Greenwich LifeSciences, Inc. (GLSI): Business Model Canvas [Dec-2025 Updated]

You're trying to size up Greenwich LifeSciences, Inc., a clinical-stage biotech betting big on preventing metastatic breast cancer recurrence with its GLSI-100 immunotherapy, and you need the hard numbers behind the promise. Honestly, the core value proposition is compelling: offering recurrence reduction potentially far beyond the $\sim\mathbf{50\%}$ seen with current HER2 treatments for patients with residual disease. Still, the immediate reality is funding the global Phase III FLAMINGO-01 trial, which drove R&D expenses to $\mathbf{\$9,630,604}$ for the nine months ending September 30, 2025, with the $\mathbf{\$3,806,978}$ in cash needing topping up via equity raises. This canvas cuts through the noise to show exactly how Greenwich LifeSciences, Inc. is structured to manage that cash burn while chasing that potential $\mathbf{12}$ years of market exclusivity; dig in below to see the whole operational picture.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Greenwich LifeSciences, Inc. relies on to push GLSI-100 through its Phase III FLAMINGO-01 trial and toward potential commercialization. This isn't a solo act; it's a network of specialized players.

Baylor College of Medicine serves as the principal investigator and leader for the entire Phase III FLAMINGO-01 trial (NCT05232916). This academic leadership is crucial for high-level clinical oversight.

The clinical trial execution relies heavily on a broad geographic footprint, which is expanding rapidly. As of late 2025, Greenwich LifeSciences reports having approximately 140 active sites globally, broken down into about 40 US sites and 100 EU sites, with plans to open up to 150 total sites globally.

The European expansion involves deep collaboration with established cooperative oncology networks. Here's a breakdown of the sites activated across those networks as of the Q1 2025 update:

The Steering Committee for FLAMINGO-01 includes key figures representing these major networks, such as Dr. Francois-Clement Bidard representing UCBG (Unicancer) and Dr. Miguel Martin representing GEICAM.

For manufacturing, Greenwich LifeSciences, Inc. depends on third-party partners to handle the complex production of GP2/GLSI-100. They have already established significant supply readiness:

• The first three commercial lots of GP2 active ingredient were manufactured in 2023.
• These initial lots could prepare approximately 200,000 doses of GP2 for clinical or commercial use.
• The first commercial lot filling GP2 into vials was manufactured in 2024.
• The plan includes manufacturing at least two more lots of finished GP2 product.

Regarding trial management, Greenwich LifeSciences, Inc. has been utilizing Contract Research Organizations (CROs) for global trial execution, noting that the experience with an external CRO has been successful. However, as of August 2025, the Company announced a strategy to build out its internal clinical operations team to reduce dependence on more expensive staffing from CROs, aiming to increase efficiency and quality.

Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Key Activities

You're managing the capital-intensive process of bringing a novel immunotherapy to market, so the key activities for Greenwich LifeSciences, Inc. (GLSI) right now are heavily weighted toward clinical execution and preparing the necessary data packages for regulatory submission.

Executing the global Phase III FLAMINGO-01 clinical trial

The core activity is driving the Phase III FLAMINGO-01 trial (NCT05232916) forward to generate the definitive data needed for a Biologics License Application (BLA). This involves managing a growing global footprint to ensure sufficient event accrual for the primary endpoint.

The trial is designed with specific patient cohorts:

• Randomized HLA-A02 patients: Approximately 500 in the GLSI-100 or placebo arms.
• Other HLA types arm: Up to 250 patients treated with GLSI-100 in a third arm.

Progress in patient screening and site activation shows momentum as of late 2025. Here's a snapshot of the operational scale:

The trial is powered to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for the final efficacy analysis. The first interim analysis for superiority and futility is planned when at least half of those events, or 14 events, have occurred. The non-HLA-A02 arm was expanded to 250 patients in 2024.

Commercial manufacturing of GP2 active ingredient and finished vials

Simultaneously, Greenwich LifeSciences, Inc. is executing parallel manufacturing activities to ensure supply readiness upon potential marketing approval. This involves producing both the active ingredient (GP2) and the final vialed product.

Manufacturing milestones achieved through 2024 include:

• Active ingredient lots manufactured: Three commercial lots in 2023.
• Finished vial lot manufactured: The first of three commercial lots in 2024.

The capacity generated from the 2023 active ingredient lots could prepare approximately 200,000 doses of GP2. The plan is to manufacture at least two more lots of finished GP2 product, completing these activities in parallel with the FLAMINGO-01 trial.

Regulatory strategy and filing preparation for a Biologics License Application (BLA)

A major regulatory activity was securing the Fast Track designation from the US Food and Drug Administration (FDA) on September 10, 2025. This designation specifically applies to GLSI-100 for patients with the HLA-A02 genotype and HER2-positive breast cancer who have completed standard of care therapy. This status is intended to expedite BLA filing by allowing more frequent communication with the FDA, potentially enabling a rolling review process.

BLA preparation hinges on integrating two main data streams:

The submission package must include both the Phase III clinical data from FLAMINGO-01 and the commercial manufacturing data, which has been under review by US and European regulators (EMA) since data from the 2023 lots were submitted.

Ongoing research and development (R&D) of the GLSI-100 immunotherapy

While the Phase III trial is the immediate focus, ongoing R&D involves refining the understanding of GLSI-100's mechanism and exploring broader indications. GLSI-100 delivers GP2, a nine-amino acid segment of the HER2/neu receptor. An estimated 75% of all breast cancers express HER2 at some level.

The R&D strategy includes leveraging existing data to potentially expand the label. Specifically, the company is considering transforming the non-HLA-A02 open label third arm into effectively a second Phase III trial, which could lead to multiple pathways for marketing approval and a larger market potential.

Securing additional equity financing via At-The-Market (ATM) offerings

Given the operational expenses, securing financing through equity offerings is a necessary key activity to bridge operations until potential commercialization. Greenwich LifeSciences, Inc. actively used its At-The-Market (ATM) agreement with H. C. Wainwright.

Financing activity reported through the first half of 2025:

Between January 1, 2025 and June 30, 2025, the company issued and sold 320,210 shares of common stock. This resulted in gross proceeds of $3,185,661, yielding net proceeds of $3,100,668 after deducting underwriting discounts and expenses. Earlier in the year, between January 1 and April 11, 2025, they had sold $1.2 million worth of shares in the ATM arrangement. As of July 28, 2025, the total shares of Common Stock issued and outstanding stood at 13,630,257.

The financial performance reflects this cash burn; for the third quarter of 2025, the reported Earnings Per Share (EPS) was -$0.30. Finance: review the cash runway based on Q3 2025 burn rate and ATM proceeds by next Tuesday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Key Resources

You're looking at the core assets that Greenwich LifeSciences, Inc. (GLSI) relies on to drive its business forward, especially as they push the FLAMINGO-01 Phase III trial. These aren't just line items; they are the tangible and intangible foundations of their value proposition.

The most critical resource is the Intellectual Property (IP) surrounding the GP2 peptide and its use as an immunotherapy for preventing breast cancer recurrence. Greenwich LifeSciences, Inc. holds exclusive worldwide rights to the patent estate covering methods of using GP2 to elicit a targeted immune response against HER2/neu-expressing cancers. Furthermore, the company's IP strategy includes potential new patent applications related to manufacturing and clinical procedures, which could layer protection beyond the potential 12 years of market exclusivity upon approval. This IP is the barrier to entry for competitors.

Regulatory milestones translate directly into resource value. Greenwich LifeSciences, Inc. secured a significant advantage when the U.S. Food and Drug Administration (FDA) granted Fast Track designation for GLSI-100 in patients with the HLA-A02 genotype and HER2-positive breast cancer who have completed standard HER2-targeted therapy. This designation, announced on September 10, 2025, is a resource because it allows for more frequent communication with the FDA and the potential for a rolling review process for the Biologic License Application (BLA).

The clinical evidence forms a powerful resource, built on the Phase IIb trial. You need to see the numbers here; they are the proof of concept that underpins everything else.

Financial stability, while constantly managed in biotech, is a necessary resource. As of September 30, 2025, Greenwich LifeSciences, Inc. reported $3,806,978 in cash and equivalents. This figure dictates the runway for ongoing operations, including the Phase III FLAMINGO-01 trial.

The human capital is another key resource, especially in a science-driven field. Greenwich LifeSciences, Inc. has built a team and advisory structure that lends credibility to the program. This includes:

• Experienced management, featuring CEO Snehal Patel.
• A distinguished oncology Steering Committee and clinical leadership, including Dr. Jaye Thompson, VP Clinical and Regulatory Affairs.
• Collaboration with prestigious academic and research networks leading the Phase III trial, such as MD Anderson Cancer Center in the Phase IIb, and global networks like US Oncology, GEICAM, GIM, Unicancer, and GBG for the ongoing FLAMINGO-01 trial.

The infrastructure supporting the clinical program is also a vital asset. The ongoing Phase III FLAMINGO-01 trial is expanding to up to 150 sites globally across the U.S. and Europe, with over 1,000 patients screened to date as of December 3, 2025. This extensive clinical footprint and patient access network are crucial for generating the data needed for BLA submission.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Value Propositions

You're looking at the core reason Greenwich LifeSciences, Inc. (GLSI) exists: to offer a significant step-change in preventing metastatic breast cancer recurrence for patients who have already completed standard-of-care treatment. This is a massive unmet need, as recurrence is a major driver of mortality in this population.

The primary value proposition centers on the lead candidate, GLSI-100, an immunotherapy built around the GP2 peptide, administered with GM-CSF to stimulate immune cells against the HER2/neu receptor.

Immunotherapy (GLSI-100) to prevent metastatic breast cancer recurrence.

The data from the prior Phase IIb clinical trial provides the foundation for this claim. The trial focused on HER2/neu 3+ over-expressor patients who had completed standard treatment, like trastuzumab.

• The Kaplan-Meier estimated 5-year Disease-Free Survival (DFS) rate in the 46 treated patients was 100% after completing the Primary Immunization Series (PIS).
• Peak immunity was reached at 6 months following the first 6 injections.
• The Phase III FLAMINGO-01 trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, based on these earlier findings.

Potential for recurrence reduction beyond the ~50% achieved by current HER2 therapies.

This is where the value proposition becomes financially compelling. Current approved products targeting HER2 have shown recurrence-free rates that imply a recurrence rate of 50% to 80% in this high-risk setting. Greenwich LifeSciences, Inc. is positioning GLSI-100 to dramatically outperform that benchmark.

Strong safety profile validated by Data Safety Monitoring Board recommendations.

While specific Data Safety Monitoring Board (DSMB) recommendations aren't detailed here, the clinical data supports a favorable safety profile, which is critical for an adjuvant therapy. The immune response data from the ongoing Phase III FLAMINGO-01 trial is trending comparably to the Phase IIb data, with the most frequent adverse event being injection site reaction.

• In the Phase IIb trial, there were no reported serious adverse events attributable to the GLSI-100 treatment.
• The PIS (Primary Immunization Series) involved 6 injections over the first 6 months.

Addresses a critical unmet need for HER2-positive patients post-standard treatment.

The target patient population has completed neoadjuvant and postoperative adjuvant trastuzumab-based therapy but still faces a high risk of recurrence. Greenwich LifeSciences, Inc. is targeting patients with residual disease or high-risk pathologic complete response at surgery. The potential market is substantial, as an estimated 75% of all breast cancers express HER2 at some level. Furthermore, the HLA-A02 allele, which is the focus of the double-blind arms, is present in about 46% of the population, with other HLA types potentially expanding the target market to 80% to 100% of patients.

Potential for 12 years of market exclusivity post-approval.

The company is actively manufacturing product lots in parallel with the FLAMINGO-01 trial to be ready for submission. If the Biologic License Application (BLA) is accepted, Greenwich LifeSciences, Inc. anticipates potentially being granted up to 12 years of market exclusivity based on current law. The recent FDA Fast Track designation on September 10, 2025, for the HLA-A02 patient population may expedite this process through increased FDA communication and potential rolling review.

Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Customer Relationships

You're managing relationships in a high-stakes clinical development environment, so every interaction with investigators, regulators, and shareholders is critical to moving GLSI-100 toward potential approval. Here's how Greenwich LifeSciences, Inc. structures those key connections as of late 2025.

High-touch, direct engagement with clinical investigators and key opinion leaders

Engagement with the clinical sites running the Phase III FLAMINGO-01 trial is extensive, involving top-tier research networks and academic institutions across the US and Europe. The company is actively managing relationships across a growing global footprint to maintain trial momentum.

The clinical trial structure involves a significant number of sites and planned participants:

The company reported that clinical site start-up activities in Europe during 2025 further increased momentum in the study. Greenwich LifeSciences, Inc. announced the expansion of the FLAMINGO-01 trial into new European countries, including Austria and Belgium, in late 2025. The trial is led by Baylor College of Medicine and a consortium of prominent clinical centers. Major KOLs (Key Opinion Leaders) joined the Steering Committee in prior years to guide the development.

Regulatory communication with the FDA and European regulators (EMA) is frequent due to Fast Track status

The relationship with the US Food and Drug Administration (FDA) is formalized and prioritized following a key regulatory event. This designation mandates more frequent communication, which is essential for a company in the middle of a pivotal Phase III trial.

• FDA granted Fast Track designation for GLSI-100 in the HLA-A02 patient population on September 10, 2025.
• This designation enables more frequent communication with the FDA to expedite the Biologic License Application (BLA) filing.
• The company may utilize a rolling review process for the BLA submission.
• The company continues discussions with the FDA and potentially European regulatory authorities (EMA) regarding availability to larger populations.
• Commercial manufacturing data has been submitted to both the FDA and European regulators (EMA) for review.

Investor relations to manage capital raising and shareholder confidence

Managing shareholder confidence requires transparency regarding trial progress and financial runway, especially given the capital-intensive nature of late-stage clinical development. Greenwich LifeSciences, Inc. has actively engaged with the investment community through offerings and corporate events.

Financial and investor metrics as of late 2025 include:

The company reported that shares were trading near its 52-week low of $7.78, with shares down over 43% in the past year as of December 3, 2025. Investor engagement included participation in conferences like the H.C. Wainwright BioConnect Investor Conference in May 2025 and CEO interviews on platforms like Bloomberg TV in June 2025.

Patient-centric engagement through clinical trial enrollment and follow-up

The core of the customer relationship is the patient population participating in the FLAMINGO-01 trial, which focuses on preventing breast cancer recurrence in HER2-positive patients who have completed standard therapy. Reaching enrollment milestones is a direct measure of patient and physician interest.

Key patient engagement statistics:

• Screened over 1,000 patients for FLAMINGO-01 as of December 3, 2025.
• Maintaining a screening rate of approximately 150 patients per quarter.
• The trial is designed to assess safety and efficacy in HER2-positive breast cancer patients with residual disease or high-risk pathologic complete response.
• The Data Safety Monitoring Board (DSMB) recommended the study continue without modifications following a review of safety data.

The company noted that reaching the 1,000 screened patients milestone confirms that interest from doctors and patients is high. The trial's primary endpoint is Invasive Breast Cancer-free Survival (IBCFS), requiring follow-up until recurrence or death.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Channels

You're looking at how Greenwich LifeSciences, Inc. (GLSI) plans to get GLSI-100 to the patients who need it, assuming they get the green light from regulators. This is all about the pipeline from the lab bench to the bedside, which, for a biotech firm, means clinical sites first, then regulatory hurdles, and finally, commercial reach.

The current backbone of Greenwich LifeSciences, Inc. (GLSI)'s channel strategy is its global clinical trial infrastructure for the Phase III FLAMINGO-01 study. As of December 3, 2025, this network included approximately 140 active sites globally, split between 40 in the U.S. and 100 in Europe. This is close to the stated goal of opening up to 150 sites globally. The European expansion has been significant, with regulators clearing the way for approximately 110-115 sites in Europe as of January 2025, adding countries like Austria, Spain, Germany, Italy, Poland, Romania, Ireland, Portugal, and Belgium to the U.S. sites. The trial is designed to enroll approximately 500 subjects in the double-blinded arms, with up to 250 patients in a third open-label arm.

Direct engagement with regulatory bodies is a critical, non-negotiable channel for a clinical-stage company. Greenwich LifeSciences, Inc. (GLSI) is actively working toward filing a Biological License Application (BLA) in the United States. The company has been submitting commercial manufacturing data to both the FDA and the European Medicines Agency (EMA) to support these filings. A major recent milestone was the FDA granting Fast Track designation for GLSI-100 in the HLA-A02 patient population on September 10, 2025. This designation opens the door for more frequent communication with the FDA and potentially a rolling review process for the BLA.

For the future commercial launch, the company acknowledges the need for external help. Greenwich LifeSciences, Inc. (GLSI) states it will be subject to regulations 'either directly or through our distribution partners' in non-U.S. countries upon approval. The manufacturing readiness suggests they are preparing for scale; the first three commercial lots of GP2 active ingredient, manufactured in 2023, could prepare approximately 200,000 doses of GP2.

Dissemination of clinical data through scientific channels is essential for credibility and future partnerships. The Phase 2b data was presented at the San Antonio Breast Cancer Symposium in December 2020. Looking ahead, the company plans to present Phase III clinical trial progress and open-label data at major conferences.

Here's a quick look at the current operational scale supporting these channels:

• Target total clinical sites globally: up to 150.
• Active clinical sites as of December 2025: approximately 140.
• Active European sites: approximately 100.
• Active U.S. sites: approximately 40.
• Screening rate: roughly 150 screenings per quarter.
• Commercial lots manufactured (active ingredient): 3 (as of 2023).
• Doses potentially prepared from initial lots: approximately 200,000.

The regulatory status itself is a channel milestone, as evidenced by the Fast Track designation:

The path to commercial distribution relies on these regulatory clearances and establishing agreements, which the company anticipates engaging in with distribution partners for international markets. Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Customer Segments

You're looking at the specific patient groups Greenwich LifeSciences, Inc. (GLSI) is targeting with its GLSI-100 immunotherapy, which is designed to prevent breast cancer recurrences. This is a highly focused segment within the broader HER2-positive cancer market.

The primary customer segment is HER2-positive breast cancer patients with residual disease post-neoadjuvant treatment. These are individuals who have already undergone intensive initial therapy but remain at high risk of the cancer returning.

Specifically, the target group consists of patients who have completed standard-of-care trastuzumab-based treatment. The Phase III FLAMINGO-01 trial is evaluating GLSI-100 in this exact population following surgery and 12 months of adjuvant trastuzumab therapy.

A key initial focus is the subset of patients with the HLA-A02 genotype. This genetic marker is critical for the mechanism of action of GLSI-100, as evidenced by the US FDA granting Fast Track designation specifically for this patient group as of September 10, 2025.

The addressable market size for the initial indication is quantified by management estimates. Greenwich LifeSciences, Inc. estimates that approximately 44,000 new patients per year may be eligible for GLSI-100 treatment annually across the US and EU for this initial indication.

Here's a breakdown of the relevant patient statistics and the trial population focus:

The company's focus on the HLA-A02 positive group is reflected directly in the Phase III trial design. The study is powered to detect a specific outcome in this group.

• FLAMINGO-01 trial designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival.
• Total events required for efficacy analysis: 28 events.
• Interim analysis planned when 14 events have occurred.
• Power set at 80% if placebo event rate is 2.4% or greater annually.

To be fair, Greenwich LifeSciences, Inc. is pre-revenue, reporting $0 in revenue for Q1 2025. The net loss for Q1 2025 was $3,258,362, with cash reserves of $2,749,959 as of March 31, 2025. The market capitalization as of September 18, 2025, was $152 million. This financial reality underscores that the customer segment definition is purely based on clinical need and market potential, not current sales.

The overall HER2-positive population is large, with HER2/neu 3+ patients comprising approximately 25% of all breast cancer patients. Greenwich LifeSciences, Inc. believes GLSI-100 may be effective in safely addressing the 50% of recurring patients who do not respond to existing therapies like Herceptin or Kadcyla.

Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Greenwich LifeSciences, Inc. (GLSI) right now, and honestly, it's all about the clinical trial. For a pre-revenue biotech like this, the cost structure is almost entirely dictated by the science and the path to market for GLSI-100.

Dominantly R&D expenses for the Phase III FLAMINGO-01 trial are the biggest drain on capital. This is where the money goes to run the pivotal study evaluating GLSI-100 in HER2/neu positive patients across up to 150 sites globally. The commitment to this trial is clear in the numbers.

Here's a look at the operating expenses for the nine months ended September 30, 2025, compared to the prior year. This shows you exactly where the cash burn is accelerating:

The R&D spend for the nine months ended September 30, 2025, hit $9,630,604. That's a significant jump from the $6,794,426 spent in the same period last year. For the most recent quarter alone, R&D was $3,521,576.

Next up are the General and Administrative (G&A) costs. These cover the necessary overhead to keep the lights on, including legal work and keeping up with public company compliance requirements on NASDAQ. For the nine months ending September 30, 2025, G&A expenses totaled $1,872,323. That compares to $1,133,230 for the first nine months of 2024. The G&A for the third quarter of 2025 specifically was $653,066.

The total operating expenses for the nine months ended September 30, 2025, were inflated by non-cash stock compensation charges, which totaled $4.6 million, skewing the reported net loss. The actual operating cash burn, which is what you really watch, rose 24% to $6.7 million over that nine-month period.

When we look at Manufacturing costs for commercial-grade GP2 production, the cost structure shifts from pure R&D to preparation for potential launch. Greenwich LifeSciences, Inc. currently relies on third-party contract manufacturers for all required raw materials, APIs, and finished product candidates. They don't own the facilities.

The manufacturing readiness is quantified by volume, not dollar cost in the latest reports:

• The first three commercial lots of GP2 active ingredient were manufactured in 2023.
• These initial lots can prepare approximately 200,000 doses for clinical or commercial use.
• In 2024, the company manufactured GP2 vials using the first of those three commercial lots, which are currently undergoing final testing.

These manufacturing activities are critical because the data from these lots will support the Biological License Application (BLA) filing alongside the Phase III data. Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Greenwich LifeSciences, Inc. (GLSI) as of late 2025. Right now, the model is entirely dependent on capital markets, not product sales, which is typical for a clinical-stage biotech deep into Phase III trials. The current revenue stream is effectively zero from operations.

The hard numbers for product sales are clear for the period ending September 30, 2025. Greenwich LifeSciences, Inc. has not yet achieved commercial viability for its lead candidate, GLSI-100. Consequently, the reported revenue reflects this pre-commercial status.

The primary, and currently sole, source of cash inflow to fund operations, particularly the ongoing Phase III trial, is equity financing. This is executed through the At-The-Market (ATM) offering facility. This structure means the company sells shares directly into the public market when management deems the timing and price appropriate.

Here's the quick math on the capital raised year-to-date 2025 to keep the lights on and the trial moving:

• Net proceeds from ATM equity sales year-to-date 2025: $6,308,784.
• This funding bridged the operating cash use, especially given the reported net loss for the nine months ended September 30, 2025, was $11,435,485.
• The company issued 621,674 shares via the ATM facility year to date to secure these net proceeds.

Future revenue potential is entirely tied to the success of GLSI-100 in the pivotal FLAMINGO-01 trial. If the data supports regulatory approval, product sales become the primary revenue driver. You should note that results from this Phase III trial are anticipated by 2026, which sets the timeline for any potential product revenue stream.

Beyond direct sales in the US, Greenwich LifeSciences, Inc. has indicated a strategy that includes potential revenue from partnerships. This would likely involve structuring deals for commercialization outside the United States. This is a standard path for a single-asset biotech, so keep an eye out for any announcements regarding ex-US licensing or partnership milestones.

• Future revenue hinges on GLSI-100 Phase III success.
• Phase III results are expected around 2026.
• Potential for licensing revenue for ex-US commercialization exists.

Finance: draft 13-week cash view by Friday.