Genelux Corporation Reports Encouraging Interim Data of Systemic Administration of Olvi-Vec in Ongoing Lung Cancer Trials

Rhea-AI Summary

Genelux (NASDAQ: GNLX) reported interim systemic Olvi-Vec data from ongoing lung cancer trials as of December 2025. In Phase 1b/2 SCLC (9 evaluable patients) the overall response rate was 33% (3/9), with two partial responses in the highest tested dose cohort showing ~55% and ~85% tumor shrinkage; disease control rate was 67% (6/9). In Phase 2 VIRO-25 NSCLC (5 evaluable patients) disease control rate was 60% (3/5) with tumor changes of +8.9%, -18.9%, and -22.7%. Olvi-Vec was reported as generally well tolerated. Additional lung cancer readouts and Phase 3 ovarian topline data expected throughout 2026.

Positive

• SCLC ORR of 33% (3/9)
• SCLC DCR of 67% (6/9)
• Cohort 4 tumor shrinkage of ~55% and ~85%
• NSCLC DCR of 60% (3/5)
• Durable PFS signals: 12.1 months and 7.7 months

Negative

• Small sample sizes: 9 SCLC and 5 NSCLC evaluable patients
• Early interim data; results remain preliminary
• No maintenance immunotherapy given, limiting durability assessment

News Market Reaction – GNLX

-23.52% 4.7x vol

30 alerts

-23.52% News Effect

+2.7% Peak Tracked

-30.3% Trough Tracked

-$58M Valuation Impact

$190M Market Cap

4.7x Rel. Volume

On the day this news was published, GNLX declined 23.52%, reflecting a significant negative market reaction. Argus tracked a peak move of +2.7% during that session. Argus tracked a trough of -30.3% from its starting point during tracking. Our momentum scanner triggered 30 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $58M from the company's valuation, bringing the market cap to $190M at that time. Trading volume was very high at 4.7x the daily average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

SCLC ORR: 33% (3/9 patients) SCLC DCR: 67% (6/9 patients) NSCLC DCR: 60% (3/5 patients) +5 more

8 metrics

SCLC ORR 33% (3/9 patients) Phase 1b/2 SCLC systemic Olvi-Vec dose-escalation cohorts

SCLC DCR 67% (6/9 patients) Phase 1b/2 SCLC systemic Olvi-Vec trial

NSCLC DCR 60% (3/5 patients) Phase 2 VIRO-25 NSCLC systemic Olvi-Vec trial

Progression-free survival 12.1 months PR patient with 1 prior line in SCLC trial (long-term follow-up)

Cash balance $21.0 million As of Sept 30, 2025 per Q3 2025 10-Q

Net loss $7.95 million Q3 2025 per 10-Q filing

Underwritten offering size 3,000,000 shares at $3.50 March 2025 equity raise, $9.6 million net proceeds

Short interest 5.56% Reported short percent of float

Market Reality Check

Price: $2.70 Vol: Volume 73,012 is below 20...

normal vol

$2.70 Last Close

Volume Volume 73,012 is below 20-day average of 104,692, suggesting modest trading interest pre-news. normal

Technical Price $4.55 is trading above the 200-day MA $3.86, indicating a pre-existing upward bias.

Peers on Argus

Peers show mixed moves: ONCY up 8.1%, IOBT up 9.6%, while AVTX and CRDF are down...

1 Up

Peers show mixed moves: ONCY up 8.1%, IOBT up 9.6%, while AVTX and CRDF are down. GNLX’s 4.36% gain appears more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Nov 26 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 26	Conference participation	Neutral	+5.7%	Announced participation in Piper Sandler healthcare conference with webcast access.
Nov 05	Earnings update	Negative	-3.3%	Reported Q3 2025 loss and limited cash runway alongside pipeline timing updates.
Sep 02	Conference participation	Neutral	-1.8%	Detailed fireside chat and investor meetings at H.C. Wainwright conference.
Aug 07	Earnings update	Negative	-5.7%	Q2 2025 loss and cash runway commentary with continued trial spending.
Jul 07	Management change	Positive	-2.7%	Appointed new General Counsel and business development head with sector experience.

Pattern Detected

News reactions have mostly aligned with fundamentals, with negative or dilutive signals often followed by share price weakness.

Recent Company History

Over the past six months, Genelux has combined steady clinical progress with financing and governance moves. Earnings reports in Q2 and Q3 2025 highlighted ongoing losses and limited cash runway but also advanced the Olvi-Vec pipeline toward key 2026 readouts. Management strengthened the leadership team and maintained conference visibility. Today’s lung cancer interim data fit the pattern of incremental clinical updates that have become central to the company’s story ahead of Phase 3 ovarian results in 2026.

Market Pulse Summary

The stock dropped -23.5% in the session following this news. A negative reaction despite positive lu...

Analysis

The stock dropped -23.5% in the session following this news. A negative reaction despite positive lung cancer signals would fit a pattern where financing needs and losses weigh on sentiment. The company reported a Q3 2025 net loss of $7.95 million and prior equity dilution via a 3,000,000-share offering. Even with SCLC ORR of 33% and NSCLC DCR of 60%, concerns about runway, past going concern language, and insider sales could have amplified downside pressure after the update.

Key Terms

overall response rate, disease control rate, progression-free survival, immune checkpoint inhibitor, +4 more

8 terms

overall response rate medical

"Overall response rate (ORR) of 33% (3/9 patients), including three PRs"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

disease control rate medical

"Disease control rate (DCR) of 67% (6/9 patients)"

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

progression-free survival medical

"achieved a PR with an ongoing progression-free survival (PFS) of 12.1 months"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

immune checkpoint inhibitor medical

"in combination with platinum chemotherapy and an immune checkpoint inhibitor (ICI)"

An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.

platinum-based chemotherapy medical

"resensitize tumors to platinum-based chemotherapy across multiple solid tumor types"

A class of cancer drugs that contain a form of the metal platinum and work by damaging tumor cells’ DNA so they can’t divide, which leads to cell death. Investors watch platinum‑based chemotherapy because it is a backbone treatment for many cancers, so clinical trial results, safety profiles, generic competition, manufacturing supply and patent status can strongly affect drug sales, company valuations and partnership or acquisition prospects.

phase 3 medical

"topline data from Phase 3 ovarian cancer trial (OnPrime/GOG-3076)"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

restricted stock units financial

"received 10,000 restricted stock units that vest over time"

Restricted stock units are a type of company reward where employees are promised shares of stock, but they only fully own these shares after meeting certain conditions, like staying with the company for a set time. They matter because they can become valuable assets and are often used to motivate employees to help the company succeed.

underwritten offering financial

"completed a March 2025 underwritten offering of 3,000,000 shares at $3.50"

An underwritten offering is when a bank or group of banks agrees to buy all of a company's new shares or bonds and then resell them to outside investors, guaranteeing the company will raise a specific amount of money. It matters to investors because it adds certainty that the funding will close while increasing the number of shares or debt in the market, which can lower the price per share and change each existing owner's ownership percentage—think of a wholesaler buying an entire shipment from a maker before it reaches stores.

AI-generated analysis. Not financial advice.

-- Interim data from 14 patients with progressive lung cancers in dose-escalation cohorts of systemically administered Olvi-Vec-primed immunochemotherapy across ongoing SCLC and NSCLC trials; enrollment ongoing –

-- In platinum-relapsed or platinum-refractory advanced SCLC, two of three partial responses (PRs) occurred in the highest dose cohort tested as of the data review cutoff date (tumor shrinkage of ~55% and ~85%), with three PRs out of nine subjects (33%) across all dose cohorts; observed durable response signals and treatment tolerability (Phase 1b/2 SCLC) --

-- In advanced or metastatic recurrent NSCLC, observed anti-tumor activity in initial dose cohort and Olvi-Vec generally well tolerated (Phase 2 VIRO-25) --

-- Additional systemic lung cancer data expected throughout 2026, alongside topline data from Phase 3 ovarian cancer trial (OnPrime/GOG-3076) in second half of 2026 --

WESTLAKE VILLAGE, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today 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.

“We are encouraged by the emerging data from our lung cancer programs, where systemically delivered Olvi-Vec continues to demonstrate promising anti-tumor activity and tolerability in patients with relapsed or refractory lung cancers,” said Thomas Zindrick, President, CEO, and Chairman of Genelux. “While these data remain preliminary, they reinforce our commitment to advancing two registration-path trials in progressive lung cancers, addressing a significant unmet medical need and building on our success in platinum-resistant/refractory ovarian cancer. We remain focused on establishing Olvi-Vec as a differentiated immunotherapeutic agent designed to modify the tumor microenvironment and resensitize tumors to platinum-based chemotherapy across multiple types of cancer. Looking ahead, 2026 will be a pivotal year with topline data from the Phase 3 registration trial in ovarian cancer expected in the second half and additional lung cancer trial readouts anticipated throughout the year.”

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
  
  

About Olvi-Vec

Olvi-Vec (olvimulogene nanivacirepvec), Genelux’s lead investigational asset, is a proprietary, modified vaccinia virus being evaluated as an oncolytic immunotherapy. Olvi-Vec’s differentiated mechanism of action (MoA) is designed to directly kill cancer cells, stimulate a tumor-specific immune response, remodel the tumor microenvironment, and resensitize tumors to platinum-based chemotherapy with or without ICIs. Genelux is developing Olvi-Vec immunotherapy for multiple cancer types in a strategically integrated program based on robust preclinical data and clinical evidence of its differentiated MoA, feasibility of repeat dosing and a dose-dependent overall survival benefit in cancer patients with primary or metastatic lung diseases. To date, Olvi-Vec has been administered to more than 150 patients across seven completed clinical trials, where Olvi-Vec has been generally well tolerated and demonstrated clinically meaningful benefits. Genelux has granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan).

About Genelux Corporation

Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Olvi-Vec is currently being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer; and VIRO-25, a multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in NSCLC. Additionally, Olvi-Vec is currently being evaluated for dose selection in Olvi-Vec-SCLC-202, a China-based, multi-center, open-label Phase 1b/2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet in progressive SCLC. The core of Genelux's discovery and development efforts revolves around its proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “potential,” “expected,” “anticipated,” “look forward,” or “aim.” Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, the potential capabilities advantages, safety, tolerability, activity and efficacy of Olvi-Vec, including the potential of Olvi-Vec to resensitize tumors to frontline platinum therapy; the potential for the ongoing Phase 1b/2 SCLC and Phase 2 VIRO-25 trials to support the systemic route of delivery program of Olvi-Vec; the potential for positive data, including the interim data reported to date from systemic administration lung cancer trials to further validate Genelux’s oncolytic immunotherapy platform; the potential regulatory requirements and approval pathway of Olvi-Vec; and the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Investor Contact

Austin Murtagh
Precision AQ
austin.murtagh@precisionaq.com

Media Contact

Ashley Murphy
Precision AQ
ashley.murphy@precisionaq.com

Source: Genelux Corporation

FAQ

What were the SCLC interim results for Genelux (GNLX) as of Dec 23, 2025?

In 9 evaluable SCLC patients Genelux reported an ORR 33% (3/9) and DCR 67% (6/9), with two PRs in the highest tested dose cohort.

What tumor shrinkage was observed in the highest SCLC dose cohort for GNLX?

Two partial responses in the highest tested cohort showed approximately 55% and 85% tumor shrinkage from baseline.

What were the interim NSCLC (VIRO-25) results for Genelux (GNLX) as of Dec 31, 2025?

In 5 evaluable NSCLC patients the trial reported a DCR 60% (3/5) with tumor changes of +8.9%, -18.9%, and -22.7% versus baseline.

Were there any durability signals reported in Genelux (GNLX) SCLC data?

Yes; two PR patients had PFS of 12.1 months and 7.7 months in long-term follow-up.

Is Olvi-Vec systemically administered and tolerable in these trials for GNLX?

The company reported systemic (intravenous) Olvi-Vec was generally well tolerated in initial dose-escalation cohorts.

When will Genelux (GNLX) report additional lung cancer and ovarian trial data in 2026?

Additional lung cancer interim readouts are expected throughout 2026 and Phase 3 ovarian topline data is expected in the second half of 2026.