Core Viewpoint - Biotech stocks are experiencing renewed momentum, with small-cap companies like Nautilus Biotechnology, PepGen, Lixte, RenovoRx, Genelux, and VolitionRx attracting investor interest through various catalysts such as insider buying, strategic partnerships, and clinical trial progress Group 1: Nautilus Biotechnology (NAUT) - Nautilus Biotechnology's stock surged 5.52% during regular trading, closing at $0.7070, and rose an additional 7.5% in after-hours trading to $0.76, with trading volume nearly double its average at 647,399 shares [2] - Recent insider buying by CEO Sujal M. Patel, who purchased 83,500 shares on September 8 and 116,500 shares on September 5, totaling over $135,000, indicates strong leadership confidence [3] - The company reported a narrower loss of $0.12 per share in Q2 2025, with an 18% drop in operating expenses, and has $179.5 million in cash, providing a financial runway through 2027 [4] Group 2: PepGen Inc. (PEPG) - PepGen's stock rebounded 7.14% in after-hours trading to $1.50 after a regular session close of $1.40, with trading volume more than double its average at 638,576 shares [4] - The company completed dosing for its 15 mg/kg arm of the FREEDOM trial, with topline data expected in early Q4 2025, following a strategic narrowing of its pipeline [5] Group 3: Lixte Biotechnology Holdings Inc. (LIXT) - Lixte's stock rose 5.85% in after-hours trading to $5.25 after closing at $4.96, with a trading volume of 503,604 shares, notable given recent volatility [5] - The company announced a $2.6 million purchase of Bitcoin and Ethereum to diversify its treasury holdings, reflecting a strategic shift in financial strategy [6] Group 4: RenovoRx Inc. (RNXT) - RenovoRx shares increased 4.22% in after-hours trading to $1.2194 after a regular session close of $1.17, with trading volume significantly above its average at 886,119 shares [6] - The company received a positive recommendation to continue its Phase III TIGeR-PaC trial for pancreatic cancer, reinforcing confidence in its lead therapy platform [7] Group 5: Genelux Corp. (GNLX) - Genelux's stock rose 4.11% in after-hours trading to $3.80 after closing at $3.65, with trading volume relatively light at 60,339 shares [8] - The recent activity follows Genelux's participation in the H.C. Wainwright Global Investment Conference [9] Group 6: VolitionRx Ltd. (VNRX) - VolitionRx's stock increased 4.27% in after-hours trading to $0.6474 after closing at $0.6209, with trading volume slightly below its average at 183,777 shares [10] - The company announced a Research License and Exclusive Commercial Option Rights Agreement with Werfen's Immunoassay Technology Center, focusing on advancing its Nu.Q NETs assay for Antiphospholipid Syndrome [10]

Company Overview - 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 [3] - The company's lead product, Olvi-Vec, is currently being evaluated in multiple clinical trials for various cancer types, including ovarian cancer and non-small-cell lung cancer [3] Upcoming Events - Thomas Zindrick, President, CEO, and Chairman, along with CFO Matt Pulisic, will participate in a fireside chat at H.C. Wainwright & Co's Annual Global Investment Conference on September 9, 2025 [1] - The session will be moderated by Biotech Equity Research Analyst Emily Bodnar and is scheduled to begin at 2:30 p.m. ET [2] Clinical Trials - Olvi-Vec is being evaluated in two U.S.-based clinical trials: - OnPrime/GOG-3076, a Phase 3 trial for platinum-resistant/refractory ovarian cancer [3] - VIRO-25, a Phase 2 trial for non-small-cell lung cancer [3] - Additionally, a China-based Phase 1b trial is assessing Olvi-Vec for recurrent small-cell lung cancer [3] Contact Information - For investor and media inquiries, contact Ankit Bhargava at Allele Communications, LLC [4]

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]