Live nieuws • Jul 02
Genelux Publishes Data Supporting Olvi-Vec Immunotherapy Progress in Ovarian Cancer Trial Genelux published translational and clinical data from its Phase 1b/2 VIRO-15 trial showing that Olvi-Vec-primed immunochemotherapy in platinum-resistant or refractory ovarian cancer was associated with immune activation, tumor microenvironment modulation and gene expression changes consistent with chemotherapy sensitization.
The company said these findings support its ongoing registrational Phase 3 OnPrime/GOG-3076 trial of Olvi-Vec in the same indication, which is central to advancing its clinical pipeline in gynecologic oncology.
Genelux shares trade at US$2.90, with the stock down 36.3% year to date.
The update gives Genelux a more detailed scientific rationale behind its late-stage Olvi-Vec program. However, a key risk is that investor sentiment may still hinge on future Phase 3 outcomes and regulatory interactions rather than early-stage translational signals. Aankondiging • Jun 30
Genelux Reports Translational and Clinical Findings from Phase 1B/2 Viro-15 Trial of Olvi-Vec-Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer Genelux Corporation announced the publication of translational and clinical findings from its Phase 1b/2 VIRO-15 trial of Olvi-Vec-primed immunochemotherapy in heavily pretreated patients with platinum-resistant/refractory ovarian cancer (PRROC). The publication reports data from translational analyses conducted as part of the Phase 1b/2 VIRO-15 study in patients with PRROC, evaluating the biological effects of Olvi-Vec on the tumor microenvironment and its impact on clinical response and survival. The clinical results are consistent with preclinical results generated by Genelux with Olvi-Vec showing in vitro viral permissivity and tumor vulnerability and the effect of Olvi-Vec primed immunochemotherapy in a mouse model of platinum-resistant ovarian cancer. Key findings include: Olvi-Vec treatment was associated with an influx of CD8+ tumor-infiltrating lymphocytes and immune activation within tumor tissue. Viral infection and killing of tumor cells were observed in patient-derived samples. RNA profiling identified coordinated transcriptional changes associated with immune activation, tumor cell killing, and enhanced sensitivity to subsequent platinum-based chemotherapy, supporting the potential role of Olvi-Vec as a tumor-priming immunotherapy. Translational findings provide mechanistic support for the observed restoration of platinum sensitivity following Olvi-Vec treatment, consistent with previously reported VIRO-15 clinical outcomes demonstrating improved progression-free survival. The findings presented in Gynecologic Oncology Reports suggest that Olvi-Vec may favorably remodel the tumor microenvironment in a manner that supports renewed responsiveness to platinum-based chemotherapy, reversing the trend of diminishing progression-free survival outcomes with increased lines of treatment, and provide additional biological rationale for the ongoing registrational Phase 3 OnPrime/GOG-3076 study evaluating Olvi-Vec-primed immunochemotherapy in PRROC. Olvi-Vec is administered intraperitoneally in the Phase 3 OnPrime/GOG-3076 study. Genelux also continues to evaluate systemic administration of Olvi-Vec in small cell lung cancer and non-small cell lung cancer in combination with frontline standard of care therapy in patients who have failed frontline therapy. Together, these studies are intended to inform the potential for systemic use of Olvi-Vec across additional clinical settings and solid tumor types. New Risk • May 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$28m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$28m free cash flow). Revenue is less than US$1m (US$8.0k revenue). Minor Risk Shareholders have been diluted in the past year (19% increase in shares outstanding). Breakeven Date Change • May 11
Forecast to breakeven in 2028 The 6 analysts covering Genelux expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$9.28m in 2028. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Aankondiging • May 01
Genelux Corporation, Annual General Meeting, Jun 16, 2026 Genelux Corporation, Annual General Meeting, Jun 16, 2026. Location: edge.media-server.com/mmc/p/j3zspvj4, United States New Risk • Mar 22
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 30% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (30% increase in shares outstanding). Revenue is less than US$1m (US$8.0k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$33m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Price Target Changed • Mar 20
Price target decreased by 9.5% to US$17.50 Down from US$19.33, the current price target is an average from 6 analysts. New target price is 629% above last closing price of US$2.40. Stock is down 39% over the past year. The company is forecast to post a net loss per share of US$0.85 next year compared to a net loss per share of US$0.95 last year. New Risk • Jan 13
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 30% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Shareholders have been diluted in the past year (30% increase in shares outstanding). Significant insider selling over the past 3 months (US$106k sold). New Risk • Jan 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Significant insider selling over the past 3 months (US$106k sold). Aankondiging • Jan 06
Genelux Corporation Reports Encouraging Interim Data of Systemic Administration of Olvi-Vec in Ongoing Lung Cancer Trials Genelux Corporation announced interim results from two ongoing trials – Phase 1b/2 SCLC and Phase 2 VIRO-25 - evaluating systemic (intravenous) administration of Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and progressive non-small cell lung cancer (NSCLC), respectively, after failure of prior platinum-based regimens. Together, the open-label studies are designed to demonstrate that the Olvi-Vec-primed immunochemotherapy mechanism of resensitizing tumors to platinum-based chemotherapy can extend beyond intraperitoneal delivery into a systemic delivery setting across multiple solid tumor types. Platinum-relapsed or platinum-refractory advanced SCLC (OLVI-VEC-SCLC-202 Ph1b/2 Clinical Trial) The open-label Phase 1b/2 SCLC trial (NCT07136285) is evaluating a single intravenous cycle with multiple doses of Olvi-Vec administered in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-relapsed or platinum-refractory disease after failing previous treatment with platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co. Ltd. (Newsoara), in China. As of the data review cutoff date of December 23, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results: 9 evaluable patients Overall response rate (ORR) of 33% (3/9 patients), including three PRs Two of the three PRs occurred in Cohort 4, the highest dose cohort tested as of the data review cutoff date, with tumor shrinkage of approximately 55% and 85% from baseline, representing an ORR of 67% (2/3) in Cohort 4 and potentially suggesting a dose-response trend Disease control rate (DCR) of 67% (6/9 patients) Tumor shrinkage of 24–85% among the six DCR patients, all of whom experienced a reduction in all target lesions from baseline Olvi-Vec generally well tolerated Exploratory durability signals: Two PR patients across different cohorts have been evaluated in long-term follow-up: A patient with 1 prior line, at last scan, achieved a PR with an ongoing progression-free survival (PFS) of 12.1 months A patient with 4 prior lines had a PFS of 7.7 months, which exceeds the PFS in the immediately preceding line in the same patient (1.9 months) by 5.8 months Notably, this SCLC trial is primarily evaluating safety and tolerability and, as such, patients who achieved objective responses from Olvi-Vec immunochemotherapy in this trial do not receive any subsequent standard maintenance immunotherapy to extend durability of response. Advanced or metastatic recurrent NSCLC (Phase 2 VIRO-25 Clinical Trial) The open-label Phase 2 VIRO-25 trial (NCT06463665) is evaluating a single intravenous cycle with multiple doses of Olvi-Vec in combination with platinum chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent NSCLC who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States. As of the data review cutoff date of December 31, 2025, systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved the following preliminary results: 5 evaluable patients DCR of 60% (3/5 patients) Tumor size changes among the three DCR patients were 8.9%, -18.9%, and -22.7%, respectively, as compared to baseline Olvi-Vec generally well tolerated Upcoming Milestones The Phase 1b/2 SCLC trial and Phase 2 VIRO-25 trial are actively enrolling in dose escalation cohorts with an aim to optimize efficacy, safety, and tolerability of Olvi-Vec. The trials are being conducted to align a systemic dosing regimen to support future multi-regional registrational clinical trials. Additional interim (updated dose-finding) data readouts expected throughout 2026 in Phase 1b/2 SCLC trial and Phase 2 VIRO-25 trial Topline data from the Phase 3 platinum-resistant/refractory ovarian cancer trial (OnPrime/GOG-3076) expected in second half of 2026. Aankondiging • Jan 02
Genelux Corporation Announces Change of Chief Medical Officer On December 30, 2025, Paul Scigalla, M.D. resigned as Chief Medical Officer of Genelux Corporation (the “Company”), effective immediately. On January 2, 2026, the Company announced the appointment of Jason Litten, M.D. as the Company’s Chief Medical Officer, effective as of January 2, 2026 (the “Effective Date”). Dr. Litten, 52, most recently served as the Chief Medical Officer of Chimeric Therapeutics Ltd. since July 2022. Dr. Litten is an expert in clinical oncology with experience developing numerous therapeutics modalities. Dr. Litten notably developed some of the first CAR-T, TCR and NK cell clinical programs, as well as leading the clinical and preclinical development of numerous therapeutic monoclonal antibodies and orally available cancer medicines. From August 2019 to March 2022, Dr. Litten served as the Chief Medical Officer at Artiva Biotherapeutics Inc. where he built and led Artiva’s clinical and regulatory functions. During his time at Artiva, Dr. Litten contributed to launching two clinical NK cell therapy programs, raising over $200 million in private financing and establishing two foundational corporate partnerships. From January 2019 to June 2019, Dr. Litten served as Chief Medical Officer at Optera Therapeutics Corp., and from September 2016 to May 2018, Dr. Litten was the Vice President of Clinical Development overseeing solid tumor programs at Juno Therapeutics Inc. Before Juno, he was Vice President of Clinical Development at Clovis Oncology Inc. Dr. Litten started his industry career in Oncology Clinical Development at Amgen Inc. Dr. Litten holds a B.S. in Finance and Economics from Cornell University and M.D. from Emory University. After medical school, he completed a Residency in General Pediatrics at University of Miami and a Clinical Fellowship in Pediatric Hematology & Oncology at UT Southwestern Medical Center at Dallas. New Risk • Nov 06
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$24m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Price Target Changed • Oct 21
Price target increased by 7.4% to US$19.33 Up from US$18.00, the current price target is an average from 6 analysts. New target price is 188% above last closing price of US$6.72. Stock is up 158% over the past year. The company is forecast to post a net loss per share of US$0.88 next year compared to a net loss per share of US$0.95 last year. Aankondiging • Jul 14
Genelux Corporation, Annual General Meeting, Aug 27, 2025 Genelux Corporation, Annual General Meeting, Aug 27, 2025. Aankondiging • Jul 07
Genelux Corporation Announces Appointment of Eric Groen as General Counsel, Corporate Secretary, Chief Compliance Officer and Head of Business Development Genelux Corporation announced the appointment of Eric Groen as General Counsel, Corporate Secretary, Chief Compliance Officer and Head of Business Development, effective July 1, 2025. Mr. Groen is an accomplished executive who has over two decades of leadership in the life sciences industry, driving results, empowering teams, and shaping positive corporate culture. Recognized as a strategic yet hands-on executive, he is passionate about advancing innovation to improve patient outcomes and is eager to help Genelux realize the full potential of Olvi-Vec for patients, shareholders, and employees. Most recently, Mr. Groen served as General Counsel of Rani Therapeutics, a clinical-stage, publicly traded biotech company. Previously, he spent 20 years in the legal department at Amgen with a proven track record in business development transactions such as Amgen’s $10 billion acquisition of Onyx Pharmaceuticals. Mr. Groen offers deep expertise across corporate law, mergers and acquisitions, licensing, compliance, and business development. He graduated from Harvard Law School with his J.D. and from the University of California, Santa Barbara with a B.A. in Political Science. New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$23m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$23m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$16m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Significant insider selling over the past 3 months (US$78k sold). Price Target Changed • Jun 05
Price target increased by 11% to US$20.00 Up from US$18.00, the current price target is an average from 4 analysts. New target price is 691% above last closing price of US$2.53. Stock is up 0.4% over the past year. The company is forecast to post a net loss per share of US$0.99 next year compared to a net loss per share of US$0.95 last year. New Risk • Apr 02
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$97.0m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (41% increase in shares outstanding). Revenue is less than US$1m (US$8.0k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$46m net loss in 3 years). Market cap is less than US$100m (US$97.0m market cap). New Risk • Mar 31
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (41% increase in shares outstanding). Revenue is less than US$1m (US$8.0k revenue). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$46m net loss in 3 years). New Risk • Mar 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 40% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Revenue is less than US$1m (US$8.0k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Share price has been volatile over the past 3 months (17% average weekly change). Aankondiging • Mar 25
Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease Genelux Corporation announced that Genelux has concluded a productive Type D meeting with the U.S. Food and Drug Administration (FDA) for Olvi-Vec in the treatment of platinum resistant/refractory ovarian cancer (PRROC). Currently, Olvi-Vec is being evaluated in the OnPrime/GOG-3076 Phase 3 registrational trial in the United States, with the primary endpoint of progression free survival (Clinicaltrials.gov identifier NCT05281471). The purpose of the FDA meeting was to discuss the FDA's expectations with respect to the requirements necessary for the granting of traditional approval of Olvi-Vec. In response to a question seeking the FDA's guidance on their expectations regarding a confirmatory trial using the ongoing On Prime/GOG-3076 trial, the FDA responded that "As stated previously, an interim analysis of overall survival (OS) should be planned at the time of the primary PFS analysis. If a clinically meaningful PFS advantage is demonstrated in the absence of a decreement in OS, this could potentially support traditional approval. The FDA further recommended Genelux request a pre-BLA meeting with FDA with topline safety and efficacy data following completion of the study to discuss next steps. The inclusion criteria allows patients to enroll regardless of (i) tumor biomarkers, (ii) platinum refractory tumors or (iii) the maximum number of prior lines of treatments (i.e., no cap on previous treatments). Olvi-Vec (olvimulogene nanivacirepvec), Genelux's most advanced product candidate is a proprietary, modified oncolytic vaccinia virus, a stable DNA virus with a large engineering capacity. Genelux is developing Olvi-Vec for the treatment of multiple types of cancer based on the results of preclinical studies that suggest Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune response. To date, Olvi-Vec has been administered to more than 150 patients in seven completed clinical trials. Olvi-Vec has be granted Fast Track designation by the US FDA for the treatment of platinum resistant/refractory ovarian cancer. Aankondiging • Feb 03
Genelux Corporation Appoints Matthew Pulisic as Chief Financial Officer Genelux Corporation announced that Matthew Pulisic has joined the company as its new Chief Financial Officer, effective January 30, 2025. Mr. Pulisic is an accomplished, senior executive with over 19 years of finance and commercial experience in the biopharmaceutical industry, having worked across the United States, Europe, and Asia. He is recognized for his expertise in financial leadership, corporate strategy and operational execution.Most recently, Mr. Pulisic served as Vice President of Finance at Arrowhead Pharmaceuticals, a publicly traded RNAi technology company. He played a key role in shaping the company’s financial direction, leading planning and analysis, establishing a commercial manufacturing facility, and driving operational improvements to support the company’s evolution from a clinical-stage to a pre-commercial organization. He began his career at Amgen, a publicly traded commercial biotechnology company, as a Research Associate and transitioned into finance where he held positions of increasing responsibility, across a breadth of finance-related positions, including Finance Director of Amgen Worldwide and Head of Capital Finance. He graduated from California Lutheran University with his M.B.A. in finance and from the University of California, Santa Cruz with his B.S. in Biochemistry and Molecular Biology. Major Estimate Revision • Nov 21
Consensus EPS estimates upgraded to US$0.89 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$0.892 to -US$0.885 per share. Revenue forecast unchanged from US$0 at last update. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target down from US$18.80 to US$18.40. Share price fell 16% to US$2.46 over the past week. Price Target Changed • Oct 29
Price target decreased by 9.6% to US$18.80 Down from US$20.80, the current price target is an average from 5 analysts. New target price is 508% above last closing price of US$3.09. Stock is down 79% over the past year. The company is forecast to post a net loss per share of US$0.89 next year compared to a net loss per share of US$1.16 last year. Aankondiging • Oct 25
Genelux Corporation Announces First Patient Dosed in Phase 2 Trial Evaluating Systemic Therapy with Olvi-Vec in Non-Small Cell Lung Cancer Genelux Corporation announced that the first patient has been dosed in the U.S.-based Phase 2 (VIRO-25) trial evaluating systemically delivered Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) who have failed frontline platinum and immune checkpoint inhibitor (ICI) therapies. The VIRO-25 clinical trial (NCT06463665 [3]), is an open-label, randomized study in NSCLC designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of ICI compared with docetaxel in patients with advanced or metastatic NSCLC who have shown first disease progression while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care. Olvi-Vec’s previous data suggests a manageable safety profile, and this trial looks to further confirm the hypothesis that Olvi-Vec may resensitize to platinum in multiple tumor types. Genelux expects interim data readout in mid-2025. Recent Insider Transactions • Aug 29
Insider recently sold US$200k worth of stock On the 27th of August, Aladar Szalay sold around 92k shares on-market at roughly US$2.19 per share. This transaction amounted to 2.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$13m more than they bought in the last 12 months. Major Estimate Revision • Aug 21
Consensus EPS estimates upgraded to US$0.88 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$0.957 to -US$0.88 per share. Revenue forecast unchanged from US$0 at last update. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$23.50 unchanged from last update. Share price was steady at US$2.05 over the past week. New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$22m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Revenue is less than US$1m (US$8.0k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$19m net loss in 3 years). Shareholders have been diluted in the past year (31% increase in shares outstanding). Market cap is less than US$100m (US$73.2m market cap). Aankondiging • Jun 18
Genelux Corporation, Annual General Meeting, Aug 01, 2024 Genelux Corporation, Annual General Meeting, Aug 01, 2024. Aankondiging • May 25
Genelux Corporation has completed a Follow-on Equity Offering in the amount of $27.5 million. Genelux Corporation has completed a Follow-on Equity Offering in the amount of $27.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,875,000
Price\Range: $4
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 6,875,000 Aankondiging • May 24
Genelux Corporation has filed a Follow-on Equity Offering. Genelux Corporation has filed a Follow-on Equity Offering.
Security Name: Ordinary Shares
Security Type: Common Stock
Security Name: Warrants
Security Type: Equity Warrant Reported Earnings • May 10
First quarter 2024 earnings released: US$0.29 loss per share (vs US$0.53 loss in 1Q 2023) First quarter 2024 results: US$0.29 loss per share (improved from US$0.53 loss in 1Q 2023). Net loss: US$7.85m (loss narrowed 24% from 1Q 2023). Revenue is forecast to grow 73% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Recent Insider Transactions • Apr 19
Insider recently sold US$256k worth of stock On the 17th of April, Aladar Szalay sold around 71k shares on-market at roughly US$3.59 per share. This transaction amounted to 1.7% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$13m more than they bought in the last 12 months. New Risk • Apr 17
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$93.0m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$170k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$39m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (9.6% increase in shares outstanding). Market cap is less than US$100m (US$93.0m market cap). Price Target Changed • Apr 03
Price target decreased by 23% to US$26.00 Down from US$33.75, the current price target is an average from 4 analysts. New target price is 435% above last closing price of US$4.86. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$0.82 next year compared to a net loss per share of US$1.16 last year. Reported Earnings • Mar 31
Full year 2023 earnings: EPS and revenues miss analyst expectations Full year 2023 results: US$1.16 loss per share (further deteriorated from US$0.57 loss in FY 2022). Net loss: US$28.3m (loss widened 443% from FY 2022). Products in clinical trials Phase I: 3 Phase III: 1 Revenue missed analyst estimates by 4.2%. Earnings per share (EPS) also missed analyst estimates by 6.7%. Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Recent Insider Transactions Derivative • Dec 17
Insider notifies of intention to sell stock Yong Yu intends to sell 33k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of December. If the sale is conducted around the recent share price of US$13.16, it would amount to US$428k. Since March 2023, Yong's direct individual holding has decreased from 150.00k shares to 32.54k. Company insiders have collectively sold US$13m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Dec 10
Insider recently sold US$436k worth of stock On the 7th of December, Yong Yu sold around 37k shares on-market at roughly US$11.85 per share. This transaction amounted to 53% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$1.9m. Insiders have been net sellers, collectively disposing of US$12m more than they bought in the last 12 months. Recent Insider Transactions • Nov 24
Insider recently sold US$210k worth of stock On the 20th of November, Yong Yu sold around 18k shares on-market at roughly US$11.60 per share. This transaction amounted to 17% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$1.9m. Insiders have been net sellers, collectively disposing of US$12m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Nov 20
Insider notifies of intention to sell stock Yong Yu intends to sell 37k shares in the next 90 days after lodging an Intent To Sell Form on the 17th of November. If the sale is conducted around the recent share price of US$13.02, it would amount to US$479k. Since March 2023, Yong's direct individual holding has decreased from 150.00k shares to 106.14k. Company insiders have collectively sold US$12m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Oct 27
Insider recently sold US$998k worth of stock On the 23rd of October, Aladar Szalay sold around 50k shares on-market at roughly US$19.97 per share. This transaction amounted to 1.2% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger sale worth US$1.9m. Insiders have been net sellers, collectively disposing of US$11m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Oct 26
Insider notifies of intention to sell stock Yong Yu intends to sell 5k shares in the next 90 days after lodging an Intent To Sell Form on the 24th of October. If the sale is conducted around the recent share price of US$19.42, it would amount to US$101k. Since December 2022, Yong's direct individual holding has decreased from 150.00k shares to 106.14k. Company insiders have collectively sold US$11m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Oct 12
Insider notifies of intention to sell stock Yong Yu intends to sell 5k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of October. If the sale is conducted around the recent share price of US$23.79, it would amount to US$124k. Since December 2022, Yong's direct individual holding has decreased from 150.00k shares to 106.14k. Company insiders have collectively sold US$11m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Sep 15
Genelux Corporation Elects John Smither as Class I Director Genelux Corporation announced that at its 2023 Annual Meeting of Stockholders held on September 11, 2023, elected John Smither as Class I Director, to serve until the Company’s 2026 Annual Meeting of Stockholders or until his successor is duly elected and qualified or until his earlier death, resignation or removal. Recent Insider Transactions • Sep 13
Insider recently sold US$879k worth of stock On the 8th of September, Aladar Szalay sold around 37k shares on-market at roughly US$23.57 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$1.8m more than they bought in the last 12 months. New Risk • Sep 12
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$15m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$15m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$35m net loss in 3 years). Significant insider selling over the past 3 months (US$915k sold). Recent Insider Transactions • Aug 31
Insider recently sold US$489k worth of stock On the 30th of August, Yong Yu sold around 20k shares on-market at roughly US$24.70 per share. This transaction amounted to 13% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$914k more than they bought in the last 12 months. Aankondiging • Aug 30
Genelux Corporation Announces Executive Changes On August 28, 2023, Genelux Corporation announced the appointment of Lourie Zak as the Company’s Chief Financial Officer and the designation of Ms. Zak as the Company’s principal financial officer and principal accounting officer, in each case effective as of August 28, 2023 (the “Effective Date”). In connection with Ms. Zak’s appointment to the position of Chief Financial Officer, and as of the Effective Date, Thomas Zindrick, the Company’s President and Chief Executive Officer, will no longer serve as the Company’s principal financial officer, and Doug Samuelson, the Company’s former Chief Financial Officer, will no longer serve as the Company’s principal accounting officer. Ms. Zak, 60, most recently served as an Executive Consultant for CFO Assignments from March 2015 to August 2023. Ms. Zak previously served as the Chief Financial Officer of Guitar Center Brands of Guitar Center Inc. from October 2014 to January 2015 and the Chief Financial Officer of SONIFI Solutions Inc. from February 2013 to October 2014. Pursuant to the terms of Ms. Zak’s employment agreement (the “Zak Employment Agreement”), effective as of the Effective Date, Ms. Zak’s employment may be terminated at-will by either party, with or without notice, subject to the terms of the Zak Employment Agreement. Ms. Zak will receive a base salary of $360,000 per year and be eligible for an annual discretionary bonus with a target amount of up to 40% of her then-current base salary based on the achievement of certain performance goals determined by the Board of Directors of the Company. Subject to approval by the Board of Directors of the Company, Ms. Zak will be issued an option to purchase 150,000 shares of common stock of the Company with a per share exercise price equal to the fair market value on the date of grant (the “Option”). The shares subject to the Option will vest over four years of continuous service to the Company, with 25% of the shares subject to the Option vesting on the first-year anniversary of the Effective Date, and the remaining shares vesting in equal monthly installments over the subsequent 36 months of continuous service thereafter. In the event of a change in control, as defined in the Company’s 2022 Equity Incentive Plan, and subject to Ms. Zak’s continuous service through such change in control, 100% of the shares subject to the unvested portion of the Option will accelerate and vest in full. The Option shall be governed in all respects by the terms of the Company’s 2022 Equity Incentive Plan, as amended, and the option agreement between Ms. Zak and the Company. Ms. Zak will be entitled to receive severance benefits in the event her employment is terminated by the Company without cause or if she resigns for good reason, provided she remains in compliance with the terms of the Zak Employment Agreement. In the event of such termination or resignation, Ms. Zak will receive (i) severance in a lump sum equal to twelve months of her then-current base salary plus her full target annual bonus for the calendar year in which such separation occurs (but only in connection with a separation occurring during the period beginning three months before and ending 18 months following a change in control), and (ii) up to twelve months of COBRA group health insurance continuation. The foregoing severance benefits are conditioned upon Ms. Zak signing and not revoking a separation agreement and release of claims by no later than the 60th day after the employment termination. Recent Insider Transactions • Aug 24
Chairman recently sold US$198k worth of stock On the 18th of August, Thomas Zindrick sold around 8k shares on-market at roughly US$23.73 per share. This transaction amounted to 36% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Thomas' only on-market trade for the last 12 months. Recent Insider Transactions Derivative • Aug 21
Chairman notifies of intention to sell stock Thomas Zindrick intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 17th of August. If the sale is conducted around the recent share price of US$23.90, it would amount to US$200k. Since September 2022, Thomas has not owned shares directly (This sale likely refers to shares that have not yet been received). There has only been one transaction (US$1.2k purchase) from insiders over the last 12 months. New Risk • Aug 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 9.2% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$17m net loss in 2 years). Aankondiging • Jul 23
Genelux Corporation, Annual General Meeting, Sep 11, 2023 Genelux Corporation, Annual General Meeting, Sep 11, 2023, at 10:00 Pacific Standard Time. Location: 4500 Riverwalk Pkwy Riverside United States Agenda: To elect the one Class I director to hold office until the Company's 2026 annual meeting of stockholders and until his successor is duly elected and qualified, or until his earlier death, resignation or removal; to ratify the selection by the Audit Committee of the Board of Directors of Weinberg & Company, P.A. as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2023; and to conduct any other business properly brought before the Annual Meeting. Aankondiging • Jul 16
Genelux Notifies the Nasdaq Stock Market that it Was Not in Compliance with Nasdaq Listing Rule 5605(c)(2)(A) Genelux Corporation announced that due to the vacancy resulting from Mr. Gabe Woodward's resignation, the Audit Committee of the Board is now comprised of two independent directors. As a result, on July 12, 2023, the Company notified The Nasdaq Stock Market LLC (Nasdaq") that it was not in compliance with Nasdaq Listing Rule 5605(c)(2)(A) (the Rule"), which requires an audit committee comprised of at least three members, each of whom must satisfy the requirements for audit committee members under the Nasdaq Listing Rules and the Securities Exchange Act of 1934, as amended. The Company expects to receive a letter from Nasdaq to formally notify the Company of its non-compliance with the Rule. The Company intends to rely on the cure provision in Nasdaq Listing Rule 5605(c)(4)(B), and intends to regain compliance with the Rule prior to the expiration of the applicable cure period specified in Nasdaq Listing Rule 5605(c)(4)(B). Aankondiging • Jul 15
Genelux Announces Resignation of Gabe Woodward from the Board On July 10, 2023, Gabe Woodward notified the board of directors (the “Board”) of Genelux Corporation (the “Company”) of his decision to resign from the Board, effective July 12, 2023. Mr. Woodward’s resignation was made in the normal course of business at the request of his partnership now that the Company’s initial public offering has been completed, and was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Aankondiging • Jul 11
Genelux Corporation Announces Publication of Phase I Trial Results of Intrapleural Administration of Olvi-Vec in Patients with Malignant Pleural Effusion from Mesothelioma, Lung or Breast Cancers in Frontiers in Frontiers in Immunology Genelux Corporation announced the publication in Frontiers in Immunology of positive results from a Phase 1 trial exploring intrapleural delivered Olvi-Vec in patients with malignant pleural effort (MPE) due to either MPM or metastatic disease (non-small cell lung cancer or breast cancer). The study was completed at Memorial Sloan Kettering Cancer Center, New York, investigated the safety, feasibility and immune activating effects of Olvi-Vec by intrapleural administration. Documented Olvi-Vec infection of tumor cells, which was also associated with reduction in tumor cell density and increase in immune cell density, confirming the mechanism of action of both direct cytotoxic and immune-activating effects. Among all patients, median overall survival (OS) was 19.5 months. The median OS among patients who had malignant pleural mesothelioma (MPM) was 22 months. There were no dose-limiting toxicities or dose de-escalations, and the maximally tolerated dose was not reached. Therefore, a recommended dose was not established. Palliative interventions have traditionally been relied upon for alleviating symptoms and preventing the recurrence of MPE, which can disrupt cancer treatments for MPE patients. However, the effectiveness of systemic immune checkpoint inhibitor therapy, chemotherapy, or a combination of therapies in MPE patients has shown limited success. This Phase 1 clinical trial enrolled eighteen MPE patients [MPM (n=15), and metastatic breast or lung diseases (n=3), who underwent a dose escalating method of intrapleural administration of Olvi-Vec following drainage of MPE. The primary objective of this trial was to determine a recommended dose. The secondary objectives were to assess feasibility, safety and tolerability; evaluate viral presence in the tumor and serum as well as viral shedding in pleural fluid, sputum, and urine; and evaluate anti-vaccinia virus immune response. Treatment with Olvi-Vec at the dose of 1x107 plaque-forming units (PFU) to 6x109 PFU was feasible and safe, with no treatment-associated mortalities or dose-limiting toxicities. Olvi-Vec was detectable in tumor cells 2-5 days post-treatment, and treatment was associated with a decrease in tumor cell density and an increase in immune cell density as assessed by a pathologist blinded to the clinical observations. When matched tumor specimens were compared (n=4), tumor cell density score decreased from pre-treatment to post-treatment in all patients. Immune cell density score increased from pre-treatment to post-treatment in 3 of 4 patients. Aankondiging • Jun 30
Genelux Corporation and TVAX Biomedical, Inc. Announces the Issuance of A United States Patent Covering the Combination of an Adoptive T Cell Therapy/Oncolytic Viral Cancer Treatment Genelux Corporation and TVAX Biomedical, Inc. announced that the United States Patent and Trademark Office granted a patent claims methods of combining vaccine-enhanced adoptive T cell therapy with oncolytic virus adjunct therapy. The patent has been exclusively licensed to V2ACT Therapeutics, LLC, a joint venture between Genelux and TVAX that was established for the purpose of developing and testing V2ACT Immunotherapy. The patent expiry, prior to any patent term extension, will be in 2036 and will add substantial intellectual property protection for V2ACT Immunotherapy. The rationale for V2ACT Immunotherapy stems from compelling scientific evidence that vaccination generates an immune response which increases the number of neoantigen-specific T cells in the body and that Olvi-Vec induces an acute inflammatory response that increases cancer tissue receptivity for the clinical effects of adoptively transferred neoantigen-specific effector T cells. This generates compelling support for the view that V2ACT Immunotherapy may safely achieve superior efficacies against a wide range of cancers. V2ACT capitalizes on the lead assets of both Genelux and TVAX as a combination therapy. Olvi-Vec has demonstrated systemic immunomodulation, an excellent safety profile, powerful immune modulation of the cancer microenvironment and well-documented anti-cancer effects over a wide range of cancers both in preclinical and Phase 2 clinical trials. TVAX Immunotherapy provides a unique neoantigen-specific adoptive T cell therapy, with an excellent safety profile and powerful anti-cancer effects on a wide range of cancers demonstrated in preclinical and Phase 2 clinical trials. Aankondiging • May 16
Genelux Corporation announced that it expects to receive $33.30494 million in funding Genelux Corporation announced a private placement to issue1,665,247 common shares at a price of $20.00 per share for the gross proceeds of approximately $33.30494 million. The initial closing of the private placement, in the amount of approximately $18 million in the aggregate, is expected to occur on or about May 19, 2023, subject to the satisfaction of customary closing conditions. Additional committed funds in the amount of approximately $15 million in the aggregate will be invested on or before November 15, 2023, at the same price as the initial closing investments. Aankondiging • Jan 27
Genelux Corporation has completed an IPO in the amount of $15 million. Genelux Corporation has completed an IPO in the amount of $15 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,500,000
Price\Range: $6
Discount Per Security: $0.42