GNLX US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-K

For

the fiscal year ended December 31, 2024

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

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 Common Stock held by non-affiliates of the registrant was approximately $57.9 million, based on the closing

price of the registrant’s Common Stock on June 30, 2024.

There

were 34,604,296 shares of Common Stock outstanding as of March 20, 2025.

DOCUMENTS INCORPORATED BY REFERENCE

Part

III of this Annual Report on Form 10-K (the Annual Report) incorporates by reference certain information from the registrant’s

definitive proxy statement relating to for its 2025 annual meeting of stockholders (the 2025 Proxy Statement), which the registrant

intends to file pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2024. Except with respect to information specifically incorporated by reference in this Form 10-K, the 2025 Proxy

Statement is not deemed to be filed as part of this Form 10-K.

GENELUX

CORPORATION

ANNUAL

REPORT ON FORM 10-K

For

the Year Ended December 31, 2024

Table

of Contents

Page No.

PART I

Item 1. Business 1

Item 1A. Risk Factors 35

Item 1B. Unresolved Staff Comments 126

Item 1C. Cybersecurity 126

Item 2. Properties 127

Item 3. Legal Proceedings 127

Item 4. Mine Safety Disclosures 127

PART II

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 140

Item 8. Financial Statements and Supplementary Data 140

Item 9A. Controls and Procedures 140

Item 9B Other Information 141

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 141

PART III

Item 10. Directors, Executive Officers and Corporate Governance 142

Item 11. Executive Compensation 142

Item 14. Principal Accountant Fees and Services 142

PART IV

Item 15. Exhibits and Financial Statement Schedules 143

i

SPECIAL

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This

Annual Report contains forward-looking statements within the meaning of the federal securities laws

made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements

of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position,

business strategy, research and development costs; the anticipated timing, costs and conduct of our clinical trials for our only product

candidate, Olvi-Vec; the timing and likelihood of regulatory filings and approvals for Olvi-Vec; our ability to commercialize Olvi-Vec,

if approved; the pricing and reimbursement of Olvi-Vec, if approved; the potential benefits of strategic collaborations and our ability

to enter into strategic arrangements; the timing and likelihood of success, plans and objectives of management for future operations;

future results of anticipated product development efforts; and our expected future financing needs, 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.

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 the sections titled “Risk

Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and

elsewhere in 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. You should, however, review the factors and risks we describe in the reports we will file from time to

time with the U.S. Securities and Exchange Commission (the SEC) after the date of this Annual Report.

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 this section under the heading “Risk Factors.” 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:

iii

PART

I

Item

1. Business

OVERVIEW

Genelux

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

for patients suffering from aggressive and/or difficult-to-treat solid 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 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.

In

September 2021, we entered into a License Agreement (the Newsoara License) with Newsoara BioPharma Co. Ltd. (Newsoara) pursuant to which

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 is

discussed in more detail in the Terms of Certain License Agreements section below.

In

January 2019, we formed V2ACT Therapeutics, LLC (V2ACT), a joint venture with TVAX Biomedical Inc. (TVAX), for the purpose of V2ACT developing

and commercializing a product candidate, V2ACT Immunotherapy, that combines an oncolytic virus (e.g., Olvi-Vec) and neoantigen-primed

adoptive cell therapy (NACT) for cancer. The V2ACT joint venture agreement and associated license agreements are discussed in more detail

in the Terms of Certain License Agreements section below.

We

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

material that we intend to use in our subsequent clinical trials of Olvi-Vec and for the initial commercial launch of Olvi-Vec, if approved.

We leased a second building in the same location which, when upgrades are completed, will provide laboratory capabilities and administrative

offices.

PIPELINE

Our

pipeline is summarized below:

OUR

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, including

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, local and systemic deliveries,

as a monotherapy and in combination with other therapies, in approximately 150 patients 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 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.

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 registration

trial in PRROC in the third quarter of 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).

The

experimental arm patients will 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. The active comparator arm patients

will receive a regimen of single agent chemotherapy with optional platinum, plus bevacizumab followed by maintenance therapy. After discussions

with the U.S. Food and Drug Administration (the FDA), we amended the protocol with respect to certain design criteria including removal

of an eligibility criterion requiring patients to have received their last platinum within 24 months of enrollment. We anticipate enrolling patients eligible under the amended protocol upon receipt of institutional review board (IRB) approvals. Total trial enrollment will be a sufficient number of patients to achieve

127 events. We anticipate reporting topline results in the first half of 2026. Additionally, in a recent communication regarding the

Phase 3 OnPrime registrational trial, the FDA stated that an interim analysis of overall survival (OS) should be

planned at the time of the primary progression-free survival (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

we request a pre-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 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 (MTD) 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, 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 (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; 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.

In

the following graphic, we show the results of three exemplary heavily pre-treated platinum-refractory (i.e., progression while on last

platinum) patients, presenting at time of enrollment with progressive disease and projected short life expectancy. All achieved PFS exceeding

any of their respective prior lines, and achieved objective partial response, suggesting meaningful clinical benefit from Olvi-Vec-primed

immunochemotherapy.

The

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

therapy (PFS of 11.0 months versus 4.5 months) with preserved or improved performance status. Historically, patients with recurrent ovarian

cancer suffer a decrease in PFS with each subsequent line of therapy. The effectiveness of subsequent lines of therapy have been described

using the “PFS Ratio,” with any ratio greater than 1.3 considered clinically meaningful. The Kaplan-Meyer survival curves

in the figure below on the left show the median PFS was 4.5 months pre Olvi-Vec and 11.0 months post Olvi-Vec. The figure below on the

right shows that 74% of patients are on the left of the effect line, suggesting a clinically meaningful benefit following Olvi-Vec primed

immunochemotherapy relative to prior lines of therapy.

The

median overall survival of patients exceeded the historical survival rates of earlier lines of therapy. 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).

Non-Small

Cell Lung Cancer

In

the fourth quarter of 2024, we initiated enrollment in the United States in our Phase 2 VIRO-25 trial in the United States, 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). A readout of interim results of this trial is expected in the second half of 2025. Subject to regulatory

authorization from the Chinese Centre for Drug Evaluation, we anticipate Newsoara initiating our Phase 2 VIRO-25 trial. We also expect

the trial to become a multi-regional clinical trial with Newsoara adding clinical trial sites and patients in China. Newsoara is generally

obligated under our collaboration agreement to fund this trial.

Small

Cell Lung Cancer

We

co-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. Data are supportive of Olvi-Vec

being a platinum resensitizing agent beyond ovarian cancer and underscore the current clinical development strategy.

Preliminary evidence indicated anti-tumor effect from Olvi-Vec immunochemotherapy.

Five of the seven (71%) evaluable participants for anti-tumor response achieved disease control rate as the best response, with the two

other participants exhibiting a partial response according to RECIST 1.1 . The five participants with disease control experienced a reduction

in all of their individual target lesions. Notably, the first participant in our current dose escalation cohort, who remains on treatment,

experienced a tumor reduction of up to 79%. Additionally, the three remaining participants with disease control, including one individual

with three prior lines of treatment, achieved stable disease at lower dose cohorts, with tumor size reductions ranging between 24% to

29.2%. Systematic administration of Olvi-Vec via intravenous delivery demonstrated a manageable safety and tolerability profile, consistent

with previous findings in other clinical studies of the investigational immunochemotherapy. Participant enrollment into dose escalation

cohorts continues to investigate safety and the recommended intravenous dose of Olvi-Vec for Phase 2 trial. We expect to provide an interim

readout (updated data) in the second half of 2025.

Pancreatic

Cancer

V2ACT

Immunotherapy is a proprietary, indication-agnostic personalized immunotherapy designed to maximize the number and effect of cancer neoantigen-specific

effector T cells within cancer tissues. It combines immunotherapeutic modalities, neoantigen-primed effector T cell immunotherapy (NACT)

and oncolytic immunotherapy (initially, Olvi-Vec), each of which is supported by extensive preclinical and clinical proof-of-concept

data, including Phase 1 and 2 clinical trials, in various cancer indications. We plan to develop V2ACT Immunotherapy with V2ACT, our

joint venture with TVAX.

V2ACT

Immunotherapy is designed to combine the benefits of agents from four of the five subcategories of immunotherapies. Neoantigen-specific

adoptive T cell therapy and Olvi-Vec employ different and potentially synergistic mechanisms for cancer cell killing and prolonging patient

survival. In January 2024, Elias Animal Health, a companion animal cancer therapeutics company developing V2ACT immunotherapy in dogs,

announced that the U.S. Department of Agriculture Center for Veterinary Biologics determined that data from the company’s ECI-OSA-04

pivotal combined safety and efficacy study demonstrated a reasonable expectation of efficacy, a critical milestone in the licensure pathway.

The

scientific rationale for V2ACT Immunotherapy is that adoptive transfer of cancer neoantigen- specific effector T cells has proven to

be an effective treatment for multiple cancers. Reducing cancer tissue associated immunosuppression could increase the anti-cancer effects

of adoptively transferred neoantigen- specific effector T cells. In addition to lysing cancer cells, Olvi-Vec induces an acute inflammatory

response within cancer tissue that modulates the immune microenvironment in a way that would be anticipated to enhance the effects of

adoptively transferred neoantigen-specific effector T cells.

In

October 2020, V2ACT filed an investigational new drug (IND) application and upon not receiving any comments from the FDA, is ready to

begin the initiation of a Phase 1b/2a clinical trial to study V2ACT Immunotherapy as a treatment for newly-diagnosed, surgically-resectable

pancreatic cancer. This clinical trial is not yet scheduled to be initiated.

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. Moroever, we have observed the potential benefits of combining

Olvi-Vec with platinum compounds in preclinical studies, and in a completed Phase 1 clinical trial combining Olvi-Vec with cisplatin

and radiation as front-line therapy in newly diagnosed head and neck cancer patients. Olvi-Vec was well tolerated and demonstrated favorable

trends in PFS and OS.

Our current plan is to expand our clinical development program by pursuing additional

indications via intravenous delivery. Other indications 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.

For

example, one program expansion may be to conduct a basket trial of Olvi-Vec in patients who are either refractory and/or intolerant to

standard of care and who have primary lung cancer or who have lung tumors metastatic from other primary tumors such as breast cancer,

colon cancer, prostate cancer, sarcoma, bladder cancer, neuroblastoma and Wilm’s tumor. A second program expansion may include

clinical trials to assess the potential therapeutic benefit of Olvi-Vec in frontline settings, such as in ovarian cancer. In a Type C

meeting written response, the FDA reiterated their previous suggestion that we propose a study in the initial treatment of patients with

ovarian cancer as an add-on study in combination with a platinum-containing regimen.

We

may also pursue additional indications via regional delivery. Potential indications include appendiceal, colorectal and gastric cancers,

other gynecologic malignancies, and peritoneal mesothelioma.

TERMS

OF CERTAIN LICENSE AGREEMENTS

Newsoara

Biopharma Co., Ltd. Agreement

In

September 2021, we entered into the Newsoara License 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 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 China (the territory, which includes mainland China, Taiwan, Hong Kong and Macau)

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

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

outside the territory any derived products developed by Newsoara.

Under

the terms of the Newsoara License 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). 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.

Newsoara

is required to use commercially reasonable efforts to research, develop, manufacture and commercialize the licensed products in the territory

in the applicable 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 and Newsoara will be responsible for funding such trial. Newsoara’s development

work will be initially focused on Olvi-Vec, and Newsoara may not develop any derived product in NSCLC or PRROC until either Olvi-Vec

has been approved in such indication in the territory or the development of Olvi-Vec in such indication has been abandoned by the parties.

In addition, Newsoara is responsible for reimbursing us for all expenses related to the VIRO-25 clinical trial.

Unless

earlier terminated, the Newsoara License shall remain in effect, on a country-by-country basis, until the expiration of the Newsoara

Royalty term. Newsoara has the right to terminate the Newsoara License for convenience with advance written notice. Each party has the

right to terminate the Newsoara License for the uncured material breach of the other party or in the case of bankruptcy of the other

party. In addition, we may terminate the Newsoara License immediately upon prior written notice to Newsoara, if they challenge any of

the licensed patents.

In

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

trials in Greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan). We are responsible for supplying Olvi-Vec at our costs of

manufacturing. In February 2023, upon the initiation of Newsoara’s Phase 1 trial, we entered into a Pharmacovigilence Agreement

with Newsoara.

V2ACT

Joint Venture

In

January 2019, we formed V2ACT as a joint venture with TVAX for the purpose of V2ACT developing and commercializing V2ACT Immunotherapy.

The joint venture is governed by an Amended and Restated Limited Liability Company Agreement entered into in June 2021 which provides

each of us and TVAX with 50% ownership interests, identical voting and management rights and responsibilities, equal representation on

the governing four-member management committee, and equal sharing of profits and losses of V2ACT.

In

June 2021, we entered into a License Agreement with V2ACT (V2ACT License), pursuant to which we granted V2ACT a worldwide, non-exclusive,

fully paid, royalty free license for our proprietary oncolytic virus (Licensed Virus(es)) to research, develop and commercialize any

product, procedure or method for the treatment of cancer that combines (a) Licensed Virus(es), and (b) autologous or allogeneic cancer-specific

T lymphocytes (T-Cell Therapeutic(s)) for the diagnosis, prevention and treatment of cancer in humans (Products). V2ACT is solely responsible,

by itself or through its sublicensees, for all research, development, manufacturing and commercialization activities with respect to

Products in the applicable field. V2ACT is required to use commercially reasonable efforts to research, develop, manufacture and commercialize

Products in the applicable field and is solely responsible for all costs and expenses incurred in connection with such activities. We

have the sole right and discretion to prepare, file, prosecute, maintain, enforce and defend the licensed patents at our cost and expense.

V2ACT has the right to terminate the V2ACT License for convenience with advance written notice. Each party has the right to terminate

the V2ACT License for the uncured material breach of the other party or in the case of bankruptcy of the other party. In addition, we

may terminate the V2ACT License immediately upon prior written notice to V2ACT, if they challenge any of the licensed patents. On September

26, 2021, we and V2ACT entered into a First Amendment to the License Agreement, whereby the territory was defined as worldwide except

for Greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan).

In

June 2021, TVAX entered into a License Agreement with V2ACT (TVAX License), pursuant to which TVAX granted V2ACT a worldwide, non-exclusive,

fully paid, royalty free license for its proprietary T-Cell Therapeutics (Licensed T-Cell Therapeutic(s)) to research, develop and commercialize

any product, procedure or method for the treatment of cancer that combines (a) any virus-based cancer therapeutics, and (b) Licensed

T-Cell Therapeutic(s) for the diagnosis, prevention and treatment of cancer in humans (TVAX Products). In addition, TVAX granted V2ACT

an exclusive (even as to TVAX and its affiliates), a fully paid, royalty free license under certain patents related to the use of virus

and cell therapies in combination to research, develop and commercialize TVAX Products in the applicable field. V2ACT is solely responsible,

by itself or through its sublicensees, for all research, development, manufacturing and commercialization activities with respect to

TVAX Products in the applicable field. V2ACT is required to use commercially reasonable efforts to research, develop, manufacture and

commercialize TVAX Products in the applicable field and is solely responsible for all costs and expenses incurred in connection with

such activities. V2ACT has the right to terminate the TVAX License for convenience with advance written notice. Each party has the right

to terminate the TVAX License for the uncured material breach of the other party or in the case of bankruptcy of the other party. In

addition, TVAX may terminate the TVAX License immediately upon prior written notice to V2ACT, if they challenge any of the licensed patents.

On September 26, 2021, V2ACT and TVAX entered into a First Amendment to the License Agreement, whereby the territory was defined as worldwide

except for Greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan).

OPERATIONS

Manufacturing

and Distribution

We

leased 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 cGMPs and all other applicable

laws and regulations.

We

recently leased 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 we 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 our 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 we believe are important

to our business, and 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 our 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 our proprietary position for our

product candidates and technology will depend on our success in obtaining effective claims for 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, 2024, our patent portfolio consisted of 11 issued U.S. patents, 1 pending U.S. patent application, 9 issued foreign patents,

7 pending foreign patent applications and one PCT application, which relate generally to the composition of our current and potential

future products, and their methods of use.

Trade

Secrets

Furthermore,

we rely 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 and invention assignment agreements with our employees. We also have confidentiality agreements

or invention assignment agreements with selected consultants. 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, as well as universities and private and public research institutions. Many of our potential competitors, alone or with their

strategic partners, may 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.

We

are focused on developing next-generation 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.