Estrella Immunopharma, Inc. (NASDAQ: ESLA; ESLAW)
is a clinical-stage biopharmaceutical company at the forefront of developing innovative T-cell therapies to revolutionize the treatment of cancer and autoimmune diseases. The company's proprietary ARTEMIS® platform has enabled the creation of its lead product candidates, EB103 and EB104, which target the CD19 and CD22 antigens expressed on the surface of B-cell malignancies and solid tumors.
Estrella's Comprehensive History and Strategic Transformation
Estrella Immunopharma, Inc. was formed on March 30, 2022, as a wholly-owned subsidiary of Eureka Therapeutics, Inc. to focus on the development of T-cell therapies. On June 28, 2022, pursuant to a Contribution Agreement, Eureka contributed certain assets related to T-cell therapies targeting CD19 and CD22 to Estrella in exchange for 105 million shares of Estrella's Series AA Preferred Stock. This transaction, known as the "Separation," allowed Estrella to establish a capital structure tailored to its strategic goals and provided increased access to capital markets.
As part of the Separation, Estrella entered into a License Agreement with Eureka and Eureka Therapeutics Cayman Ltd., granting Estrella an exclusive license to develop CD19 and CD22-targeted T-cell therapies using Eureka's ARTEMIS platform. Additionally, Estrella entered into a Services Agreement with Eureka, under which Eureka agreed to perform certain services to facilitate Estrella's exploitation of the licensed intellectual property. Eureka also contributed and assigned the Collaboration Agreement between Eureka and Imugene Limited to Estrella.
On March 2, 2023, the FDA cleared Estrella's IND application for EB103, allowing the company to proceed with the Phase III STARLIGHT-1 Clinical Trial. This milestone represented a significant advancement for Estrella as it moved its lead product candidate into late-stage clinical development. The company faced challenges in preparing for and initiating this trial, working closely with Eureka to leverage their expertise and resources.
On September 29, 2023, Estrella consummated a business combination with TradeUP Acquisition Corp., resulting in Estrella becoming a publicly-traded company. This transaction provided Estrella with additional capital to fund its ongoing research and development efforts. However, the company had to navigate the complexities of becoming a public company, including establishing the necessary infrastructure, controls, and procedures.
Financials
As of September 30, 2024, Estrella reported a cash balance of $1.8 million, providing the company with the necessary liquidity to continue advancing its lead product candidates through clinical trials. The company's net loss for the three months ended September 30, 2024, was $3.4 million, primarily driven by increased research and development expenses related to the STARLIGHT-1 clinical trial.
It's worth noting that Estrella's financial performance has been consistent with its status as a clinical-stage biotech company, with no revenue generation to date. The company's focus has been on investing in its R&D efforts to establish proof-of-concept for its ARTEMIS® platform and advance its pipeline towards regulatory approval.
For the three months ended September 30, 2024, Estrella incurred $2.83 million in research and development expenses, primarily related to conducting work for IND-enabling, IND-filing, and clinical trial preparation activities, which were mainly performed by its partner, Eureka Therapeutics. This represents a significant increase from the $0.48 million in research and development expenses incurred during the same period in 2023, as Estrella moved its lead candidate, EB103, into a Phase III clinical trial (STARLIGHT-1) following the clearance of its IND application by the FDA in March 2023.
The company's general and administrative expenses for the three months ended September 30, 2024 were $0.55 million, down from $1.39 million in the prior year period, as Estrella incurred higher professional fees and stock-based compensation costs related to the business combination with UPTD in the prior year.
Liquidity
Estrella's liquidity position is primarily supported by its cash balance of $1.8 million as of September 30, 2024. This provides the company with the necessary resources to continue its ongoing clinical trials and research activities. However, as a clinical-stage company with no revenue, Estrella will likely need to secure additional funding in the future to support its long-term development plans and potential commercialization efforts.
The company's debt-to-equity ratio stands at 0, indicating that Estrella has no outstanding debt as of the most recent quarter. The current ratio is 0.75, while the quick ratio is also 0.75, suggesting that the company's short-term assets may be slightly lower than its short-term liabilities.
Estrella has funded its operations to date primarily through the issuance of Series A preferred stock in June 2022 for $5 million, as well as the $20.1 million in net proceeds raised from the business combination with TradeUP Acquisition Corp. in September 2023. As of September 30, 2024, the company had an accumulated deficit of $22.9 million.
The company expects that its current cash resources will fund its operations for at least the next 12 months, based on its current operating plan and ability to raise additional funds through the sale of equity to White Lion Capital under a committed equity financing facility.
Estrella's Innovative ARTEMIS® T-Cell Therapy Platform
At the heart of Estrella's approach is the ARTEMIS® platform, which engineers T-cells to express receptors that closely mimic the natural T-cell receptor (TCR). This unique design allows the modified T-cells to recognize and engage with target antigens more effectively, leading to enhanced potency and specificity compared to traditional chimeric antigen receptor (CAR) T-cell therapies.
The ARTEMIS® platform offers several advantages over conventional CAR-T approaches. By leveraging the natural TCR signaling mechanisms, ARTEMIS® T-cells are able to maintain a more balanced cytokine profile, potentially reducing the risk of severe cytokine release syndrome, a common adverse event associated with CAR-T therapies. Additionally, the platform's ability to target multiple antigens, such as CD19 and CD22, provides the opportunity to develop combination therapies that can address the challenges of tumor heterogeneity and antigen escape.
Estrella's Lead Candidates: EB103 and EB104
Estrella's lead product candidates, EB103 and EB104, are prime examples of the company's innovative approach to cancer immunotherapy. EB103 is a CD19-targeted ARTEMIS® T-cell therapy currently being evaluated in the STARLIGHT-1 Phase I/II clinical trial for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). The trial recently reported the successful completion of the first dose cohort, and the Data and Safety Monitoring Board has approved the initiation of a higher-dose cohort.
EB104, on the other hand, is a dual-targeting ARTEMIS® T-cell therapy that simultaneously engages the CD19 and CD22 antigens. This unique approach aims to address the issue of antigen heterogeneity, which can lead to disease relapse in some patients treated with single-target therapies. Estrella is currently preparing to initiate clinical trials for EB104 in the near future.
As of September 30, 2024, the company has dosed two patients in the STARLIGHT-1 trial and has accrued $2.75 million in related party accrued liabilities for the milestone payments owed to Eureka Therapeutics under their Statement of Work agreement. The company has also paid $3.5 million to Eureka for fees associated with milestones achieved and deposited $1.5 million for patient treatment expenses under the Statement of Work.
Estrella's Collaboration and Licensing Agreements
Estrella's success is further bolstered by its strategic collaborations and licensing agreements. In October 2021, the company entered into a collaboration with Imugene Limited to evaluate the combination of EB103 with Imugene's CF33-CD19t oncolytic virus for the treatment of solid tumors. This partnership leverages the complementary mechanisms of action of the two therapies, potentially enhancing the overall anti-tumor efficacy.
Additionally, Estrella's licensing agreement with Eureka Therapeutics grants the company exclusive rights to the ARTEMIS® platform for the development of CD19 and CD22-targeted therapies. This arrangement ensures Estrella's access to the proprietary technology and Eureka's technical expertise, further strengthening the company's position in the T-cell therapy landscape.
On March 4, 2024, the company entered into a Statement of Work with Eureka Therapeutics to perform clinical trial services related to the STARLIGHT-1 trial, with total fees of $33 million for achievement of all milestones under the agreement.
Estrella's Regulatory Milestones and Clinical Progress
Estrella has made significant strides in advancing its pipeline, most notably with the clearance of the Investigational New Drug (IND) application for EB103 by the U.S. Food and Drug Administration (FDA) in March 2023. This milestone paved the way for the initiation of the STARLIGHT-1 clinical trial, which is currently evaluating the safety, tolerability, and preliminary anti-cancer activity of EB103 in adult patients with relapsed or refractory B-cell NHL.
The successful completion of the first dose cohort and the approval to initiate the higher-dose cohort in the STARLIGHT-1 trial represent important advancements for Estrella. These achievements demonstrate the potential of the ARTEMIS® platform to produce T-cell therapies with enhanced potency and specificity, ultimately enhancing the treatment landscape for patients with B-cell malignancies.
Estrella's Commitment to Addressing Unmet Needs
Estrella's unwavering focus on developing innovative T-cell therapies positions the company at the forefront of the cancer immunotherapy field. By leveraging the ARTEMIS® platform, Estrella aims to address the shortcomings of traditional CAR-T approaches and provide more effective and better-tolerated treatment options for patients with hematological and solid tumor malignancies.
The company's pipeline, led by EB103 and EB104, holds the potential to transform the standard of care for various cancers, including relapsed or refractory B-cell NHL, where there remains a significant unmet need for more effective and durable therapies. Estrella's commitment to advancing its clinical programs and expanding its research capabilities underscores its determination to make a lasting impact on the lives of patients.
Looking Ahead: Estrella's Future Milestones and Potential
As Estrella continues to execute on its strategic priorities, the company is poised to reach several key milestones in the coming years. The successful progression of the STARLIGHT-1 trial for EB103 and the anticipated initiation of clinical studies for EB104 will be crucial drivers of Estrella's growth and value creation.
Furthermore, the company's ability to leverage its ARTEMIS® platform to develop additional pipeline candidates targeting other cancer-associated antigens could further expand its impact and solidify its position as a leader in the T-cell therapy space. Estrella's strong financial position, backed by the recent business combination and ongoing equity financing commitments, provides the necessary resources to fund its ambitious research and development initiatives.
In conclusion, Estrella Immunopharma, Inc. (NASDAQ: ESLA; ESLAW) is a pioneering biopharmaceutical company dedicated to revolutionizing the treatment of cancer and autoimmune diseases through its innovative ARTEMIS® T-cell therapy platform. With a robust pipeline, strategic partnerships, and a seasoned management team, Estrella is well-positioned to address the unmet needs of patients and potentially transform the standard of care in the years to come.