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 March 31, 2026

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ___________ to ___________

 

GENELUX CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware		001-41599		77-0583529
(State or other jurisdiction of incorporation or organization)		Commission File Number		(IRS Employer Identification No.)

 

2625 Townsgate Road, Suite 230, Westlake Village, California 91361

(Address of Principal Executive Offices)

 

(805) 267-9889

(Registrant’s telephone number, including area code)

 

 

(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class registered:		Trading symbol:		Name of each exchange on which registered:
Common Stock, par value $0.001 per share		GNLX		The Nasdaq Stock Market LLC (Nasdaq Capital Market)

 

Securities registered under Section 12(g) of the Exchange Act: None

 

Indicate by check mark whether the issuer (1) 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 and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or smaller reporting company filer. See definition of “accelerated filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act (Check one):

 

Large Accelerated Filer ☐	Non-Accelerated Filer ☒
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 in Rule 12b-2 of the Exchange Act. Yes ☐ No ☒

 

The number of shares issued and outstanding of each of the issuer’s classes of common equity as of May 3, 2026 was 44,840,416.

 

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts contained in this Quarterly Report, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

 

Forward-looking statements contained in this Quarterly Report include statements regarding:

 

	●	the timing, progress and results of clinical studies for our product candidates, including the development of our only clinical-stage product candidate, Olvi-Vec;
	●	the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates;
	●	the potential benefits and market opportunity for our product candidates and CHOICE platform;
	●	expectations regarding the size, scope and design of clinical studies;
	●	our manufacturing, commercialization, and marketing plans and strategies;
	●	our plans to hire additional personnel and our ability to attract and retain such personnel;
	●	our estimates of the number of patients who suffer from the diseases we are targeting and potential growth in our target markets;
	●	our expectations regarding the approval and use of our product candidates;
	●	our competitive position and the development and impact of competing therapies that are or may become available;
	●	expectations regarding future events under collaboration and licensing agreements, including potential future payments, as well as our plans and strategies for entering into further collaboration and licensing agreements;
	●	our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
	●	the rate and degree of market acceptance and clinical utility of product candidates we may develop;
	●	our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
	●	our future financial performance;
	●	the period over which we estimate our existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund our future operations;
	●	our expected use of net proceeds from our financing transactions;
	●	the impact of laws and regulations;
	●	the impact of geopolitical and macroeconomic factors; and
	●	other risks and uncertainties, including those described under Part II, Item 1A, “Risk Factors” in this Quarterly Report.

 

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described under the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in our Annual Report on Form 10-K, as amended, for the year ended December 31, 2025 (the “Annual Report”) and in this Quarterly Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risks we describe in the reports we will file from time to time with the U.S. Securities and Exchange Commission (the “SEC”) after the date of this Quarterly Report.

 

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report, and while we believe such information provides a reasonable basis for these statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely on these statements.

 

 

GENELUX CORPORATION

FORM 10-Q

MARCH 31, 2026

TABLE OF CONTENTS

 

PART I— FINANCIAL INFORMATION		3
Item 1.	Condensed Financial Statements	3
	Condensed Balance Sheets	3
	Condensed Statements of Operations and Comprehensive Loss	4
	Condensed Statements of Stockholders’ Equity	5
	Condensed Statements of Cash Flows	6
	Notes to Condensed Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25
Item 4.	Controls and Procedures	25
PART II— OTHER INFORMATION		26
Item 1.	Legal Proceedings	26
Item 1A.	Risk Factors	26
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27
Item 3.	Defaults Upon Senior Securities	27
Item 4.	Mine Safety Disclosures	27
Item 5.	Other Information	27
Item 6.	Exhibits	27
SIGNATURES		29

 

 

PART I—FINANCIAL INFORMATION

 

Item 1. Condensed Financial Statements

 

Genelux Corporation
Condensed Balance Sheets

(in thousands, except per share amounts)

 

		March 31, 2026				December 31, 2025
		(unaudited)
ASSETS
Current assets:
Cash, cash equivalents and restricted cash		$	9,273			$	5,333
Marketable securities			16,936				9,262
Prepaid expenses and other current assets			545				535
Total current assets			26,754				15,130
Property and equipment, net			3,081				2,170
Right of use assets			2,393				1,583
Other assets			144				144
Total Assets		$	32,372			$	19,027
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses		$	6,095			$	4,358
Accrued payroll and payroll taxes			861				1,440
Lease liabilities, current portion			316				427
Total current liabilities			7,272				6,225
Lease liabilities, long-term portion			2,179				1,258
Total liabilities			9,451				7,483
Commitments and contingencies (Note 8)
Stockholders’ equity:
Common stock, par value $0.001, 200,000,000 shares authorized; 44,840,416 and 38,139,144 shares issued and outstanding, respectively			45				38
Treasury stock, 433,333 shares, at cost			(433	)			(433	)
Additional paid-in capital			315,780				295,468
Accumulated other comprehensive income			(5	)			9
Accumulated deficit			(292,466	)			(283,538	)
Total stockholders’ equity			22,921				11,544
Total Liabilities and Stockholders’ Equity		$	32,372			$	19,027

 

The accompanying notes are an integral part of these condensed financial statements.

 

 

Genelux Corporation
Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share amounts)

(unaudited)

 

		2026				2025
		Three Months Ended
		March 31,
		2026				2025
Revenue		$	-			$	-
Operating expenses:
Research and development			5,778				4,698
General and administrative			3,393				3,118
Total operating expenses			9,171				7,816
Operating loss			(9,171	)			(7,816	)
Other income:
Interest income			173				184
Bond accretion income			70				140
Total other income			243				324
Net loss		$	(8,928	)		$	(7,492	)
Net loss per share - basic and diluted		$	(0.20	)		$	(0.21	)
Weighted-average shares outstanding- basic and diluted			44,150,958				34,926,075
Other comprehensive loss:
Unrealized loss on marketable securities			(14	)			(35	)
Comprehensive loss		$	(8,942	)		$	(7,527	)

 

The accompanying notes are an integral part of these condensed financial statements.

 

 

Genelux Corporation

Condensed Statements of Stockholders’ Equity

(in thousands, except share amounts)

(unaudited)

 

		Shares				Amount				Shares				Amount				Capital				Income (Loss)				Deficit				Total
		Common Stock								Treasury Stock								Additional Paid-in				Accumulated Other Comprehensive				Accumulated
		Shares				Amount				Shares				Amount				Capital				Income (Loss)				Deficit				Total
Balance, December 31, 2025			38,139,144			$	38				(433,333	)		$	(433	)		$	295,468			$	9			$	(283,538	)		$	11,544
Stock compensation			-				-				-				-				1,394				-				-				1,394
Unrealized loss on marketable securities			-				-				-				-				-				(14	)			-				(14	)
Fair value of vested restricted stock units			29,063				-				-				-				319				-				-				319
Cost of stock option modifications and repricing			-				-				-				-				68				-				-				68
Issuance of common stock for cash			6,666,667				7				-				-				18,518				-				-				18,525
Issuance of common stock upon exercise of stock options			5,542				-				-				-				13				-				-				13
Net loss during the three months ended March 31, 2026			-				-				-				-				-				-				(8,928	)			(8,928	)
Balance, March 31, 2026			44,840,416			$	45				(433,333	)		$	(433	)		$	315,780			$	(5	)		$	(292,466	)		$	22,921

 

																						Accumulated
																		Additional				Other
		Common Stock								Treasury Stock								Paid-in				Comprehensive				Accumulated
		Shares				Amount				Shares				Amount				Capital				Income (Loss)				Deficit				Total
Balance, December 31, 2024			34,728,140			$	35				(433,333	)		$	(433	)		$	278,001			$	64			$	(251,393	)			26,274
Balance			34,728,140			$	35				(433,333	)		$	(433	)		$	278,001			$	64			$	(251,393	)			26,274
Unrealized loss on marketable securities			-				-				-				-				-				(35	)			-				(35	)
Stock compensation			-				-				-				-				1,423				-				-				1,423
Issuance of common stock for cash			3,000,000				3				-				-				9,550				-				-				9,553
Fair value of vested restricted stock units			-				-				-				-				103				-				-				103
Cost of stock option repricing			-				-				-				-				6				-				-				6
Issuance of common stock upon exercise of stock options			5,000				-				-				-				14				-				-				14
Net loss during the three months ended March 31, 2025			-				-				-				-				-				-				(7,492	)			(7,492	)
Net loss			-				-				-				-				-				-				(7,492	)			(7,492	)
Balance, March 31, 2025			37,733,140			$	38				(433,333	)		$	(433	)		$	289,097			$	29			$	(258,885	)		$	29,846
Balance			37,733,140			$	38				(433,333	)		$	(433	)		$	289,097			$	29			$	(258,885	)		$	29,846

 

The accompanying notes are an integral part of these condensed financial statements.

 

 

Genelux Corporation
Condensed Statements of Cash Flows

(in thousands)

(unaudited)

 

		2026				2025
		Three Months Ended
		March 31,
		2026				2025
Cash Flows from operating activities
Net loss		$	(8,928	)		$	(7,492	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense			9				59
Net amortization of premiums and discounts on marketable securities			(70	)			(140	)
Right-of-use asset			89				80
Stock compensation			1,394				1,423
Fair value of restricted stock units			319				103
Cost of stock option modifications and repricing			68				6
Changes in operating assets and liabilities:
Prepaid expenses and other assets			(10	)			(171	)
Accounts payable and accrued expenses			1,737				1,118
Accrued payroll and payroll taxes			(580	)			(340	)
Lease liability			(87	)			(81	)
Net cash used in operating activities			(6,059	)			(5,435	)
Cash Flows from investing activities
Purchases of property and equipment			(921	)			(30	)
Purchase of marketable securities			(14,398	)			(2,461	)
Proceeds from maturities of marketable securities			6,780				6,000
Net cash (used in) provided by investing activities			(8,539	)			3,509
Cash Flows from financing activities
Proceeds from the exercise of stock options			13				14
Proceeds from common stock issued			18,525				9,553
Net cash provided by financing activities			18,538				9,567
Net increase in cash, cash equivalents and restricted cash			3,940				7,641
Cash, cash equivalents and restricted cash
BEGINNING OF PERIOD			5,333				8,565
END OF PERIOD		$	9,273			$	16,206
Supplemental non-cash financing disclosures:
Unrealized loss on marketable securities		$	14			$	35
Remeasurement of right of use asset and lease liability upon lease extension		$	896			$	-

 

The accompanying notes are an integral part of these condensed financial statements.

 

 

Genelux Corporation
Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share amounts and per share data)

 

NOTE 1 – BASIS OF PRESENTATION

 

Organization and Operations

 

Genelux Corporation (Genelux or the Company), a Delaware corporation, incorporated on September 4, 2001, is a late clinical-stage biopharmaceutical company located in Westlake Village, California. The Company is engaged in the research and development of diagnostic and therapeutic solutions for cancer for which there is no effective treatment today. The Company is focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat tumor types.

 

Liquidity and Capital Resources

 

The accompanying condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The Company has experienced recurring losses from operations since inception and incurred a net loss of $8.9 million and cash used in operations of $6.1 million during the three months ended March 31, 2026. These factors raise substantial doubt about the Company’s ability to continue as a going concern. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s December 31, 2025 financial statements, has expressed substantial doubt about the Company’s ability to continue as a going concern. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to raise additional funds and implement its strategies. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

As of March 31, 2026, the Company had $9.3 million in cash, cash equivalents and restricted cash ($2.0 million in restricted cash) and $16.9 million in marketable securities. However, the Company does not have any committed external source of funds or other support for our development efforts, except for the license agreement (Newsoara License Agreement) the Company entered into with Newsoara BioPharma Co. Ltd, in September 2021 which was subsequently assigned to Newsoara HYK Biopharmaceuticals Co., Ltd. (Newsoara). Until the Company can generate sufficient product revenue to finance its cash requirements, which it may never do, the Company expects to finance its future cash needs through a combination of public or private equity offerings, which may include sales under an “at-the-market” offering program pursuant to the sales agreement the Company has with TD Securities (USA) LLC, debt and/or other capital sources such as milestone payments, royalties or other payments or funding from existing or potential collaborations, strategic alliances, licensing arrangements and other arrangements. Based on its research and development plans, the Company expects that its existing cash, cash equivalents, restricted cash and marketable securities will fund its planned operations into the first quarter of 2027. In addition, because the design and outcome of its anticipated and any future clinical trials are highly uncertain, the Company cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of Olvi-Vec or any future product candidates. The Company’s existing cash balance may not be sufficient to complete the development of Olvi-Vec or any other product candidate.

 

No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on its operations, in the case of debt financing, or cause substantial dilution for its stockholders, in case of equity financing, or require the Company to grant terms that are not favorable to the Company in future licensing agreements.

 

Basis of Presentation

 

The interim condensed financial statements have been prepared in conformity with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the SEC regarding interim financial information. Certain information and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these unaudited interim condensed financial statements should be read in conjunction with the financial statements and notes thereto contained in the Annual Report.

 

In the opinion of management, all material adjustments of a normal recurring nature have been made to present fairly the Company’s financial position as of March 31, 2026. Operating results and cash flows for the three months ended March 31, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026.

 

 

NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

There have been no changes to the significant accounting policies disclosed in the Annual Report.

 

Cash Equivalents and Restricted Cash

 

The Company considers all highly liquid marketable securities with original maturities of three months or less at the date of acquisition as cash equivalents. As of March 31, 2026 and December 31, 2025, cash equivalents were comprised of money market funds that totaled $5.0 million and $3.0 million, respectively.

 

At March 31, 2026 and December 31, 2025, there was $2.0 million restricted cash that is held as a refundable security deposit for an equipment lease (see Note 7).

 

Marketable Securities

 

The Company’s marketable securities are classified as available-for-sale and are carried at fair value, with the unrealized gains and non-credit related losses reported as a component of accumulated other comprehensive loss and included in stockholders’ equity. Realized gains and losses and declines in value determined to be other than temporary are based on the specific identification method and are included as a component of other income (expense), net in the Statements of Operations and Comprehensive Loss. There were no realized gains or losses during the three months ended March 31, 2026 and 2025. Bonds with maturity dates subsequent to March 31, 2027, are classified as long-term marketable securities, while bonds with maturity dates on or before March 31, 2027, are classified as short-term.

 

Comprehensive Loss

 

Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with shareholders. For the three months ended March 31, 2026 and 2025, comprehensive loss included $14 and $35 of unrealized loss on marketable securities, net of tax, respectively.

 

Recent Accounting Pronouncements

 

In November 2024, Financial Accounting Standards Board (FASB) issued ASU 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) Disaggregation of Income Statement Expenses. The guidance in ASU 2024-03 requires public business entities to disclose in the notes to the financial statements, among other things, specific information about certain costs and expenses including purchases of inventory; employee compensation; and depreciation and amortization expense for each caption on the income statement where such expenses are included. The update is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted, and the amendments may be applied prospectively to reporting periods after the effective date or retrospectively to all periods presented in the financial statements. The Company is currently evaluating the provisions of this guidance and assessing the potential impact on its financial statement disclosures.

 

NOTE 3 – LICENSE AGREEMENTS

 

In September 2021, the Company entered into the Newsoara License Agreement with Newsoara BioPharma Co. Ltd. In October 2025, Newsoara BioPharma Co. Ltd. assigned all of its rights and obligations under the Newsoara License Agreement to an affiliate, Newsoara HYK Biopharmaceuticals Co., Ltd. Pursuant to the Newsoara License Agreement, the Company granted Newsoara an exclusive license to research, develop, commercialize or exploit (i) any and all oncolytic viruses that are controlled by the Company, including Olvi-Vec but excluding V-VET1 (licensed viruses); (ii) any pharmaceutical product in final form that is comprised of or contains the licensed viruses as an active ingredient (licensed products); (iii) any virus developed by or behalf of Newsoara that (a) has a vaccinia virus backbone; (b) is not disclosed or covered by any of the Company’s patents; and (c) includes modifications (as compared to the licensed viruses) of a gene function with therapeutic intent (derived molecules); and (iv) any pharmaceutical product in final form that is comprised of or contains derived molecule as an active ingredient (derived products), in each case in mainland China, Taiwan, Hong Kong and Macau (the Newsoara Territory) in the field of human diagnostic, prophylactic and therapeutic uses (the Newsoara Field). The license granted to Newsoara is royalty bearing for licensed products and royalty free for derived products.

 

 

Under the Newsoara License Agreement, Newsoara granted the Company an exclusive and royalty bearing license to develop, commercialize, and exploit outside the Newsoara Territory any derived products developed by Newsoara. Under the terms of the Newsoara License Agreement and to date, the Company has received from Newsoara an aggregate of $11.0 million ($5.0 million as an upfront payment and $6.0 million as a milestone payment) associated with the Newsoara License Agreement. Newsoara is obligated to pay the Company additional development and commercial milestone payments up to $160.5 million in the aggregate upon the occurrence of certain development, regulatory and commercial milestones by the licensed products, and royalties on net sales of the licensed products in the mid-single-digit to mid-teens percentage range (the Newsoara Royalty). The Newsoara Royalty term, with respect to a licensed product and each region in the Newsoara Territory, is the period beginning on the date of first commercial sale of such licensed product in such region and ending on the last to occur of: (a) the expiration of the last to expire patent controlled by the Company (including any applicable patent term extension) in such region that contains either (i) an issued valid claim that covers the licensed product (including the licensed virus contained therein, and including the composition of matter and method of making and using thereof) or (ii) a pending valid claim that covers the sequence of the licensed virus contained therein; (b) the 10th anniversary of the first commercial sale of such licensed product in such region; and (c) the expiration of all regulatory exclusivity for such licensed product in such region. If the Company, at its discretion, elects to develop and commercialize outside the territory any derived product developed by Newsoara, the Company is required to make certain milestone and royalty payments to Newsoara.

 

Pursuant to the Newsoara License Agreement, Newsoara is required to use commercially reasonable efforts to research, develop, manufacture, and commercialize the licensed products in the Newsoara Territory in the Newsoara Field and is solely responsible for all costs and expenses incurred in connection with such activities. In addition, Newsoara is required to use commercially reasonable efforts to conduct a multi-center Phase 2 clinical trial for Olvi-Vec in NSCLC using clinical sites in the United States and China, which is the VIRO-25 clinical trial. Newsoara is generally obligated under the Newsoara License Agreement to fund the costs of the VIRO-25 clinical trial in the United States and China. In November 2023, the Company and Newsoara agreed that the Company would engage a clinical research organization (CRO) to conduct certain start-up activities for the trial in the United States only, with Newsoara to reimburse the Company for the costs and expenses. Pursuant to a letter of understanding (the LOU), in September 2025, the Company agreed with Newsoara that the CRO would conduct additional study activities beyond startup for the VIRO-25 clinical trial in the United States and Newsoara would reimburse the Company for costs and expenses related to such additional activities; however, Newsoara is permitted to defer reimbursement of the foregoing costs and expenses until the earlier of: (i) completion of its next round of financing, or (ii) December 31, 2026.

 

In November 2022, the Company entered into a Clinical Supply Agreement with Newsoara to manufacture and supply Olvi-Vec for Newsoara’s clinical trials in the Newsoara Territory. The Company is responsible for supplying Olvi-Vec at its own costs of manufacturing, without markup.

 

NOTE 4 - FAIR VALUE MEASUREMENTS

 

The Company employs a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The Company’s valuation techniques and inputs used to measure fair value and the definitions of the three levels (Level 1, Level 2, and Level 3) of the fair value hierarchy are disclosed in Note 2 - Summary of Significant Accounting Policies of Part IV, “Item 15. Exhibits and Financial Statements Schedules” of its Annual Report.

 

The Company uses prices and inputs that are current as of the measurement date, including during periods of market disruption. In periods of market disruptions, the ability to observe prices and inputs may be reduced for many instruments. This condition could cause an instrument to be reclassified from Level 1 to Level 2, or from Level 2 to Level 3. The Company recognizes transfers between levels at either the actual date of the event or a change in circumstances that caused the transfer. As of March 31, 2026 and December 31, 2025, the Company did not have any financial assets based on Level 3 measurements.

 

 

The following table presents information about the Company’s financial assets measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques utilized by the Company.

 SCHEDULE OF FINANCIAL ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS 

		Level 1				Level 2				Level 3				Total
		March 31, 2026
		Level 1				Level 2				Level 3				Total
		(in thousands)
Cash equivalents:
Money market funds		$	5,003			$	-			$	-			$	5,003
Available-for-sale securities:
US Government Agency bonds			-				8,236				-				8,236
US Treasury bonds			-				8,700				-				8,700
Marketable securities			-				8,700				-				8,700
Total financial assets		$	5,003			$	16,936			$	-			$	21,939

 

		Level 1				Level 2				Level 3				Total
		December 31, 2025
		Level 1				Level 2				Level 3				Total
		(in thousands)
Cash equivalents:
Money market funds		$	2,953			$	-			$	-			$	2,953
Available-for-sale securities:
US Government Agency bonds			-				7,983				-				7,983
US Treasury bonds			-				1,279				-				1,279
Marketable securities			-				1,279				-				1,279
Total financial assets		$	2,953			$	9,262			$	-			$	12,215

 

The underlying securities in the money market funds held by the Company are all government backed securities.

 

Cash equivalents consisted of money market funds at March 31, 2026 and December 31, 2025. Money market funds were valued by the Company using quoted prices in active markets for identical securities, which represent a Level 1 measurement within the fair value hierarchy. U.S. Government Agency bonds and U.S. Treasury bonds are government backed securities representing a Level 2 measurement.

 

NOTE 5 – INVESTMENTS

 

The Company’s marketable securities by type, consisted of the following:

 SCHEDULE OF AVAILABLE FOR SALE INVESTMENTS 

		As of March 31, 2026 (in thousands)
		Amortized Cost				Gross Unrealized Gains				Gross Unrealized Losses				Fair Value
US Government Agency bonds		$	8,240			$	-			$	(4	)		$	8,236
US Treasury bonds			8,704				-				(4	)			8,700
		$	16,944			$	-			$	(8	)		$	16,936

 

		As of December 31, 2025 (in thousands)
		Amortized Cost				Gross Unrealized Gains				Gross Unrealized Losses				Fair Value
US Government Agency bonds		$	7,977			$	6			$	-			$	7,983
US Treasury bonds			1,279				-				-				1,279
		$	9,256			$	6			$	-			$	9,262

 

As of March 31, 2026 and December 31, 2025, all available-for-sale securities consisted of investments that mature within one year.

 

No credit-related losses or impairments have been recognized on the Company’s marketable securities in available-for-sale securities during the three months ended March 31, 2026 and 2025.

 

 

NOTE 6 – BALANCE SHEET ACCOUNTS

 

Property and Equipment

 

The following table summarizes the Company’s major classes of property and equipment:

 SCHEDULE OF PROPERTY AND EQUIPMENT 

		March 31, 2026				December 31, 2025
		(in thousands)
Furniture and office equipment		$	154			$	148
Laboratory equipment			2,918				2,918
Computer equipment			127				127
Leasehold improvements			557				557
Manufacturing equipment			7				-
Construction in progress			3,255				2,347
Total gross carrying amount			7,018				6,097
Less: accumulated depreciation and amortization			(3,937	)			(3,927	)
Property and equipment, net		$	3,081			$	2,170

 

Depreciation expense for each of the three months ended March 31, 2026 and 2025 was $9 and $59, respectively.

 

Construction in progress is related to developments of the Company’s manufacturing and laboratory facilities in San Diego, California.

 

Accrued Expense

 

Accrued expenses consist of the following:

 

SCHEDULE OF ACCRUED EXPENSE

		March 31, 2026				December 31, 2025
		(in thousands)
Accrued research and development expenses		$	5,123			$	3,903
Accrued personnel-related expenses			861				1,440
Other			972				455
Total accrued expenses		$	6,956			$	5,798

 

As of March 31, 2026, the Company’s accrued research and development expenses were primarily attributable to ongoing clinical trial operations.

 

NOTE 7 – LEASES

 

Westlake Village, California: The Company leases 4,050 square feet of office space located at 2625 Townsgate Road for its corporate headquarters. The lease expires on July 14, 2027. The lease contains an option to renew for two additional five-year terms and first right of refusal for certain additional space at the same premises. The Company is not reasonably certain that it will exercise this option to renew and therefore it is not included in right-of-use assets and liabilities as of March 31, 2026.

 

San Diego, California: The Company leases 6,755 square feet of office and research and development laboratory space located at 6365 Marindustry Drive. The lease was extended to expire on October 31, 2035.

 

The Company also leases 7,569 square feet of manufacturing space located at 6335 Marindustry Drive, in which the lease was extended to expire on October 31, 2035.

 

During March 2026, the Company executed an amendment to extend the lease term for both San Diego facilities. The extension modified the lease term and resulted in a reassessment of the lease liability and right-of-use asset. As a result of the extension, the Company remeasured the lease liability using a revised discount rate as of the modification date and recorded a corresponding adjustment to the right-of-use asset.

 

 

Manufacturing equipment lease: On September 4, 2025, the Company entered into written agreements (Equipment Agreements), whereby the Company agreed to acquire certain equipment through a financing arrangement structured as a finance lease. Lease commencement will occur when the equipment is made available to the Company, which is the final onsite installation date and is expected to be approximately 14 months after the execution of the Equipment Agreements, or approximately November 2026. The Company has the option to purchase the asset at the end of the lease term for the amount of $1. At that time, recognition of the related finance lease asset and liability commences. Upon commencement, the lease term will be 60 months (Initial Term), with future lease payments up to approximately $6.2 million. The Company has the right to terminate the lease without cause at the end of the Initial Term or any term thereafter upon 90 days prior written notice without incurring penalties or interest.

 

As of March 31, 2026, no right-of-use asset or liability has been recognized in the financial statements, as the Company does not have possession of the equipment. The Equipment Agreements also include a refundable security deposit, equal to $2.0 million as of March 31, 2026, which is classified as restricted cash on the Company’s condensed balance sheet.

 

The components of lease assets and liabilities along with their classification on the Company’s condensed balance sheets were as follows:

 SCHEDULE OF COMPONENTS OF LEASE ASSETS AND LIABILITIES 

Lease Assets and Liabilities		Classification		March 31, 2026				December 31, 2025
				(in thousands)
Operating lease assets		Right-of-use assets		$	2,393			$	1,583
Current operating lease liabilities		Lease liabilities			316				427
Non-current operating lease liabilities		Lease liabilities, net of current portion			2,179				1,258

 

 SCHEDULE OF LEASE COST 

		2026				2025
		Three Months Ended March 31,
		2026				2025
		(in thousands)
Lease Cost Classification
Research and development		$	48			$	26
General and administrative expense			11				13
Lease cost			11				13

 

The following table presents maturities of operating lease liabilities on an undiscounted basis as of March 31, 2026:

 SCHEDULE OF MATURITIES LEASE LIABILITIES 

Year		Amounts
		(in thousands)
2026 (remainder)		$	403
2027			489
2028			326
2029			336
2030			347
Thereafter			1,883
Total		$	3,784
Less imputed interest			1,289
Total operating lease liabilities (include current portion)		$	2,495

 

Other Leases

 

In November 2019, the Company entered into a short-term lease agreement for one of its office facilities, which was subsequently extended until December 2022 and thereafter on a month-to-month basis. Rent expense was de minimis during the periods ended March 31, 2026 and 2025, respectively. In February 2026, the Company terminated the lease agreement effective March 31, 2026.

 

NOTE 8 – COMMITMENTS AND CONTINGENCIES

 

Legal Proceedings

 

From time to time, the Company may be subject to various claims and legal proceedings in the ordinary course of business. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount is reasonably estimable, the Company will accrue liability for the estimated loss. There were no contingent liabilities recorded as of March 31, 2026.

 

 

NOTE 9 – STOCKHOLDERS’ EQUITY

 

The following table summarizes the Company’s shares of preferred stock and common stock:

SCHEDULE OF PREFERRED STOCK AND COMMON STOCK

						Shares
		Par Value				Authorized				Issued				Outstanding
As of March 31, 2026
Preferred Stock			0.001				10,000,000				-				-
Common Stock			0.001				200,000,000				44,840,416				44,840,416
As of December 31, 2025
Preferred Stock			0.001				10,000,000				-				-
Common Stock			0.001				200,000,000				38,139,144				38,139,144

 

The Company’s Amended and Restated Certificate of Incorporation authorizes the Company to issue up to 200,000,000 shares of its common stock. Holders of shares of common stock have full voting rights, one vote for each share held of record. Shareholders are entitled to receive dividends as may be declared by the Company’s board of directors (the Board) out of funds legally available therefore and share pro rata in any distributions to shareholders upon liquidation. Shares of common stock do not include conversion, pre-emptive or subscription rights. All outstanding shares of common stock are fully paid and non-assessable. As of March 31, 2026, and December 31, 2025, there were 44,840,416 and 38,139,144 shares of common stock issued and outstanding, respectively.

 

In January 2026, the Company completed an underwritten offering of 6,666,667 shares of its common stock at an offering price of $3.00 per share. The net proceeds received from the offering were $18.5 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

 

NOTE 10 – STOCK BASED COMPENSATION

 

In August 2009, the Board approved the adoption of the 2009 Equity Incentive Plan (the 2009 Plan). No shares are available for grant under the 2009 Plan.

 

In September 2018, the Board approved the adoption of the 2019 Equity Incentive Plan (the 2019 Plan). No shares are available for grant under the 2019 Plan.

 

In June 2022, the Board approved the adoption of the 2022 Equity Incentive Plan (the 2022 Plan). The 2022 Plan provides for the grant of incentive stock options (ISOs) to employees, including employees of any parent or subsidiary, and for the grant of non-qualified stock options (NSOs), stock appreciation rights, restricted stock awards, restricted stock units (RSUs), performance awards and other forms of stock awards to employees, directors, and consultants, including employees and consultants of its affiliates. The 2022 Plan is a successor to the 2019 Plan. The aggregate number of shares of the Company’s common stock initially reserved for issuance under the 2022 Plan is 2,800,000 shares. In addition, the number of shares of the Company’s common stock reserved for issuance under the 2022 Plan will automatically increase on January 1 of each calendar year, starting on January 1, 2024 and continuing through and including January 1, 2032, in an amount equal to 5% of the total number of shares of its common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the Board. In January 2026, the number of shares available to be issued under the 2022 Plan automatically increased by 1,906,957 shares, as determined by the 2022 Plan. As of March 31, 2026, the total number of shares reserved for issuance was 3,179,349.

 

In September 2023, the Board approved the adoption of the Company’s 2023 Inducement Plan (the Inducement Plan) to reserve 1,000,000 shares of the Company’s common stock to be used exclusively for grants of awards to individuals that were not previously employees or directors of the Company as an inducement material to the individual’s entry into employment with the Company. The Inducement Plan provides for the grant of NSOs, stock appreciation rights, restricted stock awards, RSUs, performance-based cash and stock awards, and other stock-based awards. The terms and conditions of the Inducement Plan are substantially similar to the Company’s stockholder-approved 2022 Plan. In June 2025, the Board approved an increase to the number of shares of the Company’s common stock available for issuance under the Inducement Plan by 1,000,000 shares. As of March 31, 2026, the total number of shares reserved for issuance under the inducement Plan was 847,101.

 

 

The following table presents a summary of awards outstanding:

 SCHEDULE OF AWARDS OUTSTANDING

		2009 Plan				2019 Plan				2022 Plan				Inducement Plan				Total
		March 31, 2026
		2009 Plan				2019 Plan				2022 Plan				Inducement Plan				Total
Stock options			1,497,118				1,634,924				2,644,838				1,141,300				6,918,180
RSUs			-				-				1,185,494				-				1,185,494
Total awards outstanding			1,497,118				1,634,924				3,830,332				1,141,300				8,103,674

 

The following table summarizes stock-based compensation expenses included in operating expenses:

 SCHEDULE OF STOCK-BASED COMPENSATION EXPENSES

		2026				2025
		Three Months Ended March 31,
		2026				2025
		(in thousands)
General and administrative		$	966			$	1,036
Research and development			815				496
Total stock-based compensation expenses		$	1,781			$	1,532

 

		2026				2025
		Three Months Ended March 31,
		2026				2025
		(in thousands)
Stock Options		$	1,462			$	1,429
RSUs			319				103
Stock-based compensation expenses		$	1,781			$	1,532

 

Restricted Stock Units

 

The following table summarizes the activity of the Company’s RSUs:

 SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY

		Number of Restricted Shares				Weighted Average Grant Date Fair Value
Outstanding, December 31, 2025			1,221,432			$	4.41
Granted			-				-
Vested			(29,063	)			5.64
Forfeited			(6,875	)			2.29
Outstanding, March 31, 2026			1,185,494			$	5.30

 

As of March 31, 2026, $3.7 million of unamortized stock compensation expense remains.

 

Stock Options Awards

 

Option exercise prices are set forth in the grant notice, without commission or other charge, provided however, that the price per share of the shares subject to the option shall not be less than the greater of (i) 100% of the fair market value of a share of stock on the grant date, or (ii) with respect to awards under the 2019 Plan or 2022 Plan, 110% of the fair market value of a share of stock on the grant date in the case of a Participant then owning more than 10% of the total combined voting power of all classes of stock of the Company or any “subsidiary corporation” of the Company or any “parent corporation” of the Company. Options to employees, directors and consultants generally vest and become exercisable over a period not exceeding four years. Options typically expire ten years after the date of grant.

 

The Company’s policy is to recognize compensation cost for awards with only service conditions on a straight-line basis over the requisite service period for the entire award. Additionally, the Company’s policy is to issue new shares of common stock to satisfy stock option exercises. The Company applied fair value accounting for all share-based payments awards. The fair value of each option granted is estimated on the date of grant using the Black-Scholes option-pricing model.

 

 

In September 2025, the Board approved a reduction in the exercise prices of certain stock options held by employees to purchase shares of the Company’s common stock under the Company’s 2022 Plan, 2019 Plan and 2009 Plan that had exercise prices greater than $5.00 per share. The exercise price for such options was reduced to $3.33 per share, which was the closing price of the common stock on September 1, 2025, the effective date of the reduction. The total cost of the repricing was $1.3 million, of which $0.7 million was recorded as of September 30, 2025. The remainder of the cost will be recorded over the future vesting periods of the options.

 

In September 2022, the Board approved a stock option repricing whereby the exercise price of previously granted and unexercised options held by certain employees, directors and key advisers with exercise prices between $9.00 and $10.50 per share, was adjusted to $6.00 per share, the closing price of the Company’s initial public offering. The total cost of the repricing was $2.73 million, of which $2.72 million was recorded as of December 31, 2024, and the remaining cost was recorded during the twelve months ended December 31, 2025.

 

The assumptions used for the options granted during the period are as follows:

 SCHEDULE OF ASSUMPTIONS USED FOR OPTIONS GRANTED 

		Three Months Ended March 31,
		2026				2025
Exercise prices		$	4.55			$	3.95
Expected dividend yield			-				-
Expected volatility			109	%			100	%
Risk-free interest rate			3.7	%			4.4	%
Expected term of options			7.0				7.0

 

The table below summarizes the Company’s stock option activities for the three months ended March 31, 2026:

 SCHEDULE OF STOCK OPTION ACTIVITY  

		Number of Shares Subject to Outstanding Options				Weighted Average Exercise Price (Per share)				Weighted Average Remaining Contractual Terms (in Years)				Aggregate Intrinsic Value
Outstanding at December 31, 2025			6,711,979			$	3.92				4.06				-
Granted			288,154				3.60
Cancelled			(18,492	)			2.65
Exercised			(5,542	)			2.29
Expired			(57,919	)			5.67
Outstanding at March 31, 2026			6,918,180			$	5.20				6.33				162
Vested and exercisable, March 31, 2026			4,337,341			$	5.03				3.95				-
Unvested, March 31, 2026			2,580,839

 

As of March 31, 2026, unvested stock option expense of $10.9 million remained and will be amortized over the remaining vesting period, through January 2030.

 

Stock Warrants

 

The table below summarizes the Company’s warrants activities for the three months ended March 31, 2026:

 SCHEDULE OF WARRANTS ACTIVITIES

		Number of Warrant Shares				Exercise Price Range Per Share				Weighted Average Exercise Price
Outstanding, December 31, 2025			7,930,785				$3.00 – 9.00			$	5.30
Granted			-				-				-
Cancelled			-				-				-
Exercised			-				-				-
Expired			-				-				-
Outstanding, March 31, 2026			7,930,785				$3.00 – 9.00			$	5.30
Vested and exercisable, March 31, 2026			7,930,785				$3.00 – 9.00			$	5.30

 

There is no intrinsic value for warrant shares outstanding at March 31, 2026.

 

 

Employee Stock Purchase Plan

 

The Company’s 2022 Employee Stock Purchase Plan (ESPP) permits eligible employees to purchase Company shares on an after-tax basis in an amount between 1% and 15% of their earnings: (i) on May 16th of each year at a 15% discount of the fair market value of the Company’s common stock on November 17th of the previous year or May 16th of the then-current year, whichever is lower, and (ii) on November 15th of each year at a 15% discount of the fair market value of the Company’s common stock on May 17th or November 15th of the then-current year, whichever is lower. The ESPP includes an “evergreen” feature, which provides that an additional number of shares of common stock will automatically be added to the shares authorized for issuance under the ESPP on January 1st of each year, beginning on January 1, 2024 and ending on (and including) January 1, 2032. The number of shares added each calendar year will equal the lesser of 1% of the Company’s common stock outstanding on December 31st of the preceding calendar year or 2,100,000 or a lesser number as determined by the Board. In January 2026, the number of shares available to be issued under the ESPP automatically increased by 381,391 shares, as determined by the Plan. During the three months ended March 31, 2026, no shares were purchased under the ESPP and as of March 31, 2026, 1,590,932 shares remain authorized and available for issuance.

 

NOTE 11– NET LOSS PER SHARE

 

Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of outstanding common shares during the period. Diluted loss per share is computed by dividing the net loss applicable to common stockholders by the weighted average number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued.

 

The basic and diluted shares outstanding were the same, as potentially dilutive shares were considered anti-dilutive. The potentially dilutive securities consisted of the following:

 SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES

		2026				2025
		Three Months Ended March 31,
		2026				2025
Stock options			6,918,180				5,491,921
Stock warrants			7,930,785				8,017,975
Restricted stock units			1,185,494				579,714
Total			16,034,459				14,089,610

 

NOTE 12 – SEGMENT INFORMATION

 

The Company operates as a single One reportable segment as a clinical stage biopharmaceutical company. The Company’s current focus is on developing oncolytic immunotherapies for the treatment of cancer. Segment profit or loss is measured as the net loss reported in the Company’s condensed statements of operations and comprehensive loss.

 

The Company’s Chief Executive Officer serves as the Chief Operating Decision Maker (CODM). The CODM evaluates performance, allocates resources and conducts planning and forecasting using financial information as presented in the condensed statements of operations. In addition, the CODM reviews research and development expenses by program.

 

The table below details the Company’s revenues and expenses and reconciles those amounts to the Company’s net loss as computed under GAAP in the statements of operations and comprehensive loss:

 SCHEDULE OF SEGMENT INFORMATION

		2026				2025
		Three Months Ended March 31,
		2026				2025
		(in thousands)
Revenue		$	-			$	-
Less:
Research and development, excluding salaries			4,607				3,868
Salaries			2,069				1,494
Insurance			271				219
Stock-based compensation			1,781				1,533
Operating expenses			441				702
Operating loss			9,169				7,816
Other income			241				324
Net loss		$	(8,928	)		$	(7,942	)

 

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis should be read in conjunction with the financial statements of Genelux Corporation (Genelux, Company, we, us, or our) and accompanying notes included in this Quarterly Report on Form 10-Q (Quarterly Report) and the financial statements and accompanying notes thereto for the year ended December 31, 2025 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K, for the fiscal year ended December 31, 2025. See also “Special Note Regarding Forward-Looking Statements” included in this Quarterly Report.

 

Company Overview

 

Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat tumor types. Our clinical and preclinical product candidates are intended to selectively kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens. Importantly, our oncolytic immunotherapy product candidates are “off-the-shelf” personalized immunotherapies. In other words, while we administer the same virus product to different patients, the cellular immune response generated is expected to be specific to the unique neoantigens in that patient. Our lead product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity.

 

Employing our proprietary selection technology and discovery and development platform (CHOICE), we have developed an extensive library of isolated and engineered oncolytic VACV immunotherapeutic product candidates. These provide potential utility in multiple tumor types in both the monotherapy and combination therapy settings, via physician-preferred administration techniques, including regional (e.g., intraperitoneal), local and systemic (e.g., intravenous) delivery routes. Informed by our CHOICE platform and supported by extensive clinical and preclinical data, we believe we have the capacity to develop a pipeline of treatment options to address high unmet medical needs for those patients with insignificant or unsatisfactory responses to standard-of-care therapies, including chemotherapies.

 

Our operations have focused on organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales.

 

Since inception, we have incurred significant operating losses. Our net losses were $8.9 million and $7.5 million for the three months ended March 31, 2026, and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $292.5 million. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.

 

We will not generate revenue from commercially approved product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing, and distribution activities.

 

As a result, we will require substantial additional funding to support our continuing operations and to pursue our growth strategy. Until we generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings, debt and/or other sources, such as milestone payments, royalties or other payments or funding from existing or potential collaboration agreements, strategic alliances, licensing arrangements and other arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Failure to raise capital or enter into such agreements as and when needed, could have a material adverse effect on our business, results of operations and financial condition.

 

In January 2026, we completed an underwritten offering of 6,666,667 shares of our common stock at an offering price of $3.00 per share. The net proceeds received from the offering were $18.5 million, after deducting underwriting discounts and commissions and offering expenses payable by us. Due to the funds received through this offering, we had stockholders’ equity of $22.9 million at March 31, 2026. We expect our cash, cash equivalents, restricted cash and marketable securities, totaling $26.3 million at March 31, 2026, to last into the first quarter of 2027.

 

 

Recent Developments

 

Data from Lung Cancer Clinical Trials

 

On January 5, 2026, we announced interim results from two ongoing trials evaluating systemic (intravenous) administration of Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and progressive non-small cell lung cancer (NSCLC), respectively, after failure of prior platinum-based regimens.

 

Platinum-relapsed or platinum-refractory advanced SCLC (Ph1b/2 SCLC trial)

 

The open-label Phase 1b/2 SCLC trial (NCT07136285) is evaluating a single intravenous cycle with multiple doses of Olvi-Vec administered in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-relapsed or platinum-refractory disease after failing previous treatment with platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd. (Newsoara), in China.

 

As of the data review cutoff date of December 23, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results:

 

	●	9 evaluable patients   Overall response rate (ORR) of 33% (3/9 patients), including three partial responses (PRs)   - Two of the three PRs occurred in Cohort 4, the highest dose cohort tested as of the data review cutoff date, with tumor shrinkage of approximately 55% and 85% from baseline, representing an ORR of 67% (2/3) in Cohort 4 and potentially suggesting a dose-response trend - Disease control rate (DCR) of 67% (6/9 patients) - Tumor shrinkage of 24–85% among the six DCR patients, all of whom experienced a reduction in all target lesions from baseline - Olvi-Vec generally well tolerated
	●	Exploratory durability signals: Two PR patients across different cohorts have been evaluated in long-term follow-up:

 

	-	A patient with 1 prior line, at last scan, achieved a PR with an ongoing progression-free survival (PFS) of 12.1 months
	-	A patient with 4 prior lines had a PFS of 7.7 months, which exceeds the PFS in the immediately preceding line in the same patient (1.9 months) by 5.8 months

 

Advanced or metastatic recurrent NSCLC (Phase 2 VIRO-25 Clinical trial)

 

The open-label Phase 2 VIRO-25 trial (NCT06463665) is evaluating a single intravenous cycle with multiple doses of Olvi-Vec in combination with platinum chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent NSCLC who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States.

 

As of the data review cutoff date of December 31, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results:

 

	●	5 evaluable patients
	●	DCR of 60% (3/5 patients)
	●	Tumor size changes among the three DCR patients were 8.9%, -18.9%, and -22.7%, respectively, as compared to baseline
	●	Olvi-Vec generally well tolerated

 

 

Underwritten Public Offering

 

In January 2026, we completed an underwritten offering of 6,666,667 shares of our common stock at an offering price of $3.00 per share. The net proceeds received from the offering were $18.5 million after deducting underwriting discounts, and commissions, and offering expenses payable by us.

 

Officer Appointment

 

In January 2026, the Company announced the appointment of Jason Litten, M.D. as Chief Medical Officer.

 

Results of Operations

 

Net Sales

 

No revenue was recognized during the three months ended March 31, 2026 and 2025, respectively.

 

Operating Expenses

 

Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.

 

Research and Development Expenses

 

Research and development expenses consist primarily of costs incurred for our research and development activities, including our product candidate discovery efforts and preclinical and clinical studies under our research programs, which include:

 

	●	employee-related expenses, including salaries, benefits, and stock-based compensation for our research and development personnel;
	●	costs of funding research performed by third parties that conduct research and development and preclinical and clinical activities on our behalf;
	●	costs of manufacturing drug product and drug supply related to our current or future product candidates;

 

	●	costs of conducting preclinical studies and clinical trials of our product candidates;
	●	consulting and professional fees related to research and development activities, including equity-based compensation to non-employees;
	●	costs of maintaining our laboratory, including laboratory supplies and non-capital equipment used in our preclinical studies;
	●	costs related to compliance with clinical regulatory requirements; and
	●	facility costs and other allocated expenses, which include rent and maintenance of facilities, insurance, depreciation, and other supplies.

 

Research and development costs are expensed as incurred. Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our preclinical and clinical studies or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period.

 

The successful development of our product candidates is highly uncertain. We cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete development of our current or future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if they are approved. This is due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:

 

●

the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinical studies and clinical trials and other research and development activities;

 

 

	●	establishing an appropriate safety profile;
	●	successful enrollment in and completion of clinical trials;
	●	whether our product candidates show safety and efficacy in our clinical trials;
	●	receipt of marketing approvals from applicable regulatory authorities;
	●	establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
	●	obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;
	●	commercializing product candidates, if and when approved, whether alone or in collaboration with others; and
	●	continued acceptable safety profile of the products following any regulatory approval.

 

A change in the outcome of any of these variables with respect to the development of our current and future product candidates would significantly change the costs and timing associated with the development of those product candidates.

 

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect research and development costs to increase significantly for the foreseeable future as we commence and conduct clinical trials and continue the development of our current and future product candidates. However, we do not believe that it is possible at this time to accurately project expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.

 

General and Administrative Expenses

 

General and administrative expenses include salaries and other compensation-related costs, including stock-based compensation, for personnel in executive, finance, business development, operations and administrative roles. Other significant costs include professional service and consulting fees, including legal fees relating to intellectual property and corporate matters, accounting and recruiting fees and fees paid to consultants engaged to supplement our personnel as well as insurance, travel, and office-related costs not included in research and development expenses.

 

We anticipate that our general and administrative expenses will increase in the future as our business expands to support expected growth in research and development activities, including our future clinical programs. These increases are expected to result primarily from higher personnel-related costs associated with hiring additional personnel and increased fees paid to outside service providers, among other expenses. We also anticipate incurring additional expenses associated with operating as a public company, including audit, legal, regulatory and tax-related costs to comply with the rules and regulations of the U.S. Securities and Exchange Commission (the SEC), and listing standards applicable to companies listed on a national securities exchange, increased director and officer insurance premiums, and investor relations costs. In addition, if we obtain regulatory approval for any of our product candidates and do not enter into a third-party commercialization collaboration, we expect to incur significant additional costs related to establishing sales, marketing and distribution capabilities.

 

 

Results of Operations

 

Comparison of the Three Months Ended March 31, 2026 and 2025

 

The following table summarizes our results of operations for the periods indicated (in thousands):

 

		Three Months Ended March 31,
		2026				2025				Change
Revenue		$	-			$	-			$	-
Operating expenses:
Research and development			5,778				4,698				1,080
General and administrative			3,393				3,118				275
Total operating expenses			9,171				7,816				1,355
Operating loss			(9,171	)			(7,816	)			(1,355	)
Other income:
Interest income			173				184				(11	)
Bond accretion income			70				140				(70	)
Total other income			243				324				(81	)
Net loss		$	(8,928	)		$	(7,492	)		$	(1,436	)

 

Research and Development (R&D) Expenses

 

The following table summarizes our research and development expenses for the periods indicated (in thousands):

 

		Three Months Ended March 31,
		2026				2025				Change
Employee compensation and related expenses		$	1,206			$	830			$	376
Stock compensation, including the cost of stock options and restricted stock grants			815				496				319
Manufacturing and laboratory materials and other expenses			200				398				(198	)
Manufacturing quality services			374				359				15
Clinical and regulatory expenses			3,028				2,344				684
Facility-related expenses, including depreciation			122				170				(48	)
Consulting expenses and contract labor			30				99				(69	)
Other expenses			3				2				1
Total research and development expenses		$	5,778			$	4,698			$	1,080

 

R&D expenses increased by $1.1 million for the three months ended March 31, 2026, over the same period in 2025. The increase was primarily driven by $0.7 million in clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime/GOG-3076 registration trial and $0.4 million in employee compensation and related expenses.

 

 

General and Administrative Expenses

 

The following table summarizes our general and administrative expenses for the following periods indicated (in thousands):

 

		Three Months Ended March 31,
		2026				2025				Change
Employee compensation and related expenses		$	915			$	716			$	199
Stock compensation, including the cost of stock options and restricted stock grants			967				1,037				(70	)
Professional services			838				893				(55	)
Facility-related expenses			86				81				5
Insurance expenses			272				223				49
Consulting and contract labor expenses			150				74				76
Other expenses			165				94				71
Total general and administrative expenses		$	3,393			$	3,118			$	275

 

General and administrative expenses increased by $0.3 million for the three months ended March 31, 2026 over the same period in 2025 primarily as a result of an increase of $0.2 million in employee compensation and related expenses.

 

Other Income

 

Other income was $0.2 million and $0.3 million for the three months ended March 31, 2026 and 2025, respectively. There was a decrease of $0.08 million in 2026 primarily due to lower bond accretion income.

 

Liquidity and Capital Resources

 

The accompanying condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. As reflected in the accompanying financial statements, the Company has experienced recurring losses from operations since inception and incurred a net loss of $8.9 million and cash used in operations of $6.1 million during the three months ended March 31, 2026. These factors raise substantial doubt about the Company’s ability to continue as a going concern. In addition, our independent registered public accounting firm has included an explanatory paragraph in their report with respect to the uncertainty that accompanies our audited financial statements as of and for the year ended December 31, 2025. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to raise additional funds and implement its development strategies. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

As of March 31, 2026, we had cash, cash equivalents, restricted cash and marketable securities of $26.3 million. Apart from payment and reimbursement obligations of Newsoara under a license agreement with Newsoara, we do not have any committed external source of funds or other support for our developmental efforts. Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, which may include sales under an “at-the-market” offering program pursuant to our sales agreement (ATM Agreement) with TD Securities (USA) LLC, debt financings and/or other capital sources such as milestone payments, royalties or other payments or funding from existing or potential collaborations, strategic alliances, licensing arrangements and other arrangements. Based on our research and development plans, we expect that our existing cash, cash equivalents, restricted cash and marketable securities will fund our planned operations into the first quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. In addition, because the design and outcome of our anticipated and any future clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of Olvi-Vec or any future product candidates. Our existing cash balance may not be sufficient to complete the development of Olvi-Vec or any other product candidate.

 

No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in case of equity financing, or grant unfavorable terms in future licensing agreements.

 

 

Cash Flows

 

The following table sets forth the primary sources and uses of cash for each of the periods presented below:

 

		Three Months Ended March 31,
		2026				2025
		(in thousands)
Cash Flow from:
Operating activities		$	(6,059	)		$	(5,435	)
Investing activities			(8,539	)			3,509
Financing activities			18,538				9,567
Net increase in cash, cash equivalents and restricted cash		$	3,940			$	7,641
Cash, cash equivalents and restricted cash at end of period		$	9,273			$	16,206

 

During the three months ended March 31, 2026, cash flow used in operating activities was $6.1 million, which consisted of a net loss of $8.9 million, partially offset by an increase in accrued expenses of $1.7 million. Cash used in investing activities was $8.5 million, which was primarily attributable to net maturities of marketable securities of $7.6 million. Cash provided by financing activities of $18.5 million was related to cash received from sale of common stock. See “Stockholders’ Equity” in Note 9 to our condensed financial statements in Part I.

 

During the three months ended March 31, 2025, cash flow used in operating activities was $5.4 million, which consisted of a net loss of $7.5 million, non-cash expense of stock-related compensation of $1.5 million and accrued expenses of $1.1 million. Cash provided by investing activities was $3.5 million, which was primarily attributable to net purchase of marketable securities of $3.5 million. Cash provided by financing activities of $9.6 million was related to proceeds from the sale of common stock.

 

Equity Financings

 

Common Stock Issued for Cash Upon Closing of the Company’s Public Offering

 

In January 2026, we completed an underwritten offering of 6,666,667 shares of our common stock at an offering price of $3.00 per share. The net proceeds received from the offering were $18.5 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

 

Funding Requirements

 

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, initiate and conduct preclinical studies and clinical trials, and seek marketing approval for our current and any of our future product candidates. In addition, if we obtain marketing approval for any of our current or our future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution, which costs we may seek to offset through entry into collaboration agreements with third parties. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

 

We believe that our existing cash, cash equivalents, restricted cash and marketable securities will fund our planned operations into the first quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on a number of factors, including:

 

	●	the costs of conducting preclinical studies and clinical trials;
	●	the costs of manufacturing;
	●	the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinical trials for product candidates we may develop, if any;

 

 

	●	the costs, timing, and outcome of regulatory review of our product candidates;
	●	our ability to establish and maintain collaborations on favorable terms, if at all;
	●	the achievement of milestones or occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time;
	●	the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
	●	the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;
	●	the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims;
	●	our headcount growth and associated costs as we expand our business operations and research and development activities;
	●	the costs of operating as a public company; and
	●	the impact of geopolitical and macroeconomic events, including future bank failures, new or increased tariffs, funding shortages as governmental and regulatory agencies on which we rely, geopolitical tensions between the United States and China, the Russia/Ukraine conflict, conflicts in the Middle East and global pandemics on U.S. and global economic conditions including changes in monetary and fiscal policy, United States political developments and other sources of instability that may affect our ability to access capital on acceptable terms, if at all.

 

We anticipate needing to obtain further funding to achieve our business objectives beyond such date.

 

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through public or private equity offerings, which may include sales under the ATM agreement, debt financings, and/or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our common stockholders’ ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect the rights of our common stockholders. Additional debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business.

 

If we raise funds through potential collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

 

Critical Accounting Policies

 

This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances at the time such estimates are made. Actual results may differ materially from our estimates and judgments under different assumptions or conditions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in our financial statements prospectively from the date of the change in estimate.

 

 

We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. Our critical accounting policies are described in Part II. Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report. There were no material changes to these accounting policies during the three months ended March 31, 2026.

 

Recent Accounting Pronouncements

 

For a discussion of our material changes in recent accounting pronouncements, see “Recent Accounting Pronouncements” in Note 2 to our unaudited interim condensed financial statements in Part I. Item 1 “Financial Statements” in this Quarterly Report for additional information.

 

Emerging Growth Company Status

 

As an “emerging growth company,” the Jumpstart Our Business Startups Act of 2012 permits us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

There have been no material changes in the Company’s exposure to market risk from that described in “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” of its Annual Report on Form 10-K for the year ended December 31, 2025.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended (Exchange Act), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of March 31, 2026. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2026.

 

In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) or 15d-15(f) of the Exchange Act) that occurred during the period covered by this Quarterly Report that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II — OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of legal and settlement costs, diversion of management resources and other factors.

 

Item 1A. Risk Factors

 

In addition to the other information set forth in this Quarterly Report, you should carefully consider the risk factors and other cautionary statements described under the heading “Item 1A. Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “Annual Report”), which could materially affect our business, financial condition or future results. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition or future results. There have been no material changes in our risk factors from those described in our Annual Report, other than the updates to the risk factors or new risk factors set forth below.

 

International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.*

 

We operate in a global economy, which includes utilizing third-party suppliers in several countries outside the United States. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty. The U.S. government has recently announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the pharmaceutical industry. In response, certain foreign governments have announced or implemented retaliatory tariffs and other protectionist measures. Further, the Bureau of Industry and Security, U.S. Department of Commerce, has initiated an investigation to determine whether pharmaceutical ingredients, including finished drug product, manufactured outside the United States pose a national security risk and should be subject to additional tariffs. Following that investigation, the President announced a proclamation which will impose 100% tariffs on certain patented pharmaceutical products and associated pharmaceutical ingredients. We are assessing the potential impact of the proclamation on our business. These developments have created a dynamic and unpredictable trade landscape, which may adversely impact our business, results of operations, financial condition and prospects.

 

We rely on specialized laboratory equipment, supplies, and materials, all or part of which we believe may be ultimately sourced from multiple countries outside the United States, to advance our research and development efforts.

 

Current or future tariffs will result in increased research and development expenses, including with respect to increased costs associated with specialized laboratory equipment used in the manufacture of Olvi-Vec. In addition, such tariffs could increase our supply chain complexity and also potentially disrupt our existing supply chain. Unlike consumer goods, pharmaceuticals face unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly. Trade restrictions affecting the import of materials necessary for clinical trials could result in delays to our development timelines. Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence, negatively impacting our ability to secure additional financing on favorable terms or at all. In addition, as we advance toward commercialization in the future, tariffs and trade restrictions could hinder our ability to establish cost-effective production capabilities, negatively impacting our growth prospects.

 

The complexity of announced or future tariffs may also increase the risk that we or our suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S. entities, which may limit our ability to compete internationally and attract non-U.S. investment, employees, customers and suppliers. Foreign governments may also take other retaliatory actions against U.S. entities, such as decreased intellectual property protection, increased enforcement actions, or delays in regulatory approvals, which may result in heightened international legal and operational risks. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business.

 

 

Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects. In addition, trade developments have and may continue to heighten the risks related to the other risk factors described in our Annual Report.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

Not applicable.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

Trading Arrangements 

 

During the three months ended March 31, 2026, no director or officer adopted or terminated any Rule 10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement (as such terms are defined pursuant to Item 408(a) of Regulation S-K).

 

Item 6. Exhibits

 

Exhibit Number		Description
3.1		Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41599), filed with the SEC on January 30, 2023).
3.2		Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-41599), filed with the SEC on January 30, 2023).
4.1		Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-265828), as amended, originally filed with the SEC on August 29, 2022).
4.2		Form of Representative’s Warrant (incorporated by reference to Exhibit 4.7 the Amendment No. 2 of Form S-1 (File No. 333-265828), filed with the SEC on September 19, 2022).
4.3		Form of Underwriter Warrant dated March 26, 2025 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41599), filed with the SEC on March 25, 2025).
4.4		Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41599), filed with the SEC on May 24, 2024).
10.1*		Executive Employment Offer Letter, dated November 28, 2025, by and between the Registrant and Jason Litten, M.D.

 

 

Exhibit Number		Description
10.2*		Fourth Amendment to Industrial/Commercial Multi-Tenant Lease, by and between the Registrant and Marindustry Partners, LP, dated March 20, 2026.
10.3*		Industrial/Commercial Multi-Tenant Lease, by and between the Registrant and Marindustry Partners, LP, dated July 24, 2023.
10.4*		First Amendment to Industrial/Commercial Multi-Tenant Lease, by and between the Registrant and Marindustry Partners, LP, dated March 20, 2026.
10.5		Sales Agreement, dated as of March 19, 2026, by and between the Registrant and TD Securities (USA) LLC (incorporated by reference to Exhibit 1.1 to the Registrant’s Current Report on Form 8-K (File No. 001-41599), filed with the SEC on March 19, 2026).
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 and 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 - the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH		Inline XBRL Taxonomy Extension Schema Document
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document
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 (embedded within the Inline XBRL document)

 

*	Filed with this Quarterly Report on Form 10-Q.
†	This certification shall not be deemed filed for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

 

 

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.

 

Date: May 7, 2026

 

GENELUX CORPORATION
By:	/s/ Thomas Zindrick, J.D.
			Thomas Zindrick, J.D.
			President, Chief Executive Officer and Chairman
			(Principal Executive Officer)
By:	/s/ Matthew Pulisic
			Matthew Pulisic
			Chief Financial Officer
			(Principal Financial and Accounting Officer)