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, 2025
☐
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 001-41210
THARIMMUNE,
INC.
(Exact
name of registrant as specified in charter)
Delaware
84-2642541
(State
or jurisdiction of
Incorporation
or organization)
I.R.S.
Employer
Identification
No.
34
Shrewsbury Ave , Suite 1C , Red Bank , NJ
07701
(Address
of principal executive offices)
(Zip
code)
(732)
889-3111
(Registrant’s
telephone number, including area code)
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, $0.0001 par value
THAR
The
Nasdaq Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Number
of common shares outstanding as of August 11, 2025 was 4,635,251 .
TABLE
OF CONTENTS
Page
No.
PART
I – FINANCIAL INFORMATION
ITEM
1.
FINANCIAL
STATEMENTS
Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024
F-1
Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)
F-2
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)
F-3
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 (Unaudited)
F-4
Notes to Condensed Consolidated Financial Statements
F-5
ITEM
2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
4
ITEM
3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
12
ITEM
4.
CONTROLS AND PROCEDURES
13
PART II – OTHER INFORMATION
13
ITEM
1.
LEGAL PROCEEDINGS
13
ITEM
1A.
RISK FACTORS
13
ITEM
2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
13
ITEM
3.
DEFAULTS UPON SENIOR SECURITIES
14
ITEM
5.
OTHER INFORMATION
14
ITEM
6.
EXHIBITS
14
SIGNATURES
15
2
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This
Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A
of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,”
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other
comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections
about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually
achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements
involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:
●
our
projected financial position and estimated cash burn rate;
●
our
estimates regarding expenses, future revenues and capital requirements;
●
our
ability to continue as a going concern;
●
our
need to raise substantial additional capital to fund our operation;
●
the
success, cost and timing of our clinical trials;
●
our
dependence on third parties in the conduct of our clinical trials;
●
our
ability to obtain the necessary regulatory approvals to market and commercialize our product candidates;
●
the
impact of a health epidemic on our business, our clinical trials, our research programs, healthcare systems, or the global economy
as a whole;
●
the
potential that results of pre-clinical and clinical trials indicate our current product candidates or any future product candidates
we may seek to develop are unsafe or ineffective;
●
the
results of market research conducted by us or others;
●
our
ability to obtain and maintain intellectual property protection for our current and future product candidates;
●
our
ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce
or protect our intellectual property rights;
●
the
possibility that a third party may claim we or our third-party licensors have infringed, misappropriated or otherwise violated their
intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against
claims against us;
●
our
reliance on third-party suppliers and manufacturers;
●
the
success of competing therapies and products that are or become available;
●
our
ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel;
●
the
potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product
liability lawsuits to cause us to limit our commercialization of our product candidates;
●
market
acceptance of our product candidates, the size and growth of the potential markets for our current product candidates and any future
product candidates we may seek to develop, and our ability to serve those markets;
●
the
successful development of our commercialization capabilities, including sales and marketing capabilities; and
●
general
business and economic conditions, such as inflationary pressures, geopolitical conditions and other trade barriers.
All
of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ
materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will
prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties
referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other
documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially
and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake
or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or
projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form
10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public
statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements
contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form
10-Q.
This
Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company
surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications,
articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained
therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed.
While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party
sources.
3
THARIMMUNE,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30, 2025
December 31, 2024
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents
$ 2,241,980
$ 3,559,361
Prepaid expenses and other current assets
196,018
45,263
Deferred offering costs
92,168
117,000
Total current assets
2,530,166
3,721,624
Total assets
$ 2,530,166
$ 3,721,624
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable
$ 770,610
$ 1,089,666
Accrued expenses
1,057,941
1,324,316
Insurance premium financing liability
84,540
-
Note payable
249,716
-
Total current liabilities
2,162,807
2,413,982
Total liabilities
2,162,807
2,413,982
Commitments and contingencies (see Note 5)
-
Stockholders’ equity
Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding as of June 30, 2025 and December 31, 2024
-
-
Common stock, $ 0.0001 par value, 250,000,000 shares authorized, 4,221,166 shares and 1,973,999 shares issued and 4,220,920 shares and 1,973,753 shares outstanding as of June 30, 2025 and December 31, 2024, respectively
422
198
Additional paid-in capital
41,734,853
38,278,503
Accumulated deficit
( 41,297,951 )
( 36,901,094 )
Treasury stock, at cost, 246 shares held in treasury as of June 30, 2025 and December 31, 2024
( 69,965 )
( 69,965 )
Total stockholders’ equity
367,359
1,307,642
Total liabilities and stockholders’ equity
$ 2,530,166
$ 3,721,624
The
accompanying notes are an integral part of these condensed consolidated financial statements.
F- 1
THARIMMUNE,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
2025
2024
2025
2024
For the Three Months
Ended June 30,
For the Six Months
Ended June 30,
2025
2024
2025
2024
Operating expenses
Research and development
$ 546,204
$ 999,553
$ 1,140,274
$ 2,024,811
General and administrative
1,304,956
1,373,901
3,257,555
2,695,946
Total operating expenses
1,851,160
2,373,454
4,397,829
4,720,757
Loss from operations
( 1,851,160 )
( 2,373,454 )
( 4,397,829 )
( 4,720,757 )
Other income (expense)
Interest expense
( 6,161 )
( 5,217 )
( 14,632 )
( 9,917 )
Interest income
2,168
53,614
15,604
149,508
Total other income (expense), net
( 3,993 )
48,397
972
139,591
Net loss
$ ( 1,855,153 )
$ ( 2,325,057 )
$ ( 4,396,857 )
$ ( 4,581,166 )
Net loss per share:
Basic and diluted
$ ( 0.64 )
$ ( 2.42 )
$ ( 1.61 )
$ ( 4.96 )
Weighted average number of common shares outstanding*:
Basic and diluted
2,877,327
962,149
2,725,863
923,916
*
Amounts
have been retroactively restated to reflect the 1-for-15 reverse stock split effectuated on May 24, 2024 (See Note 2 to the condensed
consolidated financial statements).
The
accompanying notes are an integral part of these condensed consolidated financial statements.
F- 2
THARIMMUNE,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2025 AND 2024 (UNAUDITED)
Shares
Amount
Capital
Deficit
Shares
Amount
Total
Additional
Common Stock
Paid-in
Accumulated
Treasury Stock
Shares
Amount
Capital
Deficit
Shares
Amount
Total
For the three months ended June 30, 2024:
Balance, March 31, 2024 *
888,054
$ 90
$ 34,078,917
$ ( 26,959,635 )
246
$ ( 69,965 )
$ 7,049,407
Private investment in public equity offering, net of issuance costs of $ 268,250
207,292
21
1,815,890
-
-
-
1,815,911
Net loss
-
-
-
( 2,325,057 )
-
-
( 2,325,057 )
Stock based compensation
-
-
153,647
-
-
-
153,647
Balance, June 30, 2024
1,095,346
$ 111
$ 36,048,454
$ ( 29,284,692 )
246
$ ( 69,965 )
$ 6,693,908
For the six months ended June 30, 2024:
Balance, December 31, 2023 *
884,720
$ 89
$ 33,904,749
$ ( 24,703,526 )
246
$ ( 69,965 )
$ 9,131,347
Stock issuance pursuant to services agreement
3,334
1
20,549
-
-
-
20,550
Private investment in public equity offering, net of issuance costs of $ 268,250
207,292
21
1,815,890
-
-
-
1,815,911
Net loss
-
-
-
( 4,581,166 )
-
-
( 4,581,166 )
Stock based compensation
-
-
307,266
-
-
-
307,266
Balance, June 30, 2024
1,095,346
$ 111
$ 36,048,454
$ ( 29,284,692 )
246
$ ( 69,965 )
$ 6,693,908
For the three months ended June 30, 2025:
Balance, March 31, 2025
2,108,999
$ 211
$ 38,697,881
$ ( 39,442,798 )
246
$ ( 69,965 )
$ ( 814,671 )
Private investment in public equity offering, net of issuance costs of $ 240,000
1,551,351
155
2,259,845
-
-
-
2,260,000
At-the-market offerings, net of issuance costs
163,359
16
219,531
-
-
-
219,547
Cashless exercise of pre-funded warrants
391,157
39
( 39 )
-
-
-
-
Issuance costs related to Form S-8 Options Registration Statement
-
-
( 10,000 )
-
-
-
( 10,000 )
Stock issuance pursuant to termination agreement
6,300
1
8,252
-
-
-
8,253
Net loss
-
-
-
( 1,855,153 )
-
-
( 1,855,153 )
Stock based compensation
-
-
559,383
-
-
-
559,383
Balance, June 30, 2025
4,221,166
$ 422
$ 41,734,853
$ ( 41,297,951 )
246
$ ( 69,965 )
$ 367,359
For the six months ended June 30, 2025:
Balance, December 31, 2024
1,973,999
$ 198
$ 38,278,503
$ ( 36,901,094 )
246
$ ( 69,965 )
$ 1,307,642
Balance
1,973,999
$ 198
$ 38,278,503
$ ( 36,901,094 )
246
$ ( 69,965 )
$ 1,307,642
Private investment in public equity offering, net of issuance costs of $ 240,000
1,551,351
155
2,259,845
-
-
-
2,260,000
Private investment in public equity offering, net of issuance costs
1,551,351
155
2,259,845
-
-
-
2,260,000
At-the-market offerings, net of issuance costs
163,359
16
219,531
-
-
-
219,547
Cashless exercise of pre-funded warrants
491,157
49
( 49 )
-
-
-
-
Stock issuance pursuant to bonus liability
-
-
200,212
-
-
-
200,212
Restricted stock unit issuance pursuant to service agreement
35,000
3
( 3 )
-
-
-
-
Issuance costs related to Form S-8 Options Registration Statement
-
-
( 10,000 )
-
-
-
( 10,000 )
Stock issuance pursuant to termination agreement
6,300
1
8,252
-
-
-
8,253
Net loss
-
-
-
( 4,396,857 )
-
-
( 4,396,857 )
Stock based compensation
-
-
778,562
-
-
-
778,562
Balance, June 30, 2025
4,221,166
$ 422
$ 41,734,853
$ ( 41,297,951 )
246
$ ( 69,965 )
$ 367,359
Balance
4,221,166
$ 422
$ 41,734,853
$ ( 41,297,951 )
246
$ ( 69,965 )
$ 367,359
*
Amounts
have been retroactively restated to reflect the 1-for-15 reverse stock split effectuated on May 24, 2024 (See Note 2 to the condensed
consolidated financial statements).
The
accompanying notes are an integral part of these condensed consolidated financial statements.
F- 3
THARIMMUNE,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
2025
2024
For the Six Months Ended June 30,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 4,396,857 )
$ ( 4,581,166 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock based compensation
778,562
307,266
Stock issuance pursuant to termination agreement
8,253
-
Stock issuance pursuant to services agreement
-
20,550
Increase in operating assets:
Prepaid expenses and other current assets
( 150,755 )
( 290,579 )
Increase (decrease) in operating liabilities:
Accounts payable
( 4,571 )
( 133,548 )
Accrued expenses
( 66,163 )
( 327,007 )
Net cash used in operating activities
( 3,831,531 )
( 5,004,484 )
Net cash provided by (used in) investing activities
-
-
Cash flows from financing activities:
Proceeds from issuance of common stock upon private investment in public equity offering
2,500,000
2,084,161
Proceeds from issuance of common stock upon at-the-market offerings
266,625
-
Payment of deferred offering costs
( 272,246 )
( 319,250 )
Proceeds from insurance premium financing liability
285,178
393,960
Repayment of insurance premium financing liability
( 200,638 )
( 193,912 )
Repayment of note payable
( 64,769 )
-
Net cash provided by financing activities
2,514,150
1,964,959
Net decrease in cash
( 1,317,381 )
( 3,039,525 )
Cash, beginning of period
3,559,361
10,935,352
Cash, end of period
$ 2,241,980
$ 7,895,827
Supplemental disclosure of non-cash financing activities:
Unpaid deferred financing costs
$ -
$ 9,000
Amortization of deferred offering costs from ATM offering
$ 24,832
$ -
Reduction of premium related to insurance premium financing
$ 101,102
$ -
Issuance of note payable for settlement of previously incurred professional fees
$ 314,485
$ -
Issuance of options to settle liability
$ 200,212
$ -
The
accompanying notes are an integral part of these condensed consolidated financial statements.
F- 4
THARIMMUNE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note
1 – Description of Business and Liquidity
Nature
of Operations
Tharimmune,
Inc. (formerly, Hillstream BioPharma, Inc.) (“Tharimmune” or the “Company”) was incorporated on March 28, 2017,
as a Delaware C-corporation. At June 30, 2025, Tharimmune had one wholly-owned subsidiary: Hillstream Oncology, Inc. (“Hillstream
Oncology”), formerly, HB Pharma Corp.
Tharimmune
is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation conditions with high unmet
need. On November 3, 2023, the Company entered into a patent license agreement (the “Avior License Agreement”) with Avior
Inc. d/b/a Avior Bio, LLC (“Avior”) pursuant to which it received an exclusive sublicensable right and license to Licensed
Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and
commercialize TH104 and TH103) and to practice the Licensed Technology in connection with the foregoing, throughout the world (each as
defined in the Avior License Agreement). In February 2023, the U.S. Food and Drug Administration (“FDA”) approved an investigational
new drug (“IND”) application for TH104. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress
chronic, debilitating pruritus or “uncontrollable itching.” With respect to TH104, the Company originally intended to first
seek approval for the treatment of moderate to severe chronic pruritus in patients with primary biliary cholangitis (“PBC”),
an orphan rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritic.
The Company engaged and received positive feedback in March 2025 from the FDA regarding the additional proposed indication of temporary
prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering an area contaminated
with high-potency opioids (“PrHPO”), for which it submitted a Pre-Investigational New Drug Application (“PIND”).
With respect to the PIND for this additional proposed indication for TH104, the Company received positive feedback from the FDA regarding
a regulatory pathway that will allow it to submit a 505(b)(2) New Drug Application (“NDA”) for TH104. The FDA advised that
the Company will need to perform additional nonclinical studies ( i.e., in vitro toxicology studies), but the FDA confirmed that
it does not believe any additional clinical trials will be required to define the prophylactic dosing window prior to IND or NDA submission
for this indication, which the Company expects will be the lead program. The Company intends to pursue the pruritus in PBC indication
subsequent to the nearer term opportunity of filing an NDA for PrHPO. the Company intends to conduct a capital efficient strategy to
file an NDA for PrHPO, which involves actively progressing its Chemistry, Manufacturing, and Controls (“CMC”) plan to meet
the stringent requirements for filing an NDA with the FDA. This comprehensive plan encompasses all aspects of the manufacturing process,
quality control measures, and product stability to ensure the consistent production of a high-quality buccal film formulation known as
TH104.
On
September 11, 2024, Tharimmune entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited
(“Intract”), pursuant to which, the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha
(TNF-α) monoclonal antibody infliximab. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein
that contains both murine and human components that inhibit tumor TNF-α. Under the terms of the Intract Agreement, the Company
licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery
platform along with an existing supply agreement for infliximab to be used in the oral product development program.
The
Company has developed an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”)
targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”)
and programmed cell death protein 1 (“PD-1”). The Company is developing antibodies including bispecific antibodies and small
molecular weight bovine-derived “knob” domains which have the potential to target and bind more tightly to “undruggable”
epitopes differently than full sized antibodies. The Company is advancing HS1940, a bispecific biologic against both PD-1 and vascular
endothelial growth receptor (“VEGF”) antibody which targets both receptors. We have also developed HS3215, a bispecific antibody
against both HER2 and HER3 which targets a novel “bridging epitope” encompassing multiple domains of the HER2 extracellular
domain (“ECD”) as well as ligand-dependent and independent blocking of the ECD of HER3.
In
addition, on May 23, 2024, HB Pharma Corp. filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the
Secretary of State of the State of Delaware pursuant to which it changed its name to Hillstream Oncology, Inc. effective as of May 23,
2024.
F- 5
Liquidity
and Going Concern
The
accompanying condensed consolidated financial statements have been prepared on the basis that the Company will continue as a going concern,
which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. During
the six months ended June 30, 2025, the Company incurred operating losses in the amount of approximately $ 4.4 million, expended approximately
$ 3.8 million in net cash used in operating activities, and had an accumulated deficit of approximately $ 41.3 million as of June 30, 2025.
Through June 30, 2025, the Company has primarily financed its operations through public and private offerings of its equity securities.
On June 7, 2024, the Company filed a Registration Statement on Form S-3 with the SEC using a “shelf” registration process
pursuant to which, under an at-the-market offering agreement (the “ATM Agreement”), the Company may sell, from time to time
through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar amount of $ 1.65 million. Pursuant
to the ATM Agreement, the Company has sold 203,359 shares for net proceeds of approximately $ 0.3 million, after deducting commissions
of $ 15,506 and other offering fees of $ 41,952 . Further, on June 17, 2024, December 9, 2024, and June 13, 2025, the Company closed private
placement offerings (the “June 2024 PIPE Offering,” “December 2024 PIPE Offering” and “June 2025 PIPE Offering,”
respectively) with certain accredited investors of shares of the Company’s common stock and/or pre-funded warrants to acquire shares
of the Company’s common stock and warrants to acquire shares of the Company’s common stock, with combined net proceeds to
the Company of approximately $ 5.9 million. See Note 4 to the condensed consolidated financial statements for details regarding the various
offerings.
Based
on the Company’s limited operating history, recurring negative cash flows from operations, current plans and available resources,
the Company will need substantial additional funding to support future operating activities. The Company has concluded that the prevailing
conditions and ongoing liquidity risks faced raise substantial doubt about the Company’s ability to continue as a going concern
for at least one year following the date these condensed consolidated financial statements are issued. The accompanying condensed consolidated
financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.
The
Company may seek to raise additional funding through the sale of additional equity or debt securities, enter into strategic partnerships,
grants, or other arrangements or a combination of the foregoing to support its future operations; however, there can be no assurance
that the Company will be able to obtain additional capital on terms acceptable to the Company, on a timely basis or at all. The failure
to obtain sufficient additional funding could adversely affect the Company’s ability to achieve its business objectives and product
development timelines and may result in the Company delaying or terminating clinical trial activities which could have a material adverse
effect on the Company’s results of operations.
Other
Risks and Uncertainties
There
can be no assurance that the Company’s products, if approved, will be accepted in the marketplace, nor can there be any assurance
that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or
that such products will be successfully marketed, if at all. The Company is subject to risks common to biopharmaceutical and biotechnology
companies including, but not limited to, the development of new technological innovations, dependence on key personnel, protection of
proprietary technology, compliance with government regulations, product liability, uncertainty of market acceptance of products and the
need to obtain additional financing. The Company is dependent on third party suppliers. The Company’s products require approval
or clearance from the FDA prior to commencing commercial sales in the United States. Approvals or clearances are also required in foreign
jurisdictions in which the Company may license or sell its products. There can be no assurance that the Company’s products will
receive all of the required approvals or clearances.
F- 6
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation
These
accompanying unaudited condensed consolidated interim financial statements have been prepared by the Company pursuant to the rules and
regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. These condensed consolidated
financial statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments
and accruals) necessary for a fair statement of the balance sheet, operating results, and cash flows for the periods presented in accordance
with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Operating results for the six
months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31,
2025 or any other future period. Certain information and footnote disclosure normally included in the annual financial statements prepared
in accordance with U.S. GAAP have been omitted in accordance with the SEC’s rules and regulations for interim reporting. The Company’s
financial position, results of operations, and cash flows are presented in U.S. Dollars. These condensed consolidated financial statements
and related notes should be read in conjunction with the audited financial statements and related notes thereto for the year ended December
31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2025.
The
Company operates in one segment and the Company’s Chief Executive Officer serves as the chief operating decision maker (“CODM”).
The CODM uses net loss, as reported in the condensed consolidated financial statements, to monitor budget versus actual results and allocate
resources. The CODM is regularly provided with financial information, including expenses, in a format consistent with the condensed consolidated
statements of operations. The CODM does not review assets at a different level than those disclosed in the consolidated balance sheet.
Reverse
Stock Splits
On
May 24, 2024, the Company effectuated a reverse split of shares of its common stock at a ratio of 1-for-15 pursuant to an amendment to
the Company’s Certificate of Incorporation, as amended (the “Certificate of Incorporation”), filed with the Delaware
Secretary of State and approved by the Company’s board of directors and stockholders. The par value of the Company’s common
stock was not adjusted as a result of this or any prior reverse split. All issued and outstanding common stock share and per share amounts
contained in the condensed consolidated financial statements have been retroactively adjusted to reflect this and any prior reverse splits
for all periods presented.
Principles
of Consolidation
The
condensed consolidated financial statements include the accounts of Tharimmune and its wholly-owned subsidiary, Hillstream Oncology.
All significant intercompany balances and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements
and the reported amounts of revenue and expenses during the reporting period. Management bases its estimates on historical experience
and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable
estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates.
Areas of the condensed consolidated financial statements where estimates may have the most significant effect include research and development
expense recognition, valuation of common shares and share-based compensation, allowances of deferred tax assets, valuation of debt related
instruments, and cash flow assumptions regarding going concern considerations. Although management believes the estimates that have been
used are reasonable, actual results could vary from the estimates that were used.
Concentration
of Credit Risk
The
Company maintains cash balances with various financial institutions. Account balances at these institutions are insured by the Federal
Deposit Insurance Corporation (“FDIC”) up to $ 250,000 per depositor. At various times during the year, bank account balances
may have been in excess of federally insured limits. The Company has not experienced losses in such accounts. The Company believes that
it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash
equivalents. Cash equivalents, if any, are stated at cost and consist primarily of money market accounts.
F- 7
Research
and Development
Research
and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and
development activities, including third-party contractors to perform research, conduct clinical trials, and manufacture drug supplies
and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical
investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed
by third parties, patient enrollment in clinical trials, administrative costs incurred by third parties, and other indicators of the
services completed.
Stock-Based
Compensation
The
Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees, and directors as
an expense in the condensed consolidated statements of operations over the requisite service period based on a measurement of fair value
for each stock-based award. The fair value of common stock issued pursuant to termination agreements as well as restricted stock or restricted
stock units is generally measured as the grant-date price of the Company’s common stock. The fair value of each option grant to
employees, non-employees, and directors is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual
forfeitures. The fair value is amortized as compensation cost on the straight-line basis over the requisite service period of the awards,
which is generally the vesting period.
Prior
to January 12, 2022, the Company was a private company and the Company’s common stock has only been publicly traded since that
date. As a result, the Company has limited company-specific historical and implied volatility information. Therefore, it has estimated
its expected stock volatility based on the historical data of a publicly traded set of peer companies. The expected term of stock options
granted was between five and seven years. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in
effect at the time of grant for time periods approximately equal to the expected term of the award.
Fair
Value Measurements
The
Company applies Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic
820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the
definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received
for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between
market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize
the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions
that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent
of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments
about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best
information available in the circumstances.
The
carrying value of the Company’s cash, prepaid expenses, accounts payable, and accrued expenses approximate fair value because of
the short-term maturity of these financial instruments.
The
valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input
that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:
Level
1 Inputs: Observable inputs such as quoted prices (unadjusted) in active markets that are accessible at the measurement date
for identical, unrestricted assets or liabilities.
Level
2 Inputs: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These
include quoted prices for assets or liabilities recently traded in active markets, with similar underlying terms, as well as direct
or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals, as well
as quoted prices for identical or similar assets or liabilities in markets that are not active.
Level
3 Inputs: Unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists
for the assets or liabilities, that reflect the reporting entity’s own assumptions.
F- 8
Deferred
Offering Costs
Deferred
offering costs consists primarily of legal, accounting, underwriters’ fees, printing, and filing fees that are incurred prior to
an offering of the Company’s common stock and are initially capitalized and then subsequently reclassified to additional paid-in
capital upon completion of the offering. If an offering is not completed, any associated offering costs will be expensed immediately
upon termination of the offering. At June 30, 2025 and December 31, 2024, there were $ 92,168 and $ 117,000 , respectively, in deferred
offering costs associated with the ATM Agreement.
Insurance
Premium Financing Liability
In
January 2024, the Company entered into an insurance premium financing agreement for $ 492,450 , with a term of 10 months and an annual
interest rate of 7.5 %. The Company made a down payment of $ 98,490 and was required to make monthly principal and interest payments of
$ 40,763 over the term of the agreement, which matured in November 2024.
In
January 2025, the Company entered into an insurance premium financing agreement for $ 386,280 , with a term of 10 months and an annual
interest rate of 7.15 %. The Company made a down payment of $ 77,356 and was required to make monthly principal and interest payments of
$ 31,914 over the term of the agreement, which matures in November 2025. During the quarter ended June 30, 2025, the Company reduced its
insurance coverage, effectively reducing premiums. The Company received a refund of $ 101,102 , which was applied against the insurance
premium financing agreement. As a result, monthly principal and interest payments were reduced to $ 17,471 . Prepaid insurance at June
30, 2025 of $ 125,740 after reduction of the total premium, is included in prepaid expenses and other current assets on the accompanying
condensed consolidated balance sheet.
Retirement
Plan
The
Company has a 401(k) defined contribution plan which covers all employees that meet the plan’s eligibility requirements. Eligible
employees may contribute a percentage of their salary subject to certain limitations. The Company makes a discretionary match which is
currently equal to 3% of employee contributions. Total company contributions to the plan were $ 3,808 and $ 15,548 for the three and six
months ended June 30, 2025, respectively, and $ 0 and $ 337 for the three and six months ended June 30, 2024, respectively.
Income
Taxes
The
Company accounts for income taxes using the asset-and-liability method in accordance with FASB ASC Topic 740, Income Taxes (“ASC
740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit
carryforwards.
Deferred
income taxes are recognized for the tax effect of temporary differences between the financial statement carrying amount of assets and
liabilities and the amounts used for income tax purposes and for certain changes in valuation allowances. Valuation allowances are recorded
to reduce certain deferred tax assets when, in management’s estimation, it is more-likely-than-not that a tax benefit will not
be realized. A full valuation allowance has been recognized for all periods since it is more-likely-than-not that some portion or all
of the deferred tax assets will not be realized in future periods.
The
Company follows the guidance in FASB ASC Subtopic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions
and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement.
The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical
merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely-than-not threshold
are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the
taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that
the position is more-likely-than-not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties
related to tax positions in income tax expense. At June 30, 2025 and December 31, 2024, the Company had no unrecognized uncertain income
tax positions, and therefore no amounts have been recognized in the condensed consolidated financial statements.
F- 9
Net
Loss per Share
The
Company reports loss per share in accordance with FASB ASC Subtopic 260-10, Earnings Per Share , which provides for calculation
of basic and diluted earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss
available to common stockholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect
the potential dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per
share gives effect to common stock equivalents; however, potential common shares are excluded if their effect is anti-dilutive.
Potentially
dilutive securities not included in the computation of loss per share for the six months ended June 30, 2025 and 2024 included options
to purchase 242,206 and 6,102 shares of common stock, respectively, and 35,000 and 0 restricted stock units subject to vesting, respectively.
Other potentially dilutive securities not included in the computation of loss per share for the six months ended June 30, 2025 and 2024
included warrants to purchase 500 shares of the Company’s common stock related to the Company’s initial public offering (the
“IPO”); warrants to purchase 424 and 20,000 shares of the Company’s common stock issued in the Company’s May
2023 and November 2023 offerings, respectively; pre-funded warrants to purchase 83,063 shares of the Company’s common stock issued
in the June 2024 PIPE Offering; warrants to purchase 480,721 and 329,771 shares of the Company’s common stock issued in the December
2024 PIPE Offering and June 2024 PIPE Offering, respectively; warrants to purchase 19,786 shares of the Company’s common stock
issued to the placement agents in the June 2024 PIPE Offering; and warrants to purchase 2,533,759 shares of the Company’s common
stock issued in the June 2025 PIPE Offering. All common share amounts as of June 30, 2025 and December 31, 2024 and per share amounts
for the six months ended June 30, 2025 and 2024 have been retroactively adjusted to reflect a 1-for-15 reverse stock split of the Company’s
common stock effectuated on May 24, 2024.
Recently
Adopted Accounting Pronouncements
The
Company has evaluated all recent accounting pronouncements that were required to be adopted or are required to be adopted in the near
future and believes that none of them will have a material effect on the Company’s financial position, results of operations, or
cash flows.
Note
3 – Note Payable
The
Company issued a promissory note in the amount of $ 333,265 to satisfy an outstanding amount owed to its prior attorney. The promissory
note is payable in monthly installments of $ 24,000 through December 2025, with a final payment of $ 93,265 . No interest is due on the
outstanding balance of the note payable. However, following an event of default, the note shall accrue interest at 3.7 % on the outstanding
balance and the balance shall be immediately due in full.
As
the promissory note does not have an interest component, imputed interest at 10 %, using the prime rate plus an additional estimated factor
related to the Company’s credit rating, was calculated and the note payable is recorded at the present value of the total payments,
including the forgivable portion. The balance, at net present value, is $ 249,716 at June 30, 2025, and is considered current.
Note
4 – Common Stock
Pursuant
to the Company’s Certificate of Incorporation, the Company has 250,000,000 shares of common stock authorized for issuance. On May
24, 2024, the Company effectuated a reverse split of shares of its common stock at a ratio of 1-for-15 pursuant to an amendment to the
Company’s Certificate of Incorporation filed with the Delaware Secretary of State and approved by the Company’s board of
directors and stockholders. The par value of the Company’s common stock was not adjusted as a result of this or any prior reverse
stock split.
F- 10
On
January 24, 2024, pursuant to a corporate advisory consulting agreement, the Company issued 3,334 shares of its common stock with a per
share value of $ 6.16 , representing total compensation expense of $ 20,550 (as calculated based on the closing value of the Company’s
common stock at the effective issuance date).
On
June 7, 2024, the Company entered into the ATM Agreement with Rodman & Renshaw LLC (the “ATM Sales Manager”) under which
the Company may sell, from time to time through the ATM Sales Manager, shares of common stock in one or more offerings up to a total
dollar amount of $ 1.65 million. Sales of shares of the Company’s common stock through the ATM Sales Manager, if any, will be made
by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities
Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made directly on the Nasdaq Stock Market
LLC or any other existing trading market for the common shares. The Company’s common stock is being offered and sold pursuant to
the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus declared effective by the U.S.
Securities and Exchange Commission (the “SEC”) on March 24, 2023, and pursuant to a prospectus supplement dated June 7, 2024.
On
June 21, 2024, the Company closed a private placement offering with certain accredited investors of $ 2.08 million of the Company’s
securities consisting of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the Company’s
common stock and warrants to acquire shares of the Company’s common stock. Pursuant to the June 2024 PIPE Offering, the Company
issued 207,292 shares of its common stock at an offering price of $ 3.16 per share, pre-funded warrants to purchase up to 452,253 shares
of the Company’s common stock (the “June 2024 Pre-Funded Warrants”), and warrants to purchase up to 329,771 shares
of the Company’s common stock, exercisable at $ 3.09 per share (the “June 2024 PIPE Warrants”). Net proceeds to the
Company from the June 2024 PIPE Offering were approximately $ 1.8 million, after deducting approximately $ 268,000 in offering costs. In
addition, the Company issued placement agent warrants to purchase up to 19,786 shares of the Company’s common stock, exercisable
at $ 3.09 per share (the “June 2024 Placement Agent Warrants”).
On
December 9, 2024, the Company closed an additional private placement offering with certain accredited investors of $ 2.02 million of the
Company’s securities consisting of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the
Company’s common stock and warrants to acquire shares of the Company’s common stock. Pursuant to the December 2024 PIPE Offering,
the Company issued 470,289 shares of its common stock at an offering price of $ 2.101 per share, pre-funded warrants to purchase up to
491,157 shares of the Company’s common stock (the “December 2024 Pre-Funded Warrants”), exercisable at $ 0.001 per share,
and warrants to purchase up to 480,721 shares of the Company’s common stock, exercisable at $ 2.031 per share (the “December
2024 PIPE Warrants”). Net proceeds to the Company from the December 2024 PIPE Offering were approximately $ 1.8 million, after deducting
approximately $ 0.2 million in offering costs.
On
December 20, 2024, the Company sold 40,000 shares of its common stock pursuant to the ATM Agreement at an offering price of $ 2.0892 per
share. Net proceeds from the offering were approximately $ 73,189 , after deducting fees and other offering costs.
During
the six months ended June 30, 2025, the Company sold 163,359 shares of its common stock pursuant to the ATM Agreement at an average offering
price of $ 1.63 per share. Net proceeds from the offering were approximately $ 219,547 , after deducting fees and other offering costs.
F- 11
On
June 13, 2025, the Company closed an additional private placement offering with certain accredited investors of $ 2.50 million of the
Company’s securities consisting of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the
Company’s common stock and warrants to acquire shares of the Company’s common stock. Pursuant to the June 2025 PIPE Offering,
the Company issued 1,551,351 shares of its common stock at an offering price of $ 1.48 per share, pre-funded warrants to purchase up to
137,838 shares of the Company’s common stock (the “June 2025 Pre-Funded Warrants”), exercisable at $ 0.001 per share,
series A warrants to purchase up to 1,689,189 shares of the Company’s common stock, exercisable at $ 1.48 per share (the “June
2025 Series A Warrants”), and series B warrants to purchase up to 844,570 shares of the Company’s common stock, exercisable
at $ 3.00 per share (the “June 2025 Series B Warrants”). Net proceeds to the Company from the June 2025 PIPE Offering were
approximately $ 2.3 million, after deducting approximately $ 0.2 million in offering costs.
Note
5 – Stock Based Compensation
Incentive
Plans and Options
Under
the Company’s 2017 Stock Incentive Plan (the “2017 Plan”), the Company could grant incentive stock options, non-statutory
stock options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance units
to employees, directors, and consultants of the Company and its affiliates. Up to 261 shares of the Company’s common stock may
be issued pursuant to the 2017 Plan.
The
Company granted options to acquire 255 shares of common stock at $ 4,950 per share under the 2017 Plan. At both June 30, 2025 and December
31, 2024, there were options outstanding to acquire 255 shares of common stock. As of June 30, 2025 and December 31, 2024, all such options
were fully vested, and had a weighted average remaining contractual life of approximately 2.7 and 3.2 years, respectively.
In
July 2019, the Company authorized an additional plan, the 2019 Stock Incentive Plan (the “2019 Plan”). Under the 2019 Plan,
the Company could grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation rights,
restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates.
At both June 30, 2025 and December 31, 2024, a total of 10,452 shares were authorized for issuance under the 2019 Plan.
As
of both June 30, 2025 and December 31, 2024, the Company has granted options to acquire 10,452 shares of common stock under the 2019
Plan and no shares of common stock remain available for issuance under the 2019 Plan. There are stock options outstanding to acquire
5,512 shares of common stock with a weighted-average exercise price of $ 1,105.50 at both June 30, 2025 and December 31, 2024 and weighted
average contractual terms of 6.3 years and 6.8 years at June 30, 2025 and December 31, 2024, respectively.
On
August 17, 2023, the Company authorized the Tharimmune, Inc. 2023 Omnibus Incentive Plan (as amended, the “2023 Plan”). Under
the 2023 Plan, the Company may grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation
rights, restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates.
Initially, there were 6,934 shares of the Company’s common stock available to be issued pursuant to the 2023 Plan. Under an amendment
and restatement to the 2023 Plan approved by the Company’s stockholders on May 14, 2024, a total of up to 173,600 shares of the
Company’s common stock may be issued pursuant to the 2023 Plan. In addition, under the amendment, an “evergreen” provision
was added to automatically increase the number of shares available under the 2023 Plan on January 1 annually, beginning January 1, 2025
and ending January 1, 2033, equal to the lesser of five percent of the shares of common stock outstanding (on an as-converted basis)
on the final day of the immediately preceding calendar year or such lesser number of shares of the Company’s common stock as determined
by the Board of Directors. Effective January 1, 2025, an additional 98,688 shares of the Company’s common stock were added to the
2023 Plan. Further, effective June 10, 2025, the shareholders approved an amendment to the 2023 Plan, increasing the 2023 Plan by 520,314
shares.
F- 12
During
the three and six months ended June 30, 2025, the Company granted 133,833 options to acquire shares of common stock under the 2023 Plan.
At June 30, 2025 521,797 shares of common stock remain available for issuance under the 2023 Plan. As of
June 30, 2025 and December 31, 2024, there are stock options outstanding to acquire 236,439 and 103,188 shares of common stock with a
weighted-average exercise price of $ 2.44 and $ 3.11 , respectively, and weighted-average contractual terms of 9.4 years and 9.6 years,
respectively.
The
following table summarizes stock-based activities under the 2017 Plan, 2019 Plan, and 2023 Stock Incentive Plans:
Schedule of Stock Option Activity
Weighted
Weighted
Shares
Average
Average
Underlying
Exercise
Contractual
Options
Price
Terms
Outstanding at December 31, 2024
108,955
$ 70.46
9.5 years
Granted
133,833
$ 1.93
9.6 years
Forfeited
( 582 )
$ 2.93
9.1 years
Outstanding at June 30, 2025
242,206
$ 32.75
9.3 years
Exercisable options at June 30, 2025
239,033
$ 33.15
9.3 years
Vested and expected to vest at June 30, 2025
242,206
$ 32.75
9.3 years
The
fair value of stock option awards is estimated at the date of grant using the Black-Scholes option-pricing model. The estimated fair
value of each stock option is then expensed over the requisite service period, which is generally the vesting period (ranging between
immediate vesting and four years). The determination of fair value using the Black-Scholes model is affected by the Company’s share
price as well as assumptions regarding a number of complex and subjective variables, including expected price volatility, expected life,
risk-free interest rate, and forfeitures. Forfeitures are accounted for as they occur.
Stock
options granted during the six months ended June 30, 2025 were valued using the Black-Scholes option-pricing model with the following
weighted-average assumptions.
Schedule of Options Weighted Average Assumptions
For the six months ended June 30,
2025
2024
Expected volatility
102.3 %
N/A
Risk-free interest rate
4.61 %
N/A
Expected dividend yield
0 %
N/A
Expected life of options in years
5.0
N/A
Estimated fair value of options granted
$ 1.50
N/A
No
stock options were granted during the six months ended June 30, 2024.
F- 13
The
weighted-average grant date fair value of stock options granted during six months ended June 30, 2025 was approximately $ 1.50 . The weighted-average
fair value of stock options vested during the three and six months ended June 30, 2025 was approximately $ 13.36 and $ 17.70 , respectively,
and during each of the three and six months ended June 30, 2024 was approximately $ 1,207.78 .
Total
stock-based compensation expense included in the accompanying condensed consolidated statements of operations was as follows:
Schedule of Stock-Based Compensation Expense
2025
2024
2025
2024
For the three months ended
June 30,
For the six months ended
June 30,
2025
2024
2025
2024
Research and development
$ 262,033
$ 77,809
$ 355,898
$ 155,577
General and administrative
305,603
75,838
430,917
151,689
Total stock-based compensation
$ 567,636
$ 153,647
$ 786,815
$ 307,266
As
of June 30, 2025, the total unrecognized compensation expense related to non-vested options was approximately $ 7,000 and is expected
to be recognized over the remaining weighted-average service period of approximately 1.0 years.
Warrants
In
connection with the IPO, the Company issued warrants to purchase such number of shares of the Company’s common stock equal to 5%
of the total shares of common stock issued in the IPO, or 500 warrants. The warrants are exercisable at $ 1,875.00 per share, were not
exercisable within the first six months after issuance, and may, under certain circumstances, be exercised on a cashless basis. The exercise
price of the warrants is subject to standard anti-dilutive provision adjustments for stock splits, stock combinations, or similar events
affecting the Company’s common stock. The Company has determined that these warrants should be classified as equity instruments
since they do not require the Company to repurchase the underlying common stock and do not require the Company to issue a variable amount
of common stock. In addition, these warrants are indexed to common stock and do not have any unusual anti-dilution rights.
In
May 2023, the Company issued warrants to designees of the underwriter (the “Representative’s Warrants”) to purchase
424 shares of the Company’s common stock (which is equal to 3% of the number of shares sold in the public offering closed in May
2023) at an initial exercise price of $ 234.375 per share, subject to adjustment. The Representative’s Warrants are exercisable
at any time and from time to time, in whole or in part, during the four- and one-half year period commencing 180 days from the commencement
of sales of the shares of common stock in the public offering.
In
November 2023, the Company issued the underwriters from a private placement offering warrants to purchase 20,000 shares of common stock
with an initial exercise price of $ 18.75 , exercisable beginning May 27, 2024, and expiring May 2, 2028 (the “November 2023 Underwriters
Warrants”). As of June 30, 2025 and December 31, 2024, the November 2023 Underwriters Warrants to purchase 20,000 shares of common
stock have not yet been exercised.
F- 14
In
connection with the June 2024 PIPE Offering as described in Note 4 to the condensed consolidated financial statements, the Company issued
the June 2024 Pre-Funded Warrants to purchase 452,253 shares of the Company’s common stock at an exercise price of $ 0.001 , the
June 2024 PIPE Warrants to purchase 329,771 shares of the Company’s common stock at an exercise price of $ 3.09 , and the June 2024
Placement Agent Warrants to purchase up to 19,786 shares of the Company’s common stock, exercisable at $ 3.09 per share. The June
2024 Pre-Funded Warrants were immediately exercisable and are able to be exercised at any time until exercised in full. The June 2024
PIPE Warrants and June 2024 Placement Agent Warrants were immediately exercisable and are able to be exercised until five and a half
years from the effective date, or December 21, 2029. As of June 30, 2025, 369,190 of the June 2024 Pre-Funded Warrants have been exercised
and none of the June 2024 PIPE Warrants or June 2024 Placement Agent Warrants have been exercised.
In
connection with the December 2024 PIPE Offering as described in Note 4 to the condensed consolidated financial statements, the Company
issued the December 2024 Pre-Funded Warrants to purchase 491,157 shares of the Company’s common stock at an exercise price of $ 0.001
and the December 2024 PIPE Warrants to purchase 480,721 shares of the Company’s common stock at an exercise price of $ 2.031 . The
December 2024 Pre-Funded Warrants were immediately exercisable and are able to be exercised at any time until exercised in full. The
December 2024 PIPE Warrants are exercisable six months from the date of issuance and are able to be exercised until five and a half years
from the effective date, or December 9, 2030. As of June 30, 2025, all 491,157 of the December 2024 Pre-Funded Warrants and none of the
December 2024 PIPE Warrants have been exercised.
In
connection with the June 2025 PIPE Offering as described in Note 4 to the condensed consolidated financial statements, the Company issued
the June 2025 Pre-Funded Warrants to purchase 137,838 shares of the Company’s common stock at an exercise price of $ 0.001 , the
June 2025 Series A Warrants to purchase 1,689,189 shares of the Company’s common stock at an exercise price of $ 1.48 , and the June
2025 Series B Warrants to purchase 844,570 shares of the Company’s common stock at an exercise price of $ 3.00 . The June 2025 Pre-Funded
Warrants were immediately exercisable and are able to be exercised at any time until exercised in full. The June 2025 Series A and B
Warrants are exercisable six months from the date of issuance and are able to be exercised until five and a half years from the issuance
date, or June 13, 2031. As of June 30, 2025, none of the June 2025 Pre-Funded Warrants, June 2025 PIPE Series A Warrants, or June 2025
PIPE Series B Warrants have been exercised.
Terms
of the warrants outstanding at June 30, 2025 are as follows:
Schedule of Warrants
Initial
Expiration
Exercise
Warrants
Warrants
Warrants
Issuance Date
Exercise Date
Date
Price
Issued
Exercised
Outstanding
January 14, 2022
July 10, 2022
January 11, 2027
$ 1,875.00
500
-
500
May 2, 2023
November 2, 2023
May 2, 2028
$ 234.375
424
-
424
November 30, 2023
May 27, 2024
May 2, 2028
$ 18.75
20,000
-
20,000
June 21, 2024
June 21, 2024
N/A
$ 0.001
452,253
369,190
83,063
June 21, 2024
June 21, 2024
December 21, 2029
$ 3.09
329,771
-
329,771
June 21, 2024
June 21, 2024
December 21, 2029
$ 3.09
19,786
-
19,786
December 9, 2024
June 9, 2025
December 9, 2030
$ 2.031
480,721
-
480,721
December 9, 2024
December 9, 2024
N/A
$ 0.001
491,157
491,157
-
June 13, 2025
June 13, 2025
N/A
$ 0.001
137,838
-
137,838
June 13, 2025
December 13, 2025
June 13, 2031
$ 1.48
1,689,189
-
1,689,189
June 13, 2025
December 13, 2025
June 13, 2031
$ 3.00
844,570
-
844,570
Restricted
Stock Units
During
the six months ended June 30, 2025, as stock-based consideration for consulting services, the Company granted restricted stock units
(“RSUs”) under the 2023 Plan to an individual representing the right to receive one share of the Company’s common stock.
The RSUs will 100% vest on June 30, 2026, provided that the grantee remains a consultant of the Company.
The
grant date fair value of an RSU represents the closing price of the Company’s common stock on the date of grant. The estimated
fair value of each RSU is then expensed over the requisite service period, which is generally the vesting period (approximately a year
and a half).
The
total stock compensation expense related to RSUs for the three and six months ended June 30, 2025 was $ 12,143 and $ 20,417 , respectively.
The total estimated fair value of RSUs at June 30, 2025 was $ 69,125 , of which $ 48,708 remains to be vested quarterly through June 30,
2026.
Termination
Agreement
In
connection with the resignation of a board member, effective June 23, 2025, 6,300 shares of the Company’s common stock were issued
as stock-based compensation at an estimated fair value of $ 8,253 .
Note
6 – Commitments and Contingencies
Research
Collaboration and Product License Agreement with Minotaur Therapeutics, Inc. (“Minotaur”) and Commercial License Agreement
with Taurus Biosciences, LLC (“Taurus”)
The
Company has entered into a research collaboration and product license agreement with Minotaur (as amended, the “Minotaur Agreement”)
and a commercial license agreement with Taurus (the “Taurus Agreement”) for use of certain technology, including OmniAb antibodies,
to advance Picobodies against novel, unreachable, and undruggable epitopes in high-value validated targets starting with PD-1. The Minotaur
Agreement and Taurus Agreement are for the development of proprietary targeted biologics, including TH 1940, against PD-1. It is anticipated
that the Company will collaborate with Minotaur under the license from Taurus to discover, develop, and advance biotherapeutics against
high-value validated IO targets starting with PD-1.
F- 15
The
Minotaur Agreement included an up-front payment of $ 150,000 , which was paid in January 2023. In addition, the Company shall fund the
discovery and characterization study performed by Minotaur as set forth in the Minotaur Agreement. Pursuant to the Minotaur Agreement,
the Company shall pay Minotaur a milestone payment of $ 1,000,000 for each first Product (as defined in the Minotaur Agreement) directed
against a target and first regulatory approval in the U.S. In addition, the Company shall pay a low single digit royalty on net sales
until the later of (i) ten years after the First Commercial Sale (as defined in the Minotaur Agreement) of such Product in such country
and (ii) the expiration of the last-to-expire Valid Claim (as defined in the Minotaur Agreement) of a Collaboration Patent (as defined
in the Minotaur Agreement) or MINT Patent (as defined in the Minotaur Agreement) covering the manufacture, use, or sale of such Product.
The Taurus Agreement contains single digit payments on net product sales and certain development milestone payments tied to the advancement
through clinical trials and final regulatory approval.
Research
and Development Collaboration and License Agreement with Applied Biomedical Science Institute
On
July 5, 2023 (the “ABSI Effective Date”), the Company entered into a Research and Development Collaboration and License Agreement
(the “ABSI Agreement”) with ABSI pursuant to which ABSI granted the Company an exclusive royalty-bearing, sublicensable license
to the ABSI Patents (as defined in the ABSI Agreement) and a non-exclusive, royalty-bearing, sublicensable license to the ABSI Know-How
(as defined in the ABSI Agreement) to Exploit (as defined in the ABSI Agreement) the ABSI Products (as defined in the ABSI Agreement)
for the treatment, diagnosis, prediction, detection or prevention of disease in humans and animals worldwide (the “Territory”).
Pursuant
to the ABSI Agreement, the parties shall form a committee to manage the preclinical, investigational new drug enabling studies and such
other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product. The parties will collaborate on a Target-by-Target
basis to identify and evaluate ABSI Products directed against such Target (as defined below) with a view to identifying or generating
suitable Products (as defined in the ABSI Agreement) for the Company to Exploit. “Target” means ErB2 (Her2) and ErbB3. Upon
completion of the Discovery Timeline (as defined in the ABSI Agreement) for a Target, subject to the terms and conditions of ABSI Agreement,
the Company shall exclusively own any ABSI Products against such Target. In the event the committee determines that the discovery activities
are unsuccessful with respect to a Target, the Company may propose an additional target, which, upon approval by ABSI, shall replace
a failed Target.
Pursuant
to the ABSI Agreement: (i) the Company issued ABSI 25,107 shares of its common stock which is equal to $ 250,000 based on the ten day
trailing volume weighted-average price of the Company’s common stock prior to the date of issuance (see Note 3 to the condensed
consolidated financial statements for details of the July 27, 2023 issuance of the Company’s common stock to ABSI); (ii) in the
event the Company closes a financing pursuant to which it receives more than $ 10 million in Net Proceeds (as defined in the ABSI Agreement),
the Company shall pay ABSI a mid-six digit amount; (iii) upon the achievement of certain milestones as set forth in the ABSI Agreement,
the Company shall pay ABSI up to an aggregate of $ 8,250,000 ; (iv) after the second anniversary of the ABSI Effective Date, the Company
shall pay ABSI a low five digit amount for the first year and a mid-five digit amount thereafter during the Royalty Term (as defined
in the ABSI Agreement); and (v) during the Royalty Term for each Product, the Company shall pay ABSI a quarterly royalty on the Net Sales
(as defined in the ABSI Agreement) with royalties at percentages which range from the low to mid-single digits, with high Net Sales being
subject to lower royalty rates, subject to adjustment as set forth in the ABSI Agreement. In addition, in the event the Company transfers
all or substantially all of its rights to a Product to a third party, the Company shall pay to ABSI the percentage of Net Proceeds attributable
to the transfer of the Product. Specifically, the Company shall pay ABSI amounts at percentages which range from the mid-single digit
to low double digits depending on the Company Expenses (as defined in the ABSI Agreement), with higher Company Expenses being subject
to lower rates.
On
a Product-by-Product basis, upon the expiration of the last Royalty Term of such Product in the Territory, licenses granted to the Company
with respect to such Product shall be deemed non-exclusive, fully paid, royalty-free, perpetual and irrevocable. The ABSI Agreement shall
expire upon the expiration of the last Royalty Term of the last Product, unless such agreement is terminated earlier pursuant to its
terms. The ABSI Agreement may also be terminated (i) by either the Company or ABSI for (A) a material breach of the ABSI Agreement or
(B) bankruptcy, (ii) ABSI may terminate the ABSI Agreement upon the commencement of a Challenge Proceeding (as defined in the ABSI Agreement)
or (iii) the Company may terminate the ABSI Agreement at any time upon 90 days prior written notice to ABSI. Upon termination or expiration
of the ABSI Agreement other than as a result of a bankruptcy or Challenge Proceeding, all licenses granted to the Company pursuant to
such agreement will terminate and all rights under such licenses shall revert to ABSI.
F- 16
On
March 11, 2024, the Company entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $ 50,000
beginning March 18, 2024 with subsequent payments due on the 18 th of each calendar quarter. During the three and six months
ended June 30, 2025, the Company made payments of $ 50,000 and $ 100,000 to ABSI.
Avior
Patent License Agreement
On
November 3, 2023 (the “Avior Effective Date”), the Company entered into the Avior Patent License Agreement with Avior pursuant
to which the Company received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among
other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the
Licensed Technology in connection with the foregoing, throughout the world. Pursuant to the Avior Patent License Agreement, the Company
paid Avior an up front license fee of $ 0.4 million within ten days of the Avior Effective Date and a quarterly license fee of $ 0.15 million
which was paid at the end of each fiscal quarter following the Avior Effective Date. In addition, the Company shall pay Avior a high
single digit percentage of any upfront payments received by it as a result of the grant of any sublicenses with respect to TH104. The
Company shall also pay Avior milestone payments in the aggregate amount of $ 24,250,000 upon the occurrence of various development milestones
(the “Development Milestone Payments”). Furthermore, the Company shall pay Avior certain fees based upon sales milestones.
The payments for such sales milestones range from the low seven digits to the low eight digits with higher sales being subject to higher
fees. Finally, the Company shall pay Avior royalties based on net sales. Such royalties range from low single digit percentages to mid-single
digit percentages with higher sales being subject to lower percentages. The Avior Patent License Agreement shall expire upon the expiration
of the final payment obligation due to Avior as set forth in such agreement. Upon the expiration of the Avior Patent License Agreement,
the Company shall have a fully paid, irrevocable, freely transferable and sublicensable worldwide license to the Licensed Patent Rights
and Licensed Technology to Develop, have Developed, make, have made, use, have used sell, offer for sale, have sold, import, have imported,
export, have exported, commercialize or have commercialized any and all Licensed Products and to practice the Licensed Technology worldwide.
Pursuant to the Avior Patent License Agreement, the Company may terminate the agreement at any time without cause, upon 30 days’
prior written notice to Avior along with payment of the next unpaid Development Milestone Payment, if any. Furthermore, either the Company
or Avior may terminate the Avior Patent License Agreement (i) on written notice to the other party if the other party materially breaches
any provision of the Avior Patent License Agreement and fails to cure such breach within 30 days after the breaching party receives written
notice thereof or (ii) on written notice in the event that either party (A) becomes insolvent or admits its inability to pay its debts
generally as they become due; (B) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy
or insolvency law, which is not fully dismissed or vacated within 60 days; (C) is dissolved or liquidated or takes any corporate action
for such purpose; (D) makes a general assignment for the benefit of creditors; or (E) has a receiver, trustee, custodian or similar agent
appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
Upon termination of the Avior Patent License Agreement, the license granted pursuant to such agreement shall terminate and all rights
in the Licensed Patent Rights and Licensed Products shall revert back to Avior.
During
the three and six months ended June 30, 2025, the Company paid no milestone fees to Avior in accordance with the terms of the agreement.
F- 17
Enkefalos
License Agreement
On
June 17, 2024 (the “Enkefalos Effective Date”), the Company signed a letter of intent to enter into the Enkefalos License
Agreement with Enkefalos Biosciences Inc. (“Enkefalos”) pursuant to which the Company is licensing the global rights in all
fields of use for the products related to the compounds knows as cyclotides to deliver HER2 antibodies across the blood-brain barrier
and all associated know-how, technology, intellectual property and related information and constructs, and any associated authorized
generic rights and all related assets (collectively, the “Products” referred to in this letter as ENBI-01) from Enkefalos.
This agreement was terminated during the six months ended June 30, 2025. Pursuant to the Enkefalos License Agreement, the Company paid
Enkefalos an up-front license fee of $ 150,000 within ten days of the Enkefalos Effective Date. Upon termination of the Enkefalos License
Agreement, the license granted pursuant to such agreement terminated and all rights in the Licensed Patent Rights and Licensed Products
reverted back to Enkefalos.
Intract
Patent License Agreement
On
September 11, 2024, the Company entered into the Intract Agreement pursuant to which the Company exclusively licensed INT-023/TH023,
an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Under the terms of the Intract Agreement, the
Company licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral®
delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Pursuant
to the Intract Agreement, the Company paid Intract an up-front license fee of $ 0.4 million and Intract is eligible to receive additional
payments upon an equity financing of the Company and additional payments for future development, regulatory and commercial milestones,
as well as mid-single digit royalties based on net product sales. During the six months ended June 30, 2025, the Company amended the
Intract Agreement to change the payment terms of certain milestone fees, which increased the total milestone fees by $ 0.15 million. Pursuant
to the Intract Agreement, the Company retains a right of first refusal to continue development and commercialization after a Phase 2
clinical trial. In addition, the Company has the option to exercise the license to Intract’s platform for up to four additional
targets. The term of the Intract Agreement expires upon the final payment obligation of Tharimmune and may be terminated by Tharimmune
at any time upon 90 days written notice to Intract. Either party may terminate the Intract Agreement if the other party materially breaches
any provision of the Intract Agreement and fails to cure such breach within 30 days after the breaching party receives written notice
thereof. In addition, either party may terminate the Intract Agreement on written notice in the event that either party declare: (a)
becomes insolvent or admits inability to pay its debts generally as they become due; (b) becomes subject, voluntarily or involuntarily,
to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within 60 days;
(c) is dissolved or liquidated or takes any corporate action for such purpose; (d) makes a general assignment for the benefit of creditors;
or (e) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of
or sell any material portion of its property or business.
During
the three and six months ended June 30, 2025, the Company incurred fees of $ 0 and approximately $ 0.2 million, respectively, to Intract
in accordance with the terms of the agreement as amended.
Employment
Agreements
On
July 6, 2023, the Company entered into an amended and restated employment agreement (the “Former CEO Employment Agreement”)
with the now former CEO. The Former CEO Employment Agreement had the same terms as the COO Employment Agreement (as defined below) except,
the CEO (i) would receive a base salary of $ 500,000 per year, which could be increased by the Board; and (ii) was eligible to receive
an annual bonus equal to 60 % of his then base salary based upon the achievement of Company and individual targets to be established by
the Board, in its sole discretion. In addition, in the event the CEO’s employment was terminated by the Company other than as a
result of his death or Disability and other than for Cause, or if the CEO terminated his employment for Good Reason, then, in addition
to the Accrued Compensation, the Company would pay the CEO’s base salary and provide health benefits for a period of 18 months
following the termination date (each as defined in the Former CEO Employment Agreement). In addition, all Restricted Shares and Stock
Options (as defined in the Former CEO Employment Agreement) that had not vested as of the date of termination would be forfeited and
outstanding unvested time-based equity awards would be accelerated in accordance with the applicable vesting schedule as if the now former
CEO had been in service for an additional 12 months as of the termination date. Effective June 11, 2025, the CEO resigned, terminating
the Former CEO Employment Agreement, and entered into a settlement and general release agreement (the “CEO Settlement Agreement”).
Pursuant to the CEO Settlement Agreement, the former CEO will receive gross payments of $ 133,500 , less applicable withholdings and deductions,
to be paid upon closing of the Company raising at least $ 3 million of financing in debt, equity, or some combination thereof and the
former CEO’s unvested stock options vested immediately.
F- 18
In
connection with the appointment of the Company’s Chief Operating Officer on July 11, 2023, the Company entered into an employment
agreement (the “COO Employment Agreement”) with the COO. The COO Employment Agreement shall continue for a period of five
years and, thereafter, shall automatically renew for successive one-year terms unless either party provides the other party with written
notice of non-renewal at least 60 days prior to the last day of the then-current term. Pursuant to the COO Employment Agreement, the
COO would: (i) receive a base salary of $ 400,000 per year, which could be increased by the Board; (ii) be eligible to receive an annual
bonus equal to 50 % of his then base salary based upon the achievement of Company and individual targets to be established by the Board,
in its sole discretion; (iii) be eligible to receive equity-based compensation awards as determined by the Company; (iv) receive reimbursement
of reasonable business expenses; and (v) receive such other benefits that the Company may make available to its senior executives from
time to time along with vacation, sick and holiday pay in accordance with the Company’s policies established and in effect from
time to time. Effective June 11, 2025, in connection with the resignation of the former CEO, the COO was appointed CEO. In connection
with such appointment, the COO Employment Agreement was amended with similar terms to the agreement for the Executive Chairman of the
Board as described below (the “Chairman Employment Agreement”). The Company’s current CEO shall receive a base salary
of $ 285,000 per year, which may be increased by the Board and is eligible to receive an annual bonus equal to 60 % of his then base salary
based upon achievement of Company and individual targets to be established by the Board, in its sole discretion (the “Amended CEO
Agreement”).
In
accordance with the Former CEO Employment Agreement and COO Employment Agreement, the compensation committee approved a bonus of 50%
in equity compensation and 50% in cash compensation on January 13, 2025, based on corporate performance objectives earned during the
year ended December 31, 2024. The former CEO’s equity bonus for the year ended December 31, 2024 was made up of options to purchase
up to 80,958 shares of the Company’s common stock, which had a grant date fair value of $ 121,112 . The COO’s equity bonus
for the year ended December 31, 2024 was made up of options to purchase up to 52,875 shares of the Company’s common stock, which
had a grant date fair value of $ 79,100 .
In
connection with the appointment of the Company’s Executive Chairman of the Board (the “Chairman”), on June 11, 2025,
the Company entered into an employment agreement with the Chairman (the “Chairman Employment Agreement”). The Chairman Employment
Agreement shall continue for a period of five years and, thereafter, shall automatically renew for successive one year terms unless either
party provides the other party with written notice of non-renewal at least 60 days prior to the last day of the then current term. Pursuant
to the Chairman Employment Agreement, the Chairman shall: (i) receive a base salary of $ 285,000 per year, which may be increased by the
Board; (ii) be eligible to receive an annual bonus equal to 60 % of his then base salary based upon the achievement of Company and individual
targets to be established by the Board, in its sole discretion; (iii) be eligible to receive equity-based compensation awards as determined
by the Company; (iv) receive reimbursement of reasonable business expenses; and (v) receive such other benefits that the Company may
make available to its senior executives from time to time along with vacation, sick, and holiday pay in accordance with the Company’s
policies established and in effect from time to time.
In
the event that the Chairman’s employment is terminated by the Company other than as a result of his death or disability and other
than for cause, or if the Chairman terminates his employment for Good Reason (as defined in the Chairman Employment Agreement), then,
in addition to accrued compensation, the Company shall (i) continue to pay his base salary and provide health benefits for a period of
12 months following the termination date or, in the case of benefits, such time as he receives equivalent coverage and benefits under
plans and programs of a subsequent employer; and (ii) provide such other or additional benefits, if any, as may be provided under applicable
employee benefit plans, programs and/or arrangements of the Company (other than any severance plans or programs). In addition, all unvested
time-based equity awards (including restricted shares and stock options) shall be immediately and fully accelerate and become vested.
Moreover, stock options that have vested as of the termination date shall remain exercisable until the earlier of (i) 60 months following
such termination and (ii) the expiration date of the stock option. As noted, the terms of the COO Employment Agreement were amended to
mirror the terms of the Chairman Employment Agreement.
As
of June 30, 2025, there was accrued bonus of less than $ 0.1 million included in accrued expenses in the accompanying condensed consolidated
balance sheet.
Note
7 – Related Party Transactions
Related
Party Ownership
The
Company’s Chairman is a partner and licensed broker at President Street Global, a consultant for the Company. His combined ownership,
both individually and through President Street Global, is approximately 17.35 % of the Company’s outstanding common stock. During
the six months ended June 30, 2025, the Chairman purchased an aggregate of 337,338 common shares at the public offering price and on
the same terms as the other purchasers in the June 2025 PIPE Offering for a purchase price of $ 500,000 , which includes 337,838 June 2025
Series A Warrants, and 168,918 June 2025 Series B Warrants. The Company made payments of $ 0.3 million and $ 0.7 million for services rendered
during the three and six months ended June 30, 2025, respectively, including offering commissions received as the broker in the June
2025 PIPE Offering. During each of the three and six months ended June 30, 2024, the Company made payments of $ 0.1 million for services
rendered.
The
CEO, individually as well as through companies he serves as managing member and managing partner, collectively owns 3.53 % of the Company’s
outstanding common stock, including common shares available upon exercise of vested options to purchase shares of the Company’s
common stock. During the six months ended June 30, 2025, the CEO purchased an aggregate of 60,806 common shares in the June 2025 PIPE
Offering, including 60,806 June 2025 Series A Warrants, and 30,403 June 2025 Series B Warrants.
Note
8 – Subsequent Events
Except
as noted below, there were no material subsequent events that required recognition or additional disclosure in these condensed consolidated
financial statements.
On
July 23, 2025, the Company entered into a securities purchase agreement in relation to a registered direct public offering with certain
purchasers, under a Shelf Registration Statement, of $ 1.74 million of the Company’s securities, consisting of (i) 414,331 shares
of Common Stock, par value $ 0.0001 per share and 559,910 pre-funded warrants to acquire shares of Common Stock; and (ii) in a concurrent
private placement, 974,241 warrants to acquire shares of Common Stock at the exercise price of $ 1.66 per share, at the price of $ 1.786
for each one share of Common Stock or Pre-Funded Warrant, and Common Warrant. The offering closed on July 25, 2025.
On July 25, 2025, the Company entered into a securities purchase agreement with certain accredited individual and
institutional investors for the issuance and sale in a private placement of (i) 641,190 shares of the Company’s common stock, par
value $ 0.0001 , (ii) pre-funded warrants to purchase up to 103,490 shares of the Company’s Common Stock at an exercise price of $ 0.001
per share, (iii) common warrants to purchase up to 744,680 shares of the Company’s Common Stock, at an exercise price of $ 1.52 per
share of Common Stock, at the price of $ 1.645 for each one share of Common Stock, Pre-Funded Warrant, and Common Warrant purchased pursuant
to the Purchase Agreement. Net proceeds to the Company from the offering were approximately $ 1.1 million. The offering closed on July
31, 2025.
On
August 4, 2025, the Company’s board of directors appointed Nancy Davis as a member of the Board effective as of
August 4, 2025. Ms. Davis will serve for a term expiring at the 2026 annual meeting of stockholders.
F- 19
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
You
should read the following discussion and analysis of our financial condition and results of operations together with our unaudited interim
condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition
to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions.
Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include,
but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included in our
Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as may be amended, supplemented, or superseded from time to time
by other reports we file with the SEC. All amounts in this report are in U.S. dollars, unless otherwise noted.
Throughout
this Quarterly Report on Form 10-Q, references to “we,” “our,” “us,” the “Company,” or
“Tharimmune,” refer to Tharimmune, Inc., individually, or as the context requires, collectively with its subsidiary.
Overview
Tharimmune
is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation conditions with high unmet
need. On November 3, 2023, we entered into a patent license agreement (the “Avior License Agreement”) with Avior Inc. d/b/a
Avior Bio, LLC (“Avior”) pursuant to which we received an exclusive sublicensable right and license to Licensed Patent Rights
and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize
TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world (each as defined in the
Avior License Agreement). In February 2023, the U.S. Food and Drug Administration (“FDA”) approved an investigational new
drug (“IND”) application for TH104. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress
chronic, debilitating pruritus or “uncontrollable itching.” With respect to TH104, we originally intended to first seek approval
for the treatment of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (“PBC”), an orphan
rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritic. In March
2025, we engaged and received positive feedback from the FDA regarding the additional proposed indication of temporary prophylaxis of
respiratory and/or nervous system depression in military personnel and chemical incident responders entering an area contaminated with
high-potency opioids (“PrHPO”), for which we submitted a Pre-Investigational New Drug Application (“PIND”). With
respect to our PIND for this additional proposed indication for TH104, the Company received positive feedback from the FDA regarding
a regulatory pathway that will allow the Company to submit a 505(b)(2) New Drug Application (“NDA”) for TH104. The FDA advised
that we will need to perform additional nonclinical studies ( i.e., in vitro toxicology studies), but the FDA confirmed that it
does not believe any additional clinical trials will be required to define the prophylactic dosing window prior to IND or NDA submission
for this indication, which we expect will be the lead program for the Company. The Company intends to pursue the pruritus in PBC indication
subsequent to the nearer term opportunity of filing an NDA for PrHPO. The Company intends to conduct a capital efficient strategy to
file an NDA for PrHPO, which involves actively progressing its Chemistry, Manufacturing, and Controls (“CMC”) plan to meet
the stringent requirements for filing an NDA with the FDA. This comprehensive plan encompasses all aspects of the manufacturing process,
quality control measures, and product stability to ensure the consistent production of a high-quality buccal film formulation known as
TH104.
On
September 11, 2024, we entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”),
pursuant to which, we exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody
infliximab. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and
human components that inhibit tumor TNF-α. Under the terms of the Intract Agreement, we licensed global development and commercialization
rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement
for infliximab to be used in the oral product development program.
We
are also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”)
targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”)
and programmed cell death protein 1 (“PD-1”). We are developing antibodies including bispecific antibodies, antibody drug
conjugates (“ADCs”) and small molecular weight bovine-derived “knob” domains which have the potential to target
and bind more tightly to “undruggable” epitopes better than full sized antibodies. We are advancing HS1940, a bispecific
biologic against both PD-1 and vascular endothelial growth receptor (“VEGF”) antibody which targets both receptors. In addition,
we have completed initial pre-clinical in-vitro testing for HS3215, a HER2/HER3 bispecific antibody.
The
critical components of our business strategy to achieve our goals include:
●
Develop
TH104 as a transmucosal buccal film product for temporary prophylaxis of respiratory and/or nervous system depression in military
personnel and chemical incident responders entering and area contaminated with high-potency opioids;
●
Develop
TH104 as a transmucosal buccal film product for the treatment of moderate-to-severe chronic pruritus in PBC and other inflammatory
diseases either through strategic partnership or on our own;
●
Develop
TH023 by obtaining regulatory authorization to initiate a first-in-human bioavailability clinical trial and pursue an IND through
the FDA post optimizing its CMC program;
4
●
Create
a preclinical and clinical path forward for, HS1940, with a unique PD-1 knob-domain antibody fragment as a bispecific biologic against
PD-1 and VEGF with unique binding differentiation for IO vulnerable tumors;
●
Continue
to advance pre-clinical candidate selection activities against HER2/HER3 receptors with various antibody formats, including HS3215
designed for multiple solid tumor types;
●
Hasten
the discovery of next generation multi-specific (bi- and tri) antibodies with binding capabilities to novel epitopes of combinations
of HER2 and HER3 with and without toxin delivery capacity to multiple high unmet need rare cancers and other validated immunology
and metabolic targets; and
●
Pursue
strategic collaboration opportunities including partnering and potential merger and acquisition transactions to maximize the value
of our pipeline to bring novel therapies to patients suffering from high unmet need conditions.
License
Agreements
Applied
Biomedical Research Institute Research and Development Collaboration and License Agreement
On
July 5, 2023, we entered into the ABSI Agreement with ABSI pursuant to which ABSI granted us an exclusive royalty-bearing, sublicensable
license to the ABSI Patents and a non-exclusive, royalty-bearing, sublicensable license to the ABSI Know-How to Exploit the ABSI Products
for the treatment, diagnosis, prediction, detection or prevention of disease in humans and animals worldwide. Pursuant to the ABSI Agreement,
the parties shall form a committee to manage the preclinical, IND-enabling studies and such other activities as shall lead to the initiation
of a Phase 1 clinical trial of the ABSI Product. The parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI
Products directed against such Target with a view to identifying or generating suitable Products for our Company to Exploit. “Target”
means ErB2 (Her2) and ErbB3. Upon completion of the Discovery Timeline for a Target, subject to the terms and conditions of ABSI Agreement,
we shall exclusively own any ABSI Products against such Target. In the event the committee determines that the discovery activities are
unsuccessful with respect to a Target, we may propose an additional target, which, upon approval by ABSI, shall replace a failed Target,
each capitalized term as defined in the ABSI Agreement.
On
March 11, 2024, we entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $50,000 beginning
March 18, 2024 with subsequent payments due on the 18 th of each calendar quarter. This addendum was terminated on July 17,
2025 and no further payments are due under the addendum for research services.
Avior
Patent License Agreement
On
November 3, 2023, we entered into the Avior Patent License Agreement with Avior pursuant to which we received an exclusive sublicensable
right and license to Licensed Patent Rights and Licensed Technology to, among other things, develop, have developed, make, have made,
use, sell, import, export and commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing,
throughout the world. Pursuant to the Avior Patent License Agreement, we paid Avior an up front license fee of $0.4 million and a quarterly
license fee of $0.15 million each quarter in 2024. In addition, we shall pay Avior a high single digit percentage of any upfront payments
received by us as a result of the grant of any sublicenses with respect to TH104. We shall also pay Avior milestone payments in the aggregate
amount of $24.25 million upon the occurrence of various development milestones (the “Development Milestone Payments”). Furthermore,
we shall pay Avior certain fees based upon sales milestones. The payments for such sales milestones range from the low seven digits to
the low eight digits with higher sales being subject to higher fees. Finally, we shall pay Avior royalties based on net sales. Such royalties
range from low single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages. All capitalized
terms not otherwise defined herein shall have the meanings ascribed to them in the Avior Patent License Agreement.
5
Intract
Patent License Agreement
On
September 11, 2024, we entered into the Intract Agreement with Intract, pursuant to which the Company exclusively licensed INT-023/TH023,
an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Under the terms of the Intract Agreement, we licensed
global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform
along with an existing supply agreement for infliximab to be used in the oral product development program. Pursuant to the Intract Agreement,
we paid an upfront license fee of $0.4 million and are required to make additional payments upon an equity financing of the Company.
Intract is eligible to receive future development, regulatory and commercial milestones, as well as mid-single digit royalties based
on net product sales. Under the terms of the Intract Agreement, we retain a right of first refusal to continue development and commercialization
after a Phase 2 clinical trial and have the option to exercise the license to Intract’s platform for up to four additional targets.
The term of the Intract Agreement expires upon the final payment obligation of the Company under the Intract Agreement. In addition,
the Intract Agreement may be terminated by us at any time upon 90 days written notice to Intract. Either party may terminate the Intract
Agreement if the other party materially breaches any provision of the Intract Agreement and fails to cure such breach within 30 days
after the breaching party receives written notice thereof. In addition, either party may terminate the Intract Agreement on written notice
in the event that either party declare: (a) becomes insolvent or admits inability to pay its debts generally as they become due; (b)
becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is
not fully dismissed or vacated within 60 days; (c) is dissolved or liquidated or takes any corporate action for such purpose; (d) makes
a general assignment for the benefit of creditors; or (e) has a receiver, trustee, custodian or similar agent appointed by order of any
court of competent jurisdiction to take charge of or sell any material portion of its property or business. On March 14, 2025 we amended
the Intract Agreement to pay the milestone due upon closing of our December 2024 PIPE Offering in equal installments over the next 12
months, with the first payment beginning in the second quarter of 2025.
Recent
Developments
On
June 7, 2024, we entered into an at-the-market offering agreement (the “ATM Agreement”) with Rodman & Renshaw LLC (the
“ATM Sales Manager”) under which we may sell, from time to time through the ATM Sales Manager, shares of common stock in
one or more offerings up to a total dollar amount of $1.65 million.
To
date, we have sold 203,359 shares pursuant the ATM Agreement for net proceeds of approximately $0.3 million, after deducting commissions
of $15,505 and other offering expenses of $33,600. See Note 4 to our unaudited condensed consolidated financial statements included elsewhere
in this Quarterly Report on Form 10-Q.
In
addition, on July 23, 2025, we entered into a securities purchase agreement in relation to a registered direct public offering with certain
purchasers, under a Shelf Registration Statement, of $1.74 million of our securities, consisting of (i) 414,331 shares of Common Stock,
par value $0.0001 per share and 559,910 pre-funded warrants to acquire shares of Common Stock; and (ii) in a concurrent private placement,
974,241 warrants to acquire shares of Common Stock at the exercise price of $1.66 per share, at the price of $1.786 for each one share
of Common Stock or Pre-Funded Warrant, and Common Warrant. The offering closed on July 25, 2025.
Components
of Results of Operations
Revenue
We
did not recognize revenues for the three and six months ended June 30, 2025 and 2024.
6
Research
and Development Expenses
Research
and development expenses include personnel costs associated with research and development activities, including third-party contractors
to perform research, conduct clinical trials, and manufacture drug supplies and materials as well as stock-based compensation for our
research and development personnel. Research and development expenses are charged to operations as incurred.
We
accrue costs incurred by external service providers, including contract research organizations and clinical investigators, based on estimates
of service performed and costs incurred. These estimates include the level of services performed by third parties, patient enrollment
in clinical trials, administrative costs incurred by third parties, and other indicators of the services completed. Based on the timing
of amounts invoiced by service providers, we may also record payments made to those providers as prepaid expenses that will be recognized
as expense in future periods as the related services are rendered.
We
have incurred research and development expenses related to the development of HSB-1216, which has been deprioritized. We expect that
our research and development expenses will increase as we plan for and commence our clinical trials of HS1940 and HS3215.
We
cannot determine with certainty the duration and costs of future clinical trials of our product candidates, HS1940 and HS3215, or any
other product candidates we may develop or if, when or to what extent we will generate revenue from the commercialization and sale of
any of our product candidates for which we obtain marketing approval. We may never succeed in obtaining marketing approval for any of
our product candidates. The duration, costs and timing of clinical trials and development of our current and future product candidates
will depend on a variety of factors, including:
●
the
scope, rate of progress, expense and results of clinical trials of our current product candidates, as well as of any future clinical
trials of our future product candidates and other research and development activities that we may conduct;
●
uncertainties
in clinical trial design and patient enrollment rates;
●
the
actual probability of success for our product candidates, including their safety and efficacy, early clinical data, competition,
manufacturing capability and commercial viability;
●
significant
and changing government regulations and regulatory guidance; and
●
the
timing and receipt of any marketing approvals.
A
change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change
in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority
were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development
of a product candidate, or if we experience significant delays in our clinical trials due to slower than expected patient enrollment
or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development.
General
and Administrative Expenses
General
and administrative expenses consist primarily of compensation and consulting related expenses, including stock-based compensation for
our general and administrative personnel. General and administrative expenses also include professional fees and other corporate expenses,
including legal fees relating to corporate matters; professional fees for accounting, auditing, tax, and consulting services; insurance
costs; travel expenses and other operating costs that are not specifically attributable to research activities.
We
expect that our general and administrative expenses will increase in the future as we increase our personnel headcount to support our
continued research activities and development of our product candidates. We also incur expenses associated with being a public company,
including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, directors and officers insurance expenses,
corporate governance expenses, investor relations activities and other administrative and professional services.
7
Interest
Income
Interest
income consists of interest income from funds held in our cash accounts.
Deferred
Offering Costs
Deferred
offering costs consisted of legal, accounting, printing, and filing fees that were capitalized and offset against the proceeds from our
securities offerings. At June 30, 2025, deferred offering costs of approximately $92,000 represent
professional services incurred related to the At the Market Offering Agreement (the “ATM Agreement”), through which the Company
may sell, from time to time through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar
amount of $1.65 million. See Notes 2 and 4 to the condensed consolidated financial statements included elsewhere in this Quarterly Report
on Form 10-Q.
Results
of Operations
Three
Months Ended June 30, 2025 Compared to the Three Months Ended June 30, 2024
Three Months Ended
June 30,
2025
2024
Change
Condensed Consolidated Statements of Operations Data:
Operating expenses:
Research and development
$ 546,204
$ 999,553
$ (453,349 )
General and administrative
1,304,956
1,373,901
(68,945 )
Total operating expenses
1,851,160
2,373,454
(522,294 )
Other expense:
Interest expense
(6,161 )
(5,217 )
(944 )
Interest income
2,168
53,614
(51,446 )
Total other income (expense), net
(3,993 )
48,397
(52,390 )
Net loss
$ (1,855,153 )
$ (2,325,057 )
$ 469,904
Research
and Development Expenses
The
table below summarizes by program our research and development expenses for the periods presented:
Three Months Ended
June 30,
2025
2024
Change
HS1940
$ 69,197
$ 122,500
$ (53,303 )
HS3215
43,341
281,219
(237,878 )
TH023
62,500
-
62,500
TH104
274,783
355,603
(80,820 )
Other research and development
96,383
240,231
(143,848 )
Total research and development expenses
$ 546,204
$ 999,553
$ (453,349 )
Research
and development expenses decreased by approximately $0.5 million, or 45%, to approximately $0.5 million for the three months ended June
30, 2025 from approximately $1.0 million for three months ended June 30, 2024. The decrease was primarily the result of a decrease in
pre-clinical vendor expenses of approximately $0.3 million and license fees of approximately $0.4 million. These decreases were offset
by increases in stock-based compensation of approximately $0.2 million.
General
and Administrative Expenses
General
and administrative expenses decreased by approximately $0.1 million, or 5%, to $1.3 million for the three months ended June 30, 2025
from $1.4 million for the three months ended June 30, 2024. The change in general and administrative expenses was primarily due to a
decrease in personnel expenses of approximately $0.3 million, offset by an increase in investor relations fees of $0.2 million.
8
Interest
Expense
Interest
expense increased by approximately $1,000, or 18%, to $6,161 for the three months ended June 30, 2025 from $5,217 for the three months
ended June 30, 2024. The increase in interest expense was primarily related to the director and officer insurance premium financing liability
as well as the note payable related to the legal fees settlement.
Interest
Income
Interest
income decreased by approximately $51,000, or 96%, to $2,168 for the three months ended June 30, 2025 from $53,614 for the three months
ended June 30, 2024. The decrease in interest income was primarily due to the decrease in cash from June 2024 to June 2025.
Six
Months Ended June 30, 2025 Compared to the Six Months Ended June 30, 2024
Six Months Ended
June 30,
2025
2024
Change
Condensed Consolidated Statements of Operations Data:
Operating expenses:
Research and development
$ 1,140,274
$ 2,024,811
$ (884,537 )
General and administrative
3,257,555
2,695,946
561,609
Total operating expenses
4,397,829
4,720,757
(322,928 )
Other expense:
Interest expense
(14,632 )
(9,917 )
(4,715 )
Interest income
15,604
149,508
(133,904 )
Total other income (expense), net
972
139,591
(138,619 )
Net loss
$ (4,396,857 )
$ (4,581,166 )
$ 184,309
Research
and Development Expenses
The
table below summarizes by program our research and development expenses for the periods presented:
Six Months Ended
June 30,
2025
2024
Change
HS1940
$ 140,034
$ 264,147
$ (124,113 )
HS3215
120,953
281,219
(160,266 )
TH023
132,557
-
132,557
TH104
579,268
614,332
(35,064 )
Other research and development
167,462
865,113
(697,651 )
Total research and development expenses
$ 1,140,274
$ 2,024,811
$ (884,537 )
Research
and development expenses decreased by $0.9 million, or 44%, to $1.1 million for the six months ended June 30, 2025 from $2.0 million
for six months ended June 30, 2024. The decrease was primarily the result of a decrease in pre-clinical vendor expenses of approximately
$0.5 million, license fees of approximately $0.4 million, and clinical trials of approximately $0.2 million. These decreases were offset
by increases in stock-based compensation of approximately $0.2 million and other small increases.
General
and Administrative Expenses
General
and administrative expenses increased by $0.6 million, or 21%, to $3.3 million for the six months ended June 30, 2025 from $2.7 million
for the six months ended June 30, 2024. The change in general and administrative expenses was primarily due to increases of approximately
$0.3 million in stock compensation expense, approximately $0.5 million in investor relations, and approximately $0.2 million in director
remuneration. The increases were offset by approximately $0.4 million in decreases in personnel expense.
Interest
Expense
Interest
expense increased by approximately $5,000, or 48%, to $14,632 for the six months ended June 30, 2025 from $9,917 for the six months ended
June 30, 2024. The increase in interest expense was primarily related to the director and officer insurance premium financing liability
as well as the note payable related to the legal fees settlement.
9
Interest
Income
Interest
income decreased by approximately $0.1 million, or 90%, to $15,604 for the six months ended June 30, 2025 from $149,508 for the six months
ended June 30, 2024. The decrease in interest income was primarily due to the decrease in cash from June 2024 to June 2025.
Liquidity
and Capital Resources
The
accompanying condensed consolidated financial statements have been prepared on the basis that we will continue as a going concern, which
contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. During
the six months ended June 30, 2025, we incurred operating losses in the amount of approximately $4.4 million, expended approximately
$3.8 million of net cash in operating activities, and had an accumulated deficit of approximately $41.3 million as of June 30, 2025.
Through June 30, 2025, we have primarily financed our operations through public and private offerings of our equity securities.
In
April and May 2025, we raised net proceeds of $0.2 million pursuant to the ATM Agreement from the sale of 163,359 shares of our common
stock at an average price of $1.63 per share, after deducting sales agent commissions and other offering fees.
Further,
on June 17, 2024, December 9, 2024, and June 13, 2025, we closed private placement offerings (the “June 2024 PIPE Offering,”
“December 2024 PIPE Offering”, and “June 2025 PIPE Offering,” respectively) with certain accredited investors,
consisting of offerings of shares of our common stock and/or pre-funded warrants to acquire shares of our common stock and warrants to
acquire shares of our common stock, with combined net proceeds of approximately $5.9 million.
Based
on our limited operating history, recurring negative cash flows from operations, current plans and available resources, we will need
substantial additional funding to support future operating activities. We have concluded that the prevailing conditions and ongoing liquidity
risks faced by us raise substantial doubt about our ability to continue as a going concern for at least one year following the date the
condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. The accompanying condensed
consolidated financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.
We
may seek to raise additional funding through the sale of additional equity or debt securities, enter into strategic partnerships, grants
or other arrangements or a combination of the foregoing to support our future operations; however, there can be no assurance that we
will be able to obtain additional capital on terms acceptable to us, on a timely basis, or at all. The failure to obtain sufficient additional
funding could adversely affect our ability to achieve our business objectives and product development timelines and may result in us
delaying or terminating clinical trial activities which could have a material adverse effect on our results of operations.
Cash
Flow Activities for the Six Months Ended June 30, 2025 and 2024
The
following table sets forth a summary of our cash flows for the periods presented.
Six Months Ended June 30,
2025
2024
Net cash used in operating activities
$ (3,831,531 )
$ (5,004,484 )
Net cash provided by financing activities
2,514,150
1,964,959
Net decrease in cash
$ (1,317,381 )
$ (3,039,525 )
Cash
Flows from Operating Activities
Cash
used in operating activities for the six months ended June 30, 2025 was $3.8 million, which consisted of net loss of $4.4 million and
net changes in operating assets and liabilities of approximately $0.2 million, partially offset by non-cash stock-based compensation
of approximately $0.8 million.
10
Cash
used in operating activities for the six months ended June 30, 2024 was $5.1 million, which consisted of net loss of $4.6 million, increase
in prepaid and other current assets of $0.3 million and decrease in operating liabilities of $0.5 million, partially offset by non-cash
stock-based compensation and stock issuance of $0.3 million.
Cash
Flows from Financing Activities
Cash
provided by financing activities for the six months ended June 30, 2025 was $2.5 million. The net increase in financing activities was
due to gross proceeds from the June 2025 PIPE Offering of $2.5 million, ATM offerings of $0.3 million, and insurance premium financing
liability of $0.3 million, offset by payments of deferred offering costs of $0.3 million, repayments of insurance premium financing liability
of $0.2 million, and repayments of the note payable of $0.1 million.
Cash
provided by financing activities for the six months ended June 30, 2024 was $2.0 million. The net increase in financing activities was
due to proceeds from the insurance premium financing liability of $0.3 million, offset by repayments of insurance premium financing liability
of $0.1 million.
Reverse
Stock Split
On
May 24, 2024, the Company effectuated an additional reverse split of shares of its common stock at a ratio of 1-for-15 pursuant to an
amendment to the Company’s Certificate of Incorporation, as amended, filed with the Delaware Secretary of State and approved by
the Company’s board of directors and stockholders. The par value of the Company’s common stock was not adjusted as a result
of this or any prior reverse split. All issued and outstanding common stock share and per share amounts contained in the accompanying
condensed consolidated financial statements have been retroactively adjusted to reflect this and any prior reverse split for all periods
presented.
Critical
Accounting Policies and Use of Estimates
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S.
GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the
disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses
during the reporting period. Management bases its estimates on historical experience and on assumptions believed to be reasonable under
the circumstances. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes,
and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas,
among others: research and development expense recognition, stock-based compensation, allowances of deferred tax assets, and cash flow
assumptions regarding going concern considerations. Although management believes the estimates that have been used are reasonable, actual
results could vary from the estimates that were used.
Critical
Accounting Policies
Research
and development
Research
and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and
development activities, including third-party contractors to perform research, conduct clinical trials and manufacture drug supplies
and materials. We accrue for costs incurred by external service providers, including contract research organizations and clinical investigators,
based on our estimates of service performed and costs incurred. These estimates include the level of services performed by third parties,
patient enrollment in clinical trials, administrative costs incurred by third parties, and other indicators of the services completed.
11
Stock-based
compensation
Stock-based
compensation represents the cost related to stock-based awards granted to our employees, directors, consultants, and affiliates. We measure
stock-based compensation costs at the grant date, based on the estimated fair value of the award and recognize the cost over the requisite
service period.
We
recognize compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense
in the condensed consolidated statements of operations over the requisite service period based on a measurement of fair value for each
stock-based award. The fair value of each option grant to employees, non-employees and directors is estimated as of the date of grant
using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on a straight-line
basis over the requisite service period of the awards, which is generally the vesting period.
The
fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Prior to January
12, 2022, we were a private company and our common stock has only been publicly traded since that date. As a result, we lack company-specific
historical and implied volatility information. Therefore, we have estimated our expected stock price volatility based on the historical
volatility of a publicly traded set of peer companies. The expected term of stock options granted was between five and seven years. The
risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for
time periods approximately equal to the expected term of the award.
Recently
Issued and Adopted Accounting Standards
See
Note 2 to our condensed consolidated financial statements included elsewhere in this quarterly Report on Form 10-Q.
JOBS
Act
On
April 5, 2012, the Jumpstart Our Business Startups Act (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides
that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of
the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can
delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.
Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our internal controls over financial reporting
pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, and (ii) complying with the requirement adopted by the Public
Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on financial statements.
We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of
the completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during
the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
The
Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined
in Rule 12b-2 of the Exchange Act.
12
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer evaluated the effectiveness of our “disclosure controls and procedures”
as of June 30, 2025, the end of the period covered by this Quarterly Report on Form 10-Q. 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 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 under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive
officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation
of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer and our Interim Chief Financial Officer concluded
that, as of such date, our disclosure controls and procedures were effective.
Changes
in Internal Control over Financial Reporting
Except
as set forth above, there were no changes in our internal control over financial reporting that occurred during the quarter ended June
30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations
on Effectiveness of Controls and Procedures
In
designing and evaluating the disclosure controls and procedure, management recognizes that any controls and procedures, no matter how
well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of
controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management
is required to apply judgment in evaluating the benefits of possible controls and procedure relative to their costs.
PART
II — OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
From
time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation
is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business.
We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse
effect on our business, financial condition or operating results.
ITEM
1A. RISK FACTORS.
Risk
factors that affect our business and financial results are discussed in Part I, Item 1A “Risk Factors,” in our Annual Report
on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 26, 2025 (“Annual Report”). There have been
no material changes in our risk factors from those previously disclosed in our Annual Report. You should carefully consider the risks
described in our Annual Report which could materially affect our business, financial condition or future results. The risks described
in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently
deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results. If any of the
risks actually occur, our business, financial condition, and/or results of operations could be negatively affected.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
13
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
During
the fiscal quarter ended June 30, 2025, none of the Company’s directors or executive officer adopted or terminated any contract,
instruction, or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions
of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.”
ITEM
6. EXHIBITS.
Exhibit
No.
Description
4.1
Form of Pre-Funded Warrant Agreement (Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025)
4.2
Form of Series A Warrant (Incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025)
4.3
Form of Series B Warrant (Incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025)
10.1*+
Settlement and General Release Agreement by and between the Company and Randy Milby dated June 11, 2025
10.2*+
Amended and Restated Employment Agreement by and between the Company and Sireesh Appajosyula dated June 11, 2025
10.3
Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025)
10.4*+
Employment Agreement by and between the Company and Vincent LoPriore dated June 11, 2025
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2**
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover
Page Interactive Data File - the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2025 is formatted in Inline XBRL included in the Exhibit 101 Inline XBRL Document Set
*
Filed
herewith.
**
Furnished
herewith.
+
Indicates
a management contract or any compensatory plan, contract or arrangement.
14
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.
THARIMMUNE,
INC.
Date:
August 14, 2025
By:
/s/
Sireesh Appajosyula
Sireesh
Appajosyula
Chief
Executive Officer
(Principal
Executive Officer)
Date:
August 14, 2025
By:
/s/
Sireesh Appajosyula
Sireesh
Appajosyula
Interim
Chief Financial Officer
(Interim
Principal Financial and Accounting Officer)
15
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.