UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the Quarterly Period Ended June 30, 2026
☐
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: 001-40739
DERMATA
THERAPEUTICS, INC.
(Exact
name of registrant as specified in the charter)
Delaware
86-3218736
(State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization)
Identification
Number)
3525
Del Mar Heights Rd. , #322 , San Diego , CA
92130
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: 858 - 800-2543
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 $0.0001 per share
DRMA
The
Nasdaq Capital Market
Warrants,
exercisable for one share of Common Stock
DRMAW
The
Nasdaq Capital Market
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 registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards pursuant to Section 13(a) of the Exchange Act. ☒
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No.
There
were 4,022,143 shares of Common Stock, par value $ 0.0001 , of Dermata Therapeutics, Inc. issued and outstanding as of August 10, 2026.
DERMATA
THERAPEUTICS, INC.
Form
10-Q
Table of Contents
INDEX
Page
No.
Part
I
Financial Information
3
Item
1:
Financial Statements (unaudited)
3
Balance Sheets
3
Statements of Operations
4
Statements of Stockholders’ Equity
5
Statements of Cash Flows
7
Notes to Financial Statements
8
Item
2:
Management’s Discussion and Analysis of Financial Condition and Results of Operations
24
Item
3:
Quantitative and Qualitative Disclosures about Market Risk
33
Item
4:
Controls and Procedures
33
Part
II
Other Information
34
Item
1:
Legal Proceedings
34
Item
1A:
Risk Factors
34
Item
2:
Unregistered Sales of Equity Securities and Use of Proceeds
35
Item
3:
Defaults Upon Senior Securities
35
Item
4:
Mine Safety Disclosures
35
Item
5:
Other Information
35
Item
6:
Exhibits
36
Signatures
37
2
PART
I
ITEM
1: FINANCIAL STATEMENTS
DERMATA
THERAPEUTICS, INC.
Balance
Sheets
June 30, 2026
December 31, 2025
(unaudited)
Assets:
Cash and cash equivalents
$ 4,412,764
$ 7,521,978
Prepaid expenses and other current assets
593,604
341,848
Inventories
149,734
-
Total current assets
5,156,102
7,863,826
Property and equipment
129,367
-
Other assets
35,330
-
Total assets
$ 5,320,799
$ 7,863,826
Liabilities and Stockholders’ Equity:
Liabilities:
Accounts payable (including related party amounts of $ 137,491 and $ 86,250 , respectively)
$ 1,119,718
$ 460,811
Accrued and other current liabilities (including related party amounts of $ 0 and $ 25,000 , respectively)
713,361
1,179,635
Total liabilities
1,833,079
1,640,446
Commitments and Contingencies (see Note 6)
Stockholders’ Equity:
Common Stock, par value $ 0.0001 , 250,000,000 shares authorized; 4,022,143 shares issued and outstanding as of June 30, 2026; 2,660,110 shares issued and outstanding as of December 31, 2025.
402
266
Additional paid-in capital
81,535,983
79,457,010
Accumulated deficit
( 78,048,665 )
( 73,233,896 )
Total stockholders’ equity
3,487,720
6,223,380
Total liabilities and stockholders’ equity
$ 5,320,799
$ 7,863,826
The
accompanying notes are an integral part of these financial statements.
3
DERMATA
THERAPEUTICS, INC.
Statements
of Operations
(unaudited)
2026
2025
2026
2025
For
the three months ended June 30,
For
the six months ended June 30,
2026
2025
2026
2025
Operating expenses:
Research and development
$ 212,563
$ 617,835
$ 596,287
$ 1,898,976
Selling, general and administrative (including related party amounts of $ 428,966 and $ 619,549 for the three and six months ended June 30, 2026, respectively, and $ 0 for the three and six months ended June 30, 2025)
2,801,004
1,154,896
4,343,662
2,213,559
Total operating expenses
3,013,567
1,772,731
4,939,949
4,112,535
Loss from operations
( 3,013,567 )
( 1,772,731 )
( 4,939,949 )
( 4,112,535 )
Other income and expenses:
Interest income
46,504
71,638
125,180
107,855
Net loss
$ ( 2,967,063 )
$ ( 1,701,093 )
$ ( 4,814,769 )
$ ( 4,004,680 )
Net loss per share of Common Stock, basic and diluted
$ ( 0.74 )
$ ( 1.66 )
$ ( 1.22 )
$ ( 5.18 )
Weighted-average basic and diluted Common Stock
4,022,143
1,026,506
3,940,983
772,397
The
accompanying notes are an integral part of these financial statements.
4
DERMATA
THERAPEUTICS, INC.
Statements
of Stockholders’ Equity
(unaudited)
Shares
Par Value
Capital
Deficit
Equity
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Par Value
Capital
Deficit
Equity
Balance at December 31, 2025
2,660,110
$ 266
$ 79,457,010
$ ( 73,233,896 )
$ 6,223,380
Issuance of Common Stock from ATM sales, net of issuance costs
824,283
82
1,993,969
-
1,994,051
Issuance of Common Stock upon exercise of pre-funded warrants
537,750
54
( 54 )
-
-
Stock-based compensation
-
-
43,278
-
43,278
Net loss
-
-
-
( 1,847,706 )
( 1,847,706 )
Balance at March 31, 2026
4,022,143
$ 402
$ 81,494,203
$ ( 75,081,602 )
$ 6,413,003
Stock-based compensation
-
-
41,780
-
41,780
Net loss
-
-
-
( 2,967,063 )
( 2,967,063 )
Balance at June 30, 2026
4,022,143
$ 402
$ 81,535,983
$ ( 78,048,665 )
$ 3,487,720
The
accompanying notes are an integral part of these financial statements.
5
DERMATA
THERAPEUTICS, INC.
Statements
of Stockholders’ Equity
(unaudited)
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Par Value
Capital
Deficit
Equity
Balance at December 31, 2024
251,725
$ 25
$ 67,236,408
$ ( 65,675,339 )
$ 1,561,094
Stock-based compensation
-
-
37,189
-
37,189
Issuance of Common Stock and warrants from January 2025 PIPE, net of issuance costs
193,539
19
2,254,702
-
2,254,721
Issuance of Common Stock upon exercise of pre-funded warrants
97,746
10
967
-
977
Issuance of Common Stock and warrants from March 2025 Warrant Inducement, net of issuance costs
60,200
6
5,750,822
-
5,750,828
Net loss
-
-
-
( 2,303,587 )
( 2,303,587 )
Balance at March 31, 2025
603,210
$ 60
$ 75,280,088
$ ( 67,978,926 )
$ 7,301,222
Stock-based compensation
-
-
39,234
-
39,234
Issuance of abeyance shares
34,547
4
( 4 )
-
-
Issuance costs related to the March 2025 Warrant Inducement
-
-
( 25,112 )
-
( 25,112 )
Net loss
-
-
-
( 1,701,093 )
( 1,701,093 )
Balance at June 30, 2025
637,757
$ 64
$ 75,294,206
$ ( 69,680,019 )
$ 5,614,251
The
accompanying notes are an integral part of these financial statements.
6
DERMATA
THERAPEUTICS, INC.
Statements
of Cash Flows
(unaudited)
2026
2025
For
the six months ended June 30,
2026
2025
Cash flows from operating activities:
Net loss
$ ( 4,814,769 )
$ ( 4,004,680 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
85,058
76,422
Increase (decrease) in cash resulting from changes in:
Prepaid expenses and other current assets
( 251,756 )
212,732
Inventories
( 149,734 )
-
Other assets
( 35,330 )
-
Accounts payable
731,559
( 356,816 )
Accrued and other current liabilities
( 466,274 )
( 552,205 )
Net cash used in operating activities
( 4,901,246 )
( 4,624,547 )
Cash flows from investing activities:
Purchases of property and equipment
( 110,667 )
-
Net cash used in investing activities
( 110,667 )
-
Cash flows from financing activities:
Proceeds from issuance of Common Stock from ATM sales, net of issuance costs
1,994,051
-
Proceeds from issuance of Common Stock, pre-funded warrants, and warrants, net of issuance costs
-
7,993,425
Proceeds from exercise of pre-funded warrants
-
977
Payment of issuance costs
( 91,352 )
( 50,495 )
Net cash provided by financing activities
1,902,699
7,943,907
Net increase (decrease) in cash and cash equivalents
( 3,109,214 )
3,319,360
Cash and cash equivalents at beginning of period
7,521,978
3,161,570
Cash and cash equivalents at end of period
$ 4,412,764
$ 6,480,930
Non-cash financing activities:
Issuance Common Stock upon exercise of pre-funded warrants
$ 54
$ -
Purchases of property and equipment included in accounts payable
$ 18,700
-
March 2025 Warrant Inducement issuance costs in accounts payable
$ -
$ 12,987
Issuance of abeyance shares
$ -
$ ( 4 )
Supplemental disclosure:
Cash paid for taxes
$ 950
$ 950
The
accompanying notes are an integral part of these financial statements.
7
DERMATA
THERAPEUTICS, INC.
Notes
to Financial Statements
(unaudited)
1.
Organization and Basis of Presentation
Dermata
Therapeutics, Inc., (the “Company”), was formed in December 2014 as a Delaware limited liability company (“LLC”)
under the name Dermata Therapeutics, LLC. On March 24, 2021, the Company converted from an LLC to a Delaware C-corporation and changed
its name to Dermata Therapeutics, Inc. On August 17, 2021, the Company completed its initial public offering. The Company’s shares
of Common Stock and warrants are listed on the Nasdaq Stock Market LLC (“Nasdaq”) under the symbols “DRMA,” and
“DRMAW,” respectively. During September 2025, the Company made a strategic shift from researching and developing prescription
products to becoming a science-driven leader in dermatologic solutions anticipating the launch of its first direct-to-consumer (“DTC”)
products from its Tome skincare, expected on August 25, 2026.
Reverse
Stock Splits
On
July 15, 2025, the Company held its annual meeting of stockholders at which time the stockholders approved the adoption of an amendment
to its Amended and Restated Certificate of Incorporation, as amended, to effect a reverse stock split of its issued and outstanding shares
of Common Stock, at a specific ratio, ranging from one-for-two to one-for-thirty, with the exact ratio determined by the Company’s
board of directors without further approval or authorization of its stockholders. On August 1, 2025, the Company effected the reverse
split of its shares of Common Stock at a ratio of 1-for-10 , as approved by the Company’s board of directors (the “2025 Reverse
Stock Split”). The par value was not adjusted as a result of the 2025 Reverse Stock Split. All issued and outstanding shares of
Common Stock and per share amounts contained in the financial statements have been retroactively adjusted to reflect this reverse stock
split for all periods presented.
Liquidity
and Going Concern Uncertainty
Since
its inception, the Company has devoted substantially all of its resources to research and development activities, and during 2026, on
marketing and other pre-launch commercial activities in preparation of its first product launch, and has not generated any revenue or
commercialized any product. As of June 30, 2026, cash and cash equivalents totaled $ 4.4 million, and the Company had an accumulated deficit
of $ 78.0 million. For the six months ended June 30, 2026, and the year ended December 31, 2025, the Company used cash of approximately
$ 4.9 million and approximately $ 7.8 million, respectively, in operations. The Company’s existing cash and cash equivalents are
expected to fund operations into the fourth quarter of 2026.
The
Company anticipates that it will continue to incur net losses for at least the next twelve months from the date of this filing. While
the Company expects to launch its first commercial product on August 25, 2026, it is uncertain when the Company will generate operating
income to sustain operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern
for the one-year period following the date that these financial statements were issued.
Historically,
the Company’s principal sources of cash have included proceeds from the issuance of equity securities and debt. The
Company’s principal use of cash has been for operations, and the Company expects that the principal uses of cash in the future
will be for continuing operations, including various marketing expenditures, including, but not limited to, branding, paid media,
marketing use studies, advertising, software subscriptions, and launch events and tradeshows, as well as non-marketing expenses
including funding of research and development, litigation expenses, and general working capital requirements. The Company expects
that as marketing expenses continue to grow, it will need to raise additional capital to sustain operations.
8
Management’s
Plan to Continue as a Going Concern
To
continue as a going concern, the Company will need, among other things, to raise additional capital resources. Until the Company can
generate significant cash from operations, management’s plans to obtain such resources for the Company include proceeds from offerings
of the Company’s equity securities or debt, generating product revenue from sales of skincare products, or transactions involving
product development, technology licensing or collaboration. Management can provide no assurance that any sources of a sufficient amount
of financing or collaboration agreements will be available to the Company on favorable terms, if at all. The Company’s ability
to raise additional capital may be adversely impacted by the ongoing litigation with a former licensor (see Note 6), potential worsening of global economic conditions, tariffs, potential future
global pandemics or health crises, and the disruptions to, and volatility in, the credit and financial markets in the United States.
Because of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s
ability to continue as a going concern for one year from the issuance of the financial statements, which is not alleviated by management’s
plans. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial
statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or
the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern.
Basis
of Presentation
The
accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United
States (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information
and notes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements reflect
all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results
of operations, cash flows, and stockholders’ equity for the interim periods presented. Interim results are not necessarily indicative
of results for a full year. The preparation of financial statements in conformity with GAAP requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ materially
from those estimates. The unaudited financial statements included in this Form 10-Q should be read in conjunction with the audited financial
statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with
the Securities and Exchange Commission (the “SEC”) on March 26, 2026, which includes a broader discussion of the Company’s
business and the risks inherent therein.
2.
Summary of Significant Accounting Policies
Use
of Estimates
The
Company’s financial statements are prepared in accordance with GAAP. The preparation of the Company’s financial statements
requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, and expenses and disclosure
of contingent assets and liabilities in the financial statements and accompanying notes. On an ongoing basis, management evaluates these
estimates and judgments, including those related to ongoing litigation (see Note 6). The Company bases its estimates on various assumptions
that it believes are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or
conditions.
Segment
Information
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and
the Company’s chief operating decision maker view the Company’s operations and manage its business in one operating segment.
Cash
and Cash Equivalents
The
Company deposits its cash and cash equivalents with accredited financial institutions. Cash and cash equivalents are held in business
checking, cash sweep, and overnight money market mutual fund accounts. Only the business checking account is insured by the Federal Deposit
Insurance Corporation (“FDIC”), with coverage up to $ 250,000 . Cash and cash equivalent deposits in excess of $ 250,000 are
not covered by insurance provided by the FDIC. The cash sweep and overnight money market mutual fund accounts are invested overnight
in highly liquid, short-term investments. The Company considers all highly liquid investments with a maturity date of 90 days or less
at the date of purchase to be cash equivalents.
9
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash and cash equivalents. The
Company is exposed to credit risk in the event of a default by the financial institutions holding the Company’s cash sweep and
overnight money market mutual fund accounts, and the Company’s business checking account, to the extent of the amounts held in
excess of FDIC limits. The Company limits its credit risk by placing its cash and cash equivalents with financial institutions it believes
are of high quality. To date, the Company has not experienced any losses on its deposits of cash and cash equivalents, and periodically
evaluates the creditworthiness of its financial institutions.
Fair
Value Measurement
The
Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers
include Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs
other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs
in which little or no market data exists, therefore requiring an entity to develop its own assumptions. The Company believes the carrying
amount of cash and cash equivalents and accounts payable approximate their estimated fair values due to the short-term nature of these
assets and liabilities.
Inventories
Inventories
consist of raw materials procured for the purpose of manufacturing the Company’s Tome skincare products, as well as work-in-process
product components, and are stated at the lower of cost or net realizable value. Costs for inventories include shipping, delivery, freight,
non-refundable taxes, duties, and other landing costs. The Company’s policy is to perform an assessment of the recoverability of
capitalized inventories during each reporting period and to write down any excess, obsolete, damaged, or expired materials to their estimated
realizable value in the period in which the impairment is first identified. Given the early stage of the Company’s commercialization
strategy, no impairments of inventories have been recorded as of June 30, 2026.
Property
and Equipment
Property
and equipment are stated at cost less accumulated depreciation. Depreciation expense is calculated on a straight-line basis over the
estimated useful lives of the related assets. Repairs and maintenance costs are expensed as incurred. Depreciation begins when the relevant
assets are placed into service, which is expected to begin in the third quarter of 2026. Estimated useful lives by major asset category
are as follows:
Schedule
of Property and Equipment Estimated Useful Lives
Property and Equipment
Useful
Life (in years)
Tradeshow booth
2
Capitalized software costs
3
Capitalized
Software Costs
Capitalized
software costs consist of implementation costs for cloud computing arrangements, which primarily relate to the implementation of the
Company’s ecommerce platform in preparation of its commercial launch, as well as a planning and budgeting tool. Capitalized software
costs also consist of costs capitalized for the development of the Company’s product website. Implementation costs for cloud computing
arrangements and website development costs are accounted for in accordance with Accounting Standard Codification (“ASC”)
350-40, Intangibles - Goodwill and Other - Internal Use Software, which requires capitalization of eligible costs beginning when management
authorizes and commits to the funding of the project with the required authority, and it is probable the project will be completed and
the website or software will be used to perform the functions intended. As of June 30, 2026, implementation costs for cloud computing
arrangements of approximately $ 18,000 and $ 35,000 are included in the accompanying balance sheets in prepaid expenses and other current
assets and other assets, respectively, depending on whether the related asset is considered current or noncurrent. As of December 31, 2025, implementation costs for cloud computing arrangements of approximately
$ 14,000 are included in the accompanying balance sheets in prepaid expenses and other current assets. Website development costs are included
in property and equipment, see Note 3.
10
Amortization
of capitalized implementation costs is recorded on a straight-line basis over the term of the associated hosting arrangement, inclusive
of renewal periods that are reasonably certain to be exercised, ranging from two to three years. Capitalized website development costs
are amortized on a straight-line basis over their estimated useful life of three years. Amortization of capitalized software costs begin
when the relevant software projects are ready for their intended use, which is expected to begin in the third quarter of 2026.
Interest
Income
Interest
income consists of interest income earned on cash and cash equivalents from interest bearing demand accounts.
Patent
Costs
Patent
costs related to obtaining and maintaining patent protection in both the United States and other countries are expensed as incurred.
Patent costs are classified as selling, general and administrative expenses.
Research
and Development Costs
Research
and development costs are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses
for personnel, including stock-based compensation expense and discretionary incentive bonuses, if any, external research and development
costs incurred under agreements with contract research or laboratory organizations, costs related to compliance with regulatory requirements,
costs related to developing future product candidates, and other allocated expenses.
Payments
for research and development activities are based on the terms of the individual agreements, which may differ from the pattern of costs
incurred, and payments made in advance of performance are reflected in the accompanying balance sheets as prepaid expenses and other
current assets. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating
the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events,
invoices received, and contracted costs. The Company uses judgments and estimates to determine the prepaid or accrued balances at the
end of any reporting period. Actual results could differ from the Company’s estimates.
Selling,
General and Administrative Costs
Selling,
general and administrative costs are expensed in the period incurred. Selling, general and administrative costs primarily consist of
personnel-related expenses, including stock-based compensation and discretionary incentive bonuses, if any, marketing and brand-related
expenses, including marketing studies of product candidates, paid media and advertising costs, as well as legal fees incurred relating
to corporate, litigation, and patent matters, professional fees incurred for accounting, auditing, tax, and other consulting services,
insurance costs, and other allocated expenses.
Payments
for selling, general and administrative activities are based on the terms of the individual agreements, which may differ from the pattern
of costs incurred, and payments made in advance of performance are reflected in the accompanying balance sheets as prepaid expenses and
other current assets. The Company records accruals for estimated costs incurred for ongoing selling, general and administrative activities.
When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion
of events, invoices received, and contracted costs. The Company uses judgments and estimates to determine the prepaid or accrued balances
at the end of any reporting period. Actual results could differ from the Company’s estimates.
11
Income
Taxes
The
Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax
assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities
using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates
on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
The
Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized.
In making such a determination, management considers all available positive and negative evidence, including future reversals of existing
taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management
determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management
would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
The
Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely
than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions
that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50
percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties
related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax
liability.
Stock-Based
Compensation
The
Company measures and recognizes compensation expense for all stock-based awards made to employees, directors, and non-employees, based
on estimated fair values recognized using the straight-line method over the requisite service period. The fair value of options to purchase
Common Stock granted to employees is estimated on the grant date using the Black-Scholes valuation model. The calculation of stock-based
compensation expense requires that the Company make certain assumptions and judgments about variables used in the Black-Scholes model,
including the expected term of the stock-based award, expected volatility of the underlying Common Stock, dividend yield, and the risk-free
interest rate. Forfeitures are accounted for in the period they occur.
Warrants
The
Company performs an assessment of warrants upon issuance to determine their proper classification in the financial statements based upon
the warrant’s specific terms, in accordance with the authoritative guidance provided in ASC 480, Distinguishing Liabilities
from Equity (“ASC 480”) , and ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC
815-40”) . The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480 and whether
the warrants meet all of the requirements for equity classification under ASC 815-40, including whether the warrants are indexed in the
Company’s own Common Stock and whether the warrant holders could potentially require cash settlement of the warrants.
For
issued or modified warrants that meet all the criteria for equity classification, the warrants are required to be recorded as a component
of additional paid-in capital. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants
are required to be liability-classified and recorded at their initial fair value on the date of issuance and remeasured at fair value
at each balance sheet date thereafter. The Company has performed an assessment of all warrants issued and modified and determined that
the Company’s warrants are equity classified.
Comprehensive
Loss
Comprehensive
loss includes net loss and other comprehensive income (loss) for the periods presented. The Company did not have other comprehensive
income (loss) items such as unrealized gains and losses. As such, for the three and six months ended June 30, 2026, and 2025, comprehensive
loss was equal to the net loss.
12
Net
Loss Per Share of Common Stock
Basic
net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted-average number of shares outstanding
during the period. The weighted-average number of shares of Common Stock outstanding includes (i) pre-funded warrants because their exercise
requires only nominal consideration for the delivery of shares, and (ii) shares held in abeyance because there is no consideration required
for delivery of the shares, (collectively, “basic shares”), without consideration of common stock equivalents. Diluted net
loss per share is calculated by adjusting basic shares outstanding for the dilutive effect of common stock equivalents outstanding for
the period. For purposes of the diluted net loss per share calculation, stock options and warrants are considered to be common stock
equivalents but are excluded from the calculation of diluted net loss per common stock if their effect would be anti-dilutive.
The
common share equivalents that are not included in the calculation of diluted net loss per common share but could potentially dilute basic
earnings per share in the future are as follows:
Schedule
of Potentially Diluted Basic Earnings Per Share
2026
2025
As
of June 30,
2026
2025
Common Stock options
164,411
20,477
Common Stock warrants
5,424,598
1,238,949
Total potentially dilutive securities
5,589,009
1,259,426
Recent
Accounting Pronouncements
For
the six months ended June 30, 2026, the Company reviewed recent accounting standards and identified the following as relevant to the
Company.
In
November 2024, the Financial Accounting Standards Board (“FASB”) issued ASU 2024-03, Disaggregation of Income Statement
Expenses (“ASU 2024-03”) . ASU 2024-03 requires additional disclosures and disaggregation of certain costs and expenses
presented on the face of the income statement. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026,
and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the
impact of this guidance on its financial statements.
In
September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal Use Software (Subtopic 350-40): Targeted
Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”) . ASU 2025-06 updates the accounting for internal-use
software by replacing former stage-based rules with a principles-based framework. Entities will now capitalize costs associated with
internal-use software only when management has authorized and committed funding and it is probable that the project will be completed
and the software will be used to perform the intended function. ASU 2025-06 also supersedes website development cost guidance, moving
it to ASC 350-40. These amendments are effective for interim and annual periods beginning after December 15, 2027, with early adoption
permitted. The Company elected to early adopt this accounting guidance prospectively as of January 1, 2026, which did not have a material
impact on its financial statements or its related disclosures.
In
December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements (“ASU 2025-11”) ,
which clarifies the guidance in Topic 270 to improve the consistency of interim financial reporting. The ASU provides a comprehensive
list of required interim disclosures and introduces a disclosure principle requiring entities to disclose events since the end of the
last annual reporting period that have a material impact on the entity. ASU 2025-11 is effective for fiscal years beginning after December
15, 2027, including interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the
impact of adopting ASU 2025-11 on its financial statements and related disclosures.
13
3.
Balance Sheet Details
The
following provides certain balance sheet details:
Schedule
of Balance Sheet Details
June 30, 2026
December 31, 2025
Inventories:
Raw materials
$ 96,392
$ -
Work-in-process
53,342
-
Total inventories
$ 149,734
$ -
Prepaid expenses and other current assets:
Prepaid insurance
$ 49,606
$ 255,272
Prepaid selling and marketing expenses
60,782
30,000
Prepaid annual subscriptions
72,230
42,571
Prepaid other
25,695
14,005
Deposit for inventory purchases
356,011
-
Deposit for property and equipment
29,280
-
Total prepaid expenses and other current assets
$ 593,604
$ 341,848
Property and equipment:
Tradeshow booth
$ 70,500
$ -
Capitalized website costs
58,867
-
Total property and equipment
$ 129,367
$ -
Accrued and other current liabilities:
Accrued compensation and benefits
$ 342,500
$ 979,453
Accrued legal fees
82,883
-
Accrued consulting fees
240,750
199,750
Accrued other
47,228
432
Total accrued and other current liabilities
$ 713,361
$ 1,179,635
4.
Equity Securities
A
summary of the Company’s equity securities as of June 30, 2026, is as follows:
Schedule of
Equity Securities
Description
Authorized
Issued
Reserved
Outstanding
Common Stock, par value $0.0001
250,000,000
4,022,143
-
4,022,143
Preferred Stock
10,000,000
-
-
-
Warrants
-
5,424,598
-
5,424,598
2021 Omnibus Equity Incentive Plan
402,214
149,502
252,712
149,411
Nonqualified Inducement Stock Option Grant
15,000
15,000
-
15,000
Total equity securities
260,417,214
9,611,243
252,712
9,611,152
Common
Stock
In
January 2026, the Company extended its At The Market Offering Agreement (the “ATM Agreement”) with its sales agent (the “Sales
Agent”), providing for the additional sale of up to $ 705,000 of its shares of Common Stock as set forth in the ATM Agreement, adding
to the registered capacity of approximately $ 1.4 million which remained as of December 31, 2025, for total remaining capacity of approximately
$ 2.1 million. During January 2026, the Company issued 824,283 shares of its Common Stock under the ATM Agreement, resulting in net proceeds
of approximately $ 2.0 million after paying the Sales Agent a fixed commission rate of 3.0 % of approximately $ 67,000 and other transactional
fees. After issuance of the 824,283 shares of its Common Stock under its ATM Agreement during January 2026, no capacity remained under
the Company’s ATM Agreement.
14
On
December 29, 2025, the Company closed a private placement (the “December 2025 PIPE”) priced at the market under Nasdaq rules,
in which it sold 1,484,312 shares of Common Stock, pre-funded warrants to purchase an aggregate of 537,750 shares of Common Stock with
an exercise price of $ 0.001 per share (“December 2025 Pre-Funded Warrants”), 2,022,062 Series C warrants (the “Series
C Warrants”) to purchase up to an aggregate of 2,022,062 shares of Common Stock, and 2,022,062 Series D warrants (the “Series
D Warrants”) to purchase up to an aggregate of 2,022,062 shares of Common Stock (together the “December 2025 PIPE Warrants”),
for gross proceeds of approximately $ 4.1 million. The December 2025 PIPE Warrants have an exercise price of $ 2.04 . Certain Company insiders,
including the Company’s Chief Executive Officer and Chief Financial Officer, participated in the December 2025 PIPE. These Company
insiders purchased an aggregate of 735,294 shares of Common Stock and December 2025 PIPE Warrants to purchase up to an aggregate of 1,470,588
shares of Common Stock, for an aggregate purchase price of approximately $ 1.5 million. The purchase price per share of Common Stock and
accompanying December 2025 PIPE Warrants for these Company insiders was the same as paid by other investors in the December 2025 PIPE.
The December 2025 PIPE Warrants were exercisable subject to stockholder approval, which the Company received at a stockholder meeting
on May 27, 2026. In connection with the December 2025 PIPE, the Company entered into a registration rights agreement with the investors,
pursuant to which the Company agreed to prepare and file a registration statement with the Securities and Exchange Commission (“SEC”)
registering the resale of the shares of Common Stock underlying the securities sold in the December 2025 PIPE financing. The Company
filed a Form S-3 on January 22, 2026, which was declared effective by the SEC on January 29, 2026. The Company received net cash proceeds
of approximately $ 3.8 million from the December 2025 PIPE after deducting approximately $ 0.3 million of placement agent fees and legal
and audit firm fees. During the first quarter of 2026, all of the 537,750 December 2025 Pre-Funded Warrants were exercised, leaving no
prefunded warrants outstanding.
H.C.
Wainwright & Co., LLC (“Wainwright”) acted as the exclusive placement agent for the December 2025 PIPE. In addition to
the placement agent fees, the Company issued to Wainwright, or its designees, warrants (the “December 2025 PIPE Placement Agent
Warrants”) to purchase up to an aggregate of 141,544 shares of Common Stock at an exercise price equal to $ 2.55 per share. The
December 2025 PIPE Placement Agent Warrants were exercisable subject to stockholder approval, which the Company received at a stockholder
meeting on May 27, 2026. The grant date fair value of the December 2025 PIPE Placement Agent Warrants was $ 0.2 million, which represents
a non-cash issuance cost, and which was determined using the Black-Scholes option pricing model, using the following significant assumptions:
expected term of 5.4 years, expected volatility of 134.9 %, risk-free interest rate of 3.67 % and dividend yield of 0.0 %.
In
November 2025, the Company extended its ATM Agreement with its Sales Agent, providing for the additional sale of up to approximately
$ 1.8 million of its shares of Common Stock as set forth in the ATM Agreement. The Sales Agent was entitled to compensation at a fixed
commission rate of 3.0 % of the gross sales price of the shares of Common Stock sold pursuant to the ATM Agreement, as well as other transactional
fees. During December 2025, the Company issued 149,341 shares of Common Stock under the ATM Agreement resulting in gross proceeds of
$ 0.4 million before deducting approximately $ 15,000 of Sales Agent issuance costs. After issuance of the 149,341 shares during December
2025, approximately $ 1.4 million remained registered under the ATM Agreement as of December 31, 2025, which was subsequently utilized
during the first quarter of 2026, leaving no remaining capacity as of March 31, 2026 and June 30, 2026.
On
March 27, 2025, the Company entered into an inducement offer letter agreement (the “March 2025 Inducement Letter”) with a
holder (the “Holder”) of certain of its existing warrants to purchase an aggregate of 483,447 shares of the Company’s
Common Stock. Such existing warrants were made up of (i) certain of the May 17, 2024 warrants (the “May 2024 Warrants”),
which were issued in two separate series, having an exercise price of $ 49.10 per share, and (ii) the September 16, 2024 warrants, which
were issued in two separate series, having an exercise price of $ 15.80 per share (the “September 2024 Warrants” and together
with the May 2024 Warrants, the “Existing Warrants”), for gross proceeds of approximately $ 6.2 million. Pursuant to the March
2025 Inducement Letter, the Holder agreed to exercise for cash its Existing Warrants at a reduced exercise price of $ 12.84 per share
in consideration for the Company’s agreement to issue in a private placement (i) new Series A common stock purchase warrants (the
“New Series A Warrants”) to purchase up to 498,080 shares of Common Stock and (ii) new Series B common stock purchase warrants
(the “New Series B Warrants” and together with the New Series A Warrants, the “New Warrants”) to purchase up
to 468,813 shares of Common Stock. The New Warrants were exercisable subject to stockholder approval, which the Company received at a
stockholder meeting on July 15, 2025. The Company received net proceeds of approximately $ 5.7 million from the exercise of the Existing
Warrants by the Holder, after deducting approximately $ 0.5 million of financial advisor fees and legal and audit firm fees.
15
Wainwright
acted as the exclusive financial advisor for the March 2025 inducement. In addition to the financial advisor fees, the Company issued
to Wainwright, or its designees, warrants (the “March 2025 Financial Advisor Warrants”) to purchase up to an aggregate of
33,840 shares of Common Stock at an exercise price equal to $ 16.05 per share. The grant date fair value of the March 2025 Financial Advisor
Warrants was $ 0.4 million, which represents a non-cash issuance cost, and which was determined using the Black-Scholes option pricing
model, using the following significant assumptions: expected term of 5.3 years, expected volatility of 143.0 %, risk-free interest rate
of 3.98 % and dividend yield of 0.0 %.
On
January 21, 2025, the Company closed a private placement (the “January 2025 PIPE”) priced at the market under Nasdaq rules,
in which it sold 193,539 shares of Common Stock, pre-funded warrants to purchase an aggregate of 7,246 shares of Common Stock with an
exercise price of $ 0.01 per share (“January 2025 Pre-Funded Warrants”), and 200,785 warrants (the “January 2025 PIPE
Warrants”) to purchase up to an aggregate of 200,785 shares of Common Stock, for gross proceeds of approximately $ 2.5 million.
The January 2025 PIPE Warrants have an exercise price of $ 12.70 . Certain Company insiders, including the Company’s Chief Executive
Officer, Chief Financial Officer and certain members of the Company’s board of directors, participated in the January 2025 PIPE.
These Company insiders purchased an aggregate of 122,047 shares of Common Stock and January 2025 PIPE Warrants to purchase up to an aggregate
of 122,047 shares of Common Stock, for an aggregate purchase price of approximately $ 1.55 million. The purchase price per share of Common
Stock and accompanying January 2025 PIPE Warrant for these Company insiders was the same as paid by other investors in the January 2025
PIPE. The January 2025 Warrants were exercisable subject to stockholder approval, which the Company received at a stockholder meeting
on July 15, 2025. In connection with the January 2025 PIPE, the Company entered into a registration rights agreement with the investors,
pursuant to which the Company agreed to prepare and file a registration statement with the SEC registering the resale of the shares of
Common Stock underlying the securities sold in the January 2025 PIPE financing. The Company filed a Form S-3 on January 30, 2025, which
was declared effective by the SEC on February 5, 2025. The Company received net cash proceeds of approximately $ 2.2 million from the
January 2025 PIPE after deducting approximately $ 0.3 million of placement agent fees and legal and audit firm fees. During the first
quarter of 2025, all of the January 2025 Pre-Funded Warrants were exercised. As of March 31, 2025, no January 2025 Pre-Funded Warrants
remained outstanding.
Wainwright
acted as the exclusive placement agent for the January 2025 PIPE. In addition to the placement agent fees, the Company issued to Wainwright,
or its designees, warrants (the “January 2025 PIPE Placement Agent Warrants”) to purchase up to an aggregate of 14,053 shares
of Common Stock at an exercise price equal to $ 15.88 per share. The grant date fair value of the January 2025 PIPE Placement Agent Warrants
was $ 0.2 million, which represents a non-cash issuance cost, and which was determined using the Black-Scholes option pricing model, using
the following significant assumptions: expected term of 5.4 years, expected volatility of 145.7 %, risk-free interest rate of 4.45 % and
dividend yield of 0.0 %.
Preferred
Stock
While
the Company has 10,000,000 shares of preferred stock authorized with a par value of $ 0.0001 , no shares of preferred stock are outstanding
as of June 30, 2026, or December 31, 2025.
Warrants
Summary
of Warrants Outstanding
The
table below lists outstanding warrants for the dates presented, excluding 537,750 pre-funded warrants with an exercise price of $ 0.001
outstanding as of December 31, 2025, which were exercised during the first quarter of 2026, leaving no pre-funded warrants outstanding
as of June 30, 2026.
16
The
warrants outstanding as of June 30, 2026, are exercisable into 5,424,598 shares of Common Stock which had a fair value of $ 1.29 per share
based on the closing trading price on June 30, 2026. The aggregate intrinsic value of warrants outstanding as of June 30, 2026, is calculated
as the difference between the exercise price of the warrants and the closing market price of the Company’s Common Stock on that
date. The intrinsic value of warrants outstanding as of June 30, 2026, was zero .
Schedule
of Information of Outstanding Warrants
Quantity of Warrants Outstanding as of
Description
June 30, 2026
December 31, 2025
Exercise Price
Expiration Date
Pre-IPO Series 1a Warrants
-
19
$ 49,200
3/14/2026
IPO Warrants
1,230
1,230
16,800
8/17/2026
IPO Underwriter Warrants
53
53
19,320
8/17/2026
March 2023 Offering Placement Agent Warrants
753
753
579.38
3/16/2028
May 2023 PIPE Placement Agent Warrants
371
371
428.45
5/23/2028
November 2023 Placement Agent Warrants
1,619
1,619
122.09
11/20/2028
May 2024 Series A Common Warrants
2,334
2,334
49.10
11/21/2029
May 2024 Placement Agent Warrants
3,613
3,613
64.50
11/21/2029
September 2024 PIPE Placement Agent Warrants
13,386
13,386
22.88
3/18/2030
January 2025 PIPE Warrants
80,051
80,051
12.70
7/15/2030
January 2025 Repriced PIPE Warrants
120,734
120,734
2.04
5/27/2031
January 2025 PIPE Placement Agent Warrants
14,053
14,053
15.88
7/15/2030
March 2025 Warrant Inducement Series A
498,080
498,080
12.84
7/15/2030
March 2025 Warrant Inducement Series B
468,813
468,813
12.84
1/15/2027
March 2025 Financial Advisor Warrants
33,840
33,840
16.05
7/15/2030
December 2025 PIPE Series C Warrants
2,022,062
2,022,062
2.04
5/27/2031
December 2025 PIPE Series D Warrants
2,022,062
2,022,062
2.04
5/27/2028
December 2025 PIPE Placement Agent Warrants
141,544
141,544
2.55
5/27/2031
Total warrants outstanding
5,424,598
5,424,617
Warrant
Inducements
In
March 2025, the Company entered into the March 2025 Inducement Letter with a Holder who agreed to exercise 483,447 warrants to purchase
Common Stock at a reduced exercise price of $ 12.84 per share in exchange for 498,080 New Series A Warrants and 468,813 New Series B Warrants
with an exercise price of $ 12.84 per share. The March 2025 Inducement Letter, which resulted in the lowering of the exercise price of
the Existing Warrants and the issuance of the New Warrants, is considered a modification of the Existing Warrants under the guidance
ASC 815-40. The modification is consistent with the equity issuance classification under that guidance as the reason for the modification
was to induce the holders of the Existing Warrants to cash exercise their warrants, which raised equity capital and generated net proceeds
of approximately $ 5.7 million. As the Existing Warrants and the New Warrants were classified as equity instruments before and after the
exchange, and as the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of
approximately $ 4.9 million as an equity issuance cost.
Warrant
Modification
In
connection with the December 2025 PIPE, the Company and certain holders of the Company’s outstanding warrants that participated
as investors in the January 2025 PIPE, agreed to amend certain outstanding warrants to purchase up to an aggregate of 120,734 shares
of the Company’s common stock that were previously issued on January 23, 2025, with an exercise price of $ 12.70 per share (which
exercise price reflects a 1-for-10 reverse stock split effected by the Company on August 1, 2025), effective upon the closing of the
December 2025 PIPE, such that the amended warrants have a reduced exercise price of $ 2.04 per share. The amended warrants are exercisable
and will expire five years from May 27, 2026. The modification of the January 2025 PIPE Warrants was accounted for as a modification
of equity-linked instruments. In accordance with ASC 815-40, as the warrants were classified as equity instruments before and after the
modification, and as the modification was directly attributable to an equity offering, the Company recognized the effect of the modification
of approximately $ 0.1 million as an equity issuance cost.
17
Placement
Agent Warrants
The
Company works with Wainwright to act as its investment bank for certain financing transactions. Per the terms of the Company’s
engagement letter with Wainwright, the Company pays compensation in the form of fees and reimbursed expenses, as well as the issuance
to Wainwright, or its designees, warrants to purchase Common Stock of the Company equal to 7.0% of aggregate number of Common Stock issued
in a related to the financing at an exercise price equal to 125% of the financing price.
5.
Equity Incentive Plan
Under
its 2021 Omnibus Equity Incentive Plan as amended (“2021 Plan”), the Company may grant options to purchase shares of Common
Stock, restricted stock awards, performance stock awards, incentive bonus awards, other cash-based awards or directly issue shares of
Common Stock to our employees, directors, and consultants. The five percent evergreen provision resulted in an additional 133,005 and
12,588 shares of Common Stock issuable pursuant to the 2021 Plan as of January 1, 2026, and 2025, respectively. In addition, on May 27,
2026, the Company’s shareholders approved an amendment to the Company’s 2021 Plan to increase the number of shares available
for issuance thereunder to 402,214 shares. As of June 30, 2026, there remained 252,712 shares reserved for issuance under the 2021 Plan,
as amended.
Stock
awards may be granted at an exercise price per share of not less than 100% of the fair market value at the date of grant. Stock awards
granted are exercisable over a maximum term of 10 years from the date of grant and generally vest over a period of four years for employees
and one year for directors of the Company’s Board and consultants.
On
March 9, 2026, the Company appointed a new Vice President of Marketing to help launch the Company’s Tome skincare line. Upon commencement
of employment, the new employee was provided a non-qualified stock option inducement grant to purchase up to 15,000 shares of the Company’s
Common Stock with an exercise price of $ 1.33 per share based upon the Company’s Nasdaq closing stock price on that day (the “Inducement
Award”). The Inducement Award was made outside of the Company’s 2021 Plan, was made in accordance with Nasdaq Listing Rule
5635(c)(4), and was unanimously approved by the Company’s Board of Directors. The terms and conditions of the Inducement Award
are substantially the same as those awards granted under the Company’s 2021 Plan, including a four-year vesting period.
Fair
Value Measurement
The
Company uses the Black-Scholes option valuation model, which requires the use of highly subjective assumptions, to determine the fair
value of stock-based awards. The fair value of each employee stock option is estimated on the grant date under the fair value method
using the Black-Scholes model. The estimated fair value of each stock option is then expensed over the requisite service period, which
is generally the vesting period. The assumptions and estimates that the Company uses in the Black-Scholes model are as follows:
●
Fair
Value of Common Stock. The fair value of Common Stock is measured as the Company’s closing price of Common Stock on the
date of grant.
●
Risk-Free
Interest Rate. The Company bases the risk-free interest rate used in the Black-Scholes valuation model on the implied yield available
on U.S. Treasury zero-coupon issues with a term equivalent to that of the expected term of the options.
●
Expected
Term. The expected term represents the period that the Company’s stock-based awards are expected to be outstanding, which
is calculated using the simplified method for stock-based awards granted to employees, as the Company has insufficient historical
information to provide a basis for an estimate. The simplified method calculates the expected term as the average of the vesting
term plus the contractual life of the options. As permitted under ASC 718, the Company has elected to use the contractual term as
the expected term for certain non-employee awards, on an award-by-award basis.
18
●
Volatility.
Beginning on January 1, 2026, based on the availability of sufficient historical trading data of the Company’s own common stock,
the Company determines the expected stock volatility based on its historical volatility. Prior to January 1, 2026, the Company lacked
sufficient historical trading history and, as such, determined volatility based on the historical volatilities of industry peers
that consisted of several public companies with comparable characteristics, including therapeutic indications.
●
Dividend
Yield. The expected dividend assumption is based on the Company’s current expectations about its anticipated dividend policy.
To date, the Company has not declared any dividends to common shareholders and, therefore, the Company has used an expected dividend
yield of zero.
The
Company granted stock options during the first quarter of 2026 and 2025. There were no stock option grants during the second quarter
of 2026 or 2025. The following table presents the weighted-average assumptions used for stock options granted during the following periods:
Schedule
of Weighted Average Assumptions used for Stock Options
2026
2025
Six
Months Ended June 30,
2026
2025
Grant date fair value
$ 1.91
$ 11.59
Risk-free interest rate
3.8 %
4.7 %
Dividend yield
0.00 %
0.00 %
Expected life in years
6.0
5.9
Expected volatility
135 %
110 %
Stock-based
Compensation Expense
In
general, stock-based compensation is allocated to research and development expense or selling, general and administrative expense according
to the classification of cash compensation paid to the employee, director, or consultant to whom the stock award was granted. The following
table summarizes the total stock-based compensation expense included in the Company’s statements of operations:
Schedule
of Stock Based Compensation Expense
2026
2025
2026
2025
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Research and development
$ 3,991
$ 8,100
$ 18,303
$ 15,720
Selling, general and administrative
37,789
31,134
66,755
60,702
Total
$ 41,780
$ 39,234
$ 85,058
$ 76,422
Stock
Option Award Activity
A
summary of the Company’s stock option activity (inclusive of the Inducement Award) is as follows:
Schedule
of Stock Option Activity
Number of
Options
Outstanding
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term (in
Years)
Balance at December 31, 2025
20,477
$ 25.27
8.9
Options granted
147,000
2.09
-
Options exercised
-
-
-
Options forfeited
( 3,066 )
6.00
-
Balance at June 30, 2026
164,411
$ 4.91
9.4
Options exercisable at June 30, 2026
17,666
$ 18.73
8.7
19
The
aggregate intrinsic value of options outstanding and exercisable as of June 30, 2026, is calculated as the difference between the exercise
price of the underlying options and the closing market price of the Company’s Common Stock on June 30, 2026, which was $ 1.29 per
share. The intrinsic value of options outstanding and exercisable as of June 30, 2026, was zero .
As
of June 30, 2026, total unrecognized compensation cost related to stock options was approximately $ 0.4 million and the weighted average
period over which this cost is expected to be recognized is 2.8 years.
6.
Commitments and Contingencies
Clinical
Trials
During
the first quarter of 2025, the Company announced top-line results from a Phase 3 STAR-1 clinical trial of XYNGARI™, formerly its
lead prescription candidate for the treatment of moderate-to-severe acne. The total contract amount with the clinical research organization
was approximately $ 7.0 million, and the contract extended from the fourth quarter of 2023 to the first half of 2025. During the six months
ended June 30, 2025, the Company recognized $ 0.7 million in research and development expense related to the clinical research organization
for the STAR-1 trial. No additional expense related to the Phase 3 STAR-1 clinical trial was incurred during the six months ended June
30, 2026.
Supplier
Agreement
On
February 27, 2020, the Company entered into an exclusive Supply Agreement (“Supplier Agreement”) with Reka-Farm, LLC (“Reka-Farm”),
whereby Reka-Farm will supply the Company with the Spongilla raw materials necessary for use in the development of our products.
The Supplier Agreement has an indefinite term unless and until terminated. The Supplier Agreement may be terminated (i) by either party
for material breach with 90 days written notice, if such material breach is not cured within such notice period and (ii) by the Company
for any reason or no reason upon 90 days written notice to Reka-Farm. For the term of the Supplier Agreement, Reka-Farm is prohibited
from supplying Spongilla for development and sale of any other product outside of the Russian Federation, other than Cosmetic
Products (as defined in the Supplier Agreement). Pursuant to the Supplier Agreement, the Company pays a pre-negotiated price per kilogram
for Spongilla supplied by Reka-Farm, and the Company is required to pay to Reka-Farm a royalty payment of less than one percent
of the Net Sales (as defined in the Supplier Agreement) of any products we develop containing Spongilla raw material supplied
by Reka-Farm.
As
a result of Russia’s invasion of Ukraine, the United States, the United Kingdom, and the European Union governments, among others,
have developed coordinated sanctions and export-control measure packages against Russian individuals and entities. The Company is currently
a party to an exclusive Supplier Agreement for the supply of the Spongilla raw material used in the Company’s Tome skincare
brand. The counterparty to this supply agreement, Reka-Farm, is a Russian entity. The imposition of enhanced export controls and economic
sanctions on transactions with Russia and Russian entities by the United States, the United Kingdom, and/or the European Union could
prevent the Company from performing under this existing contract or any future contract it may enter or may prevent the Company from
remitting payment for raw material purchased from the Company’s supplier. The Company has recently received a shipment of raw material
from its supplier after the implementation of export controls and sanctions, containing additional quantities of Spongilla raw
material, which the Company believes will provide the Company with sufficient quantities of Spongilla to support the planned launch
and sale of the Tome skincare products, based on current assumptions. While the Company plans to order additional shipments of raw materials
to support the commercial sales of its products, the timing of such order(s) is unknown. Depending on the extent and breadth of new sanctions
or export controls that may be imposed against Russia, otherwise or as a result of the impact of the war in Ukraine, it is possible that
the Company’s ability to obtain additional supply of the Spongilla raw material used in Tome skincare products could be
negatively impacted, which could adversely affect its business, results of operations, and financial condition.
Reka-Farm
is the sole supplier of the Company’s Spongilla raw materials used in its skincare products. The Company has evaluated other
suppliers of Spongilla from other regions of the world; however, no other supplier nor their Spongilla supply has met the
quality standards set forth by the Company’s manufacturing practices. An alternative source to supply Spongilla raw materials
could be the aquaculture of Spongilla in a lab setting, which could significantly increase the cost of raw materials as well as
the availability of raw materials due to the cost and time to develop and build an aquaculture infrastructure to supply Spongilla
in commercial quantities. If Reka-Farm is unavailable to supply Spongilla raw materials to the Company, it could adversely affect
its business, results of operations, and financial condition.
20
Collaboration
Agreement
On
January 17, 2025, the Company entered into a Clinical Trial Collaboration Agreement (the “Clinical Trial Agreement”) with
Revance Therapeutics, Inc. (“Revance”), pursuant to which the Company and Revance intend to conduct a multi-center clinical
trial (the “Trial”) to evaluate the topical application of Dermata Compound, the Company’s topical Spongilla powder
(formerly referred to as DMT310 or XYNGARI), with Daxxify (daxibotulinumtoxinA-lanm), Revance’s botulinum toxin type A. Pursuant
to the terms of the Clinical Trial Agreement, Revance has granted the Company a non-exclusive, worldwide, non-transferable, royalty-free
license, with a right to sublicense (subject to limitations), to use certain Revance intellectual property, solely as necessary or useful
for the Company to conduct the trial under the Clinical Trial Agreement. The Company has granted Revance a similar license to use Dermata
Compound (as defined in the Clinical Trial Agreement) and other compound(s) under the Clinical Trial Agreement. The Clinical Trial Agreement
will terminate upon completion of the Trial, the delivery of the data resulting from the Trial and the completion of any statistical
analyses of the data resulting from the Trial. Either party may terminate the Clinical Trial Agreement upon a material breach by the
other party that remains uncured following 30 days after the date of written notice of such breach. In addition, either party may terminate
the Clinical Trial Agreement immediately upon written notice if such party reasonably deems it necessary in order to protect the safety,
health or welfare of subjects enrolled in the Trial. The Company has agreed to sponsor, conduct, and fund the Phase 2a clinical trial,
but no financial obligations or consideration is contemplated in the Clinical Trial Agreement, and the Company has placed the Phase 2a
clinical trial on hold at this time.
License
Agreements
On
March 31, 2017, the Company entered into a license agreement, as amended (the “License Agreement”) with Villani, Inc. (“Villani”)
whereby Villani granted the Company an exclusive, sub-licensable, royalty-bearing license (the “License”) under the Licensed
Patents (as defined in the License Agreement), to formulate, develop, seek regulatory approval for, make or sell products that contained
Spongilla lacustris (alone or in combination with other active or inactive ingredients) for the treatment of diseases, disorders
and conditions of the skin, including but not limited to acne, rosacea, psoriasis, atopic dermatitis, seborrheic dermatitis, actinic
keratosis and eczema that were developed using certain licensed know-how (“Licensed Products”). The Company was responsible
for the development (including manufacturing, packaging, non-clinical studies, clinical trials and obtaining regulatory approval and
commercialization (including marketing, promotion, distribution, etc.)) for all Licensed Products. The original License Agreement was
amended in 2019, and pursuant to the amended License Agreement, the Company was required to make future milestone payments to Villani
in an aggregate amount of up to $ 20.25 million upon the achievement of specified development and sales milestones, payable in cash or
in equity, at the option of Villani, as well as single-digit royalty payments on net sales. On July 30, 2021, the Company further amended
the License Agreement in the Second Amendment to the License and Settlement Agreement (the “Second Amendment”). Pursuant
to the Second Amendment, the Company was required to make future milestone payments to Villani in an aggregate amount of up to $ 40.5
million upon the achievement of specified development and sales milestones, payable in cash or in equity, at the option of Villani, as
well as single-digit royalty payments on net sales. The Second Amendment includes customary terms relating to, among others, indemnification,
intellectual property protection, confidentiality, remedies, and warranties.
On
November 10, 2025, the Company received a notice of material breach and demand for cure (the “Notice”) from Villani alleging
that the Company breached the License Agreement as a result of the Company’s recent strategic shift to focus on DTC skincare products.
The Notice alleged that the Company (i) failed to use Commercially Reasonable Efforts (as defined in the License Agreement) to pursue
a prescription product business, (ii) failed to provide Villani with advance notice of certain submissions to regulatory authorities,
(iii) used Licensed Know-How (as defined in the License Agreement) outside of the Field (as defined in the License Agreement) and (iv)
the Company’s anticipated OTC kits did not qualify as Licensed Products (as defined in the License Agreement). On November 11,
2025, Villani delivered an additional notice to the Company (the “Additional Notice”) whereby Villani requested (i) the reversion
and assignment of all assets regarding Spongilla -based products back to Villani, (ii) that the Company preserve all Spongilla
inventory, and (iii) the Company preserve all documents, data, and tangible materials related to Spongilla . The Company disputes
the allegations contained in the Notice and the Additional Notice. As part of the Company’s strategic pivot in September 2025,
on November 17, 2025, the Company provided notice to terminate the License Agreement with an effective date of February 15, 2026. The
termination of the License Agreement was effective February 15, 2026 and the Company believes it has fulfilled its obligations under
the termination provisions of the License Agreement. As of June 30, 2026, the Company has not accrued any payments related to the Villani
Notices. See related additional disclosures under Legal Proceedings disclosure below.
21
Legal
Proceedings
On
April 23, 2026, Dermata was served with a complaint filed by Villani, Inc. (“Villani”) in the U.S. District Court for
the Central District of California (“Lawsuit”). The Lawsuit alleges the Company made false or misleading advertising statements
under the Lanham Act 15 USC §1125, breach of contract, and conversion, and seeks injunctive relief. In connection with the Lawsuit,
on April 26, 2026, Villani filed a motion seeking a temporary restraining order (“TRO”), and on June 18, 2026 filed a motion
seeking a preliminary injunction.
On
May 6, 2026, the court denied the TRO in part as related to Villani’s breach of contract and conversion claims, and granted the
TRO in part as related to certain of Villani’s false or misleading advertising claims, which imposed certain temporary restrictions
on specific statements the Company could make pending further proceedings. A hearing on Villani’s motion for a preliminary injunction
was held on July 16, 2026, and at that hearing the Court extended the TRO pending its decision.
On
August 5, 2026, the Court denied Villani’s motion for a preliminary injunction in its entirety and vacated the injunctive relief
granted in the TRO. As a result, the Company is not currently subject to any injunctive restrictions. In denying the motion, the Court
found that Villani was not likely to succeed on its Lanham Act, conversion, and declaratory judgment claims and that, although questions
exist going to the merits of Villani’s breach of contract claim, Villani had not established a likelihood of immediate irreparable
harm, and the balance of equities favored the Company. The Lawsuit remains pending, and Villani may continue to seek injunctive relief,
including a permanent injunction as the case proceeds.
On
June 5, 2026, Villani filed a Statement of Claims with the American Arbitration Association, commencing arbitration based on the same
conduct alleged in the Lawsuit (“Arbitration”). Villani alleges breach of contract, breach of the duty of good faith and
fair dealing, false advertising under the Lanham Act 15 USC § 1125, violation of California Business and Professions Code §§
17200, et seq., and conversion. Villani seeks money damages in the Arbitration.
At
this time, the Company is unable to reasonably estimate the likelihood of an unfavorable outcome or the amount or range of potential
loss, if any, that may result from this matter. Although the TRO has been vacated and Villani’s motion for a preliminary injunction
was denied, Villani continues to seek injunctive relief in the Lawsuit and money damages in the Arbitration. Any future injunctive relief,
or an arbitration award for damages, could have an adverse impact on the Company’s operations, financial condition, and results
of operations, particularly if any such restrictions were broad in scope or remained in place for an extended period.
The
Company will continue to monitor developments in this matter and will adjust its disclosures as appropriate.
Registration
Rights Agreements
In
connection with the January 2025 Private Placement, the Company entered into a registration rights agreement with the purchasers, dated
as of January 21, 2025, (the “January 2025 Registration Rights Agreement”). The January 2025 Registration Rights Agreement
provided that the Company shall file a registration statement covering the resale of all of the registrable securities with the SEC.
The registration statement on Form S-3 required under the Registration Rights Agreement was filed with the SEC on January 30, 2025, and
became effective on February 5, 2025.
In
connection with the December 2025 Private Placement, the Company entered into a registration rights agreement with the purchasers, dated
as of December 23, 2025, (the “December 2025 Registration Rights Agreement”). The December 2025 Registration Rights Agreement
provided that the Company shall file a registration statement covering the resale of all of the registrable securities with the SEC.
The registration statement on Form S-3 required under the December 2025 Registration Rights Agreement was filed with the SEC on January
22, 2026, and became effective on January 29, 2026.
Upon
the occurrence of any Event as defined in the January 2025 Registration Rights Agreement and the December 2025 Registration Rights Agreement,
which, among others, prohibits the purchasers from reselling the securities for more than ten consecutive calendar days or more than
an aggregate of fifteen calendar days during any 12-month period, and should the registration statement cease to remain continuously
effective, the Company would be obligated to pay to each purchaser, on each monthly anniversary of each such Event, an amount in cash,
as partial liquidated damages and not as a penalty, equal
to the product of 2.0% multiplied by the aggregate subscription amount paid by such purchaser in the Private Placement, up to a maximum
of 12% of the aggregate subscription amount. As of June 30, 2026, the Company accrued a settlement offer related to a liquidation damages claim, which is included
in accrued and other current liabilities.
22
7.
Segment Information
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision maker (“CODM”), in deciding how to allocate resources and in assessing performance. The Company and the
Company’s chief operating decision maker view the Company’s operations and manage its business in one operating segment,
which is the business of developing, branding, marketing, and commercializing direct to consumer skincare products.
The
CODM, who is the Chief Executive Officer (“CEO”), President, and Chairman of the Board, manages and allocates resources to
the operations of the Company on an entity-wide basis. The Company’s measure of segment profit or loss is net loss. Managing and
allocating resources on an entity-wide basis enables the CEO to assess the overall level of resources available and how to best deploy
these resources across functions that are in line with the Company’s long-term company-wide strategic goals. Consistent with this
decision-making process, the CEO uses financial information for purposes of evaluating performance, forecasting future period financial
results, allocating resources, and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The
CODM does not review assets in evaluating the results of the Company, and therefore, such information is not presented.
Given
the Company’s September 2025 strategic pivot to prioritize the development and distribution of Tome skincare products, the segment
information disclosure has been recast for all periods presented to reflect this change. The following table summarizes the segment’s
financial information including the Company’s significant segment expenses:
Schedule
of Segment Financial Information
2026
2025
2026
2025
Three
Months Ended June 30,
Six
Months Ended June 30,
2026
2025
2026
2025
Research and development
$
$
$
$
Clinical
78,263
( 20,676 )
78,263
705,645
Chemistry, manufacturing and controls and nonclinical
27,756
166,478
60,258
311,179
Personnel related
106,544
472,033
457,766
882,152
Total research and development
$ 212,563
$ 617,835
$ 596,287
$ 1,898,976
Selling, general and administrative
Compliance
1,289,233
755,020
2,301,029
1,474,664
Marketing
626,905
-
833,238
-
Commercial readiness
128,947
-
128,947
-
Personnel related
755,919
399,876
1,080,448
738,895
Total selling, general and administrative
$ 2,801,004
$ 1,154,896
$ 4,343,662
$ 2,213,559
Interest income
46,504
71,638
125,180
107,855
Net loss
$ ( 2,967,063 )
$ ( 1,701,093 )
$ ( 4,814,769 )
$ ( 4,004,680 )
8.
Related Party Transactions
In
September 2025, the Company entered into a Master Services Agreement with Wilder & Partners, LLC, currently doing business as Reunion
(“Reunion”), an agency that assists the Company in branding, marketing, and product design for the Company’s first
product launch, expected August 25, 2026. The founding partner of Reunion is the Company Chief Executive Officer’s son-in-law and,
as such, falls within the Company’s Policy and Procedures for Related Party Transactions. Accordingly, the Board of Directors,
inclusive of the Audit Committee, considered, reviewed, and unanimously approved the retention of Reunion as the branding agency, authorizing
management to negotiate and execute an agreement on terms substantially consistent with the proposal reviewed. For the three and six
months ended June 30, 2026, the Company incurred approximately $ 0.4 million and $ 0.6 million, respectively, of marketing expenses related
to Reunion, of which approximately $ 0.1 million was outstanding and included in accounts payable as of June 30, 2026. In addition, $ 0.1
million was outstanding and included in accounts payable and accrued and other current liabilities as of December 31, 2025.
In
connection with the January 2025 PIPE financing, certain Company insiders, including the Company’s CEO, Chief Financial Officer
and certain members of the Company’s board of directors, participated in the offering. These Company insiders purchased an aggregate
of 122,047 shares of Common Stock and Warrants to purchase up to an aggregate of 122,047 shares of Common Stock, for an aggregate purchase
price of $ 1.55 million. The purchase price per share and accompanying Warrant for these Company insiders was the same as paid by other
investors in the January 2025 PIPE. See Note 4 – Equity Securities.
In
connection with the December 2025 PIPE financing, certain Company insiders, including the Company’s CEO, CFO and certain members
of the Company’s management, participated in the offering. These Company insiders purchased an aggregate of 735,294 shares of Common
Stock and Warrants to purchase up to an aggregate of 1,470,588 shares of Common Stock, for an aggregate purchase price of $ 1.5 million.
The purchase price per share and accompanying Warrant for these Company insiders was the same as paid by other investors in the December
2025 PIPE. In addition, in connection with the December 2025 PIPE, the Company and certain holders of the Company’s outstanding
warrants who participated as investors in the January 2025 PIPE, including certain Company insiders, agreed to amend certain outstanding
warrants to purchase up to an aggregate of 120,734 shares of the Company’s common stock that were previously issued on January
23, 2025, with an exercise price of $ 12.70 per share (which exercise price reflects a one-for-10 reverse stock split effected by the
Company on August 1, 2025), effective upon the closing of the December 2025 PIPE, such that the amended warrants have a reduced exercise
price of $ 2.04 per share, which was the same exercise price as what other investors received in the December 2025 PIPE. The amended warrants
are exercisable subject to stockholder approval and will expire five years from May 27, 2026, the effective date of such stockholder
approval. See Note 4 – Equity Securities.
9.
Subsequent Events
On
August 5, 2026, the Court denied Villani’s motion for a preliminary injunction in its entirety and vacated the injunctive relief
granted in the TRO. As a result, the Company is not currently subject to any injunctive restrictions. See Note 6 – Legal Proceedings.
23
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 together with our financial statements
and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking
statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking
statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those
under “Risk Factors.”
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations,
assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which
may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future
results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of
historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our
use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,”
“would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,”
“continue,” “plan,” “point to,” “project,” “predict,” “could,”
“intend,” “target,” “potential” and other similar words and expressions of the future.
There
are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking
statement made by us. These factors include, but are not limited to:
●
our
lack of operating history;
●
the
expectation that we will incur significant operating losses for the foreseeable future and will need significant additional capital;
●
our
current and future capital requirements to support our development and commercialization efforts for our products and our ability
to satisfy our capital needs;
●
the
accuracy of our estimates regarding expenses, future revenues, capital expenditures, our need for additional financing and our anticipated
cash runway;
●
our
dependence on our products, which are still in various stages of development;
●
our
ability to acquire sufficient quantities of raw material needed to manufacture our products;
●
our,
or that of our third-party manufacturers, ability to manufacture current Good Manufacturing Practices (“cGMPs”) quantities
of our products as required to support commercial quantities of our products;
●
the
possibility that an over the counter (“OTC”) formulation, dosage, combinations, or indication will fall outside the scope
of applicable OTC monographs, will require new drug applications (“NDA”), or are otherwise challenged by the U.S. Food
and Drug Administration (“FDA”), state boards, or other regulators, any of which could delay or prevent launch and commercialization
or require reformulation, relabeling, additional testing, or other corrective actions;
●
the
possibility that positive clinical data are not predictive of consumer experience or commercial performance of a product;
24
●
our
ability to timely secure and scale manufacturing, packaging, and quality systems suitable for commercialization, including meeting
lot release, stability, shelf life, and container-closure requirements, and to manage product returns, recalls, or withdrawals if
quality issues arise;
●
our
ability to successfully execute our strategic pivot from Rx to direct-to-consumer (“DTC”), including our capacity to
design, formulate, manufacture, package and distribute products that comply with applicable federal, state and international requirements
and standards, including FDA OTC monographs, current good manufacturing practices applicable to our products, labeling and Drug Facts
requirements, and other enforcement policies;
●
our
ability to establish and maintain distribution and sales channels, including DTC e-commerce,
business-to-business (“B2B”) professional/clinic channels, and any retail partners,
and to manage channel economics, chargebacks, returns, and working capital needs;
●
our
ability to internally develop new inventions and intellectual property;
●
interpretations
of current laws and the passage of future laws;
●
impacts
of increased trade tariffs, import quotas or other trade restrictions or measures taken by the United States and other countries,
including the recent and potential changes in U.S. trade policies that may be made by the Trump presidential administration;
●
acceptance
of our business model by investors;
●
the
accuracy of our estimates regarding expenses and capital requirements; and
●
our
ability to adequately support organizational and business growth.
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipated in such forward-looking statements.
Please see “Part I—Item 1A—Risk Factors” for additional risks which could adversely impact our business and financial
performance.
All
forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by
reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking
statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections
in good faith and believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will
result or be achieved or accomplished.
Overview
We
are a scientific leader in skincare, dedicated to the development and commercialization of products that address common and underserved
skin conditions. Dermata initially was founded with a focus on researching and developing prescription products subject to the FDA approval
process. In September 2025, after an extensive review of current trends in dermatology, changing consumer preferences, additional non-clinical
and clinical development costs, and go-to market costs for a prescription, or Rx, acne product, management, with approval from our board
of directors, determined that a strategic shift to developing and distributing DTC and B2B skincare products, that are backed by science,
would be a better path to commercialization for the Company with potentially greater financial upside and faster time to market. We believe
we can leverage our history and knowledge of Rx dermatology to create skincare products that are effective and safe, and available to
consumers without the nuisance of obtaining a prescription. We believe this strategic repositioning will accelerate our path to commercialization,
reduce our regulatory burden, and decrease development expenses, all while enabling us to address broad consumer segments in the skincare
market.
25
We
believe the skincare market, from a cosmetic, and over-the-counter (“OTC”), and Rx perspective, has seen a substantial shift
towards consumers first relying upon multifaceted cosmetics and OTC products that simplify routines. Consumer preferences are changing
to favor natural products that do more for their skin. There appears to be a resurgence of interest in traditional remedies to help with
skin renewal and general cosmetic appearance. With consumers searching for multifunctional products to simplify their routines while
valuing brand loyalty and sustainable practices. We believe there remains a gap in the skincare market for in-office level treatments
that are available for home use and believe we have a product to fill this void. We believe that if we can provide consumers with a unique
topical skincare product, we have an opportunity to capture a large segment of consumers seeking to simplify their skincare routine without
needing to schedule an in-office visit with an aesthetician or a dermatologist. While this is a major shift in strategy for our company,
we believe pursuing the commercial sale of unique cosmetic skincare products is the best path forward to meet our mission of providing
consumers with efficacious and safe skincare treatment options.
We
view this shift in consumer preferences as a significant benefit for our strategic repositioning. We have gained substantial clinical
knowledge of various dermatology diseases and skin conditions or our years of developing prescription products. We plan to leverage this
knowledge to create a diversified product line of skincare treatments that consumers can access directly for each of their skincare needs.
While our background is in prescription products, we plan to leverage the unique attributes of our hero ingredient, Spongilla lacustris ,
to develop multiple skincare treatments for a variety of consumer and professional needs. We expect to launch our first cosmetic product,
our Tome Foundational Treatment, on August 25, 2026, with those on our waitlist being able to preorder early. In the future, we plan
to offer additional products that target specific needs of consumers. For example, for consumers who have more sensitive skin, we may
plan to commercialize a milder version of our Foundational Treatment that could be used more often.
Our
core products, like our Foundational Treatment, will utilize our Bioneedle, which is 100% Spongilla lacustris powder, to provide
a once-weekly, skin renewal routine that is a simple addition to skincare routines. This once weekly routine will contain our Bioneedle
which will be combined with a fluidizing agent for easy application. Our Bioneedle is derived from a wild harvested freshwater sponge,
Spongilla lacustris or Spongilla , which is processed into a fine, purified powder and packaged with no additives. Spongilla
is a unique freshwater sponge that only grows in commercial quantities in select regions of the world, which gives our Bioneedle
its distinctive properties. The combination of a proprietary harvesting protocol, developed by our exclusive supplier over 20 plus years
of harvesting, and the post-harvest processing procedures we developed, produces a cosmetic ingredient that we believe optimizes the
Bioneedle for a unique and simple skin renewal routine, unlike most skincare on the market.
We
also plan to sell directly to skincare professionals, like aestheticians and dermatologists, as we believe many consumers are still seeking
professional expertise for their skincare. We believe our Foundational Treatment is safe enough to be used at home but also powerful
enough for the office. This dual distribution channel will allow consumers to have the product applied in the manner they are most comfortable,
while allowing skincare professionals to provide additional services to their clients. The unique once weekly application schedule provides
flexibility to skincare professionals to tailor the treatment for each individual patient, whether that patient comes back weekly or
once a month while completing weekly applications at home. We believe our Foundational Treatment will provide skincare professionals
will a treatment option for patients that may be less intense than microneedling, lasers, or chemical peels, but offers patients the
skin renewal results they seek.
In
addition to in-office application for skin renewal, based on the mechanism of Bioneedle, we also believe there is a market for our technology
to aid in the intradermal delivery of macromolecules, like botulinum toxin, that must be applied by certified professionals. Currently
botulinum toxins are only approved for intramuscular injections of the face to reduce forehead, lateral canthal, and glabella deep lines.
However, we believe there is an untapped aesthetic market seeking needle free, topical applications of botulinum toxin for superficial
aesthetic conditions, like reducing fine lines, pore size, and sebum product or improving luminosity, brightness and overall aesthetic
appearance. Therefore, we believe developing a less painful, less time-consuming topical delivery of botulinum toxin into the dermis
for various aesthetic conditions, would provide physicians with an attractive alternative to intradermal injections of botulinum toxins.
While we have no current timeline for the launch of this program we plan to continue to explore additional uses for this platform and
look forward to getting our technology in the hands of aestheticians and dermatologists so they may better serve the medical and aesthetic
needs of their patients.
26
We
have taken steps to secure inventory of Spongilla raw material in advance of the planned launch of our Tome skincare products.
We believe we have sufficient quantities of processed Spongilla raw material inventory on hand to support the expected August
25, 2026, commercial launch and initial commercialization activities thereafter, based on our current operating plans, expected production
volumes and internal assumptions. We continue to evaluate additional inventory procurement opportunities and manufacturing planning activities
to support future commercial demand.
Recent
Developments
On
August 5, 2026, we announced the planned commercial launch date of our first direct-to-consumer skincare product, Foundational Treatment.
We expect to start selling the Foundational Treatment on August 25, 2026, with people on the waitlist getting early access to preorder.
The Foundational Treatment will contain 4 weekly treatments and will be priced at $178.00 USD retail, or about $45 per treatment.
Critical
Accounting Estimates
We
have based our management’s discussion and analysis of financial condition and results of operations on our financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial
statements requires us to make estimates, judgments, and assumptions that affect the reported amounts of assets and liabilities at the
date of the financial statements as well as the reported expenses during the reporting periods. On an ongoing basis, we evaluate our
estimates and judgments that are based on historical experience and on various other assumptions that we believe to be reasonable under
the circumstances. The result of these evaluations forms the basis for making judgments about the carrying values of assets and liabilities
and the reported amount of expenses that are not readily apparent from other sources. Actual results may differ from these estimates
under different assumptions or conditions.
Management
considers an accounting estimate to be critical if it requires a significant level of estimation uncertainty, and changes in the estimate
are reasonably likely to have a material effect on our financial condition or results of operations. There are items within our financial
statements that require estimation but are not deemed critical, as defined above. For a detailed discussion of our significant accounting
policies and related judgments, see Note 2 - Summary of Significant Accounting Policies to our unaudited financial statements contained
within this Form 10-Q.
Fluctuations
in Operating Results
Our
results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future.
We anticipate that our quarterly and annual results of operations will be impacted for the foreseeable future by several factors, including
the marketing expenses associated with the launch of our first Tome skincare products and resulting revenues, if any, in the second half
of 2026. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a good indication
of our future performance.
Results
of Operations
Three
Months Ended June 30, 2026, and 2025
The
following table summarizes our results of operations for the periods presented:
Three
Months Ended June 30,
2026
2025
Difference
Operating expenses:
Research and development
$ 212,563
$ 617,835
$ (405,272 )
Selling, general and administrative
2,801,004
1,154,896
1,646,108
Total operating expenses
3,013,567
1,772,731
1,240,836
Loss from operations
(3,013,567 )
(1,772,731 )
(1,240,836 )
Other income and expenses:
Interest income
46,504
71,638
(25,134 )
Net loss
$ (2,967,063 )
$ (1,701,093 )
$ (1,265,970 )
27
Research
and Development Expenses
Research
and development expenses decreased by $0.4 million from $0.6 million for the three months ended June 30, 2025, to $0.2 million for the
three months ended June 30, 2026. The decrease in research and development expenses resulted primarily from the Company’s decision
to prioritize the commercial launch of its first product, resulting in a decrease in research and development efforts during the three
months ended June 30, 2026. While we continue to focus on designing, packaging, and manufacturing of our first commercial products, as
well as product development, we anticipate that research and development expenses will continue to decrease as we prepare for launching
our first commercial product, expected on August 25, 2026.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses increased by approximately $1.6 million from $1.2 million for the three months ended June 30, 2025,
to $2.8 million for the three months ended June 30, 2026. The increase in selling, general and administrative expenses was primarily
attributable to the Company’s decision to prioritize the commercial launch of its first product, resulting in significant pre-launch
commercialization activities during the three months ended June 30, 2026. This resulted in an increase of $0.6 million of marketing and
other commercialization expenses and an increase of $0.3 million of compensation expense primarily due to a reallocation of employee
duties from research and development to selling, general and administrative expense, as a result of the shift in business focus towards
commercialization. In addition, legal fees increased by $0.7 million during the three months ended June 30, 2026, due to ongoing litigation
and other legal matters. We anticipate that selling, general and administrative expenses will continue to increase related to marketing,
branding, advertising, and personnel expenses as we continue to prepare for our first product launch in the third quarter
of 2026.
Other
Income and Expenses
We
earn interest income via overnight deposits on our cash and cash equivalents. Interest income was $47,000 for the second quarter of 2026
compared to $72,000 for the second quarter of 2025. The decrease in interest income resulted from decreased cash balances.
Six
Months Ended June 30, 2026, and 2025
The
following table summarizes our results of operations for the periods presented:
Six Months Ended June 30,
2026
2025
Difference
Operating expenses:
Research and development
$ 596,287
$ 1,898,976
$ (1,302,689 )
Selling, general and administrative
4,343,662
2,213,559
2,130,103
Total operating expenses
4,939,949
4,112,535
827,414
Loss from operations
(4,939,949 )
(4,112,535 )
(827,414 )
Other income and expenses:
Interest income
125,180
107,855
17,325
Net loss
$ (4,814,769 )
$ (4,004,680 )
$ (810,089 )
Research
and Development Expenses
Research
and development expenses decreased by $1.3 million from $1.9 million for the six months ended June 30, 2025, to $0.6 million for the
six months ended June 30, 2026. The decrease in research and development expenses resulted from $0.6 million of decreased clinical expenses
from the XYNGARI™ STAR-1 acne study, which was completed during the second quarter of 2025. Additionally, research and development
expenses decreased another $0.7 million, as a result of the Company’s decision to prioritize the commercial launch of its first
product, resulting in a decrease in research and development efforts during the six months ended June 30, 2026.
28
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses increased by $2.1 million from $2.2 million for the six months ended June 30, 2025, to $4.3 million
for the six months ended June 30, 2026. The increase in selling, general and administrative expenses was primarily attributable to the
Company’s decision to prioritize the commercial launch of its first product, resulting in significant pre-launch commercialization
activities during the six months ended June 30, 2026. This resulted in an increase of $0.9 million of marketing and other commercialization
expenses and an increase of $0.3 million of compensation expense primarily due to a reallocation of employee duties from research and
development to selling, general and administrative expense, as a result of the shift in business focus towards commercialization. In
addition, legal fees increased by $0.8 million during the six months ended June 30, 2026, due to ongoing litigation and other legal matters,
and audit fees increased by $0.1 million.
Other
Income and Expenses
We
earn interest income via overnight deposits on our cash and cash equivalents. Interest income was $125,000 for the six months ended June
30, 2026 compared to $108,000 for the six months June 30, 2025. The increase of $17,000 in interest income resulted primarily from interest
received related to the Employee Retention Tax Credit payments received during the first quarter of 2026.
Cash
Flows
The
following table summarizes our cash flows from operating and financing activities:
Six
Months Ended June 30,
2026
2025
Statements of cash flows data:
Total net cash provided by (used in):
Operating activities
$ (4,901,246 )
$ (4,624,547 )
Investing activities
$ (110,667 )
$ -
Financing activities
$ 1,902,699
$ 7,943,907
Increase (decrease) in cash and cash equivalents
$ (3,109,214 )
$ 3,319,360
Operating
activities
Cash
used in operations of approximately $4.9 million for the six months ended June 30, 2026, was the result of the net loss of $4.8 million
as well as increases in prepaid and other current assets of $0.3 million and increased inventories of $0.1 million, as well as a decrease
accrued and other current liabilities of approximately $0.5 million, partially offset by an increase in accounts payable of $0.7 million
and non-cash stock-based compensation of $0.1 million.
Cash
used in operations of $4.6 million for the six months ended June 30, 2025, was the result of the net loss of $4.0 million and decreases
in accounts payable and accrued and other current liabilities of approximately $0.9 million, partially offset by the decrease of prepaid
expenses and other current assets of approximately $0.2 million and non-cash stock-based compensation of $0.1 million.
Investing
activities
Cash
used in investing activities of $0.1 million for the six months ended June 30, 2026 consisted of the purchases of property and equipment.
29
Financing
activities
Cash
provided by financing activities of $1.9 million for the six months ended June 30, 2026, was the result of approximately $2.0 million
in net proceeds from ATM sales during the first quarter of 2026, partially offset by approximately $0.1 million of payments for issuance-related
costs from the December 2025 PIPE financing.
Cash
provided by financing activities of $7.9 million for the six months ended June 30, 2025, was the result of the January 2025 PIPE financing
which raised net proceeds of $2.2 million, and the March 2025 Inducement financing which raised net proceeds of $5.7 million.
Liquidity
and Capital Resources
Since
our inception, we have not generated any revenue or commercialized any products. As of June 30, 2026, our cash and cash equivalents totaled
$4.4 million, and we had an accumulated deficit of $78.0 million. For the six months ended June 30, 2026, and the year ended December
31, 2025, we used cash of $4.9 million and approximately $7.8 million, respectively, in operations. We expect our current cash resources
to fund operations into the fourth quarter of 2026.
We
anticipate that we will continue to incur net losses for at least the next twelve months from the date of this filing. While we plan
to launch our first DTC product, expected on August 25, 2026, it is uncertain when we will generate operating income to sustain operations, if
ever. These factors raise substantial doubt about our ability to continue as a going concern for the one-year period following the date
that these financial statements were issued.
Historically,
our principal sources of cash have included proceeds from the issuance of equity securities. Our principal uses of cash have been for
operations, and we expect that the principal uses of cash in the future will be for continuing operations, including various marketing
expenditures, including, but not limited to, branding, paid media, marketing use studies, advertising, software subscriptions, and launch
events and tradeshows, as well as non-marketing expenses including funding of research and development, and general working capital requirements.
We expect that as marketing expenses continue to grow, we may need to raise additional capital to sustain operations.
Future
Capital Requirements
We
plan to focus our efforts in the near term on the development and commercialization of our Tome skincare product, our Foundational Treatment.
We anticipate we will continue to incur net losses for the foreseeable future as we complete the launch of our Tome Foundational Treatment
and ramp up marketing activities. We also plan to invest in developing additional skincare products to add to our portfolio that complement
our Foundational Treatment. In addition, we plan to seek opportunities to identify, acquire or in license and develop additional skincare
candidates, potentially expand commercial capabilities, and expand our corporate infrastructure. We may not be able to complete the development
and initiate commercialization of these programs without raising additional capital.
Our
primary uses of capital are, and we expect will continue to be, compensation and related expenses, marketing and advertising expenses,
external research, development and manufacturing costs, legal and other regulatory expenses, and administrative and overhead costs. Our
future funding requirements will be heavily dependent upon any product revenues generated from our first product launch, of which we
cannot estimate at this time, as well as the resources needed to support additional development of future products.
We
believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements
into the fourth quarter of 2026. We have based this estimate of cash runway on assumptions that may prove to be wrong, and we could utilize
our available capital resources sooner than we expect. We may require additional capital to continue to commercialize our Tome skincare
products, and to pursue in-licenses or acquisitions of other drug candidates. Accordingly, beyond our current cash and any proceeds from
the sales of our common stock pursuant to the ATM Agreement, if any, we will require substantial additional financing to support our
operations. We expect our expenses and capital requirements to increase in connection with our ongoing activities, including the commercial
launch of our first Tome skincare products.
Additional
funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable
us to continue to implement our long-term business strategy. If we are unable to raise sufficient additional capital, we may need to
substantially curtail our planned operations and the pursuit of our growth strategy.
30
We
may raise additional capital through the sale of equity or convertible debt securities. In such an event, the terms of these securities
may include liquidation or other preferences that adversely affect the rights of a holder of our common stock.
Because
of the numerous risks and uncertainties associated with launching our first products, as well as any revenues generated from those products,
we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on many factors,
including:
●
the
number and characteristics of the skincare products we pursue;
●
the
scope, progress, results, and costs of developing our products, and marketing such products if commercialized;
●
the
timing of, and the costs involved in, launching our products;
●
the
cost of manufacturing our products and any products we successfully commercialize;
●
our
ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;
●
the
costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims, including litigation costs
and the outcome of such litigation; and
●
the
timing, receipt and amount of revenues, if any, or milestone payments related to or royalties on, our current or future products,
if any.
We
continue to refocus our business on skincare products and other operations and potential product acquisitions and in-licensing. We have
evaluated and expect to continue to evaluate a wide array of strategic transactions as part of our plan to acquire or in-license and
develop additional products to add to our Tome skincare brand. Strategic transaction opportunities that we may pursue could materially
affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both. Accordingly,
we expect to continue to opportunistically seek access to additional capital to license or acquire additional products or companies to
expand our Tome skincare brand and operations, or for general corporate purposes. Strategic transactions may require us to raise additional
capital through one or more public or private debt or equity financings or could be structured as a collaboration or partnering arrangement.
We have no arrangements, agreements, or understandings in place at the present time to enter into any acquisition, in licensing or similar
strategic business transaction.
If
we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, would
result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to
take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional
equity that we raise may contain terms, such as liquidation and other preferences that are not favorable to us or our stockholders. If
we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable
rights to our technologies, future revenue streams or products or to grant licenses on terms that may not be favorable to us.
We
cannot be certain that additional funding will be available on acceptable terms, or at all. In addition, future debt financing into which
we enter may impose upon us covenants that restrict our operations, including limitations on our ability to incur liens or additional
debt, pay dividends, redeem our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions.
31
If
we are unable to raise additional capital when required or on acceptable terms, we may be required to significantly delay, scale back
or discontinue the development and commercialization of one or more of our products, restrict our operations or obtain funds by entering
into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and our relationships
with third parties with whom we have business relationships, at least until additional funding is obtained. If we do not have sufficient
funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that would likely result in our
stockholders losing some or all of their investment in us. In addition, our ability to achieve profitability or to respond to competitive
pressures would be significantly limited.
Going
Concern
Since
inception, we have devoted substantially all of our resources to research and development activities, and during 2026, on marketing and
other pre-launch commercial activities in preparation of its first product launch. In September 2025, we made a strategic pivot from
research and developing prescription products to becoming a science-driven leader in dermatologic solutions, anticipating our first DTC
product launch from our Tome skincare brand, expected on August 25, 2026. We have not generated revenues and have not yet achieved profitable operations,
nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations, if achieved, could be
sustained on a continuing basis. In addition, we operate in an environment of rapid technological change, and we are largely dependent
on the services of our employees and consultants. Further, our future operations are dependent on the success of our efforts to raise
additional capital. These uncertainties raise substantial doubt about our ability to continue as a going concern for 12 months after
the issuance date of our financial statements. The accompanying financial statements have been prepared on a going concern basis. The
financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of
assets or the amounts and classification of liabilities that may result from the possible inability of the company to continue as a going
concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course
of business. We incurred a net loss of $4.8 million for the six months ended June 30, 2026, and had an accumulated deficit of $78.0 million
as of June 30, 2026. We anticipate incurring additional losses until such time, if ever, we can generate sufficient revenue from our
products currently in development, or products we are in the process commercializing. Our primary source of capital has been the issuance
of equity and equity-linked securities.
JOBS
Act Accounting Election
On
April 5, 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was signed into law. The JOBS Act contains provisions
that, among other things, reduce certain reporting requirements for an “emerging growth company”. As an “emerging growth
company,” we elected not to take advantage of the extended transition period afforded by the JOBS Act for the implementation of
new or revised accounting standards, and as a result, we will comply with new or revised accounting standards on the relevant dates on
which adoption of such standards is required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision
not to take advantage of the extended transition period is irrevocable.
Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we are not required to, among other things,
(i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404,
(ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall
Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight
Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the
audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items
such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation
to median employee compensation. These exemptions will apply until the fifth anniversary of the completion of our initial public offering,
which would be August 2026, or until we no longer meet the requirements for being an “emerging growth company,” whichever
occurs first.
32
Recent
Accounting Pronouncements
See
Item 1 of Part I, “Notes to Financial Statements — Note 2 — Summary of Significant Accounting Policies” for a
discussion of recent accounting pronouncements.
ITEM
3: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4: CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures as of June 30, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e)
and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required
to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported,
within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal
financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management
necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based
on the evaluation of our disclosure controls and procedures as of June 30, 2026, our Chief Executive Officer and Chief Financial Officer
concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Evaluation
of Changes in Internal Control over Financial Reporting
There
was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during
the most recent quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. From time to time, we make
changes to our internal control over financial reporting that are intended to enhance its effectiveness and which do not have a material
effect on our overall internal control over financial reporting.
33
PART
II – OTHER INFORMATION
ITEM
1: LEGAL PROCEEDINGS
On
April 23, 2026, Dermata was served with a complaint filed by Villani, Inc. (“Villani”) in the U.S. District Court for
the Central District of California (“Lawsuit”). The Lawsuit alleges the Company made false or misleading advertising statements
under the Lanham Act 15 USC § 1125, breach of contract, and conversion, and seeks injunctive relief. In connection with the Lawsuit,
on April 26, 2026, Villani filed a motion seeking a temporary restraining order (“TRO”), and on June 18, 2026 filed a motion
seeking a preliminary injunction.
On
May 6, 2026, the court denied the TRO in part as related to Villani’s breach of contract and conversion claims, and granted the
TRO in part as related to certain of Villani’s false or misleading advertising claims, which imposed certain temporary restrictions
on specific statements the Company could make pending further proceedings. A hearing on Villani’s motion for a preliminary injunction
was held on July 16, 2026, and at that hearing the Court extended the TRO pending its decision.
On
August 5, 2026, the Court denied Villani’s motion for a preliminary injunction in its entirety and vacated the injunctive relief
granted in the TRO. As a result, the Company is not currently subject to any injunctive restrictions. In denying the motion, the Court
found that Villani was not likely to succeed on its Lanham Act, conversion, and declaratory judgment claims and that, although questions
exist going to the merits of Villani’s breach of contract claim, Villani had not established a likelihood of immediate irreparable
harm and the balance of equities favored the Company. The Lawsuit remains pending, and Villani may continue to seek injunctive relief,
including a permanent injunction, and damages as the case proceeds.
On
June 5, 2026, Villani filed a Statement of Claims with the American Arbitration Association, commencing arbitration based on the same
conduct alleged in the Lawsuit (“Arbitration”). Villani alleges breach of contract, breach of the duty of good faith and
fair dealing, false advertising under the Lanham Act 15 USC § 1125, violation of California Business and Professions Code §§
17200, et seq., and conversion. Villani seeks money damages in the Arbitration.
At
this time, the Company is unable to reasonably estimate the likelihood of an unfavorable outcome or the amount or range of potential
loss, if any, that may result from this matter. Although the TRO has been vacated and Villani’s motion for a preliminary injunction
was denied, Villani continues to seek injunctive relief and damages in the Lawsuit and money damages in the Arbitration. Any future injunctive
relief, or an arbitration award for damages, could have an adverse impact on the Company’s operations, financial condition, and
results of operations, particularly if any such restrictions were broad in scope or remained in place for an extended period.
The
Company will continue to monitor developments in this matter and will adjust its disclosures as appropriate.
ITEM
1A: RISK FACTORS
Our
operations and financial results are subject to various risks and uncertainties, including those described in Part I, Item 1A, “Risk
Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026. No material
changes to such risk factors have occurred during the six months ended June 30, 2026, except as described below:
We
are involved in litigation with Villani, Inc. relating to our Spongilla-based products and commercialization activities, which could
adversely affect our business, operations, financial condition and ability to commercialize our products.
On
April 23, 2026, Villani, Inc. (“Villani”) filed a complaint against us in the U.S. District Court for the Central District
of California asserting claims for false advertising under the Lanham Act, breach of contract, and conversion, and seeking injunctive
relief (the “Lawsuit”). On June 5, 2026, Villani filed a Statement of Claims with the American Arbitration Association, commencing
arbitration based on the same conduct alleged in the Lawsuit (“Arbitration”). Villani alleges breach of contract, breach
of the duty of good faith and fair dealing, false advertising under the Lanham Act 15 USC § 1125, violation of California Business
and Professions Code §§ 17200, et seq., and conversion. Villani seeks money damages in the Arbitration.
34
In
connection with the litigation, Villani sought a temporary restraining order (“TRO”) and preliminary injunction in the
Lawsuit. On May 6, 2026, the Court denied the TRO in part related to the breach of contract and conversion claims and granted the
TRO in part on the false or misleading advertising statements, which imposed certain temporary restrictions on specific statements
the Company could make pending further proceedings. On August 5, 2026, the Court denied Villani’s motion for a preliminary
injunction and vacated the injunctive relief granted in the TRO, and the company is not currently subject to any injunctive
restrictions. In denying the motion, the Court found that questions exist going to the merits of Villani’s breach of contract
claim, but that Villani had not established a likelihood of immediate irreparable harm and that the balance of equities favored the
Company. Villani continues to seek permanent injunctive relief in the Lawsuit and money damages in the Arbitration. We are
vigorously defending ourselves against these claims; however, litigation and arbitration proceedings are inherently uncertain,
costly, and time-consuming.
While
we are not currently restrained from manufacturing, promoting, advertising, using, selling, offering for sale, distributing, or delivering
in commerce any product or regimen containing Spongilla , if Villani were to obtain injunctive relief at a later stage of the Lawsuit,
an arbitration award, or otherwise, we could be restricted or delayed in our ability to market, manufacture, distribute, advertise, sell,
or commercialize certain of our current or planned products, including products containing our Spongilla . Such restrictions could
disrupt our planned product launches, impair relationships with suppliers, manufacturers, distributors, marketing partners, or customers,
require us to modify our products, branding, formulations, or marketing claims, or otherwise adversely affect our commercialization strategy.
In addition, defending this matter may require significant management attention and financial resources, result in substantial legal
expenses, divert resources from our business operations and strategic initiatives, and expose us to reputational harm.
Our
failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.
Our
common stock is currently listed on the Nasdaq Capital Market. Continued listing of a security on Nasdaq Capital Market is conditioned
upon compliance with various continued listing standards. In the past, we have received notices from Nasdaq’s Listing Qualifications
Department indicating that we had not complied with certain of the Nasdaq Capital Market’s continued listing standards. While we
have regained compliance for each instance, there can be no assurance that we will continue to maintain compliance with the Nasdaq listing
requirements.
Upon
approval of the Securities and Exchange Commission, Nasdaq amended its listing rules on July 22, 2026, to provide that where a
listed company fails to meet the continued listing requirement for market value of listed securities of at least $5 million for 30
consecutive business days, such deficiency will result in immediate suspension and delisting, bypassing typical grace periods and
restricting appeal rights (the “MVLS Requirement”). On July 29, 2026, the SEC’s Division of Trading and
Markets confirmed that it had received notices of intention to petition the full SEC for review of the approval, which automatically
stayed the order implementing the rule pending further action from the SEC. This process is pending as of the filing date of this
Quarterly Report on Form 10-Q with no prescribed timeline for SEC action. As of the time of this filing, our market value of listed
securities is currently below $5 million. Because we are currently below the $5 million threshold, if and when the
MVLS Requirement becomes effective, we may become subject to immediate suspension and delisting, without any opportunity to
cure, if our market value of listed securities remains below $5 million for 30 consecutive business days.
A
delisting could substantially decrease trading in our common stock, adversely affect the market liquidity of our common stock as a result
of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws, adversely affect
our ability to obtain financing on acceptable terms, if at all, and may result in the potential loss of confidence by investors, suppliers,
and employees and lead to fewer business development opportunities. Additionally, the market price of our common stock may decline further,
and stockholders may lose some or all of their investment.
In
the event of a delisting, we anticipate that we would take actions to restore our compliance with the Nasdaq Capital Market or another
national exchange’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common
stock to remain listed on the Nasdaq Capital Market, stabilize our market price, improve the liquidity of our common stock, or prevent
future non-compliance with the Nasdaq Capital Market or another national exchange’s listing requirements.
ITEM
2: UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3: DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4: MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5: OTHER INFORMATION
Rule
10b5-1 Trading Plans
During
the fiscal quarter ended June 30, 2026, no director or “officer” (as defined in Rule 16a-1(f) under the Exchange Act) of
the Company adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,”
as each term is defined in Item 408(c) of Regulation S-K.
35
ITEM
6: EXHIBITS
Exhibit
No.
Description
10.1
Fourth Amendment to the Dermata Therapeutics, Inc. 2021 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 27, 2026).
31.1*
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).
31.2*
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).
32.1**
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b).
101.INS*
XBRL
Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
*
Filed herewith.
**
Furnished, not filed.
36
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.
Dermata
Therapeutics, Inc.
Date:
August 11, 2026
By:
/s/
Gerald T. Proehl
Gerald
T. Proehl
President
and Chief Executive Officer
(Principal
Executive Officer)
By:
/s/
Kyri K. Van Hoose
Kyri
K. Van Hoose
Senior
Vice President, Chief Financial Officer
(Principal
Financial Officer and Principal Accounting Officer)
37
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