted common stock required to be issued, for services rendered through February 28, 2018;

 

On January 4, 2019, 115,050 Shares at a value of $1.25 per share were issued for services rendered.

 

On April 1, 2019, 95,050 shares at a value ranging from $1.25-$2.41 per share were issued for services rendered.

 

On July 1, 2019, 79,672 shares at a value ranging from $1.25-$2.76 per share were issued for services rendered.

 

On August 28, 2019, 600,000 shares at a value ranging from $1.25-$2.00 per share were issued for services rendered.

 

On December 1, 2019, the Company canceled 250,000 restricted shares of the Company’s common stock that were previously issued to the Chief Executive Officer under the Stock Award letter dated August 28, 2019.

 

During the first quarter of 2020, 122,200 shares at a value ranging from $.42-$2.79 per share were issued for services rendered.

 

Holders are entitled to one vote for each share of common stock. No preferred stock has been issued.

 

NOTE 7 – 2016 INCENTIVE STOCK PLAN

 

On August 1, 2016, the Company adopted the 2016 Incentive Stock Plan (the “Plan”). The Plan provides for the granting of options to employees, directors, consultants and advisors to purchase up to 3,000,000 shares of the Company’s common stock. The Board is responsible for administration of the Plan. The Board determines the term of each option, the option exercise price, the number of shares for which each option is granted and the rate at which each option is exercisable. Incentive stock options may be granted to any officer or employee at an exercise price per share of not less than the fair market value per common share on the date of the grant. On August 1, 2019, the Board increased the plan to 10,000,000 shares of common stock.

 

For options granted October 1, 2017, the following factors were used: volatility 45.07%; expected term of 3 years, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $1.25 per share.

 

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For options granted July 1, 2018, the following factors were used: volatility 31.34%; expected term of 3 years, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $1.25 per share.

 

For options granted May 1, 2018, the following factors were used: volatility 62.16%; expected term of 3 years, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $1.25 per share.

 

On July 1, 2018 options for 75,000 shares were issued to our Counsel for services rendered totaling $21,000. These shares are vested immediately and expire on July 1, 2023. The exercise price is $1.25.

 

For the year ended December 31, 2019 and 2018, 210,000 and -0- options were exercised, respectively. Non-vested Options for 97,639 shares were forfeited during March 2018.

 

On December 1, 2019, the Company granted to its majority shareholder options to purchase 750,000 common shares of the Company at an exercise price per share will be $1.00. All shares will immediately vest, and the Option will expire five years from the date of issuance.

 

At December 31, 2019 and 2018 options representing 3,486,667 shares and 2,243,250 shares were vested or exercisable, respectively.

 

All options issued to-date expire after five years from the issue date. Except for the option for 1,750,000 shares issued to the CEO and to the Company’s counsel for 40,000 shares that vested immediately, all the options issued to date vest over three years.

 

Stock options are accounted for in accordance with FASB ASC Topic 718, Compensation –Stock Compensation, with option expense amortized over the vesting period based on the Black-Scholes option-pricing model fair value on the grant date, which includes a number of estimates that affect the amount of expense. During the three months ended June 30, 2020 and 2019, $106,487 and $48,372, respectively, for stock based compensation. During the six months ended June 30, 2020 and 2019, $158,964 and $61,786, respectively, of expensed stock options has been recorded as stock-based compensation and classified in general and administrative expense on the Statement of Operations. The total amount of unrecognized compensation cost related to non-vested options was $268,728 as of June 30, 2020. This amount will be recognized over a period of 36 months expiring June 30, 2023.

 

The grant date fair value of options granted during the year of 2018 and 2019 were estimated on the grant date using the Black-Scholes model with the following assumptions: For options granted May 1, 2018, the following factors were used; volatility 62.16%; expected term of 3 years, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $1.25 per share. For options granted July 1, 2018, the following factors were used; volatility 31.34%; expected term of 3 years, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $1.25 per share.

 

For options granted February 1, 2019: Volatility 50.58%, term 3yrs, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $2.00 per share.

 

For options granted April 1, 2019: Volatility 48.52%, term 3yrs, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $1.25 per share.

 

For options granted August 1, 2019: Volatility 62.43%, term 3yrs, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $2.00 per share.

 

For options granted October 1, 2019: Volatility 48.57%, term 3yrs, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $2.00 per share.

 

For options granted December 1, 2019: Volatility 61.91%, term 3yrs, risk-free interest rate of 2.00%, dividend yield of 0% and exercise price of $1.00 per share.

 

The grant date fair value of options granted during the year of 2020 were estimated on the grant date using the Black-Scholes model with the following assumptions: For the options granted March 1, 2020 the fair market value is $0.45, exercise $0.25, rate 2%, and volatility 39.73%.

 

Option values are calculated using Black Scholes with the following inputs: expected volatilities are based on the average volatilities of six similar companies; fair market values are calculated using the implied share values of recent company financings or OTC closing prices for that day, whichever is more suitable; risk-free rate used was 2%.

 

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NOTE 8 – COMMITMENTS

 

Intellectual property

 

Effective May 1, 2016, the Company entered into a Research Agreement (the “Research Agreement”) with the University of Central Florida (“UCF” or the “University”) for the development of a prototype surgical robotic device supporting minimal invasive surgical facial corrections.

 

The Agreement provides that the University will provide personnel to accomplish the objectives as stated in the Statement of Work over a period extending to September 30, 2017. Effective May 1, 2016, the research agreement with the University of Central Florida has been extended to April 30, 2021. No additional payments to the University were required.

 

The Company agreed to extend funding of $163,307 from AVRA’s existing funds.

 

In addition, AVRA has paid $43,548 for outright ownership of the University’s Intellectual Property resulting from the collaboration, which amount is shown as Intellectual Property. Management has assessed the carrying value of the asset at December 31, 2019 and has recorded an impairment loss in the amount of $43,548.

 

For the three and six months ended, June 30, 2020 and 2019, $-0- had been paid under the Agreement. The balance of the amount owing to the University was fully paid on February 24, 2017 and April 7, 2017. Additionally, a $68,952 matching funds grant from the Florida High Tech Corridor Council (FHTCC) was approved on July 16, 2016 which will provide the University research funds in addition to the Company’s funding obligation to the University. The FHTCC research grant is subject to certain research obligations and action requirements which if not met may result in the loss of the FHTCC research funding. The agreement further provides for the payment of a 1% royalty to the University in any year when the sales of products using the intellectual property exceeds $20,000,000.

 

Employment Agreements

 

On July 1, 2016, the Company entered into an Employment Agreement with its Chairman and Chief Executive Officer. The agreement provides for an annual salary of $120,000 per year, increasing to $180,000 per year beginning July 2017. Through December 2016, the employee agreed to not receive the compensation in cash until the Board of Directors deemed it prudent to pay some or all of his salary. Further the Agreement provides that the employee will receive a three-year option to purchase 1,000,000 shares of the Company’s common stock at an exercise price of $0.10 per share, and becoming fully vested on August 15, 2016.

 

On August 1, 2016, the Company entered into a one-year Employment Agreement with its Chief Financial Officer. The agreement provides for an annual salary of $108,000 per year. Through December 2016, the employee agreed to not receive the compensation in cash until the Board of Directors deemed it prudent to pay some or all of his salary. Further the Agreement provides that the employee will receive a three-year option to purchase 210,000 shares of the Company’s common stock at an exercise price of $0.10 per share, with 70,000 shares becoming fully vested upon each yearly anniversary. The options are to be surrendered and cancelled if the Agreement is terminated. The Agreement has expired but its compensation terms continue in effect as long as the employee remains employed by the Company.

 

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On August 1, 2016, the Company entered into a three-year Employment Agreement with its Vice President of Global Business Development. The agreement provides for an annual salary of $96,000 per year, increasing to $144,000 per year beginning July 2017. Through December 2016, the employee agreed to not receive the compensation in cash until the Board of Directors deemed it prudent to pay some or all of his salary. Further the Agreement provides that the employee will receive a three-year option to purchase 300,000 shares of the Company’s common stock at an exercise price of $0.10 per share, with 100,000 shares vested on each yearly anniversary.

 

Further, on July 1, 2016, the Company entered into Indemnification Agreements with the Chairman and Chief Executive Officer, and on August 1, 2016 the Chief Financial Officer and the Vice-President of Global Business Development providing for the Company to indemnify the individuals for all expenses, judgments, etc. incurred while serving in various capacities with the Company.

 

Commencing March 1, 2018, the Company entered into an employment agreement with its new Chief Strategy Officer whereby compensation will be determined upon sufficient funding of the Company. The Company granted a 300,000 share stock award under its 2016 Incentive Stock Plan, which vests in five equal annual installments of 60,000 shares each.

 

In addition, on May 1, 2018 options for 250,000 shares that vest monthly over 3 years were also issued to our Chief Strategy Officer. These options expire on May 1, 2023 and are exercisable at $1.25.

 

Commencing January 1, 2019, the Company entered into a consulting agreement with an IR/PR Company whereby compensation will be $1,500 per month for six months. During third quarter 2019, these services stopped. On July 1, 2019, the Company issued 36,000 restricted common shares as part of the compensation.

 

Lease

 

The Company occupies office and laboratory space in Orlando, Florida under a lease agreement that expired on July 31, 2018. Effective August 1, 2018 and expiring July 31, 2019, the Company signed a new agreement, with monthly payments of $1,829.25 plus applicable sales tax. Effective August 1, 2019, the Company signed a year lease agreement, provides that the Company pay insurance, maintenance and taxes with a monthly lease expense of $2,454.75 plus applicable sales tax. Effective January 15, 2020, the Company amended its August 1, 2019 lease agreement reducing its monthly lease payment to $2,223 plus applicable sales tax. On April 30, 2020, the rent due under our lease agreement had been reduced by 50% for the months of April and May, 2020. Either party may cancel the agreement at any time with 30 days’ notice (see Note 15).

 

NOTE 9 – OTHER MATTERS

 

On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally.

 

The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations. Management is actively monitoring the global situation on its financial condition, liquidity, operations, suppliers, industry, and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition, or liquidity for fiscal year 2020.

 

On March 27, 2020, President Trump signed into law the “Coronavirus Aid, Relief, and Economic Security (CARES) Act.” The CARES act was enacted as a response to the COVID-19 outbreak discussed above and is meant to provide companies with economic relief.  The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions, and technical corrections to tax depreciation methods for qualified improvement property.  

 

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NOTE 10 – SUBSEQUENT EVENTS

 

The Company has evaluated subsequent events through the date that the financial statements were issued and determined that there were subsequent events requiring adjustments to or disclosure in the financial statements.

 

Effective January 1, 2021, the Company signed an amendment which modified the August 1, 2020 agreement, increasing the monthly lease expense to $1,964.74 plus applicable sales tax.

 

On October 26, 2020, AVRA issued an aggregate 256,027 Units (“Units”) at a price of $1.00 per Unit in a private offering (the “Offering”) to four “accredited investors.” Each Unit consisted of (a) four shares of our common stock (“Shares”); (b) a three-year warrant to purchase five Shares at an exercise price of $0.40 per Share; and (c) a put option of their Membership Units in Avra Air LLC for one share of our common stock. As a result of the foregoing, the investors were issued an aggregate of 1,024,108 Shares, warrants to purchase 1,280,135 Shares and put options for 256,027 Shares. One of the accredited investors, per his original commitment, subsequently invested an additional $45,000 on May 3, 2021 in this same Unit funding thus receiving an additional 180,000 Shares, a warrant to purchase 225,000 Shares and a put option for 45,000 Shares.

 

On August 21, 2020 and October 19, 2020 the Company borrowed from its CEO, $17,700 and $11,500, respectively, under non-interest bearing promissory notes which mature on December 31, 2020 and on December 31, 2021, respectively. These were subsequently converted into shares via the purchase of Units in the following December 22, 2020 funding.

 

On December 22, 2020 one accredited investor and the CEO invested $25,000 and $202,700, respectively, into 227,700 Units at a price of $1.00 per Unit in a private offering (the “Offering”). Each Unit consisted of (a) four shares of our common stock; and (b) a three-year warrant to purchase five Shares at an exercise price of $0.40 per share. As a result of the foregoing, they were issued an aggregate of 910,800 Shares, and warrants to purchase 1,138,500 shares. The CEO used a total of $202,700 of Notes due to him from the Company to purchase these Units.

 

On January 26, 2021, AVRA issued an aggregate 235,000 Units (“Units”) at a price of $1.00 per Unit in a private offering (the “Offering”) to four “accredited investors.” Each Unit consisted of (a) four shares of our common stock (“Shares”); and (b) a three-year warrant to purchase five Shares at an exercise price of $0.40 per Share. As a result of the foregoing, the investors were issued an aggregate of 940,000 Shares, and warrants to purchase 1,175,000 Shares.

 

On June 3, 2021, the Board of Directors ratified the following issuances of common stock:

 

1.The Company issued 33,000 shares of restricted common stock required to be issued for services through June 1, 2021 to Farhan Taghizadeh, per his employment agreement dated September 15, 2020.

 

2.The Company issued 10,000 shares of restricted common stock required to be issued to Ettore Tomassetti per his Stock Award dated April 15, 2019.

 

3.The Company issued 160,000 shares of restricted common stock required to be issued to Nikhil Shah per his Stock Grant Award dated April 15, 2019 and his Employment Agreement dated March 1, 2018.

 

4.The Company issued 5,600 shares of restricted common stock required to be issued for services through June 1, 2021 to Maria Carin Bruck, per her services agreement dated October 1, 2018.

 

5.The Company issued 3.889 shares of restricted common stock required to be issued for services through June 1, 2021 to Robert Santangelo, per his services agreement dated February 15, 2019.

 

6.The Company issued 19,445 shares of restricted common stock required to be issued for services through June 1, 2021 to Vipul Patel, per his services agreement dated September 1, 2019.

 

7.The Company issued 7,000 shares of restricted common stock required to be issued for services through June 1, 2021 to Henry Gewanter, per his services agreement dated February 10, 2020.

 

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8.The Company issued 19,444 shares of restricted common stock required to be issued to Jared Stammel per his Stock Award dated September 1, 2020.

9.The Company issued 25,000 shares of restricted common stock required to be issued to Robert Chanson, per his services agreement dated February 20, 2021.

 

10.On October 26, 2020, the Company received a commitment to sell 135,000 units for $135,000. A $25,000 promissory note plus accrued interest of $1,027 was converted towards the commitment for 26,027 units. On May 3, 2021, the Company received $45,000 towards his commitment and the remaining balance is $63,973. The balance is due on or before October 21, 2021. (this later expired without any further payments being made) (this was also covered in paragraph above with regards to the 256,027 Units funding)

 

In July, 2021 several holders of stock options elected to exercise their stock options with a cashless exercise provision resulting in the issuance of 629,375 shares of common stock.

 

On September 22, 2021, the Company’s CEO, converted a total of $50,000 of notes payable into 384,615 shares of common stock and converted $50,000 of accrued salary into 384,615 shares of common stock.

 

On October 1, 2021, the Company’s CEO, converted a total of $595,000 of accrued salary into 5,950,000 shares of common stock at a price of $0.10 per share and agreed to receive 450,000 shares of common stock for $45,000 of the remaining salary due for the three months ending December 31, 2021at a price of $0.10 per share.

 

On October 1, 2021, a former employee now a consultant elected to convert a total of $251,500 of accrued consulting fees into 2,515,000 shares of common stock at a price of $0.10 per share, converted $161,500 of accrued salary into 1,615,000 shares of common stock at a price of $0.10 per share. and $4,500 of expenses into 45,000 shares of common stock at a price of $0.10 per share.

 

Between October 5, 2021 and December 8, 2021 the Company sold a total of 2,229,231 shares of common stock at prices ranging between $0.13 and $0.52 per share. The Company received proceeds of $315,200.

 

On October 1, 2021 the Company issued a total of 1,500,000 of stock options to consultants with an exercise price of $0.25 per option.

 

On October 1, 2021 the Company issued 50,000 of stock options to each of its independent Directors with an exercise price of $0.25 per option.

 

On October 1, 2021 the Company issued 350,000 of stock options to its Chief Medical Officer with an exercise price of $0.25 per option.

 

On October 1, 2021 the Company issued a total of 390,000 of stock options to Company’s CEO with an exercise price of $0.25 per option for the extension of loans.

 

On October 1, 2021 the Company issued a total of 174,553 shares of common stock to several consultants.

 

On October 1, 2021 the Company issued 25,000 shares of common stock to its Chief Medical Officer.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

When used in this report, unless otherwise indicated, the terms “Avra,” “the Company,” “we,” “us” and “our” refer to Avra Medical Robotics, Inc.

 

Note Regarding Forward Looking Statements

 

This report contains forward-looking statements that reflect our current views about future events. We use the words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal” or the negatives of such terms or other similar expressions. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

 

Overview

 

We are a medical robotics company developing a fully autonomous medical robotic system using proprietary software which integrates Artificial Intelligence (“AI”) and Deep Learning, or machine learning, (“DL”). By using an AI and DL enhanced software program, we are creating an intelligent robotic system that we believe can “robotize” a wide range of medical procedures currently being performed by human hands. We are concentrating our research and development efforts to meet rising expectations of patients and practitioners alike for the precision, safety and speed offered by an AI enhanced robotics platform system that can be combined with proven medical devices, end-effectors and surgical instruments.

 

We believe that progress in mechanical and software engineering has made possible lightweight and relatively inexpensive robotic devices for difficult procedures in various medical fields. Medical robots are already being successfully employed in several areas of surgery, including Urology (Prostate), Colo-Rectal, Gynecology, Thoracic, General Surgery, Orthopedics, and Neuro and Spine Surgery. Robots are also being used for Telemedicine and assistive robotic methods are addressing the delivery of healthcare in inaccessible locations, ranging from rural areas lacking specialist expertise to post-disaster scenarios, and battlefield areas. With the aging population dominating demographics in the U.S. across all spectrums of healthcare, robotic technologies are being developed toward promoting improved function, lower morbidity and improved overall outcomes.

 

We are developing a treatment-independent autonomous robotics system utilizing our proprietary AI-driven precision guidance system, applicable to a variety of minimally and non-invasive procedures, with an initial focus on skin resurfacing aesthetic procedures utilizing several FDA approved skin enhancing techniques robotized for superior performance and optimal results. Our medical robotic system is being developed to deliver skin resurfacing treatments, such as micro-needling and laser therapies with improved efficiency, accuracy and precision over current procedures conducted by human hand, and only requiring the doctor to input or just confirm treatment parameters. As a result, use of our medical robotic system is expected to provide improved quality and safety as well as improve patient throughput and workflow.

 

Our autonomous medical robotics system is being developed to be compatible with available FDA approved surgical tools and end-effectors, enabling us to initially penetrate a sizable and fast-growing aesthetics market, which includes micro-needling and laser solutions. Our robotics system will allow doctors, and anyone permitted to treat patients, defined at the State level, such as a licensed aesthetician, to treat damaged skin autonomously by delivering, for example, micro-needling to the skin. The micro-needling catalyzes the natural process of collagen remodeling, consisting of formation of new collagen, elastin, and vascularization in the papillary dermis, similar to the effect of laser treatments.

 

We expect our robotic system to eliminate many of the common errors that occur during handheld procedures, such as over- or under- exposure of the needles or energy-based instruments that can have terrible cosmetic results and even injure the patient. In addition, our system is being designed to continuously adjust treatment parameters, such as penetration depth, time, and energy in order to individualize the outcome based on our algorithms.

 

Our robotic system has been designed and developed through a seamless collaboration of the surgeon, the engineer and the scientist. Since the medical robotic industry has progressed greatly in miniaturization, adaptability and lower costs, we believe that the Avra “brains” technology component can lead to dramatic opportunities in all of medicine.

 

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The advantages of robotizing already FDA approved aesthetic devices are many. In contrast to a human using a handheld device, our aesthetics robotic system has the potential to perform each and every procedure with unsurpassed precision without constraint of age, proficiency, experience or fatigue. Likewise, in many skin related treatments the amount of energy delivered, distance and/or depth of the instrument to, or into, the skin, and treating only the affected area are critical to the outcome. The robotic system can maintain these parameters with unparalleled accuracy. The system can also replicate the same procedure time and again precisely. Delivery of certain aesthetic treatments by robotic systems is believed to be the most efficient option, requiring fewer visits per patient while increasing patient throughput — a benefit for patients and practitioners alike.

 

Advantages of using our medical robotic approach to procedures include:

 

  Reduced cost per treatment.

 

  Better treatment accuracy.

 

  Better treatment outcomes.

 

  Increased patient throughput and revenue generation for the physician.

 

  Easier multi-platform integration.

 

  Addresses shortfall of physicians/surgeons.

 

  Easier future integration of medical and technological advancements such as molecular biologics.

 

We believe that our initial medical robotic system for the aesthetics market should find rapid acceptance based on the aforementioned advantages of using the attribute of robotics versus traditional manual applications. Furthermore, there is general acceptance by consumers for fee-for-service cash payments in the facial aesthetics market thereby avoiding medical insurance reimbursement issues.

 

Our medical robotic system utilizes a robotic arm that has 7-degrees of freedom integrated with our proprietary AI-driven control software and algorithms. The robotic arm was designed and built under the required medical device standards of the U.S. Food and Drug Administration (the “FDA”). Our strategy is to integrate the robotic arm with FDA approved devices, which is expected to allow for a more expedited approval of the integrated system. We believe that the FDA approval process will primarily focus upon validation of the medical robotic system’s software control. This could lead to a less onerous, more de-risked regulatory path to approval, particularly if strong preclinical results are achieved. Subsequent to the completion of the FDA preclinical work, estimated to take six months, we believe that we will be able to additionally modify and robotize certain non-invasive instruments that do not require FDA approvals and proceed to the cosmetic treatments marketplace. This action could sharply reduce the time to commercial operations and revenues.

 

We previously retained the services of The Horizon Phoenix Group (“HPG”), a consulting firm experienced in securing U.S. and foreign regulatory approvals for medical devices, in order to initiate the regulatory process. Working with HPG, we prepared and filed an application with the FDA for our initial medical robotic system and in August 2019 held an initial pre-collaboration meeting with the FDA. We believe that this is the first of a series of meetings where the Avra system and its regulatory requirements will be discussed in ever-increasing specificity. This should allow for a more focused regulatory process, saving both resources and time. The robotic arm that we intend to utilize for our system has already been granted approval in the EU and received a CE mark. We have begun implementing a quality and regulatory system that will serve as the foundation for U.S., Canadian, European, Australian, Japanese, and Brazilian market access for our medical robotic system. The Medical Device Single Audit Program(“MDSAP”), which we plan to employ, is a single inspection that, when completed, is expected to support market access to these six most important medical device marketplaces.

 

Since 2016, we had a research partnership with the University of Central Florida (“UCF”) to develop a prototype intelligent medical robotic system. UCF is recognized particularly for its work in the area of medical robotic research and design, with a focus on the guidance systems. Avra has paid UCF a one-time fee for outright ownership of work developed by UCF in the collaboration. The Research Agreement was extended several times and expired on April 30, 2021. To further the depth of our research and development we also began a partnership in 2021 with Florida Polytechnic University and are actively working with them on developing our system. Avra recently brought in two Associate Professors and a graduate to join Avra’s engineering development team. Effective October 11th, 2021 Avra executed a Sponsored Student Project Agreement which included two payments of $8,030 each covering Fall semester in 2021 and Spring semester in 2022.

 

18

 

On September 10, 2019, we entered into a collaborative research and development agreement with Infinite Mind, LLC, now known as Avra Air, LLC (“Avra Air”). Avra Air is in the business of developing computerized systems for robot operation and automation employing software and AI for applications in various industries and has more recently expanded to the development of air sanitizing devices to help address such pathogens as COVID-19. Our CEO is also an owner of Avra Air. Avra Air, with the use of Avra’s facilities and cooperation of Avra personnel, will seek to develop software and AI systems for robots that are relevant to the field of medical treatment or diagnostics. As part of the collaboration, Avra Air has granted Avra an exclusive, worldwide, full paid-up, perpetual, royalty-free license to commercialize any technology (including any patents) developed by Avra Air individually or jointly with Avra during the term of the agreement as well as existing technology of AVRA AIR in the field of medical robotics. This license survives termination of the agreement.

 

On November 6, 2020, AVRA made an investment of $210,000 in Avra Air which was made with $40,000 in cash and the balance by the issuance to Avra Air of 472,222 restricted shares of our common stock valued at $0.36 per share. In exchange for the investment. Avra received (a) a 49.8% limited liability company membership interest in Avra Air; and (b) the remaining 50% of a vehicular air sterilization provisional patent that Avra did not yet control. In addition, Avra also agreed to pay Avra Air a royalty payment of $1.50 per vehicular air sterilization kit for two years from the date that a first kit that uses the patent is sold. On December 22, 2020, the Company issued 472,222 shares of its common stock towards the acquisition of its interest in Avra Air. Avra Air has recently built a prototype portable air de-contaminant system which it plans to market soon.

 

Our senior leadership team and advisory boards have broad and deep experience in clinical practice, medical research, innovation and development in the medical robotics field. We believe that our team, which has been active in the medical robotics field for many years, brings the necessary skills and experience to develop and commercialize intelligent medical robotic systems, as well as in marketing, supply chain management, and the implementation of all other aspects of our planned business operations.

 

We believe we can rapidly develop and commercialize its initial medical robotic system in the aesthetic skin resurfacing market because of the following advantages and progress made to date, including:

 

  Our team is experienced in medical robotic engineering.

 

  We are working in conjunction with preeminent physicians, engineers and scientific institutions.

 

  We have substantially completed the design phase and are ready to complete a final, integrated prototype for the regulatory approval process which has been initiated.

 

  Our robotic arm was built under the required medical device standards of the FDA and has already received a CE Mark in Europe.

 

  Our strategy is to integrate the robotic arm with FDA approved devices for skin resurfacing, which we anticipate will allow for a more expedited regulatory approval, with the FDA approval process primarily focused upon validation of the medical robotic system’s software control. We held a pre-collaboration meeting with the FDA in August 2019, which should allow us to better focus on only the meaningful required activities, saving both resources and time.

 

  We have begun implementing a quality and regulatory system that will serve as the foundation for U.S., Canadian, European, Australian, Japanese, and Brazilian market access for AVRA’s medical robotic system. MDSAP, which we plan to employ, is a single inspection that, when completed, is expected to support market access to the six most important medical device marketplaces.

 

  We believe that our treatment-independent medical robotics platform system will be compatible with currently and yet to be approved end-effectors and/or surgical tools enabling rapid entry into the skin resurfacing and other markets with new and improved devices.

 

19

 

Results of Operations

 

Introduction

 

The financial statements appearing elsewhere in this report have been prepared assuming the Company will continue as a going concern. The Company was recently formed and has not established sufficient operations or revenues to sustain the Company. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

 

The following table provides selected balance sheet data for our Company at June 30, 2020 (unaudited) and December 31, 2019:

 

Balance Sheet Data:  As of   As of 
   June 30,   December 31, 
   2020   2019 
         
Cash  $5,416   $28,474 
Total Assets  $65,750   $132,524 
Total Liabilities  $1,270,892   $1,195,782 
Total Stockholders’ Deficit  $(1,205,142)  $(1,063,258)

  

To date, the Company has relied on debt and equity raised in private offerings and shareholder loans to finance operations and no other sources of capital has been identified. If we experience a shortfall in operating capital, we could be faced with having to limit our research and development activities.

 

Three months ended June 30, 2020, as compared to three months ended June 30, 2019

 

Revenues. We had no revenues during either the three months ended June 30, 2020 or the three months ended June 30, 2019.

 

Research and Development Expenses. Research and development expenses during the three months ended June 30, 2020 were $-0-, as compared to $27,812 for the three months ended June 30, 2019. Research and development expenses reflect continuing development work on the Company’s prototype robotic system at its facilities at UCF’s incubator in Orlando, Florida.

 

General and Administrative Expenses. We incurred $219,988 and $504,696 in general and administrative expenses during the three months ended June 30, 2020 and June 30, 2019, respectively. General and administrative expenses include compensation for the management staff, legal and other professional expenses related to the Company’s filings as a public company with the Securities and Exchange Commission (the “SEC”) and stock-based compensation expense related to the Company’s 2016 Stock Incentive Plan.

 

Other Income/Expenses. We had $313 of other expenses during the three months ended June 30, 2020 consisting of interest expense related to loans. This is compared to other expenses of $6,492 for the three months ended June 30, 2019, consisting of $6,493 in interest expense offset by $1 in interest earned.

 

Net Loss. We incurred a net loss of $220,301 for the three months ended June 30, 2020, as compared to a net loss of $539,000 for the three months ended June 30, 2019. The decrease in net loss from the 2019 quarter to the 2020 quarter is in large part due to decreases in stock-based compensation expense.

 

Six months ended June 30, 2020, as compared to six months ended June 30, 2019

 

Revenues. We had no revenues during either the six months ended June 30, 2020 or the six months ended June 30, 2019.

 

Research and Development Expenses. Research and development expenses during the six months ended June 30, 2020 were $2,000, as compared to $51,874 for the six months ended June 30, 2019. Research and development expenses reflect continuing development work on the Company’s prototype robotic system at its facilities at UCF’s incubator in Orlando, Florida.

 

20

 

General and Administrative Expenses. We incurred $524,659 and $874,963 in general and administrative expenses during the six months ended June 30, 2020 and June 30, 2019, respectively. General and administrative expenses include compensation for the management staff, legal and other professional expenses related to the Company’s filings as a public company with the Securities and Exchange Commission (the “SEC”) and stock-based compensation expense related to the Company’s 2016 Stock Incentive Plan.

 

Other Income/Expenses. We had $657 of other expenses during the six months ended June 30, 2020 consisting of interest expense related to loans. This is compared to other expenses of $7,644 for the six months ended June 30, 2019, consisting of $7,649 in interest expense offset by $5 in interest earned.

 

Net Loss. We incurred a net loss of $527,316 for the six months ended June 30, 2020, as compared to a net loss of $934,481 for the six months ended June 30, 2019. The decrease in net loss from the 2019 period to the 2020 period is in large part due to decreases in stock-based compensation expense.

 

Liquidity and Capital Resources

 

The Company expects to require substantial funds for research and development, to continue to develop, secure marketing approval for and ultimately manufacture and market its initial medical robotic system. Until the Company is able to generate revenues from the sale of its initial medical robotic system, it expects to meet its operating cash flow requirements from the net proceeds of this Offering and if necessary, from future public or private sales of its securities and, if possible, on favorable terms, by entering into development partnerships to assist the Company with its technology development activities.

 

During the period from inception (February 4, 2015) through June 30, 2020, the Company raised (a) $1,900 from an initial private offering of its common stock in February 2017; (b) $480,000 from the private offering of the convertible notes completed in June 2017; (c) $135,000 from a private offering of 135,000 shares of common stock at a price of $1.00 per share completed in February 2017; (d) $542,260 from a private offering of 433,808 shares of stock in a private offering at a price of $1.25 per share completed in September 2017; and (e) $20,000 from the private sale of 16,000 shares of our common stock at a price of $1.25 per share in August 2018.

 

In March 2019, the Company sold 7.5 Units in a private offering of ten (10) units (“Units”), each Unit consisting of a $10,000 principal amount six-month promissory note bearing interest at the rate of 5% per annum and a three-year warrant to purchase 5,000 shares of common stock at an exercise price of $1.25 per share.

 

In addition to the foregoing, from December 2018 thru June 2020, the Company obtained fourteen loans from Barry F. Cohen, our Chief Executive Officer totaling $468,500. The loans were due 12 months from funding date and did not bear interest. With the exception of two loans totaling $145,000, all of these loans were subsequently repaid in full via conversions into restricted company shares or Units including one loan for $100,000 which was used to exercise a stock option for 1,000,000 shares held by Mr. Cohen.

 

While we have been successful in raising funds to fund our operations since inception and we believe that we will be successful in obtaining the necessary financing to fund our operations going forward, we do not have any committed sources of funding and there are no assurances that we will be able to secure additional funding. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern; however, if the efforts noted above are not successful, it would raise substantial doubt about the Company’s ability to continue as a going concern. If we cannot obtain financing, then we may be forced to further curtail our operations or consider other strategic alternatives. Even if we are successful in raising the additional financing, there is no assurance regarding the terms of any additional investment and any such investment or other strategic alternative would likely substantially dilute our current shareholders.

 

Critical Accounting Policies

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ from those estimates.  Significant estimates included deferred revenue, costs incurred related to deferred revenue, the useful lives of property and equipment and the useful lives of intangible assets.

 

21

 

Income Taxes

 

The Company accounts for income taxes in accordance with ASC 740, Accounting for Income Taxes, as clarified by ASC 740-10, Accounting for Uncertainty in Income Taxes.  Under this method, deferred income taxes are determined based on the estimated future tax effects of differences between the financial statement and tax basis of assets and liabilities given the provisions of enacted tax laws.  Deferred income tax provisions and benefits are based on changes to the assets or liabilities from year to year.  In providing for deferred taxes, the Company considers tax regulations of the jurisdictions in which the Company operates, estimates of future taxable income, and available tax planning strategies.  If tax regulations, operating results or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required.  Valuation allowances are recorded related to deferred tax assets based on the “more likely than not” criteria of ASC 740.

  

ASC 740-10 requires that the Company recognize 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.

 

Off-Balance Sheet Arrangements

 

There are no 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 is material to investors.

 

Item 3. Quantitative Disclosures About Market Risks.

 

As a “smaller reporting company,” we are not required to provide the information required by this Item.

 

Item 4. Controls and Procedures.

 

Our Chief Executive Officer and Acting Chief Financial Officer, as our principal executive, financial and accounting Officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of June 30, 2020, to ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC, including to ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Acting Chief Financial Officer, as our principal executive, financial and accounting officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based on that evaluation, our Chief Executive Officer and Acting Chief Financial Officer, as our principal executive, financial and accounting officer, has concluded that as of June 30, 2020, our disclosure controls and procedures were not effective at the reasonable assurance level due to the material weaknesses identified and described in Item 9A(b) of our Annual Report on Form 10-K for the year ended December 31, 2019.

 

Our Chief Executive Officer and Acting Chief Financial Officer, as our principal executive, financial and accounting officer, does not expect that our disclosure controls or internal controls will prevent all error and all fraud. Although our disclosure controls and procedures were designed to provide reasonable assurance of achieving their objectives and our principal executive officer has determined that our disclosure controls and procedures are effective at doing so, a control system, no matter how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of the system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented if there exists in an individual a desire to do so. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

Changes in Internal Controls Over Financial Reporting

 

There were no changes in our internal controls over financial reporting that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

22

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

Not Applicable.

 

Item 1A. Risk Factors.

 

As a “smaller reporting company,” we are not required to provide the information required by this Item.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5. Other Information.

 

None.

 

23

 

Item 6. Exhibits.

 

Exhibit No.   Description of Exhibit
     
31.1   Section 302 Certification
     
32.1   Section 906 Certification
     
101.INS   Inline XBRL Instance Document
     
101.SCH   Inline XBRL Taxonomy Extension Schema Document
     
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document
     
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document
     
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document
     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

24

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  AVRA MEDICAL ROBOTICS, INC.
     
Dated: July 18, 2022 By: /s/ Barry F. Cohen
    Barry F. Cohen, Chief Executive Officer and
Acting Chief Financial Officer
    (Principal Executive, Financial and
Accounting Officer)

 

 

25

 

 

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