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 create 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 research, development, and eventual commercialization of these T-cell therapies, with revenue generation currently dependent on future product approvals and sales, as it has not yet generated any revenue from product sales. The primary customer segments are patients with relapsed or refractory B-cell malignancies and, in the future, potentially patients with solid tumors and autoimmune diseases. The company operates under a platform dynamic centered on its proprietary ARTEMIS® T Cell Receptor Platform, which is exclusively licensed from Eureka Therapeutics.

The company's lead product candidate, EB103, is a CD19-directed ARTEMIS T-cell therapy currently in the dose expansion portion of a Phase I/II clinical trial (STARLIGHT-1) for relapsed/refractory B-cell Non-Hodgkin’s Lymphomas. As of December 2025, the Phase I dose-escalation phase (n=9) was completed, with an independent Data Safety Monitoring Board (DSMB) recommending advancement to Phase II. In the high-dose cohort of Phase I, a 100% complete response rate at Month 1 was observed in all five evaluable patients, with no treatment-related serious adverse events reported across all nine patients. The company is also developing EB104, which utilizes ARTEMIS® technology to target both CD19 and CD22, aiming to reduce relapse due to CD19 antigen loss. 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, suggesting potential to control tumor cells not expressing CD19. 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 where the virus induces CD19 expression on tumor cells, making them targets for EB103 T-cells. The research plan under the Collaboration Agreement with Imugene was completed as of August 30, 2023. The company's preclinical pipeline also includes EB201, a CD19-redirected ARTEMIS T-cell therapy being explored 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. Research and development expenses totaled approximately $10.2 million ², an increase from approximately $6.4 million ³ for the unaudited twelve months ended December 31, 2024. This increase was primarily due to higher service fees and the dosing of seven patients and a second site activation under the Statement of Work (SOW) for the STARLIGHT-1 clinical trial in 2025, compared to two patients dosed in 2024. General and administrative expenses were approximately $2.8 million ⁴ for the year ended December 31, 2025, up from approximately $2.4 million ⁵ for the unaudited twelve months ended December 31, 2024, driven by higher professional fees and stock-based compensation. As of December 31, 2025, the company had cash and cash equivalents of approximately $1.4 million ⁶ and an accumulated deficit of approximately $37.0 million ⁷. Net cash used in operating activities for the year ended December 31, 2025, was approximately $1.8 million ⁸.

During the year, significant operational developments included the completion of the Phase I dose-escalation portion of the STARLIGHT-1 clinical trial for EB103, with the DSMB recommending advancement to Phase II. Patient dosing for Phase II commenced in January 2026. The company also completed a private placement between May and September 2025, raising gross proceeds of approximately $2.4 million ⁹. Subsequent to the fiscal year end, on January 6, 2026, a registered direct offering and concurrent private placement generated gross proceeds of approximately $8.0 million ¹⁰. The company 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 with the ongoing Phase I/II STARLIGHT-1 clinical trial of EB103. The company anticipates completing the Phase II portion of the STARLIGHT-1 clinical trial in 1H2027. Management is of the opinion that the company 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, necessitating additional financing.

A major growth area for Estrella is the effective progression of EB103, its lead product candidate, through clinical development. The company believes its autologous T-cell therapies have the potential to overcome major limitations of currently approved CAR-T cells with superior safety and efficacy, allowing access to significantly more patients. The safety profile of EB103 positions it 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. The company is 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.

The company 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, Estrella plans to submit an IND filing for this "mark and kill" strategy in the future. At this time, specific solid tumor indications or an exact timeframe for filing the IND application have not been determined. This strategy aims to overcome the challenge of a lack of tumor-specific targets in solid tumors by inducing CD19 expression on solid tumor cells, making them targets for EB103 T-cells.

Operationally, the company expects research and development expenses to continue to increase as it 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. The company will also incur additional legal, accounting, and other expenses associated with operating as a public company.

Regarding capital allocation, Estrella recently completed a private placement between May and September 2025, receiving gross proceeds of approximately $2.4 million ⁹. 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 ¹⁰. The company has cumulatively incurred approximately $16.4 million ¹¹ to Eureka for milestones achieved under the SOW for the STARLIGHT-1 clinical trial as of December 31, 2025, and holds an accrued liability to related parties of approximately $12.4 million ¹² for corresponding milestones. The Common Stock Purchase Agreement with White Lion Capital LLC expired on December 30, 2025, and is no longer a source of liquidity.

Estrella Immunopharma faces significant risks, including its status as a clinical-stage biotechnology company with a history of substantial net losses, approximately $13.1 million ¹ for the year ended December 31, 2025, and an accumulated deficit of approximately $37.0 million ⁷ as of December 31, 2025. The company will require substantial additional funding to advance its product candidates, as evidenced by its cash and cash equivalents of approximately $1.4 million ⁶ as of December 31, 2025, and recurring losses raise substantial doubt about its ability to continue as a going concern. Clinical trials are expensive, time-consuming, and have uncertain outcomes, with potential delays in patient enrollment, serious adverse events, or failures to demonstrate safety and efficacy. The company is heavily dependent on Eureka Therapeutics 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. Certain officers and directors, including the CEO, have actual or potential conflicts of interest due to dual roles or equity interests in Eureka. The company relies on third parties, such as Contract Research Organizations (CROs) and collaborators like Imugene, to conduct preclinical studies and clinical trials, and their unsatisfactory performance could cause delays. Intellectual property protection is critical, with many rights in-licensed from Eureka, and challenges to these rights could be expensive and time-consuming. The regulatory approval process is lengthy and unpredictable, with potential for delays or rejections. The company handles sensitive personal data and is subject to stringent data privacy laws (GDPR, CCPA, HIPAA), with non-compliance potentially leading to significant fines up to the greater of €20 million or 4% of total global annual turnover ¹³ under GDPR, or £17.5 million or 4% of global turnover ¹⁴ under UK GDPR, and reputational harm. Material weaknesses in internal control over financial reporting related to a lack of qualified accounting personnel have been identified. 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. Geopolitical risks, including the continuing military action in Ukraine, the war between Israel and Hamas, and the armed conflict between the United States/Israel and Iran, could materially and adversely affect financial position and operations, including capital markets access. Inflation and higher interest rates could increase operating costs and reduce liquidity. Disruptions at the FDA and other government agencies, such as the approximately 20,000 ¹⁵ position reduction at HHS in March 2025, including about 3,500 ¹⁶ at the FDA, and an additional net loss of 473 ¹⁷ FDA employees in fiscal year 2026, could hinder regulatory review and delay product development.

Management's message to shareholders conveys a commitment to developing T-cell therapies to address treatment challenges in cancer and autoimmune diseases, emphasizing the potential for safer and more efficacious treatments compared to traditional CAR-T therapies. The company's strategic priorities include effectively progressing EB103, its lead product candidate, through clinical development, with the anticipation of completing the Phase II portion of the STARLIGHT-1 clinical trial in 1H2027. A second strategic priority is to expand the Total Addressable Market (TAM) in CD19-positive cancers by demonstrating the safety and efficacy of ARTEMIS T-cell therapy for patients ineligible for currently approved T-cell therapies, aiming for broader adoption in community hospital settings and high-risk patient groups. The third key strategic priority is to advance the second product candidate, EB104, into clinical development, with an Investigational New Drug (IND) filing being compiled for the treatment of relapsed/refractory and high-risk B cell malignancies. Management also highlights the exploration of EB103 in conjunction with CF33-CD19t for solid tumors and a continued commitment to innovating and advancing a novel T-cell therapy pipeline for diverse indications beyond cancer, such as autoimmune diseases, exemplified by the preclinical EB201 program for Systemic Lupus Erythematosus (SLE).