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Greenwich LifeSciences Approved to Expand FLAMINGO-01 in the UK
Greenwich LifeSciences announced the regulatory approval to expand FLAMINGO-01 into the U.K. The Company's application to expand FLAMINGO-01 into the UK has been formally approved by UK regulators, thus adding potentially 5-10 geographically distributed UK sites to the approximately 170-180 approved sites in the US and Europe. The Company is collaborating with The Royal Marsden, a leading cancer research institute. Working with The Royal Marsden, we have been in discussions with many academic sites located in the following cities: London, Cambridge, Edinburgh, Oxford, Manchester, Southhampton, Cardiff, and potentially other cities. With regulatory approval, these start-up discussions will now move forward. The principal investigator at Royal Marsden, who will be serving as the UK national principal investigator, also plans to join the Steering Committee. Based on 2019 and 2021-2022 data from Cancer Research UK, there are approximately 59,400 new breast cancer cases in the UK every year. Breast cancer is the most common cancer in females, which is 30% of all new female cancer cases.
Greenwich LifeSciences Updates FLAMINGO-01 Clinical Trial
Greenwich LifeSciences provided the following clinical updates on FLAMINGO-01. The FLAMINGO-01 DSMB met in May 2026 and recommended the study continue as is without modification. On December 22, 2025, the company announced the following objectives: "The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01. The planned modifications subject to regulatory approval include: increasing the size of the study, which would increase the power of the study thus decreasing the risk by designing the study to assume more recurrences even though fewer recurrences may be anticipated and observed, doubling or quadrupling the enrollment rate, which will increase the patient years in the study more rapidly thus proportionately increase the event rate, which may shorten the time to reach an interim analysis or milestone, continuing to enroll past the interim analyses so that the current momentum at the clinical sites continues, using the interim analysis to potentially resize the study or to change the subsequent interim analysis, to change the number of events triggering an analysis, or to change the timing of the study based on recommendations by an independent committee, and using a recently manufactured GP2 commercial drug product lot in FLAMINGO-01." The Company plans to now leverage the increased enrollment rate resulting from the combination of all HLA types together with the following: 1) the very high interest from patients and clinicians which has led to almost 200 clinical trial sites in the US and Europe, 2) the clinical operational capability in place 3) the currently trending low event rate, and 4) the efficient cost structure and burn rate that the Company has successfully funded through small capital raises. The cash burn will be manageable as in the past due to the efficiently run and internalized clinical operations. The Company's annual burn rate was approximately $7M in 2024 and 2023 and $10M in 2025. For the Q2 the burn rate is expected to be approximately $2M versus a $4.7M burn rate in the Q1 of 2026, leading to a Q2 2026 cash balance of approximately $8.9M as of June 30, and an expected burn rate of $2M-$4M per quarter going forward. The above preliminary financial figures are unaudited and are subject to change following completion of the Company's financial review for Q2 2026. This capital raising strategy may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities. By increasing the original FLAMINGO-01 trial design HR = 0.3 to a design HR = 0.55 and by doubling the events required to trigger the first interim analysis from 14 to 28 events, the probability of success or power at the first interim analysis, if a lower study result HR = 0.3 is realized, increases from less than 20% to more than 85%.
Greenwich LifeSciences Updates FLAMINGO-01 Clinical Trial Progress
Greenwich LifeSciences provided the following update on the combination of both HLA-A*02 and non-HLA-A*02 patients in FLAMINGO-01 in Europe. The company previously announced that US clinical sites started enrolling both HLA-A*02 and non-HLA-A*02 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-A*02patients 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 has completed their review and will also allow the combination of both HLA-A*02 and non-HLA-A*02 patients in Europe. Thus, 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-A*02 and non-HLA-A*02 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-A*02 population.
Greenwich LifeSciences Presents ASCO Annual Meeting Abstract
Greenwich LifeSciences presents the published abstract and poster from the ASCO annual meeting. The abstract is shown below. This is the second abstract and poster presented jointly with the Steering Committee of FLAMINGO-01 with statistically significant injection site reaction immune response data, with subgroup analysis by the most prevalent HLA types. In the non-HLA-A*02 open label arm where all patients were treated with GLSI-100, immune responses to GP2 were measured at baseline and over time using skin tests and ISRs. An ISR reaction, erythema or induration, was used to assess in vivo immune responses in patients. The diameter of the reaction was assessed 48-72 hours after injection but is not reported here. In this preliminary data analysis, there was a significant increase in percentage of patients experiencing an ISR reaction in vaccination 4, vaccination 5 or vaccination 6 compared to the baseline vaccination. There were 208 patients with both baseline vaccination and vaccination 4, 5 or 6 assessments. There was a significant increase in the percentage of patients experiencing erythema ISRs after the 4th, 5th or 6th vaccination compared to the ISRs from the 1st vaccination. In this preliminary analysis, the frequency of ISRs increased significantly from 20.2% of the patients experiencing an ISR after the first vaccination to 55.3% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination, representing an increase of 2.7x or 174%. There was a significant increase in the percentage of patients experiencing induration ISRs after the 4th, 5th or 6th vaccination compared to the ISRs from the 1st vaccination. In this preliminary analysis, the frequency of ISRs increased significantly from 14.9% of the patients experiencing an ISR after the first vaccination to 34.6% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination, representing an increase of 2.3x or 132%. As reported in Table 1, each HLA-A type exhibited more frequent immune reactivity with increased GLSI-100 vaccinations with frequency increasing by 60% to 280% over the frequency after the first vaccination. These results are consistent with the GP2 DTH results presented at AACR. A positive immune response is an indicator that the immune system has been activated against recurring cancer cells, potentially leading to the prevention of metastatic breast cancer. The company previously announced that in the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the Primary Immunization Series is completed shows an approximately 70%-80% reduction in recurrence rate. Thus, the immune response data is supporting the mechanism of action that reduces recurrences and prevents metastatic breast cancer. This statistically significant non-HLA-A*02 open label arm immune response data for both DTH and ISRs is trending similarly to the immune response data in the HLA-A*02 patients in the Phase IIb study and the HLA-A*02 arms of FLAMINGO-01. The study is ongoing and data collection and cleaning continue, while some patients may still be in their PIS vaccination phase, so final results may vary. The statistically significant increase in the incidence of ISR reactions over time found in this preliminary analysis of GLSI-100 treated non-HLA-A*02 patients shows that GLSI-100 treatment should not be limited to HLA-A*02 patients. Patients treated with GLSI-100 were increasingly able to mount an immune response to GP2 as evidenced in this preliminary data. Future investigations may explore the use of immune responses to assess correlation of DTH to ISRs, immunogenicity of GLSI-100 by specific HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders.
Greenwich LifeSciences Updates 10-K Filing for Fiscal Year 2025
Greenwich LifeSciences provided an update on its Form 10-K filing for the fiscal year ending December 31, 2025. "The Form 10-K for the fiscal year ending December 31, 2025, continues to be audited by our new auditor and we believe it is in the final approval steps. The Form 10-K also includes the 2024 audit that was previously audited by the prior auditor. As previously indicated, the accounts payable adjustments are related to the large global Phase III clinical trial underway and the unexpectedly large increase in screening and patient enrollment in Europe in 2024 and 2025. Both auditors in a dual auditor filing must agree in order to make timely filings, which did not occur in March or April, and such coordination is still required as part of the final approval steps. The Company believes that it did not contribute to the delays in filing and instead did everything possible to file on time. The Company provided the 10K filing information with large increases to accounts payable to the auditors for review in early February 2026 and requested and anticipated an early filing. The Company has further improved its accounts payable estimations using current clinical trial data in its financials for Form 10-Q for the period ending March 31, 2026. The Company believes that the accounts payable adjustments are not material to the Company or its investors and does not change the fundamentals of the Company. The shift in expenses does not change the cash balance or the net cash used in operating activities of the Company. As previously announced, the Company's ending cash balance as of March 31, 2026 is approximately $10.5 million, which the Company believes is an improvement over 2025 ending cash balances, and includes the retirement of over 75% of accounts payable for the fiscal year ending December 31, 2025. This $10.5 million cash balance is more than the 2025 net cash used in operating activities which is approximately $9.9 million. The above figures are unaudited and are subject to change following the completion of the Company's financial audit for the year ending December 31, 2025 and the review for the period ending March 31, 2026."
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