Item 1A. Risk Factors 27
Item 1B. Unresolved Staff Comments 97
Item 1C. Cybersecurity 97
Item 2. Properties 98
Item 3. Legal Proceedings 98
Item 4. Mine Safety Disclosures 98
PART II
Item 6. Reserved 99
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 111
Item 8. Financial Statements and Supplementary Data 111
Item 9A. Controls and Procedures 111
Item 9B Other Information 112
Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 112
PART III
Item 10. Directors, Executive Officers and Corporate Governance 113
Item 11. Executive Compensation 113
Item 14. Principal Accountant Fees and Services 113
PART IV
Item 15. Exhibits and Financial Statement Schedules 114
i
FORWARD-LOOKING
STATEMENTS
This
Annual Report on Form 10-K (Annual Report) contains certain forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and we intend that such forward-looking
statements be subject to the safe harbors created thereby. All statements other than statements of historical facts contained in this
Annual Report, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors
that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements.
Forward-looking
statements contained in this Annual Report include statements regarding:
● expectations regarding the size, scope and design of clinical studies;
● our manufacturing, commercialization, and marketing plans and strategies;
● our expectations regarding the approval and use of our product candidates;
● our future financial performance;
● our expected use of net proceeds from our financing transactions;
● the impact of laws and regulations;
● the impact of geopolitical and macroeconomic factors; and
In
some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,”
“expect,” “plan,” “anticipate,” “could,” “intend,” “target,”
“project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential”
or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Annual
Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about
future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking
statements speak only as of the date of this Annual Report and are subject to a number of risks, uncertainties and assumptions described
under “Item 1A. Risk Factors” of Part I and “Item 7. Management’s Discussion and Analysis of Financial Condition
and Results of Operations” of Part II of this Annual Report. Because forward-looking statements are inherently subject to risks
and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these
forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements
may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover,
we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management
to predict all risk factors and uncertainties. Except as required by applicable law, we undertake no obligation to publicly update or
revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances
or otherwise. Readers should carefully review these risks, as well as the additional risks described in other documents we file from
time to time with the Securities and Exchange Commission (the SEC). Statements made herein are as of the date of the filing of this Annual
Report with the SEC and should not be relied upon as of any subsequent date. In addition, statements that “we believe” and
similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us
as of the date of this Annual Report, and while we believe such information provides a reasonable basis for these statements, such information
may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review
of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely
on these statements.
ii
SUMMARY
OF RISKS ASSOCIATED WITH OUR BUSINESS
We
face many risks and uncertainties, as more fully described in under Part I, Item 1A, “Risk Factors” in this Annual Report.
Some of these risks and uncertainties are summarized below. The summary below does not contain all of the information that may be important
to you, and you should read this summary together with the more detailed discussion of these risks and uncertainties contained in “Risk
Factors.” Some of the material risks associated with our business include the following:
PART
I
Item
1. BUSINESS
A.
Overview
Genelux
is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic viral immunotherapies for patients
suffering from aggressive and/or difficult-to-treat tumor types. Our clinical and preclinical product candidates are intended to selectively
kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens. Importantly, our oncolytic immunotherapy
product candidates are “off-the-shelf” personalized immunotherapies. In other words, while we administer the same virus product
to different patients, the cellular immune response generated is expected to be specific to the unique neoantigens in that patient. Our
lead product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable
DNA virus with a large engineering capacity.
Employing
our proprietary selection technology and discovery and development platform (CHOICE), we have developed an extensive library of isolated
and engineered oncolytic VACV immunotherapeutic product candidates. These provide potential utility in multiple tumor types in both the
monotherapy and combination therapy settings, via physician-preferred administration techniques, including regional (e.g., intraperitoneal),
local and systemic (e.g., intravenous) delivery routes. Informed by our CHOICE platform and supported by extensive clinical and preclinical
data, we believe we have the capacity to develop a pipeline of treatment options to address high unmet medical needs for those patients
with insignificant or unsatisfactory responses to standard-of-care therapies, including chemotherapies.
We
are executing a late-stage clinical program of our lead product candidate, Olvi-Vec, to demonstrate platinum-resensitization in multiple
indications. We are currently evaluating Olvi-Vec in three clinical trials:
The
Phase 3 registrational trial, called the OnPrime/GOG-3076 trial, is evaluating the administration of Olvi-Vec intraperitoneally to treat
patients with PRROC. The Phase 2 NSCLC trial, called the VIRO-25 trial, and the Phase 1b/2 SCLC trial are evaluating Olvi-Vec administered
systemically (i.e., intravenously) to treat patients with recurrent NSCLC and SCLC, respectively. Our development of Olvi-Vec is discussed
in more detail in the Development Programs section below.
In
September 2021, we entered into a License Agreement (the Newsoara License Agreement) with Newsoara BioPharma Co. Ltd. In October
2025, Newsoara BioPharma Co. Ltd. assigned all of its rights and obligations under the Newsoara License Agreement to an affiliate,
Newsoara HYK Biopharmaceuticals Co., Ltd. We refer herein to the counterparty to the Newsoara License Agreement as Newsoara.
Pursuant to the Newsoara License Agreement, we granted Newsoara an exclusive license to research, develop, commercialize or exploit
Olvi-Vec in China, which includes mainland China, Taiwan, Hong Kong and Macau, for all human diagnostic, prophylactic and
therapeutic uses (the Newsoara Field). The Newsoara License Agreement is discussed in more detail in the Newsoara License
Agreement section below.
We
have a facility in San Diego, California for current Good Manufacturing Practice (cGMP) manufacturing. The facility is producing cGMP
material that is being used in our ongoing clinical trials in the U.S. and China and that we intend to use in additional clinical trials
of Olvi-Vec and for the initial commercial launch of Olvi-Vec, if approved. We also lease a second building in the same location which,
when upgrades are completed, will provide laboratory capabilities and administrative offices.
B.
Pipeline
Our
pipeline is summarized below:
C.
Strategy
Our
strategy is to leverage our deep internal capabilities in the clinical development of oncolytic viruses to create a leading immunotherapy
company, discovering, developing and commercializing next-generation products for the treatment of a broad range of cancers, initially
solid tumors, many of which are among the most difficult cancers to treat. We are focused on the execution and success of our clinical
programs and, over time, on building our organization into a fully-integrated therapeutics company. Key elements of our strategy include:
The
Genelux Approach
Oncolytic
VACV
Olvi-Vec
utilizes VACV as the backbone of our proprietary CHOICE discovery platform. VACV is a member of the Orthopoxvirus genus and contains
a single linear DNA genome.
Our
proprietary CHOICE discovery platform is designed to allow us to develop new product candidates rapidly from conception through the initiation
of clinical trials. The discovery platform is based on our collection of various strains of VACV based on multiple selection criteria,
both in vitro (e.g., viral replication rate, plaque size, transgene expression efficiency, etc.) and in vivo (e.g., viral titer, antitumor
activities, safety, etc.).
We
have generated an extensive portfolio of oncolytic vaccinia immunotherapy clinical candidates, of which, Olvi-Vec is the furthest along
in clinical development. In addition to Olvi-Vec, we have over 500 different versions of the VACV armed with greater than 110 transgenes,
having a variety of engineered attributes, including immune modulatory and tumor cell killing properties.
Our
oncolytic immunotherapy product candidates are intended to selectively kill tumor cells and induce a robust immune response against a
patient’s tumor neoantigens. Importantly, these product candidates are “off-the-shelf” personalized immunotherapies.
In other words, while we administer the same virus product to different patients, the cellular immune response generated is expected
to be specific to the unique neoantigens in that patient.
Olvi-Vec
Our
current development focus is on our lead product candidate, Olvi-Vec (USAN: olvimulogene nanivacirepvec; laboratory name: GLV-1h68; previously
known as GL-ONC1), a genetically stable, attenuated Lister-Institute of Viral Preparations (LIVP) strain of VACV. We modified the LIVP
strain by integrating three foreign gene expression cassettes—Ruc-GFP (a fusion gene of Renilla luciferase
and green fluorescent protein); LacZ (ß-galactosidase gene from E. coli); and gusA (ß- glucuronidase
from E. coli)—to selectively disrupt non-essential vaccinia genes (F14.5L, thymidine kinase (TK), and hemagglutinin
(HA) loci, respectively).
We
are developing Olvi-Vec for the treatment of multiple cancers based on the results of preclinical studies that suggest Olvi-Vec has the
potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune
response. To date, Olvi-Vec has been studied in multiple early- and mid-phase clinical trials via regional, and systemic deliveries,
as a monotherapy and in combination with other therapies, in seven completed clinical trials with a variety of cancer types. Those clinical
trials have yielded data that has informed our current and future clinical strategy and trial design involving multiple indications and
methods of delivery.
In
our completed clinical trials, irrespective of the route of administration, dosing regimen or cancer type, Olvi-Vec was:
● Shown to enhance chemotherapeutic activities in a combination therapy setting.
In
addition, in clinical trials in which Olvi-Vec was systemically administered, Olvi-Vec was:
● Capable of infecting tumor tissues and reducing circulating tumor cells.
Mechanism
of Action
Olvi-Vec
is a robust immune modulator that selectively replicates in tumor cells, unleashing the body’s immune system to mount a personalized
attack against cancer cells throughout the body. Olvi-Vec is believed to accomplish this by the following processes:
The
following diagram sets forth Olvi-Vec’s proposed mechanism of action.
D.
Development Programs
Platinum
Resistant/Refractory Ovarian Cancer
We
envision that Olvi-Vec-primed immunochemotherapy may overcome chemotherapy resistance for patients with end-stage ovarian cancer that
would otherwise consider palliative care or use of drugs with historically poor response rates. We initiated a Phase 3 OnPrime/GOG-3076
registration trial in PRROC in 2022. The trial is an open-label, randomized control design (2:1 randomization), enrolling patients who
are platinum resistant/refractory by standard definitions and received a minimum of 3 prior lines of therapy. The trial is designed to
address a broad and underserved pool of patients and the inclusion criteria allows patients to enroll regardless of (i) tumor biomarkers,
(ii) platinum refractory tumors or (iii) the maximum number of prior lines of treatments (i.e., no cap on previous treatments).
Patients
in the experimental arm of the trial receive a single cycle (two doses) of Olvi-Vec administered intraperitoneally and, approximately
four weeks later, a regimen of a platinum-based doublet plus bevacizumab followed by maintenance therapy.
Patients
in the active comparator arm of the trial receive a regimen of single agent chemotherapy with optional platinum, plus bevacizumab followed
by maintenance therapy. Total trial enrollment will be a number of patients sufficient to achieve a primary progression-free survival
analysis (PFS) of 127 events. We anticipate reporting topline results in the second half of 2026. Additionally, in communication regarding
the Phase 3 OnPrime/GOG-3076 registrational trial in March 2025, the FDA stated that an interim analysis of overall survival (OS) should
be planned at the time of the primary PFS analysis and confirmed that if a clinically meaningful PFS advantage is demonstrated in the
absence of a decrement in OS, this could potentially support traditional approval. The FDA further recommended us to request a pre-Biologics
License Application (BLA) meeting with the FDA with topline safety and efficacy data following completion of the trial so that the FDA
may discuss next steps.
The
following graphic summarizes the study design for the Phase 3 OnPrime/GOG-3076 registration trial.
Previously,
we conducted a Phase 1b/2 clinical trial of Olvi-Vec, which was administered intraperitoneally in a single round of treatment consisting
of a bolus infusion on two consecutive days. In the Phase 1b portion of the clinical trial, patients were treated with Olvi-Vec alone,
in three dose escalation cohorts. In the Phase 2 portion of the clinical trial, we implemented a cohort designed to treat patients with
Olvi-Vec, at the dose of the first cohort in the Phase 1b portion, and approximately six weeks thereafter, patients were administered
a chemotherapy regimen consisting of a platinum-based doublet (+/- bevacizumab). Patients enrolled into the trial were heavily pretreated
(with a median of four prior lines of therapy), with confirmed progressive disease (PD) at the time of enrollment, and had PRROC, with
poor responses to conventional chemotherapies. The topline data of the Phase 2 portion was published in JAMA Oncology in May 2023.
In
the Phase 1b portion of the clinical trial, no virus- related severe organ toxicity was observed by clinical or serologic parameters,
and a maximum tolerated dose was not reached. Olvi-Vec treatment was observed to be well tolerated.
In
the Phase 2 portion of the clinical trial, data from patients who received Olvi-Vec-primed immunochemotherapy supported that there was
demonstrated responsiveness to platinum- based therapy, to which they previously were deemed resistant or refractory, leading to the
hypothesis that treatment with Olvi-Vec may re-sensitize patients to platinum-based therapies. As shown in the following figure, this
was documented by multiple efficacy evaluation endpoints (based on pre-chemotherapy baseline), such as overall response rate (ORR), as
determined by RECIST 1.1 Criteria by CT scans and GCIG CA-125 Response Criteria, and durability of responses as determined by duration
of response, PFS and OS.
Importantly,
relative to historical comparisons, the heavily pretreated patients with median 4 prior lines receiving Olvi-Vec-primed immunochemotherapy
generally showed marked clinical benefits, particularly with respect to ORR per RECIST 1.1 (54%: 19% CRs; 35% PRs) with durable response,
median PFS (11.0 months) and median OS (15.7 months). Historically, for such patients the expected ORR per RECIST 1.1 would be < 20%,
median PFS < 4 months, and median OS < 12 months. Of note, an ORR by RECIST 1.1 of 54% and median PFS of 11.4 months were achieved
in patients with platinum-refractory disease versus the historically expected ORR per RECIST 1.1 of < 10%, median PFS < 3 months;
prior to joining our trial, these patients progressed during, or within one month after, receiving their most recent prior platinum-based
therapy.
With
13 objective responders per RECIST 1.1 out of 24 evaluable patients, the trial results exceeded the pre-defined threshold of 43%, and
after our discussions with the FDA, supported moving into a Phase 3 trial.
The
majority of patients treated with Olvi-Vec-primed immunochemotherapy showed clinical benefits exceeding their own last prior line of
therapy (median PFS of 11.0 months versus 4.5 months) with preserved or improved performance status. Additionally, 20% of patients were
long-term survivors, which is generally regarded as a hallmark of clinically beneficial immunotherapies.
Systemic
Administration
We
selected recurrent lung cancers (recurrent SCLC and recurrent NSCLC) as our initial registration-path indications for intravenous delivery
of Olvi-Vec-primed immunochemotherapy because of the promising preclinical and clinical data generated in patients with lung disease
(primary or metastatic) in our prior clinical trials. We believe intravenous delivery of Olvi-Vec to the lung, unlike other viruses that
are administered locally, is particularly compelling because of the ‘first pass effect’ (i.e., after administration the virus
reaches the heart and is then first transported to the lungs). In preclinical studies, we have repeatedly observed the eradication of
distal pulmonary metastases from multiple tumor types by intravenously administered Olvi-Vec. In a previous Phase 1b trial, Olvi-Vec
demonstrated a dose-dependent overall survival benefit in heavily pre-treated solid tumor patients.
In
addition, we selected recurrent patients because of the promising preclinical and clinical data generated in recurrent ovarian cancer
patients in our Phase 2 VIRO-15 trial. Each of these trials is designed to enroll and re-challenge patients who have failed prior platinum
therapy (and, in the case of the NSCLC re-challenge patients who also failed a prior immune checkpoint inhibitor).
The
Phase 1b/2 SCLC trial and Phase 2 VIRO-25 trial are actively enrolling in dose escalation cohorts to inform dose selection for the subsequent
portion of the studies.
Non-Small
Cell Lung Cancer
In
2024, we initiated enrollment in the dose escalation portion of our Phase 2 VIRO-25 trial in the United States, prior to selecting a
dose to potentially move into an open-label, randomized, and controlled clinical trial of Olvi-Vec in patients with recurrent NSCLC (after
progression on a front-line maintenance Immune Checkpoint Inhibitor-based regimen).
The
following graphic summarizes the study design for the Phase 2 VIRO-25 trial:
In
January 2026, we announced initial interim results from the VIRO-25 trial. As of the data review cutoff date of December 31, 2025, systemic
administration of Olvi-Vec in the initial dose escalation cohorts of the trial achieved the following preliminary results:
● 5 evaluable patients
● Disease control response (DCR) of 60% (3/5 patients)
● Olvi-Vec was generally well tolerated
We
expect to report additional updated dose-finding data from this trial throughout 2026.
Small
Cell Lung Cancer
We
sponsor with Newsoara an ongoing Phase 1b/2 clinical trial of Olvi-Vec in patients with recurrent SCLC in China. The following graphic
summarizes the study design for the Phase 1b/2 trial.
A
readout of interim results in the Phase 1b portion of this trial was disclosed in the first quarter of 2025. In January 2026, we announced
additional interim results from the SCLC trial. As of the data review cutoff date of December 23, 2025, systemic administration of Olvi-Vec
in the initial dose escalation cohorts in this trial achieved the following preliminary results:
● 9 evaluable patients
● Disease control rate of 67% (6/9 patients)
● Olvi-Vec was generally well tolerated
Notably,
this SCLC trial is primarily evaluating safety and tolerability and, as such, patients who achieved objective responses from Olvi-Vec
immunochemotherapy in this trial do not receive any subsequent standard maintenance immunotherapy to extend durability of response.
We
expect to report additional updated dose-finding data from this trial throughout 2026.
Additional
Potential Indications for Olvi-Vec
We
believe our preclinical and clinical data support the broad development of Olvi-Vec in patients with liquid or (metastatic) solid tumors,
as a monotherapy or in combination with other therapies. We believe that the potential to induce immune responses may represent an important
mechanism to control tumor growth, prevent the spread of tumors, improve the ability to surgically remove tumors and perhaps reduce the
need for surgery, and reduce or delay the onset of relapse.
Indications
for development will be selected from the balance of more than 20 major human cancers against which Olvi-Vec has shown activity in preclinical
studies, including blood (other leukemia/lymphoma), breast, colon, kidney, lung, prostate and skin (melanoma) cancers.
Newsoara
License Agreement
In
September 2021, we entered into the Newsoara License Agreement, pursuant to which we granted Newsoara an exclusive license to
research, develop, commercialize or exploit (i) any and all oncolytic viruses that are controlled by us, including Olvi-Vec but
excluding V-VET1 (licensed viruses); (ii) any pharmaceutical product in final form that is comprised of or contains the licensed
viruses as an active ingredient (licensed products); (iii) any virus developed by or on behalf of Newsoara that (a) has a vaccinia
virus backbone; (b) is not disclosed or covered by any of our patents; and (c) includes modifications (as compared to the licensed
viruses) of a gene function with therapeutic intent (derived molecules); and (iv) any pharmaceutical product in final form that is
comprised of or contains derived molecule as an active ingredient (derived products), in each case in mainland China, Taiwan, Hong
Kong and Macau (the Newsoara Territory) in the field of human diagnostic, prophylactic and therapeutic uses (the Newsoara Field).
The license granted to Newsoara is royalty bearing for licensed products and royalty free for derived products. Under the Newsoara
License Agreement, Newsoara granted us an exclusive and royalty bearing license to develop, commercialize and exploit outside the
Newsoara Territory any derived products developed by Newsoara.
Under
the terms of the Newsoara License Agreement and to date, we have received from Newsoara an aggregate of $11.0 million ($5.0 million as
an upfront payment and $6.0 million as a milestone payment) associated with the Newsoara License Agreement. Newsoara is obligated to
pay us additional development and commercial milestone payments up to $160.5 million in the aggregate upon the occurrence of certain
development, regulatory and commercial milestones by the licensed products, and royalties on net sales of the licensed products in the
mid-single-digit to mid-teens percentage range (the Newsoara Royalty). The Newsoara Royalty term, with respect to a licensed product
and each region in the territory, is the period beginning on the date of first commercial sale of such licensed product in such region
and ending on the last to occur of: (a) the expiration of the last to expire patent controlled by us (including any applicable patent
term extension) in such region that contains either (i) an issued valid claim that covers the licensed product (including the licensed
virus contained therein, and including the composition of matter and method of making and using thereof) or (ii) a pending valid claim
that covers the sequence of the licensed virus contained therein; (b) the 10th anniversary of the first commercial sale of such licensed
product in such region; and (c) the expiration of all regulatory exclusivity for such licensed product in such region. If we, at our
discretion, elect to develop and commercialize outside the territory any derived product developed by Newsoara, we are required to make
certain milestone and royalty payments to Newsoara.
Pursuant
to the Newsoara License Agreement, Newsoara is required to use commercially reasonable efforts to research, develop, manufacture and
commercialize the licensed products in the Newsoara Territory in the Newsoara Field and is solely responsible for all costs and
expenses incurred in connection with such activities. In addition, Newsoara is required to use commercially reasonable efforts to
conduct a multi-center Phase 2 clinical trial for Olvi-Vec in NSCLC using clinical sites in the United States and China, which is
the VIRO-25 clinical trial. Newsoara is generally obligated under the Newsoara License Agreement to fund the costs of the VIRO-25
clinical trial in the United States and China. In November 2023, we and Newsoara agreed that we would engage a clinical research
organization (CRO) to conduct certain start-up activities for the trial in the United States only, with Newsoara to reimburse us for
the costs and expenses. Pursuant to a letter of understanding (the LOU), in September 2025, we agreed with Newsoara that the CRO
would conduct additional study activities beyond startup for the VIRO-25 clinical trial in the United States and Newsoara would
reimburse us for costs and expenses related to such additional activities; however, Newsoara is permitted to defer reimbursement of
the foregoing costs and expenses until the earlier of: (i) completion of its next round of financing, or (ii) December 31,
2026.
In
November 2022, we entered into a Clinical Supply Agreement with Newsoara to manufacture and supply Olvi-Vec for Newsoara’s clinical
trials in the Newsoara Territory. We are responsible for supplying Olvi-Vec to Newsoara, and Newsoara will pay us the cost of manufacturing.
E.
Operations
Manufacturing
and Distribution
We
lease a 7,569 square-foot building in San Diego, California where we have established and equipped our own manufacturing facility in
order to secure supplies for clinical trials and commercial launch. The facility includes laboratories, production cleanrooms, and installed
equipment, to accept and prepare raw materials, and produce drug substance and drug product in accordance with cGMP and all other applicable
laws and regulations.
We
also lease a 6,755 square-foot building in the same location which, when upgrades are completed, will provide laboratory capabilities
and administrative offices.
We
maintain agreements with our raw material and component suppliers, as well as with contract laboratories to provide services such as
analytical development and validation, raw material testing, release testing of drug substance and drug product and stability testing.
We also contract with a third party for the labeling, packaging and distribution of our clinical material and expect to do so in the
future for commercial Olvi-Vec product, assuming it receives regulatory approval. We do not have long-term supply arrangements in place
with raw material and component suppliers.
Sales
and Marketing
None
of our product candidates has been approved for sale. If and when our product candidates receive marketing approval, we intend to commercialize
them on our own, or jointly with a partner, in the United States and potentially with pharmaceutical or biotechnology partners in other
geographies. We currently have no sales, marketing or commercialization capabilities and have no experience as a company performing such
activities. However, we intend to build the necessary capabilities and infrastructure over time following the advancement of our product
candidates through clinical development. Clinical data, the size of the opportunity and the size of the commercial infrastructure required
will influence our commercialization plans and decision making.
Intellectual
Property
Our
success depends upon protecting and enhancing our proprietary technologies, inventions and improvements that are believed to be important
to our business. We strive to and intend to seek, maintain and defend intellectual property rights, whether developed internally or licensed
from third parties. We rely on a combination of patent, trademark, copyright and trade secret laws in the United States and other jurisdictions
as well as confidentiality procedures and contractual provisions to protect our proprietary technology and brand.
Patents
The
U.S. patent system permits the filing of provisional and non-provisional patent applications. A provisional patent application is not
examined for patentability by the U.S. Patent and Trademark Office (USPTO), and automatically expires 12 months after its filing date.
As a result, a provisional patent application cannot mature into an issued patent. Provisional patent applications are often used, among
other things, to establish an early effective filing date for a later-filed non-provisional patent application. A non-provisional patent
application is examined by the USPTO and can mature into a patent once the USPTO determines that the claimed invention meets the standards
of patentability.
Individual
patents extend for varying periods of time depending on the date of filing of the patent application, the priority date claimed, and
the legal term of patents as determined by the applicable law in the countries in which those patents are obtained. Generally, patents
issued from applications filed in the United States are effective for 20 years from the earliest non-provisional filing date. In addition,
in certain instances, a patent term can be extended to recapture a portion of the term effectively lost as a result of the FDA regulatory
review period; however, the restoration period cannot be longer than five years and the total patent term including the restoration period
must not exceed 14 years following FDA approval. Additionally, patent term adjustments can extend the term to account for certain delays
by the USPTO during prosecution before that office. The duration of non-U.S. patents varies in accordance with provisions of applicable
local law, but typically, the life of a non-U.S. patent is 20 years from the earliest international filing date, not inclusive of any
patent term extension that may be available. The actual protection afforded by a patent varies on a product-by-product basis, from country
to country and depends upon many factors, including the type of patent, the scope of its coverage, the availability of extensions of
patent term, the availability of legal remedies in a particular country and the validity and enforceability of the patent.
National
and international patent laws concerning protein-based biologics such as our products remain highly unsettled. No consistent policy regarding
the patent eligibility or the breadth of claims allowed in patents in this field has emerged to date among the United States, Europe
or other countries. Changes in either the patent laws or in interpretations of patent laws in the United States or other countries can
diminish our ability to protect our inventions and enforce our intellectual property rights. Accordingly, we cannot predict the breadth
or enforceability of claims that may be granted in our patents or in third party patents. The biotechnology and pharmaceutical industries
are characterized by extensive intellectual property litigation. Our ability to maintain and solidify a proprietary position for our
product candidates and technology will depend on our success in obtaining effective claims in our patents and enforcing those claims
once a patent is granted. We do not know whether any of our patent applications will result in the issuance of any patents. Our issued
patents may be challenged, invalidated or circumvented, and the rights granted under any issued patents may not provide us with sufficient
protection or competitive advantages against competitors with similar technology. Furthermore, our competitors may independently develop
and commercialize similar drugs or duplicate our technology, business model or strategy without infringing our patents. Because of the
extensive time required for clinical development and regulatory review of any drug we may develop from our product candidates, it is
possible that, before any of our drugs can be commercialized, any related patent may expire or remain in force for only a short period
following commercialization, thereby reducing any advantage of any such patent.
As
of December 31, 2025, our patent portfolio consisted of 12 issued U.S. patents, 9 issued foreign patents, and 7 pending foreign patent
applications, which relate generally to the composition of our current and potential future products, their methods of use and methods of manufacture. Our issued patents are expected to expire between 2026 and 2038.
Trade
Secrets
We
rely, in part, upon trade secrets and know-how and continuing technological innovation and in-licensing opportunities to develop, strengthen
and maintain our competitive position. We seek to protect our proprietary information, in part, using confidentiality agreements with
our collaborators, employees and consultants, invention assignment agreements with our employees, and contractual protections in agreements
with third party vendors and collaborators. These agreements are designed to protect our proprietary information and, in the case of
the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party.
These agreements may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise
become known or be independently discovered by competitors. To the extent that our collaborators, employees and consultants use intellectual
property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
Trademarks
We
believe our rights under issued and pending trademarks are important and valuable and we strive to and intend to seek, maintain and defend
our trademark rights.
“Genelux”
is the subject of issued trademark registrations in the European Union, the United Kingdom, China and in several other countries.
Our
unregistered trademarks include “CHOICE”.
Competition
The
biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis
on proprietary rights. We face significant competition from many sources, including pharmaceutical, biopharmaceutical and biotechnology
companies. Potential competitors also include academic institutions, government agencies, and other public and private research organizations
that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and
commercialization of cancer therapies. Many of our potential competitors, alone or with their strategic partners, have substantially
greater financial, technical and other resources than we do, such as larger research and development, clinical, marketing and manufacturing
organizations. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated
among a smaller number of competitors.
Competition
in cancer therapeutics comes in many forms, where different technologies are employed against different molecular targets or biological
systems. These therapies include oncolytic viral immunotherapies, immunotherapy antibodies (including monoclonal antibodies, bi-specific
antibodies, and antibody-drug conjugates), cancer vaccines, cell-based therapies, therapies aimed at activating innate immunity, and
traditional cancer therapies like chemotherapy and radiation. We are developing next-generation oncolytic viral immunotherapies for the
treatment of cancer. Any viral immunotherapies that we successfully develop and commercialize will compete with existing therapies and
new therapies that may become available in the future.
We
believe that our product candidates, if and when marketed, would largely complement rather than compete directly with existing treatment
options.
PRROC
We
are aware of numerous companies either marketing or focused on developing competing therapies for the treatment of ovarian cancer, including
PRROC:
NSCLC
We
are conducting a Phase 2 clinical trial of Olvi-Vec for the treatment of recurrent NSCLC, and have not yet initiated a registrational
trial for Olvi-Vec in NSCLC. If we complete one or more registrational trials and achieve regulatory approval of Olvi-Vec for recurrent
NSCLC, we will face competition. Besides brand and generic chemotherapies used to treat NSCLC, there are many companies already marketing
competing products for NSCLC, including large pharmaceutical and biotechnology companies like Roche/Genentech, Inc., Merck & Co.,
Astrazeneca, Novartis Pharmaceuticals Corporation, Pfizer, Inc., Johnson & Johnson, Eli Lilly & Co., and Bristol Myers Squibb.
In addition, if Olvi-Vec completes one or more registrational trials and achieves regulatory approval, we expect there to be additional
product candidates approved for NSCLC by that time which would compete with Olvi-Vec.
SCLC
We
are conducting a Phase 1b/2 clinical trial of Olvi-Vec for the treatment of recurrent SCLC, and have not yet initiated a registrational
trial for Olvi-Vec in SCLC. If we complete one or more registrational trials and achieve regulatory approval of Olvi-Vec for recurrent
SCLC, we will face competition. Besides brand and generic chemotherapies used to treat SCLC, there are many companies already marketing
competing products for SCLC, including large pharmaceutical and biotechnology companies like Amgen, Roche/Genentech, Inc., Merck &
Co., Astrazeneca and Bristol Myers Squibb. In addition, if Olvi-Vec completes one or more registrational trials and achieves regulatory
approval, we expect there to be additional product candidates approved for SCLC by that time which would compete with Olvi-Vec.
Generic
Competition
The
enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Patient Protection and Affordable Care
Act as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA) created an abbreviated pathway for
the approval of biosimilar and interchangeable biological products. The abbreviated regulatory pathway establishes legal authority for
the FDA to review and approve biosimilar biological products, including the possible designation of a biosimilar as “interchangeable”
based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar product cannot be approved by
the FDA until 12 years after the original branded product was approved under a BLA. Certain changes, however, and supplements to an approved
BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest, or other related entity
do not qualify for the 12-year exclusivity period.
Olvi-Vec
and our other product candidates are all biological product candidates. We anticipate being awarded data exclusivity for each of our
biological product candidates that is subject to its own BLA for 12 years in the United States, up to 11 years in Europe and varying
durations in other markets.
GOVERNMENT
REGULATION AND PRODUCT APPROVAL
In
the United States, the FDA regulates biological products under the Federal Food, Drug, and Cosmetic Act (FDCA), the Public Health Service
Act (PHSA), and regulations and guidance documents implementing these laws. The FDCA, PHSA and their corresponding regulations govern,
among other things, the testing, manufacturing, safety, purity, potency, labeling, packaging, storage, record keeping, distribution,
reporting, advertising and other promotional practices involving biological products. Consent from the FDA is required before conducting
human clinical testing of biological products. FDA licensure also must be obtained before marketing of biological products. The process
of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations
require the expenditure of substantial time and financial resources.
U.S.
Biological Products Development Process
Any
biologic product must be licensed by the FDA before it may be legally marketed in the United States. The process required by the FDA
before a biologic product candidate may be marketed in the United States generally involves the following:
● Review of the product by an FDA advisory committee, if applicable;
The
testing and approval process of product candidates requires substantial time, effort, and financial resources. Satisfaction of the FDA’s
pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type,
complexity, and novelty of the product or disease. Before testing any biologic product candidate in humans, the product candidate must
undergo preclinical testing. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry,
toxicity and formulation, as well as in vivo studies to assess the potential safety and activity of the product candidate and to establish
a rationale for therapeutic use. The conduct of the preclinical tests must comply with federal regulations and requirements including
GLPs.
Concurrent
with clinical trials, companies usually are required to complete some long-term preclinical testing, such as animal tests of reproductive
adverse events and carcinogenicity, and must also develop additional information about the chemistry and physical characteristics of
the drug and finalize a process for manufacturing the drug in commercial quantities in accordance with cGMP requirements. The manufacturing
process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer
must develop methods for testing the identity, strength (potency), quality and purity of the final drug product. Additionally, appropriate
packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo
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 criteria, 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
trial patients. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to
comply with the IRB’s requirements or if the trial poses an unexpected serious harm to subjects. The FDA or an IRB may also impose
conditions on the conduct of a clinical trial. Clinical trial sponsors may also choose to discontinue clinical trials as a result of
risks to subjects, a lack of favorable results, or changing business priorities.
Compliance
with cGMP Requirements
Manufacturers
of biological products must comply with applicable cGMP regulations, including quality control and quality assurance and maintenance
of records and documentation. Manufacturers and others involved in the manufacture and distribution of such products also must register
their establishments with the FDA and certain state agencies. Both domestic and foreign manufacturing establishments must register and
provide additional information to the FDA upon their initial participation in the manufacturing process. Establishments may be subject
to periodic, unannounced inspections by government authorities to ensure compliance with cGMP requirements and other laws. Discovery
of problems may result in a government entity placing restrictions on a product, manufacturer or holder of an approved BLA, and may extend
to requiring withdrawal of the product from the market. The FDA will not approve a BLA unless it determines that the manufacturing processes
and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
Concurrent
with clinical trials, companies usually complete additional preclinical studies and must also develop additional information about the
physical characteristics of the biologic product candidate as well as finalize a process for manufacturing the product candidate in commercial
quantities in accordance with cGMP requirements. To help reduce the risk of the introduction of adventitious agents or of causing other
adverse events with the use of biological products, the PHSA emphasizes the importance of manufacturing control for products whose attributes
cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate
and, among other requirements, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the
final biologic product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate
that the biologic product candidate does not undergo unacceptable deterioration over its shelf life.
In