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: March 31, 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 May 15, 2023, the registrant had 5,614,028 shares of common stock outstanding.
nEXGEL ,
INC.
TABLE
OF CONTENTS
PART
I – FINANCIAL INFORMATION
ITEM
1.
Condensed
Consolidated Financial Statements (Unaudited)
3
Condensed
Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022
3
Condensed
Consolidated Statements of Operations for the Three Months Ended March 31, 2023 and 2022
4
Condensed
Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31, 2023 and 2022
5
Condensed
Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2023 and 2022
6
Notes
to Condensed Consolidated Financial Statements
7
ITEM
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
24
ITEM
3.
Quantitative
and Qualitative Disclosures About Market Risk
30
ITEM
4.
Controls
and Procedures
30
PART II – OTHER INFORMATION
ITEM
1.
Legal
Proceedings
30
ITEM
1A.
Risk
Factors
30
ITEM
2.
Unregistered
Sales of Equity Securities and Use of Proceeds
30
ITEM
3.
Defaults
Upon Senior Securities
30
ITEM
4.
Mine
Safety Disclosures
30
ITEM
5.
Other
Information
30
ITEM
6.
Exhibits
31
Signatures
31
2
Table of Contents
PART
I – FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NEXGEL,
INC
CONDENSED
CONSOLIDATED BALANCE SHEETS
AS
OF MARCH 31, 2023 AND DECEMBER 31, 2022
(Unaudited)
(in
thousands, except share and per share data)
March
31,
2023
December
31,
2022
ASSETS:
Current
Assets:
Cash
$ 787
$ 1,101
Marketable
securities
5,016
5,508
Accounts
receivable, net
380
222
Inventory
968
502
Prepaid
expenses and other current assets
129
172
Total
current assets
7,280
7,505
Goodwill
311
311
Intangibles,
net
16
20
Property
and equipment, net
1,282
721
Operating
lease - right of use asset
2,022
1,737
Other
assets
95
63
Total
assets
$ 11,006
$ 10,357
LIABILITIES
AND STOCKHOLDERS’ EQUITY
Current
Liabilities:
Accounts
payable
$ 987
$ 265
Accrued
expenses and other current liabilities
112
130
Notes
payable, current portion
15
15
Warrant
liability
176
242
Operating
lease liability, current portion
232
207
Total
current liabilities
1,522
859
Operating
lease liability, net of current portion
1,864
1,593
Notes
payable, net of current portion
266
268
Total
liabilities
3,652
2,720
Commitments
and Contingencies (Note 15)
-
-
Preferred stock,
par value $ 0.001 per share, 5,000,000 shares authorized, no shares issued and outstanding
-
-
Common stock, par
value $ 0.001 per share, 25,000,000 shares authorized; 5,614,028 and 5,577,916 shares issued and outstanding as of March 31, 2023
and December 31, 2022, respectively
6
6
Additional
paid-in capital
19,213
19,189
Accumulated
deficit
( 12,372 )
( 11,558 )
Total
NexGel stockholders’ equity
6,847
7,637
Non-controlling
interest in joint venture
507
-
Total stockholders’ equity
7,354
7,637
Total
liabilities and stockholders’ equity
$ 11,006
$ 10,357
The
accompanying notes are an integral part of these consolidated financial statements.
3
Table of Contents
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR
THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited)
(in
thousands, except share and per share data)
cash flows
2023
2022
Three
months ended
March
31,
2023
2022
Revenues,
net
$ 620
$ 396
Cost
of revenues
677
418
Gross
loss
( 57 )
( 22 )
Operating
expenses
Research
and development
29
24
Selling,
general and administrative
797
766
Total
operating expenses
826
790
Loss
from operations
( 883 )
( 812 )
Other
income (expense)
Interest
income (expense), net
( 1 )
( 744 )
Loss
on debt extinguishment
-
( 150 )
Changes
in fair value of warrant liability and warrant modification expense
66
( 130 )
Gain on investment in marketable securities
7
Other income
4
-
Total
other income (expense), net
76
( 1,024 )
Loss
before income taxes
( 807 )
( 1,836 )
Income
tax expense
—
—
Net
loss
( 807 )
( 1,836 )
Less:
Income attributable to non-controlling interest in joint venture
7
—
Net
loss attributable to NexGel stockholders
$ ( 814 )
$ ( 1,836 )
Net
loss per common share - basic
$ ( 0.15 )
$ ( 0.33 )
Net
loss per common share - diluted
$ ( 0.15 )
$ ( 0.33 )
Weighted
average shares used in computing net loss per common share - basic
5,586,326
5,572,234
Weighted
average shares used in computing net loss per common share – diluted
5,586,326
5,572,234
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
Table of Contents
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited)
(in
thousands, except share data)
equity
Shares
Amount
Capital
Interest
(Accumulated
(Deficit)
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
Balance
5,614,028
$ 6
$ 19,213
$ 507
$ ( 12,372 )
$ 7,354
equity
Shares
Amount
Capital
Interest
Deficit)
(Deficit)
Common
Stock
Additional
Paid-in
Non- controlling
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Interest
Deficit
Equity
Balance,
January 1, 2022
5,572,234
$ 6
$ 18,891
$
—
$ ( 6,812 )
$ 12,085
Balance
5,572,234
$ 6
$ 18,891
$
—
$ ( 6,812 )
$ 12,085
Stock-based
compensation
—
—
55
—
—
55
Net
loss
—
—
—
—
( 1,836 )
( 1,836 )
Net
income (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
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
Table of Contents
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR
THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited)
(in
thousands)
Cash flows
2023
2022
Three
Months Ended March 31,
2023
2022
Operating
Activities
Net
loss
$ ( 814 )
$ ( 1,836 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Income
attributable to non-controlling interest in joint venture
7
-
Depreciation
and amortization
31
28
Changes
in ROU asset and operating lease liability
11
10
Share-based
compensation
24
55
Gain on investment in marketable securities
7
-
Changes
in fair value of warrant liability and warrant modification
( 66 )
130
Amortization
of deferred financing costs
-
741
Loss
on extinguishment of debt
-
150
Changes
in operating assets and liabilities:
Accounts
receivable
( 158 )
77
Inventory
( 466 )
11
Prepaid
expenses and other assets
11
( 90 )
Accounts
payable
722
( 71 )
Accrued
expenses and other current liabilities
( 18 )
( 2 )
Net
Cash Used in Operating Activities
( 709 )
( 797 )
Investing
Activities
Proceeds
from sales of marketable securities
485
—
Capital
expenditures
( 88 )
—
Net
Cash Provided by Investing Activities
397
—
Financing
Activities
Principle
payment of notes payable
( 2 )
( 2,033 )
Net
Cash Used in Financing Activities
( 2 )
( 2,033 )
Net
Decrease in Cash
( 314 )
( 2,830 )
Cash – Beginning
of period
1,101
13,350
Cash – End
of period
$ 787
$ 10,520
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.
6
Table of Contents
Table
of Contents
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.
Stock
Split
On
November 29, 2021, the Company effected a 1-for-35 reverse stock split of our issued and outstanding common stock (the “Reverse
Stock Split”). As a result of the Reverse Stock Split, each issued and outstanding share of our common stock, and the per share
exercise price of and number of shares of the Company’s common stock underlying our outstanding equity awards and warrants, was
automatically proportionally adjusted based on the 1-for-35 Reverse Stock Split ratio. No fractional shares of common stock were issued
in connection with the reverse stock split, and all such fractional interests were rounded up to the nearest whole number.
Except
as otherwise provided herein, all share and per-share amounts of our common stock, equity awards and warrants, including the shares of
common stock and warrants being offered hereby, have been adjusted to give effect to the Reverse Stock Split for all periods presented.
The Reverse Stock Split did not alter the par value of the Company’s common stock, which remains at $ 0.001 per share, modify any
voting rights or other terms of our common stock, or impact the amount of preferred stock the Company is authorized to issue.
Basis
of Presentation
The
accompanying interim unaudited condensed consolidated financial statements and footnotes of NexGel have been prepared in accordance
with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information
and the instructions to Rule 10-01 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly,
they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion
of management, these unaudited 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 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.
Principals
of Consolidation
The accompanying
consolidated financial statements include the accounts of the Company and its consolidated wholly-owned subsidiary, NexGelRx, Inc. and
the JV (see Note 11).
7
Table of Contents
2.
Going Concern
As
of March 31, 2023, the Company had a cash balance of $ 787 thousand (including cash equivalents) and $ 5.0 million of marketable securities
(see Note 3 for details of our marketable securities). For the three months ended March 31, 2023, the Company incurred a net loss of $ 814
thousand and had a net usage of cash in operating activities of $ 709 thousand. In addition, the Company had a working capital of $ 5.8
million as of March 31, 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 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 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 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 consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that
affect the amounts reported in the 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.
8
Table of Contents
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 statement of operations of the year in which such change occurs. The total unrealized gain related to the marketable securities was
inconsequential during the three months ended March 31, 2023.
The
Company had the following marketable securities as of March 31, 2023 and December 31, 2022:
Schedule
of Marketable Securities
March
31,
December
31,
2023
2022
Marketable
Securities
United
States treasury bills (due February 23, 2023)
$ -
$ 492
United
States treasury bills (due April 27, 2023)
20
20
United
States treasury bills (due June 15, 2023)
4,384
4,384
United
States treasury bills (due July 13, 2023)
127
127
United
States treasury bills (due August 10, 2023)
485
485
Total
$ 5,016
$ 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 $ 19 thousand as of March 31, 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 consolidated statements of income 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.
9
Table of Contents
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 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. 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.
10
Table of Contents
Prepaid
Expenses and Other Current Assets
Prepaid
expenses and other current assets is recorded at historical cost and is primarily made up of $ 28 thousand and $ 63 thousand of prepaid
insurance, and $ 101 thousand and $ 109 thousand general prepaid expenses and other current assets as of March 31, 2023 and December 31,
2022, respectively.
Other
Assets
Other
assets are recorded at historical costs, and as of March 31, 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
March
31, 2023
Level
1
Level
2
Level
3
Fair
Value
Assets
Marketable
securities:
United
States treasury bills
$ 5,016
$ -
$ -
$ 5,016
Total
$ 5,016
$ -
$ -
$ 5,016
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 warrant 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.
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Revenue
Recognition
On
January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with
Customers (“ASC 606”). The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer
of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in
exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible
more judgment and estimates may be required within the revenue recognition process than required under existing GAAP including identifying
performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating
the transaction price to each separate performance obligation. The Company adopted ASC 606 for all applicable contracts using the modified
retrospective method, which would have required a cumulative-effect adjustment, if any, as of the date of adoption. The adoption of ASC
606 did not have a material impact on the Company’s consolidated financial statements as of the date of adoption. As a result,
a cumulative-effect adjustment was not required.
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
revenue
2023
2022
Three
months ended
March
31,
2023
2022
Contract
manufacturing
$ 380
$ 135
Custom
and white label finished goods manufacturing
4
—
NexGel
branded consumer products
222
213
Other
14
48
Total
$ 620
$ 396
As
of March 31, 2023 and December 31, 2022, the Company did not have any contract assets or contract liabilities from contracts with customers.
As of March 31, 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.
12
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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, the Financial Accounting Standards Board (“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 nonemployees 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 early adopted this new standard in the third quarter of 2019 and
it did not have a material impact to its 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.
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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 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 requires recognition of leases on the 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.
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Table of Contents
In
June 2016, FASB issued Accounting Standards Update (“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 March 1, 2023 and subsequent interim periods. The Company is currently evaluating the impact the adoption of ASU 2016-13 will
have on the Company’s consolidated financial statements.
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 March 31, 2023 ($ in thousands):
Schedule
of Future Minimum Lease Payments
Operating
Lease
Maturity
of Lease Liability
Liability
2023
$ 184
2024
245
2025
245
2026
301
2027
315
Thereafter
1,115
Total undiscounted operating lease payments
$ 2,405
Less: Imputed interest
( 309 )
Present value of operating
lease liability
$ 2,096
Weighted average remaining lease term
8.9
years
Weighted average discount rate
3.5 %
Total
operating lease expense for the three months ending March 31, 2023 and 2022, was $ 65
thousand and $ 61
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
March 31,
2023
Cash paid for amounts included in the measurement
of lease liability:
Operating cash flows from operating
lease
$ 54
5.
Inventory
Inventory
consists of the following ($ in thousands):
Schedule
of Inventory
March 31,
December 31,
2023
2022
Raw materials
$ 582
$ 295
Work-in-progress
63
51
Finished goods
323
156
Inventory, gross
968
502
Less: Inventory reserve
for excess and slow moving inventory
—
—
Total
$ 968
$ 502
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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
March
31,
December
31,
(Years)
2023
2022
Machinery
and equipment
3
- 10
$ 1,478
$ 973
Office
furniture and equipment
3
- 10
158
59
Leasehold
improvements
6
233
228
Construction
in progress
N/A
35
55
Property and equipment, gross
1,904
1,315
Less:
accumulated depreciation and amortization
( 622 )
( 594 )
Property
and equipment, net
$ 1,282
$ 721
Depreciation
expense for the three months ended March 31, 2023 and 2022 was $ 27 thousand and $ 25 thousand, respectively.
7.
Intangible Assets
The
following provides a breakdown of identifiable intangible assets as of March 31, 2023 and December 31, 2022:
Schedule
of Breakdown of Identifiable Intangible Assets
March 31,
December 31,
2023
2022
Product/Technology Related
Identifiable
intangible assets, gross
$ 31
$ 31
Accumulated amortization
( 29 )
( 26 )
Product/Technology Related
identifiable intangible assets, net
2
5
Marketing Related
Customer related intangible
asset, gross
17
17
Tradename related intangible
asset, gross
7
7
Accumulated
amortization
( 10 )
( 9 )
Marketing
related identifiable intangible assets, net
14
15
Total
Identifiable intangible assets, net
$ 16
$ 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 $ 4 thousand and $ 3 thousand for the three months ended March
31, 2023 and 2022, respectively.
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Table of Contents
As
of March 31, 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
$ 4
2024
2
2025
2
2026
2
2027
2
Thereafter
4
Total
$ 16
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
March 31,
December 31,
2023
2022
Salaries, benefits, and incentive
compensation
$ 38
$ 56
Franchise tax accrual
58
52
Other
16
22
Total accrued expenses
and other current liabilities
$ 112
$ 130
9.
Common Stock
At
March 31, 2023, the Company has reserved common stock for issuance in relation to the following:
Schedule
of Reserved Common Stock For Issuance in Relation
Share-based
compensation plan
542,469
Warrants
to purchase common stock
3,557,190
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. The Company initially reserved a total of 57,143 shares of the Company’s common stock for awards
under the 2019 Plan. Effective as of May 26, 2020 and May 3, 2021, respectively, the Board approved an increase of the number of authorized
shares of common stock reserved under the 2019 Plan from 57,143 shares of common stock to 485,715 and from 485,715 shares of common stock
to 571,429 shares of common stock, all of which may be delivered pursuant to incentive stock options.
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Table of Contents
On
March 23, 2023, the board of directors of the Company approved an increase of the number of shares to be reserved under the Company’s
2019 Plan by 300,000 shares of common stock, or from an aggregate number of 571,429 to 871,429 shares of common stock
(the “2019 Plan Increase”). The Company expects the 2019 Plan Increase to satisfy the Company’s anticipated equity
incentive award requirements for at least two years.
Subject
to adjustments pursuant to the 2019 Plan, the maximum number of shares of common stock with respect to which stock options 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 March 31, 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
627,219
7,183
237,027
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.
18
Table of Contents
The
following table summarizes the Company’s incentive stock option activity and related information for the period ended March 31,
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
—
—
—
Expired
—
—
—
Outstanding
at March 31, 2023
542,469
$ 2.340058
8.20
Exercisable
at March 31, 2023
351,398
$ 1.777947
7.42
As
of March 31, 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 March 31, 2023, there was approximately $ 23 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 ending March 31, 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, Compensation-Stock Compensation (“ASC 718”), the Company has measured the value of the 84,750
shares granted based on a closing price of the closing price of the Company’s stock at the grant date of the RSU Grant ($ 1.82 per
share).
19
Table of Contents
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 March 31, 2023
121,787
$ 1.68
Exercisable
at March 31, 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. Stock based compensation of $ 24 thousand and $ 55 thousand has been recorded for the year ended March 31,
2023 and 2022, respectively. As of March 31, 2023, there was $ 116 thousand unrecognized share-based compensation related to unvested
RSUs, which the Company expects to recognize over the next 3 years.
Warrants
The
following table shows a summary of common stock warrants through March 31, 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
( 30,430 )
0.69
—
Forfeited
—
—
—
Cancelled
( 49,570 )
1.18
—
Expired
—
—
—
Outstanding at March
31, 2023
3,557,190
$ 5.256569
3.47
Exercisable at March
31, 2023
3,557,190
$ 5.256569
3.47
As
of March 31, 2023, vested outstanding warrants had $ 90 thousand intrinsic value as the exercise price is greater than the estimated fair
value of the underlying common stock.
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11.
Noncontrolling Interest in Joint Venture
On
March 1, 2023, the Company acquired a 50 % interest in
a newly formed joint venture (“JV”), named CG Converting and Packaging, LLC, with C.G. Laboratories Inc. (“CG Labs”)
for its converting and packaging business. 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. As of March 31, 2023, the Company has contributed $ 100,000 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 beginning May 28, 2021 (twelve 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. On March 26, 2021, the SBA announced
that all EIDL loans issued in 2020 will start repayment 24 months from the date of the SBA Note.
The
SBA has since extended the repayment start to 30 months from the date of the SBA Note. The Company made its first payment in December
2022. The balances of the principal and accrued interest amounted to $ 281 thousand and $ 283 thousand as of March 31, 2023 and December
31, 2022, respectively.
The
future annual principal amounts and accrued interest to be paid as of March 31, 2023 are as follows:
Schedule
of Debt Instruments
Amount
For
the year ending December 31 ($ in thousands):
2023
(remainder of the year)
$ 4
2024
5
2025
5
2026
5
2027
6
Thereafter
256
Total
$ 281
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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 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 years 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
( 30,430 )
( 54 )
Change
in fair value of warrant liability
-
( 12 )
Fair
value as of year ended 3/31/2023
234,875
$ 176
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.
22
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Revenues
from three customers that exceeded 10% of total revenues for the three months ended March 31, 2023 were 52 %, 21 %, and 13 %. The accounts
receivable from the top three customers were 0 %, 25 %, and 31 % as well as 10 % from one other customer of the total accounts receivable
as of March 31, 2023.
Revenues
from three customers that exceeded 10% of total revenues for the three months ended March 31, 2022 were 52 %, 12 %, and 12 %. The accounts
receivable from the top three customers were 0 %, 0 %, and 40 % as well as 16 % and 22 % from two other customers of the total accounts receivable
as of March 31, 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 March 31, 2023, the total amount exceeding such limit was $ 335 thousand. 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 an 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 $ 40,000 for services as of March 31, 2023
and December 31, 2022, included in accounts payable in the accompanying consolidated balance sheets.
18.
Subsequent Events
Management
of the Company has performed a review of events and transactions occurring after the consolidated balance sheet date to determine if
there were any such events or transactions requiring adjustment to or disclosure in the accompanying consolidated financial statements.
23
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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;
●
inadequate
capital;
●
inadequate
or an inability to raise sufficient capital to execute our business plan;
●
our
ability to comply with current good manufacturing practices;
●
loss
or retirement of key executives;
●
our
plans to make significant additional outlays of working capital before we expect to generate significant revenues and the uncertainty
regarding when we will begin to generate significant revenues, if we are able to do so;
●
adverse
economic conditions and/or intense competition;
●
loss
of a key customer or supplier;
●
entry
of new competitors;
24
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●
adverse
federal, state and local government regulation;
●
technological
obsolescence of our manufacturing process and equipment;
●
technical
problems with our research and products;
●
risks
of mergers and acquisitions including the time and cost of implementing transactions and the potential failure to achieve expected
gains, revenue growth or expense savings;
●
price
increases for supplies and components; and
●
the
inability to carry out our business plans.
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 statements of operations for the comparison periods
identified.
Comparison
of the Three Months ended March 31, 2023 and 2022
Revenues,
net .
For
the three months ended March 31, 2023 revenues were $620 thousand and increased by $224 thousand, or 56.6%, when compared to $396 thousand
for the three months ended March 31, 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 March 1, 2023 through March 31,
2023 of $189 thousand.
25
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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.
Gross
profit (loss) . Our gross loss was $57 thousand for the three months ended March 31, 2023 compared to a gross loss of $22 thousand
for the three months ended March 31, 2022. The increase of $35 thousand in gross loss quarter over quarter was primarily due to the higher
volume of contract manufacturing sales against fixed costs partially offset by higher manufacturing labor costs. Gross loss was approximately
(9.2%) for the three months ended March 31, 2023 compared to a gross loss of (5.6%) for the three months ended March 31, 2022.
The
components of cost of revenues are as follows for the three months ended March 31, 2023 and 2022 ($ in thousands):
Three
Months Ended
March
31,
2023
2022
Cost
of revenues
Materials
and finished products
$ 355
$ 94
Compensation
and benefits
171
171
Depreciation
and amortization
20
21
Equipment,
production and other expenses
131
132
Total
cost of revenues
$ 677
$ 418
Cost
of revenues increased by $259 thousand, or 62.0%, to $677 thousand for the three months ended March 31, 2023, as compared to $418 thousand
for the three months ended March 31, 2022. The increase in cost of revenues is primarily aligned with the new product line growth and
an increase in compensation and benefits in the current year.
26
Table of Contents
Selling,
general and administrative expenses . The following table highlights Selling, general and administrative expenses by type for the
three months ended March 31, 2023 and 2022 ($ in thousands):
Three
Months Ended
March
31,
2023
2022
Selling,
general and administrative expenses
Compensation
and benefits
$ 161
$ 112
Share-based
compensation
19
18
Depreciation
and amortization
10
7
Advertising,
marketing, & Amazon fees
94
39
Investor
& shareholder services
96
149
Franchise
tax & corporate insurance
44
49
Professional
& consulting fees
263
226
Other
expenses and professional fees
110
166
Total
Selling, general and administrative expenses
$ 797
$ 766
Selling, general and administrative expenses increased
by $31 thousand, or 4.0%, to $797 thousand for the three months ended March 31, 2023, as compared to $766 thousand for the three months
ended March 31, 2022. The increase in Selling, general and administrative expenses is primarily attributable to the factors described
below.
Compensation and benefits increased by $49 thousand, or 43.8%, to $161
thousand for the three months ended March 31, 2023, as compared to $112 thousand for the three months ended March 31, 2022. The number
of employees decreased compared to the prior period and officer compensation increased in conjunction with contract renewals.
Share-based
compensation increased by $1 thousand, or 5.6%, to $19 thousand for the three months ended March 31, 2023, as compared to $18 thousand
for the three months ended March 31, 2022. The share-based compensation related to the issuance of stock options and restricted awards
to our officers, employees, and advisors in the prior year period.
Advertising,
marketing, Amazon fees increased by $55 thousand, or 141%, to $94 thousand for the three months ended March 31, 2023, as compared to
$39 thousand for the three months ended March 31, 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 $53 thousand, or 35.6%, to $96 thousand for the three months ended March 31, 2023, as compared
to $149 thousand for the three months ended March 31, 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 decreased by $5 thousand, or 10.2%, to $44 thousand for the three months ended March 31, 2023, as compared
to $49 thousand for the three months ended March 31, 2022.
Professional
and consulting fees increased by $37 thousand, or 16.4%, to $263 thousand for the three months ended March 31, 2023, as compared to $226
thousand for the three months ended March 31, 2022. We continued to incur accounting and consulting fees associated with public company
governance requirements.
Other
Expenses decreased by $56 thousand, or 33.7%, to $110 thousand for the three months ended March 31, 2023 from $166 thousand for the three
months ended March 31, 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 $29 thousand and $24 thousand for the three months ended March 31,
2023 and March 31, 2022, respectively.
27
Table of Contents
Liquidity
and Capital Resources
Cash
Flow
(in
thousands)
March
31,
March
31,
2023
2022
Net
cash used in operating activities
$ (709)
$ (797)
Net
cash provided by investing activities
397
—
Net
cash used in financing activities
(2 )
(2,033)
Net
increase (decrease) in cash and cash equivalents
(314)
(2,830)
Cash
and cash equivalents at beginning of year
1,101
13,350
Cash
and cash equivalent at end of quarter
$ 787
$ 10,520
As
of March 31, 2023, we had $787 thousand of cash and $5.0 million 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 $709 thousand and $797 thousand for the three months ended March 31, 2023 and 2022, respectively.
Net
cash provided by investing activities was $397 thousand and $0 thousand for the three months ended March 31, 2023 and 2022, respectively,
consisting of the sales of marketable securities of $485 thousand and purchases of capital equipment
of $88 thousand for three months ended March 31, 2023. There were no investing activities for the three months ended March 31,
2022.
Net
cash used in financing activities for the three months ended March 31, 2023 and 2022 was $2 thousand and $2.0 million is
attributable to the principal payments of notes payable and convertible notes, respectively.
At
March 31, 2023, current assets totaled $7.3 million and current liabilities totaled $1.5 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 $5.8 million
at March 31, 2023, compared to a working capital of $6.6 million at December 31, 2022. The decrease in the working capital as
of March 31, 2023 is primarily attributable to the loss from operations of $883 thousand.
We
have never declared or paid any cash dividends on our common stock. For the foreseeable future, we anticipate that all available fund
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.
28
Table of Contents
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 March 31, 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.
29
Table of Contents
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
required.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures.
As
of March 31, 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 March 31, 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 March 31, 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 March 31, 2023
The
Company did not sell any unregistered securities during the three months ended March 31, 2023.
(b) Issuer
Repurchases of Securities during the three months ended March 31, 2023
The
Company did not repurchase any of its securities during the three months ended March 31, 2023.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
Not
applicable.
30
Table of Contents
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 March 31, 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.
31
Table of Contents
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:
May 15, 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)
32
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.