Greenwich LifeSciences, Inc.

Galena Biopharma, Inc. (trading on The Capital Market LLC) is a clinical-stage biopharmaceutical company focused on developing immunotherapy treatments for cancer. The company's primary product candidate is GLSI-100, a combination therapy comprising GP2, a nine amino acid transmembrane peptide derived from the HER2/neu protein, and GM-CSF, an immunoadjuvant. GP2 is designed to elicit a targeted immune response against HER2/neu-expressing cancers, which are present in approximately 75 percent of breast cancers across varying expression levels.

The company is currently advancing Flamingo-01, a Phase III randomized, multicenter, placebo-controlled clinical trial evaluating GLSI-100's safety and efficacy in HER2/neu positive breast cancer patients with residual disease or high-risk pathologic complete response following neoadjuvant and postoperative adjuvant trastuzumab-based therapy. Flamingo-01 is enrolling patients in the United States and expanding into Europe with plans to open up to 150 sites globally.

Galena's development program is supported by clinical data from earlier trials, including a Phase IIb trial that demonstrated substantial reduction in cancer recurrences in HER2/neu 3+ positive patients treated with GLSI-100 over a five-year follow-up period. The company has also completed three Phase I clinical trials evaluating GP2 in various combinations and patient populations, all demonstrating favorable safety profiles with no serious adverse events attributed to GLSI-100 treatment.

The company holds an exclusive worldwide license agreement with the Henry M. Jackson Foundation for GP2 technology, which provides patent protection extending through 2032 in major markets including the United States, Europe, Japan, Australia, and Canada. Galena plans to register GP2 as a biologic product, which may provide ten to twelve years of market exclusivity upon FDA approval.

The company does not operate manufacturing facilities and relies on third-party contract manufacturers for production of raw materials, active pharmaceutical ingredients, and finished product. Galena is pursuing a pipeline strategy to expand GP2 into additional HER2/neu-expressing cancers and patient populations pending receipt of sufficient capital.