Greenwich LifeSciences Presentation Feb 2025
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Greenwich LifeSciences Presentation Feb 2025
- 1. © 2024 GLSI Image: T-cells targeting cancer cell 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
- 2. 2 © 2024 GLSI 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 to any other person or used for any other purpose without the prior consent of the Company. This presentation contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements including, but not limited to: risks associated with the success of clinical trials, research and development programs, regulatory approval processes for clinical trials, competitive technologies and products, intellectual property rights and the need for additional financing. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. Except as required by law, the Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events. The information contained herein is based on sources, which we believe to be reliable, but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. Although every effort has been made to assure the accuracy of the statements in this presentation, we make no representation or warranty as to the accuracy or completeness of the statements in this presentation. Furthermore, we make forward-looking statements in this report about the Company’s plans, objectives, expectations, and intentions. This presentation is not an offer to sell any securities of the Company and is not to be used in connection with any offer to sell or any inquiry about or evaluation of any securities of the Company. Any such sale, or opportunity, will be subject to appropriate documentation and due diligence.
- 3. 3 © 2024 GLSI 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 of prominent networks - up to 150 sites in US & EU • Conservative design of Phase III trial to reproduce Phase IIb results • Phase IIb Trial Results: Randomized, multi-center (16 centers), placebo- controlled, substantial reduction in recurrence rate, peak immunity after 6 months, minimal to no side effects, no SAEs attributable to GP2, led by MD Anderson Cancer Center • Potential Opportunities to Expand Market: – HER2/neu 1-2+ patients with Herceptin - increase market from 25% to 75% – Other HLA types – increase from 40-50% up to 80% of all patients – Combination with CD4/CD8 peptides and checkpoints – Other HER2/neu cancers • NASDAQ Ticker “GLSI”: Raised $40m since IPO ✓
- 4. 4 © 2024 GLSI • Raised approximately $36.5M from IPO & Follow-on in 2020 • Added to Russell 2000 twice: 2021 and 2024 • 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 a non-penny stock from prior day close • Management & Directors ownership (tightly held): 75-85% • Low float - Locked up from IPO in Sept 2020 through June 2025 at BOD discretion $158 19m shares SABCS 2020 12/9/20 $70 7m shares AACR 2021 4/9/21 $49 ASCO 2021 & Russell 2000 June 2021 $5.75 IPO 9/25/20 $53 7m shares New Hire 3/9/21 $128 9m shares SABCS 2020 12/10/20 $40.00 Follow-on 12/22/20 First Year Share Price Performance After Presenting Key Phase IIb Data in 2020/2021
- 5. 5 © 2024 GLSI 2020-2021 - Four Posters Highlighting Efficacy, Mechanism of Action, Safety, & Prognostic Factors 2021 American Association for Cancer Research (AACR) Immune Response Supports Mechanism of Action 2020 San Antonio Breast Cancer Symposium (SABCS) 0% Recurrences Over 5 Years in Phase IIb Trial 2021 American Society of Clinical Oncology (ASCO) Injection Related Immune Reactions, No GP2 Related SAEs 2021 SABCS Baseline GP2 Immune Response May Predict Faster & Earlier Recurrence
- 6. 6 © 2024 GLSI 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** Injection Site & Systemic Adverse Events (AE) are Positive Sign of Immune Response – No SAEs attributable to GP2 treatment Peak Immunity After 6 Months & PIS **Results subject to final Clinical Trial Study Report being prepared for filing of BLA per 10K, ending 12/31/23
- 7. 7 © 2024 GLSI 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. The majority of events were of grade 1, mild severity. Two patients reported grade 4 AEs deemed unrelated to study medication. One GP2+GM-CSF patient experienced grade 4 hypoglycemia and recovered. A GM-CSF only patient was diagnosed with renal cell carcinoma, a second primary diagnosis, which was classified as grade 4. No serious adverse events considered related to study medication were reported
- 8. 8 © 2024 GLSI 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 reactions. The most frequent injection site reactions were erythema, pruritus and induration, as presented in Table 2. The incidence in AEs was similar across HER2 3+ and HER2 1-2+ patients.
- 9. 9 © 2024 GLSI 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 150 sites in 6 countries
- 10. 10 © 2024 GLSI 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, Institut Curie (Unicancer) • Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University • Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M (GBG) • Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, GEICAM • Dr. Joyce A. O'Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center & Chair, Breast Cancer Program, US Oncology/Sarah Cannon • Dr. Hope S. Rugo – Professor of Medicine and Winterhof Family Professor of Breast Oncology, University of California, San Francisco • Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital • Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins SKCCC
- 11. 11 © 2024 GLSI 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)
- 12. 12 © 2024 GLSI Breast Cancer – Still a Substantial Unmet Need In the initial GP2 indication, approximately 17,000 new patients could be treated per year, saving up to 1,500 to 2,000 lives per year. • 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 their breast cancer will not recur, with the odds of recurrence slowly decreasing over the first 5 years. Herceptin reduces recurrence rates from 25% to 12%. • Neoadjuvant Setting: Kadcyla is approved for use in patients with residual disease, who do not achieve a pCR, as determined at time of surgery. Kadcyla reduces recurrence rates from 22% to 11%. • Neither Perjeta or Nerlynx fully address this unmet need, even in their most efficacious subpopulations. GP2 Addresses Unmet Need: GP2 & GM-CSF starting in Year 2 act with minimal to no side effects & no SAEs. pCR = pathologic complete response, the lack of all signs of cancer in tissue samples remove during surgery or biopsy due to Neoadjuvant treatment.
- 13. 13 © 2024 GLSI GP2 Phase III Clinical Trial Dosing • Study allows prior use of pertuzumab, trastuzumab, and ado-trastuzumab emtansine and concurrent neratinib • Final DTH/immunologic assays at 48 months and at time of recurrence 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 1 2 3 4 5 6 12 0 Doses Months 18 24 30 36 Primary Immunization Series (6 Doses) Boosters (5 Doses) X X X X X X X X X X X X X X X X X X X X Immunologic DTH
- 14. 14 © 2024 GLSI 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 normal life free of toxic treatments, especially if the chance of recurrence is reduced substantially • GP2 can be the treatment that will naturally overlap with or follow Herceptin, Kadcyla, or Enhertu or any of the other Herceptin derivatives being developed 5% Metastatic Preventing Recurrences may prevent 95% of Metastatic Breast Cancer 11 GP2 Doses Over 3 Years Follow-up / Surveillance Period Primary Treatment Diagnosis Imaging Biopsy Surgery Chemotherapy Radiation Anti-HER2 Rx Anti-Estrogen Rx Observation Cannot Predict Recurrence Patient Anxiety Imaging Labs Anti-HER2 Rx Chemotherapy Recurrence
- 15. 15 © 2024 GLSI Joint Analysis Trial *DFS – Disease Free Survival Herceptin Approved for Adjuvant Treatment of HER2/neu 3+ Breast Cancer Synergy with Herceptin Alone ** Phase IIb Results for GP2 Target Population, if Fully Immunized (median 5 years follow-up) 100.0% 89.4% ** 5 Year Disease Free Survival without use of Kadcyla, Perjeta, Nerlynx, Enhertu, or Tukysa ROW strategy: GP2 could eventually be developed with only trastuzumab biosimilar
- 16. GP2 Clinical Data: GP2 is Immunogenic & Clinically Effective © 2024 GLSI 16
- 17. 17 © 2024 GLSI HER2/neu Signaling Pathway Well Studied ➢ HER2/neu pathway activates cancer cell proliferation ➢ Overexpression of HER2/neu correlates strongly with aggressive cancers GP2 Peptide 3D Structure of HER2/neu Protein
- 18. 18 © 2024 GLSI 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 • Given once per month for six months followed by 5 booster doses every 6 months = 11 doses over 3 years • Mechanism of Action: 4 primary steps, followed by a secondary epitope spreading & broader immune response 5 -15° angle
- 19. 19 © 2024 GLSI Summary of GP2 Completed Trials - N=146 GP2-Treated Patients to Date with No SAEs Attributable to GP2 Study Design and Control Product, Dose, and Route Regimen Number of Subjects Population Duration of Follow-Up Phase 1b 04-20017, (MCHL-SG (40-38a)) 3x3 Dose- escalation • GP2 at 100, 500, 1000mcg • GM-CSF at 250mcg (reduced to 125mcg in many subjects) • Intradermal 6 doses, every 3-4 weeks 18 • Breast cancer • HER2/neu 1-3+ • HLA-A*02 • Node negative Primary safety follow-up for the duration of treatment + 30 days. Phase 1b (C.2008.146) 3x3 Dose- escalation • GP2+GM-CSF • GP2 at 100, 500, 1,000mcg • GM-CSF at 125, 250mcg • Intradermal • Concurrent iv trastuzumab 6 doses, every 3 weeks 17 • Breast cancer • HER2/neu 1-3+ • HLA-A*02 and HLA-A*03 Primary safety follow-up for the duration of treatment + 30 days. Phase 1 3x3 Dose- escalation • GP2+AE37+GM-CSF • GP2 at 100, 250, 500mcg • AE37 at 100, 250, 500mcg • GM-CSF at 125mcg • Intradermal 6 doses, 1 month apart 22 • Breast and ovarian cancer • HER2/neu 1-3+ • HLA-A*02 and HLA-A*03 1.5 years Phase 2b (C.2007.098) Randomized, Single-Blind • GLSI-100 or GM-CSF alone • GP2 500mcg • GM-CSF 125mcg • 6 doses, 1 month apart • 4 boosters beginning at 12 mo. then every 6 mo. 180 GLSI-100 (n = 89) GM-CSF alone (n = 91) • Breast cancer • HER2/neu 1-3+ • HLA-A*02 • Node-positive and High-risk node-negative 5 years
- 20. 20 © 2024 GLSI GP2 Phase III Trial Commenced: Strategy – Conservatively Reproduce Phase IIb Trial in Larger Population © 2024 GLSI 20
- 21. 21 © 2024 GLSI Flamingo-01 - Phase III Trial Flamingo-01 Has Commenced • Approximately 100 sites are active, with another 50 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- risk pathologic complete response at surgery • What is next – transition into pre-commercialization activities: – Working with the FDA in preparation for a BLA submission and commercial launch – Implementing a global strategy for launching GP2 in international markets outside the US and Europe – 1st commercial lot completed - large scale manufacturing, packaging, and marketing • Additional activities/milestones: – Phase III clinical trial progress and open label data may be presented at major conferences – Licensing discussions may accelerate as the interim analysis approaches – Other assets may be developed by acquisition or internal research, including T cell therapies that may be discovered in the Phase III trial by studying GP2’s robust immunogenicity – Additional patents for GP2 based on the Phase III trial findings, manufacturing, and pharmacy procedures are planned to be filed to extend patent life
- 22. 22 © 2024 GLSI Flamingo-01 - Phase III Trial Schema & Interim Analysis Preliminary Sizing of Trial: Approximately 498 subjects will be enrolled. To detect a hazard ratio of 0.3 in IDFS, 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. Phase III Trial Schema Interim Analysis Design • GLSI-100 (GP2 + GM-CSF), Placebo (Saline) • Compare iDFS of GP2-treated versus placebo using standard of care Stratified by: • Residual disease/pCR • Hormone receptor status • Geographic region
- 23. 23 © 2024 GLSI Expand by HLA - GP2-HLA Predicted Binding & Prevalence Allele Method used PercentRank HLA-A*02:03 Consensus (ann/smm) 2.4 HLA-A*30:02 Consensus (ann/smm) 4.1 HLA-A*26:01 Consensus (ann/smm) 7.4 HLA-A*02:01 Consensus (ann/comblib_sidney2008/smm) 7.9 HLA-A*68:02 Consensus (ann/comblib_sidney2008/smm) 8.5 HLA-A*03:01 Consensus (ann/smm) 10.1 HLA-A*24:02 Consensus (ann/smm) 11.1 Allele White Allele Black Allele Hispanic Allele Asian/ Pacific A*02:01 45.6% C*04:01 29.0% A*02:01 37.1% A*11:01 38.4% C*07:01 27.7% C*07:01 25.4% C*04:01 25.4% A*24:02 33.7% A*01:01 27.4% C*06:02 23.0% A*24:02 24.9% C*07:02 33.3% A*03:01 23.8% A*02:01 22.3% C*07:02 24.2% C*01:02 27.7% C*07:02 21.5% A*23:01 20.7% C*07:01 20.8% A*33:03 23.3% C*04:01 21.2% C*02:02 19.0% C*03:04 14.4% C*08:01 21.6% B*44:02 20.2% A*03:01 18.7% A*03:01 14.3% C*03:04 19.9% B*07:02 18.1% C*07:02 18.1% B*07:02 13.2% A*02:01 18.1% GP2 Binding Predictions: IEDB recommended | Low percentile rank = Good binders Frequency of Class I MHC alleles HLA in the North America - Data from HLA Matchmaker
- 24. 24 © 2024 GLSI Surgery 9-12% 9-12% 5-10% 17% 5-10% 17% Conclusion: GP2 should eventually be pursued in both settings for all HER2 positive patients Projected 5 Year Recurrence Rates Target Population for Phase III Trial: Residual Disease & High Risk pCR Annual recurrence rate = 3.0-3.4% Annual recurrence rate design for Phase III trial = 2.4% Surgery GP2 May Address Unmet Need in Both HER2/neu 3+ Adjuvant & Neoadjuvant Settings
- 25. 25 © 2024 GLSI 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% of dose) 2. Injection site reaction measurements which are correlated to DTH in Phase IIb trial 3. Single cell sequencing of T cells resulting from spiked dendritic cells 4. TCR sequencing from frozen blood samples over course of Phase III trial (Example: extensive sequencing of COVID-19 infection & vaccinated patient samples) 5. Potential for ctDNA analysis of plasma 6. Potential for Elispot assay for quantification of functional GP2 specific T cells
- 26. 26 © 2024 GLSI GP2 Commercial Opportunity © 2024 GLSI 26
- 27. 27 © 2024 GLSI • HER2/neu 3+ protein over-expression (25%) & 1-2+ expression (50%) – All breast cancer patients are tested for HER2/neu expression by immunohistochemistry (IHC) or fluoresecence in situ hybridisation (FISH) Potential Indications of GP2 & Herceptin in Various Populations in Neoadjuvant Setting True Negative 25% HER2/neu 1-2+ 50% HER2/neu 3+ 25% • Node Positive (60%) & High Risk Node Negative (40%) – Node positive – cancer has spread to lymph nodes – High risk node negative – no cancer in lymph nodes but at high risk for recurrence – The more lymph node involvement the more aggressive the cancer • Hormone Receptor Positive (60%) & Hormone Receptor Negative (40%) • HLA Type: HLA-A2 (40-50%) & HLA-A3,A24 (30%) – Human leukocyte antigen (HLA) presents peptide from inside cancer cell to killer T-cells – HLA also presents injected peptide to create killer T-cells following intradermal injection • 30% of 282k new US breast cancer patients per year could lead to up to 85k new patients per year for GP2 • 30% of 3.8m long term US breast cancer survivors could be candidates for GP2
- 28. 28 © 2024 GLSI 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 available breast cancer market or up to 2.4x that of Herceptin in adjuvant setting • GP2 could be a long term treatment that treats survivors (3.8m as of 2021) • Herceptin/Perjeta/Nerlynx/Kadcyla pricing from $75k - $125k per patient per year • 11 doses over 3 years in initial indication Herceptin GP2 US Market Potential (Size = 3.8m current breast cancer survivors and 282k new patients per year) HER2/neu Expressors (1-3+) 25% (3+) 25-75% (1-3+) HLA Type 100% 50-80% (2/3/24/26) Node Positive (NP) or High Risk Node Negative (HRNN) 50% 50% Target Market Potential 12.5% 6.25 - 30% Theoretical New Patients per Year 17,625 – 84,600 Adjuvant Patients Treated per Year (est. from sales) 27,000 – 40,000 Estimated Adjuvant Setting US Revenue ($ billions) $2-3 Estimated Price (first year) $74,500 TBD (6 primary + 1 booster) Estimated Price (booster) Not Approved TBD (4 boosters over 2 years) Estimated 2017 Global Revenue ($ billions) $7 Adjuvant Setting $2-3 Metastatic Breast Cancer $4-5 35,250
- 29. 29 © 2024 GLSI Denotes cancers where HER2/neu over expression has been reported Potential Commercial Opportunities / Additional Indications for GP2: HER2/neu Expressed in Multiple Cancers
- 30. 30 © 2024 GLSI 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 • Snehal Patel, MS, MBA – CEO, Board – 30 years of biopharma / Wall Street experience – Large pharma operations / management experience • Joe Daugherty, M.D. – CMO, Board – 35 years of biopharma experience – Assisted over 20 public and private companies • Jaye Thompson, Ph.D. – VP Clinical & Regulatory – 30 years of active involvement in over 200 clinical trials for drugs, biologics and devices – Founder of multiple CROs • Christine Fischette, Ph.D. – VP Business Development – 30 years of big pharma R&D & commercialization – Business development / multiple licensing transactions • Eric Rothe – Board & Founder of GLSI • Ken Hallock – Board & Major Investor indexCopy_01
- 31. 31 © 2024 GLSI • GP2 manufactured by straightforward amino acid chemistry – Manufactured by FDA-approved commercial facility with multiple back-up facilities – Commercial manufacturing commenced Manufacturing / Regulatory / IP – 3 clinical lots followed by 3 commercial lots – GM-CSF is commercially available, along with Saline/WFI, which will all be sold independently • Discussing potency assay / HLA companion diagnostic • GP2 registered as biologic with CBER – 12 years exclusivity in US • GP2 issued patents provide protection through 2032 in the major markets (US, EU, Canada, Australia, & Japan), including ongoing prosecution in emerging markets - patent term extensions possible • New patent applications
- 32. 32 © 2024 GLSI GLSI Strategy is to Conduct Additional GP2 Trials • 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 by starting treatment in neoadjuvant setting in another Phase II/III trial and utilize immune response data, if possible, to “optimize” timing of inoculations • Expand to HER2 low breast cancer and other HER2 expressing cancers using optimized treatment methods and add checkpoint inhibitors Greenwich’s current strategy is as follows: Add Checkpoint Inhibitors ROE of developing GP2 could be high!
- 33. 33 © 2024 GLSI 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 or Kadcyla, led by Baylor & consortium of prominent networks - up to 150 sites in US & EU • Conservative design of Phase III trial to reproduce Phase IIb results • Phase IIb Trial Results: Randomized, multi-center (16 centers), placebo- controlled, substantial reduction in recurrence rate, peak immunity after 6 months, minimal to no side effects, no SAEs attributable to GP2, led by MD Anderson Cancer Center • Potential Opportunities to Expand Market: – HER2/neu 1-2+ patients with Herceptin - increase market from 25% to 75% – Other HLA types – increase from 40-50% up to 80% of all patients – Combination with CD4/CD8 peptides and checkpoints – Other HER2/neu cancers • NASDAQ Ticker “GLSI”: Raised $40m since IPO ✓
- 34. 34 © 2024 GLSI GLSI Sponsorship in Houston each October – 5K Race
- 35. For Additional Information, Please Contact: Snehal Patel CEO Telephone: 832.819.3232 E-mail: [email protected] Website: greenwichlifesciences.com © 2024 GLSI NASDAQ: GLSI