GENELUX Corp

Previous wording

Since inception, we have incurred significant operating losses. Our net losses were $14.6 million and $16.2 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $236.1 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 $7.5 million and $7.9 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $258.9 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

During the year ended December 31, 2023, we closed our initial public offering (“IPO”) and two Private Placements and received $37.8 million of net proceeds from these offerings. During the nine months ended September 30, 2024, we closed a second public offering and received $27.7 million of net proceeds from that offering. Due to the funds received through these offerings, and the conversion of preferred stock and convertible notes payable upon the closing of the IPO, we have shareholders’ equity of $33.1 million at September 30, 2024. We now expect our cash and cash equivalents, and short and long-term investments, totaling $35.1 million at September 30, 2024, to last until the first quarter of 2026.

Current wording

During the year ended December 31, 2023, we closed our initial public offering (“IPO”) and two PIPE transactions and received $37.8 million of net proceeds from these transactions. During the year ended December 31, 2024, we closed a second public offering and received $27.7 million of net proceeds from that offering. During the three months ended March 31, 2025, we closed a third public offering and received $9.6 million of net proceeds from that offering. Due to the funds received through these offerings, and the conversion of preferred stock and convertible notes payable upon the closing of the IPO, we have shareholders’ equity of $29.8 million at March 31, 2025. We now expect our cash and cash equivalents, and short-term investments, totaling $35.1 million at March 31, 2025, to last until the third quarter of 2026.

Previous wording

In May 2024, we completed an underwritten offering of our common stock, in which we issued and sold 7,500,000 shares of our common stock at a price of $4.00 per share, which included 625,000 shares of common stock at $4.00 per share pursuant to the underwriters’ partial exercise of their option to purchase additional shares of common stock. The total gross proceeds received from the offering were $30.0 million and we raised $27.7 million in net proceeds after deducting underwriting discounts and commissions and offering expenses payable by us.

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 net proceeds received from the offering were $9.6 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

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 2024. 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 U.S. The total amount of the contract is up to $10.1 million.

Current 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.

Previous wording

Research and development expenses were $4.1 million and $2.8 million for the three months ended September 30, 2024 and 2023, respectively, an increase of $1.2 million. Significant variations between periods are primarily a result of a $0.4 million increase in stock-related compensation in 2024, relating to the increased cost of stock options and restricted stock units in 2024; and a $0.9 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime Registration trial in 2024.

Current wording

Research and development expenses were $4.7 million and $4.0 million for the three months ended March 31, 2025 and 2024, respectively, an increase of $0.7 million. Significant variations between periods are primarily a result of a $1.4 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime Registration trial in 2025, partially offset by a $0.6 million decrease in stock-related compensation in 2025, relating to the decreased cost of stock options and restricted stock units in 2025.

Previous wording

General and administrative expenses were $2.9 million and $2.5 million for the three months ended September 30, 2024 and 2023, respectively, an increase of $0.4 million. Significant variations between periods are primarily a result of a $0.7 million increase in stock compensation expense in 2024, due to the increase in the cost of stock options and restricted stock units in 2024; offset by a $0.3 million decrease in professional service expenses in 2024, primarily resulting from decreased corporate legal costs.

Current wording

General and administrative expenses were $3.1 million and $4.1 million for the three months ended March 31, 2025 and 2024, respectively, a decrease of $1.0 million. Significant variations between periods are primarily a result of a $0.7 million decrease in stock compensation expense in 2025, due to the decrease in the cost of stock options and restricted stock units in 2025.

Previous wording

Other income (expenses), net, were $0.5 million and $(0.4) million for the three months ended September 30, 2024 and 2023, respectively. During the three months ended September 30, 2024, other income consisted of interest income of $0.5 million from the investment into money market funds and short and long-term investments, while during the same period in 2023, other income consisted of interest income of $0.04 million and financing costs of $0.4 million.

Current wording

Other income was $0.3 million for the three months ended March 31, 2025 and 2024, respectively. During the three months ended March 31, 2025, other income consisted of interest income of $0.2 million and bond accretion income of $0.1 million from the investment into money market funds and short and long-term bond investments, while during the same period in 2024, other income consisted of interest income of $0.1 million and bond accretion income of $0.2 million.

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 us. 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 the case of equity financing, or grant unfavorable terms in licensing 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 the Company. Even if the Company is 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.

Previous wording

The table below summarizes our cash flow activities for the nine months ended September 30, 2024 and 2023 (in thousands):

Current wording

The table below summarizes our cash flow activities for the three months ended March 31, 2025 and 2024 (in thousands):

Previous wording

During the nine months ended September 30, 2024, we used cash from operating activities of $16.9 million, compared to $13.4 million used during the nine months ended September 30, 2023. During the nine months ended September 30, 2024, we incurred a net loss of $20.9 million and had non-cash expenses of $6.1 million, compared to a net loss of $21.5 million and non-cash expenses of $9.4 million during the nine months ended September 30, 2023. The primary non-cash expense during both periods was stock-related compensation totaling $6.0 million and $4.4 million during the nine months ended September 30, 2024 and 2023, respectively; and the fair value of warrants issued in connection with the conversion of convertible notes of $3.1 million during the nine months ended September 30, 2023. The net change in operating assets and liabilities during the nine months ended September 30, 2024 used cash of $2.1 million, compared to $1.3 million used during the nine months ended September 30, 2023. The primary source of cash relating to operating assets and liabilities during the nine months ended September 30, 2024 was the increase in accounts payable and accrued expenses of $0.3 million and the primary use of cash was the decrease in accrued payroll and payroll taxes of $1.4 million. The primary use of cash during the nine months ended September 30, 2023 was the decrease in accounts payable and accrued expenses of $2.1 million.

Current wording

During the three months ended March 31, 2025, we used cash from operating activities of $5.4 million, compared to $4.4 million used during the three months ended March 31, 2024. During the three months ended March 31, 2025, we incurred a net loss of $7.5 million and had non-cash expenses of $1.5 million, compared to a net loss of $7.9 million and non-cash expenses of $2.9 million during the three months ended March 31, 2024. The primary non-cash expense during both periods was stock-related compensation totaling $1.5 million and $2.8 million during the three months ended March 31, 2025 and 2024, respectively. The net change in operating assets and liabilities during the three months ended March 31, 2025 provided cash of $0.5 million, compared to $0.6 million provided during the three months ended March 31, 2024. The primary source of cash relating to operating assets and liabilities during the three months ended March 31, 2025 was the increase in accounts payable and accrued expenses of $1.1 million, while the primary source of cash during the three months ended March 31, 2024 was the increase in accounts payable and accrued expenses of $1.5 million.

Previous wording

Net cash used in investing activities for the nine months ended September 30, 2024 was $14.8 million, consisting of the net purchases of short and long-term investments of $14.5 million, and purchases of property and equipment primarily for construction-in-progress of $0.3 million. Net cash used in investing activities for the nine months ended September 30, 2023 was $0.8 million, consisting of the purchase of property and equipment.

Current wording

Net cash provided by investing activities for the three months ended March 31, 2025 was $3.5 million, consisting of the net maturities of short-term investments of $3.5 million, and purchases of property and equipment of $0.03 million. Net cash used in investing activities for the three months ended March 31, 2024 was $1.7 million, consisting of net purchases of short and long-term investments of $1.7 million, and the purchase of property and equipment of $0.03 million.

Previous wording

During the nine months ended September 30, 2024, we provided cash from operating activities of $28.4 million, compared to $43.6 million provided during the nine months ended September 30, 2023. For the nine months ended September 30, 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 equity awards programs of $0.05 million.

Current wording

During the three months ended March 31, 2025, we provided cash from operating activities of $9.6 million, compared to $0.7 million provided during the three months ended March 31, 2024. For the three months ended March 31, 2025, cash provided by financing activities consisted of proceeds from the sale of common stock of $9.6 million and proceeds from the exercise of stock options of $0.01 million. For the three months ended March 31, 2024, cash provided by financing activities consisted of proceeds from the exercise of stock warrants of $0.7 million.

Previous wording

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

Current wording

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

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, 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 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.

Previous wording

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. While our significant accounting policies are more fully described in Note 2 to our financial statements appearing elsewhere in this Quarterly Report, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments.

Current wording

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. While our significant accounting policies are more fully described in Note 2 to our unaudited financial statements appearing elsewhere in this Quarterly Report, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments.

Previous wording

During the nine months ended September 30, 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

During the three months ended March 31, 2025 and 2024, we did not have, and we do not 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 Quarterly 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 2 to our unaudited financial statements appearing elsewhere in this Quarterly Report.