GENELUX Corp

Previous wording

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.

Current wording

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Previous wording

Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid 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 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.

Current wording

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.

Previous wording

Since inception, we have incurred significant operating losses. Our net losses were $29.9 million and $28.3 million, respectively, for the years ended December 31, 2024 and 2023. As of December 31, 2024, we had an accumulated deficit of $251.4 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.

Current wording

Since inception, we have incurred significant operating losses. Our net losses were $32.1 million and $29.9 million, respectively, for the years ended December 31, 2025 and 2024. As of December 31, 2025, we had an accumulated deficit of $283.5 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.

Previous wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing 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. Our 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.

Current wording

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.

Previous wording

On March 26, 2025, the Company completed an underwritten offering of 3,000,000 shares of its common stock at an offering price of $3.50 per share. The gross proceeds received from the offering were $10.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

Current wording

In March 2025, we completed an underwritten offering of 3,000,000 shares of our common stock at $3.50 per share. The net proceeds received from the offering were $9.6 million, after deducting underwriting discounts, and commissions, and offering expenses payable by the Company.

Previous wording

In October 2024, we announced that the first patient had been dosed in a Phase 2, open-label, randomized, and controlled clinical trial designed to evaluate the efficacy and safety of intravenously delivered Olvi-Vec oncolytic VACV for patients with recurrent non-small cell lung cancer (NSCLC) in the United States. In accordance with our license agreement with our partner in China, Newsoara BioPharma Co. Ltd. (Newsoara), Newsoara is generally obligated to fund the Phase 2 clinical trial in its entirety. In November 2023, we agreed with Newsoara that Genelux would directly engage a contract research organization on mutually agreeable terms to conduct certain startup activities for the NSCLC trial in the U.S. only, with Newsoara reimbursing us for the costs and expenses of such agreed-upon startup activities. Newsoara is permitted to defer such reimbursement payments until the completion of its next round of financing, which Newsoara expects to occur in 2025. During the quarter ended September 30, 2024, the Company entered into a Clinical Trial Services Agreement with Hong Kong Tigermed Consulting Co., Ltd., to provide regulatory and development support services for the NSCLC trial in the United States.

Current wording

In October 2024, the Company announced that the first patient had been dosed in a Phase 2, open-label, randomized, and controlled clinical trial designed to evaluate the efficacy and safety of intravenously delivered Olvi-Vec oncolytic VACV for patients with recurrent non-small cell lung cancer (NSCLC) in the United States. Pursuant to the Company’s license agreement (as amended, the Newsoara License Agreement) with its partner in China, Newsoara HYK Biopharmaceuticals Co., Ltd. (Newsoara), Newsoara is generally obligated to fund the Phase 2 NSCLC trial in its entirety in the United States and China (VIRO-25 Trial). In November 2023, the Company agreed with Newsoara that the Company would directly engage a contract research organization (CRO) on mutually agreeable terms to conduct certain startup activities for the VIRO-25 Trial in the U.S. only, with Newsoara reimbursing the Company for the costs and expenses of such agreed-upon startup activities. 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 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.

Previous wording

During the year ended December 30, 2023, under our license agreement with Newsoara, we invoiced and collected $0.2 million relating to supplying product for Newsoara to use in its clinical trials. During the year ended December 31, 2024, we recognized revenue of $0.01 million relating to the Company’s license agreement with ELIAS Animal Health, LLC.

Current wording

During the year ended December 31, 2025 and 2024, we recognized revenue of $0.01 million relating to our license agreement with ELIAS Animal Health, LLC, respectively.

Previous wording

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 judgement and estimates are made in determining the accrued expense balances at the end of any reporting period.

Current wording

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.

Previous wording

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 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.

Current wording

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.

Previous wording

General and administrative expenses include salaries and other compensation-related costs, including stock-based compensation, for personnel in executive, finance and accounting, 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 fees, recruiting costs and costs for consultants who we utilize to supplement our personnel, insurance costs, travel costs, facility and office-related costs not included in research and development expenses.

Current wording

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.

Previous wording

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 will likely include increased costs related to the hiring of additional personnel and fees to outside service providers, among other expenses. We also anticipate increased expenses associated with being a public company, including costs for audit, legal, regulatory and tax-related services related to compliance 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, 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 expenses related to building a sales and marketing team to support product sales, marketing and distribution activities.

Current wording

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.

Previous wording

The following table summarizes our results of operations for the years ended December 31, 2024 and 2023 (in thousands):

Current wording

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

Previous wording

We have experienced recurring losses from operations since inception and incurred a net loss of $29.9 million and used cash in operations of $21.2 million during the year ended December 31, 2024. These factors raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement our strategies. The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

Current wording

We have experienced recurring losses from operations since inception and incurred a net loss of $32.1 million and used cash in operations of $25.3 million during the year ended December 31, 2025. These factors raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement our strategies. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Previous wording

As of December 31, 2024, we had cash and short-term investments of $30.9 million, however we do not have any committed external source of funds or other support for our development 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 and debt financings, or other capital sources such as potential collaborations, strategic alliances, licensing arrangements and other arrangements. Based on our research and development plans, we expect that our existing cash balance may not enable us to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of filing of this Annual Report. 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. Additionally, although we have commitments from investors to fund the remaining aggregate investment amounts in connection with our Private Placements, we may not receive some or all of the committed proceeds, due to ongoing liquidity constraints or other factors. The failure to receive all or some of the committed proceeds would exhaust our available capital resources sooner than expected and will require us to obtain further funding to achieve our business objectives.

Current wording

As of December 31, 2025, we had cash, cash equivalents, restricted cash and marketable securities of $14.6 million and subsequent net proceeds of $18.5 million that were received in January 2026, representing a pro forma balance of $33.1 million. However we do not have any committed external source of funds or other support for our development efforts, except for the Newsoara License Agreement. 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, 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 our research and development plans, we expect that our existing cash balance may not enable us to fund our planned operating expenses and capital expenditure requirements for the next 12 months from the date of filing of this Annual Report. In addition, because the design and outcome of our anticipated and any future clinical trials are 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.

Previous wording

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.

Current wording

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 us. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt, or cause substantial dilution for our stockholders, in case of equity financing, or grant unfavorable terms in future licensing agreements.

Previous wording

During the year ended December 31, 2024, we provided cash from financing activities of $28.5 million, compared to $44.0 million provided during the year ended December 31, 2023. For the year ended December 31, 2024, cash provided by financing activities consisted of proceeds from the sale of common stock of $27.7 million, proceeds from the exercise of stock warrants of $0.7 million, and proceeds from our company’s equity awards programs of $0.1 million.

Current wording

During the year ended December 31, 2024, cash flow used in operating activities was $21.2 million, which consisted of a net loss of $29.9 million, non-cash expense of stock-related compensation of $8.1 million and accrued expenses of $2.2 million, and partially offset by a decrease in accrued payroll of $1.1 million. Cash used in investing activities was $8.1 million, which was primarily attributable to net purchase of marketable securities of $7.8 million. Cash provided by financing activities of $28.5 million was related to proceeds from the sale of common stock of $27.7 million and proceeds from the exercise of stock warrants of $0.7 million.

Previous wording

On March 26, 2025, we completed an underwritten offering of 3,000,000 shares of our common stock at an offering price of $3.50 per share. The gross proceeds received from the offering were $10.5 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

Current wording

In March 2025, we completed an underwritten offering of 3,000,000 shares of our common stock, at an offering price of $3.50- per share. The gross proceeds received from the offering were $10.5 million and we raised $9.6 million in net proceeds after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Previous wording

In February 2024, we entered into a Sales Agreement with Guggenheim Securities, LLC (Guggenheim) implementing an “at-the-market” offering program (the ATM). In the ATM, we may offer and sell, from time to time and at our option, up to an aggregate of $100.0 million of shares of our common stock through Guggenheim, acting as sales agent. Guggenheim is entitled to a fixed commission rate of up to 3.0% of the gross sales proceeds of shares sold under the ATM. During the year ended December 31, 2024, we sold an aggregate of 5,460 shares of common stock under the ATM for net proceeds of approximately $15.2 thousand after deducting compensation of approximately $470 payable to Guggenheim.

Current wording

In February 2024, we entered into a Sales Agreement with Guggenheim Securities, LLC (Guggenheim) (the 2024 Sales Agreement) implementing an “at-the-market” offering program (the ATM). In the ATM, we had the ability to offer and sell, from time to time and at our option, up to an aggregate of $100.0 million of shares of our common stock through Guggenheim, acting as sales agent. Guggenheim was entitled to a fixed commission rate of up to 3.0% of the gross sales proceeds of shares sold under the ATM. During the year ended December 31, 2024, we sold an aggregate of 5,460 shares of common stock under the ATM for net proceeds of $0.02 million after deducting compensation. No shares were offered under the ATM during the year ended December 31, 2025. In March 2026, we terminated the 2024 Sales Agreement.

Previous wording

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.

Current wording

We expect our expenses to increase in connection with ongoing operations, particularly as research and development activities continue, including the initiation and conduct of preclinical studies and clinical trials, and efforts to obtain marketing approval for current and future product candidates. In addition, if marketing approval is obtained for any current or future product candidates, significant commercialization expenses are expected, including costs related to product sales, marketing, manufacturing, and distribution, which may be partially offset through collaboration agreements with third parties. Additional costs associated with operating as a public company are also expected. Accordingly, substantial additional funding will be required to support continuing operations. If capital cannot be raised when needed or on acceptable terms, research and development programs or future commercialization efforts may be delayed, reduced, or eliminated.

Previous wording

We believe that our existing cash, cash equivalents and short-term investments may not enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months from the date of filing of this Annual Report. 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:

Current wording

We believe that our existing cash, cash equivalents, restricted cash and marketable securities may not enable us to fund our operating expenses and capital expenditure requirements for the next 12 months from the date of filing of this Annual Report. Our future capital requirements will depend on a number of factors, including:

Previous wording

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 and debt financings 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.

Current wording

Until such time, if ever, as substantial product revenues are generated, cash requirements are expected to be financed through public or private equity offerings, debt and/or other sources, including as milestone payments, royalties or other payments or funding from existing or potential collaboration agreements, strategic alliances, licensing arrangements and other arrangements. To the extent additional capital is raised through the issuance of equity or convertible debt securities, existing stockholders’ ownership interests may be diluted, and such securities may include liquidation or other preferences that could adversely affect the rights of common stockholders. Debt financing, if available, may involve restrictive covenants that limit the ability to take certain actions, including incurring additional indebtedness, making capital expenditures, business development activities or declaring dividends, which could adversely affect business operations.

Previous wording

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. Our ability to raise additional funds also may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic events such as actual or anticipated changes in interest rates and economic inflation, current and future bank failures, tariffs, global pandemics, geopolitical tensions between the United States and China and the impact of the Russia/Ukraine conflict and the conflicts in the Middle East. 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.

Current wording

If funding is obtained through collaborations, strategic alliances, or licensing arrangements with third parties, valuable rights to technologies, future revenue streams, research programs, or product candidates may be relinquished, or licenses may be granted on terms that are not favorable. The ability to raise additional funds may also be adversely affected by global economic conditions and volatility in U.S. and international credit and financial markets resulting from geopolitical and macroeconomic events, including changes in interest rates and inflation, current or future bank failures, tariffs, global pandemics, geopolitical tensions between the United States and China, the Russia/Ukraine conflict, and conflicts in the Middle East. If additional funding cannot be obtained when needed, product development or future commercialization efforts may be delayed, limited, reduced, or terminated, or rights to develop and commercialize product candidates may need to be granted to third parties that would otherwise be retained.

Previous wording

During the years ended December 31, 2024 and 2023, we did not have, and we do not currently have, any off-balance sheet arrangements (as defined under SEC rules).

Current wording

We have not entered into, nor do we currently have, any off-balance sheet arrangements (as defined under SEC rules).

Previous wording

For a description of recently issued accounting standards that may have a material impact on our financial statements or will otherwise apply to our operations, please see Note 2 to our audited financial statements appearing elsewhere in this Annual Report.

Current wording

For a description of recently issued accounting standards that may have a material impact on our financial statements or will otherwise apply to our operations, please see Note 1 to the audited financial statements appearing elsewhere in this Annual Report.