UPTDU TradeUP Acquisition Corporation

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 10, 2024

 

Estrella Immunopharma, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-40608		86-1314502
(State or other jurisdiction		(Commission File Number)		(IRS Employer
of incorporation)				Identification Number)

 

5858 Horton Street, Suite 370 Emeryville, California		94608
(Address of principal executive offices)		(Zip Code)

 

(510) 318-9098

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act.

 

Title of each class		Trading Symbol		Name of each exchange  on which registered
Common Stock, par value $0.0001 per share		ESLA		The Nasdaq Stock Market LLC
Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50		ESLAW		The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging  growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On April 10, 2024, Estrella Immunopharma, Inc. (the “Company”) posted to the Company’s website at www.estrellabio.com an investor presentation to be used from time to time in meetings with investors and analysts. A copy of the investor presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

The information contained in Exhibit 99.1 is being furnished under Item 7.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Investor Presentation dated April 10, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	Estrella Immunopharma, Inc.
	By:	/s/ Cheng Liu
	Name:	Dr. Cheng Liu
	Title:	Chief Executive Officer
Date: April 10, 2024

 

 

 

 

 

Exhibit 99.1

 

Developing CD19 - Redirected ARTEMIS ® T - Cell Therapy for Cancers and Autoimmune Diseases April 10, 2024

Disclaimer 2 Limitations Any reproduction or distribution of this Presentation, in whole or in part, or the disclosure of its contents, without the pr ior consent of Estrella Immunopharma, Inc. (“we,” “us,” “our” or the “Company”) is prohibited. By accepting this Presentation, each recipient agrees: (i) to maintain the confidentiality of all information tha t i s contained in this Presentation and not already in the public domain; and (ii) to use this Presentation for the sole purpose of evaluating the Company. Only those particular representations and warra nti es that may be made by the Company in a definitive written agreement, when and if one is executed, and subject to such limitations and restrictions as may be specified in such agreement, shall ha ve any legal effect. Certain information contained herein has been derived from sources prepared by third parties. While such information is believed to be reliable for the purposes used herein the Co mpa ny makes no representation or warranty with respect to the accuracy of such information. This Presentation does not purport to contain all of the information that may be required to evaluate a possible transaction. Th is Presentation is not intended to form the basis of any investment decision by the recipient and does not constitute investment, tax or legal advice. No representation or warranty, express or implied, is or will be given by the Company or any of its affiliates, directors, officers, employees or advisors or any other person as to the accuracy or completeness of the information in this Presentation or any o the r written, oral or other communications transmitted or otherwise made available to any party in the course of its evaluation of a possible transaction, and no responsibility or liability whatsoev er is accepted for the accuracy or sufficiency thereof or for any errors, omissions or misstatements, negligent or otherwise, relating thereto. Accordingly, none of the Company or any of its affiliates, direct ors , officers, employees or advisers or any other person shall be liable for any direct, indirect or consequential loss or damages suffered by any person as a result of relying on any statement in or omissi on from this Presentation and any such liability is expressly disclaimed. Forward - Looking Statements In addition, this presentation may contain certain 'forward - looking statements' within the meaning of the Private Securities Lit igation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. These include statements regarding the Company and its management tea m’s expectations, hopes, beliefs, intentions, or strategies regarding the future. Moreover, any statements referring to projections, forecasts, or other characterizations of future events or circ ums tances, including any underlying assumptions, are forward - looking statements. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' ' pos sible,' 'potential,' 'predict,' 'project,' 'should,' 'would,' and similar expressions may identify forward - looking statements, but the absence of these words does not mean a statement is not forward - looking. Forward - lo oking statements in this presentation may include, for example, statements about the Company’s ability to develop its product candidates, expectations around the efficacy and risk profile o f i ts cell therapy products, the benefits of the collaboration between the Company and Imugene, performance expectations of its cell therapy products, the profile and potential application of CD19 Tar get ing ARTEMIS® T - Cell Therapy to autoimmune diseases, expectations regarding the potential market size and the patient populations for our product candidates, and the initiation, timing, progr ess , and results of future preclinical studies, clinical trials, and our research and development programs. These forward - looking statements involve risks, uncertainties (some of which are beyond the Company’s cont rol), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward - looking statements. These risks and unce rtainties include, but are not limited to, risks that the Company’s preclinical or clinical programs do not advance or result in approved products on a timely or cost - effective basis, or at all; t hat many product candidates do not become approved drugs on a timely or cost - effective basis, or at all; and the risk that the Company does not obtain sufficient financing, or financing on favorable t erms, in connection with funding its planned clinical trial of EB103 and its other preclinical or clinical programs. For a discussion of other risks and uncertainties, and other important factors, any of whic h c ould cause the Company’s actual results to differ from those contained in the forward - looking statements, see the section titled 'Risk Factors' in the Company’s Registration Statement on Form S - 1/A filed wi th the Securities and Exchange Commission on December 18, 2023, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with t he Securities and Exchange Commission. All information in this presentation is as of the date of the presentation, and the Company undertakes no obligation to publicly update any forward - looking statement, w hether as a result of new information, future events, or otherwise, except as required by law. Therefore, you should not rely on these forward - looking statements as representing the Company’s view s as of any date subsequent to the date of this presentation. Except as required by law, the Company is not undertaking any obligation to update or revise any forward - looking statements, whether as a result of new information, future events, or otherwise.

Executive Summary: Background and Opportunity 3 • The “Mark and Kill” approach by combining specially designed oncolytic viruses that label solid tumor cells with CF33 - CD19t (“Mark”) and EB103 (“Kill”) is a potential breakthrough for treating solid tumors with T - cell therapy. ARTEMIS ® vs. CAR - T * Superior efficacy Enhanced tumor infiltration Less T - cell exhaustion Reduced cytokine release syndrome (CRS) and cytokine released toxicities * According to head - to - head comparison studies conducted by independent 3 rd parties • Estrella’s EB103 , which utilizes ARTEMIS ® T - cell engineering technology, has been validated preclinically and clinically with favorable safety profile and promising efficacy signals. Recent success treat ing blood cancers with T - cell immunotherapy • Juno Therapeutics (Juno) and Kite Pharma (Kite) were leaders in developing T - cell immunotherapy targeting CD19 • FDA approved T - cell immunotherapy targeting CD19 for blood cancer in 2017 • Average price of treatment is around $400,000 per patient • Juno and Kite acquired by Bristol - Myers Squibb(Nasdaq: BMY) and Gilead Science (Nasdaq: GILD) for $9 billion and $11. 9 billion in 201 8 and 201 7, respectively Opportunity remains for 2nd generation CD19 - targeted T - cell therapies with less toxicity, and autoimmune disease market is wide - open • Current CD19 T - cell therapy has severe side effects including Cytokine release syndrome (CRS) and neurotoxicity • Autoimmune disease, which affects as many as 50 million people in the U.S., have NOT been successfully treated by T - cell immunotherapy

Estrella Immunopharma 4 Harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer. • Lead product candidate, EB103, the next - generation CD19 - targeted ARTEMIS ® T - cell therapies with superior efficacy, enhanced tumor infiltration, and less T - cell exhaustion. • EB104, a CD19/22 Dual - Targeting ARTEMIS ® T - cell therapies with more efficacy, reducing relapse due to CD19 antigen loss. Our Product s In partnership with Imugene, we combine our ARTEMIS ® technology with o ncolytic v irus “CF33 - CD19t” to treat solid tumors in a “Mark and Kill ” strategy. Our Partnership Our Mission A clinical - stage biopharmaceutical company developing T - cell therapies with the potential to more effectively treat patients with cancers and autoimmune diseases .

Estrella’s Scientific Advisory Board Includes World - Class Thought Leaders 5 • Research Professor of microbiology and immunology at University of North Carolina • Director of the Lineberger Comprehensive Cancer Center Immunotherapy Program at University of North Carolina at Chapel Hill • Chief of the Cell Therapy and Transplant Section in the Division of Oncology and Director of Cancer Immunotherapy Program at Children’s Hospital of Philadelphia • Principal Investigator for CD19 CAR - T Kymriah by Novartis • Cell Biologist at UC Berkeley • Former editor - in - chief of The Proceedings of the National Academy of Sciences and the Annual Review of Cell and Developmental Biolog y • 2013 Nobel Prize in Physiology or Medicine • Physician, scientist, drug developer, entrepreneur, and pioneer of targeted alpha particle therapies • Memorial Sloan Kettering Cancer Center, Former Chairman of Leukemia Service • Associate Clinical Professor of Medicine at University of California, San Francisco • Former CSO and Head of Research and Non - Clinical Development of CytomX • Former Senior VP and CSO of Five Prime Therapeutics • Former VP of Novartis Vaccines & Diagnostics, and ED of Oncology Biologics in Novartis Institutes of Biomedical Research Gi a npietro Dotti, MD David Scheinberg, MD, PhD Michael Kavanaugh, MD Stephan Grupp, MD, PhD Randy Schekman, PhD

Estrella Immunopharma Licensed Patents on CD19 - ARTEMIS ® 6 ARTEMIS ® Four issued patents in the US and 62 applications pending worldwide CD19 Issued patents in the US and have 23 applications worldwide

Estrella Pipeline and Strategy 7 ▪ Our approach is to rapidly advance our lead product candidate EB103, CD19 - Redirected ARTEMIS ® T - Cell programs in relapsed/refractory and high - risk blood cancers first . ▪ We are also developing EB104 , CD19/22 Dual Targeting ARTEMIS ® T - Cell Therapy to treat patients with lower surface CD19 density or a greater prevalence of CD22. ▪ Meanwhile, in partnership with Imugene we are developing EB103+ CF33 - CD19t using the “Mark - and - Kill” approach to address various types of solid tumors . ▪ For indications beyond cancers, we are working on IND enabling studies of CD19 - Redirected ARTEMIS ® T - Cell Programs for the treatment of autoimmune diseases, starting with systemic lupus erythematosus (SLE). Partner Clinical Pre - Clinical Late - Discovery Early - Discovery Program Indications HEMATOLOGIC MALINGNANCIES EB103 (CD19) Diffuse large B cell lymphoma (DLBCL), Follicular Lymphoma (FL), and other types of B - cell Lymphoma EB104 (CD19/CD22) Diffuse large B cell lymphoma (DLBCL), Follicular Lymphoma (FL), and other types of B - cell Lymphoma SOLID TUMORS Combination: EB103 + CF33 - CD19t Multiple indications AUTOIMMUNE DISEASES EB201 Systemic Lupus Erythematosus (SLE)

Lead Product: EB103 (CD19 - Redirected ARTEMIS ® T - Cell Therapy) 8

EB103 T - Cells 9 EB103 CD19 - Redirected ARTEMIS ® T Cells EB103 Engineered to express ARTEMIS ® cell receptors (i.e., the AbTCR and co - stimulatory molecule) on cell surfaces. Once infused, EB103 T - cells(cell receptors) recognize and bind the CD19 - positive cancer cells. Cell receptors, AbTCR/CD3 complex - mediated signal transduction within the EB103 T - cell is initiated, leading to the activation of the EB103 T - cell. The second “enhancement” signal is generated when the co - stimulatory molecule expressed on the EB103 T - cells binds to its target, CD19. EB103 T - cells seek out CD19 - positive cancer cells, bind to and destroy them. The key units of our novel, proprietary CD 19 - Redirected ARTEMIS ® T Cells comprised of an antibody - T - cell - receptor (AbTCR) and a co - stimulatory molecule : The Antibody - T - Cell Receptor (AbTCR) serves as the core component featuring : • A target - binding domain derived from an antibody fragment antigen - binding (Fab) region • An effector domain derived from portions of a human gamma/delta (γδ) T - cell receptor (TCR) The Co - Stimulatory Molecule is an additional key component featuring: • A target - binding domain derived from a single - chain variable fragment (scFv) • A co - stimulatory domain derived from portions of a human co - stimulatory receptor Both the AbTCR and the co - stimulatory molecule bind to the CD19 antigen , a well - validated target commonly overexpressed on blood cancer cells. Key Unit – AbTCR and Co - stim CD19 - Redirected EB103 T Cell Cancer Cell AbTCR Co - stim CD19 CD19

Proprietary ARTEMIS ® Technology ARTEMIS ® ARTEMIS ® receptor is primarily localized in microvilli. (Collaboration: Alice Liang, Ph.D. Director of Microscopy Laboratory, NYU Langone Health NYU School of Medicine) Superiority to Conventional CAR - T ▪ ARTEMIS ® T - cell therapy is clinically validated in patients ▪ ARTEMIS ® vs. CAR - T * x Superior efficacy x Enhanced tumor infiltration x Less T cell exhaustion x Reduced Cytokine release syndrome (CRS) and cytokine related toxicities 10 * According to head - to - head comparison studies conducted by independent 3 rd parties

Better Safety and Potent Anti - tumor Efficacy 11 10 5 10 6 10 7 10 8 10 9 10 10 10 11 0 5 10 15 20 25 30 35 Days post implantation Total Flux (p/s) mean +/ - SEM Mock CAR ARTEMIS Dose **** IL - 2 IL - 10 IFN - TNF - 700 600 500 400 300 200 100 0 Serum Cytokines (pg/mL) Mock CAR ARTEMIS ** *** * ▪ Collaboration research between Eureka Therapeutics, Inc., Estrella’s parent company, and Dr . Grupp’s team showed CD19 ARTEMIS ® T - cell Therapy demonstrated better safety and anti - tumor efficacy. ▪ The research paper Xu et al. Cell Discovery (2018) 4:62 published in Nature in 2018. Stephan A. Grupp, MD, PhD ▪ Delivered CAR T - cell therapy to the first pediatric patient in the world (Emily Whitehead) ▪ Led the first multicenter global study of Kymriah®, which became the first CAR - T therapy to receive approval from the FDA • Potent anti - tumor activity • Better safety profile • Longer durability with less exhausted phenotype ARTEMIS ® vs. CAR - T cells

Snapshots of Estrella CD19 Therapy in Lymphoma Patients 12 ▪ Collaboration research with the First Affiliated Hospital of Xi’an Jiaotong University for exploratory, single - arm, open - label, non - randomized early investigator initiated study (“IIS”). 2021 826 Novel CD19 - Specific γ/δ TCR - T Cells in Relapsed or Refractory Diffuse Large B - Cell Lymphoma Oral presentation Monday, December 13, 2021: 5:15 PM

EB103 Clinical Studies 13 (1) Reference: He et al. Journal of Cancer and Clinical Oncology 10 June 2022 A novel antibody - TCR(AbTCR) T - cell therapy is safe and effective against CD19 - positive relapsed/refractory B - cell Lymphoma ▪ This IIS study (1) provides data that indicates that EB103 has anti - tumor activity and an attractive safety profile in patients with CD19 - positive r/r B - cell lymphoma. (a) Treatment response and duration of response after initial infusion of EB103 T - cells. Black arrows indicate ongoing remission and follow - up. (b) Best response for the 12 patients. Best response was defined as the best response (i.e., CR > PR > SD > PD) the patient achieved at any time after receiving EB103. CR - complete response, PR - partial response, SD - stable disease, PD - progressive disease. (c) Representative radiographic images of two responders (BH05 - P10 and BH05 - P19) at baseline and the indicated time points after EB103. Red or yellow arrows mark the tumor lesions. Full body images are PET - CT scans. Cross - sectional images are PET scans (top rows) and CT scans (bottom rows). Scale bars: black, 20 cm; red, 6 cm.

EB103 Clinical Studies 14 (1) This IIS was conducted at The First Affiliated Hospital of Xi’an Jiaotong University in China and was registered at www.clinicaltrials.gov as #NCT03642496 Reference: He et al. Journal of Cancer and Clinical Oncology 10 June 2022 A novel antibody - TCR(AbTCR) T - cell therapy is safe and effective against CD19 - positive relapsed/refractory B - cell Lymphoma ▪ This IIS study (1) provides data that indicates that EB103 has anti - tumor activity and an attractive safety profile in patients with CD19 - positive r/r B - cell lymphoma. » The study enrolled patients from November 2018 to January 2020 (1) 16 patients were enrolled, and 12 patients were treated. » Of the 12 patients treated, six patients (50%) achieved a complete response (“CR”), and four (33%) achieved a partial response (“PR”), with a best objective response rate of 83%. » CRs were durable, including two patients with ongoing CRs for 22.7 months and 23.2 months. EB103 was well - tolerated with an attractive safety profile. » No patients experienced severe (grade > 3) CRS, and only one patient experienced ICANS of any grade. Significant elevations of cytokine levels were not seen, even in patients with marked expansion of EB103 T - cells. ▪ Levels of cytokines and serum inflammatory markers after EB103 T - cell infusion (a) Cytokine levels (b) Serum c - reactive protein (CRP) and ferritin levels in patients during the first month of EB 103 . Horizontal lines denote median values . Patients’ best responses are denoted by color of the symbols : CR (red), PR (blue), SD (green), and PD (black) . Values less than the limit of detection were recorded as half the lower limit

CD - 19 Targeted CAR - T Therapies Market 15 Source: Datamonitor, June 2022 Currently approved CD - 19 targeted CAR - T therapies projected sales in lymphoma: $5+ billion (2031) $1,540 $5,301 $0 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 CD19 CAR - T Product Sales Projection (2018 - 2031) $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 $ in Millions

CD - 19 CAR - T Company Acquisitions 16 ▪ 1st Generation CD - 19 CAR - T Companies Valued at $9 - 12B at the Time of Acquisition FDA approved T - cell therapies are limited to hematologic malignancies $11.9 billion In 2017 by Gilead $9 billion in 2018 by Celgene ▪ Three FDA approved CAR - T therapies historical sales from 2017 to 2022, and projected sales in 2026 Treatment Price (WAC) Kymriah (Novartis) $373,000 - $475,000 Treatment Price (WAC) Yescarta (Gilead/Kite) $373,000 Treatment Price (WAC) Breyanzi (BMS/Juno) $410,300 Note: WAC, wholesale acquisition costs Source: Datamonitor, January 2022 202 6 E 2022 A 2021A 2020A 2019A 2018A 2017A Kymriah ($MM) (Novartis) $196 $ 230 $205 $159 $76 $6 USA $ 1,090 202 6 E $ 536 2022 A $ 587 2021A $474 2020A $278 2019A $76 2018A $6 2017A Worldwide Yescarta ($MM) (Gilead/Kite) $1,160 $ 406 $362 $373 $26 3 - - USA $1, 481 $794 $ 695 $563 $456 $264 - - Worldwide 202 6 E 2022 A 2021A 2020A 2019A 2018A 2017A Breyanzi ($MM) (BMS/Juno) $151 $ 84 - - - - - - - - USA $1,515 $ 182 $ 87 - - - - - - - - Worldwide

Highlights of EB103 Program 17 ▪ ARTEMIS ® T - cell engineering technology may offer advantages over existing CAR - T technologies, including a potentially improved safety profile and reduced side effects. ▪ IND clearance in Q1 2023, Phase I trials expected to commence in 1H 2024. Antibody - based target recognition AbTCR includes portions of a human TCR Co - stimulation provided as a separate molecule ▪ The ability to achieve high specificity and binding affinity to intended cancer target when compared to TCRs. ▪ The AbTCR associates with the endogenous CD3 complex enabling the AbTCR to use the same activation and regulatory signaling pathways employed by natural TCRs . ▪ This feature may lead to improved safety in patients. ▪ The AbTCR construct does not include an intracellular signaling domain covalently - linked to a co - stimulatory domain, and thus has the potential to eliminate T - cell hyperactivation and consequently, lower the risk of CRS and ICANS commonly observed with CAR - T therapy.

EB104 (CD19/22 Dual - Targeting ARTEMIS ® T - Cell Therapy) 18

EB104 19 CD19/CD22 - Redirected EB104 T Cell EB104 Preclinical Data EB104 Engineered to express ARTEMIS ® cell receptors (i.e., the AbTCR and co - stimulatory molecule) on cell surfaces. AbTCR in EB104 recognize and binds to both CD19 and CD22 antigen . Once infused, EB104 T - cells(cell receptors) recognize and bind the CD19 - and CD22 - positive cancer cells. Cell receptors, AbTCR/CD3 complex - mediated signal transduction within the EB104 T - cell is initiated, leading to the activation of the EB104 T - cell. The second “enhancement” signal is generated when the co - stimulatory molecule expressed on the EB104 T - cells binds to its target, CD19. EB104 T - cells seek out CD19 - and CD22 - positive cancer cells, bind to and destroy them. ▪ Results showed that EB104 T - cells have the potential to eradicate Nalm - 6 Primary Tumors and Nalm - 6 - CD19ko re - challenge tumors in the xenograft model, suggesting that EB104 T - cells have the potential to control the growth of tumor cells that do not express CD19. » A Nalm - 6 - CD19ko cell line constructed, with the “knockout” of CD19 gene expression to tested the activity of EB104 in mice using NSGTM xenograft models. » Inoculated NSGTM mice, that were CD19 positive four days before receiving (i) mock control T - cells, (ii) EB103 T - cells, and (iii) EB104 T - cells. The Primary Nalm - 6 Tumors in EB103 and EB104 groups resulted in remission. » Then inoculated the NSGTM mice with 1% Nalm - 6 - CD19ko to mimic diminished CD19 surface expression, creating “re - challenge” tumors. » EB103 T - cells not able to control the re - challenge tumors in the EB103 T - cell group, the re - challenge tumors in the EB104 T - cell group resulted in remission. CD19/CD22 - Redirected EB104 T Cell Cancer Cell AbTCR Co - stim CD22 CD19

20 CF33 - CE19t and EB103 (Collaboration with Imugene)

CF33 - CE19t and EB103 21 • 2 nd generation CD19 T - cell Immunotherapy with a “Mark and Kill” strategy • In a partnership with Imugene , we are investigating the use of EB103 in conjunction with Imugene’s product candidate, CF33 - CD19t, to treat solid tumors in a “ Mark and Kill” strategy Highlights The Mark - and - Kill Approach To address the lack of solid tumor - specific targets currently available, we use CF 33 - CD 19 t , an oncolytic virus , to force solid tumor cells to express the CD 19 protein on the cell surface . The CD19 - Redirected ARTEMIS ® T Cells can then pursue and kill the CD19 - labeled solid tumors , offering a potential treatment solution to cancers where there are no inherently abundant solid tumor - specific targets available. Partnership with Imugene (AUX: IMU) • Founded: 2012 • Headquarter: Melbourne, Australia • Market Cap: AUD 734 m illion (1) • Management : o Paul Hopper ( Executive Chairman; S erial bioentrepreneur) o Leslie Chong (CEO; F ormer clinical program lead at Genentech) (1) As of April 4 th ,2 02 4 .

Solid Tumor Market Potentials 22 • CF33 Oncolytic Virus ( “ Mark ” the T umor - Imugene) • T - Cell Therapy ( “ Kill ” the T umor - Estrella ) Solid tumors represent : » 1.6 million new cases » 90% of total diagnoses in US each year » 0 FDA approved CAR - T /TCR (T - Cell Receptor) therapies ~ $20 billion combined market capitalization realized by Juno and Kite with T - cell therapies treating CD19+ liquid tumors Treating Solid Tumor with Estrella’s CD - 19 T - cell Therapies: “Mark and Kill Strategy” Estimated New Cancer Cases in United States, 20 22 * * Source: American Cancer Society, Cancer Facts & Figures 202 2 Leukemia&Lymphoma 13% Liver 2% Ovary 1% Breast 13% Pancreas 3% Lung & Bronchus 10% other solid tumor 58%

20 Going Beyond Cancers: CD19 ARTEMIS® T - Cell Therapy for Autoimmune Diseases

Autoimmune Diseases & SLE Market Overview • Autoimmune diseases represent a significant health concern globally, characterized by the immune system mistakenly attacking the body's own tissues. o Approximately one in ten individuals globally are affected by autoimmune disorders. Over 80 types of autoimmune diseases identified, including systemic lupus erythematosus, rheumatoid arthritis, type 1 diabetes, and multiple sclerosis. o In 2022, the global market size for autoimmune disease therapeutics was valued at $72.05 billion, expected to grow to $94.87 billion by 2030. o North America holds a substantial market share, accounting for over 42.4% of the global revenue in 2021. • Systemic Lupus Erythematosus (SLE), commonly known as lupus, is a chronic autoimmune disease with symptoms ranging from mild to life - threatening due to systemic inflammation. o The prevalence of SLE in the United States is approximately 72.8 per 100,000 person - years. o Factors driving this growth include the increasing prevalence of SLE, advancements in medical treatments, and the introduction of new biological therapies​. o By 2025, the global market size for SLE treatments is expected to reach $3.8 billion​. Autoimmune Disease Therapeutics Market Size & Share Research [2023 - 2030], SNS Insider. Lupus Market Research Report by Type, Treatment, End User, and Region - Forecast till 2032 , MRFR, March 2024

CD19 Targeting ARTEMIS® T - Cell Therapy for SLE Targeted B - cell Depletion o CD19 CAR - T cells are engineered to recognize and bind to CD19, a protein expressed on the surface of B cells. o By targeting CD19, ARTEMIS ® T cells can specifically eliminate B cells, which are responsible for the production of autoantibodies in autoimmune diseases like SLE. Autoimmune Regulation o Reduction in autoantibody - producing B cells leads to a decrease in the systemic autoimmune response. o The therapy aims to restore immune system balance by removing cells that mistakenly attack the body's own tissues. Clinical Application o Initial clinical trials with anti - CD19 CAR - T cells show promise for refractory SLE, where standard treatments are ineffective. o Anti - CD19 and anti - B cell maturation antigen (BCMA) CAR - T cells have been used in diseases such as SLE and myasthenia gravis with positive outcomes. Unlike traditional immunosuppressive treatments, EB201 therapy offers the potential for durable remission in certain B - cell mediated autoimmune diseases, such as SLE CD19 - Redirected EB201 T Cell B Cell AbTCR Co - stim CD19 CD19 CD19 - Redirected EB 2 0 1 T Cell

Competitive Landscape of CD19 Targeting SLE Programs EB201 Unique Advantages o EB201 utilizes a n anti - CD19 fully - human binder with the potential of lower immunogenicity. The same binder has been used in ARTEMIS ® T - cell therapy against r/r B - cell lymphoma IIT in China, with 20 patients’ data reported 1 . o Preclinical and early clinical validations suggest CD19 - Redirected ARTEMIS ® T cells outperforms existing FDA - approved CD19 CAR - T therapies in both safety and efficacy, particularly by potentially decreasing risks of CRS and ICANS. o EB103 program has received IND clearance for blood cancers and is expected to commence Phase I trials in the first half of 2024. EB201 program intends to treat SLE patients with the same ARTEMIS ® T cell being used in EB103. Platform Current Phase Company Program NEX - T Phase 1 Bristol Myers Squibb BMS - 986353 CAR - T IND cleared Cabaletta Bio CABA - 201 CAR - T Phase 1 Kyverna Therapeutics KYV - 101 CD19 - Targeted T - cell Therapy Programs in SLE The potential applicability of EB103 in autoimmune diseases like SLE demonstrates Estrella's innovative approach to leveraging T - cell therapy across a broader spectrum of diseases. 1 Li, C., Zhou, F., Wang, J., Chang, Q., Du, M., Luo, W., Zhang, Y., Xu, J., Tang, L., Jiang, H., Liu, L., Kou, H., Lu, C., Liao, D., Wu, J., Wei, Q., Ke, S., Deng, J., Liu, C., & Mei, H. (2023). Novel CD19 - specific γ/δ TCR - T cells in relapsed or refractory diffuse large B - cell lymphoma. Journal of Hematology & Oncology He, P., Liu, H., Zimdahl, B., Wang, J., Luo, M., Chang, Q., Tian, F., Ni, F., Yu, D., Liu, H., Chen, L., Wang, H., Zhang, M., Grupp, S. A., & Liu, C. (2022). A novel antibody - TCR (AbTCR) T - cell therapy is safe and effective against CD19 - positive relapsed/refractory B - cell lymphoma. Journal of Cancer Research and Clinical Oncology

Summary 27

Estrella Expects to Achieve High Return T h rough the Potentially Decreased Risk of its Product Candidates 28 ▪ CD 19 T cell product average price of $ 400 K per treatment is expected to be covered by insurance ▪ Juno and Kite acquisition of $ 9 billion and $ 11 . 7 billion respectively, provide the reference for potential company value for blood cancer market ▪ Potential success to treat autoimmune disease would expand sales and potentially drive Estrella Immunopharma valuation beyond those of Juno and Kite ▪ Potential for expansion into autoimmune disease market with the same CD19 - targeted T - cell therapy ▪ Proven safety of targeting CD19; four CD19 CAR - T therapies have been approved by FDA to date ▪ Target large blood cancer market: $2 billion in sales for CD19+ in lymphoma alone as of 2021 ▪ ARTEMIS ® technology has undergone independent 3 rd part y head - to - head comparison studies, suggesting superior safety profile, anti - tumor activity and durability compared to FDA - approved products , Kymriah and Yescarta ▪ CD19 - targeted T - cell therapy has been validated in patients in multiple clinical studies High Return Decreased Risk

Developing CD19 - Redirected ARTEMIS ® T - Cell Therapy for Cancers and Autoimmune Diseases

v3.24.1.u1

Cover	Apr. 10, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Apr. 10, 2024
Entity File Number	001-40608
Entity Registrant Name	Estrella Immunopharma, Inc.
Entity Central Index Key	0001844417
Entity Tax Identification Number	86-1314502
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	5858 Horton Street
Entity Address, Address Line Two	Suite 370
Entity Address, City or Town	Emeryville
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94608
City Area Code	510
Local Phone Number	318-9098
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Common Stock Par Value 0. 0001 Per Share [Member]
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	ESLA
Security Exchange Name	NASDAQ
Warrants Each Whole Warrant Exercisable For One Share Of Common Stock At Exercise Price Of 11. 50 [Member]
Title of 12(b) Security	Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50
Trading Symbol	ESLAW
Security Exchange Name	NASDAQ

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