Greenwich Lifesciences, Inc. is a clinical-stage biopharmaceutical company developing immunotherapy products for HER2-positive cancers, focusing on breast cancer recurrence prevention.

# Company Overview: Greenwich Lifesciences, Inc.

## Business Focus
- Greenwich Lifesciences is a **clinical-stage biopharmaceutical company** developing immunotherapy products for cancer treatment, with a primary focus on breast cancer and other HER2/neu-expressing cancers.
- The company's lead candidate is **GLSI-100**, an immunotherapy designed to prevent breast cancer recurrences.
- GLSI-100 is a combination of **GP2**, a HER2/neutransmembrane peptide that stimulates targeted immune responses against HER2-positive cancers, and **GM-CSF**, an immunoadjuvant (Recombinant human granulocyte macrophage colony-stimulating factor).
- The product aims to address patients with residual disease or high-risk conditions after standard trastuzumab-based therapies, with a focus on HER2/neu-positive breast cancer patients.

## Clinical Development
- The flagship product is currently in **Phase III clinical trials** (Flamingo-01), which are evaluating the efficacy and safety of GLSI-100 versus placebo.
- Previous clinical trials include:
  - **Phase IIb**: A trial of 180 patients showing promising data with no recurrences reported among certain subpopulations.
  - **Phase I**: Multiple trials demonstrating safety, immune response, and tolerability with no significant adverse events.
  - The trials involve HLA-A*02 positive patients and are designed to prevent recurrence in high-risk breast cancer patients.

## Market and Regimen
- The target market includes approximately **700,000 new breast cancer patients annually** in the U.S. and Europe.
- HER2/neu3+ patients comprise about **25% of all breast cancer patients**.
- The company estimates **40-50% of the U.S. and European population** carry the HLA-A*02 allele, and that about **50% of patients** are node-positive or high-risk node-negative.
- The product is expected to complement existing therapies such as Herceptin, Kadcyla, Enhertu, and others targeting HER2-expressing cancers.

## Employees
- As of April 11, 2025, Greenwich Lifesciences has a total of **8 employees**:
  - 4 full-time employees
  - 4 part-time employees

## Financials
- The company has **not reported any revenue** from product sales or licensing.
- For the fiscal year ended December 31, 2024:
  - A net loss of **$15.8 million**.
  - An **accumulated deficit of $66.2 million**.

## Market Capitalization (as of June 28, 2024)
- The market value of non-affiliated shareholders' equity was **approximately $101 million**, based on a closing stock price of **$17.26 per share**.
- Issued and outstanding shares as of April 11, 2025, total **13,273,539 shares** of common stock with a par value of $0.001 per share.

## Corporate Strategy
- The company currently **lacks sales, marketing, or distribution capability**.
- It plans to partner or license the product internationally and hopes to establish a U.S. commercial team if approved.
- The company aims to advance GLSI-100 into **Phase III trials** and support global registration, potentially exploring additional HER2-expressing cancers.

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**Summary:**  
Greenwich Lifesciences is a small, clinical-stage biotech company specializing in cancer immunotherapy targeting HER2-positive cancers, especially breast cancer. It is in late-stage clinical trials with no current revenues and has a net loss of $15.8 million in 2024. The company has 8 employees and a market capitalization of roughly $101 million as of mid-2024.

A clinical-stage biopharmaceutical company focused on developing immunotherapy for breast cancer recurrences through GLSI-100.

# Company Overview

## Business Focus
The company is a clinical-stage biopharmaceutical firm dedicated to developing GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. 

### Product Candidate
- **GP2:** A 9-amino acid transmembrane peptide derived from the HER2/neu protein that activates a targeted immune response against HER2/neu-expressing cancers.
- **Combination Treatment:** GP2 is administered with recombinant human granulocyte macrophage colony-stimulating factor (GM-CSF), enhancing the immune response.

## Clinical Trials
- **Current Phase III Trial:** Named Flamingo-01, it is evaluating GLSI-100 in HER2/neu positive patients with residual disease or high-risk pathologic complete response after trastuzumab-based treatment. 
  - **Global Expansion:** The trial will include up to 150 sites worldwide and has already commenced in the U.S. 
  - **Previous Trials:** The company has completed multiple prior phase trials, including a Phase IIb trial which showed promising results with a 100% reduction in recurrence rates in certain patient groups.

## Market Data
- **Target Patient Population:** The company estimates that HER2/neu 3+ breast cancer patients represent about 25% of all breast cancer cases. The addressable market could include approximately 6% of breast cancer patients who undergo surgery.
- **Market Size Estimation:** According to the American Cancer Society, approximately 282,000 new breast cancer patients are diagnosed per year in the U.S., reflecting significant potential market opportunities.

## Financials
- **Revenue:** The company has not generated revenue as of now since it is still in the development phase.
- **Income:** Reported net losses of $8.9 million and $7.8 million for the years ending December 31, 2023 and 2022, respectively. The accumulated deficit amounted to approximately $50.4 million as of December 31, 2023.
- **Number of Employees:** The company currently has 3 full-time employees and 4 part-time employees.

## Future Outlook
The company plans to seek significant additional financing to support ongoing operations and clinical trials. Future market strategy includes building commercialization capabilities if products receive approval while also aiming to expand into various HER2/neu-expressing cancers beyond breast cancer. 

## Conclusion
As a clinical-stage biopharmaceutical company, this entity is positioned at the forefront of cancer immunotherapy, with a particular focus on innovative treatments that harness the power of the immune system, holding potential benefits for both patients and investors alike.

Greenwich LifeSciences, Inc.

10-K / April 15, 2025

10-K / April 15, 2024

10-K / April 15, 2025

Company Overview: Greenwich Lifesciences, Inc.

Business Focus

Clinical Development

Market and Regimen

Employees

Financials

Market Capitalization (as of June 28, 2024)

Corporate Strategy