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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, 2018

2020

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 001-38815

soly-20200930_g1.jpg
Soliton, Inc.


(Exact Name of Registrant as Specified in Its Charter)


Delaware

36-4729076

Delaware

384136-4729076
(State or Other Jurisdiction of

(Primary Standard Industrial(I.R.S. Employer Identification No.)
Incorporation or Organization)

(I.R.S. Employer

Identification No.)

Classification Code Number)

5304 Ashbrook Drive

Houston, Texas

77081

(Address of Principal Executive Offices)

(Zip Code)

713-305-5041


5304 Ashbrook Drive
Houston, Texas 77081
(Registrant'sAddress of Principal Executive Offices) (Zip Code)
Registrant’s Telephone Number, Includingincluding Area Code)


Code:

(844) 705-4866
(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common StockSOLYThe Nasdaq Stock Market

Indicate by check mark whether the registrant: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 thatperiods as the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  [   ]    No   [ X  ]

Indicate by check mark whether the registrant has submitted electronically if any,and every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  [ X  ]    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”,filer,” “accelerated filer”,filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer [   ] Accelerated Filer [   ] Non-Accelerated Filer [ X ] Smaller Reporting Company [ X ] Emerging Growth Company [ X ]

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   [ X ]

Indicate the

The number of shares outstanding of each of the issuer's classes ofCompany's outstanding common stock as of the latest practicable date: 14,613,000 as of March 1, 2019.


November 3, 2020 was 21,189,943
.




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EXPLANATORY NOTE

         Soliton, Inc. (the “Company”) became subject to the filing requirements of Sections 13 and 15(d) of the Securities Exchange Act of 1934, as amended (“Exchange Act”) when its Registration Statement on Form 8-A became effective on February 15, 2019 (the “Effective Date”). The Company’s Post-Qualification Offering Statement on Form 1-A (File No. 024-10854), filed with the Securities and Exchange Commission (the “SEC”) on February 13, 2019, as amended (“Form 1-A”), included financial statements for the fiscal years ended December 31, 2017 and 2016 and for the six month periods ended June 30, 2018 and 2017. This Quarterly Report on Form 10-Q is being filed pursuant to Rule 13a-13 of the Exchange Act, in order to file financial statements for the third fiscal quarter subsequent to the most recent periods reported in the Form 1-A.


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PART I - FINANCIAL INFORMATION

Item 1.

Financial Statements

Item 1.    Financial Statements
SOLITON, INC.

CONDENSED BALANCE SHEETS

(UNAUDITED)

  

As of

 
  

September 30,
2018

  

December 31,
2017

 

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $197,975  $18,412 

Prepaid expenses and other current assets

  15,389   7,746 

Total current assets

  213,364   26,158 

Deferred direct issuance costs - proposed offering

  278,212    

Property and equipment, net of accumulated depreciation

  262,789   336,726 

Intangible assets, net of accumulated amortization

  83,740   92,102 

Other assets

  23,283   23,283 

Total assets

 $861,388  $478,269 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

        

Current liabilities:

        

Accounts payable

 $1,767,713  $445,453 

Accrued liabilities

  1,192,718   853,443 

Dividends payable

  4,293,260   3,333,260 

Accrued interest

  79,988    

Accrued interest - related party

  916,944   295,830 

Convertible notes payable, net

  1,756,155    

Convertible notes payable - related party

  8,422,000   6,025,000 

Deferred rent

  5,950    

Total current liabilities

  18,434,728   10,952,986 

Deferred rent

  18,418   25,878 

Total liabilities

  18,453,146   10,978,864 

Commitments and contingencies

        

Stockholders’ deficit

        

Series A preferred stock, $0.001 par value, liquidation value of $1,999,997, 416,666 shares designated, issued and outstanding

  417   417 

Series B preferred stock, $0.001 par value, liquidation value of $14,000,641, 2,118,100 shares designated, issued and outstanding

  2,118   2,118 

Common stock, $0.001 par value, 100,000,000 authorized, 1,898,056 and 1,820,556 shares issued and outstanding, respectively

  1,898   1,821 

Additional paid-in capital

  21,795,522   21,031,388 

Accumulated deficit

  (39,391,713

)

  (31,536,339

)

Total stockholders’ deficit

  (17,591,758

)

  (10,500,595

)

Total liabilities and stockholders’ deficit

 $861,388  $478,269 

(in thousands, except for share data)September 30,
2020
December 31,
2019
ASSETS
Current assets:
Cash and cash equivalents$34,626 $11,876 
Restricted cash200 200 
Total cash34,826 12,076 
Inventory266 
Prepaid expenses and other current assets314 96 
Total current assets35,406 12,172 
Property and equipment, net of accumulated depreciation1,334 848 
Intangible and other assets129 121 
Total assets$36,869 $13,141 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$655 $1,338 
Accrued and other current liabilities1,690 1,529 
Total current liabilities2,345 2,867 
Commitments and contingencies (Note 5)
Stockholders’ equity (deficit):
Common stock, $0.001 par value, 100,000,000 authorized, 21,189,943 shares issued and outstanding at September 30, 2020 and 16,932,184 shares issued and outstanding at December 31, 201921 17 
  Additional paid-in capital100,546 66,300 
  Accumulated deficit(66,043)(56,043)
      Total stockholders’ equity34,524 10,274 
         Total liabilities and stockholders’ equity$36,869 $13,141 
See accompanying notes to the unaudited condensed financial statements.

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SOLITON, INC.

CONDENSED STATEMENTS OF OPERATIONS

(UNAUDITED)

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  

2018

  

2017

  

2018

  

2017

 

Revenue

 $  $  $  $ 
                 

Operating expenses:

                

Research and development

  1,717,113   717,785   3,804,015   3,144,771 

Sales and marketing

  109,565   30,198   178,115   77,098 

Depreciation and amortization expense

  30,028   32,449   90,321   99,048 

General and administrative expenses

  794,991   720,411   2,078,191   2,264,506 

Total operating expenses

  2,651,697   1,500,843   6,150,642   5,585,423 
                 

Loss from operations

  (2,651,697

)

  (1,500,843

)

  (6,150,642

)

  (5,585,423

)

                 

Other (expense) income:

                

Interest expense

  (327,978

)

  (102,345

)

  (747,492

)

  (183,331

)

Other income

  1,054   2,082   2,760   3,414 

Total other (expense) income

  (326,924

)

  (100,263

)

  (744,732

)

  (179,917

)

                 

Loss before income taxes

  (2,978,621

)

  (1,601,106

)

  (6,895,374

)

  (5,765,340

)

Income tax (expense) benefit

            
                 

Net loss

 $(2,978,621

)

 $(1,601,106

)

 $(6,895,374

)

 $(5,765,340

)

                 

Dividend to series A and B preferred stockholders

  (320,000

)

  (320,000

)

  (960,000

)

  (960,000

)

Net loss attributable to common stockholders

 $(3,298,621

)

 $(1,921,106

)

 $(7,855,374

)

 $(6,725,340

)

                 

Net loss per common share, basic and diluted

 $(1.74

)

 $(1.12

)

 $(4.23

)

 $(4.01

)

                 

Weighted average number of common shares outstanding, basic and diluted

  1,898,056   1,720,556   1,855,190   1,677,690 


Three Months Ended
September 30,
Nine Months Ended
September 30,
(in thousands, except for share and per share data)2020201920202019
Revenue$$$$
Operating expenses:
Research and development1,256 2,430 3,762 3,660 
Sales and marketing474 34 560 137 
Depreciation and amortization87 73 229 146 
General and administrative1,852 1,764 5,531 5,720 
Total operating expenses3,669 4,301 10,082 9,663 
Loss from operations(3,669)(4,301)(10,082)(9,663)
Other income (expense):
Interest expense(823)
Interest income76 82 
Total other income (expense)76 82 (814)
Net loss(3,593)(4,295)(10,000)(10,477)
Dividend to Series A and B preferred stockholders(160)
Net loss attributable to common stockholders$(3,593)$(4,295)$(10,000)$(10,637)
Net loss per common share, basic and diluted$(0.17)$(0.27)$(0.55)$(0.83)
Weighted average number of common shares outstanding, basic and diluted21,062,444 15,994,002 18,244,330 12,877,047 
See accompanying notes to the unaudited condensed financial statements.

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SOLITON, INC.

CONDENSED STATEMENTS OF CASH FLOWS

CHANGES IN

STOCKHOLDERS’ EQUITY (DEFICIT)
(UNAUDITED)

  

Nine Months Ended

September 30,

 
  

2018

  

2017

 

CASH FLOWS FROM OPERATING ACTIVITIES:

        

Net loss

 $(6,895,374

)

 $(5,765,340

)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation and amortization

  90,321   99,048 

Share-based compensation

  661,205   427,902 

Write-down of intangible assets

  19,138    

Amortization of debt discount

  44,921    

Changes in operating assets - (Increase)/Decrease:

        

Prepaid expenses and other current assets

  (7,643

)

  14,902 

Changes in operating liabilities - Increase/(Decrease):

        

Accounts payable

  1,322,260   207,769 

Accrued liabilities

  339,275   104,485 

Accrued interest

  79,988    

Accrued interest - related party

  621,114   183,331 

Deferred rent

  (1,510

)

  1,853 

NET CASH USED IN OPERATING ACTIVITIES:

  (3,726,305

)

  (4,726,050

)

         

CASH FLOWS FROM INVESTING ACTIVITIES:

        

Payments for the purchase of property and equipment

  (16,008

)

  (47,189

)

Payments for acquisition of intangibles

  (11,152

)

  (17,644

)

NET CASH USED IN INVESTING ACTIVITIES:

  (27,160

)

  (64,833

)

         

CASH FLOWS FROM FINANCING ACTIVITIES:

        

Proceeds from issuance of convertible notes, net of $163,760 of issuance costs

  1,814,240    

Proceeds from issuance of convertible notes - related party

  2,397,000   5,000,000 

Payment of deferred direct issuance costs - proposed offering

  (278,212

)

   

NET CASH PROVIDED BY FINANCING ACTIVITIES:

  3,933,028   5,000,000 
         

Net increase in cash and cash equivalents

  179,563   209,117 

Cash and cash equivalents, beginning of period

  18,412   155,892 

Cash and cash equivalents, end of period

 $197,975  $365,009 
         

Supplemental cash flow disclosures:

        

Cash paid for interest

 $  $ 

Cash paid for income taxes

 $  $ 
         

Non-cash investing and financing activities:

        

Accrued preferred dividends

 $960,000  $960,000 

Warrants debt discount on convertible notes

 $103,006  $ 

Common StockAdditional
Paid-In
Capital
Accumulated
Deficit
Total
(in thousands)SharesPar
Balance, December 31, 201916,932 $17 $66,300 $(56,043)$10,274 
Stock-based compensation— — 711 — 711 
Issuance of common shares11 — — — — 
Net loss— — — (3,271)(3,271)
Balance, March 31, 202016,943 $17 $67,011 $(59,314)$7,714 
Stock-based compensation— — 736 — 736 
Issuance of common shares30 — — — — 
Issuance of common shares from June 2020 Offering, net of costs4,217 32,042 — 32,046 
Net loss— — — (3,136)(3,136)
Balance, June 30, 202021,190 $21 $99,789 $(62,450)$37,360 
Stock-based compensation— — 757 — 757 
Net loss— — — (3,593)(3,593)
Balance, September 30, 202021,190 $21 $100,546 $(66,043)$34,524 
See accompanying notes to the unaudited condensed financial statements.

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SOLITON, INC.

CONDENSED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY (DEFICIT)
(UNAUDITED)
(CONTINUED)


Series A
Preferred Stock
Series B
Preferred Stock
Common StockAdditional
Paid-In
Capital
Accumulated
Deficit
Total
(in thousands)SharesParSharesParSharesPar
Balance, December 31, 2018417 $2,118 $1,998 $$22,569 $(42,131)$(19,558)
Stock-based compensation— — — — — — 512 — 512 
Debt discount on convertible notes and notes payable – issuance of warrants— — — — — — 146 — 146 
Payment of deferred direct issuance costs— — — — — — (186)— (186)
Issuance of common shares for extinguishment of preferred shares(417)(2,118)(2)2,535 — — 
Issuance of common shares for extinguishment of convertible debt— — — — 6,825 11,778 — 11,785 
Issuance of common shares for extinguishment of dividends payable— — — — 955 4,772 — 4,773 
Issuance of common shares from IPO, net of costs— — — — 2,173 9,872 — 9,874 
Issuance of common shares for accelerated vesting— — — — 127 — 
Accrued preferred dividends— — — — — — — (160)(160)
Net loss— — — — — — — (3,209)(3,209)
Debt forgiveness— — — — — — 434 — 434 
Balance, March 31, 2019— $— — $— 14,613 $14 $49,897 $(45,500)$4,411 
Stock-based compensation— — — — — — 686 — 686 
Issuance of common shares from PIPE Offerings, net of costs— — — — 675 8,641 — 8,642 
Issuance of common shares— — — — 406 (1)— 
Net loss— — — — — — — (2,973)(2,973)
Balance, June 30, 2019— $— — $— 15,694 $16 $59,223 $(48,473)$10,766 
Stock-based compensation— — — — — — 662 — 662 
Issuance of common shares for extinguishment of convertible debt— — — — 273 48 — 48 
PIPE deal costs— — — — — 
Issuance of common shares— — — — 438 — 
Net loss— — — — — — — (4,295)(4,295)
Balance, September 30, 2019— $— — $— 16,405 $16 $59,934 $(52,768)$7,182 
See accompanying notes to the unaudited condensed financial statements
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SOLITON, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
For the Nine Months Ended
September 30,
20202019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss$(10,000)$(10,477)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization209 146 
Stock-based compensation2,204 1,860 
Write-down of intangible asset20 
Amortization of debt discount665 
Changes in operating assets - (increase)/decrease:
   Inventory(266)
Prepaid expenses and other current assets(218)(188)
Changes in operating liabilities - increase/(decrease):
Accounts payable(932)(820)
Accrued and other current liabilities161 404 
Non-convertible accrued interest - non-related and related party11 
Convertible accrued interest - related party146 
NET CASH USED IN OPERATING ACTIVITIES:(8,822)(8,253)
CASH FLOWS FROM INVESTING ACTIVITIES:
Payments for the purchase of property and equipment(446)(819)
Payments for intangibles(28)(4)
NET CASH USED IN INVESTING ACTIVITIES:(474)(823)
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of non-convertible notes payable and accrued interest - related party and non-related party(1,005)
Proceeds from issuance of non-convertible notes payable - non-related party300 
Proceeds from issuance of common shares from IPO, net of costs9,714 
Proceeds from issuance of common shares from PIPE Offerings, net of costs8,643 
Proceeds from issuance of common shares from June 2020 Offering, net of costs32,046 
NET CASH PROVIDED BY FINANCING ACTIVITIES:32,046 17,652 
Net increase in cash, cash equivalents and restricted cash22,750 8,576 
Cash, cash equivalents and restricted cash, beginning of period12,076 133 
Cash, cash equivalents and restricted cash, end of period$34,826 $8,709 
Supplemental cash flow disclosures:
Cash paid for interest$$20 
Non-cash investing and financing activities:
Additions to property and equipment included in accounts payable$249 $
Accrued preferred dividends$$160 
Accrued direct issuance costs - offering$$(277)
Capital contributions - debt forgiveness$$434 
Issuance of common stock for extinguishment of convertible note payable and accrued interest - related party and non-related party$$11,833 
Issuance of common stock for extinguishment of dividends payable$$4,773 
Debt discount on convertible notes and notes payable - issuance of warrants$$146 
Issuance of common stock for extinguishment of preferred stock A and preferred stock B$$

See accompanying notes to the unaudited condensed financial statements
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SOLITON, INC.
NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

Note 1 - Description of the Business, Basis of Presentation and Summary of Significant Accounting Policies

Description of the Business

Soliton, Inc. (“Soliton” or the “Company”) was organized under the laws of the State of Delaware on March 27, 2012. The Company operates in one1 segment as a medical device company organized to develop and commercialize products utilizing aits proprietary Rapid Acoustic Pulse ("RAP") technology platform. We areThe Company is a pre-revenue stage company with ourits first productproducts being developed for the removal of tattoos.

Going Concern

tattoos and the reduction of cellulite. The Company received clearance from the U.S. Food & Drug Administration ("FDA") for its tattoo removal indication in June of 2019 and has recently completed a four-site pivotal trial for the reduction of cellulite and filed a 510(k) with the FDA seeking clearance for this indication. The Company is based in Houston, Texas. Upon completion of the development of its products and regulatory clearances to market such products, the Company anticipates revenue will be driven by the sale of its RAP console and disposable cartridges to dermatologists, plastic surgeons and other physician offices, as well as medi-spas under the supervision of a doctor.

Basis of Presentation
The accompanying condensed interim financial statements are unaudited. These unaudited condensed interim financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission ("SEC") for interim financial information. Accordingly, they do not include all the information and notes required by generally accepted accounting principles in the United States of America ("GAAP") for complete financial statements. These unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and accompanying notes as found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 2, 2020. In the opinion of management, the unaudited condensed interim financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2019 unaudited condensed balance sheet included herein was derived from the audited financial statements, but does not include all disclosures, including notes, required by GAAP for complete financial statements.
The Company operates in 1 reportable segment based on management’s view of its business for purposes of evaluating performance and making operating decisions.
The preparation of these unaudited condensed interim financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company's significant estimates and assumptions include work performed but not yet billed by contract manufacturers, engineers and research organizations, the valuation of equity related instruments, depreciable lives of long-lived assets (including property and equipment and intangible assets), and the valuation allowance related to deferred taxes. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made. Some of these judgments can be subjective and complex, and, consequently, actual results could differ from those estimates.
The coronavirus disease (“COVID-19”) pandemic has negatively impacted, and may continue to negatively impact, the macroeconomic environment in the United States and globally, including our business, financial condition and results of operations. Due to the evolving and uncertain nature of COVID-19, it is reasonably possible that it could materially impact our estimates, particularly those that require consideration of forecasted financial information, in the near to medium term. These estimates relate to certain accounts including, but not limited to, the valuation allowance related to deferred taxes, intangible assets, and other long-lived assets. The magnitude of the impact will depend on numerous evolving factors that we may not be able to accurately predict, including the duration and extent of the pandemic, the impact of federal, state, local and foreign governmental actions, consumer and provider behavior in response to the pandemic and such governmental actions, and the economic and operating conditions that we may face in the aftermath of COVID-19.
On June 30, 2020, the Company completed a public offering ("June 2020 Offering") of 4,216,868 shares of common stock for total gross proceeds of approximately $35.0 million. The shares of Company common stock were sold at a public offering price of $8.30 per share and were purchased by the underwriters from the Company at a price of $7.719 per share. The June 2020 Offering was made under a prospectus supplement and related prospectus filed with the SEC pursuant to the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-236963). Net proceeds from the sale of the common
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stock on June 30, 2020 was approximately $32.0 million after deducting underwriting discounts and estimated offering expenses.
Material Uncertainties
The Company is an early stage and emerging growth company and has not generated any revenues to date. As such, the Company is subject to all of the risks associated with early stage and emerging growth companies. Since inception, the Company has incurred losses and negative cash flows from operating activities. The Company does not expect to generate positive cash flows from operating activities in
For the near future.

For thethree and nine months ended September 30, 20182020 and 2017,2019, the Company incurred net losses of $6,895,374$3.6 million and $5,765,340,$4.3 million, respectively, and $10.0 million and $10.5 million, respectively, and had net cash flows used in operating activities for the nine months ended September 30, 2020 and 2019 of $3,726,305$8.8 million and $4,726,050,$8.3 million, respectively. At September 30, 2018,2020, the Company had an accumulated deficit of $39,391,713, negative$66.0 million, working capital of $18,221,364$33.1 million and cash, cash equivalents and restricted cash of $197,975.$34.8 million. The Company does not expect to experience positive cash flows from operating activities in the near future, if at all. future. The Company expects its cash, cash equivalents and restricted cash on hand of $34.8 million as of September 30, 2020 will be sufficient to fund the Company's operations into the third quarter of 2022 but not beyond.

The Company anticipates incurring operating losses for the next severalfew years as it completes the development of its products, and seeks requested regulatory clearances to market such products and supports the commercial launch of its products. These factors raise substantial doubtuncertainties about the Company's ability to fund operations in future years. If the Company needs to raise additional capital in order to continue asto execute its business plan or a going concern within one year afterchange to its business plan, including obtaining additional regulatory clearance for its products currently under development and commercializing and generating revenues from products under development, there is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the dateCompany. A failure to raise sufficient capital could adversely impact the Company’s ability to achieve its intended business objectives and meet its financial statements are issued.obligations beyond the third quarter of 2022. The accompanying condensed financial statements have been prepared on a going concern basis and do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

On February 19,

Inventory
Inventory is valued at the lower of cost or net realizable value using the first-in, first-out ("FIFO") method. Inventory consists of raw materials purchased by the Company and held offsite by a vendor.
Intangible Assets

Intangible assets include trademarks. At September 30, 2020 and December 31, 2019, the Company consummated its initial public offering (“IPO”). In the IPO, the Company sold a totalhad trademarks of 2,172,591 shares of common stock at a purchase price of $5.00 per share for gross proceeds of $10,862,955$0.1 million and net proceeds of approximately $9,700,000. In connection with the closing of the IPO, the Company's convertible notes (and related accrued interest) of $11,784,987 were converted into 6,825,391 shares of the Company's common stock, accrued dividends of $4,773,480 were converted into 954,696 shares of the Company's common stock and preferred stock, both Series A and Series B, were converted into 2,534,766 shares of the Company's common stock. In addition, 100,000 shares of restricted grants vested in November 2018 and 127,500 shares of unvested restricted grants were immediately vested upon the completion of the IPO. Total shares of common stock outstanding at the closing of the IPO amounted to 14,613,000. Upon the closing of the IPO, certain notes were to be automatically converted according to their terms into the Company’s common stock to the extent and provided that certain holders of these notes are not permitted to convert such notes to the extent that the holders or any of its affiliates would beneficially own in excess of 4.99% of the Company’s common stock after such conversion. Due to this 4.99% limitation, principal representing $47,781 of these notes remained outstanding and will be converted into 273,034 shares of our common stock at such time as the 4.99% limitation continues to be met. The maturity date of these notes is automatically extended until such date the notes are fully converted and these notes cease to accrue interest and are not repayable in cash.

The Company estimates its current cash resources, including the approximate $9,700,000 of net proceeds from the IPO is sufficient to fund its operations into but not beyond February 2020. The Company also recognizes it will need to raise additional capital in order to continue to execute its business plan, including obtaining regulatory clearance for its products currently under development and commercializing and generating revenues from products under development. There is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company. A failure to raise sufficient capital, generate sufficient product revenues, control expenditures and regulatory matters, among other factors, will adversely impact the Company’s ability to meet its financial obligations as they become due and payable and to achieve its intended business objectives. If the Company is unable to raise sufficient additional funds, it will have to scale back its operations.

Basis of Presentation

The accompanying interim financial statements are unaudited. These unaudited interim financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission ("SEC") for interim financial information. Accordingly, they do not include all the information and footnotes required by U.S. Generally Accepted Accounting Principles ("GAAP") for complete financial statements. These unaudited interim financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2017 as found in the Offering Circular on Form 1-A. In the opinion of management, the unaudited interim financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of September 30, 2018 and the results of operations for the three and nine months ended September 30, 2018 and 2017. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2017 balance sheet included herein was derived from the audited financial statements, but does not include all disclosures, including notes, required by GAAP for complete financial statements.

Use of Estimates in Financial Statement Presentation

The preparation of these financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company's significant estimates and assumptions include stock-based compensation, depreciable lives of long-lived assets (including property and equipment and intangible assets), and the valuation allowance related to deferred taxes. Some of these judgments can be subjective and complex, and, consequently, actual results could differ from those estimates. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made. Actual results could differ from those estimates.

Cash and Cash Equivalents

The Company considers all highly liquid accounts with original maturities of three months or less to be cash equivalents. The Company participates in an insured cash sweep program through its bank that sweeps cash balances exceeding the FDIC insured limit of $250,000 into multiple accounts. Periodically in the ordinary course of business, the Company may carry cash balances at financial institutions in excess of the insured limits of $250,000.

Property and Equipment

Property and equipment are stated at historical cost and depreciated on a straight-line basis over the estimated useful lives, generally three to five years. Leasehold improvements are depreciated over the shorter of the remaining lease term or useful lives of the assets. Upon disposition of the assets, the costs and related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Repairs and maintenance costs are included as expense in the accompanying statement of operations.

Intangible Assets

Intangible assets include patents and trademarks. Patent related costs in connection with filing and prosecuting patent applications and patents filed by the Company are expensed as incurred, and are classified as research and development expenses.$0.1 million, respectively. The Company does not amortize trademarks with indefinite useful lives;lives, rather, such assets are required to be tested for impairment at least annually or sooner if events or changes in circumstances indicate that the asset may be impaired.

Long-Lived Assets

The During the three months ended September 30, 2020, the Company evaluates its long-lived assets, including equipment, for impairment whenever events or changes in circumstances indicate that the carryingwrote down a trademark with a net book value of these assets may not be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset to the future undiscounted cash flows expected to result from the use of the asset and its eventual disposition. If the asset is considered impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired assets.

Deferred Rent

Deferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or are less than the cash payments required.

Convertible Debt

When conversion terms related to convertible debt would be triggered by future events not controlled by the Company, the Company accounts for the conversion feature as contingent conversion options. Recognition of the intrinsic value of the conversion option is recognized only upon the occurrence of a triggering event.

Fair Value Measurements

Fair value is defined as the price which would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A three-tier fair value hierarchy which prioritizes the inputs used in the valuation methodologies, as follows:

Level 1 Inputs - Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.

$19.7 thousand.

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Level 2 Inputs - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means.

Level 3 Inputs - Unobservable inputs for determining the fair values of assets or liabilities that reflect an entity’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities.

At September 30, 2018 and December 31, 2017, the carrying amounts of the Company's financial instruments, including cash and accounts payable, approximate their respective fair value due to the short-term nature of these instruments.

At September 30, 2018 and December 31, 2017, the Company does not have any assets or liabilities required to be measured at fair value in accordance with FASB ASC Topic 820, Fair Value Measurement.

Revenue Recognition

Prior to January 1, 2017, revenues were recognized when the four basic criteria for recognition were met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) consideration is fixed or determinable; and (4) collectability is reasonably assured. The Company adopted new accounting guidance for revenue recognition effective January 1, 2018 which did not have a material impact on the Company’s financial statements. Beginning from January 1, 2018, revenues are recognized when control of the promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services

Research and Development Expenses

Research and development expenses are recognized as incurred and include the costs related to the Company's various contract research service providers, suppliers, engineering studies, supplies, outsourced testing and consulting, clinical costs, and salaries and related costs of employees working directly on research activities.

Stock-Based Compensation

Stock-based compensation expense includes the estimated fair value of equity awards vested during the reporting period. The expense for equity awards vested during the reporting period is determined based upon the grant date fair value of the award and is recognized as expense over the applicable vesting period of the stock award using the straight-line method.

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Income Taxes

The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of reported assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Tax rate changes are reflected in income during the period such changes are enacted. All of the Company's tax years remain subject to examination by the tax authorities.

Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company's financial statement as of September 30, 2018. The Company does not expect any significant changes in the unrecognized tax benefits within twelve months of the reporting date.

The Company classified interest expense and any related penalties related to income tax uncertainties as a component of income tax expense. No interest or penalties have been recognized in 2018 and 2017.

Net Loss per Common Share

Basic net loss per common share areis computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. Unvested restricted stock awards contain dividend rights and are considered participating securities as contemplated for the computations of basic and diluted earnings or loss per share. These securities do not participate in losses and accordingly no such allocation has been made in the periods presented. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive.
As of September 30, 2018 and 2017,2020, potentially dilutive securities included options to purchase 2,235,000 and 03,409,550 common shares, respectively, preferred stock convertiblewarrants to 2,534,766purchase 1,324,608 common shares accrued preferred stock dividend convertible at a price determined by the Company's Board of Directors (the "Board") (the Company also had the option to pay the accrued preferred stock dividend in cash),and unvested restricted stock of 227,500 and 405,000 shares, respectively, notes and accrued interest convertible120,842 shares. 
As of September 30, 2019, potentially dilutive securities included options to purchase 2,843,550 common shares, upon a future financing and warrants to purchase 91,350 and 0888,333 common shares respectively. On November 1, 2018, the Company filed an amendment to Article 4and unvested restricted stock of the Company's Amended and Restated Certificate of Incorporation, whereby it increased the authorized shares of the Company's common stock to 19,000,000 shares of common stock, $0.001 par value per share, and 2,534,766 shares of preferred stock, $0.001 par value per share. On February 19, 2019, the Company filed an amendment to the Company's Amended and Restated Certificate of Incorporation, whereby it, among other items, increased the authorized shares of the Company's common stock to 100,000,000 shares of common stock, $0.001 par value per share, and eliminated the ability to issue preferred stock.

JOBS Act Accounting Election

The Company is an emerging growth company ("EGC"), as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). The JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company’s financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

170,834 shares.


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Subsequent Events

The Company’s management reviewed all material events through the date that the financial statements were issued for subsequent event disclosure consideration. See Note 8 for additional information.

Recent Accounting Standards

In February 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-02,Leases (Topic 842) ("ASU 2016-02"ASC 842"), which establishes a right-of-use (“ROU”) model requiring a lessee to recognize a ROU asset and a lease liability for all leases with terms greater-thangreater than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. This guidance isASC 842 was originally effective for public EGC companies like the Company, for fiscal years beginning after December 15, 2019, includingand interim periods beginning after December 15, 2020 with early adoption permitted. In October 2019, the FASB delayed the implementation of ASC 842 for private companies until fiscal years beginning after December 15, 2020. In June 2020, the FASB further delayed the implementation of ASC 842 for private companies until fiscal years beginning after December 15, 2021 and interim periods within those fiscal years. Ayears beginning after December 15, 2022. Given the Company's status as an Emerging Growth Company ("EGC"), the Company will adopt ASC 842 in accordance with the private company guidance. The modified retrospective transition approach is required forapplies to leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company has the option to instead apply the provisions at the effective date without adjusting the comparative periods presented. The Company is currently evaluating the impact of this guidance on its financial position, results of operations, and cash flows.

In June 2018, the FASB issued ASU No. 2018-07, Compensation Stock Compensation (Topic 718), Improvements to Non-employee Share-Based Payment Accounting. This ASU is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share based compensation. The guidance is effective for the Company for the fiscal year beginning January 1, 2020. While the exact impact of this standard is not known, the guidance is not expected to have a material impact on the Company’s financial statements, as non-employee stock compensation is nominal relative to the Company's total expenses for the nine months ended September 30, 2018.

The Company does not believe that any other recently issued effective standards, or standards issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements.

Reclassifications

In certain instances, amounts reported in prior years' financial statements have been reclassified to conform to the current financial statement presentation. Such reclassifications had an effect on previously reported cash flows between operating and investing activities.

Note2- Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following:

following (
in thousands):
September 30,
2020
December 31,
2019
 

September 30,

2018

  

December 31,

2017

 

Prepaid insurance

 $14,248  $6,300 Prepaid insurance$207 $94 

Other receivables

  1,141   1,446 
Other prepaids and receivablesOther prepaids and receivables107 

Total prepaid expenses and other current assets

 $15,389  $7,746 Total prepaid expenses and other current assets$314 $96 


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September 30, 2020, other prepaids and receivables largely included payments made to vendors for work that has not yet been completed and for payments made as a result of listing requirements for public companies.

Note 3 - Property and Equipment

Property

As of September 30, 2020 and December 31, 2019, the net carrying value of property and equipment consisted of the following:

was approximately $1.3 million and $0.8 million, respectively, and included $0.7 million and $0, respectively, in construction-in-process for equipment being built and software being developed but not yet placed into service.
  

September 30,

2018

  

December 31,

2017

 

Computer equipment and software

 $93,065  $95,130 

Research and development equipment

  244,481   241,377 

Leasehold improvements

  242,167   242,167 

Furniture

  19,893   19,893 

Software

  11,020    

Subtotal

  610,626   598,567 

Less: accumulated depreciation

  (347,837

)

  (261,841

)

Total property and equipment, net

 $262,789  $336,726 

Depreciation expense for the three months ended September 30, 20182020 and 20172019 was $30,028$0.1 million and $32,449,$0.1 million, respectively. Depreciation expense for the nine months ended September 30, 20182020 and 20172019 was $89,945$0.2 million and $97,805,$0.1 million, respectively.

Note 4 - Intangible Assets

Intangible assets consisted of the following:

  

September 30,

2018

  

December 31,

2017

 

Patents

 $  $22,527 

Trademarks

  83,740   72,590 

Subtotal

  83,740   95,117 

Less: accumulated amortization

     (3,015

)

Total intangible assets, net

 $83,740  $92,102 

Amortization expense for the three months ended September 30, 2018 and 2017 was $0. Amortization expense for the nine months ended September 30, 2018 and 2017 was $376 and $1,243, respectively.

Note 54 - Convertible Notes Payable

On January 18, 2017, the Board approved a note purchase agreement (the "First Note") allowing the Company to sell an aggregate of $3,000,000 of convertible bridge notes (the "Notes"). The Notes were convertible into either the Company’s preferred or common stock (depends on the equity securities offered in the equity financing) at 75% of the price paid per share in a subsequent equity financing where the Company receives gross proceeds of not less than $5,000,000 or at 85% of the per share price determined by dividing the equity value of the Company that is expected to be available for distribution to the Company’s stockholders by the aggregate number of the Company’s fully-diluted common shares upon

In connection with the closing of a sale, liquidation, merger, or change of control of the Company. The Notes bore interest at 8.25% per annum and initially matured on January 31, 2018, which date was extended as discussed below. At maturity, the interest rate increased to 12.0% per annum.

The Company closed the initial tranche of the First Note on January 23, 2017 for $1,000,000, followed by a tranche on March 1, 2017 for $1,000,000 and a final tranche on April 27, 2017 for $1,000,000.

On June 19, 2017, the Company entered into the first amendment ("First Amendment") to the First Note to allow for the sale and issuance of an additional $3,250,000 of Notes up to an aggregated amount of $6,250,000.

The Company closed $1,300,000 on June 19, 2017 under the First Amendment and closed an additional $700,000 on July 17, 2017. No additional tranches were issued under the First Amendment.

As of September 30, 2018, the total amount of issuance under the First Note and First Amendment amounted to $5,000,000 and were issued to a single related party, who is a major stockholder of the Company.

On November 1, 2017, the Board approved a second note purchase agreement (the "Second Note") allowing the Company to sell an aggregate of $1,900,000 of Notes. The Notes were convertible into either the Company’s preferred or common stock (depends on the equity securities offered in the equity financing) at 75% of the price paid per share in a subsequent equity financing where the Company receives gross proceeds of not less than $5,000,000 or at 85% of the per share price determined by dividing the equity value of the Company that is expected to be available for distribution to the Company’s stockholders by the aggregate number of the Company’s fully-diluted common shares upon the closing of a sale, liquidation, merger, or change of control of the Company. The Notes bore interest at 8.25% per annum and initially matured on June 29, 2018, which date was extended as discussed below. At maturity, the interest rate increased to 12.0% per annum.

The Company closed the initial tranche of the Second Note on November 9, 2017 for $400,000, followed by a tranche on December 1, 2017, for $375,000, a third tranche on December 26, 2017 for $250,000, a fourth tranche on January 8, 2018 for $250,000, a fifth tranche on January 25, 2018 for $250,000 and a final trancheIPO on February 13, 2018 for $375,000 for a total19, 2019, convertible notes (and related accrued interest) of $1,900,000

On June 29, 2018, the Company and the related party modified the maturity date of the Notes entered into under the First Note and Second Note to April 30, 2019.

As of September 30, 2018, the total amount of issuance under the Second Note amounted to $1,900,000 and$11.8 million were issued to a single related party, who is a major stockholder of the Company.

On April 2, 2018, the Board approved a note purchase agreement (the "Third Note"), which was amended on August 10, 2018, allowing the Company to sell an aggregate of $500,000 of Notes. The Third Note provided that, on the closing date of the IPO, the outstanding principal and accrued, but unpaid, interest would be converted into 6,825,391 shares of common stock at the conversion price of $0.175. However, certainstock. Certain notes automatically converted, according to their terms, into common stock. Certain holders arewere not permitted to convert theirsuch notes whento the extent that the holders or any of its affiliates would beneficially own in excess of 4.99% of the Company’s common stock after such conversion. The holdersDue to this limitation, principal representing less than $0.1 million of these notes was later converted into 273,034 shares of the Company’s outstanding preferred shares agreed to waiveCompany's common stock in August and September 2019 when the adjustment toconversion did not result in the preferred stock conversion price triggered by the Third Note. The Notes bore interest at 10.0% per annumholders and mature on April 2, 2020.

any of its affiliates owning more
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As of September 30, 2018, the total amount of issuance under the Third Note amounted to $500,000. The Company issued $250,000 to a single related party, who is a major stockholder

than 4.99% of the Company, and $250,000 to four non-related party investors.

On April 17, 2018, the Board approved a note purchase agreement (the "Fourth Note") allowing the Company to sell an aggregate of $3,000,000 of Notes. The Fourth Note provided that onCompany's outstanding common shares. All remaining debt instruments were settled at the closing date of the IPO, the outstanding principal and accrued, but unpaid, interest would be converted into common stock at the conversion price of $1.75. The holders of the Company’s outstanding preferred shares agreed to waive the adjustment to the preferred stock conversion price triggered by the Fourth Note. The Notes bore interest at 10.0% per annum and mature two years from the Note issuance date.

As of September 30, 2018, the total amount of issuance under the Fourth Note amounted to $3,000,000. The Company issued $1,272,000 in principal amount of such Notes to related party investors and $1,728,000 to non-related party investors.

The Company incurred issuance costs relating to the Fourth Note in the amount of $163,760, which is being amortized over 24-months. At September 30, 2018, the unamortized balance amounted to $136,184.

The Company also issued warrants to purchase 91,350 shares of common stock at a price of $1.75 per share to placement agents in connection with the Notes issued under the Fourth Note in the amount of $103,006. For additional information, see Note 7. The value of these warrants is also being amortized over 24-months. At September 30, 2018, the unamortized balance amounted to $85,661.

As of September 30, 2018, the net amount of the Notes for Non-Related Party amounted to $1,756,155.

The following table summarizes convertible notes payable and interest as of September 30, 2018:

  

Interest Rate

  

Related Party

  

Non-Related Party

  

Total

 
  

Initial

  

Post-

Maturity

  

Principal

  

Interest

  

Principal

  

Interest

  

Principal

  

Interest

 

First Note

  8.25

%

  12.00

%

 $5,000,000      $      $5,000,000     

Second Note

  8.25

%

  12.00

%

  1,900,000              1,900,000     

Third Note

  10.00

%

  10.00

%

  250,000       250,000       500,000     

Fourth Note

  10.00

%

  10.00

%

  1,272,000       1,728,000       3,000,000     

Total

         $8,422,000  $916,944  $1,978,000  $79,988  $10,400,000  $996,932 

Unamortized Discount

  

 

             (221,845

)

     (221,845

)

   

Total, Net

         $8,422,000  $916,944  $1,756,155  $79,988  $10,178,155  $996,932 

IPO.

Note 65 - Commitments and Contingencies

On April 5, 2012, the Company entered into a Patent and Technology License Agreement with The University of Texas M.D. Anderson Cancer Center (“("MD Anderson”Anderson"). Pursuant to the agreement, the Company obtained a royalty-bearing, worldwide, exclusive license to intellectual property including patent rights related to the patents and technology the Company uses. Under the agreement, Soliton agreed to paythe Company paid a nonrefundable license documentation fee in the high-five digits 30 days after the effective date of the agreement. Additionally, Solitonthe Company agreed to pay a nonrefundable annual maintenance fee starting on the third anniversary of the effective date of the agreement, which escalates each anniversary.anniversary and is currently in the mid-five digits. Additionally, the Company agreed to a running royalty percentage of net sales.sales in the mid-single digits. The Company also agreed to make certain milestone payments in the low to mid-six digits and sublicensing payments.

payments, including a $0.25 million milestone payment made in June 2019 after the Company received FDA clearance for our RAP device for tattoo removal. The specific patents initially subject to the agreement expire between 2031 and 2032.


MD Anderson has the right to terminate the agreement upon advancedadvance notice in the event of a default by Soliton.the Company. The agreement will expire upon the expiration of the licensed intellectual property. The rights obtained by the Company pursuant to the agreement are made subject to the rights of the U.S. government to the extent that the technology covered by the licensed intellectual property was developed under a funding agreement between MD Anderson and the U.S. government. To the extent that is the case, the Company's license agreement with, and the intellectual property rights it has licensed from MD Anderson, are subject to such a funding agreement and any superior rights that the U.S. government may have with respect to the licensed intellectual property. Therefore, there is a risk that the intellectual property rights the Company has licensed from MD Anderson may be non-exclusive or void if a funding agreement related to the licensed technology between MD Anderson and the U.S. government does exist and depending on the terms of such an agreement. Notwithstanding the foregoing, the Company does not believe our RAP technology received any federal funding. All out-of-pocket expenses incurred by MD Anderson in filing, prosecuting and maintaining the licensed patents have been and shall continue to be assumed by the Company.

Leases

For the nine months ended September 30, 2020 and 2019, the Company paid approximately $0.1 million and $0.1 million, respectively, for expenses related to this agreement.

As the inventor of the intellectual property licensed from MD Anderson, Dr. Capelli, the Company's Vice Chairman, Chief Science Officer and Co-Founder, is entitled to 50% of the license income (which is determined after MD Anderson recoups any costs associated therewith) that the Company is required to pay to MD Anderson pursuant to the Company's license agreement with MD Anderson. For the nine months ended September 30, 2020, Dr. Capelli was paid $37.5 thousand from MD Anderson. In addition, Dr. Capelli is entitled to 50% of the proceeds (after the recoupment of any costs associated therewith) from the sale by MD Anderson of 175,000 shares issued to MD Anderson in connection with the license agreement.
Purchase Commitments

On November 20, 2019, the Company entered into a cooperative development addendum ("Addendum") to its engineering and development services master agreement with Emphysys, Inc. ("Emphysys”). The Addendum states that Emphysys will provide the Company with engineering and design service labor related to shockwave technology for use in dermatology and aesthetics fields for a 36 month period ending July 1, 2022.

During the term of the Addendum, the Company agreed to certain minimum annual expenditures. If the Company fails to spend such minimum annual amounts or if the Company terminates the Addendum without cause, the Company will be required to pay Emphysys an early termination fee of no more than $0.4 million. In the event that all or substantially all of the stock or assets of either party are sold then, at the request of the other party, the Addendum may be terminated (without the requirement to pay a termination fee) and the obligation of Emphysys to provide future services to the Company shall terminate. Pursuant to the Addendum, with certain exceptions, Emphysys covenanted that it will not perform or agree to perform services with any company other than Soliton in the area of arc-discharge driven acoustical shockwave generation for medical dermatological or aesthetic dermatological indications during the term of the Addendum or any extension thereof, and for a period of six months after the termination of the Addendum.

As of September 30, 2020, the Company had purchase obligations of $2.9 million to Emphysys. This commitment is for services used in the ordinary course of business and does not represent excess commitments or loss contracts. The remaining minimum purchase obligations are $1.3 million and $1.6 million, respectively, for the 12 month periods ending June 30, 2021 and June 30, 2022. If we fail to spend such minimum annual amounts or if the Company terminates the Addendum without cause, the Company will be required to pay Emphysys an early termination fee of no more than $0.4 million.
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On March 6, 2020, the Company entered into a manufacturing service agreement (the "Agreement") with Sanmina Corporation ("Sanmina"). The Agreement states that Sanmina will provide the Company with certain manufactured products for a one year period, with pricing adjusted for material variations of market prices for components, parts and raw material, including variations resulting from allocations, shortages or tariffs. In addition, pricing will be based on the forecasted volumes provided by the Company and the projected inventory turns as agreed by both parties.
Either party may terminate the Agreement or an order under the Agreement for default, if the other party materially breaches the Agreement; provided, however, no termination shall occur until thirty days after the defaulting party is notified in writing of the material breach and has failed to cure or give adequate assurances of performance within the thirty day period after notice of material breach. In addition, the Company may terminate the Agreement for any reason upon thirty days’ prior written notice and may terminate any order under the Agreement for any reason upon 120 days’ (before scheduled shipment) prior written notice. Sanmina may terminate the Agreement for any reason upon ninety days’ notice. In the event the Agreement or an order under the Agreement is terminated for any reason other than a breach by Sanmina, the Company is required to pay Sanmina termination charges equal to (i) the contract price for all finished product existing at the time of termination; (ii) Sanmina’s cost (including labor, components and applicable mark-ups per the pricing model) for all work in process; and (iii) the cost of components ordered by Sanmina pursuant to the Agreement.
Lease Commitments
The Company leases space for its corporate office, which provides for a five-yearan original 63 month term beginning on July 15, 2015, forFebruary 1, 2016, with initial rent payments of $8,053$7.9 thousand per month.month that escalate annually to a maximum of $8.9 thousand per month through the expiration of the agreement. On September 15, 2020, the Company entered into a 12 month extension of its corporate office lease. Total rent expense under this office space lease arrangement for each of the three months ended September 30, 2018 and 2017 was $24,157 and for the nine months ended September 30, 20182020 and 20172019 was $65,108$24.2 thousand and $72,473,$23.6 thousand, respectively, and $0.1 million and $0.1 million, respectively.

Future minimum lease payments as of September 30, 20182020 were as follows:

less than $0.2 million through the lease term ending April 30, 2022.

Year Ending December, 31

 

Amount

 

2018

 $25,164 

2019

  103,737 

2020

  108,429 

Thereafter

  36,668 

Total future minimum lease payments

 $273,998 
Letters of Credit

The Company has an irrevocable letter of credit which supports its obligations to pay or perform according to the requirements of an underlying agreement with a certain vendor. Such letter of credit has an initial term of one year, renews automatically for an additional year and can only be modified or canceled with the approval of the beneficiary. As of September 30, 2020, the letter of credit was not used.
Legal Proceedings

In the normal course of business, from time-to-time, the Company may be subject to claims in legal proceedings. However, the Company does not believe it is currently a party to any pending legal actions. Notwithstanding, legal proceedings are subject-tosubject to inherent uncertainties and an unfavorable outcome could include monetary damages, and in such event, could result in a material adverse impact on the Company's business, financial position, results of operations or cash flows.

Employment Agreements
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TableThe Company has agreements with certain employees to provide certain benefits in the event of Contents
termination where the base salary and certain other benefits would amount to $2.9 million using the rate of compensation in effect at November 2, 2020.

Note 76 - Stockholders’ Deficit

Preferred Stock

The Company was authorized to issue 2,534,766 shares of preferred stock with a par value of $0.001 per share with such designation, rights, and preferences as may be determined from time-to-time by the Company's Board.

As of September 30, 2018 and December 31, 2017, there were 416,666 Series A preferred stock and 2,118,100 Series B preferred stock issued and outstanding.

The Series A preferred stock has the following features:

1.

Dividends accrue at a rate of 8% per annum based on $4.80 per Series A preferred share, the dividends are cumulative but non-compounding and payable upon the Company’s voluntary or involuntary liquidation, dissolution or winding up, the exercise of conversion rights of the holder, the declaration by the Company’s Board, upon a closing of the sale of the Company’s common shares to the public at a price of at least $24.00 per share with at least $50,000,000 of gross proceeds and the common shares listed on the New York Stock Exchange or NASDAQ Capital Market, and upon conversion of at least 50.1% of the issued and outstanding Series A preferred stock. The Company has the option to pay the dividend in cash or by issuing common stock.

2.

A liquidation right preferable over the right of the Company’s common stock.

3.

Each share of the Series A preferred stock has one voting right.

4.

Each share of the Series A preferred stock is convertible by the holder, at any time, into shares of common stock equal to $4.80 divided by a conversion price, initially set at $4.80. The conversion price is adjustable upon certain events.

The Series B preferred stock has similar rights as Series A preferred stock except that the dividends are based on $6.61 per Series B preferred share and Series B preferred stock is convertible into common stock at a rate of $6.61 divided by a conversion price initially set at $6.61. As of September 30, 2018 and December 31, 2017, accrued dividends for preferred stock were $4,293,260 and $3,333,260, respectively. At September 30, 2018, the conversion price for the Series A and Series B preferred stock were $4.80 and $6.61, respectively. The holder of the Series A and Series B preferred stock has agreed to convert the preferred stock into common stock upon the completion of the Company's IPO. The holders of the Company’s outstanding shares of preferred stock agreed to waive the adjustment to the conversion price of the preferred stock upon the issuances of the Third and Fourth Note.

All outstanding shares of Series A and Series B preferred stock and accrued dividends on these shares were converted into common stock upon the Company’s IPO on February 14, 2019. The Company amended its articles of incorporation on February 19, 2019 to no longer have preferred shares authorized under the amended articles of incorporation.

Adoption of 2012 Long Term Incentive Plan

In November 2012, the Company’s Board and stockholders adopted the 2012 Long Term Incentive Plan (the “2012 Stock Plan”). The 2012 Stock Plan is designed to enable the Company to offer employees, officers, directors and consultants, as defined, an opportunity to acquire a proprietary interest in the Company. The types of awards that may be granted under the 2012 Stock Plan include stock options, stock appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Company’s Board. The 2012 Stock Plan reserves shares of common stock for issuance in accordance with the 2012 Stock Plan’s terms. Total number of shares reserved and available for issuance under the plan is 789,745 shares. As of September 30, 2018, 14,745 shares remained available for grant under the 2012 Stock Plan.

Equity (Deficit)
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Adoption of 2018 Stock Plan

In June 2018, the Company’s Board of Directors (the "Board") and stockholders adopted the 2018 Stock Plan. The 2018 Stock Plan is designed to enable the Company to offer employees, officers, directors and consultants, as defined, an opportunity to acquire a proprietary interest in the Company. The types of awards that may be granted under the 2018 Stock Plan include stock options, stock appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Company’s Board. The 2018 Stock Plan reserves shares of common stock for issuance in accordance with the 2018 Stock Plan’s terms. Total number of shares reserved and available for issuance under the plan is 3,000,0004,150,000 shares. As of September 30, 2018, 780,0002020, 755,450 shares remained available for grant under the 2018 Stock Plan.

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Restricted Stock

During

Restricted stock activity for the three and nine months ended September 30, 20182020 is summarized as follows:
Number of
Shares
Weighted-
Average
Grant Date
Fair Value
Outstanding, December 31, 2019158,336 $11.54 
Vested(37,494)11.54 
Outstanding, September 30, 2020120,842 $11.54 
On May 8, 2019, the Company granted and 2017,issued 200,000 shares of restricted common stock to three consultants in connection with the provision of services pursuant to agreements entered into in April 2019. The consultants were each accredited investors. 25,000 shares vested within four months of the approval date of the agreement. The remaining 175,000 shares vest over 42 months, beginning on September 19, 2019. As of September 30, 2020, 79,158 shares have vested life-to-date and 120,842 remain unvested.
During the three months ended September 30, 2020 and 2019, the Company recorded $142,634$0.1 million and $427,902,$0.2 million, respectively, in stock-based compensation for the restricted shares previously issued. During the nine months ended September 30, 20182020 and 2017, 77,5002019, the Company recorded $0.4 million and $0.8 million, respectively, in stock-based compensation for the restricted shares vested each period and at September 30, 2018, 227,500 shares remain to vest. previously issued.
As of September 30, 2018, unamortized2020, there was $1.3 million of unrecognized compensation expense related to the restricted stock grant was $370,101.

All unvested restricted stock grants at September 30, 2018 vested immediately upon the Company’s IPO on February 14, 2019.

shares.


Stock Options

The following table summarizes stock option activities for the nine months ended September 30, 2018:

2020:
  

Number of

Shares

  

Weighted

Average

Exercise Price

  

Weighted

Average

Remaining Life

(in Years)

  

Aggregate

Intrinsic Value

 

Outstanding, December 31, 2017

  15,000  $0.13   9.75  $ 

Granted

  2,220,000   1.75         

Exercised

              

Canceled

              

Outstanding, September 30, 2018

  2,235,000  $1.74   9.69  $23,100 
                 

Exercisable, September 30, 2018

  3,750  $0.13   9.01  $5,775 
Number of
Shares
Weighted
Average
Exercise Price
Weighted
Average
Remaining Life
(in Years)
Aggregate
Intrinsic
Value
(in thousands)
Outstanding, December 31, 20192,883,550 $2.70 8.62$23,862 
Granted526,000 11.08 — — 
Outstanding, September 30, 20203,409,550 $4.00 8.11$12,424 
Exercisable, September 30, 20201,612,250 $2.41 7.84$8,434 

During the nine months ended September 30, 2018,2020, the Company granted its employees 2,220,000certain individuals options to purchase the Company’s526,000 shares of common stock with an average exercise price of $1.75$11.08 per share, for a term of 10with contractual terms ranging from one to ten years, and a vesting period of 4periods ranging from 8.33% monthly over one year to 25.00% per year over four years. The options have an aggregatedaggregate grant date fair value of $2,694,567$4.2 million that was calculated using the Black-Scholes option-pricingoption pricing model. Variables used in the Black-Scholes option-pricingoption pricing model include: (1) discount rate of 2.77%rates ranging from 0.1% to 1.6% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected life oflives ranging from 5.50 years to 6.25 years based on the simplified method provided in Staff Accounting Bulletin,(vesting plus contractual term divided by two), (3) expected volatility rangeranging from 84.5%83.1% to 84.7%88.3% based on the historical volatility of comparable companies' stock, (4) no0 expected dividends and (5) fair marketvalue of the Company's stock ranging from $6.44 to $13.50 per share.
All options issued and outstanding are being amortized over their respective vesting periods. During the three months ended September 30, 2020 and 2019, the Company recorded option expense of $0.6 million and $0.5 million, respectively. During the nine months ended September 30, 2020 and 2019, the Company recorded option expense of $1.8 million and $1.1 million, respectively. The unrecognized compensation expense for options at September 30, 2020 was $5.8 million.

Warrants
During the year ended December 31, 2018, the Company issued warrants to purchase 776,350 shares of common stock at an exercise price of $1.75. The warrants expire five years from the date of issuance. The warrants were issued to placement agents and investors in connection with certain notes.
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In January and February 2019, the Company issued warrants to purchase 300,000 shares of common stock at an exercise price of $1.75 on various dates. The warrants were issued to investors in connection with certain notes.
On February 19, 2019, the Company issued warrants to the underwriters of the Company's IPO to purchase 152,081 shares of common stock at an exercise price of $6.00. The warrants expire five years from the date of issuance.
The aggregate grant date fair value of these 1,228,431 warrants was $1.6 million, which was determined utilizing the Black-Scholes option pricing model. Variables used in the Black-Scholes option pricing model include (1) discount rates in the range of 2.5% to 2.8% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected terms of five years based on the terms of the warrants, (3) expected volatility of 84.1% to 85.8% based on the historical volatility of comparable companies' stock, (4) 0 expected dividends, and (5) fair value of the Company's stock at $1.67 per share whichfor warrants issued prior to the IPO, a value was determined by the Company's Board after reviewing and considering, among other factors, a valuation report issued by an independent appraisal firm.

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Tablefirm, or the fair value of Contentsthe Company's stock at the closing of its IPO on February 19, 2019 of $4.87 for warrants on that day.

All options

As a result of the Company’s IPO closing on February 19, 2019, $0.7 million of unamortized discount on issuance costs were accelerated and recorded as expense, including $0.1 million for costs associated with convertible notes, $0.1 million for warrants issued in connection with the convertible notes and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at September 30, 2018 was $2,492,402. During$0.5 million for warrants issued in connection with non-convertible notes issued prior to the three months ended September 30, 2018 and 2017,IPO. Warrants issued to underwriters in connection with the IPO were treated as deal costs.
PIPE Offerings
On June 16, 2019, the Company recorded option expense of $171,327entered into a private offering with certain institutional and $0, respectively. Duringaccredited investors for the nine months ended September 30, 2018 and 2017,sale by the Company recorded option expense of $233,303675,000 units (each a “June Unit”) at $14.00 per June Unit for total gross proceeds of $9.5 million. Each June Unit consisted of (i) 1 share of the Company’s common stock, and $0, respectively.

Warrants

On April 20, 2018, the Company issued warrants(ii) a warrant to purchase 79,3500.7 shares (a total of 472,500) of common stock (each a “June Warrant”) (collectively, "June PIPE"). The June Warrants included in the June Units are exercisable at an exercisea price of $1.75. The warrants$16.00 per share commencing on the date of issuance and will expire on April 20, 2023. The warrantsAugust 23, 2024. On July 1, 2019, the Company filed a Registration Statement on Form S-1 to register for resale the common stock underlying the June Units sold with the Company's June 2019 private offering. Net proceeds from the closing of the sale of the June Units on June 19, 2019 were issued to a$8.6 million after deducting the placement agent in connection with notes issued under the Fourth Note.

On June 8, 2018, the Company issued warrants to purchase 12,000 shares of common stock at an exercise price of $1.75. The warrants expire on June 8, 2023. The warrants were issued to a placement agent in connection with notes issued under the Fourth Note.

fees and offering expenses.

The grant date fair value of these 91,350 warrants472,500 June Warrants was $103,006,$4.4 million, which was determined utilizing the Black-Scholes option pricing model. Variables used in the Black-Scholes option-pricingoption pricing model include (1) discount rate of 2.8%1.9% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected term of 5five years based on the simplified method provided in Staff Accounting Bulletin,term of the warrants, (3) expected volatility of 84%84.9% based on the historical volatility of comparable companies' stock, (4) 0 expected dividends, and (5) fair value of the Company's stock at $14.30 per share.
On October 10, 2019, the Company entered into a private offering with certain institutional and accredited investors for the sale by the Company of 485,250 units (each an “October Unit”) at $12.88 per October Unit for total gross proceeds of $6.3 million. Each October Unit consisted of (i) 1 share of the Company’s common stock and (ii) a warrant to purchase 1.1 shares (a total of 533,775) of common stock (each an “October Warrant”) (collectively, "October PIPE"). The October Warrants included in the October Units are exercisable at a price of $12.88 per share commencing on the date of issuance and will expire on October 10, 2024. On November 8, 2019, the Company filed a Registration Statement on Form S-1 to register for resale the common stock underlying the October Units sold with the Company's October 2019 private offering. Net proceeds from the closing of the sale of the October Units on October 11, 2019 were $5.7 million after deducting the placement agent fees and offering expenses.
The grant date fair value of these 533,775 October Warrants was $4.5 million, which was determined utilizing the Black-Scholes option pricing model. Variables used in the Black-Scholes option pricing model include (1) discount rate of 1.6% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected term of five years based on the term of the warrants, (3) expected volatility of 82.9% based on the historical volatility of comparable companies' stock, (4) no expected dividends, and (5) fair market value of the Company's stock at $1.67$12.88 per share which value was determined by the Company's Board after reviewing and considering, among other factors, a valuation report issued by an independent appraisal firm.

share.

The fair value amount wasof the warrants from the two PIPE transactions were included in discounts on convertible notes payable and being amortized over the life of the convertible notes payable. At September 30, 2018, the unamortized balance amounted to $85,661.

additional paid-in-capital as deal costs.
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During the three and nine months ended September 30, 2018, the Company recorded amortization expense related to these warrants of $10,643 and $17,345, respectively.

The following table summarizes warrant activitiesactivity for the nine months ended September 30, 2018:

  

Number of

Shares

  

Weighted

Average

Exercise Price

  

Weighted

Average

Remaining

Contractual

Term (in Years)

  

Aggregate

Intrinsic

Value

 

Outstanding, December 31, 2017

    $     $ 
                 

Granted

  91,350   1.75         

Exercised

              

Canceled

              

Outstanding, September 30, 2018

  91,350  $1.75   4.57  $ 
                 

Exercisable, September 30, 2018

  91,350  $1.75   4.57  $ 

2020:
Number of
Shares
Weighted
Average
Exercise Price
Weighted
Average
Remaining
Contractual
Term
(in Years)
Aggregate
Intrinsic
Value
(in thousands)
Outstanding, December 31, 20191,374,608 $10.97 4.43$14 
Granted— — 
Exercised(40,891)1.75 — 247 
Forfeited (cashless exercise)(9,109)1.75 — — 
Outstanding, September 30, 20201,324,608 $11.32 3.70$
Exercisable, September 30, 20201,324,608 $11.32 3.70$

Note 87 - Subsequent Events


On August 7, 2018,October 22, 2020, the Company's Board authorized itappointed Niquette Hunt as an independent member of the Company’s Board, effective on such date. Ms. Hunt was also appointed to commenceserve on the Board’s audit committee and compensation committee. Ms. Hunt will participate in the Company’s standard compensation program for non-employee directors, including annual cash compensation of $38,000, annual compensation of $9,000 and $6,000 for serving as a new offering for up to $485,000 10% non-convertible promissory notes, which were accompanied bymember of the audit committee and compensation committee, respectively, and an initial award of a five-year warrant10 year option to purchase one share of Common stock with an exercise price of $1.75 per share for each dollar in principal amount of notes purchased (collectively, the "Fifth Note") that can be exercised (i) at any time on or after the issuance of the notes and (ii) on or prior to the close of business on the five-year anniversary of the issuance of the notes. Mr. Klemp, Dr. Capelli, Ms. Bisson and other members of management collectively purchased $125,000 of such notes and warrants. The principal and interest on the Fifth Note was due on the earlier of one-year from the date of issuance or upon successful completion of the IPO.

On August 31, 2018, the Company's Board approved a $200,000 increase to the Fifth Note authorized on August 7, 2018. On December 21, 2018, the Company's Board approved an additional $300,000 increase to the Fifth Note authorized on August 7, 2018 up to a maximum of $985,000. From October 2018 to February 2019, the Company issued $125,000 and $860,000 of the Fifth Note to related parties and non-related parties, respectively. On February 15, 2019, the Company paid $1,005,039 in principal and interest to the note holders to repay the Fifth Note in full.

On November 1, 2018, the Company filed an amendment to its certificate of incorporation to increase the authorized30,000 shares of the Company's common stock, to 19,000,000 shares of common stock, $0.001 par value per share,under the Company's 2018 Stock Plan, with 4 year annual vesting and 2,534,766 shares of preferred stock, $0.001 par value per share. On February 19, 2019, the Company amended its articles of incorporation to no longer have preferred shares authorized and increased the authorized shares of common stock to 100,000,000.

In January 2019, Mr. Klemp, Dr. Capelli, Mr. Tanner, Ms. Bisson and one other individual agreed to the extinguishment of about $484,000 in deferred compensation which had been earned through September 30, 2018, and which was to be repaid out of the proceeds from this offering. In recognition of this extinguishment, on February 5, 2019, the Company granted the same parties an aggregate of 401,750 options to purchase common stock with an exercise price equal to the closing price of $1.75 per share and a term of 10 years. These options vest in four installments over the next year.

On February 19, 2019, the Company consummated its IPO. In the IPO, the Company sold a total of 2,172,591 shares ofCompany's common stock at a purchase price of $5.00 per share for gross proceeds of $10,862,955 and net proceeds of approximately $9,700,000. In connection withon the closingdate of the IPO,appointment.


On October 23, 2020, the Company's convertible notes (and related accrued interest)Board appointed Michael K. Kaminer, M.D., as an independent member of $11,784,987 were converted into 6,825,391the Company’s Board, effective on such date. Dr. Kaminer was also appointed to serve on the Board’s nominating and governance committee. Dr. Kaminer will participate in the Company’s standard compensation program for non-employee directors, including annual cash compensation of $38,000, annual compensation of $5,000 for serving as a member of the nominating and governance committee and an initial award of a 10 year option to purchase 30,000 shares of the Company's common stock, accrued dividendsunder the Company's 2018 Stock Plan, with 4 year annual vesting and an exercise price equal to the closing price of $4,773,480 were convertedthe Company's common stock on the date of the appointment.

On October 30, 2020, the Company entered into 954,696an employment agreement with Brad Hauser to serve as the Company's President and Chief Executive Officer effective November 2, 2020. Mr. Hauser was granted a restricted stock unit award for 200,000 shares of the Company's common stock, and preferredunder the Company's 2018 Stock Plan, with 4 year annual vesting at a price equal to the closing price of the Company's common stock both Series A and Series B, were converted into 2,534,766on the date of the appointment. Mr. Hauser was also granted a 10 year option to purchase 350,000 shares of the Company's common stock. In addition, 100,000 shares of restricted grants vested in Novemberstock, under the Company's 2018 Stock Plan, with a 4 year annual vesting and 127,500 shares of unvested restricted grants were immediately vested uponan exercise price equal to the completionclosing price of the IPO. Total shares ofCompany's common stock outstanding aton the closingdate of the IPO amountedappointment.

On October 30, 2020, Dr. Chris Capelli transitioned to 14,613,000. Upon the closingposition of Chief Science Officer and the Board appointed Mr. Capelli as Vice Chairman of the IPO, certain notes were to be automatically converted according to their terms into the Company’s common stock to the extent and provided that certain holders of these notes are not permitted to convert such notes to the extent that the holders or any of its affiliates would beneficially own in excess of 4.99% of the Company’s common stock after such conversion. Due to this 4.99% limitation, principal representing $47,781 of these notes remained outstanding and will be converted into 273,034 shares of our common stock at such time as the 4.99% limitation continues to be met. The maturity date of these notes is automatically extended until such date the notes are fully converted and these notes cease to accrue interest and are not repayable in cash.

On February 25, 2019,Board. In connection with Dr. Capelli's transition, the Company finalizedentered into an amendment to Dr. Capelli's amended and restated employment agreements with Walter Kemp, Christopher Capelli, Joe Tanner and Lori Bisson and included these employment agreements as Exhibits herein in this report on Form 10-Q.

agreement.



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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See our Post-Qualification Amendment toAnnual Report on Form 10-K for the Offering Statement dated February 13,year ended December 31, 2019 filed with the SEC on March 2, 2020 (the “2019 Annual Report on Form 10-K”), under "Risk Factors", available on the SEC'sSecurity and Exchange Commission's (“SEC”) EDGAR website at www.sec.gov, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Form 10-Q.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained in this quarterly report on Form 10-Q are

We make forward-looking statements withinunder the meaning“Management’s Discussion and Analysis of Section 27AFinancial Condition and Results of the Securities ActOperations” and in other sections of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).this Form 10-Q. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “should,” “would,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or “continue,” and the negative of these terms and other comparable terminology. However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the numerous risks and uncertainties described under “Risk Factors” as discussed in our Post-Qualification Amendment2019 Annual Report on Form 10-K and in other filings made by us from time to time with the Offering Statement dated February 13, 2019, under "Risk Factors", available on the SEC's EDGAR website at www.sec.gov, and a copy may also be obtained by contacting the Company.

SEC.

While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this Form 10-Q may describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. All forward-looking statements made in this Form 10-Q speak only as of the date of this report. We are under no duty to update any of these forward-looking statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend to do so.

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Forward-looking statements include, but are not limited to, statements about:

our ability to obtain additional funding to commercialize RAPour Rapid Acoustic Pulse (“RAP”) for tattoo removal and, if approved, cellulite reduction, to develop the RAP device for other indications and develop our dermatological technologies;

our ability to obtain clearance from the FDA to market our technology for the improvement in the appearance of cellulite;

the timing of our commercial launch, which we expect to occur in the first half of 2021 and which is subject to the aesthetic market stabilizing in response to COVID-19;
the need to obtain regulatory approval for when we modify our Generation 1 RAP2.0 device and the potential to obtain an additional approvalprepare for our initial commercial launch, when we modify the Generation 1 RAPinitially launched device to become ourbe a Generation 23.0 device before our initial market launch and the need to become our Generation 3 device before our nationwide launch;

obtain regulatory approval for other indications;

the success of our future clinical trials;

compliance with obligations under our intellectual property license with The University of Texas M.D. Anderson Cancer Center (“MD Anderson;

Anderson”);

market acceptance of the RAP device;

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competition from existing products or new products that may emerge;

potential product liability claims;

our dependency on third-party manufacturers to supply or manufacture our products;

our ability to establish or maintain collaborations, licensing or other arrangements;

our ability and third parties’ abilities to protect intellectual property rights;

our ability to adequately support future growth; and

our ability to attract and retain key personnel to manage our business effectively.

effectively;

22

Tablerisks associated with our identification of Contentsmaterial weaknesses in our control over financial reporting;
natural disasters affecting us, our primary manufacturer or our suppliers;

our ability to establish relationships with health care professionals and organizations;
market and economic uncertainty caused by the COVID-19 outbreak;
general economic uncertainty that adversely affects spending on cosmetic procedures;
volatility in the market price of our stock; and
potential dilution to current stockholders from the issuance of equity awards.
We caution you not to place undue reliance on the forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statements contained in this Form 10-Q.
You should not rely upon forward-looking statements as predictions of future events. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Therefore, you should not rely on any of the forward-looking statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Overview


We are a medical technology company focused on developing and commercializing products utilizing our proprietary designed acoustic shockwave technology platform referred to as Rapid Acoustic Pulse ("RAP").RAP. We are a pre-revenue stage company with our first product currently being developedpreparing for launch for the removal of tattoos. tattoos and the reduction of cellulite, if approved. We received clearance for our initial device from the U.S. Food and Drug Administration ("FDA") on May 24, 2019 allowing our device to be used as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.

Commercial upgrades to our Generation 2.0 device to improve usability were subsequently approved through a Special 510(k) in March 2020. This improved device was utilized in our recently completed pivotal cellulite trial, the data from which was included in the 510(k) pre-market application of our Generation 2.0 device for the temporary reduction in the appearance of cellulite filed on June 30, 2020. The 510(k) notice was found administratively complete and is currently under substantive review.Our product will need to receive clearance from the Food and Drug Administration ("FDA"),FDA in order to be marketed for non-tattoo indications in the United States. We expect to submit our filing for premarket clearance approval with the FDA in the first quarter of 2019. We also intend to secure regulatory approval in numerous international markets and are currently developing a regulatory strategy for these markets.


Our ongoing research and development activities are primarily focused on finalizing the commercial device and cartridge design for tattoo removal and cellulite reduction, obtaining FDA clearance for our system for the treatment of cellulite, and then developing our system and treatment head for additional indications. In addition to these development activities, we are exploring additional uses of RAP technology for the dermatology, plastic surgery, and aesthetic markets, as well as new methods for improving the safety and efficacy of laser-based devices. We concluded a pivotal study for the reduction of cellulite and submitted this data to the FDA for consideration in a 510(k) premarket clearance filing on June 30, 2020 that
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cleared the FDA's acceptance review on July 15, 2020 and moved to a substantive review. We have also completed a proof-of-concept clinical trial for the treatment of fibrotic scars.

Our business model anticipates generating revenue from the sale of our RAP console to dermatologists, plastic surgeons, and other physician offices, as well as medi-spas under the supervision of a doctor. More importantly, we expectOur model contemplates recurring revenues will be generated by the sale of disposable cartridges that are utilized with each patient visit and treatment. Finally, weWe believe additional revenues will result from maintenance services to our customers. Our system comprises a control unitconsole with a hand piece and our consumable treatment cartridges, which are designed to allow a physician to perform a single tattoo removal treatment per office visit involving multiple laser passes on an average-sized tattoo. In simple terms, weor one side of the body per cellulite reduction treatment. We expect this to translate into approximately one treatment cartridge per patient, per visit.

Our ongoing research and development activities are primarily focused on obtaining FDA clearance for our system and then developing our system and treatment headvisit for tattoo removal procedures. In addition to these development activities related to tattoo removal, we are exploring additional uses of RAP technologyand two cartridges per patient, per visit for the dermatology, plastic surgery, and aesthetic markets, as well as new methods for improving the safety and efficacy of laser-based devices.

cellulite, if approved.


The medical technology and aesthetic product markets are highly competitive and dynamic and are characterized by rapid and substantial technological development and product innovations. We will compete with many other technologies for consumer demand. Further, the aesthetic industry in which we will operate is particularly vulnerable to economic trends. The decision to undergo a procedure from our systems will be driven by consumer demand. Procedures performed using our systems arewill be elective procedures, the cost of which must be borne by the patient and are not reimbursable through government or private health insurance. In times of economic uncertainty or recession, individuals often reduce the amount of money that they spend on discretionary items, including aesthetic procedures. The general economic difficulties being experienced and the lack of availability of consumer credit for some of our customers' patients could adversely affect the markets in which we will operate.

Recent Developments


Effective October 30, 2020, the Board of Directors of Soliton, Inc. (the “Company”) appointed Brad Hauser as President and Chief Executive Officer, effective on November 2, 2020. On October 30, 2020, Dr. Chris Capelli transitioned to the position of Chief Science Officer and the Board of Directors (the "Board") appointed him as Vice Chairman of the Board.

On October 23, 2020, the Board appointed Mr. Michael Kaminer, M.D., co-founder of SkinCare Physicians, as an independent member of our Board.

On October 22, 2020, the Board appointed Ms. Niquette Hunt, President and CEO of Candesant Biomedical, as an independent member of our Board.

On July 10, 2018,15, 2020, we commencedannounced that our first proof of concept trial510(k) application for premarket clearance filed with the FDA for our second generation RAP device for cellulite reduction has cleared the agency's administrative acceptance review. The device is already indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients and this latest new application is for the reductiontemporary improvement of the appearance of cellulite. The application is now in substantive review. The FDA has responded to our application with a request for additional information on certain questions related to our technology and clinical data. Our team is preparing responses to their questions and will submit these responses in the next four to six weeks. We enrolled five patients who each received one treatment on one thigh and three treatments separated by three weeks onexpect the other thigh. The proofFDA to respond within approximately thirty days of concept trial is on-going, as additional treatments are planned, and as such, results have not been finalized.

On February 19, 2019, we consummated our initial public offering (“IPO”). In the IPO, we sold a total of 2,172,591 shares of common stock at a purchase price of $5.00 per share for gross proceeds of $10,862,955 and net proceeds of approximately $9,700,000. In connection with the closing of the IPO, our convertible notes (and related accrued interest) of $11,784,987 were converted into 6,825,391 sharesreceipt of our common stock, accrued dividends of $4,773,480 were converted into 954,696 shares of our common stock and preferred stock, both Series A and Series B, were converted into 2,534,766 shares of our common stock. In addition, 100,000 shares of restricted grants vested in November 2018 and 127,500 shares of unvested restricted grants were immediately vested upon the completion of the IPO. Total shares of common stock outstanding at the closing of the IPO amounted to 14,613,000. Upon the closing of the IPO, certain notes were to be automatically converted according to their terms into our common stock to the extent and provided that certain holders of these notes are not permitted to convert such notes to the extent that the holdersformal response with either additional questions or any of its affiliates would beneficially own in excess of 4.99% of our common stock after such conversion. Due to this 4.99% limitation, principal representing $47,781 of these notes remained outstanding and will be converted into 273,034 shares of our common stock at such timea final decision. We believe we could potentially receive a clearance as soon as the 4.99% limitation continues to be met. The maturity datefourth quarter of these notes is automatically extended until such date the notes are fully converted and these notes cease to accrue interest and are not repayable in cash.

Results of Operations for the Three Months Ended September 30, 2018 Compared to the Three Months Ended September 30, 2017

Below is a summary of the results of operations for the three months ended September 30, 2018 and 2017:

  

Three Months Ended

 
  

September 30,

 
  

2018

  

2017

  

$ Change

  

% Change

 

Operating expenses

                

Research and development

 $1,717,113  $717,785  $999,328   139.22

%

Sales and marketing

  109,565   30,198   79,367   262.82

%

Depreciation and amortization

  30,028   32,449   (2,421

)

  (7.46

)%

General and administrative

  794,991   720,411   74,580   10.35

%

Total operating expenses

 $2,651,697  $1,500,843  $1,150,854   76.68

%

Research and development. Research and development ("R&D") expenses increased by $999,328 compared to the same period in 2017, primarily due to increases in contract engineering expenses of $838,922, salaries and related expenses of $86,782, which are largely due to personnel expenses being allocated more to R&D in the current period than in the prior period, clinical trial expenses of $29,444, and license and other expenses of $72,793. These increases were primarily offset by decreases in animal research expenses of $28,613. The overall increase in R&D costs reflects2020 but have aligned our transition from pure research to more development related activities.

Sales and marketing. Sales and marketing ("S&M") expenses increased by $79,367 compared to the same period in 2017, primarily due to increases in expenses related to social media development of $64,950 and our Scientific Advisory Board ("SAB") and the related cost of meetings with this group and other advisors of $14,417. We include our SAB fees in S&M because they primarily advise on our product launch and marketing decisions related to dermatologists and prospective patients.

General and administrative. General and administrative ("G&A") expenses increased by $74,580 compared to same period in 2017. This increase was primarily due to increases in membership expenses of $2,518, IT related expenses of $27,263, accounting and other professional expenses of $25,532, investor relations expenses of $22,539 and non-cash expenses related to the granting of stock options of $171,330. These increases were primarily offset by decreases in salaries and related expenses of $151,792, travel and related expenses of $19,732 and other expenses of $3,078.

Results of Operations for the Nine Months Ended September 30, 2018 Compared to the Nine Months Ended September 30, 2017

Below is a summary of the results of operations for the nine months ended September 30, 2018 and 2017:

  

Nine Months Ended

 
  

September 30,

 
  

2018

  

2017

  

$ Change

  

% Change

 

Operating expenses

                

Research and development

 $3,804,015  $3,144,771  $659,244   20.96

%

Sales and marketing

  178,115   77,098   101,017   131.02

%

Depreciation and amortization

  90,321   99,048   (8,727

)

  (8.81

)%

General and administrative

  2,078,191   2,264,506   (186,315

)

  (8.23

)%

Total operating expenses

 $6,150,642  $5,585,423  $565,219   10.12

%

Research and development. R&D expenses increased by $659,244 compared to the same period in 2017, primarily due to increases in contract engineering expenses of $821,149, salaries and related expenses of $189,104, which are largely due to personnel expenses being allocated more to R&D in the current period than in the prior period, and license and other expenses of $97,224. These increases were offset by decreases in animal research expenses of $203,099 and clinical trial expenses of $245,134.

Sales and marketing. S&M expenses increased by $101,017 compared to the same period in 2017, primarily due to an increase in expenses related to social media development of $108,500 offset by decreases in our SAB and other conference related expenses of meetings of $7,483. We include our SAB fees in S&M because they primarily advise on our product launch and marketing decisions related to dermatologists and prospective patients.

General and administrative. G&A expenses decreased by $186,315 compared to same period in 2017 primarily due to decreases in salaries and related expenses of $357,236, primarily due to the accrual of bonuses ininternal plans around the first quarter of 2017 that was forgiven2021. These timelines may be impacted by COVID-related delays in 2018, travel expensesFDA submission review.


On September 9, 2020, we entered into a distribution and sales agreement with Aesthetic Solutions, Inc. to distribute our RAP device and advanced design cartridges during the initial U.S. commercial launch targeted for the first half of $140,323, which were higher2021.

On August 13, 2020, we announced we completed the design process for an advanced hand piece and cartridge for our RAP device. The new design for the hand piece and cartridge includes several improved features providing ease of use and a more user-friendly experience. Our engineering and design services partner has now assembled the new hand piece and cartridge and successfully tested its functionality. We intend to file a Special 510(k) with the FDA to gain clearance for these updates to our device.

During the first quarter of 2020, we completed the follow-up visits for the patients enrolled in our cellulite pivotal study across four clinical sites. We treated 67 subjects and included the prior yearresults for 62 of these subjects in our analysis due to the clinical trialsexclusion of one no-show subject and incomplete follow-ups for another four subjects. Each patient received one treatment targeting dimples and ridges for approximately 20-30 minutes. As a measure of patient satisfaction, 91.9% of the subjects agreed or strongly agreed that their cellulite appeared improved 12 weeks after treatment. The primary endpoint of the study, a mean change in cellulite severity score of 1.0 or better, was exceeded with an actual mean change of 1.16, resulting in a positive outcome. Further, there were being conducted in that period, requiring significant travel tono unexpected or serious adverse events and the trial site, and other expenses of $30,071. These decreasesaverage pain scores were primarily offset by an increase in stock compensation expenses of $233,305, driven primarily by the increase in expenses related to the granting of stock options, membership expenses of $14,763, IT expenses of $55,390, investor relations expenses of $22,539 and accounting and other professional expenses of $15,318.

2.4 on a 10-point scale.
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Liquidity


In light of the widespread impact of COVID-19, our view of the ideal launch window for our RAP device changed. Instead of launching our RAP device focused solely on tattoo removal in mid-2020, we elected to delay that launch until the aesthetic and Capital Resources

Sincefinancial markets are demonstrating greater stability. Given these conditions, we expect the most appropriate launch window for our inception,new technology will open in the first half of 2021. We are making plans to launch the RAP device during the first half of 2021, which will include the tattoo removal and priorcellulite reduction indications, subject to FDA clearance of the latter. We believe the opportunity to launch both indications simultaneously will enhance both physician and patient adoption and result in a stronger launch of our IPO,technology. In the meantime, we will remain highly focused on our regulatory pathway for cellulite reduction.


Due to COVID-19, we have financedexperienced significant follow-up visit cancellations in our operations through private placementsongoing 26 week cellulite clinical trial assessment and increased difficulty in executing the initiation of common stock, convertible preferred stock, convertible and non-convertible bridge notes. On September 30, 2018, we had $197,975 of cash and cash equivalents.

On February 19, 2019, we consummated our IPO. Infurther clinical trials at sites around the IPO, we sold a total of 2,172,591 shares of common stock at a purchase price of $5.00 per share for gross proceeds of $10,862,955 and net proceeds of approximately $9,700,000. In connection with the closing of the IPO, our convertible notes (and related accrued interest) of $11,784,987 were converted into 6,825,391 shares of our common stock, accrued dividends of $4,773,480 were converted into 954,696 shares of our common stock.

country. We now expect to continueinitiate our planned additional fibrotic scar proof-of-concept study in the first half of 2021 and have been unable to invest incomplete the 26 week follow up visits for our researchcellulite clinical trial, as such, we have amended the study protocol to add a 52 week follow-up assessment visit and development effortswe are actively executing those assessments. Based on these delays, we expect it to support our current initiatives. We will not generate revenue until our commercial RAP units are cleared byextend the time required to file for additional, longer-term cellulite reduction claims with the FDA and sold.

for initial approvals of a hypertrophic scar indication that we may seek in the future.


At September 30, 2020, we had cash, cash equivalents and restricted cash on hand of $34.8 million. We estimatedo not expect to experience positive cash flows from operating activities in the near future, if at all. We expect our current cash, resources, including the approximate $9,700,000cash equivalents and restricted cash on hand of net proceeds from the IPO is$34.8 million as of September 30, 2020 will be sufficient to fund our operations into the third quarter of 2022 but not beyond February 2020. beyond.
We also recognizesanticipate incurring operating losses for the next several years as we willcomplete the development of our products, seek requested regulatory clearances to market such products and support the commercial launch of our products. These factors raise uncertainties about our ability to fund operations in future years. If we need to raise additional capital in order to continue to execute our business plan, including obtaining additional regulatory clearance for our products currently under development and commercializing and generating revenues from products under development. There aredevelopment, there is no assurancesassurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us. A failure to raise sufficient capital generate sufficient product revenues, control expenditures and regulatory matters, among other factors, willcould adversely impact our ability to achieve our intended business objectives and meet our financial obligations as they become due and payable into the third quarter of 2022 but not beyond.


Results of Operations for the Three and Nine Months Ended September 30, 2020 Compared to the Three and Nine Months Ended September 30, 2019

Below is a summary of the results of operations (in thousands):
Three Months Ended September 30,
20202019Change
($)
%
Change
Operating expenses
Research and development$1,256 $2,430 $(1,174)(48.31)%
Sales and marketing474 34 440 1,294.12 %
Depreciation and amortization87 73 14 19.18 %
General and administrative1,852 1,764 88 4.99 %
Total operating expenses$3,669 $4,301 $(632)(14.69)%

Research and development. Research and development expenses decreased by $1.2 million compared to the same period in 2019, mainly due to decreases in expenses for contract engineering of $0.9 million, clinical trials of $0.5 million and animal research of $0.1 million offset by increases in expenses for salaries and related costs of $0.2 million and stock-based compensation of $0.1 million.
Sales and marketing. Sales and marketing expenses increased by $0.4 million compared to the same period in 2019, largely due to increases in expenses for brand awareness as we prepare to commercialize our products of $0.1 million, social media development of $0.1 million, salaries and related costs of $0.1 million and other expenses totaling $0.1 million.

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General and administrative. General and administrative expenses increased by $0.1 million compared to the same period in 2019. This increase was primarily due to increases in expenses for information technology of $0.1 million and several miscellaneous costs of $0.1 million offset by a decrease in expenses for travel and related costs of $0.1 million.

Below is a summary of the results of operations (in thousands):

Nine Months Ended September 30,
20202019Change
($)
%
Change
Operating expenses
Research and development$3,762 $3,660 $102 2.79 %
Sales and marketing560 137 423 308.76 %
Depreciation and amortization229 146 83 56.85 %
General and administrative5,531 5,720 (189)(3.30)%
Total operating expenses$10,082 $9,663 $419 4.34 %

Research and development. Research and development expenses increased by $0.1 million compared to the same period in 2019, mainly due to increases in expenses for salaries and related costs of $0.3 million and stock-based compensation of $0.2 million offset by decreases in expenses for clinical trials of $0.4 million.
Sales and marketing. Sales and marketing expenses increased by $0.4 million compared to the same period in 2019, largely attributed to increases in expenses for brand awareness as we prepare to commercialize our products of $0.1 million, salaries and related costs of $0.1 million, social media development of $0.1 million and other expenses totaling $0.1 million.
General and administrative. General and administrative expenses decreased by $0.2 million compared to the same period in 2019. This decrease was primarily due to decreases in expenses for travel and related costs of $0.2 million, investor relations of $0.2 million, salaries and benefits of $0.1 million and other expenses totaling $0.1 million, offset by an increase in expenses for insurance and other expenses of $0.2 million, information technology of $0.1 million and stock-based compensation of $0.1 million.
Liquidity and Capital Resources
On September 30, 2020, we had $34.6 million of cash and cash equivalents and $0.2 million in restricted cash representing a letter of credit benefiting our contract manufacturer.
On June 30, 2020, we completed a public offering for the sale of 4,216,868 shares of our common stock for total gross proceeds of approximately $35.0 million. Net proceeds from the offering were approximately $32.0 million after deducting placement agent fees and estimated offering expenses.

We will not generate revenue until we have completed the commercialization of our RAP units and initiated sales of the units. We expect to continue to invest in our research and development efforts to support our current initiatives.

We estimate our current cash, cash equivalents and restricted cash resources of $34.8 million at September 30, 2020 is sufficient to fund our operations into the third quarter of 2022 but not beyond. We anticipate incurring operating losses for the next several years as we complete the development of our products, seek requested regulatory clearances to market such products and support the commercial launch of our products. These factors raise uncertainties about our ability to fund operations in future years. If we need to raise additional capital in order to continue to execute our business plan, including obtaining additional regulatory clearance for our products currently under development and commercializing and generating revenues from products under development, there is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us. A failure to raise sufficient capital could adversely impact our ability to achieve our intended business objectives. Ifobjectives and meet our financial obligations as they become due and payable into the third quarter of 2022 but not beyond.

The COVID-19 global pandemic has resulted in travel restrictions and temporary shut-downs of non-essential businesses in many states in the United States. We are able to remain open but have required our employees to work from home for a portion of the work week. Due to many uncertainties, we are unable to raise sufficient additional funds, we will have to scale back our operations.

estimate the pandemic’s financial impact or duration at this time.
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Summary of Cash Flows

The following table summarizes our cash flows for the nine months ended September 30, 20182020 and 2017, respectively:

  

For the nine months ended September 30,

 
  

2018

  

2017

 

Net cash used in operating activities

 $(3,726,305

)

 $(4,726,050

)

Net cash used in investing activities

  (27,160

)

  (64,833

)

Net cash provided by financing activities

  3,933,028   5,000,000 

Net increase in cash and cash equivalents

 $179,563  $209,117 

2019 respectively (in thousands):


20202019
Net cash used in operating activities$(8,822)$(8,253)
Net cash used in investing activities(474)(823)
Net cash provided by financing activities32,046 17,652 
Net increase in cash$22,750 $8,576 

Cash Flows for the nine months ended September 30, 20182020 and 2017

2019

Operating activities.Net cash used in operating activities was $3,726,305$8.8 million during the nine months ended September 30, 2018,2020 and consisted of a net loss of $6,895,374, which was offset by$10.0 million and a net change in operating assets and liabilities of $2,353,484 and$1.2 million offset by non-cash items of $815,585.$2.4 million. The significant items in the change in operating assets and liabilities included a use of cash for prepaid expenses and other current assets of $0.2 million, inventory of $0.3 million and accounts payable of $0.9 million offset by an increase in accrued liabilities of $0.2 million. The increase in prepaid expenses of $7,643 offsetwas largely driven by a net increase in liabilities of $2,361,127, including an increase in accounts payable of $1,322,260, accrued liabilities of $339,275, accrued interest, related partynew insurance policies, reporting software for public companies and non-related party, of $701,102 and aprepayments for work that had not yet been performed by contractors by September 30, 2020. The decrease in deferred rent of $1,510. The increase in accounts payable was largelymainly due to extended payment terms established with severallarger payables at December 31, 2019 to a few of our largest vendors. The amounts owed to such vendors during our IPO process.were not of the same magnitude at September 30, 2020. The increase in accrued liabilities was driven primarily by salary deferralsa few vendors focused on expanding our brand identity and building our brand website during the period. Non-cash items consisted largely of stock-based compensation of $2.2 million and depreciation and amortization expense of $0.2 million.
Net cash used in operating activities was $8.3 million during the nine months ended September 30, 2019 and consisted of a net loss of $10.5 million and a net change in operating assets and liabilities of $0.4 million offset by non-cash items of $2.6 million. The change in operating assets and liabilities included a use of cash for managementprepaid expenses and other current assets of $323,906$0.2 million and accounts payable of $0.8 million offset by accrued liabilities of $0.4 million and accrued interest - non-related and related party of $0.2 million. The decrease in accounts payable was largely due to payments to several vendors, previously on extended terms, as a result of our IPO closing and returning to consistent terms with vendors. The decrease in accrued liabilities was driven primarily by the settlement of accruals for several large vendors that was enacted to conserve operating cash.were paid during the period. The increase in accrued interest-related party iswas due to the issuance of the related party convertible notes and the calculation of interest thereon. Non-cash items consisted largely of depreciation and amortization expense of $90,321,accelerated amortization of deferred financing costsdebt discount of $44,921, impairment of intangible assets of $19,138$0.7 million and stock-based compensation of $661,205.

Net cash used in operating activities was $4,726,050 during the nine months ended September 30, 2017, and consisted of a net loss of $5,765,340, which was offset by a net change in operating assets and liabilities of $512,340 and by non-cash items of $526,950. The significant items in the change in operating assets included a decrease in prepaid expenses and other assets of $14,902 offset by increases in liabilities, including accrued liabilities of $104,485, accounts payable of $207,769, accrued interest-related party of $183,331 and deferred rent of $1,853. The increase in accrued interest-related party is due to the issuance of the related party convertible notes and the calculation of interest thereon. Non-cash items consisted of depreciation and amortization expense of $99,048 and stock-based compensation of $427,902.

$1.9 million.

Investing activities.Net cash used in investing activities for the nine months ended September 30, 20182020 was $27,160$0.5 million compared to $64,833$0.8 million for the same comparable period in 2017. For2019. The cash used in 2020 was largely attributed to $0.4 million of construction-in-process as our manufacturing partner developed GEN 2.2 devices to be used for testing and then moved into use in clinical trials while the nine months ended September 30, 2018 and 2017, $16,008 and $47,189, respectively,amount used in 2019 was utilized towardslargely due to the purchasedevelopment of property and$0.8 million of lab equipment as a result of the investment in our research equipment and office and research facilities. We invested $11,152 and $17,644 towards the acquisition of intangiblesto be used in the same periods in 2018field at clinical trial sites and 2017, respectively.

held by a vendor for future clinical use.
27

Financing activities.Net cash provided by financing activities during the nine months ended September 30, 20182020 was $3,933,028 and consisted$32.0 million, a result of thenet proceeds from the issuance of convertible notes - related party and non-related party for $2,397,000 and $1,978,000, respectively. In addition, $163,760 was a use of cash for debt issuance costs related to the issuance of the convertible notes non-related party and $278,212 was a use of cash for financing cost related to our IPO. Net cash provided by financing activities forJune 2020 Offering. For the nine months ended September 30, 2017 was2019, we received cash proceeds of $9.7 million from our IPO, net of deal costs and other expenses, and cash proceeds from our June 2019 PIPE Offering of $8.6 million, net of deal costs and other expenses. We also received cash proceeds of $0.3 million from the issuance of non-convertible notes payable to non-related parties. These amounts were offset by a use of cash for the payment of non-convertible notes and accrued interest to both related to $5,000,000 convertible note issuances to a related party.

and non-related parties of $1.0 million.

Contractual Obligations and Commitments

On April 5, 2012, we entered into a Patent and Technology License Agreement with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”).Anderson. Pursuant to the agreement, we obtained a royalty-bearing, worldwide, exclusive license to intellectual property including patent rights related to the patents and technology we use. Under the agreement, we agreed to pay a nonrefundable license documentation fee in the high-five digits 30 days after the effective date of the agreement. Additionally, we agreed to pay a nonrefundable annual maintenance fee starting on the third anniversary of the effective date of the agreement, which escalates each anniversary.anniversary and is currently in the upper-five digits. Additionally, we agreed to a running royalty percentage of net sales. sales in the mid-single digits.
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We also agreed to make certain milestone payments in the low to mid-six digits and sublicensing payments.

The specific patents initially subject to the agreement expire between 2031 and 2032.


MD Anderson has the right to terminate the agreement upon advancedadvance notice in the event of a default by Soliton. The agreement will expire upon the expiration of the licensed intellectual property. The rights obtained by us pursuant to the agreement are made subject to the rights of the U.S. government to the extent that the technology covered by the licensed intellectual property was developed under a funding agreement between MD Anderson and the U.S. government. To the extent that is the case, our license agreement with, and the intellectual property rights we have licensed from MD Anderson, are subject to such a funding agreement and any superior rights that the U.S. government may have with respect to the licensed intellectual property. Therefore, there is a risk that the intellectual property rights we have licensed from MD Anderson may be non-exclusive or void if a funding agreement related to the licensed technology between MD Anderson and the U.S. government does exist and depending on the terms of such an agreement. Notwithstanding the foregoing, we do not believe our RAP technology received any federal funding. All out-of-pocket expenses incurred by MD Anderson in filing, prosecuting and maintaining the licensed patents have been and shall continue to be assumed by us.

For the nine months ended September 30, 2020 and 2019, we paid approximately $0.1 million and $0.1 million, respectively, for expenses related to this agreement.

As the inventor of the intellectual property licensed from MD Anderson, Dr. Capelli, our Vice Chairman, Chief Science Officer and Co-Founder, is entitled to 50% of the license income (which is determined after MD Anderson recoups any costs associated therewith) that we are required to pay to MD Anderson pursuant to our license agreement with MD Anderson. For the nine months ended September 30, 2020, Dr. Capelli was paid $37.5 thousand from MD Anderson. In addition, Dr. Capelli is entitled to 50% of the proceeds (after the recoupment of any costs associated therewith) from the sale by MD Anderson of 175,000 shares issued to MD Anderson in connection with the license agreement.
On November 20, 2019, we entered into a cooperative development addendum ("Addendum") to our engineering and development services master agreement with Emphysys, Inc. ("Emphysys”). The Addendum states that Emphysys will provide us with engineering and design services related to shockwave technology for use in dermatology and aesthetics fields for a 36 month period ending July 1, 2022.

During the term of the Addendum, we agreed to certain minimum annual expenditures. If we fail to spend such minimum annual amounts or if we terminate the Addendum without cause, we will be required to pay Emphysys a termination fee ranging in the low to mid-six digits. In the event that all or substantially all of the stock or assets of either party are sold then, at the request of the other party, the Addendum may be terminated (without the requirement to pay a termination fee) and the obligation of Emphysys to provide future services to us shall terminate. Pursuant to the Addendum, with certain exceptions, Emphysys covenanted that it will not perform or agree to perform services with any company other than Soliton in the area of arc-discharge driven acoustical shockwave generation for medical dermatological or aesthetic dermatological indications during the term of the Addendum or any extension thereof, and for a period of six months after the termination of the Addendum.

On March 6, 2020, we entered into a manufacturing service agreement (the "Agreement") with Sanmina Corporation ("Sanmina"). The Agreement states that Sanmina will provide us with certain manufactured products for a one year period, with pricing adjusted for material variations of market prices for components, parts and raw material, including variations resulting from allocations, shortages or tariffs. In addition, pricing will be based on the forecasted volumes provided by us and the projected inventory turns as agreed by both parties.
Either party may terminate the Agreement or an order under the Agreement for default, if the other party materially breaches the Agreement; provided, however, no termination shall occur until thirty days after the defaulting party is notified in writing of the material breach and has failed to cure or give adequate assurances of performance within the thirty day period after notice of material breach. In addition, we may terminate the Agreement for any reason upon thirty days’ prior written notice and may terminate any order under the Agreement for any reason upon 120 days’ (before scheduled shipment) prior written notice. Sanmina may terminate the Agreement for any reason upon ninety days’ notice. In the event the Agreement or an order under the Agreement is terminated for any reason other than a breach by Sanmina, we are required to pay Sanmina termination charges equal to (i) the contract price for all finished product existing at the time of termination; (ii) Sanmina’s cost (including labor, components and applicable mark-ups per the pricing model) for all work in process; and (iii) the cost of components ordered by Sanmina pursuant to the Agreement.
Purchase Commitments
As of September 30, 2020, we had purchase obligations of $2.9 million to Emphysys. This commitment is for services used in the ordinary course of business and does not represent excess commitments or loss contracts. The remaining minimum purchase obligations are $1.3 million and $1.6 million, respectively, for the 12 month periods ending June 30, 2021 and
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June 30, 2022. If we fail to spend such minimum annual amounts or if the Company terminates the Addendum without cause, the Company will be required to pay Emphysys an early termination fee of no more than $0.4 million.
Lease Commitments

We lease space for our corporate office, which provides for a five-yearan original 63 month term beginning on July 15, 2015, forFebruary 1, 2016, with initial rent payments of $8,053$7.9 thousand per month.month that escalate annually to a maximum of $8.9 thousand per month through the expiration of the agreement. On September 15, 2020, we entered into a 12 month extension of our corporate office lease. Rent expense for non-cancellable operating leases with scheduled rent increases will be recognized on a straight-line basis over the lease term.

Future minimum lease payments under the operating leases as of September 30, 20182020 were as follows:

Year Ending December, 31

 

Amount

 

2018

 $25,164 

2019

  103,737 

2020

  108,429 

Thereafter

  36,668 

Total future minimum lease payments

 $273,998 

less than $0.2 million through the lease term ending April 30, 2022.
Employment Agreements
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TableWe have agreements with key employees to provide certain benefits in the event of Contentstermination where the base salary and certain other benefits would aggregate $2.9 million using the rate of compensation in effect at November 2, 2020.

Purchase Commitments

Off-balance Sheet Arrangements
As of September 30, 2018, we had no non-cancellable purchase obligations to contract manufacturers and suppliers.

Unrecognized Tax Benefits

As of September 30, 2018, we have not recorded a provision for income taxes in our financial statements as we have been in a loss position since inception and we cannot be more certain than not that we will be able to recognize the income tax benefit from our NOL carry forward in the future.

Off-balance Sheet Arrangements

As of September 30, 2018,2020, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Critical Accounting Policies and Significant Judgments and Estimates

The financial statements in this quarterly report have been prepared in accordance with generally accepted accounting principles in the United States of America ("GAAP"). The preparation of financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the amounts reported in the financial statements, including the notes thereto. We consider critical accounting policies to be those that require more significant judgments and estimates in the preparation of our financial statements, including the following: research and development expenses, long lived assets, intangible assets valuations, accrued liabilities, income tax valuations, warrants, and stock-based compensation. Management relies on historical experience and other assumptions believed to be reasonable in making its judgments and estimates. Actual results could differ materially from those estimates.

Management believes its application of accounting policies, and the estimates inherently required therein, are reasonable. These accounting policies and estimates are periodically reevaluated, and adjustments are made when facts and circumstances dictate a change.

Our accounting policies are more fully described under the heading “Description of the Business and Summary of Significant Accounting Policies” in Note 1 to our Financial Statements included in this Form 10-Q.
We believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain.
Research and Development Costs
We record accrued expenses for estimated costs of our research and development activities conducted by third-party service providers, which include the conducting of pre-clinical studies, preparation for and conducting of clinical trials and contract engineering activities. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced, and we include these costs in accrued liabilities in the balance sheets and within research and development expense in the statements of operations. These costs are a significant component of our research and development expenses. We record accrued expenses for these costs based on the estimated amount of work completed and in accordance with agreements established with these third parties.
We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant
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23

Table

judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of Contentsthe status and timing of services performed may vary from our estimates and could result in us reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations, engineering firms and other third-party service providers. To date, there have been no material differences from our accrued expenses to actual expenses.
Impairment of Long-Lived Assets
Management reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be realizable or at a minimum annually during the fourth quarter of the year. If an evaluation is required, the estimated future undiscounted cash flows associated with the asset are compared to the asset’s carrying value to determine if an impairment of such asset is necessary. The effect of any impairment would be to expense the difference between the fair value of such asset and its' carrying value.
Components of our Results of Operations and Financial Condition
Operating expenses
We classify our operating expenses into four categories: (i) research and development; (ii) sales and marketing; (iii) general and administrative; and (iv) depreciation.
Research and development. Research and development expenses consist primarily of:
costs incurred to conduct research, such as animal research;
costs related to the design and development of our technology, including fees paid to contract engineering firms and contract manufacturers;
salaries and expenses, including stock-based compensation, related to our employees primarily engaged in research and development activities;
fees paid to clinical consultants, clinical trial sites and vendors, including clinical research organizations, in preparation for clinical trials and our applications with the FDA;
costs to develop and defend our intellectual property; and
costs related to compliance with regulatory requirements.
We recognize all research and development costs as they are incurred. Pre-clinical costs, contract engineering and design costs, patent costs and other development costs incurred by third parties are expensed as the contracted work is performed.
We expect our research and development expenses to increase in the future as we advance our product into and through clinical trials, pursue additional regulatory approvals of our product in the United States, and continue commercial development of our RAP device and replaceable cartridge. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The probability of success for our technology may be affected by a variety of factors including: the quality of our product, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability. We may not succeed in achieving all necessary regulatory approvals for our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development process or when and to what extent, if any, we will generate revenue from the commercialization and sale of our device.
Sales and marketing
Sales and marketing expenses consist of marketing, conferences, web development, advisory boards and other miscellaneous expenses. We expect our sales and marketing expense to increase due to the anticipated growth of our business and related infrastructure as well as expanding our sales personnel, selling costs, and other costs which will begin to be incurred upon the commercialization of our products. We recognize expenses to develop advertising materials as they are incurred.
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General and administrative
General and administrative expenses consist of personnel related costs, which include salaries, as well as the costs of professional services, such as accounting and legal, facilities, information technology, stock-based compensation and other administrative expenses. We expect our general and administrative expense to increase due to the anticipated growth of our business and related infrastructure as well as accounting, insurance, investor relations and other costs associated with becoming a public company.
Depreciation and amortization
Depreciation expense consists of depreciation on our property and equipment. We depreciate our assets over their estimated useful lives. We estimate research and development equipment and lab equipment to have a five year life; computer equipment and software to have a three year life; furniture to have a three year life; and leasehold improvements to be depreciated over the shorter of the remaining lease term or useful lives of the asset.
Accounting for warrants
We issued warrants to purchase shares of common stock related to (i) bridge notes issued prior to our IPO, (ii) private investment in public equity ("PIPE") offerings, and (iii) as part of underwriter compensation in 2019 and 2018. We accounted for such warrants in accordance with Accounting Standards Codification (ASC) Topic 480-10, Distinguishing Liabilities from Equity, which identifies three categories of freestanding financial instruments that are required to be accounted for as a liability. Based on this guidance, we determined, for each issuance, that warrants did not need to be accounted for as a liability. Accordingly, the warrants were classified as equity and are not subject to remeasurement at each balance sheet date. In addition, we account for issuance costs of warrants issued with debt instruments in accordance with ASC 470-20, Debt with Conversion and Other Options, which states proceeds from the sale of a debt instrument with stock purchase warrants (detachable call options) are allocated to elements based on the relative fair values of the debt instrument without the warrants and of the warrants themselves at time of issuance. The portion of the proceeds so allocated to the warrants are accounted for as paid-in capital. The remainder of the proceeds are allocated to the debt instrument, which may result in a discount or premium.
Related registration rights agreements for each private placement are accounted for in accordance with ASC Topic 450-20, Loss Contingencies, which requires measurement of the contingent liability when an entity would be required to deliver shares under a registration payment arrangement, the transfer of consideration is probable and the number of shares to be delivered can be reasonably estimated. Accordingly, there is no liability under the payment arrangement requiring disclosure or recognition.
The fair value of warrants is estimated using the Black-Scholes option pricing model, based on the market value of the underlying common stock at the measurement dates, the contractual terms of the warrants, risk-free interest rates and historical volatility of comparable companies' stock. There are no expected dividends.
Stock-based compensation
Stock-based compensation transactions are recognized as compensation expense in the statements of operations based on their fair values on the date of the grant. The expense for equity awards expected to vest is recognized over the applicable vesting period of the stock award using either the straight-line method or the accelerated method, depending on the vesting structure, and is included in general and administrative, research and development or sales and marketing expenses, depending upon the classification of the grantee. We estimate the fair value of options granted using the Black-Scholes option pricing model. This estimate uses assumptions regarding a number of inputs that require us to make significant estimates and judgments. Because we are a new publicly traded common stock, the expected volatility assumption was based on industry peer information.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

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

Item 4.    Controls and Procedures
Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting

We maintain a set of disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, designed to ensure that material information required to be disclosed in our filings under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the
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SEC’s rules and forms and that material information is accumulated and communicated to our management, including our Chief Executive Officer (“CEO”), who serves as our principal executive officer, and Chief Financial Officer (“CFO”), who serves as our principal accounting officer, as appropriate, to allow timely decisions regarding required disclosures.

Under the supervision, and with the participation of our management, including our CEO and CFO, we conducted an evaluation of the effectiveness, as of September 30, 2018,2020, of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act.procedures. Based upon such evaluation and due to both the limited staffing of the Company at its early stage of development and the existence of the material weaknesses in our internal control over financial reporting described below, our CEO and CFO have concluded that, as of September 30, 2018,2020, our disclosure controls and procedures were not effective. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure
A material weakness is a control deficiency, or combination of control deficiencies, that information required toresult in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. As previously disclosed by an issuer in our annual Report on Form 10-K for the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer or officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Based on the evaluation,year ended December 31, 2019, our management concluded that our internal control over financial reporting was, and continues to be ineffective, as of September 30, 2020 due to material weaknesses in the form of (i)our internal controls arising from a lack of segregation of duties; (ii)duties, the limitations of our financial accounting system;system to properly segregate duties, and (iii) the absence of internal staff with extensive knowledge of SEC financial and GAAP reporting. As a result

Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the lackextent possible, the initiation of executive financetransactions, the custody of assets and accounting personnel within the Company,recording of transactions should be performed by separate individuals. Management evaluated the impact of our failure to maintain effective segregation of duties on our assessment of our internal controls related to preparation and review of the Company’s financial statements and related disclosures were not adequate.

To address these concerns, our management has reassessed its finance staffing needs and taken steps to begin to add adequate staffing and resources for thecontrol over financial reporting process by hiringand has concluded that the control deficiency represents a Corporate Controller at the corporate office. Additionalmaterial weakness. In April 2019, an additional experienced personnel will bestaff was hired in the accounting and finance department as it becomes economically feasible and sustainable, atin August 2020, an experienced employee was hired in the corporate office. New proceduresaccounting and finance department to focus on the further development of internal controls. In addition, we are retaining appropriate consultants and upgrading our accounting system in the fourth quarter of 2020. Furthermore, management added additional mitigating controls with regards to cash disbursements; changes were implemented and internal controls are continually being documented surrounding the month end financial closing and financial reportingmade in our authorization processes to improve segregation of duties; and we performed additional analysis and other post-closing procedures to ensure proper and thorough review of journal entries, account reconciliations andour financial statements.statements were prepared in accordance with GAAP. Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.

Changes in Internal Control over Financial Reporting

We have not experienced any material impact to our internal controls over financial reporting despite the fact that most of our employees are working remotely due to the COVID-19 pandemic. We are continually monitoring and assessing the COVID-19 situation on our internal controls to minimize the impact on their design and operating effectiveness.

Other than as described above, there has been no change in our internal control over financial reporting during our most recent calendar quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II - OTHER INFORMATION

Item 1.

Legal Proceedings

Item 1.    Legal Proceedings
From time to time in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. We are not able to estimate an aggregate amount or range of reasonably possible losses for those legal matters for which losses are not probable and estimable. We have insurance policies covering potential losses where such coverage is cost effective.

We are not at this time involved in any legal proceedings that we believe could have a material effect on our business, financial condition, results of operations or cash flows.

proceedings.

Item 1A.

Risk Factors

Item 1A.    Risk Factors
In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section entitled “Risk Factors” in our Post-Qualification Amendment to2019 Annual Report on Form 10-K and our Form 10-Q for the Offering Statement dated February 13, 2019,quarters ended March 31, 2020 and June 30, 2020 filed with the SEC, which are incorporated herein by reference. The risks described in the Offering Circular2019 Annual Report on Form 10-K and our Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020 are not the only risks facing our company.Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. There have been no material changes to our risk factors from those set forth in our 2019 Annual Report on Form 10-K and our Form 10-Q for the Offering Circular.

quarters ended March 31, 2020 and June 30, 2020, except as follows:
A significant disruption in our information technology and computer systems we rely on could harm us.

We are currently making, and expect to continue to make, substantial investments in our information technology systems and infrastructure, some of which are significant. Upgrades involve replacing existing systems with successor systems, outsourcing critical information technology to third parties, making changes to existing systems, including the migration of applications to the cloud, or cost-effectively acquiring new systems with new functionality. Implementing new systems carries significant potential risks, including failure to operate as designed, potential loss or corruption of data or information, changes in security processes, cost overruns, implementation delays, disruption of operations, and the potential inability to meet business and reporting requirements. We rely on strategic partners and other service providers to help us with certain significant information technology projects and services. Information technology projects or services frequently are long-term in nature and may take longer to complete and cost more than we expect and may not deliver the benefits we project once they are complete. Furthermore, pursuing multiple initiatives simultaneously could make implementation significantly more challenging. We are aware of inherent risks associated with replacing these systems and outsourcing critical information technology functions and there can be no assurance that we will not experience significant issues with our existing systems prior to implementation, that our technology initiatives will be successfully deployed as planned or that they will be timely implemented without significant disruption to our operations. Any system implementation and transition difficulty may result in operational challenges, reputational harm, and increased costs that could materially and adversely affect our business operations and results of operations.

If we are unable to protect our new branding trademarks from infringement, our business prospects may be harmed.

We currently have applied for a registered trademark for the use of our product brand name in association with our commercial products to be offered in the United States. Although we may take steps to monitor the possible infringement or misuse of our brand name or other trademarks once they are obtained, it is possible that third parties may infringe, dilute or otherwise violate our trademark rights. Any unauthorized use of our trademarks could harm our reputation or commercial interests. In addition, our enforcement against third-party infringers or violators may be unduly expensive and time-consuming, and any remedy obtained may constitute insufficient redress relative to the damages we may suffer. Our business may be materially adversely affected in the event we are unable to protect our trademarks.

Our senior management has recently undergone a significant transition and our future success depends on our ability to identify, attract and retain key executives and other qualified personnel in the current environment.

We experienced significant executive transitions in late 2020. On November 2, 2020, we announced the appointment of Brad Hauser to the role of Chief Executive Officer and President. As part of the organizational transition, Soliton Co-Founder and Chief Science Officer Christopher Capelli, M.D., was advanced from the CEO role to Vice Chairman of the Company’s board of directors and continues to lead Soliton’s research and development efforts as Chief Science Officer.

27


We must also attract, retain and motivate additional highly-qualified employees. We may experience difficulty in managing transitions and assimilating our newly-hired personnel, which may adversely affect our business. The unexpected loss of services of one or more of our officers or directors could have a material adverse effect on our business because of their skills, knowledge of our market and financial products, years of industry experience and the difficulty of finding qualified replacement personnel. We recognize that the medical device industry is competitive and replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully manage, develop and grow in our industry. If we fail to identify and develop or recruit successors, we are at risk of being harmed by the departures of key employees.

The ongoing coronavirus (COVID-19) pandemic may negatively impact the timing of our planned commercial launch and therefore our business, financial condition, results of operations and growth.

The global spread of the COVID-19 pandemic and measures introduced by local, state and federal governments to contain the virus and mitigate its public health effects have created significant impact to the global economy. The duration and severity of this pandemic is unknown and the extent of the business disruption and financial impact depend on factors beyond our knowledge and control.Shelter-in-place, quarantine, executive orders or related measures to combat the spread of COVID-19, as well as the perceived need by individuals to continue such practices to avoid infection, among other factors, have negatively impacted and are expected to continue to negatively impact our clinical trials.Additionally, these factors may impact the timing of our planned commercial launch should we determine that the aesthetics marketplace has not demonstrated enough recovery for the successful introduction of new technology. Governmental authorities in certain of our markets have begun re-opening and lifting or relaxing shelter-in-place and quarantine measures only to revert such restrictions in the face of increases in new COVID-19 cases. The United States has seen an unprecedented unemployment rate since the start of the pandemic. As a result, we may face a challenging environment for patients to elect cosmetic procedures.

Item 2.

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

We closed the initial tranche of the August 7, 2018 Fifth Note on October 19, 2018, for $207,346. The principalEquity Securities and interest on the Fifth Note was due on the earlierUse of one-year from the date of issuance or upon successful completion of our IPO. For each dollar in principal amount of notes purchased by investors, we issued the investors a five-year warrant to purchase one share of common stock at an exercise price of $1.75 per share that can be exercised (i) at any time on or after the issuances of the Fifth Note and (ii) on or prior to the close of business on the five-year anniversary of the issuances of the Fifth Note. Mr. Klemp, Dr. Capelli, Ms. Bisson and other members of management collectively purchased $125,000 of such notes and warrants.

The issuance of the above notes and warrants was exempt from registration under the Securities Act in reliance upon Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder, and the issuance of the options was exempt from registration under the Securities Act in reliance upon Rule 701.

Proceeds
None.
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Item 3.

Defaults Upon Senior Securities

Item 3.    Defaults Upon Senior Securities
None.

Item 4.

Mine Safety Disclosures

Item 4.    Mine Safety Disclosures
Not applicable.

Item 5.

Other Information

As discussed in our Form 1-A, we stated that we intended to enter into employment agreements with our named executive officers upon the closing of our IPO on the following terms: (i) Mr. Klemp - base salary: $200,000; cash bonus target for 2019: 50%; option grant value target for 2019: $750,000; (ii) Dr. Capelli - base salary: $425,000; cash bonus target for 2019: 35%; option grant value target for 2019: $750,000; (iii) Ms. Bisson - base salary: $265,000; cash bonus target for 2019: 38%; option grant value target for 2019: $450,000; and (iv) Mr. Tanner - base salary: $250,000; cash bonus target for 2019: 36%; option grant value target for 2019: $350,000.

On February 25, 2019, we entered into employment agreements with each of the foregoing named executive officers. Each employment agreement provides for an initial term of one year, which will be automatically renewed for additional one-year terms unless either party chooses not to renew the employment agreement. The employment agreements provide for an initial base salary, cash bonus target, and option grant value target in accordance with the above disclosure set forth in our Form 1-A. Notwithstanding the targeted bonus and option amounts, the final determination on the amount of the bonus or option grant, if any, will be made by the Compensation Committee of the Board of Directors, based on criteria established by the Compensation Committee.

Pursuant to the employment agreements, if the named executive officer is terminated at our election without “cause” (as defined in the employment agreement), or by the named executive officer for “good reason” (as defined in the employment agreement), the named executive officer shall be entitled to receive severance payments equal to twelve months base salary, with respect to Mr. Klemp and Dr. Capelli, and nine months base salary, with respect to Ms. Bisson and Mr. Tanner, and, in each case, a pro rata portion of the target bonus, if any, for the year in which such termination occurs. Pursuant to the employment agreements, the named executive officers agreed not to compete with us until twelve months after the termination of their employment, with respect to Mr. Klemp and Dr. Capelli, and nine months after termination of their employment, with respect to Ms. Bisson and Mr. Tanner.

On February 26, 2019, our Board of Directors approved the following policy for compensating our independent members of the Board:

Each independent director shall receive annual cash compensation of $35,000. In addition, the chair person of the Audit Committee, Compensation Committee and Nominating and Governance Committee shall receive an annual compensation of $15,000, $10,000 and $7,500, respectively; the other members of such committees shall receive an annual compensation of $7,500, $5,000 and $5,000, respectively. In addition, since the independent directors had not received any compensation during 2018, the Board approved a one-time cash payment to each independent director of $25,000.

Upon the initial appointment (or election) of independent directors to the Board, the director will be issued a 10-year option to purchase 30,000 shares of our common stock, under our incentive stock plan, with four-year annual vesting and an exercise price equal the closing price of our common stock on the date of the appointment (or election). Since our current independent directors received such a grant upon joining, no additional option grants were made to such directors.

Annually, on the date of our annual meeting, each independent director that is re-elected at the annual meeting will be issued, upon a motion and approval of the Board of Directors, a 10-year option to purchase 15,000 shares of our common stock, under our incentive stock plan, with a one-year vesting period and an exercise price equal the closing price of our common stock on the date of the annual meeting.

Item 5.    Other Information
None.
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Item 6.

Exhibits

Item 6.    Exhibits
INDEX TO EXHIBITS

Exhibit

Number

Description

10.1*Exhibit
Number
Description
10.1* +
10.2*
10.3*31.1*Employment Agreement by and between Soliton, Inc. and Joe Tanner, effective February 25, 2019
10.4*Employment Agreement by and between Soliton, Inc. and Lori Bisson, effective February 25, 2019

31.1*

31.2*

32.1*(1)

32.2*(1)

101.INS*XBRL Instance Document
101.SCH*XBRL Taxonomy Extension Schema Document
101.CAL*SXRLXBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*XBRL Taxonomy Extension Label Linkbase Document
101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document

*

Filed herewith.

(1)

The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

*Filed herewith.
+    Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the SEC, certain portions of this exhibit have been redacted. The Company hereby agrees to furnish supplementally to the SEC, upon its request, an unredacted copy of this exhibit.

(1)The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
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SIGNATURES

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

SOLITON, INC.

SIGNATURE

TITLE

DATE

SIGNATURETITLEDATE

/s/ Christopher Capelli

Bradley Hauser

Chief Executive Officer, President and Director

March 1, 2019

 Christopher Capelli


(principal executive officer)
November 12, 2020
Bradley Hauser

/s/ Lori Bisson

Chief Financial Officer and Executive Vice-President

March 1, 2019

 Lori Bisson


(principal financial and accounting officer)
November 12, 2020
Lori Bisson

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