#GLSI

1 week ago

Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01 Greenwich LifeSciences (Nasdaq: GLSI) reported an increased patient screen rate in its Phase III trial FLAMINGO-01 for GLSI-100. The annualized screening rate rose to over 800 patients per year, a ~33% increase from the prior 600 per year.The company recorded ~200 patients screened per quarter across US and EU sites, attributing the rise to new sites activated in 2025 and stronger momentum at existing sites.

#GLSI Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01

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StockTitan

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1 month ago

Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy Greenwich LifeSciences (Nasdaq: GLSI) updated investors on cash burn and financing for its Phase III FLAMINGO-01 trial of GLSI-100. The company said ATM sales in 2025 exceeded its 2025 cash burn of approximately $9.5M, leaving ~$6M at 12/31/2025. Through the first three weeks of January 2026 the ATM raised ~$7M, bringing cash to ~$12.5M as of 1/23/2026. Figures are preliminary and unaudited. Management said 2026–2027 burn rates are expected to rise and ongoing ATM use may reduce need for a large near-term financing, but no assurance exists.

#GLSI Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy

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1 month ago

Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01 Greenwich LifeSciences (Nasdaq: GLSI) said the FDA approved use of the first commercially manufactured lot of GP2 vials in the Phase III FLAMINGO-01 trial of GLSI-100 to prevent breast cancer recurrence. The company noted three commercial active-ingredient lots made in 2023 (enough for ~200,000 doses), one finished vial lot filled in 2024, and stability programs yielding 3 years of stability data supporting vial expiration. GLSI plans to start using the new vials at 40 US sites in the coming weeks and expects to submit commercial manufacturing data to support a US BLA filing under Fast Track.

#GLSI Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01

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Market Wire News

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2 months ago

BREAKING NEWS: ( NASDAQ: #GLSI ) Buy Recommendation Issued On GLSI By H.C. Wainwright

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Market Wire News

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2 months ago

JUST IN: ( NASDAQ: #GLSI ) Greenwich LifeSciences Inc. (NASDAQ: GLSI) Sees Notable Increase in Monday Morning Market Activity

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StockTitan

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2 months ago

Greenwich LifeSciences Extends Lock-up of Directors and Officers to September 30, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast

#GLSI Greenwich LifeSciences Extends Lock-up of Directors and Officers to September 30, 2026

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2 months ago

Greenwich LifeSciences Provides Additional Updates on FLAMINGO-01 and Corporate Strategy Greenwich LifeSciences (Nasdaq: GLSI) provided updates on its Phase III trial FLAMINGO-01 evaluating Fast Track designated GLSI-100 to prevent breast cancer recurrence and on corporate strategy on Dec 22, 2025.Key points: the FLAMINGO-01 DSMB met twice in 2025 and recommended continuing the study without modification; ~140 sites are actively enrolling with plans to activate ~10 additional approved sites in 2026 and to pursue sites in the UK and Canada; planned protocol modifications (subject to regulatory approval) include resizing the study and increasing enrollment rate; the company reports an annual cash burn of approximately $7 million (2023–2025) and is using an ATM financing strategy to support operations while pursuing partnerships.

#GLSI Greenwich LifeSciences Provides Additional Updates on FLAMINGO-01 and Corporate Strategy

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3 months ago

Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01 Greenwich LifeSciences (Nasdaq: GLSI) reported a preliminary analysis from the open-label non-HLA-A*02 arm of FLAMINGO-01 showing an approximately 80% reduction in recurrence rate in the fully enrolled 250-patient arm by two analytic methods. Method 1 compared treated patients after the Primary Immunization Series to historical T-DM1 (KATHERINE) recurrence rates; Method 2 compared recurrence during the 6-month PIS (100 patient-years) to post-PIS follow-up (132 patient-years). The first patient completed all primary and booster vaccinations. Results are preliminary, the arm has no direct placebo comparator, and data are not completed or fully reviewed.

#GLSI Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01

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3 months ago

Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences,

#GLSI Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01

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3 months ago

Greenwich LifeSciences Provides Global Update on FLAMINGO-01, Screening Over 1,000 Patients to Date Greenwich LifeSciences (Nasdaq: GLSI) provided a global update on its Phase III trial FLAMINGO-01 evaluating GLSI-100 to prevent breast cancer recurrence. The company has screened over 1,000 patients to date across 140 active sites (about 40 US sites and 100 EU sites).Screening is progressing at ~150 patients per quarter (~600 per year). Management is considering continuing enrollment in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses define appropriate arm sizes, and reports interest from additional countries to join the study.

#GLSI Greenwich LifeSciences Provides Global Update on FLAMINGO-01, Screening Over 1,000 Patients to Date

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5 months ago

Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial Greenwich LifeSciences (Nasdaq: GLSI) announced expansion of its Phase III trial FLAMINGO-01 of GLSI-100 to Austria after formal European regulator approval on Oct 9, 2025. Austria is added to existing approved countries including Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.The company cited Austrian cancer data showing 6,070 new breast cancer cases in 2022 and 1,789 breast cancer deaths in 2022. Greenwich is collaborating with principal investigators at Ordensklinikum Linz, has begun site training, and said it hopes to activate the Linz site in 2025 while considering additional sites in Vienna and Salzburg.

#GLSI Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial

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5 months ago

Major Breast Cancer Trial Expansion: Greenwich LifeSciences Adds Belgium to Global Phase III Study GLSI-100 immunotherapy trial for breast cancer prevention expands to Belgium under Dr. Patrick Neven at UZ Leuven. Trial now spans 10 countries including US and major EU nations.

#GLSI Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Belgium

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5 months ago

9,065 Annual Breast Cancer Cases: Greenwich LifeSciences Expands Critical Phase III Trial to Portugal GLSI-100 immunotherapy trial FLAMINGO-01 receives regulatory approval in Portugal, joining 8 other countries. Study targets breast cancer recurrence prevention in 9,065 annual cases.

#GLSI Greenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial

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5 months ago

3,700+ Irish Breast Cancer Patients Now Eligible: Greenwich LifeSciences Expands Global Phase III Trial Biotech firm expands FLAMINGO-01 trial of GLSI-100 immunotherapy to Ireland, joining 7 other countries. Study targets breast cancer recurrence prevention at St. Vincent's Hospital Dublin.

#GLSI Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Ireland

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6 months ago

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation Greenwich LifeSciences (NASDAQ:GLSI) announced that the FDA has granted Fast Track designation for GLSI-100, its immunotherapy treatment for HLA-A*02 breast cancer patients. This designation may accelerate drug approval through enhanced FDA communication and rolling review process.The company's Phase IIb clinical trial demonstrated impressive results with an 80% or greater reduction in cancer recurrences over 5 years in HER2/neu 3+ patients. The treatment showed no serious adverse events and was well-tolerated across 146 treated patients. GLSI-100 achieved peak immunity at 6 months, with booster injections providing extended protection.The Fast Track status was granted based on GLSI-100's potential to improve invasive breast cancer-free survival in HER2-positive breast cancer patients with HLA-A*02 genotype who completed standard HER2/neu targeted therapy.

#GLSI Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

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Oninvest

@oninvest.bsky.social

6 months ago

Noble initiates on Greenwich LifeSciences with 'buy', TP implying 280% upside – Oninvest The company is developing a vaccine that would prevent breast cancer recurrence

💊 Noble Capital initiated coverage on #GLSI with a $45 target — nearly 3× upside.

GLSI is developing GLSI-100, a late-stage vaccine to prevent recurrence of HER2+ breast cancer, with a potential 2028 launch. More on this here 👇 en.oninvest.com/article/nobl...

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StockTitan

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6 months ago

Breast Cancer Immunotherapy Developer Greenwich LifeSciences Receives First Research Coverage from Noble Clinical-stage biotech Greenwich LifeSciences receives equity research coverage from Noble Capital Markets for GLSI-100 immunotherapy in Phase III FLAMINGO-01 trial.

#GLSI Noble Capital Markets Initiates Equity Research Coverage on Greenwich LifeSciences

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6 months ago

Greenwich LifeSciences Announces Plan to Build Out Internal Clinical Operations Team Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, announced plans to build its internal clinical trial management team for the Phase III FLAMINGO-01 trial of GLSI-100, an immunotherapy for breast cancer recurrence prevention.The company aims to reduce dependency on Clinical Research Organizations (CROs) by hiring dedicated internal staff, which is expected to lower costs and increase efficiency in managing clinical trial operations. This strategic shift will enable Greenwich to handle multiple trials simultaneously, including potential expansion of HLA-A*02 patient trials and development of other in-licensed drug candidates.

#GLSI Greenwich LifeSciences Announces Plan to Build Out Internal Clinical Operations Team

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7 months ago

Greenwich LifeSciences Targets 12,800 Annual Breast Cancer Cases with Romanian Trial Expansion Phase III FLAMINGO-01 study adds Romanian sites led by Dr. Antone, targeting country's 12,861 annual breast cancer cases. Patient enrollment to begin in coming months. See details.

#GLSI Greenwich LifeSciences Announces Expansion of Flamingo-01 into Romania

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Small Cap Strategist

@smcapstrategist.bsky.social

11 months ago

SmCpStr Technicals – Technical Indicators for Small-cap Stocks

Small-cap stocks oversold with improving relative strength, Mon Apr 7th - #SPAI #STRO #ANRO #DDD #PET #ONCY #ISPR #BAER #GLSI - More: crystalequityresearch.com/SmCpStr/ - #smallcap

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StockTitan

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11 months ago

Major Breakthrough: Cancer Prevention Trial Reports Positive Data, Elite Hospitals Join New data reveals promising immune responses in breast cancer prevention trial. Study expands to 150+ global sites with Yale, Johns Hopkins backing. See full analysis.

#GLSI Greenwich LifeSciences Provides Global Update on FLAMINGO-01

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Small Cap Strategist

@smcapstrategist.bsky.social

11 months ago

SmCpStr Technicals – Technical Indicators for Small-cap Stocks

Small-cap stocks with strong volume gains, Wed Apr 2nd - #SONM #TIVC #IBG #VMAR #TCRT #SASR #RPAY #MBIO #HCWB #GLSI #CGNT #ANGO #VLN #FMBS #CLBR - More: crystalequityresearch.com/SmCpStr/ - #smallcap

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StockTitan

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11 months ago

Clinical Trial Success: GLSI's Breast Cancer Therapy Shows Promising Results in Expanded Patient Group Phase III trial reveals strong immune responses for breast cancer prevention therapy. Patent filing could double patient reach to 88,000 annually. See market impact analysis.

#GLSI Greenwich LifeSciences Announces Positive Immune Response Data from FLAMINGO-01 Phase III Clinical Trial

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StockTitan

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11 months ago

Major Insider Confidence Signal: Greenwich LifeSciences Leadership Locks Shares Until 2026 Management extends share lock-up through 2026 while advancing Phase III breast cancer immunotherapy trial. Strong insider confidence signal for investors.

#GLSI Greenwich LifeSciences Extends Lock-up of Directors and Officers to March 31, 2026

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StockTitan

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11 months ago

Greenwich's Breast Cancer Drug Proves Safe in Phase III Trial, Building on 80% Recurrence Reduction GLSI-100 immunotherapy demonstrates positive safety data in FLAMINGO-01 trial, following earlier Phase IIb success with 80% breast cancer recurrence reduction. DSMB backs trial continuation.

#GLSI Greenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01

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