Estrella Immunopharma, Inc.

Estrella Immunopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing T-cell therapies for cancers and autoimmune diseases, aiming to provide safer and more efficacious treatments than traditional CAR-T therapies by leveraging cellular engineering technologies to overcome limitations such as high toxicity and prohibitive costs. The company's core business model revolves around the development and potential commercialization of its proprietary ARTEMIS® T Cell Receptor Platform, which designs T cells to be activated and regulated upon engagement with cancer targets using cellular mechanisms that mimic endogenous T-cell receptors. Revenue generation is currently not from product sales, as the company is clinical-stage, but rather through financing activities to fund its research and development. Primary customer segments, once products are approved, are anticipated to be patients with B-cell malignancies, solid tumors, and autoimmune diseases.

The company's lead product candidate, EB103, is a CD19-directed ARTEMIS T-cell therapy designed for patients with relapsed or refractory B-cell malignancies, particularly those ineligible for currently approved T-cell therapies. As of December 2025, EB103 is in the dose expansion portion of a Phase I/II clinical trial (STARLIGHT-1). The Phase I dose-escalation phase (n=9) reported no treatment-related serious adverse events and a 100% complete response rate at Month 1 in all five evaluable patients in the high-dose cohort. The second product candidate, EB104, also utilizes ARTEMIS® technology but targets both CD19 and CD22, aiming to reduce relapse due to CD19 antigen loss and treat patients with lower CD19 density. Preclinical data for EB104 showed durable tumor control and clearance of Nalm-6 Primary Tumors and Nalm-6-CD19ko re-challenge tumors in a xenograft model for over 60 days, or 40 days after re-challenge. Additionally, Estrella is exploring the use of EB103 in conjunction with Imugene's oncolytic virus, CF33-CD19t, for solid tumors, employing a "mark and kill" strategy to induce CD19 expression on tumor cells. The research plan under the Collaboration Agreement with Imugene was completed as of August 30, 2023. The company is also developing EB201, a CD19-redirected ARTEMIS T-cell therapy, in preclinical stages for Systemic Lupus Erythematosus (SLE).

For the fiscal year ended December 31, 2025, Estrella Immunopharma reported a net loss of approximately $13.1 million ¹ and net cash used in operating activities of approximately $1.8 million ². The company had cash and cash equivalents of approximately $1.4 million ³ and an accumulated deficit of approximately $37.0 million ⁴ as of December 31, 2025. Research and development expenses for the year ended December 31, 2025, were approximately $10.2 million ⁵, an increase from approximately $6.4 million ⁶ for the unaudited twelve months ended December 31, 2024. General and administrative expenses increased to approximately $2.8 million ⁷ for the year ended December 31, 2025, from approximately $2.4 million ⁸ for the unaudited twelve months ended December 31, 2024. The working capital deficit as of December 31, 2025, was approximately $11.9 million ⁹.

The increase in research and development expenses year-over-year was primarily due to higher service fees incurred during the clinical phase of the STARLIGHT-1 trial, including the dosing of seven patients and a second site activation in 2025, compared to two patients dosed in 2024. General and administrative expenses rose mainly due to higher professional fees and stock-based compensation expense related to stock options granted in October 2024 under the 2023 Omnibus Incentive Plan. The company has not generated any revenue from product sales to date.

Significant operational developments during the period include the completion of the Phase I dose-escalation portion of the STARLIGHT-1 clinical trial for EB103, with an independent Data Safety Monitoring Board recommending advancement to the Phase II expansion phase at the recommended Phase II dose. Patient dosing for Phase II commenced in January 2026. The company also completed a private placement between May and September 2025, receiving gross proceeds of approximately $2.4 million ¹⁰. Subsequent to the fiscal year end, on January 6, 2026, Estrella consummated a registered direct offering and concurrent private placement, resulting in gross proceeds of approximately $8.0 million ¹¹. The company also established a wholly owned subsidiary in Hong Kong on November 27, 2024.

Estrella Immunopharma expects its expenses and operating losses to increase significantly as it continues to advance its product candidates through clinical development, particularly in connection with the Phase I/II STARLIGHT-1 clinical trial of EB103. The company does not expect to generate any revenue from product sales for the foreseeable future. Management is of the opinion that Estrella will not have sufficient funds to meet its working capital requirements and debt obligations as they become due starting from one year from the date of this report.

A major growth area for Estrella is the effective progression of EB103, its lead product candidate, through clinical development. The company anticipates completing the Phase II portion of the STARLIGHT-1 clinical trial in 1H2027. The strategy is to expand the Total Addressable Market (TAM) in CD19-positive cancers by demonstrating EB103's safety and efficacy for patients ineligible for currently approved T-cell therapies. This safety profile is expected to allow for potential use in earlier-line treatments, broader adoption in community hospital settings, and the ability to treat high-risk patient groups, thereby increasing market penetration and patient accessibility.

Another growth vector involves advancing EB104 into clinical development. Estrella is currently compiling an Investigational New Drug (IND) filing for EB104 for the treatment of relapsed/refractory and high-risk B cell malignancies. Phase I trials for EB104 may not commence until the FDA has approved the IND application. EB104's dual-targeting strategy for CD19 and CD22 has the potential to more effectively treat patients with lower surface CD19 density or a greater prevalence of CD22, potentially reducing relapse due to CD19 antigen loss.

Estrella also plans to explore the use of EB103 in conjunction with CF33-CD19t for multiple indications of solid tumors through clinical development. If the Phase I/II STARLIGHT-1 Clinical Trial is successful, the company plans to submit an IND filing for this "mark and kill" strategy in the future. At this time, specific solid tumor indications to target or an exact timeframe for filing the IND application have not been determined. This strategy aims to overcome the barrier of lacking tumor-specific targets in solid tumors by inducing CD19 protein expression on solid tumor cells, making them targets for EB103 T-cells.

The company is committed to continued innovation to develop and advance a novel T-cell therapy pipeline. This includes developing more disruptive therapies with the potential for adoption in earlier lines of treatment, delivery in community outpatient settings, and treatment of patients in diverse indications beyond cancer, such as autoimmune diseases. The EB201 program, currently in preclinical development, is being explored as a potential therapeutic approach targeting Systemic Lupus Erythematosus (SLE).

In terms of operational outlook, research and development expenses are expected to continue to increase as the company advances IND filings, preclinical and clinical development of product candidates, seeks regulatory approval, scales up clinical and regulatory capabilities, adapts to requirements for marketed products, and maintains and expands its intellectual property portfolio. General and administrative expenses are also expected to rise due to additional legal, accounting, and other expenses associated with operating as a public company. The company relies entirely on Eureka Therapeutics, Inc. for manufacturing EB103 and other ARTEMIS® T-cell product candidates for preclinical studies and clinical trials, and Eureka is currently its sole supplier of clinical drug product.

Regarding capital allocation, Estrella recently completed a private placement between May and September 2025, receiving gross proceeds of approximately $2.4 million ¹⁰. Subsequent to the fiscal year end, on January 6, 2026, the company consummated a registered direct offering and concurrent private placement, resulting in gross proceeds of approximately $8.0 million ¹¹. The company's ability to fund operations is dependent on cash on hand and its ability to raise additional debt or equity financing. The Common Stock Purchase Agreement with White Lion Capital LLC expired on December 30, 2025, and is no longer a source of liquidity. The company has outstanding warrants with an exercise price of $11.50 per share ¹², which is significantly higher than the common stock closing price of $1.25 per share ¹³ as of March 12, 2026, making it unlikely that holders will exercise these warrants for near-term liquidity.

Estrella Immunopharma faces substantial risks, including its status as a clinical-stage biotechnology company with a history of significant net losses, approximately $13.1 million ¹ for the year ended December 31, 2025, and an accumulated deficit of approximately $37.0 million ⁴ as of December 31, 2025. The company's recurring losses and need for additional financing raise substantial doubt about its ability to continue as a going concern, with management explicitly stating that they will not have sufficient funds to meet working capital requirements and debt obligations starting one year from the date of the report. The success of the business heavily depends on the successful clinical development and regulatory approval of its lead product candidate, EB103, and the expansion of its pipeline using the ARTEMIS® platform, both of which are uncertain and subject to potential delays, failures to demonstrate safety and efficacy, or serious adverse events in clinical trials. Interim data, such as the 100% complete response rate at Month 1 in the high-dose cohort of the Phase I STARLIGHT-1 trial, are based on a small number of patients (n=9) ¹⁴ and limited follow-up, and may not be predictive of future results. The company is heavily dependent on Eureka Therapeutics, Inc. for manufacturing (as its sole supplier of clinical drug product), research and development support, and information technology systems under a Services Agreement, and any disruption or termination of these services would severely impact operations. Conflicts of interest may arise due to dual roles or equity interests of certain officers and directors, including the CEO, in Eureka. Estrella also relies on third parties like Contract Research Organizations (CROs) and collaborators such as Imugene, whose unsatisfactory performance could delay development timelines. Intellectual property protection, much of which is in-licensed from Eureka and expires on October 21, 2036 ¹⁵, is critical, and challenges to validity, enforceability, or scope could diminish its value. The regulatory approval process is lengthy and unpredictable, with potential for delays or rejections, and even if approved, products may face significant competition, fail to achieve market acceptance, or be subject to unfavorable pricing and reimbursement policies. The company handles sensitive personal data and is subject to stringent data privacy laws (e.g., GDPR, CCPA, HIPAA), with non-compliance potentially leading to significant fines, such as up to the greater of €20 million or 4% of total global annual turnover ¹⁶ under GDPR, or £17.5 million or 4% of global turnover ¹⁷ under UK GDPR. Material weaknesses in internal control over financial reporting related to a lack of qualified accounting personnel have been identified, which could affect the reliability of consolidated financial statements. The company has a history of non-compliance with Nasdaq listing standards, including minimum bid price and market value requirements, and failure to maintain compliance could result in delisting. The market price of its Common Stock is likely to be highly volatile, and future sales of shares, including those under the 2023 Omnibus Incentive Plan where the share reserve automatically increases by up to 5% ¹⁸ of outstanding common stock annually, could result in substantial dilution. Geopolitical risks, including the 2022 Russian invasion of Ukraine, the 2023 Israel/Hamas conflict, and the 2026 armed conflict between the United States/Israel and Iran, could materially and adversely affect financial position and operations. Disruptions at government agencies like the FDA, including a major restructuring in March 2025 that reduced HHS staffing by approximately 20,000 positions ¹⁹ and the FDA by about 3,500 positions ²⁰, and a net loss of an additional 473 employees ²¹ in fiscal year 2026, could hinder regulatory reviews. The company's limited understanding of Artificial Intelligence (AI) poses risks, as competitors may leverage AI more effectively, leading to countervailing discoveries or security vulnerabilities.

Management's message to shareholders conveys a commitment to advancing T-cell therapies to address treatment challenges in cancer and autoimmune diseases, aiming for safer and more efficacious options than traditional CAR-T therapies. They emphasize leveraging cutting-edge cellular engineering technologies to overcome limitations such as high toxicity and prohibitive costs, thereby making T-cell therapy accessible to a larger patient population. A key strategic priority is the effective progression of EB103, their lead product candidate, through clinical development, with the anticipation of completing the Phase II portion of the STARLIGHT-1 clinical trial in 1H2027. Another strategic focus is expanding the total addressable market in CD19-positive cancers by demonstrating EB103's safety profile for earlier-line treatments, broader adoption in community hospital settings, and treatment of high-risk patient groups. Additionally, management is prioritizing the advancement of their second product candidate, EB104, into clinical development, and exploring the use of EB103 in conjunction with CF33-CD19t for solid tumors. They also highlight a commitment to continued innovation to develop a novel T-cell therapy pipeline for diverse indications beyond cancer, such as autoimmune diseases. Despite recent financing activities, including gross proceeds of approximately $2.4 million ¹⁰ from a private placement between May and September 2025, and approximately $8.0 million ¹¹ from a registered direct offering and concurrent private placement on January 6, 2026, management explicitly states that they will not have sufficient funds to meet working capital requirements and debt obligations as they become due starting from one year from the date of this report.