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: SeptemberJune 30, 20222023

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: 001-41173

NexGel, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware 26-4042544
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization) (I.R.S. Employer
Identification Number)
   

2150 Cabot Blvd West, Suite B

Langhorne, PA

 19047
(Address of principal executive office) (Zip Code)

 

Registrant’s telephone number, including area code: (215) 702-8550

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

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 NXGL The Nasdaq Capital Market LLC
Warrants to Purchase Common Stock NXGLW The NasdaqCapital Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

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

 

Large accelerated filer ☐Accelerated filer ☐
  
Non-accelerated filer 
  
Smaller reporting company Emerging growth company

 

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

 

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

 

As of November 8, 2022,August 11, 2023, the registrant had 5,572,2345,696,064 shares of common stock outstanding.

 

 

 

 

nEXGEL, INC.

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION 
   
ITEM 1.Condensed Consolidated Financial Statements (Unaudited)3
 Condensed Consolidated Balance Sheets as of SeptemberJune 30, 20222023 and December 31, 202120223
 Condensed Consolidated Statements of Operations for the Three and NineSix Months Ended SeptemberJune 30, 20222023 and 202120224
 Condensed Consolidated Statements of Stockholders’ Equity for the Three and NineSix Months Ended SeptemberJune 30, 20222023 and 202120225
 Condensed Consolidated Statements of Cash Flows for the NineSix Months Ended SeptemberJune 30, 20222023 and 2021202276
 Notes to Condensed Consolidated Financial Statements8
7
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2223
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk2830
ITEM 4.Controls and Procedures28
PART II – OTHER INFORMATION
ITEM 1.Legal Proceedings29
ITEM 1A.Risk Factors29
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds29
ITEM 3.Defaults Upon Senior Securities29
ITEM 4.Mine Safety Disclosures29
ITEM 5.Other Information29
ITEM 6.Exhibits30
   
SignaturesPART II – OTHER INFORMATION 
ITEM 1.Legal Proceedings30
ITEM 1A.Risk Factors30
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds30
ITEM 3.Defaults Upon Senior Securities30
ITEM 4.Mine Safety Disclosures30
ITEM 5.Other Information30
ITEM 6.Exhibits31
Signatures32

 

2
Table of Contents

 

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

NEXGEL, INC

CONDENSED CONSOLIDATED BALANCE SHEETS

AS OF SEPTEMBERJUNE 30, 20222023 AND DECEMBER 31, 20212022

(Unaudited)

(in thousands, except share and per share data)

 

 September 30, December 31, 
 2022  2021  

June 30,

2023

 

December 31,

2022

 
ASSETS:                
Current Assets:                
Cash and cash equivalents $1,427  $13,350 
Cash $3,691  $1,101 
Marketable securities  5,985   -   612   5,508 
Accounts receivable, net  265   209   950   222 
Inventory  399   291   1,079   502 
Prepaid expenses and other current assets  239   77   366   172 
Total current assets  8,315   13,927   6,698   7,505 
Goodwill  311   311   311   311 
Intangibles, net  23   33   13   20 
Property and equipment, net  737   723   1,413   721 
Operating lease - right of use asset  1,785   1,926   1,967   1,737 
Other assets  63   63   95   63 
Total assets $11,234  $16,983  $10,497  $10,357 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current Liabilities:                
Accounts payable $358  $254  $1,058  $265 
Accrued expenses and other current liabilities  164   62   202   130 
Convertible notes payable  -   2,037 
Notes payable, current portion  14   10 
Current portion of note payable  15   15 
Warrant liability  372   318   165   242 
Operating lease liability, current portion  207   207   232   207 
Total current liabilities  1,115   2,888   1,672   859 
Long-Term Liabilities:        
Operating lease liability, net of current portion  1,632   1,744   1,819   1,593 
Notes payable, net of current portion  269   266   265   268 
Total long-term liabilities  1,901   2,010 
Total liabilities  3,016   4,898   3,756   2,720 
                
Commitments and Contingencies (Note 14)  -   - 
Commitments and Contingencies (Note 15)  -   - 
                
Preferred Stock, par value $0.001 per share, 5,000,000 shares authorized, no shares issued and outstanding  -   - 
Common Stock, par value $0.001 per share, 25,000,000 shares authorized; 5,572,234 shares issued and outstanding as of both September 30, 2022 and December 31, 2021  6   6 
STOCKHOLDERS’ EQUITY        
Preferred stock, par value $0.001 per share, 5,000,000 shares authorized, no shares issued and outstanding  -   - 
Common stock, par value $0.001 per share, 25,000,000 shares authorized; 5,696,064 and 5,577,916 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively  6   6 
Additional paid-in capital  19,122   18,891   19,242   19,189 
Accumulated deficit  (10,910)  (6,812)  (13,067)  (11,558)
Total NexGel stockholders’ equity  6,181   7,637 
Non-controlling interest in joint venture  560   - 
Total stockholders’ equity  8,218   12,085   6,741   7,637 
Total liabilities and stockholders’ equity $11,234  $16,983  $10,497  $10,357 

 

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

3
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NEXGEL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE AND NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 20222023 AND 20212022

(Unaudited)

(in thousands, except share and per share data)

 

 2022  2021  2022  2021  2023  2022  2023  2022 
 Three Months Ended Nine Months Ended  Three Months Ended Six Months Ended 
 September 30,  September 30,  June 30,  June 30, 
 2022  2021  2022  2021  2023  2022  2023  2022 
Revenues, net $568  $335  $1,524  $1,018  $1,167  $561  $1,786  $956 
                                
Cost of revenues  420   392   1,304   1,113   992   460   1,669   884 
                                
Gross (loss)/profit  148   (57)  220   (95)
Gross profit  175   101   117   72 
                                
Operating expenses                                
Research and development  193   -   328   17   55   111   84   135 
Selling, general and administrative  992   553   2,459   1,571   882   708   1,679   1,467 
Total operating expenses  1,185   553   2,787   1,588   937   819   1,763   1,602 
                                
Loss from operations  (1,037)  (610)  (2,567)  (1,683)  (762)  (718)  (1,646)  (1,530)
                                
Other expense, net                
Other income (expense)                
Interest expense  (242)  (534)  (1,334)  (1,052)  (9)  (348)  (10)  (1,092)
Interest income  2   -   2   - 
Loss on debt extinguishment  -   -   (150)  (25)  -   -   -   (150)
Warrant modification expense  (57)  -   (57)  - 
Debt discount costs  -   -   -   (68)
Other income  -   -   2   147   -   2   4   2 
Gain on investments in marketable securities  5   -   5   - 
Gain on investments  116   -   124   - 
Changes in fair value of warrant liability  104   2   3   10   11   29   77   (101)
Total other expense, net  (190)  (532)  (1,531)  (988)
Total other income (expense), net  120   (317)  197   (1,341)
Loss before income taxes  (1,227)  (1,142)  (4,098)  (2,671)  (642)  (1,035)  (1,449)  (2,871)
Income tax expense  -   -   -   -   -   -   -   - 
Net loss $(1,227) $(1,142)  (4,098)  (2,671) $(642) $(1,035)  (1,449)  (2,871)
Less: Income attributable to non-controlling interest in joint venture  53   -   60   - 
Net loss attributable to NexGel stockholders  (695)  (1,035)  (1,509)  (2,871)
Net loss per common share - basic $(0.22) $(0.38)  (0.74)  (0.91) $(0.12) $(0.19)  (0.27)  (0.52)
Net loss per common share - diluted $(0.22) $(0.38)  (0.74)  (0.91) $(0.12) $(0.19)  (0.27)  (0.52)
Weighted average shares used in computing net loss per common share - basic  5,572,234   2,979,371   5,572,234   2,942,057   5,662,338   5,572,234   5,624,275   5,572,234 
Weighted average shares used in computing net loss per common share – diluted  5,572,234   2,979,371   5,572,234   2,942,057   5,662,338   5,572,234   5,624,275   5,572,234 

 

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

 

4
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NEXGEL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 20222023 AND 2021

(Unaudited)

(in thousands, except share data)

  Shares  Amount  Capital  Deficit  Equity 
  Common Stock  Additional
Paid-in
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Deficit  Equity 
Balance, January 1, 2022  5,572,234  $6  $18,891  $(6,812) $12,085 
                     
Stock-based compensation  -   -   55   -   55 
                     
Net loss  -   -   -   (1,836)  (1,836)
                     
Balance, March 31, 2022  5,572,234   6   18,946   (8,648)  10,304 
                     
Stock-based compensation  -   -   54   -   54 
                     
Restricted stock vesting  -   -   25   -   25 
                     
Net loss  -   -   -   (1,035)  (1,035)
                     
Balance, June 30, 2022  5,572,234   6   19,025   (9,683)  9,348 
                     
Stock-based compensation  -   -   55   -   55 
                     
Restricted stock vesting  -   -   42   -   42 
                     
Net loss  -   -   -   (1,227)  (1,227)
                     
Balance, September 30, 2022  5,572,234  $6  $19,122  $(10,910) $8,218 

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NEXGEL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

(Unaudited)

(in thousands, except share data)

 

  

 

Common Stock

  Additional
Paid-in
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Deficit  Equity 
Balance, January 1, 2021  2,838,047  $3  $2,570  $(2,502) $71 
                     
Stock-based compensation  -   -   69   -   69 
                     
Restricted stock vesting  -   -   21   -   21 
                     
Issuances of common stock, net of issuance costs  101,800   -   285   -   285 
                     
Warrants issued for debt issuance  -   -   (18)  -   (18)
                     
Beneficial conversion and warrant features of convertible debt  -   -   1,276   -   1,276 
                     
Net loss  -   -   -   (704)  (704)
                     
Balance, March 31, 2021  2,939,847   3   4,203   (3,206)  1,000 
                     
Stock-based compensation  -   -   74   -   74 
                     
Restricted stock vesting  39,524   -   21   -   21 
                     
Net loss  -   -   -   (825)  (825)
                     
Balance, June 30, 2021  2,979,371   3   4,298   (4,031)  270 
                     
Stock-based compensation  -   -   24   -   24 
                     
Restricted stock vesting  -   -   21   -   21 
                     
Beneficial conversion and warrant features of convertible debt  -   -   1,311   -   1,311 
                     
Net loss  -   -   -   (1,142)  (1,142)
                     
Balance, September 30, 2021  2,979,371  $3  $5,654  $(5,173) $484 
  Shares  Amount  Capital  Interest  Deficit  Equity 
  Common Stock  

Additional

Paid-in

  

Non-

controlling

  Accumulated  

Total

Stockholders’

 
  Shares  Amount  Capital  Interest  Deficit  Equity 
Balance, January 1, 2023  5,577,916  $6  $19,189  $-  $(11,558) $7,637 
                         
Restricted stock vesting  5,682   -   24   -   -   24 
                         
Exercise of warrants  30,430   -   -   -   -   - 
                         
Non-controlling interest in JV  -   -   -   500   -   500 
                         
Net income (loss)  -   -   -   7   (814)  (807)
                         
Balance, March 31, 2023  5,614,028  $6  $19,213  $507  $(12,372) $7,354 
                         
Stock-based compensation  -   -   29   -   -   29 
                         
Exercise of warrants  82,036   -   -   -   -   - 
                         
Net income (loss)  -   -   -   53   (695)  (642)
                         
Balance, June 30, 2023  5,696,064  $6  $19,242  $560  $(13,067) $6,741 

  Shares  Amount  Capital  Deficit)  (Deficit) 
  Common Stock  Additional
Paid-in
  Retained
Earnings
(Accumulated
  Total
Stockholders’
Equity
 
  Shares  Amount  Capital  Deficit)  (Deficit) 
Balance, January 1, 2022  5,572,234  $6  $18,891  $(6,812) $  12,085 
                     
Stock-based compensation  -   -   55   -   55 
                     
Net loss  -   -   -   (1,836)  (1,836)
                             
Balance, March 31, 2022  5,572,234  $6  $18,946  $(8,648) $10,304 
Balance  5,572,234  $6  $18,946  $(8,648) $10,304 
                     
Stock-based compensation  -   -   54   -   54 
                     
Restricted stock vesting  -   -   25   -   25 
                     
Net loss  -   -   -   (1,035)  (1,035)
Net income (loss)  -   -   -   (1,035)  (1,035)
                     
Balance, June 30, 2022  5,572,234  $6  $19,025  $(9,683) $9,348 
Balance  5,572,234  $6  $19,025  $(9,683) $9,348 

 

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

 

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NEXGEL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 20222023 AND 20212022

(Unaudited)

(in thousands)

 

  2022  2021 
  Nine Months Ended September 30, 
  2022  2021 
Operating Activities        
Net loss $(4,098) $(2,671)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  84   206 
Changes in ROU asset and operating lease liability  29   16 
Share-based compensation  231   229 
Changes in fair value of warrant liability  (3)  (10)
Amortization of deferred financing costs  1,325   1,058 
Warrant modification expense  57   - 
Loss on extinguishment of debt  150   25 
Gain on investments in marketable securities  (5)  - 
Forgiveness of debt  -   (147)
Beneficial conversion feature in excess of face value  -   52 
         
Changes in operating assets and liabilities:        
Accounts receivable  (56)  (121)
Inventory  (108)  (28)
Prepaid expenses and other current assets  (162)  39 
Accounts payable  104   (145)
Accrued expenses and other current liabilities  109   (21)
Deferred revenue  -   (38)
         
Net Cash Used in Operating Activities  (2,343)  (1,556)
         
Investing Activities        
Investment in marketable securities  (6,980)  - 
Proceeds from sale of marketable securities  1,000   - 
Capital expenditures  (88)  (390)
Net Cash Used in Investing Activities  (6,068)  (390)
         
Financing Activities        
Issuance of common stock, net of issuance costs  -   285 
Proceeds from notes payable  -   15 
Principal payment of notes payable  (3,512)  - 
Proceeds from notes payable (PPP)  -   127 
Proceeds from convertible notes  -   2,957 
Payment of financing costs  -   (115)
Principal payment on convertible notes  -   (100)
Net Cash Provided by (Used In) Financing Activities  (3,512)  3,169 
Net Increase (Decrease) in Cash and Cash Equivalents  (11,923)  1,223 
Cash and Cash Equivalents – Beginning of period  13,350   32 
Cash and Cash Equivalents – End of period $1,427  $1,255 
Supplemental Disclosure of Cash Flows Information        
Cash paid during the year for:        
Interest  -   - 
Taxes  -   - 
         
Supplemental Non-cash Investing and Financing Activities        
Fair value of beneficial conversion and warrant features of convertible notes payable $-  $2,587 
Original issue discounts recognized on convertible notes payable $-  $653 
Warrants issued for debt and equity financing costs $-  $203 
Operating lease, ROU assets and liabilities $-  $2,050 
  2023  2022 
  Six Months Ended June 30, 
  2023  2022 
Operating Activities        
Net loss $(1,509) $(2,871)
Adjustments to reconcile net loss to net cash used in operating activities:        
Income attributable to non-controlling interest in joint venture  60   - 
Depreciation and amortization  68   57 
Changes in ROU asset and operating lease liability  21   19 
Share-based compensation and restricted stock vesting  53   134 
Gain on investment in marketable securities  124   - 
Changes in fair value of warrant liability and warrant modification  (77)  101 
Amortization of deferred financing costs  -   1,086 
Loss on extinguishment of debt  -   150 
         
Changes in operating assets and liabilities:        
Accounts receivable  (728)  (91)
Inventory  (577)  (90)
Prepaid expenses and other assets  (226)  (286)
Accounts payable  793   268 
Accrued expenses and other current liabilities  72   28 
Net Cash Used in Operating Activities  (1,926)  (1,495)
         
Investing Activities        
Proceeds from sales of marketable securities  4,772   - 
Investment in marketable securities  -   (5,371)
Capital expenditures  (253)  (31)
Net Cash Provided by Investing Activities  4,519   (5,402)
         
Financing Activities        
Principle payments of notes payable  (3)  (2,033)
Net Cash Used in Financing Activities  (3)  (2,033)
Net Decrease in Cash  2,590   (8,930)
Cash – Beginning of period  1,101   13,350 
Cash – End of period $3,691  $4,420 
Supplemental Disclosure of Cash Flows Information        
Cash paid during the year for:        
Interest $-  $- 
Taxes $-  $- 
         
Supplemental Non-cash Investing and Financing activities        
Property and equipment contributed as capital investment to JV $500  $- 
ROU asset and operating lease liabilities recognized upon consolidation of JV $334  $- 

 

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

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NEXGEL, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share data)

1. Description of Business, the Spin-offStock Split and Basis of Presentation

Description of Business

 

NexGel, Inc. (“NexGel” or the “Company”) manufactures high water content, electron beam cross-linked, aqueous polymer hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and cosmetics. The Company specializes in custom gels by capitalizing on proprietary manufacturing technologies. NexGel has historically served as a contract manufacturer, supplying our gels to third parties who incorporate them into their own products, and havehas recently began producing the Company’s own consumer products using our gels focused on proprietary branded products and white label opportunities. Both the Company’s gels and consumer products are manufactured using proprietary and non-proprietary mixing, coating and cross-linking technologies. Together, these technologies enable NexGel to produce gels that can satisfy rigid tolerance specifications with respect to a wide range of physical characteristics (e.g., thickness, water content, adherence, absorption, moisture vapor transmission rate (a measure of the passage of water vapor through a substance) and release rate) while maintaining product integrity. Additionally, the Company has the manufacturing capability to offer broad choices in the selection of liners onto which the gels are coated. Consequently, NexGel and our customers are able to determine tolerances in moisture vapor transmission rate and active ingredient release rates while personalizing color and texture.

 

NexGel was previously known as AquaMed Technologies, Inc. (“AquaMed”) before changing its name to NexGel, Inc. on November 14, 2019.

 

The condensed consolidated financial statements include the accounts ofOn March 1, 2023, the Company and its consolidated wholly-owned subsidiary, NexGelRx, Inc.

Stock Split

On November 29, 2021, the Company effectedacquired a 1-for-35 reverse stock split50 of our issued% interest in a newly formed joint venture (“JV”), CG Converting and outstanding common stock (the “Reverse Stock Split”Packaging, LLC, with C.G. Laboratories Inc. (“CG Labs”). for its converting and packaging business. The agreement is effective March 1, 2023. As a result of this transaction, the Reverse Stock Split, each issued and outstanding share of our common stock, and the per share exercise price of and number of sharesCompany owns 50% of the Company’s common stock underlying our outstanding equity awards and warrants, was automatically proportionally adjusted based on the 1-for-35 Reverse Stock Split ratio. No fractional shares of common stock were issued in connectionJV, with the reverse stock split, and all such fractional interests were rounded up to the nearest whole number.remaining 50% held by CG Labs.

Except as otherwise provided herein, all share and per-share amounts of our common stock, equity awards and warrants, including the shares of common stock and warrants being offered hereby, have been adjusted to give effect to the Reverse Stock Split for all periods presented. The Reverse Stock Split did not alter the par value of the Company’s common stock, which remains at $0.001 per share, modify any voting rights or other terms of our common stock, or impact the amount of preferred stock the Company is authorized to issue.

 

Basis of Presentation

 

The accompanying interim unaudited condensed consolidated financial statements and footnotes of NexGel have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the instructions to Rule 10-01 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, these unaudited condensed consolidated financial statements contain all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods, but are not necessarily indicative of the results of operations to be anticipated for the full year ending December 31, 20222023. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.2022.

 

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its consolidated wholly-owned subsidiary, NexGelRx, Inc. and the fifty percent (50%) owned JV (see Note 11).

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2. Going Concern

As of SeptemberJune 30, 2022,2023, the Company had a cash balance of $1.43.7 million (including cash equivalents) and $6.0612 millionthousand of marketable securities (see Note 3 for details of our marketable securities). For the ninesix months ended SeptemberJune 30, 2022,2023, the Company incurred a net loss of $4.11.5 million and had a net usage of cash in operating activities of $2.31.9 million. In addition, the Company had a working capital of $7.25.0 million as of SeptemberJune 30, 2022. Additionally, we2023. We believe we have sufficient cash and marketable securities to operate our business plan through 2024.

On December 27, 2021, the Company sold an aggregate of 2,585,000 units at a price to the public of $5.50 per unit (the “Offering”), each unit consisting of one share of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and a warrant to purchase one share of Common Stock at an exercise price of $5.50 per share (the “Warrants”), for net proceeds of $14.2 million.

Proceeds from the Offering are expected to be used for working capital, new product development and testing, and general business operations.2025.

 

Management is exploring new product channel sales in adjacent industries, such as cosmetics, athletic products, and proprietary medical devices. The Company has increased focusedits focus on sales and developing a sales pipeline for potential customers. This customer base expansion will enable us to provide financial stability for the foreseeable future, expand our current processes, and position us for long-term shareholder value creation.

 

We have sufficient capital to maintain as a going concern due to the capital raise that occurred on December 27, 2021. We intend to maintain and attempt to grow our existing contract manufacturing business. We also plan to continue building and developing our catalog of consumer products for sale to branding partners and to use our in-house capabilities to create and test market additional branded products. These products will be target marketed and sold online through social media, television and online marketplaces. Furthermore, the Company plans to develop its own proprietary medical devices and explore drug delivery programs for its technology. Additionally, the Company continues to evaluate strategic initiatives (e.g., acquisitions) and additional capital raises through debt or equity may be necessary to achieve these objectives.

 

We expect to continue incurring losses for the near-term future. Our ability to continue to operate as a going concern in the long-term is dependent upon our ability to manage and grow our current products and to ultimately achieve profitable operations. Management may consider various options to raise capital to fund potential acquisitions through equity or debt offerings. There can be no assurances, however, that management will be able to obtain sufficient additional funds, if needed, or that such funds, if available, will be obtained on terms satisfactory to us. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern. Additionally, it is reasonably possible that estimates made in the condensed consolidated financial statements have been, or will be, materially and adversely impacted in the near term as a result of these conditions, including the recoverability of long-lived assets.

 

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3. Significant Accounting Policies and Estimates

Use of Estimates

 

The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. These estimates and assumptions include an allowances for doubtful accounts, inventory reserves, deferred taxes, share-based compensation and related valuation allowances and fair value of long-lived assets. Actual results could differ from the estimates.

 

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Reclassifications

We have reclassified, combined or separately disclosed certain amounts in the prior years’ condensed consolidated financial statements and accompanying footnotes to conform with the current period’s presentation.

Cash and Cash Equivalents

 

Cash and cash equivalents is comprised of cash in banks and highly liquid investments, including U.S. treasury bills purchased with an original maturity of three months or less. Cash equivalents consist ofless as well as investments in money market funds for which the carrying amount approximates fair value, due to the short maturities of these investments.

 

Marketable Securities

 

The Company classifies its marketable securities as held-to-maturity, which include U.S. treasury bills with original maturities of greater than three months. These securities are carried at cost. fair value with any change in fair value recorded as an unrealized gain (loss) in the consolidated statement of operations of the period in which such change occurs.

The total unrecognized gain related toCompany had the following marketable securities was inconsequential during the nine months ended Septemberas of June 30, 2022.2023 and December 31, 2022:

Schedule of Marketable Securities 

 June 30, December 31, 
 September 30, 2022  2023  2022 
Marketable Securities            
United States treasury bills (due December 29, 2022) $494 
United States treasury bills (due February 23, 2023)  492  $-  $492 
United States treasury bills (due April 27, 2023)  -   20 
United States treasury bills (due June 15, 2023)  4,387   -   4,384 
United States treasury bills (due July 13, 2023)  127   127   127 
United States treasury bills (due August 10, 2023)  485   485   485 
Total $5,985  $612  $5,508 

 

Accounts Receivable, net

 

Trade accounts receivable are stated at the amount the Company expects to collect and do not bear interest. The Company evaluates the collectability of accounts receivable and records a provision to the allowance for doubtful accounts based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience. Provisions to the allowances for doubtful accounts are recorded in selling, general, and administrative expenses. Account balances are charged off against the allowance when it is probable that the receivable will not be recovered. The allowance for doubtful accounts was $1017 thousand as of SeptemberJune 30, 20222023, and $49 thousand as of December 31, 2021.2022.

 

Inventory and Cost of RevenuesGoods Sold

 

Inventory is stated at the lower of cost, the value determined by the first-in, first-out method, or net realizable value. The Company evaluates inventories for excess quantities, obsolescence, and shelf-life expiration. This evaluation includes an analysis of historical sales levels by product, projections of future demand, the risk of technological or competitive obsolescence for products, general market conditions, and a review of the shelf-life expiration dates for products. These factors determine when, and if, the Company adjusts the carrying value of inventory to estimated net realizable value.

 

The balance is made up of raw materials, work-in-progress, and finished goods of $285 thousand, $87 thousand, and $27 thousand on September 30, 2022, respectively, and the balance was made up of raw materials, work-in-progress, and finished goods of $266 thousand, $0, and $25 thousand on December 31, 2021, respectively. Inventory is maintained at the Company’s warehouse and at an Amazon fulfillment center.

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The Company produces proprietary branded products and white label opportunities in our manufacturing of consumer products. In our contract manufacturing, the Company builds its products based on customer orders and immediately ships the products upon completion of the production process.

 

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The balance is made up of raw materials, work-in-progress, and finished goods. Inventory is maintained primarily at the Company’s warehouse and at an Amazon fulfillment center.

 

The “Cost of Revenues”revenues” line item in the condensed consolidated statements of operations is comprised of the book value of inventory sold to customers during the reporting period. When circumstances dictate that we use net realizable value as the basis for recording inventory, we base our estimates on expected future selling prices less expected disposal costs.

 

Research and Development

 

Our research and development activities focus on new and innovative products designed to support revenue growth. Research and development expenses consist primarily of contracted development and testing efforts associated with development of products.

 

Shipping and Handling Revenue and Expense

 

Shipping and handling revenue and expense are included in our condensed consolidated statements of operations in Revenuerevenues and Costcost of revenues, respectively. This is primarily through shipping fees incurred in the Amazon marketplace.

 

Property and Equipment, net

 

Property and equipment is recorded at historical cost, net of accumulated depreciation and amortization. Depreciation is provided over the assets’ useful lives on a straight-line basis. Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or lease terms. Repairs and maintenance costs are expensed as incurred.

 

Management periodically assesses the estimated useful life over which assets are depreciated or amortized. If the analysis warrants a change in the estimated useful life of property and equipment, management will reduce the estimated useful life and depreciate or amortize the carrying value prospectively over the shorter remaining useful life.

 

The carrying amounts of assets sold or retired and the related accumulated depreciation are eliminated in the period of disposal and the resulting gains and losses are included in the results of operations during the same period.

 

Impairment of Long-Lived Assets

The Company reviews its property and equipment and any identifiable intangibles for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted operating cash flow expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Long-lived assets to be disposed of are reported at the lower of carrying amount or fair value less costs to sell.

Goodwill and Intangible Assets

 

In applying the acquisition method of accounting, amounts assigned to identifiable assets and liabilities acquired were based on estimated fair values as of the date of acquisition, with the remainder recorded as goodwill. Identifiable intangible assets are initially recorded at fair value using generally accepted valuation methods appropriate for the type of intangible asset. Identifiable intangible assets with definite lives are amortized over their estimated useful lives and are reviewed for impairment if indicators of impairment arise. Intangible assets with indefinite lives are tested for impairment within one year of acquisitions or annually as of December 31, and whenever indicators of impairment exist. The fair value of intangible assets areis compared with their carrying values, and an impairment loss would be recognized for the amount by which a carrying amount exceeds its fair value.

 

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The Company performed the annual assessment and concluded it is more likely than not that the fair value exceeds the carrying value.value and no impairments were recognized in the year ended December 31, 2022.

Prepaid Expenses and Other Current Assets

 

Prepaid expenses and other current assets isare recorded at historical cost and is primarily made up of $9896 thousand and $2363 thousand of prepaid insurance, and $141270 thousand and $54109 thousand general prepaid expenses and other current assets as of SeptemberJune 30, 20222023, and December 31, 2021,2022, respectively.

 

Other Assets

 

Other assets isare recorded at historical costs, and as of SeptemberJune 30, 20222023, and December 31, 2021,2022, the balance is primarily made upcomprised of spare parts for manufacturing equipment. Spare parts are stated at cost andOther assets are not subject to depreciation until such time that they are placed into service and the part that is being replaced is disposed.

 

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Fair Value Measurements

 

The Company utilizes the fair value hierarchy to apply fair value measurements. The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair values that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each level within the hierarchy is described below:

 

Level 1 —Quoted— Quoted prices for identical assets or liabilities in active markets.

 

Level 2 —Quoted— 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; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.

 

Level 3 —Valuations— Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable.

 

The Company considers the carrying amounts of its financial instruments (cash, accounts receivable and accounts payable, notes payable and convertible notes payable) in the balance sheet to approximate fair value because of the short-term or highly liquid nature of these financial instruments.

 

The following table sets forth the fair value of the Company’s financial assets within the fair value hierarchy:

 Schedule of Fair Value of Financial Assets

 Level 1  Level 2  Level 3  Fair Value  Level 1  Level 2  Level 3  Fair Value 
 September 30, 2022     June 30, 2023    
 Level 1  Level 2  Level 3  Fair Value  Level 1  Level 2  Level 3  Fair Value 
Assets                         
Marketable securities:                                      
United States treasury bills $5,985  $  $  $5,985  $612  $     -  $-  $612 
Total $5,985  $  $  $5,985  $612  $-  $-  $612 

 

  Level 1  Level 2  Level 3  Fair Value 
     December 31, 2022    
  Level 1  Level 2  Level 3  Fair Value 
Assets                
Marketable securities:                
United States treasury bills $5,508  $      -  $     -  $5,508 
Total $5,508  $-  $-  $5,508 

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Warrant Liability

 

Warrants to purchase common stock were issued in connection with equity financing raises, which occurred on September 2, 2021, March 11, 2021, February 3, 2021, December 24, 2020, March 18, 2020, September 10,during 2019 and November 6, 2019.through 2021. The fair values of the warrants are estimated as of the date of issuance and again at each periodyear end using a Black-Scholes option valuation model. At issuance, the fair values of the warrants are recognized as an equity issuance cost within additional paid-in-capital. Fair value adjustments to the warrant liability are recognized in other income (expense) in the accompanying condensed consolidated statements of operations.

 

Revenue Recognition

 

On January 1, 2018, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under existing GAAP including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The Company adopted ASC 606 for all applicable contracts using the modified retrospective method, which would have required a cumulative-effect adjustment, if any, as of the date of adoption. The adoption of ASC 606 did not have a material impact on the Company’s consolidated financial statements as of the date of adoption. As a result, a cumulative-effect adjustment was not required.

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The Company currently recognizes revenue predominately from three types of revenue, contract manufacturing, custom and white label finished goods manufacturing and our branded products. Revenues from manufactured and branded products are recognized at the point where the customer obtains control of the goods and the Company satisfies its performance obligation, which generally is at the time the customer receives the product.

 

The Company’s customers consist of other life sciences companies and Amazon retail customers. Revenues are entirely concentrated in the United States. Payment terms vary by the type and location of customer and may differ by jurisdiction and customer, but payment is generally required in a term ranging from 30 to 60 days from date of shipment.

 

Estimates for product returns, allowances and discounts are recorded as a reduction of revenue and are established at the time of sale. Returns are estimated through a comparison of historical return data and are determined for each product and adjusted for known or expected changes in the marketplace specific to each product, when appropriate. Historically, sales return provisions have not been material. Amounts accrued for sales allowances and discounts are based on estimates of amounts that are expected to be claimed on the related sales and are based on historical data. Payments for allowances and discounts have historically been immaterial.

 

Disaggregated revenue by sales type:

 Schedule of Disaggregated Revenue by Sales Type 

 2022  2021  2023  2022 
 Three months ending  Three months ended 
 September 30,  June 30, 
 2022  2021  2023  2022 
Contract manufacturing $277  $180  $887  $324 
Custom and white label finished goods manufacturing  15   -      19 
NexGel branded consumer products  231   155   259   180 
Other  45   -   21   38 
Total $568  $335  $1,167  $561 

 

  2022  2021 
  Nine months ending 
  September 30, 
  2022  2021 
Contract manufacturing $736  $559 
Custom and white label finished goods manufacturing  34   194 
NexGel branded consumer products  623   265 
Other  131    
Total $1,524  $1,018 
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  2023  2022 
  Six months ended 
  June 30, 
  2023  2022 
Contract manufacturing $1,267  $459 
Custom and white label finished goods manufacturing  4   19 
NexGel branded consumer products  493   392 
Other  22   86 
Total $1,786  $956 

 

As of SeptemberJune 30, 20222023, and December 31, 2021,2022, the Company did not have any contract assets or contract liabilities from contracts with customers. As of SeptemberJune 30, 20222023, and December 31, 2021,2022, there were no remaining performance obligations that the Company had not satisfied.

The Company has four distinct lines of business; Contract Manufacturing, Custom & White Label, Consumer Branded Products, and Medical Devices.

Contract Manufacturing

Customers order rolls of gel (“rollstock”). The rollstock is shipped to our customers, which they package into finished goods. Historically, this has been the Company’s primary source of revenue.

Custom & White Label

These products often infuse various ingredients into our base gel to develop unique product offerings to satisfy market demand (e.g. aloe infused into the gel for a beauty mask). The rollstock is converted and packaged into salable units. The finished goods are shipped to the customer, who is ultimately responsible for product distribution. Frequently these products started as development deals, in which the customer paid the Company a small fee to develop a specific product. Once completed, the customer places a large order for newly developed product.

Consumer Branded Products

These products are finished goods marketed and sold directly to the customer by the Company through online and retail channels. The Company is responsible for sales, marketing, and distribution. These products carry the Company’s brand names.

Medical Devices

Medical Devices are a hybrid business, combining elements of Custom & White Label and Consumer Branded Products. Medical Devices, which are not yet marketed, are expected to be distributed through strategic partnerships. The Company will manufacture and possibly convert/package the device while the strategic partner brings the product to market. Small market Medical Devices could be launched by the Company, but also be offered to a distributor to reach the full scale of the market.

 

Share-based Compensation

 

On August 28, 2019, the Company adopted the 2019 Long-Term Incentive Plan, as amended (the “2019 Plan”). See Note 10 below for further details regarding the 2019 Plan.

 

The 2019 Plan provides certain employees, contractors, and outside directors with share-based compensation in the form of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalent rights and other awards. The fair values of incentive stock option award grants are estimated as of the date of grant using a Black-Scholes option valuation model. Compensation expense is recognized in the statements of operations on a straight-line basis over the requisite service period, which is generally the vesting period required to obtain full vesting. Forfeitures are accounted for when they occur.

 

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In June 2018, the Financial Accounting Standards Board (“FASB”)FASB issued Accounting Standards Update (“ASU”) No. 2018-07, Compensation - Stock Compensation (Topic 718) - Improvements to Nonemployee Share-Based Payment Accounting. These amendments expand the scope of Topic 718, Compensation - Stock Compensation, to include share-based payments issued to nonemployeesnon-employees for goods or services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. This new standard iswas effective for the Company on January 1, 2020. The Company early adopted this new standard early in the third quarter of 2019 and it did not have a material impact to its condensed consolidated financial statements.

 

Income Taxes

 

Income taxes are accounted for using an asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial statement and tax bases of assets and liabilities at the applicable tax rates. Deferred tax assets are reduced by a valuation allowance when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates.

 

Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by a tax authority and based upon the technical merits of the tax position. The tax benefit recognized in the condensed consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. An unrecognized tax benefit, or a portion thereof, is presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward if such settlement is required or expected in the event the uncertain tax position is disallowed.

Leases

ASC 842, Leases, requires recognition of leases on the condensed consolidated balance sheets as right-of-use (“ROU”) assets and lease liabilities. ROU assets represent the Company’s right to use underlying assets for the lease terms and lease liabilities represent the Company’s obligation to make lease payments arising from the leases. Operating lease ROU assets and operating lease liabilities are recognized based on the present value and future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company used its estimated incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. A number of the lease agreements contain options to renew and options to terminate the leases early. The lease term used to calculate ROU assets and lease liabilities only includes renewal and termination options that are deemed reasonably certain to be exercised.

The Company recognized lease liabilities, with corresponding ROU assets, based on the present value of unpaid lease payments for existing operating leases longer than twelve months. The ROU assets were adjusted per ASC 842 transition guidance for existing lease-related balances of accrued and prepaid rent, and unamortized lease incentives provided by lessors. Operating lease cost is recognized as a single lease cost on a straight-line basis over the lease term and is recorded in selling, general and administrative expenses. Variable lease payments for common area maintenance, property taxes and other operating expenses are recognized as expense in the period when the changes in facts and circumstances on which the variable lease payments are based occur. The Company has elected not to separate lease and non-lease components for all property leases for the purposes of calculating ROU assets and lease liabilities.

Segment Reporting

The Company operates in one business segment as a contract manufacturer of aqueous polymer hydrogels. As a result, the Company’s operations are a single reportable segment, which is consistent with the Company’s internal management reporting.

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Recently Issued Accounting Standards

 

From time to time, new accounting pronouncements are issued by the FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption.

 

In June 2016, the FASB issued Accounting Standards Update (“ASU”)ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 significantly changes the impairment model for most financial assets and certain other instruments. ASU 2016-13 will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in earlier recognition of allowances for credit losses on loans and other financial instruments. ASU 2016-13 is effective for the Company’s fiscal year beginning January 1, 2023 and subsequent interim periods. The Company is currently evaluating the impact the adoption of ASU 2016-13 will have on the Company’s consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment. ASU 2017-04 simplifies the manner in which an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Under the amendments in ASU 2017-04, an entity should (1) perform its annual or interim goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount, and (2) recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value, with the understanding that the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, ASU 2017-04 requires any reporting unit with a zero or negative carrying amount to perform Step 2 of the goodwill impairment test. We adopted ASU 2017-04 effective January 1, 2021.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which simplifies the accounting for income taxes. This guidance will be effective for entities for the fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 on a prospective basis, with early adoption permitted. We adopted ASU 2019-12 effective January 1, 2021 and the adoption of this guidance did not have a material impact on ourcondensed consolidated financial statements.

 

4. Leases

The Company has one operating lease for a commercial manufacturing facility and administrative offices located in Langhorne, Pennsylvania that runs through January 2031. There are two options that can extend the lease term for five years each. The exercise of the lease options to renew is solely at the Company’s discretion.

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The following table presents information about the amount and timing of the liability arising from the Company’s operating lease as of SeptemberJune 30, 20222023 ($ in thousands):

 Schedule of Future Minimum Lease Payments 

 Operating  Operating 
 Lease  Lease 
Maturity of Lease Liability Liability  Liability 
2022 $52 
2023  207  $122 
2024  207   245 
2025  207   245 
2026  263   301 
2027  315 
Thereafter  1,165   1,115 
Total undiscounted operating lease payments $2,101   2,343 
Less: Imputed interest  (262)  (292)
Present value of operating lease liability $1,839  $2,051 
Weighted average remaining lease term  8.25 years   8.6 years 
Weighted average discount rate  3.0%  3.5%

 

Total operating lease expense for the ninesix months ending Septemberended June 30, 20222023, and 20212022, was $155136 thousand and $192103 thousand, respectively, and is recorded in cost of revenuesgoods sold and selling, general, and administrative expenses onin the accompanying condensed consolidated statement of operations.

 

Supplemental cash flows information related to leases was as follows ($ in thousands):

 Schedule of Supplemental Cash Flows Information Related to Leases 

 September 30,  June 30, 
 2022  2023 
Cash paid for amounts included in the measurement of lease liability:       
Operating cash flows from operating lease $155  $136 

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5. Inventory

Inventory consists of the following ($ in thousands):

 Schedule of Inventory 

 September 30, December 31,  June 30, December 31, 
 2022 2021  2023  2022 
Raw materials $285  $266  $638  $295 
Work-in-progress 87 -   43   51 
Finished goods  27  25   398   156 
Inventory, gross  399  291   1,079   502 
Less: Inventory reserve for excess and slow moving inventory           
Total $399 $291  $1,079  $502 

 

Inventory is maintained at the Company’s warehouse, an outsourced third-party contract manufacturing vendor, and at an Amazon fulfillment center.centers. The Company builds its contract manufacturing products based on customer orders and immediately ships the products upon completion of the production process.

 

6. Property and Equipment, Net

Property and equipment consist of the following ($ in thousands):

 Schedule of Property and Equipment 

 Useful Life September 30, December 31,  Useful Life June 30, December 31, 
 (Years)  2022  2021  (Years)  2023  2022 
Machinery and equipment  3 - 10  $972  $940  3 - 10  $1,530  $973 
Office furniture and equipment  3 - 10   59   50  3 - 10   159   59 
Leasehold improvements  6   228   228  6   261   228 
Construction in progress  -   48   -  N/A   118   55 
Property and equipment, gross      1,307   1,218 
Total property and equipment     2,068   1,315 
Less: accumulated depreciation and amortization      (570)  (495)     (655)  (594)
Property and equipment, net     $737  $723     $1,413  $721 

 

Depreciation expense for the ninesix months ended SeptemberJune 30, 20222023, and 20212022 was $7461 thousand and $7549 thousand, respectively.

 

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7. Intangible Assets

 

The following provides a breakdown of identifiable intangible assets as of SeptemberJune 30, 20222023 and December 31, 2021 ($ in thousands):2022:

 Schedule of Breakdown of Identifiable Intangible Assets

 September 30, December 31,  June 30, December 31, 
 2022  2021  2023  2022 
Product/Technology Related                
Identifiable intangible assets, gross $31  $31  $31  $31 
Accumulated amortization  (24)  (16)  (31)  (26)
Product/Technology related identifiable intangible assets, net  7   15 
Product/Technology Related identifiable intangible assets, net  -   5 
Marketing Related                
Customer related intangible asset, gross  17   17   17   17 
Tradename related intangible asset, gross  7   7   7   7 
Accumulated amortization  (8)  (6)  (11)  (9)
Marketing related identifiable intangible assets, net  16   18   13   15 
Total identifiable intangible assets, net $23  $33 
Total Identifiable intangible assets, net $13  $20 

 

In connection with the May 29, 2020, acquisition of SportSports Defense, in 2020, the Company identified intangible assets of $55 thousand representing technology related and customer related intangibles. These assets are being amortized on a straight-line basis over their weighted average estimated useful life of 3.75.7 years and amortization expense amounted to $107 thousand for each of the ninesix months periods ended SeptemberJune 30, 2023, and 2022, and 2021.respectively.

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As of SeptemberJune 30, 2022,2023, the estimated annual amortization expense for each of the next five fiscal years is as follows ($ in thousands):follows:

 Schedule of Estimated Annual Amortization Expense 

       
2022 (reminder of the year) $4 
($ in thousands):    
2023 8  $2 
2024 2   2 
2025 2   2 
2026 2   2 
2027  2 
Thereafter  5   3 
Total $23  $13 

8. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following ($ in thousands):

 Schedule of Accrued Expenses and Other Current Liabilities

 September 30, December 31,  June 30, December 31, 
 2022 2021  2023  2022 
Salaries, benefits, and incentive compensation $48  $54  $72  $56 
Franchise tax accrual  107  -   64   52 
Other  9  8   66   22 
Total accrued expenses and other current liabilities $164 $62  $202  $130 

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9. Common Stock

Share issuances

In connection with the Offering on December 27, 2021, the Company sold an aggregate of 2,585,000 units at a price to the public of $5.50 per unit, each unit consisting of one share of our common stock, and a warrant to purchase one share of our common stock at an exercise price of $5.50 per share. In addition, the Company granted the underwriter with respect to the Offering a 45-day option to purchase up to 387,750 additional shares of our common stock, and/or 387,750 additional warrants, to cover over-allotments in connection with the Offering, which the Underwriter partially exercised to purchase 387,750 warrants on December 27, 2021.

From January 1, 2021 through March 31, 2021, the Company entered into Securities Purchase Agreements with certain accredited investors whereby we sold 101,800 shares of our common stock at a price per share equal to $2.80 for an aggregate purchase price of $285 thousand.

 

At SeptemberJune 30, 2022,2023, the Company has reserved common stock for issuanceissued securities in relation to the following:

Schedule of Reserved Common Stock For IssuanceIssued Securities in Relation

Share-based compensation plan329,937528,182
Warrants to purchase common stock3,637,1903,442,904
Restricted stock units121,787

10. Share-based Compensation

The 2019 Plan provides for the granting of incentive stock options, nonqualified stock options, restricted stock, stock appreciation rights (“SARs”), restricted stock units, performance awards, dividend equivalent rights and other awards, which may be granted singly, in combination, or in tandem, and which may be paid in cash, shares of common stock of the Company or a combination of cash and shares of common stock of the Company. The Company initially reserved a totalup to an amount of 57,143 shares of the Company’s common stock for awards under the 2019 Plan. Effective as of May 26, 2020 and May 3, 2021, respectively, the Board approved an increase of the number of authorized shares of common stock reserved under the 2019 Plan from 57,143 shares of common stock to 485,715 and from 485,715 shares of common stock to 571,429871,429 shares of common stock, all of which may be delivered pursuant to incentive stock options. Subject to adjustments pursuant to the 2019 Plan, the maximum number of shares of common stock with respect to which stock optionsoption or SARs may be granted to an executive officer during any calendar year is 14,286 shares of common stock.

 

Incentive stock options

On March 8, 2023, the Company granted a contractor an option to purchase up to 17,532 shares of the Company’s common stock at a per share exercise price of $2.00 under the Company’s 2019 Plan. This option award vests over a period of 12 months.

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The following table contains information about the 2019 Plan as of SeptemberJune 30, 2022:2023:

Schedule of Information about Incentive Plan

  Awards        Awards 
  Reserved for  Awards  Awards  Available for 
  Issuance  Issued  Exercised  Grant 
2019 Plan  571,429   329,937   7,183   234,309 
  Awards  Awards     Awards 
  

Reserved for

Issuance

  Issued & Outstanding  

Awards

Exercised

  

Available for

Grant

 
2019 Plan(1)  871,429   612,932   7,183   251,314 
Awards granted outside of the 2019 Plan(2)  -   37,037   11,364   - 

 

17(1)Includes incentive stock options and restricted stock units discussed below.
(2)Includes shares of restricted common stock granted outside of the 2019 Plan to our Chief Executive Officer, Adam Levy.
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The following table summarizes the Company’s incentive stock option activity and related information for the period ended SeptemberJune 30, 2022:2023:

Schedule of Incentive Stock Option Activity

      Weighted       Weighted 
    Weighted Average     Weighted Average 
    Average Contractual     Average Contractual 
 Number of Exercise Term in  Number of Exercise Term in 
 Options  Price  Years  Options Price Years 
Outstanding at January 1, 2022  434,939  $1.675747   8.56 
            
Outstanding at January 1, 2023  524,937  $2.351416   8.38 
Granted           17,532   2.00   10.0 
Exercised                  
Forfeited                  
Cancelled  (105,002)  1.40      (10,000)  1.75    
Expired           (4,287)  1.40    
Outstanding at September 30, 2022  329,937  $1.763503   7.83 
Exercisable at September 30, 2022  318,508  $1.726311   7.81 
Outstanding at June 30, 2023  528,182  $2.35886   7.99 
Exercisable at June 30, 2023  337,111  $1.774915   7.21 

 

As of SeptemberJune 30, 2022,2023, vested outstanding stock options had $169129 thousand intrinsic value as the exercise price is greater than the estimated fair value of the underlying common stock.stock, respectively. As of SeptemberJune 30, 2022,2023, there was approximately $8517 thousand of total unrecognized share-based compensation related to unvested stock options, which the Company expects to recognize over the next 11 months excluding options fully contingent upon certain sales-based milestones being achieved within 1218 months.to 36 months of commercial release.

 

The Company recognizes compensation expense for stock option awards on a straight-line basis over the applicable service period of the award. The service period is generally the vesting period. The following assumptions were used to calculate share-based compensation expense for yearthe period ended SeptemberJune 30, 2022:2023:

Schedule of Assumptions used in Share-based Compensation

VolatilityVolatility257.64171.12%-183.48%
Risk-free interest rate4.21%
Dividend yield0.0%
Expected term0.46% - 0.86%
Dividend yield0.0%
Expected term5.0 - 5.755.50 years

 

The Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior. Accordingly, the Company has elected to use the “simplified method” to estimate the expected term of its share-based awards. The simplified method computes the expected term as the sum of the award’s vesting term plus the original contractual term divided by two.

 

Based on the lack of historical data of volatility for the Company’s common stock, the Company based its estimate of expected volatility on a weighted-average of the historical volatility of comparable public companies that manufacture similar products and are similar in size, stage of life cycle, and financial leverage.

 

Restrictive stock awardsStock Awards

 

Effective as of August 1, 2022, the Company granted a restricted stock award of 84,750 shares of the Company’s common stock to the certain officers and employees, all of which shares vest in four equal installments on each of January 1, 2023, January 1, 2024, January 1, 2025 and January 1, 2026. Under ASC 718, Compensation-Stock Compensation(“ASC 718”), the Company has measured the value of the 84,750 shares granted based on a closing price of the closing price of the Company’s stock at the grant date of the RSU Grant ($1.82 per share).

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Effective as of January 1, 2022, the Company granted a restricted stock award of 11,364 shares of the Company’s common stock to Adam Levy for his service as our Chief Executive Officer pursuant to the terms of his Executive Employment Agreement dated November 4, 2021, all of which shares vested monthly from January 1, 2022 through December 31, 2022. Under ASC 718, the Company has measured the value of the 11,364 shares granted based on the closing price of the Company’s stock at the grant date of the RSU Grant ($4.40 per share).

 

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On March 8, 2021,Effective as of January 3, 2023, the Company granted a restricted stock award of 39,52437,037 shares of the Company’s common stock to Adam Levy for his service as our Chief Executive Officer and Chief Financial Officer from October 1, 2020 through Septemberpursuant to the terms of his Executive Employment Agreement dated December 30, 2021,2022, all of which shares vested immediately.monthly from January 3, 2023 through December 31, 2023. Under ASC 718, the Company has measured the value of the 39,52437,037 shares granted based on the closing price of the Company’s stock at the grant date of the RSU Grant ($2.101.35 per share).

Schedule of Restricted Stock Units GrantGranted

    Weighted     Weighted 
    Average     Average 
 Number of Grant Date  Number of Grant Date 
 Units  Fair Value  Units  Fair Value 
Outstanding at January 1, 2022    $ 
Outstanding at January 1, 2023  90,432  $1.43 
Granted  96,114   1.60   37,037   1.35 
Exercised and converted to common shares        (5,682)  4.40 
Forfeited            
Outstanding at September 30, 2022  96,114  $1.60 
Exercisable at September 30, 2022  8,523  $4.40 
Outstanding at June 30, 2023  121,787  $1.68 
Exercisable at June 30, 2023  30,466  $1.68 

 

Compensation expense will be recognized ratably over the total vesting schedule. The Company will periodically adjust the cumulative compensation expense for forfeited awards. As of June 30, 2023, there was $121 thousand unrecognized share-based compensation related to unvested RSUs, which the Company expects to recognize over the next 3 years.

Stock based compensation and restricted stock vesting of $53 thousand and $134 thousand has been recorded for the six months ended June 30, 2023, and 2022, respectively.

Warrants

 

The following table shows a summary of common stock warrants through SeptemberJune 30, 2022:2023:

Summary of Common Stock Warrants

    Weighted Weighted     Weighted Weighted 
    Average Average     Average Average 
 Number of Exercise Contractual  Number of Exercise Contractual 
 Warrants  Price  Term in Years  Warrants  Price  Term in Years 
Outstanding at January 1, 2022  3,637,190  $5.16281   4.63 
Outstanding at January 1, 2023  3,637,190  $5.16281   3.65 
Granted                  
Exercised           (112,466)  0.55    
Forfeited                  
Cancelled           (81,820)  0.91    
Expired                  
Outstanding at September 30, 2022  3,637,190  $5.16281   3.90 
Exercisable at September 30, 2022  3,637,190  $5.16281   3.90 
Outstanding at June 30, 2023  3,442,904  $5.414793   3.35 
Exercisable at June 30, 2023  3,442,904  $5.414793   3.35 

 

As of SeptemberJune 30, 2022,2023, vested outstanding warrants had $1580 thousand intrinsic value as the exercise price is greater than the estimated fair value of the underlying common stock.

 

11. Notes PayableNoncontrolling Interest in Joint Venture

 

PPP LoanOn March 1, 2023, the Company acquired a 50% interest in a JV, named CG Converting and Packaging, LLC, with C.G. Laboratories Inc. (“CG Labs”) for its converting and packaging business (see Note 1). The JV is owned 50% by the Company and 50% by CG Labs. CG Labs contributed its existing converting and packaging division to the JV, including, but not limited to, its facilities, equipment, employees, and customers. The Company will contribute $500,000 to the JV, on a schedule to be determined, to be used for equipment and facility upgrades as well as general corporate purposes for JV. As of June 30, 2023, the Company has contributed $350,000 of its $500,000 commitment.

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The JV is considered to be a variable interest entity (“VIE”), as defined by authoritative accounting guidance. A VIE must be consolidated by a reporting entity if the reporting entity is the primary beneficiary because it has (i) the power to direct the VIE’s activities that most significantly impact the VIE’s economic performance and (ii) the obligation to absorb losses of the VIE or the right to receive benefits from the VIE. All major decisions related to the JV that most significantly impact its economic performance, including but not limited to operating procedures with respect to business affairs. Therefore, we have consolidated the JV.

 

On April 22, 2020, the Company, entered into a promissory note with PNC Bank, N.A. (the “PNC Bank”), which provides for a loan in the amount of $12. 147,300Notes Payable (the “PPP Loan”) pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act. On March 4, 2021, the Company received a second PPP Loan in the amount of $127,400 thousand under Phase II of the Paycheck Protection Program. On June 2, 2021, the Company received notice from PNC Bank that its initial loan of $147,300 had been forgiven in its entirety by the Small Business Administration (“SBA”). On November 16, 2021, the Company received notice from PNC Bank that its second PPP loan of $127,400 had been forgiven in its entirety by the SBA.

 

Economic Injury Disaster Loan

 

On May 28, 2020, the Company entered into the standard loan documents required for securing a loan (the “EIDL Loan”) from the SBA under its Economic Injury Disaster Loan (“EIDL”) assistance program in light of the impact of the COVID-19 pandemic on the Company’s business. Pursuant to that certain Loan Authorization and Agreement (the “SBA Loan Agreement”), the principal amount of the EIDL Loan is up to $260,500, with proceeds to be used for working capital purposes. Interest accrues at the rate of 3.75% per annum. Installment payments, including principal and interest, are due monthly beginning May 28, 2021 (twelvewhich the Company began paying in December 2022 (thirty months from the date of the SBA Note) in the amount of $1,270. The balance of principal and interest is payable thirty years from the date of the SBA Note. In connection therewith, the Company received an $88,000 thousand advance, which does not have to be repaid. On March 26, 2021, the SBA announced that all EIDL loans issued in 2020 will start repayment 24 months from the date of the SBA Note. The SBA has since extended the repayment start to 30 months from the date of the SBA Note. The balances of the principal and accrued interest amounted to $283280 thousand and $276283 thousand as of SeptemberJune 30, 20222023 and December 31, 2021,2022, respectively.

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12. Convertible Notes Payable

 

On December 24, 2020, the Company issued a $100 thousand 6% Secured Convertible Promissory Note which was convertible into sharesThe future annual principal amounts and accrued interest to be paid as of the Company’s common stock at a price per shareJune 30, 2023 are as follows:

Schedule of $2.80Debt Instruments. The note was fully repaid (including all accrued but unpaid interest) on March 14, 2021.

  Amount 
For the year ending December 31 ($ in thousands):    
2023 (remainder of the year) $3 
2024  5 
2025  5 
2026  5 
2027  6 
Thereafter  256 
Total $280 

 

On January 19, 2021, the Company issued a $13. 15 thousand Secured Convertible Promissory Note which was convertible into shares of the Company’s common stock at a price per share of $1.05Notes Payable. The note was fully repaid (including all accrued but unpaid interest) on March 14, 2021.

Auctus Fund Financing

 

On March 11, 2021, the Company andissued Auctus Fund, LLC, a Delaware limited liability company (“Auctus”) entered into a one-year senior secured convertible promissory note in the principal amount of $1,680 thousand1.68, million, which includesincluded $180 thousand of interest which was deemed fully earned as of the issuance date (the “Auctus Note”). The Auctus Note was fully repaid (including all principal and interest) on March 15, 2022 with a one-time cash payment of $1,680 thousand1.68.

Investor Private Placement Offering million.

 

On September 2, 2021, the Company closed a private placement offering with twenty accredited investors (the “September 2 Investors”) whereby the Company issued to the September 2 Investorscertain holders one-year subordinated secured convertible promissory notes in the aggregate principal amount of $1,814 thousand,, which includesincluded $194 thousand of interest which was deemed fully earned as of the issuance date (the “September 2 Notes”).

On January 25, 2022, the Company repaid aone of the September 2 InvestorNotes in full with a one-time cash payment of $300 thousand of outstanding principal and accrued but unpaid interest. The Company did incur a 105%incurred pre-payment penalty of $16,80017 thousand with respect to the repayment of the investor’s note and the remaining unamortized debt discount in the amount of $133 thousand was written off and both amounts were recorded as a loss on extinguishment of debt of $150 thousand in accompany condensed consolidated statement of operations during 2022. The repayment extinguished the note in its entirety.

On September 6, 2022, the outstanding balance on the remaining September 2 Notes remaining outstanding balanceNotes’ was repaid in full which consisted of principal and interest of $1,478 thousand. thousand.

 

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13.

14. Warrant Liability

On September 2, 2021, March 11, 2021, February 3, 2021, December 24, 2020, March 18, 2020, September 10, 2019, and November 6, 2019, the Company issued 22,019, 34,286, 7,4287,429, 7,286, 44,286, 35,71435,715 and 114,286 warrants, respectively, as equity issuance consideration, in connection with a private placement of the Company’s common stock. The warrants entitle the holder to purchase one share of our common stock at an exercise price equal to $0.49 to $5.25 per share at any time on or after their issuance date and on or prior to the close of business 3 or 5 years, as applicable, after the issuance date (the “Termination Date”). The Company determined that these warrants are free standing financial instruments that are legally detachable and separately exercisable from the common stock included in the public share offering. Management also determined that the warrants required classification as a liability pursuant to ASC 815, Derivatives and Hedging.815. In accordance with the accounting guidance, the outstanding warrants are recognized as a warrant liability on the balance sheet and are measured at their inception date fair value and subsequently re-measured at each reporting period with changes being recorded as a component of other expense, netincome in the statement of operations.

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On September 6, 2022, the Company agreed to extend the September 10, 2019 and November 6, 2019 warrants an additional six months until March 9, 2023 and May 5, 2023, respectively. The warrants were remeasured as of September 6, 2022 and consequently resulted in a warrant modification expense of $57 thousand.

 

The warrants outstanding and fair values at each of the respective valuation dates are summarized below:

Schedule of Warrant Liability

  Warrants  Fair Value    
Warrant Liability Outstanding  per Share  Fair Value 
Fair Value as of period ending 12/31/2021  265,305     $318 
Modification of warrants          57 
Change in fair value of warrant liability          (3)
Fair Value as of period ending 9/30/2022  265,305      $372 
Warrant Liability Warrants Outstanding  Fair Value per Share  Fair Value 
Fair value as of year ended 12/31/2022  265,305     $242 
Exercise of warrants  (194,286)           (154)
Change in fair value of warrant liability  -      77 
Fair value as of period ended 6/30/2023  71,019      $165 

 

The warrant liabilities are considered Level 3 liabilities on the fair value hierarchy as the determination of fair value includes various assumptions about of future activities and the Company’s stock prices and historical volatility of other comparable public companies usedGuideline Public Companies as inputs. As of September 30, 2022, none of the warrants have been exercised.

 

14.15. Commitments and Contingencies

Litigation

 

The Company may be subject to legal proceedings and claims that arise in the ordinary course of business. Management is not currently aware of any matters that will have a material effect on the financial position, results of operations, or cash flows of the Company.

 

Service Agreement

On March 21, 2023, the Company entered into a Services Agreement with GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (“Haleon”) to supply material for a consumer product to be developed and released in the future. There can be no guaranty that a consumer product will be released or, if released, that it will be successful. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC is a Haleon group company.

15.16. Concentrations of Risk

The Company’s revenues are concentrated in a small group of customers with some individually having more than 10% of total revenues.

 

Revenues from two customers that exceeded 10% of total revenues for the ninesix months ended SeptemberJune 30, 20222023, were 3940% and 2714%. The accounts receivable from those top two customers were 0% and 22% as well as 13%, 15%, and 16% from three other customers of the total accounts receivable as of June 30, 2023.

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Revenues from two customers that exceeded 10% of total revenues for the six months ended June 30, 2022, were 40% and 25%. The accounts receivable from those top two customers by revenue were6%, and 5346%, respectively, as well as 1715% and 1922% from two other customers of the total accounts receivable as of SeptemberJune 30, 2022.

Revenues from three customers that exceeded 10% of total revenues for the nine months ended September 30, 2021 were 33%, 38%, and 24%. The accounts receivable from the top three customers by revenue were 16%, 17%, and 0%, respectively, as well as 18% from one other customer of the total accounts receivable as of September 30, 2021.

 

The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. Cash balances are maintained principally at major U.S. financial institutions and are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to regulatory limits. Such cash balances are currently in excess of the FDIC insurance limit of $250 thousand. As of SeptemberJune 30, 2022,2023, the total amount exceeding such limit was $1,1563 thousand.million. The Company has not experienced any credit losses associated with its cash balances in the past. The Company invests its cash equivalents in U.S. treasury bills with original maturities of three months or less.

 

Marketable securities are comprised of U.S. treasury bills with original maturities greater than three months. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash, cash equivalents, and marketable securities and performs periodic evaluations of the credit standing of such institutions.

 

17. Related Party Transactions

Convertible Promissory Note

On September 2, 2021, the Company issued three Secured Convertible Promissory Notes to members of the board of directors in aggregate amounts of $150,000 to Mr. Stein, $150,000 to Mr. Stefansky (Bezalel Partners, LLC), and $50,000 to Dr. Zeldis as part of the September 2 Notes. The notes were repaid in full in 2022.

Advances

Dr. Jerome Zeldis, a member of the Company board of directors, has an outstanding balance due of $25,000 for services as of June 30, 2023 and $40,000 as of December 31, 2022, included in accounts payable in the accompanying condensed consolidated balance sheets.

18. Subsequent Events

Management of the Company has performed a review of events and transactions occurring after the condensed consolidated balance sheet date to determine if there were any such events or transactions requiring adjustment to or disclosure in the accompanying condensed consolidated financial statements and has noted none except as follows.

In July 2023, the Company announced a new strategic relationship with Enigma Health, a new joint venture company, for retail distribution and marketing services in North America. In addition to the Company, Enigma Health will also be providing services for Moiety, Inc., a topical lotion and creams manufacturer.

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

 

The following discussion and analysis ofare intended to help prospective investors understand our business, financial condition, and results of operations, liquidity and capital resources. You should be read this discussion in conjunction with the condensedour financial statements and related notes above.thereto included elsewhere in this information statement.

The statements in this discussion regarding industry outlook, expectations regarding our future performance, liquidity and capital resources and other non-historical statements are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the risks and uncertainties described in “Special Note Regarding Forward-Looking Statements.” Actual results may differ materially from those contained in any forward-looking statements.

The NexGel Financial Statements, discussed below, reflect the NexGel financial condition, results of operations, and cash flows. The financial information discussed below and included in this information statement, however, may not necessarily reflect what the NexGel financial condition, results of operations, or cash flows would have been had NexGel been operated as a separate, independent entity during the years presented, or what the NexGel financial condition, results of operations, and cash flows may be in the future.

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,” “would,” “predict,” “potential,” “continue,” “expect,” “anticipate,” “future,” “intend,” “plan,” “believe,” “estimate,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will actually be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:

 

 our ability to continue as a going concern;

 inadequate capital;

 inadequate or an inability to raise sufficient capital to execute our business plan;

 our ability to comply with current good manufacturing practices;

 loss or retirement of key executives;

 our plans to make significant additional outlays of working capital before we expect to generate significant revenues and the uncertainty regarding when we will begin to generate significant revenues, if we are able to do so;

 adverse economic conditions and/or intense competition;

 loss of a key customer or supplier;

 entry of new competitors;

 adverse federal, state and local government regulation;

 technological obsolescence of our manufacturing process and equipment;

 technical problems with our research and products;

 risks of mergers and acquisitions including the time and cost of implementing transactions and the potential failure to achieve expected gains, revenue growth or expense savings;

 price increases for supplies and components; and

 the inability to carry out our business plans.

 

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For a discussion of these and other risks that relate to our business and investing in shares of our common stock, you should carefully review the risks and uncertainties described elsewhere in this Quarterly Report on Form 10-Q. The forward-looking statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

 

Overview

 

We manufacture high water content, electron beam cross-linked, aqueous polymer hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and cosmetics. We specialize in custom gels by capitalizing on proprietary manufacturing technologies. We have historically served as a contract manufacturer, supplying our gels to third parties who incorporate them into their own products and have recently began producing our own consumer products using our gels focused on proprietary branded products and white label opportunities. Both our gels and our consumer products are manufactured using proprietary and non-proprietary mixing, coating and cross-linking technologies. Together, these technologies enable us to produce gels that can satisfy rigid tolerance specifications with respect to a wide range of physical characteristics (e.g., thickness, water content, adherence, absorption, moisture vapor transmission rate [a measure of the passage of water vapor through a substance] and release rate) while maintaining product integrity. Additionally, we have the manufacturing capabilityability to offer broad choices in the selection of liners onto which the gels are coated. Consequently, we and our customers are able to determine tolerances in moisture vapor transmission rate and active ingredient release rates while personalizing color and texture.

 

Joint Venture

On March 1, 2023, the Company acquired of 50% interest in a newly formed joint venture (“JV”), CG Converting and Packaging, LLC, with C.G. Laboratories Inc. (“CG Labs”) for its converting and packaging business. The agreement is effective March 1, 2023. As a result of this transaction, the Company owns 50% of the JV, with the remaining 50% held by CG Labs.

Results of Operations

 

The following sections discuss and analyze the changes in the significant line items in our condensed consolidated statements of operations for the comparison periods identified.

 

Comparison of the Three Months ended SeptemberJune 30, 20222023, and 20212022

 

Revenues, net.

 

For the three months ended SeptemberJune 30, 20222023, revenues were $568 thousand$1.17 million and increased by $233$606 thousand, or 69.6%108.0%, when compared to $335$561 thousand for the three months ended SeptemberJune 30, 2021.2022. The increase in our overall revenues was primarily due to sales growth in branded consumer products andboth our contract manufacturing products.and branded products, including the revenue from CG Labs from April 1, 2023 through June 30, 2023 of $602 thousand.

The Company has four distinct lines of business; Contract Manufacturing, Custom & White Label, Consumer Branded Products, and Medical Devices as further described below.

Contract Manufacturing

Customers order rolls of gel (“rollstock”). The rollstock is shipped to our customers, which they package into finished goods. Historically, this has been the Company’s primary source of revenue.

Custom & White Label

These products often infuse various ingredients into our base gel to develop unique product offerings to satisfy market demand (e.g. aloe infused into the gel for a beauty mask). The rollstock is converted and packaged into salable units. The finished goods are shipped to the customer, who is ultimately responsible for product distribution. Frequently these products started as development deals, in which the customer paid the company a small fee to develop a specific product. Once completed, the customer places a large order for newly developed product.

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Consumer Branded Products

These products are finished goods marketed and sold directly to the customer by the Company through online and retail channels. The Company is responsible for sales, marketing, and distribution. These products carry the Company’s brand names.

Medical Devices

Medical Devices are a hybrid business, combining elements of Custom & White Label and Consumer Branded Products. Medical Devices, which are not yet marketed, are expected to be distributed through strategic partnerships. The Company will manufacture and possibly convert/package the device while the strategic partner brings the product to market. Small market Medical Devices could be launched by the Company, but also be offered to a distributor to reach the full scale of the market.

 

Gross profit (loss). Our gross profit was $148$175 thousand for the three months ended SeptemberJune 30, 20222023, compared to a gross lossprofit of $57$101 thousand for the three months ended SeptemberJune 30, 2021.2022. The increase of $74 thousand in gross profit recorded for the three months ended September 30, 2022, as compared to a loss recorded for the three months ended September 30, 2021,quarter over quarter was primarily due to the higher volume of contract manufacturing sales against fixed costs.costs partially offset by higher manufacturing labor costs and increased manufacturing of promotional materials, customer product samples and other marketing materials to support our new product launches. Gross profit was approximately 26%15% for the three months ended SeptemberJune 30, 20222023, compared to a gross lossprofit of (17)%18% for the three months ended SeptemberJune 30, 2021. The Company anticipates continued improvement in gross margins due to both increased revenue against fixed facility expenses and larger productions runs on commercially proven products.2022.

 

The components of cost of revenues are as follows for the three months ended SeptemberJune 30, 20222023 and 20212022 ($ in thousands):

 

  

Three Months Ended

September 30,

 
  2022  2021 
Cost of revenues      
Materials and finished products $113  $121 
Compensation and benefits  176   157 
Depreciation and amortization  20   22 
Equipment, production and other expenses  111   92 
Total cost of revenues $420  $392 

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  Three Months Ended 
  June 30, 
  2023  2022 
Cost of revenues        
Materials and finished products $594  $196 
Compensation and benefits  163   163 
Depreciation and amortization  21   22 
Equipment, production and other expenses  214   79 
Total cost of revenues $992  $460 

 

Cost of revenues increased by $28$532 thousand, or 7.1%115.7%, to $420$992 thousand for the three months ended SeptemberJune 30, 2022,2023, as compared to $392$460 thousand for the three months ended SeptemberJune 30, 2021.2022. The increase in cost of revenues is pertains to and increase in materials and finished products and equipment, production and other expenses. These increases primarily alignedalign with the revenuenew product line growth in the current year.and increased amounts of promotional materials, customer product samples and other marketing materials to support our new product launches.

 

Selling, general, and administrative expenses. The following table highlights selling, general, and administrative expenses by type for the three months ended SeptemberJune 30, 20222023 and 20212022 ($ in thousands):

 

 Three Months Ended 
 

Three Months Ended

September 30,

  June 30, 
 2022  2021  2023  2022 
Selling, general and administrative expenses                
Compensation and benefits $118  $87  $176  $121 
Share-based compensation  85   45   23   43 
Depreciation and amortization  4   3   16   7 
Advertising, marketing, & Amazon fees  166   80 
Investor & shareholder services  140   129 
Franchise tax & corporate insurance  63   48 
Professional & consulting fees  246   217 
Other expenses and professional fees  785   418   52   63 
Total Selling, general and administrative expenses $992  $553 
Total selling, general and administrative expenses $882  $708 

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Selling, general and administrative expenses increased by $439$174 thousand, or 79.4%24.6%, to $992$882 thousand for the three months ended SeptemberJune 30, 2022,2023, as compared to $553$708 thousand for the three months ended SeptemberJune 30, 2021.2022. The increase in selling,Selling, general and administrative expenses is primarily attributable to an increase of franchise tax expense, increased research and development investment and the costs for professional fees and other administrative expenses in the current period associated with public company governance requirements. The exceptionally high franchise tax charge of $220 thousand was due to the company’s IPO and related increase in gross assets. In August of 2022 the Company reduced its authorized shares at its annual stockholders’ meeting. The result of this reduction, assuming a similar asset base as the Company currently has will reduce the 2023 franchise tax liability to approximately $28 thousand.factors described below.

 

Compensation and benefits increased by $31$55 thousand, or 35.6%45.5%, to $118$176 thousand for the three months ended SeptemberJune 30, 2022,2023, as compared to $87$121 thousand for the three months ended SeptemberJune 30, 2021.2022. The number of employees increased compared to the prior period and officer compensation increased in conjunction with contract renewals.

 

Share-based compensation increaseddecreased by $40$20 thousand, or 88.9%46.5%, to $85$23 thousand for the three months ended SeptemberJune 30, 2022,2023, as compared to $45$43 thousand for the three months ended SeptemberJune 30, 2021.2022. The decrease in share-based compensation related to the issuance of stock options and restricted stock awards and options to our CEO, restricted stock awards to allofficers, employees, and optionsadvisors in the prior year period that were not issued in the current period.

Advertising, marketing, Amazon fees increased by $86 thousand, or 107.5% to board members, employees,$166 thousand for the three months ended June 30, 2023, as compared to $80 thousand for the three months ended June 30, 2022. The increase is due to the increased Amazon selling fees and advisors.Amazon Advertising, which correlates with our increase in Branded Sales, as well as an increase in advertising and marketing in channels outside of Amazon.

Investor and shareholder services increased by $11 thousand, or 8.5% to $140 thousand for the three months ended June 30, 2023, as compared to $129 thousand for the three months ended June 30, 2022. The increase is due to an increase in investor outreach.

Franchise taxes and corporate insurance increased by $15 thousand, or 31.3% to $63 thousand for the three months ended June 30, 2023, as compared to $48 thousand for the three months ended June 30, 2022.

Professional and consulting fees increased by $29 thousand, or 13.4% to $246 thousand for the three months ended June 30, 2023, as compared to $217 thousand for the three months ended June 30, 2022. We continued to incur accounting and consulting fees associated with public company governance requirements.

 

Other expenses and professional fees increaseddecreased by $367$11 thousand, or 87.8%17.5%, to $785$52 thousand for the three months ended SeptemberJune 30, 20222023 from $418$63 thousand for the three months ended SeptemberJune 30, 2021.2022. Other selling, general and administrative expenses generally consist of costs associated with our selling efforts and general management, including information technology, travel, training and recruiting. We continued to incur legal, accounting and consulting fees associated with public company governance requirements, however, the increase in professional fees compared to the prior year period was primarily due to the increase in professional fees in connection with our in the NASDAQ up-listing on December 27, 2021.

 

Research and development expenses. Research and development expenses increased by $193were $55 thousand and $111 thousand for the three months ended SeptemberJune 30, 2023 and June 30, 2022, from $0 for the three months ended September 30, 2021. The increase is due to the initiation of two proof of concept studies for drug delivery candidates utilizing our hydrogel technology.respectively.

Comparison of the NineSix Months ended SeptemberJune 30, 20222023 and 20212022

 

Revenues, net.

 

For the ninesix months ended SeptemberJune 30, 20222023, revenues were $1,524 thousand$1.79 million and increased by $506$830 thousand, or 49.7%86.8%, when compared to $1,018$956 thousand for the ninesix months ended SeptemberJune 30, 2021.2022. The increase in our overall revenues was primarily due to sales growth of new products as well asin both our initiatives in custom labelcontract manufacturing and branded consumer product.products, including the revenue from CG Labs from April 1, 2023 through June 30, 2023 of $792 thousand.

 

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Gross profit (loss). Our gross profit was $220$117 thousand for the ninesix months ended SeptemberJune 30, 20222023, compared to a gross lossprofit of $(95)$72 thousand for the ninesix months ended SeptemberJune 30, 2021.2022. The increase in profit recorded for the ninesix months ended SeptemberJune 30, 2022,2023, as compared to a loss recorded for the ninesix months ended SeptemberJune 30, 2021,2022, was primarily due to the higher volume of contract manufacturing sales against fixed costs.costs, partially offset by increased manufacturing of promotional materials, customer product samples and other marketing materials to support our new product launches. Gross profit was approximately 14.4%7% for the ninesix months ended SeptemberJune 30, 20222023, compared to a gross lossprofit of (9.3)%8% for the ninesix months ended SeptemberJune 30, 2021.2022. The components of cost of revenues are as follows for the ninesix months ended SeptemberJune 30, 20222023 and 20212022 ($ in thousands):

  

Nine Months Ended

September 30,

 
  2022  2021 
Cost of revenues        
Materials and finished products $403  $351 
Compensation and benefits  518   419 
Depreciation and amortization  63   65 
Equipment, production and other expenses  320   278 
Total cost of revenues $1,304  $1,113 

  

Six Months Ended

June 30,

 
  2023  2022 
Cost of revenues        
Materials and finished products $949  $290 
Compensation and benefits  334   342 
Depreciation and amortization  42   43 
Equipment, production, and other expenses  344   209 
Total cost of revenues $1,669  $884 

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Cost of revenues increased by $191$785 thousand, or 17.2%88.8%, to $1,304$1.67 million for the six months ended June 30, 2023, as compared to $884 thousand for the ninesix months ended SeptemberJune 30, 2022, as compared to $1,113 thousand for the nine months ended September 30, 2021. 2022. The increase in cost of revenues ispertains to and increase in materials and finished products and equipment, production and other expenses. These increases primarily alignedalign with the new product line growth in the current year.and increased amounts of promotional materials, customer product samples and other marketing materials to support our new product launches.

 

Selling, general, and administrative expenses. The following table highlights selling, general, and administrative expenses by type for the ninesix months ended SeptemberJune 30, 20222023 and 20212022 ($ in thousands):

 

 

Nine Months Ended

September 30,

  

Six Months Ended

June 30,

 
 2022 2021  2023  2022 
Selling, general and administrative expenses     
Selling, general, and administrative expenses        
Compensation and benefits $379  $259  $321  $233 
Share-based compensation 219 230   42   61 
Depreciation and amortization 11 10   26   14 
Other expenses and professional fees  1,850  1,072 
Total Selling, general and administrative expenses $2,459 $1,571 
Advertising, marketing, & Amazon fees  260   119 
Investor & shareholder services  237   278 
Franchise tax & corporate insurance  122   97 
Professional & consulting fees  552   443 
Other expenses  119   222 
Total selling, general and administrative expenses $1,679  $1,467 

 

Selling, general, and administrative expenses increased by $888$212 thousand, or 56.5%14.5%, to $2,459 thousand$1.68 million for the ninesix months ended SeptemberJune 30, 2022,2023, as compared to $1,571 thousand$1.47 million for the ninesix months ended SeptemberJune 30, 2021.2022. The increase in selling, general, and administrative expenses is primarily attributable to our costs for professional fees and other administrative expenses in the current period associated with public company governance requirements.

 

Compensation and benefits increased by $120$88 thousand, or 46.3%37.8%, to $379$321 thousand for the ninesix months ended SeptemberJune 30, 2022,2023, as compared to $259$233 thousand for the ninesix months ended SeptemberJune 30, 2021.2022. The number of employees increased compared to the prior period and officer compensation increased in conjunction with contract renewals.

 

Share-based compensation decreased by $11$19 thousand, or 4.8%31.1%, to $219$42 thousand for the ninesix months ended SeptemberJune 30, 2022,2023, as compared to $230$61 thousand for the ninesix months ended SeptemberJune 30, 2021.2022. The share-based compensation related to the issuance of stock restricted stock awards and options to our CEO restricted stock awards to all employees and options to board members, employees, and advisors.

 

Other expenses and professionalAdvertising, marketing, Amazon fees increased by $778$141 thousand or 72.6%118.5%, to $1.9 million$260 thousand for the ninesix months ended SeptemberJune 30, 2022 from $1.1 million2023, as compared to $119 thousand for the ninesix months ended SeptemberJune 30, 2022. The increase is due to the increased Amazon selling fees as well as an increase in advertising and marketing.

Investor and shareholder services decreased by $41 thousand or 14.7%, to $237 thousand for the six months ended June 30, 2023, as compared to $278 thousand for the six months ended June 30, 2022. The decrease is due to initial fees related to the Nasdaq listing in 2022 upon the IPO occurring on December 27, 2021.

Franchise taxes and corporate insurance increased by $25 thousand or 25.8%, to $122 thousand for the six months ended June 30, 2023, as compared to $97 thousand for the six months ended June 30, 2022.

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Professional and consulting fees increased by $109 thousand or 24.6% to $552 thousand for the six months ended June 30, 2023, as compared to $443 thousand for the six months ended June 30, 2022. We continued to incur accounting and consulting fees associated with public company governance requirements.

Other expenses decreased by $103 thousand, or 46.4%, to $119 thousand for the six months ended June 30, 2023 from $222 thousand for the six months ended June 30, 2022. Other selling, general and administrative expenses generally consist of costs associated with our selling efforts and general management, including information technology, travel, training and recruiting. We continued to incur legal, accounting and consulting fees associated with public company governance requirements, however, the increase in professional fees compared to the prior year period was primarily due to the increase in professional fees in connection with our in the NASDAQ up-listing on December 27, 2021.

 

Research and development expenses. Research and development expenses increaseddecreased by $311$51 thousand to $328$84 thousand for the ninesix months ended SeptemberJune 30, 20222023 from $17$135 thousand for the ninesix months ended SeptemberJune 30, 2021.2022. The increasedecrease is due to the initiationcompletion of development efforts of two proof of concept studies for drug delivery candidates utilizing our hydrogel technology as well as continuing development on the NEXDrape medical device.technology.

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Liquidity and Capital Resources

Cash Flow

(in thousands)

  September 30,  September 30, 
  2022  2021 
Net cash used in operating activities $(2,343) $(1,556)
Net cash used in investing activities  (6,068)  (390)
Net cash provided by (used in) financing activities  (3,512)  3,169 
Net increase (decrease) in cash and cash equivalents  (11,923)  1,223 
Cash and cash equivalents at beginning of period  13,350   32 
Cash and cash equivalent at end of period $1,427  $1,255 
  June 30,  June 30, 
  2023  2022 
Net cash used in operating activities $(1,926) $(1,495)
Net cash provided by investing activities  4,519   (5,402)
Net cash used in financing activities  (3)  (2,033)
Net increase (decrease) in cash and cash equivalents  2,590   (8,930)
Cash and cash equivalents at beginning of year  1,101   13,350 
Cash and cash equivalent at end of quarter $3,691  $4,420 

 

As of SeptemberJune 30, 2022,2023, we had $1.4$3.7 million of cash and $612 thousand of marketable securities, compared to $1.1 million of cash equivalents and $6.0$5.5 million of marketable securities compared to $13.4 million of cash at December 31, 2021.2022. Net cash used in operating activities was $2.3$1.9 million and $1.6$1.5 million for the ninesix months ended SeptemberJune 30, 2023 and 2022, respectively.

Net cash provided by investing activities was $4.5 million and 2021, respectively. See Notes 2net cash used in investing activities was $5.4 million for the six months ended June 30, 2023 and 32022, respectively, consisting of our financial statements abovethe sales of marketable securities of $4.8 million and purchases of capital equipment of $253 thousand for a more detailed discussion of our marketable securities.six months ended June 30, 2023.

 

Net cash used in investing activities was $6,068 thousand and $390 thousand for the nine months ended September 30, 2022 and 2021, respectively, consisting of investments in marketable securities of $6,980 thousand, the sale of marketable securities for $1,000 thousand, and purchases of capital equipment of $88 thousand for the nine months ended September 30, 2022 and purchases of capital equipment of $390 thousand in the prior year period.

Net cash used by financing activities for the ninesix months ended SeptemberJune 30, 2023 and 2022 was $3.5$3 thousand and $2 million whichand is attributable to the principal payments of convertible notes of $3.5 million. For the nine months ended September 30, 2021 cash flows from financing activities were $3.2 million which is attributable to the issuance of common stock of $285 thousand and proceeds of a notes payable of $15 thousand and proceeds from the PPP loan of $127 thousand and convertible notes, payable, net of $2.8 million, net of costs and principal payments of convertible notes of $100 thousand.respectively.

 

At SeptemberJune 30, 2022,2023, current assets totaled $8.3$6.7 million and current liabilities totaled $1.1$1.7 million, as compared to current assets totaling $13.9$7.5 million and current liabilities totaling $2.9 million$859 thousand at December 31, 2021.2022. As a result, we had working capital of $7.2$5.0 million at SeptemberJune 30, 2022,2023, compared to a working capital of $11.0$6.6 million at December 31, 2021.2022. The decrease in the working capital as of SeptemberJune 30, 20222023 is primarily attributable to the repaymentloss from operations of convertible notes payable of $3.5 million in the current period.

On December 27, 2021, the Company sold an aggregate of 2,585,000 units at a price to the public of $5.50 per unit (the “Offering”), each unit consisting of one share of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and a warrant to purchase one share of Common Stock at an exercise price of $5.50 per share (the “Warrants”), pursuant to that certain Underwriting Agreement, dated as of December 21, 2021 (the “Underwriting Agreement”), between the Company and Maxim Group LLC (the “Underwriter”). In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriter a 45-day option to purchase up to 387,750 additional shares of Common Stock, and/or 387,750 additional Warrants, to cover over-allotments in connection with the Offering, which the Underwriter partially exercised to purchase 387,750 Warrants on December 27, 2021. On December 27, 2021, the Company received gross proceeds of approximately $14.2 million, before deducting underwriting discounts and commissions of seven percent (7%) of the gross proceeds and estimated Offering expenses.

Pursuant to the Underwriting Agreement, the Company also agreed to issue to the Underwriter warrants (the “Underwriter’s Warrants”) to purchase up to a total of 155,100 shares of Common Stock (6% of the shares of Common Stock sold in the Offering). The Underwriter’s Warrants are exercisable at $6.1875 per share of Common Stock and have a term of five years. The Underwriter’s Warrants are subject to a lock-up for 180 days from the commencement of sales in the Offering, including a mandatory lock-up period in accordance with FINRA Rule 5110(e), and will be non-exercisable for six (6) months after December 21, 2021.

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On September 2, 2021, the Company entered into a securities purchase agreement pursuant to which the Company issued to twenty investors a 12% senior secured convertible promissory note in the principal amount of $1.8 million, including $194 thousand (which represents the twelve months of guaranteed interest which was earned in full as of September 2, 2021), which is convertible into shares of the Company’s common stock at a price per share of $5.25 subject to certain adjustments as discussed herein in Note 13 in the Notes to Condensed Consolidated Financials. The net proceeds received by the Company were $1.5 million after deducting fees and expenses related to the transaction. The purchasers in the September 2021 securities purchase agreement also received warrants to purchase shares of our common stock. On January 25, 2022, the Company repaid an investor in full with a one-time cash payment of $300 thousand of outstanding principal and accrued but unpaid interest the September 2 Offering. The Company did incur a 105% pre-payment penalty of $16,800 with respect to the repayment of the investor’s note and the repayment extinguished the note in its entirety. Furthermore, the remaining September 2 Notes’ were fully repaid (including all principal and interest) on September 6, 2022 with a one-time cash payment of $1.5$1.6 million.

On March 11, 2021, the Company and Auctus entered into a senior secured convertible promissory note in the principal amount of $1,680 thousand, which includes $180 thousand of interest which was deemed fully earned as of the issuance date. The Auctus Note was fully repaid (including all principal and interest) on March 15, 2022 with a one-time cash payment of $1,680 thousand.

 

We have never declared or paid any cash dividends on our common stock. For the foreseeable future, we anticipate that all available funds and any earnings generated in our business will be used to finance the growth of our business and will not be paid out as dividends to our shareholders. Any future determination related to our dividend policy will be made at the discretion of our Board of Directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions, business prospects and other factors our Board of Directors may deem relevant.

 

Management is exploring new product channel sales in consumer products, such as cosmetics, athletic products, and proprietary medical devices. The Company has increased its focus on sales and developing a sales pipeline for potential customers. This customer base expansion will enable us to provide financial stability for the foreseeable future, expand our current processes, and position us for long-term shareholder value creation.

 

We believe we have sufficient cash and marketable securitiescapital to operate our business plan through 2024.maintain as a going concern due to the capital raise that occurred on December 27, 2021. We intend to maintain and attempt to grow our existing contract manufacturing business. We also plan to continue building and developing ourits catalog of consumer products for sale to branding partners and to use our in-house capabilities to create and test market additional branded products. These products will be target marketed and sold online through social media, television and online marketplaces. Furthermore, the Company plans to develop its own proprietary medical devices and explore drug delivery programs for its technology. Additionally, the Company continues to evaluate strategic initiatives (e.g., acquisitions) and additional capital raises through debt or equity may be necessary to achieve these objectives.

 

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We expect to continue incurring losses for the near-term future. Our ability to continue to operate as a going concern in the long termlong-term is dependent upon our ability to manage and grow our current products and to ultimately achieve profitable operations. Management may consider various options to raise capital to fund potential acquisitions through equity or debt offerings. There can be no assurances, however, that management will be able to obtain sufficient additional funds, if needed, or that such funds, if available, will be obtained on terms satisfactory to us. The financial statements do not include any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern.

 

Additionally, it is reasonably possible that estimates made in the financial statements have been, or will be, materially and adversely impacted in the near term as a result of these conditions, including the recoverability of long-lived assets.

 

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Off Balance Sheet Arrangements

 

As of SeptemberJune 30, 2022,2023, we had no off-balance sheet arrangements in the nature of guarantee contracts, retained or contingent interests in assets transferred to entities (or similar arrangements serving as credit, liquidity or market risk support to entities for any such assets), or obligations (including contingent obligations) arising out of variable interests in entities providing financing, liquidity, market risk or credit risk support to us, or that engage in leasing, hedging or research and development services with us.

 

Critical Accounting Policies and Estimates

 

The preparation of our Financial Statements in accordance with generally accepted accounting principles is based on the selection and application of accounting policies that require us to make significant estimates and assumptions about the effects of matters that are inherently uncertain. We consider the accounting policies discussed below to be critical to the understanding of our Financial Statements. Actual results could differ from our estimates and assumptions, and any such differences could be material to our Financial Statements.

 

Share-based compensation – We utilize share-based compensation in the form of incentive stock options. The fair values of incentive stock option award grants are estimated as of the date of grant using a Black-Scholes option valuation model. Compensation expense is recognized in the statements of operations on a straight-line basis over the requisite service period, which is generally the vesting period required to obtain full vesting. The expected term of the awards granted is estimated using the simplified method which computes the expected term as the sum of the award’s vesting term plus the original contractual term divided by two.

 

Warrant Liability – Warrants to purchase common stock were issued in connection with equity financing raises which occurred on September 2, 2021, March 11, 2021, February 3, 2021, December 24, 2020, March 18, 2020, September 10,during 2019 and November 6, 2019.through 2021. The fair values of the warrants are estimated as of the date of issuance and again at each periodyear end using a Black-Scholes option valuation model. At issuance, the fair value of the warrant is recognized as an equity issuance cost within additional paid-in-capital. Fair value adjustments to the warrant liability are recognized in other income (expense) in the statements of operations. The expected term of the awards granted are based on either the 3 yearthree-year or five-year contractual expiration date.

 

Black Scholes Inputs - The fair value of each stock option award and warrant issued was estimated on the date of grant using a Black-Scholes option-valuation model, which requires management to make certain assumptions regarding: (i) fair value of the common stock that underlies the stock option; (ii) the expected volatility in the market price of our common stock; (iii) dividend yield; (iv) risk-free interest rates; and (iv) the period of time employees are expected to hold the award prior to exercise (referred to as the expected term). Under the Black-Scholes option-valuation model, entities typically estimate the expected volatility based on historical volatilities of the entity’s own common stock. Based on the lack of historical data of volatility for the Company’s common stock, the Company based its estimate of expected volatility on a weighted average of the historical volatility of comparable public companies that manufacture similar products and are similar in size, stage of life cycle, and financial leverage. The fair value of the common stock that underlies the stock option is estimated by the Company considering the price of the most recent issuance of the Company’s common stock. The dividend yield is based upon the assumption that the Company will not declare a dividend over the life of the options. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for bonds with maturities consistent with the expected term of the related award.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not required.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures.

 

As of SeptemberJune 30, 2022,2023, we conducted an evaluation of the effectiveness of our “disclosure controls and procedures” (“Disclosure Controls”), as defined by Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The Disclosure Controls evaluation was done under the supervision and with the participation of management, including our chief executive officer and chief financial officer. There are inherent limitations to the effectiveness of any system of disclosure controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives. Based upon this evaluation, our chief executive officer and chief financial officer have concluded that our Disclosure Controls and Procedures were effective as of SeptemberJune 30, 20222023 at a reasonable level of assurance.

 

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Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting during the fiscal quarter ended SeptemberJune 30, 20222023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

From time to time, we may become involved in various lawsuits investigations and claims thatlegal proceedings which arise in the ordinary course of business. As of the date of this filing, weHowever, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are neither a party to any litigation nor are wecurrently not aware of any such threatenedlegal proceedings or pending litigation that might resultclaims.

There are no material proceedings in which any of our directors, officers or affiliates or any registered or beneficial shareholder of more than 5% of our common stock is an adverse party or has a material interest adverse effect to our business.interest

 

ITEM 1A. RISK FACTORS

 

There have been no material changes to our risk factors as previously disclosed in our most recent Form 10-K filing.Not required for smaller reporting companies.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

(a)Unregistered Sales of Equity Securities

(a) Sales of Unregistered Securities during the three months ended June 30, 2023

 

None.The Company did not sell any unregistered securities during the three months ended June 30, 2023.

 

(b)Issuer Purchases of Equity Securities

(b) Issuer Repurchases of Securities during the three months ended June 30, 2023

 

None.The Company did not repurchase any of its securities during the three months ended June 30, 2023.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

Not applicable.

 

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ITEM 6. EXHIBITS

 

See “Index to Exhibits” for a description of our exhibits.

 

Index to Exhibits

 

Exhibit No.Description
3.1Certificate of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.1 to Form S-1, filed with the SEC on January 9, 2019).
3.2Certificate of Amendment to Certificate of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.2 to Form S-1, filed with the SEC on January 9, 2019).
3.3Amended and Restated Certificate of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.3 to Amendment No. 1 to Form S-1, filed with the SEC on March 11, 2019).
3.4Certificate of Amendment to the Amended and Restated Certificate of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, filed with the SEC on November 14, 2019)
3.5Certificate of Amendment to the Amended and Restated Certificate of Incorporation of NexGel, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, filed with the SEC on May 29, 2020)
3.6Certificate of Amendment to the Amended and Restated Certificate of Incorporation of NexGel, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, filed with the SEC on August 2, 2021)
3.7Amended and Restated Bylaws of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.5 to Amendment No. 1 to Form S-1, filed with the SEC on March 11, 2019).
31.1*Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
31.2*Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
32.1*Certification of Chief Executive Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*Certification of Chief Financial Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*The following materials from the Company’s Quarterly Report on Form 10-Q for the fiscal quarter June 30, 2021,2022, formatted in iXBRL (Inline eXtensible Business Reporting Language), (i) Balance Sheets, (ii) Statements of Operations, (iii) Statements of Stockholders’ Equity, (iv) Statements of Cash Flows, and (v) Notes to the Financial Statements.
104*Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit).

*Filed herewith.

**Certain exhibits and schedules have been omitted and the Company agrees to furnish supplementary to the Securities and Exchange Commission a copy of any omitted exhibits upon request.

 

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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.

 

 NEXGEL, INC.
   
Date: November 8, 2022August 14, 2023By:/s/ Adam Levy
 Name:Adam Levy
 Title:Chief Executive Officer
  (Principal Executive Officer)
   
 By:/s/ Adam E. Drapczuk III
 Name:Adam E. Drapczuk III
 Title:Chief Financial Officer
  (Principal Financial Officer)

 

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