GNLX US Equity☆

Item 1A. Risk Factors 31

Item 1B. Unresolved Staff Comments 114

Item 1C. Cybersecurity 114

Item 2. Properties 115

Item 3. Legal Proceedings 115

Item 4. Mine Safety Disclosures 115

PART II

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 129

Item 8. Financial Statements and Supplementary Data 129

Item 9A. Controls and Procedures 129

Item 9B Other Information 130

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 130

PART III

Item 10. Directors, Executive Officers and Corporate Governance 131

Item 11. Executive Compensation 133

Item 14. Principal Accountant Fees and Services 147

PART IV

Item 15. Exhibits and Financial Statement Schedules 149

i

SPECIAL

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This

Annual Report on Form 10-K (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 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 risks and uncertainties associated with our business, many of which are beyond our control. 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 recently 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 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 (PRROC)

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

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 their last platinum within 24 months from enrollment. The trial was 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) 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. We recently amended the protocol with respect to certain design criteria and expect to

begin enrolling patients upon receipt of institutional

review board (IRB) approvals. The enrollment will be approximately 186 patients. We expect to report topline results in the second half of 2025.

The

following graphic summarizes the study design for the Phase 3 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, progression free survival (PFS) and overall survival (OS).

Importantly,

relative to historical comparisons, patients receiving Olvi-Vec-primed immunochemotherapy generally showed marked clinical benefits,

particularly with respect to ORR per RECIST 1.1 (54%) 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 < 3 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 < 20%, 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 U.S. Food and Drug Administration (FDA), supported moving into a Phase 3 trial.

The median PFS of the patients’ immediately preceding line of therapy was approximately 4.5 months versus 11.0

months achieved after treatment with Olvi-Vec.

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.

Non-Small

Cell Lung Cancer (NSCLC)

We

selected recurrent NSCLC as our first registration-path indication 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 intra-tumorally and that

are less amenable to repeat injections, 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

the second half of 2023, we began regulatory study start-up in the United States of a Phase 2, 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) (VIRO-25). We expect to begin enrolling patients in VIRO-25 in the first half of 2024. VIRO-25

is expected 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 (SCLC)

We

co-sponsor with Newsoara an ongoing Phase 1b/2 clinical trial of Olvi-Vec in patients with recurrent small cell lung cancer that we initiated

in China in April 2023. A readout of interim results in the Phase 1b portion of this trial is expected in the second half of 2024, after

which we will move into the Phase 2 portion of the trial.

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

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.

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. 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 that regard, 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.

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.

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, 2023, our patent portfolio consisted of 19 issued U.S. patents, one pending U.S. patent application, 14 issued foreign

patents, six 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.

Competition

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

systems. We are aware of a number of companies developing competing therapies for the treatment of cancer which generally fall into the

following treatment groups:

These

technologies and compounds can focus on very specific targets, such as up-and down-regulating genes, hyperactive protective factors,

growth factors, and the immune system or broadly attack the cancer in the manner of conventional chemotherapy and radiation. We believe

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

options.

We

are aware of several other companies developing therapies based on VACV. To our knowledge, the only clinical product based on VACV that

has advanced beyond Phase 1 clinical development is Pexa-Vec, being jointly developed by SillaJen and Transgene. Pexa-Vec has a different

product profile from Olvi-Vec, including a different strain of VACV and different transgenes. In August 2019, SillaJen announced the

discontinuation of its Phase 3 PHOCUS trial of Pexa-Vec in advanced liver cancer for futility.

PRROC

We

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

including PRROC:

○ Nemvaleukin alfa, an engineered interleukin-2, by Mural Oncology;

○ Relacorilant, an anti-glucocorticoid, by Corcept Therapeutics Inc.; and

NSCLC

We

are also aware of other companies either marketing or focused on developing competing therapies for the treatment of NSCLC, which generally

fall into the following treatment groups:

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 NSCLC therapies.

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 unacceptable deterioration over its shelf life.

A

clinical trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data,

any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical testing

may continue even after the IND is submitted. The IND automatically becomes effective 30 calendar days after receipt by the FDA,

unless before that time the FDA raises concerns or questions related to a proposed clinical trial, including concerns that human

research subjects will be exposed to unreasonable health risks, and places the clinical trial on a clinical hold. For later stage

studies, in addition to a safety concern, the FDA may place a study on hold for faulty design issues. In such a case, the IND

sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA also may impose partial or

full clinical holds on a biologic product candidate at any time before or during clinical trials due to safety or study design

(later phase studies) concerns or non-compliance. If the FDA imposes a clinical hold, trials may not recommence without FDA

authorization and then only under terms authorized by the FDA. Accordingly, we cannot be sure that submission of an IND, or addition of new studies to an existing IND, will result

in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that partially or fully suspend or

terminate such studies.

Human

Clinical Trials Under an IND

Clinical

trials involve the administration of the investigational product to healthy volunteers or patients under the supervision of qualified

investigators which generally are physicians not employed by, or under, the control of the trial sponsor. Clinical trials must be conducted

under written study protocols detailing, among other things, the objectives of the trial, subject selection and exclusion, the trial

procedures, the parameters to be used in monitoring safety, the effectiveness criteria to be evaluated, and a statistical analysis plan.

Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND.

Further,

clinical trials must be conducted in accordance with federal regulations and GCP requirements, which include the requirements that all

research subjects provide their informed consent in writing for their participation in any clinical trial, as well as review and approval

by an IRB at each study site participating in the clinical trial or a central IRB. An IRB is charged with protecting the welfare and

rights of trial participants and considers items such as whether the risks to individuals participating in the clinical trials are minimized

and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must

be signed by each clinical trial subject, or their legal representative, reviews and approves the study protocol, and must monitor the

clinical trial until completed.

Human

clinical trials typically are conducted in three sequential phases that may overlap or be combined:

Post-approval

clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial approval. These clinical trials are

used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term

safety follow-up.

During

all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical

data and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the

FDA.

Written

IND safety reports must be promptly submitted to the FDA and the investigators for: serious and unexpected adverse events; any findings

from other studies, in vivo laboratory tests or in vitro testing that suggest a significant risk for human subjects; or any clinically

important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The

sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days

after the sponsor’s initial receipt of the information. Relevant additional information obtained by the sponsor that pertains to

a previously submitted IND safety report must be submitted as a follow-up IND safety report. Such report should be submitted within 15

calendar days after the sponsor receives the information.

Information

about certain clinical trials, including a description of the study and, in some cases, study results, must be submitted within specific

timeframes to the National Institutes of Health (NIH) for public dissemination on their clinicaltrials.gov website. Manufacturers or

distributors of investigational products for the diagnosis, monitoring, or treatment of one or more serious or life-threatening diseases

or conditions where no other comparable or satisfactory therapeutic options exist must also have a publicly available policy on evaluating

and responding to requests for expanded access, sometimes called “compassionate use,” requests.

Additionally,

some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor that regularly

reviews accumulated data and advises the study sponsor regarding the continuing safety of the trial. This group may also review interim

data to assess the continuing validity and scientific merit of the clinical trial. This group receives special access to unblinded data

during the clinical trial and may advise the sponsor to halt the clinical trial if it determined there is an unacceptable safety risk

for subjects or on other grounds, such as no demonstration of efficacy.

The

FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes

that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical