{"url_path":"/sec/glsi/10-k/2026/item-1","section_key":"item-1","section_title":"Item 1 BUSINESS**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-06-01","source_url":"https://www.sec.gov/Archives/edgar/data/1799788/0001493152-26-026651-index.html","accession_number":"0001493152-26-026651","cik":"0001799788","ticker":"GLSI","issuer_name":"Greenwich LifeSciences, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1799788/0001493152-26-026651-index.html","primary_entity_key":"0001799788","primary_entity_name":"Greenwich LifeSciences, Inc."},"word_count":11191,"has_tables":true,"body_markdown":"**ITEM\n1. BUSINESS**\n\n \n\n**BUSINESS**\n\n \n\n**Overview**\n\n \n\nWe\nare a clinical-stage biopharmaceutical company focused on our Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an\nimmunotherapy to prevent breast cancer recurrences. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface\nreceptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate\n(2+), and high (3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. We are currently expanding Flamingo-01\ninto 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\nand postoperative adjuvant trastuzumab based treatment.\n\n \n\n**Our\nProduct Candidate**\n\n \n\nGP2\nis a HER2/*neu* transmembrane peptide that elicits a targeted immune response against HER2/*neu*-expressing cancers. Below\nis an image of a cell surface showing therapeutically relevant cell surface proteins in cancer. Breast cancers and other solid tumors\nwith elevated expression of HER2/*neu* protein are highly aggressive with an increased disease recurrence and a worse prognosis.\n\n \n\n \n\n**GM-CSF\nImmunoadjuvant**\n\n \n\nRecombinant\nhuman granulocyte macrophage colony-stimulating factor or GM-CSF (sargramostim, Leukine®) has been shown to enhance monocyte and\nneutrophil cytotoxicity against melanoma tumor cells and to enhance activity-dependent cellular cytotoxicity of monocytes and neutrophils\nagainst targets coated with the anti-ganglioside antibodies. GP2 will be delivered in combination with GM-CSF to induce GP2 peptide specific\nimmunity. GP2 treatment is administered via an intradermal injection by mixing GP2 peptide and GM-CSF at the time of administration.\n\n \n\nGM-CSF\nis available in lyophilized form exclusively from one manufacturer. We will continue to be dependent on the manufacturer for our supply\nof GM-CSF in our ongoing GP2 clinical trials and upon potential commercialization of GP2. Although GM-CSF is only approved for sale in\nthe U.S. by the FDA and is available in other countries on a named patient basis through a specialized company that focuses on making\nproducts approved in the U.S. available globally, GM-CSF may be registered for sale in other countries by the manufacturer in the future.\n\n \n\n**Cancer\nImmunotherapy**\n\n \n\nCancer\nimmunotherapy is a new method of cancer treatment among more established treatment options such as surgery, chemotherapy, targeted therapy,\nand radiation therapy. This method seeks to stimulate an individual’s immune system to selectively attack cancer cells while not\naffecting normal cells or to deliver certain immune system components in order to inhibit the spread of cancer. Thus, cancer immunotherapy\nis an important and rapidly emerging field, which has led to new clinical research studies and garnered the attention of biotechnology\nand pharmaceutical companies, regulatory agencies, payors and hospital systems, cancer patients and their families, and the general public\nat large.\n\n \n\n6\n\n[Table of Contents](#toc_001)\n\n \n\nCancer\nimmunotherapy harnesses the body’s natural immune system response to fight and/or prevent tumor growth. An essential characteristic\nof the immune system, which is a network of tissues, cells, and signaling molecules that work to protect the body, is its ability to\ndifferentiate foreign threats, including cancerous growths, from normal cells. Despite the fact that tumor cells originate from normal\ncells, tumor cells can be recognized as foreign threats because of their ability to elicit the production of tumor antigens. These antigens\nmay be released in the interstitial tissues, and eventually in the bloodstream or may remain on the surface of cognate cancer cells.\nThe HER2/*neu* protein is one of the most widely expressed tumor antigens in multiple malignances.\n\n \n\nSeveral\ncell types play an important role in the development and maintenance of immune responses against cancer. The most important cell types\nwith regard to immune response are antigen-presenting cells (“APCs”) and lymphocytes. APCs include various subtypes, such\nas dendritic cells, monocytes and macrophages. Once a patient is exposed to a tumor antigen (either by the presence of cancer itself\nor through active immunization through a vaccine type immunotherapeutic), the tumor antigen gets recognized by the APC and becomes “processed”\nthrough digestion into smaller fragments within the APC. Subsequently, the APC “communicates” with a specific type of lymphocyte\ncalled a T-cell. Inactive T-cells search for tumor antigens by transiently binding to antigens presented by major histocompatibility\ncomplexes (“MHCs”) on the APCs. There is great variability in the expression of different subtypes of MHCs in the human population.\nThe MHC system expresses human leukocyte antigens (“HLAs”) and these HLA subtypes determine the vigor and duration of any\ngiven T-cell response to a cancer among different patients.\n\n \n\nAs\nshown below, following GP2 immunotherapy, CD8+ cytotoxic T lymphocytes recognize and destroy HER2/*neu*-expressing cancer cells.\nGP2 is administered in combination with an FDA-approved immunoadjuvant GM-CSF, which stimulates the proliferation of antigen presenting\ncells. Preclinical studies have shown that T cells sensitized against the GP2 peptide demonstrate significant recognition of HER2/*neu*-expressing\ntumors. Both ovarian and breast cancer-specific CTLs recognize GP2, which is widely expressed in HER2/*neu*-expressing tumors and\nis capable of inducing tumor-specific CTL populations in vitro.\n\n \n\n \n\n**Breast\nCancer Treatment Approach — Adjuvant & Neoadjuvant Treatments**\n\n \n\nAs\nshown below, in the adjuvant setting, a HER2/*neu* 3+ patient typically receives Herceptin in the first year following breast cancer\nsurgery, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years\nfollowing surgery. Herceptin has been shown to reduce recurrence rates by approximately 50%, from 25% to 12%, in the adjuvant setting.\nIn the neoadjuvant setting, a HER2/*neu* 3+ patient receives treatment before surgery and based on the results of a biopsy at surgery,\nwill receive Herceptin or Kadcyla, a more potent form of Herceptin, following surgery. Kadcyla has been shown to reduce recurrence rates\nby 50%, from 22% to 11%, in the neoadjuvant setting. Accordingly, we believe that GP2 may be effective in safely addressing the 50% of\nrecurring patients who do not respond to either Herceptin or Kadcyla.\n\n \n\nGP2\nis administered in combination with the immunoadjuvant GM-CSF in years 2-4, following the first year of treatment with Herceptin, in\na series of 11 intradermal injections comprising 6 primary injections over 6 months (1 injection per month) followed by 5 booster injections\nevery 6 months thereafter.\n\n \n\n7\n\n[Table of Contents](#toc_001)\n\n \n\nThe\nadverse events observed to date have been well-tolerated with no SAEs reported in the Phase IIb clinical trial considered related to\nGLSI-100 treatment. Therefore, GLSI-100 is well-positioned to serve this population at this stage of treatment. We believe that clinicians\nand patients are seeking a de-escalation and a return to normal life free of toxic treatments, especially if the chance of recurrence\nis reduced substantially. GLSI-100 may significantly reduce the incidence of recurrence/metastatic disease and need for additional therapy.\nLastly, we believe that GP2 may be the treatment that will synergistically overlap with or follow trastuzumab based treatments, such\nas Herceptin, Kadcyla, Enhertu or any of the other Herceptin derivatives or antibody drug conjugates being developed.\n\n \n\n \n\n**GP2\nClinical Data & Phase III Clinical Trial (Flamingo-01)**\n\n \n\nIn\nthe Phase IIb and 3 Phase I clinical trials where 146 patients received GP2 immunotherapy, there were no serious adverse events observed\nrelated to the immunotherapy or any other GP2 combination treatments.\n\n \n\n**Clinical\nTrial Description**\n \n**Status**\n\nGP2\nPhase III Clinical Trial – Flamingo-01\n \nEnrolling\nin US\n\n●\nA\nRandomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/*neu* Peptide GLSI-100\n(GP2 + GM-CSF) in HER2/*neu* Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative\nTrastuzumab-based Therapy\n \nand\nEurope\n\n \n \n \n \n\nGP2\nPhase IIb Clinical Trial\n \nTrial\nCompleted\n\n●\nProspective,\nRandomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/*neu* Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in\nHLA-A*02+ Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence\n \n \n\n●\n89\npatients treated with GP2 + GM-CSF, 91 placebo patients treated with GM-CSF\n \n \n\n \n \n \n \n\nGP2\nPhase I Clinical Trial — Combination with AE37\n \nTrial\nCompleted\n\n●\nPhase\nI Safety Trial of the GP2 + GM-CSF Vaccine in Combination with the Helper Peptide AE37 + GM-CSF Vaccine\n \n \n\n●\n22\npatients treated with GP2 + AE37 + GM-CSF\n \n \n\n \n \n \n \n\nGP2\nPhase I Clinical Trial — Combination with Trastuzumab\n \nTrial\nCompleted\n\n●\nPhase\nIb Trial of Combination Immunotherapy with HER2/*neu* Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients\n \n \n\n●\n17\npatients treated with GP2 + GM-CSF + trastuzumab\n \n \n\n \n \n \n \n\nFirst\nGP2 Phase I Clinical Trial\n \nTrial\nCompleted\n\n●\nPhase\nIb Trial of HER2/*neu* Peptide (GP2) Vaccine in Breast Cancer Patients\n \n \n\n●\n18\npatients treated with GP2 + GM-CSF\n \n \n\n \n\n8\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Phase\nI Clinical Trials**\n\n \n\n*First\nGP2 Phase I Clinical Trial*\n\n \n\nAs\nshown in the table above, the first GP2 Phase I clinical trial was conducted at Walter Reed Army Medical Center. The clinical trial was\nconducted in patients over the age of 18 years with a diagnosis of HER2/*neu* 1-3+, node negative breast cancer who had undergone\nprimary surgical and medical therapies and who were without evidence of disease at the time of enrollment into the clinical trial. Patients\nwere HLA typed and HLA-A*02 patients were skin tested for recall antigens. HLA-A*02 patients found to be immunologically intact received\nthe 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\nall patients that participated in the clinical trial, the maximum observed local toxicity that occurred was grade 1 in 38.9% and grade\n2 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\ngrade 2 in 33.3% of the patients. The most common local reactions included erythema and induration (100% of patients), pruritis (25%),\nand inflammation (23%). The most common systemic reactions were grade 1 fatigue (40%) and grade 1 arthralgia/myalgia (15%). There were\nno recurrences and no deaths reported among the patients that participated in the clinical trial. Additional data analysis reported by\nthe investigators, included topics such as pre-existing immunity, effects of dosing, and epitope spreading.\n\n \n\n*GP2\nPhase I Clinical Trial — Combination with Trastuzumab*\n\n \n\nPreclinical\nresearch previously demonstrated that a synergy may exist between trastuzumab and GP2 peptide-stimulated CTLs ex vivo. Pretreatment of\nbreast cancer cells with trastuzumab followed by incubation with GP2 peptide-induced CTLs resulted in enhanced cytotoxicity in 3 tumor\ncell lines compared to treatment with trastuzumab or GP2-specific CTLs alone. These results suggest that concurrent GP2 vaccination during\ntrastuzumab therapy may be a possible combination immunotherapy.\n\n \n\nAs\nshown in the table above, a Phase I trial evaluating the combination therapy of GP2 + GM-CSF administered simultaneously with trastuzumab\nwas 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.\n\n \n\n*GP2\nPhase I Clinical Trial — Combination with AE37*\n\n \n\nAs\nshown 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\nenrolled, 22 were treated and 14 patients completed the 6 vaccination series. Final results suggest that the combination of GP2 and AE37\npeptides is well tolerated at each of the tested dosing levels. Additionally, we believe that the combination is capable of stimulating\nstrong peptide-specific in vivo immune responses.\n\n \n\nDuring\nthe primary vaccination series, an AE37/GP2+GM-CSF dual peptide vaccine resulted in robust T-cell proliferation. However, significant\nimmune responses became more variable at 6 and 12 months post vaccination suggesting the need for boosters in some individuals.\n\n \n\n9\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Phase\nII Clinical Trial**\n\n \n\n*GP2\nPhase IIb Clinical Trial Overview*\n\n \n\n**Phase\nII Clinical Trial Study Report:** We are preparing a comprehensive study report of the Phase II trial for the FDA prior to the filing\nof a BLA. This report will include the patients with breast cancer recurrences, the last known date of patients who did not recur (censoring\ndata), the adverse events, immune responses, and other final study report analyses. This report will serve to complement the Phase III\ndata and to provide a drug product dossier that can also be submitted to regulatory agencies in other countries for marketing approval.\nThe use of GM-CSF as an adjuvant in GLSI-100 may also be included in the dossier as GM-CSF is only commercially available in the US at\nthis time.\n\n \n\nWe\nhave experienced significant interest from investors, strategics, analysts, and regulators in the 5 year follow-up data we published\nand the 3 and 4 year follow-up data independently published by the clinical investigators. The differences between these publications\ncan be best explained by the increased maturity of the data as each year progressed. In all 3 publications, no recurrences or a 100%\nreduction in recurrence rate, were reported in the sub-population that the Flamingo-01 design has been based on and any differences between\nthe number of patients in the treated or placebo groups has been shown to be immaterial.\n\n \n\nWe\ndid not have responsibility for the conduct of the trial or for the data from the Phase II trial. After the trial had already started,\nwe received the rights to the Phase II trial data pursuant to a license agreement with the Henry Jackson Foundation (HJF) that entitled\nus to all of the GP2 data from the Phase II trial and all prior trials, but did not provide us with the ability to participate in the\nPhase II trial as a regulatory clinical sponsor. The lead clinicians and HJF were responsible for project and site management, medical\nmonitoring, data monitoring of case report forms (CRFs), correspondence with the FDA, and creation, data entry and management of the\ndatabase. We were provided study updates but were not provided an opportunity to participate in any of the above activities or to review\nthe publications of the 3 and 4 year follow-up data by the lead clinicians. Thus, the comprehensive study report will rely on cooperation\nfrom HJF and the clinical sites who are responsible for providing the final data accurately to us.\n\n \n\nWe\nare currently comparing the final CRFs and database provided by HJF and have noted the following inconsistencies as the comprehensive\nstudy report is being prepared. The lead clinicians reported in an annual report to the FDA and in their publication of 4 year follow-up\ndata a 6th recurrence in the HER2 positive control arm of the study. We conservatively chose not to report this 6th recurrence since\nit was not reported in the data provided by HJF, even though adding this recurrence to the control arm would significantly lower the\np-value and improve the evidence of efficacy of GLSI-100. As a result of detailed due diligence, we became aware in Q4 of 2023 of a potential\nrecurrence in the HER2 positive treated arm. This patient was not reported as a recurrence in the database, on a CRF that should be used\nfor a recurrence, in reports from the lead clinicians to the FDA, or in the 3 or 4 year follow-up data published by the lead clinicians.\nSome CRFs report a recurrence, but the critical CRF that confirms a recurrence was not completed or entered into the database provided\nby HJF. We have since initiated an effort to confirm with HJF and the clinicians who treated this patient the status of this patient,\nand if the final CRFs and database should be modified. It appears that this patient, who had completed treatment with GLSI-100, experienced\na local recurrence that responded well to additional treatment and survived without additional evidence of disease or distant metastasis\nfor the duration of study follow-up. Any discrepancies noted to date in the review of the censoring date recorded in the database do\nnot materially change the study results and the median duration of follow-up remains 5 years.\n\n \n\nWhile\na recurrence in the control arm would decrease the p-value and still result in a 100% reduction in the recurrence rate, a recurrence\nin the treated arm would increase the p-value and would result in an 80% reduction in the recurrence rate. In either case, we believe\nthat the reduction in recurrence rate is clinically meaningful and substantial compared to the approximately 20-50% reduction in recurrences\nof all other approved breast cancer drugs for this patient population. These findings have not materially affected the power of the Phase\nIII study as the assumptions for that design were selected conservatively.\n\n \n\nIn\na prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical\ntrial of HLA-A*02 breast cancer patients, 46 HER2/*neu*3+ over-expressor patients were treated with GLSI-100 and 50 placebo patients\nwere treated with GM-CSF alone. After 5 years of follow-up, there was a substantial reduction in cancer recurrences in the HER2/*neu*3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the\ntime required to reach peak immunity and thus maximum efficacy and protection. Based on this data, we believe that treatment with GLSI-100\nstarting approximately in the second year following surgery may dramatically lower breast cancer recurrences in this patient population.\n\n \n\n10\n\n[Table of Contents](#toc_001)\n\n \n\nThe\ndesign of the Phase IIb trial was as follows:\n\n \n\n \n●\nProspective,\nrandomized, single-blinded, placebo-controlled phase IIb clinical trial of GP2 + GM-CSF or GM-CSF alone in HER2/*neu* 1-3+,\nHLA-A*02 patients.\n\n \n \n \n\n \n●\nHigh-risk\nbreast cancer patients (Node Positive, High Risk Node Negative) who were disease-free and immunocompetent after having completed\nstandard of care therapy.\n\n \n \n \n\n \n●\nThe\nprimary endpoint was to determine if GP2 + GM-CSF reduces breast cancer recurrence rates versus GM-CSF alone. A recurrence is defined\nas either a pathologically confirmed recurrence or a new radiographic finding of recurrence during standard of care follow-up.\n\n \n\n \n\nThe\nPhase IIb clinical trial closed in December 2018. The final median 5 year follow-up data is presented below. A total 180 intent-to-treat\npatients enrolled in the clinical trial. HER2/*neu* status was determined based on the expression levels of the HER2/*neu*\nprotein in each patient using standard of care HER2/*neu*diagnostic technology. The trial was prospectively designed to analyze\nthese 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):\n\n \n\n \n●\nHER2/*neu*3+ Positive Over Expressors: In the 96 HER2/*neu* 3+, HLA-A*02 patients, a substantial reduction in recurrences was observed\nin the efficacy population. A patient was in the efficacy population if they were treated, followed, and remained disease free over\nthe first 6 months, which is the time we believe is required to reach peak immunity and thus maximum efficacy and protection. This\npatient population was treated with GLSI-100 following the first year of trastuzumab treatment, which followed surgery.\n\n \n \n \n\n \n●\nHER2/*neu*1-2+ Low to Intermediate Expressors: In the 72 HER2/*neu* 1-2+, HLA-A*02 patients, no reduction in recurrence rates were\nobserved, but trastuzumab was not administered to these patients. Thus, we may pursue a future trial with GP2 in combination with\ntrastuzumab based therapy and other synergistic agents.\n\n \n\n*5\nYear Data Set of GP2 Phase IIb Trial: HER2 3+ (Positive or Over Expressors) Patients Who are in the Efficacy Population*\n\n \n\nThe\nfigure below shows a time series of the GLSI-100 immunotherapy injections, adverse events (“AE”), immune response, and 100%\ndisease-free survival (0% recurrence rate) in HER2 positive breast cancer patients over median 5 years. The Kaplan Meier curve and p\nvalue, which are based on recurrence rates or disease free survival and censoring data, is subject to change pending the completion of\nthe Phase II Clinical Trial Study Report described above. This time series highlights that the 10 GLSI-100 immunotherapy injections over\nthe 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.\nThe immune response also included injection site and systemic reactions that peaked at approximately 6 months. We believe that these\nAEs are a positive sign that the immune system responded to GLSI-100 immunotherapy and contributed to the decline in metastatic breast\ncancer recurrence. The observed AEs associated with GLSI-100 injections were temporary and declined after GLSI-100 injections ended.\n\n \n\n \n\n*Safety\n& Immune Response Data of GP2 Phase II Trial*\n\n \n\nIn\nboth the HER2/*neu* 3+ and the HER2/*neu*1-2+ patient populations, GP2 was shown to be well tolerated. The observed AEs primarily\nconsisted of injection site reactions which could be mitigated by reducing the GM-CSF dose (and then the GP2 dose, if necessary). No\nSAEs reported in the GP2 treated patients were considered attributable to GLSI-100.\n\n \n\n11\n\n[Table of Contents](#toc_001)\n\n** **\n\nGLSI-100\nimmunotherapy demonstrated GP2-specific immune responses, which we believe supports GP2’s mechanism of action. Statistically significant\npeak immunity was typically observed after 6 months of GLSI-100 treatment, as measured in both the Dimer Binding Assay and the Delayed\nType Hypersensitivity (DTH) skin test. The HER2/neu 3+ population’s immune response was similar to the HER2/neu 1-2+ population’s\nimmune response, suggesting the potential to treat the HER2/neu 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy\nin combination with trastuzumab (Herceptin) based products and other synergistic clinically active agents. The broad based immune response\nsuggests the potential for GP2 to treat other HER2/neu 1-3+ expressing cancers. Further, booster injections given every 6 months after\nthe PIS were observed to elicit a prolonged immune response, which may provide longer term protection.\n\n** **\n\n**Phase\nIII Trial, Flamingo-01**\n\n \n\nWe\nhave commenced Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site. Flamingo-01includes\nan interim analysis and uses a similar treatment regime\nas the Phase IIb clinical trial.\n\n \n\nThe\nprimary 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\nat surgery or stage III at presentation with pathologic complete response (“pCR”) at surgery) and have completed both neoadjuvant\nand postoperative adjuvant trastuzumab-based standard of care therapy.\n\n \n\nAn\noverview of the anticipated Phase III clinical trial design is shown below:\n\n \n\n \n\n \n\n \n\n**U.S.\nand European Breast Cancer Market**\n\n \n\nWe\nbelieve that the market for GP2 is large. The American Cancer Society estimates that approximately 1 in 8 U.S. women (12.8%) will develop\ninvasive breast cancer over her lifetime. The American Cancer Society, Economic Impact, & European Cancer Information System 2025\nestimate approximately 700,000 new breast cancer patients per year and 9.5 million current breast cancer survivors in the U.S. and Europe\nin 2025. An estimated 42,000 female breast cancer deaths will occur in the U.S. in 2025. HER2/*neu*3+ breast cancer patients comprise\napproximately 25% of all breast cancer patients. Approximately 40% to 50% of the U.S. and European population contains the HLA-A*02 allele,\nwhile node positive and high risk node negative patients comprise approximately 50% of the market. Therefore, we believe that the U.S.\nmarket for the first indication for GP2, if approved, could be the combination of the three populations above which together comprises\napproximately 6.25% of breast cancer patients who undergo surgery.\n\n \n\n12\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Competition**\n\n \n\nCancer\nimmunotherapy has become a significant growth area for the biopharmaceutical industry, attracting large pharmaceutical companies as well\nas small niche players. Generally, our principal competitors in the cancer immunotherapy market comprise both types of companies with\ncurrently approved products for various indications, such as manufacturers of approved bispecific antibodies, CAR-T cells, and checkpoint\ninhibitors, as well as companies currently engaged in cancer immunotherapy clinical development. The large and medium-size players who\nhave successfully obtained approval for cancer immunotherapy products include Bristol-Myers Squib Company, Merck & Co., Inc., Genentech,\nInc. (a subsidiary of Roche Holding AG), AstraZeneca PLC, Celgene Corporation, Johnson & Johnson, Amgen, Novartis, Juno Therapeutics,\nInc. (a subsidiary of Celgene), Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc. and Pfizer, Inc./EMD Serono, Inc.\nMost of these companies, either alone or together with their collaborative partners, have substantially greater financial resources than\nwe do.\n\n \n\nCompanies\ndeveloping novel products with similar indications to those we are pursuing are expected to influence our ability to penetrate and maintain\nmarket share, if GLSI-100 is approved. For patients with early stage breast cancer, adjuvant or neoadjuvant therapy is often given to\nprevent recurrence and increase the chance of long-term disease free survival. Adjuvant or neoadjuvant therapy for breast cancer can\ninclude chemotherapy, hormonal therapy, radiation therapy, or combinations thereof. In addition, the HER2 targeted drug Herceptin (trastuzumab\nor biosimilar) alone or in combination with Perjeta (pertuzumab), both manufactured and marketed by Roche/Genentech, may currently only\nbe given to patients with tumors with high expression of HER2/*neu*. Following adjuvant treatment in the first year following surgery,\nonly Nerlynx is approved for extended andjuvant treatment and would potentially compete with GLSI-100 if not used synergistically. We\nbelieve that GP2 will act synergistically with Herceptin, Perjeta, Nerlynx, and the newest entrants Kadcyla and Enhertu.\n\n \n\nThere\nare a number of approved HER2/*neu* targeted therapies, some of which include the following: Genentech’s Herceptin, Perjeta\n(pertuzumab) and Kadcyla (TDM-1, ado-trastuzumab emtansine); Puma’s Nerlynx (neratinib); Daichi Sanko’s Enhertu (TDXD, fam-trastuzumab\nderuxtecan-nxki), and Seattle Genetics’ Tukysa (tucatanib). In addition, the following biosimilars to trastuzumab have been approved:\nBiocon/Mylan’s (Ogivri — trastuzumab-dkst; Celltrion/Teva’s (Herzuma — trastuzumab-pkrb); Samsung/Biogen/Merck’s\n(Ontruzant — trastuzumab-dttb); Pfizer’s (Trazimera — trastuzumab-qyyp); and Allergan/Amgen’s (Kanjinti; trastuzumab-anns).\nFurthermore, the following immune checkpoint inhibitors have also been approved or are under review by the FDA to treat breast cancer\npatients: Merck’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolumab). Moreover we believe that drug candidates\nfrom Sellas (formerly Galena), Marker (formerly TapImmune), Epithany, Antigen Express (Generex subsidiary), and various companies pursuing\nneoantigen technologies are in clinical development and are being pursued for different sub-populations or are behind GP2 in clinic development.\n\n \n\n13\n\n[Table of Contents](#toc_001)\n\n \n\nMany\nof our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources\nthan we do, and more experience in obtaining FDA and other regulatory approvals of treatments and in commercializing those treatments.\nAccordingly, our competitors may be more successful than us in obtaining approval for cancer immunotherapy products and achieving widespread\nmarket acceptance. Our competitors’ treatments may be more effectively marketed and sold than any products we may commercialize,\nthus causing limited market share before we can recover the expenses of developing and commercializing our cancer immunotherapy product\ncandidate.\n\n \n\nMergers\nand acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller\nnumber of our competitors. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative\narrangements with large and established companies. These activities may lead to consolidated efforts that allow for more rapid development\nof cancer immunotherapy product candidates.\n\n \n\nThese\ncompetitors also compete with us in the recruiting and retaining of qualified scientific and management personnel, the ability to work\nwith specific clinical contract organizations due to conflict of interest, and the conduct of trials in the ability to recruit clinical\ntrial sites and patients for our clinical trials.\n\n \n\nWe\nexpect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, price, and the\navailability of coverage and reimbursement from government and other third-party payors. Our commercial opportunity could be reduced\nor eliminated if our competitors develop and commercialize products that are viewed as safer, more convenient, or less expensive than\nany products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than\nwe may obtain approval for our current product candidate or any other future product candidate, which could result in our competitors\nestablishing a strong market position before we are able to enter the market.\n\n \n\n**Manufacturing**\n\n \n\nWe\ndo not own or operate manufacturing facilities for the production of our product candidate nor do we have plans to develop our own manufacturing\noperations in the foreseeable future. We currently depend on third-party contract manufacturers for all of our required raw materials,\nactive pharmaceutical ingredients (“APIs”), and finished product candidate for our clinical trials and potential commercial\nsupply.\n\n \n\n**Exclusive\nLicense**\n\n \n\nThe\nHenry M. Jackson Foundation out-licenses technology of the U.S. military and it conducts research and manages clinical trials. HJF managed\nthe GP2 Phase IIb clinical which was led by MD Anderson Cancer Center, oversaw all regulatory filings with the FDA for all 4 GP2 clinical\ntrials (including the 3 Phase I and the Phase IIb clinical trials), and possesses all patient and manufacturing data from such trials.\n\n \n\nIn\nApril 2009, we entered into an exclusive license agreement, as amended, with HJF pursuant to which HJF granted us exclusive worldwide\nrights to several U.S. and foreign patents and patent applications covering methods of using GP2 as an immunotherapy that elicits a targeted\nimmune response against HER2/*neu*-expressing cancers. In consideration for such licensed rights, we issued HJF 202,619 shares of\nour common stock. In addition, we are required to pay an annual maintenance fee and milestone payments of up to an aggregate of $5.7\nmillion. 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\ndate we have not been required to make any milestone or royalty payments to HJF. The term of the exclusive license shall terminate at\nsuch time that the last licensed patent or patent application expires or is abandoned, unless terminated earlier pursuant to the terms\nof the exclusive license agreement. We may terminate the license by giving 90 days notice. HJF may terminate the license if we do not\nmake required payments, if we default in our performance obligations, if we do not sufficiently develop and advance GP2 towards commercialization,\nand for various other reasons.\n\n \n\n14\n\n[Table of Contents](#toc_001)\n\n \n\nIn\nconnection with the exclusive license agreement with HJF, we were the financial and corporate sponsors of the GP2 Phase IIb clinical\ntrial. HJF has provided us with all FDA correspondences and GP2 patient and manufacturing data for the history of the drug’s development\nfor all 4 clinical trials, and we have incorporated this data into our corporate investigational new drug application (“IND”)\nwith the FDA.\n\n \n\n**Intellectual\nProperty Portfolio**\n\n \n\nOur\ncommercial success depends in part on our ability to avoid infringing the proprietary rights of third parties, our ability to obtain\nand maintain proprietary protection for our technologies where applicable, and our ability to prevent others from infringing our proprietary\nrights. We intend to protect our proprietary technologies by, among other methods, evaluating relevant patents, establishing defensive\npositions, monitoring European Union oppositions and pending intellectual property rights, preparing litigation strategies in view of\nthe U.S. legislative framework, and filing U.S. and international patent applications on technologies, inventions and improvements that\nare important to our business. Patents and other intellectual property rights are crucial to our success. We intend to protect our intellectual\nproperty rights through available means including filing and prosecuting patent applications in the U.S. and other countries, protecting\ntrade secrets, and utilizing regulatory protections such as data exclusivity. In addition, we include restrictions regarding use and\ndisclosure of our proprietary information in our contracts with third parties, and utilize customary confidentiality agreements with\nour employees, consultants, clinical investigators, and scientific advisors to protect our confidential information and know-how. Together\nwith our licensors, we also rely on trade secrets to protect our combined technology especially where we do not believe patent protection\nis appropriate or obtainable. It is our policy to operate without knowingly infringing on, or misappropriating, the proprietary rights\nof others.\n\n \n\nAn\ninternational patent law treaty (“PCT”) provides a unified procedure for filing patent applications to protect inventions\nin each of its contracting states. Thus, a single PCT application can be converted into a national stage patent application in any of\nthe more than 145 PCT contracting states, and is considered a simple, cost-effective means for seeking patent protection in numerous\nregions or countries. This nationalization (converting into an application in any of the contracting states) typically occurs 18 months\nafter the PCT application filing date. We also rely on trade secrets, know-how, and continuing technological innovation to develop and\nmaintain our proprietary position.\n\n \n\nThe\nterm of individual patents depends upon the legal term of the patents in countries in which they are obtained. In most countries, including\nthe U.S., the patent term is generally 20 years from the earliest date of filing a non-provisional patent application in the applicable\ncountry. In the U.S., a patent’s term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee\nfor administrative delays by the U.S. Patent and Trademark Office in examining and granting a patent or may be shortened if a patent\nis terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date.\n\n \n\n*HJF\nLicense*\n\n \n\nPursuant\nto our exclusive license agreement with HJF, we were granted exclusive worldwide rights to several U.S. and foreign patents and patent\napplications covering methods of using GP2. The GP2 issued patents provide protection ranging from 2026 through 2032 in major markets\nsuch as the U.S., Europe, Japan, Australia, and Canada, with ongoing prosecution of pending patent applications in other markets. We\nplan to register GP2 as a biologic, which may be subject to 10-12 years market exclusivity in the U.S. upon receiving marketing approval.\n\n \n\nThe\nfollowing summarizes the two patent families subject to our exclusive license agreement with HJF. We have licensed rights to issued patents\nand pending patent applications in certain countries with respect to the two patent families below and do not own or have rights to any\nother patents or patent applications for GP2 or any other products:\n\n \n\n \n●\nGP2\n+ GM-CSF Patent Family — A patent application has been filed and licensed describing methods and compositions for the induction\nof a cytotoxic T-cell response to the GP2 peptide with the effect of inducing and maintaining a protective or therapeutic immunity\nagainst breast cancer. Patent claims describe the use of the GP2 technology including dosing, formulation, identification of patients,\nand use in combination with GM-CSF. Patents issued in the U.S. will expire in 2032 and 2029 and international patents will expire\nin 2029.\n\n \n\n15\n\n[Table of Contents](#toc_001)\n\n \n\n \n●\nGP2\n+ Herceptin Patent Family — A patent application has been filed and licensed describing methods and compositions of GP2 peptide\nin combination with a HER2/*neu* targeting antibody such as Herceptin. U.S. and certain foreign patent claims describe the method\nand timing of administration. Patents issued in the U.S. will expire in 2028 and 2026 and international patents will expire in 2026.\n\n \n\n**Corporate\nStrategy**\n\n \n\nWe\ndo not have a sales, marketing, or product distribution strategy for our GP2 immunotherapy or any future product candidates because GP2\nis still in clinical development. Our future commercial strategy, if our GP2 immunotherapy or any future product candidates are approved,\nmay include the use of strategic partners, distributors, a contract sales force, or the establishment of our own commercial and specialty\nsales force for the U.S. market, as well as similar strategies for regions and territories outside the U.S. We plan to further evaluate\nthese options as we approach submission of a new drug application or biologics license application for one our product candidates for\none or more indications.\n\n \n\nThe\nGP2 issued patents provide protection ranging from 2026 through 2032 in various markets, and we plan to register GP2 as a biologic, which\nmay be subject to 10-12 years market exclusivity in the U.S. upon receiving marketing approval. During this period of exclusivity, we\nintend to advance GP2 into a Phase III clinical trial in the U.S. and pursue a European and global clinical trial strategy to support\nGP2 registration outside of the U.S. We are considering various options to fund the Phase III clinical trial including financing and/or\nstrategic transactions. Our strategy during such time also includes building a commercialization team, pursuing additional funding, and\npursuing strategic collaborations to support the future global marketing and sales of GP2, if approved. A long term global and regional\nlicensing process has been initiated and will continue as the Phase III trial commences.\n\n \n\n**Pipeline\nStrategy — Including GP2 In Other HER2/neu-Expressing Cancers**\n\n \n\nWe\nare developing follow-on indications for GP2 by designing and planning additional clinical trials to expand the breast cancer patient\npopulation and to pursue additional HER2/*neu*-expressing cancers. Pending the receipt of sufficient capital, the Phase III clinical\ntrial can be supplemented with additional clinical trials designed to evaluate the safety and efficacy of GLSI-100 in (1) patients immediately\nupon diagnosis in parallel to neoadjuvant treatment and surgery to provide maximum protection against breast cancer recurrence as soon\nas possible, (2) other HLA patients in the same HER2/*neu* 3+ breast cancer patient population, (3) breast cancer patients who are\nlow to intermediate expressors of HER2/*neu*(1-2+) or (4) other HER2/*neu*-expressing cancers including, but not limited to,\novarian, gastrointestinal, and colon cancers.\n\n \n\n**Government\nRegulations**\n\n \n\nThe\nFDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among\nother things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,\nstorage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting\nof biologics such as those we are developing. Along with third-party contractors, we will be required to navigate the various preclinical,\nclinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct clinical\ntrials or seek approval or licensure of our current product candidate or any future product candidates. The process of obtaining regulatory\napprovals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure\nof substantial time and financial resources. A company can make only those claims relating to safety and efficacy, purity and potency\nthat are approved by the FDA and in accordance with the provisions of the approved label.\n\n \n\nThe\nprocess required by the FDA before biologic product candidates may be marketed in the U.S. generally involves the following:\n\n \n\n \n●\ncompletion\nof preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices,\nor GLP, regulations;\n\n \n \n \n\n \n●\nsubmission\nto the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant\nchanges are made;\n\n \n\n16\n\n[Table of Contents](#toc_001)\n\n \n\n \n●\napproval\nby an independent IRB or ethics committee at each clinical site before the trial is begun;\n\n \n \n \n\n \n●\nperformance\nof adequate and well-controlled human clinical trials to establish the safety and efficacy of product;\n\n \n \n \n\n \n●\nmanufacture\nof product with adequate controls so that the product has the purity and potency of the proposed biologic product candidate for its\nintended purpose;\n\n \n \n \n\n \n●\npreparation\nof and submission to the FDA of a BLA, after completion of all pivotal clinical trials;\n\n \n \n \n\n \n●\nsatisfactory\ncompletion of an FDA Advisory Committee review, if applicable;\n\n \n \n \n\n \n●\na\ndetermination by the FDA within 60 days of its receipt of a BLA to file the application for review;\n\n \n \n \n\n \n●\nsatisfactory\ncompletion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced\nto assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to preserve the biological product’s\ncontinued safety, purity and potency, and of selected clinical investigations to assess compliance with GCP; and\n\n \n \n \n\n \n●\nFDA\nreview and approval of the BLA to permit commercial marketing of the product for particular indications for use in the U.S., which\nmust be updated annually when significant changes are made.\n\n \n\nThe\ntesting and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for\nour current product candidate or any future product candidates will be granted on a timely basis, if at all. Prior to beginning the first\nclinical trial with a product candidate, a sponsor must submit an IND to the FDA. An IND is a request for authorization from the FDA\nto administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational\nplan and the protocol(s) for clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology,\npharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information;\nand any available human data or literature to support the use of the investigational product. An IND must become effective before human\nclinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day\ntime period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical\nhold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission\nof an IND therefore may or may not result in FDA authorization to begin a clinical trial.\n\n \n\nClinical\ntrials involve the administration of the investigational product to human patients under the supervision of qualified investigators in\naccordance with GCP, which include the requirement that all research patients provide their informed consent for their participation\nin any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial,\nthe parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing\nIND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments.\nFurthermore, an IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and\nits informed consent form before the clinical trial begins at that site and must monitor the clinical trial until completed. Regulatory\nauthorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the patients\nare being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some clinical trials also\ninclude oversight by a Data and Safety Monitoring Board, or DSMB, organized by the clinical trial sponsor, which provides authorization\nfor whether or not a clinical trial may move forward at designated check points based on access to certain data from the clinical trial\nand may halt the clinical trial if it determines that there is an unacceptable safety risk for patients or other grounds, such as no\ndemonstration of efficacy. There are also requirements governing the reporting of ongoing clinical trials and clinical trial results\nto public registries.\n\n \n\nFor\npurposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.\n\n \n\n \n●\n**Phase\n1** — The investigational product is initially introduced into healthy human patients or patients with the target disease\nor condition. These clinical trials are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of\nthe investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence\non effectiveness.\n\n \n\n17\n\n[Table of Contents](#toc_001)\n\n \n\n \n●\n**Phase\n2**— The investigational product is administered to a limited patient population with a specified disease or condition to\nevaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.\nMultiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical\ntrials.\n\n \n \n \n\n \n●\n**Phase\n3**— The investigational product is administered to an expanded patient population to further evaluate dosage, to provide\nstatistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed\nclinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product\nand to provide an adequate basis for product approval.\n\n \n \n \n\n \n●\n**Phase\n4**— In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product\nis approved to gain more information about the product. These so-called Phase 4 clinical trials may be made a condition to approval\nof the BLA.\n\n \n\nPhase\n1, Phase 2 and Phase 3 testing may not be completed successfully within a specified period, if at all, and there can be no assurance\nthat the data collected will support FDA approval or licensure of the product. Concurrent with clinical trials, companies may complete\nadditional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize\na process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must\nbe capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing\nthe identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate\npackaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo\nunacceptable deterioration over its shelf life.\n\n \n\n**BLA\nSubmission and Review by the FDA**\n\n \n\nAssuming\nsuccessful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development,\nnonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or\nmore indications. The BLA must include all relevant data available from pertinent preclinical studies and clinical trials, including\nnegative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry,\nmanufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored clinical trials intended to\ntest the safety and effectiveness of a use of the product, or from a number of alternative sources, including clinical trials initiated\nby investigators. The submission of a BLA requires payment of a substantial user fee to FDA, and the sponsor of an approved BLA is also\nsubject to annual product and establishment user fees. These fees are typically increased annually. A waiver of user fees may be obtained\nunder certain limited circumstances.\n\n \n\nOnce\na BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application for filing,\nor, if the application relates to an unmet medical need in a serious or life-threatening indication, six months after the FDA accepts\nthe application for filing. The review process is often significantly extended by FDA requests for additional information or clarification.\nThe 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,\nprocessed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may convene\nan advisory committee to provide clinical insight on application review questions. Before approving a BLA, the FDA will typically inspect\nthe facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing\nprocesses and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within\nrequired specifications. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable,\nit will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission\nof any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria\nfor approval.\n\n \n\nThe\ntesting and approval process requires substantial time, effort and financial resources, and each may take several years to complete.\nThe FDA may not grant approval on a timely basis, or at all, and we may encounter difficulties or unanticipated costs in its efforts\nto secure necessary governmental approvals, which could delay or preclude us from marketing our product. After the FDA evaluates a BLA\nand conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the\nFDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with\nspecific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application\nis complete and the application is not ready for approval. A Complete Response Letter may request additional information or clarification.\nThe FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information\nand/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.\n\n \n\n18\n\n[Table of Contents](#toc_001)\n\n \n\nIf\nregulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which such product may be\nmarketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, plan to mitigate risks, which\ncould include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods,\npatient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed\nlabeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance\nwith pre- and post-marketing regulatory standards is not maintained or if problems occur after the product reaches the marketplace. The\nFDA may require one or more Phase 4 post-market clinical trials and surveillance to further assess and monitor the product’s safety\nand effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing\nclinical trials. In addition, new government requirements, including those resulting from new legislation, may be established, or the\nFDA’s policies may change, which could delay or prevent regulatory approval of our product under development.\n\n \n\nA\nsponsor may seek approval of its product candidate under programs designed to accelerate FDA’s review and approval of new drugs\nand biological products that meet certain criteria. Specifically, new drugs and biological products are eligible for Fast Track designation\nif they are intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for\nthe condition. For a product candidate with Fast Track designation, the FDA may consider sections of the BLA for review on a rolling\nbasis before the complete application is submitted if relevant criteria are met. A Fast Track designated product candidate may also qualify\nfor priority review, under which the FDA sets the target date for FDA action on the BLA at six months after the FDA accepts the application\nfor filing. Priority review is granted when there is evidence that the proposed product would be a significant improvement in the safety\nor effectiveness of the treatment, diagnosis, or prevention of a serious condition. If criteria are not met for priority review, the\napplication is subject to the standard FDA review period of 10 months after FDA accepts the application for filing. Priority review designation\ndoes not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.\n\n \n\nUnder\nthe Accelerated Approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to\npredict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably\nlikely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity,\nor prevalence of the condition and the availability or lack of alternative treatments. Post-marketing clinical trials or completion of\nongoing clinical trials after marketing approval are generally required to verify the biologic’s clinical benefit in relationship\nto the surrogate endpoint or ultimate outcome in relationship to the clinical benefit.\n\n \n\nIn\naddition, a sponsor may seek FDA designation of its product candidate as a Breakthrough Therapy, if the product candidate is intended,\nalone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary\nclinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically\nsignificant endpoints, such as substantial treatment effects observed early in clinical development. If the FDA designates a breakthrough\ntherapy, it may take actions appropriate to expedite the development and review of the application. Breakthrough designation also allows\nthe sponsor to file sections of the BLA for review on a rolling basis.\n\n \n\nFast\nTrack, Priority Review and Breakthrough Therapy designations do not change the standards for approval but may expedite the development\nor approval process.\n\n \n\n**Other\nHealthcare Laws and Compliance Requirements**\n\n \n\nOur\nsales, promotion, medical education and other activities following product approval will be subject to regulation by numerous regulatory\nand law enforcement authorities in the U.S. in addition to FDA, including potentially the Federal Trade Commission, the Department of\nJustice, the Centers for Medicare and Medicaid Services, other divisions of the Department of Health and Human Services and state and\nlocal governments. Our promotional and scientific/educational programs must comply with the federal Anti-Kickback Statute, the Foreign\nCorrupt Practices Act, the False Claims Act, or FCA, the Veterans Health Care Act, physician payment transparency laws, privacy laws,\nsecurity laws, and additional state laws similar to the foregoing.\n\n \n\n19\n\n[Table of Contents](#toc_001)\n\n \n\nThe\nfederal Anti-Kickback Statute prohibits, among other things, the offer, receipt, or payment of remuneration in exchange for or to induce\nthe referral of patients or the use of products or services that would be paid for in whole or part by Medicare, Medicaid or other federal\nhealth care programs. Remuneration has been broadly defined to include anything of value, including cash, improper discounts, and free\nor reduced price items and services. The government has enforced the Anti-Kickback Statute to reach large settlements with healthcare\ncompanies based on sham research or consulting and other financial arrangements with physicians. Further, a person or entity does not\nneed to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, the government\nmay assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false\nor fraudulent claim for purposes of the FCA. Many states have similar laws that apply to their state health care programs as well as\nprivate payors.\n\n \n\nThe\nFCA imposes liability on persons who, among other things, present or cause to be presented false or fraudulent claims for payment by\na federal health care program. The FCA has been used to prosecute persons submitting claims for payment that are inaccurate or fraudulent,\nthat are for services not provided as claimed, or for services that are not medically necessary. Actions under the FCA may be brought\nby the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the FCA can result\nin significant monetary penalties and treble damages. The federal government is using the FCA, and the accompanying threat of significant\nliability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country, for example, in\nconnection with the promotion of products for unapproved uses and other sales and marketing practices. The government has obtained multi-million\nand multibillion dollar settlements under the FCA in addition to individual criminal convictions under applicable criminal statutes.\nIn addition, companies have been forced to implement extensive corrective action plans, and have often become subject to consent decrees\nor corporate integrity agreements, restricting the manner in which they conduct their business. The federal Health Insurance Portability\nand Accountability Act of 1996, or HIPAA, also created federal criminal statutes that prohibit, among other things, knowingly and willfully\nexecuting a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying,\nconcealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery\nof or payment for healthcare benefits, items or services. Given the significant size of actual and potential settlements, it is expected\nthat the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’\ncompliance with applicable fraud and abuse laws.\n\n \n\nIn\naddition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare\nproviders. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively,\nthe Affordable Care Act, among other things, imposed new reporting requirements on drug manufacturers for payments or other transfers\nof value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their\nimmediate family members. Failure to submit required information may result in civil monetary penalties**.**Certain states also mandate\nimplementation of commercial compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking\nand reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.\n\n \n\nWe\nmay also be subject to data privacy and security regulation by both the federal government and the states in which it conducts its business.\nHIPAA, as amended by HITECH, and their respective implementing regulations, imposes specified requirements relating to the privacy, security\nand transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security\nstandards directly applicable to “business associates,” defined as independent contractors or agents of covered entities\nthat create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a\ncovered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates\nand possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal\ncourts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In\naddition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other\nin significant ways and may not have the same effect.\n\n \n\n20\n\n[Table of Contents](#toc_001)\n\n \n\nIf\nour operations are found to be in violation of any of such laws or any other governmental regulations that apply to it, we may be subject\nto penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations,\nexclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability\nto operate our business and our financial results.\n\n \n\nAlso,\nthe U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries\nfrom making improper payments to foreign officials for the purpose of obtaining or retaining business. We cannot assure you that our\ninternal control policies and procedures will protect us from reckless or negligent acts committed by our employees, future distributors,\npartners, collaborators or agents. Violations of these laws, or allegations of such violations, could result in fines, penalties or prosecution\nand have a negative impact on our business, results of operations and reputation.\n\n \n\n**Coverage\nand Reimbursement**\n\n \n\nSales\nof pharmaceutical products depend significantly on the availability of third-party coverage and reimbursement. Third-party payors include\ngovernment health administrative authorities, managed care providers, private health insurers and other organizations. Although we currently\nbelieve that third-party payors will provide coverage and reimbursement for our product candidate, if approved, these third-party payors\nare increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant\nuncertainty exists as to the reimbursement status of newly approved healthcare products. We may need to conduct expensive clinical trials\nto demonstrate the comparative cost-effectiveness of our product candidate. Seeking coverage and reimbursement from third-party payors\ncan be time consuming and expensive. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an\nadequate reimbursement rate will be approved. Reimbursement may not be available or sufficient to allow us to sell our product on a competitive\nand profitable basis.\n\n \n\n**Foreign\nRegulation**\n\n \n\nIn\naddition to regulations in the U.S., we are and will be subject, either directly or through our distribution partners, to a variety of\nregulations in other jurisdictions governing, among other things, clinical trials and commercial sales and distribution of our product,\nif approved.\n\n \n\nWhether\nor not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S. countries\nprior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the U.S. have\nprocesses that require the submission of a clinical trial application much like an IND prior to the commencement of human clinical trials.\nIn Europe, for example, a clinical trial application, or CTA, must be submitted to the competent national health authority and to independent\nethics committees in each country in which a company plans to conduct clinical trials. Once the CTA is approved in accordance with a\ncountry’s requirements, clinical trials may proceed in that country.\n\n \n\nThe\nrequirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to\ncountry, even though there is already some degree of legal harmonization in the European Union member states resulting from the national\nimplementation of underlying E.U. legislation. In all cases, the clinical trials are conducted in accordance with GCP and other applicable\nregulatory requirements.\n\n \n\nTo\nobtain regulatory approval of a new drug or medicinal product in the European Union, a sponsor must obtain approval of a marketing authorization\napplication. The way in which a medicinal product can be approved in the European Union depends on the nature of the medicinal product.\n\n \n\nThe\ncentralized procedure results in a single marketing authorization granted by the European Commission that is valid across the European\nUnion, as well as in Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for human drugs that are: (i) derived\nfrom biotechnology processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain\ndiseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases,\n(iii) officially designated as “orphan drugs” and (iv) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy\nor tissue-engineered medicines. The centralized procedure may, at the request of the applicant, also be used for human drugs which do\nnot fall within the above mentioned categories if the human drug (a) contains a new active substance which was not authorized in the\nEuropean Community; or (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical\ninnovation or that the granting of authorization in the centralized procedure is in the interests of patients or animal health at the\nEuropean Community level.\n\n \n\n21\n\n[Table of Contents](#toc_001)\n\n \n\nUnder\nthe centralized procedure in the European Union, the maximum timeframe for the evaluation of a marketing authorization application by\nthe EMA is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response\nto questions asked by the Committee for Medicinal Products for Human Use, or CHMP), with adoption of the actual marketing authorization\nby the European Commission thereafter. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product\nis expected to be of a major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria:\nthe seriousness of the disease to be treated; the absence of an appropriate alternative therapeutic approach, and anticipation of exceptional\nhigh therapeutic benefit. In this circumstance, EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days\nand the opinion issued thereafter.\n\n \n\nThe\nmutual recognition procedure, or MRP, for the approval of human drugs is an alternative approach to facilitate individual national marketing\nauthorizations within the European Union. The MRP may be applied for all human drugs for which the centralized procedure is not obligatory.\nThe MRP is applicable to the majority of conventional medicinal products, and is based on the principle of recognition of an already\nexisting national marketing authorization by one or more member states.\n\n \n\nThe\ncharacteristic of the MRP is that the procedure builds on an already existing marketing authorization in a member state of the E.U. that\nis used as reference in order to obtain marketing authorizations in other E.U. member states. In the MRP, a marketing authorization for\na drug already exists in one or more member states of the E.U. and subsequently marketing authorization applications are made in other\nEuropean Union member states by referring to the initial marketing authorization. The member state in which the marketing authorization\nwas first granted will then act as the reference member state. The member states where the marketing authorization is subsequently applied\nfor act as concerned member states.\n\n \n\nThe\nMRP is based on the principle of the mutual recognition by European Union member states of their respective national marketing authorizations.\nBased on a marketing authorization in the reference member state, the applicant may apply for marketing authorizations in other member\nstates. In such case, the reference member state shall update its existing assessment report about the drug in 90 days. After the assessment\nis completed, copies of the report are sent to all member states, together with the approved summary of product characteristics, labeling\nand package leaflet. The concerned member states then have 90 days to recognize the decision of the reference member state and the summary\nof product characteristics, labeling and package leaflet. National marketing authorizations shall be granted within 30 days after acknowledgement\nof the agreement.\n\n \n\nShould\nany Member State refuse to recognize the marketing authorization by the reference member state, on the grounds of potential serious risk\nto public health, the issue will be referred to a coordination group. Within a timeframe of 60 days, member states shall, within the\ncoordination group, make all efforts to reach a consensus. If this fails, the procedure is submitted to an EMA scientific committee for\narbitration. The opinion of this EMA Committee is then forwarded to the Commission, for the start of the decision-making process. As\nin the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing Committee\non Human Medicinal Products or Veterinary Medicinal Products, as appropriate.\n\n \n\nFor\nother countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing\nthe conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical\ntrials are conducted in accordance with GCP and the other applicable regulatory requirements.\n\n \n\nIf\nwe fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical\ntrials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.\n\n \n\n22\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Human\nCapital Management**\n\n \n\nAs\nof May 26, 2026 we had 4 full-time employees and 9 part-time employees. We are not a party to any collective bargaining agreements.\nWe believe that we maintain good relations with our employees. We do not have any employees that\nare represented by a labor union or covered under a collective bargaining agreement. Our future success depends on our ability to attract,\ndevelop and retain key personnel, maintain our culture, and ensure diversity and inclusion in our board, management and broader workforce.\nOur human resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing\nand additional employees."}