Greenwich Lifesciences, Inc. · NASDAQ:GLSI
Greenwich Lifesciences — Investor Presentation (June 2025)
36 slides from Greenwich Lifesciences's investor presentation, June 2025
Slide 1: Greenwich LifeSciences: GLSI-100 Phase III Trial FLAMINGO-01
GREENWICH LIFESCIENCES Planned GLSI-100 (GP2 + GM-CSF) Phase III Clinical Trial, FLAMINGO-01 A Breakthrough Targeted Immunotherapy to Prevent Breast Cancer Recurrences NASDAQ: GLSI Snehal Patel, CEO © 2025 GLSI Image: T-cells targeting cancer cell
Slide 2: Safe Harbor Statement
Safe Harbor Statement This document is the property of Greenwich LifeSciences, Inc., (the “Company” or “Greenwich LifeSciences”). This document is non-directive in nature (contains no recommendations regarding financial actions related to the Company). This document is not to be copied or delivered
Slide 3: GLSI-100 (GP2 + GM-CSF) Executive Summary
GLSI-100 (GP2 + GM-CSF) Executive Summary • Flamingo-01 - Current Phase III Trial with Interim Analysis: 9 amino acid HER2/neu peptide + GM-CSF immunotherapy for breast cancer in HER2/neu 3+, HLA-A2 patients following neoadjuvant, surgery, & adjuvant Herceptin or Kadcyla, led by Baylor & consortium
Slide 4: First Year Share Price Performance After Presenting Key Phase IIb Data in 2020/2021
First Year Share Price Performance After Presenting Key Phase IIb Data in 2020/2021 • Raised approximately $36.5M from IPO & Follow-on in 2020 • Peak share prices and trading volume driven by data publications • 30x or 2,940% return from intraday high on 12/9/20, possibly highest intraday return for
Slide 5: 2020-2021 - Four Posters Highlighting Efficacy, Mechanism of Action, Safety, & Prognostic Factors
2020-2021 - Four Posters Highlighting Efficacy, Mechanism of Action, Safety, & Prognostic Factors 2020 San Antonio Breast Cancer Symposium (SABCS) 2021 American Association for Cancer Research (AACR) 0% Recurrences Over 5 Years in Phase IIb Trial Immune Response Supports Mechanism of Action 2021 Ame
Slide 6: 5 Year Data Set of GP2 Phase IIb Trial is Complete
5 Year Data Set of GP2 Phase IIb Trial is Complete HER2 3+ (Positive) Patients who Completed the Primary Immunization Series (PIS) 100% Disease Free Survival, 0% Metastatic Breast Cancer Recurrences** Peak Immunity After 6 Months & PIS Injection Site & Systemic Adverse Events (AE) are Positive Sign
Slide 7: ASCO 2021 – Systemic & Injection Site Reactions
ASCO 2021 – Systemic & Injection Site Reactions Figure 2: Incidence of Maximum Severity Grade Adverse Events The maximal severity grade for any AE, systemic and injection site reaction, for each patient was identified. There was no difference between the two treatment arms, as presented in Figure 2.
Slide 8: ASCO 2021 – Incidence of Adverse Events
ASCO 2021 – Incidence of Adverse Events Tables 1 & 2: Incidence of Adverse Events The first occurrence of frequently reported AEs is tabulated in Table 1. The most common AE was injection site reaction. Almost every patient, in both the GP2+GM-CSF and GM- CSF only arms, reported injection site react
Slide 9: 4 Year Performance Since IPO – Planning & Initiation of Phase III Trial
4 Year Performance Since IPO – Planning & Initiation of Phase III Trial in up to 150 sites in 6 Countries 2022 – 2024 Events • Major KOLs joined Steering Committee • 35-40 US sites initiated in 2023-2024 • Large academic networks added • EMA approved 105-120 sites in 2024-2025 • Total sites up to 15
Slide 10: Flamingo-01 Steering Committee
Flamingo-01 Steering Committee The Steering Committee is comprised of the following members : • Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine • Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group,
Slide 11: Flamingo-01 Clinical Site Map – Up to 150 sites in US/EU
Flamingo-01 Clinical Site Map – Up to 150 sites in US/EU Participating networks: USOncology/Sarah Cannon, TRIO-US, GEICAM (Spain), Unicancer (France), GBG (Germany), GIM (Italy) © 2025 GLSI 11
Slide 12: Breast Cancer – Still a Substantial Unmet Need
Breast Cancer – Still a Substantial Unmet Need • Unmet Need is to address the 50% of recurring patients who do not respond to Herceptin or Kadcyla – an opportunity for GP2. • Adjuvant Setting: Following breast cancer surgery, HER2/neu 3+ patients receive Herceptin in the first year and then hope tha
Slide 13: GP2 Phase III Clinical Trial Dosing
GP2 Phase III Clinical Trial Dosing Potential Data Read Out: Interim analysis planned after ½ of prescribed events have occurred 1 year 1 year Surgery GP2 – 11 doses over 3 years Primary Immunization Series (6 Doses) Boosters (5 Doses) Doses Months 0 1 2 3 4 5 6 12 18 24 30 36 Immunologic X X X X X
Slide 14: GP2 Market Positioning & Feedback from KOLs
GP2 Market Positioning & Feedback from KOLs • As only injection site reactions were observed (which speaks to the immunogenicity of GP2) and with no SAEs attributable to GP2, GP2 can be positioned as the final treatment for patients post surgery • Patients are seeking a de-escalation and a return to
Slide 15: Synergy with Herceptin Alone
** 5 Year Disease Free Survival Synergy with Herceptin Alone ** without use of Kadcyla, Perjeta, Nerlynx, Enhertu, or Tukysa Herceptin Approved for Adjuvant Treatment of HER2/neu 3+ Breast Cancer Phase IIb Results for GP2 Target Population, if Fully Immunized (median 5 years follow-up) 100.0% 89.4%
Slide 16: GP2 Clinical Data: GP2 is Immunogenic & Clinically Effective
GP2 Clinical Data: GP2 is Immunogenic & Clinically Effective 16 © 2025 GLSI
Slide 17: HER2/neu Signaling Pathway Well Studied
HER2/neu Signaling Pathway Well Studied ➢ HER2/neu pathway activates cancer cell proliferation ➢ Overexpression of HER2/neu correlates strongly with aggressive cancers 3D Structure of HER2/neu Protein GP2 Peptide © 2025 GLSI 17
Slide 18: GP2 Product Description & Mechanism of Action
GP2 Product Description & Mechanism of Action • 9 amino acid transmembrane peptide segment of HER2/neu protein • Intradermal injection in combination with an FDA-approved immunoadjuvant GM-CSF, following 1st year of Herceptin treatment in Adjuvant Setting 5 -15° angle • Given once per month for six
Slide 19: Summary of GP2 Completed Trials - N=146 GP2-Treated Patients to Date with No SAEs
Summary of GP2 Completed Trials - N=146 GP2-Treated Patients to Date with No SAEs Attributable to GP2 Design and Number of Duration of Study Product, Dose, and Route Regimen Population Control Subjects Follow-Up 3x3 Dose- • GP2 at 100, 500, 1000mcg 6 doses, every 18 • Breast cancer Primary safety Ph
Slide 20: GP2 Phase III Trial Commenced: Strategy – Conservatively Reproduce Phase IIb Trial
GP2 Phase III Trial Commenced: Strategy – Conservatively Reproduce Phase IIb Trial in Larger Population © 2025 GLSI 20 20 © 2025 GLSI
Slide 21: Flamingo-01 - Phase III Trial Has Commenced
Flamingo-01 - Phase III Trial Flamingo-01 Has Commenced • Approximately 120 sites are active, with another 30 approved EU sites in start-up • Flamingo-01 is evaluating the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high- ris
Slide 22: Flamingo-01 - Phase III Trial Schema & Interim Analysis
Flamingo-01 - Phase III Trial Schema & Interim Analysis Phase III Trial Schema Interim Analysis Design Stratified by: Preliminary Sizing of Trial: • Residual disease/pCR Approximately 498 subjects • Hormone receptor status will be enrolled. To detect a • Geographic region hazard ratio of 0.3 in IDFS
Slide 23: Flamingo-01 - HLA Prevalence, Safety, & Immune Response Data Trending as Expected
Flamingo-01 - HLA Prevalence, Safety, & Immune Response Data is Trending as Expected in Both HLA Arms Preliminary Flamingo-01 data available to date is summarized in a blinded manner. This summary may not reflect results at the end of the study. • Safety data in both the HLA-A*02 treated and placebo
Slide 24: Expand by HLA - GP2-HLA Observed & Predicted Prevalence
Expand by HLA - GP2-HLA Observed & Predicted Prevalence Preliminary Flamingo-01 data available to date is summarized in a blinded manner. This summary may not reflect results at the end of the study. • Across all screened patients, HLA-A*02 prevalence is about 46%. The double HLA-A*02 prevalence, in
Slide 25: GP2 May Address Unmet Need in Both HER2/neu 3+ Adjuvant & Neoadjuvant Settings
GP2 May Address Unmet Need in Both HER2/neu 3+ Adjuvant & Neoadjuvant Settings Surgery Surgery Projected 5 Year Recurrence Rates 9-12% 9-12% 5-10% 17% 5-10% 17% Conclusion: GP2 should eventually be pursued in Target Population for Phase III Trial: Residual Disease both settings for all HER2 & High R
Slide 26: GP2 Specific & Secondary Immune Response TCR Sequencing
GP2 Specific & Secondary Immune Response TCR Sequencing Multiple Open Label Immune Response Assessments are Planned to Potentially Identify GP2 Specific T cells, Biomarkers, Booster Strategies, and Early Recurrers 1. Delayed Type Hypersensitive (DTH) skin test for in vivo immune response to GP2 (20%
Slide 27: GP2 Commercial Opportunity
GP2 Commercial Opportunity © 2025 GLSI 27 © 2025 GLSI
Slide 28: Potential Indications of GP2 & Herceptin in Various Populations in Neoadjuvant Setting
Potential Indications of GP2 & Herceptin in Various Populations in Neoadjuvant Setting • HER2/neu 3+ protein over-expression (25%) & True Negative 25% 1-2+ expression (50%) HER2/neu 1-2+ – All breast cancer patients are tested for HER2/neu 50% expression by immunohistochemistry (IHC) or HER2/neu 3+
Slide 29: Commercial Opportunity for GP2 in Breast Cancer in US
Commercial Opportunity for GP2 in Breast Cancer in US • 1 in 8 U.S. women (12.8%) will develop invasive breast cancer over her lifetime, with 317k new breast cancer patients per year in 2025 • An estimated 42k female breast cancer deaths will occur in the US in 2025 • GP2’s target market is 6-30% of
Slide 30: Potential Commercial Opportunities / Additional Indications for GP2
Potential Commercial Opportunities / Additional Indications for GP2: HER2/neu Expressed in Multiple Cancers Denotes cancers where HER2/neu over expression has been reported © 2025 GLSI 30
Slide 31: Veteran Management Team / Board
Veteran Management Team / Board • David McWilliams, MBA – Chairman, Board – 40 years of start-up / CEO experience – CEO of 2 private and 3 public biotech companies indexCopy_01 • Snehal Patel, MS, MBA – CEO, Board – 30 years of biopharma / Wall Street experience – Large pharma operations / managemen
Slide 32: Manufacturing / Regulatory / IP
Manufacturing / Regulatory / IP • GP2 manufactured by straightforward amino acid chemistry – Manufactured by FDA-approved commercial facility with multiple back-up facilities – Commercial manufacturing commenced – 3 clinical lots followed by 3 commercial lots – GM-CSF is commercially available, alon
Slide 33: GLSI Strategy is to Conduct Additional GP2 Trials
GLSI Strategy is to Conduct Additional GP2 Trials Greenwich’s current strategy is as follows: • Reproduce Phase IIb trial in Add Checkpoint Inhibitors Phase III trial in HER2 positive patients only – no material changes to treatment regimen, upgrade immune response assays, expand to multiple HLA typ
Slide 34: GP2 Conclusions: A Breakthrough Targeted Immunotherapy for Prevention of HER2/neu Cancer
GP2 Conclusions: A Breakthrough Targeted Immunotherapy for Prevention of HER2/neu Cancer • Flamingo-01 - Phase III Trial with Interim Analysis: 9 amino acid HER2/neu peptide + GM-CSF immunotherapy for breast cancer in HER2/neu 3+, HLA-A2 patients following neoadjuvant, surgery, & adjuvant Herceptin
Slide 35: GLSI Sponsorship of 5k Race in Houston each October
GLSI Sponsorship of 5k Race in Houston each October © 2025 GLSI 35
Slide 36: For Additional Information, Please Contact: Snehal Patel CEO
NASDAQ: GLSI For Additional Information, Please Contact: Snehal Patel CEO Telephone: 832.819.3232 E-mail: info@greenwichlifesciences.com Website: greenwichlifesciences.com © 2025 GLSI
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