GNLX US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-K

For

the fiscal year ended December 31, 2025

OR

For

the transition period from to

Commission

file number 001-41599

GENELUX

CORPORATION

(Exact

name of registrant as specified in its charter)

(State or other jurisdiction of (I.R.S. Employer

incorporation or organization) Identification No.)

2625

Townsgate RoadSuite 230

Westlake

VillageCA91361

(Address

of principal executive offices)

(Zip

Code)

(805)267-9889

(Registrant’s

telephone number, including area code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value $0.001 per share GNLX The Nasdaq Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

☐ ☐ ☒ ☒

☒

Emerging growth company

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the Registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the Registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The

aggregate market value of the registrant’s voting and non-voting outstanding common stock held by non-affiliates was approximately

$89.1 million, based upon the closing price of the registrant’s common stock on June 30, 2025.

As

of March 16, 2026, 44,805,811 shares of registrant’s Common Stock were issued and outstanding.

DOCUMENTS

INCORPORATED BY REFERENCE

The

registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended

December 31, 2025. Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form

10-K.

Table

of Contents

Page No.

PART I

Item 1. Business 2

Item 1A. Risk Factors 27

Item 1B. Unresolved Staff Comments 97

Item 1C. Cybersecurity 97

Item 2. Properties 98

Item 3. Legal Proceedings 98

Item 4. Mine Safety Disclosures 98

PART II

Item 6. Reserved 99

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 111

Item 8. Financial Statements and Supplementary Data 111

Item 9A. Controls and Procedures 111

Item 9B Other Information 112

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 112

PART III

Item 10. Directors, Executive Officers and Corporate Governance 113

Item 11. Executive Compensation 113

Item 14. Principal Accountant Fees and Services 113

PART IV

Item 15. Exhibits and Financial Statement Schedules 114

i

FORWARD-LOOKING

STATEMENTS

This

Annual Report on Form 10-K (Annual Report) contains certain 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 we intend that such forward-looking

statements be subject to the safe harbors created thereby. All statements other than statements of historical facts contained in this

Annual Report, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors

that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements

expressed or implied by the forward-looking statements.

Forward-looking

statements contained in this Annual Report include statements regarding:

● expectations regarding the size, scope and design of clinical studies;

● our manufacturing, commercialization, and marketing plans and strategies;

● our expectations regarding the approval and use of our product candidates;

● our future financial performance;

● our expected use of net proceeds from our financing transactions;

● the impact of laws and regulations;

● the impact of geopolitical and macroeconomic factors; and

In

some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,”

“expect,” “plan,” “anticipate,” “could,” “intend,” “target,”

“project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential”

or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Annual

Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about

future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking

statements speak only as of the date of this Annual Report and are subject to a number of risks, uncertainties and assumptions described

under “Item 1A. Risk Factors” of Part I and “Item 7. Management’s Discussion and Analysis of Financial Condition

and Results of Operations” of Part II of this Annual Report. Because forward-looking statements are inherently subject to risks

and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these

forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements

may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover,

we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management

to predict all risk factors and uncertainties. Except as required by applicable law, we undertake no obligation to publicly update or

revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances

or otherwise. Readers should carefully review these risks, as well as the additional risks described in other documents we file from

time to time with the Securities and Exchange Commission (the SEC). Statements made herein are as of the date of the filing of this Annual

Report with the SEC and should not be relied upon as of any subsequent date. In addition, statements that “we believe” and

similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us

as of the date of this Annual Report, and while we believe such information provides a reasonable basis for these statements, such information

may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review

of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely

on these statements.

ii

SUMMARY

OF RISKS ASSOCIATED WITH OUR BUSINESS

We

face many risks and uncertainties, as more fully described in under Part I, Item 1A, “Risk Factors” in this Annual Report.

Some of these risks and uncertainties are summarized below. The summary below does not contain all of the information that may be important

to you, and you should read this summary together with the more detailed discussion of these risks and uncertainties contained in “Risk

Factors.” Some of the material risks associated with our business include the following:

PART

I

Item

1. BUSINESS

A.

Overview

Genelux

is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic viral immunotherapies for patients

suffering from aggressive and/or difficult-to-treat tumor types. Our clinical and preclinical product candidates are intended to selectively

kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens. Importantly, our oncolytic immunotherapy

product candidates are “off-the-shelf” personalized immunotherapies. In other words, while we administer the same virus product

to different patients, the cellular immune response generated is expected to be specific to the unique neoantigens in that patient. Our

lead product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable

DNA virus with a large engineering capacity.

Employing

our proprietary selection technology and discovery and development platform (CHOICE), we have developed an extensive library of isolated

and engineered oncolytic VACV immunotherapeutic product candidates. These provide potential utility in multiple tumor types in both the

monotherapy and combination therapy settings, via physician-preferred administration techniques, including regional (e.g., intraperitoneal),

local and systemic (e.g., intravenous) delivery routes. Informed by our CHOICE platform and supported by extensive clinical and preclinical

data, we believe we have the capacity to develop a pipeline of treatment options to address high unmet medical needs for those patients

with insignificant or unsatisfactory responses to standard-of-care therapies, including chemotherapies.

We

are executing a late-stage clinical program of our lead product candidate, Olvi-Vec, to demonstrate platinum-resensitization in multiple

indications. We are currently evaluating Olvi-Vec in three clinical trials:

The

Phase 3 registrational trial, called the OnPrime/GOG-3076 trial, is evaluating the administration of Olvi-Vec intraperitoneally to treat

patients with PRROC. The Phase 2 NSCLC trial, called the VIRO-25 trial, and the Phase 1b/2 SCLC trial are evaluating Olvi-Vec administered

systemically (i.e., intravenously) to treat patients with recurrent NSCLC and SCLC, respectively. Our development of Olvi-Vec is discussed

in more detail in the Development Programs section below.

In

September 2021, we entered into a License Agreement (the Newsoara License Agreement) with Newsoara BioPharma Co. Ltd. In October

2025, Newsoara BioPharma Co. Ltd. assigned all of its rights and obligations under the Newsoara License Agreement to an affiliate,

Newsoara HYK Biopharmaceuticals Co., Ltd. We refer herein to the counterparty to the Newsoara License Agreement as Newsoara.

Pursuant to the Newsoara License Agreement, we granted Newsoara an exclusive license to research, develop, commercialize or exploit

Olvi-Vec in China, which includes mainland China, Taiwan, Hong Kong and Macau, for all human diagnostic, prophylactic and

therapeutic uses (the Newsoara Field). The Newsoara License Agreement is discussed in more detail in the Newsoara License

Agreement section below.

We

have a facility in San Diego, California for current Good Manufacturing Practice (cGMP) manufacturing. The facility is producing cGMP

material that is being used in our ongoing clinical trials in the U.S. and China and that we intend to use in additional clinical trials

of Olvi-Vec and for the initial commercial launch of Olvi-Vec, if approved. We also lease a second building in the same location which,

when upgrades are completed, will provide laboratory capabilities and administrative offices.

B.

Pipeline

Our

pipeline is summarized below:

C.

Strategy

Our

strategy is to leverage our deep internal capabilities in the clinical development of oncolytic viruses to create a leading immunotherapy

company, discovering, developing and commercializing next-generation products for the treatment of a broad range of cancers, initially

solid tumors, many of which are among the most difficult cancers to treat. We are focused on the execution and success of our clinical

programs and, over time, on building our organization into a fully-integrated therapeutics company. Key elements of our strategy include:

The

Genelux Approach

Oncolytic

VACV

Olvi-Vec

utilizes VACV as the backbone of our proprietary CHOICE discovery platform. VACV is a member of the Orthopoxvirus genus and contains

a single linear DNA genome.

Our

proprietary CHOICE discovery platform is designed to allow us to develop new product candidates rapidly from conception through the initiation

of clinical trials. The discovery platform is based on our collection of various strains of VACV based on multiple selection criteria,

both in vitro (e.g., viral replication rate, plaque size, transgene expression efficiency, etc.) and in vivo (e.g., viral titer, antitumor

activities, safety, etc.).

We

have generated an extensive portfolio of oncolytic vaccinia immunotherapy clinical candidates, of which, Olvi-Vec is the furthest along

in clinical development. In addition to Olvi-Vec, we have over 500 different versions of the VACV armed with greater than 110 transgenes,

having a variety of engineered attributes, including immune modulatory and tumor cell killing properties.

Our

oncolytic immunotherapy product candidates are intended to selectively kill tumor cells and induce a robust immune response against a

patient’s tumor neoantigens. Importantly, these product candidates are “off-the-shelf” personalized immunotherapies.

In other words, while we administer the same virus product to different patients, the cellular immune response generated is expected

to be specific to the unique neoantigens in that patient.

Olvi-Vec

Our

current development focus is on our lead product candidate, Olvi-Vec (USAN: olvimulogene nanivacirepvec; laboratory name: GLV-1h68; previously

known as GL-ONC1), a genetically stable, attenuated Lister-Institute of Viral Preparations (LIVP) strain of VACV. We modified the LIVP

strain by integrating three foreign gene expression cassettes—Ruc-GFP (a fusion gene of Renilla luciferase

and green fluorescent protein); LacZ (ß-galactosidase gene from E. coli); and gusA (ß- glucuronidase

from E. coli)—to selectively disrupt non-essential vaccinia genes (F14.5L, thymidine kinase (TK), and hemagglutinin

(HA) loci, respectively).

We

are developing Olvi-Vec for the treatment of multiple cancers 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 studied in multiple early- and mid-phase clinical trials via regional, and systemic deliveries,

as a monotherapy and in combination with other therapies, in seven completed clinical trials with a variety of cancer types. Those clinical

trials have yielded data that has informed our current and future clinical strategy and trial design involving multiple indications and

methods of delivery.

In

our completed clinical trials, irrespective of the route of administration, dosing regimen or cancer type, Olvi-Vec was:

● Shown to enhance chemotherapeutic activities in a combination therapy setting.

In

addition, in clinical trials in which Olvi-Vec was systemically administered, Olvi-Vec was:

● Capable of infecting tumor tissues and reducing circulating tumor cells.

Mechanism

of Action

Olvi-Vec

is a robust immune modulator that selectively replicates in tumor cells, unleashing the body’s immune system to mount a personalized

attack against cancer cells throughout the body. Olvi-Vec is believed to accomplish this by the following processes:

The

following diagram sets forth Olvi-Vec’s proposed mechanism of action.

D.

Development Programs

Platinum

Resistant/Refractory Ovarian Cancer

We

envision that Olvi-Vec-primed immunochemotherapy may overcome chemotherapy resistance for patients with end-stage ovarian cancer that

would otherwise consider palliative care or use of drugs with historically poor response rates. We initiated a Phase 3 OnPrime/GOG-3076

registration trial in PRROC in 2022. The trial is an open-label, randomized control design (2:1 randomization), enrolling patients who

are platinum resistant/refractory by standard definitions and received a minimum of 3 prior lines of therapy. The trial is designed to

address a broad and underserved pool of patients and 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).

Patients

in the experimental arm of the trial receive a single cycle (two doses) of Olvi-Vec administered intraperitoneally and, approximately

four weeks later, a regimen of a platinum-based doublet plus bevacizumab followed by maintenance therapy.

Patients

in the active comparator arm of the trial receive a regimen of single agent chemotherapy with optional platinum, plus bevacizumab followed

by maintenance therapy. Total trial enrollment will be a number of patients sufficient to achieve a primary progression-free survival

analysis (PFS) of 127 events. We anticipate reporting topline results in the second half of 2026. Additionally, in communication regarding

the Phase 3 OnPrime/GOG-3076 registrational trial in March 2025, the FDA stated that an interim analysis of overall survival (OS) should

be planned at the time of the primary PFS analysis and confirmed that if a clinically meaningful PFS advantage is demonstrated in the

absence of a decrement in OS, this could potentially support traditional approval. The FDA further recommended us to request a pre-Biologics

License Application (BLA) meeting with the FDA with topline safety and efficacy data following completion of the trial so that the FDA

may discuss next steps.

The

following graphic summarizes the study design for the Phase 3 OnPrime/GOG-3076 registration trial.

Previously,

we conducted a Phase 1b/2 clinical trial of Olvi-Vec, which was administered intraperitoneally in a single round of treatment consisting

of a bolus infusion on two consecutive days. In the Phase 1b portion of the clinical trial, patients were treated with Olvi-Vec alone,

in three dose escalation cohorts. In the Phase 2 portion of the clinical trial, we implemented a cohort designed to treat patients with

Olvi-Vec, at the dose of the first cohort in the Phase 1b portion, and approximately six weeks thereafter, patients were administered

a chemotherapy regimen consisting of a platinum-based doublet (+/- bevacizumab). Patients enrolled into the trial were heavily pretreated

(with a median of four prior lines of therapy), with confirmed progressive disease (PD) at the time of enrollment, and had PRROC, with

poor responses to conventional chemotherapies. The topline data of the Phase 2 portion was published in JAMA Oncology in May 2023.

In

the Phase 1b portion of the clinical trial, no virus- related severe organ toxicity was observed by clinical or serologic parameters,

and a maximum tolerated dose was not reached. Olvi-Vec treatment was observed to be well tolerated.

In

the Phase 2 portion of the clinical trial, data from patients who received Olvi-Vec-primed immunochemotherapy supported that there was

demonstrated responsiveness to platinum- based therapy, to which they previously were deemed resistant or refractory, leading to the

hypothesis that treatment with Olvi-Vec may re-sensitize patients to platinum-based therapies. As shown in the following figure, this

was documented by multiple efficacy evaluation endpoints (based on pre-chemotherapy baseline), such as overall response rate (ORR), as

determined by RECIST 1.1 Criteria by CT scans and GCIG CA-125 Response Criteria, and durability of responses as determined by duration

of response, PFS and OS.

Importantly,

relative to historical comparisons, the heavily pretreated patients with median 4 prior lines receiving Olvi-Vec-primed immunochemotherapy

generally showed marked clinical benefits, particularly with respect to ORR per RECIST 1.1 (54%: 19% CRs; 35% PRs) with durable response,

median PFS (11.0 months) and median OS (15.7 months). Historically, for such patients the expected ORR per RECIST 1.1 would be < 20%,

median PFS < 4 months, and median OS < 12 months. Of note, an ORR by RECIST 1.1 of 54% and median PFS of 11.4 months were achieved

in patients with platinum-refractory disease versus the historically expected ORR per RECIST 1.1 of < 10%, median PFS < 3 months;

prior to joining our trial, these patients progressed during, or within one month after, receiving their most recent prior platinum-based

therapy.

With

13 objective responders per RECIST 1.1 out of 24 evaluable patients, the trial results exceeded the pre-defined threshold of 43%, and

after our discussions with the FDA, supported moving into a Phase 3 trial.

The

majority of patients treated with Olvi-Vec-primed immunochemotherapy showed clinical benefits exceeding their own last prior line of

therapy (median PFS of 11.0 months versus 4.5 months) with preserved or improved performance status. Additionally, 20% of patients were

long-term survivors, which is generally regarded as a hallmark of clinically beneficial immunotherapies.

Systemic

Administration

We

selected recurrent lung cancers (recurrent SCLC and recurrent NSCLC) as our initial registration-path indications for intravenous delivery

of Olvi-Vec-primed immunochemotherapy because of the promising preclinical and clinical data generated in patients with lung disease

(primary or metastatic) in our prior clinical trials. We believe intravenous delivery of Olvi-Vec to the lung, unlike other viruses that

are administered locally, is particularly compelling because of the ‘first pass effect’ (i.e., after administration the virus

reaches the heart and is then first transported to the lungs). In preclinical studies, we have repeatedly observed the eradication of

distal pulmonary metastases from multiple tumor types by intravenously administered Olvi-Vec. In a previous Phase 1b trial, Olvi-Vec

demonstrated a dose-dependent overall survival benefit in heavily pre-treated solid tumor patients.

In

addition, we selected recurrent patients because of the promising preclinical and clinical data generated in recurrent ovarian cancer

patients in our Phase 2 VIRO-15 trial. Each of these trials is designed to enroll and re-challenge patients who have failed prior platinum

therapy (and, in the case of the NSCLC re-challenge patients who also failed a prior immune checkpoint inhibitor).

The

Phase 1b/2 SCLC trial and Phase 2 VIRO-25 trial are actively enrolling in dose escalation cohorts to inform dose selection for the subsequent

portion of the studies.

Non-Small

Cell Lung Cancer

In

2024, we initiated enrollment in the dose escalation portion of our Phase 2 VIRO-25 trial in the United States, prior to selecting a

dose to potentially move into an open-label, randomized, and controlled clinical trial of Olvi-Vec in patients with recurrent NSCLC (after

progression on a front-line maintenance Immune Checkpoint Inhibitor-based regimen).

The

following graphic summarizes the study design for the Phase 2 VIRO-25 trial:

In

January 2026, we announced initial interim results from the VIRO-25 trial. As of the data review cutoff date of December 31, 2025, systemic

administration of Olvi-Vec in the initial dose escalation cohorts of the trial achieved the following preliminary results:

● 5 evaluable patients

● Disease control response (DCR) of 60% (3/5 patients)

● Olvi-Vec was generally well tolerated

We

expect to report additional updated dose-finding data from this trial throughout 2026.

Small

Cell Lung Cancer

We

sponsor with Newsoara an ongoing Phase 1b/2 clinical trial of Olvi-Vec in patients with recurrent SCLC in China. The following graphic

summarizes the study design for the Phase 1b/2 trial.

A

readout of interim results in the Phase 1b portion of this trial was disclosed in the first quarter of 2025. In January 2026, we announced

additional interim results from the SCLC trial. As of the data review cutoff date of December 23, 2025, systemic administration of Olvi-Vec

in the initial dose escalation cohorts in this trial achieved the following preliminary results:

● 9 evaluable patients

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

● Olvi-Vec was generally well tolerated

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.

We

expect to report additional updated dose-finding data from this trial throughout 2026.

Additional

Potential Indications for Olvi-Vec

We

believe our preclinical and clinical data support the broad development of Olvi-Vec in patients with liquid or (metastatic) solid tumors,

as a monotherapy or in combination with other therapies. We believe that the potential to induce immune responses may represent an important

mechanism to control tumor growth, prevent the spread of tumors, improve the ability to surgically remove tumors and perhaps reduce the

need for surgery, and reduce or delay the onset of relapse.

Indications

for development will be selected from the balance of more than 20 major human cancers against which Olvi-Vec has shown activity in preclinical

studies, including blood (other leukemia/lymphoma), breast, colon, kidney, lung, prostate and skin (melanoma) cancers.

Newsoara

License Agreement

In

September 2021, we entered into the Newsoara License Agreement, pursuant to which we granted Newsoara an exclusive license to

research, develop, commercialize or exploit (i) any and all oncolytic viruses that are controlled by us, including Olvi-Vec but

excluding V-VET1 (licensed viruses); (ii) any pharmaceutical product in final form that is comprised of or contains the licensed

viruses as an active ingredient (licensed products); (iii) any virus developed by or on behalf of Newsoara that (a) has a vaccinia

virus backbone; (b) is not disclosed or covered by any of our patents; and (c) includes modifications (as compared to the licensed

viruses) of a gene function with therapeutic intent (derived molecules); and (iv) any pharmaceutical product in final form that is

comprised of or contains derived molecule as an active ingredient (derived products), in each case in mainland China, Taiwan, Hong

Kong and Macau (the Newsoara Territory) in the field of human diagnostic, prophylactic and therapeutic uses (the Newsoara Field).

The license granted to Newsoara is royalty bearing for licensed products and royalty free for derived products. Under the Newsoara

License Agreement, Newsoara granted us an exclusive and royalty bearing license to develop, commercialize and exploit outside the

Newsoara Territory any derived products developed by Newsoara.

Under

the terms of the Newsoara License Agreement and to date, we have received from Newsoara an aggregate of $11.0 million ($5.0 million as

an upfront payment and $6.0 million as a milestone payment) associated with the Newsoara License Agreement. Newsoara is obligated to

pay us additional development and commercial milestone payments up to $160.5 million in the aggregate upon the occurrence of certain

development, regulatory and commercial milestones by the licensed products, and royalties on net sales of the licensed products in the

mid-single-digit to mid-teens percentage range (the Newsoara Royalty). The Newsoara Royalty term, with respect to a licensed product

and each region in the territory, is the period beginning on the date of first commercial sale of such licensed product in such region

and ending on the last to occur of: (a) the expiration of the last to expire patent controlled by us (including any applicable patent

term extension) in such region that contains either (i) an issued valid claim that covers the licensed product (including the licensed

virus contained therein, and including the composition of matter and method of making and using thereof) or (ii) a pending valid claim

that covers the sequence of the licensed virus contained therein; (b) the 10th anniversary of the first commercial sale of such licensed

product in such region; and (c) the expiration of all regulatory exclusivity for such licensed product in such region. If we, at our

discretion, elect to develop and commercialize outside the territory any derived product developed by Newsoara, we are required to make

certain milestone and royalty payments to Newsoara.

Pursuant

to the Newsoara License Agreement, Newsoara is required to use commercially reasonable efforts to research, develop, manufacture and

commercialize the licensed products in the Newsoara Territory in the Newsoara Field and is solely responsible for all costs and

expenses incurred in connection with such activities. In addition, Newsoara is required to use commercially reasonable efforts to

conduct a multi-center Phase 2 clinical trial for Olvi-Vec in NSCLC using clinical sites in the United States and China, which is

the VIRO-25 clinical trial. Newsoara is generally obligated under the Newsoara License Agreement to fund the costs of the VIRO-25

clinical trial in the United States and China. In November 2023, we and Newsoara agreed that we would engage a clinical research

organization (CRO) to conduct certain start-up activities for the trial in the United States only, with Newsoara to reimburse us for

the costs and expenses. Pursuant to a letter of understanding (the LOU), in September 2025, we agreed with Newsoara that the CRO

would conduct additional study activities beyond startup for the VIRO-25 clinical trial in the United States and Newsoara would

reimburse us for costs and expenses related to such additional activities; however, Newsoara is permitted to defer reimbursement of

the foregoing costs and expenses until the earlier of: (i) completion of its next round of financing, or (ii) December 31,

2026.

In

November 2022, we entered into a Clinical Supply Agreement with Newsoara to manufacture and supply Olvi-Vec for Newsoara’s clinical

trials in the Newsoara Territory. We are responsible for supplying Olvi-Vec to Newsoara, and Newsoara will pay us the cost of manufacturing.

E.

Operations

Manufacturing

and Distribution

We

lease a 7,569 square-foot building in San Diego, California where we have established and equipped our own manufacturing facility in

order to secure supplies for clinical trials and commercial launch. The facility includes laboratories, production cleanrooms, and installed

equipment, to accept and prepare raw materials, and produce drug substance and drug product in accordance with cGMP and all other applicable

laws and regulations.

We

also lease a 6,755 square-foot building in the same location which, when upgrades are completed, will provide laboratory capabilities

and administrative offices.

We

maintain agreements with our raw material and component suppliers, as well as with contract laboratories to provide services such as

analytical development and validation, raw material testing, release testing of drug substance and drug product and stability testing.

We also contract with a third party for the labeling, packaging and distribution of our clinical material and expect to do so in the

future for commercial Olvi-Vec product, assuming it receives regulatory approval. We do not have long-term supply arrangements in place

with raw material and component suppliers.

Sales

and Marketing

None

of our product candidates has been approved for sale. If and when our product candidates receive marketing approval, we intend to commercialize

them on our own, or jointly with a partner, in the United States and potentially with pharmaceutical or biotechnology partners in other

geographies. We currently have no sales, marketing or commercialization capabilities and have no experience as a company performing such

activities. However, we intend to build the necessary capabilities and infrastructure over time following the advancement of our product

candidates through clinical development. Clinical data, the size of the opportunity and the size of the commercial infrastructure required

will influence our commercialization plans and decision making.

Intellectual

Property

Our

success depends upon protecting and enhancing our proprietary technologies, inventions and improvements that are believed to be important

to our business. We strive to and intend to seek, maintain and defend intellectual property rights, whether developed internally or licensed

from third parties. We rely on a combination of patent, trademark, copyright and trade secret laws in the United States and other jurisdictions

as well as confidentiality procedures and contractual provisions to protect our proprietary technology and brand.

Patents

The

U.S. patent system permits the filing of provisional and non-provisional patent applications. A provisional patent application is not

examined for patentability by the U.S. Patent and Trademark Office (USPTO), and automatically expires 12 months after its filing date.

As a result, a provisional patent application cannot mature into an issued patent. Provisional patent applications are often used, among

other things, to establish an early effective filing date for a later-filed non-provisional patent application. A non-provisional patent

application is examined by the USPTO and can mature into a patent once the USPTO determines that the claimed invention meets the standards

of patentability.

Individual

patents extend for varying periods of time depending on the date of filing of the patent application, the priority date claimed, and

the legal term of patents as determined by the applicable law in the countries in which those patents are obtained. Generally, patents

issued from applications filed in the United States are effective for 20 years from the earliest non-provisional filing date. In addition,

in certain instances, a patent term can be extended to recapture a portion of the term effectively lost as a result of the FDA regulatory

review period; however, the restoration period cannot be longer than five years and the total patent term including the restoration period

must not exceed 14 years following FDA approval. Additionally, patent term adjustments can extend the term to account for certain delays

by the USPTO during prosecution before that office. The duration of non-U.S. patents varies in accordance with provisions of applicable

local law, but typically, the life of a non-U.S. patent is 20 years from the earliest international filing date, not inclusive of any

patent term extension that may be available. The actual protection afforded by a patent varies on a product-by-product basis, from country

to country and depends upon many factors, including the type of patent, the scope of its coverage, the availability of extensions of

patent term, the availability of legal remedies in a particular country and the validity and enforceability of the patent.

National

and international patent laws concerning protein-based biologics such as our products remain highly unsettled. No consistent policy regarding

the patent eligibility or the breadth of claims allowed in patents in this field has emerged to date among the United States, Europe

or other countries. Changes in either the patent laws or in interpretations of patent laws in the United States or other countries can

diminish our ability to protect our inventions and enforce our intellectual property rights. Accordingly, we cannot predict the breadth

or enforceability of claims that may be granted in our patents or in third party patents. The biotechnology and pharmaceutical industries

are characterized by extensive intellectual property litigation. Our ability to maintain and solidify a proprietary position for our

product candidates and technology will depend on our success in obtaining effective claims in our patents and enforcing those claims

once a patent is granted. We do not know whether any of our patent applications will result in the issuance of any patents. Our issued

patents may be challenged, invalidated or circumvented, and the rights granted under any issued patents may not provide us with sufficient

protection or competitive advantages against competitors with similar technology. Furthermore, our competitors may independently develop

and commercialize similar drugs or duplicate our technology, business model or strategy without infringing our patents. Because of the

extensive time required for clinical development and regulatory review of any drug we may develop from our product candidates, it is

possible that, before any of our drugs can be commercialized, any related patent may expire or remain in force for only a short period

following commercialization, thereby reducing any advantage of any such patent.

As

of December 31, 2025, our patent portfolio consisted of 12 issued U.S. patents, 9 issued foreign patents, and 7 pending foreign patent

applications, which relate generally to the composition of our current and potential future products, their methods of use and methods of manufacture. Our issued patents are expected to expire between 2026 and 2038.

Trade

Secrets

We

rely, in part, upon trade secrets and know-how and continuing technological innovation and in-licensing opportunities to develop, strengthen

and maintain our competitive position. We seek to protect our proprietary information, in part, using confidentiality agreements with

our collaborators, employees and consultants, invention assignment agreements with our employees, and contractual protections in agreements

with third party vendors and collaborators. These agreements are designed to protect our proprietary information and, in the case of

the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party.

These agreements may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise

become known or be independently discovered by competitors. To the extent that our collaborators, employees and consultants use intellectual

property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.

Trademarks

We

believe our rights under issued and pending trademarks are important and valuable and we strive to and intend to seek, maintain and defend

our trademark rights.

“Genelux”

is the subject of issued trademark registrations in the European Union, the United Kingdom, China and in several other countries.

Our

unregistered trademarks include “CHOICE”.

Competition

The

biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis

on proprietary rights. We face significant competition from many sources, including pharmaceutical, biopharmaceutical and biotechnology

companies. Potential competitors also include academic institutions, government agencies, and other public and private research organizations

that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and

commercialization of cancer therapies. Many of our potential competitors, alone or with their strategic partners, have substantially

greater financial, technical and other resources than we do, such as larger research and development, clinical, marketing and manufacturing

organizations. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated

among a smaller number of competitors.

Competition

in cancer therapeutics comes in many forms, where different technologies are employed against different molecular targets or biological

systems. These therapies include oncolytic viral immunotherapies, immunotherapy antibodies (including monoclonal antibodies, bi-specific

antibodies, and antibody-drug conjugates), cancer vaccines, cell-based therapies, therapies aimed at activating innate immunity, and

traditional cancer therapies like chemotherapy and radiation. We are developing next-generation oncolytic viral immunotherapies for the

treatment of cancer. Any viral immunotherapies that we successfully develop and commercialize will compete with existing therapies and

new therapies that may become available in the future.

We

believe that our product candidates, if and when marketed, would largely complement rather than compete directly with existing treatment

options.

PRROC

We

are aware of numerous companies either marketing or focused on developing competing therapies for the treatment of ovarian cancer, including

PRROC:

NSCLC

We

are conducting a Phase 2 clinical trial of Olvi-Vec for the treatment of recurrent NSCLC, and have not yet initiated a registrational

trial for Olvi-Vec in NSCLC. If we complete one or more registrational trials and achieve regulatory approval of Olvi-Vec for recurrent

NSCLC, we will face competition. Besides brand and generic chemotherapies used to treat NSCLC, there are many companies already marketing

competing products for NSCLC, including large pharmaceutical and biotechnology companies like Roche/Genentech, Inc., Merck & Co.,

Astrazeneca, Novartis Pharmaceuticals Corporation, Pfizer, Inc., Johnson & Johnson, Eli Lilly & Co., and Bristol Myers Squibb.

In addition, if Olvi-Vec completes one or more registrational trials and achieves regulatory approval, we expect there to be additional

product candidates approved for NSCLC by that time which would compete with Olvi-Vec.

SCLC

We

are conducting a Phase 1b/2 clinical trial of Olvi-Vec for the treatment of recurrent SCLC, and have not yet initiated a registrational

trial for Olvi-Vec in SCLC. If we complete one or more registrational trials and achieve regulatory approval of Olvi-Vec for recurrent

SCLC, we will face competition. Besides brand and generic chemotherapies used to treat SCLC, there are many companies already marketing

competing products for SCLC, including large pharmaceutical and biotechnology companies like Amgen, Roche/Genentech, Inc., Merck &

Co., Astrazeneca and Bristol Myers Squibb. In addition, if Olvi-Vec completes one or more registrational trials and achieves regulatory

approval, we expect there to be additional product candidates approved for SCLC by that time which would compete with Olvi-Vec.

Generic

Competition

The

enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Patient Protection and Affordable Care

Act as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA) created an abbreviated pathway for

the approval of biosimilar and interchangeable biological products. The abbreviated regulatory pathway establishes legal authority for

the FDA to review and approve biosimilar biological products, including the possible designation of a biosimilar as “interchangeable”

based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar product cannot be approved by

the FDA until 12 years after the original branded product was approved under a BLA. Certain changes, however, and supplements to an approved

BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest, or other related entity

do not qualify for the 12-year exclusivity period.

Olvi-Vec

and our other product candidates are all biological product candidates. We anticipate being awarded data exclusivity for each of our

biological product candidates that is subject to its own BLA for 12 years in the United States, up to 11 years in Europe and varying

durations in other markets.

GOVERNMENT

REGULATION AND PRODUCT APPROVAL

In

the United States, the FDA regulates biological products under the Federal Food, Drug, and Cosmetic Act (FDCA), the Public Health Service

Act (PHSA), and regulations and guidance documents implementing these laws. The FDCA, PHSA and their corresponding regulations govern,

among other things, the testing, manufacturing, safety, purity, potency, labeling, packaging, storage, record keeping, distribution,

reporting, advertising and other promotional practices involving biological products. Consent from the FDA is required before conducting

human clinical testing of biological products. FDA licensure also must be obtained before marketing of biological products. The process

of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations

require the expenditure of substantial time and financial resources.

U.S.

Biological Products Development Process

Any

biologic product must be licensed by the FDA before it may be legally marketed in the United States. The process required by the FDA

before a biologic product candidate may be marketed in the United States generally involves the following:

● Review of the product by an FDA advisory committee, if applicable;

The

testing and approval process of product candidates requires substantial time, effort, and financial resources. Satisfaction of the FDA’s

pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type,

complexity, and novelty of the product or disease. Before testing any biologic product candidate in humans, the product candidate must

undergo preclinical testing. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry,

toxicity and formulation, as well as in vivo studies to assess the potential safety and activity of the product candidate and to establish

a rationale for therapeutic use. The conduct of the preclinical tests must comply with federal regulations and requirements including

GLPs.

Concurrent

with clinical trials, companies usually are required to complete some long-term preclinical testing, such as animal tests of reproductive

adverse events and carcinogenicity, and must also develop additional information about the chemistry and physical characteristics of

the drug and finalize a process for manufacturing the drug in commercial quantities in accordance with cGMP requirements. The manufacturing

process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer

must develop methods for testing the identity, strength (potency), quality and purity of the final drug product. Additionally, appropriate

packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo