What changed in this filing

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Item 1. Business

2023-03-31 compared with 2022-03-21 · 199 added, 219 removed, 611 unchanged (41% of the section changed)

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.

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 are planning to commence 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.

The Phase III clinical trial protocol including the patient population, trial size, statistical

analysis plan, interim analysis, adaptive features, and manufacturing information are still under discussion with the FDA and therefore

subject to change.

We are also currently completing the last steps to manufacture GP2 clinical drug product and to

open clinical sites.

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.

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

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.

Product Candidate

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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.

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.

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

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

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

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.

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affecting normal cells or to deliver certain immune system components in order to inhibit the spread of cancer.

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.

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

immunotherapy harnesses the body’s natural immune system response to fight and/or prevent tumor growth.

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every 6 months thereafter.

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, we believe

that 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.

Based on the results of our clinical studies to date, we believe that 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.

Clinical Data & Planned Phase III Trial

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.

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.

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

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.

Trial Description

GP2 Phase III Clinical Trial –

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

Phase III Clinical Trial – Flamingo-01

Enrolling in US

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

Phase IIb Clinical Trial

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shown in the table above, the first GP2 Phase I clinical trial was conducted at Walter Reed Army Medical Center.

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

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 who 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

who 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.

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.

were HLA typed and HLA-A*02 patients were skin tested for recall antigens.

HLA-A*02 patients found to be immunologically intact received

There were no grade 3-5 toxicities observed among the 18 patients that received a total of 108 doses of GP2 + GM-CSF.

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%).

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.

Phase I Clinical Trial — Combination with Trastuzumab

research previously demonstrated that a synergy may exist between trastuzumab and GP2 peptide-stimulated CTLs ex vivo.

of breast cancer cells with trastuzumab followed by incubation with GP2 peptide-induced CTLs resulted in enhanced cytotoxicity in 3 tumor

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.

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Phase I Clinical Trial — Combination with AE37

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

While 28 patients enrolled, 22 were treated and 14 patients completed the 6 vaccination series.

Final results

of this Phase I trial 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.

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.

the primary vaccination series, an AE37/GP2+GM-CSF dual peptide vaccine resulted in robust T-cell proliferation.

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Phase IIb Clinical Trial Overview

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.

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.

design of the Phase IIb trial was as follows:

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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.

Phase IIb clinical trial closed in December 2018.

The final median 5 year follow-up data is presented below.

A total of 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, no recurrences were observed in the efficacy population ( p = 0.0338 ).

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.

we may pursue a future trial with GP2 in combination with trastzumab based therapy and other synergistic agents.

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):

3+ Positive Over Expressors:

In the 96 HER2/ neu 3+, HLA-A*02 patients, no recurrences were observed in the efficacy population

( p = 0.0338 ).

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.

population was treated with GLSI-100 following the first year of trastuzumab treatment, which followed surgery.

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

trastzumab based therapy and other synergistic agents.

Year Data Set of GP2 Phase IIb Trial:

HER2 3+ (Positive or Over Expressors)

Patients Who are in the Efficacy Population

HER2 3+ (Positive or Over Expressors) Patients Who are in the Efficacy Population

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 the effect of the 10 GLSI-100 immunotherapy injections over the first 2.5 years (as depicted by the 10 arrows on the

We observed a potent immune response which typically peaked at 6 months.

The immune response also included injection site

and systemic reactions that typically 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.

observed AEs associated with GLSI-100 injections were temporary and declined after GLSI-100 injections ended.

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.

& 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.

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).

SAEs reported in the GP2 treated patients were considered attributable to GLSI-100.

immunotherapy demonstrated GP2-specific immune responses.

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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

are planning to commence a Phase III clinical trial with an interim analysis and are currently completing the last steps to manufacture

GP2 clinical drug product and to open clinical trial sites, using a similar treatment regime as the Phase IIb clinical

The Phase III clinical trial protocol including the patient population, trial size, statistical analysis plan, interim analysis,

adaptive features, and manufacturing information are still under discussion with the FDA and therefore subject to change.

Further, booster injections given every 6 months after the PIS were observed to elicit a prolonged immune response, which may provide

longer term protection.

III Trial, Flamingo-01

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.

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

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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.

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.

An estimated 43,600 female breast cancer deaths will occur in the U.S.

HER2/ neu 3+ breast cancer patients comprise approximately 25% of all breast cancer patients.

Approximately 40% to 50% of the

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.

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.

immunotherapy has become a significant growth area for the biopharmaceutical industry, attracting large pharmaceutical companies as well

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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.

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.

believe that GP2 will act synergistically with Herceptin, Perjeta, Nerlynx, and the newest entrants Kadcyla and Enhertu.

are a number of approved HER2/ neu targeted therapies, some of which include the following:

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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:

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;

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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.

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.

April 2009, we entered into an exclusive license agreement, as amended, with HJF pursuant to which HJF granted us exclusive worldwide

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We plan to further evaluate

these options as we approach submission of a new drug application or biologics license application for one of our

product candidates for one or more indications.

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.

GP2 issued patents provide protection ranging from 2026 through 2032 in various markets, and we plan to register GP2 as a biologic, which

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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.

A long term global and regional

licensing process has been initiated and will continue as the Phase III trial commences.

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

Pending the receipt of sufficient capital, we may conduct 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.

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.

FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among

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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;

of product with adequate controls so that the product has the purity and potency of the proposed biologic product candidate for its

intended purpose;

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

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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.

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

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of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

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

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.

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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

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.

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.

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

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.

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.

2 — The investigational product is administered to a limited patient population with a specified disease or condition to

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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.

These so-called Phase 4 clinical trials may be made a condition to approval

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

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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.

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.

A waiver of user fees may be obtained

under certain limited circumstances.

a BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application for filing,

37 unchanged sentences

with pre- and post-marketing regulatory standards is not maintained or if problems occur after the product reaches the marketplace.

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

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.

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.

sponsor may seek approval of its product candidate under programs designed to accelerate FDA’s review and approval of new drugs

17 unchanged sentences

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.

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.

addition, a sponsor may seek FDA designation of its product candidate as a Breakthrough Therapy, if the product candidate is intended,

185 unchanged sentences

Capital Management

of March 21, 2022 we had 3 full-time employee and 3 part-time employees.

We are not a party to any collective bargaining

of March 15, 2023 we had 3 full-time employees and 3 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.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business