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Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended September 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: 001-41358

 

ACLARION, INC.
(Exact name of registrant as specified in its charter)

 

Delaware   47-3324725
(State or other jurisdiction of incorporation)   (IRS Employer Identification No.)

 

8181 Arista Place, Suite 100

Broomfield, Colorado 80021

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (833) 275-2266

 

Not Applicable

(Former name or former address, 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
Common Stock, par value $0.00001 per share   ACON   The Nasdaq Stock Market LLC
Warrants, each exercisable for one share of Common Stock   ACONW   The Nasdaq Stock Market LLC

 

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

 

As of November 14, 2022, there were 7,821,515 shares of the registrant's common stock, $0.00001 par value per share, outstanding.

 

   

 

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.

 

Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Forward-looking statements are subject to risks and uncertainties that could cause actual results to be materially different from those indicated (both favorably and unfavorably). These risks and uncertainties include, but are not limited to, those described in the Risk Factors section of the Company’s Prospectus dated April 21, 2022, as filed with the Securities and Exchange Commission on April 25, 2022, under Rule 424(b)(4). Caution should be taken not to place undue reliance on any such forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed as exhibits completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward- looking statements in this Quarterly Report on Form 10-Q by these cautionary statements.

 

 

 

 2 

 

 

Table of Contents

 

      Page  
PART I. FINANCIAL INFORMATION      
         
Item 1. Financial Statements   4  
  Condensed Balance Sheets   4  
  Condensed Statements of Operations   5  
  Condensed Statements of Changes in Mezzanine Shares and Deficiency in Stockholders' Equity   6  
  Condensed Statements of Cash Flows   7  
  Notes to Condensed Financial Statements   8  
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   21  
Item 3. Quantitative and Qualitative Disclosures About Market Risk   28  
Item 4. Controls and Procedures   28  
         
PART II. OTHER INFORMATION      
         
Item 1. Legal Proceedings   29  
Item 1A. Risk Factors   29  
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   29  
Item 3. Defaults Upon Senior Securities   29  
Item 4. Mine Safety Disclosures   29  
Item 5. Other Information   29  
Item 6. Exhibits   29  
  Signatures   31  

 

 

 3 

 

 

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

Aclarion, Inc.

Condensed Balance Sheets

 

 

    Sep 30, 2022     Dec 31, 2021  
    (Unaudited)        
ASSETS                
Current assets:                
Cash   $ 2,656,108     $ 432,530  
Restricted cash     10,000       20,000  
Accounts receivable, net     25,499       6,280  
Prepaids and other current assets     188,314       273,394  
Total current assets     2,879,921       732,204  
                 
Non-current assets:                
Property and equipment, net     4,035       12,636  
Intangible assets, net     1,217,206       1,144,625  
Total non-current assets     1,221,241       1,157,261  
                 
Total assets   $ 4,101,162     $ 1,889,465  
                 
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)                
                 
Current liabilities:                
Accounts payable   $ 718,278     $ 1,065,304  
Accrued and other liabilities     450,148       696,582  
Promissory note payable           2,000,000  
Preferred dividends payable           3,856,898  
Total current liabilities     1,168,426       7,618,784  
                 
Commitments and contingencies (See Note 9)            
                 
Redeemable preferred stock: (See Note 8)                
Series B-2 preferred stock - $0.0001 par value, 1,600,000 authorized and 1,584,660 shares issued and outstanding at December 31, 2021           16  
Series B-3 preferred stock - $0.0001 par value, 4,300,000 authorized and 4,228,149 shares issued and outstanding at December 31, 2021           42  
Additional paid-in capital - series B2 and B3 preferred stock           7,102,229  
Total mezzanine equity           7,102,287  
                 
Stockholders' equity (deficit):                
Series A preferred stock - $0.00001 par value, 6,247,695 authorized and 6,247,695 shares issued and outstanding at December 31, 2021           62  
Series B preferred stock - $0.00001 par value, 5,180,814 authorized and 5,160,096 shares issued and outstanding at December 31, 2021           52  
Series B-1 preferred stock - $0.00001 par value, 10,758,338 authorized and 7,274,404 shares issued and outstanding at December 31, 2021           73  
Common stock - $0.00001 par value, 200,000,000 authorized and 7,821,515 and 905,685 shares issued and outstanding (see Note 1)     78       9  
Additional paid-in capital     41,510,853       19,054,234  
Accumulated deficit     (38,578,195 )     (31,886,036 )
Total stockholders’ equity (deficit)     2,932,736       (12,831,606 )
                 
Total liabilities, mezzanine, and stockholders’ equity (deficit)   $ 4,101,162     $ 1,889,465  

 

 

See accompanying notes to condensed financial statements.

 

 

 4 

 

 

Aclarion, Inc.

Condensed Statements of Operations

(unaudited)

 

 

                 
   Three months ended September 30,   Nine months ended September 30, 
   2022   2021   2022   2021 
                 
Revenue  $18,222   $10,865   $37,924   $48,315 
Cost of Revenue   17,028    16,086    48,009    52,954 
Net profit (loss)   1,194    (5,221)   (10,085)   (4,639)
                     
Operating expenses:                    
Sales and marketing   159,388    78,377    353,456    209,206 
Research and development   290,966    275,284    848,995    605,749 
General and administrative   1,184,100    438,373    3,559,225    1,064,826 
Total operating expenses   1,634,454    792,034    4,761,676    1,879,781 
                     
Income (loss) from operations   (1,633,260)   (797,255)   (4,771,761)   (1,884,420)
                     
Other income (expense):                    
PPP Loan Forgiveness       128,320        373,511 
Interest expense   (2,070)   (167,626)   (1,505,477)   (307,668)
Changes in fair value of redeemable preferred stock       (2,122,234)       (2,122,234)
Other, net   2,297    6,377    602    4,692 
Total other income (expense)   227    (2,155,163)   (1,504,875)   (2,051,699)
                     
Income (loss) before income taxes   (1,633,033)   (2,952,418)   (6,276,636)   (3,936,119)
Income tax provision                
Net income (loss)  $(1,633,033)  $(2,952,418)  $(6,276,636)  $(3,936,119)
                     
Dividends accrued for preferred stockholders       (290,735)   (415,523)   (716,573)
Net income (loss) allocable to common stockholders  $(1,633,033)  $(3,243,153)  $(6,692,159)  $(4,652,692)
Net income (loss) per share allocable to common shareholders, basic and diluted:  $(0.21)  $(3.58)  $(1.21)  $(5.14)
Weighted average shares of common stock outstanding, basic and diluted:   7,821,515    905,685    5,516,238    905,685 

 

 

See accompanying notes to condensed financial statements.

 

 

 5 

 

Aclarion, Inc.

Condensed Statements of Changes in Mezzanine Shares and Stockholders Equity (Deficit)

(unaudited)

 

 

                                                   
   Series A-1   Series A-2   Series A-3   Series A-4   Series B 
   Preferred Stock   Preferred Stock   Preferred Stock   Preferred Stock   Preferred Stock 
   Shares   Value   Shares   Value   Shares   Value   Shares   Value   Shares   Value 
                                         
Balance, December 31, 2020   1,777,630   $18    1,444,037   $14    935,296   $9    2,090,732   $21    5,160,096   $52 
Issuance of warrants                                        
Preferred stock dividend payable                                        
Share-based compensation                                        
Net loss                                        
Balance, September 30, 2021   1,777,630   $18    1,444,037   $14    935,296   $9    2,090,732   $21    5,160,096   $52 
                                                   
                                                   
                                                   
Balance, December 31, 2021   1,777,630   $18    1,444,037   $14    935,296   $9    2,090,732   $21    5,160,096   $52 
Issuance of warrants                                        
Exercise of convertible note warrants                                        
Preferred stock dividend payable                                        
Conversion of preferred stock to common stock   (1,777,630)   (18)   (1,444,037)   (14)   (935,296)   (9)   (2,090,732)   (21)   (5,160,096)   (52)
Conversion of accrued interest on promissory notes                                        
Issuance of common stock and warrants related to IPO, net issuance costs                                        
Share-based compensation                                        
Net loss                                        
Balance, September 30, 2022      $       $       $       $       $ 

 

 

                                             
   Series B1   Series B2   Series B3           Additional         
   Preferred Stock   Preferred Stock   Preferred Stock   Common Stock   Paid-In   Accumulated     
   Shares   Value   Shares   Value   Shares   Value   Shares   Value   Capital   Deficit   Total 
                                             
Balance, December 31, 2020   7,274,404   $73       $       $    905,685   $9   $18,846,352   $(25,930,149)   (7,083,601)
Issuance of warrants                                   30,393        30,393 
Preferred stock dividend payable                                       (716,573)   (716,573)
Share-based compensation                                   93,476        93,476 
Net loss                                       (3,936,119)   (3,936,119)
Balance, September 30, 2021   7,274,404   $73       $       $    905,685   $9   $18,970,221   $(30,582,841)   (11,612,424)
                                                        
                                                        
                                                        
Balance, December 31, 2021   7,274,404   $73       $       $    905,685   $9   $19,054,234   $(31,886,036)  $(12,831,606)
Issuance of warrants                                   1,280        1,280 
Exercise of convertible note warrants                           60,408    1    152,653         152,653 
Preferred stock dividend payable                           984,537    10    4,272,411    (415,523)   3,856,898 
Conversion of preferred stock to common stock   (7,274,404)   (73)                   3,279,117    33    7,102,441        7,102,287 
Conversion of accrued interest on promissory notes                           426,768    4    1,855,154        1,855,158 
Issuance of common stock and warrants related to IPO, net issuance costs                           2,165,000    22    8,021,854        8,021,876 
Share-based compensation                                   1,050,826        1,050,826 
Net loss                                       (6,276,636)   (6,276,636)
Balance, September 30, 2022      $       $       $    7,821,515   $78   $41,510,853   $(38,578,195)   2,932,736 

 

 

 6 

 

 

Aclarion, Inc.

Condensed Statements of Cash Flows

(unaudited)

 

           
   Nine Months Ended September 30, 
   2022   2021 
Cash flows from operating activities          
Net (loss)  $(6,276,636)  $(3,936,119)
Adjustments to reconcile net (loss) to net cash used in operation activities          
Depreciation and amortization   141,852    139,847 
Share-based compensation   1,050,826    93,476 
Warrants issued as non-cash finance charge       30,393 
Gain on forgiveness of PPP loans       (373,511)
Loss on disposal of furniture and equipment   3,789     
Changes in fair value of redeemable preferred stock       2,122,234 
Change in assets and liabilities          
Accounts receivable   (19,220)   11,824 
Prepaids and other current assets   85,081    (92,710)
Accounts payable   (347,026)   157,830 
Accrued and other liabilities   981,504    164,642 
Accrued interest on promissory and convertible notes   200,712    114,404 
Net cash used in operations   (4,179,118)   (1,567,690)
           
Cash flows from investing activities          
Increase in intangible assets   (160,622)   (84,984)
Proceeds from sale of fixed assets   1,000     
Net cash used in investing activities   (159,622)   (84,984)
           
Cash flows from financing activities          
Proceeds from issuance of PPP Loan       125,000 
Proceeds from issuance of convertible notes       814,500 
Proceeds (repayment) from issuance of promissory notes   (2,000,000)   2,000,000 
Issuance of common stock and warrants related to IPO, net issuance costs   8,552,318     
Net cash provided by financing activities  $6,552,318   $2,939,500 
           
Net increase in cash   2,213,578    1,286,826 
Cash beginning of period   452,530    14,984 
Cash end of period  $2,666,108   $1,301,810 
           
Non-cash financing activities:          
Dividends accrued on preferred shares  $415,523   $716,573 
Exercise of convertible note warrants  $262,171   $ 
Conversion of preferred stock to common stock  $25,754,379   $ 
Conversion of preferred stock dividends to common stock  $4,272,420   $ 
Conversion of accrued interest on promissory notes to common stock and warrants  $1,856,438   $ 
Issuance of underwriter's warrants related to IPO  $74,677   $ 

 

 

See accompanying notes to condensed financial statements.

 

 

 7 

 

 

Aclarion, Inc.

Notes to Condensed Financial Statements

(unaudited)

 

 

NOTE 1. THE COMPANY AND BASIS OF PRESENTATION

 

The Company

 

Aclarion, Inc., formerly Nocimed, Inc., (the “Company” or “Aclarion”) is a healthcare technology company that leverages magnetic resonance spectroscopy (“MRS”), and a proprietary biomarker to optimize clinical treatments. The Company was formed in February 2015, is incorporated in Delaware, and has its principal place of business in Broomfield, Colorado.

 

Basis of Presentation

 

The accompanying condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information required by U.S. GAAP for complete financial statements. The interim condensed financial statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair representation of the results for the periods presented and should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2021, which include a complete set of footnote disclosures, including our significant accounting policies. The audited financial statements and notes thereto for the year ended December 31, 2021, are included in the Prospectus dated April 21, 2022, as filed with the SEC on April 25, 2022, under Rule 424(b)(4). The results for interim periods are not necessarily indicative of the results that may be expected for a full fiscal year or for any other future period.

 

Reclassifications

 

Certain accounts relating to the prior year have been reclassified to conform to the current period’s presentation. These reclassifications had no effect on the net income or net assets as previously reported.

 

Risks and Uncertainties

 

The Company is subject to various risks and uncertainties frequently encountered by companies in the early stages of development. Such risks and uncertainties include, but are not limited to, its limited operating history, competition from other companies, limited access to additional funds, dependence on key personnel, and management of potential rapid growth. To address these risks, the Company must, among other things, develop its customer base; implement and successfully execute its business and marketing strategy; develop follow-on products; provide superior customer service; and attract, retain, and motivate qualified personnel. There can be no guarantee that the Company will be successful in addressing these or other such risks.

 

The Company is also subject to risks and uncertainties as a result of the coronavirus disease (“COVID-19”) pandemic. The pandemic continues to evolve and its impact on the Company’s business will depend on several factors that are highly uncertain and unpredictable, including, the efficacy and adoption of vaccines, future resurgences of the virus and its variants, the imposition of governmental lockdowns, quarantine and physical distancing requirements, patient capacity at hospitals and healthcare systems, the duration and severity of healthcare worker shortages, and the willingness and ability of patients to seek care and treatment due to safety concerns or financial hardship. As such, given the dynamic nature of this situation, the Company cannot reasonably estimate the impacts of COVID-19 on our financial condition, results of operations or cash flows in the future. We are focused on navigating these recent challenges presented by COVID-19 and believe we are in a strong position to continue to sustain and grow our business.

 

 

 

 

 8 

 

 

Initial Public Offering

 

On April 21, 2022, the registration statement for our initial public offering (“IPO”) was declared effective. In connection with the effectiveness of the IPO registration statement:

 

  · we effected a 1-for-7.47 reverse stock split of our outstanding common stock;
     
  · accordingly, all common share amounts and per share data presented in our condensed financial statements have been retrospectively adjusted to reflect the reverse stock split for all periods presented;
     
  · we filed a restated Certificate of Incorporation with the State of Delaware and we adopted new restated Bylaws;
     
  · certain outstanding common stock warrants were exercised on a net share basis for 60,408 common shares (451,245 pre-split shares);
     
  · 24,495,004 (pre-split) outstanding shares of our preferred stock were converted into 3,279,117 post-split shares of common stock;
     
  · all accrued dividends on our outstanding Series B, B-1, B-2 and B-3 preferred stock were converted to 984,429 post-split common shares; and
     
  · all accrued interest on the Company's outstanding secured promissory notes was converted into (i) 426,768 post-split common shares and (ii) 426,768 post-split common stock warrants, with beneficial conversion rates charged to interest expense upon conversion.

 

On April 26, 2022, the Company completed its IPO of 2,165,000 units, at a public offering price of $4.35 per unit. Each unit consisted of (i) one share of common stock and (ii) one common stock warrant with an exercise price of $4.35 per share. Following the commencement of the IPO, the underwriters partially exercised their over-allotment option and purchased an additional 324,750 common stock warrants. After deducting underwriter's commissions and expenses, we received net proceeds of approximately $8.6 million and our common stock and warrants started trading on Nasdaq under the ticker symbols “ACON” and “ACONW”, respectively.

 

In connection with the IPO, we issued to the representative of the underwriters a common stock warrant for 173,200 shares with an exercise price of $5.44 per share. The representative's warrants are exercisable commencing October 26, 2022 and will expire on April 26, 2027.

 

On April 21, 2022, 1,204,819 outstanding common stock options previously awarded to the Company's Executive Chairman, Dr. Jeffrey Thramann, vested in connection with the completion of the IPO pursuant to the terms of such options. The exercise price of these options is $1.94 per share. The options have a 10-year term.

 

On April 21, 2022, in connection with the IPO, the Company adopted the 2022 Aclarion Equity Incentive Plan, or “2022 Plan”. Our board of directors has appointed the compensation committee of our board of directors as the committee under the 2022 Plan with the authority to administer the 2022 Plan. The aggregate number of our shares of common stock that may be issued or used for reference purposes under the 2022 Plan may not exceed 2,000,000 shares, subject to adjustments as described in the 2022 Plan.

 

On April 29, 2022, in connection with the IPO, a bonus was paid to David Neal and Brent Ness of $100,000 each. On May 13, 2022, in connection with the IPO, a bonus of $130,000 was paid to James Peacock.

 

On May 2, 2022, in connection with the IPO, the Company paid the University of California - San Francisco the amount of $123,828 to satisfy the Indexed Milestone Payment obligation included within the exclusive license agreement.

 

 

 

 

 9 

 

 

Reverse Stock Split

 

On April 21, 2022, the Company effected a 1-for-7.47 reverse stock split (the “Stock Split”) of its issued and outstanding common stock. As a result of the Stock Split, unless described otherwise, all references to common stock, options to purchase common stock, share data, per share data and related information contained in these financial statements have been retrospectively adjusted to reflect the effect of the Stock Split for all periods presented. In addition, any fractional shares that would otherwise be issued as a result of the Stock Split were rounded up to the nearest whole share. Further, the number of shares issuable and exercise prices of stock options and warrants have been retrospectively adjusted in these financial statements for all periods presented to reflect the Stock Split.

 

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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.

 

The financial statements include some amounts that are based on management's best estimates and judgments. The most significant estimates relate to depreciation, amortization, and valuation of capital stock and warrants and options to purchase shares of the Company's preferred and common stock. These estimates may be adjusted as more current information becomes available, and any adjustment could be significant.

 

Valuation of Derivative Instruments

 

Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815-40, Derivatives and Hedging: Contracts on an Entity’s Own Equity, addresses whether an equity-linked contract qualifies as equity in the entity’s financial statements. Agreements where an entity has insufficient authorized and unissued shares to settle the contract generally are accounted for as a liability and marked to fair value through earnings each reporting period. The Company evaluates its financial instruments, to determine if such instruments are liabilities or contain features that qualify as embedded derivatives. For financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then revalued at each reporting date, with changes in the fair value reported as charges or credits to income.

 

Fair Value Measurements

 

The carrying values of the Company’s financial instruments including cash equivalents, restricted cash, accounts receivable and accounts payable, and notes payable are approximately equal to their respective fair values due to the relatively short-term nature of these instruments.

 

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Assets and liabilities recorded at fair value in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair value. The fair value hierarchy distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs), and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).

 

Cash and Cash Equivalents

 

The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The Company had no cash equivalents for all periods presented. The Company maintains cash deposits at several financial institutions, which are insured by the Federal Deposit Insurance Corporation up to $250,000. The Company’s cash balance may at times exceed these limits. On September 30, 2022, and December 31, 2021, the Company had $2,416,000 and $201,000, respectively, in excess of federally insured limits. The Company continually monitors its positions with, and the credit quality of, the financial institutions with which it invests. The Company maintains no international bank accounts. As of September 30, 2022, $10,000 of the Company’s cash was restricted as collateral related to the credit card program offered by our bank.

 

 

 

 

 10 

 

 

Accounts Receivable, Less Allowance for Doubtful Accounts

 

The Company estimates an allowance for doubtful accounts based upon an evaluation of the current status of receivables, historical experience, and other factors as necessary. It is reasonably possible that the Company’s estimate of the allowance for doubtful accounts will change. The allowance for doubtful accounts was $0 at September 30, 2022, and December 31, 2021.

 

Revenue Recognition

 

Revenues are recognized when a contract with a customer exists, and at that point in time when we have delivered a Nociscan report to our customer. Revenue is recognized in the amount that reflects the negotiated consideration expected to be received in exchange for those reports. Following the delivery of the report, the company has no ongoing obligations or services to provide to the customer. Customers pay no other upfront, licensing, or other fees. To date, our reports are not reimbursable under any third-party payment arrangements, The Company invoices its customers based on the billing schedules in its sales arrangements. Payment terms range generally from 30 to 90 days, from the date of invoice.

 

Liquidity, Capital Resources and Going Concern

 

The Company believes that the net proceeds from the April 2022 initial public offering will be sufficient to fund current operating plans into the second quarter of 2023. The Company has based these estimates, however, on assumptions that may prove to be wrong, and could spend available financial resources much faster than we currently expect. The Company will need to raise additional funds to continue funding our technology development and commercialization efforts over the following nine months. Management has plans to secure such additional funding.

 

As a result of the Company’s recurring losses from operations, and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to the Company’s ability to continue as a going concern.

 

Share-Based Compensation

 

The Company issues stock-based compensation awards to employees and directors in the form of stock options. The Company measures and recognizes compensation expense for all stock-based awards based on the awards’ fair value. Share-based compensation for stock options awards are measured on the date of grant using a Black-Scholes-Merton option pricing model.

 

Awards vest either on a graded schedule or at the grant date. The Company determines the fair value of each award as a single award and recognizes the expense on a straight-line basis over the service period of the award, which is generally the vesting period. The exercise price of stock options granted is equal to the fair market value of the Company’s common stock on the date of grant. Stock options expire ten years from the date of grant.

 

Deferred Financing Costs

 

The Company capitalizes certain legal, accounting, and other fees and costs that are directly attributable to in-process equity financings as deferred offering costs until such financings are completed. Upon the completion of an equity financing, these costs are recorded as a reduction of additional paid-in capital of the related offering. Upon the completion of the IPO in April 2022, approximately $1.5 million of offering costs related to the IPO were reclassified to additional paid-in capital. The Company had no deferred financing costs as of September 30, 2022.

 

Emerging Growth Company Status

 

The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies.

 

 

 

 

 11 

 

 

NOTE 3. RECENT ACCOUNTING PRONOUNCEMENTS

 

In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”), which simplifies the accounting for convertible instruments. The guidance removes certain accounting models that separate the embedded conversion features from the host contract for convertible instruments. The guidance also modifies how certain convertible instruments, that may be settled in cash or shares, impact the calculation of diluted earnings per share. ASU 2020-06 allows for a modified or full retrospective method of transition. This update is effective for emerging growth companies following private company adoption dates in fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, and early adoption is permitted. The Company is currently evaluating the potential impact that adoption of this new standard will have on its financial statements.

 

In February 2016, the FASB issued its new lease accounting guidance in ASU 2016-02, Leases (Topic 842). Under the new guidance, lessees will be required to recognize for all leases (with the exception of short-term leases) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. ASU 2016-02, as subsequently amended for various technical issues, is effective for emerging growth companies following private company adoption dates in fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. The Company has adopted the new guidance, which did not have a material impact on its financial statements.

 

NOTE 4. REVENUE

 

Contract Balances

 

The timing of revenue recognition, billings, and cash collections may result in trade, unbilled receivables, and deferred revenues on the balance sheets. At times, revenue recognition may occur before the billing, resulting in an unbilled receivable, which would represent a contract asset. The contract asset would be a component of accounts receivable and other assets for the current and non-current portions, respectively. In the event the Company receives advances or deposits from customers before revenue is recognized, this would result in a contract liability.

 

NOTE 5. SUPPLEMENTAL FINANCIAL INFORMATION

 

Balance Sheets

 

Accrued and other liabilities

 

 

September 30,

2022

  

December 31,

2021

 
         
Accrued salaries and expenses   450,148    340,363 
Accrued interest       356,219 
Accrued and other liabilities  $450,148   $696,582 

 

NOTE 6. LEASES

 

Rent expense for the three months ended September 30, 2022 and 2021 was $1,366 and $16,933, respectively. Rent expense for the nine months ended September 30, 2022 and 2021 was $33,876, and $48,697, respectively. The Company entered into a subleasing agreement in 2021 and realized $26,340 and $25,140 of sublease income for the nine months ended September 30, 2022, and 2021. Both the lease and sublease are netted within the general & administrative line item in the Condensed Statements of Operations. Our current office lease and sublease expired on June 30, 2022.

 

 

 

 

 12 

 

 

NOTE 7. INTANGIBLE ASSETS

 

The Company’s intangible assets are as follows: 

Schedule of intangible assets 

September 30,

2022

  

December 31,

2021

 
         
Patents and licenses  $2,099,480   $1,938,858 
UC royalty   200,000    150,000 
Other   5,017    5,017 
Total intangible assets gross   2,304,497    2,093,875 
Less: accumulated amortization   (1,087,292)   (949,250)
Intangible assets, net  $1,217,206   $1,144,625 

 

Patents and licenses costs are accounted for as intangible assets and amortized over the life of the patent or license agreement and charged to research and development. UC royalties are paid annually, amortized over twelve months, and charged to cost of revenue.

 

Amortization expense related to purchased intangible assets was $33,958 and $33,387 for the three months ended September 30, 2022, and 2021, respectively. Amortization expense related to purchased intangible assets was $100,541 and $94,762 for the nine months ended September 30, 2022, and 2021, respectively.

 

NOTE 8. SHORT TERM NOTES AND CONVERTIBLE DEBT

 

Convertible Notes:

 

There were no convertible note purchases for the nine months ending September 30, 2022.

 

During the year ended December 31, 2021, and 2020, accredited investors purchased $814,500 and $1,598,488 of our convertible notes, respectively. In addition, the holders of the Company’s short-term notes exchanged their notes for this issuance of convertible notes. The convertible notes accrued interest at 10.0% per year and were originally scheduled to mature on December 31, 2020, which the holders agreed to extend until September 30, 2021. While the convertible notes contained a provision to automatically convert into shares of common stock at a discount to the price in the next Qualified Financing, the Qualified Financing did not occur prior to the June 30, 2021 maturity date of the convertible notes. In accordance with the terms of the convertible notes, the principal plus accrued, but unpaid, interest on the convertible notes (aggregating to $3,201,977) was required to be automatically converted into 4,228,149 Series B-3 Preferred Shares. The Company did not have the Series B-3 preferred shares authorized for issuance, and the Company established a liability to issue these shares. This liability was adjusted to fair value until the B-3 preferred shares were authorized and issued December 3, 2021 (See Note 10).

 

NuVasive, Inc. Convertible Note and SAFE Agreement:

 

In February 2020, NuVasive and the Company renegotiated and amended their prior marketing agreement. In consideration of changing the marketing agreement, NuVasive and the Company entered into a $2.0 million (Simple Agreement for Future Equity “SAFE”) agreement. The SAFE provided that NuVasive would receive $2 million of capital stock if the Company would raise a minimum of $10.0 million of new capital on or before December 31, 2020, which was later extended to June 30, 2021. If the $10.0 million was not raised, the Company would issue to NuVasive 1,584,660 Series B-2 preferred shares. The $10.0 million was not raised and the Company issued 1,584,660 Series B-2 preferred shares to NuVasive in December 2021.

 

The Company recorded the SAFE when issued at its fair value, which was measured at $2 million, as NuVasive was to receive a variable number of shares with an aggregate value of $2 million.

 

 

 

 

 13 

 

 

The Company recorded the liability to issue the 1,584,660 Series B-2 preferred shares at its fair value of $2 million (a per-share value of $1.2621), based on third-party valuations at June 30, 2021, and marked the liability to fair value on September 30, 2021, and at the time the B-2 preferred shares were issued December 3, 2021.

 

In March 2020, the Company negotiated an additional investment agreement with NuVasive whereby NuVasive purchased $308,720 of convertible notes under the same terms as the existing holders of the Company's convertible notes.

 

In June 2021, NuVasive’s convertible note principal plus accrued, but unpaid, interest was converted (in accordance with the terms of all of the convertible notes) into Series B-3 Preferred shares (see Convertible Notes above). The B-3 preferred shares were issued December 3, 2021.

 

Cares Act Paycheck Protection Program Loan (PPP Loan)

 

The Company did not enter into any Paycheck Protection Program (“PPP”) loans during the nine months ended September 30, 2022.

 

In April 2020 and February 2021, the Company entered into two promissory notes evidencing an unsecured loan (the “Loans”) in the amounts of $245,191 and $125,000, respectively, made to the Company under the Paycheck Protection Program (the “PPP”). The PPP was established under the CARES Act administered by the U.S. Small Business Administration.

 

The PPP promissory notes were to mature in March 2022 (2020 note) and January 2026 (2021 note) and bear interest at a rate of 1% per annum, payable monthly commencing in June 2019 and November 2020. The Loans could be prepaid by the Company at any time prior to maturity with no prepayment penalties. The proceeds from the Loans could only be used for payroll costs (including benefits), interest on mortgage obligations, rent, utilities and interest on certain other debt obligations.

 

The Loans contained customary events of default relating to, among other things, payment defaults, making materially false and misleading representations to the lender, or breaching the terms of the Loan documents. The occurrence of an event of default would result in an increase in the interest rate to 18% per annum and provide the lender with customary remedies, including the right to require immediate payment of all amounts owed under the promissory note.

 

Pursuant to the terms of the CARES Act and the PPP, the Company applied in February 2021 to the lender for forgiveness of the amount due on the Loans. In May 2021, the Company was notified that 100% of the first loan of $245,191 and related interest of $2,622 had been forgiven, and in August 2021 the Company was notified that 100% of the second loan of $125,000 and related interest of $698 had been forgiven. The amounts eligible for forgiveness was based on the amount of Loan proceeds used by the Company for the payment of certain covered costs, including payroll costs (including benefits), interest on mortgage obligations, rent and utilities, subject to certain limitations and reductions in accordance with the CARES Act and the PPP.

 

Promissory Notes Payable

 

In June 2021, the Company issued $2.0 million of promissory notes that matured at the earlier of the consummation of a Qualified Financing or May 31, 2022. The promissory notes incorporated the following major attributes: secured by a lien and security interest on substantially all of the Company’s assets; interest accrues at 33%; holder option to convert the accrued interest into the Company securities being offered in a Qualified Financing at 30% (i.e. 70% discount) of the price being paid by other investors in the Qualified Financing; and automatic conversion in the case of a Qualifying IPO of the accrued interest into the Company securities being offered in the Qualifying IPO at 30% (70% discount) of the price being paid by other investors in the Qualifying IPO. If the promissory notes remained outstanding after May 31, 2022, the Company had the option to extend the promissory notes upon the payment of an extension fee, which consisted of 150,000 warrants (20,080 warrants post-split) with a five-year term, to purchase shares of the Company’s common stock at a price of $ 0.01 per share ($0.0747 post-split).

 

On April 21, 2022, the registration statement for our initial public offering (IPO) was declared effective. In connection with the effectiveness of the IPO registration statement, all accrued interest on the Company's outstanding secured promissory notes was converted into (i) 426,768 post-split common shares and (ii) 426,768 post-split common stock warrants, with a $1,299,507 beneficial conversion rate charged to interest expense.

 

On April 27, 2022, the Company used $2 million of the IPO proceeds to retire all outstanding secured promissory notes. 

 

 

 

 

 14 

 

 

NOTE 9. COMMITMENTS AND CONTINGENCIES

 

Royalty Agreement

 

The Company has an exclusive license agreement with the Regents of the University of California to make, use, sell and otherwise distribute products under certain of the Regents of the University of California’s patents anywhere in the world. The Company is obligated to pay a minimum annual royalty of $50,000, and an earned royalty of 4% of net sales. The minimum annual royalty will be applied against the earned royalty due for the calendar year in which the minimum payment was made. The license agreements expire upon expiration of the patents and may be terminated earlier if the Company so elects. The U.S. licensed patents that are currently issued expire between 2026 and 2029, without considering any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The Company recorded royalty costs of $12,500 for the three months ended September 30, 2022, and 2021, respectively, and $37,500 for the nine months ended September 30, 2022, and 2021, respectively, which were recorded in cost of revenue.

 

Additionally, the Company was obligated to make a cash Indexed Milestone Payment to the Regents of the University of California in the event of either a Change of Control or an Initial Public Offering (IPO). This cash payment was calculated as follows: 28,532 post-split shares (213,313 pre-split shares) of Company common stock times the IPO price of $4.34. On May 2, 2022, in connection with the IPO, the Company paid the University of California - San Francisco the amount of $123,828 to satisfy the Indexed Milestone Payment obligation included within the exclusive license agreement.

 

Litigation

 

To date, the Company has not been involved in legal proceedings arising in the ordinary course of its business. If any legal proceeding occurs, the Company would record a provision for a loss when it believes that it is both probable that a loss has been incurred and the amount can be reasonably estimated, although litigation is inherently unpredictable and is subject to significant uncertainties, some of which are beyond the Company’s control. Should any of these estimates and assumptions change or prove to have been incorrect, the Company could incur significant charges related to legal matters that could have a material impact on its results of operations, financial position and cash flows.

 

Stock Option Grant to our Executive Chairman

 

In September 2021, the Board of Directions approved a stock option grant of 1,204,819 post-split shares to Dr. Jeffrey Thramann, our Executive Chairman. These options are conditional, such that they vest only upon the occurrence of certain specified events, including an IPO, a next round financing, the merger of the Company with a SPAC, or the sale of the Company. The amount of stock options that will vest upon such specified events depends upon the terms and timing of the applicable event. In the case of an IPO, the number of shares that will vest is equal to 16.7% of the Company’s pre-IPO fully diluted shares (inclusive of the portion of Dr. Thramann’s option grant that will become vested). Any remaining portion of the option grant will be cancelled. The agreement with Dr. Thramann also contains provisions in the event of his voluntary resignation from the company, as well as other provisions if he is terminated by the Company.

 

On April 21, 2022, 1,204,819 outstanding common stock options previously awarded to Dr. Jeffrey Thramann vested in connection with the completion of the IPO pursuant to the terms of such options. The exercise price of these options is $1.94 per share. The options have a 10-year term.

 

 

 

 

 15 
 

 

 

NOTE 10. STOCKHOLDERS’ EQUITY

 

The Company filed an Amended and Restated Certificate of Incorporation on April 21, 2022, as part of the initial public offering (IPO). The Company is authorized to issue two classes of stock to be designated, respectively, “Common Stock” and “Preferred Stock.” The total number of shares which the Company is authorized to issue is two hundred twenty million (220,000,000) shares. Two hundred million (200,000,000) shares are authorized to be Common Stock, having a par value per share of $0.00001. Twenty million (20,000,000) shares are authorized to be Preferred Stock, having a par value per share of $0.00001.

 

Prior to the IPO, the Company had authorized two classes of shares. These classes included shares of common stock and preferred stock. There was one authorized series of shares of common stock and eight existing authorized series of preferred stock: Series A-1, A-2, A-3, A-4, B, B-1, B-2, and B-3.

 

The preferred shares converted to common shares on a 1:1 pre-split basis immediately prior to the Stock Split on April 21, 2022. Those common shares were adjusted to reflect the Stock Split as described in Note 1 Reverse Stock Split.

 

Preference Amounts  Issue Date  Total Face Value of Investment   Issue Purchase Price/Share 
            
Series A-1 Preferred Stock  12/31/2014  $1,247,541   $0.70 
Series A-1 has a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation is capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
Series A-2 Preferred Stock  12/31/2014  $1,114,797   $0.77 
Series A-2 has a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation is capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
Series A-3 Preferred Stock  12/31/2014  $795,002   $0.85 
Series A-3 has a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation is capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
Series A-4 Preferred Stock  12/31/2014  $1,965,288   $0.94 
Series A-4 has a 1x liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation is capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
Series B Preferred Stock  12/5/2015  $5,013,579   $1.00 
Series B has a 1x senior liquidation preference junior to B/B1 plus participation on an as-converted to common basis, which participation is capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
The dividend rate is 6.0% Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. 
            
Series B-1 Preferred Stock  7/27/2017  $1,500,000   $1.26 
   8/2/2018  $5,217,698   $1.26 
   3/1/2019  $2,463,328   $1.26 
              
Series B-1 has a 1x senior liquidation preference junior to B2/B3 plus participation on an as-converted to common basis, which participation is capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
The dividend rate is 6.0%. Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. 

 

 

 

 16 

 

 

Preference Amounts  Issue Date  Total Face Value of Investment   Issue Purchase Price/Share 
              
Series B-2 Preferred Stock  12/3/2021  $1,774,819   $1.12 
              
Series B-2 has a 1x senior liquidation preference plus participation on an as-converted to common basis, which participation is capped at 3x, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
The dividend rate is 6.0%. Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. Redemption is available by a majority vote of holders commencing after fifth anniversary from issuance, payable in three annual installments. 
              
Series B-3 Preferred Stock  12/3/2021  $5,327,468   $1.26 
              
Series B-3 has a 2x senior liquidation preference, conversion into common stock at a ratio of 1:1, limited anti-dilution protection, and voting rights on an as-converted to common basis. 
              
The dividend rate is 6.0%. Dividends are cumulative. Accrued and unpaid dividends are payable in shares of common stock in certain events (including an IPO) at the then current fair market value of the common stock. Redemption is available by a majority vote of holders commencing after fifth anniversary from issuance, payable in three annual installments. 

 

Warrants

 

Warrants issued with Convertible Notes

 

During the years ended December 31, 2021, and 2020, the Company issued 17,286 and 58,846 warrants, respectively, to certain investors who participated over an agreed investment minimum amount in the purchase of our convertible notes. The value of the warrants was recorded as a debt discount and expensed based on the fair value. Just prior to the IPO, these common stock warrants were exercised on a net share basis for 60,408 common shares (451,245 pre-split shares). A loss on warrants exercised of $152,653 was recorded.

 

Warrants issued in connection with the IPO

 

In connection with the Company’s IPO, all accrued interest on the Company's outstanding secured promissory notes were converted into (i) 426,768 post-split common shares and (ii) 426,768 post-split common stock warrants, with beneficial conversion rates charged to interest expense upon conversion. These warrants have an exercise price of $4.35 per share.

 

In the IPO, the Company sold 2,165,000 units, at a public offering price of $4.35 per unit. Each unit consisted of (i) one share of common stock and (ii) one common stock warrant (“IPO Warrant”) with an exercise price of $4.35 per share. The common stock and the IPO Warrants were immediately separable and issued separately in the offering. The IPO Warrants are listed and tradeable on the NASDAQ stock market, immediately exercisable at the option of the holder, and expire five years from the date of issuance.

 

On April 22, 2022, the underwriters partially exercised their over-allotment option for an additional 324,750 IPO Warrants.

 

In connection with the IPO, we issued to the representative of the underwriters common stock warrants for 173,200 shares with an exercise price of $5.44 per share. The representative's warrants are exercisable commencing October 26, 2022, and will expire on April 26, 2027.

 

The Company evaluated the terms of all warrants issued at the IPO and determined that they should be classified as equity instruments based upon accounting guidance provided in ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. Since the Company determined that the warrants were equity classified, the Company recorded the proceeds from the IPO, net of issuance costs, within common stock at par value and the balance of proceeds to additional paid in capital.

 

As of September 30, 2022, 2,489,750 IPO Warrants were outstanding.

 

 

 

 

 17 

 

 

NOTE 11. NET LOSS PER SHARE OF COMMON STOCK

 

Basic and diluted net loss per share is computed by dividing net loss attributable to stockholders by the weighted average number shares of common stock outstanding during the year. Potentially dilutive outstanding shares of common stock equivalents were excluded from the computation of diluted net loss per share for loss periods presented because including them would have been antidilutive.

 

A reconciliation of the numerator and denominator used in the calculation of basic and diluted net loss per share attributable to stockholders follows:

 

                
   Three Months Ended September 30,   Nine Months Ended September 30, 
   2022   2021   2022   2021 
Numerator:                
Net (loss) used to compute basic and diluted loss per common share  $(1,633,033)  $(3,243,153)  $(6,692,159)  $(4,652,692)
Denominator:                    
Weighted average shares used to compute basic and dilutive loss per share   7,821,515    905,685    5,516,238    905,685 

 

The potentially dilutive shares of the Company’s common stock resulting from the assumed exercise of outstanding stock options, warrants, and the conversion of preferred shares are excluded from the computation of diluted net loss per share when their effect would have been anti-dilutive. Net loss per share excluded 5,617,143 and 3,562,379 shares for the three months ended September 30, 2022, and 2021, respectively, and 5,588,823 and 3,131,860 shares for the nine months ended September 30, 2022, and 2021, respectively.

 

NOTE 12. STOCK OPTION PLANS

 

2022 Aclarion Equity Incentive Plan

 

On April 21, 2022, in connection with the IPO, the Company adopted the 2022 Aclarion Equity Incentive Plan, or “2022 Plan”. Our board of directors has appointed the compensation committee of our board of directors as the committee under the 2022 Plan with the authority to administer the 2022 Plan. The aggregate number of our shares of common stock that may be issued or used for reference purposes under the 2022 Plan may not exceed 2,000,000 shares, subject to adjustments as described in the 2022 Plan.

 

Options granted under the 2022 Plan may be incentive stock options or non-statutory stock options, as determined by the administrator at the time of grant of an option. Restricted stock may also be granted under the 2022 Plan. The options vest in accordance with the grant terms and are exercisable for a period of up to 10 years from grant date.

 

The fair value of the options granted for the three months and nine months ended September 30, 2022, were estimated at the date of grant using the Black-Scholes-Merton option pricing model with the following assumptions:

Risk-free interest rate (4/2022 – 8/2022)     1.99%  
Risk-free interest rate (9/2022)     3.67%  
Dividend yield     0.00  
Expected term     6-8 years  
Expected volatility     66.35%  

 

 

 

 

 

 18 

 

 

Nocimed, Inc. 2015 Stock Plan

 

The Company maintains the Nocimed, Inc. 2015 Stock Plan, or the “Existing Plan”, under which the Company could grant 2,440,931 post-split shares or options of the Company to our employees, consultants, and other service providers. The Company has suspended the Existing Plan in connection with the IPO. No further awards will be granted under the Existing Plan, but awards granted prior to the suspension date will continue in accordance with their terms and the terms of the Existing Plan.

 

The fair value of the options granted for the nine months ended September 30, 2022, and 2021, were estimated at the date of grant using the Black-Scholes-Merton option pricing model with the following assumptions:

Risk-free interest rate     1.99%  
Dividend yield     0.00  
Expected term     6-8 years  
Expected volatility     25.00%  

  

Determining Fair Value of Stock Options

 

The fair value of each grant of stock options was determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.

 

Valuation and Amortization Method —The Company estimates the fair value of its stock options using the Black-Scholes-Merton option-pricing model. This fair value is then amortized over the requisite service periods of the awards.

 

Expected Term—The Company estimates the expected term of stock option by taking the average of the vesting term and the contractual term of the option, as illustrated by the simplified method.

 

Expected Volatility—The expected volatility is derived from the Company’s expectations of future market volatility over the expected term of the options.

 

Risk-Free Interest Rate—The risk-free interest rate is based on the U.S. Treasury yield curve on the date of grant.

 

Dividend Yield—The dividend yield assumption is based on the Company’s history and expectation of no dividend payouts.

 

Stock Award Activity

 

A summary of option activity under the Company’s incentive plans is as follows:

                     
   Options Outstanding   Weighted Average Exercise Price   Weighted Average Remaining Contractual Life (In Years)   Aggregate Intrinsic Value of Unexercised Options 
Balance at December 31, 2021   2,255,672   $1.84    9.2     
Options granted   529,619                
Options exercised                    
Options forfeited/expired   (50,201)               
Balance at September 30, 2022   2,735,090   $1.91    8.6      
                     
Exercisable at December 31, 2021   592,532   $1.58        $215,641 
Exercisable at September 30, 2022   2,101,708   $1.86        $0 

 

 

 

 

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The aggregate intrinsic value in the table above of the unexercised options reflects the total pre-tax intrinsic value (the difference between the Nasdaq closing price on September 30, 2022 and the exercise price of the options that would have been received by option holders if all options exercisable had been exercised). 

 

The following table summarizes the total stock-based compensation expense included in the Company’s statements of operations for the periods presented:

                
   Three months ended September 30,   Nine months ended September 30, 
   2022   2021   2022   2021 
                 
Sales and marketing  $848   $1,850   $2,544   $2,890 
Research and development   4,272    10,994    10,401    12,610 
General and administrative   321,079    71,168    1,037,882    77,976 
Share-based compensation  $326,199   $84,012   $1,050,826   $93,476 

 

As of September 30, 2022, total unrecognized compensation cost related to stock options was $615,973 and the weighted average period over which this cost is expected to be recognized is 8.6 years.

 

NOTE 13. SUBSEQUENT EVENTS

 

In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 855, Subsequent Events, management has performed an evaluation of subsequent events through the date that the financial statements were available to be issued on November 14, 2022, and has determined that it does not have any material subsequent events to disclose in these financial statements.

 

 

 

 

 

 

 20 

 

 

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

 

The following discussion and analysis should be read in conjunction with the unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report and our audited financial statements and related notes included in our Prospectus dated April 21, 2022 as filed with the SEC on April 25, 2022 under Rule 424(b)(4). This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report. You should carefully read the “Risk Factors” section of this Quarterly Report and of our Prospectus dated April 21, 2022 as filed with the SEC on April 25, 2022 under Rule 424(b)(4) to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section entitled “Special Note Regarding Forward-Looking Statements.”

 

Overview

 

Corporate Information

 

We currently operate as a Delaware corporation, under the name Aclarion, Inc.

 

Effect of COVID-19 Pandemic on business operations

 

The COVID-19 Pandemic is not currently impacting plans for marketing our products or our continuing development efforts, as all such activities have been conducted by us using remote work strategies. The Company cannot accurately predict the longer- term impact of the COVID-19 Pandemic on its business.

 

 

 

 

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Results of operations

 

For the Three Months Ended September 30, 2022, and 2021:

 

The following table summarizes our results of operations for the three months ended September 30, 2022, and 2021.

 

   Three Months Ended September 30,   Change 
   2022   2021   Amount 
             
Revenue  $18,222   $10,865   $7,357 
Cost of revenue   17,028    16,086    942 
Gross margin   1,194    (5,221)   6,415 
                
Operating expenses:               
Sales and marketing   159,388    78,377    81,011 
Research and development   290,966    275,284    15,682 
General and administrative   1,184,100    438,373    745,727 
Total operating expenses   1,634,454    792,034    842,420 
                
Income (loss) from operations   (1,633,260)   (797,255)   (836,005)
                
Other income (expense):               
PPP loan forgiveness       128,320    (128,320)
Interest expense   (2,070)   (167,626)   165,556 
Changes in fair value of redeemable preferred stock       (2,122,234)   2,122,234 
Other, net   2,297    6,377    (4,080)
Total other income (expense)   227    (2,155,163)   2,155,390 
                
Income (loss) before income taxes   (1,633,033)   (2,952,418)   1,319,385 
Income tax provision               
Net income (loss)  $(1,633,033)   (2,952,418)  $1,319,385 
                
Dividends accrued for preferred stockholders:  $   $(290,735)  $290,735 
Net income (loss) allocable to common stockholders:  $(1,633,033)  $(3,243,153)  $1,610,120 
Net income (loss) per share allocable to common stockholders, basic and diluted:  $(0.21)  $(3.58)  $3.37 
Weighted average shares of common stock outstanding, basic and diluted: (1)   7,821,515    905,685    6,915,830 

 

(1) The weighted average shares of common stock outstanding is presented on a post-split basis. The Company implemented to a 1-for-7.47 reverse stock split of our shares of common stock immediately prior to the effectiveness of our IPO on April 21, 2022.

  

 

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Total revenues. Total revenues for the quarter ended September 30, 2022 were $18,222, which was an increase of $7,357, or 68%, from $10,865 for the quarter ended September 30, 2021. The increase in revenues resulted from a Purchase Order from the University of North Carolina at Chapel Hill for site trainings.

 

Cost of Revenue. Direct cost of revenue is comprised of hosting and software costs, field support, UCSF royalty cost, NuVasive commission of 6%, partner fees (Radnet), and credit card fees. Total cost of revenue was $17,028 for the quarter ended September 30, 2022, compared to $16,086 for the quarter ended September 30, 2021, an increase of 6%. This change is due to the increase in revenues and related costs.

 

Sales and Marketing. Sales and marketing expenses were $159,388 for the quarter ended September 30, 2022, compared to $78,377 for the quarter ended September 30, 2021, an increase of $81,011 or 103%. This increase was driven by investment in website and branding development.

 

Research and Development. Research and development expenses were $290,966 for the quarter ended September 30, 2022, compared to $275,284 for the quarter ended September 30, 2021, an increase of $15,682 or 6%. The increase was due to additional project engineering services.

 

General and Administrative. General and administrative expenses were $1,184,099 for the quarter ended September 30, 2022, an increase of $745,726 or 170%, from $438,373 for the quarter ended September 30, 2021. The increase in general and administrative expenses was driven by increased compensation expense related to the vesting of the Executive Chairman’s and executive’s outstanding common stock options, increased compensation expense related to new management, increased compensation expense related to management and Executive Chairman bonuses, and an increase in directors’ and officers’ liability insurance.

 

Interest Expense. Interest expense was $2,070 for the quarter ended September 30, 2022, a decrease of $165,556, from the $167,626 for the quarter ended September 30, 2021. The decrease in interest expense was primarily driven by the interest expense on a promissory note converted into common shares and common stock warrants in connection with the effectiveness of the IPO.

 

 

 

 

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For the Nine Months Ended September 30, 2022, and 2021:

 

The following table summarizes our results of operations for the nine months ended September 30, 2022, and 2021.

 

   Nine Months Ended September 30,   Change 
   2022   2021   Amount 
             
Revenue  $37,924   $48,315   $(10,391)
Cost of revenue   48,009    52,954    (4,945)
Gross margin   (10,085)   (4,639   (5,446)
                
Operating expenses:               
Sales and marketing   353,456    209,206    144,250 
Research and development   848,995    605,749    243,246 
General and administrative   3,559,225    1,064,826    2,494,399 
Total operating expenses   4,761,676    1,879,781    2,881,895 
                
Income (loss) from operations   (4,771,761)   (1,884,420)   (2,887,341)
                
Other income (expense):               
PPP loan forgiveness       373,511    (373,511)
Interest expense   (1,505,477)   (307,668)   (1,197,809)
Changes in fair value of redeemable preferred stock       (2,122,234)   2,122,234 
Other, net   602    4,692    (4,090)
Total other income (expense)   (1,504,875)   (2,051,699)   546,824 
                
(Loss) before income taxes   (6,276,636)   (3,936,119)   (2,340,517)
Income tax provision            
Net (loss)  $(6,276,636)   (3,936,119)  $(2,340,517)
                
Dividends accrued for preferred stockholders:  $(415,523)  $(716,573)  $301,050 
Net income (loss) allocable to common stockholders:  $(6,692,159)  $(4,652,692)  $(2,039,467)
Net income (loss) per share allocable to common stockholders, basic and diluted:  $(1.21)  $(5.14)  $3.92 
Weighted average shares of common stock outstanding, basic and diluted: (1)   5,516,238    905,685    4,610,553 

  

Total revenues. Total revenues for the nine months ended September 30, 2022 were $37,924, which was a decrease of $10,391, or 22%, from $48,315 for the nine months ended September 30, 2021. The decrease in revenues resulted from a decrease in the number of medical professionals ordering Nociscan reports for their patients, with no material changes in prices during the year.

 

Cost of Revenue. Direct cost of revenue is comprised of hosting and software costs, field support, UCSF royalty cost, NuVasive commission of 6%, partner fees (Radnet), and credit card fees. Total cost of revenue was $48,009 for the nine months ended September 30, 2022, compared to $52,954 for the nine months ended September 30, 2021, a decrease of $4,945, or 9%. This change is due to the decrease in revenues and related costs.

 

Sales and Marketing. Sales and marketing expenses were $353,456 for the nine months ended September 30, 2022, compared to $209,206 for the nine months ended September 30, 2021, an increase of $144,250, or 69%, This increase was driven by investment in website and branding development.

 

 

 

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Research and Development. Research and development expenses were $848,995 for the nine months ended September 30, 2022, compared to $605,749 for the nine months ended September 30, 2021, an increase of $243,246 or 40%. Approximately $123,000 of the increase was related to the milestone payment to UCSF.  The remaining increase was due to additional project engineering services.

 

General and Administrative. General and administrative expenses were $3,559,225 for the nine months ended September 30, 2022, an increase of $2,494,399 or 234%, from $1,064,826 for the nine months ended September 30, 2021. The increase in general and administrative expenses was driven by increased compensation expense related to the vesting of the Executive Chairman’s and executive’s outstanding common stock options, increased compensation expense related to new management, director and executive chairman bonuses, and an increase in directors’ and officers’ liability insurance.

 

Interest Expense. Interest expense was $1,505,477 for the nine months ended September 30, 2022, an increase of $1,197,809, or 389%, from the $307,668 for the nine months ended September 30, 2021. The increase in interest expense was primarily driven by the $1.3 million beneficial conversion rate charged to interest expense for the conversion of all accrued interest on the Company's outstanding secured promissory notes into common shares and common stock warrants in connection with the effectiveness of the IPO.

 

Critical accounting policies and use of estimates

 

Our Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.

 

While our significant accounting policies are described in more detail in the notes to our financial statements appearing at the end of this prospectus, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

 

Revenue Recognition

 

The Company derives its revenues from one source, the delivery of Nociscan reports to medical professionals. Revenues are recognized when a contract with a customer exists, and the control of the promised services are transferred to our customers. The amount of revenue recognized reflects the consideration we expect to receive in exchange for those services. Substantially all of our revenues are generated from contracts with customers in the United States.

 

Equity-Based Compensation

 

Certain of our employees and consultants have received grants of common stock options in our company. These awards are accounted for in accordance with guidance prescribed for accounting for equity-based compensation. Based on this guidance and the terms of the awards, the awards are equity classified.

 

Until our April 2022 IPO, we were a private company with no active public market for our common equity. Therefore, we had periodically determined the overall value of our company and the estimated per share fair value of our common equity at their various dates using contemporaneous valuations performed in accordance with the guidance outlined in the American Institute of CPA’s Practice Aid. Since a public trading market for our common stock has been established in connection with the completion of our IPO, it will no longer be necessary for us to estimate the fair value of our common stock in connection with our accounting for equity awards we may grant, as the fair value of our common stock will be its public market trading price.

 

For financial reporting purposes, we performed common stock valuations as a private company with the assistance of a third-party specialist.  Subsequent to the initial public offering, the fair value of the Company’s common stock underlying its equity awards is based on the quoted market price of the Company’s common stock on the grant date.

 

 

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Going Concern

 

The Company believes that cash on hand of $2.7 million will be sufficient to fund current operating plans into the second quarter of 2023. The Company has based these estimates, however, on assumptions that may prove to be wrong, and could spend available financial resources much faster than we currently expect. The Company will need to raise additional funds to continue funding our technology development and commercialization efforts over the following nine months. Management has plans to secure such additional funding.

 

As a result of the Company’s recurring losses from operations, and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to the Company’s ability to continue as a going concern.

 

Liquidity and capital resources

 

Sources of liquidity

 

To date, we have financed our operations primarily through private placements of preferred shares and debt financing, PPP loans that were forgiven, and an initial public offering on April 21, 2022.

 

Through September 30, 2022, we raised an aggregate of $33,145,148 of gross proceeds from $19,319,098 of preferred and common stock, $2,928,541 from the sale of convertible notes, $2,000,000 from secured promissory notes payable, $370,191 of PPP loans that were forgiven, and net proceeds of $8,527,318 from the IPO, after underwriter compensation and deductions. As of September 30, 2022, we had cash of $2,666,108.

 

Cash flows

 

The following table summarizes our sources and uses of cash for each of the periods presented:

 

   Nine months Ended September 30, 
   2022   2021 
         
Cash used in operating activities  $(4,179,118)  $(1,567,690)
Cash used in investing activities   (159,622)   (84,984)
Cash provided by financing activities   6,552,318    2,939,500 
Net increase in cash  $2,213,578   $1,286,826 

 

Operating activities

 

During the nine months ended September 30, 2022, operating activities used $4,179,118 of cash.  This use of cash consisted primarily of compensation and benefit expense, bonuses in connection with the completion of the IPO, a milestone payment to UCSF, directors’ and officers’ liability insurance, and pre-IPO marketing activities. During the nine months ended September 30, 2021, operating activities used $1,567,690 of cash, consisting primarily of compensation and benefit expense, consulting, and professional fees.

 

Investing activities

 

During the nine months ended September 30, 2022 and 2021, investing activities used $159,622 and $84,984 of cash, respectively. These investing activities consisted almost entirely of patent and license maintenance.

 

 

 26 

 

 

Financing activities

 

During the nine months ended September 30, 2022, net cash provided by financing activities was $6,552,318, which included the net of $8,552,318 (net of underwriter compensation and deductions but excluding $25,000 pre-payment in 2021) of initial public offering proceeds and $2,000,000 repayment of promissory notes. During the nine months ended September 30, 2021, net cash provided by financing activities was $2,939,500, which included $2,000,000 from issuance of promissory notes, $814,500 from our sale of convertible notes and the issuance of a $125,000 PPP loan to the Company.

 

Funding requirements

 

Developing medical technology products is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate meaningful revenues. Accordingly, we may need to obtain substantial additional funds to achieve our business objectives.

 

Adequate additional funds may not be available to us on acceptable terms, or at all. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity securities, the ownership interest of existing stockholders may be diluted. Any debt or preferred equity financing, if available, may involve agreements that include restrictive covenants that may limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, which could adversely impact our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute existing stockholders’ ownership interests.

 

If we raise additional funds through licensing agreements and strategic collaborations with third parties, we may have to relinquish valuable rights to our technology, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds, we may be required to delay, limit, reduce and/or terminate development of our product candidates or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

 

Contractual obligations and commitments

 

Our current office lease and sublease expired on June 30, 2022.  The Company does not have any contractual obligations not otherwise on our balance sheet as of September 30, 2022.

  

Off-balance sheet arrangements

 

We did not have, during the periods presented, and we do not currently have any off-balance sheet arrangements as defined in the rules and regulations of the SEC.

 

Recently issued accounting pronouncements

 

We have reviewed all recently issued standards and have determined that, other than as disclosed in Note 2 to our condensed financial statements appearing in this quarterly report, such standards will not have a material impact on our financial statements or do not otherwise apply to our operations.

 

Emerging growth company and smaller reporting company status

 

The JOBS Act permits an emerging growth company such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of this extended transition period and, as a result, we will not adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for public entities. Accordingly, our financial statements may not be comparable to other public companies that do not elect the extended transition period.

 

 

 27 

 

 

We are also a “smaller reporting company” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

 

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 are not required to provide the information required under this item.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our chief executive and financial officers, evaluated the effectiveness of our disclosures controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of September 30, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2022, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

Management determined that, as of September 30, 2022, there were no changes in our internal control over financial reporting that occurred during the fiscal quarter then ended that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 28 

 

 

PART II—OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any material legal proceedings, the adverse outcome of which, in our management’s opinion, individually or in the aggregate, could have a material adverse effect on the results of our operations or financial position. There are no material proceedings in which any of our directors, officers or affiliates or any registered or beneficial stockholder of more than 5% of our common stock is an adverse party or has a material interest adverse to our interest.

 

Item 1A. Risk Factors.

 

In addition to the information set forth in this Form 10-Q, you should carefully consider the risk factors disclosed in the Risk Factors section of the Company’s Prospectus dated April 21, 2022, as filed with the SEC on April 25, 2022, under Rule 424(b)(4). There have been no material changes to our risk factors from those included in such Prospectus. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.

 

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

 

Item 6. Exhibits.

 

The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Quarterly Report are listed in the Exhibit Index below. The exhibits listed in the Exhibit Index are incorporated by reference herein.

 

Exhibit

Number

  Description of Document  

Incorporated by

reference from Form

 

Filing

Date

 

Exhibit

Number

 

Filed

Herewith

                     
1.1   Underwriting Agreement dated April 21, 2022   8-K   04-27-2022   1.1    
3.1   Certificate of Incorporation of the Company   8-K   04-27-2022   3.1    
3.2   Bylaws of the Company   8-K   04-27-2022   3.2    
4.1   Form of Common Stock Certificate   10-Q   06-06-2022   4.1    
4.2   Form of Public Warrant   8-K   04-27-2022   4.1    
4.3   Form of Representative’s Common Stock Purchase Warrant   8-K   04-27-2022   4.2    
4.4   Description of Securities   10-Q   06-06-2022   4.4    

 

 

 29 

 

 

10.1 # Employment Agreement of Jeff Thramann   S-1/A   03-23-2022   10.1    
10.2 # Employment Agreement of Brent Ness   S-1/A   03-23-2022   10.2    
10.3 # Employment Agreement of John Lorbiecki   S-1/A   03-23-2022   10.3    
10.4 # Form of Aclarion, Inc. 2022 Equity Incentive Plan   S-1   01-06-2022   10.4    
10.5   Senior Secured Bridge Note   S-1/A   03-04-2022   10.5    
10.6   License Agreement with UCSF the Regents of the University of California   S-1   01-06-2022   10.6    
10.7   Amendment to UC License Agreement   S-1/A   03-04-2022   10.7    
10.8 ** NuVasive Amended and Restated Commission Agreement dated February 28, 2020   S-1/A   03-23-2022   10.8    
10.9   Amended and Restated Investor Rights Agreement dated July 27, 2017   S-1/A   03-23-2022   10.9    
10.10   First Amendment to Amended and Restated Investor Rights Agreement dated February 20, 2020   S-1/A   03-23-2022   10.10    
10.11   NuVasive SAFE (Simple Agreement for Future Equity) dated February 28, 2020   S-1/A   03-23-2022   10.11    
10.12 ** Right of First Offer Agreement   S-1/A   03-23-2022   10.12    
10.13   First Amendment to Right of First Offer Agreement   S-1/A   03-23-2022   10.13    
10.14   Second Amendment to Right of First Offer Agreement   S-1/A   03-23-2022   10.14    
10.15   Convertible Note and Warrant Purchase Agreement   S-1/A   03-23-2022   10.16    
10.16   Warrant Agent Agreement dated April 21, 2022   8-K   04-27-2022   10.1    
10.17   Siemens Strategic Collaboration Agreement   S-1   01-06-2022   10.17    
10.18 # Aclarion, Inc. 2022 Equity Incentive Plan – Form of Option Grant Notice and Stock Option Agreement   S-1   01-06-2022   10.20    
10.19 # Aclarion, Inc. 2022 Equity Incentive Plan – Form of RSU Grant Notice and RSU Agreement   S-1   01-06-2022   10.21    
10.20 # Nocimed, Inc. 2015 Stock Plan   S-8   05-26-2022   99.4    
10.21 # Nocimed, Inc. 2015 Stock Plan – Form of Option Grant Notice and Stock Option Agreement   S-8   05-26-2022   99.5    
31.1   Section 302 Certification by the Corporation’s Chief Executive Officer               X
31.2   Section 302 Certification by the Corporation’s Chief Financial Officer               X
32.1   Section 906 Certification by the Corporation’s Chief Executive Officer               X
32.2   Section 906 Certification by the Corporation’s Chief Financial Officer               X
     
101.INS   Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL 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 in IXBRL, and included in exhibit 101).

___________________________

# Indicates management contract or compensatory plan.
** Certain portions of the exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.

 

 

 30 

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) 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.

 

  ACLARION, INC.  
       
  By: /s/ John Lorbiecki  
    John Lorbiecki  
   

Chief Financial Officer

(Principal Financial and Accounting Officer

 
Date: November 14, 2022      

 

 

 

 31 

 

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