GLSI US Equity☆

Item 1A Risk Factors 22

Item 1B Unresolved Staff Comments 50

Item 2 Properties 50

Item 3 Legal Proceedings 50

Item 4 Mine Safety Disclosures 50

PART II

Item 6 [Reserved] 51

Item 7A Quantitative and Qualitative Disclosures About Market Risk 54

Item 8 Financial Statements and Supplementary Data 54

Item 9A Controls and Procedures 54

Item 9B Other Information 54

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 54

PART III

Item 10 Directors, Executive Officers, and Corporate Governance 55

Item 11 Executive Compensation 59

Item 14 Principal Accountant Fees and Services 62

PART IV

SIGNATURES 64

Table of Contents

Forward-Looking

Statements

This

Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of

the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as

amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,”

“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”

“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other

comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections

about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually

achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially

from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements

involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

● our projected financial position and estimated cash burn rate;

● our estimates regarding expenses, future revenues and capital requirements;

● our ability to continue as a going concern;

● our need to raise substantial additional capital to fund our operations;

● the success, cost and timing of our clinical trials;

● our dependence on third parties in the conduct of our clinical trial;

● the results of market research conducted by us or others;

● our reliance on third-party suppliers and manufacturers;

● the success of competing therapies and products that are or become available;

All

of our forward-looking statements are as of the date of this Annual Report on Form 10-K only. In each case, actual results may differ

materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will

prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties

referred to in this Annual Report on Form 10-K or included in our other public disclosures or our other periodic reports or other documents

or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely

affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan

to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections

or other circumstances affecting such forward-looking statements occurring after the date of this Annual Report on Form 10-K, even if

such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements

or disclosures by us following this Annual Report on Form 10-K that modify or impact any of the forward-looking statements contained

in this Annual Report on Form 10-K will be deemed to modify or supersede such statements in this Annual Report on Form 10-K.

This

Annual Report on Form 10-K may include market data and certain industry data and forecasts, which we may obtain from internal company

surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications,

articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained

therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed.

While we believe that such studies, clinical trials and publications are reliable, we have not independently verified market and industry

data from third-party sources.

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Risk

Factor Summary

Our

business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what

we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider

the full discussion of our risk factors in the section titled “Risk Factors”, together with the other information in this

Annual Report on Form 10-K. If any of the following risks actually occurs (or if any of those listed elsewhere in this Annual Report

on Form 10-K occur), our business, reputation, financial condition, results of operations, revenue, and future prospects could be seriously

harmed. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important

factors that adversely affect our business.

Risks

Relating to Our Business

We

have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses

for the foreseeable future.

We

need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of

our product candidate. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development

programs or commercialization efforts.

Clinical-stage

biopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which may entail

substantial risk.

We

may find it difficult to enroll patients in our clinical trials given the limited number of patients who have the diseases for which

our product candidate is being studied which could delay or prevent the start of clinical trials for our product candidate.

The

results of preclinical studies or earlier clinical trials are not necessarily predictive of future results. Our existing product candidate

in clinical trials, and any other product candidates that may advance into clinical trials, may not have favorable results in later clinical

trials or receive regulatory approval.

Clinical

drug development involves a lengthy and expensive process with an uncertain outcome.

Our

current and future product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects or

have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result

in significant negative consequences following any regulatory approval.

Our

product development program may not uncover all possible adverse events that patients who take our product candidate may experience.

The number of patients exposed to our product candidate and the average exposure time in the clinical development program may be inadequate

to detect rare adverse events or chance findings that may only be detected once the product is administered to more patients and for

greater periods of time.

Our

future success is dependent on the regulatory approval of our product candidate.

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We

have limited to no manufacturing, sales, marketing or distribution capability and must rely upon third parties for such.

We

are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product

candidate.

In

the clinical trials using GP2, GM-CSF is also administered and its availability is dependent upon a third-party manufacturer, which may

or may not reliably provide GM-CSF, thus jeopardizing the completion of the trials.

We

rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their

contractual duties or meet expected deadlines, or if we lose any of our CROs or other key third-party vendors, we may not be able to

obtain regulatory approval for or commercialize our current or future product candidates on a timely basis, if at all.

We

are dependent on technologies we license, and if we lose the right to license such technologies or we fail to license new technologies

in the future, our ability to develop new products would be harmed, and if we fail to meet our obligations under our license agreements,

we may lose the ability to develop our product candidate.

Our

commercial success depends upon attaining significant market acceptance of our current product candidate and future product candidates,

if approved, among physicians, patients, healthcare payors and cancer treatment centers.

Even

if we are able to commercialize our current product candidate or any future product candidates, the products may not receive coverage

and adequate reimbursement from third-party payors in the U.S. and in other countries in which we seek to commercialize our products,

which could harm our business.

We

face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully

than we do.

The

price of our common stock may fluctuate substantially.

Because

certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions

requiring stockholder approval.

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PART

I

ITEM

1. BUSINESS

BUSINESS

Overview

We

are a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences

in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface

receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate

(2+), and high (3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. In a completed randomized, single-blinded,

placebo-controlled, multi-center Phase IIb clinical trial led by MD Anderson Cancer Center, no recurrences were observed in patients

treated with GLSI-100 in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patients were treated, followed,

and remained disease free over the first 6 months, which is the time required to reach peak immunity and thus maximum efficacy and protection

(p = 0.0338). For the 146 patients who have been treated with GLSI-100 to date over 4 clinical trials, treatment was well tolerated and

no serious adverse events were observed related to the immunotherapy.

We

have commenced Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site. Flamingo-01

is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive patients with residual disease or high-risk pathologic

complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.

Our

Product Candidate

GP2

is a HER2/neu transmembrane peptide that elicits a targeted immune response against HER2/neu-expressing cancers. Below

is an image of a cell surface showing therapeutically relevant cell surface proteins in cancer. Breast cancers and other solid tumors

with elevated expression of HER2/neu protein are highly aggressive with an increased disease recurrence and a worse prognosis.

GM-CSF

Immunoadjuvant

Recombinant

human granulocyte macrophage colony-stimulating factor or GM-CSF (sargramostim, Leukine®) has been shown to enhance monocyte and

neutrophil cytotoxicity against melanoma tumor cells and to enhance activity-dependent cellular cytotoxicity of monocytes and neutrophils

against targets coated with the anti-ganglioside antibodies. GP2 will be delivered in combination with GM-CSF to induce GP2 peptide specific

immunity. GP2 treatment is administered via an intradermal injection by mixing GP2 peptide and GM-CSF at the time of administration.

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

GP2 Phase IIb Clinical Trial Trial Completed

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

GP2 Phase I Clinical Trial — Combination with AE37 Trial Completed

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

GP2 Phase I Clinical Trial — Combination with Trastuzumab Trial Completed

● 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.

Phase

II Clinical Trial

GP2

Phase IIb Clinical Trial Overview

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, GLSI-100 treatment resulted in no recurrences in 46 HER2/neu 3+ over-expressor patients

versus 50 placebo patients who were treated with GM-CSF. After 5 years of follow-up, there were 0% cancer recurrences in the HER2/neu

3+ patients treated with GLSI-100 versus an 11% cancer recurrence rate in the placebo arm treated with GM-CSF (p = 0.0338) in the

population that was treated, 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:

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):

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. 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.

GLSI-100

immunotherapy demonstrated GP2-specific immune responses. We believe that this data and the absence of observed metastatic breast cancer

recurrence in the HER2/neu 3+ population in the Phase IIb clinical trial, support 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.

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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.

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, with approximately 282,000 new breast cancer patients per year and 3.8 million current breast

cancer survivors in the U.S. in 2021. An estimated 43,600 female breast cancer deaths will occur in the U.S. in 2021. HER2/neu 3+

breast cancer patients comprise approximately 25% of all breast cancer patients. Approximately 40% to 50% of the U.S. 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% 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 (DS-8201,

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:

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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:

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

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.

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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