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, 2022
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ___________ to ___________
Commission
file number: 001-36278
NexGel,
Inc.
(Exact
name of registrant as specified in its charter)
Delaware
26-4042544
(State
or other jurisdiction of incorporation or organization)
(I.R.S.
Employer Identification Number)
2150
Cabot Blvd West , Suite B
Langhorne ,
PA
19047
(Address
of principal executive office)
(Zip
Code)
Registrant’s
telephone number, including area code: (215) 702-8550
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common
Stock, par value $0.001
NXGL
The
Nasdaq Capital Market LLC
Warrants
to Purchase Common Stock
NXGLW
The
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 10, 2022, the registrant had 5,572,234 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 June 30, 2022 and December 31, 2021
3
Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2022 and 2021
4
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2022 and 2021
5
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021
6
Notes to Condensed Consolidated Financial Statements
7
ITEM
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
19
ITEM
3.
Quantitative and Qualitative Disclosures About Market Risk
25
ITEM
4.
Controls and Procedures
25
PART II – OTHER INFORMATION
ITEM
1.
Legal Proceedings
25
ITEM
1A.
Risk Factors
25
ITEM
2.
Unregistered Sales of Equity Securities and Use of Proceeds
25
ITEM
3.
Defaults Upon Senior Securities
25
ITEM
4.
Mine Safety Disclosures
25
ITEM
5.
Other Information
25
ITEM
6.
Exhibits
26
Signatures
27
2
Table of Contents
PART
I – FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NEXGEL,
INC
CONDENSED
CONSOLIDATED BALANCE SHEETS
AS
OF JUNE 30, 2022 AND DECEMBER 31, 2021
(Unaudited)
(in
thousands, except share and per share data)
June 30,
December 31,
2022
2021
ASSETS:
Current Assets:
Cash and cash equivalents
$ 4,420
$ 13,350
Marketable securities
5,371
-
Accounts receivable, net
300
209
Inventory
381
291
Prepaid expenses and other current assets
313
77
Total current assets
10,785
13,927
Goodwill
311
311
Intangibles, net
26
33
Property and equipment, net
704
723
Operating lease - right of use asset
1,832
1,926
Other assets
113
63
Total assets
$ 13,771
$ 16,983
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$ 522
$ 254
Accrued expenses and other current liabilities
85
62
Convertible notes payable
1,240
2,037
Note payable, current portion
18
10
Warrant liability
419
318
Operating lease liability, current portion
207
207
Total current liabilities
2,491
2,888
Long-Term Liabilities:
Operating lease liability, net of current portion
1,669
1,744
Notes payable, net of current portion
263
266
Total long-term liabilities
1,932
2,010
Total liabilities
4,423
4,898
Commitments and Contingencies (Note 14)
-
-
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, 750,000,000 shares authorized; 5,572,234 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively
6
6
Additional paid-in capital
19,025
18,891
Accumulated deficit
( 9,683 )
( 6,812 )
Total stockholders’ equity
9,348
12,085
Total liabilities and stockholders’ equity
$ 13,771
$ 16,983
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
Table of Contents
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2022 AND 2021
(Unaudited)
(in
thousands, except share and per share data)
2022
2021
2022
2021
Three Months Ended
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Revenues, net
$ 561
$ 417
$ 956
$ 683
Cost of revenues
460
413
884
722
Gross (loss)/profit
101
4
72
( 39 )
Operating expenses
Research and development
111
10
135
17
Selling, general and administrative
708
547
1,467
1,017
Total operating expenses
819
557
1,602
1,034
Loss from operations
( 718 )
( 553 )
( 1,530 )
( 1,073 )
Other income (expense)
Interest expense
( 348 )
( 370 )
( 1,092 )
( 518 )
Loss on debt extinguishment
—
—
( 150 )
( 25 )
Debt discount costs
—
( 52 )
—
( 68 )
Other income
2
147
2
147
Changes in fair value of warrant liability
29
2
( 101 )
8
Total other income (expense)
( 317 )
( 273 )
( 1,341 )
( 456 )
Loss before income taxes
( 1,035 )
( 826 )
( 2,871 )
( 1,529 )
Income tax expense
—
—
—
—
Net loss
$ ( 1,035 )
$ ( 826 )
( 2,871 )
( 1,529 )
Net loss per common share - basic
$ ( 0.19 )
$ ( 0.28 )
( 0.52 )
( 0.52 )
Net loss per common share - diluted
$ ( 0.19 )
$ ( 0.28 )
( 0.52 )
( 0.52 )
Weighted average shares used in computing net loss per common share - basic
5,572,234
2,939,837
5,572,234
2,918,759
Weighted average shares used in computing net loss per common share – diluted
5,572,234
2,939,837
5,572,234
2,918,759
The
accompanying notes are an integral part of these condensed financial statements.
4
Table of Contents
NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2022 AND 2021
(Unaudited)
(in
thousands, except share data)
Shares
Amount
Capital
Deficit)
Equity (Deficit)
Common Stock
Additional
Paid-in
Retained
Earnings
(Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit)
Equity (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
Stock-based compensation
-
-
54
-
54
Restricted stock vesting
-
-
25
-
25
Net loss
-
-
-
( 1,035 )
( 1,035 )
Balance, June 30, 2022
5,572,234
$ 6
$ 19,025
$ ( 9,683 )
$ 9,348
Common Stock
Additional
Paid-in
Retained
Earnings
(Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit)
Equity (Deficit)
Balance, January 1, 2021
2,838,047
$ 3
$ 2,570
$ ( 2,502 )
$ 71
Stock-based compensation
-
-
69
-
69
Restricted stock vesting
-
-
21
-
21
Issuances of common stock, net of issuance costs
101,800
-
285
-
285
Warrants issued for debt issuance
-
-
( 18 )
-
( 18 )
Beneficial conversion and warrant features of convertible debt
-
-
1,276
-
1,276
Net loss
-
-
-
( 704 )
( 704 )
Balance, March 31, 2021
2,939,847
$ 3
$ 4,203
$ ( 3,206 )
$ 1,000
Stock-based compensation
-
-
74
-
74
Restricted stock vesting
39,324
-
21
-
21
Net loss
-
-
-
( 826 )
( 826 )
Balance, June 30, 2021
2,979,171
$ 3
$ 4,298
$ ( 4,032 )
$ 269
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 SIX MONTHS ENDED JUNE 30, 2022 AND 2021
(Unaudited)
(in
thousands)
2022
2021
Six Months Ended June 30,
2022
2021
Operating Activities
Net loss
$ ( 2,871 )
$ ( 1,529 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
57
56
Changes in ROU asset and operating lease liability
19
6
Share-based compensation
134
185
Changes in fair value of warrant liability
101
( 8 )
Amortization of deferred financing costs
1,086
528
Loss on extinguishment of debt
150
24
Forgiveness of debt
-
( 148 )
Beneficial conversion feature in excess of face value
-
51
Changes in operating assets and liabilities:
Accounts receivable
( 91 )
( 146 )
Inventory
( 90 )
7
Prepaid expenses and other assets
( 286 )
61
Accounts payable
268
( 67 )
Accrued expenses and other liabilities
28
( 15 )
Deferred revenue
-
( 38 )
Net Cash Used in Operating Activities
( 1,495 )
( 1,033 )
Investing Activities
Investment in marketable securities
( 5,371 )
-
Capital expenditures
( 31 )
( 267 )
Net Cash Used in Investing Activities
( 5,402 )
( 267 )
Financing Activities
Issuance of common stock, net of issuance costs
-
285
Proceeds from notes payable
-
15
Principle payment of notes payable
( 2,033 )
( 15 )
Proceeds from notes payable (PPP)
-
128
Proceeds from convertible notes
-
1,337
Principal payment on convertible notes
-
( 100 )
Net Cash Provided by (Used In) Financing Activities
( 2,033 )
1,650
Net Increase (Decrease) in Cash and Cash Equivalents
( 8,930 )
350
Cash and Cash Equivalents – Beginning of period
13,350
32
Cash and Cash Equivalents – End of period
$ 4,420
$ 382
Supplemental Disclosure of Cash Flows Information
Cash paid during the year for:
Interest
-
-
Taxes
-
-
Supplemental Non-cash Investing and Financing activities
Fair value of beneficial conversion and warrant features of Convertible Notes Payable
$ -
$ 1,276
Original issue discounts recognized on Convertible Notes Payable
$ -
$ 343
Warrants issued for debt and equity financing costs
$ -
$ 130
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
Table of Contents
NEXGEL,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in
thousands, except share and per share data)
1. Description of Business, the Spin-off and Basis of Presentation
Description
of Business
NexGel,
Inc. (“NexGel” or the “Company”) manufactures high water content, electron beam cross-linked, aqueous polymer
hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and cosmetics. The Company specializes in custom
gels by capitalizing on proprietary manufacturing technologies. NexGel has historically served as a contract manufacturer, supplying
our gels to third parties who incorporate them into their own products and have 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 ability to offer
broad choices in the selection of liners onto which the gels are coated. Consequently, NexGel and our customers are able to determine
tolerances in moisture vapor transmission rate and active ingredient release rates while personalizing color and texture.
NexGel
was previously known as AquaMed Technologies, Inc. (“AquaMed”) before changing its name to NexGel, Inc. on November 14, 2019.
The
consolidated financial statements include the accounts of the Company and its consolidated wholly-owned subsidiary, NexGelRx, Inc.
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 financial statements and footnotes of NexGel, Inc. 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, 2022. These financial statements should be read in conjunction with the
audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10 -K for the year ended
December 31, 2021.
2.
Going Concern
As
of June 30, 2022, the Company had a cash balance of $ 4.4
million (including cash equivalents) and $ 5.4
million of marketable securities (see Note 3
for details of our marketable securities). For the six months ended June 30, 2022, the Company incurred a net loss of $ 2.87
million and had a net usage of cash in operating
activities of $ 1.50
million. In addition, the Company had a working
capital of $ 8.30 million
as of June 30, 2022. Additionally, we believe we have sufficient cash and marketable securities to operate our business plan through 2024.
7
Table of Contents
On
December 27, 2021, the Company sold an aggregate of 2,585,000 units at a price to the public of $ 5.50 per unit (the “Offering”),
each unit consisting of one share of the Company’s common stock, par value $ 0.001 per share (the “Common Stock”), and
a warrant to purchase one share of Common Stock at an exercise price of $ 5.50 per share (the “Warrants”), for net proceeds
of $ 13.2 million.
Proceeds
from the offerings are expected to be used for working capital, new product development and testing, and general business operations.
Management
is exploring new product channel sales in adjacent industries, such as cosmetics, athletic products, and proprietary medical devices.
The Company has increased focused 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
allowance 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.
Reclassifications
We
have reclassified, combined or separately disclosed certain amounts in the prior years’ condensed consolidated financial statements
and accompanying footnotes to conform with the current period’s presentation.
Cash
and cash equivalents
Cash
and cash equivalents is comprised of cash in banks and highly liquid investments, including U.S. treasury bills purchased with an original
maturity of three months or less. Cash equivalents consist of investments in money market funds for which the carrying amount approximates
fair value, due to the short maturities of these investments.
Marketable
securities
The
Company classifies its marketable securities as held-to-maturity, which include U.S. treasury bills with original maturities of greater
than three months. These securities are carried at cost. The total unrecognized gain related to the marketable securities was inconsequential
during the six months ended June 30, 2022.
Schedule
of Marketable Securities
June 30, 2022
Marketable Securities
Cash equivalents:
United States treasury bills (due August 23, 2022)
$ 1,497
Cash equivalents
$ 1,497
Marketable securities:
United States treasury bills (due December 29, 2022)
494
United States treasury bills (due February 23, 2023)
493
United States treasury bills (due June 15, 2023)
4,384
Total marketable securities
5,371
Total
$ 6,868
8
Table of Contents
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 $ 6 thousand as of June 30, 2022
and $ 4 thousand as of December 31, 2021.
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
balance is made up of raw materials, work-in-progress, and finished goods of $ 256 thousand, $ 90 thousand, and $ 35 thousand on June 30,
2022, respectively, and the balance was made up of raw materials, work-in-progress, and finished goods of $ 266 thousand, $ 0 , and $ 25
thousand on December 31, 2021, respectively. Inventory is maintained at the Company’s warehouse and at an Amazon fulfillment center.
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
“Cost of goods sold” 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.
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 Revenue, net. 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.
9
Table of Contents
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 are 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.
Prepaid
expenses and other current assets
Prepaid
expenses and other current assets is recorded at historical cost and is primarily made up of $ 111 thousand and $ 23 thousand of prepaid
insurance, and $ 202 thousand and $ 54 general prepaid expenses and other current assets as of June 30, 2022 and December 31, 2021, respectively.
Other
Assets
Other
assets is recorded at historical costs, and as of June 30, 2022 and December 31, 2021, the balance is entirely made up of spare parts
for manufacturing equipment. Other assets are stated at cost and 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, 2022
Level 1
Level 2
Level 3
Fair Value
Assets
Cash equivalents:
United States treasury bills
$ 1,497
$ —
$ —
$ 1,497
Cash equivalents
$ 1,497
$ —
$ —
$ 1,497
Marketable securities:
United States treasury bills
$ 5,371
$ —
$ —
$ 5,371
Marketable securities
$ 5,371
$ —
$ —
$ 5,371
Total
$ 6,868
$ —
$ —
$ 6,868
10
Table of Contents
Warrant
Liability
Warrants
to purchase common stock were issued in connection with equity financing raises, which occurred on September 2, 2021, March 11, 2021,
February 3, 2021, December 24, 2020, March 18, 2020, September 10, 2019 and November 6, 2019. The fair values of the warrants are estimated
as of the date of issuance and again at each period 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.
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 accounting principles
generally accepted in the United States of America (“U.S. 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 our manufacturing is recognized at the point where the customer obtains control
of the goods and the Company satisfies its performance obligation, which generally is at the time the customer receives the product.
The
Company’s customers consist of other life sciences companies and Amazon retail customers. Revenues are entirely
concentrated in the United States. Payment terms vary by the type and location of customer and may differ by jurisdiction and
customer but payment is generally required in a term ranging from 30 to 60 days from date of shipment.
Estimates
for product returns, allowances and discounts are recorded as a reduction of revenue and are established at the time of sale. Returns
are estimated through a comparison of historical return data and are determined for each product and adjusted for known or expected changes
in the marketplace specific to each product, when appropriate. Historically, sales return provisions have not been material. Amounts
accrued for sales allowances and discounts are based on estimates of amounts that are expected to be claimed on the related sales and
are based on historical data. Payments for allowances and discounts have historically been immaterial.
Disaggregated
revenue by sales type:
Schedule
of Disaggregated
Revenue by Sales Type
2022
2021
Three months ending
June 30,
2022
2021
Contract manufacturing
$ 324
$ 153
Custom and white label finished goods manufacturing
19
153
NexGel branded consumer products
180
111
Other
38
—
Total
$ 561
$ 417
2022
2021
Six months ending
June 30,
2022
2021
Contract manufacturing
$ 459
$ 379
Custom and white label finished goods manufacturing
19
194
NexGel branded consumer products
392
110
Other
86
—
Total
$ 956
$ 683
11
Table of Contents
As
of June 30, 2022 and December 31, 2022, the Company did not have any contract assets or contract liabilities from contracts with customers.
As of June 30, 2022 and December 31, 2021, there were no remaining performance obligations that the Company had not satisfied.
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 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 is 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 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.
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting
bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that
are not yet effective will not have a material impact on our financial position or results of operations upon adoption.
In
June 2016, the Financial Accounting Standards Board (“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.
In
January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment.
ASU 2017-04 simplifies the manner in which an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill
impairment test. Under the amendments in ASU 2017-04, an entity should (1) perform its annual or interim goodwill impairment test by
comparing the fair value of a reporting unit with its carrying amount, and (2) recognize an impairment charge for the amount by which
the carrying amount exceeds the reporting unit’s fair value, with the understanding that the loss recognized should not exceed
the total amount of goodwill allocated to that reporting unit. Additionally, ASU 2017-04 requires any reporting unit with a zero or negative
carrying amount to perform Step 2 of the goodwill impairment test. We adopted ASU 2017-04 effective March 1, 2021.
In
December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which simplifies the
accounting for income taxes. This guidance will be effective for entities for the fiscal years, and interim periods within those fiscal
years, beginning after December 15, 2020 on a prospective basis, with early adoption permitted. We will adopt ASU 2019-12 effective March
1, 2021 and do not expect the adoption of this guidance to have a material impact on our consolidated financial statements.
12
Table of Contents
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.
The
following table presents information about the amount and timing of the liability arising from the Company’s operating lease as
of June 30, 2022 ($ in thousands):
Schedule
of Future Minimum Lease Payments
Operating
Lease
Maturity of Lease Liability
Liability
2022
$ 104
2023
207
2024
207
2025
207
2026
263
Thereafter
1,165
Total undiscounted operating lease payments
$ 2,153
Less: Imputed interest
( 277 )
Present value of operating lease liability
$ 1,876
Weighted average remaining lease term
8.5 years
Weighted average discount rate
3.0 %
Total
operating lease expense for the three months ending June 30, 2022 and 2021, respectively, was $ 103 thousand and $ 103 thousand, and is
recorded in cost of goods sold and selling, general and administrative expenses on the 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,
2022
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from operating lease
$ 103
5.
Inventory
Inventory
consists of the following ($ in thousands):
Schedule
of Inventory
June 30,
December 31,
2022
2021
Raw materials
$ 256
$ 266
Work-in-progress
90
-
Finished goods
35
25
Inventory, gross
381
291
Less: Inventory reserve for excess and slow moving inventory
—
—
Total
$ 381
$ 291
Inventory
is maintained at the Company’s warehouse and at an Amazon fulfillment center. The Company builds its contract manufacturing products
based on customer orders and immediately ships the products upon completion of the production process.
13
Table of Contents
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)
2022
2021
Machinery and equipment
3 - 10
$ 971
$ 940
Office furniture and equipment
3 - 10
50
50
Leasehold improvements
6
228
228
Property and equipment, gross
1,249
1,218
Less: accumulated depreciation and amortization
( 545 )
( 495 )
Property and equipment, net
$ 704
$ 723
Depreciation
expense for the six months ended June 30, 2022 and 2021 was $ 49 thousand and $ 49 thousand, respectively.
7.
Intangible Assets
The
following provides a breakdown of identifiable intangible assets as of June 30, 2022 and December 31, 2021:
Schedule
of Breakdown of Identifiable Intangible Assets
June 30,
December 31,
2022
2021
Product/Technology Related
Identifiable intangible assets, gross
$ 31
$ 31
Accumulated amortization
( 22 )
( 16 )
Product/Technology Related identifiable intangible assets, net
9
15
Marketing Related
Customer related intangible asset, gross
17
17
Tradename related intangible asset, gross
7
7
Accumulated amortization
( 7 )
( 6 )
Marketing related identifiable intangible assets, net
17
18
Total Identifiable intangible assets, net
$ 26
$ 33
In
connection with the acquisitions of Sport Defense, the Company identified intangible assets of $ 26 thousand representing technology related
and customer related intangibles. These assets are being amortized on a straight-line basis over their weighted average estimated useful
life of 3.7 years and amortization expense amounted to $ 7 and $ 7 thousand for the six months ended June 30, 2022 and 2021, respectively.
As
of June 30, 2022, the estimated annual amortization expense for each of the next five fiscal years is as follows:
Schedule
of Estimated Annual Amortization Expense
2022
$ 7
2023
8
2024
2
2025
2
2026
2
Thereafter
5
Total
$ 26
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,
2022
2021
Salaries, benefits, and incentive compensation
$ 78
$ 54
Other
7
8
Total accrued expenses and other current liabilities
$ 85
$ 62
14
Table of Contents
9.
Common Stock
Share
issuances
On
December 27, 2021, the Company sold an aggregate of 2,585,000 units at a price to the public of $ 5.50 per unit (the “Offering”),
each unit consisting of one share of our common stock, and a warrant to purchase one share of our common stock at an exercise price of
$ 5.50 per share . In addition, the Company granted the underwriter with respect to the Offering a 45 -day option to purchase
up to 387,750 additional shares of our common stock, and/or 387,750 additional warrants, to cover over-allotments in connection with
the Offering, which the Underwriter partially exercised to purchase 387,750 warrants on December 27, 2021.
From
January 1, 2021 through March 31, 2021, the Company entered into Securities Purchase Agreements with certain accredited investors whereby
we sold 101,800 shares of our common stock at a price per share equal to $ 2.80 for an aggregate purchase price of $ 285,000 .
At
June 30, 2022, 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
334,938
Warrants to purchase common stock
3,637,190
10.
Share-based Compensation
On
August 28, 2019, the Company adopted the 2019 Long-Term Incentive Plan (the “2019 Plan”). 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. 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
The
following table contains information about the 2019 Plan as of June 30, 2022:
Schedule
of Information about Incentive Plan
Awards
Awards
Reserved for
Awards
Available for
Issuance
Issued
Grant
2019 Plan
571,429
334,938
227,491
The
following table summarizes the Company’s incentive stock option activity and related information for the period ended June 30,
2022:
Schedule of Incentive Stock Option Activity
Weighted
Weighted
Average
Average
Contractual
Number of
Exercise
Term in
Options
Price
Years
Outstanding at January 1, 2022
434,939
$ 1.675747
8.56
Granted
—
—
—
Exercised
—
—
—
Forfeited
—
—
—
Cancelled
( 100,001 )
1.40
—
Expired
—
—
—
Outstanding at June 30, 2022
334,938
$ 1.758076
8.08
Exercisable at June 30, 2022
312,790
$ 1.600341
8.02
15
Table of Contents
As
of June 30, 2022, vested outstanding stock options had $ 205 thousand intrinsic value as the exercise price is greater than the estimated
fair value of the underlying common stock. As of June 30, 2022, there was approximately $ 85 thousand of total unrecognized share-based
compensation related to unvested stock options, which the Company expects to recognize over the next 12 months.
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 year ended June 30, 2022:
Schedule of Assumptions used in Share-based Compensation
Volatility
171.12 %- 183.48 %
Risk-free interest rate
0.46 % - 0.86 %
Dividend yield
0.0 %
Expected term
5.0 - 5.75 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 January 1, 2022, the Company granted a restricted stock award of 11,364 shares of the Company’s common stock to the 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, Compensation-Stock Compensation (“ASC
718”), the Company has measured the value of the 11,364 shares granted based on a closing price of the closing price of the Company’s
stock at the grant date of the RSU Grant ($ 4.40 per share).
On
March 8, 2021, the Company granted a restricted stock award of 39,524 shares of the Company’s common stock to the Adam Levy for
his service as our Chief Executive Officer and Chief Financial Officer from October 1, 2020 through September 30, 2021, all of which
shares vested immediately. Under ASC 718, Compensation-Stock Compensation (“ASC 718”), the Company has measured the value
of the 39,924 shares granted based on a closing price of the closing price of the Company’s stock at the grant date of the RSU
Grant ($ 2.10 per share).
Warrants
The
following table shows a summary of common stock warrants through June 30, 2022:
Summary of Common Stock Warrants
Weighted
Weighted
Average
Average
Number of
Exercise
Contractual
Warrants
Price
Term in Years
Outstanding at January 1, 2022
3,637,190
$ 5.16281
4.63
Granted
—
—
—
Exercised
—
—
—
Forfeited
—
—
—
Cancelled
—
—
—
Expired
—
—
—
Outstanding at June 30, 2022
3,637,190
$ 5.16281
4.14
Exercisable at June 30, 2022
3,637,190
$ 5.16281
4.14
As
of June 30, 2022, vested outstanding warrants had $ 195 thousand intrinsic value as the exercise price is greater than the estimated fair
value of the underlying common stock.
16
Table of Contents
11.
Note Payable
PPP
Loan
On
April 22, 2020, the Company, entered into a promissory note (the “Promissory Note”) with PNC Bank, N.A. (the “Bank”),
which provides for a loan in the amount of $ 147,300 (the “PPP Loan”) pursuant to the Paycheck Protection Program under the
Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). On March 4, 2021, the Company received a second PPP
Loan in the amount of $ 127,400 thousand under Phase II of the Paycheck Protection Program. On June 2, 2021, the Company received notice
from PNC Bank that its initial loan of $ 147,300 had been forgiven in its entirety by the SBA. On November 16, 2021, the Company received
notice from PNC Bank that its second PPP loan of $ 127,400 had been forgiven in its entirety by the SBA.
Economic
Injury Disaster Loan
On
May 28, 2020, the Company entered into the standard loan documents required for securing a loan (the “EIDL Loan”) from the
SBA under its Economic Injury Disaster Loan (“EIDL”) assistance program in light of the impact of the COVID-19 pandemic on
the Company’s business. Pursuant to that certain Loan Authorization and Agreement (the “SBA Loan Agreement”), the principal
amount of the EIDL Loan is up to $ 260,500 , with proceeds to be used for working capital purposes. Interest accrues at the rate of 3.75 %
per annum. Installment payments, including principal and interest, are due monthly beginning May 28, 2021 (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 26 months from the date of the SBA Note.
12.
Convertible Notes Payable
On
December 24, 2020, the Company issued an $ 100,000
6 %
Secured Convertible Promissory Note which was convertible into shares of the Company’s common stock at a price per share of $ 2.80 .
The note was fully-repaid (including all accrued but unpaid interest) on March 14, 2021.
On
January 19, 2021, the Company issued a $ 15,000
Secured Convertible Promissory Note which was convertible into shares of the Company’s common stock at a price per share of
$ 1.05 .
The note was fully-repaid (including all accrued but unpaid interest) on March 14,
2021.
Auctus
Fund Financing
On
March 11, 2021, the Company Auctus Fund, LLC, a Delaware limited liability company (“Auctus”) a senior secured
convertible promissory note in the principal amount of $ 1,680,000 ,
which includes $ 180,000 of
interest which was deemed fully earned as of the Issuance Date (the “Auctus Note”). The Auctus Note was
fully-repaid (including all principal and interest) on March 15, 2022 with a one-time cash payment of $ 1,680,000 .
Investor
Private Placement Offering
On
September 2, 2021, the Company conducted a closing of a private placement offering (the “September 2 Offering”) with twenty
accredited investors (the “September 2 Investors”) whereby the Company entered into a securities purchase agreement (the
“September 2 Purchase Agreement”) with the September 2 Investors pursuant to which the Company issued to the Investors subordinated
secured convertible promissory notes in the aggregate principal amount of $ 1,620,000 (the “September 2 Notes”). The net proceeds
received by the Company were $ 1,504,400 (after deducting fees owed to its placement agent, Alere (as defined and discussed below)). The
Company intended to use the net proceeds for working capital and general corporate purposes.
17
Table of Contents
The
Notes have a maturity date of one year from September 2, 2021. The Notes bear interest at a rate of 12 % per annum, which is also payable
on maturity, with the understanding that the first 12 months of interest (equal to an aggregate of $ 194,400 ) is guaranteed and deemed
to be earned in full as of September 2, 2021. In the event the Company fails to pay any amount when due under the September 2 Notes,
the interest rate will increase to the greater of 18 % or the maximum amount permitted by law. The September 2 Notes may be prepaid during
the first 180 calendar days from September 2, 2021 subject to a 110 % prepayment penalty on all principal and accrued but unpaid interest
then outstanding. The September 2 Notes may not be prepaid in whole or in part after 180 calendar days from September 2, 2021. The September
2 Investors may convert any amount due under the September 2 Notes at any time, and from time to time, into shares of the Company’s
common stock at a conversion price of $ 5.25 per share; provided, however, that the September 2 Investors may not convert any portion
of the September 2 Notes that would cause such Investor to beneficially own in excess of 4.99 % of the Company’s common stock. The
conversion price and number of shares of the Company’s common stock issuable upon conversion of the September 2 Notes will be subject
to adjustment from time to time for any subdivision or consolidation of shares and other dilutive events. If the Company issues common
stock or securities convertible into common stock at a per share price lower than the conversion price of $ 5.25 (the “Base Price”),
then the conversion price of the September 2 Notes will be reduced to the new Base Price at the option of the holder.
On
January 25, 2022, the Company repaid a September 2 Investor in full with a one-time cash payment of $ 300,000 of outstanding principal
and accrued but unpaid interest the September 2 Offering. The Company did incur a 105 % pre-payment penalty of $ 16,800 with respect to
the repayment of the investor’s note and the repayment extinguished the note in its entirety.
As
of June 30, 2022, the September 2 Notes’ outstanding balance was $ 1,239,503 , which consisted of principal of $ 1,478,400 , net of
unamortized balance of $ 195,182 of a beneficial conversion and warrant features, unamortized original issue discount of $ 27,415 and unamortized
debt issuance costs of $ 16,302 .
13.
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
Warrants
Fair Value
Warrant Liability
Outstanding
per Share
Fair Value
Fair Value as of period ending 12/31/2021
265,305
$ 318
Change in fair value of warrant liability
101
Fair Value as of period ending 6/30/2022
265,305
$ 419
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. As of June 30, 2022, none of the warrants have been exercised.
14.
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.
15.
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, 2022 were 40 % and 25 % . The accounts receivable
from the 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.
Revenues
from three customers that exceeded 10% of total revenues for the six months ended June 30, 2021 were 28 % , 24 % , and 16 % . The accounts
receivable from the top three customers by revenue were 13 % , 0 % , and 44 % as well as 25 % from one other customer of the total accounts
receivable as of June 30, 2021.
The
Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents and
marketable securities. Cash balances are maintained principally at major U.S. financial institutions and are insured by the Federal Deposit
Insurance Corporation (“FDIC”) up to regulatory limits. Such cash balances are currently in excess of the FDIC insurance
limit of $ 250,000 . As of June 30, 2022, the total amount exceeding such limit was $ 4,170,000 . 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.
18
Table of Contents
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed
financial statements and related notes above.
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events,
future financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,”
“could,” “would,” “predict,” “potential,” “continue,” “expect,”
“anticipate,” “future,” “intend,” “plan,” “believe,” “estimate,”
and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should
not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will
actually be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s
good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance
or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could
cause such differences include, but are not limited to:
●
our
ability to continue as a going concern;
●
inadequate
capital;
●
inadequate
or an inability to raise sufficient capital to execute our business plan;
●
our
ability to comply with current good manufacturing practices;
●
loss
or retirement of key executives;
●
our
plans to make significant additional outlays of working capital before we expect to generate significant revenues and the uncertainty
regarding when we will begin to generate significant revenues, if we are able to do so;
●
adverse
economic conditions and/or intense competition;
●
loss
of a key customer or supplier;
●
entry
of new competitors;
●
adverse
federal, state and local government regulation;
●
technological
obsolescence of our manufacturing process and equipment;
●
technical
problems with our research and products;
●
risks
of mergers and acquisitions including the time and cost of implementing transactions and the potential failure to achieve expected
gains, revenue growth or expense savings;
●
price
increases for supplies and components; and
●
the
inability to carry out our business plans.
19
Table of Contents
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.
Results
of Operations
The
following sections discuss and analyse the changes in the significant line items in our statements of operations for the comparison periods
identified.
Comparison
of the Three Months ended June 30, 2022 and 2021
Revenues,
net .
For
the three months ended June 30, 2022 revenues were $561 thousand and increased by $144 thousand, or 35%, when compared to $417 thousand
for the three months ended June 30, 2021. The increase in our overall revenues was due to sales growth of new products as well as our
initiatives in custom label manufacturing and branded consumer product.
Gross
profit (loss) . Our gross profit was $101 thousand for the three months ended June 30, 2022 compared to a gross profit of $4 thousand
for the three months ended June 30, 2021. The profit recorded for the three months ended June 30, 2022, as compared to a profit recorded
for the three months ended June 30, 2021, was primarily due to the higher volume of contract manufacturing sales against fixed costs.
Gross profit was approximately 18% for the three months ended June 30, 2022 compared to a gross profit of 1% for the three months ended
June 30, 2021. The Company anticipates continued improvement in gross margins due to both increased revenue against fixed facility expenses
and larger productions runs on commercially proven products.
The
components of cost of revenues are as follows for the three months ended June 30, 2022 and 2021 ($ in thousands):
Three Months Ended
June 30,
2022
2021
Cost of revenues
Materials and finished products
$ 196
$ 171
Compensation and benefits
163
134
Depreciation and amortization
22
22
Equipment, production and other expenses
79
86
Total cost of revenues
$ 460
$ 413
Cost
of revenues increased by $47 thousand, or 11.0%, to $460 thousand for the three months ended June 30, 2022, as compared to $413 thousand
for the three months ended June 30, 2021. The increase in cost of revenues is primarily aligned with the new product line growth in the
current year.
20
Table of Contents
Selling,
general and administrative expenses . The following table highlights Selling, general and administrative expenses by type for the
three months ended June 30, 2022 and 2021 ($ in thousands):
Three Months Ended
June 30,
2022
2021
Selling, general and administrative expenses
Compensation and benefits
$ 135
$ 83
Share-based compensation
79
95
Depreciation and amortization
4
4
Other expenses and professional fees
490
365
Total Selling, general and administrative expenses
$ 708
$ 547
Selling,
general and administrative expenses increased by $161 thousand, or 29%, to $708 thousand for the three months ended June 30, 2022, as
compared to $547 thousand for the three months ended June 30, 2021. 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 $52 thousand, or 63%, to $135 thousand for the three months ended June 30, 2022, as compared to $83 thousand
for the three months ended June 30, 2021. The number of employees increased compared to the prior period and officer compensation increased
in conjunction with contract renewals.
Share-based
compensation decreased by $16 thousand, or 17%, to $79 thousand for the three months ended June 30, 2022, as compared to $95 thousand
for the three months ended June 30, 2021. 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.
Other
Expenses and professional fees increased by $125 thousand, or 34%, to $490 thousand for the three months ended June 30, 2022 from $365
thousand for the three months ended June 30, 2021. Other Selling, general and administrative expenses generally consist of costs associated
with our selling efforts and general management, including information technology, travel, training and recruiting. We continued to incur
legal, accounting and consulting fees associated with public company governance requirements, however, the increase in professional fees
compared to the prior year period was the primary an increase in professional fees in connections with our in the NASDAQ up-listing on
December 27, 2021.
Research
and development expenses . Research and development expenses increased by $101 thousand to $111 thousand for the three months ended
June 30, 2022 from $10 thousand for the three months ended June 30, 2021. The increase is due to the initiation of two proof of concept
studies for drug delivery candidates utilizing our hydrogel technology as well as continuing development on the NEXDrape medical device.
Comparison
of the Six Months ended June 30, 2022 and 2021
Revenues,
net .
For
the six months ended June 30, 2022 revenues were $956 thousand and increased by $273 thousand, or 40%, when compared to $683 thousand
for the six months ended June 30, 2021. The increase in our overall revenues was due to sales growth of new products as well as our initiatives
in custom label manufacturing and branded consumer product.
21
Table of Contents
Gross
profit (loss) . Our gross profit was $72 thousand for the six months ended June 30, 2022 compared to a gross loss of $39 thousand
for the six months ended June 30, 2021. The profit recorded for the six months ended June 30, 2022, as compared to a loss recorded for
the six months ended June 30, 2021, was primarily due to the higher volume of contract manufacturing sales against fixed costs. Gross
profit was approximately 8% for the six months ended June 30, 2022 compared to a gross loss of 6% for the six months ended June 30, 2021.
The components of cost of revenues are as follows for the six months ended June 30, 2022 and 2021 ($ in thousands):
Six Months Ended
June 30,
2022
2021
Cost of revenues
Materials and finished products
$ 290
$ 231
Compensation and benefits
342
262
Depreciation and amortization
43
43
Equipment, production and other expenses
209
186
Total cost of revenues
$ 884
$ 722
Cost
of revenues increased by $162 thousand, or 22%, to $884 thousand for the six months ended June 30, 2022, as compared to $722 thousand
for the six months ended June 30, 2021. The increase in cost of revenues is primarily aligned with the new product line growth in the
current year.
Selling,
general and administrative expenses . The following table highlights Selling, general and administrative expenses by type for the
six months ended June 30, 2022 and 2021 ($ in thousands):
Six Months Ended
June 30,
2022
2021
Selling, general and administrative expenses
Compensation and benefits
$ 261
$ 172
Share-based compensation
134
185
Depreciation and amortization
7
7
Other expenses and professional fees
1,065
653
Total Selling, general and administrative expenses
$ 1,467
$ 1,017
Selling,
general and administrative expenses increased by $450 thousand, or 44%, to $1,467 thousand for the six months ended June 30, 2022, as
compared to $1,017 thousand for the six months ended June 30, 2021. 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 $89 thousand, or 52%, to $261 thousand for the six months ended June 30, 2022, as compared to $172 thousand
for the six months ended June 30, 2021. The number of employees increased compared to the prior period and officer compensation increased
in conjunction with contract renewals.
Share-based
compensation decreased by $51 thousand, or 28%, to $134 thousand for the six months ended June 30, 2022, as compared to $185 thousand
for the six months ended June 30, 2021. 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.
Other
expenses and professional fees increased by $412 thousand, or 63%, to $1.1 million for the six months ended June 30, 2022 from $653 thousand
for the six months ended June 30, 2021. Other Selling, general and administrative expenses generally consist of costs associated with
our selling efforts and general management, including information technology, travel, training and recruiting. We continued to incur
legal, accounting and consulting fees associated with public company governance requirements, however, the increase in professional fees
compared to the prior year period was the primary an increase in professional fees in connections with our in the NASDAQ up-listing on
December 27, 2021.
Research
and development expenses . Research and development expenses increased by $118 thousand to $135 thousand for the six months ended
June 30, 2022 from $17 thousand for the six months ended June 30, 2021. The increase is due to the initiation of two proof of concept
studies for drug delivery candidates utilizing our hydrogel technology as well as continuing development on the NEXDrape medical device.
22
Table of Contents
Liquidity
and Capital Resources
Cash
Flow
(in
thousands)
June 30,
June 30,
2022
2021
Net cash used in operating activities
$ (1,495 )
$ (1,033 )
Net cash used in investing activities
(5,402 )
(267 )
Net cash provided by (used in) financing activities
(2,033 )
1,650
Net increase (decrease) in cash and cash equivalents
(8,930 )
350
Cash and cash equivalents at beginning of year
13,350
32
Cash and cash equivalent at end of year
$ 4,420
$ 382
As
of June 30, 2022, we had $4.4 million of cash and cash equivalents and $5.4 million of marketable securities, compared to $13.4
million of cash at December 31, 2021. Net cash used in operating activities was $1.5 million and $1.0 million for the six months
ended June 30, 2022 and 2021, respectively. See Notes 2 and 3 of our financial statements above for a more detailed
discussion of our marketable securities.
Net
cash used in investing activities was $5,402 thousand and $267 thousand for the six months ended June 30, 2022 and 2021, respectively,
consisting of investments in marketable securities of $5,371 and purchases of capital equipment of $31 thousand for the six months ended
June 30, 2022 and purchases of capital equipment of $267 thousand in the prior year period.
Net
cash used by financing activities for the six months ended June 30, 2022 was $2.0 million which is attributable to the principal payments
of convertible notes of $2.0 million. For the six months ended June 30, 2021 cash flows from financing activities were $1.7 million which
is attributable to the issuance of common stock of $285 thousand and proceeds of a notes payable of $15 thousand and proceeds from the
PPP loan of $128 thousand and convertible notes payable of $1.34 million.
At
June 30, 2022, current assets totaled $10.8 million and current liabilities totaled $2.5 million, as compared to current assets totaling
$13.9 million and current liabilities totaling $2.9 million at December 31, 2021. As a result, we had working capital of $8.3 million
at June 30, 2022, compared to a working capital of $11.0 million at December 31, 2021. The decrease in the working capital as
of June 30, 2022 is primarily attributable to the repayment of convertible notes payable of $2.0 million in the current period and investments
in marketing securities of $5.4 million in the six months ended June 30, 2022.
On
December 27, 2021, the Company sold an aggregate of 2,585,000 units at a price to the public of $5.50 per unit (the “Offering”),
each unit consisting of one share of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and
a warrant to purchase one share of Common Stock at an exercise price of $5.50 per share (the “Warrants”), pursuant to that
certain Underwriting Agreement, dated as of December 21, 2021 (the “Underwriting Agreement”), between the Company and Maxim
Group LLC (the “Underwriter”). In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriter a
45-day option to purchase up to 387,750 additional shares of Common Stock, and/or 387,750 additional Warrants, to cover over-allotments
in connection with the Offering, which the Underwriter partially exercised to purchase 387,750 Warrants on December 27, 2021. On December
27, 2021, the Company received gross proceeds of approximately $14.2 million, before deducting underwriting discounts and commissions
of seven percent (7%) of the gross proceeds and estimated Offering expenses.
Pursuant
to the Underwriting Agreement, the Company also agreed to issue to the Underwriter warrants (the “Underwriter’s Warrants”)
to purchase up to a total of 155,100 shares of Common Stock (6% of the shares of Common Stock sold in the Offering). The Underwriter’s
Warrants are exercisable at $6.1875 per share of Common Stock and have a term of five years. The Underwriter’s Warrants are subject
to a lock-up for 180 days from the commencement of sales in the Offering, including a mandatory lock-up period in accordance with FINRA
Rule 5110(e), and will be non-exercisable for six (6) months after December 21, 2021.
On
September 2, 2021, the Company entered into a securities purchase agreement pursuant to which the Company issued to twenty investors
a 12% senior secured convertible promissory note in the principal amount of $1.8 million, including $194 thousand (which represents the
twelve months of guaranteed interest which was earned in full as of September 2, 2021), which is convertible into shares of the Company’s
common stock at a price per share of $5.25 subject to certain adjustments as discussed herein in Note 13 in the Notes to the Consolidated
Financials. The net proceeds received by the Company were $1.5 million after deducting fees and expenses related to the transaction.
The purchasers in the September 2021 securities purchase agreement also received warrants to purchase shares of our common stock. On
January 25, 2022, the Company repaid an investor in full with a one-time cash payment of $300 thousand of outstanding principal and accrued
but unpaid interest the September 2 Offering. The Company did incur a 105% pre-payment penalty of $16,800 with respect to the repayment
of the investor’s note and the repayment extinguished the note in its entirety.
23
Table of Contents
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.
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, 2022, we had no off-balance sheet arrangements in the nature of guarantee contracts, retained or contingent interests in
assets transferred to entities (or similar arrangements serving as credit, liquidity or market risk support to entities for any such
assets), or obligations (including contingent obligations) arising out of variable interests in entities providing financing, liquidity,
market risk or credit risk support to us, or that engage in leasing, hedging or research and development services with us.
Critical
Accounting Policies and Estimates
The
preparation of our Financial Statements in accordance with generally accepted accounting principles is based on the selection and application
of accounting policies that require us to make significant estimates and assumptions about the effects of matters that are inherently
uncertain. We consider the accounting policies discussed below to be critical to the understanding of our Financial Statements. Actual
results could differ from our estimates and assumptions, and any such differences could be material to our Financial Statements.
Share-based
compensation – We utilize share-based compensation in the form of incentive stock options. The fair values of incentive stock
option award grants are estimated as of the date of grant using a Black-Scholes option valuation model. Compensation expense is recognized
in the statements of operations on a straight-line basis over the requisite service period, which is generally the vesting period required
to obtain full vesting. The expected term of the awards granted is estimated using the simplified method which computes the expected
term as the sum of the award’s vesting term plus the original contractual term divided by two.
Warrant
Liability – Warrants to purchase common stock were issued in connection with equity financing raises which occurred on September
2, 2021, March 11, 2021, February 3, 2021, December 24, 2020, March 18, 2020, September 10, 2019 and November 6, 2019. The fair values
of the warrants are estimated as of the date of issuance and again at each period 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 the 3 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.
24
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 June 30, 2022, 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, 2022 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, 2022 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 lawsuits, investigations and claims that arise in the ordinary course of business. As of the
date of this filing, we are neither a party to any litigation nor are we aware of any such threatened or pending litigation that might
result in a material adverse effect to our business.
ITEM
1A. RISK FACTORS
There
have been no material changes to our risk factors as previously disclosed in our most recent Form 10-K filing.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a)
Unregistered
Sales of Equity Securities
None.
(b)
Issuer
Purchases of Equity Securities
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
Not
applicable.
25
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 June 30, 2021, 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.
26
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:
August 10, 2022
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)
27
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.