Core Insights - Genelux Corporation is advancing its late clinical-stage immuno-oncology product, Olvi-Vec, with significant clinical readouts expected in the coming year, particularly for platinum-resistant/refractory ovarian cancer [1][2][4] Pipeline Highlights - The Phase 3 OnPrime/GOG-3076 trial for Olvi-Vec in platinum-resistant/refractory ovarian cancer is on track, with topline data anticipated in the first half of 2026 [5] - Ongoing trials for small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) are expected to provide important data updates later this year, which may support the systemic delivery program of Olvi-Vec [2][5] Business Updates - The company appointed Eric Groen as General Counsel and Chief Compliance Officer, enhancing its leadership team with over 20 years of experience in the life sciences industry [3][6] - The CEO emphasized the potential of Olvi-Vec to redefine treatment paradigms for recurrent tumors and the company's growth phase [4] Financial Results - For Q2 2025, Genelux reported a net loss of $7.5 million, or $0.20 per share, compared to a net loss of $6.6 million, or $0.22 per share, in Q2 2024 [11][19] - Research and development expenses increased to $4.8 million from $4.4 million year-over-year, primarily due to higher clinical trial costs [10] - General and administrative expenses rose to $3.0 million from $2.5 million, driven by increased salaries and professional services [11] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $28.1 million, expected to fund operations into Q3 2026 [9]

[PART I—FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section presents Genelux Corporation's unaudited condensed financial statements for the quarter ended June 30, 2025, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed explanatory notes [Item 1. Condensed Financial Statements](index=6&type=section&id=Item%201.%20Condensed%20Financial%20Statements) This section presents Genelux Corporation's unaudited condensed financial statements for the quarter ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows. It also includes detailed notes explaining the basis of presentation, significant accounting policies, license agreements, fair value measurements, investments, balance sheet accounts, leases, commitments and contingencies, stockholders' equity, stock-based compensation, net loss per share, and segment information [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) The Condensed Balance Sheets show a decrease in total assets and stockholders' equity for Genelux Corporation from December 31, 2024, to June 30, 2025, primarily driven by a reduction in cash and cash equivalents and short-term investments, while total liabilities remained relatively stable Condensed Balance Sheets Summary | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | **Total Assets** | $32,247 | $34,716 | | **Total Liabilities** | $8,349 | $8,442 | | **Total Stockholders' Equity** | $23,898 | $26,274 | | Cash and cash equivalents | $6,546 | $8,565 | | Short-term investments | $21,426 | $22,330 | | Accounts payable and accrued expenses | $6,033 | $5,570 | - Total Assets decreased by **$2,469 thousand** from **$34,716 thousand** at December 31, 2024, to **$32,247 thousand** at June 30, 2025[15](index=15&type=chunk) - Total Stockholders' Equity decreased by **$2,376 thousand** from **$26,274 thousand** at December 31, 2024, to **$23,898 thousand** at June 30, 2025[15](index=15&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Genelux Corporation reported a net loss of $7,456 thousand for the three months ended June 30, 2025, an increase from $6,576 thousand in the prior year period. For the six months ended June 30, 2025, the net loss was $14,948 thousand, up from $14,426 thousand in the same period of 2024, primarily due to increased operating expenses, particularly in research and development Condensed Statements of Operations and Comprehensive Loss Summary | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $ - | $ - | $ - | $ 8 | | Research and development | $ 4,758 | $ 4,417 | $ 9,456 | $ 8,427 | | General and administrative | $ 3,034 | $ 2,475 | $ 6,152 | $ 6,588 | | Total operating expenses | $ 7,792 | $ 6,892 | $ 15,608 | $ 15,015 | | Net loss | $ (7,456) | $ (6,576) | $ (14,948) | $ (14,426) | | Loss per share - Basic and Diluted | $ (0.20) | $ (0.22) | $ (0.41) | $ (0.51) | - Net loss increased by **$880 thousand** for the three months ended June 30, 2025, compared to the same period in 2024[18](index=18&type=chunk) - Research and development expenses increased by **$341 thousand (7.7%)** for the three months ended June 30, 2025, and by **$1,029 thousand (12.2%)** for the six months ended June 30, 2025, year-over-year[18](index=18&type=chunk) [Condensed Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) The Condensed Statements of Stockholders' Equity detail changes in equity components, showing an increase in common stock shares and additional paid-in capital due to stock compensation and issuance of common shares for cash and warrants, alongside an accumulated deficit from ongoing net losses Condensed Statements of Stockholders' Equity Summary | Metric (in thousands) | Balance at Dec 31, 2024 | Balance at June 30, 2025 | | :-------------------- | :---------------------- | :----------------------- | | Common Stock Shares | 34,728,140 | 37,759,016 | | Common Stock Amount | $35 | $38 | | Additional Paid-in Capital | $278,001 | $290,631 | | Accumulated Deficit | $(251,393) | $(266,341) | | Total Stockholders' Equity | $26,274 | $23,898 | - Issuance of **3,000,000 common shares** for cash and warrants, net of costs, contributed **$9,553 thousand** to additional paid-in capital during the six months ended June 30, 2025[21](index=21&type=chunk) - Stock compensation expense for the six months ended June 30, 2025, totaled **$2,713 thousand**[21](index=21&type=chunk)[25](index=25&type=chunk) [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) The Condensed Statements of Cash Flows indicate a net decrease in cash and cash equivalents for the six months ended June 30, 2025, primarily due to cash used in operating activities, partially offset by cash provided by financing activities from common stock issuance Condensed Statements of Cash Flows Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Operating activities | $ (12,494) | $ (11,178) | | Investing activities | $ 856 | $ (18,797) | | Financing activities | $ 9,619 | $ 28,415 | | Net decrease in cash and cash equivalents | $ (2,019) | $ (1,560) | | Cash and cash equivalents, end of period | $ 6,546 | $ 7,858 | - Net cash used in operating activities increased to **$12,494 thousand** for the six months ended June 30, 2025, from **$11,178 thousand** in the prior year period[25](index=25&type=chunk) - Cash provided by financing activities was **$9,619 thousand** in 2025, primarily from the sale of common stock, a significant decrease from **$28,415 thousand** in 2024[25](index=25&type=chunk) [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes provide essential context and detail for the condensed financial statements, covering the company's organization, liquidity concerns, accounting policies, and specific financial instruments and transactions [NOTE 1 – BASIS OF PRESENTATION](index=11&type=section&id=NOTE%201%20%E2%80%93%20BASIS%20OF%20PRESENTATION) This note outlines Genelux Corporation's organization as a late clinical-stage biopharmaceutical company focused on oncolytic viral immunotherapies. It highlights recurring losses and substantial doubt about the company's ability to continue as a going concern, emphasizing the need for additional funding to support operations and development plans for its product candidate, Olvi-Vec - Genelux Corporation is a late clinical-stage biopharmaceutical company focused on developing oncolytic viral immunotherapies for cancer[28](index=28&type=chunk) - The company has experienced recurring losses from operations since inception, with a net loss of **$14.9 million** and cash used in operations of **$12.5 million** during the six months ended June 30, 2025, raising substantial doubt about its ability to continue as a going concern[29](index=29&type=chunk) - As of June 30, 2025, the company had **$28.1 million** in cash, cash equivalents, and short-term investments, which are expected to fund planned operations for the next **12 months** from the filing date, but additional financing will be required for long-term development and commercialization[30](index=30&type=chunk) [NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=12&type=section&id=NOTE%202%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note confirms no changes to significant accounting policies from the Annual Report, detailing the classification of cash and cash equivalents, available-for-sale investments, and comprehensive loss. It also discusses recent accounting pronouncements, including ASU 2024-03 and ASU 2023-07, and their potential impact

Core Insights - Genelux Corporation has appointed Eric Groen as General Counsel, Corporate Secretary, Chief Compliance Officer, and Head of Business Development, effective July 1, 2025 [2][3] - Eric Groen brings over two decades of experience in the life sciences industry, with a strong background in legal expertise, business development, and navigating regulatory environments [3][4] - Groen's previous roles include General Counsel at Rani Therapeutics and a 20-year tenure at Amgen, where he was involved in significant transactions, including Amgen's $10 billion acquisition of Onyx Pharmaceuticals [4] Company Overview - Genelux is a late-stage clinical biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [6][7] - The company's leading product candidate, Olvi-Vec, is currently undergoing a Phase 3 trial for its efficacy and safety in treating platinum-resistant/refractory ovarian cancer [6][7] - Genelux utilizes its proprietary CHOICE™ platform to develop a library of engineered oncolytic vaccinia virus immunotherapeutic candidates, including Olvi-Vec [6][7] Appointment Details - Eric Groen's appointment is seen as pivotal for Genelux, as he aims to drive strategic growth, expand collaborations, and enhance regional partnerships [5] - Groen received an inducement award of stock options to purchase 270,000 shares at an exercise price of $2.83 per share, with a vesting schedule over four years [5]

Core Viewpoint - Genelux Corporation (GNLX) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in a company's earnings picture, specifically the consensus of EPS estimates from sell-side analysts [1][2]. - A strong correlation exists between earnings estimate revisions and near-term stock price movements, making the Zacks rating system valuable for investors [4][6]. Institutional Investor Influence - Institutional investors utilize earnings estimates to determine the fair value of a company's shares, impacting stock price movements through their large transactions [4]. Business Improvement Indicators - The rising earnings estimates and the Zacks rating upgrade for Genelux Corporation indicate an improvement in the company's underlying business, suggesting potential upward pressure on the stock price [5][10]. Earnings Estimate Revisions for Genelux Corporation - For the fiscal year ending December 2025, Genelux Corporation is expected to earn -$0.90 per share, reflecting a 5.3% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Genelux Corporation has increased by 15.6% [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 20% of Zacks-covered stocks receive a 'Strong Buy' or 'Buy' rating, indicating superior earnings estimate revisions [9][10].

Core Insights - Genelux Corporation reported a productive first quarter of 2025, establishing a strong foundation for advancing its lead product, Olvi-Vec, in various cancer indications [2][3] Pipeline Highlights - The FDA provided encouraging feedback on the OnPrime Phase 3 trial for Olvi-Vec in resistant/refractory ovarian cancer, indicating potential for traditional approval if a meaningful progression-free survival advantage is demonstrated [3] - Preliminary data from the Phase 1b/2 trial of Olvi-Vec in small cell lung cancer showed a 71% disease control rate, with significant tumor reductions observed in participants [4] - Patient enrollment is increasing in the ongoing Phase 2 trial for recurrent non-small cell lung cancer, with interim results expected in the second half of 2025 [5] Business Updates - Matthew Pulisic was appointed as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [6] - The company completed an underwritten offering of 3,000,000 shares at $3.50 per share, raising approximately $10.5 million to strengthen its balance sheet and extend its operational runway [7] Financial Results - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled $35.1 million, expected to provide runway into the third quarter of 2026 [8] - Research and development expenses increased to $4.7 million from $4.0 million year-over-year, primarily due to higher clinical trial costs [9] - General and administrative expenses decreased to $3.1 million from $4.1 million year-over-year [10] - The net loss for the first quarter of 2025 was $7.5 million, or $0.21 per share, compared to a net loss of $7.9 million, or $0.29 per share, in the same period of 2024 [11]

PART I—FINANCIAL INFORMATION [Item 1. Condensed Financial Statements](index=6&type=section&id=Item%201.%20Condensed%20Financial%20Statements) Genelux's unaudited financial statements detail asset growth, reduced net loss, and cash increase from a public offering [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) | Metric | March 31, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :------------------ | | Cash and cash equivalents | $16,206 | $8,565 | | Short-term investments | $18,896 | $22,330 | | Total Current Assets | $35,945 | $31,548 | | Total Assets | $38,985 | $34,716 | | Total Current Liabilities | $7,689 | $6,903 | | Total Liabilities | $9,139 | $8,442 | | Total Shareholders' Equity | $29,846 | $26,274 | [Condensed Statements of Operations](index=7&type=section&id=Condensed%20Statements%20of%20Operations) | Metric | Three Months Ended March 31, 2025 (Unaudited) (in thousands) | Three Months Ended March 31, 2024 (Unaudited) (in thousands) | | :------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | | Revenues | $0 | $8 | | Research and development | $4,698 | $4,010 | | General and administrative | $3,118 | $4,113 | | Total operating expenses | $7,816 | $8,123 | | Loss from operations | $(7,816) | $(8,115) | | Total other income | $324 | $265 | | NET LOSS | $(7,492) | $(7,850) | | LOSS PER COMMON SHARE - BASIC AND DILUTED | $(0.21) | $(0.29) | | WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING | 34,926,075 | 26,849,737 | [Condensed Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) | Metric | Three Months Ended March 31, 2025 (Unaudited) (in thousands) | Three Months Ended March 31, 2024 (Unaudited) (in thousands) | | :---------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net loss | $(7,492) | $(7,850) | | Net unrealized loss on short and long-term investments | $(35) | $(19) | | Comprehensive loss | $(7,527) | $(7,869) | [Condensed Statements of Shareholders' Equity](index=9&type=section&id=Condensed%20Statements%20of%20Shareholders%27%20Equity) Total Shareholders' Equity increased from **$26,274 thousand** at December 31, 2024, to **$29,846 thousand** at March 31, 2025[23](index=23&type=chunk) The increase was primarily driven by **$9,553 thousand** from common stock issuance in a secondary public offering and **$1,423 thousand** from stock compensation, partially offset by a net loss of **$7,492 thousand**[23](index=23&type=chunk) [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(5,435) | $(4,354) | | Net cash provided by (used in) investing activities | $3,509 | $(1,691) | | Net cash provided by financing activities | $9,567 | $688 | | Net increase (decrease) in cash and cash equivalents | $7,641 | $(5,357) | | Cash and cash equivalents at the end of period | $16,206 | $4,061 | [Notes to Condensed Financial Statements (Unaudited)](index=12&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20(Unaudited)) [NOTE 1 – BASIS OF PRESENTATION](index=12&type=section&id=NOTE%201%20%E2%80%93%20BASIS%20OF%20PRESENTATION) Genelux, a late clinical-stage biopharmaceutical company, faces going concern doubts despite sufficient short-term funding - Genelux Corporation is a late clinical-stage biopharmaceutical company focused on developing oncolytic viral immunotherapies for cancer[29](index=29&type=chunk) - The company's recurring losses from operations and cash usage raise substantial doubt about its ability to continue as a going concern, necessitating additional funds[31](index=31&type=chunk) - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled **$35,102 thousand**, expected to fund operations for at least the next 12 months[32](index=32&type=chunk) [NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=NOTE%202%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This section outlines Genelux's key accounting policies, including revenue recognition, stock-based compensation, and potentially dilutive securities - No revenues were recognized during the three months ended March 31, 2025, compared to **$8 thousand** in the same period of 2024, related to a license agreement with ELIAS Animal Health, LLC[40](index=40&type=chunk) - Stock-based compensation fair value is estimated using the Black-Scholes option-pricing model and recognized as expense over the vesting period[48](index=48&type=chunk)[49](index=49&type=chunk) | Potentially Dilutive Securities | March 31, 2025 | March 31, 2024 | | :------------------------------ | :------------- | :------------- | | Stock options | 5,491,921 | 5,118,920 | | Stock warrants | 8,017,975 | 397,975 | | Restricted stock units | 579,714 | 57,323 | | **Total** | **14,089,610** | **5,574,218** | [NOTE 3 - FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES](index=16&type=section&id=NOTE%203%20-%20FAIR%20VALUE%20OF%20FINANCIAL%20ASSETS%20AND%20LIABILITIES) This note details the fair value measurements of financial assets, primarily cash equivalents and short-term investments, categorized by valuation input levels | Asset Type | Level 1 (in thousands) | Level 2 (in thousands) | Level 3 (in thousands) | Total (in thousands) | | :----------------------- | :------ | :------ | :------ | :------ | | Cash equivalents: | | | | | | Money market funds | $13,800 | $— | $— | $13,800 | | Short-term investments: | | | | | | US Government Agency bonds | $— | $4,958 | $— | $4,958 | | US Treasury bonds | $— | $13,938 | $— | $13,938 | | **Total** | **$13,800** | **$18,896** | **$—** | **$32,696** | [NOTE 4 – SHORT AND LONG-TERM INVESTMENTS](index=17&type=section&id=NOTE%204%20%E2%80%93%20SHORT%20AND%20LONG-TERM%20INVESTMENTS) This section provides details on the company's short and long-term investments, primarily US Government Agency and Treasury bonds | Investment Type | Amortized Cost (in thousands) | Gross Unrealized Gains (in thousands) | Gross Unrealized Losses (in thousands) | Credit Losses (in thousands) | Fair Value (in thousands) | | :------------------------ | :------------- | :--------------------- | :---------------------- | :------------ | :--------- | | US Government Agency bonds | $4,954 | $4 | $— | $— | $4,958 | | US Treasury bonds | $13,915 | $23 | $— | $— | $13,938 | | **Total** | **$18,869** | **$27** | **$—** | **$—** | **$18,896** | - All available-for-sale securities consisted of investments that mature within one year as of March 31, 2025 and 2024[57](index=57&type=chunk) [NOTE 5 - PROPERTY AND EQUIPMENT](index=17&type=section&id=NOTE%205%20-%20PROPERTY%20AND%20EQUIPMENT) This note details the net property and equipment, along with the depreciation expense for the quarter | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :------------- | :------------------ | | Property and equipment, net | $1,287 | $1,316 | | Depreciation expense (Q1) | $59 | $84 | [NOTE 6 – ACCRUED PAYROLL AND PAYROLL TAXES](index=17&type=section&id=NOTE%206%20%E2%80%93%20ACCRUED%20PAYROLL%20AND%20PAYROLL%20TAXES) This section presents the accrued payroll and payroll taxes at the end of the reporting periods | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :------------- | :------------------ | | Accrued payroll and payroll taxes | $664 | $1,004 | [NOTE 7 – LEASE LIABILITIES](index=17&type=section&id=NOTE%207%20%E2%80%93%20LEASE%20LIABILITIES) This note provides information on the company's right-of-use assets, lease liabilities, and amortization expense | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------ | :------------- | :------------------ | | Right of use assets | $1,680 | $1,760 | | Lease liabilities | $1,787 | $1,868 | | Amortization of ROU assets (Q1) | $80 | $164 | [NOTE 8 - SHAREHOLDERS' EQUITY](index=18&type=section&id=NOTE%208%20-%20SHAREHOLDERS%27%20EQUITY) This section details changes in shareholders' equity, including common stock issuances and stock option grants - As of March 31, 2025, there were **37,733,140 shares** of common stock issued and outstanding, up from **34,728,140 shares** at December 31, 2024[65](index=65&type=chunk) - In March 2025, the company completed an underwritten offering of **3,000,000 common shares** at **$3.50 per share**, yielding **$9,553 thousand** in net proceeds[66](index=66&type=chunk) - A warrant to purchase **120,000 shares** of common stock at **$4.20 per share** was issued to the underwriter, exercisable until March 25, 2030[67](index=67&type=chunk) - During Q1 2025, **275,000 stock options** were granted under the Inducement Plan, and **2,679,069 shares** were available for grant under the 2022 Plan[71](index=71&type=chunk)[72](index=72&type=chunk) [NOTE 9 - LEGAL MATTERS](index=22&type=section&id=NOTE%209%20-%20LEGAL%20MATTERS) This note confirms the absence of material legal proceedings and the potential for future ordinary course legal involvement - The company is not currently subject to any material legal proceedings[83](index=83&type=chunk) - Future involvement in legal proceedings, claims, investigations, and government inquiries is possible in the ordinary course of business[83](index=83&type=chunk) [NOTE 10 – SEGMENT INFORMATION](index=22&type=section&id=NOTE%2010%20%E2%80%93%20SEGMENT%20INFORMATION) This section clarifies that the company operates as a single reportable segment focused on oncolytic immunotherapies - The company operates and manages its business as one reportable and operating segment, focused on developing oncolytic immunotherapies for cancer[84](index=84&type=chunk) | Segment Expense | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenue | $0 | $8 | | Research and development, excluding salaries | $3,868 | $3,145 | | Stock-based compensation | $1,533 | $2,792 | | NET LOSS | $(7,492) | $(7,850) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section reviews Genelux's financial condition and operational results, highlighting ongoing losses, funding needs, and recent developments [Overview](index=23&type=section&id=Overview) Genelux, a late clinical-stage biopharmaceutical company, faces significant operating losses and requires additional funding for its growth strategy - Genelux is a late clinical-stage biopharmaceutical company focused on developing oncolytic viral immunotherapies for aggressive and/or difficult-to-treat solid tumor types, with Olvi-Vec as its lead product candidate[87](index=87&type=chunk) - The company has incurred significant operating losses since inception, with a net loss of **$7.5 million** for Q1 2025 and an accumulated deficit of **$258.9 million** as of March 31, 2025[91](index=91&type=chunk) - Substantial additional funding is required to support continuing operations and growth strategy, expected to be financed through equity/debt offerings or collaborations[93](index=93&type=chunk) [Recent Developments](index=24&type=section&id=Recent%20Developments) Recent developments include a successful public offering, progress in a Phase 2 clinical trial, and a key executive appointment - In March 2025, Genelux completed an underwritten public offering of **3,000,000 shares** of common stock at **$3.50 per share**, generating **$9.6 million** in net proceeds[95](index=95&type=chunk) - The first patient was dosed in a US-based Phase 2 clinical trial for recurrent non-small cell lung cancer (NSCLC) in October 2024, with Newsoara BioPharma Co. Ltd. generally obligated to fund the trial[96](index=96&type=chunk) - Matthew Pulisic was appointed Chief Financial Officer, effective January 30, 2025[97](index=97&type=chunk) [Components of Results of Operations](index=25&type=section&id=Components%20of%20Results%20of%20Operations) This section details the components of Genelux's operating results, including revenues and increasing research and development and general and administrative expenses - No revenues were recognized in Q1 2025, compared to **$0.008 million** in Q1 2024, related to a license agreement[98](index=98&type=chunk) - Operating expenses consist of research and development (R&D) and general and administrative (G&A) expenses[99](index=99&type=chunk) - R&D expenses are expensed as incurred and are expected to increase significantly as product candidates advance through clinical development[100](index=100&type=chunk)[104](index=104&type=chunk) - G&A expenses are anticipated to increase in the future due to business expansion and costs associated with operating as a public company[106](index=106&type=chunk) [Results of Operations (Comparison of the Three Months Ended March 31, 2025 and 2024)](index=27&type=section&id=Results%20of%20Operations%20(Comparison%20of%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024)) This section compares the company's financial performance for the three months ended March 31, 2025, and 2024, highlighting changes in revenues, expenses, and net loss | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Revenues | $0 | $8 | | Research and development | $4,698 | $4,010 | | General and administrative | $3,118 | $4,113 | | Total operating expenses | $7,816 | $8,123 | | Net loss | $(7,492) | $(7,850) | - Research and development expenses increased by **$0.7 million**, primarily due to a **$1.4 million** increase in clinical and regulatory expenses for the Phase 3 On Prime Registration trial, partially offset by a **$0.6 million** decrease in stock-related compensation[109](index=109&type=chunk) - General and administrative expenses decreased by **$1.0 million**, mainly due to a **$0.7 million** decrease in stock compensation expense[111](index=111&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Genelux faces going concern doubts due to recurring losses but has sufficient cash and investments for the next 12 months, with future funding needs expected from external sources - Recurring losses from operations raise substantial doubt about the company's ability to continue as a going concern, as noted by the independent registered public accounting firm[113](index=113&type=chunk) - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled **$35.1 million**, expected to fund operating expenses and capital expenditure requirements for at least the next 12 months[114](index=114&type=chunk) - Future cash needs are expected to be financed through public/private equity offerings, debt financings, or other capital sources like collaborations[114](index=114&type=chunk) [Cash Flows](index=29&type=section&id=Cash%20Flows) This section summarizes the company's cash flow activities, highlighting a significant increase in financing cash due to a public offering | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(5,435) | $(4,354) | | Net cash provided by (used in) investing activities | $3,509 | $(1,691) | | Net cash provided by financing activities | $9,567 | $688 | | Net increase (decrease) in cash | $7,641 | $(5,357) | - Net cash provided by financing activities significantly increased in Q1 2025 due to proceeds from a secondary public offering[119](index=119&type=chunk) [Equity Financings](index=29&type=section&id=Equity%20Financings) This section details the company's recent equity financing activities, including a public offering and the issuance of a warrant - In March 2025, the company completed an underwritten offering of **3,000,000 shares** of common stock at **$3.50 per share**, generating **$9.6 million** in net proceeds[120](index=120&type=chunk) - A warrant to purchase **120,000 shares** of common stock at an exercise price of **$4.20 per share** was issued to the underwriter[121](index=121&type=chunk) [Funding Requirements](index=30&type=section&id=Funding%20Requirements) Genelux anticipates significantly increased expenses for R&D and commercialization, necessitating substantial additional funding beyond the next 12 months - The company expects expenses to increase significantly for R&D, clinical trials, and commercialization, requiring substantial additional funding beyond the next 12 months[122](index=122&type=chunk)[124](index=124&type=chunk) - Failure to raise additional capital could force delays, reductions, or termination of product development or commercialization efforts[122](index=122&type=chunk)[127](index=127&type=chunk) - Future capital requirements depend on various factors including clinical trial costs, manufacturing, regulatory review, collaborations, and macroeconomic events[125](index=125&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Financial statement preparation involves significant estimates and judgments, particularly for prepaid R&D expenses and stock-based compensation valuation - Preparation of financial statements requires significant estimates and judgments, particularly for prepaid research and development expenses and stock-based compensation[128](index=128&type=chunk)[129](index=129&type=chunk) - Estimates for prepaid R&D expenses are based on progress of specific tasks and vendor information, subject to adjustment if actual timing or effort varies[130](index=130&type=chunk)[132](index=132&type=chunk) - Stock-based compensation fair value is estimated using the Black-Scholes option-pricing model, with assumptions for volatility, expected term, risk-free interest rate, and dividend yield[137](index=137&type=chunk) [Off-Balance Sheet Arrangements](index=33&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms that the company had no off-balance sheet arrangements during the reported periods - The company did not have any off-balance sheet arrangements during the three months ended March 31, 2025 and 2024[139](index=139&type=chunk) [Recent Accounting Pronouncements](index=33&type=section&id=Recent%20Accounting%20Pronouncements) This section discusses the company's evaluation of recent accounting pronouncements, specifically ASU 2024-03 - The company is evaluating ASU 2024-03, which requires public business entities to disaggregate income statement expenses, effective for annual reporting periods beginning after December 15, 2026[152](index=152&type=chunk) [Emerging Growth Company Status](index=33&type=section&id=Emerging%20Growth%20Company%20Status) Genelux qualifies as an "emerging growth company" and "smaller reporting company," benefiting from reduced public company reporting requirements - Genelux is an "emerging growth company" and "smaller reporting company," allowing it to take advantage of reduced public company reporting requirements[141](index=141&type=chunk)[148](index=148&type=chunk) - The company has irrevocably elected to "opt out" of the extended transition period for complying with new or revised financial accounting standards[141](index=141&type=chunk)[147](index=147&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the company does not have material market risks requiring quantitative and qualitative disclosures - The company states that this item is not applicable, indicating no material market risks requiring disclosure[142](index=142&type=chunk) [Item 4. Control and Procedures](index=33&type=section&id=Item%204.%20Control%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Disclosure controls and procedures were deemed effective at a reasonable assurance level as of March 31, 2025[143](index=143&type=chunk) - There have been no material changes in internal control over financial reporting during the period covered by this Quarterly Report[145](index=145&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings but acknowledges the potential for future involvement in various types of legal claims - The company is not currently the subject of any material legal proceeding[83](index=83&type=chunk)[147](index=147&type=chunk) - Future involvement in legal proceedings, claims, investigations, and government inquiries is possible, including those related to intellectual property, data privacy, and consumer protection[83](index=83&type=chunk)[147](index=147&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Genelux faces substantial risks in finance, development, manufacturing, commercialization, IP, and regulatory compliance [Risks Related to our Financial Position and Need for Additional Capital](index=34&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) Genelux has incurred significant operating losses and requires substantial additional financing, raising going concern doubts - Genelux has incurred significant operating losses since inception, with a net loss of **$7.5 million** for Q1 2025 and an accumulated deficit of **$258.9 million** as of March 31, 2025[149](index=149&type=chunk) - The company will require substantial additional financing to advance product candidates through development and commercialization, which may not be available on acceptable terms, or at all[153](index=153&type=chunk) - The independent registered public accounting firm has included a "going concern" explanatory paragraph, indicating substantial doubt about the company's ability to continue as a going concern[162](index=162&type=chunk) [Risks Related to Product Discovery, Development and Regulatory Approval](index=39&type=section&id=Risks%20Related%20to%20Product%20Discovery%2C%20Development%20and%20Regulatory%20Approval) Product development faces risks including reliance on a single candidate, trial uncertainties, and potential adverse events impacting approval - The company currently has only one product candidate, Olvi-Vec, in clinical development; its failure could adversely affect the business and require discontinuing development of other candidates based on the same therapeutic approach[170](index=170&type=chunk)[173](index=173&type=chunk) - The Phase 3 registration trial for Olvi-Vec in PRROC initiated enrollment in Q3 2022, with topline results anticipated in the first half of 2026[165](index=165&type=chunk) - Fast track designation for Olvi-Vec does not guarantee a faster development or regulatory review/approval process, nor does it increase the likelihood of marketing approval[194](index=194&type=chunk)[195](index=195&type=chunk) - Serious adverse events or unexpected properties of product candidates identified during development or after approval could halt development, lead to refusal of regulatory approval, or revocation of marketing authorizations[200](index=200&type=chunk)[202](index=202&type=chunk) [Risks Related to Manufacturing](index=57&type=section&id=Risks%20Related%20to%20Manufacturing) Biopharmaceutical manufacturing is complex, highly regulated, and costly, posing risks from quality control, raw material shortages, and regulatory non-compliance - The manufacture of biopharmaceutical products, especially viral immunotherapies, is complex, time-consuming, highly regulated, and costly, posing risks related to quality control, raw material shortages, and product loss[241](index=241&type=chunk)[245](index=245&type=chunk) - Changes in product candidate manufacturing or formulation, such as the new mammalian-cell-based production system, may result in additional costs or delays and require regulatory comparability assessments[246](index=246&type=chunk)[247](index=247&type=chunk) - Failure to comply with stringent regulations (cGMP) or meet volume requirements could lead to delays in development and commercialization, or inability to meet demand[252](index=252&type=chunk)[253](index=253&type=chunk) [Risks Related to Reliance on Third Parties](index=59&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) Reliance on third parties for supply, clinical trials, and collaborations introduces risks of disruption, non-compliance, and potential delays or termination - The company relies on third parties for raw material supply, quality testing, packaging, and distribution, with risks of supply disruption, non-compliance, and increased costs[256](index=256&type=chunk)[257](index=257&type=chunk) - Reliance on third-party CROs and study sites for preclinical and clinical trials reduces control and poses risks of delays, non-compliance with regulatory requirements (GCP), and data integrity issues[259](index=259&type=chunk)[260](index=260&type=chunk) - Collaborations, such as with Newsoara, carry risks including non-performance, insufficient funding, and potential termination, which could delay development and commercialization plans[270](index=270&type=chunk)[271](index=271&type=chunk) [Risks Related to Commercialization](index=64&type=section&id=Risks%20Related%20to%20Commercialization) Commercialization success depends on market acceptance, competitive landscape, accurate market size estimates, and public perception of immuno-oncology - Successful commercialization of approved product candidates depends on effective market launch, marketing, sales, manufacturing, and achieving market acceptance by physicians, patients, and payors[280](index=280&type=chunk)[297](index=297&type=chunk) - The company faces significant competition from major biopharmaceutical companies and other therapies in the cancer treatment market, including other oncolytic viral immunotherapies[282](index=282&type=chunk)[284](index=284&type=chunk) - The size of the potential market for product candidates is difficult to estimate, and inaccurate assumptions could lead to smaller actual markets and adversely affect potential revenues[300](index=300&type=chunk) - Negative developments in the field of immuno-oncology or adverse events in clinical trials could damage public perception and demand for the company's oncolytic VACV platform and product candidates[301](index=301&type=chunk) [Risks Related to Our Intellectual Property](index=71&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Commercial success hinges on robust intellectual property protection, which is uncertain and vulnerable to litigation, inadequate patent terms, and biosimilar competition - Commercial success depends on obtaining and maintaining patent and other intellectual property protection for technology and product candidates, which is highly uncertain and subject to litigation[304](index=304&type=chunk)[305](index=305&type=chunk) - The patent portfolio as of December 31, 2024, includes **11 issued U.S. patents**, **1 pending U.S. patent application**, **9 issued foreign patents**, and **7 pending foreign patent applications**[308](index=308&type=chunk) - Patent terms may be inadequate to protect competitive position, and biological product candidates like Olvi-Vec may face biosimilar competition sooner than anticipated due to the Biologics Price Competition and Innovation Act (BPCIA)[332](index=332&type=chunk)[334](index=334&type=chunk) - Third parties may initiate legal proceedings alleging infringement of their intellectual property rights, leading to substantial costs, diversion of resources, and potential loss of rights[316](index=316&type=chunk) [Risks Related to Government Regulation](index=80&type=section&id=Risks%20Related%20to%20Government%20Regulation) Extensive and evolving healthcare, data privacy, and reimbursement regulations pose significant compliance risks and could impact product marketability and profitability - The company is subject to extensive federal and state healthcare laws, including fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), and non-compliance could lead to substantial penalties[341](index=341&type=chunk)[342](index=342&type=chunk)[343](index=343&type=chunk) - Sales of products depend on adequate coverage and reimbursement from third-party payors, and unfavorable policies or cost containment measures could limit revenue and profitability[345](index=345&type=chunk)[347](index=347&type=chunk) - The company is subject to stringent and evolving U.S. and foreign data privacy and security laws (e.g., CCPA, GDPR), with actual or perceived failure to comply leading to regulatory investigations, litigation, and fines[367](index=367&type=chunk)[370](index=370&type=chunk)[378](index=378&type=chunk) - New legislation, such as the Inflation Reduction Act (IRA), and judicial decisions (e.g., Loper Bright Enterprises v. Raimondo) may increase compliance costs and adversely affect marketability and regulatory processes[237](index=237&type=chunk)[352](index=352&type=chunk)[357](index=357&type=chunk) [Risks Related to Our Business and Operations](index=87&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Operations) Business operations face risks from dependence on key personnel, growth management challenges, macroeconomic conditions, cybersecurity threats, and tax limitations - The company is highly dependent on key personnel, including its President, CEO, and Chairman, and faces intense competition for qualified managerial, scientific, and medical talent[381](index=381&type=chunk)[382](index=382&type=chunk) - Managing future growth, including expanding the organization and effectively managing outsourced activities, poses significant challenges and could disrupt operations[384](index=384&type=chunk)[385](index=385&type=chunk) - Unfavorable market and economic conditions, international trade policies (tariffs, sanctions), and public health crises (pandemics) could materially and adversely affect preclinical studies, clinical trials, and financial results[390](index=390&type=chunk)[396](index=396&type=chunk)[398](index=398&type=chunk) - Compromised information technology systems or data, including from cyber-attacks or personnel error, could lead to regulatory investigations, litigation, fines, and business disruptions[400](index=400&type=chunk)[402](index=402&type=chunk)[410](index=410&type=chunk) - The company has significant net operating loss (NOL) carryforwards and research and development tax credits, but their utilization to reduce future tax payments may be limited or restricted by ownership changes or state laws[418](index=418&type=chunk)[419](index=419&type=chunk) [Risks Related to Our Common Stock](index=96&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The common stock's market price may be volatile, and future issuances could dilute existing stockholders, while organizational provisions may hinder acquisitions - The market price of the common stock may be volatile and fluctuate substantially due to various factors, including operating results, clinical trial outcomes, regulatory developments, and overall market conditions[430](index=430&type=chunk)[432](index=432&type=chunk)[434](index=434&type=chunk) - The company does not intend to pay dividends on its common stock, limiting returns to stock appreciation[436](index=436&type=chunk) - Principal stockholders and management own a significant percentage of the stock, enabling them to exert substantial control over matters subject to stockholder approval[437](index=437&type=chunk) - Future sales and issuances of common stock or rights to purchase common stock, including through equity incentive plans and public offerings, could result in additional dilution for existing stockholders[441](index=441&type=chunk)[445](index=445&type=chunk) - Provisions in the company's organizational documents and Delaware law could make an acquisition more difficult and may prevent attempts by stockholders to replace or remove current management[449](index=449&type=chunk)[450](index=450&type=chunk) [General Risk Factors](index=103&type=section&id=General%20Risk%20Factors) Operating as a public company increases costs and management time, and changes in accounting standards or tax laws could adversely affect financial results - Operating as a public company incurs significantly increased legal, accounting, and compliance costs, requiring substantial management time for new initiatives and corporate governance practices[456](index=456&type=chunk)[457](index=457&type=chunk) - Failure to build adequate finance infrastructure and improve accounting systems and controls could impair the ability to produce accurate and timely financial statements, as required by the Sarbanes-Oxley Act[458](index=458&type=chunk)[461](index=461&type=chunk) - Changes in financial accounting standards or tax laws could cause adverse and unexpected revenue fluctuations and affect reported results of operations[462](index=462&type=chunk)[463](index=463&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=105&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports that there were no unregistered sales of equity securities during the period - No unregistered sales of equity securities occurred during the period[467](index=467&type=chunk) [Item 3. Defaults Upon Senior Securities](index=105&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that it is not applicable to the company - This item is not applicable[468](index=468&type=chunk) [Item 4. Mine Safety Disclosures](index=105&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that it is not applicable to the company - This item is not applicable[469](index=469&type=chunk) [Item 5. Other Information](index=105&type=section&id=Item%205.%20Other%20Information) This section reports that there is no other information to disclose - No other information to disclose[470](index=470&type=chunk) [Item 6. Exhibits](index=105&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, various warrant agreements, and officer certifications - Exhibits include Amended and Restated Certificate of Incorporation, Bylaws, various forms of Warrants to Purchase Common Stock, and Officer Certifications (31.1, 31.2, 32.1)[471](index=471&type=chunk)[472](index=472&type=chunk)[473](index=473&type=chunk) [SIGNATURES](index=108&type=section&id=SIGNATURES) The report is duly signed on behalf of Genelux Corporation by its President, CEO, Chairman, and Chief Financial Officer on May 6, 2025 - The report was signed by Thomas Zindrick, J.D. (President, CEO, and Chairman) and Matthew Pulisic (Chief Financial Officer) on May 6, 2025[475](index=475&type=chunk)

Core Insights - Genelux Corporation is a late clinical-stage immuno-oncology company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [4] Group 1: Upcoming Events - Thomas Zindrick, President, CEO, and Chairman, along with Matt Pulisic, CFO, will discuss clinical-stage programs and milestones at the Citizens Life Sciences Conference on May 7-8, 2025 [1] - The conversation is scheduled for May 8, 2025, at 1:30 p.m. ET, and a webcast link will be available for the event [2] - The company will also hold one-on-one meetings during the conference for institutional investors interested in engaging with management [3] Group 2: Clinical Trials - Olvi-Vec is currently being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a Phase 3 trial for platinum-resistant/refractory ovarian cancer, and VIRO-25, a Phase 2 trial for non-small-cell lung cancer [4] - Additionally, Olvi-Vec is being assessed in a China-based Phase 1b trial for recurrent small-cell lung cancer [4] Group 3: Company Overview - Genelux's discovery and development efforts are centered around its proprietary CHOICE™ platform, which has led to a library of engineered oncolytic vaccinia virus immunotherapeutic candidates, including Olvi-Vec [4]

Core Insights - Genelux Corporation has reached alignment with the U.S. FDA on key elements of the approval pathway for Olvi-Vec in treating platinum-resistant/refractory ovarian cancer [1][4] - The company reported a net loss of $29.9 million for the year ending December 31, 2024, compared to a net loss of $28.3 million in 2023 [15][21] - Genelux has strengthened its management team and balance sheet, positioning itself for future growth and clinical development [2][7] Pipeline Highlights - The ongoing Phase 3 OnPrime/GOG-3076 trial is focused on platinum-resistant/refractory ovarian cancer, with a primary endpoint of progression-free survival (PFS) [3] - The FDA indicated that an interim analysis of overall survival (OS) should be planned alongside the primary PFS analysis, which could support traditional approval if a meaningful PFS advantage is demonstrated [4] - The trial aims to enroll enough patients to achieve 127 events, with topline data expected in the first half of 2026 [5] Clinical Trials Updates - Preliminary data from the Phase 1b/2 Olvi-Vec-SCLC-202 trial showed a 71% disease control rate in patients with extensive small cell lung cancer [11] - The Phase 2 VIRO-25 trial is actively enrolling patients with recurrent non-small cell lung cancer, with interim data anticipated in the second half of 2025 [6] Financial Overview - The company closed an underwritten offering of 3 million shares at $3.50 per share, raising approximately $10.5 million for working capital and clinical development [8][10] - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled $30.9 million, providing a runway into the first quarter of 2026 [12] - Research and development expenses increased to $19.0 million in 2024 from $12.8 million in 2023, primarily due to higher clinical trial costs [13] Management Changes - Matt Pulisic has joined Genelux as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [7]

[Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions that the Annual Report contains forward-looking statements subject to known and unknown risks and uncertainties, which the company does not publicly update - The report contains forward-looking statements regarding future results, business strategy, R&D costs, clinical trials for Olvi-Vec, regulatory approvals, commercialization, pricing, reimbursement, strategic collaborations, and financing needs[11](index=11&type=chunk) - These statements are subject to known and unknown risks, uncertainties, and important factors that may cause actual results to be materially different from those expressed or implied[11](index=11&type=chunk) - The company operates in an evolving environment with new risk factors emerging, and it undertakes no obligation to publicly update or revise any forward-looking statements, except as required by applicable law[12](index=12&type=chunk) [Summary of Risks Associated with Our Business](index=4&type=section&id=SUMMARY%20OF%20RISKS%20ASSOCIATED%20WITH%20OUR%20BUSINESS) This section summarizes material risks including financial losses, financing needs, early-stage product development, regulatory complexities, and intellectual property challenges - The company has incurred **significant losses** since inception and anticipates continued losses, potentially never achieving profitability[17](index=17&type=chunk) - Substantial additional financing is required for Olvi-Vec development and future product candidates; failure to obtain it could force delays or termination of programs[17](index=17&type=chunk) - Product candidates are in preclinical/clinical stages, not approved for sale, and may never receive regulatory approval or become commercially viable[17](index=17&type=chunk) - The company's sole clinical product candidate is Olvi-Vec; its failure would adversely affect the business[17](index=17&type=chunk) - Compliance with federal and state healthcare laws, including fraud and abuse laws, is critical; non-compliance could lead to substantial penalties[17](index=17&type=chunk) - Inability to obtain, maintain, and protect intellectual property rights could harm the company's competitive position[17](index=17&type=chunk) [PART I](index=5&type=section&id=PART%20I) [Item 1. Business](index=5&type=section&id=Item%201.%20Business) This section provides a comprehensive overview of Genelux Corporation's business, including its focus on oncolytic viral immunotherapies, its lead product candidate Olvi-Vec, its proprietary discovery platform, clinical pipeline, strategic objectives, manufacturing capabilities, and intellectual property [Overview](index=5&type=section&id=OVERVIEW) Genelux is a late clinical-stage biopharmaceutical company specializing in next-generation oncolytic viral immunotherapies for aggressive solid tumors, with Olvi-Vec as its lead product - Genelux is a late clinical-stage biopharmaceutical company focused on oncolytic viral immunotherapies for aggressive solid tumors[18](index=18&type=chunk) - Olvi-Vec (olvimulogene nanivacirepvec) is the lead product candidate, a proprietary, modified strain of the vaccinia virus (VACV)[18](index=18&type=chunk) - The company utilizes its proprietary CHOICE selection technology and discovery and development platform to create an extensive library of oncolytic VACV immunotherapeutic product candidates[19](index=19&type=chunk) - Genelux has a cGMP manufacturing facility in San Diego, California, for clinical trials and initial commercial launch of Olvi-Vec, if approved[22](index=22&type=chunk) [Pipeline](index=6&type=section&id=PIPELINE) Genelux's pipeline is centered on Olvi-Vec, with ongoing clinical trials for various indications, including Phase 3 for Ovarian Cancer and Phase 2 for Non-Small Cell Lung Cancer | Olvi-Vec Route | Indication | Design | Phase 3 | Anticipated Milestones | Collaborators | |---|---|---|---|---|---| | Regional | Ovarian Cancer (platinum-resistant/refractory) | Olvi-Vec (i.pe) +Platinum-based regimen | Ph3 OnPrime/GOG-3076 Trial Actively Enrolling | Topline results expected in 1H, 2026 | (Cooperative Group. U.S-based trial) | | Systemic | Non-Small Cell Lung Cancer (recurrent/platinum-ICI failure) | Olvi-Vec (IV) +Platinum/Checkpoint inhibitor-based regimen | Ph2 Actively Enrolling | Interim readout expected 2H, 2025 | U.S-based trial | | Systemic | Small Cell Lung Cancer (recurrent/platinum failure) | Olvi-Vec (IV) +Platinum-based regimen | Ph1b/2 Actively Enrolling | Interim readout (updated data) expected in 2H, 2025 | NEWSGARA (Greater China-based trials) | | Systemic | Ovarian Cancer (recurrent/platinum failure) | Olvi-Vec (IV) +Platinum-based regimen | Ph1b/2 Regulatory Submission | Interim readout (updated data) expected in 2H, 2025 | NEWSGARA (Greater China-based trials) | | Systemic | Pancreatic Cancer (recurrent) | Olvi-Vec (IV) +Adoptive Cell Therapy | Regulatory Submission | | (Worldwide Rights Ex-Greater China) | [Our Strategy](index=6&type=section&id=OUR%20STRATEGY) Genelux's strategy focuses on advancing Olvi-Vec through late-stage clinical development, supporting its partner Newsoara, preparing for US launch, strengthening manufacturing, leveraging its CHOICE platform, and seeking additional collaborations - Advance lead product candidate, Olvi-Vec, through late-stage clinical development focused on platinum re-sensitization and seek regulatory approval. Phase 3 OnPrime trial for PRROC initiated enrollment in Q3 2022, and Phase 2 VIRO-25 trial for recurrent NSCLC initiated enrollment in Q4 2024[25](index=25&type=chunk) - Support clinical and commercial development of Olvi-Vec with strategic partner Newsoara in China, including co-sponsored Phase 1b/2 clinical trial in SCLC and planned Phase 2 VIRO-25 and ovarian cancer trials[25](index=25&type=chunk) - Prepare for US launch in ovarian cancer by expanding preliminary commercial strategy initiatives[29](index=29&type=chunk) - Broaden and strengthen internal manufacturing capabilities using the in-house cGMP manufacturing facility in San Diego[29](index=29&type=chunk) - Leverage the CHOICE discovery platform to build a portfolio of oncology product candidates and progress them into clinical development[29](index=29&type=chunk) - Seek additional development and commercial collaborations for Olvi-Vec and other product candidates, retaining US rights and pursuing strategic partnerships in other geographic areas[29](index=29&type=chunk) [The Genelux Approach](index=7&type=section&id=THE%20GENELUX%20APPROACH) Genelux's approach uses oncolytic vaccinia virus (VACV) as the backbone of its proprietary CHOICE discovery platform to develop immunotherapies like Olvi-Vec, designed to selectively kill tumor cells and induce a robust immune response - Olvi-Vec utilizes VACV as the backbone of the proprietary CHOICE discovery platform, which allows for rapid development of new product candidates[26](index=26&type=chunk)[27](index=27&type=chunk) - The company has an extensive portfolio of over **500 different versions of VACV** armed with more than **110 transgenes**, with Olvi-Vec being the most clinically advanced[28](index=28&type=chunk) - Oncolytic immunotherapy product candidates are 'off-the-shelf' personalized immunotherapies, designed to selectively kill tumor cells and induce a robust immune response against a patient's tumor neoantigens[30](index=30&type=chunk) - Olvi-Vec's mechanism of action involves selectively replicating in tumor cells, converting the tumor microenvironment to an immunoreactive state, causing tumor cell necrosis, and enhancing neoantigen presentation to stimulate a tumor-specific immune response[33](index=33&type=chunk)[34](index=34&type=chunk) [Development Programs](index=9&type=section&id=DEVELOPMENT%20PROGRAMS) Genelux is actively advancing Olvi-Vec through several development programs, including a Phase 3 registration trial for platinum-resistant/refractory ovarian cancer (PRROC) and systemic administration trials for recurrent lung cancers [Platinum Resistant/Refractory Ovarian Cancer (PRROC)](index=9&type=section&id=Platinum%20Resistant%2FRefractory%20Ovarian%20Cancer) Genelux initiated a Phase 3 OnPrime registration trial for Olvi-Vec in PRROC, following positive Phase 1b/2 data showing re-sensitization to platinum-based therapy and significantly improved outcomes - A Phase 3 OnPrime registration trial for Olvi-Vec in PRROC initiated enrollment in Q3 2022, targeting a broad and underserved patient population with a **2:1 randomization design**[37](index=37&type=chunk) - The FDA confirmed that a clinically meaningful PFS advantage without OS decrement could support traditional approval, and recommended a pre-BLA meeting after trial completion[38](index=38&type=chunk) - Phase 2 data showed Olvi-Vec re-sensitized PRROC patients to platinum-based therapy, with a **54% ORR (RECIST 1.1)**, **11.0 months median PFS**, and **15.7 months median OS**, significantly outperforming historical comparisons (<20% ORR, <4 months PFS, <12 months OS)[43](index=43&type=chunk)[44](index=44&type=chunk) Phase 2 PRROC Clinical Trial Efficacy Endpoints (All Patients, n=27) | Endpoint | Value (95% CI) | |---|---| | ORR by RECIST 1.1 | 54% (33 - 74) | | Duration of Response | 7.6 mos (3.7 - 9.6) | | ORR by CA-125 | 85% (65 - 96) | | Median PFS | 11.0 mos (6.7 - 13.0) | | Median Overall Survival (OS) | 15.7 mos (12.3 - 23.8) | [Systemic Administration](index=12&type=section&id=Systemic%20Administration) Genelux is pursuing systemic administration of Olvi-Vec for recurrent lung cancers, with a Phase 2 NSCLC trial initiated in Q4 2024 and promising preliminary data from an SCLC trial in China - Recurrent lung cancers (SCLC and NSCLC) were selected for intravenous Olvi-Vec delivery due to promising preclinical and clinical data and the 'first pass effect' to the lungs[53](index=53&type=chunk) - Phase 2 VIRO-25 trial for recurrent NSCLC in the US initiated enrollment in Q4 2024, with interim results expected in 2H 2025; Newsoara is expected to fund and add sites in China[56](index=56&type=chunk) - A co-sponsored Phase 1b/2 clinical trial for recurrent SCLC in China is ongoing, with interim results in Q1 2025 supporting Olvi-Vec as a platinum re-sensitizing agent[58](index=58&type=chunk)[61](index=61&type=chunk) - Preliminary SCLC data showed a **71% disease control rate** among evaluable participants, with tumor reductions up to **79%**, and a manageable safety profile[62](index=62&type=chunk) [Pancreatic Cancer](index=14&type=section&id=Pancreatic%20Cancer) Genelux, through its V2ACT joint venture, is developing V2ACT Immunotherapy for pancreatic cancer, combining Olvi-Vec with neoantigen-primed adoptive cell therapy, with an IND filed but no clinical trial yet scheduled - V2ACT Immunotherapy, a joint venture with TVAX, combines an oncolytic virus (Olvi-Vec) and neoantigen-primed adoptive cell therapy (NACT) for cancer[63](index=63&type=chunk) - The scientific rationale is that Olvi-Vec enhances the effects of adoptively transferred neoantigen-specific effector T cells by modulating the immune microenvironment[65](index=65&type=chunk) - An IND application for V2ACT Immunotherapy as a treatment for newly-diagnosed, surgically-resectable pancreatic cancer was filed in October 2020, but a clinical trial is not yet scheduled[66](index=66&type=chunk) [Additional Potential Indications for Olvi-Vec](index=15&type=section&id=Additional%20Potential%20Indications%20for%20Olvi-Vec) Genelux believes preclinical and clinical data support broad development of Olvi-Vec for various liquid and solid tumors, with future plans for intravenous delivery and potential basket or frontline ovarian cancer trials - Preclinical and clinical data support broad development of Olvi-Vec in patients with liquid or metastatic solid tumors, as monotherapy or in combination[68](index=68&type=chunk) - The company plans to expand its clinical development program by pursuing additional indications via intravenous delivery, selecting from over **20 major human cancers**[69](index=69&type=chunk) - Potential program expansions include basket trials for refractory/intolerant lung cancer patients (primary or metastatic) and frontline ovarian cancer studies, as suggested by the FDA[70](index=70&type=chunk) [Terms of Certain License Agreements](index=15&type=section&id=TERMS%20OF%20CERTAIN%20LICENSE%20AGREEMENTS) Genelux has entered into key license agreements, including an exclusive license with Newsoara BioPharma for Olvi-Vec in China and a joint venture with TVAX Therapeutics (V2ACT) for V2ACT Immunotherapy [Newsoara Biopharma Co., Ltd. Agreement](index=15&type=section&id=Newsoara%20Biopharma%20Co.,%20Ltd.%20Agreement) Genelux granted Newsoara an exclusive license for Olvi-Vec in China, receiving $11.0 million in upfront and milestone payments, with potential for up to $160.5 million in additional milestones and mid-single-digit to mid-teens royalties - Genelux granted Newsoara an exclusive license to research, develop, and commercialize Olvi-Vec in China for all human diagnostic, prophylactic, and therapeutic uses[72](index=72&type=chunk) Newsoara License Agreement Financials | Item | Amount (USD) | |---|---| | Aggregate payments received to date | **$11.0 million** (upfront + milestone) | | Additional development and commercial milestone payments | Up to **$160.5 million** | | Royalties on net sales | Mid-single-digit to mid-teens percentage range | - Newsoara is obligated to use commercially reasonable efforts for development and commercialization, and is responsible for all associated costs, including funding a multi-center Phase 2 clinical trial for Olvi-Vec in NSCLC[75](index=75&type=chunk) [V2ACT Joint Venture](index=16&type=section&id=V2ACT%20Joint%20Venture) Genelux formed V2ACT Therapeutics as a 50/50 joint venture with TVAX, granting V2ACT worldwide, non-exclusive, royalty-free licenses for combined virus and T-cell therapies, with V2ACT solely responsible for all development and commercialization costs - V2ACT Therapeutics, LLC was formed in January 2019 as a **50/50 joint venture** with TVAX Biomedical Inc. to develop and commercialize V2ACT Immunotherapy[78](index=78&type=chunk) - Genelux granted V2ACT a worldwide, non-exclusive, fully paid, royalty-free license for its proprietary oncolytic virus (Licensed Virus(es)) for combination cancer treatments[80](index=80&type=chunk) - V2ACT is solely responsible for all research, development, manufacturing, and commercialization activities and costs for the Products[80](index=80&type=chunk) [Operations](index=17&type=section&id=OPERATIONS) Genelux's operations include establishing its own cGMP manufacturing facility, relying on third parties for raw materials and services, and building sales and marketing capabilities for future US market entry [Manufacturing and Distribution](index=17&type=section&id=Manufacturing%20and%20Distribution) Genelux operates its own cGMP manufacturing facility in San Diego and has leased a second building for future expansion, while relying on third-party suppliers and contract laboratories for raw materials, testing, and distribution - Genelux operates its own **7,569 square-foot cGMP manufacturing facility** in San Diego, California, for clinical trials and commercial launch supplies[82](index=82&type=chunk) - A second **6,755 square-foot building** in the same location has been leased for future laboratory capabilities and administrative offices[83](index=83&type=chunk) - The company relies on agreements with raw material and component suppliers, contract laboratories for testing, and a third party for labeling, packaging, and distribution of clinical material[84](index=84&type=chunk) [Sales and Marketing](index=18&type=section&id=Sales%20and%20Marketing) Genelux currently lacks sales, marketing, or commercialization capabilities as no products are approved, but plans to build this infrastructure for independent US commercialization and international partnerships upon approval - None of the company's product candidates have been approved for sale, and it currently lacks sales, marketing, or commercialization capabilities[86](index=86&type=chunk) - If product candidates receive marketing approval, Genelux intends to commercialize them independently or jointly with partners in the United States and other geographies, building the necessary infrastructure over time[86](index=86&type=chunk) [Intellectual Property](index=18&type=section&id=INTELLECTUAL%20PROPERTY) Genelux protects its proprietary technologies through patents, trademarks, copyrights, and trade secrets, with a portfolio including 11 issued U.S. patents and 9 issued foreign patents as of December 31, 2024 [Patents](index=18&type=section&id=Patents) Genelux relies on patents to protect its technology and product candidates, navigating complex U.S. and international patent systems, with a portfolio including 11 issued U.S. patents and 9 issued foreign patents as of December 31, 2024 - The U.S. patent system involves provisional and non-provisional applications, with patents generally effective for **20 years** from the earliest non-provisional filing date, potentially extended by FDA regulatory review or USPTO delays[88](index=88&type=chunk)[89](index=89&type=chunk) - The patentability and claim breadth for protein-based biologics remain unsettled, and changes in patent laws or interpretations can diminish protection[90](index=90&type=chunk) - As of December 31, 2024, the patent portfolio consisted of **11 issued U.S. patents**, **1 pending U.S. patent application**, **9 issued foreign patents**, **7 pending foreign patent applications**, and one PCT application, covering current and future products and methods of use[92](index=92&type=chunk) [Trade Secrets](index=19&type=section&id=Trade%20Secrets) Genelux protects its proprietary information and know-how through trade secrets, relying on confidentiality and invention assignment agreements, but faces risks of breaches or independent discovery by competitors - The company relies on trade secrets and know-how, protected by confidentiality agreements with collaborators, employees, and consultants, and invention assignment agreements with employees[93](index=93&type=chunk) - Agreements may be breached, and trade secrets could become known or independently discovered by competitors, for which adequate remedies may not exist[93](index=93&type=chunk)[91](index=91&type=chunk) [Trademarks](index=19&type=section&id=Trademarks) Genelux considers its trademarks and trade names important for brand recognition, with 'Genelux' registered in several countries and 'CHOICE' as an unregistered trademark - 'Genelux' is an issued trademark registration in the European Union, United Kingdom, China, and other countries[95](index=95&type=chunk) - The unregistered trademark includes 'CHOICE'[96](index=96&type=chunk) [Competition](index=19&type=section&id=COMPETITION) Genelux faces intense competition in the biotechnology and pharmaceutical industries from various entities developing cancer therapies, including oncolytic viral immunotherapies, other immunotherapies, and traditional treatments [Competition in Cancer Therapeutics](index=19&type=section&id=Competition%20in%20Cancer%20Therapeutics) The cancer therapeutics market is highly competitive, with numerous companies and institutions developing treatments across various modalities, including oncolytic viral immunotherapies, other immunotherapies, and traditional therapies - The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary rights[97](index=97&type=chunk) - Genelux faces significant competition from pharmaceutical, biopharmaceutical, and biotechnology companies, as well as universities and research institutions, many of which have greater resources[97](index=97&type=chunk) - Competition in cancer therapeutics includes oncolytic viral immunotherapies (e.g., Amgen's IMLYGIC, Daiichi Sankyo's DELYTACT), approved immunotherapy antibodies, cancer vaccines, cell-based therapies, therapies activating innate immunity, and traditional cancer therapies[101](index=101&type=chunk)[103](index=103&type=chunk) [PRROC Competition](index=21&type=section&id=PRROC) For platinum-resistant/refractory ovarian cancer (PRROC), Genelux competes with various marketed generic and brand-name chemotherapies and product candidates in late-stage development - Currently marketed products for ovarian cancer include generic chemotherapies (cisplatin, carboplatin, paclitaxel) and brand products like Abbvie's ELAHERE, Sanofi-Aventis's TAXOTERE, Roche/Genentech's AVASTIN, GSK's ZEJULA, and AstraZeneca's LYNPARZA[105](index=105&type=chunk) - Product candidates in registration trials or later development for PRROC include Relacorilant (Corcept Therapeutics), Raludotatug deruxtecan (Daiichi Sankyo), Anlotinib (Advenchen Laboratories), and Afureserib (Laekna Therapeutics)[105](index=105&type=chunk) [NSCLC Competition](index=21&type=section&id=NSCLC) In non-small cell lung cancer (NSCLC), Genelux faces competition from various chemotherapies and numerous product candidates in late-stage development targeting specific pathways - Chemotherapies for NSCLC include cisplatin, carboplatin, vinorelbine tartrate, paclitaxel, and brand products like Sanofi-Aventis's TAXOTERE and Eli Lilly's ALIMTA[104](index=104&type=chunk) - Product candidates in registration trials or later development for NSCLC target various mechanisms, including Checkpoint inhibitors (**17 candidates**), Tubulin inhibitors (**2**), KRAS inhibitors (**4**), EGFR inhibitors (**3**), DNA topoisomerase inhibitors (**4**), and VEGF inhibitors (**2**)[106](index=106&type=chunk) [SCLC Competition](index=22&type=section&id=SCLC) For small cell lung cancer (SCLC), current marketed products include topotecan hydrochloride and several immunotherapies, with numerous product candidates also in late-stage development - Currently marketed products for SCLC include topotecan hydrochloride, Amgen's IMDELLTRA, Jazz Pharmaceuticals' ZEPZELCA, Roche/Genentech's TECENTRIQ, AstraZeneca's IMFINZI, Merck's KEYTRUDA, and Bristol Myers Squibb's OPDIVO + YERVOY[107](index=107&type=chunk) - Product candidates in registration trials or later development for SCLC include Nibrozetone (EpicentRx), Tremelimumab (AstraZeneca), Ifinatamab deruxtecan (Daiichi Sankyo and Merck), Tifcemalimab (Junshi Biosciences), and Serplulimab (Shanghai Henlius Biotech)[110](index=110&type=chunk) [Generic Competition](index=23&type=section&id=Generic%20Competition) The BPCIA established an abbreviated pathway for biosimilar approval, granting 12 years of data exclusivity for original branded biological products, which Genelux anticipates for Olvi-Vec, though this exclusivity could be challenged or shortened - The BPCIA created an abbreviated pathway for biosimilar approval, establishing **12 years of data exclusivity** for original branded biological products approved under a BLA[111](index=111&type=chunk) - Olvi-Vec and other product candidates are biological products, and Genelux anticipates being awarded **12 years of data exclusivity** in the United States, up to **11 years in Europe**, and significant durations in other markets[112](index=112&type=chunk) - There is a risk that this exclusivity could be changed in the future due to congressional action, proposed budgets, or international trade agreements, or that the FDA may not consider Genelux's products as reference products[117](index=117&type=chunk) [Government Regulation and Product Approval](index=23&type=section&id=Government%20Regulation%20and%20Product%20Approval) The development and commercialization of biological products in the U.S. are extensively regulated by the FDA, involving a lengthy and costly process from preclinical testing to post-approval requirements, with expedited programs not guaranteeing success [U.S. Biological Products Development Process](index=23&type=section&id=U.S.%20Biological%20Products%20Development%20Process) The U.S. biological product development process is lengthy and expensive, requiring preclinical testing, IND submission, IRB/IBC approvals, and multi-phase human clinical trials, with extensive regulatory monitoring and potential delays - The U.S. biological product development process involves preclinical testing (GLP), IND application, IRB/IBC approval, human clinical trials (GCP), BLA submission, FDA review, facility inspections, and user fees[114](index=114&type=chunk)[115](index=115&type=chunk) - Clinical trials typically proceed through three sequential phases: Phase 1 (safety, dosage tolerance), Phase 2 (adverse effects, preliminary efficacy, optimal dosage), and Phase 3 (statistically confirm potency and safety for approval)[120](index=120&type=chunk)[127](index=127&type=chunk) - The FDA can place clinical trials on hold due to safety concerns, faulty design, or non-compliance, and sponsors must submit prompt safety reports for serious adverse events[117](index=117&type=chunk)[123](index=123&type=chunk) [Compliance with cGMP Requirements](index=26&type=section&id=Compliance%20with%20cGMP%20Requirements) Manufacturers of biological products must adhere to cGMP regulations, verified through periodic inspections, and failure to comply can lead to product restrictions, market withdrawal, or delays in BLA approval - Manufacturers of biological products must comply with cGMP regulations, including quality control, quality assurance, and maintenance of records and documentation[128](index=128&type=chunk) - Establishments must register with the FDA and state agencies and are subject to periodic, unannounced inspections to ensure cGMP compliance[128](index=128&type=chunk) - The FDA will not approve a BLA unless manufacturing processes and facilities comply with cGMP requirements and assure consistent product quality[128](index=128&type=chunk) [U.S. FDA Review and Approval Process](index=26&type=section&id=U.S.%20FDA%20Review%20and%20Approval%20Process) The FDA review and approval process for biological products involves submitting a BLA with extensive data, paying user fees, meeting pediatric study requirements, and undergoing thorough review, potentially including advisory committee input and facility inspections - A BLA, including preclinical and clinical data, CMC information, and proposed labeling, is submitted to the FDA for marketing approval[131](index=131&type=chunk) - BLAs generally require significant user fees under PDUFA, and pediatric data submission is mandated by PREA, with potential deferrals or waivers[132](index=132&type=chunk)[133](index=133&type=chunk) - The FDA conducts an in-depth review of the BLA, may refer it to an advisory committee, determines if a REMS is necessary, and inspects manufacturing and clinical sites before issuing an approval or complete response letter[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) [Expedited Development and Review Programs](index=28&type=section&id=Expedited%20Development%20and%20Review%20Programs) The FDA offers programs like Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval to expedite development and review for product candidates treating serious conditions with unmet medical needs, though these do not guarantee approval - Fast Track designation expedites development and review for product candidates treating serious conditions with unmet medical needs, offering frequent FDA interactions and potential rolling review[141](index=141&type=chunk) - Breakthrough Therapy designation is for product candidates showing substantial improvement over existing therapies, including Fast Track features plus more intensive FDA interaction and expedited development/review[142](index=142&type=chunk) - Accelerated Approval may be granted for serious conditions based on surrogate endpoints, contingent on confirmatory clinical studies to verify clinical benefit[145](index=145&type=chunk) [Post-Approval Requirements](index=30&type=section&id=Post-Approval%20Requirements) After regulatory approval, biological products are subject to extensive and ongoing FDA requirements, including annual user fees, cGMP compliance, adverse event reporting, and strict adherence to labeling and promotional regulations, with non-compliance leading to significant penalties - Approved products are subject to ongoing annual program user fees, potential confirmatory studies, and rigorous cGMP compliance for manufacturing, quality control, and record-keeping[148](index=148&type=chunk)[149](index=149&type=chunk) - Post-approval requirements include reporting cGMP deviations, adverse effects, updated safety/efficacy information, and compliance with electronic record/signature requirements, with potential for official lot release by the FDA[150](index=150&type=chunk) - Manufacturers must comply with advertising and promotion requirements, including the prohibition of promoting off-label uses, with violations potentially leading to significant regulatory actions, fines, and criminal penalties[153](index=153&type=chunk)[154](index=154&type=chunk) [Other Healthcare Laws and Regulations](index=31&type=section&id=Other%20Healthcare%20Laws%20and%20Regulations) Genelux's business activities are subject to numerous federal and state healthcare laws beyond FDA regulations, including anti-kickback statutes, false claims laws, HIPAA, and physician payment transparency requirements, with non-compliance risking substantial penalties - Business activities are subject to federal and state healthcare laws, including the Anti-Kickback Statute, which prohibits remuneration to induce referrals or purchases under federal healthcare programs[157](index=157&type=chunk) - The federal civil and criminal false claims laws, including the False Claims Act, prohibit presenting false or fraudulent claims for federal funds[158](index=158&type=chunk) - HIPAA imposes requirements on healthcare benefit programs regarding privacy, security, and transmission of individually identifiable health information[158](index=158&type=chunk) - The Physician Payments Sunshine Act requires manufacturers to report payments or transfers of value to physicians and teaching hospitals[158](index=158&type=chunk) - Non-compliance with these laws can lead to significant civil, criminal, and administrative penalties, damages, fines, imprisonment, and exclusion from government-funded healthcare programs[159](index=159&type=chunk) [Coverage and Reimbursement](index=33&type=section&id=Coverage%20and%20Reimbursement) The commercial success of Genelux's products depends on obtaining adequate coverage and reimbursement from third-party payors, a process that is uncertain, time-consuming, and costly, potentially limiting net revenue and profitability - Sales of approved product candidates depend on the availability of coverage and adequate reimbursement from third-party payors, including government programs, managed care, and private insurers[160](index=160&type=chunk) - Third-party payors are increasingly reducing reimbursements, limiting coverage to specific formularies, and implementing cost-containment programs, including price controls[160](index=160&type=chunk) - Obtaining coverage and reimbursement may require expensive pharmacoeconomic studies to demonstrate medical necessity and cost-effectiveness, with no assurance of consistent or adequate rates[162](index=162&type=chunk) - Unfavorable coverage policies and reimbursement rates, or increased pressure from managed care, could significantly reduce revenues and prevent profitability[163](index=163&type=chunk) [Health Reform](index=34&type=section&id=Health%20Reform) U.S. and foreign health reform initiatives, such as the ACA and IRA, significantly impact the biopharmaceutical industry by aiming to contain costs and control drug pricing, creating regulatory uncertainty that could affect profitability - The ACA and other health reform measures aim to contain healthcare costs, improve quality, and expand access, significantly affecting the biopharmaceutical industry[166](index=166&type=chunk)[167](index=167&type=chunk) - The Inflation Reduction Act (IRA) establishes a Drug Price Negotiation Program for certain high-expenditure biologics under Medicare Parts B and D, and imposes rebates for price increases exceeding inflation[168](index=168&type=chunk)[170](index=170&type=chunk) - The U.S. Supreme Court's Loper Bright decision overturned the Chevron doctrine, potentially leading to additional legal challenges to federal agency regulations, including the FDA, and increasing regulatory uncertainty[171](index=171&type=chunk) - State-level legislation and regulations are also increasing to control pharmaceutical pricing, including importation programs, which could adversely affect product pricing and reimbursement[173](index=173&type=chunk) [Data Privacy and Security](index=36&type=section&id=Data%20Privacy%20and%20Security) Genelux is subject to stringent and evolving data privacy and security obligations, including federal and international laws, contractual requirements, and industry standards, with non-compliance or security incidents risking regulatory investigations, litigation, fines, and reputational harm - The company processes confidential and sensitive information, including personal data and intellectual property, making it subject to numerous data privacy and security obligations[175](index=175&type=chunk) - Compliance is required with U.S. laws like HIPAA (for protected health information) and the California Consumer Privacy Act (CCPA), as well as international regulations like the EU GDPR and UK GDPR[175](index=175&type=chunk)[176](index=176&type=chunk) - Cyber-attacks, malicious activity, and personnel misconduct pose threats to information systems and data, with potential for significant disruptions, data loss, reputational harm, and regulatory actions[179](index=179&type=chunk) - The use of generative AI technologies by employees could lead to additional compliance costs, regulatory investigations, and lawsuits[177](index=177&type=chunk) [Additional Regulation](index=37&type=section&id=Additional%20Regulation) Genelux is subject to environmental, health, and safety laws governing hazardous substances and waste, and must comply with the U.S. Foreign Corrupt Practices Act (FCPA) and similar foreign anti-corruption laws, with violations leading to criminal and civil penalties - The company is subject to federal and state environmental, health, and safety laws (e.g., OSHA, RCRA, TSCA) governing hazardous substances and waste, with potential liability for damages and fines[180](index=180&type=chunk) - The U.S. Foreign Corrupt Practices Act (FCPA) prohibits U.S. corporations from engaging in corrupt activities to obtain or retain business abroad, including interactions with foreign healthcare professionals[181](index=181&type=chunk) - Violations of the FCPA or equivalent foreign laws can result in criminal and civil fines, imprisonment, disgorgement, and suspension from government contracts[181](index=181&type=chunk) [Human Capital Resources](index=37&type=section&id=Human%20Capital%20Resources) Genelux prioritizes attracting and retaining top talent by fostering a safe and rewarding workplace with career development opportunities, competitive compensation, and robust benefits, with 24 employees as of December 31, 2024 - The company's human capital strategy focuses on attracting, motivating, and retaining highly qualified personnel through a rewarding workplace, career development, and strong compensation/benefits[183](index=183&type=chunk) Employee Count as of December 31, 2024 | Category | Number of Employees | |---|---| | Total Full-time and Part-time | **24** | | Research and Development & Manufacturing | **15** | | Management and Administrative | **9** | - The company monitors success using metrics like employee engagement, vacancy rates, promotion rates, and diversity representation, and uses stock-based compensation to attract and retain talent[185](index=185&type=chunk) [Corporate Information](index=38&type=section&id=Corporate%20Information) Genelux Corporation, incorporated in Delaware in September 2001, completed its IPO in January 2023 and is listed on the Nasdaq Capital Market under 'GNLX', operating as an 'emerging growth company' and 'smaller reporting company' - Genelux Corporation was incorporated in Delaware in September 2001, with principal executive offices in Westlake Village, California[186](index=186&type=chunk) - The company completed its IPO in January 2023, and its common stock is listed on the Nasdaq Capital Market under the symbol 'GNLX'[186](index=186&type=chunk) - Genelux is an 'emerging growth company' (EGC) until December 31, 2028, or earlier if certain conditions are met, and also a 'smaller reporting company' (SRC), benefiting from reduced reporting requirements[186](index=186&type=chunk) [Available Information](index=38&type=section&id=Available%20Information) Genelux Corporation is subject to the informational requirements of the Securities Exchange Act of 1934, filing Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K with the SEC, all available on the SEC's and company's websites - Genelux is subject to the informational requirements of the Exchange Act, filing Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K with the SEC[187](index=187&type=chunk) - Company filings are available free of charge on the SEC's website (http://www.sec.gov) and the company's website (www.genelux.com)[187](index=187&type=chunk)[188](index=188&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section details the significant risks associated with investing in Genelux, covering financial position, product development, manufacturing, reliance on third parties, commercialization, intellectual property, government regulation, business operations, and common stock [Risks Related to our Financial Position and Need for Additional Capital](index=39&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) Genelux has incurred significant and increasing losses, with an accumulated deficit of $251.4 million as of December 31, 2024, and anticipates continued losses, requiring substantial additional financing that may not be available on acceptable terms - Genelux has incurred significant operating losses since inception, with net losses of **$29.9 million in 2024** and **$28.3 million in 2023**, and an accumulated deficit of **$251.4 million** as of December 31, 2024[191](index=191&type=chunk)[598](index=598&type=chunk) - The company expects to incur significant and increasing operating losses for the foreseeable future and may never achieve or maintain profitability, requiring substantial additional financing[191](index=191&type=chunk)[194](index=194&type=chunk) - Failure to obtain necessary capital could force delays, limits, reductions, or termination of product development programs, commercialization efforts, or other operations[194](index=194&type=chunk) - The report of the independent registered public accounting firm included a 'going concern' explanatory paragraph, indicating substantial doubt about the company's ability to continue operations[207](index=207&type=chunk) - Two investors from private placements were contractually obligated to fund **$24.0 million**, but have not made these payments, which could exhaust available capital sooner than expected[197](index=197&type=chunk)[198](index=198&type=chunk) [Risks Related to Product Discovery, Development and Regulatory Approval](index=45&type=section&id=Risks%20Related%20to%20Product%20Discovery,%20Development%20and%20Regulatory%20Approval) Genelux's product development is highly uncertain, with Olvi-Vec being its only clinical-stage candidate based on a novel oncolytic VACV platform, facing risks of delays, unexpected adverse events, and difficulties in patient enrollment, with interim data not predicting final results - The success of the business depends on identifying and successfully developing product candidates from its CHOICE platform, but Olvi-Vec is currently the only one in clinical trials, and its failure could adversely affect other programs[209](index=209&type=chunk)[218](index=218&type=chunk)[220](index=220&type=chunk) - Product candidates are in preclinical and clinical stages, not approved for commercial sale, and may never receive regulatory approval or become commercially viable due to the lengthy, expensive, and uncertain development process[211](index=211&type=chunk)[224](index=224&type=chunk) - Delays in initiating or completing clinical trials can occur due to various factors, including inability to generate sufficient preclinical data, regulatory approval delays, slow patient enrollment, and manufacturing issues[226](index=226&type=chunk)[227](index=227&type=chunk) - Results of preclinical studies and early clinical trials may not be predictive of future clinical trial results, and interim/topline data are subject to change and audit[239](index=239&type=chunk)[243](index=243&type=chunk) - Serious adverse events or undesirable side effects during development or after approval could halt development, lead to regulatory refusal, or revocation of marketing authorizations[252](index=252&type=chunk) - The company anticipates using its product candidates in combination with third-party drugs/devices, over which it has limited control regarding supply, regulatory status, or approval[258](index=258&type=chunk)[259](index=259&type=chunk) [Risks Related to Manufacturing](index=68&type=section&id=Risks%20Related%20to%20Manufacturing) Genelux faces multiple manufacturing risks due to the complex, time-consuming, and highly regulated nature of biopharmaceutical production, including difficulties in scaling up, quality control issues, raw material shortages, and contamination, which can lead to delays and increased costs - The manufacture of biopharmaceutical products, especially viral immunotherapies, is complex, time-consuming, highly regulated, and costly, with risks in production, quality control, and supply chain[301](index=301&type=chunk)[302](index=302&type=chunk) - Changes in product candidate manufacturing or formulation, such as switching to a mammalian-cell-based system, may result in additional costs, delays, and require regulatory notification or authorization, potentially affecting clinical trial results[306](index=306&type=chunk)[308](index=308&type=chunk) - Failure to comply with cGMP requirements or meet volume demands could lead to delays in development and commercialization, loss of potential revenues, and regulatory enforcement actions[314](index=314&type=chunk)[315](index=315&type=chunk)[316](index=316&type=chunk) - If the company's manufacturing facility is not approved or cannot meet volume requirements, finding alternative facilities or CMOs could significantly delay development and commercialization[310](index=310&type=chunk) [Risks Related to Reliance on Third Parties](index=72&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) Genelux relies heavily on third parties for raw material supply, quality testing, packaging, distribution, and the conduct of preclinical studies and clinical trials, with failures by these third parties risking significant delays, increased costs, and an inability to obtain regulatory approval or commercialize products - The company relies on third parties to supply and quality-test ingredients, components, and to package and distribute products, facing risks like reduced control, termination of agreements, and supply disruptions[319](index=319&type=chunk)[320](index=320&type=chunk) - Reliance on third-party CROs, study sites, and others to conduct preclinical studies and clinical trials reduces control over these activities, and their failure to perform satisfactorily could delay or prevent regulatory approval[323](index=323&type=chunk)[324](index=324&type=chunk) - Collaboration agreements and strategic alliances, such as with Newsoara, may not yield anticipated benefits, and partners may not perform as expected, delay trials, or terminate agreements, impacting development and commercialization[332](index=332&type=chunk)[336](index=336&type=chunk) - Disruptions at the FDA and other government agencies due to funding shortages or global health concerns could hinder their ability to review and approve new products in a timely manner[345](index=345&type=chunk)[347](index=347&type=chunk) [Risks Related to Commercialization](index=79&type=section&id=Risks%20Related%20to%20Commercialization) Genelux faces significant challenges in commercializing any approved product candidates, including establishing effective marketing, sales, and distribution capabilities, achieving market acceptance, and securing adequate coverage and reimbursement from third-party payors, all within an intensely competitive landscape - Successful commercialization of approved product candidates depends on launching sales, obtaining favorable labels, creating market demand, building sales forces, manufacturing sufficient quantities, and securing reimbursement[349](index=349&type=chunk) - The company faces significant competition from major biopharmaceutical companies, specialty firms, and research institutions in cancer immunotherapy, many with greater financial and technical resources[351](index=351&type=chunk)[361](index=361&type=chunk) - Even with marketing approval, products may fail to achieve market acceptance due to physician/patient reluctance to switch, adverse events, cost, or competition, limiting revenue and profitability[367](index=367&type=chunk)[368](index=368&type=chunk) - Estimating the potential market for product candidates is difficult and uncertain, and inaccurate assumptions could lead to smaller actual markets and adversely affect revenues[372](index=372&type=chunk) - Negative developments in immuno-oncology, including adverse events in clinical trials or competitor therapies, could damage public perception of the oncolytic VACV platform and product candidates[373](index=373&type=chunk) [Risks Related to Our Intellectual Property](index=88&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Genelux's success hinges on protecting its intellectual property, including patents, trade secrets, and trademarks, but faces risks of patent invalidation, infringement claims, difficulties in global enforcement, and challenges in maintaining trade secret confidentiality - Commercial success depends on obtaining and maintaining patent and other intellectual property protection for its technology and product candidates, but the patent positions in biotechnology are highly uncertain and subject to litigation[377](index=377&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk) - The patent prosecution process is expensive and complex, and pending applications may not result in meaningful protection, or issued patents may be challenged, invalidated, or circumvented[382](index=382&type=chunk)[380](index=380&type=chunk) - Failure to comply with obligations in license agreements could lead to loss of intellectual property rights critical to the business[386](index=386&type=chunk)[387](index=387&type=chunk) - Protecting trade secrets and know-how is crucial, but confidentiality agreements may be breached, or information independently discovered, impairing competitive position[390](index=390&type=chunk)[391](index=391&type=chunk) - Third parties may allege infringement of their IP rights, leading to costly and time-consuming litigation, potential monetary damages, or forced cessation of development/commercialization[392](index=392&type=chunk) - Protecting IP globally is expensive and challenging, as foreign laws may offer less extensive protection, and compulsory licensing laws could diminish patent value[396](index=396&type=chunk)[397](index=397&type=chunk)[399](index=399&type=chunk) - Changes to patent law, such as the Leahy-Smith Act, or U.S. Supreme Court rulings, could diminish the value of patents and weaken the ability to obtain or enforce IP[402](index=402&type=chunk)[403](index=403&type=chunk) - Patent terms may be inadequate to protect competitive position, and biological product candidates may face biosimilar competition sooner than anticipated due to limited exclusivity periods[412](index=412&type=chunk)[416](index=416&type=chunk) - Inadequate protection of trademarks and trade names could hinder brand recognition and competitive effectiveness[420](index=420&type=chunk)[422](index=422&type=chunk) [Risks Related to Government Regulation](index=99&type=section&id=Risks%20Related%20to%20Government%20Regulation) Genelux is subject to extensive and evolving government regulations, including federal and state healthcare fraud and abuse laws, data privacy laws, and anti-corruption laws, with non-compliance risking substantial penalties and significant uncertainty regarding coverage and reimbursement from third-party payors - Failure to comply with federal and state healthcare laws, including fraud and abuse laws (Anti-Kickback Statute, False Claims Act, HIPAA, Sunshine Act), could result in substantial civil and criminal penalties, exclusion from healthcare programs, and reputational harm[424](index=424&type=chunk)[425](index=425&type=chunk)[426](index=426&type=chunk) - Inadequate coverage, reimbursement, or unfavorable payment rates from government or third-party payors, or competition from less expensive therapies, could limit revenue and profitability[428](index=428&type=chunk)[430](index=430&type=chunk)[431](index=431&type=chunk) - New legislation and regulatory proposals, such as the ACA and IRA (including drug price negotiation and rebates), may increase compliance costs and adversely affect marketability and pricing of products[436](index=436&type=chunk)[437](index=437&type=chunk)[443](index=443&type=chunk) - The company is subject to stringent and evolving U.S. (HIPAA, CCPA, MHMD) and foreign (GDPR, UK GDPR) data privacy and security laws, with non-compliance or security incidents potentially leading to regulatory actions, litigation, fines, and reputational harm[454](index=454&type=chunk)[455](index=455&type=chunk)[457](index=457&type=chunk)[459](index=459&type=chunk)[469](index=469&type=chunk) - Compliance with environmental, health, and safety laws and the U.S. Foreign Corrupt Practices Act (FCPA) is required, with violations potentially leading to fines, penalties, and adverse business consequences[470](index=470&type=chunk)[450](index=450&type=chunk)[453](index=453&type=chunk) [Risks Related to Our Business and Operations](index=109&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Operations) Genelux's operations are highly dependent on key personnel, and the inability to attract and retain qualified talent could hinder business strategy, while managing organizational growth, potential future acquisitions, and adverse macroeconomic conditions pose significant risks - The company is highly dependent on key personnel, including its President, CEO, and Chairman; failure to attract, motivate, and retain highly qualified personnel could impede business strategy and R&D objectives[473](index=473&type=chunk)[474](index=474&type=chunk)[475](index=475&type=chunk) - Expanding the organization will require managing growth effectively, including hiring additional personnel and improving operational/financial controls, with potential difficulties disrupting operations[478](index=478&type=chunk) - Future acquisitions or strategic partnerships may increase capital requirements, dilute stockholders, incur debt, and subject the company to integration and unknown liability risks[482](index=482&type=chunk)[483](index=483&type=chunk) - Unfavorable market and economic conditions, including prolonged downturns, could adversely affect the ability to raise capital and strain suppliers[484](index=484&type=chunk) - Public health crises (e.g., pandemics) could materially disrupt preclinical studies and clinical trials, causing delays in patient enrollment, site initiation, and supply chains[486](index=486&type=chunk)[489](index=489&type=chunk) - Compromise of information technology systems or data (including sensitive information) due to cyber-attacks, malicious activity, or human error could lead to regulatory investigations, litigation, fines, business disruptions, and reputational harm[490](index=490&type=chunk)[492](index=492&type=chunk)[502](index=502&type=chunk) - The use of product candidates in clinical trials and commercial sale exposes the company to product liability claims, which could result in substantial liabilities, loss of revenue, and reputational damage[506](index=506&type=chunk)[508](index=508&type=chunk) [Risks Related to Our Common Stock](index=119&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Genelux's common stock may experience volatility and lack sustained liquidity, leading to potential losses for investors, with operating results expected to fluctuate, and future stock sales and issuances potentially diluting existing ownership - An active, liquid, and orderly trading market for common stock may not be sustained, leading to difficulties in selling shares quickly or at market price[520](index=520&type=chunk) - Operating results are subject to quarterly fluctuations, making future predictions difficult, and failure to meet investor/analyst expectations could cause stock price declines[521](index=521&type=chunk)[523](index=523&type=chunk) - The market price of common stock may be volatile and fluctuate substantially due to various factors, including clinical trial results, regulatory developments, competition, and macroeconomic conditions[524](index=524&type=chunk)[528](index=528&type=chunk)[531](index=531&type=chunk) - The company does not intend to pay dividends on common stock, so returns are limited to stock value appreciation[534](index=534&type=chunk) - Principal stockholders and management own a significant percentage of stock, enabling them to exert substantial control over matters requiring stockholder approval[535](index=535&type=chunk) - Future sales and issuances of common stock or rights to purchase common stock, including under equity incentive plans, could result in additional dilution of existing stockholders' ownership[539](index=539&type=chunk)[542](index=542&type=chunk) - As an 'emerging growth company' and 'smaller reporting company,' reduced reporting requirements may make common stock less attractive to some investors, potentially leading to a less active trading market and more volatile stock price[543](index=543&type=chunk)[546](index=546&type=chunk) - Provisions in the company's organizational documents and Delaware law could make an acquisition more difficult and prevent attempts by stockholders to replace management[547](index=547&type=chunk)[548](index=548&type=chunk)[550](index=550&type=chunk) [Item 1B. Unresolved Staff Comments](index=126&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) This section states that the company has no unresolved comments from the SEC staff regarding its filed reports - The company has no unresolved staff comments[568](index=568&type=chunk) [Item 1C. Cybersecurity](index=126&type=section&id=Item%201C.%20Cybersecurity) This section outlines Genelux's cybersecurity risk management and governance, employing external consultants and internal processes to identify, assess, and mitigate threats, with Board oversight and dedicated teams for incident response [Risk management and strategy](index=126&type=section&id=Risk%20management%20and%20strategy) Genelux implements various information security processes, including engaging external cybersecurity consultants, to identify, assess, and manage material risks from cybersecurity threats, integrating these efforts into its overall enterprise risk management program - Genelux implements information security processes to identify, assess, and manage cybersecurity threats to its critical computer networks, services, and data[569](index=569&type=chunk) - The company engages external cybersecurity and IT consultants to monitor threats, analyze reports, conduct scans, and perform third-party threat assessments[570](index=570&type=chunk) - Cybersecurity risk management is integrated into the company's overall enterprise risk management program and includes vulnerability management, disaster recovery, network security, employee training, and cybersecurity insurance[571](index=571&type=chunk)[572](index=572&type=chunk) - A vendor management program is in place to manage cybersecurity risks associated with third-party service providers[574](index=574&type=chunk) [Governance](index=131&type=section&id=Governance) The Board of Directors, through its Audit Committee, oversees Genelux's cybersecurity risk management, with a dedicated Cybersecurity Risk Management Team responsible for implementation, incident preparation, and reporting to senior management and the Board - The Board of Directors, with the Audit Committee, oversees the company's cybersecurity risk management processes[577](index=577&type=chunk) - A Cybersecurity Risk Management Team, including the General Counsel and external consultants, is responsible for implementing and maintaining these processes[578](index=578&type=chunk) - Cybersecurity incidents are escalated to the CFO and CEO, who work with the Incident Response Team, and certain incidents are reported to the Audit Committee[580](index=580&type=chunk) [Item 2. Properties](index=131&type=section&id=Item%202.%20Properties) Genelux leases its corporate headquarters in Westlake Village, California (4,050 sq ft), two facilities in San Diego, California (7,569 sq ft for manufacturing/lab, 6,755 sq ft for future lab/offices), and a business office in Redlands, California (1,884 sq ft) - Corporate headquarters are in Westlake Village, California (**4,050 sq ft**, lease expires July 2027)[582](index=582&type=chunk) - Two facilities are leased in San Diego, California: a **7,569 sq ft** facility for manufacturing and translational science laboratory, and a **6,755 sq ft** facility for future laboratory and administrative offices. Both leases expire in October 2030 with five-year extension options[582](index=582&type=chunk) - A business office is located in Redlands, California (**1,884 sq ft**) on a month-to-month lease[582](index=582&type=chunk) [Item 3. Legal Proceedings](index=131&type=section&id=Item%203.%20Legal%20Proceedings) Genelux Corporation is not currently involved in any material legal proceedings, but acknowledges the potential for future legal proceedings, claims, investigations, and government inquiries arising in the ordinary course of its business - The company is not currently the subject of any material legal proceeding[584](index=584&type=chunk) - Future involvement in legal proceedings, claims, investigations, and government inquiries is possible in the ordinary course of business, including those related to intellectual property, data privacy, and contractual rights[584](index=584&type=chunk) [Item 4. Mine Safety Disclosures](index=131&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Genelux Corporation - This item is not applicable[585](index=585&type=chunk) [PART II](index=132&type=section&id=PART%20II) [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=132&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section provides information on Genelux's common stock, which began trading on the Nasdaq Capital Market under 'GNLX' following its IPO in January 2023, with approximately 1,026 stockholders of record as of March 13, 2025, and no intention to pay dividends [Market Information](index=132&type=section&id=Market%20Information) Genelux's common stock, with a par value of $0.001 per share, is traded on The Nasdaq Capital Market under the symbol 'GNLX', with trading commencing on January 26, 2023, following its initial public offering - Common stock is traded on The Nasdaq Capital Market under the symbol 'GNLX'[587](index=587&type=chunk) - Trading commenced on January 26, 2023, after the initial public offering (IPO)[587](index=587&type=chunk) [Holders of Record](index=132&type=section&id=Holders%20of%20Record) As of March 13, 2025, Genelux Corporation had approximately 1,026 stockholders of record for its common stock - As of March 13, 2025, there were approximately **1,026 stockholders of record** of the company's common stock[588](index=588&type=chunk) [Dividend Policy](index=132&type=section&id=Dividend%20Policy) Genelux Corporation has never declared or paid cash dividends on its common stock and does not anticipate doing so in the foreseeable future, intending to retain all available funds for business development - The company has never declared or paid cash dividends on its common stock[589](index=589&type=chunk) - Genelux intends to retain all available funds and future earnings for business development and expansion, and does not anticipate paying cash dividends in the foreseeable future[589](index=589&type=chunk) [Securities Authorized for Issuance under Equity Compensation Plans](index=132&type=section&id=Securities%20Authorized%20for%20Issuance%20under%20Equity%20Compensation%20Plans) Information regarding securities authorized for issuance under equity compensation plans is incorporated by reference from Item 12 of Part III of this Annual Report on Form 10-K - Information about equity compensation plans is incorporated by reference from Item 12 of Part III[590](index=590&type=chunk) [Recent Sales of Unregistered Securities](index=132&type=section&id=Recent%20Sales%20of%20Unregistered%20Securities) This section states that there have been no recent sales of unregistered securities - No recent sales of unregistered securities[591](index=591&type=chunk) [Purchases of Equity Securities by the Issuer and Affiliated Purchasers](index=132&type=section&id=Purchases%20of%20Equity%20Securities%20by%20the%20Issuer%20and%20Affiliated%20Purchasers) This section states that there were no purchases of equity securities by the issuer or affiliated purchasers - Not applicable[592](index=592&type=chunk) [Item 6. Reserved](index=132&type=section&id=Item%206.%20Reserved) This item is reserved and contains no information - This item is reserved[593](index=593&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=133&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Genelux's financial condition and results of operations for the years ended December 31, 2024 and 2023, highlighting recurring losses, significant accumulated deficit, and ongoing need for substantial additional funding [Overview](index=133&type=section&id=Overview) Genelux is a late clinical-stage biopharmaceutical company focused on oncolytic viral immunotherapies, with Olvi-Vec as its lead candidate, having incurred significant operating losses and an accumulated deficit of $251.4 million as of December 31, 2024, and requiring substantial additional funding - Genelux is a late clinical-stage biopharmaceutical company developing oncolytic viral immunotherapies, with Olvi-Vec as its lead product candidate[595](index=595&type=chunk) - The company has incurred significant operating losses since inception, with net losses of **$29.9 million in 2024** and **$28.3 million in 2023**, and an accumulated deficit of **$251.4 million** as of December 31, 2024[598](index=598&type=chunk) - Genelux expects to continue incurring significant and increasing expenses and operating losses, requiring substantial additional funding to support development, manufacturing, regulatory approval, and potential commercialization[598](index=598&type=chunk)[599](index=599&type=chunk)[600](index=600&type=chunk) [Recent Developments](index=134&type=section&id=Recent%20Developments) Genelux recently completed an underwritten public offering on M

Group 1 - Genelux Corporation (GNLX) has experienced a significant decline of 29.7% over the past four weeks, but it is now in oversold territory, indicating a potential trend reversal [1] - The Relative Strength Index (RSI) for GNLX is currently at 29.16, suggesting that the heavy selling pressure may be exhausting itself [5] - There is strong consensus among Wall Street analysts that GNLX will report better earnings than previously predicted, with a 33% increase in the consensus EPS estimate over the last 30 days [7] Group 2 - GNLX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [8]