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Greenwich LifeSciences, Inc.

GLSI
OvervaluedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$15.14
▼ -0.24 · -1.58%

Financials

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52W LOW $7.7852W HIGH $34.10
Volume
129.10 K
Value Traded
2.74 M
Short % Float
21.32%
-10.84%Week
+0.73%1 Month
-23.54%3 Month
-41.27%6 Month
-16.39%5 Year
+380.87%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
222.23 M
EPS (TTM)
-1.48
P/E Ratio
-
Ent. Value
213.35 M
Total Shares
14.68 M
Float Shares
7.65 M
Insiders
47.91%
Institutions
11.64%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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PoA blends historical approval base rates, trial design score and FDA review track record.

GLSI Catalyst Timeline

Dated clinical, regulatory and corporate events for Greenwich LifeSciences, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Greenwich LifeSciences, Inc.

171Total events
8Upcoming
21Tier-1 (high impact)
2022 to 2027Coverage

Upcoming catalysts 2

T2Quarterly Update
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TBD
T1Interim Analysis
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GLSI-100

Event history 50

●Quarterly UpdateCorporate
Board extends lock-up of directors, officers, and pre-IPO investors to January 31, 2027
▲Other Regulator MilestoneGLSI-100Ex-US Regulatory
Regulatory approval to expand FLAMINGO-01 into the United Kingdom
breast cancersource ↗
▲Enrollment UpdateGLSI-100Trial
Non-HLA-A*02 arm fully enrolled (250 patients)
breast cancersource ↗
▲FDA Feedback ReceivedGLSI-100FDA Meeting
FDA and EMA regulatory authorities reviewed and objectives met for FLAMINGO-01 modifications
breast cancersource ↗
▲Enrollment MilestoneGLSI-100Trial
Screened over 1,500 patients in FLAMINGO-01
breast cancersource ↗
▲Enrollment CompleteGLSI-100Trial
Non-HLA-A*02 open label arm fully enrolled (250 patients)
breast cancersource ↗
◆Other Regulator MilestoneGLSI-100Ex-US Regulatory
Study design under review by UK and Canada regulators
breast cancersource ↗
▲EMA ValidationGLSI-100Ex-US Regulatory
EMA allows combination of both HLA-A*02 and non-HLA-A*02 patients in FLAMINGO-01
breast cancersource ↗
▲Enrollment CompleteGLSI-100Trial
250 patient non-HLA-A*02 arm fully enrolled
breast cancersource ↗
▲Interim AnalysisGLSI-100Trial
Preliminary analysis of recurrence rates in non-HLA-A*02 arm shows ~70-80% reduction
breast cancersource ↗
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Past FDA Catalysts and PDUFA Decisions

How GLSI actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-06-01GLSI-100 Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D35 / 100
Pipeline Score
$52M
Pipeline Value
Overvalued
Valuation Signal
1
Drugs Scored
0.2x
rNPV / MCap
Top 54%
Micro Cap
(rank 356 of 658)
Percentile Rank
Greenwich LifeSciences, Inc. faces pipeline headwinds (35/100), with $327M risk-adjusted pipeline value, led by GLSI-100 in Breast Cancer (Phase 3).
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
GLSI-100 Monoclonal antibodyNCT05232916Breast CancerPhase 3 RECRUITING 2,250Dec 1, 2031
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Clinical Trial Results

Readouts, endpoints and source filings for every GLSI program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
GLSI-100
Fast Track
breast cancer recurrencesPhase 32026-07-20promising reduction in recurrence rates among treated patientsRead MoreGreenwich LifeSciences Provides Clinical Updates on FLAMINGO-01Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Patel SnehalDirector, Officer (CEO and CFO), 10% OwnerBuy 700 5,611,402 held$13.10 07/29/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in GLSI for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

GLSI Institutional Ownership Trends

Options Data

Option Volume

Open Interest
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Today vs avg
Option Volume
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Real-Time Option Chain

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Competitive positioning

How GLSI ranks across every disease it competes in

Competitive Position is a premium feature
See how GLSI ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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GLSI News

GLSI
Aug 10, 2026
GLSIGeneral
▲ +7.9%on this news

Greenwich LifeSciences Extends Lock-up of Directors and Officers to January 31, 2027

Greenwich LifeSciences has extended the lock-up period for its directors and officers until January 31, 2027. This decision reflects the company's confidence as it progresses in its Phase III clinical trial, FLAMINGO-01, aimed at preventing breast cancer recurrences. The company is also preparing for upcoming conferences that may facilitate strategic transactions.

Read more →
GLSI
Jul 22, 2026
GLSIPhases
▼ -9.4%on this news

Greenwich LifeSciences Announces Approval to Expand FLAMINGO-01 into the United Kingdom

Greenwich LifeSciences has received regulatory approval to expand its Phase III clinical trial, FLAMINGO-01, into the United Kingdom. This expansion will potentially add 5-10 new sites across various UK cities, increasing patient enrollment opportunities. The trial evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with promising preliminary results indicating significant reductions in recurrence rates.

Read more →
GLSI
Jul 20, 2026
GLSIPhases
▼ -13.8%on this newsshared move

Greenwich LifeSciences Provides Clinical Updates on FLAMINGO-01

Greenwich LifeSciences has provided updates on its Phase III trial, FLAMINGO-01, which evaluates GLSI-100 for preventing breast cancer recurrences. The Data Safety Monitoring Board has recommended the study continue without modifications. The company plans to increase enrollment rates significantly, which may enhance the trial's statistical power and reduce risks. Preliminary data indicates a promising reduction in recurrence rates among treated patients.

Read more →
GLSI
Jul 16, 2026
GLSIPhases

Greenwich LifeSciences Announces European Approval for Combining Both HLA Populations in FLAMINGO-01

Greenwich LifeSciences has received European approval to combine HLA-A*02 and non-HLA-A*02 patients in its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. This change aligns with a similar protocol in the US, potentially doubling enrollment rates. Preliminary data indicates a significant reduction in recurrence rates, although results are still subject to further analysis.

Read more →
GLSI
Jul 9, 2026
GLSIPhases

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.

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GLSI
Jun 1, 2026
GLSIPhases
▲ +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.

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GLSI
Jun 1, 2026
GLSIPhases
▲ +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.

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GLSI
May 22, 2026
GLSIFDA Updates

Greenwich 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.

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GLSI
Apr 23, 2026
GLSIConferences/Events
▼ -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.

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GLSI
Apr 22, 2026
GLSIFDA Updates
▲ +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.

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GLSI
Apr 20, 2026
GLSIPhases
▼ -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.

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GLSI
Apr 14, 2026
GLSIGeneral
▼ -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 →
GLSI
Apr 7, 2026
GLSIPhases

Greenwich 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.

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GLSI
Mar 19, 2026
GLSIPhases

Greenwich 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
Mar 18, 2026
GLSIConferences/Events
▼ -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.

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GLSI
Mar 17, 2026
GLSIPhases
▲ +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
Mar 16, 2026
GLSIPhases
▲ +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 →
GLSI
Mar 3, 2026
GLSIPhases

Greenwich 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 →

About Greenwich LifeSciences, Inc.

Stafford, TX 13 employees greenwichlifesciences.com
Headquarters3992 BLUEBONNET DR, BUILDING 14, STAFFORD, TX, 77477
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