Greenwich Lifesciences, Inc. · NASDAQ:GLSI

Greenwich Lifesciences — Investor Presentation (November 2021)

40 slides from Greenwich Lifesciences's investor presentation, Nov 10, 2021

  1. Slide 1: Planned GLSI-100 (GP2 + GM-CSF) Phase III Clinical Trial

    GREENWICH LIFESCIENCES Planned GLSI-100 (GP2 + GM-CSF) Phase Ill Clinical Trial A Breakthrough Targeted Immunotherapy to Prevent Breast Cancer Recurrences NASDAQ: GLSI Snehal Patel, CEO Greenwich LifeSciences © 2021 GLSI Imaae: T-cells targeting cancer cell

  2. 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

  3. Slide 3: GLSI-100 (GP2 + GM-CSF) Executive Summary

    GLSI-100 (GP2 + GM-CSF) Executive Summary « Planned Phase Ill 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 Ilb Trial Results: 0% recurrences, i

  4. Slide 4: 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) 1.00 0.75 Probability Disease-Free Survival 0.25 0.50 0.00 Number at Risk 100.0% <_< . es —e Change from 1.8 235 89.4% ibeseline 1.6 os p<0.05 14 3% 1.2 28 ¢ 10 £§ 0.8 ©

  5. 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

  6. Slide 6: GP2 Phase III Clinical Trial Dosing

    GP2 Phase III Clinical Trial Dosing Herceptin’ a, Potential Data Read Out: Interim analysis planned trastuzumab (ne . after % of prescribed events have occurred ) 5) 5 (7) PERJETA PertUZUMA torinjcion 7-)Kadcyla ad-trastuzumab emtansine Doses Months 0 1 2 3 4 5 6 12 18 24 30 36 Immunologic X XxX Xx

  7. 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 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

  8. Slide 8: Synergy with Herceptin Alone

    Synergy with Herceptin Alone ** —_** 5 Year 100% Disease Free = Survival without use of Kadcyla, 0% Metastatic Cancer Recurrences Perjeta, Nerlynx, Enhertu, or Tukysa Herceptin Approved for Adjuvant Treatment of HER2/neu 3+ Breast Cancer Phase IIb Results for GP2 Target DFS" Population, if Fully Imm

  9. Slide 9: GP2 Clinical Data

    GP2 Clinical Data: ‘Sa Ge GP2 is immunogenic & Clinically Effective '

  10. Slide 10: 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 MAPK Cell cycle progression Proliferation {ieSooncas © 2021 GLSI 10

  11. Slide 11: GP2 Product Description & Mechanism of Action

    GP2 Product Description & Mechanism of Action * Q 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

  12. Slide 12: Summary of GP2 Completed Trials

    Summary of GP2 Completed Trials — N=138 GP2-Treated Patients to Date with No SAEs Attributable to GP2 Phase 1b 04-20017, (MCHL-SG (40-38a)) Phase 1b (C.2008.146) Phase 2b (C.2007.098) Greenwich LifeSciences 3x3 Dose- escalation 3x3 Dose- escalation 3x3 Dose- escalation Randomized, Single-Blind GM-CS

  13. Slide 13: 2020 San Antonio Breast Cancer Symposium (SABCS)

    2020 San Antonio Breast Cancer Symposium (SABCS) 0% Recurrences Over 5 Years in Phase Ilb Trial “San Ant Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase Ilb study evaluating the reduction of recurrences using HER2/neu peptide GP2

  14. Slide 14: SABCS 2020 — Populations Well Balanced

    SABCS 2020 — Populations Well Balanced HER2 3+ HER2 1-2+ — = ae GP2 Placebo GP2 Placebo Table 1: Clinicopathologic ais (n= 46) (n= 50) (n= 36) (n=37) i i As 50.5 52.1 50.8 49.9 c haracteristics by Treatment Group (rasan [min, max]) (26.9-72.3) (33.7-72.1) (36.7-76.7) (26.3-69.2) for HER2 3+ and HER2

  15. Slide 15: SABCS 2020 — 100% Disease Free Survival

    SABCS 2020 — 100% Disease Free Survival Figure 1: HER2 3+ Patients Who Completed Primary Immunization Series Following Trastuzumab 1.00 i 2 5 i 89.4% ees GP2 eo Median 5 year treatment be follow-up after started a Be start of medianof 4 treatment & 17.1months 29 | 6.4 years after surgery So follow-u

  16. Slide 16: 2021 American Association for Cancer Research (AACR)

    2021 American Association for Cancer Research (AACR) Immune Response Supports Mechanism of Action Final five year median follow-up data from a prospective, randomized, placebo- -controlled, single-| -blinded, multicenter, phase Ilb study evaluating a time series of immune responses using HER2/neu pe

  17. Slide 17: AACR 2021 — Immune Response Peaks at Months

    AACR 2021 — Immune Response Peaks at 6 Months Figure 1: Immune Response & DFS in HER2 3+ Patients Who Completed Primary Immunization Series S 100.0% GP2-specified CTLs were 4 1 bu 1 ms ; . Gx = , ee quantified using the Ig:A2 = a a | Dimer Assay. The assay Pa br —_______, 2.0 89.4% was assessed over

  18. Slide 18: AACR 2021 — Immune Response Assays

    © AACR 2021 — Immune Response Assays Dimer Binding Assay The Dimer Binding Assay detects the percentage of GP2 specific killer T cells that can kill recurring cancer cells. Ex vivo immune response was assessed over 2.5 years with blood draws at baseline, then after the 3rd and 6th immunizations in t

  19. Slide 19: AACR 2021 — Immune Response Dimer Binding Assay

    AACR 2021 — Immune Response Dimer Binding Assay Figure 2: GP2-specific CTLs by Dimer Assay for HER2 3+ * 18 i Change from Baseline 1.6 *»<0.05 1.4 * 2” 5 10 € 0.8 4 0.6 0.4 0.2 0.0 2 i) © © v % & SF FS SC S S »* SS ok & ny eg g ge m@ GP2+GM-CSF m@ GIM-CSF alone The same Dimer Binding Assay data for

  20. Slide 20: AACR 2021 — Immune DTH Skin Test

    Figure 3: Delayed Type Hypersensitivity Skin Test (DTH) 12 10 8 Median Orthogonal Measurement (mm) 14 12 10 Median Orthoganal Measurement (mm) © AACR 2021 — Immune DTH Skin Test ™@ GP2+GM-CSF | GM-CSF alone Pre-Vaccination =-GP2 - HER2/1+/2+ +GM-CSF - HER2/1+/2+ —GP2 - HER2/3+ —GM-CSF - HER2/3+ Pre-

  21. Slide 21: 2021 American Society of Clinical Oncology (ASCO)

    2021 American Society of Clinical Oncology (ASCO) Injection Related Immune Reactions, No GP2 Related SAEs For Audio Recording, Please Visit: Final five year median follow-up safety data from a prospective, randomized, placebo-controlled, single- blinded, multicenter, phase IIb study evaluating the u

  22. Slide 22: ASCO 2021 — Final Year Data Set of GP2 Phase IIb Trial

    ASCO 2021 — Final 5 Year Data Set of GP2 Phase IIb Trial Figure 1: Safety, Immune Response, & DFS in HER2 3+ Patients Who Completed Primary Immunization Series Figure 1 shows a time series of 100.0% the GP2 immunotherapy r=) oo = : aa aap injections, adverse events (AE), ~ Peak : =a ore immune respo

  23. Slide 23: ASCO 2021 — Systemic & Injection Site Reactions

    ASCO 2021 — Systemic & Injection Site Reactions Figure 2: Incidence of Maximum Severity Grade Adverse Events _— 80.0 — @ GP2+GM-CSF z 70.0 Injection Site a GM:CSF clone reee Systemic Reaction = 60.0 vy: Any Event & woo p=0.845 0. = Ss = 0.646 p=0.952 g, 30.0 £ 20.0 | | ®% 10.0 1S) ae | - | Fg Vag Ve

  24. Slide 24: ASCO 2021 — Incidence of Adverse Events

    ASCO 2021 — Incidence of Adverse Events Tables 1 & 2: Incidence of Adverse Events Table 1: Incidence of First Occurrence of Most Frequent Adverse Events Table 2: Incidence of First Occurrence of Injection Site Reactions GP2 Placebo GP2 Placebo gp2 | Placebo |] yi eice GP2 Placebo GP2 Placebo GP2 Pla

  25. Slide 25: GP2 Planned Phase III Trial

    GP2 Planned Phase Ill Trial: a b ie Strategy — Conservatively Reproduce Phase lib Trialin Latger Population,

  26. Slide 26: ASCO 2021 - Baylor Lead Site & Phase III Clinical Trial Design

    ASCO 2021 - Baylor Lead Site & Phase Ill Clinical Trial Design Greenwich LifeSciences i’, David B McV BACKGROUND GP2 is a biologic nine amino acid peptide of the HERZineu protein delivered in combination with an FDA- approved immunoadjuvant, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF,

  27. Slide 27: ASCO 2021 - Phase III Trial Schema & Interim Analysis

    ASCO 2021 —- Phase Ill Trial Schema & Interim Analysis Phase Ill Trial Schema Interim Analysis Design Major Screening Criteria: Stratified by: Preliminary Sizing of Trial: * HER2/neu 3+ and HLA-A2+ End of + Residual disease/pCR A ' iy 408: sui + Residual disease post neo- trastuzumab + Prior or conc

  28. Slide 28: GP2 May Address Unmet Need in Both Adjuvant & Neoadjuvant Settings

    GP2 May Address Unmet Need in Both HER2/neu 3+ Adjuvant & Neoadjuvant Settings Adjuvant Neoadjuvant Enver oer Any LN LN+ ER/PR + ER/PR - 4+ LN LN+ Chemotherapy Chemotherapy + trastuzumab + trastuzumab + pertuzumab Chemotherapy | | Chemotherapy J [surgery ] a + trastuzumab + trastuzumab > neratinib +

  29. Slide 29: Manufacturing / Regulatory / IP

    Manufacturing / Regulatory / IP ¢ GP2 manufactured by straightforward amino acid chemistry | e | — Manufactured by FDA-approved commercial PTE % facility with multiple back-up facilities aon — Detailed CMC plan reviewed by FDA ; 7 *% *. — Commenced engineering scale-up run for commercial scale manuf

  30. Slide 30: GP2 Commercial Opportunity

    GP2 e by gs Commercial. Opportunity” § © 2021 GLSI

  31. Slide 31: 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% acc — Allbreast cancer patients are tested for HER2/neu o i 50% expression by immunohistochemistry (IHC) or HER2/Ineu 3

  32. Slide 32: Commercial Opportunity for GP2 in Breast Cancer

    Commercial Opportunity for GP2 in Breast Cancer 1 in 8 U.S. women (12.8%) will develop invasive breast cancer over her lifetime, with 282k new breast cancer patients per year in 2021 An estimated 43,600 female breast cancer deaths will occur in the US in 2021 GP2’s target market is 6-30% of availabl

  33. Slide 33: 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 7)Kadcyla ‘a

  34. Slide 34: Potential Commercial Opportunities / Additional Indications

    Potential Commercial Opportunities / Additional Indications for GP2: HER2/neu Expressed in Multiple Cancers Estimated New Cases Figure 3. Leading Sites of New Cancer Cases and Deaths - 2021 Estimates Estimated Deaths Male Prostate 248,530 26% Lung & bronchus 119,100 12% Colon & rectum 79,520 BS Urin

  35. Slide 35: Veteran Management Team / Board

    Veteran Management Team / Board * David McWilliams, MBA — Chairman, Board DKS Coy — 40 years of start-up / CEO experience — CEO of 2 private and 3 public biotech companies ENCYSIVE ¢ Snehal Patel, MS, MBA— CEO, Board ‘a (ae — 30 years of biopharma / Wall Street experience Sena ay) Bayer — Large phar

  36. Slide 36: Capitalization & Share Price Appreciation

    Capitalization & Share Price Appreciation * Raised approximately $36.5M from IPO & As of 6/30/21 Follow-on in 2020 Cash $29.8m ¢ Added to Russell 2000 on 6/28/21 Common Shares 12.9m « Peak share prices and trading volume driven Warrants & Options 0.1m by data publications Fully Diluted Shares 13.0m

  37. Slide 37: Trading & Transaction Comparables

    Trading & Transaction Comparables Trading Comparables As of Market Close on 6/25/21 Company ewnics Price 52 Wk Range Avg Volume (3mo) Market Cap Comments Late-Stage Breast Cancer /ImmunoOncology Greenwich LifeSciences $43.80 $3.26 - 158.07 422,126 $565M Recently announced positive Phase II data Rece

  38. Slide 38: 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 Phase III trial in HER2 positive patients only — no material changes to treatment regimen, upgrade immune response assays, expand to multiple HLA types Optimize GP2 treatment

  39. Slide 39: GP2 Conclusions: A Breakthrough Targeted Immunotherapy

    GP2 Conclusions: A Breakthrough Targeted Immunotherapy for Prevention of HER2/neu Cancer ¢ Phase IIb trial: In HER2 3+ patients, 0% breast cancer recurrences post-surgery, if fully immunized, (p = 0.0338), peak immunity after 6 months, minimal to no side effects, median 5 years follow-up, randomized

  40. Slide 40: For Additional Information, Please Contact

Greenwich LifeSciences — Investor Presentation (November 2021) on 6ix