Overview
- TickerGRML on Nasdaq1
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersOmaha, Nebraska1
- Business address13576 Walnut Street, Suite A, Omaha, Ne 681442
- Filer category, Emerging growth company2
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Corp., in a transaction that expands the Company’s operations into the development and mining of critical and precious minerals.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 2 fiscal years, latest first.6
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Professional fees | $3.4M | $2.8M |
| General and administrative | $3.1M | $2.8M |
| Research and development | $634.2K | |
| Total operating expenses | $7.1M | $5.5M |
| Net operating loss | -$7.1M | -$5.5M |
| Interest expense | -$2.3M | -$356.6K |
| Change in fair value of warrant liability | -$28.5K | -$2.0K |
| Settlement expense | $1.2M | |
| Other income (expense) | $115.1K | -$251.6K |
| Total other income (expense) | -$3.4M | -$610.1K |
| Net loss before income taxes | -$10.6M | -$6.2M |
| Net loss | -$10.6M | -$6.2M |
| Net loss per share: Basic (in Dollars per share) | -$0.22 | -$0.32 |
| Net loss per share: Diluted (in Dollars per share) | -$0.22 | -$0.32 |
| Weighted average common shares outstanding (in Shares) | 48.5M shares | 19.2M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.6
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 | 2022-08-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $7.2M | $63.7K | ||
| Prepaid expenses | $117.1K | $94.1K | ||
| Total current assets | $7.3M | $157.8K | ||
| Licenses | $2.3M | $2.3M | ||
| Patents | $48.4K | $48.4K | ||
| Total other assets | $2.3M | $2.3M | ||
| Total assets | $9.6M | $2.5M | ||
| Accounts payable | $44.6K | $63.7K | ||
| Accrued expenses | $32.2K | $912.1K | ||
| Notes payable | $240.8K | $1.3M | ||
| Total current liabilities | $76.8K | $1.2M | ||
| Warrant liability | $53.0K | $24.5K | ||
| Total liabilities | $129.8K | $1.3M | ||
| Common stock, par value $0.0001, 1,000,000,000 shares authorized; 72,536,722 and 27,080,915 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $7.3K | $2.7K | ||
| Common stock to be issued | $516.0K | |||
| Additional paid-in capital | $30.1M | $11.7M | ||
| Accumulated deficit | -$21.1M | -$10.6M | ||
| Total stockholders equity | $9.5M | $1.2M | -$442.7K | |
| Total liabilities and stockholders equity | $9.6M | $2.5M | ||
| Preferred stock, par value (in Dollars per share) | $0.00 | $0.00 | ||
| Preferred stock, shares authorized (in Shares) | 100.0M shares | 100.0M 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) | 1.0B shares | 1.0B shares | ||
| Common stock, shares issued (in Shares) | 72.5M shares | 27.1M shares | ||
| Common stock, shares outstanding (in Shares) | 72.5M shares | 27.1M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 | 2022-08-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $7.2M | $63.7K | ||
| Prepaid expenses | $117.1K | $94.1K | ||
| Total current assets | $7.3M | $157.8K | ||
| Licenses | $2.3M | $2.3M | ||
| Patents | $48.4K | $48.4K | ||
| Total other assets | $2.3M | $2.3M | ||
| Total assets | $9.6M | $2.5M | ||
| Accounts payable | $44.6K | $63.7K | ||
| Accrued expenses | $32.2K | $912.1K | ||
| Notes payable | $240.8K | $1.3M | ||
| Total current liabilities | $76.8K | $1.2M | ||
| Warrant liability | $53.0K | $24.5K | ||
| Total liabilities | $129.8K | $1.3M | ||
| Common stock, par value $0.0001, 1,000,000,000 shares authorized; 72,536,722 and 27,080,915 shares issued and outstanding as of December 31, 2025 and 2024, respectively | $7.3K | $2.7K | ||
| Common stock to be issued | $516.0K | |||
| Additional paid-in capital | $30.1M | $11.7M | ||
| Accumulated deficit | -$21.1M | -$10.6M | ||
| Total stockholders equity | $9.5M | $1.2M | -$442.7K | |
| Total liabilities and stockholders equity | $9.6M | $2.5M | ||
| Preferred stock, par value (in Dollars per share) | $0.00 | $0.00 | ||
| Preferred stock, shares authorized (in Shares) | 100.0M shares | 100.0M 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) | 1.0B shares | 1.0B shares | ||
| Common stock, shares issued (in Shares) | 72.5M shares | 27.1M shares | ||
| Common stock, shares outstanding (in Shares) | 72.5M shares | 27.1M 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 2 fiscal years, latest first.6
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$10.6M | -$6.2M |
| Changes in fair value of warrant liability | $28.5K | $2.0K |
| Commitment fee | $250.0K | |
| Impairment on intangible assets | $10.0K | |
| Interest expense | $2.3M | $141.8K |
| Settlement on note payable | $1.2M | |
| Conversion of debt to equity | $448.8K | |
| Consulting fees | $516.0K | |
| Stock-based compensation | $1.6M | $2.6M |
| Prepaid expenses | -$23.0K | -$90.2K |
| Accounts payable | -$19.1K | -$187.6K |
| Accrued expenses | -$879.9K | $1.1M |
| Tax payable | -$568.1K | |
| Related party payable | -$31.0K | -$128.0K |
| Other Liabilities | $60.0K | |
| Net cash used in operating activities | -$5.9M | -$2.9M |
| Acquisition of drug license | -$123.5K | |
| Net cash used in investing activities | -$123.5K | |
| Proceeds from convertible promissory note, net of issuance cost | $2.1M | $2.1M |
| Proceeds from sales of stocks and warrants, net | $11.4M | $175.0K |
| Proceeds from stock subscriptions | $500.0K | |
| Proceeds from sale of preferred B shares | $500.0K | |
| Payments on notes payable | -$2.7M | |
| Payments for deferred financing costs | -$25.0K | |
| Proceeds from FPA settlement | $140.6K | |
| Payments on financed director and officer insurance | -$40.2K | |
| Proceeds from At-the-Market sales of common shares | $1.1M | |
| Proceeds from related party loans | $100.0K | |
| Proceeds from shareholders | $120.0K | |
| Payments to shareholders | -$120.0K | |
| Merger proceeds net of transaction cost | $778.9K | |
| Net cash provided by financing activities | $13.0M | $3.1M |
| NET CHANGE IN CASH | $7.1M | $60.9K |
| Note payable settled with issuance of common stock | $1.5M | $5.3M |
| Interest payable settled with issuance of common stock | $57.6K | $60.0K |
| Reversal of OID | $681.5K | |
| Repurchase of warrants | $679.6K | |
| Issuance of warrants | -$679.6K | |
| Discretionary non-cash payment to creditor with issuance of common stock | $202 | $154.8K |
| Conversion of Preferred B Shares to common stock | -$625 | |
| Deemed dividend - warrant modification | -$1.5M | |
| Non-cash equity payment for inducement fee on note payable | $978.0K | |
| Non-cash directors and officers insurance | $154.5K | |
| Non-cash PIPE Funds used for merger transaction close | $3.0M | |
| Commitment fee paid in stock | $250.0K | |
| Assumed income tax payable from merger | $568.1K | |
| Assumed warrant liability from merger | $22.5K | |
| Warrant conversion | $96.2K | |
| Interest Paid | $79.2K | $2.5K |
| Taxes Paid | $551.6K |
No quarter-by-quarter statement was filed.
Corporate structure
Greenland Mines Ltd 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 Greenland Mines Ltd
- DAVIDSON KEMPNER CAPITAL MANAGEMENT LP Filed SCHEDULE 13G on Greenland Mines Ltd, latest Sep 2, 2026
- Strategic EP, LLC Filed SCHEDULE 13G on Greenland Mines Ltd, latest Mar 13, 2026
- Austria Capital LLC Filed SCHEDULE 13G/A on Greenland Mines Ltd, latest Jul 2, 2025 (2 filings since Jul 2, 2025)
- CHARDAN CAPITAL MARKETS LLC Filed SC 13G on Greenland Mines Ltd, latest Jun 27, 2024
- Shaolin Capital Management LLC Filed SC 13G/A on Greenland Mines Ltd, latest Feb 22, 2024 (2 filings since Feb 14, 2023)
- MMCAP International Inc. SPC Filed SC 13G/A on Greenland Mines Ltd, latest Feb 13, 2024 (3 filings since Apr 7, 2022)
- Space Summit Capital LLC Filed SC 13G/A on Greenland Mines Ltd, latest Feb 8, 2023 (2 filings since Apr 1, 2022)
- Lawrence Feis Filed SC 13G/A on Greenland Mines Ltd, latest Jan 6, 2023 (2 filings since Apr 7, 2022)
- Greenland Mines Ltd Omaha, Nebraska
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Greenland Mines Ltd 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 | $7.2M6 Dec 31, 2025 | $63.7K6 Dec 31, 2024 | +11159.0% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Patents, net | $48.4K6 Dec 31, 2025 | $48.4K6 Dec 31, 2024 | 0% |
| Licenses, net | $2.3M6 Dec 31, 2025 | $2.3M6 Dec 31, 2024 | 0% |
Properties, in its own words
The Company does not directly own or lease any material physical properties. The Company is currently using two (2) offices in Charlotte, NC and Omaha, NE, each consisting of approximately 400 sq ft square feet. The Omaha, NE office is provided for the Company’s use rent-free by the Company’s CEO. We rent out Charlotte, NC office for $700 a month, or $8,400 annually. We believe that our facilities are generally in good condition and suitable for operating our business.
Our principal executive office is located at 1300 South Boulevard, Suite D, Charlotte, NC 28203.
Item 2 of the 10-K filed Apr 1, 2026.3
Leadership
Who has led Greenland Mines Ltd, and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerJoseph Sinkule Aug 8, 2025 to now10
- Chief executive officerJiande Chen Mar 30, 2022 to Mar 30, 202211
- Chief financial officerJeff Leblanc Aug 8, 2025 to now12
- Chief financial officerCong Edward Wang Mar 30, 2022 to Mar 30, 202213
Board members and other officers (9)
- Board memberJason David Sawyer Jul 23, 2026 to now14
- Board memberJoseph Sinkule Aug 8, 2025 to now10
- Board memberRiad Hussein El-Dada Aug 8, 2025 to now15
- Board memberSamuel M. Zentman Aug 8, 2025 to now16
- Board memberShalom Hirschman Aug 8, 2025 to now17
- Board memberCong Edward Wang Mar 30, 2022 to Mar 30, 202213
- Board memberJiande Chen Mar 30, 2022 to Mar 30, 202211
- Board memberRaymond John Gibbs Mar 30, 2022 to Mar 30, 202218
- Board memberWeikwang Ng Mar 30, 2022 to Mar 30, 202219
Former names
Timeline
- Oct 2, 20268-K Executive or director change20
- Sep 28, 20268-K Entered a material agreement21
- Sep 23, 20268-K Entered a material agreement22
- Sep 11, 20268-K Executive or director change23
- Sep 4, 20268-K Entered a material agreement; Completed an acquisition or sale; Unregistered sale of shares24
- Aug 27, 20268-K Entered a material agreement; Regulation FD disclosure25
- Aug 24, 20268-K Entered a material agreement26
- Aug 10, 20268-K Shareholder vote27
- Jul 23, 20268-K Entered a material agreement; Change to shareholders' rights; Other events28
- Jul 21, 20268-K Shareholder vote29
- Jul 20, 20268-K Regulation FD disclosure30
- Jul 8, 20268-K Change of auditor31
- Aug 8, 2025New chief executive Joseph Sinkule becomes CEO10
- Mar 30, 2022New chief executive Jiande Chen becomes CEO11
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/202632
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
266 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 82 major events, 33 insider forms, 14 large holders, 116 other. The latest 20:
- Oct 5, 20264 PRIMARY DOCUMENT EDGAR
- Oct 2, 20268-K CURRENT REPORT EDGAR
- Oct 1, 2026144 EDGAR
- Sep 28, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
- Sep 28, 20268-K CURRENT REPORT EDGAR
- Sep 23, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
- Sep 23, 20268-K CURRENT REPORT EDGAR
- Sep 23, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
- Sep 11, 20268-K CURRENT REPORT EDGAR
- Sep 4, 20268-K CURRENT REPORT EDGAR
- Sep 2, 2026SCHEDULE 13G EDGAR
- Aug 27, 20268-K CURRENT REPORT EDGAR
- Aug 27, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
- Aug 25, 2026424B5 PROSPECTUS SUPPLEMENTAL EDGAR
- Aug 25, 20264 PRIMARY DOCUMENT EDGAR
- Aug 24, 20268-K CURRENT REPORT EDGAR
- Aug 24, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
- Aug 17, 202610-Q QUARTERLY REPORT EDGAR
- Aug 14, 202610-Q/A AMENDMENT NO. 1 TO FORM 10-Q/A EDGAR
- Aug 14, 202610-K/A AMENDMENT NO. 1 TO FORM 10-K EDGAR
The 266 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
10 open-market trades by officers, directors and large owners since October 2021: 6 buys and 4 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 25, 2026 | LeBlanc JeffChief Financial Officer | Buy | 14,000 | $9.72 | $136.1K | Form 4 |
| Jul 22, 2026 | Sawyer Jason DavidDirector | Buy | 240,000 | $0.23 | $55.2K | Form 4 |
| Jul 20, 2026 | McGarity JonDirector | Buy | 140,000 | $0.18 | $25.2K | Form 4 |
| Jul 16, 2026 | LeBlanc JeffChief Financial Officer | Buy | 1,400,000 | $0.18 | $252.0K | Form 4 |
| Jun 25, 2026 | El-Dada Riad HusseinDirector | Sale | 175,000 | $0.23 | $40.2K | Form 4 |
| Jul 2, 2024 | Urbach Steven10% owner | Sale | 180,000 | $2.05 | $369.0K | Form 4 |
| Jul 1, 2024 | Urbach Steven10% owner | Sale | 115,136 | $2.06 | $237.2K | Form 4 |
| Jun 28, 2024 | Urbach Steven10% owner | Sale | 47,000 | $2.53 | $118.9K | Form 4 |
| Apr 7, 2022 | Redwoods Capital LLC10% owner | Buy | 37,500 | $10.00 | $375.0K | Form 4 |
| Apr 4, 2022 | Redwoods Capital LLC10% owner | Buy | 377,500 | $10.00 | $3.8M | 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.
- DAVIDSON KEMPNER CAPITAL MANAGEMENT LPSCHEDULE 13G, 1 filing Sep 2, 202633
- Strategic EP, LLCSCHEDULE 13G, 1 filing Mar 13, 202634
- Austria Capital LLCSCHEDULE 13G/A, 2 filings Jul 2, 202535
- CHARDAN CAPITAL MARKETS LLCSC 13G, 1 filing Jun 27, 202436
- Shaolin Capital Management LLCSC 13G/A, 2 filings Feb 14, 2023 to Feb 22, 202437
- MMCAP International Inc. SPCSC 13G/A, 3 filings Apr 7, 2022 to Feb 13, 202438
- Space Summit Capital LLCSC 13G/A, 2 filings Apr 1, 2022 to Feb 8, 202339
- Lawrence FeisSC 13G/A, 2 filings Apr 7, 2022 to Jan 6, 202340
SEC filer profile
How Greenland Mines Ltd is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARGreenland Mines Ltd1
- CIK0001907223
- Employer ID (EIN)86-27274413
- 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 address13576 Walnut Street, Suite A, Omaha, NE 681441
- Phone(833) 931-63301
- Shares outstanding158,850,637 as of Aug 17, 20268
- Public float$52.6M as of Jun 30, 20253
- AuditorBCRG Group, Irvine, CA PCAOB ID 7158; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceJan 31, 20221
- Filings266 in all: 8-K (79), 4 (26), CORRESP (15), 10-Q (14), 425 (13), UPLOAD (11), NT 10-Q (9), 424B3 (8)1
All 37 form types
424B5 (8), S-4/A (8), 3 (7), PRE 14A (7), DEF 14A (6), EFFECT (6), SC 13G (5), SC 13G/A (5), 10-K (4), S-1 (4), 8-K/A (3), DEFA14A (3), NT 10-K (3), SCHEDULE 13G (3), 10-K/A (2), 144 (2), 8-A12B (2), S-1/A (2), 10-Q/A (1), 25-NSE (1), CERT (1), DEFM14A (1), DEFR14A (1), DRS (1), S-3 (1), S-4 (1), S-8 (1), S-8 POS (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Apr 1, 2026
Quarterly report (10-Q) Aug 17, 2026
Proxy statement (DEF 14A) Jun 22, 2026
Latest 8-K (8-K) Oct 2, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | GRML | Nasdaq |
| Warrants | GRMLW | Nasdaq |
From the cover page of the 10-K filed Apr 1, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Greenland Mines Ltd names in Item 1A of its 10-K filed Apr 1, 2026: 60 risks under these headings, as written.3
- Risks Related to Our Business and Operations
- We are dependent on the success of our biosimilar and gene therapy product candidates, which are still in early stages of development.
- We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
- We are unable to estimate the actual funds that we will require for development and any approved marketing and commercialization activities.
- We may be required to make significant payments to third parties under the agreements pursuant to which we acquired our gene therapy and biosimilar product candidates.
- We are highly dependent on the services of our key executives and personnel, including our Chief Executive Officer, Dr. Joseph Sinkule (Pharm. D.) and if we are not able to retain these members of our management or recruit additional management, clinical and scientific personnel, our business will suffer.
- We need to attract and retain key personnel.
- Our employees, independent contractors, principal investigators, consultants, commercial collaborators, manufacturers, service providers and other vendors, or those of our affiliates, may engage in misconduct or other improper activities.
- Operation of our business internationally exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business in various jurisdictions globally.
- Risks Related to Development of Biosimilar Biologics and Cell and Gene Therapies
- If we are unable to obtain regulatory approval for, or successfully commercialize, bevacizumab-anew, or rituximab-anew, our business will be harmed.
- The evolving regulatory approval processes of the FDA, EMA and comparable foreign authorities are lengthy, time-consuming, rigorous, and inherently unpredictable. If we and our collaboration partners are ultimately unable to obtain regulatory approval for our product candidates, our business will be harmed.
The other 50 risks
- The results of previous clinical trials may not be predictive of future results, and the results of our future clinical trials may not satisfy the requirements of the FDA, EMA or other foreign regulatory agencies.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval.
- If we receive approval, regulatory agencies require that we report certain information about adverse medical events.
- If other biosimilars of bevacizumab (Avastin) or rituximab-anew (Rituxan/Mabthera) are determined to be interchangeable and our biosimilar product candidates for these reference products are not, our business would suffer.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates, and our insurance coverage may not be sufficient to satisfy any liability that may arise.
- Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
- If a regulatory agency discovers previously unknown problems with an approved product, they may impose restrictions on that product.
- We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, more effective, or less expensive than ours.
- Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations.
- If an improved version of a reference product, such as Avastin, is developed or if the market for the reference product significantly declines, sales or potential sales of our biosimilar product candidates may suffer.
- We currently have no marketing and sales organization. If we are unable to establish sales and marketing capabilities in jurisdictions for which we choose to retain commercialization rights, we may be unable to generate any revenue.
- We may need to enter into agreements with other companies that can provide capabilities and funds for the development and commercialization of our product candidates. If we are unsuccessful in forming or maintaining these agreements on favorable terms, our business could be harmed.
- The third-party coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
- Our biosimilar product candidates, if approved, will face price competition from both the respective reference products and other biosimilars.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
- Our AAV-based gene therapy product candidates and our lentiviral-based gene therapy product candidate are based on new gene transfer technology, which makes it difficult to predict the time and cost of product candidate development and of subsequently obtaining regulatory approval.
- Clinical development of our gene therapy candidates will require the development and use of new in vitro assays that can detect and measure different isoforms and metabolites of Klotho.
- Regulatory requirements governing gene therapy products have changed frequently and may continue to change in the future.
- The FDA, NIH and the EMA have each expressed interest in further regulating biotechnology, including gene therapy and genetic testing.
- Even if we obtain FDA approval for our gene therapy product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential.
- Even if our product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payors, or others in the medical community necessary for commercial success.
- Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
- Increasing demand for compassionate use or expanded access of our unapproved therapies could negatively affect our reputation and harm our business.
- Risks Related to Our Reliance on Third Parties
- We will rely on third parties to manufacture and quality control test our product candidates, to conduct our preclinical and clinical trials, and perform other tasks for us.
- We expect to depend on third parties for the commercialization of our biosimilar and gene therapy product candidates in certain major markets outside the United States, and their failure to commercialize in those markets could harm our business and operating results.
- We and RLS, and our gene therapy CDMO, are subject to significant regulation with respect to manufacturing our product candidates. RLS and the CDMO’s manufacturing facilities may not continue to meet regulatory requirements or may not be able to meet supply demands.
- Risks Related to Intellectual Property
- If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
- Third parties may assert that we are employing their proprietary technology without authorization.
- Third parties could bring claims against us that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial monetary damages.
- We may not identify relevant patents or may incorrectly interpret the relevance, scope, or expiration of a patent, which might adversely affect our ability to develop and market our products.
- We may become involved in lawsuits to protect or enforce any future patents, which could be expensive, time-consuming, and unsuccessful.
- We may be unable to obtain and maintain effective patent rights for our product candidates or any future product candidates.
- Obtaining and, once patents are obtained, maintaining our patent protection will depend on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may not be able to protect our intellectual property rights throughout the world.
- Risks Related to Our Business Operations
- We may not be successful in our efforts to identify, develop or commercialize additional product candidates.
- We may be subject, directly or indirectly, to federal and state healthcare laws and regulations, including fraud and abuse, false claims, physician payment transparency and health information privacy and security laws. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
- General Risks
- We are subject to a variety of stringent and changing privacy and data security laws, contractual obligations, self-regulatory schemes, government regulation, and standards related to data privacy and security. The actual or perceived failure by us, our partners, or vendors to comply with such obligations could harm our reputation, subject us to significant fines and liability, disrupt our clinical trials, or otherwise adversely affect our business.
- If our security measures are compromised now, or in the future, or the security, confidentiality, integrity, or availability of, our information technology, software, services, communications or data is compromised, limited or fails, it could result in material harm to our business.
- There is no assurance that we will be able to reach and service customers in a profitable manner.
- We may in the future issue more shares that could cause a loss of control by our present management and current stockholders.
- The elimination of personal liability of director and officers under Delaware law and the existence of indemnification rights held by our directors, officers and employees may result in substantial expenses.
- We may undertake one or more significant corporate transactions that may not achieve their intended results, may adversely affect our financial condition and our results of operations, or result in unforeseeable risks to our business.
- The JOBS Act permits “emerging growth companies” like us to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies.
- We have not paid dividends to date and do not intend to pay any dividends in the near future.
- If large amounts of our common shares held by our existing stockholders are sold in the future, the market price of our common shares could decline.
- Investors may suffer substantial dilution or an unrealized loss of seniority in preferences and privileges if we need to seek additional funding in the future.
- We may need additional capital in the future, which may not be available to us on favorable terms, and may dilute your ownership of our common stock.
- We may expand through acquisitions of, or investments in, other companies or through business relationships, all of which may result in additional dilution to our stockholders and consumption of resources that are necessary to sustain our business.
- If we fail to comply with the continued listing requirements of Nasdaq, specifically, Nasdaq Listing Rule 5450(a)(2), we may face possible delisting, which would result in a limited public market for our shares and make obtaining future debt or equity financing more difficult for us.
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 11SEC EDGARJiande Chen, Chief executive officer
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- 14SEC EDGARJason David Sawyer, Board member
- 15SEC EDGARRiad Hussein El-Dada, Board member
- 16SEC EDGARSamuel M. Zentman, Board member
- 17SEC EDGARShalom Hirschman, Board member
- 18SEC EDGARRaymond John Gibbs, Board member
- 19SEC EDGARWeikwang Ng, Board member
- 20SEC EDGARExecutive or director change
- 21SEC EDGAREntered a material agreement
- 22SEC EDGAREntered a material agreement
- 23SEC EDGARExecutive or director change
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- 26SEC EDGAREntered a material agreement
- 27SEC EDGARShareholder vote
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- 29SEC EDGARShareholder vote
- 30SEC EDGARRegulation FD disclosure
- 31SEC EDGARChange of auditor
- 32NasdaqNasdaq calendar
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