NASDAQ: GLSI

GM-CSF
is available in lyophilized form exclusively from one manufacturer. We will continue to be dependent on the manufacturer for our supply
of GM-CSF in our ongoing GP2 clinical trials and upon potential commercialization of GP2. Although GM-CSF is only approved for sale in
the U.S. by the FDA and is available in other countries on a named patient basis through a specialized company that focuses on making
products approved in the U.S. available globally, GM-CSF may be registered for sale in other countries by the manufacturer in the future.

Cancer
Immunotherapy

Cancer
immunotherapy is a new method of cancer treatment among more established treatment options such as surgery, chemotherapy, targeted therapy,
and radiation therapy. This method seeks to stimulate an individual’s immune system to selectively attack cancer cells while not
affecting normal cells or to deliver certain immune system components in order to inhibit the spread of cancer. Thus, cancer immunotherapy
is an important and rapidly emerging field, which has led to new clinical research studies and garnered the attention of biotechnology
and pharmaceutical companies, regulatory agencies, payors and hospital systems, cancer patients and their families, and the general public
at large.

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Cancer
immunotherapy harnesses the body’s natural immune system response to fight and/or prevent tumor growth. An essential characteristic
of the immune system, which is a network of tissues, cells, and signaling molecules that work to protect the body, is its ability to
differentiate foreign threats, including cancerous growths, from normal cells. Despite the fact that tumor cells originate from normal
cells, tumor cells can be recognized as foreign threats because of their ability to elicit the production of tumor antigens. These antigens
may be released in the interstitial tissues, and eventually in the bloodstream or may remain on the surface of cognate cancer cells.
The HER2/neu protein is one of the most widely expressed tumor antigens in multiple malignances.

Several
cell types play an important role in the development and maintenance of immune responses against cancer. The most important cell types
with regard to immune response are antigen-presenting cells (“APCs”) and lymphocytes. APCs include various subtypes, such
as dendritic cells, monocytes and macrophages. Once a patient is exposed to a tumor antigen (either by the presence of cancer itself
or through active immunization through a vaccine type immunotherapeutic), the tumor antigen gets recognized by the APC and becomes “processed”
through digestion into smaller fragments within the APC. Subsequently, the APC “communicates” with a specific type of lymphocyte
called a T-cell. Inactive T-cells search for tumor antigens by transiently binding to antigens presented by major histocompatibility
complexes (“MHCs”) on the APCs. There is great variability in the expression of different subtypes of MHCs in the human population.
The MHC system expresses human leukocyte antigens (“HLAs”) and these HLA subtypes determine the vigor and duration of any
given T-cell response to a cancer among different patients.

As
shown below, following GP2 immunotherapy, CD8+ cytotoxic T lymphocytes recognize and destroy HER2/neu-expressing cancer cells.
GP2 is administered in combination with an FDA-approved immunoadjuvant GM-CSF, which stimulates the proliferation of antigen presenting
cells. Preclinical studies have shown that T cells sensitized against the GP2 peptide demonstrate significant recognition of HER2/neu-expressing
tumors. Both ovarian and breast cancer-specific CTLs recognize GP2, which is widely expressed in HER2/neu-expressing tumors and
is capable of inducing tumor-specific CTL populations in vitro.

Breast
Cancer Treatment Approach — Adjuvant & Neoadjuvant Treatments

As
shown below, in the adjuvant setting, a HER2/neu 3+ patient typically receives Herceptin in the first year following breast cancer
surgery, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years
following surgery. Herceptin has been shown to reduce recurrence rates by approximately 50%, from 25% to 12%, in the adjuvant setting.
In the neoadjuvant setting, a HER2/neu 3+ patient receives treatment before surgery and based on the results of a biopsy at surgery,
will receive Herceptin or Kadcyla, a more potent form of Herceptin, following surgery. Kadcyla has been shown to reduce recurrence rates
by 50%, from 22% to 11%, in the neoadjuvant setting. Accordingly, we believe that GP2 may be effective in safely addressing the 50% of
recurring patients who do not respond to either Herceptin or Kadcyla.

GP2
is administered in combination with the immunoadjuvant GM-CSF in years 2-4, following the first year of treatment with Herceptin, in
a series of 11 intradermal injections comprising 6 primary injections over 6 months (1 injection per month) followed by 5 booster injections
every 6 months thereafter.

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The
adverse events observed to date have been well-tolerated with no SAEs reported in the Phase IIb clinical trial considered related to
GLSI-100 treatment. Therefore, GLSI-100 is well-positioned to serve this population at this stage of treatment. We believe that clinicians
and patients are seeking a de-escalation and a return to normal life free of toxic treatments, especially if the chance of recurrence
is reduced substantially. GLSI-100 may significantly reduce the incidence of recurrence/metastatic disease and need for additional therapy.
Lastly, we believe that GP2 may be the treatment that will synergistically overlap with or follow trastuzumab based treatments, such
as Herceptin, Kadcyla, Enhertu or any of the other Herceptin derivatives or antibody drug conjugates being developed.

GP2
Clinical Data & Phase III Clinical Trial (Flamingo-01)

In
the Phase IIb and 3 Phase I clinical trials where 146 patients received GP2 immunotherapy, there were no serious adverse events observed
related to the immunotherapy or any other GP2 combination treatments.

Clinical
Trial Description

Status

GP2
Phase III Clinical Trial – Flamingo-01

Enrolling
in US

●
A
Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100
(GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative
Trastuzumab-based Therapy

and
Europe

GP2
Phase IIb Clinical Trial

Trial
Completed

●
Prospective,
Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in
HLA-A*02+ Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence

●
89
patients treated with GP2 + GM-CSF, 91 placebo patients treated with GM-CSF

GP2
Phase I Clinical Trial — Combination with AE37

Trial
Completed

●
Phase
I Safety Trial of the GP2 + GM-CSF Vaccine in Combination with the Helper Peptide AE37 + GM-CSF Vaccine

●
22
patients treated with GP2 + AE37 + GM-CSF

GP2
Phase I Clinical Trial — Combination with Trastuzumab

Trial
Completed

●
Phase
Ib Trial of Combination Immunotherapy with HER2/neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients

●
17
patients treated with GP2 + GM-CSF + trastuzumab

First
GP2 Phase I Clinical Trial

Trial
Completed

●
Phase
Ib Trial of HER2/neu Peptide (GP2) Vaccine in Breast Cancer Patients

●
18
patients treated with GP2 + GM-CSF

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Phase
I Clinical Trials

First
GP2 Phase I Clinical Trial

As
shown in the table above, the first GP2 Phase I clinical trial was conducted at Walter Reed Army Medical Center. The clinical trial was
conducted in patients over the age of 18 years with a diagnosis of HER2/neu 1-3+, node negative breast cancer who had undergone
primary surgical and medical therapies and who were without evidence of disease at the time of enrollment into the clinical trial. Patients
were HLA typed and HLA-A*02 patients were skin tested for recall antigens. HLA-A*02 patients found to be immunologically intact received
the vaccine. There were no grade 3-5 toxicities observed among the 18 patients that received a total of 108 doses of GP2 + GM-CSF. Among
all patients that participated in the clinical trial, the maximum observed local toxicity that occurred was grade 1 in 38.9% and grade
2 in 61.1% of the patients. The maximum systemic toxicity observed during the clinical trial was grade 0 in 5.6%, grade 1 in 61.1%, and
grade 2 in 33.3% of the patients. The most common local reactions included erythema and induration (100% of patients), pruritis (25%),
and inflammation (23%). The most common systemic reactions were grade 1 fatigue (40%) and grade 1 arthralgia/myalgia (15%). There were
no recurrences and no deaths reported among the patients that participated in the clinical trial. Additional data analysis reported by
the investigators, included topics such as pre-existing immunity, effects of dosing, and epitope spreading.

GP2
Phase I Clinical Trial — Combination with Trastuzumab

Preclinical
research previously demonstrated that a synergy may exist between trastuzumab and GP2 peptide-stimulated CTLs ex vivo. Pretreatment of
breast cancer cells with trastuzumab followed by incubation with GP2 peptide-induced CTLs resulted in enhanced cytotoxicity in 3 tumor
cell lines compared to treatment with trastuzumab or GP2-specific CTLs alone. These results suggest that concurrent GP2 vaccination during
trastuzumab therapy may be a possible combination immunotherapy.

As
shown in the table above, a Phase I trial evaluating the combination therapy of GP2 + GM-CSF administered simultaneously with trastuzumab
was conducted. The combination therapy was found to be well tolerated when given concurrently in 17 clinically disease-free, HER2/neu
over-expressing breast cancer patients.

GP2
Phase I Clinical Trial — Combination with AE37

As
shown in the table above, a Phase I trial evaluating the combination therapy of GP2 + GM-CSF administered simultaneously with HER2/neu
peptide AE37 in 22 clinically disease-free, HER2/neu breast cancer and ovarian cancer patients was conducted. While 28 patients
enrolled, 22 were treated and 14 patients completed the 6 vaccination series. Final results suggest that the combination of GP2 and AE37
peptides is well tolerated at each of the tested dosing levels. Additionally, we believe that the combination is capable of stimulating
strong peptide-specific in vivo immune responses.

During
the primary vaccination series, an AE37/GP2+GM-CSF dual peptide vaccine resulted in robust T-cell proliferation. However, significant
immune responses became more variable at 6 and 12 months post vaccination suggesting the need for boosters in some individuals.

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Phase
II Clinical Trial

GP2
Phase IIb Clinical Trial Overview

Phase
II Clinical Trial Study Report: We are preparing a comprehensive study report of the Phase II trial for the FDA prior to the filing
of a BLA. This report will include the patients with breast cancer recurrences, the last known date of patients who did not recur (censoring
data), the adverse events, immune responses, and other final study report analyses. This report will serve to complement the Phase III
data and to provide a drug product dossier that can also be submitted to regulatory agencies in other countries for marketing approval.
The use of GM-CSF as an adjuvant in GLSI-100 may also be included in the dossier as GM-CSF is only commercially available in the US at
this time.

We
have experienced significant interest from investors, strategics, analysts, and regulators in the 5 year follow-up data we published
and the 3 and 4 year follow-up data independently published by the clinical investigators. The differences between these publications
can be best explained by the increased maturity of the data as each year progressed. In all 3 publications, no recurrences or a 100%
reduction in recurrence rate, were reported in the sub-population that the Flamingo-01 design has been based on and any differences between
the number of patients in the treated or placebo groups has been shown to be immaterial.

We
did not have responsibility for the conduct of the trial or for the data from the Phase II trial. After the trial had already started,
we received the rights to the Phase II trial data pursuant to a license agreement with the Henry Jackson Foundation (HJF) that entitled
us to all of the GP2 data from the Phase II trial and all prior trials, but did not provide us with the ability to participate in the
Phase II trial as a regulatory clinical sponsor. The lead clinicians and HJF were responsible for project and site management, medical
monitoring, data monitoring of case report forms (CRFs), correspondence with the FDA, and creation, data entry and management of the
database. We were provided study updates but were not provided an opportunity to participate in any of the above activities or to review
the publications of the 3 and 4 year follow-up data by the lead clinicians. Thus, the comprehensive study report will rely on cooperation
from HJF and the clinical sites who are responsible for providing the final data accurately to us.

We
are currently comparing the final CRFs and database provided by HJF and have noted the following inconsistencies as the comprehensive
study report is being prepared. The lead clinicians reported in an annual report to the FDA and in their publication of 4 year follow-up
data a 6th recurrence in the HER2 positive control arm of the study. We conservatively chose not to report this 6th recurrence since
it was not reported in the data provided by HJF, even though adding this recurrence to the control arm would significantly lower the
p-value and improve the evidence of efficacy of GLSI-100. As a result of detailed due diligence, we became aware in Q4 of 2023 of a potential
recurrence in the HER2 positive treated arm. This patient was not reported as a recurrence in the database, on a CRF that should be used
for a recurrence, in reports from the lead clinicians to the FDA, or in the 3 or 4 year follow-up data published by the lead clinicians.
Some CRFs report a recurrence, but the critical CRF that confirms a recurrence was not completed or entered into the database provided
by HJF. We have since initiated an effort to confirm with HJF and the clinicians who treated this patient the status of this patient,
and if the final CRFs and database should be modified. It appears that this patient, who had completed treatment with GLSI-100, experienced
a local recurrence that responded well to additional treatment and survived without additional evidence of disease or distant metastasis
for the duration of study follow-up. Any discrepancies noted to date in the review of the censoring date recorded in the database do
not materially change the study results and the median duration of follow-up remains 5 years.

While
a recurrence in the control arm would decrease the p-value and still result in a 100% reduction in the recurrence rate, a recurrence
in the treated arm would increase the p-value and would result in an 80% reduction in the recurrence rate. In either case, we believe
that the reduction in recurrence rate is clinically meaningful and substantial compared to the approximately 20-50% reduction in recurrences
of all other approved breast cancer drugs for this patient population. These findings have not materially affected the power of the Phase
III study as the assumptions for that design were selected conservatively.

In
a prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical
trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100 and 50 placebo patients
were treated with GM-CSF alone. After 5 years of follow-up, there was a substantial reduction in cancer recurrences in the HER2/neu
3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the
time required to reach peak immunity and thus maximum efficacy and protection. Based on this data, we believe that treatment with GLSI-100
starting approximately in the second year following surgery may dramatically lower breast cancer recurrences in this patient population.

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The
design of the Phase IIb trial was as follows:

●
Prospective,
randomized, single-blinded, placebo-controlled phase IIb clinical trial of GP2 + GM-CSF or GM-CSF alone in HER2/neu 1-3+,
HLA-A*02 patients.

●
High-risk
breast cancer patients (Node Positive, High Risk Node Negative) who were disease-free and immunocompetent after having completed
standard of care therapy.

●
The
primary endpoint was to determine if GP2 + GM-CSF reduces breast cancer recurrence rates versus GM-CSF alone. A recurrence is defined
as either a pathologically confirmed recurrence or a new radiographic finding of recurrence during standard of care follow-up.

The
Phase IIb clinical trial closed in December 2018. The final median 5 year follow-up data is presented below. A total 180 intent-to-treat
patients enrolled in the clinical trial. HER2/neu status was determined based on the expression levels of the HER2/neu
protein in each patient using standard of care HER2/neu diagnostic technology. The trial was prospectively designed to analyze
these fully treated patients by 2 distinct patient populations, namely HER2/neu 3+ (positive or over expressors) and HER2/neu
1-2+ (low to intermediate expressors):

●
HER2/neu
3+ Positive Over Expressors: In the 96 HER2/neu 3+, HLA-A*02 patients, a substantial reduction in recurrences was observed
in the efficacy population. A patient was in the efficacy population if they were treated, followed, and remained disease free over
the first 6 months, which is the time we believe is required to reach peak immunity and thus maximum efficacy and protection. This
patient population was treated with GLSI-100 following the first year of trastuzumab treatment, which followed surgery.

●
HER2/neu
1-2+ Low to Intermediate Expressors: In the 72 HER2/neu 1-2+, HLA-A*02 patients, no reduction in recurrence rates were
observed, but trastuzumab was not administered to these patients. Thus, we may pursue a future trial with GP2 in combination with
trastuzumab based therapy and other synergistic agents.

5
Year Data Set of GP2 Phase IIb Trial: HER2 3+ (Positive or Over Expressors) Patients Who are in the Efficacy Population

The
figure below shows a time series of the GLSI-100 immunotherapy injections, adverse events (“AE”), immune response, and 100%
disease-free survival (0% recurrence rate) in HER2 positive breast cancer patients over median 5 years. The Kaplan Meier curve and p
value, which are based on recurrence rates or disease free survival and censoring data, is subject to change pending the completion of
the Phase II Clinical Trial Study Report described above. This time series highlights that the 10 GLSI-100 immunotherapy injections over
the first 2.5 years (as depicted by the 10 arrows on the x-axis) demonstrated a potent immune response that typically peaked at 6 months.
The immune response also included injection site and systemic reactions that peaked at approximately 6 months. We believe that these
AEs are a positive sign that the immune system responded to GLSI-100 immunotherapy and contributed to the decline in metastatic breast
cancer recurrence. The observed AEs associated with GLSI-100 injections were temporary and declined after GLSI-100 injections ended.

Safety
& Immune Response Data of GP2 Phase II Trial

In
both the HER2/neu 3+ and the HER2/neu 1-2+ patient populations, GP2 was shown to be well tolerated. The observed AEs primarily
consisted of injection site reactions which could be mitigated by reducing the GM-CSF dose (and then the GP2 dose, if necessary). No
SAEs reported in the GP2 treated patients were considered attributable to GLSI-100.

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GLSI-100
immunotherapy demonstrated GP2-specific immune responses, which we believe supports GP2’s mechanism of action. Statistically significant
peak immunity was typically observed after 6 months of GLSI-100 treatment, as measured in both the Dimer Binding Assay and the Delayed
Type Hypersensitivity (DTH) skin test. The HER2/neu 3+ population’s immune response was similar to the HER2/neu 1-2+ population’s
immune response, suggesting the potential to treat the HER2/neu 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy
in combination with trastuzumab (Herceptin) based products and other synergistic clinically active agents. The broad based immune response
suggests the potential for GP2 to treat other HER2/neu 1-3+ expressing cancers. Further, booster injections given every 6 months after
the PIS were observed to elicit a prolonged immune response, which may provide longer term protection.

Phase
III Trial, Flamingo-01

We
have commenced Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site. Flamingo-01includes
an interim analysis and uses a similar treatment regime
as the Phase IIb clinical trial.

The
primary objective of Flamingo-01 is to assess the safety and efficacy of GLSI-100 compared to placebo in HLA-A*02 positive and HER2/neu
positive breast cancer patients who have a high risk of disease recurrence (stage I, II, or III at presentation with residual disease
at surgery or stage III at presentation with pathologic complete response (“pCR”) at surgery) and have completed both neoadjuvant
and postoperative adjuvant trastuzumab-based standard of care therapy.

An
overview of the anticipated Phase III clinical trial design is shown below:

U.S.
and European Breast Cancer Market

We
believe that the market for GP2 is large. The American Cancer Society estimates that approximately 1 in 8 U.S. women (12.8%) will develop
invasive breast cancer over her lifetime. The American Cancer Society, Economic Impact, & European Cancer Information System 2025
estimate approximately 700,000 new breast cancer patients per year and 9.5 million current breast cancer survivors in the U.S. and Europe
in 2025. An estimated 42,000 female breast cancer deaths will occur in the U.S. in 2025. HER2/neu 3+ breast cancer patients comprise
approximately 25% of all breast cancer patients. Approximately 40% to 50% of the U.S. and European population contains the HLA-A*02 allele,
while node positive and high risk node negative patients comprise approximately 50% of the market. Therefore, we believe that the U.S.
market for the first indication for GP2, if approved, could be the combination of the three populations above which together comprises
approximately 6.25% of breast cancer patients who undergo surgery.

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Competition

Cancer
immunotherapy has become a significant growth area for the biopharmaceutical industry, attracting large pharmaceutical companies as well
as small niche players. Generally, our principal competitors in the cancer immunotherapy market comprise both types of companies with
currently approved products for various indications, such as manufacturers of approved bispecific antibodies, CAR-T cells, and checkpoint
inhibitors, as well as companies currently engaged in cancer immunotherapy clinical development. The large and medium-size players who
have successfully obtained approval for cancer immunotherapy products include Bristol-Myers Squib Company, Merck & Co., Inc., Genentech,
Inc. (a subsidiary of Roche Holding AG), AstraZeneca PLC, Celgene Corporation, Johnson & Johnson, Amgen, Novartis, Juno Therapeutics,
Inc. (a subsidiary of Celgene), Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc. and Pfizer, Inc./EMD Serono, Inc.
Most of these companies, either alone or together with their collaborative partners, have substantially greater financial resources than
we do.

Companies
developing novel products with similar indications to those we are pursuing are expected to influence our ability to penetrate and maintain
market share, if GLSI-100 is approved. For patients with early stage breast cancer, adjuvant or neoadjuvant therapy is often given to
prevent recurrence and increase the chance of long-term disease free survival. Adjuvant or neoadjuvant therapy for breast cancer can
include chemotherapy, hormonal therapy, radiation therapy, or combinations thereof. In addition, the HER2 targeted drug Herceptin (trastuzumab
or biosimilar) alone or in combination with Perjeta (pertuzumab), both manufactured and marketed by Roche/Genentech, may currently only
be given to patients with tumors with high expression of HER2/neu. Following adjuvant treatment in the first year following surgery,
only Nerlynx is approved for extended andjuvant treatment and would potentially compete with GLSI-100 if not used synergistically. We
believe that GP2 will act synergistically with Herceptin, Perjeta, Nerlynx, and the newest entrants Kadcyla and Enhertu.

There
are a number of approved HER2/neu targeted therapies, some of which include the following: Genentech’s Herceptin, Perjeta
(pertuzumab) and Kadcyla (TDM-1, ado-trastuzumab emtansine); Puma’s Nerlynx (neratinib); Daichi Sanko’s Enhertu (TDXD, fam-trastuzumab
deruxtecan-nxki), and Seattle Genetics’ Tukysa (tucatanib). In addition, the following biosimilars to trastuzumab have been approved:
Biocon/Mylan’s (Ogivri — trastuzumab-dkst; Celltrion/Teva’s (Herzuma — trastuzumab-pkrb); Samsung/Biogen/Merck’s
(Ontruzant — trastuzumab-dttb); Pfizer’s (Trazimera — trastuzumab-qyyp); and Allergan/Amgen’s (Kanjinti; trastuzumab-anns).
Furthermore, the following immune checkpoint inhibitors have also been approved or are under review by the FDA to treat breast cancer
patients: Merck’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolumab). Moreover we believe that drug candidates
from Sellas (formerly Galena), Marker (formerly TapImmune), Epithany, Antigen Express (Generex subsidiary), and various companies pursuing
neoantigen technologies are in clinical development and are being pursued for different sub-populations or are behind GP2 in clinic development.

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Many
of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources
than we do, and more experience in obtaining FDA and other regulatory approvals of treatments and in commercializing those treatments.
Accordingly, our competitors may be more successful than us in obtaining approval for cancer immunotherapy products and achieving widespread
market acceptance. Our competitors’ treatments may be more effectively marketed and sold than any products we may commercialize,
thus causing limited market share before we can recover the expenses of developing and commercializing our cancer immunotherapy product
candidate.

Mergers
and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller
number of our competitors. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies. These activities may lead to consolidated efforts that allow for more rapid development
of cancer immunotherapy product candidates.

These
competitors also compete with us in the recruiting and retaining of qualified scientific and management personnel, the ability to work
with specific clinical contract organizations due to conflict of interest, and the conduct of trials in the ability to recruit clinical
trial sites and patients for our clinical trials.

We
expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, price, and the
availability of coverage and reimbursement from government and other third-party payors. Our commercial opportunity could be reduced
or eliminated if our competitors develop and commercialize products that are viewed as safer, more convenient, or less expensive than
any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than
we may obtain approval for our current product candidate or any other future product candidate, which could result in our competitors
establishing a strong market position before we are able to enter the market.

Manufacturing

We
do not own or operate manufacturing facilities for the production of our product candidate nor do we have plans to develop our own manufacturing
operations in the foreseeable future. We currently depend on third-party contract manufacturers for all of our required raw materials,
active pharmaceutical ingredients (“APIs”), and finished product candidate for our clinical trials and potential commercial
supply.

Exclusive
License

The
Henry M. Jackson Foundation out-licenses technology of the U.S. military and it conducts research and manages clinical trials. HJF managed
the GP2 Phase IIb clinical which was led by MD Anderson Cancer Center, oversaw all regulatory filings with the FDA for all 4 GP2 clinical
trials (including the 3 Phase I and the Phase IIb clinical trials), and possesses all patient and manufacturing data from such trials.

In
April 2009, we entered into an exclusive license agreement, as amended, with HJF pursuant to which HJF granted us exclusive worldwide
rights to several U.S. and foreign patents and patent applications covering methods of using GP2 as an immunotherapy that elicits a targeted
immune response against HER2/neu-expressing cancers. In consideration for such licensed rights, we issued HJF 202,619 shares of
our common stock. In addition, we are required to pay an annual maintenance fee and milestone payments of up to an aggregate of $5.7
million. We are also required to make 2.5-5% royalty payments based on the sales of GP2 and to reimburse HJF for patent expenses. To
date we have not been required to make any milestone or royalty payments to HJF. The term of the exclusive license shall terminate at
such time that the last licensed patent or patent application expires or is abandoned, unless terminated earlier pursuant to the terms
of the exclusive license agreement. We may terminate the license by giving 90 days notice. HJF may terminate the license if we do not
make required payments, if we default in our performance obligations, if we do not sufficiently develop and advance GP2 towards commercialization,
and for various other reasons.

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In
connection with the exclusive license agreement with HJF, we were the financial and corporate sponsors of the GP2 Phase IIb clinical
trial. HJF has provided us with all FDA correspondences and GP2 patient and manufacturing data for the history of the drug’s development
for all 4 clinical trials, and we have incorporated this data into our corporate investigational new drug application (“IND”)
with the FDA.

Intellectual
Property Portfolio

Our
commercial success depends in part on our ability to avoid infringing the proprietary rights of third parties, our ability to obtain
and maintain proprietary protection for our technologies where applicable, and our ability to prevent others from infringing our proprietary
rights. We intend to protect our proprietary technologies by, among other methods, evaluating relevant patents, establishing defensive
positions, monitoring European Union oppositions and pending intellectual property rights, preparing litigation strategies in view of
the U.S. legislative framework, and filing U.S. and international patent applications on technologies, inventions and improvements that
are important to our business. Patents and other intellectual property rights are crucial to our success. We intend to protect our intellectual
property rights through available means including filing and prosecuting patent applications in the U.S. and other countries, protecting
trade secrets, and utilizing regulatory protections such as data exclusivity. In addition, we include restrictions regarding use and
disclosure of our proprietary information in our contracts with third parties, and utilize customary confidentiality agreements with
our employees, consultants, clinical investigators, and scientific advisors to protect our confidential information and know-how. Together
with our licensors, we also rely on trade secrets to protect our combined technology especially where we do not believe patent protection
is appropriate or obtainable. It is our policy to operate without knowingly infringing on, or misappropriating, the proprietary rights
of others.

An
international patent law treaty (“PCT”) provides a unified procedure for filing patent applications to protect inventions
in each of its contracting states. Thus, a single PCT application can be converted into a national stage patent application in any of
the more than 145 PCT contracting states, and is considered a simple, cost-effective means for seeking patent protection in numerous
regions or countries. This nationalization (converting into an application in any of the contracting states) typically occurs 18 months
after the PCT application filing date. We also rely on trade secrets, know-how, and continuing technological innovation to develop and
maintain our proprietary position.

The
term of individual patents depends upon the legal term of the patents in countries in which they are obtained. In most countries, including
the U.S., the patent term is generally 20 years from the earliest date of filing a non-provisional patent application in the applicable
country. In the U.S., a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee
for administrative delays by the U.S. Patent and Trademark Office in examining and granting a patent or may be shortened if a patent
is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date.

HJF
License

Pursuant
to our exclusive license agreement with HJF, we were granted exclusive worldwide rights to several U.S. and foreign patents and patent
applications covering methods of using GP2. The GP2 issued patents provide protection ranging from 2026 through 2032 in major markets
such as the U.S., Europe, Japan, Australia, and Canada, with ongoing prosecution of pending patent applications in other markets. We
plan to register GP2 as a biologic, which may be subject to 10-12 years market exclusivity in the U.S. upon receiving marketing approval.

The
following summarizes the two patent families subject to our exclusive license agreement with HJF. We have licensed rights to issued patents
and pending patent applications in certain countries with respect to the two patent families below and do not own or have rights to any
other patents or patent applications for GP2 or any other products:

●
GP2
+ GM-CSF Patent Family — A patent application has been filed and licensed describing methods and compositions for the induction
of a cytotoxic T-cell response to the GP2 peptide with the effect of inducing and maintaining a protective or therapeutic immunity
against breast cancer. Patent claims describe the use of the GP2 technology including dosing, formulation, identification of patients,
and use in combination with GM-CSF. Patents issued in the U.S. will expire in 2032 and 2029 and international patents will expire
in 2029.

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●
GP2
+ Herceptin Patent Family — A patent application has been filed and licensed describing methods and compositions of GP2 peptide
in combination with a HER2/neu targeting antibody such as Herceptin. U.S. and certain foreign patent claims describe the method
and timing of administration. Patents issued in the U.S. will expire in 2028 and 2026 and international patents will expire in 2026.

Corporate
Strategy

We
do not have a sales, marketing, or product distribution strategy for our GP2 immunotherapy or any future product candidates because GP2
is still in clinical development. Our future commercial strategy, if our GP2 immunotherapy or any future product candidates are approved,
may include the use of strategic partners, distributors, a contract sales force, or the establishment of our own commercial and specialty
sales force for the U.S. market, as well as similar strategies for regions and territories outside the U.S. We plan to further evaluate
these options as we approach submission of a new drug application or biologics license application for one our product candidates for
one or more indications.

The
GP2 issued patents provide protection ranging from 2026 through 2032 in various markets, and we plan to register GP2 as a biologic, which
may be subject to 10-12 years market exclusivity in the U.S. upon receiving marketing approval. During this period of exclusivity, we
intend to advance GP2 into a Phase III clinical trial in the U.S. and pursue a European and global clinical trial strategy to support
GP2 registration outside of the U.S. We are considering various options to fund the Phase III clinical trial including financing and/or
strategic transactions. Our strategy during such time also includes building a commercialization team, pursuing additional funding, and
pursuing strategic collaborations to support the future global marketing and sales of GP2, if approved. A long term global and regional
licensing process has been initiated and will continue as the Phase III trial commences.

Pipeline
Strategy — Including GP2 In Other HER2/neu-Expressing Cancers

We
are developing follow-on indications for GP2 by designing and planning additional clinical trials to expand the breast cancer patient
population and to pursue additional HER2/neu-expressing cancers. Pending the receipt of sufficient capital, the Phase III clinical
trial can be supplemented with additional clinical trials designed to evaluate the safety and efficacy of GLSI-100 in (1) patients immediately
upon diagnosis in parallel to neoadjuvant treatment and surgery to provide maximum protection against breast cancer recurrence as soon
as possible, (2) other HLA patients in the same HER2/neu 3+ breast cancer patient population, (3) breast cancer patients who are
low to intermediate expressors of HER2/neu (1-2+) or (4) other HER2/neu-expressing cancers including, but not limited to,
ovarian, gastrointestinal, and colon cancers.

Government
Regulations

The
FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among
other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,
storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting
of biologics such as those we are developing. Along with third-party contractors, we will be required to navigate the various preclinical,
clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct clinical
trials or seek approval or licensure of our current product candidate or any future product candidates. 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. A company can make only those claims relating to safety and efficacy, purity and potency
that are approved by the FDA and in accordance with the provisions of the approved label.

The
process required by the FDA before biologic product candidates may be marketed in the U.S. generally involves the following:

●
completion
of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices,
or GLP, regulations;

●
submission
to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant
changes are made;

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●
approval
by an independent IRB or ethics committee at each clinical site before the trial is begun;

●
performance
of adequate and well-controlled human clinical trials to establish the safety and efficacy of product;

●
manufacture
of product with adequate controls so that the product has the purity and potency of the proposed biologic product candidate for its
intended purpose;

●
preparation
of and submission to the FDA of a BLA, after completion of all pivotal clinical trials;

●
satisfactory
completion of an FDA Advisory Committee review, if applicable;

●
a
determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

●
satisfactory
completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced
to assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to preserve the biological product’s
continued safety, purity and potency, and of selected clinical investigations to assess compliance with GCP; and

●
FDA
review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the U.S., which
must be updated annually when significant changes are made.

The
testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for
our current product candidate or any future product candidates will be granted on a timely basis, if at all. Prior to beginning the first
clinical trial with a product candidate, a sponsor must submit an IND to the FDA. An IND is a request for authorization from the FDA
to administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational
plan and the protocol(s) for clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology,
pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information;
and any available human data or literature to support the use of the investigational product. An IND must become effective before human
clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day
time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical
hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission
of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

Clinical
trials involve the administration of the investigational product to human patients under the supervision of qualified investigators in
accordance with GCP, which include the requirement that all research patients provide their informed consent for their participation
in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial,
the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing
IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments.
Furthermore, an IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and
its informed consent form before the clinical trial begins at that site and must monitor the clinical trial until completed. Regulatory
authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the patients
are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some clinical trials also
include oversight by a Data and Safety Monitoring Board, or DSMB, organized by the clinical trial sponsor, which provides authorization
for whether or not a clinical trial may move forward at designated check points based on access to certain data from the clinical trial
and may halt the clinical trial if it determines that there is an unacceptable safety risk for patients or other grounds, such as no
demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical trials and clinical trial results
to public registries.

For
purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

●
Phase
1 — The investigational product is initially introduced into healthy human patients or patients with the target disease
or condition. These clinical trials are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of
the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence
on effectiveness.

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●
Phase
2 — The investigational product is administered to a limited patient population with a specified disease or condition to
evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.
Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical
trials.

●
Phase
3 — The investigational product is administered to an expanded patient population to further evaluate dosage, to provide
statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed
clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product
and to provide an adequate basis for product approval.

●
Phase
4 — In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product
is approved to gain more information about the product. These so-called Phase 4 clinical trials may be made a condition to approval
of the BLA.

Phase
1, Phase 2 and Phase 3 testing may not be completed successfully within a specified period, if at all, and there can be no assurance
that the data collected will support FDA approval or licensure of the product. Concurrent with clinical trials, companies may complete
additional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize
a process for manufacturing the product 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, must develop methods for testing
the identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency. 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.

BLA
Submission and Review by the FDA

Assuming
successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development,
nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or
more indications. The BLA must include all relevant data available from pertinent preclinical studies and clinical trials, including
negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry,
manufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored clinical trials intended to
test the safety and effectiveness of a use of the product, or from a number of alternative sources, including clinical trials initiated
by investigators. The submission of a BLA requires payment of a substantial user fee to FDA, and the sponsor of an approved BLA is also
subject to annual product and establishment user fees. These fees are typically increased annually. A waiver of user fees may be obtained
under certain limited circumstances.

Once
a BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application for filing,
or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months after the FDA accepts
the application for filing. The review process is often significantly extended by FDA requests for additional information or clarification.
The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured,
processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may convene
an advisory committee to provide clinical insight on application review questions. Before approving a BLA, the FDA will typically inspect
the facility or facilities where the product is manufactured. The FDA will not approve an application 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. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable,
it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission
of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria
for approval.

The
testing and approval process requires substantial time, effort and financial resources, and each may take several years to complete.
The FDA may not grant approval on a timely basis, or at all, and we may encounter difficulties or unanticipated costs in its efforts
to secure necessary governmental approvals, which could delay or preclude us from marketing our product. After the FDA evaluates a BLA
and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the
FDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with
specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application
is complete and the application is not ready for approval. A Complete Response Letter may request additional information or clarification.
The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information
and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

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If
regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which such product may be
marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, plan to mitigate risks, which
could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods,
patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed
labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance
with pre- and post-marketing regulatory standards is not maintained or if problems occur after the product reaches the marketplace. The
FDA may require one or more Phase 4 post-market clinical trials and surveillance to further assess and monitor the product’s safety
and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing
clinical trials. In addition, new government requirements, including those resulting from new legislation, may be established, or the
FDA’s policies may change, which could delay or prevent regulatory approval of our product under development.

A
sponsor may seek approval of its product candidate under programs designed to accelerate FDA’s review and approval of new drugs
and biological products that meet certain criteria. Specifically, new drugs and biological products are eligible for Fast Track designation
if they are intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for
the condition. For a product candidate with Fast Track designation, the FDA may consider sections of the BLA for review on a rolling
basis before the complete application is submitted if relevant criteria are met. A Fast Track designated product candidate may also qualify
for priority review, under which the FDA sets the target date for FDA action on the BLA at six months after the FDA accepts the application
for filing. Priority review is granted when there is evidence that the proposed product would be a significant improvement in the safety
or effectiveness of the treatment, diagnosis, or prevention of a serious condition. If criteria are not met for priority review, the
application is subject to the standard FDA review period of 10 months after FDA accepts the application for filing. Priority review designation
does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.

Under
the Accelerated Approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to
predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably
likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity,
or prevalence of the condition and the availability or lack of alternative treatments. Post-marketing clinical trials or completion of
ongoing clinical trials after marketing approval are generally required to verify the biologic’s clinical benefit in relationship
to the surrogate endpoint or ultimate outcome in relationship to the clinical benefit.

In
addition, a sponsor may seek FDA designation of its product candidate as a Breakthrough Therapy, if the product candidate is intended,
alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary
clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically
significant endpoints, such as substantial treatment effects observed early in clinical development. If the FDA designates a breakthrough
therapy, it may take actions appropriate to expedite the development and review of the application. Breakthrough designation also allows
the sponsor to file sections of the BLA for review on a rolling basis.

Fast
Track, Priority Review and Breakthrough Therapy designations do not change the standards for approval but may expedite the development
or approval process.

Other
Healthcare Laws and Compliance Requirements

Our
sales, promotion, medical education and other activities following product approval will be subject to regulation by numerous regulatory
and law enforcement authorities in the U.S. in addition to FDA, including potentially the Federal Trade Commission, the Department of
Justice, the Centers for Medicare and Medicaid Services, other divisions of the Department of Health and Human Services and state and
local governments. Our promotional and scientific/educational programs must comply with the federal Anti-Kickback Statute, the Foreign
Corrupt Practices Act, the False Claims Act, or FCA, the Veterans Health Care Act, physician payment transparency laws, privacy laws,
security laws, and additional state laws similar to the foregoing.

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The
federal Anti-Kickback Statute prohibits, among other things, the offer, receipt, or payment of remuneration in exchange for or to induce
the referral of patients or the use of products or services that would be paid for in whole or part by Medicare, Medicaid or other federal
health care programs. Remuneration has been broadly defined to include anything of value, including cash, improper discounts, and free
or reduced price items and services. The government has enforced the Anti-Kickback Statute to reach large settlements with healthcare
companies based on sham research or consulting and other financial arrangements with physicians. Further, a person or entity does not
need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, the government
may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false
or fraudulent claim for purposes of the FCA. Many states have similar laws that apply to their state health care programs as well as
private payors.

The
FCA imposes liability on persons who, among other things, present or cause to be presented false or fraudulent claims for payment by
a federal health care program. The FCA has been used to prosecute persons submitting claims for payment that are inaccurate or fraudulent,
that are for services not provided as claimed, or for services that are not medically necessary. Actions under the FCA may be brought
by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the FCA can result
in significant monetary penalties and treble damages. The federal government is using the FCA, and the accompanying threat of significant
liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country, for example, in
connection with the promotion of products for unapproved uses and other sales and marketing practices. The government has obtained multi-million
and multibillion dollar settlements under the FCA in addition to individual criminal convictions under applicable criminal statutes.
In addition, companies have been forced to implement extensive corrective action plans, and have often become subject to consent decrees
or corporate integrity agreements, restricting the manner in which they conduct their business. The federal Health Insurance Portability
and Accountability Act of 1996, or HIPAA, also created federal criminal statutes that prohibit, among other things, knowingly and willfully
executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery
of or payment for healthcare benefits, items or services. Given the significant size of actual and potential settlements, it is expected
that the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’
compliance with applicable fraud and abuse laws.

In
addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare
providers. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively,
the Affordable Care Act, among other things, imposed new reporting requirements on drug manufacturers for payments or other transfers
of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their
immediate family members. Failure to submit required information may result in civil monetary penalties. Certain states also mandate
implementation of commercial compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking
and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.

We
may also be subject to data privacy and security regulation by both the federal government and the states in which it conducts its business.
HIPAA, as amended by HITECH, and their respective implementing regulations, imposes specified requirements relating to the privacy, security
and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security
standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities
that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a
covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates
and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal
courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In
addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other
in significant ways and may not have the same effect.

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If
our operations are found to be in violation of any of such laws or any other governmental regulations that apply to it, we may be subject
to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations,
exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability
to operate our business and our financial results.

Also,
the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries
from making improper payments to foreign officials for the purpose of obtaining or retaining business. We cannot assure you that our
internal control policies and procedures will protect us from reckless or negligent acts committed by our employees, future distributors,
partners, collaborators or agents. Violations of these laws, or allegations of such violations, could result in fines, penalties or prosecution
and have a negative impact on our business, results of operations and reputation.

Coverage
and Reimbursement

Sales
of pharmaceutical products depend significantly on the availability of third-party coverage and reimbursement. Third-party payors include
government health administrative authorities, managed care providers, private health insurers and other organizations. Although we currently
believe that third-party payors will provide coverage and reimbursement for our product candidate, if approved, these third-party payors
are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant
uncertainty exists as to the reimbursement status of newly approved healthcare products. We may need to conduct expensive clinical trials
to demonstrate the comparative cost-effectiveness of our product candidate. Seeking coverage and reimbursement from third-party payors
can be time consuming and expensive. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an
adequate reimbursement rate will be approved. Reimbursement may not be available or sufficient to allow us to sell our product on a competitive
and profitable basis.

Foreign
Regulation

In
addition to regulations in the U.S., we are and will be subject, either directly or through our distribution partners, to a variety of
regulations in other jurisdictions governing, among other things, clinical trials and commercial sales and distribution of our product,
if approved.

Whether
or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S. countries
prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the U.S. have
processes that require the submission of a clinical trial application much like an IND prior to the commencement of human clinical trials.
In Europe, for example, a clinical trial application, or CTA, must be submitted to the competent national health authority and to independent
ethics committees in each country in which a company plans to conduct clinical trials. Once the CTA is approved in accordance with a
country’s requirements, clinical trials may proceed in that country.

The
requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to
country, even though there is already some degree of legal harmonization in the European Union member states resulting from the national
implementation of underlying E.U. legislation. In all cases, the clinical trials are conducted in accordance with GCP and other applicable
regulatory requirements.

To
obtain regulatory approval of a new drug or medicinal product in the European Union, a sponsor must obtain approval of a marketing authorization
application. The way in which a medicinal product can be approved in the European Union depends on the nature of the medicinal product.

The
centralized procedure results in a single marketing authorization granted by the European Commission that is valid across the European
Union, as well as in Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for human drugs that are: (i) derived
from biotechnology processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain
diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases,
(iii) officially designated as “orphan drugs” and (iv) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy
or tissue-engineered medicines. The centralized procedure may, at the request of the applicant, also be used for human drugs which do
not fall within the above mentioned categories if the human drug (a) contains a new active substance which was not authorized in the
European Community; or (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical
innovation or that the granting of authorization in the centralized procedure is in the interests of patients or animal health at the
European Community level.

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Under
the centralized procedure in the European Union, the maximum timeframe for the evaluation of a marketing authorization application by
the EMA is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response
to questions asked by the Committee for Medicinal Products for Human Use, or CHMP), with adoption of the actual marketing authorization
by the European Commission thereafter. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product
is expected to be of a major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria:
the seriousness of the disease to be treated; the absence of an appropriate alternative therapeutic approach, and anticipation of exceptional
high therapeutic benefit. In this circumstance, EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days
and the opinion issued thereafter.

The
mutual recognition procedure, or MRP, for the approval of human drugs is an alternative approach to facilitate individual national marketing
authorizations within the European Union. The MRP may be applied for all human drugs for which the centralized procedure is not obligatory.
The MRP is applicable to the majority of conventional medicinal products, and is based on the principle of recognition of an already
existing national marketing authorization by one or more member states.

The
characteristic of the MRP is that the procedure builds on an already existing marketing authorization in a member state of the E.U. that
is used as reference in order to obtain marketing authorizations in other E.U. member states. In the MRP, a marketing authorization for
a drug already exists in one or more member states of the E.U. and subsequently marketing authorization applications are made in other
European Union member states by referring to the initial marketing authorization. The member state in which the marketing authorization
was first granted will then act as the reference member state. The member states where the marketing authorization is subsequently applied
for act as concerned member states.

The
MRP is based on the principle of the mutual recognition by European Union member states of their respective national marketing authorizations.
Based on a marketing authorization in the reference member state, the applicant may apply for marketing authorizations in other member
states. In such case, the reference member state shall update its existing assessment report about the drug in 90 days. After the assessment
is completed, copies of the report are sent to all member states, together with the approved summary of product characteristics, labeling
and package leaflet. The concerned member states then have 90 days to recognize the decision of the reference member state and the summary
of product characteristics, labeling and package leaflet. National marketing authorizations shall be granted within 30 days after acknowledgement
of the agreement.

Should
any Member State refuse to recognize the marketing authorization by the reference member state, on the grounds of potential serious risk
to public health, the issue will be referred to a coordination group. Within a timeframe of 60 days, member states shall, within the
coordination group, make all efforts to reach a consensus. If this fails, the procedure is submitted to an EMA scientific committee for
arbitration. The opinion of this EMA Committee is then forwarded to the Commission, for the start of the decision-making process. As
in the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing Committee
on Human Medicinal Products or Veterinary Medicinal Products, as appropriate.

For
other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing
the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical
trials are conducted in accordance with GCP and the other applicable regulatory requirements.

If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical
trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

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Human
Capital Management

As
of May 26, 2026 we had 4 full-time employees and 9 part-time employees. We are not a party to any collective bargaining agreements.
We believe that we maintain good relations with our employees. We do not have any employees that
are represented by a labor union or covered under a collective bargaining agreement. Our future success depends on our ability to attract,
develop and retain key personnel, maintain our culture, and ensure diversity and inclusion in our board, management and broader workforce.
Our human resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing
and additional employees.