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

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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 18th 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.

 

 

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.

 

 

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 to744,680 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.

 

 

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;

 

 

	●	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 18th 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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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)