Greenwich LifeSciences, Inc.

Greenwich LifeSciences, Inc. is a clinical-stage biopharmaceutical company focused on developing an immunotherapy to prevent breast cancer recurrences. The company's primary product candidate is GLSI-100, which is currently being evaluated in a Phase III clinical trial called Flamingo-01. GLSI-100 combines GP2, a 9 amino acid transmembrane peptide derived from the HER2/neu protein, with GM-CSF. The HER2/neu protein is expressed in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. The Flamingo-01 trial is designed to assess the safety and efficacy of GLSI-100 in HER2/neu positive patients who have residual disease or a high-risk pathologic complete response at surgery, and who have completed both neoadjuvant and postoperative adjuvant trastuzumab-based treatment. Greenwich LifeSciences is expanding Flamingo-01 into Europe, with plans to open up to 150 sites globally. GP2 works by eliciting a targeted immune response against HER2/neu-expressing cancers. GM-CSF, or recombinant human granulocyte macrophage colony-stimulating factor (sargramostim, Leukine®), acts as an immunoadjuvant, enhancing the immune response. GLSI-100 is administered via an intradermal injection, mixing GP2 peptide and GM-CSF at the time of administration. GM-CSF is available in lyophilized form exclusively from one manufacturer. While GM-CSF is approved for sale in the U.S. by the FDA, it is available in other countries on a named patient basis through a specialized company.