What changed in this filing

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Item 1. Business

2025-04-15 compared with 2024-04-15 · 37 added, 39 removed, 814 unchanged (9% of the section changed)

are a clinical-stage biopharmaceutical company focused on our Phase III clinical

trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences.

are a clinical-stage biopharmaceutical company focused on our Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an

immunotherapy to prevent breast cancer recurrences.

GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface

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The combination of GP2 + GM-CSF is called GLSI-100.

have commenced Flamingo-01, a Phase III clinical trial, with plans to expand into Europe and to open up to 150 sites globally.

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.

We are currently expanding Flamingo-01

into Europe with plans to open up to 150 sites globally.

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.

Product Candidate

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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

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immunotherapy demonstrated GP2-specific immune responses, which we believe supports GP2’s mechanism of action.

Statistically

significant peak immunity was typically observed after 6 months of GLSI-100 treatment, as measured in both the Dimer Binding Assay

and the Delayed Type Hypersensitivity (DTH) skin test.

The HER2/ neu 3+ population’s immune response was similar to the

HER2/ neu 1-2+ population’s immune response, suggesting the potential to treat the HER2/ neu 1-2+ population

(including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and

other synergistic clinically active agents.

The broad based immune response suggests the potential for GP2 to treat other

HER2/ neu 1-3+ expressing cancers.

Further, booster injections given every 6 months after the PIS were observed to elicit a

prolonged immune response, which may provide longer term protection.

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

The broad based immune response suggests the potential for GP2 to treat other HER2/ neu 1-3+ expressing cancers.

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

III Trial, Flamingo-01

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

Breast Cancer Market

and European Breast Cancer Market

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.

women (12.8%) will

develop invasive breast cancer over her lifetime.

American Cancer Society, Economic Impact, & European Cancer Information System 2025 estimate

approximately 700,000 new breast cancer patients per year and 9.5 million current breast cancer survivors in the U.S.

and Europe in

An estimated 42,000 female breast cancer deaths will occur in the U.S.

breast cancer patients comprise approximately 25% of all breast cancer patients.

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.

population contains the HLA-A*02 allele, while node positive and high risk node negative patients comprise approximately 50% of the

Therefore, we believe that the U.S.

market for the first indication for GP2, if approved, could be the combination of the

three populations above which together comprises approximately 6.25% of breast cancer patients who undergo surgery.

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

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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 (TDXD, fam-trastuzumab

deruxtecan-nxki), and Seattle Genetics’ Tukysa (tucatanib).

In addition, the following biosimilars to trastuzumab have been approved:

Biocon/Mylan’s (Ogivri — trastuzumab-dkst;

Celltrion/Teva’s (Herzuma — trastuzumab-pkrb);

Samsung/Biogen/Merck’s (Ontruzant — trastuzumab-dttb);

Samsung/Biogen/Merck’s

(Ontruzant — trastuzumab-dttb);

Pfizer’s (Trazimera — trastuzumab-qyyp);

and Allergan/Amgen’s

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:

Furthermore, the following immune checkpoint inhibitors have also been approved or are under review by the FDA to treat breast cancer

Merck’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolumab).

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.

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.

of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources

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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