Greenwich Lifesciences, Inc. · NASDAQ:GLSI
Greenwich Lifesciences — IPO Roadshow (June 2020)
14 slides from Greenwich Lifesciences's IPO roadshow presentation, Jun 23, 2020
Slide 1: Greenwich LifeSciences Investor Presentation June 2020
Greenwich LifeSciences Investor Presentation June 2020 Filed pursuant to Rule 433 of the Securities Act of 1933 Issuer Free Writing Prospectus dated June 22, 2020 Relating to the Preliminary Prospectus dated June 22, 2020 Registration Statement File No. 333-238829
Slide 2: Registration statement and forward-looking statements notice
Greenwich LifeSciences (“we“ or “us”) has filed a registration statement (including a preliminary prospectus) (the “Registration Statement”) with the Securities and Exchange Commission (the “SEC”) on Form S - 1 /A (SEC File No . 333 - 238829 ) for the offering to which this presentation relates . Su
Slide 3: Offering Details
Offering Details ISSUER Greenwich LifeSciences , Inc. PROPOSED TICKER/EXCHANGE GLSI / NASDAQ Capital Markets OFFERING TYPE IPO GROSS PROCEEDS $8,000,000 (15% over - allotment option) USE OF PROCEEDS (i) Complete manufacturing of product candidate GP2 (ii) Enroll and treat the first 50 to 100 patient
Slide 4: About Us
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy, to prevent breast cancer recurrences in patients who have previously undergone surgery o We have an exclusive worldwide license agreement with The Henry M. Jackson Foundation (HJ
Slide 5: GP2: A Breakthrough Targeted Immunotherapy
Breast cancer and other solid tumors with an elevated expression of HER 2 / neu protein are highly aggressive with an increased disease recurrence and worse prognosis • HER 2 / neu is expressed in a variety of common cancers, including 75 % of breast cancers at low, intermediate, and high levels • G
Slide 6: Substantial Unmet Need
Following breast cancer surgery, a HER 2 / neu high level expressor patient receives Herceptin in the first year, with the hope that their breast cancer will not recur, with the odds of recurrence slowly decreasing over the first 5 years after surgery • Herceptin has been shown to reduce recurrence
Slide 7: The Potential Market for GP2 is Large
1 in 8 U . S . women ( 12 . 4 % ) will develop invasive breast cancer over her lifetime, with 266 k new breast cancer patients per year in 2018 • GP 2 ’s target market is 6 - 30 % of available breast cancer market or up to 2 . 4 x that of Herceptin in adjuvant setting ‒ Herceptin’s estimated global
Slide 8: GP2 Overview
GP2 Overview GP 2 is a 9 amino acid transmembrane peptide segment of the HER 2 / neu protein • Intradermal injections are administered in combination with an FDA - approved immunoadjuvant GM - CSF, following 1 st year of Herceptin treatment in Adjuvant Setting • One dose per month for 6 months follo
Slide 9: Compelling Phase IIb Clinical Data
GP 2 displayed efficacy in a Phase IIb clinical trial of 180 patients led by MD Anderson Cancer Center • After median 5 years of follow - up, there were 0 % cancer recurrences in HER 2 / neu high level expressor patients when fully vaccinated versus 11 % placebo recurrence rate ( 96 patients , p= 0
Slide 10: Upcoming Phase III Clinical Trial
We are planning to launch a Phase III clinical trial in 2020 , using a similar treatment regime as the Phase IIb clinical trial • The manufacturing plan and the Phase III trial protocol have been reviewed by the FDA and final revisions to the Phase III trial protocol are underway • Manufacturing of
Slide 11: Corporate strategy
Our corporate strategy includes advancing GP 2 into a Phase III clinical trial in the U . S . with favorable regulatory designations and pursuing a European and global clinical trial strategy to support GP 2 registration outside of the U . S . • We are considering various options to fund the Phase I
Slide 12: Capitalization (as of 3/31/20)
Capitalization (as of 3/31/20) COMMON SHARES 8,535,619 SERIES A, B, C & D PREFERRED SHARES 1,980,365 WARRANTS AND OPTIONS 0 FULLY DILUTED SHARES 10,515,984 INSIDER OWNERSHIP 80.5% 13
Slide 13: Seasoned Management Team
• 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
Slide 14: Investment Highlights
• Investment opportunity initially focusing on a breakthrough targeted immunotherapy for 6 % to 30 % of breast cancer market ‒ GP 2 may be used to address the 50 % of recurring patients who do not respond to existing treatments • GP 2 has demonstrated the ability to dramatically effect breast cancer