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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended: June 30, 2023
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) |
|
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
Nasdaq Capital 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 August 11, 2023, the registrant had 5,696,064 shares of common stock outstanding.
nEXGEL,
INC.
TABLE
OF CONTENTS
PART
I – FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NEXGEL,
INC
CONDENSED
CONSOLIDATED BALANCE SHEETS
AS
OF JUNE 30, 2023 AND DECEMBER 31, 2022
(Unaudited)
(in
thousands, except share and per share data)
| |
June 30, 2023 | | |
December 31, 2022 | |
ASSETS: | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash | |
$ | 3,691 | | |
$ | 1,101 | |
Marketable securities | |
| 612 | | |
| 5,508 | |
Accounts receivable, net | |
| 950 | | |
| 222 | |
Inventory | |
| 1,079 | | |
| 502 | |
Prepaid expenses and other current assets | |
| 366 | | |
| 172 | |
Total current assets | |
| 6,698 | | |
| 7,505 | |
Goodwill | |
| 311 | | |
| 311 | |
Intangibles, net | |
| 13 | | |
| 20 | |
Property and equipment, net | |
| 1,413 | | |
| 721 | |
Operating lease - right of use asset | |
| 1,967 | | |
| 1,737 | |
Other assets | |
| 95 | | |
| 63 | |
Total assets | |
$ | 10,497 | | |
$ | 10,357 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,058 | | |
$ | 265 | |
Accrued expenses and other current liabilities | |
| 202 | | |
| 130 | |
Current portion of note payable | |
| 15 | | |
| 15 | |
Warrant liability | |
| 165 | | |
| 242 | |
Operating lease liability, current portion | |
| 232 | | |
| 207 | |
Total current liabilities | |
| 1,672 | | |
| 859 | |
Operating lease liability, net of current portion | |
| 1,819 | | |
| 1,593 | |
Notes payable, net of current portion | |
| 265 | | |
| 268 | |
Total liabilities | |
| 3,756 | | |
| 2,720 | |
| |
| | | |
| | |
Commitments and Contingencies (Note 15) | |
| - | | |
| - | |
| |
| | | |
| | |
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 | |
| 19,242 | | |
| 19,189 | |
Accumulated deficit | |
| (13,067 | ) | |
| (11,558 | ) |
Total NexGel stockholders’ equity | |
| 6,181 | | |
| 7,637 | |
Non-controlling interest in joint venture | |
| 560 | | |
| - | |
Total stockholders’ equity | |
| 6,741 | | |
| 7,637 | |
Total liabilities and stockholders’ equity | |
$ | 10,497 | | |
$ | 10,357 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
(in
thousands, except share and per share data)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues, net | |
$ | 1,167 | | |
$ | 561 | | |
$ | 1,786 | | |
$ | 956 | |
| |
| | | |
| | | |
| | | |
| | |
Cost of revenues | |
| 992 | | |
| 460 | | |
| 1,669 | | |
| 884 | |
| |
| | | |
| | | |
| | | |
| | |
Gross profit | |
| 175 | | |
| 101 | | |
| 117 | | |
| 72 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 55 | | |
| 111 | | |
| 84 | | |
| 135 | |
Selling, general and administrative | |
| 882 | | |
| 708 | | |
| 1,679 | | |
| 1,467 | |
Total operating expenses | |
| 937 | | |
| 819 | | |
| 1,763 | | |
| 1,602 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (762 | ) | |
| (718 | ) | |
| (1,646 | ) | |
| (1,530 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (9 | ) | |
| (348 | ) | |
| (10 | ) | |
| (1,092 | ) |
Interest income | |
| 2 | | |
| - | | |
| 2 | | |
| - | |
Loss on debt extinguishment | |
| - | | |
| - | | |
| - | | |
| (150 | ) |
Other income | |
| - | | |
| 2 | | |
| 4 | | |
| 2 | |
Gain on investments | |
| 116 | | |
| - | | |
| 124 | | |
| - | |
Changes in fair value of warrant liability | |
| 11 | | |
| 29 | | |
| 77 | | |
| (101 | ) |
Total other income (expense), net | |
| 120 | | |
| (317 | ) | |
| 197 | | |
| (1,341 | ) |
Income tax expense | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (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 | |
$ | (0.12 | ) | |
$ | (0.19 | ) | |
| (0.27 | ) | |
| (0.52 | ) |
Net loss per common share - diluted | |
$ | (0.12 | ) | |
$ | (0.19 | ) | |
| (0.27 | ) | |
| (0.52 | ) |
Weighted average shares used in computing net loss per common share - basic | |
| 5,662,338 | | |
| 5,572,234 | | |
| 5,624,275 | | |
| 5,572,234 | |
Weighted average shares used in computing net loss per common share – diluted | |
| 5,662,338 | | |
| 5,572,234 | | |
| 5,624,275 | | |
| 5,572,234 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
(in
thousands, except share data)
| |
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.
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR
THE SIX MONTHS ENDED JUNE 30, 2023 AND 2022
(Unaudited)
(in
thousands)
| |
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 | | |
| - | |
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.
NEXGEL,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in
thousands, except share and per share data)
1.
Description of Business, Stock Split and Basis of Presentation
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 has 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.
On
March 1, 2023, the Company acquired a 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.
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, 2023. 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, 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).
2.
Going Concern
As
of June 30, 2023, the Company had a cash balance of $3.7 million (including cash equivalents) and $612 thousand of marketable securities
(see Note 3 for details of our marketable securities). For the six months ended June 30, 2023, the Company incurred a net loss of $1.5
million and had a net usage of cash in operating activities of $1.9 million. In addition, the Company had a working capital of $5.0 million
as of June 30, 2023. We believe we have sufficient cash and marketable securities to operate our business plan through 2025.
Management
is exploring new product channel sales in adjacent industries, 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
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.
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 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.
Cash
Cash
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 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 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
Company had the following marketable securities as of June 30, 2023 and December 31, 2022:
Schedule
of Marketable Securities
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Marketable Securities | |
| | | |
| | |
United States treasury bills (due February 23, 2023) | |
$ | - | | |
$ | 492 | |
United States treasury bills (due April 27, 2023) | |
| - | | |
| 20 | |
United States treasury bills (due June 15, 2023) | |
| - | | |
| 4,384 | |
United States treasury bills (due July 13, 2023) | |
| 127 | | |
| 127 | |
United States treasury bills (due August 10, 2023) | |
| 485 | | |
| 485 | |
Total | |
$ | 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 $17 thousand as of June 30, 2023,
and $9 thousand as of December 31, 2022.
Inventory
and Cost of Goods 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
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.
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” 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 revenues and cost 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 is compared with their carrying values, and an impairment
loss would be recognized for the amount by which a carrying amount exceeds its fair value.
The
Company performed the annual assessment and concluded it is more likely than not that the fair value exceeds the carrying 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 are recorded at historical cost and is primarily made up of $96 thousand and $63 thousand of prepaid
insurance, and $270 thousand and $109 thousand general prepaid expenses and other current assets as of June 30, 2023, and December 31,
2022, respectively.
Other
Assets
Other
assets are recorded at historical costs, and as of June 30, 2023, and December 31, 2022, the balance is primarily comprised of spare
parts for manufacturing equipment. Other assets are not subject to depreciation until such time that they are placed into service and
the part that is being replaced is disposed.
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 prices for identical assets or liabilities in active markets.
Level
2 — 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 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 | |
| |
| | |
June 30, 2023 | | |
| |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable securities: | |
| | | |
| | | |
| | | |
| | |
United States treasury bills | |
$ | 612 | | |
$ | - | | |
$ | - | | |
$ | 612 | |
Total | |
$ | 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 | |
Warrant
Liability
Warrants
to purchase common stock were issued in connection with equity financing raises, which occurred during 2019 through 2021. The fair values
of the warrants are estimated as of the date of issuance and again at each year 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
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
| |
2023 | | |
2022 | |
| |
Three months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Contract manufacturing | |
$ | 887 | | |
$ | 324 | |
Custom and white label finished goods manufacturing | |
| — | | |
| 19 | |
NexGel branded consumer products | |
| 259 | | |
| 180 | |
Other | |
| 21 | | |
| 38 | |
Total | |
$ | 1,167 | | |
$ | 561 | |
| |
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 June 30, 2023, and December 31, 2022, the Company did not have any contract assets or contract liabilities from contracts with customers.
As of June 30, 2023, and December 31, 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.
In
June 2018, 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 non-employees for goods or
services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. This new
standard was effective for the Company on January 1, 2020. The Company 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.
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by 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, FASB issued 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 condensed 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.
The
following table presents information about the amount and timing of the liability arising from the Company’s operating lease as
of June 30, 2023 ($ in thousands):
Schedule
of Future Minimum Lease Payments
| |
Operating | |
| |
Lease | |
Maturity of Lease Liability | |
Liability | |
2023 | |
$ | 122 | |
2024 | |
| 245 | |
2025 | |
| 245 | |
2026 | |
| 301 | |
2027 | |
| 315 | |
Thereafter | |
| 1,115 | |
Total undiscounted operating lease payments | |
| 2,343 | |
Less: Imputed interest | |
| (292 | ) |
Present value of operating lease liability | |
$ | 2,051 | |
Weighted average remaining lease term | |
| 8.6 years | |
Weighted average discount rate | |
| 3.5 | % |
Total
operating lease expense for the six months ended June 30, 2023, and 2022, was $136 thousand and $103 thousand, respectively, and is
recorded in cost of goods sold and selling, general, and administrative expenses in the accompanying condensed consolidated statement
of operations.
Supplemental
cash flows information related to leases was as follows ($ in thousands):
Schedule
of Supplemental
Cash Flows Information Related to Leases
| |
June 30, | |
| |
2023 | |
Cash paid for amounts included in the measurement of lease liability: | |
| | |
Operating cash flows from operating lease | |
$ | 136 | |
5.
Inventory
Inventory
consists of the following ($ in thousands):
Schedule
of Inventory
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Raw materials | |
$ | 638 | | |
$ | 295 | |
Work-in-progress | |
| 43 | | |
| 51 | |
Finished goods | |
| 398 | | |
| 156 | |
Inventory, gross | |
| 1,079 | | |
| 502 | |
Less: Inventory reserve for excess and slow moving inventory | |
| — | | |
| — | |
Total | |
$ | 1,079 | | |
$ | 502 | |
Inventory
is maintained at the Company’s warehouse, an outsourced third-party contract manufacturing vendor, and at Amazon fulfillment 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 | | |
June 30, | | |
December 31, | |
| |
(Years) | | |
2023 | | |
2022 | |
Machinery and equipment | |
3 - 10 | | |
$ | 1,530 | | |
$ | 973 | |
Office furniture and equipment | |
3 - 10 | | |
| 159 | | |
| 59 | |
Leasehold improvements | |
6 | | |
| 261 | | |
| 228 | |
Construction in progress | |
N/A | | |
| 118 | | |
| 55 | |
Total property and equipment | |
| | |
| 2,068 | | |
| 1,315 | |
Less: accumulated depreciation and amortization | |
| | |
| (655 | ) | |
| (594 | ) |
Property and equipment, net | |
| | |
$ | 1,413 | | |
$ | 721 | |
Depreciation
expense for the six months ended June 30, 2023, and 2022 was $61 thousand and $49 thousand, respectively.
7.
Intangible Assets
The
following provides a breakdown of identifiable intangible assets as of June 30, 2023 and December 31, 2022:
Schedule
of Breakdown of Identifiable Intangible Assets
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Product/Technology Related | |
| | | |
| | |
Identifiable intangible assets, gross | |
$ | 31 | | |
$ | 31 | |
Accumulated amortization | |
| (31 | ) | |
| (26 | ) |
Product/Technology Related identifiable intangible assets, net | |
| - | | |
| 5 | |
Marketing Related | |
| | | |
| | |
Customer related intangible asset, gross | |
| 17 | | |
| 17 | |
Tradename related intangible asset, gross | |
| 7 | | |
| 7 | |
Accumulated amortization | |
| (11 | ) | |
| (9 | ) |
Marketing related identifiable intangible assets, net | |
| 13 | | |
| 15 | |
Total Identifiable intangible assets, net | |
$ | 13 | | |
$ | 20 | |
In
connection with the May 29, 2020, acquisition of Sports Defense, 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 5.7 years and amortization expense amounted to $7 thousand for the six months ended June 30, 2023, and 2022,
respectively.
As
of June 30, 2023, the estimated annual amortization expense for each of the next five fiscal years is as follows:
Schedule
of Estimated Annual Amortization Expense
| |
| | |
($ in thousands): | |
| | |
2023 | |
$ | 2 | |
2024 | |
| 2 | |
2025 | |
| 2 | |
2026 | |
| 2 | |
2027 | |
| 2 | |
Thereafter | |
| 3 | |
Total | |
$ | 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
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Salaries, benefits, and incentive compensation | |
$ | 72 | | |
$ | 56 | |
Franchise tax accrual | |
| 64 | | |
| 52 | |
Other | |
| 66 | | |
| 22 | |
Total accrued expenses and other current liabilities | |
$ | 202 | | |
$ | 130 | |
9.
Common Stock
At
June 30, 2023, the Company has reserved common stock for issued securities in relation to the following:
Schedule
of Reserved Common Stock For Issued Securities in Relation
Share-based compensation plan | |
| 528,182 | |
Warrants to purchase common stock | |
| 3,442,904 | |
Restricted stock units | |
| 121,787 | |
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 up to an amount of 871,429 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
option 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.
The
following table contains information about the 2019 Plan as of June 30, 2023:
Schedule
of Information about Incentive Plan
| |
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 | | |
| - | |
The
following table summarizes the Company’s incentive stock option activity and related information for the period ended June 30,
2023:
Schedule
of Incentive Stock Option Activity
| |
| | |
| | |
Weighted | |
| |
| | |
Weighted | | |
Average | |
| |
| | |
Average | | |
Contractual | |
| |
Number of | | |
Exercise | | |
Term in | |
| |
Options | | |
Price | | |
Years | |
Outstanding at January 1, 2023 | |
| 524,937 | | |
$ | 2.351416 | | |
| 8.38 | |
Granted | |
| 17,532 | | |
| 2.00 | | |
| 10.0 | |
Exercised | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | |
Cancelled | |
| (10,000 | ) | |
| 1.75 | | |
| — | |
Expired | |
| (4,287 | ) | |
| 1.40 | | |
| — | |
Outstanding at June 30, 2023 | |
| 528,182 | | |
$ | 2.35886 | | |
| 7.99 | |
Exercisable at June 30, 2023 | |
| 337,111 | | |
$ | 1.774915 | | |
| 7.21 | |
As
of June 30, 2023, vested outstanding stock options had $129 thousand intrinsic value as the exercise price is greater than the estimated
fair value of the underlying common stock, respectively. As of June 30, 2023, there was approximately $17 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 18 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 the period ended June 30, 2023:
Schedule
of Assumptions used in Share-based Compensation
Volatility | |
| 257.64 | % |
Risk-free interest rate | |
| 4.21 | % |
Dividend yield | |
| 0.0 | % |
Expected term | |
| 5.50 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 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 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, 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).
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).
Effective
as of January 3, 2023, the Company granted a restricted stock award of 37,037 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 December 30, 2022, all
of which shares vested monthly from January 3, 2023 through December 31, 2023. Under ASC 718, the Company has measured the value of the
37,037 shares granted based on the closing price of the Company’s stock at the grant date of the RSU Grant ($1.35 per share).
Schedule
of Restricted Stock Units Granted
| |
| | |
Weighted | |
| |
| | |
Average | |
| |
Number of | | |
Grant Date | |
| |
Units | | |
Fair Value | |
Outstanding at January 1, 2023 | |
| 90,432 | | |
$ | 1.43 | |
Granted | |
| 37,037 | | |
| 1.35 | |
Exercised and converted to common shares | |
| (5,682 | ) | |
| 4.40 | |
Forfeited | |
| — | | |
| — | |
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 June 30, 2023:
Summary
of Common Stock Warrants
| |
| | |
Weighted | | |
Weighted | |
| |
| | |
Average | | |
Average | |
| |
Number of | | |
Exercise | | |
Contractual | |
| |
Warrants | | |
Price | | |
Term in Years | |
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 June 30, 2023 | |
| 3,442,904 | | |
$ | 5.414793 | | |
| 3.35 | |
Exercisable at June 30, 2023 | |
| 3,442,904 | | |
$ | 5.414793 | | |
| 3.35 | |
As
of June 30, 2023, vested outstanding warrants had $0 intrinsic value as the exercise price is greater than the estimated fair value of
the underlying common stock.
11.
Noncontrolling Interest in Joint Venture
On
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.
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.
12.
Notes Payable
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 which 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 $8,000 advance, which does not have to be repaid. The balances
of the principal and accrued interest amounted to $280 thousand and $283 thousand as of June 30, 2023 and December 31, 2022, respectively.
The
future annual principal amounts and accrued interest to be paid as of June 30, 2023 are as follows:
Schedule
of Debt Instruments
| |
Amount | |
For the year ending December 31 ($ in thousands): | |
| | |
2023 (remainder of the year) | |
$ | 3 | |
2024 | |
| 5 | |
2025 | |
| 5 | |
2026 | |
| 5 | |
2027 | |
| 6 | |
Thereafter | |
| 256 | |
Total | |
$ | 280 | |
13.
Convertible Notes Payable
On
March 11, 2021, the Company issued Auctus Fund, LLC, a Delaware limited liability company a one-year senior secured convertible promissory
note in the principal amount of $1.68 million, which included $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 $1.68 million.
On
September 2, 2021, the Company issued to certain holders one-year subordinated secured convertible promissory notes in the aggregate
principal amount of $1,814
thousand, which included $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 one of the September 2 Notes in full with a one-time cash payment of $300
thousand of outstanding principal and accrued but unpaid interest. The Company incurred pre-payment penalty of $17
thousand with respect to the repayment of the 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’ was repaid in full which consisted
of principal of $1,478
thousand.
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, 7,429, 7,286, 44,286, 35,715 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.
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 income in the statement of operations.
The
warrants outstanding and fair values at each of the respective valuation dates are summarized below:
Schedule
of Warrant Liability
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 Guideline Public Companies as
inputs.
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.
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 six months ended June 30, 2023, were 40% and 14%. 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.
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 were 6% and 46% as well as 15% and 22% from two other customers of the total accounts receivable
as of June 30, 2022.
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 June 30, 2023, the total amount exceeding such limit was $3 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.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis are intended to help prospective investors understand our business, financial condition, results of
operations, liquidity and capital resources. You should read this discussion in conjunction with our financial statements and related
notes 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; |
|
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inadequate
capital; |
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inadequate
or an inability to raise sufficient capital to execute our business plan; |
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our
ability to comply with current good manufacturing practices; |
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● |
loss
or retirement of key executives; |
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● |
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; |
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● |
adverse
economic conditions and/or intense competition; |
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● |
loss
of a key customer or supplier; |
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● |
entry
of new competitors; |
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● |
adverse
federal, state and local government regulation; |
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● |
technological
obsolescence of our manufacturing process and equipment; |
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● |
technical
problems with our research and products; |
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● |
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; |
|
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● |
price
increases for supplies and components; and |
|
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● |
the
inability to carry out our business plans. |
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 ability
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 June 30, 2023, and 2022
Revenues,
net.
For
the three months ended June 30, 2023, revenues were $1.17 million and increased by $606 thousand, or 108.0%, when compared to $561 thousand
for the three months ended June 30, 2022. The increase in our overall revenues was primarily due to sales growth in both our contract
manufacturing 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.
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. Our gross profit was $175 thousand for the three months ended June 30, 2023, compared to a gross profit of $101 thousand
for the three months ended June 30, 2022. The increase of $74 thousand in gross profit quarter over quarter was primarily due to the
higher volume of contract manufacturing sales against fixed costs partially offset by higher manufacturing labor costs and increased manufacturing of promotional materials, customer product samples and other marketing materials to support
our new product launches. Gross
profit was approximately 15% for the three months ended June 30, 2023, compared to a gross profit of 18% for the three months ended
June 30, 2022.
The
components of cost of revenues are as follows for the three months ended June 30, 2023 and 2022 ($ in thousands):
| |
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 $532 thousand, or 115.7%, to $992 thousand for the three months ended June 30, 2023, as compared to $460 thousand
for the three months ended June 30, 2022. The increase in cost of revenues is pertains to and increase in materials and finished products and equipment,
production and other expenses. These increases primarily align with the new product line growth and increased amounts of promotional materials, customer product samples and other marketing materials to support
our new product launches.
Selling,
general, and administrative expenses. The following table highlights selling, general, and administrative expenses by type for the
three months ended June 30, 2023 and 2022 ($ in thousands):
| |
Three Months Ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Selling, general and administrative expenses | |
| | | |
| | |
Compensation and benefits | |
$ | 176 | | |
$ | 121 | |
Share-based compensation | |
| 23 | | |
| 43 | |
Depreciation and amortization | |
| 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 | |
| 52 | | |
| 63 | |
Total selling, general and administrative expenses | |
$ | 882 | | |
$ | 708 | |
Selling,
general and administrative expenses increased by $174 thousand, or 24.6%, to $882 thousand for the three months ended June 30, 2023,
as compared to $708 thousand for the three months ended June 30, 2022. The increase in Selling, general and administrative expenses is
primarily attributable to the factors described below.
Compensation
and benefits increased by $55 thousand, or 45.5%, to $176 thousand for the three months ended June 30, 2023, as compared to $121 thousand
for the three months ended June 30, 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 $20 thousand, or 46.5%, to $23 thousand for the three months ended June 30, 2023, as compared to $43 thousand
for the three months ended June 30, 2022. The decrease in share-based compensation related to the issuance of stock options and restricted
awards to our officers, employees, and advisors 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 $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 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 decreased by $11 thousand, or 17.5%, to $52 thousand for the three months ended June 30, 2023 from $63 thousand for the three
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.
Research
and development expenses. Research and development expenses were $55 thousand and $111 thousand for the three months ended June 30,
2023 and June 30, 2022, respectively.
Comparison
of the Six Months ended June 30, 2023 and 2022
Revenues,
net.
For
the six months ended June 30, 2023, revenues were $1.79 million and increased by $830 thousand, or 86.8%, when compared to $956 thousand
for the six months ended June 30, 2022. The increase in our overall revenues was primarily due to sales growth in both our contract manufacturing
and branded products, including the revenue from CG Labs from April 1, 2023 through June 30, 2023 of $792 thousand.
Gross
profit. Our gross profit was $117 thousand for the six months ended June 30, 2023, compared to a gross profit of $72 thousand
for the six months ended June 30, 2022. The increase in profit recorded for the six months ended June 30, 2023, as compared to the
six months ended June 30, 2022, was primarily due to the higher volume of contract manufacturing sales against fixed costs, partially offset by increased manufacturing of promotional materials,
customer product samples and other marketing materials to support our new product launches. Gross
profit was approximately 7% for the six months ended June 30, 2023, compared to a gross profit of 8% for the six months ended June
30, 2022. The components of cost of revenues are as follows for the six months ended June 30, 2023 and 2022 ($ in
thousands):
| |
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 | |
Cost
of revenues increased by $785 thousand, or 88.8%, to $1.67 million for the six months ended June 30, 2023, as compared to $884 thousand
for the six months ended June 30, 2022. The increase in cost of revenues pertains to and increase in materials and finished products
and equipment, production and other expenses. These increases primarily align with the new product line growth and increased amounts
of promotional materials, customer product samples and other marketing materials to support our new product launches.
Selling,
general, and administrative expenses. The following table highlights selling, general, and administrative expenses by type for the
six months ended June 30, 2023 and 2022 ($ in thousands):
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Selling, general, and administrative expenses | |
| | | |
| | |
Compensation and benefits | |
$ | 321 | | |
$ | 233 | |
Share-based compensation | |
| 42 | | |
| 61 | |
Depreciation and amortization | |
| 26 | | |
| 14 | |
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 $212 thousand, or 14.5%, to $1.68 million for the six months ended June 30, 2023, as
compared to $1.47 million for the six months ended June 30, 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 $88 thousand, or 37.8%, to $321 thousand for the six months ended June 30, 2023, as compared to $233 thousand
for the six months ended June 30, 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 $19 thousand, or 31.1%, to $42 thousand for the six months ended June 30, 2023, as compared to $61 thousand
for the six months ended June 30, 2022. The share-based compensation related to the issuance of stock restricted stock awards and options
to our CEO and options to board members, employees, and advisors.
Advertising,
marketing, Amazon fees increased by $141 thousand or 118.5%, to $260 thousand for the six months ended June 30, 2023, as compared to
$119 thousand for the six months ended June 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.
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.
Research
and development expenses. Research and development expenses decreased by $51 thousand to $84 thousand for the six months ended June
30, 2023 from $135 thousand for the six months ended June 30, 2022. The decrease is due to the completion of development efforts of two
proof of concept studies for drug delivery candidates utilizing our hydrogel technology.
Liquidity
and Capital Resources
Cash
Flow
(in
thousands)
| |
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 June 30, 2023, we had $3.7 million of cash and $612 thousand of marketable securities,
compared to $1.1 million of cash and $5.5 million of marketable securities at December 31,
2022. Net cash used in operating activities was $1.9 million and $1.5 million for the six months ended June 30, 2023 and 2022, respectively.
Net
cash provided by investing activities was $4.5 million and net cash used in investing activities was $5.4 million for the six months
ended June 30, 2023 and 2022, respectively, consisting of the sales of marketable securities of
$4.8 million and purchases of capital equipment of $253 thousand for six months ended June 30, 2023.
Net
cash used in financing activities for the six months ended June 30, 2023 and 2022 was $3 thousand and $2 million and is attributable
to the principal payments of notes payable and convertible notes, respectively.
At
June 30, 2023, current assets totaled $6.7 million and current liabilities totaled $1.7 million, as compared to current assets totaling
$7.5 million and current liabilities totaling $859 thousand at December 31, 2022. As a result, we had working capital of $5.0 million
at June 30, 2023, compared to a working capital of $6.6 million at December 31, 2022. The decrease in the working capital as of
June 30, 2023 is primarily attributable to the loss from operations of $1.6 million.
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
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 its 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 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.
Off
Balance Sheet Arrangements
As
of June 30, 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 during
2019 through 2021. The fair values of the warrants are estimated as of the date of issuance and again at each year 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 three-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.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
required.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures.
As
of June 30, 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 June 30, 2023 at a reasonable level of assurance.
Changes
in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial reporting during the fiscal quarter ended June 30, 2023 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 and legal proceedings which arise in the ordinary course of business. However,
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 currently not aware of any such legal proceedings or claims.
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 to our interest
ITEM
1A. RISK FACTORS
Not
required for smaller reporting companies.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a)
Sales of Unregistered Securities during the three months ended June 30, 2023
The
Company did not sell any unregistered securities during the three months ended June 30, 2023.
(b)
Issuer Repurchases of Securities during the three months ended June 30, 2023
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.
ITEM
6. EXHIBITS
See
“Index to Exhibits” for a description of our exhibits.
Index
to Exhibits
Exhibit
No. |
|
Description |
3.1 |
|
Certificate 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). |
3.2 |
|
Certificate 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). |
3.3 |
|
Amended 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). |
3.4 |
|
Certificate 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) |
3.5 |
|
Certificate 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) |
3.6 |
|
Certificate 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) |
3.7 |
|
Amended 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, 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. |
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:August
14, 2023 |
By: |
/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) |
EXHIBIT
31.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
PURSUANT
TO RULES 13a-14(A) AND 15d-14(A)
OF
THE SECURITIES EXCHANGE ACT OF 1934
I,
Adam Levy, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of NexGel, Inc. (the “registrant”); |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15I and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a. |
all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2023 |
By:
|
/s/
Adam Levy |
|
|
Adam
Levy |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
EXHIBIT
31.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
PURSUANT
TO RULES 13a-14(A) AND 15d-14(A)
OF
THE SECURITIES EXCHANGE ACT OF 1934
I,
Adam E. Drapczuk III, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of NexGel, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a. |
all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2023 |
By:
|
/s/
Adam E. Drapczuk III |
|
|
Adam
E. Drapczuk III |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial Officer) |
EXHIBIT
32.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
PURSUANT
TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
This
certification is furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly
Report on Form 10-Q (the “Form 10-Q”) for the six months ended June 30, 2023, of NexGel, Inc. (the “Company”).
I, Adam Levy, the Chief Executive Officer and Principal Executive Officer of the Company, certify that, based on my knowledge:
(1) |
The
Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and |
|
|
(2) |
The
information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations
of the Company as of and for the periods covered in this report. |
Date:
August 14, 2023 |
By: |
/s/
Adam Levy |
|
Name:
|
Adam
Levy |
|
Title: |
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
The
foregoing certification is being furnished as an exhibit to the Form 10-Q pursuant to Item 601(b)(32) of Regulation S-K and Section 906
of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and, accordingly,
is not being filed as part of the Form 10-Q for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not
incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
EXHIBIT
32.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
PURSUANT
TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
This
certification is furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350) and accompanies the Quarterly
Report on Form 10-Q (the “Form 10-Q”) for the six months ended June 30, 2023 of NexGel, Inc. (the “Company”).
I, Adam E. Drapczuk III, the Chief Financial Officer and Principal Financial Officer of the Company, certify that, based on my knowledge:
(1) |
The
Form 10-Q fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and |
|
|
(2) |
The
information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations
of the Company as of and for the periods covered in this report. |
Date:
August 14, 2023 |
By: |
/s/
Adam E. Drapczuk III |
|
Name:
|
Adam
E. Drapczuk III |
|
Title: |
Chief
Financial Officer |
|
|
(Principal
Financial Officer) |
The
foregoing certification is being furnished as an exhibit to the Form 10-Q pursuant to Item 601(b)(32) of Regulation S-K and Section 906
of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and, accordingly,
is not being filed as part of the Form 10-Q for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not
incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 11, 2023 |
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-41173
|
|
Entity Registrant Name |
NexGel,
Inc.
|
|
Entity Central Index Key |
0001468929
|
|
Entity Tax Identification Number |
26-4042544
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
2150
Cabot Blvd West
|
|
Entity Address, Address Line Two |
Suite B
|
|
Entity Address, City or Town |
Langhorne
|
|
Entity Address, State or Province |
PA
|
|
Entity Address, Postal Zip Code |
19047
|
|
City Area Code |
(215)
|
|
Local Phone Number |
702-8550
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
Elected Not To Use the Extended Transition Period |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
5,696,064
|
Common Stock, par value 0.001 [Member] |
|
|
Title of 12(b) Security |
Common
Stock, par value $0.001
|
|
Trading Symbol |
NXGL
|
|
Security Exchange Name |
NASDAQ
|
|
Warrants to Purchase Common Stock [Member] |
|
|
Title of 12(b) Security |
Warrants
to Purchase Common Stock
|
|
Trading Symbol |
NXGLW
|
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Security Exchange Name |
NASDAQ
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current Assets: |
|
|
Cash |
$ 3,691
|
$ 1,101
|
Marketable securities |
612
|
5,508
|
Accounts receivable, net |
950
|
222
|
Inventory |
1,079
|
502
|
Prepaid expenses and other current assets |
366
|
172
|
Total current assets |
6,698
|
7,505
|
Goodwill |
311
|
311
|
Intangibles, net |
13
|
20
|
Property and equipment, net |
1,413
|
721
|
Operating lease - right of use asset |
1,967
|
1,737
|
Other assets |
95
|
63
|
Total assets |
10,497
|
10,357
|
Current Liabilities: |
|
|
Accounts payable |
1,058
|
265
|
Accrued expenses and other current liabilities |
202
|
130
|
Current portion of note payable |
15
|
15
|
Warrant liability |
165
|
242
|
Operating lease liability, current portion |
232
|
207
|
Total current liabilities |
1,672
|
859
|
Operating lease liability, net of current portion |
1,819
|
1,593
|
Notes payable, net of current portion |
265
|
268
|
Total liabilities |
3,756
|
2,720
|
Commitments and Contingencies (Note 15) |
|
|
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 |
19,242
|
19,189
|
Accumulated deficit |
(13,067)
|
(11,558)
|
Total NexGel stockholders’ equity |
6,181
|
7,637
|
Non-controlling interest in joint venture |
560
|
|
Total stockholders’ equity |
6,741
|
7,637
|
Total liabilities and stockholders’ equity |
$ 10,497
|
$ 10,357
|
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
25,000,000
|
25,000,000
|
Common stock, shares issued |
5,696,064
|
5,577,916
|
Common stock, shares outstanding |
5,696,064
|
5,577,916
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenues, net |
$ 1,167
|
$ 561
|
$ 1,786
|
$ 956
|
Cost of revenues |
992
|
460
|
1,669
|
884
|
Gross profit |
175
|
101
|
117
|
72
|
Operating expenses |
|
|
|
|
Research and development |
55
|
111
|
84
|
135
|
Selling, general and administrative |
882
|
708
|
1,679
|
1,467
|
Total operating expenses |
937
|
819
|
1,763
|
1,602
|
Loss from operations |
(762)
|
(718)
|
(1,646)
|
(1,530)
|
Other income (expense) |
|
|
|
|
Interest expense |
(9)
|
(348)
|
(10)
|
(1,092)
|
Interest income |
2
|
|
2
|
|
Loss on debt extinguishment |
|
|
|
(150)
|
Other income |
|
2
|
4
|
2
|
Gain on investments |
116
|
|
124
|
|
Changes in fair value of warrant liability |
11
|
29
|
77
|
(101)
|
Total other income (expense), net |
120
|
(317)
|
197
|
(1,341)
|
Loss before income taxes |
(642)
|
(1,035)
|
(1,449)
|
(2,871)
|
Income tax expense |
|
|
|
|
Net loss |
(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 |
$ (0.12)
|
$ (0.19)
|
$ (0.27)
|
$ (0.52)
|
Net loss per common share - diluted |
$ (0.12)
|
$ (0.19)
|
$ (0.27)
|
$ (0.52)
|
Weighted average shares used in computing net loss per common share - basic |
5,662,338
|
5,572,234
|
5,624,275
|
5,572,234
|
Weighted average shares used in computing net loss per common share – diluted |
5,662,338
|
5,572,234
|
5,624,275
|
5,572,234
|
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v3.23.2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Noncontrolling Interest [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2021 |
$ 6
|
$ 18,891
|
|
$ (6,812)
|
$ 12,085
|
Balance, shares at Dec. 31, 2021 |
5,572,234
|
|
|
|
|
Net income (loss) |
|
|
|
(1,836)
|
(1,836)
|
Stock-based compensation |
|
55
|
|
|
55
|
Balance at Mar. 31, 2022 |
$ 6
|
18,946
|
|
(8,648)
|
10,304
|
Balance, shares at Mar. 31, 2022 |
5,572,234
|
|
|
|
|
Balance at Dec. 31, 2021 |
$ 6
|
18,891
|
|
(6,812)
|
12,085
|
Balance, shares at Dec. 31, 2021 |
5,572,234
|
|
|
|
|
Net income (loss) |
|
|
|
|
(2,871)
|
Balance at Jun. 30, 2022 |
$ 6
|
19,025
|
|
(9,683)
|
9,348
|
Balance, shares at Jun. 30, 2022 |
5,572,234
|
|
|
|
|
Balance at Mar. 31, 2022 |
$ 6
|
18,946
|
|
(8,648)
|
10,304
|
Balance, shares at Mar. 31, 2022 |
5,572,234
|
|
|
|
|
Restricted stock vesting |
|
25
|
|
|
25
|
Net income (loss) |
|
|
|
(1,035)
|
(1,035)
|
Stock-based compensation |
|
54
|
|
|
54
|
Balance at Jun. 30, 2022 |
$ 6
|
19,025
|
|
(9,683)
|
9,348
|
Balance, shares at Jun. 30, 2022 |
5,572,234
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 6
|
19,189
|
|
(11,558)
|
7,637
|
Balance, shares at Dec. 31, 2022 |
5,577,916
|
|
|
|
|
Restricted stock vesting |
|
24
|
|
|
24
|
Restricted stock vesting, shares |
5,682
|
|
|
|
|
Exercise of warrants |
|
|
|
|
|
Exercise of stock warrants, shares |
30,430
|
|
|
|
|
Non-controlling interest in JV |
|
|
500
|
|
500
|
Net income (loss) |
|
|
7
|
(814)
|
(807)
|
Balance at Mar. 31, 2023 |
$ 6
|
19,213
|
507
|
(12,372)
|
7,354
|
Balance, shares at Mar. 31, 2023 |
5,614,028
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 6
|
19,189
|
|
(11,558)
|
$ 7,637
|
Balance, shares at Dec. 31, 2022 |
5,577,916
|
|
|
|
|
Restricted stock vesting, shares |
|
|
|
|
121,787
|
Net income (loss) |
|
|
|
|
$ (1,449)
|
Balance at Jun. 30, 2023 |
$ 6
|
19,242
|
560
|
(13,067)
|
6,741
|
Balance, shares at Jun. 30, 2023 |
5,696,064
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 6
|
19,213
|
507
|
(12,372)
|
7,354
|
Balance, shares at Mar. 31, 2023 |
5,614,028
|
|
|
|
|
Exercise of warrants |
|
|
|
|
|
Exercise of stock warrants, shares |
82,036
|
|
|
|
|
Net income (loss) |
|
|
53
|
(695)
|
(642)
|
Stock-based compensation |
|
29
|
|
|
29
|
Balance at Jun. 30, 2023 |
$ 6
|
$ 19,242
|
$ 560
|
$ (13,067)
|
$ 6,741
|
Balance, shares at Jun. 30, 2023 |
5,696,064
|
|
|
|
|
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Operating Activities |
|
|
|
|
|
Net loss |
$ (695)
|
$ (1,035)
|
$ (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
|
$ 13,350
|
Cash – End of period |
$ 3,691
|
$ 4,420
|
3,691
|
4,420
|
$ 1,101
|
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
|
|
|
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v3.23.2
Description of Business, Stock Split and Basis of Presentation
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Description of Business, Stock Split and Basis of Presentation |
1.
Description of Business, Stock Split and Basis of Presentation
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 has 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.
On
March 1, 2023, the Company acquired a 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.
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, 2023. 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, 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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v3.23.2
Going Concern
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Going Concern |
2.
Going Concern
As
of June 30, 2023, the Company had a cash balance of $3.7 million (including cash equivalents) and $612 thousand of marketable securities
(see Note 3 for details of our marketable securities). For the six months ended June 30, 2023, the Company incurred a net loss of $1.5
million and had a net usage of cash in operating activities of $1.9 million. In addition, the Company had a working capital of $5.0 million
as of June 30, 2023. We believe we have sufficient cash and marketable securities to operate our business plan through 2025.
Management
is exploring new product channel sales in adjacent industries, 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
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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v3.23.2
Significant Accounting Policies and Estimates
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Significant Accounting Policies and Estimates |
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 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.
Cash
Cash
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 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 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
Company had the following marketable securities as of June 30, 2023 and December 31, 2022:
Schedule
of Marketable Securities
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Marketable Securities | |
| | | |
| | |
United States treasury bills (due February 23, 2023) | |
$ | - | | |
$ | 492 | |
United States treasury bills (due April 27, 2023) | |
| - | | |
| 20 | |
United States treasury bills (due June 15, 2023) | |
| - | | |
| 4,384 | |
United States treasury bills (due July 13, 2023) | |
| 127 | | |
| 127 | |
United States treasury bills (due August 10, 2023) | |
| 485 | | |
| 485 | |
Total | |
$ | 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 $17 thousand as of June 30, 2023,
and $9 thousand as of December 31, 2022.
Inventory
and Cost of Goods 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
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.
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” 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 revenues and cost 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 is compared with their carrying values, and an impairment
loss would be recognized for the amount by which a carrying amount exceeds its fair value.
The
Company performed the annual assessment and concluded it is more likely than not that the fair value exceeds the carrying 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 are recorded at historical cost and is primarily made up of $96 thousand and $63 thousand of prepaid
insurance, and $270 thousand and $109 thousand general prepaid expenses and other current assets as of June 30, 2023, and December 31,
2022, respectively.
Other
Assets
Other
assets are recorded at historical costs, and as of June 30, 2023, and December 31, 2022, the balance is primarily comprised of spare
parts for manufacturing equipment. Other assets are not subject to depreciation until such time that they are placed into service and
the part that is being replaced is disposed.
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 prices for identical assets or liabilities in active markets.
Level
2 — 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 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 | |
| |
| | |
June 30, 2023 | | |
| |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable securities: | |
| | | |
| | | |
| | | |
| | |
United States treasury bills | |
$ | 612 | | |
$ | - | | |
$ | - | | |
$ | 612 | |
Total | |
$ | 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 | |
Warrant
Liability
Warrants
to purchase common stock were issued in connection with equity financing raises, which occurred during 2019 through 2021. The fair values
of the warrants are estimated as of the date of issuance and again at each year 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
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
| |
2023 | | |
2022 | |
| |
Three months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Contract manufacturing | |
$ | 887 | | |
$ | 324 | |
Custom and white label finished goods manufacturing | |
| — | | |
| 19 | |
NexGel branded consumer products | |
| 259 | | |
| 180 | |
Other | |
| 21 | | |
| 38 | |
Total | |
$ | 1,167 | | |
$ | 561 | |
| |
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 June 30, 2023, and December 31, 2022, the Company did not have any contract assets or contract liabilities from contracts with customers.
As of June 30, 2023, and December 31, 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.
In
June 2018, 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 non-employees for goods or
services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. This new
standard was effective for the Company on January 1, 2020. The Company 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.
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by 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, FASB issued 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 condensed consolidated financial statements.
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
Leases |
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.
The
following table presents information about the amount and timing of the liability arising from the Company’s operating lease as
of June 30, 2023 ($ in thousands):
Schedule
of Future Minimum Lease Payments
| |
Operating | |
| |
Lease | |
Maturity of Lease Liability | |
Liability | |
2023 | |
$ | 122 | |
2024 | |
| 245 | |
2025 | |
| 245 | |
2026 | |
| 301 | |
2027 | |
| 315 | |
Thereafter | |
| 1,115 | |
Total undiscounted operating lease payments | |
| 2,343 | |
Less: Imputed interest | |
| (292 | ) |
Present value of operating lease liability | |
$ | 2,051 | |
Weighted average remaining lease term | |
| 8.6 years | |
Weighted average discount rate | |
| 3.5 | % |
Total
operating lease expense for the six months ended June 30, 2023, and 2022, was $136 thousand and $103 thousand, respectively, and is
recorded in cost of goods sold and selling, general, and administrative expenses in the accompanying condensed consolidated statement
of operations.
Supplemental
cash flows information related to leases was as follows ($ in thousands):
Schedule
of Supplemental
Cash Flows Information Related to Leases
| |
June 30, | |
| |
2023 | |
Cash paid for amounts included in the measurement of lease liability: | |
| | |
Operating cash flows from operating lease | |
$ | 136 | |
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v3.23.2
Inventory
|
6 Months Ended |
Jun. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Inventory |
5.
Inventory
Inventory
consists of the following ($ in thousands):
Schedule
of Inventory
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Raw materials | |
$ | 638 | | |
$ | 295 | |
Work-in-progress | |
| 43 | | |
| 51 | |
Finished goods | |
| 398 | | |
| 156 | |
Inventory, gross | |
| 1,079 | | |
| 502 | |
Less: Inventory reserve for excess and slow moving inventory | |
| — | | |
| — | |
Total | |
$ | 1,079 | | |
$ | 502 | |
Inventory
is maintained at the Company’s warehouse, an outsourced third-party contract manufacturing vendor, and at Amazon fulfillment centers.
The Company builds its contract manufacturing products based on customer orders and immediately ships the products upon completion of
the production process.
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v3.23.2
Property and Equipment, Net
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, Net |
6.
Property and Equipment, Net
Property
and equipment consist of the following ($ in thousands):
Schedule
of Property
and Equipment
| |
Useful Life | | |
June 30, | | |
December 31, | |
| |
(Years) | | |
2023 | | |
2022 | |
Machinery and equipment | |
3 - 10 | | |
$ | 1,530 | | |
$ | 973 | |
Office furniture and equipment | |
3 - 10 | | |
| 159 | | |
| 59 | |
Leasehold improvements | |
6 | | |
| 261 | | |
| 228 | |
Construction in progress | |
N/A | | |
| 118 | | |
| 55 | |
Total property and equipment | |
| | |
| 2,068 | | |
| 1,315 | |
Less: accumulated depreciation and amortization | |
| | |
| (655 | ) | |
| (594 | ) |
Property and equipment, net | |
| | |
$ | 1,413 | | |
$ | 721 | |
Depreciation
expense for the six months ended June 30, 2023, and 2022 was $61 thousand and $49 thousand, respectively.
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v3.23.2
Intangible Assets
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets |
7.
Intangible Assets
The
following provides a breakdown of identifiable intangible assets as of June 30, 2023 and December 31, 2022:
Schedule
of Breakdown of Identifiable Intangible Assets
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Product/Technology Related | |
| | | |
| | |
Identifiable intangible assets, gross | |
$ | 31 | | |
$ | 31 | |
Accumulated amortization | |
| (31 | ) | |
| (26 | ) |
Product/Technology Related identifiable intangible assets, net | |
| - | | |
| 5 | |
Marketing Related | |
| | | |
| | |
Customer related intangible asset, gross | |
| 17 | | |
| 17 | |
Tradename related intangible asset, gross | |
| 7 | | |
| 7 | |
Accumulated amortization | |
| (11 | ) | |
| (9 | ) |
Marketing related identifiable intangible assets, net | |
| 13 | | |
| 15 | |
Total Identifiable intangible assets, net | |
$ | 13 | | |
$ | 20 | |
In
connection with the May 29, 2020, acquisition of Sports Defense, 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 5.7 years and amortization expense amounted to $7 thousand for the six months ended June 30, 2023, and 2022,
respectively.
As
of June 30, 2023, the estimated annual amortization expense for each of the next five fiscal years is as follows:
Schedule
of Estimated Annual Amortization Expense
| |
| | |
($ in thousands): | |
| | |
2023 | |
$ | 2 | |
2024 | |
| 2 | |
2025 | |
| 2 | |
2026 | |
| 2 | |
2027 | |
| 2 | |
Thereafter | |
| 3 | |
Total | |
$ | 13 | |
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v3.23.2
Accrued Expenses and Other Current Liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
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
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Salaries, benefits, and incentive compensation | |
$ | 72 | | |
$ | 56 | |
Franchise tax accrual | |
| 64 | | |
| 52 | |
Other | |
| 66 | | |
| 22 | |
Total accrued expenses and other current liabilities | |
$ | 202 | | |
$ | 130 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.23.2
Common Stock
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Common Stock |
9.
Common Stock
At
June 30, 2023, the Company has reserved common stock for issued securities in relation to the following:
Schedule
of Reserved Common Stock For Issued Securities in Relation
Share-based compensation plan | |
| 528,182 | |
Warrants to purchase common stock | |
| 3,442,904 | |
Restricted stock units | |
| 121,787 | |
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v3.23.2
Share-based Compensation
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Share-based Compensation |
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 up to an amount of 871,429 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
option 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.
The
following table contains information about the 2019 Plan as of June 30, 2023:
Schedule
of Information about Incentive Plan
| |
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 | | |
| - | |
(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. |
The
following table summarizes the Company’s incentive stock option activity and related information for the period ended June 30,
2023:
Schedule
of Incentive Stock Option Activity
| |
| | |
| | |
Weighted | |
| |
| | |
Weighted | | |
Average | |
| |
| | |
Average | | |
Contractual | |
| |
Number of | | |
Exercise | | |
Term in | |
| |
Options | | |
Price | | |
Years | |
Outstanding at January 1, 2023 | |
| 524,937 | | |
$ | 2.351416 | | |
| 8.38 | |
Granted | |
| 17,532 | | |
| 2.00 | | |
| 10.0 | |
Exercised | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | |
Cancelled | |
| (10,000 | ) | |
| 1.75 | | |
| — | |
Expired | |
| (4,287 | ) | |
| 1.40 | | |
| — | |
Outstanding at June 30, 2023 | |
| 528,182 | | |
$ | 2.35886 | | |
| 7.99 | |
Exercisable at June 30, 2023 | |
| 337,111 | | |
$ | 1.774915 | | |
| 7.21 | |
As
of June 30, 2023, vested outstanding stock options had $129 thousand intrinsic value as the exercise price is greater than the estimated
fair value of the underlying common stock, respectively. As of June 30, 2023, there was approximately $17 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 18 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 the period ended June 30, 2023:
Schedule
of Assumptions used in Share-based Compensation
Volatility | |
| 257.64 | % |
Risk-free interest rate | |
| 4.21 | % |
Dividend yield | |
| 0.0 | % |
Expected term | |
| 5.50 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 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 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, 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).
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).
Effective
as of January 3, 2023, the Company granted a restricted stock award of 37,037 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 December 30, 2022, all
of which shares vested monthly from January 3, 2023 through December 31, 2023. Under ASC 718, the Company has measured the value of the
37,037 shares granted based on the closing price of the Company’s stock at the grant date of the RSU Grant ($1.35 per share).
Schedule
of Restricted Stock Units Granted
| |
| | |
Weighted | |
| |
| | |
Average | |
| |
Number of | | |
Grant Date | |
| |
Units | | |
Fair Value | |
Outstanding at January 1, 2023 | |
| 90,432 | | |
$ | 1.43 | |
Granted | |
| 37,037 | | |
| 1.35 | |
Exercised and converted to common shares | |
| (5,682 | ) | |
| 4.40 | |
Forfeited | |
| — | | |
| — | |
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 June 30, 2023:
Summary
of Common Stock Warrants
| |
| | |
Weighted | | |
Weighted | |
| |
| | |
Average | | |
Average | |
| |
Number of | | |
Exercise | | |
Contractual | |
| |
Warrants | | |
Price | | |
Term in Years | |
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 June 30, 2023 | |
| 3,442,904 | | |
$ | 5.414793 | | |
| 3.35 | |
Exercisable at June 30, 2023 | |
| 3,442,904 | | |
$ | 5.414793 | | |
| 3.35 | |
As
of June 30, 2023, vested outstanding warrants had $0 intrinsic value as the exercise price is greater than the estimated fair value of
the underlying common stock.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.2
Noncontrolling Interest in Joint Venture
|
6 Months Ended |
Jun. 30, 2023 |
Equity Method Investments and Joint Ventures [Abstract] |
|
Noncontrolling Interest in Joint Venture |
11.
Noncontrolling Interest in Joint Venture
On
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.
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.
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- DefinitionThe entire disclosure for equity method investments and joint ventures. Equity method investments are investments that give the investor the ability to exercise significant influence over the operating and financial policies of an investee. Joint ventures are entities owned and operated by a small group of businesses as a separate and specific business or project for the mutual benefit of the members of the group.
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v3.23.2
Notes Payable
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Notes Payable |
12.
Notes Payable
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 which 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 $8,000 advance, which does not have to be repaid. The balances
of the principal and accrued interest amounted to $280 thousand and $283 thousand as of June 30, 2023 and December 31, 2022, respectively.
The
future annual principal amounts and accrued interest to be paid as of June 30, 2023 are as follows:
Schedule
of Debt Instruments
| |
Amount | |
For the year ending December 31 ($ in thousands): | |
| | |
2023 (remainder of the year) | |
$ | 3 | |
2024 | |
| 5 | |
2025 | |
| 5 | |
2026 | |
| 5 | |
2027 | |
| 6 | |
Thereafter | |
| 256 | |
Total | |
$ | 280 | |
|
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.23.2
Convertible Notes Payable
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Convertible Notes Payable |
13.
Convertible Notes Payable
On
March 11, 2021, the Company issued Auctus Fund, LLC, a Delaware limited liability company a one-year senior secured convertible promissory
note in the principal amount of $1.68 million, which included $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 $1.68 million.
On
September 2, 2021, the Company issued to certain holders one-year subordinated secured convertible promissory notes in the aggregate
principal amount of $1,814
thousand, which included $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 one of the September 2 Notes in full with a one-time cash payment of $300
thousand of outstanding principal and accrued but unpaid interest. The Company incurred pre-payment penalty of $17
thousand with respect to the repayment of the 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’ was repaid in full which consisted
of principal of $1,478
thousand.
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v3.23.2
Warrant Liability
|
6 Months Ended |
Jun. 30, 2023 |
Warrant Liability |
|
Warrant Liability |
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, 7,429, 7,286, 44,286, 35,715 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.
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 income in the statement of operations.
The
warrants outstanding and fair values at each of the respective valuation dates are summarized below:
Schedule
of Warrant Liability
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 Guideline Public Companies as
inputs.
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
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.
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v3.23.2
Concentrations of Risk
|
6 Months Ended |
Jun. 30, 2023 |
Risks and Uncertainties [Abstract] |
|
Concentrations of Risk |
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 six months ended June 30, 2023, were 40% and 14%. 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.
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 were 6% and 46% as well as 15% and 22% from two other customers of the total accounts receivable
as of June 30, 2022.
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 June 30, 2023, the total amount exceeding such limit was $3 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.
|
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v3.23.2
Related Party Transactions
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
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.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
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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v3.23.2
Significant Accounting Policies and Estimates (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Use of 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 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.
|
Cash |
Cash
Cash
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 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 |
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 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
Company had the following marketable securities as of June 30, 2023 and December 31, 2022:
Schedule
of Marketable Securities
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Marketable Securities | |
| | | |
| | |
United States treasury bills (due February 23, 2023) | |
$ | - | | |
$ | 492 | |
United States treasury bills (due April 27, 2023) | |
| - | | |
| 20 | |
United States treasury bills (due June 15, 2023) | |
| - | | |
| 4,384 | |
United States treasury bills (due July 13, 2023) | |
| 127 | | |
| 127 | |
United States treasury bills (due August 10, 2023) | |
| 485 | | |
| 485 | |
Total | |
$ | 612 | | |
$ | 5,508 | |
|
Accounts Receivable, net |
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 $17 thousand as of June 30, 2023,
and $9 thousand as of December 31, 2022.
|
Inventory and Cost of Goods Sold |
Inventory
and Cost of Goods 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
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.
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” 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 |
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
Shipping
and handling revenue and expense are included in our condensed consolidated statements of operations in revenues and cost of revenues,
respectively. This is primarily through shipping fees incurred in the Amazon marketplace.
|
Property and Equipment, net |
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 |
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 |
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 is compared with their carrying values, and an impairment
loss would be recognized for the amount by which a carrying amount exceeds its fair value.
The
Company performed the annual assessment and concluded it is more likely than not that the fair value exceeds the carrying 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
Prepaid
expenses and other current assets are recorded at historical cost and is primarily made up of $96 thousand and $63 thousand of prepaid
insurance, and $270 thousand and $109 thousand general prepaid expenses and other current assets as of June 30, 2023, and December 31,
2022, respectively.
|
Other Assets |
Other
Assets
Other
assets are recorded at historical costs, and as of June 30, 2023, and December 31, 2022, the balance is primarily comprised of spare
parts for manufacturing equipment. Other assets are not subject to depreciation until such time that they are placed into service and
the part that is being replaced is disposed.
|
Fair Value Measurements |
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 prices for identical assets or liabilities in active markets.
Level
2 — 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 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 | |
| |
| | |
June 30, 2023 | | |
| |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable securities: | |
| | | |
| | | |
| | | |
| | |
United States treasury bills | |
$ | 612 | | |
$ | - | | |
$ | - | | |
$ | 612 | |
Total | |
$ | 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 | |
|
Warrant Liability |
Warrant
Liability
Warrants
to purchase common stock were issued in connection with equity financing raises, which occurred during 2019 through 2021. The fair values
of the warrants are estimated as of the date of issuance and again at each year 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 |
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
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
| |
2023 | | |
2022 | |
| |
Three months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Contract manufacturing | |
$ | 887 | | |
$ | 324 | |
Custom and white label finished goods manufacturing | |
| — | | |
| 19 | |
NexGel branded consumer products | |
| 259 | | |
| 180 | |
Other | |
| 21 | | |
| 38 | |
Total | |
$ | 1,167 | | |
$ | 561 | |
| |
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 June 30, 2023, and December 31, 2022, the Company did not have any contract assets or contract liabilities from contracts with customers.
As of June 30, 2023, and December 31, 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 |
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.
In
June 2018, 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 non-employees for goods or
services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. This new
standard was effective for the Company on January 1, 2020. The Company 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
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 |
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 |
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.
|
Recently Issued Accounting Standards |
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by 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, FASB issued 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 condensed consolidated financial statements.
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v3.23.2
Significant Accounting Policies and Estimates (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Marketable Securities |
The
Company had the following marketable securities as of June 30, 2023 and December 31, 2022:
Schedule
of Marketable Securities
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Marketable Securities | |
| | | |
| | |
United States treasury bills (due February 23, 2023) | |
$ | - | | |
$ | 492 | |
United States treasury bills (due April 27, 2023) | |
| - | | |
| 20 | |
United States treasury bills (due June 15, 2023) | |
| - | | |
| 4,384 | |
United States treasury bills (due July 13, 2023) | |
| 127 | | |
| 127 | |
United States treasury bills (due August 10, 2023) | |
| 485 | | |
| 485 | |
Total | |
$ | 612 | | |
$ | 5,508 | |
|
Schedule of Fair Value of Financial Assets |
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 | |
| |
| | |
June 30, 2023 | | |
| |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable securities: | |
| | | |
| | | |
| | | |
| | |
United States treasury bills | |
$ | 612 | | |
$ | - | | |
$ | - | | |
$ | 612 | |
Total | |
$ | 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 | |
|
Schedule of Disaggregated Revenue by Sales Type |
Disaggregated
revenue by sales type:
Schedule
of Disaggregated
Revenue by Sales Type
| |
2023 | | |
2022 | |
| |
Three months ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Contract manufacturing | |
$ | 887 | | |
$ | 324 | |
Custom and white label finished goods manufacturing | |
| — | | |
| 19 | |
NexGel branded consumer products | |
| 259 | | |
| 180 | |
Other | |
| 21 | | |
| 38 | |
Total | |
$ | 1,167 | | |
$ | 561 | |
| |
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 | |
|
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
Schedule of Future Minimum Lease Payments |
The
following table presents information about the amount and timing of the liability arising from the Company’s operating lease as
of June 30, 2023 ($ in thousands):
Schedule
of Future Minimum Lease Payments
| |
Operating | |
| |
Lease | |
Maturity of Lease Liability | |
Liability | |
2023 | |
$ | 122 | |
2024 | |
| 245 | |
2025 | |
| 245 | |
2026 | |
| 301 | |
2027 | |
| 315 | |
Thereafter | |
| 1,115 | |
Total undiscounted operating lease payments | |
| 2,343 | |
Less: Imputed interest | |
| (292 | ) |
Present value of operating lease liability | |
$ | 2,051 | |
Weighted average remaining lease term | |
| 8.6 years | |
Weighted average discount rate | |
| 3.5 | % |
|
Schedule of Supplemental Cash Flows Information Related to Leases |
Supplemental
cash flows information related to leases was as follows ($ in thousands):
Schedule
of Supplemental
Cash Flows Information Related to Leases
| |
June 30, | |
| |
2023 | |
Cash paid for amounts included in the measurement of lease liability: | |
| | |
Operating cash flows from operating lease | |
$ | 136 | |
|
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v3.23.2
Inventory (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory |
Inventory
consists of the following ($ in thousands):
Schedule
of Inventory
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Raw materials | |
$ | 638 | | |
$ | 295 | |
Work-in-progress | |
| 43 | | |
| 51 | |
Finished goods | |
| 398 | | |
| 156 | |
Inventory, gross | |
| 1,079 | | |
| 502 | |
Less: Inventory reserve for excess and slow moving inventory | |
| — | | |
| — | |
Total | |
$ | 1,079 | | |
$ | 502 | |
Inventory
is maintained at the Company’s warehouse, an outsourced third-party contract manufacturing vendor, and at Amazon fulfillment centers.
The Company builds its contract manufacturing products based on customer orders and immediately ships the products upon completion of
the production process.
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v3.23.2
Property and Equipment, Net (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Property
and equipment consist of the following ($ in thousands):
Schedule
of Property
and Equipment
| |
Useful Life | | |
June 30, | | |
December 31, | |
| |
(Years) | | |
2023 | | |
2022 | |
Machinery and equipment | |
3 - 10 | | |
$ | 1,530 | | |
$ | 973 | |
Office furniture and equipment | |
3 - 10 | | |
| 159 | | |
| 59 | |
Leasehold improvements | |
6 | | |
| 261 | | |
| 228 | |
Construction in progress | |
N/A | | |
| 118 | | |
| 55 | |
Total property and equipment | |
| | |
| 2,068 | | |
| 1,315 | |
Less: accumulated depreciation and amortization | |
| | |
| (655 | ) | |
| (594 | ) |
Property and equipment, net | |
| | |
$ | 1,413 | | |
$ | 721 | |
|
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v3.23.2
Intangible Assets (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Breakdown of Identifiable Intangible Assets |
The
following provides a breakdown of identifiable intangible assets as of June 30, 2023 and December 31, 2022:
Schedule
of Breakdown of Identifiable Intangible Assets
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Product/Technology Related | |
| | | |
| | |
Identifiable intangible assets, gross | |
$ | 31 | | |
$ | 31 | |
Accumulated amortization | |
| (31 | ) | |
| (26 | ) |
Product/Technology Related identifiable intangible assets, net | |
| - | | |
| 5 | |
Marketing Related | |
| | | |
| | |
Customer related intangible asset, gross | |
| 17 | | |
| 17 | |
Tradename related intangible asset, gross | |
| 7 | | |
| 7 | |
Accumulated amortization | |
| (11 | ) | |
| (9 | ) |
Marketing related identifiable intangible assets, net | |
| 13 | | |
| 15 | |
Total Identifiable intangible assets, net | |
$ | 13 | | |
$ | 20 | |
|
Schedule of Estimated Annual Amortization Expense |
As
of June 30, 2023, the estimated annual amortization expense for each of the next five fiscal years is as follows:
Schedule
of Estimated Annual Amortization Expense
| |
| | |
($ in thousands): | |
| | |
2023 | |
$ | 2 | |
2024 | |
| 2 | |
2025 | |
| 2 | |
2026 | |
| 2 | |
2027 | |
| 2 | |
Thereafter | |
| 3 | |
Total | |
$ | 13 | |
|
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v3.23.2
Accrued Expenses and Other Current Liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of 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
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Salaries, benefits, and incentive compensation | |
$ | 72 | | |
$ | 56 | |
Franchise tax accrual | |
| 64 | | |
| 52 | |
Other | |
| 66 | | |
| 22 | |
Total accrued expenses and other current liabilities | |
$ | 202 | | |
$ | 130 | |
|
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v3.23.2
Common Stock (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Schedule of Reserved Common Stock For Issued Securities in Relation |
At
June 30, 2023, the Company has reserved common stock for issued securities in relation to the following:
Schedule
of Reserved Common Stock For Issued Securities in Relation
Share-based compensation plan | |
| 528,182 | |
Warrants to purchase common stock | |
| 3,442,904 | |
Restricted stock units | |
| 121,787 | |
|
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v3.23.2
Share-based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Information about Incentive Plan |
The
following table contains information about the 2019 Plan as of June 30, 2023:
Schedule
of Information about Incentive Plan
| |
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 | | |
| - | |
(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. |
|
Schedule of Incentive Stock Option Activity |
The
following table summarizes the Company’s incentive stock option activity and related information for the period ended June 30,
2023:
Schedule
of Incentive Stock Option Activity
| |
| | |
| | |
Weighted | |
| |
| | |
Weighted | | |
Average | |
| |
| | |
Average | | |
Contractual | |
| |
Number of | | |
Exercise | | |
Term in | |
| |
Options | | |
Price | | |
Years | |
Outstanding at January 1, 2023 | |
| 524,937 | | |
$ | 2.351416 | | |
| 8.38 | |
Granted | |
| 17,532 | | |
| 2.00 | | |
| 10.0 | |
Exercised | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | |
Cancelled | |
| (10,000 | ) | |
| 1.75 | | |
| — | |
Expired | |
| (4,287 | ) | |
| 1.40 | | |
| — | |
Outstanding at June 30, 2023 | |
| 528,182 | | |
$ | 2.35886 | | |
| 7.99 | |
Exercisable at June 30, 2023 | |
| 337,111 | | |
$ | 1.774915 | | |
| 7.21 | |
|
Schedule of Assumptions used in Share-based Compensation |
Schedule
of Assumptions used in Share-based Compensation
Volatility | |
| 257.64 | % |
Risk-free interest rate | |
| 4.21 | % |
Dividend yield | |
| 0.0 | % |
Expected term | |
| 5.50 years | |
|
Schedule of Restricted Stock Units Granted |
Schedule
of Restricted Stock Units Granted
| |
| | |
Weighted | |
| |
| | |
Average | |
| |
Number of | | |
Grant Date | |
| |
Units | | |
Fair Value | |
Outstanding at January 1, 2023 | |
| 90,432 | | |
$ | 1.43 | |
Granted | |
| 37,037 | | |
| 1.35 | |
Exercised and converted to common shares | |
| (5,682 | ) | |
| 4.40 | |
Forfeited | |
| — | | |
| — | |
Outstanding at June 30, 2023 | |
| 121,787 | | |
$ | 1.68 | |
Exercisable at June 30, 2023 | |
| 30,466 | | |
$ | 1.68 | |
|
Summary of Common Stock Warrants |
The
following table shows a summary of common stock warrants through June 30, 2023:
Summary
of Common Stock Warrants
| |
| | |
Weighted | | |
Weighted | |
| |
| | |
Average | | |
Average | |
| |
Number of | | |
Exercise | | |
Contractual | |
| |
Warrants | | |
Price | | |
Term in Years | |
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 June 30, 2023 | |
| 3,442,904 | | |
$ | 5.414793 | | |
| 3.35 | |
Exercisable at June 30, 2023 | |
| 3,442,904 | | |
$ | 5.414793 | | |
| 3.35 | |
|
X |
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Notes Payable (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Debt Instruments |
The
future annual principal amounts and accrued interest to be paid as of June 30, 2023 are as follows:
Schedule
of Debt Instruments
| |
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 | |
|
X |
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Warrant Liability (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Warrant Liability |
|
Schedule of Warrant Liability |
The
warrants outstanding and fair values at each of the respective valuation dates are summarized below:
Schedule
of Warrant Liability
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 | |
|
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Description of Business, Stock Split and Basis of Presentation (Details Narrative)
|
Jun. 30, 2023 |
Mar. 01, 2023 |
Joint Venture [Member] |
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
Minority percentage |
50.00%
|
50.00%
|
Joint Venture [Member] |
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
Acquisition percentage |
|
50.00%
|
CG Labs [Member] |
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
Acquisition percentage |
|
50.00%
|
X |
- DefinitionPercentage of voting equity interests acquired at the acquisition date in the business combination.
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v3.23.2
Going Concern (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
Cash |
$ 3,691
|
|
$ 3,691
|
|
$ 1,101
|
Marketable securities |
612
|
|
612
|
|
$ 5,508
|
Net loss |
695
|
$ 1,035
|
1,509
|
$ 2,871
|
|
Net cash used in operating activities |
|
|
1,926
|
$ 1,495
|
|
Working capital |
$ 5,000
|
|
$ 5,000
|
|
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v3.23.2
Schedule of Marketable Securities (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Total |
$ 612
|
$ 5,508
|
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|
|
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|
|
Total |
612
|
5,508
|
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|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Total |
|
492
|
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|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Total |
|
20
|
US Treasury Securities [Member] | June 15, 2023 [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Total |
|
4,384
|
US Treasury Securities [Member] | July 13, 2023 [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Total |
127
|
127
|
US Treasury Securities [Member] | August 10, 2023 [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
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$ 485
|
$ 485
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v3.23.2
Schedule of Fair Value of Financial Assets (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total |
$ 612
|
$ 5,508
|
US Treasury Securities [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total |
612
|
5,508
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total |
612
|
5,508
|
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total |
612
|
5,508
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
Total |
|
|
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|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
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|
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v3.23.2
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 2,068
|
$ 1,315
|
Less: accumulated depreciation and amortization |
(655)
|
(594)
|
Property and equipment, net |
1,413
|
721
|
Machinery and Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 1,530
|
973
|
Machinery and Equipment [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful Life (Years) |
3 years
|
|
Machinery and Equipment [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful Life (Years) |
10 years
|
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 159
|
59
|
Furniture and Fixtures [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful Life (Years) |
3 years
|
|
Furniture and Fixtures [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful Life (Years) |
10 years
|
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful Life (Years) |
6 years
|
|
Total property and equipment |
$ 261
|
228
|
Construction in Progress [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 118
|
$ 55
|
X |
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v3.23.2
Schedule of Incentive Stock Option Activity (Details) - Equity Option [Member] - 2019 Plan [Member]
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of options, outstanding, beginning balance | shares |
524,937
|
Weighted average exercise price, outstanding beginning balance | $ / shares |
$ 2.351416
|
Weighted average remaining contractual term |
8 years 4 months 17 days
|
Number of options, granted | shares |
17,532
|
Weighted average exercise price, granted | $ / shares |
$ 2.00
|
Weighted average remaining contractual term, Granted |
10 years
|
Number of options, exercised | shares |
|
Weighted average exercise price, exercised | $ / shares |
|
Number of options, forfeited | shares |
|
Weighted average exercise price, forfeited | $ / shares |
|
Number of options, cancelled | shares |
(10,000)
|
Weighted average exercise price, cancelled | $ / shares |
$ 1.75
|
Number of options, expired | shares |
(4,287)
|
Weighted average exercise price, expired | $ / shares |
$ 1.40
|
Number of options, outstanding, ending balance | shares |
528,182
|
Weighted average exercise price, outstanding ending balance | $ / shares |
$ 2.35886
|
Weighted average remaining contractual term |
7 years 11 months 26 days
|
Number of options, exercisable | shares |
337,111
|
Weighted average exercise price, exercisable | $ / shares |
$ 1.774915
|
Weighted average remaining contractual term, exercisable |
7 years 2 months 15 days
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v3.23.2
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v3.23.2
Schedule of Restricted Stock Units Granted (Details)
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of units, exercised and converted to common shares |
(112,466,000)
|
Restricted Stock Units (RSUs) [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of units outstanding beginning |
90,432
|
Weighted average grant date fair value outstanding beginning | $ / shares |
$ 1.43
|
Number of units, granted |
37,037
|
Weighted average grant date fair value, granted | $ / shares |
$ 1.35
|
Number of units, exercised and converted to common shares |
(5,682)
|
Weighted average grant date fair value, exercised and converted to common shares | $ / shares |
$ 4.40
|
Number of units, forfeited |
|
Weighted average grant date fair value, forfeited | $ / shares |
|
Number of units outstanding beginning |
121,787
|
Weighted average grant date fair value outstanding ending | $ / shares |
$ 1.68
|
Number of units exercisable |
30,466
|
Weighted average grant date fair value exercisable | $ / shares |
$ 1.68
|
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v3.23.2
Summary of Common Stock Warrants (Details)
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Number of warrants, outstanding beginning balance | shares |
3,637,190
|
Weighted average exercise price, outstanding beginning balance | $ / shares |
$ 5.16281
|
Weighted average remaining contractual term |
3 years 7 months 24 days
|
Number of warrants, granted | shares |
|
Weighted average exercise price, granted | $ / shares |
|
Number of warrants, exercised | shares |
(112,466,000)
|
Weighted average exercise price, exercised | $ / shares |
$ 0.55
|
Number of warrants, forfeited | shares |
|
Weighted average exercise price, forfeited | $ / shares |
|
Number of warrants, cancelled | shares |
(81,820,000)
|
Weighted average exercise price, cancelled | $ / shares |
$ 0.91
|
Number of warrants, expired | shares |
|
Weighted average exercise price, expired | $ / shares |
|
Number of warrants, outstanding ending balance | shares |
3,442,904
|
Weighted average exercise price, outstanding ending balance | $ / shares |
$ 5.414793
|
Weighted average remaining contractual term |
3 years 4 months 6 days
|
Number of warrants, exercisable | shares |
3,442,904
|
Weighted average exercise price, exercisable | $ / shares |
$ 5.414793
|
Weighted average remaining contractual term, exercisable |
3 years 4 months 6 days
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v3.23.2
Share-based Compensation (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
|
|
3 Months Ended |
6 Months Ended |
|
Jan. 03, 2023 |
Oct. 01, 2022 |
Aug. 01, 2022 |
Jan. 01, 2022 |
Mar. 31, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 08, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Restricted stock vesting, shares |
|
|
|
|
|
|
121,787
|
|
|
[custom:UnrecognizedShareBasedCompensationExpense] |
|
|
|
|
|
|
$ 121
|
|
|
Stock based compensation and restricted stock vesting |
|
|
|
|
|
|
53
|
$ 134
|
|
Intrinsic value of vested outstanding warrants |
|
|
|
|
|
|
$ 0
|
|
|
Officers and Employees [Member | Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of units, granted |
|
|
|
84,750
|
|
|
|
|
|
Restricted stock vesting, shares |
|
|
|
84,750
|
|
|
|
|
|
Share price |
|
|
|
$ 1.82
|
|
|
|
|
|
Chief Executive Officer [Member] | Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of units, granted |
|
37,037
|
|
|
11,364
|
|
|
|
|
Restricted stock vesting, shares |
|
37,037
|
|
|
11,364
|
|
|
|
|
Share price |
|
$ 1.35
|
|
|
$ 4.40
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Restricted stock vesting, shares |
|
|
|
|
|
5,682
|
|
|
|
2019 Plan [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of options, granted |
[1] |
|
|
|
|
|
612,932
|
|
|
2019 Plan [Member] | Equity Option [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of shares granted |
|
|
|
|
|
|
17,532
|
|
|
Exercise price of options |
|
|
|
|
|
|
$ 2.00
|
|
|
Intrinsic value |
|
|
|
|
|
|
$ 129
|
|
|
Unrecognized share-based compensation expense |
|
|
|
|
|
|
$ 17
|
|
|
2019 Plan [Member] | Equity Option [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Period of recognition of stock based compensation expense |
|
|
|
|
|
|
18 months
|
|
|
2019 Plan [Member] | Equity Option [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Period of recognition of stock based compensation expense |
|
|
|
|
|
|
36 months
|
|
|
2019 Plan [Member] | Executive Officer [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of shares granted |
|
|
|
|
|
|
14,286
|
|
|
2019 Plan [Member] | Contractor [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of options, granted |
|
|
|
|
|
|
|
|
17,532
|
Exercise price of options |
|
|
$ 2.00
|
|
|
|
|
|
|
2019 Plan [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of options, granted |
|
|
|
|
|
|
871,429
|
|
|
|
|
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v3.23.2
Convertible Notes Payable (Details Narrative) - USD ($) $ in Thousands |
|
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
|
Sep. 02, 2021 |
Mar. 11, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Sep. 06, 2022 |
Mar. 15, 2022 |
Jan. 25, 2022 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
Principal amount of debt |
|
|
|
|
|
|
|
|
$ 1,680
|
|
Interest expense |
|
|
$ 9
|
$ 348
|
$ 10
|
$ 1,092
|
|
|
|
|
Gains loss on extinguishment of debt |
|
|
|
|
|
$ (150)
|
|
|
|
|
Secured Convertible Promissory Note [Member] |
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
Interest expense |
$ 194
|
|
|
|
|
|
|
|
|
|
Outstanding principal and accrued unpaid interest |
|
|
|
|
|
|
|
|
|
$ 300
|
Pre payment penalty |
|
|
|
|
|
|
|
|
|
17
|
Unamortized debt discount |
|
|
|
|
|
|
|
|
|
$ 133
|
Gains loss on extinguishment of debt |
|
|
|
|
|
|
$ 150
|
|
|
|
Secured Convertible Promissory Note [Member] | Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
Principal amount of debt |
$ 1,814
|
|
|
|
|
|
|
$ 1,478
|
|
|
Auctus Note [Member] |
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
Principal amount of debt |
|
$ 1,680
|
|
|
|
|
|
|
|
|
Debt Instrument, Periodic Payment, Interest |
|
$ 180
|
|
|
|
|
|
|
|
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v3.23.2
Warrant Liability (Details Narrative) - Private Placement [Member] - $ / shares
|
Jun. 30, 2023 |
Sep. 02, 2021 |
Mar. 11, 2021 |
Feb. 03, 2021 |
Dec. 24, 2020 |
Mar. 18, 2020 |
Nov. 06, 2019 |
Sep. 10, 2019 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrants outstanding |
|
22,019
|
34,286
|
7,429
|
7,286
|
44,286
|
114,286
|
35,715
|
Minimum [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Exercise price |
$ 0.49
|
|
|
|
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Exercise price |
$ 5.25
|
|
|
|
|
|
|
|
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v3.23.2
Concentrations of Risk (Details Narrative) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Concentration Risk [Line Items] |
|
|
Cash, FDIC insured amount |
$ 250
|
|
Cash, exceeding |
$ 3
|
|
Customer One [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] |
|
|
Concentration Risk [Line Items] |
|
|
Concentration risk, percentage |
40.00%
|
40.00%
|
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
Concentration Risk [Line Items] |
|
|
Concentration risk, percentage |
0.00%
|
6.00%
|
Customer Two [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] |
|
|
Concentration Risk [Line Items] |
|
|
Concentration risk, percentage |
14.00%
|
25.00%
|
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
Concentration Risk [Line Items] |
|
|
Concentration risk, percentage |
22.00%
|
46.00%
|
One Other Customer [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
Concentration Risk [Line Items] |
|
|
Concentration risk, percentage |
13.00%
|
15.00%
|
Two Other Customer [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
Concentration Risk [Line Items] |
|
|
Concentration risk, percentage |
15.00%
|
22.00%
|
Three Other Customer [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
Concentration Risk [Line Items] |
|
|
Concentration risk, percentage |
16.00%
|
|
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v3.23.2
Related Party Transactions (Details Narrative) $ in Thousands |
Jun. 30, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
Mar. 15, 2022
USD ($)
|
Sep. 02, 2021
USD ($)
Integer
|
Related Party Transaction [Line Items] |
|
|
|
|
Debt instrument face amount |
|
|
$ 1,680
|
|
Mr. Stein [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Number Of Debt Instruments | Integer |
|
|
|
3
|
Debt instrument face amount |
|
|
|
$ 150,000
|
Mr.Stefansky [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Debt instrument face amount |
|
|
|
150,000
|
Dr.Jerome Zeldis [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Debt instrument face amount |
|
|
|
$ 50,000
|
Due from related parties, current |
$ 25,000
|
$ 40,000
|
|
|
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NexGel (NASDAQ:NXGL)
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NexGel (NASDAQ:NXGL)
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