Greenwich LifeSciences Presents ASCO Annual Meeting Abstract
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 hours ago
0mins
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-A02 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-A02 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-A02 open label arm immune response data for both DTH and ISRs is trending similarly to the immune response data in the HLA-A02 patients in the Phase IIb study and the HLA-A02 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-A02 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.
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Current: 26.175
Low
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Averages
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About GLSI
Greenwich LifeSciences, Inc. is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9-amino acid transmembrane peptide of the human epidermal growth factor receptor 2 (HER2) /neu protein, a cell surface receptor protein that is expressed in a variety of common cancers. It has commenced a Phase III clinical trial, Flamingo-01, an immunotherapy to prevent breast cancer recurrences. GP2 is delivered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) to induce GP2 peptide-specific immunity. GP2 treatment is administered via an intradermal injection by mixing GP2 peptide and GM-CSF at the time of administration. Its cancer immunotherapy seeks to stimulate an individual's immune system to selectively attack cancer cells while not affecting normal cells or to deliver immune system components to inhibit the spread of cancer.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Accounts Payable Adjustments: The company reported significant increases in accounts payable due to unexpectedly high patient screening and enrollment in clinical trials in Europe during 2024 and 2025, but believes these adjustments do not materially affect its financial fundamentals.
- Cash Flow Status: As of March 31, 2026, the company reported a cash balance of approximately $10.5 million, an improvement over 2025, and has retired over 75% of its accounts payable, indicating positive progress in financial management.
- Clinical Trial Data: In the FLAMINGO-01 trial, over 1,300 patients have been screened, with preliminary analysis showing a 70-80% reduction in recurrence rates in the non-HLA-A*02 arm after completing the Primary Immunization Series, indicating the potential efficacy of GLSI-100.
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- Vaccine Composition and Mechanism: GLSI-100 is an investigational cancer vaccine containing GP2 peptide and Granulocyte Macrophage-stimulating factor (GM-CSF), aimed at preventing metastasis through immunotherapy targeting HER2+ breast cancer, showcasing its potential in tumor immunotherapy.
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- Market Reaction: GLSI is currently trading at $27.73, up 5.94%, reflecting positive investor sentiment towards the clinical data of the vaccine, which may drive further growth in the biopharmaceutical sector.
See More
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- Clinical Trial Progress: The company is conducting the Flamingo-01 trial for GLSI-100, having screened over 1,300 patients, with preliminary data indicating a 70% to 80% reduction in breast cancer recurrence rates after the initial six-dose treatment series, showcasing promising therapeutic potential.
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- Impact of Filing Delay: The failure to submit the quarterly report on time may affect investor confidence, leading to concerns about the company's future financial transparency, which could exert negative pressure on the stock price.
- Market Reaction: Despite the compliance notification, the market's response to Greenwich LifeSciences has been relatively stable, indicating that investor confidence in the company's fundamentals has not been significantly impacted.
- Future Outlook: The company must resolve the compliance issue promptly to avoid further regulatory actions and ensure its continued listing on Nasdaq, thereby maintaining investor trust and market reputation.
See More
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- Stock Trading Status: The company's common stock continues to trade on the Nasdaq Capital Market under the symbol 'GLSI', indicating that despite compliance issues, the liquidity of its shares remains unaffected in the market.
- Future Plans: The company intends to file its 10-K for the fiscal year 2025 as soon as possible, demonstrating a proactive approach to resolving compliance issues and aiming to restore full compliance with Nasdaq regulations.
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See More
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- Significant Immune Response Increase: Data presented at the 2026 AACR Annual Meeting revealed that the vaccine candidate GLSI-100 showed nearly a 4-fold increase in immune response in non-HLA-A*02 patients, with some patients improving by 2 to 8 times, demonstrating its broader applicability.
- Clinical Trial Results: In the Phase III FLAMINGO-01 trial, delayed-type hypersensitivity (DTH) responses in the specific HLA-A*02 patient cohort increased fourfold from month 4 to 6 of treatment, indicating significant immune activation by the vaccine.
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See More
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- Financial Reporting Progress: Greenwich LifeSciences is currently auditing its 10-K report for the fiscal year ending December 31, 2025, with final approval expected soon, although delays due to auditor coordination issues may impact investor confidence.
- Accounts Payable Adjustments: The company reported significant increases in accounts payable due to unexpectedly high patient screening and enrollment in clinical trials in Europe during 2024 and 2025, but believes these adjustments do not materially affect its financial fundamentals.
- Cash Flow Status: As of March 31, 2026, the company reported a cash balance of approximately $10.5 million, an improvement over 2025, and has retired over 75% of its accounts payable, indicating positive progress in financial management.
- Clinical Trial Data: In the FLAMINGO-01 trial, over 1,300 patients have been screened, with preliminary analysis showing a 70-80% reduction in recurrence rates in the non-HLA-A*02 arm after completing the Primary Immunization Series, indicating the potential efficacy of GLSI-100.
See More
Greenwich LifeSciences Reports Positive Phase 3 Data for Breast Cancer Vaccine
- Clinical Trial Results: Greenwich LifeSciences presented positive Phase 3 FLAMINGO-01 data at ASCO, indicating that GLSI-100 achieved a 70%-80% reduction in recurrence rates among non-HLA-A*02 subjects, establishing a strong foundation for future market promotion.
- Vaccine Composition and Mechanism: GLSI-100 is an investigational cancer vaccine containing GP2 peptide and Granulocyte Macrophage-stimulating factor (GM-CSF), aimed at preventing metastasis through immunotherapy targeting HER2+ breast cancer, showcasing its potential in tumor immunotherapy.
- New Testing Arm Progress: A new testing arm of approximately 250 non-HLA-A*02 patients has completed enrollment, evaluating GLSI-100 administered via 6 intradermal injections over 6 months and 5 subsequent boosters over 2.5 years, further validating its immune response.
- Market Reaction: GLSI is currently trading at $27.73, up 5.94%, reflecting positive investor sentiment towards the clinical data of the vaccine, which may drive further growth in the biopharmaceutical sector.
See More
Greenwich LifeSciences Updates Financial Status Amid Nasdaq Filing Delay
- Financial Status Update: Greenwich LifeSciences reported that the delay in its 2025 annual report audit does not materially affect its cash position, with an unaudited cash balance of approximately $10.5 million as of March 31, 2026, ensuring business fundamentals remain stable.
- Clinical Trial Progress: The company is conducting the Flamingo-01 trial for GLSI-100, having screened over 1,300 patients, with preliminary data indicating a 70% to 80% reduction in breast cancer recurrence rates after the initial six-dose treatment series, showcasing promising therapeutic potential.
- Nasdaq Compliance Notice: Greenwich received a compliance notice from Nasdaq on April 22, 2026, for failing to file its annual Form 10-K on time, with subsequent notices indicating ongoing audits involving accounts payable adjustments related to patient screening and enrollment.
- Positive Investor Sentiment: Retail sentiment on Stocktwits remains bullish with extremely high message volumes, and the stock has gained nearly 24% year-to-date, reflecting strong market interest and confidence in the Flamingo trial.
See More
Greenwich LifeSciences Receives Nasdaq Notification on Compliance
- Compliance Notification: Greenwich LifeSciences (GLSI) received a notification from Nasdaq on Friday indicating non-compliance with listing rules due to the late filing of its Quarterly Report on Form 10-Q for the three months ended March 31, 2026, although the notice does not have an immediate effect on the listing or trading of the company's common stock.
- Impact of Filing Delay: The failure to submit the quarterly report on time may affect investor confidence, leading to concerns about the company's future financial transparency, which could exert negative pressure on the stock price.
- Market Reaction: Despite the compliance notification, the market's response to Greenwich LifeSciences has been relatively stable, indicating that investor confidence in the company's fundamentals has not been significantly impacted.
- Future Outlook: The company must resolve the compliance issue promptly to avoid further regulatory actions and ensure its continued listing on Nasdaq, thereby maintaining investor trust and market reputation.
See More
Greenwich LifeSciences Receives Nasdaq Notification Regarding 10-K Filing
- Nasdaq Compliance Notification: Greenwich LifeSciences received a notification from Nasdaq indicating non-compliance due to the failure to file its 10-K report for the fiscal year ending December 31, 2025, although this notice does not have an immediate impact on the listing or trading of its stock.
- Stock Trading Status: The company's common stock continues to trade on the Nasdaq Capital Market under the symbol 'GLSI', indicating that despite compliance issues, the liquidity of its shares remains unaffected in the market.
- Future Plans: The company intends to file its 10-K for the fiscal year 2025 as soon as possible, demonstrating a proactive approach to resolving compliance issues and aiming to restore full compliance with Nasdaq regulations.
- Investor Attention: Despite facing compliance challenges, recent open-label data and patent claims from Greenwich LifeSciences continue to attract investor interest, which may influence its future market performance.
See More
Greenwich LifeSciences Expands Vaccine Trial to Broader Patient Population
- Trial Expansion Plans: CEO Snehal Patel announced that the FDA has reviewed plans to expand the trial to include all patient types, with over 1,300 patients enrolled, indicating a significant market opportunity for the breast cancer vaccine.
- Significant Immune Response Increase: Data presented at the 2026 AACR Annual Meeting revealed that the vaccine candidate GLSI-100 showed nearly a 4-fold increase in immune response in non-HLA-A*02 patients, with some patients improving by 2 to 8 times, demonstrating its broader applicability.
- Clinical Trial Results: In the Phase III FLAMINGO-01 trial, delayed-type hypersensitivity (DTH) responses in the specific HLA-A*02 patient cohort increased fourfold from month 4 to 6 of treatment, indicating significant immune activation by the vaccine.
- Positive Market Reaction: Shares of Greenwich LifeSciences rose over 2% in premarket trading on Monday, and the stock has increased by over 28% year-to-date, reflecting bullish sentiment among retail investors regarding the company's prospects.
See More
