Greenwich Lifesciences, Inc. · NASDAQ:GLSI
Greenwich Lifesciences — Investor Presentation (October 2020)
25 slides from Greenwich Lifesciences's investor presentation, Oct 9, 2020
Slide 1: Planned GP2 Phase III Clinical Trial
GREENWICH LIFESCIENCES Planned GP2 Phase Ill Clinical Trial A Breakthrough Targeted Immunotherapy to Prevent Breast Cancer Recurrences NASDAQ: GLSI Snehal Patel, CEO David McWilliams, Chairman Greenwich LifeSciences © 2020 GLSI nage es Geng Gace cal
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: 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 that th
Slide 4: Synergy with Herceptin & No Recurrences if Fully Immunized
Synergy with Herceptin & No Recurrences if Fully Immunized Herceptin Approved for Adjuvant Treatment of HER2/neu 3+ Breast Cancer. DFS! iy Absolute DFS a3 yeas 867% ACTH) fo] Eo z 024 Hazard ratio=0.48 (95% confidence interval: 0.39-0.59) 0.0001 cr a a a a a Dts oe abe i 750 a a a ee en ee ee ee ‘AC
Slide 5: GP2 positioned as the final treatment post surgery
* As only injection site reactions were observed (which speaks to the immunogenicity of GP2) and no SAEs, GP2 can be positioned as the final treatment for patients post surgery * Patients are seeking a de-escalation and a return to normal life free of toxic treatments, especially if the chance of re
Slide 6: Veteran Management Team / Board
Veteran Management Team / Board David McWilliams, MBA — Chairman, Board c) MeKinseyS Company — 40 years of start-up / CEO experience — CEO of 2 private and 3 public biotech companies Abbots oO Ee aed Snehal Patel, MS, MBA-— CEO, Board — 30 years of biopharma / Wall Street experience eeeA racanneuric
Slide 7: GP2 Executive Summary
GP2 Executive Summary « Planned Phase III Trial: 9 amino acid HER2/neu peptide + GM-CSF immunotherapy for breast cancer in adjuvant/neoadjuvant setting (post- surgery) in HER2/neu 3+, HLA-A2 patients in Y2 following Herceptin or Kadcyla « Phase IIb Trial Results: No recurrences, if fully immunized,
Slide 8: 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 Cell cycle progression Proliferation © 2020 GLSI 8
Slide 9: 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 Leukine’ Herceptin: sargramostim trastuzumab
Slide 10: GP2 Clinical Data: GP2 is Immunogenic & Clinically Effective
GP2 Clinical Data: GP2 is Immunegenic & Clinically Effective
Slide 11: Summary of All GP2 Trials - Phase I & Phase IIb
Summary of All GP2 Trials - 3 Phase | & 1 Phase IIb (Total N=138 Patients Treated to Date with No SAEs) Protocol No./ Protocol Title Status Protocol No. C.2007.098/IRBNet# 363083 Trial e Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the Completed HER2/neu Peptide GP2 + GM-C
Slide 12: Design of Phase IIb Clinical Trial
Design of Phase IIb Clinical Trial * Prospective, randomized, single-blinded, placebo-controlled phase IIb clinical trial of GP2 + GM-CSF or GM-CSF alone in 180 intent to treat HER2/neu 1-3+, HLA-A2 patients at 16 civilian/military clinical sites, led by MD Anderson * High-risk breast cancer patient
Slide 13: Phase IIb Clinical Data — No SAEs
Phase IIb Clinical Data — No SAEs * Maximum local and systemic toxicities were primarily grade 1 and grade 2 * Toxicities ranged from redness at injection site to flu-like symptoms and can be largely attributed to GM-CSF, not GP2 100 Toxicity: The maximum local and systemic toxicity experienced by p
Slide 14: Immune response observed peaking after 6 months
+ Immune response was observed peaking after 6 months compared to baseline, measured by Prlaved ype Hypersensitivity (DTH skin test using GP2) and immunolo ical assay. DTH response rate for treated patients is very high. Orthogonal mean baseline vs 6 months: 4.141.1mm versus 15.3+ 2.2mm (4 standard
Slide 15: GP2 Planned Phase III Trial: Conservatively Reproduce Phase IIb
GP2 Planned Phase Ill Trial: Strategy = Conservatively Reproduce Phase Ilb Trialin Latger Population ,
Slide 16: Phase III Clinical Trial - Protocol Reviewed by FDA
Phase Ill Clinical Trial - Protocol Reviewed by FDA Title: “Study Evaluating The Reduction Of Recurrences Using HER2/neu Peptide GP2 + GM-CSF Vaccine After Adjuvant Trastuzumab In HLA-A2-Positive, HER2-Positive (3+) Women With Operable Breast Cancer” Major Screening Criteria: + HER2/neu 3+ and HLA-A
Slide 17: GP2 Phase III Clinical Trial Dosing
GP2 Phase Ill Clinical Trial Dosing Herceptin trastuzumeb nerlyny’ Potential Data Read Out: If 1.5 years enrollment & ect) es median 2 year endpoint, data read out near end of 3% year from start of trial (range 1.25 — 2.75 years in trial) Boosters (5 Doses) GP2 — 11 doses over 3 years PERJETA PertUZ
Slide 18: Manufacturing / Regulatory / IP
Manufacturing / Regulatory / IP GP2 manufactured by straightforward amino acid chemistry Manufactured by FDA-approved commercial a ae a facility with multiple back-up facilities Rae Detailed CMC plan reviewed by FDA Di s Commenced engineering scale-up run for commercial scale manufacturing Phase Ill
Slide 19: GP2 Commercial Opportunity
GP2 ix. Commercial. Opportunity” »
Slide 20: Potential Additional Indications of GP2 & Herceptin
Potential Additional Indications of GP2 & Herceptin in Various Populations in Adjuvant Setting HER2/neu 3+ protein over-expression True Necstive (25%) & 1-2+ expression (50%) 25% — All breast cancer patients are tested for HER2/neu I expression by immunohistochemistry (IHC) or HER2Ineu 3+ fluoresece
Slide 21: US Market Potential
1 in 8 U.S. women (12.4%) will develop invasive breast cancer over her lifetime, with 266k new breast cancer patients per year in 2018 GP2’s target market is 6-30% of available breast cancer market or up to 2.4x that of Herceptin in adjuvant setting GP2 could be a long term treatment that treats sur
Slide 22: Current Adjuvant Treatments: Herceptin, Perjeta, Nerlynx
+ Genentech’s Herceptin (trastuzumab) in Y1 post-surgery — Reduces recurrence rates from 25% to 12% by Y4 post-surgery » Node Positive and High Risk Node Negative > Side Effects: Cardiotoxic, 1 year treatment only + Genentech’s Perjeta (pertuzumab) in Y1 with Herceptin — Reduces recurrence rates in
Slide 23: Potential Commercial Opportunities / Additional Indications
Potential Commercial Opportunities / Additional Indications for GP2 : HER2/neu Expressed in Multiple Cancers Figure 3. Leading Sites of New Cancer Cases and Deaths - 2018 Estimates Male Female 164,690 19% Breast 266,120 30% 121,680 14% Lung & bronchus 112,350 13%. 3 Colon & rectum & is Uterine corpu
Slide 24: GP2 Conclusions: A Breakthrough Targeted Immunotherapy
GP2 Conclusions: A Breakthrough Targeted Immunotherapy for Prevention of HER2/neu Cancer Phase IIb trial: No breast cancer recurrences post-surgery, if fully immunized, (p = 0.0338), with minimal to no side effects, at median 5 years follow-up, randomized, placebo-controlled, multi-center (16 sites,
Slide 25: For Additional Information, Please Contact
Greenwich LifeSciences — Investor Presentation (October 2020) on 6ix