New Risk • Aug 12
New major risk - Revenue and earnings growth Earnings have declined by 36% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Earnings have declined by 36% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$19m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change). Announcement • Jul 16
Greenwich LifeSciences Announces European Approval For Combining Both HLA Populations In FLAMINGO-01 Greenwich LifeSciences previously announced that US clinical sites started enrolling both HLA-A02 and non-HLA-A02 patients in the same randomized arms in FLAMINGO-01, based on the FDA's review of such protocol changes, effectively more than doubling the enrollment rate of the pivotal arm of the study. Non-HLA-A02 patients who represent about 55% of the population and were on waiting lists for up to a year are now eligible for enrollment. The European Medicines Agency (EMA) has completed their review and will also allow the combination of both HLA-A02 and non-HLA-A02 patients in Europe. All 170-180 clinical sites in the US and Europe are now operating under the same protocol and could continue enrolling up to the first interim analysis. Data can be analyzed by individual HLA types as well. Additional feedback is expected from UK and Canadian regulators. The Company plans to provide updates regarding the resulting improved trial design, including a pathway for the Company to now pursue approval for both HLA-A02 and non-HLA-A02 patients using the increased statistical power of a combined analysis of the two patient groups together potentially doubling the market for GP2 by accelerating the clinical development of the non-HLA-A02 population. More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection. In the non-HLA-A02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate. This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A02 patients is trending similarly to the HLA-A02 arms of FLAMINGO-01 and to the Phase IIb study. The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company's website. As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time. As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline. Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A02 only patients are being vaccinated. Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ. In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which is the time required to reach peak immunity and thus maximum efficacy and protection. 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally. 
