Greenwich Lifesciences, Inc. · NASDAQ:GLSI
Greenwich Lifesciences — Investor Presentation (November 2020)
27 slides from Greenwich Lifesciences's investor presentation, Nov 19, 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 © 2020 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: 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, vers
Slide 4: GP2 Phase III Clinical Trial Dosing
GP2 Phase Ill Clinical Trial Dosing K Hercep pti nerlynx Potential Data Read Out: If 1.5 years enrollment & See ere median 2 year endpoint, data read out near end of 34 ear from start of trial (range 1.25 — 2.75 years in trial 5 y (rang y 2 ae @ _er GP2 — 11 doses over 3 years PERJETA pertuzumab PKa
Slide 5: 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 6: 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 Phase Ilb Results for GP2 Target Population, if Fully Immunized jee 7 (median 34 month follow-up) 10 Absolute DFS at 35 years 867% (ACTH os ACT i va 3 : tau a : 8 cay 024
Slide 7: 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 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 toxi
Slide 8: GP2 Clinical Data: GP2 is Immunogenic & Clinically Effective
GP2 Clinical Data: GP2 is Immunogenic & Clinically Effective
Slide 9: 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 HER2 HERS: 3D Structure b Vi of HER2/neu P Protein (res) eo ae = a Pat yo mTOR FKHR GSK-3 a ro on Di FasL. MAPK SS Cell cycle Le Sur
Slide 10: 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 1% year of Herceptin treatment in Adjuvant Setting Leukine’ Herceptin’ sargramostim trastuzumab
Slide 11: Summary of All GP2 Trials - Phase I & Phase IIb
Summary of All GP2 Trials - 3 Phase 1 & 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 * GM-CSF alone GP + GM-CSF GndeO | Grdel | Grde2 | Grde3 Grade0 | Grad
Slide 14: Phase IIb — GP2 is Clinically & Immunologically Effective
Phase Ilb — GP2 is Clinically & Immunologically Effective + Immune response was observed peaking after 6 months compared to baseline, measured pupelayed ype Hypersensitivity (DTH skin test using GP2) and immunolo ical assay. DTH response rate for treated patients is very high. Orthogonal mean baseli
Slide 15: GP2 Planned Phase III Trial
GP2 Planned Phase III Trial: Strategy= Conservatively Reproduce Phase IIb 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” Randomization: End of 1st year + NP or high-risk
Slide 17: Manufacturing / Regulatory / IP
Manufacturing / Regulatory / IP * GP2 manufactured by straightforward amino acid chemistry — Manufactured by FDA-approved commercial a a * 8 facility with multiple back-up facilities 4) — Detailed CMC plan reviewed by FDA i 5 * ¥ — Commenced engineering scale-up run for fe commercial scale manufactu
Slide 18: GP2 Commercial Opportunity
GP29 Bis. Commercial Opportunity’
Slide 19: Potential Additional Indications of GP2 & Herceptin in Various Populations
Potential Additional Indications of GP2 & Herceptin in Various Populations in Adjuvant Setting HER2/neu 3+ protein over-expression True Negative (25%) & 1-2+ expression (50%) 25% er — All breast cancer patients are tested for HER2/neu 50% expression by immunohistochemistry (IHC) or HER2/neu 3+ fluor
Slide 20: Commercial Opportunity for GP2 in Breast Cancer
Commercial Opportunity for GP2 in Breast Cancer 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 GP
Slide 21: GP2 Acts Synergistically with Herceptin, Perjeta, Nerlynx, Kadcyla and Enhertu
GP2 Acts Synergistically with Herceptin, Perjeta, Nerlynx, & the Newest Entrants Kadcyla and Enhertu Herceptin: * Genentech’s Herceptin (trastuzumab) in Y1 post-surgery trastuzumab — Reduces recurrence rates from 25% to 12% by Y4 post-surgery > Node Positive and High Risk Node Negative > Side Effect
Slide 22: Potential Commercial Opportunities / Additional Indications for GP2
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 164,590 19% Breast 266,120 30% 121,680 14% Lung & bronchus: 112,350 13% 3 75,610 9% Colon & rectum 64.640 1
Slide 23: Trading & Transaction Comparables
Trading & Transaction Comparables Trading Comparables As of market close on 11/17/20 Symbol Name Price Change Volume DayRange 52WkRange Market Cap.Comments Late Stage Breast Cancer / ImmunoOncology PBYL |PUMA BIOTECHNOLOGY 9.38 |& +0.30+3.30% |370.61k |8.91-9.49 5.50-15.00 372.97 Fame play comp wath
Slide 24: 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 saaiaibig O Eines Snehal Patel, MS, MBA-— CEO, Board — 30 years of biopharma / Wall Street experience ca ae Ui — Large pharma operations /
Slide 25: Capitalization (as of 9/30/20)
Capitalization (as of 9/30/20) CASH $6.2m COMMON SHARES 11,970,185 WARRANTS AND OPTIONS 100,870 FULLY DILUTED SHARES 12,071,055 OWNERSHIP (TIGHTLY HELD: 76% Insiders + 14% Family Trusts) 90% LIABILITIES $1.6m Over $20M in private capital and grants have been invested in GP2 prior to IPO © 2020 GLSI
Slide 26: GP2 Conclusions: A Breakthrough Targeted Immunotherapy
GP2 Conclusions: A Breakthrough Targeted Immunotherapy for Prevention of HER2/neu Cancer @ a 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 si
Slide 27: Snehal Patel
Snehal Patel CEO Telephone: 832.819.3232 _ f ; E-mail: info@greenwichlif nces.ca n Website: greenwichlifesciences.com ag a £. ve
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