| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Greenwich LifeSciences, Inc.$19.8
+0.23 (+1.18%)
D 23Pipeline Score Richly Valued Biotech · Clinical
Market Cap
383.08 M
EPS
-1.46
P/E Ratio
-
Value Trade
3.01 M
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
5.21 M
Operating CF
-4.70 M
Total Assets
10.51 M
Total Liabilities
5.24 M
Equity
5.27 M
D/E Ratio
12,345
3.99 %
Week
14.97 %
1 Month
12.49 %
3 Month
238.43 %
6 Month
-16.39 %
5 Year
380.87 %
All Time
Cash Data
Cash Position
10.51 M
Monthly Burn
1.57 M
Runway
5.7 mo
Burn Trend
SEC Filing
Jun 4, 2026
Overview
Volume
64.69 K
52 Week Range
7.78 - 34.10
% held by Insiders
52.61 %
% held by Institutions
11.78 %
Enterprise Value
379.27 M
Total Shares
13.84 M
Short %
24.9 %
Float Shares
5.86 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Greenwich LifeSciences, Inc.
150Total events
4Upcoming
18Tier-1 (high impact)
2022 – 2026Coverage
Upcoming catalysts 4
TBD
T2Timing Guidance
Interim analysis for superiority and futility will be conducted when at least 14 events have occurred
Event history 146
Jul 9, 2026
▲Other Regulator MilestoneGP2Ex-US Regulatory
EMA approval for use of commercially manufactured GP2 in FLAMINGO-01 in Europe
breast cancersource ↗
Jul 9, 2026
▲Enrollment MilestoneGLSI-100Trial
Non-HLA-A*02 arm fully enrolled (250 patients)
breast cancersource ↗
Jul 9, 2026
▲Topline ReadoutGLSI-100Clinical Data
Preliminary analysis of recurrence rates in non-HLA-A*02 arm shows ~70-80% reduction
breast cancersource ↗
Jun 1, 2026
▲Poster PresentationGLSI-100Presentation
Preliminary injection site reaction immune response results from open-label arm of FLAMINGO-01 presented at ASCO 2026
breast cancersource ↗
Jun 1, 2026
▲Enrollment CompleteGLSI-100Trial
Non-HLA-A*02 open label arm fully enrolled (250 patients)
breast cancersource ↗
Jun 1, 2026
Jun 1, 2026
◆Quarterly UpdateCorporate
Form 10-K for fiscal year ending December 31, 2025 in final approval steps
Jun 1, 2026
▲Enrollment MilestoneGLSI-100Trial
Non-HLA-A*02 arm of FLAMINGO-01 fully enrolled with 250 patients
breast cancersource ↗
Jun 1, 2026
▲Interim AnalysisGLSI-100Trial
Preliminary analysis shows 70-80% reduction in recurrence rate in non-HLA-A*02 arm after PIS
breast cancersource ↗
Jun 1, 2026
●Enrollment UpdateGLSI-100Trial
Over 1,300 patients screened with current screen rate of ~800 patients per year
breast cancersource ↗
May 20, 2026
▼Quarterly UpdateCorporate
Received Nasdaq notice regarding late Form 10-Q filing for Q1 2026
Drug Pipeline Intelligence
D23
Pipeline Score $43M
Pipeline ValueRichly Valued
Valuation Signal1
Drugs Scored0.1x
rNPV / MCap Top 22%
Micro Cap (rank 712 of 911)
Percentile RankGreenwich LifeSciences, Inc. faces pipeline headwinds (23/100), with $290M risk-adjusted pipeline value, led by GLSI-100 in Breast Cancer (Phase 3), but cash runway is a concern.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GLSI-100 Monoclonal antibody | Breast Cancer | Phase 3 | NCT05232916 | 48% | $290M | RECRUITING | 750 | FAST | B (73) | Dec 1, 2026 | MODERATE_RISK | LOW Jun 4, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
GLSI-100 Fast Track | breast cancer recurrence prevention | Phase 3 | 2026-06-01 | 20.2% of the patients experiencing an ISR after the first vaccination; 55.3% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination; 14.9% of the patients experiencing an ISR after the first vaccination; 34.6% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination; approximately 70-80% reduction in recurrence rate Read More | Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at ASCO Meeting 2026 Read More | |
GLSI-100 Fast Track | breast cancer recurrence prevention | Phase 3 | 2026-06-01 | 20.2% of the patients experiencing an ISR after the first vaccination; 55.3% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination; 14.9% of the patients experiencing an ISR after the first vaccination; 34.6% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination; approximately 70-80% reduction in recurrence rate Read More | Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at ASCO Meeting 2026 Read More | |
GLSI-100 Fast Track | breast cancer recurrence prevention | Phase 3 | 2026-06-01 | 20.2% of the patients experiencing an ISR after the first vaccination; 55.3% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination; 14.9% of the patients experiencing an ISR after the first vaccination; 34.6% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination; approximately 70-80% reduction in recurrence rate Read More | Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at ASCO Meeting 2026 Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in GLSI
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
GLSI Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
GLSI▲ +1.2%today
Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01
Greenwich LifeSciences has received European approval for the use of commercially manufactured GP2 in its Phase III clinical trial, FLAMINGO-01, aimed at preventing breast cancer recurrences. The EMA's approval follows the FDA's earlier endorsement, allowing clinical sites across Europe and the US to treat patients with GP2. The trial has shown promising results, with a significant reduction in recurrence rates observed in treated patients.
Read more →GLSI▲ +8.9%on this news
Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at ASCO Meeting 2026
Greenwich LifeSciences presented promising data from the FLAMINGO-01 Phase III trial at the ASCO Annual Meeting 2026. The study focuses on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. Preliminary results show a significant increase in immune responses following multiple vaccinations, with indications of a substantial reduction in recurrence rates. The trial continues to gather data, with future analyses planned to further explore treatment efficacy.
Read more →GLSI▲ +8.9%on this news
Greenwich LifeSciences Provides Update Regarding Form 10-K Filing
Greenwich LifeSciences, Inc. updated stakeholders on its Form 10-K filing for the fiscal year ending December 31, 2025, which is currently under audit. Delays in filing are attributed to coordination issues between its new and previous auditors, although the company insists it has acted timely. Despite these delays, the firm reported a strong cash position of approximately $10.5 million and positive preliminary results from its Phase III trial, FLAMINGO-01, which assesses GLSI-100 for preventing breast cancer recurrences. The company is optimistic about its financial health and clinical progress amid the filing challenges.
Read more →GLSIGreenwich LifeSciences Announces Receipt of Nasdaq Notice Regarding Late Form 10-Q Filing
Greenwich LifeSciences, Inc. announced it received a notice from Nasdaq regarding its late filing of the Form 10-Q for Q1 2026. This notification indicates non-compliance with Nasdaq rules but does not affect the trading of its stock. The company continues to focus on its Phase III clinical trial for GLSI-100, an immunotherapy for breast cancer.
Read more →GLSI▼ -5.1%on this news
Greenwich LifeSciences Announces Acceptance of Abstract at ASCO 2026
Greenwich LifeSciences has announced that an abstract regarding its Phase III trial of GLSI-100 has been accepted for presentation at the ASCO 2026 Annual Meeting. The abstract will showcase preliminary data on immune response and recurrence rates in breast cancer patients. The conference will take place from May 28 to June 2, 2026, where the company aims to engage with key stakeholders.
Read more →GLSI▲ +8.9%on this newsshared move
Greenwich LifeSciences Announces Receipt of Nasdaq Notice Regarding Late Form 10-K Filing
Greenwich LifeSciences, Inc. announced it received a notice from Nasdaq regarding its failure to file the Annual Report on Form 10-K for the fiscal year ending December 31, 2025. Despite this, the company's stock remains unaffected and continues to trade on the Nasdaq Capital Market. Greenwich is focused on its Phase III trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences.
Read more →GLSI▼ -11.6%on this newsshared move
Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at AACR Meeting 2026
Greenwich LifeSciences presented promising preliminary data from its FLAMINGO-01 Phase III trial at the AACR Meeting 2026. The data indicates a significant increase in delayed-type hypersensitivity (DTH) reactions among patients treated with GLSI-100, suggesting its potential effectiveness in preventing breast cancer recurrences. The trial has screened over 1,300 patients, reflecting strong interest, although the low recurrence rate poses challenges in validating immune response measures.
Read more →GLSI▼ -5.3%on this news
Greenwich LifeSciences Provides Update on Financing Strategy
Greenwich LifeSciences, Inc. provided updates on its financing strategy and the Phase III clinical trial FLAMINGO-01 for GLSI-100, an immunotherapy for breast cancer. The company raised over $10.5 million in Q1 2026, exceeding its cash burn rate. Preliminary data from the trial indicates a promising reduction in recurrence rates, although results are still subject to review and may change.
Read more →GLSIGreenwich LifeSciences Provides Update on Patent Claims Potentially Doubling GP2 Market Potential
Greenwich LifeSciences has announced new patent claims that could potentially double the market for its immunotherapy GLSI-100, aimed at preventing breast cancer recurrences. The claims are based on significant immune response data from the ongoing Phase III trial, FLAMINGO-01. The company plans to expand its analysis of T cell responses, which may enhance treatment efficacy for a broader patient population.
Read more →GLSIGreenwich LifeSciences Announces Addition of City of Hope to FLAMINGO-01
Greenwich LifeSciences has announced the addition of City of Hope as a clinical site for its Phase III FLAMINGO-01 trial, aimed at evaluating GLSI-100, an immunotherapy for breast cancer. Involvement of Dr. Hope S. Rugo, an expert in breast oncology, is anticipated to enhance the study's outcomes. The trial now potentially has a greater reach with a total of 190-200 clinical sites. Preliminary results have indicated a promising reduction in recurrence rates, though these findings are still in the early analysis stage.
Read more →GLSI▼ -11.1%on this newsshared move
Greenwich LifeSciences Provides Update on Upcoming AACR Meeting
Greenwich LifeSciences, Inc. (GLSI) announced that two abstracts and two posters related to its Phase III clinical trial, FLAMINGO-01, have been accepted for presentation at the AACR Annual Meeting 2026. The presentations will include significant findings on the immune response to GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. This will be the first time data indicating a statistically significant immune response will be presented. The findings are expected to offer insights into the potential effectiveness of GLSI-100 in improving long-term survival for breast cancer patients.
Read more →GLSI▲ +6.8%on this newsshared move
Greenwich LifeSciences Provides Update Showing Continued Reduction in Recurrence Rate in the Open Label Arm of FLAMINGO-01
Greenwich LifeSciences has reported a significant reduction in breast cancer recurrence rates in the open label arm of its Phase III trial, FLAMINGO-01. The data indicates a recurrence rate of less than 1% per year for patients treated with GLSI-100, compared to a historical rate of 4% in similar populations. This promising outcome suggests potential efficacy of GLSI-100 in preventing recurrences, with further updates expected.
Read more →GLSI▲ +5.2%on this newsshared move
Greenwich LifeSciences Announces Use of Commercially Manufactured GP2 in FLAMINGO-01
Greenwich LifeSciences, Inc. has made significant progress in its Phase III clinical trial, FLAMINGO-01, by receiving FDA approval for commercially manufactured GP2 vials, which are now being supplied to 40 U.S. treatment sites. The company aims to secure additional approvals from European and Canadian regulators for wider participation in the trial. Preliminary findings indicate an 80% reduction in breast cancer recurrence rates among patients treated with its immunotherapy, GLSI-100. Plans are underway to ramp up production capacity to meet potential commercial demand.
Read more →GLSIGreenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01
Greenwich LifeSciences reported a significant increase in patient screening rates for its Phase III trial, FLAMINGO-01, achieving over 800 patients annually. This marks a 33% increase due to new site activations and heightened patient interest. Preliminary results indicate an 80% reduction in breast cancer recurrence rates in the non-HLA-A*02 arm, aligning with previous trial outcomes.
Read more →GLSI▲ +9.6%on this news· ran to +22% by day 3
Greenwich LifeSciences Announces Acceptance of Two Abstracts at AACR Annual Meeting 2026
Greenwich LifeSciences, Inc. announced the acceptance of two abstracts for the AACR Annual Meeting 2026, highlighting their Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 for preventing breast cancer recurrences. The abstracts will be published on March 17, 2026, with presentations during the conference from April 17-22, 2026. CEO Snehal Patel noted the significance of the collaboration with the FLAMINGO-01 Steering Committee.
Read more →GLSI▲ +9.6%on this news
Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy
Greenwich LifeSciences provided an update on its FLAMINGO-01 trial and financing strategy. The company has successfully raised over $7 million through its ATM financing, boosting its cash balance to approximately $12.5 million. This funding may cover the company's cash needs for 2026, despite projected increases in cash burn rates. The trial continues to enroll patients, with a focus on cost-saving measures.
Read more →GLSI▲ +5.7%on this news· ran to +51% by day 3shared move
Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01
Greenwich LifeSciences announced that the FDA has approved the first commercial lot of GP2 for use in its Phase III trial, FLAMINGO-01. This approval supports the company's plans to file a Biological License Application (BLA) in the US. The company aims to utilize the new GP2 vials at 40 clinical sites across the US shortly, enhancing its manufacturing capabilities.
Read more →GLSI▲ +19.8%on this news
Greenwich LifeSciences Extends Lock-up of Directors and Officers to September 30, 2026
Greenwich LifeSciences has announced an extension of the lock-up period for its directors, officers, and pre-IPO investors until September 30, 2026. This decision aims to align the interests of these shareholders with the company's long-term objectives and support the ongoing FLAMINGO-01 Phase III clinical trial for GLSI-100, an immunotherapy for breast cancer. The trial has seen significant patient enrollment, enhancing the potential for impactful results.
Read more →GLSIGreenwich LifeSciences Provides Additional Updates on FLAMINGO-01 and Corporate Strategy
Greenwich LifeSciences provided updates on its Phase III trial, FLAMINGO-01, which evaluates GLSI-100 for preventing breast cancer recurrences. The Data Safety Monitoring Board recommended continuing the study without modifications. The company discussed its clinical and financing strategies at a recent conference, highlighting the potential for GLSI-100 to significantly impact patient outcomes and healthcare costs.
Read more →GLSIGreenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01
Greenwich LifeSciences has announced a preliminary analysis demonstrating an approximately 80% reduction in breast cancer recurrence rates in the non-HLA-A*02 arm of its Phase III trial FLAMINGO-01. This analysis is based on 250 fully enrolled patients and suggests trends aligned with earlier Phase IIb trial results for HLA-A*02 patients. The data indicates a significant improvement in recurrence rates as patients complete the primary immunization series. The company remains cautious, noting that the results are preliminary and subject to change upon further review.
Read more →GLSI▲ +7.5%on this news· ran to +26% by day 3
Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01
Greenwich LifeSciences has completed enrollment in the open label arm of its Phase III clinical trial, FLAMINGO-01, evaluating GLSI-100 for preventing breast cancer recurrences. The trial includes approximately 250 non-HLA-A*02 patients, which could significantly increase the eligible patient population. The company anticipates analyzing the immune response and recurrence rates in this group compared to historical data.
Read more →GLSI▲ +5.1%on this news· ran to +20% by day 3shared move
Greenwich LifeSciences Provides Global Update on FLAMINGO-01, Screening Over 1,000 Patients to Date
Greenwich LifeSciences has announced that it has screened over 1,000 patients in its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 for preventing breast cancer recurrences. The trial has a screening pace of approximately 150 patients per quarter across various sites in the US and Europe, with plans to expand globally. CEO Snehal Patel highlighted the high level of interest from both doctors and patients, suggesting a positive outlook for future enrollment and interim analyses.
Read more →GLSIGreenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial
Greenwich LifeSciences has announced the expansion of its Phase III clinical trial, FLAMINGO-01, to Austria, following approval from European regulators. This trial evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The addition of Austria allows for increased patient participation in a region with a high incidence of breast cancer.
Read more →GLSI▲ +5.3%on this news
Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Belgium
Greenwich LifeSciences has announced the expansion of its Phase III clinical trial, FLAMINGO-01, to Belgium, following approval from European regulators. This trial evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The initiative is led by Dr. Patrick Neven at UZ Leuven, enhancing the study's reach and expertise in a country with high breast cancer incidence.
Read more →GLSIGreenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial
Greenwich LifeSciences has announced the addition of Portugal to its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy for preventing breast cancer recurrences. The expansion follows formal approval from European regulators, allowing participation alongside other countries. Dr. Luís António Marques da Costa will lead the trial in Portugal, enhancing the study's credibility and reach.
Read more →GLSIGreenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Ireland
Greenwich LifeSciences has announced the expansion of its Phase III clinical trial, FLAMINGO-01, to Ireland, following approval from European regulators. This trial evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The addition of Ireland allows more patients access to this innovative treatment, with Dr. Janice Walshe leading the effort in Dublin.
Read more →GLSIGreenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation
Greenwich LifeSciences has announced that its immunotherapy GLSI-100 has been granted Fast Track designation by the FDA for patients with HER2-positive breast cancer. This designation may facilitate earlier drug approval and allows for more frequent communication with the FDA. The company is optimistic about the potential impact of GLSI-100 on preventing cancer recurrences in the targeted patient population.
Read more →GLSINoble Capital Markets Initiates Equity Research Coverage on Greenwich LifeSciences
Greenwich LifeSciences, Inc. has announced that Noble Capital Markets has initiated equity research coverage on the company. This coverage comes as the company is conducting its Phase III clinical trial, FLAMINGO-01, which evaluates the efficacy of GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The trial is set to include up to 150 sites worldwide and aims to provide significant insights into breast cancer treatment.
Read more →GLSIGreenwich LifeSciences Announces Plan to Build Out Internal Clinical Operations Team
Greenwich LifeSciences announced its plan to establish an internal clinical operations team to manage its Phase III trial, FLAMINGO-01. This move aims to reduce reliance on external Clinical Research Organizations, thereby cutting costs and enhancing operational efficiency. The company is hiring skilled personnel to oversee the trial, which evaluates GLSI-100 for preventing breast cancer recurrences.
Read more →GLSIGreenwich LifeSciences Announces Expansion of Flamingo-01 into Romania
Greenwich LifeSciences has received approval to expand its Phase III clinical trial, FLAMINGO-01, into Romania, adding new clinical sites. This trial evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The initiative is supported by local experts and aims to address the high incidence of breast cancer in Romania.
Read more →GLSIGreenwich LifeSciences Provides Update on CEO Interviews & Corporate Events
Greenwich LifeSciences, Inc. has provided an update on CEO interviews and corporate events, highlighting the progress of its Phase III clinical trial, FLAMINGO-01, for GLSI-100. This immunotherapy aims to prevent breast cancer recurrences in patients post-surgery. The trial is set to expand globally with plans for up to 150 clinical sites. The company emphasizes the importance of ongoing communication through CEO interviews available on its website.
Read more →GLSIGreenwich LifeSciences Provides Global Update on FLAMINGO-01
Greenwich LifeSciences has provided an update on its Phase III clinical trial, FLAMINGO-01, evaluating GLSI-100 for preventing breast cancer recurrences. The trial has shown promising preliminary data regarding immune responses and has expanded its non-HLA-A*02 arm. The company plans to increase the number of clinical sites globally to enhance patient recruitment and is considering further developments based on interim analyses.
Read more →GLSIGreenwich LifeSciences Announces Positive Immune Response Data from FLAMINGO-01 Phase III Clinical Trial
Greenwich LifeSciences announced positive preliminary immune response data from its Phase III FLAMINGO-01 trial evaluating the GLSI-100 immunotherapy. The data indicates increasing immune responses among patients over time, suggesting the therapy's effectiveness in preventing breast cancer recurrences. Additionally, the company has filed patent claims for a broader patient base, potentially doubling the market for the treatment. The CEO is considering design modifications to further the trial's efficacy and market potential.
Read more →GLSIGreenwich LifeSciences Extends Lock-up of Directors and Officers to March 31, 2026
Greenwich LifeSciences, Inc. has announced the extension of the lock-up period for shares held by its directors, officers, and pre-IPO investors until March 31, 2026. This decision reflects the company’s commitment to stability while it conducts its Phase III clinical trial, FLAMINGO-01, aimed at evaluating GLSI-100, an immunotherapy targeting breast cancer recurrences. The trial is set to include around 500 patients and is expanding to 150 global sites, highlighting the company's ambitions within the oncology space. The lock-up will prevent current shareholders from selling their shares, ensuring focus on the upcoming clinical developments.
Read more →GLSIGreenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01
Greenwich LifeSciences has provided an update on the safety data from its Phase III trial FLAMINGO-01, evaluating GLSI-100, an immunotherapy for breast cancer. The Data Safety Monitoring Board has recommended continuing the study as no serious adverse events have been reported. Preliminary safety data indicates that GLSI-100 is well tolerated and shows promising results, including a significant reduction in cancer recurrence based on previous Phase IIb findings. Further analysis and potential future presentations of data are anticipated as the study matures.
Read more →GLSIGreenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01
Greenwich LifeSciences announced an update on its Phase III trial FLAMINGO-01, focusing on GLSI-100 immunotherapy for breast cancer recurrences. Preliminary HLA data shows about 46% of screened patients possess at least one HLA-A*02 allele, aligning with the company’s expectations. The trial includes a newly expanded third arm for patients lacking this allele, potentially providing insights into immune responses across multiple HLA types. CEO Snehal Patel emphasized the study's capability to analyze diverse patient populations and its significance in guiding future commercial strategies.
Read more →GLSIGreenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe
Greenwich LifeSciences has received approval from the EMA to expand its Phase III clinical trial FLAMINGO-01 by adding 11 new sites in Spain, Germany, and Poland, bringing the total number of sites in Europe to approximately 110-115. The company's CEO noted a significant increase in patient screening in Europe, reflecting high interest in the trial. Furthermore, Greenwich LifeSciences plans to submit applications for additional sites in Ireland, Romania, and possibly other European countries.
Read more →GLSIGreenwich LifeSciences Announces Activation of Flamingo-01 in Poland
Greenwich LifeSciences, Inc. has announced the activation of clinical sites in Poland for its Phase III clinical trial, FLAMINGO-01, focused on evaluating GLSI-100 for preventing breast cancer recurrences. The trial aims to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients. Notably, nine to eleven Polish sites are set to participate, which have been approved by local authorities. The involvement of Dr. Piotr Wysocki, a key figure in Polish oncology, further strengthens the trial's foundation in the country.
Read more →GLSIGreenwich LifeSciences Announces Additions of Harvard and Johns Hopkins to Flamingo-01
Greenwich LifeSciences, Inc. has announced the inclusion of Harvard University and Johns Hopkins University as new clinical sites for its Phase III trial, FLAMINGO-01, evaluating the immunotherapy GLSI-100 for preventing breast cancer recurrences. With the addition of notable researchers to the trial's Steering Committee, the initiative aims to enhance its scope and efficacy. The trial, which is focused on high-risk HER2-positive breast cancer patients, represents a significant move towards expanding advanced immunotherapy options in cancer care.
Read more →GLSIGreenwich LifeSciences Provides Update on Commercial Manufacturing
Greenwich LifeSciences, Inc. has provided an update on its commercial manufacturing progress for GP2, an immunotherapy aimed at preventing breast cancer recurrences. The company has successfully manufactured the first three commercial lots of GP2 and initiated drug stability programs. This data is critical for the upcoming submission of a Biological License Application (BLA) in the U.S. and other countries. CEO Snehal Patel highlighted the importance of regulatory reviews and ongoing clinical trials, alongside the company’s plans to expand its market strategy and establish a trade name for GP2.
Read more →GLSIGreenwich LifeSciences Announces Partnership with GBG in Germany for Flamingo-01
Greenwich LifeSciences has announced a partnership with the German Breast Group (GBG) to expand its Phase III clinical trial, FLAMINGO-01, for the immunotherapy GLSI-100. Approximately 38 clinical sites in Germany are set to participate, with the first patient randomized in October 2024. This collaboration aims to improve outcomes for HER2-positive breast cancer patients at high risk of recurrence. The GBG is recognized for its extensive patient data and contributions to breast cancer research, enhancing the potential impact of the trial in Europe.
Read more →GLSIGreenwich LifeSciences Partners with Unicancer Expanding Flamingo-01 into France
Greenwich LifeSciences, Inc. has announced the activation of clinical sites in France for its Phase III clinical trial, FLAMINGO-01, which investigates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The partnership with Unicancer, the largest cancer research network in France, will enable the trial to reach a broader patient demographic across approximately 19 clinical sites. The initiative aligns with the pressing need for breast cancer treatment options, given the high incidence of the disease in France. The trial expands the company’s research efforts internationally, promising significant advancements in oncology.
Read more →GLSIGreenwich LifeSciences Partners with GIM in Italy
Greenwich LifeSciences has announced a partnership with the largest breast cancer research group in Italy, GIM, to conduct the FLAMINGO-01 clinical trial. This trial evaluates the immunotherapy GLSI-100 for preventing breast cancer recurrences and includes participation from nine top enrolling institutions. Significant efforts for in-person training and startup activities have already commenced, aiming to enhance patient access and involvement in this important research initiative. The partnership underscores Greenwich's commitment to expanding its clinical reach and improving treatment options in breast cancer care.
Read more →GLSIGreenwich LifeSciences Provides Update on Corporate Events
Greenwich LifeSciences, Inc. has provided an update on its corporate events scheduled for 2024, including major conferences and an investor meeting. The company is focused on the clinical development of GLSI-100, an immunotherapy designed to prevent recurrences of breast cancer. Notably, the company is conducting the Phase III FLAMINGO-01 trial, led by Baylor College of Medicine, which will evaluate GLSI-100's safety and efficacy in HER2 positive breast cancer patients. The initiative reflects the company's commitment to addressing the needs of breast cancer patients and expanding its clinical research efforts globally.
Read more →GLSIGreenwich LifeSciences Provides Update on Expansion of Flamingo-01 into Spain
Greenwich LifeSciences, Inc. has announced the expansion of its Phase III clinical trial, FLAMINGO-01, into Spain, partnering with GEICAM to incorporate 38 hospital sites. So far, about 30 sites have completed site initiation visits, and 19 have been activated for patient screening and treatment. The collaboration aims to enhance the study's success by training site staff, which is expected to facilitate a swift increase in patient enrollment. The company anticipates further updates on the expansion to additional European countries as part of the trial's international outreach.
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Greenwich LifeSciences Set to Join Russell 2000 Index Again
Greenwich LifeSciences, Inc. has announced its inclusion in the Russell 2000 Index, effective July 1, 2024. This milestone comes as the company continues its Phase III clinical trial, FLAMINGO-01, evaluating the immunotherapy GLSI-100 for preventing breast cancer recurrences. The CEO indicated that this addition could enhance institutional ownership similar to past occurrences. The trial is significant for its planned expansion into European territories and aims to include up to 150 clinical sites worldwide.
Read more →GLSIGreenwich LifeSciences Announces $2.5 Million Private Placement
Greenwich LifeSciences has announced a private placement raising approximately $2.5 million through the sale of shares to its CEO, Snehal Patel. This funding aims to enhance the clinical development of their immunotherapy, GLSI-100, which is currently undergoing a Phase III trial known as FLAMINGO-01. The securities will not be registered under federal securities laws, adding an element of regulatory complexity to the transaction. The company plans to use the net proceeds for further clinical development and operational needs.
Read more →GLSIGreenwich LifeSciences Extends Lock-up of Directors and Officers to June 30, 2025
Greenwich LifeSciences, Inc. has announced an extension of the lock-up period for its directors, officers, and pre-IPO investors until June 30, 2025. This decision underscores the company's focus on long-term stability following its IPO. The company is currently conducting a Phase III clinical trial, referred to as Flamingo-01, to evaluate the efficacy of its immunotherapy GLSI-100 in preventing breast cancer recurrences. The ongoing trial aims to enroll up to 500 patients and will include multiple clinical sites across the U.S. and plans for international expansion.
Read more →GLSI▲ +8.2%on this newsshared move
Greenwich LifeSciences Partners with GEICAM in Spain & Conducts First Site Initiation Visits in Europe
Greenwich LifeSciences, Inc. has announced a partnership with GEICAM to initiate the FLAMINGO-01 Phase III clinical trial for GLSI-100 in Europe. The collaboration involves 38 clinical sites across Spain, where the vaccine aims to prevent breast cancer recurrences in high-risk patients. The project benefits from GEICAM's extensive research network and expertise in oncology. The company looks forward to ramping up its presence in Europe as it progresses with the trial, which is expected to provide critical insights for breast cancer treatments.
Read more →GLSIGreenwich LifeSciences Flamingo-01 Phase III Clinical Trial Approved to Expand into Five Largest European Countries
Greenwich LifeSciences has received approval to expand its Flamingo-01 Phase III clinical trial for GLSI-100 into five major European countries: Spain, France, Germany, Italy, and Poland. This approval allows the activation of 105 clinical trial sites, with initial site training and visits commencing soon. The trial is designed to evaluate the efficacy of GLSI-100 in preventing breast cancer recurrences and has generated significant interest within the European medical community. The company aims to optimize the site activation process to make the treatment available to patients as rapidly as possible.
Read more →GLSIGreenwich LifeSciences Flamingo-01 Manufacturing & Protocol Accepted by European Regulators
Greenwich LifeSciences, Inc. announced that European regulators have accepted its application to expand the Phase III Flamingo-01 clinical trial into Europe. This trial, which evaluates the immunotherapy GLSI-100 for preventing breast cancer recurrences, has passed regulatory review by the European Medicines Agency (EMA). The company will now move forward with activating approximately 105 clinical sites across five European countries. CEO Snehal Patel emphasized the importance of continuing dialogue with EMA as they prepare for a future EU licensing application.
Read more →GLSI▲ +22.7%on this news· ran to +56% by day 3
Greenwich LifeSciences Provides Update on Phase III Clinical Trial, Flamingo-01
Greenwich LifeSciences provided an update on the Phase III clinical trial, Flamingo-01, focusing on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The trial's Safety Monitoring Board has recommended continuing without modifications, with no serious adverse events reported. European regulatory approval is anticipated in 2024, which would enable additional clinical sites across Europe. Furthermore, plans to expand participation in the trial, including enrolling more non-HLA-A*02 patients, are underway.
Read more →GLSIGreenwich LifeSciences Extends Lock-up of Directors and Officers to End of 2024
Greenwich LifeSciences, Inc. has announced an extension of the lock-up period for its directors, officers, and certain shareholders until December 31, 2024. This lock-up will prevent these individuals from selling their shares of common stock. The decision reflects the company’s ongoing commitment to its development of GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences.
Read more →GLSIGreenwich LifeSciences, Inc. Announces Partnership with Baylor College of Medicine for its Planned Phase III Clinical Trial STAFFORD, Texas-(BUSINESS WIRE)- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a
LifeSciences, Inc. Announces Partnership with Baylor College of Medicine for its Planned Phase III Clinical Trial Texas-(BUSINESS WIRE)- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an
Read more →GLSIGreenwich LifeSciences, Inc. Announces Pricing of Initial Public Offering STAFFORD, TX / [Business Wire] /
LifeSciences, Inc. Announces Pricing of Initial Public Offering TX / [Business Wire] / September 24, 2020 / Greenwich LifeSciences, Inc. (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recu
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