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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, 2022

 

or

 

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

 

For the Transition Period from _________ to _________

 

Commission file number: 001-37603

 

BIORESTORATIVE THERAPIES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   91-1835664
(State or other Jurisdiction of Incorporation or Organization)   (I.R.S. Employer Identification No.)

 

40 Marcus Drive, Melville, New York

  11747
(Address of Principal Executive Offices)   (Zip Code)

 

(631) 760-8100

(Registrant’s telephone number, including area code)

 

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

 

Title of each class   Trading symbol(s)  

Name of exchange on which registered

Common Stock, $0.0001 par value   BRTX   Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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 ☒ No ☐

 

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 (§ 232.405 of this chapter) 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 “large accelerated filer,” “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

 

Indicate by checkmark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐

 

As of August 8, 2022, there were 3,645,886 shares of the registrant’s common stock outstanding.

 

 

 

 
 

 

BIORESTORATIVE THERAPIES, INC., AND SUBSIDIARY

FORM 10-Q

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2022 AND 2021

 

TABLE OF CONTENTS

 

  Page
   
PART I. FINANCIAL INFORMATION 3
     
ITEM 1. Financial Statements 3
     
  Condensed Consolidated Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021 3
     
  Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2022 and 2021 (unaudited) 4
     
  Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Three and Six Months Ended June 30, 2022 and 2021 (unaudited) 5
     
  Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021 (unaudited) 6
     
  Notes to Condensed Consolidated Financial Statements (unaudited) 7
     
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
     
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk 25
     
ITEM 4. Controls and Procedures 25
     
PART II. OTHER INFORMATION 27
     
ITEM 1A. Risk Factors 27
     
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 27
     
ITEM 6. Exhibits 28
     
SIGNATURES 29

 

2

 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BIORESTORATIVE THERAPIES, INC., AND SUBSIDIARY

CONDENSED Consolidated Balance Sheets

 

    June 30,     December 31,  
    2022     2021  
    (Unaudited)        
ASSETS                
                 
Current Assets:                
Cash   $ 17,933,724     $ 21,026,727  
Accounts receivable     16,000       5,000  
Prepaid expenses and other current assets     374,493       436,181  
Total Current Assets     18,324,217       21,467,908  
                 
Property and equipment, net     266,750       37,993  
Right of use asset     299,783       357,805  
Intangible assets, net     550,703       589,740  
                 
Total Assets   $ 19,441,453     $ 22,453,446  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                 
Current Liabilities:                
Accounts payable   $ 378,233     $ 50,827  
Accrued expenses and other current liabilities     114,659       134,970  
Lease liability, current portion     128,889       119,055  
PPP loan payable, current portion     -       58,970  
Total Current Liabilities     621,781       363,822  
                 
Lease liability, net of current portion     234,060       301,645  
PPP loan payable, net of current portion     -       191,030  
                 
Total Liabilities     855,841       856,497  
                 
Commitments and Contingencies     -          
                 
Stockholders’ Equity                
Preferred stock, $0.01 par value; Authorized, 20,000,000 shares; Series A Convertible Preferred stock, $0.01 par value; 1,543,158 Authorized, issued and outstanding     15,432       15,432  
Common stock, $0.0001 par value; Authorized, 75,000,000 shares; 3,643,709 and 3,520,391 issued and outstanding at June 30, 2022 and December 31, 2021, respectively     365       353  
Additional paid in capital     162,207,334       155,727,292  
Accumulated deficit     (143,637,519 )     (134,146,128 )
                 
Total Stockholders’ Equity     18,585,612       21,596,949  
                 
Total Liabilities and Stockholders’ Equity   $ 19,441,453     $ 22,453,446  

 

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements.

 

3

 

 

BIORESTORATIVE THERAPIES, INC., AND SUBSIDIARY

CONDENSED Consolidated STATEMENTS OF OPERATIONS

(Unaudited)

 

    June 30, 2022     June 30, 2021     June 30, 2022     June 30, 2021  
    For the Three Months Ended     For the Six Months Ended  
    June 30, 2022     June 30, 2021     June 30, 2022     June 30, 2021  
                         
Revenues   $ 71,100     $ 15,000     $ 87,100     $ 33,000  
                                 
Operating expenses:                                
Marketing and promotion     245       6,220       714       8,820  
Consulting     35,450       1,648       121,521       10,037  
Research and development     1,075,224       160,898       1,850,561       326,152  
General and administrative     3,588,809       3,401,497       7,796,725       18,297,910  
Total operating expenses     4,699,728       3,570,263       9,769,521       18,642,919  
                                 
Loss from operations     (4,628,628 )     (3,555,263 )     (9,682,421 )     (18,609,919 )
                                 
Other (income) expense:                                
Interest expense     46,613       507,332       75,624       1,106,006  
Gain on PPP loan forgiveness     -       -       (250,000 )     -  
Grant income     -       -       (16,654 )     -  
Total other (income) expense     46,613       507,332       (191,030 )     1,106,006  
                                 
Net loss   $ (4,675,241 )   $ (4,062,595 )   $ (9,491,391 )   $ (19,715,925 )
                                 
Net Loss Per Share - Basic and Diluted   $ (1.28 )   $ (5.10 )   $ (2.65 )   $ (25.84 )
                                 
Weighted Average Number of Common Shares Outstanding - Basic and Diluted     3,638,383       795,877       3,581,110       763,085  

 

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements.

 

4

 

 

BIORESTORATIVE THERAPIES, INC., AND SUBSIDIARY

CONDENSED Consolidated STATEMENTS of CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

 

    Shares     Amount     Shares     Amount     Capital     Deficit     (Deficit)  
    Series A Convertible Preferred Stock     Common Stock    

Additional

Paid-in

    Accumulated    

Total Stockholders’

Equity
 
    Shares     Amount     Shares     Amount     Capital     Deficit     (Deficit)  
                                           
Balance at January 1, 2022     1,543,158     $ 15,432       3,520,391     $ 353     $ 155,727,292     $ (134,146,128 )   $ 21,596,949  
                                                         
Stock-based compensation:                                                        
- restricted share units     -       -       97,828       10       1,164,125       -       1,164,135  
- options     -       -       -       -       2,138,949       -       2,138,949  
- common stock     -       -       13,500       1       72,818       -       72,819  
Net loss     -       -       -       -       -       (4,816,150 )     (4,816,150 )
                                                         
Balance as of March 31, 2022     1,543,158       15,432       3,631,719       364       159,103,184       (138,962,278 )     20,156,702  
                                                         
Stock-based compensation:                                                        
- restricted share units     -       -       6,220       1       1,190,349       -       1,190,350  
- options     -       -       -       -       1,865,297       -       1,865,297  
- common stock     -       -       5,770       -       48,504       -       48,504  
Net loss     -       -       -       -       -       (4,675,241 )     (4,675,241 )
                                                         
Balance as of June 30, 2022     1,543,158     $ 15,432       3,643,709     $ 365     $ 162,207,334     $ (143,637,519 )   $ 18,585,612  
                                                         
Balance at January 1, 2021     -     $ -       715,544     $ 72     $ 88,511,269     $ (89,842,833 )   $ (1,331,492 )
                                                         
Shares issued in exchange for notes payable and accrued interest     -       -       4,852       -       213,673       -       213,673  
Shares issued in cashless exercise of warrants     -       -       73,582       7       (7 )     -       -  
Stock-based compensation:                                                        
- restricted share units     -       -       -       -       179,098               179,098  
- options     -       -       -       -       13,897,669       -       13,897,669  
Net loss     -       -       -       -       -       (15,653,330 )     (15,653,330 )
                                                         
Balance as of March 31, 2021     -       -       793,978       79       102,801,702       (105,496,163 )     (2,694,382 )
                                                         
Shares issued in exchange for notes payable and accrued interest     -       -       3,217       -       103,703       -       103,703  
Shares issued in cashless exercise of warrants     -       -       39,750       5       (82,136 )     -       (82,131 )
Stock-based compensation:                                                     -  
- restricted share units     -       -       -       -       1,164,135       -       1,164,135  
- options     -       -       -       -       1,762,329       -       1,762,329  
Net loss     -       -       -       -       -       (4,062,595 )     (4,062,595 )
                                                         
Balance as of June 30, 2021     -     $ -       836,945     $ 84     $ 105,749,733     $ (109,558,758 )   $ (3,808,941 )

 

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements.

 

5

 

 

BIORESTORATIVE THERAPIES, INC. & SUBSIDIARY
 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

 

    June 30, 2022     June 30, 2021  
    Six Months Ended  
    June 30, 2022     June 30, 2021  
Cash flows from operating activities:                
Net Loss   $ (9,491,391 )   $ (19,715,925 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Amortization of debt discount     -       742,534  
Depreciation and amortization     57,526       46,035  
Stock-based compensation - options     4,004,246       15,659,998  
Stock-based compensation - common stock     121,324       -  
Stock-based compensation - RSUs     2,354,485       1,343,233  
Gain on PPP loan forgiveness     (250,000 )     -  
Non-cash lease expense     58,022       58,022  
Changes in operating assets and liabilities:                
Accounts receivable     (11,000 )     2,000  
Prepaid assets and other current assets     61,688       50,643  
Accounts payable     327,406       (21,159 )
Accrued expenses and other current liabilities     (20,311 )     328,174  
Lease liability     (57,751 )     (49,085 )
                 
Net cash used in operating activities     (2,845,756 )     (1,555,530 )
                 
Cash flows from investing activities:                
                 
Purchases of equipment     (247,247 )     -  
                 
Net cash used in investing activities     (247,247 )     -  
                 
Cash flows from financing activities:                
Proceeds from PPP Loan     -       250,000  
                 
Net cash provided by financing activities     -       250,000  
                 
Net decrease in cash and cash equivalents     (3,093,003 )     (1,305,530 )
                 
Cash - beginning of period     21,026,727       3,064,610  
                 
Cash - end of period   $ 17,933,724     $ 1,759,080  
                 
Non-cash investing and financing activities:                
Shares issued in exchange for notes payable and accrued interest   $ -     $ 235,245  

 

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements.

 

6

 

 

BIORESTORATIVE THERAPIES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

NOTE 1 – NATURE OF THE ORGANIZATION, LIQUIDITY, AND BUSINESS

 

Corporate History

 

BioRestorative Therapies, Inc. has one wholly-owned subsidiary, Stem Pearls, LLC (“Stem Pearls”). BioRestorative Therapies, Inc. and its subsidiary are referred to collectively as “BRT” or the “Company”.

 

On October 27, 2021, the Company effected a 1-for-4,000 reverse stock split of its common stock. The Company has retroactively applied the reverse stock split made effective on October 27, 2021 to share and per share amounts on the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2021. In connection with the reverse stock split, the Company’s authorized number of shares of common stock was reduced from 300,000,000,000 to 75,000,000. The Company’s authorized number of shares of preferred stock was not affected by the reverse stock split.

 

On November 9, 2021, the Company completed a $23,000,000 underwritten public offering of units of securities pursuant to which an aggregate of 2,300,000 shares of the Company’s common stock and warrants for the purchase of an aggregate of 2,645,000 shares of the Company’s common stock were issued. The Company intends to use the net proceeds from the offering as follows: (i) undertaking of clinical trials with respect to BRTX-100 and its related collection and delivery procedure; (ii) pre-clinical research and development with respect to the Company’s ThermoStem Program; and (iii) for general corporate and working capital purposes. In connection with the public offering, the Company’s common stock was listed on the Nasdaq Capital Market.

 

Nature of the Business

 

BRT develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells. BRT’s website is at www.biorestorative.com. BRT is currently developing a Disc/Spine Program referred to as “brtxDISC”. Its lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. The product is intended to be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complimentary therapeutic to a surgical procedure. BRT is also engaging in research efforts with respect to a platform technology utilizing brown adipose (fat) for therapeutic purposes to treat type 2 diabetes, obesity and other metabolic disorders and has labeled this initiative its ThermoStem Program. Further, BRT has licensed a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic products or material to the spine and discs or other potential sites.

 

Liquidity

 

The accompanying unaudited condensed consolidated financial statements have been prepared on the basis that the Company will continue as a going concern, which contemplates realization of assets and satisfying liabilities in the normal course of business. At June 30, 2022, the Company had an accumulated deficit of $143.6 million and a working capital surplus of $17.7 million. For the six months ended June 30, 2022, the Company had a net loss of $9.5 million (of which, $6.5 million was attributable to non-cash stock-based compensation) and negative cash flows from operations of $2.8 million. The Company’s operating activities consume the majority of its cash resources. The Company anticipates that it will continue to incur net losses as it executes its development plans for 2022 and beyond, as well as other potential strategic and business development initiatives. In addition, the Company has had and expects to have negative cash flows from operations, at least into the near future. The Company has previously funded, and plans to continue funding, these losses primarily through current cash on hand and additional infusions of cash from equity and debt financing.

 

The Company believes that it has been able to mitigate the above factors with regard to its ability to continue as a going concern as a result of its November 9, 2021, public offering pursuant to which the Company received net proceeds of approximately $21.1 million. As a result of the above, and cash on hand as of June 30, 2022, the Company believes it has sufficient cash to fund operations for the twelve months subsequent to the filing date.

 

7

 

 

Current funds noted above will not be sufficient to enable the Company to fully complete its development activities or attain profitable operations. If the Company is unable to obtain such needed additional financing on a timely basis, the Company may have to curtail its development, marketing and promotional activities, which would have a material adverse effect on the Company’s business, financial condition and results of operations, and ultimately the Company could be forced to discontinue its operations and liquidate.

 

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the unaudited condensed consolidated financial statements do not necessarily purport to represent realizable or settlement values. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.

 

NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial information as of and for the three and six months ended June 30, 2022 and 2021 has been prepared in accordance with GAAP for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of the Company’s financial position at such dates and the operating results and cash flows for such periods. Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period.

 

Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission (the “SEC”). These unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s audited consolidated financial statements for the year ended December 31, 2021, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2022.

 

Principles of Consolidation

 

The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated upon consolidation.

 

Use of Estimates

 

The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions, revenue and expenses and disclosure of contingent liabilities at the date of the unaudited condensed consolidated financial statements. The Company bases its estimates and assumptions on historical experience, known or expected trends and various other assumptions that it believes to be reasonable. As future events and their effects cannot be determined with precision, actual results could differ from these estimates which may cause the Company’s future results to be affected.

 

The Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation of the accompanying unaudited condensed consolidated financial statements. Significant estimates include the carrying value of intangible assets, deferred tax asset and valuation allowance, and assumptions used in the Black-Scholes option pricing model, such as expected volatility, risk-free interest rate, and expected divided rate.

 

Revenue

 

The Company derives all of its revenue pursuant to a license agreement between the Company and a stem cell treatment company (“SCTC”) entered into in January 2012 and amended in November 2015. Pursuant to the license agreement, the SCTC granted to the Company a license to use certain intellectual property related to, among other things, stem cell disc procedures, and the Company has granted to the SCTC a sublicense to use, and the right to sublicense to third parties the right to use, in certain locations in the United States and the Cayman Islands, certain of the licensed intellectual property. In consideration of the sublicenses, the SCTC has agreed to pay the Company royalties on a per disc procedure basis.

 

8

 

 

The Company’s contracted transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The Company’s contracts have a single performance obligation with a fixed determinable contract value. The Company’s performance obligation is satisfied upon the transfer of risk of loss to the customer. All sales have fixed pricing and there are currently no variable components included in the Company’s revenue. The timing of the Company’s revenue recognition may differ from the timing of receiving royalty payments. A receivable is recorded when revenue is recognized prior to receipt of a royalty payment and the Company has an unconditional right to the royalty payment. Alternatively, when a royalty payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. During the three months ended June 30, 2022 and 2021, the Company recognized $71,100 and $15,000, respectively, of revenue related to the Company’s sublicenses. During the six months ended June 30, 2022 and 2021, the Company recognized $87,100 and $33,000, respectively, of revenue related to the Company’s sublicenses.

 

Contract Modifications

 

There were no contract modifications during the three and six months ended June 30, 2022. Contract modifications are not routine in the performance of the Company’s contracts.

 

Cash

 

The Company considers all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. Cash and cash equivalents held at financial institutions may at times exceed insured amounts. The Company believes it mitigates such risk by investing in or through, as well as maintaining cash balances with, major financial institutions. There were no cash equivalents as of June 30, 2022, and December 31, 2021.

 

Accounts Receivable

 

Accounts receivable are reported at their outstanding unpaid principal balances, net of allowances for doubtful accounts. The Company periodically assesses its accounts receivable and other receivables for collectability on a specific identification basis. The Company provides for allowances for doubtful accounts based on management’s estimate of uncollectible amounts considering age, collection history, and any other factors considered appropriate. Payments are generally due within 30 days of invoice. The Company writes off accounts receivable against the allowance for doubtful accounts when a balance is determined to be uncollectible. The Company had no balances related to allowances for doubtful accounts as of June 30, 2022 and December 31, 2021.

 

Property and Equipment

 

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the related assets, generally 315 years. Expenditures that enhance the useful lives of assets are capitalized and depreciated over the remainder of the useful life. Computer equipment costs are capitalized as incurred and depreciated on a straight-line basis over a range of 35 years.

 

Leasehold improvements are amortized over the lesser of (i) the useful life of the asset or (ii) the remaining lease term. Maintenance and repairs are expensed as incurred. The Company capitalizes costs attributable to the betterment of property and equipment when such betterment enhances the functionality of the asset or extends the useful life of the asset. Should an asset be disposed of before the end of its useful life, the cost and accumulated depreciation at that date are removed from the consolidated balance sheets, with the resulting gain or loss, if any, reflected in operations in that period.

 

9

 

 

Impairment of Long-Lived Assets

 

The Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the carrying amount to the forecasted undiscounted net cash flows of the operation to which the assets relate. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written down to fair value first, followed by other long-lived assets of the operation. Fair value is determined based on discounted cash flows or appraised values, depending on the nature of the assets. There are no impairment charges for all periods presented.

 

Intangible Assets

 

The Company records its intangible assets at cost, for those intangible assets not acquired in a business combination, in accordance with Accounting Standards Codification (“ASC”) 350, Intangibles – Goodwill and Other. Definite-lived intangible assets are amortized using the straight-line method over their estimated useful life, which is determined by either the term of the underlying agreement they related to or identifying the period over which the cash flows from the asset are expected to be generated.

 

Advertising and Marketing Costs

 

The Company expenses advertising and marketing costs as they are incurred. Advertising and marketing expenses were $245 and $6,220 for the three months ended June 30, 2022 and 2021, respectively. Advertising and marketing expenses were $714 and $8,820 for the six months ended June 30, 2022 and 2021, respectively. Advertising and marketing expenses are recorded in marketing and promotion on the unaudited condensed consolidated statements of operations.

 

Fair Value Measurements

 

As defined in ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), fair value is the price that would be received for an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent measurement.

 

Level 1: Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and listed equities.
   
Level 2: Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments in this category generally include non-exchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
   
Level 3: Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used with internally-developed methodologies that result in management’s best estimate of fair value.

 

Fair Value of Financial Instruments

 

The carrying value of cash, accounts receivable, accounts payable and accrued expenses, and other current liabilities approximate their fair values based on the short duration of these instruments.

 

10

 

 

Net Loss per Common Share

 

Net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. All vested outstanding options and warrants are considered potential common stock. The dilutive effect, if any, of stock options, warrants, and restricted stock units (“RSUs”) are calculated using the treasury stock method. All outstanding convertible notes are considered common stock at the beginning of the period or at the time of issuance, if later, pursuant to the if-converted method. Since the effect of common stock equivalents is anti-dilutive with respect to losses, options, warrants, RSUs and convertible notes have been excluded from the Company’s computation of net loss per common share for the three and six months ended June 30, 2022 and 2021.

 

The following table summarizes the securities that were excluded from the diluted loss per share calculation:

 

    Three Months Ended  
    June 30,  
    2022     2021  
             
Options     864,609       588,047  
Warrants     4,739,733       3,626,847  
Unvested RSUs     214,303       293,479  
Convertible notes – common stock     -       198,949 (1)
Total     5,818,645       4,707,322  

 

    Six Months Ended  
    June 30,  
    2022     2021  
             
Options     864,609       588,047  
Warrants     4,739,733       3,626,847  
Unvested RSUs     214,303       293,479  
Convertible notes – common stock     -       198,949 (1)
Total     5,818,645       4,707,322  

 

  (1) As of June 30, 2021, all of the convertible notes had variable conversion prices and the shares issuable were estimated based on the market conditions. Pursuant to the note agreements, there were 12,876,003 shares of common stock reserved for future note conversions as of June 30, 2021.

 

Stock-based Compensation

 

The Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in the condensed consolidated statements of operations.

 

For stock options issued to employees and members of the board of directors for their services, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.

 

11

 

 

Pursuant to Accounting Standards Update (“ASU”) 2018-07 Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, the Company accounts for stock options issued to non-employees for their services in accordance with ASC 718. The Company uses valuation methods and assumptions to value the stock options that are consistent with the process for valuing employee stock options noted above.

 

Grant income

 

Funding received under research grants for reimbursement of research and development expenses is recorded as grant income in the other (income) expense section of the condensed consolidated statements of operations.

 

Income Taxes

 

The Company accounts for income taxes pursuant to the asset and liability method which requires the recognition of deferred income tax assets and liabilities related to the expected future tax consequences arising from temporary differences between the carrying amounts and tax bases of assets and liabilities based on enacted statutory tax rates applicable to the periods in which the temporary differences are expected to reverse. Any effects of changes in income tax rates or laws are included in income tax expense in the period of enactment.

 

The Company records valuation allowances against deferred tax assets when it is more likely than not that all or a portion of a deferred tax asset will not be realized. The Company routinely evaluates the realizability of deferred tax assets by assessing the likelihood that deferred tax assets will be recovered based on all available positive and negative evidence, including scheduled reversals of deferred tax liabilities, estimates of future taxable income, tax planning strategies and results of operations. Estimating future taxable income is inherently uncertain and requires judgment. In projecting future taxable income, historical results are considered along with certain assumptions related to future earnings. At June 30, 2022 and December 31, 2021, the Company had a full valuation allowance applied against its deferred tax assets.

 

From time to time the Company may recognize an income tax benefit, in its consolidated statements of operations, related to uncertain tax positions taken. For uncertain tax positions that are “more likely than not” to sustain an income tax audit, the Company may record an allowance against certain deferred tax assets related to these positions. The Company’s practice is to recognize interest and penalties, if any, related to uncertain tax positions in income tax expense in the unaudited condensed consolidated statements of operations.

 

Leases

 

A lease is defined as an agreement that conveys the right to control the use of identified property, plant or equipment (right of use asset or “ROU asset”) for a period of time in exchange for consideration. The Company accounts for it leases in accordance with ASC 842, Leases, which requires that an ROU asset identified in a lease to be recorded as a noncurrent asset with a related liability. The Company does not record ROU assets for those agreements of a twelve-month duration or less. The Company recognized a ROU asset and corresponding lease liability on its balance sheets related to its office lease agreement. See Note 8 - Leases for further discussion, including the impact on the Company’s financial statements and related disclosures.

 

ROU assets include any initial direct costs and prepaid lease payments and exclude any lease incentives. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The lease terms may include options to extend or terminate the lease if it is reasonably certain that the Company will exercise that option.

 

Research and Development Expenses

 

Research and development expenses are expensed as incurred and recorded as a component of operating expenses in the Company’s Condensed Consolidated Statements of Operations.

 

12

 

 

NOTE 3 – INTANGIBLE ASSETS

 

The Company is a party to a license agreement with the SCTC (as amended) (the “SCTC Agreement”). Pursuant to the SCTC Agreement, the Company obtained, among other things, a worldwide (excluding Asia and Argentina), exclusive, royalty-bearing license from the SCTC to utilize or sublicense a certain method for culturing cells and a worldwide, exclusive, royalty-bearing license from the SCTC to utilize or sublicense a certain medical device patent for the administration of specific cells and/or cell products to the disc and/or spine (and other parts of the body). Pursuant to the license agreement with the SCTC, certain performance milestones (or payouts in lieu of performance milestones) had to be satisfied in order for the Company to maintain its exclusive rights with regard to the disc/spine technology (subject to the SCTC’s compliance with its obligations under the SCTC Agreement). The Company did not timely satisfy the third of these performance milestones (which needed to be satisfied by February 2022). Accordingly, such rights may currently be non-exclusive. The Company and the SCTC are currently negotiating the terms of an agreement confirming the exclusive nature of the license. No assurance can be given in this regard. In February 2017, the Company received authorization from the Food and Drug Administration (the “FDA”) to proceed with a Phase 2 clinical trial. The Company has commenced such clinical trial. In March 2022, a United States patent relating to the Company’s BRTX-100 clinical program was issued. The patent along with the license agreement gave rise to definite lived intangible assets. The below table details the activity related to those intangible assets from January 1, 2021 through June 30, 2022:

 

    Patents and Trademarks     Licenses     Accumulated Amortization     Total  
Balance as of January 1, 2021   $ 3,676     $ 1,301,500     $ (640,908 )   $ 664,268  
Amortization expense     -       -       (74,528 )     (74,528 )
Balance as of December 31, 2021     3,676       1,301,500       (715,436 )     589,740  
Amortization expense     -       -       (39,037 )     (39,037 )
Balance as of June 30, 2022   $ 3,676     $ 1,301,500     $ (754,473 )   $ 550,703  
Weighted average remaining amortization period at June 30, 2022 (in years)     -       7.43                  

 

Accumulated amortization of intangible assets consists of the following:

 

    Patents and Trademarks     Licenses     Accumulated Amortization  
Balance as of January 1, 2021   $ 3,676     $ 637,232     $ 640,908  
Amortization expense     -       74,528       74,528  
Balance as of December 31, 2021     3,676       711,760       715,436  
Amortization expense     -       39,037       39,037  
Balance as of June 30, 2022   $ 3,676     $ 750,797     $ 754,473  

 

NOTE 4 – ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 

Accrued expenses and other current liabilities consist of:

 

    June 30, 2022    

December 31, 2021

 
             
Accrued payroll   $ 26,250     $ 28,370  
Accrued research and development expenses     -       29,672  
Accrued general and administrative expenses     88,409       76,928  
Total accrued expenses   $ 114,659     $ 134,970  

 

13

 

 

NOTE 5 – NOTES PAYABLE

 

A summary of the notes payable activity during the six months ended June 30, 2022 is presented below:

 

    PPP Loan  
Outstanding, January 1, 2022   $ 250,000  
Issuances     -  
Forgiveness     (250,000 )
Outstanding, June 30, 2022   $ -  

 

On March 14, 2021, under the U.S. Small Business Administration’s Paycheck Protection Program (“PPP”), the Company entered into a note payable with a financial institution for $250,000 at an interest rate of 1% per annum and a maturity date of March 14, 2026. Pursuant to the note, principal and interest payments were deferred for ten months. At that time the Company was able to apply for loan forgiveness. At December 31, 2021, $250,000 was outstanding. On January 5, 2022, the total amount of the PPP loan was forgiven.

 

NOTE 6 – STOCKHOLDERS’ EQUITY (DEFICIT)

 

Series A Preferred

 

On November 8, 2021, in connection with the Company’s public offering, the Company’s Board of Directors adopted a resolution allowing for the authorization of and issuance of 1,543,458 shares of the Company’s Preferred Stock, $.01 par value per share, designated as Series A Preferred Stock (“Series A”). The Series A has a liquidation preference of $0.001 per share.

 

Dividends

 

Series A holders shall be entitled to receive, when and as declared by the Board of Directors, dividends on an equivalent basis without preference with the holders of the shares of the Company’s common stock based upon the number of shares of common stock into which the Series A is then convertible.

 

Voting Rights

 

Series A holders shall be entitled to vote on all matters presented to the stockholders of the Company and shall be entitled to such number of votes that equal the number of shares of common stock into which each share of Series A held may be converted; provided, however, that in no event shall a Series A holder be entitled to vote more than 4.99% of the then outstanding shares of common stock.

 

Conversion

 

Optional Conversion - Each share of Series A shall be convertible, at any time, at the option of the Series A holder, into one share of common stock; provided, however, that in no event shall a Series A holder be entitled to convert any shares of Series A to the extent that such conversion would result in beneficial ownership by the Series A holder of more than 4.99% of the outstanding shares of common stock.

 

Automatic Conversion – If an event occurs which has the effect of reducing a Series A holder’s beneficial ownership of shares of common stock to less than 4.5% of the then publicly disclosed outstanding shares of common stock, then, within five business days thereafter, the Series A holder shall provide notice to the Company to such effect. Such notice shall have the effect of a notice of conversion such that the Series A holder’s post-conversion ownership of common stock will be 4.99% of the then publicly disclosed outstanding shares of common stock.

 

14

 

 

2021 Stock Incentive Plan

 

On March 18, 2021, the Company’s Board of Directors adopted the BioRestorative Therapies, Inc. 2021 Stock Incentive Plan (the “2021 Plan”). Pursuant to the 2021 Plan, a total of 1,175,000 shares of common stock are authorized to be issued pursuant to the grant of stock options, restricted stock units, restricted stock, stock appreciation rights and other incentive awards. As of June 30, 2022, based on stock options and restricted stock units currently outstanding under the 2021 Plan, no shares remain available for future grants under the 2021 Plan.

 

Warrant and Option Valuation

 

The Company has computed the fair value of warrants and options granted using the Black-Scholes option pricing model. The expected term used for warrants and options issued to non-employees is the contractual life and the expected term used for options issued to employees and directors is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” employee option grants. The Company is utilizing an expected volatility figure based on a review of the historical volatilities, over a period of time equivalent to the expected life of the instrument being valued, of similarly positioned public companies within its industry. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued.

 

Warrant Activity Summary

 

No warrants were granted or issued during the six months ended June 30, 2022 and 2021.

 

A summary of the warrant activity during the six months ended June 30, 2022, is presented below:

 

                Weighted        
          Weighted     Average        
          Average     Remaining     Aggregate  
    Number of     Exercise     Life     Intrinsic  
    Warrants     Price     In Years     Value  
Outstanding, January 1, 2022     4,739,871     $ 11.78       4.9     $      -  
Granted     -       -                  
Exercised     -       -                  
Expired     (138 )     16,107.00                  
Outstanding, June 30, 2022     4,739,733     $ 10.92       4.4     $ -  
                                 
Exercisable, June 30, 2022     4,739,733     $ 10.92       4.4     $ -  

 

15

 

 

The following table presents information related to warrants at June 30, 2022:

 

 

Warrants Outstanding     Warrants Exercisable  
            Weighted        
      Outstanding     Average     Exercisable  
Exercise     Number of     Remaining Life     Number of  
Price     Warrants     In Years     Warrants  
$ 10.00       4,501,937       4.4       4,501,937  
$ 12.50       235,970       4.4       235,970  
$ 60.00       250       2.5       250  
$ 800.00       869       2.3       869  
$ 2,240.00       39       2.0       39  
$ 3,400.00       264       1.8       264  
$ 4,000.00       55       1.8       55  
$ 8,000.00       19       1.3       19  
$ 14,000.00       18       1.0       18  
$ 16,000.00       298       1.6       298  
$ 16,600.00       14       0.3       14  
          4,739,733       4.4       4,739,733  

 

Stock Options

 

The Company grants stock options to certain employees which is recognized as compensation expense on a straight-line basis over the vesting term of the grants. Vesting terms are generally two years, and grants expire between five and ten years.

 

For the three months ended June 30, 2022 and 2021, the Company recognized compensation expense related to stock option grants of $1.9 million and $1.7 million, respectively. For the six months ended June 30, 2022 and 2021, the Company recognized compensation expense related to stock option grants of $4.0 million and $15.6 million, respectively. The Company values these option grants using the Black-Scholes option pricing model. In applying the Black-Scholes option pricing model to stock options granted, the Company used the following assumptions:

 

    For the Six Months Ended     For the Six Months Ended  
    June 30,     June 30,  
    2022     2021  
Risk free interest rate     2.42 %     1.71 %
Expected term (years)     3.50       5.50  
Expected volatility     286 %     228 %
Expected dividends     0.00 %     0.00 %

 

The Company granted options for the purchase of 25,000 shares of common stock during the six months ended June 30, 2022, with a grant date fair value of $4.88 per share. At June 30, 2022, the unamortized compensation expense related to these grants was $0.1 million.

 

The Company granted options for the purchase of 586,959 shares of common stock during the six months ended June 30, 2021, with a grant date fair value of $47.25 per share, after taking into effect the reverse stock split. At June 30, 2022, the unamortized compensation expense related to these grants was $5.7 million.

 

A summary of the stock option activity during the six months ended June 30, 2022 is presented below:

 

                  Weighted        
            Weighted     Average        
            Average     Remaining     Aggregate  
      Number of     Exercise     Life     Intrinsic  
      Options     Price     In Years     Value  
Outstanding, January 1, 2022       839,639     $ 18.73       9.5                 -  
Granted       25,000       4.92                  
Forfeited       (30 )     3,273.00                  
Outstanding, June 30, 2022       864,609     $ 18.73       8.8     $ -  
                                   
Exercisable, June 30, 2022       532,045     $ 17.50       9.0     $ -  

 

16

 

 

The following table presents information related to stock options at June 30, 2022:

 

Options Outstanding     Options Exercisable  
            Weighted        
      Outstanding     Average     Exercisable  
Exercise     Number of     Remaining Life     Number of  
Price     Options     In Years     Options  
$ 4.92       25,000       4.8       -  
$ 13.50 (1)     838,550       9.0       530,994  
$ 1,040.00       44       7.3       44  
$ 3,000.00       1,004       4.6       996  
$ 22,800.00       1       2.0       1  
$ 48,200.00 - $52,000.00       9       1.5       9  
$ 120,000.00       1       0.4       1  
          864,609       8.8       532,045  

 

(1) Subject to reduction to $5.08 per share in the event of stockholder approval of certain amendments to the 2021 Plan.

 

Restricted Stock Units

 

Pursuant to the 2021 Plan, the Company grants RSUs to employees, consultants and non-employee directors (“Eligible Individuals”). The number, terms and conditions of the RSUs that are granted to Eligible Individuals are determined on an individual basis by the plan administrator. On the distribution date, the Company shall issue to the Eligible Individual one share of the Company’s common stock for each vested and nonforfeitable RSU.

 

On March 18, 2022, the Company, granted an aggregate of 24,876 RSUs to its Chief Executive Officer, President and Chairman of the Board and its Vice President, Research and Development with a fair value of $4.21 per share. The RSUs vest in twelve equal monthly installments.

 

A summary of our unvested RSUs as of June 30, 2022 is as follows:

 

    Number of  
    Shares  
Outstanding, January 1, 2022     293,479  
Granted     24,876  
Forfeited     -  
Vested     (104,052 )
Outstanding, June 30, 2022     214,303  

 

The following table presents information related to stock compensation expense:

 

    For the Three Months Ended     For the Six Months Ended     Unrecognized at     Weighted Average Remaining Amortization    
    June 30,     June 30,     June 30,     Period  
    2022     2021     2022     2021     2022     (Years)  
Consulting   $ 23,210     $ -     $ 96,029     $ -     $                           -                 -  
Research and development     -       24,304       -       49,245       -       -  
General and administrative     3,080,941       2,902,160       6,384,025       16,953,806       13,843,633       1.4  
    $ 3,104,151     $ 2,926,464     $ 6,480,054     $ 17,003,231     $ 13,843,633       1.4  

 

17

 

 

Note 7 - COMMITMENTS AND CONTINGENCIES

 

Clinical Services Agreement

 

On December 20, 2021, the Company entered into a Master Clinical Services Agreement (the “Clinical Services Agreement”) with Professional Research Consulting, Inc. (“PRC”) pursuant to which PRC will provide trial management services related to the Company’s Phase 2 clinical trials. The Clinical Services Agreement has a 46-month term with an estimated budgeted cost of $5,844,380. Upon execution of the Clinical Services Agreement, the Company made an upfront payment of $328,152 which was recorded as a prepaid expense on the condensed consolidated balance sheet at December 31, 2021, and is being expensed over the life of the Clinical Services Agreement as the services are rendered. During the three and six months ended June 30, 2022, the Company incurred $0.6 million and $1.0 million, respectively, of research and development expense related to this agreement and had a balance in prepaid expense of approximately $0.3 million at June 30, 2022 associated with the Clinical Services Agreement.

 

Note 8 - LEASES

 

The Company is a party to a lease for 6,800 square feet of space located in Melville, New York (the “Melville Lease”) with respect to its corporate and laboratory operations. The Melville Lease is scheduled to expire in December 2024 and provides for an annual base rental during the term, which commenced as of January 1, 2020, ranging between $153,748 and $173,060. The remaining term of this lease is approximately 2.5 years at June 30, 2022.

 

When calculating the present value of lease liabilities for operating leases, the Company discounted the lease payments using its estimated incremental borrowing rate at the inception of the term. The weighted average incremental borrowing rate applied to the Melville Lease was 12%.

 

The following table presents net lease cost and other supplemental lease information:

 

   

Six Months Ended June 30, 2022

   

Six Months Ended June 30, 2021

 
Lease cost                
Operating lease cost (cost resulting from lease payments)   $ 81,566     $ 79,186  
Net lease cost   $ 81,566     $ 79,186  
                 
Operating lease – operating cash flows (fixed payments)   $ 81,566     $ 79,186  
Operating lease – operating cash flows (liability reduction)   $ 57,751     $ 49,085  
Non-current leases – right of use assets   $ 299,783     $ 415,827  
Current liabilities – operating lease liabilities   $ 128,889     $ 109,856  
Non-current liabilities – operating lease liabilities   $ 234,060     $ 362,949  

 

Future minimum payments under non-cancelable leases for operating leases for the remaining terms of the leases as of June 30, 2022:

 

Fiscal Year   Operating Leases  
Remainder of 2022   $ 81,566  
2023     168,028  
2024     173,060  
Total future minimum lease payments     422,654  
Amount representing interest     (59,705 )
Present value of net future minimum lease payments   $ 362,949  

 

NOTE 9 – SUBSEQUENT EVENTS

 

Issuance of Common Stock

 

On July 18, 2022, the Company issued 1,036 shares each to Lance Alstodt, Chief Executive Officer, and Francisco Silva, Vice President of Research and Development, in lieu of cash for salary, with a fair value of $2.93 per share.

 

18

 

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q includes a number of forward-looking statements that reflect management’s current views with respect to future events and financial performance. Forward-looking statements are projections in respect of future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. These statements include statements regarding the intent, belief or current expectations of us and members of our management team, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks set forth in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Factors That May Affect Future Results and Financial Condition” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 30, 2022, any of which may cause our company’s or our industry’s 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 in our forward-looking statements. These risks and factors include, by way of example and without limitation:

 

our ability to obtain financing needed to complete our clinical trials and implement our business plan;
our ability to successfully develop and commercialize BRTX-100, our lead product candidate for the treatment of chronic lumbar disc disease, as well as our metabolic ThermoStem Program;
our possible lack of exclusive rights with regard to our licensed technology;
our ability to protect our proprietary rights;
our ability to achieve and sustain profitability of the existing lines of business;
our ability to attract and retain world-class research and development talent;
our ability to attract and retain key science, technology and management personnel and to expand our management team;
the accuracy of estimates regarding expenses, future revenue, capital requirements, profitability, and needs for additional financing;
business interruptions resulting from geo-political actions, including war and terrorism or disease outbreaks (such as the recent outbreak of COVID-19);
our ability to attract and retain customers; and
our ability to navigate through the increasingly complex therapeutic regulatory environment.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity or performance. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

 

Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the SEC. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes in the future operating results over time, except as required by law. We believe that our assumptions are based upon reasonable data derived from and known about our business and operations. No assurances are made that actual results of operations or the results of our future activities will not differ materially from our assumptions.

 

As used in this Quarterly Report on Form 10-Q and unless otherwise indicated, the terms “Company,” “we,” “us” and “our” refer to BioRestorative Therapies, Inc., a Delaware corporation, and its wholly-owned subsidiary, Stem Pearls, LLC, a New York limited liability company. Unless otherwise specified, all dollar amounts are expressed in United States dollars.

 

19

 

 

Intellectual Property

 

This report includes references to our federally registered trademarks, BioRestorative Therapies and Dragonfly design, BRTX-100 and ThermoStem. We also own an allowed trademark application for BRTX. The Dragonfly Logo is also registered with the U.S. Copyright Office. This report may also include references to trademarks, trade names and service marks that are the property of other organizations. Solely for convenience, trademarks and trade names referred to in this report appear without the ®, SM or ™ symbols, and copyrighted content appears without the use of the symbol ©, but the absence of use of these symbols does not reflect upon the validity or enforceability of the intellectual property owned by us or third parties.

 

Corporate History

 

Our offices are located in Melville, New York where we have established a laboratory facility in order to increase our capabilities for the further development of possible cellular-based treatments, products and protocols, stem cell-related intellectual property and translational research applications.

 

As of June 30, 2022, our accumulated deficit was $143.6 million. We have historically only generated a modest amount of revenue, and our losses have principally been operating expenses incurred in research and development, non-cash expenses such as stock-based compensation, plus costs associated with meeting the requirements of being a public company. We expect to continue to incur substantial costs for these activities over at least the next year.

 

Business Overview

 

We develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult (non-embryonic) stem cells. We are currently pursuing our Disc/Spine Program with our initial investigational therapeutic product being called BRTX-100. In March 2022, a United States patent issued in our Disc/Spine Program. We submitted an IND application to the FDA to obtain authorization to commence a Phase 2 clinical trial investigating the use of BRTX-100, our lead cell therapy candidate, in the treatment of chronic lower back pain arising from degenerative disc disease. We have received such authorization from the FDA and have commenced such clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical trial agreements, the enrollment of patients in the clinical trials, the purchase of manufacturing equipment, the expansion of our laboratory to include capabilities for clinical production and the certification of our clinical grade cell therapy manufacturing facility. We have obtained a license to use technology for investigational adult stem cell treatment of disc and spine conditions, including protruding and bulging lumbar discs. The technology is an advanced stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain, and numbness and tingling in the leg and foot. We are also developing our ThermoStem Program. This pre-clinical program involves the use of brown adipose (fat) in connection with the cell-based treatment of type 2 diabetes and obesity as well as hypertension, other metabolic disorders and cardiac deficiencies. United States patents related to the ThermoStem Program were issued in September 2015, January 2019, March 2020, March 2021, and July 2021; Australian patents related to the ThermoStem Program were issued in April 2017, October 2019 and August 2021; Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021, and February 2022; Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, and March 2022; and European patents related to the ThermoStem Program were issued in April 2020 and January 2021.

 

We have licensed a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic products or materials to the spine and discs or other potential sites. We anticipate that FDA approval or clearance will be necessary for this device prior to commercialization. We do not intend to utilize this device in connection with our contemplated Phase 2 clinical trial with regard to BRTX-100.

 

Revenue

 

We derived all of our revenue pursuant to a license agreement with the SCTC entered into in January 2012, as amended in November 2015. Pursuant to the license agreement, the SCTC granted to us a license to use certain intellectual property related to, among other things, stem cell disc procedures and we have granted to the SCTC a sublicense to use, and the right to sublicense to third parties the right to use, in certain locations in the United States and the Cayman Islands, certain of the licensed intellectual property. In consideration of the sublicenses, the SCTC has agreed to pay us royalties on a per disc procedure basis.

 

20

 

 

Results of Operations

 

Comparison of the Three Months Ended June 30, 2022 to the Three Months Ended June 30, 2021

 

Our financial results for the three months ended June 30, 2022 are summarized as follows in comparison to the three months ended June 30, 2021:

 

    For The Three Months Ended  
    June 30,  
    2022     2021  
Revenues   $ 71,100     $ 15,000  
                 
Operating Expenses:                
Marketing and promotion     245       6,220  
Consulting     35,450       1,648  
Research and development     1,075,224       160,898  
General and administrative     3,588,809       3,401,497  
Total Operating Expenses     4,699,728       3,570,263  
Loss From Operations     (4,628,628 )     (3,555,263 )
                 
Other Expense:                
Interest expense     46,613       507,332  
Total Other Expense     46,613       507,332  
Net Loss   $ (4,675,241 )   $ (4,062,595 )

 

Revenues

 

For the three months ended June 30, 2022 and 2021, we generated $71,000 and $15,000, respectively, of royalty revenue in connection with our sublicense agreement. We do not expect that such increased level of revenues related to this agreement will continue in future periods.

 

Marketing and Promotion

 

Marketing and promotion expenses include advertising and promotion, marketing and seminars, meals, entertainment and travel expenses. For the three months ended June 30, 2022 and 2021, marketing and promotion expenses were insignificant. Marketing and promotion expenses for the prior year period included expenditures related to an advertising consulting agreement which was no longer in effect during 2022.

 

Consulting

 

Consulting expenses consist of consulting fees and stock-based compensation to consultants. For the three months ended June 30, 2022, consulting expenses increased by $33,802, from $1,648 to $35,450, as compared to the three months ended June 30, 2021, primarily due to stock-based compensation of $23,210 issued to consultants during the three months ended June 30, 2022.

 

Research and Development

 

Research and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development; (b) our Scientific Advisory Board members; and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives. For the three months ended June 30, 2022, research and development expenses increased by $914,326, or 568%, from $160,898 to $1,075,224, as compared to the three months ended June 30, 2021, as we recommenced our research and development initiatives, including the engagement of PRC Clinical to serve as our CRO in connection with our clinical trials, following the completion of our public offering of common stock and warrants in November 2021.

 

21

 

 

We expect that our higher level of research and development expenses will continue in subsequent fiscal periods.

 

General and Administrative

 

General and administrative expenses consist primarily of salaries, bonuses, payroll taxes, severance costs and stock-based compensation to employees (excluding any cash or non-cash compensation of our Vice President of Research and Development and our laboratory staff), as well as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses. For the three months ended June 30, 2022, general and administrative expenses increased by $0.2 million, or 6%, from $3.4 million to $3.6 million, as compared to the three months ended June 30, 2021. The increase is primarily due to an increase in stock-based compensation related to various consultants and executives during three months ended June 30, 2022.

 

We expect that our general and administrative expenses will increase as we expand our staff, develop our infrastructure, and incur additional costs to support the growth of our business.

 

Interest expense

 

For the three months ended June 30, 2022, interest expense decreased $460,719, or 91%, as compared to the three months ended June 30, 2021. The decrease was due to the exchange of our outstanding interest-bearing convertible debt for common and preferred shares and warrants in connection with our public offering in November 2021.

 

Comparison of the Six Months Ended June 30, 2022 to the Six Months Ended June 30, 2021

 

Our financial results for the six months ended June 30, 2022 are summarized as follows in comparison to the six months ended June 30, 2021:

 

    For The Six Months Ended  
    June 30,  
    2022     2021  
Revenues   $ 87,100     $ 33,000  
                 
Operating Expenses:                
Marketing and promotion     714       8,820  
Consulting     121,521       10,037  
Research and development     1,850,561       326,152  
General and administrative     7,796,725       18,297,910  
Total Operating Expenses     9,769,521       18,642,919  
Loss From Operations     (9,682,421 )     (18,609,919 )
                 
Other (Income) Expense:                
Interest expense     75,624       1,106,006  
Gain on PPP loan forgiveness     (250,000 )     -  
Grant income     (16,654 )     -  
Total Other (Income) Expense     (191,030 )     1,106,006  
Net Loss   $ (9,491,391 )   $ (19,715,925 )

 

22

 

 

Revenues

 

For the six months ended June 30, 2022 and 2021, we generated $87,100 and $33,000, respectively, of royalty revenue in connection with our sublicense agreement. We do not expect that such increased level of revenues related to this agreement will continue in future periods.

 

Marketing and Promotion

 

Marketing and promotion expenses include advertising and promotion, marketing and seminars, meals, entertainment and travel expenses. For the six months ended June 30, 2022 and 2021, marketing and promotion expenses were insignificant.

 

We expect that marketing and promotion expenses will increase in the future as we increase our marketing activities following full commercialization of our products and services.

 

Consulting

 

Consulting expenses consist of consulting fees and stock-based compensation to consultants. For the six months ended June 30, 2022, consulting expenses increased by $111,484, from $10,037 to $121,521, as compared to the six months ended June 30, 2021, primarily due to stock-based compensation of $96,030 issued to consultants who provided public relations services during the six months ended June 30, 2022.

 

Research and Development

 

Research and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development; (b) our Scientific Advisory Board members; and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives. For the six months ended June 30, 2022, research and development expenses increased by $1,524,409, or 467%, from $326,152 to $1,850,561, as compared to the six months ended June 30, 2021, as we recommenced our research and development initiatives, including the engagement of PRC Clinical to serve as our CRO in connection with our clinical trials, following the completion of our public offering of common stock and warrants in November 2021.

 

We expect that our higher level of research and development expenses will continue in subsequent fiscal periods.

 

General and Administrative

 

General and administrative expenses consist primarily of salaries, bonuses, payroll taxes, severance costs and stock-based compensation to employees (excluding any cash or non-cash compensation of our Vice President of Research and Development and our laboratory staff), as well as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses. For the six months ended June 30, 2022, general and administrative expenses decreased by $10.5 million, or 57%, from $18.3 million to $7.8 million, as compared to the six months ended June 30, 2021. The decrease is primarily due to a decrease of approximately $10.5 million in stock-based compensation during the six months ended June 30, 2022 as compared to June 30, 2021, which related to grants issued to our executives.

 

We expect that our general and administrative expenses will increase as we expand our staff, develop our infrastructure, and incur additional costs to support the growth of our business.

 

Interest expense

 

For the six months ended June 30, 2022, interest expense decreased $1,030,382, or 93%, as compared to the six months ended June 30, 2021. The decrease was due to the exchange of our outstanding convertible debt for common and preferred shares and warrants in connection with our public offering in November 2021.

 

Gain on PPP loan forgiveness

 

Under the terms of the U.S. Small Business Administration’s Paycheck Protection Program (“PPP”), our $250,000 PPP loan was forgiven during the six months ended June 30, 2022.

 

23

 

 

Grant income

 

Grant income of $16,654 during the six months ended June 30, 2022 consists of funding received under a $256,000 National Institutes of Health Small Business Technology Transfer (STTR) Phase 1 grant, which we were awarded in September 2021.

 

Liquidity and Capital Resources

 

Liquidity

 

We measure our liquidity in a number of ways, including the following:

 

    June 30,     December 31,  
    2022     2021  
             
Cash   $ 17,933,724     $ 21,026,727  
                 
Working Capital   $ 17,702,436     $ 21,104,086  
                 
Notes Payable (Gross)   $ -     $ 250,000  

 

Availability of Additional Funds

 

Based upon our accumulated deficit of $143,637,519 as of June 30, 2022, along with our forecast for continued operating losses and our need for financing to fund our contemplated clinical trials, we will eventually require additional equity and/or debt financing to continue our operations. However, we believe we have sufficient liquidity to continue our operations for the next twelve months from the date of this report.

 

Our operating needs include the planned costs to operate our business, including amounts required to fund our clinical trials, working capital and capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement our product and service offerings.

 

We may be unable to raise sufficient additional capital when we need it or raise capital on favorable terms. Future financing may require us to pledge certain assets and enter into covenants that could restrict certain business activities or our ability to incur further indebtedness and may contain other terms that are not favorable to our stockholders or us. If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms.

 

Cash Flows

 

During the six months ended June 30, 2022 and 2021, our sources and uses of cash were as follows:

 

    Six Months Ended June 30,  
    2022     2021  
Net cash used in operating activities   $ (2,845,756 )   $ (1,555,530 )
Net cash used in investing activities     (247,247 )     -  
Net cash provided by financing activities     -       250,000  
Net decrease in cash   $ (3,093,003 )   $ (1,305,530 )

 

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Operating Activities

 

Net cash used in operating activities was $2,845,756 for the six months ended June 30, 2022, primarily due to cash used to fund the net loss of $9,491,391, which was partially offset by non-cash expenses of $6,595,602 related primarily to stock-based compensation and $300,033 of cash provided by changes in operating assets and liabilities. Net cash used in operating activities was $1,555,530 for the six months ended June 30, 2021, primarily due to cash used to fund the net loss of $19,715,925 which was partially offset by non-cash expenses of $17,849,822 related primarily to stock-based compensation and $310,573 of cash provided by changes in operating assets and liabilities.

 

Investing Activities

 

Net cash used in investing activities consisted of $247,247 of equipment purchases during the six months ended June 30, 2022. There were no cash flows from investing activities during the six months ended June 30, 2021.

 

Financing Activities

 

There were no cash flows from financing activities during the six months ended June 30, 2022. Net cash provided by financing activities during the six months ended June 30, 2021 was $250,000, which related entirely to a loan received under the U.S. Small Business Administration’s Paycheck Protection Program.

 

Significant Accounting Policies and Estimates

 

Our significant accounting policies are fully described in the notes to our unaudited condensed consolidated financial statements included herein for the quarter ended June 30, 2022, and in the notes to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 30, 2022 (“Annual Report”). At June 30, 2022, there were no changes to our critical accounting policies and estimates as disclosed in the Annual Report.

 

Off-Balance Sheet Arrangements

 

We have 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 stockholders.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and as such are not required to provide the information under this item.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act 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 officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives.

 

Under the supervision and with the participation of our management, including our principal executive officer and our principal financial officer, we are required to perform an evaluation of our disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Exchange Act. As of June 30, 2022 our management has completed their evaluation and has concluded that our disclosure controls and procedures were not effective, as a result of the material weaknesses in internal control over financial reporting described below, and thus that there remains a reasonable possibility that a material misstatement of the Company’s interim financial statements will not be prevented or detected on a timely basis. Our assessment of internal controls over financial reporting does not include an evaluation by the Company’s registered public accounting firm.

 

25

 

 

Material Weaknesses in Internal Control over Financial Reporting

 

Management assessed the effectiveness of the Company’s internal control over financial reporting as of the quarter ended June 30, 2022 based on the framework established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management has determined that the Company’s internal control over financial reporting as of June 30, 2022 was not effective.

 

A material weakness, as defined in the standards established by the Sarbanes-Oxley, is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis.

 

The ineffectiveness of the Company’s internal control over financial reporting was due to the following material weaknesses:

 

Lack of adherence to formal policies and procedures;
Lack of risk assessment procedures on internal controls to detect financial reporting risks in a timely manner; and
Lack of sufficient formal procedures and controls to achieve complete and accurate financial reporting and disclosures, including controls over the preparation and review of journal entries and account reconciliations.

 

Management’s Plan to Remediate the Material Weaknesses

 

Management has been implementing and continues to implement measures designed to ensure that control deficiencies contributing to the material weakness are remediated, such that these controls are designed, implemented, and operating effectively. The remediation actions include:

 

Engagement of external financial consulting firm to continue to enhance financial reporting, financial operations and internal controls; and
Documentation of key procedures and controls using a risk-based approach.

 

Management will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.

 

Changes in Internal Control Over Financial Reporting

 

Other than described above there have been no changes in our internal control over financial reporting that occurred during the three months ended June 30, 2022 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II – OTHER INFORMATION

 

Item 1A. Risk Factors

 

In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Factors That May Affect Future Results and Financial Condition” in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 30, 2022, which could materially affect our business, financial condition or future results.

 

There were no material changes in the Company’s risk factors from the risks disclosed in the Annual Report.

 

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

 

During the three months ended June 30, 2022, we issued the following securities in transactions not involving any public offering. For each of the following transactions, we relied upon Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), as transactions by an issuer not involving any public offering. For each such transaction, we did not use general solicitation or advertising to market the securities, the securities were offered to a limited number of persons, the investors had access to information regarding us (including information contained in our Annual Report on Form 10-K for the year ended December 31, 2021, our Quarterly Report on Form 10-Q for the period ended March 31, 2022, and Current Reports on Form 8-K filed with the Securities and Exchange Commission and press releases made by us), and we were available to answer questions by prospective investors. We reasonably believe that each of the investors is an accredited investor.

 

          Warrants              
Date Issued   Common Stock     Shares    

Exercise

Price

   

Term

(Years)

    Purchaser(s)     Consideration(1)  
4/29/2022     3,000           -             -       -                     (2)   $                12,660 (3)
4/29/2022     2,500       -       -       -       (2)   $ 10,550 (3)

 

(1) The value of the non-cash consideration was estimated to be the fair value of our restricted common stock. Since our shares are thinly traded in the open market, the fair value of our equity instruments was estimated by management based on observations of the cash sale prices of both restricted shares and freely tradeable shares.
(2) Accredited investor.
(3) Issued in lieu of cash for consulting services rendered.

 

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Item 6. Exhibits

 

        Incorporated by Reference

Exhibit

Number

  Exhibit Description   Form   Exhibit   Filing Date
                 
3.1   Certificate of Incorporation, as amended   10-K   3.1   3/30/2022
3.2   Certificate of Designation of Preferred Stock (Series A)   8-K   3.1   11/15/2021
3.3   Bylaws   8-K   3.4   12/23/2014
31.1*   Certification of Principal Executive Officer            
31.2*   Certification of Principal Financial Officer            
32.1**   Section 1350 Certification of Principal Executive Officer and Principal Financial Officer            
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 Date File (embedded within the Inline XBRL document)            

 

Filed herewith.
** In accordance with SEC Release 33-8238, Exhibit 32.1 is being furnished and not filed.

 

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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.

 

BIORESTORATIVE THERAPIES, INC.  
   
By: /s/ Lance Alstodt  
  Lance Alstodt  
  Chief Executive Officer, President, and Chairman of the Board  
  (Principal Executive Officer)  
Date: August 15, 2022  
   
By: /s/ Robert E. Kristal  
  Robert E. Kristal  
  Chief Financial Officer  
  (Principal Financial Officer)  
Date: August 15, 2022  

 

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