As filed with the U.S. Securities and Exchange Commission on December 22, 2025 Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________________ ESTRELLA IMMUNOPHARMA, INC. (Exact Name of Registrant as Specified in its Charter) ____________________________ (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 6770 86-1 ...

As filed with the U.S. Securities and Exchange Commission on December 22, 2025 Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________________ ESTRELLA IMMUNOPHARMA, INC. (Exact Name of Registrant as Specified in its Charter) ____________________________ (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 6770 86-1 ...

Financial Performance - The net loss for the three months ended September 30, 2025, was approximately $4.8 million, compared to a net loss of $3.4 million for the same period in 2024, indicating a 41% increase in losses [176]. - Estrella's accumulated deficit as of September 30, 2025, was approximately $36.4 million [163]. - The company reported a net cash used in operating activities of approximately $1.6 million for the nine months ended September 30, 2025, primarily due to a net loss of approximately $12.5 million [192]. Research and Development Expenses - Estrella has incurred approximately $4.2 million in research and development expenses for the three months ended September 30, 2025, compared to $2.8 million for the same period in 2024, reflecting a 50% increase [173]. - For the nine months ended September 30, 2025, research and development expenses totaled approximately $10.2 million, up from $6.4 million in 2024, representing a 59% increase [177]. - The company expects significant increases in expenses as it continues research and development and seeks marketing approval for its product candidates [183]. Cash and Liabilities - As of September 30, 2025, Estrella had cash of approximately $1.6 million and a working capital deficit of approximately $11.3 million [181]. - As of September 30, 2025, Estrella has accrued approximately $12.9 million in liabilities related to dosing milestones for the STARLIGHT-1 clinical trial [161]. - The company has accrued approximately $12.9 million in liabilities related to milestones achieved as of September 30, 2025, including the completion of nine patients' dosing and a second site activation milestone [203]. Capital and Financing - The company plans to raise additional capital to fund research and development programs, but there is no assurance that financing will be available on acceptable terms [191]. - Net cash provided by financing activities was approximately $2.3 million for the nine months ended September 30, 2025, primarily from a private placement [194]. - As of September 30, 2025, the company had issued 70,000 Equity Line Shares to White Lion for an aggregate consideration of $79,491 under the Common Stock Purchase Agreement [189]. Clinical Trial Obligations - The total fees for the clinical trial services under Statement of Work No. 001 with Eureka amount to $33.0 million for achieving all milestones [161]. - The company has a total fee obligation of $33.0 million to Eureka for the Phase I/II clinical trial of its product candidate, EB103 [202]. - The company has fully paid the $1.0 million license fee to Eureka and earned two development milestones, with payments of $50,000 each for the IND submission and first patient dosed [199]. Legal and Contingencies - The company is subject to loss contingencies, including legal proceedings and claims, which may require accruals when a liability is probable and can be reasonably estimated [197]. General and Administrative Expenses - The company incurred approximately $649,000 in general and administrative expenses for the three months ended September 30, 2025, compared to $551,000 for the same period in 2024, reflecting an increase of 18% [175]. Derivative Liabilities - The fair value of the derivative liability related to the True-Up Shares was valued at $385,355 as of September 30, 2025, using a Monte Carlo Simulation model [207]. Revenue Generation - Estrella has not generated any revenue since its inception and does not expect to do so for at least the next few years [182].

Group 1 - The S&P 500 has gained 35% since its lows in April, indicating optimism for continued market rally into 2026 [1] - Executives are cautioning about a potential equity market drop of more than 10% in the next 12 to 24 months, which is described as normal market behavior [2] Group 2 - Royalty Management Holding Corp. (RMCO) moved up 51 spots to 30th place on Barchart's top 100 stocks to buy list [3] - Estrella Immunopharma (ESLA) also rose 51 spots to 18th place, both being penny stocks trading below $5 [3] Group 3 - Royalty Management went public on November 6, 2023, through a combination with American Acquisition Opportunity Inc., a SPAC that raised $100 million in March 2021 [4] - The SPAC focused its search on companies with land and resource holdings, with its management team linked to American Resources Corporation (AREC) [5] Group 4 - AREC stock has increased by 953% from its low of 38 cents in April, attracting investors to Royalty Management and RMCO stock [6] - The SPAC extended its timeline to effect a combination from March 2022 to September 2022, announcing the combination with Royalty Management on June 28, 2022 [6]

[CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=4&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section provides a standard disclaimer for forward-looking statements, highlighting inherent uncertainties and the company's non-obligation to update them - Forward-looking statements are identified by words like 'plan,' 'believe,' 'expect,' and are based on current management expectations, subject to inherent uncertainties and changes in circumstances[9](index=9&type=chunk)[10](index=10&type=chunk) - These statements involve risks and uncertainties, including those described in 'Risk Factors' (Part II, Item 1A) and the Annual Report on Form 10-KT[10](index=10&type=chunk) - The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law[12](index=12&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents Estrella Immunopharma's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, changes in equity, and cash flows, with detailed notes [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This section presents the unaudited condensed consolidated balance sheets, detailing assets, liabilities, and equity as of specific dates Condensed Consolidated Balance Sheet Highlights | Metric | As of June 30, 2025 (Unaudited) | As of December 31, 2024 | | :-------------------------------- | :------------------------------- | :---------------------- | | Cash and cash equivalent | $1,316,594 | $916,916 | | Total current assets | $1,480,527 | $1,640,777 | | Total Assets | $2,980,527 | $3,140,777 | | Total current liabilities | $9,075,195 | $2,997,046 | | Total Liabilities | $9,075,195 | $2,997,046 | | Accumulated deficit | $(31,576,492) | $(23,927,303) | | Total Stockholders' (Deficit) Equity | $(6,094,668) | $143,731 | - Total current liabilities significantly increased by **$6.1 million**, primarily due to a substantial rise in accrued liability - related party and the recognition of derivative liabilities[17](index=17&type=chunk) - Total Stockholders' (Deficit) Equity shifted from a positive balance of **$0.14 million** to a deficit of **$(6.1 million)**, reflecting increased losses[17](index=17&type=chunk) [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) This section presents the unaudited condensed consolidated statements of operations, outlining revenues, expenses, and net loss for the reported periods Condensed Consolidated Statements of Operations Highlights | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $4,660,301 | $3,525,000 | $6,070,489 | $3,550,000 | | General and administrative | $883,727 | $424,447 | $1,577,837 | $868,977 | | Total operating expenses | $5,544,028 | $3,949,447 | $7,648,326 | $4,418,977 | | Net loss | $(5,544,878) | $(3,951,072) | $(7,649,189) | $(4,420,602) | | Net loss per share, basic and diluted | $(0.15) | $(0.11) | $(0.21) | $(0.12) | - Net loss increased for both the three-month period (from **$(3.95) million** to **$(5.54) million**) and the six-month period (from **$(4.42) million** to **$(7.65) million**) year-over-year[18](index=18&type=chunk) - Research and development expenses rose significantly, by **$1.14 million (32.2%)** for the three months and **$2.52 million (71.0%)** for the six months, reflecting increased clinical trial activities[18](index=18&type=chunk) [Unaudited Condensed Consolidated Statements of Changes in Preferred Stock and Stockholders' (Deficit) Equity](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Preferred%20Stock%20and%20Stockholders'%20(Deficit)%20Equity) This section details changes in preferred stock and stockholders' (deficit) equity, reflecting capital transactions and net loss over the period Changes in Stockholders' (Deficit) Equity | Metric | Balance, December 31, 2024 | Stock-based compensation | Issuance of common stock for PIPE investment | Net loss | Balance, June 30, 2025 | | :----------------------------------- | :------------------------- | :----------------------- | :------------------------------------------- | :------------------------- | :------------------------- | | Common Stock Shares | 36,680,870 | - | 900,000 | - | 37,580,870 | | Common Stock Amount | $3,668 | - | $90 | - | $3,758 | | Treasury Stock | $(568,917) | - | - | - | $(598,379) | | Additional Paid-in Capital | $24,636,283 | $318,193 | $1,121,969 | - | $26,076,445 | | Accumulated Deficit | $(23,927,303) | - | - | $(7,649,189) | $(31,576,492) | | Total Stockholders' (Deficit) Equity | $143,731 | $318,193 | $1,122,059 | $(7,649,189) | $(6,094,668) | - Total Stockholders' (Deficit) Equity decreased from a positive **$0.14 million** at December 31, 2024, to a deficit of **$(6.1 million)** at June 30, 2025, primarily due to the net loss incurred[19](index=19&type=chunk) - The issuance of common stock for PIPE investment contributed **$1.12 million** to additional paid-in capital during the period[19](index=19&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the unaudited condensed consolidated statements of cash flows, categorizing cash movements from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows Highlights | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $(7,649,189) | $(4,420,602) | | Net cash used in operating activities | $(880,860) | $(4,526,147) | | Net cash provided by (used in) financing activities | $1,280,538 | $(354,440) | | Net Change in Cash | $399,678 | $(4,880,587) | | Cash at end of the period | $1,316,594 | $4,165,428 | - Net cash used in operating activities significantly decreased from **$(4.53) million** in 2024 to **$(0.88) million** in 2025, primarily due to an increase in accrued liability - related party[21](index=21&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) - Net cash provided by financing activities was **$1.28 million** in 2025, a substantial increase from net cash used of **$(0.35) million** in 2024, driven by proceeds from the PIPE investment[21](index=21&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures and explanations for the condensed consolidated financial statements, covering organization, accounting policies, commitments, related party transactions, and equity [Note 1 — Organization and Business Operation](index=9&type=section&id=Note%201%20%E2%80%94%20Organization%20and%20Business%20Operation) This note describes the company's formation, business as a clinical-stage biopharmaceutical entity, and current financial position regarding liquidity - Estrella Immunopharma, Inc. is a clinical-stage biopharmaceutical company developing T-cell therapies for blood cancers and solid tumors, formed through a separation from Eureka Therapeutics, Inc[24](index=24&type=chunk)[26](index=26&type=chunk) - The FDA cleared the IND application for EB103, allowing the Phase I/II STARLIGHT-1 Clinical Trial to proceed, with patient enrollment ongoing as of June 30, 2025[28](index=28&type=chunk) - The company completed a business combination with TradeUP Acquisition Corp. (UPTD) on September 29, 2023, and established a wholly-owned subsidiary in Hong Kong in November 2024[29](index=29&type=chunk)[31](index=31&type=chunk) - As of June 30, 2025, the company had **$1.3 million** in cash and an accumulated deficit of **$31.6 million**, but management believes it has sufficient funds for the next 12 months through an Equity Line with White Lion[33](index=33&type=chunk)[39](index=39&type=chunk) [Note 2 — Significant accounting policies](index=11&type=section&id=Note%202%20%E2%80%94%20Significant%20accounting%20policies) This note outlines the significant accounting policies and estimates used in preparing the financial statements, including U.S. GAAP compliance and derivative liabilities - The financial statements are prepared in accordance with U.S. GAAP for interim reporting, with certain information condensed or omitted per SEC rules[40](index=40&type=chunk) - The company is an 'emerging growth company' and has elected the extended transition period for complying with new or revised accounting standards[43](index=43&type=chunk)[44](index=44&type=chunk) - Significant estimates include stock-based compensation, derivative liability, and deferred income tax asset valuation[47](index=47&type=chunk) - Derivative liabilities, specifically 'True Up Shares' from the Securities Purchase Agreement, are bifurcated and classified as a liability, measured at fair value with subsequent changes recognized in the consolidated statements of operations[64](index=64&type=chunk)[65](index=65&type=chunk) [Note 3 — Other payables and accrued liabilities](index=17&type=section&id=Note%203%20%E2%80%94%20Other%20payables%20and%20accrued%20liabilities) This note details the composition and changes in other payables and accrued liabilities, including professional fees and payroll taxes Other Payables and Accrued Liabilities | Category | As of June 30, 2025 (Unaudited) | As of December 31, 2024 | | :-------------------------------- | :------------------------------- | :---------------------- | | Accrued professional fees | $98,660 | $177,029 | | Salary and payroll taxes payable | $12,107 | $14,100 | | Others | $- | $10,631 | | Total other payables and accrued liabilities | $110,767 | $201,760 | - Total other payables and accrued liabilities decreased by **$90,993** from December 31, 2024, to June 30, 2025, primarily due to a reduction in accrued professional fees[84](index=84&type=chunk) [Note 4 — Commitments and contingencies](index=17&type=section&id=Note%204%20%E2%80%94%20Commitments%20and%20contingencies) This note describes the company's contractual commitments and potential liabilities, including agreements for clinical trials and equity financing - Eureka is solely responsible for the manufacture and supply of clinical quantities of licensed products under the License Agreement[85](index=85&type=chunk) - The Equity Line Agreement with White Lion allows the company to sell up to **$50 million** in common stock, with **70,000 shares** issued for **$0.08 million** as of June 30, 2025, subject to certain limitations and stockholder approval[86](index=86&type=chunk)[195](index=195&type=chunk) - An amendment to the Common Stock Purchase Agreement extends its term to December 30, 2025, and introduces a 'Rapid Purchase' mechanism for expedited share settlements[87](index=87&type=chunk)[88](index=88&type=chunk) - The Collaboration Agreement with Imugene for solid tumor treatments was completed as of August 30, 2023, with no associated R&D expenses in the current periods[95](index=95&type=chunk) [Note 5 — Related Party Transactions](index=19&type=section&id=Note%205%20%E2%80%94%20Related%20Party%20Transactions) This note details transactions with related parties, including license agreements, clinical trial services, consulting, and office subleases - Under the License Agreement with Eureka, Estrella has an exclusive license for T-cell therapies, with upfront payments fully made and two development milestones achieved and paid as of June 30, 2025[97](index=97&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk)[205](index=205&type=chunk) - The Statement of Work (SOW) with Eureka for the STARLIGHT-1 clinical trial has total fees of **$33.0 million**; as of June 30, 2025, **$3.5 million** has been paid, **$1.5 million** deposited, and **$8.8 million** accrued for six patient dosings and a site activation[105](index=105&type=chunk)[108](index=108&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[210](index=210&type=chunk) - A consulting agreement with CoFame Investment Holding LLC, a related party, resulted in **$0.11 million** in consulting expenses for the six months ended June 30, 2025[114](index=114&type=chunk)[115](index=115&type=chunk) - Office sublease agreements with Eureka incurred **$0.012 million** in rent expense for the six months ended June 30, 2025[118](index=118&type=chunk)[120](index=120&type=chunk) [Note 6 — Preferred Stock](index=23&type=section&id=Note%206%20%E2%80%94%20Preferred%20Stock) This note describes the issuance and conversion of preferred stock, including Series AA and Series A, prior to the business combination - Estrella issued **105,000,000 shares** of Series AA Preferred Stock to Eureka in exchange for T-cell therapy assets[121](index=121&type=chunk) - Series A Preferred Stock was issued to third-party investors for gross proceeds, with significant terms including dividend rights (**8% non-cumulative**), liquidation preferences, and voting rights[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[128](index=128&type=chunk) - All Series A and Series AA Preferred Stock automatically converted into Estrella Common Stock immediately prior to the business combination on September 29, 2023[130](index=130&type=chunk)[134](index=134&type=chunk) [Note 7 — Stockholders' Equity (Deficit)](index=26&type=section&id=Note%207%20%E2%80%94%20Stockholders'%20Equity%20(Deficit)) This note details the components of stockholders' equity (deficit), including common stock, additional paid-in capital, and derivative liabilities - As of June 30, 2025, the company had **37,580,870 shares** of Common Stock issued and **37,065,589 shares** outstanding[135](index=135&type=chunk) - The company issued **900,000 shares** of Common Stock for **$1.35 million** in gross proceeds as part of a private placement offering as of June 30, 2025, which includes a 'True-Up Shares' contingent value protection feature[140](index=140&type=chunk)[196](index=196&type=chunk) - The 'True-Up Shares' feature is classified as a derivative liability, valued at **$0.19 million** as of June 30, 2025, using a Monte Carlo Simulation model[141](index=141&type=chunk)[142](index=142&type=chunk) - The company has **2,214,993 public warrants** outstanding, exercisable at **$11.50 per share**, which are accounted for as equity instruments[143](index=143&type=chunk)[144](index=144&type=chunk)[146](index=146&type=chunk) - A stock repurchase program authorized up to **$1.0 million**, with approximately **$0.4 million** remaining available as of June 30, 2025[148](index=148&type=chunk) [Note 8 — Stock Based Compensation](index=28&type=section&id=Note%208%20%E2%80%94%20Stock%20Based%20Compensation) This note outlines the company's stock-based compensation plan, granted options, and associated expenses recognized during the periods - The 2023 Omnibus Incentive Plan authorized **3,520,123 shares**, with **3,600,000 options** granted in October 2024 to employees, directors, and consultants[150](index=150&type=chunk) Stock-Based Compensation Expense | Expense Category | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $10,301 | $20,489 | | General and administrative | $148,797 | $297,704 | | Total stock-based compensation | $159,098 | $318,193 | - As of June 30, 2025, there were **$1.6 million** in unvested compensation costs, expected to be recognized over a weighted average remaining service period of **2.78 years**[151](index=151&type=chunk) [Note 9 — Leases](index=29&type=section&id=Note%209%20%E2%80%94%20Leases) This note describes the company's short-term operating lease agreements for office space and the associated rent expenses - The company entered into short-term office sublease agreements with Eureka, classified as operating leases, with a monthly sublease fee of **$2,000**[117](index=117&type=chunk)[118](index=118&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) - The company elected not to apply ROU asset and lease liability recognition requirements for these short-term leases, recognizing monthly payments in profit or loss on a straight-line basis[154](index=154&type=chunk) - Rent expense for both the three and six months ended June 30, 2025, was **$0.006 million** and **$0.012 million**, respectively[155](index=155&type=chunk) [Note 10 — Segment Information](index=30&type=section&id=Note%2010%20%E2%80%94%20Segment%20Information) This note states that the company operates as a single segment and provides a breakdown of operating expenses by category - The company operates as a single operating and reportable segment, with the Chief Executive Officer serving as the chief operating decision-maker[156](index=156&type=chunk) Operating Expenses by Category | Operating Expenses | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Clinical trial related service fee | $4,625,000 | $3,500,000 | $6,000,000 | $3,500,000 | | Consulting fee | $25,000 | $25,000 | $50,000 | $50,000 | | Stock-based compensation | $159,098 | $- | $318,193 | $- | | Salary expense | $131,096 | $131,063 | $260,807 | $251,549 | | Professional fee | $475,437 | $152,148 | $760,527 | $351,304 | | Insurance expense | $83,636 | $87,494 | $164,693 | $174,987 | | Other general and administrative fee | $44,761 | $53,742 | $94,106 | $91,137 | | Loss before income tax | $5,544,028 | $3,949,447 | $7,648,326 | $4,418,977 | | Net loss | $5,544,878 | $3,951,072 | $7,649,189 | $4,420,602 | [Note 11 — Subsequent Events](index=30&type=section&id=Note%2011%20%E2%80%94%20Subsequent%20Events) This note confirms that no material subsequent events occurred after the balance sheet date requiring disclosure - No material subsequent events requiring recognition or disclosure were identified after the balance sheet date through the issuance date of the financial statements[158](index=158&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of financial condition and operations, covering strategic developments, performance, liquidity, and Nasdaq compliance [Overview](index=31&type=section&id=Overview) Estrella Immunopharma is a clinical-stage biopharmaceutical company focused on T-cell therapies, advancing clinical trials with no product revenue and an accumulated deficit - The company is a clinical-stage biopharmaceutical company developing T-cell therapies for blood cancers and solid tumors, utilizing Eureka's ARTEMIS platform[160](index=160&type=chunk)[162](index=162&type=chunk) - The FDA cleared the IND application for EB103, allowing the Phase I/II STARLIGHT-1 Clinical Trial to proceed, with six patients dosed as of June 30, 2025[163](index=163&type=chunk)[164](index=164&type=chunk) - Estrella has funded operations primarily from Series A Preferred Stock issuance (**$5.0 million**) and net proceeds from the Business Combination (**$20.1 million**)[165](index=165&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of approximately **$31.6 million** and expects significant increases in expenses for ongoing R&D, clinical development, and regulatory activities[166](index=166&type=chunk)[167](index=167&type=chunk) [Recent Developments](index=33&type=section&id=Recent%20Developments) This section details the business combination, corporate changes, and Nasdaq non-compliance notices regarding minimum bid price and market value of listed securities - The Business Combination with UPTD on September 29, 2023, was accounted for as a 'reverse recapitalization,' with Estrella as the accounting acquirer, leading to increased public company expenses[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) - The company merged with its wholly-owned subsidiary, Estrella BioPharma Inc., on June 30, 2024, and changed its fiscal year end from June 30 to December 31 on November 25, 2024[174](index=174&type=chunk)[175](index=175&type=chunk) - Estrella received Nasdaq notices for non-compliance with the minimum closing bid price (**$1.00**) and minimum Market Value of Listed Securities (**$35 million**) rules, with compliance periods until October 27, 2025, and January 28, 2026, respectively[177](index=177&type=chunk)[232](index=232&type=chunk)[234](index=234&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) The company has not generated revenue, focusing on product development, and reported increased net losses and operating expenses due to higher clinical trial costs [Results of Operations for the three months ended June 30, 2025 and 2024 (unaudited)](index=34&type=section&id=Results%20of%20Operations%20for%20the%20three%20months%20ended%20June%2030,%202025%20and%202024%20(unaudited)) This section analyzes the company's financial performance for the three months ended June 30, 2025 and 2024, highlighting key expense changes and net loss Three Months Ended June 30 - Key Financials | Expense Category | 2025 (Unaudited) | 2024 (Unaudited) | Change | | :----------------------------------- | :----------------- | :----------------- | :------- | | Research and Development Expenses | $4,660,301 | $3,525,000 | +$1,135,301 | | General and Administrative Expenses | $883,727 | $424,447 | +$459,280 | | Net Loss | $(5,544,878) | $(3,951,072) | $(1,593,806) | - Research and development expenses increased by **$1.1 million (32.2%)** due to higher clinical phase service fees and three patient dosings under the SOW[179](index=179&type=chunk) - General and administrative expenses increased by **$0.46 million (108.2%)** primarily due to professional fees and stock-based compensation[181](index=181&type=chunk) [Results of Operations for the six months ended June 30, 2025 and 2024 (unaudited)](index=35&type=section&id=Results%20of%20Operations%20for%20the%20six%20months%20ended%20June%2030,%202025%20and%202024%20(unaudited)) This section analyzes the company's financial performance for the six months ended June 30, 2025 and 2024, detailing expense increases and net loss Six Months Ended June 30 - Key Financials | Expense Category | 2025 (Unaudited) | 2024 (Unaudited) | Change | | :----------------------------------- | :----------------- | :----------------- | :------- | | Research and Development Expenses | $6,070,489 | $3,550,000 | +$2,520,489 | | General and Administrative Expenses | $1,577,837 | $868,977 | +$708,860 | | Net Loss | $(7,649,189) | $(4,420,602) | $(3,228,587) | - Research and development expenses increased by **$2.5 million (71.0%)** due to higher clinical phase service fees and four patient dosings and one site activation under the SOW[183](index=183&type=chunk) - General and administrative expenses increased by **$0.71 million (81.6%)** mainly due to professional fees and stock-based compensation[185](index=185&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity challenges with a working capital deficit, relying on future financing as it generates no revenue and expects continued losses - As of June 30, 2025, the company had approximately **$1.3 million** in cash and a working capital deficit of approximately **$7.6 million**[187](index=187&type=chunk) - The company has not generated any revenue to date and expects continued losses, making future operations highly dependent on additional financing[188](index=188&type=chunk)[193](index=193&type=chunk) - The exercise of outstanding tradeable warrants is unlikely to provide significant liquidity, as the current stock price (**$0.84**) is substantially lower than the exercise price (**$11.50**)[194](index=194&type=chunk) - The Equity Line Agreement with White Lion allows for up to **$50.0 million** in common stock purchases, but issuances exceeding **20%** of outstanding stock require stockholder approval, which has not been obtained[195](index=195&type=chunk) - Net cash used in operating activities improved significantly to **$(0.9) million** for the six months ended June 30, 2025, from **$(4.5) million** in the prior year, while net cash provided by financing activities was **$1.3 million**, primarily from a private placement[198](index=198&type=chunk)[200](index=200&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) The company reported no off-balance sheet arrangements as of the specified reporting dates - As of June 30, 2025, and December 31, 2024, the company did not have any off-balance sheet arrangements[202](index=202&type=chunk) [Commitments & Contingencies](index=38&type=section&id=Commitments%20%26%20Contingencies) This section details the company's contractual obligations and potential liabilities, including license agreements, clinical trial commitments, and equity line agreements - Under the License Agreement, the **$1.0 million** upfront fee has been fully paid, and two development milestones (**$0.05 million** each) related to IND submission and first patient dosing have been achieved and paid[204](index=204&type=chunk)[205](index=205&type=chunk) - The Statement of Work for the STARLIGHT-1 clinical trial involves total fees of **$33.0 million**; as of June 30, 2025, **$3.5 million** has been paid, **$1.5 million** deposited for patient treatment, and **$8.8 million** accrued for six patient dosings and a site activation[209](index=209&type=chunk)[210](index=210&type=chunk) - The Equity Line Agreement with White Lion provides a commitment for up to **$50.0 million** in common stock purchases, with **70,000 shares** issued for **$0.08 million** as of June 30, 2025[211](index=211&type=chunk) [Critical Accounting Policies and Estimates](index=39&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section identifies derivative liabilities and stock-based compensation as critical accounting policies and estimates due to the significant judgment and assumptions required for their valuation - Derivative liabilities, specifically the 'True Up Shares' from the Securities Purchase Agreement, are measured at fair value using a Monte Carlo Simulation model, with a fair value of **$0.19 million** as of June 30, 2025[213](index=213&type=chunk)[214](index=214&type=chunk) - Stock-based compensation costs are recognized as an expense over the service period, with fair value estimated using the Black-Scholes-Merton option-pricing model, which relies on significant assumptions[215](index=215&type=chunk)[216](index=216&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Estrella Immunopharma, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[220](index=220&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective due to a material weakness related to insufficient qualified personnel for complex accounting and financial statement preparation [Evaluation of Disclosure Controls and Procedures](index=41&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section details management's conclusion regarding the effectiveness of the company's disclosure controls and procedures - Management concluded that the company's disclosure controls and procedures were not effective at a reasonable assurance level as of June 30, 2025[222](index=222&type=chunk) [Material Weaknesses](index=41&type=section&id=Material%20Weaknesses) This section identifies a material weakness related to the lack of qualified personnel for complex accounting and financial statement preparation - A material weakness was identified due to the lack of qualified full-time personnel with appropriate accounting knowledge and experience to address complex U.S. GAAP issues and prepare/review financial statements[223](index=223&type=chunk) [Changes in Internal Control over Financial Reporting](index=41&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section outlines remediation efforts for internal control weaknesses, noting that effectiveness has not yet been achieved - Remediation efforts implemented in 2024 include adding qualified personnel, implementing processes for non-routine transactions, and establishing narratives and policies for business processes[224](index=224&type=chunk)[226](index=226&type=chunk) - Despite remediation efforts, disclosure controls and procedures were still not effective as of June 30, 2025[224](index=224&type=chunk) [Limitations on Effectiveness of Controls and Procedures](index=41&type=section&id=Limitations%20on%20Effectiveness%20of%20Controls%20and%20Procedures) This section acknowledges the inherent limitations of controls and procedures, which can only provide reasonable assurance - Management acknowledges that controls and procedures, regardless of design, can only provide reasonable assurance due to inherent limitations and resource constraints[225](index=225&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no material legal proceedings during the quarter ended June 30, 2025 - No material legal proceedings were reported for the quarter ended June 30, 2025[228](index=228&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the risk factors from the Annual Report on Form 10-KT, highlighting Nasdaq non-compliance and potential delisting risks - The company refers to the risk factors detailed in its Annual Report on Form 10-KT filed on March 25, 2025[229](index=229&type=chunk) - The company is currently not in compliance with Nasdaq's minimum bid price (**$1.00**) and minimum Market Value of Listed Securities (**$35 million**) requirements, facing potential delisting[230](index=230&type=chunk)[232](index=232&type=chunk)[234](index=234&type=chunk) - Non-compliance could adversely affect the market liquidity and price of common stock, and the company's ability to raise capital[236](index=236&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds%20from%20Registered%20Securities) The company reported no unregistered sales of equity securities or use of proceeds from registered securities during the quarter - No unregistered sales of equity securities or use of proceeds from registered securities were reported[237](index=237&type=chunk) [Item 3. Defaults Upon Senior Securities](index=43&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the quarter - No defaults upon senior securities were reported[238](index=238&type=chunk) [Item 4. Mine Safety Disclosures](index=43&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[239](index=239&type=chunk) [Item 5. Other Information](index=43&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter - No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[240](index=240&type=chunk) [Item 6. Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q - Exhibits include certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL documents (101.INS, 101.CAL, 101.SCH, 101.DEF, 101.LAB, 101.PRE, 104)[242](index=242&type=chunk) [SIGNATURES](index=44&type=section&id=SIGNATURES) This section contains the signatures of the principal executive officer, principal financial officer, and directors, certifying the report filing - The report was signed by the Principal Executive Officer (Cheng Liu), Principal Financial Officer (Peter Xu), and Directors on August 11, 2025[247](index=247&type=chunk)[248](index=248&type=chunk)

Financial Performance - Estrella Immunopharma, Inc. reported a net loss of approximately $2.1 million for the three months ended March 31, 2025, compared to a net loss of $0.5 million for the same period in 2024[172]. - As of March 31, 2025, Estrella had an accumulated deficit of approximately $26.0 million[158]. - Net cash used in operating activities was approximately $0.5 million for the three months ended March 31, 2025, primarily due to a net loss of approximately $2.1 million[183]. - The company has not generated any revenue since its inception and does not expect to do so for at least the next few years[174]. - The Company has not generated any revenue from product sales and has no product candidates approved for sale[190]. Research and Development Expenses - Research and development expenses increased significantly to approximately $1.4 million for the three months ended March 31, 2025, from $25,000 in the same period of 2024, primarily due to higher service fees during the clinical phase[169]. - Estrella's research and development expenses for the three months ended March 31, 2025, included $10,188 in stock-based compensation[170]. - The company anticipates significant increases in expenses as it continues to advance preclinical and clinical development and seeks regulatory approval for its product candidates[175]. Cash and Capital Management - As of March 31, 2025, Estrella had cash of approximately $0.4 million and a working capital deficit of approximately $3.3 million[173]. - The Company plans to raise additional capital to continue research and development programs, but there is no assurance that financing will be available on acceptable terms[182]. - The Company has entered into a Common Stock Purchase Agreement allowing for the purchase of up to $50.0 million in shares, subject to stockholder approval for issuances exceeding 20% of outstanding shares[181]. Agreements and Milestones - Estrella has incurred approximately $11.2 million in payments to Eureka for services and upfront fees related to the License Agreement and Services Agreement[158]. - The total fees for the Statement of Work No. 001 related to the STARLIGHT-1 clinical trial amount to $33.0 million for achieving all milestones[176]. - The total fees payable to Eureka under the Statement of Work for the Phase I/II clinical trial of EB103 amount to $33.0 million, with $3.5 million paid as of March 31, 2025[193]. - The Company has fully paid the $1.0 million license fee to Eureka and completed two development milestones, earning milestone payments of $50,000 each[189]. - The Company has accrued approximately $4.1 million in liabilities related to three completed patient dosing milestones as of March 31, 2025[194]. Business Combination - The company completed a Business Combination with TradeUP Acquisition Corp. on September 29, 2023, raising net proceeds of approximately $20.1 million[157]. Stock Performance - As of May 8, 2025, the closing price of the Company's common stock was $1.10 per share, significantly lower than the exercise price of $11.50 for outstanding tradeable warrants[180]. Collaboration Agreements - The research plan under the Collaboration Agreement with Imugene was completed as of August 30, 2023[191].

Financial Performance - As of September 30, 2024, the company reported an accumulated deficit of approximately $22.9 million[171]. - The company incurred a net loss of approximately $3.4 million for the three months ended September 30, 2024, compared to a net loss of $1.9 million for the same period in 2023[184]. - The company had cash of approximately $1.8 million as of September 30, 2024, and has not generated any revenue to date[185][186]. - The company had net cash used in operating activities of approximately $2.2 million, primarily due to a net loss of approximately $3.4 million[198]. - The company anticipates ongoing losses and negative cash flows until product candidates receive regulatory approval and generate revenue[186]. Research and Development Expenses - For the three months ended September 30, 2024, research and development expenses increased to approximately $2.8 million from $0.5 million in the same period of 2023[180]. - The company expects significant increases in expenses related to ongoing research and development and public company operations[187]. - As of September 30, 2024, the company has paid $3.5 million to Eureka for milestone achievements related to the development of EB103[169]. - The company has entered into a Statement of Work with Eureka, agreeing to pay total fees of $33.0 million for milestone achievements in the STARLIGHT-1 clinical trial[169]. - Total fees of $33.0 million are agreed upon for achieving milestones in the STARLIGHT-1 clinical trial, with approximately $6.3 million expensed to Eureka as of September 30, 2024[191]. - The research plan under the Collaboration Agreement with Imugene was completed as of August 30, 2023, with costs shared equally between the parties[208]. Business Combination and Financing - The Business Combination on September 29, 2023, resulted in net proceeds of approximately $20.1 million after various deductions[188]. - The company remitted approximately $9.3 million to Eureka upon consummation of the Business Combination and expects to use the remaining net proceeds for preclinical and clinical development and compliance costs[190]. - The company plans to raise additional capital in the future to continue research and development programs, but the ability to do so is subject to various risks and uncertainties[197]. - The company had net cash provided by financing activities of approximately $20.0 million for the three months ended September 30, 2023, primarily from the Business Combination[201]. Stock and Equity - As of September 30, 2024, the closing price of the company's Common Stock was $1.16 per share, significantly lower than the exercise price of the Warrants at $11.50 per share, making it unlikely for warrant holders to exercise their warrants[194]. - The company has not issued any Equity Line Shares under the Common Stock Purchase Agreement, which allows for the purchase of up to $50.0 million in shares, pending majority stockholder approval[196]. Liabilities and Compensation - The company accrued $2.75 million in liabilities related to two patient dosing milestones completed during the three months ended September 30, 2024[211]. - As of September 30, 2024, the company had fully paid the license fee to Eureka, which included a one-time payment of $1.0 million and milestone payments upon FDA approval[206][205]. Accounting and Reporting - Stock-based compensation costs are recognized as an expense over the requisite service period based on fair value measurements using the Black-Scholes-Merton option-pricing model[217]. - The fair value of stock options is amortized on a straight-line basis over the vesting period, which generally equals the requisite service period[220]. - The company is classified as an emerging growth company, allowing it to delay the adoption of certain accounting standards until they apply to private companies[220]. - The company accounts for equity instruments issued to non-employees using the fair value of services received or the fair value of the equity instrument, whichever is more reliable[219]. - Compensation expense for awards with graded vesting is recognized over the requisite service period applicable to each individual award[220]. - Forfeitures of stock-based awards are recognized when realized, impacting the overall compensation expense[220]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[222].

Financial Performance - The company reported a net loss of approximately $7.3 million for the year ended June 30, 2024, compared to a net loss of $11.1 million for the same period in 2023, indicating a reduction in losses by approximately 34%[618]. - As of June 30, 2024, the company had an accumulated deficit of approximately $19.5 million and cash reserves of approximately $4.2 million[608][619]. - The company has not generated any revenue to date and does not expect to do so for at least the next few years until product candidates receive regulatory approval[620]. - Net cash used in operating activities was approximately $16.1 million for the year ended June 30, 2024, primarily due to a net loss of approximately $7.3 million and a $9.3 million decrease in accounts payable[631]. - Net cash provided by financing activities was approximately $12.8 million for the year ended June 30, 2024, primarily from $20 million net proceeds received from the Business Combination[633]. Research and Development - Research and development expenses decreased to approximately $4.1 million for the year ended June 30, 2024, from $10.5 million in 2023, primarily due to lower service fees with Eureka[615]. - The company anticipates significant increases in expenses as it continues research and development and seeks marketing approval for its product candidates[621]. - The company has entered into a Statement of Work with Eureka for clinical trial services, with total fees of $33 million for achieving specified milestones[605]. - As of June 30, 2024, the company had expensed $3.5 million to Eureka for milestone achievements related to the Phase I/II clinical trial of EB103, with total fees of $33 million for all milestones[624]. Capital and Financing - The company raised net proceeds of approximately $20.1 million from the Business Combination on September 29, 2023, after deducting transaction-related expenses[622]. - The company has funded its operations primarily through the issuance of Series A Preferred Stock and proceeds from the Business Combination, with a focus on advancing clinical development[606]. - The company plans to raise additional capital in the future to continue research and development programs, but there is no assurance that financing will be available on acceptable terms[630]. - The common stock purchase agreement with White Lion allows the company to direct purchases of up to $50 million in common stock, subject to stockholder approval for issuances equaling 20% or more of outstanding shares[628]. Operating Expenses - The company incurred general and administrative expenses of approximately $3.2 million for the year ended June 30, 2024, up from $0.7 million in 2023, largely due to increased professional fees and stock-based compensation[618]. - The company expects to incur additional costs associated with operating as a public company following the Business Combination, including increased audit and legal fees[612]. - The company remitted approximately $9.3 million to Eureka upon the consummation of the Business Combination, with expectations to use remaining net proceeds for preclinical and clinical development and compliance costs[623]. - The company incurred approximately $5.1 million in cash released from the trust account due to the Business Combination, offset by a $0.1 million loan to UPTD[633]. Stock-Based Compensation - Stock-based compensation costs are recognized as an expense over the requisite service period based on fair value measurements using the Black-Scholes-Merton option-pricing model[135]. - The fair value of stock options is estimated at the grant date, considering factors such as expected life, volatility, and risk-free interest rate[135]. - Compensation expense for awards with graded vesting is recognized using the straight-line method over the vesting term[643]. - Forfeitures of stock-based awards are recognized when realized, impacting future compensation expense calculations[643]. - The company accounts for equity instruments issued to non-employees based on the more reliable fair value of services received or the equity instrument itself[643]. - Different assumptions in future grants could materially affect stock-based compensation expense in future periods[643]. Market Risks - The company is subject to various risks and uncertainties that could impact its ability to raise capital and the success of its research and development programs[626]. - The company does not provide quantitative and qualitative disclosures about market risk as it is not required for smaller reporting companies[645]. Stock Performance - The closing price of the company's common stock was $1.05 per share as of June 30, 2024, significantly lower than the warrant exercise price of $11.50 per share, making warrant exercise unlikely[627].

Financial Performance - The company has an accumulated deficit of approximately $15.5 million as of March 31, 2024[180]. - The company incurred a net loss of approximately $0.5 million for the three months ended March 31, 2024, down from $2.7 million for the same period in 2023[190]. - The company incurred a net loss of approximately $3.4 million for the nine months ended March 31, 2024, compared to $8.4 million for the same period in 2023[195]. - As of March 31, 2024, the company reported a net cash used in operating activities of approximately $15.8 million, primarily due to a net loss of $3.4 million and a $9.3 million decrease in accounts payable[209]. Research and Development Expenses - Research and development expenses for the three months ended March 31, 2024, were approximately $25,000, a significant decrease from $2.6 million for the same period in 2023[187]. - For the nine months ended March 31, 2024, research and development expenses were approximately $0.6 million, a decrease from $7.9 million for the same period in 2023[192]. - The company expects significant increases in expenses related to ongoing research and development and public company operations following the Business Combination[199]. General and Administrative Expenses - General and administrative expenses increased to approximately $0.4 million for the three months ended March 31, 2024, compared to $0.1 million for the same period in 2023[189]. - General and administrative expenses for the nine months ended March 31, 2024, were approximately $2.8 million, up from $0.5 million for the same period in 2023[194]. Cash and Financing Activities - As of March 31, 2024, the company had cash of approximately $4.7 million, with no revenue generated to date[196][198]. - The company received net proceeds of approximately $20.1 million from the Business Combination after deducting $5.07 million for stock redemptions and transaction expenses[200]. - Financing activities provided approximately $13.1 million, primarily from the $20 million net proceeds of the Business Combination, offset by transaction costs and stockholder payments[214]. Clinical Trials and Regulatory Approvals - The FDA cleared the IND application for EB103, allowing the company to proceed with the Phase I/II Starlight-1 Clinical Trial expected to commence in the first half of 2024[178]. - The company prepaid $3.5 million to Eureka for the initiation of the Phase I/II clinical trial of EB103, a T-cell therapy, with total fees of $33 million for achieving all milestones[202]. Stock and Equity - The company has issued 312,200 shares of common stock as Founder Shares and 1,107,500 shares as Private Shares, which are entitled to registration rights[225]. - A registration statement was filed with the SEC on October 10, 2023, and was declared effective on December 28, 2023[225]. - The company has the right to require White Lion to purchase up to $50 million in newly issued shares of Common Stock, subject to stockholder approval for issuances exceeding 20% of outstanding shares[223]. Stock-Based Compensation - The company recognizes stock-based compensation costs over the requisite service period based on fair value, using the Black-Scholes-Merton option-pricing model[227]. - Stock-based compensation expense could be materially impacted by changes in assumptions used for future grants[229]. - The company accounts for equity instruments issued to non-employees based on the fair value of services received or the equity instrument, whichever is more reliable[230]. - Compensation expense for awards with graded vesting is recognized over the requisite service period, generally equal to the vesting term[231]. Market and Capital Risks - The company is subject to various uncertainties regarding its ability to raise additional capital, which is critical for ongoing research and development programs[208]. - As of May 13, 2024, the closing price of the company's Common Stock was $1.07 per share, significantly lower than the warrant exercise price of $11.50, making warrant exercise unlikely[206]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[232].

As filed with the U.S. Securities and Exchange Commission on December 15, 2023 Registration No. 333-274931 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ––––––––––––––––––––––––––––– ESTRELLA IMMUNOPHARMA, INC. (Exact Name of Registrant as Specified in its Charter) _____________________________ | Delaware | 6770 | 86-1314502 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard ...