Overview
- TickerESLA on Nasdaq1
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersEmeryville, California1
- Business address5858 Horton Street, Suite 370, Emeryville, Ca 946082
- Filer category, Emerging growth company2
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Effectively progress EB103, our lead product candidate, through clinical development. We believe our autologous T-cell therapies have the potential to overcome major limitations of currently approved CAR-T cells with superior safety and efficacy, allowing access to significantly more patients. As of December 2025, we have completed the dosing of nine patients in the Phase I dose escalation phase of STARLIGHT-1 and have initiated Phase II dose expansion phase at the RP2D. We anticipate completing the Phase II portion of the STARLIGHT-1 clinical trial in 1H2027.3 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 1 fiscal year, latest first.6
| Period ending | 2025-12-31 |
|---|---|
| Research and development (including $10,125,000 for the year ended December 31, 2025 and $2,801,435 for the six months ended December 31, 2024, from a related party) | $10.2M |
| General and administrative | $2.8M |
| Total operating expenses | $13.1M |
| Loss from Operations | -$13.1M |
| Loss before income taxes | -$13.1M |
| Income tax provision | -$838 |
| Net loss | -$13.1M |
| Net loss applicable to common stock per share, basic (in Dollars per share) | -$0.35 |
| Net loss applicable to common stock per share, diluted (in Dollars per share) | -$0.35 |
| Weighted average common stock outstanding, basic (in Shares) | 36.8M shares |
| Weighted average common stock outstanding, diluted (in Shares) | 36.8M shares |
| Research and development - related party | $10.1M |
| General and administrative - related party | $265.4K |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.6
| Period ending | 2025-12-31 | 2024-12-31 | 2024-06-30 |
|---|---|---|---|
| Cash and cash equivalents | $1.4M | $916.9K | |
| Prepaid expenses and other receivable | $292.7K | $723.9K | |
| Total current assets | $1.7M | $1.6M | |
| Prepaid expenses, related party , non-current | $1.5M | $1.5M | |
| Total Assets | $3.2M | $3.1M | |
| Other payables and accrued liabilities | $238.4K | $201.8K | |
| Derivative liabilities | $356.5K | ||
| Franchise tax payable | $4.1K | ||
| Income tax payable | $50 | ||
| Total current liabilities | $13.5M | $3.0M | |
| Total Liabilities | $13.5M | $3.0M | |
| Common stock, $0.0001 par value; 250,000,000 shares authorized; 38,486,219 and 36,680,870 shares issued as of December 31, 2025 and 2024, respectively | $3.8K | $3.7K | |
| Additional paid-in capital | $27.2M | $24.6M | |
| Accumulated deficit | -$37.0M | -$23.9M | |
| Treasury stock, at cost 515,281 and 486,979 shares as of December 31, 2025 and 2024, respectively | -$598.4K | -$568.9K | |
| Total Stockholders (Deficit) Equity | -$10.4M | $143.7K | $4.3M |
| Total Liabilities and Stockholders (Deficit) Equity | $3.2M | $3.1M | |
| Preferred Stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred Stock, shares authorized (in Shares) | 10.0M shares | 10.0M shares | |
| Preferred Stock, shares issued (in Shares) | 0 shares | 0 shares | |
| Preferred Stock, shares outstanding (in Shares) | 0 shares | 0 shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 250.0M shares | 250.0M shares | |
| Common stock, shares issued (in Shares) | 38.5M shares | 36.7M shares | |
| Treasury stock, cost (in Shares) | 515.3K shares | 487.0K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2024-06-30 |
|---|---|---|---|
| Cash and cash equivalents | $1.4M | $916.9K | |
| Prepaid expenses and other receivable | $292.7K | $723.9K | |
| Total current assets | $1.7M | $1.6M | |
| Prepaid expenses, related party , non-current | $1.5M | $1.5M | |
| Total Assets | $3.2M | $3.1M | |
| Other payables and accrued liabilities | $238.4K | $201.8K | |
| Derivative liabilities | $356.5K | ||
| Franchise tax payable | $4.1K | ||
| Income tax payable | $50 | ||
| Total current liabilities | $13.5M | $3.0M | |
| Total Liabilities | $13.5M | $3.0M | |
| Common stock, $0.0001 par value; 250,000,000 shares authorized; 38,486,219 and 36,680,870 shares issued as of December 31, 2025 and 2024, respectively | $3.8K | $3.7K | |
| Additional paid-in capital | $27.2M | $24.6M | |
| Accumulated deficit | -$37.0M | -$23.9M | |
| Treasury stock, at cost 515,281 and 486,979 shares as of December 31, 2025 and 2024, respectively | -$598.4K | -$568.9K | |
| Total Stockholders (Deficit) Equity | -$10.4M | $143.7K | $4.3M |
| Total Liabilities and Stockholders (Deficit) Equity | $3.2M | $3.1M | |
| Preferred Stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred Stock, shares authorized (in Shares) | 10.0M shares | 10.0M shares | |
| Preferred Stock, shares issued (in Shares) | 0 shares | 0 shares | |
| Preferred Stock, shares outstanding (in Shares) | 0 shares | 0 shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 250.0M shares | 250.0M shares | |
| Common stock, shares issued (in Shares) | 38.5M shares | 36.7M shares | |
| Treasury stock, cost (in Shares) | 515.3K shares | 487.0K shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 1 fiscal year, latest first.6
| Period ending | 2025-12-31 |
|---|---|
| Net loss | -$13.1M |
| Stock-based compensation | $619.0K |
| Change in fair value of derivative liabilities | $38.2K |
| Prepaid expenses and other receivable | $431.2K |
| Accounts payable - related party | $550.3K |
| Other payables and accrued liabilities | $36.7K |
| Accrued liability - related party | $9.6M |
| Franchise tax payable | -$4.1K |
| Income tax payables | -$50 |
| Net cash used in operating activities | -$1.8M |
| Payments of transactions cost | -$117.5K |
| Proceeds from issuance of common stock for PIPE investment | $2.4M |
| Purchase of treasury stock | -$29.5K |
| Net cash provided by (used in) financing activities | $2.3M |
| Net Change in Cash | $467.4K |
| Cash paid for income tax | $913 |
| Recognition of derivative liabilities upon closing of the PIPE investment | $318.3K |
No quarter-by-quarter statement was filed.
Corporate structure
Estrella Immunopharma, Inc. sits at the top of its group. 1 entity on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Estrella Immunopharma, Inc.
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Estrella Immunopharma, Inc., latest Aug 14, 2026 (2 filings since May 15, 2026)
- Eureka Therapeutics, Inc. Filed SC 13D on Estrella Immunopharma, Inc., latest Oct 30, 2023
- Karpus Management, Inc. Filed SC 13G/A on Estrella Immunopharma, Inc., latest Mar 10, 2023 (4 filings since Oct 8, 2021)
- ATW SPAC MANAGEMENT LLC Filed SC 13G/A on Estrella Immunopharma, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
- BOOTHBAY FUND MANAGEMENT, LLC Filed SC 13G/A on Estrella Immunopharma, Inc., latest Jan 31, 2023 (2 filings since Feb 4, 2022)
- Jianwei Li Filed SC 13G/A on Estrella Immunopharma, Inc., latest Mar 17, 2022
- Space Summit Capital LLC Filed SC 13G/A on Estrella Immunopharma, Inc., latest Feb 2, 2022
- K2 PRINCIPAL FUND, L.P. Filed SC 13G/A on Estrella Immunopharma, Inc., latest Oct 8, 2021
- Estrella Immunopharma, Inc. Emeryville, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Estrella Immunopharma, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $1.4M6 Dec 31, 2025 | $916.9K6 Dec 31, 2024 | +51.0% |
| Deposits held (banks) | $1.5M6 Dec 31, 2025 | $1.5M9 Dec 31, 2024 | 0% |
Properties, in its own words
Our principal executive office in the U.S., which we lease, is located at 5858 Horton Street, Suite 370, Emeryville, CA 94608. The Company does not own any real estate. We believe that our existing office space is sufficient for our current needs.
Item 2 of the 10-K filed Mar 18, 2026.3
Leadership
Who has led Estrella Immunopharma, Inc., and when. Pick a name to see everywhere that person has worked.
Chief financial officer
Board members and other officers (4)
- Board memberDengyao Jia Oct 1, 2025 to now11
- Board memberXuejun Janelle Wu Oct 10, 2023 to Oct 10, 202312
- Board memberWeston Twigg Jul 22, 2021 to Jul 22, 202113
- Board memberTao Jiang Jul 26, 2021 to Jul 26, 202114
Former names
- TradeUP Acquisition Corp.Feb 19, 2021 to Sep 20, 20232
Timeline
- Sep 8, 20268-K Listing notice or transfer15
- Aug 21, 20268-K Listing notice or transfer16
- Jun 30, 20268-K Shareholder vote17
- Jan 13, 20268-K Listing notice or transfer18
- Jan 6, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure19
- Dec 4, 20258-K Other events20
- Nov 6, 20258-K Other events21
- Sep 29, 20258-K Other events22
- Sep 26, 20258-K Executive or director change23
- Aug 7, 20258-K Listing notice or transfer24
- Jun 5, 20258-K Other events25
- Jun 3, 20258-K Entered a material agreement; Unregistered sale of shares; Other events26
Calendar
Drug trials and FDA: coming up
- Jul 31, 2027Phase 1/2 trial readout expected Phase 1/2 trial of EB103 in B-Cell Non-Hodgkin's Lymphoma (NHL): primary completion expected Jul 31, 2027 (ClinicalTrials.gov NCT06343311).27
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
209 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 60 major events, 24 insider forms, 14 large holders, 89 other. The latest 20:
- Sep 8, 20268-K CURRENT REPORT EDGAR
- Aug 26, 20264 PRIMARY DOCUMENT EDGAR
- Aug 25, 20264 EDGAR
- Aug 21, 20268-K CURRENT REPORT EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 13, 202610-Q QUARTERLY REPORT EDGAR
- Jun 30, 20268-K CURRENT REPORT EDGAR
- May 27, 2026DEF 14A EDGAR
- May 18, 202610-Q QUARTERLY REPORT EDGAR
- May 18, 2026NT 10-Q NOTIFICATION OF LATE FILING EDGAR
- May 15, 2026SCHEDULE 13G EDGAR
- Apr 30, 202610-K/A AMENDMENT NO. 1 TO FORM 10-K EDGAR
- Apr 29, 20264 EDGAR
- Mar 18, 202610-K ANNUAL REPORT EDGAR
- Feb 13, 2026424B3 PROSPECTUS EDGAR
- Jan 23, 2026EFFECT EDGAR
- Jan 22, 2026CORRESP EDGAR
- Jan 22, 2026S-1/A REGISTRATION STATEMENT EDGAR
- Jan 16, 2026S-1/A REGISTRATION STATEMENT EDGAR
- Jan 13, 20268-K CURREN REPORT EDGAR
The 209 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
4 open-market trades by officers, directors and large owners since October 2021: 4 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Oct 7, 2025 | Xu JiandongChief Financial Officer | Buy | 1,000 | $1.33 | $1.3K | Form 4 |
| Sep 22, 2025 | Xu JiandongChief Financial Officer | Buy | 1,000 | $1.16 | $1.2K | Form 4 |
| Sep 11, 2025 | Xu JiandongChief Financial Officer | Buy | 100 | $1.04 | $104 | Form 4 |
| Mar 4, 2022 | Li Jianwei | Buy | 141,970 | $314,700.00 | $44.7B | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 2 filings May 15, 2026 to Aug 14, 202628
- Eureka Therapeutics, Inc.SC 13D, 1 filing Oct 30, 202329
- Karpus Management, Inc.SC 13G/A, 4 filings Oct 8, 2021 to Mar 10, 202330
- ATW SPAC MANAGEMENT LLCSC 13G/A, 2 filings Feb 14, 2022 to Feb 14, 202331
- BOOTHBAY FUND MANAGEMENT, LLCSC 13G/A, 2 filings Feb 4, 2022 to Jan 31, 202332
- Jianwei LiSC 13G/A, 1 filing Mar 17, 202233
- Space Summit Capital LLCSC 13G/A, 1 filing Feb 2, 202234
- K2 PRINCIPAL FUND, L.P.SC 13G/A, 1 filing Oct 8, 202135
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Armistice Capital, LLC | 3,975,220 | $4.1M | 0.1% | −123,780 |
| Vanguard Capital Management LLC | 416,852 | $433.5K | 0.0% | +34,383 |
| Geode Capital Management, LLC | 141,321 | $147.0K | 0.0% | −16,164 |
| Vanguard Fiduciary Trust Co | 64,921 | $67.5K | 0.0% | No change |
| BlackRock, Inc. | 52,033 | $54.1K | 0.0% | +12,143 |
| State Street Corp | 43,252 | $45.0K | 0.0% | No change |
| Renaissance Technologies LLC | 39,100 | $40.7K | 0.0% | −23,695 |
| Northern Trust Corp | 34,861 | $36.3K | 0.0% | +15,237 |
| Us Bancorp \de\ | 20,000 | $20.8K | 0.0% | +3,096 |
| Tower Research Capital LLC (TRC) | 3,308 | $3.4K | 0.0% | −1,551 |
| UBS Group AG | 1,721 | $1.8K | 0.0% | −13,358 |
| Toronto Dominion Bank | 1,089 | $1.1K | 0.0% | No change |
| Wolverine Asset Management LLC | 468 | $487 | 0.0% | No change |
| Barclays PLC | 126 | $131 | 0.0% | New |
| Caitong International Asset Management Co., Ltd | 2 | $2 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Estrella Immunopharma, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGAREstrella Immunopharma, Inc.1
- CIK0001844417
- Employer ID (EIN)86-13145023
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address5858 Horton Street, Suite 370, Emeryville, CA 946081
- Phone(510) 318-90981
- Shares outstanding43,497,864 as of Aug 11, 20268
- Public float$20.5M as of Mar 12, 20263
- AuditorMacias Gini & O’Connell LLP, Irvine, California PCAOB ID 324; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceFeb 19, 20211
- Filings255 in all: 8-K (61), CORRESP (22), 3 (17), UPLOAD (17), 424B3 (16), 10-Q (15), 425 (15), 4 (14)1
All 35 form types
S-1/A (13), SC 13G/A (9), S-4/A (7), SC 13G (6), EFFECT (5), 10-K (4), DEF 14A (3), NT 10-Q (3), S-1 (3), SEC STAFF LETTER (3), 10-K/A (2), 8-K/A (2), DEFA14A (2), PRE 14A (2), PRER14A (2), 10-KT (1), 25-NSE (1), 424B4 (1), 424B5 (1), 8-A12B (1), CERT (1), S-3 (1), S-4 (1), S-8 (1), SC 13D (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 18, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) May 27, 2026
Latest 8-K (8-K) Sep 8, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | ESLA | Nasdaq |
| Warrants, each warrant exercisable for one share of Common Stock, each at an exercise price of $11.50 per share | ESLAW | Nasdaq |
From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Estrella Immunopharma, Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 72 risks under these headings, as written.3
- Risks Related to Estrella’s Operating History and Financial Condition
- We are a clinical stage biotechnology company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
- We will need substantial additional funds to advance development of product candidates, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or potential future product candidates and technologies.
- Members of our management team have limited experience in managing the day-to-day operations of a public company and, as a result, we may incur additional expenses associated with the management of our company.
- Our consolidated financial statements expressing substantial doubt about our ability to continue as a going concern due to our history of recurring losses and our expectation that negative cash flows from operations will continue until we can generate sufficient revenue. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations.
- Risks Related to the Development and Clinical Testing of Our Product Candidates
- Our current product candidates are in either preclinical or clinical development. One or all of our current product candidates may fail in clinical development or suffer delays that materially and adversely affect their commercial viability.
- We may not be successful in our efforts to use and expand our use of the ARTEMIS® platform to expand our pipeline of product candidates.
- Although we intend to explore other therapeutic opportunities in addition to the product candidates that we are currently developing, we may fail to identify viable new product candidates for clinical development for a number of reasons. If we fail to identify additional potential product candidates, our business could be materially harmed.
- The occurrence of serious complications or side effects in connection with use of our product candidates, either in clinical trials or post-approval, could lead to discontinuation of our clinical development programs, refusal of regulatory authorities to approve our product candidates or, post-approval, revocation of marketing authorizations or refusal to approve applications for new indications, which could severely harm our business, prospects, operating results and financial condition.
- While our IND for EB103 was cleared by the FDA on March 2, 2023 and we believe our pipeline will yield additional INDs, we may not be able to file additional INDs to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
- Interim, topline and preliminary data that we announce or publish from time to time for any clinical trials that we initiate may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data.
The other 62 risks
- We and our collaborators may not achieve projected discovery and development milestones and other anticipated key events in the time frames that we or they announce, which could have an adverse impact on our business and could cause our stock price to decline.
- Clinical trials are expensive, time-consuming, and difficult to design and implement.
- If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- If clinical trials for our product candidates are prolonged, delayed, or stopped, we may be unable to seek or obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue.
- If we decide to seek orphan drug designation for one or more of our product candidates, we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation for our current or future product candidates that we may develop.
- We may not be able to conduct, or contract with others to conduct, animal testing in the future, which could harm our research and development activities.
- Risks Related to Third Parties
- We rely on third parties to conduct our preclinical studies and our clinical trial for EB103, and plan to rely on third parties to conduct any clinical trials for our other product candidates, and those third parties may not perform satisfactorily.
- We depend on strategic partnerships, such as the Licensing Agreement with Eureka and may in the future depend on collaborations, such as our prior Collaboration Agreement with Imugene, for the development and commercialization of EB103, EB104, and future product candidates in certain indications, and if these arrangements are unsuccessful, this could impair our ability to generate revenues and materially harm our results of operations.
- We may not realize the anticipated benefits of our prior collaboration agreement with Imugene.
- We may not be able to enter into additional strategic transactions on acceptable terms, if at all, which could adversely affect our ability to develop and commercialize current and potential future product candidates and technologies, impact our cash position, increase our expenses and present significant distractions to our management.
- The manufacturing of our product candidates is complex. We may encounter difficulties in production, and because we currently rely on Eureka as our sole supplier of clinical drug product, any such difficulties or any disruption in our relationship with Eureka could delay or halt our clinical programs and, if approved, commercial supply.
- Changes in methods of product candidate manufacturing or formulation may result in the need to perform new clinical trials, which would require additional costs and cause delay.
- Risks Related to Our Business and Operations
- If the market opportunities for our current and potential future product candidates, are smaller than we believe they are, our future product revenues may be adversely affected, and our business may suffer.
- Our management has a limited understanding of artificial intelligence (“AI”), and may not be able to fully assess potential risks posed to our business by AI or to capture any potential benefits to our business AI could provide. In the event AI is used to better effect by our competitors it could lead to countervailing discoveries that may undermine our current pipeline. Our limited understanding of AI could also lead to potential security risks and breaches.
- We face competition from companies that have developed or may develop product candidates for the treatment of the diseases that we may target, including companies developing novel therapies and platform technologies. If these companies develop therapies or platform technologies more rapidly than we do, or if their therapies or platform technologies are more effective or have fewer side effects, our ability to develop and successfully commercialize therapies may be adversely affected.
- Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan.
- We may experience difficulties in managing our growth and expanding our operations.
- If any of our product candidates is approved for marketing and commercialization in the future and we are unable to develop sales, marketing, and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, we will be unable to successfully commercialize any such future products.
- Public opinion and scrutiny of immunotherapy approaches may impact public perception of Estrella and product candidates, or may adversely affect our ability to conduct our business and our business plans.
- Our potential future international operations may expose us to business, political, operational, and financial risks associated with doing business outside of the United States.
- Our business entails a significant risk of product liability, and our inability to obtain sufficient insurance coverage could have a material adverse effect on our business, financial condition, results of operations and prospects.
- Our employees, principal investigators, consultants, and commercial collaborators may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We depend on sophisticated information technology systems and data processing to operate our business. If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, we may face costs, significant liabilities, harm to our brand, and business disruption.
- If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
- Our business, operations, financial position and clinical development plans and timelines could be materially adversely affected by the continuing military action in Ukraine, the war between Israel and Hamas, and the armed conflict between the United States/Israel and Iran.
- Recent volatility in capital markets and lower market prices for our securities may affect our ability to access new capital through sales of shares of our Common Stock or issuance of indebtedness, which may harm our liquidity, limit our ability to grow our business, pursue acquisitions or improve our operating infrastructure and restrict our ability to compete in our markets.
- Inflation and higher interest rates could increase our operating costs and adversely affect our liquidity and ability to raise capital.
- Risks Related to the Separation and Our Relationship with Eureka
- We will incur incremental costs as a standalone public company.
- Certain of our officers or directors may have actual or potential conflicts of interest because of their equity interests in or positions with Eureka.
- We rely on Eureka for our research and development efforts.
- Risks Related to Our Intellectual Property
- If we are unable to obtain or protect intellectual property rights related to our in-licensed technology, future technologies and current or future product candidates, or if our intellectual property rights are inadequate, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market or successfully commercialize any product candidates we may develop.
- Our in-licensed patent rights may not cover our products or processes, including ARTEMIS®, or any otherwise viable commercial products or processes and/or may be invalid or unenforceable
- Our licenses and other material contracts may be invalid, unenforceable, or limited as to intellectual property and/or may impede, limit, or eliminate our ability to secure or protect our intellectual property, including in-licensed patent rights and any future developments.
- The patent protection and patent prosecution for some of our product candidates and technologies may be dependent on third parties.
- We may be unable to acquire or in-license any relevant third-party intellectual property rights that we identify as necessary or important to our business operations.
- We currently, and in the future may continue to, enter into agreements involving licenses or collaborations that provide for access or sharing of intellectual property. These intellectual property-related agreements may impose certain obligations and restrictions on our ability to develop and commercialize our product candidates and technologies that are the subject of such licenses.
- If we fail to comply with our obligations under any existing or future license, collaboration or other intellectual property-related agreements, we may be required to pay damages and could lose intellectual property rights that may be necessary for developing, commercializing and protecting our current or future technologies or product candidates or we could lose certain rights to grant sublicenses.
- Patent terms may not be able to protect our competitive position for an adequate period of time with respect to our current or future technologies or product candidates.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current or any future technologies or product candidates.
- We or our licensors may be subject to lawsuits or litigation to protect or enforce our in-licensed patents or other intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products.
- We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
- Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or violating their intellectual property rights, or seeking to invalidate or avoid our in-licensed patent rights, the outcome of which would be uncertain and could have a material adverse impact on the success of our business.
- Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our Common Stock to decline.
- Intellectual property rights of third parties could adversely affect our ability to commercialize our current in-licensed technologies or future technologies or product candidates, and we might be required to litigate or obtain licenses from third parties to develop or market our current in-licensed technologies or future technologies or product candidates, which may not be available on commercially reasonable terms or at all.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets or other proprietary information of third parties, including our employees’ or consultants’ former employers or their clients.
- Our licensors or we may be subject to claims challenging the inventorship of our in-licensed patents and other intellectual property.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our licensors’ patent protection could be reduced or eliminated for non-compliance with these requirements.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- Intellectual property rights do not necessarily address all potential threats to our business.
- If any negative data were to arise with respect to the use of our licensed technology in territories where such technology is licensed to a third party, it could negatively affect our ability to develop our product candidates in territories where we license such technology.
- Risks Related to Government Regulation
- Clinical development includes a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
- We may be unable to obtain U.S. or foreign regulatory approval and, as a result, be unable to commercialize our current or potential future product candidates.
- Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
- Even if we receive regulatory approval for any of our current or potential future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our current or potential future product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
- Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
- Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
- Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
- If we or our existing or potential future collaborators, manufacturers or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions, which could affect our ability to develop, market and sell our product candidates and may harm our reputation.
- If we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm our business.
- Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
- We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal or civil liability and harm our business.
- General Risk Factors
Legal proceedings
From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. We currently are not a party to any material litigation or other material legal proceedings.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 10SEC EDGARLuqi Wen, Chief financial officer
- 11SEC EDGARDengyao Jia, Board member
- 12SEC EDGARXuejun Janelle Wu, Board member
- 13SEC EDGARWeston Twigg, Board member
- 14SEC EDGARTao Jiang, Board member
- 15SEC EDGARListing notice or transfer
- 16SEC EDGARListing notice or transfer
- 17SEC EDGARShareholder vote
- 18SEC EDGARListing notice or transfer
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- 20SEC EDGAROther events
- 21SEC EDGAROther events
- 22SEC EDGAROther events
- 23SEC EDGARExecutive or director change
- 24SEC EDGARListing notice or transfer
- 25SEC EDGAROther events
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