Dallas, Texas – Greenwich LifeSciences, Inc., a late-stage biotech company in Texas, is making waves with its innovative immunotherapy treatment for breast cancer. Focused on developing a therapeutic vaccine to prevent breast cancer recurrence after surgery, the company’s sole drug candidate, GLSI-100, shows promising results in phase 3 trials.

The vaccine incorporates GM-CSF and GP2, targeting the HER2 protein to train the body to recognize and attack remaining cancer cells post-surgery. Current standards of care for HER2-positive breast cancer involve post-operative treatments like trastuzumab. However, GLSI’s phase 2b study showed a 5-year disease-free survival rate of 100% in patients receiving GP2, compared to 89.4% in those who received a placebo.

With the ongoing phase 3 trial, FLAMINGO-01, enrolling HER2-positive breast cancer patients with residual disease after initial treatment, GLSI aims to further demonstrate the efficacy of GLSI-100 in preventing cancer recurrence. The study is set to be completed by December 2026, with an interim analysis expected after key endpoints are reached.

While the company’s financials show $5.5 million in cash and a 2-quarter cash runway, a recent private placement raised an additional $2.5 million for continued operations. Despite the promising prospects of GLSI-100, concerns remain about the company’s limited resources and the challenging landscape of improving current standards of care for HER2-positive breast cancer.

Investors are advised to approach GLSI with caution due to its high-risk profile, limited funding, and the long trial runway ahead. With uncertainties surrounding the FLAMINGO-01 trial results until at least 2025, a conservative approach to investing in Greenwich LifeSciences is recommended for the time being.