Overview
- TickerINKT on Nasdaq2
- IndustryBiological Products, (No Diagnostic Substances)2
- HeadquartersNew York, United States2
- Incorporated inDE4
- Business address149 Fifth Avenue, Suite 500, New York, Ny 100104
- Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company4
- Legal formCorporation2
- LEI529900Z7778N8ZY89B902
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressc/o The Corporation Trust Company, Corporation Trust Center 1209 Orange Street, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 64674212
See how the biggest companies compare on our leaderboards
MiNK Therapeutics, Inc. (“we,” “our,” or “MiNK”) is focused on developing innovative treatments for cancer and immune-mediated diseases using allogeneic, ex-vivo expanded invariant natural killer T ("iNKT") cells. Amid a broader industry renaissance in innate immunity—highlighted by surging investment and clinical activity in NK, γδ T, and iNKT-based therapies—iNKT cells represent a distinct T cell (“T”) population that uniquely bridges innate and adaptive immunity. They combine durable memory responses characteristic of adaptive T cells with rapid, MHC-independent rapid cytolytic capabilities of natural killer ("NK") cells. This dual functionality enables direct tumor killing via CD1d and stress ligands, potent orchestration of the tumor microenvironment through activation of dendritic cells and NK cells, elimination of immunosuppressive myeloid populations, and restoration of exhausted…6 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.11
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $5.8M | $6.3M |
| General and administrative | $6.7M | $4.3M |
| Change in fair value of related party note | $154.8K | $638.0K |
| Operating loss | -$12.6M | -$11.3M |
| Interest income, net | $180.2K | $172.6K |
| Other income (expense), net | -$32.4K | $330.9K |
| Net loss | -$12.5M | -$10.8M |
| Basic net loss per common share | -$2.93 | -$2.86 |
| Diluted net loss per common share | -$2.93 | -$2.86 |
| Weighted average number of common shares outstanding, basic | 4.3M shares | 3.8M shares |
| Weighted average number of common shares outstanding, diluted | 4.3M shares | 3.8M shares |
| Foreign currency translation loss | -$87.3K | -$200.6K |
| Comprehensive loss | -$12.6M | -$11.0M |
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.11
| Period ending | 2025-12-31 | 2025-01-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $13.4M | $4.6M | ||
| Prepaid expenses | $276.4K | $246.6K | ||
| Other current assets | $211.2K | $164.2K | ||
| Total current assets | $13.8M | $5.0M | ||
| Equipment, net of accumulated depreciation of $612,245 and $524,639 at December 31, 2025 and December 31, 2024, respectively | $390.9K | $732.9K | ||
| Total assets | $14.2M | $5.7M | ||
| Accounts payable | $3.4M | $2.7M | ||
| Accrued liabilities | $1.6M | $1.9M | ||
| Related party note | $5.2M | |||
| Other current liabilities | $2.8M | $2.4M | ||
| Total current liabilities | $13.0M | $7.0M | ||
| Related party note | $4.9M | |||
| Due to related parties | $15.4M | $13.4M | ||
| Common stock, par value $0.00001 per share, 150,000,000 shares authorized, 4,706,246 and 3,963,045 shares issued at December 31, 2025 and December 31, 2024, respectively | $48 | $40 | ||
| Additional paid-in capital | $143.2M | $125.2M | ||
| Accumulated other comprehensive loss | -$718.9K | -$631.6K | ||
| Accumulated deficit | -$156.7M | -$144.2M | ||
| Total stockholders' deficit | -$14.2M | -$19.6M | -$18.1M | |
| Total liabilities and stockholders' deficit | $14.2M | $5.7M | ||
| Equipment, net of accumulated depreciation | $612.2K | $524.6K | ||
| Common stock, par value | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 150.0M shares | 150.0M shares | ||
| Common stock, shares issued | 4.7M shares | 4.0M shares |
| Period ending | 2025-12-31 | 2025-01-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $13.4M | $4.6M | ||
| Prepaid expenses | $276.4K | $246.6K | ||
| Other current assets | $211.2K | $164.2K | ||
| Total current assets | $13.8M | $5.0M | ||
| Equipment, net of accumulated depreciation of $612,245 and $524,639 at December 31, 2025 and December 31, 2024, respectively | $390.9K | $732.9K | ||
| Total assets | $14.2M | $5.7M | ||
| Accounts payable | $3.4M | $2.7M | ||
| Accrued liabilities | $1.6M | $1.9M | ||
| Related party note | $5.2M | |||
| Other current liabilities | $2.8M | $2.4M | ||
| Total current liabilities | $13.0M | $7.0M | ||
| Related party note | $4.9M | |||
| Due to related parties | $15.4M | $13.4M | ||
| Common stock, par value $0.00001 per share, 150,000,000 shares authorized, 4,706,246 and 3,963,045 shares issued at December 31, 2025 and December 31, 2024, respectively | $48 | $40 | ||
| Additional paid-in capital | $143.2M | $125.2M | ||
| Accumulated other comprehensive loss | -$718.9K | -$631.6K | ||
| Accumulated deficit | -$156.7M | -$144.2M | ||
| Total stockholders' deficit | -$14.2M | -$19.6M | -$18.1M | |
| Total liabilities and stockholders' deficit | $14.2M | $5.7M | ||
| Equipment, net of accumulated depreciation | $612.2K | $524.6K | ||
| Common stock, par value | $0.00 | $0.00 | $0.00 | |
| Common stock, shares authorized | 150.0M shares | 150.0M shares | ||
| Common stock, shares issued | 4.7M shares | 4.0M 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.11
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$12.5M | -$10.8M |
| Depreciation | $181.7K | $215.4K |
| Share-based compensation | $2.7M | $1.8M |
| Loss on disposal of assets | $169.8K | |
| Gain on deconsolidation | -$185.4K | |
| Gain on forgiveness of liability | -$1.8M | |
| Change in fair value of related party note | $154.8K | $638.0K |
| Interest accrued on related party note | $100.0K | $79.4K |
| Prepaid expenses | -$29.8K | -$194.2K |
| Accounts payable | $689.7K | -$1.2M |
| Accrued liabilities and other current liabilities | $720.2K | -$393.8K |
| Other operating assets and liabilities | $1.9M | $2.2M |
| Net cash used in operating activities | -$5.9M | -$9.6M |
| Net proceeds from sale of equity | $14.5M | |
| Proceeds from issuance of related party note | $5.0M | |
| Proceeds from sale of shares in private placement | $5.8M | |
| Purchase of treasury shares to satisfy tax withholdings | -$173.4K | |
| Proceeds from employee stock purchases and option exercises | $440.3K | $20.0K |
| Net cash provided by financing activities | $14.7M | $10.8M |
| Effect of exchange rate changes on cash | -$13.4K | -$54.7K |
| Net increase in cash and cash equivalents | $8.8M | $1.2M |
| Cash paid for interest | $9.5K | $13.1K |
| Issuance of stock options for payment of certain employee bonuses | $1.0M | |
| Insurance financing agreement | $257.2K | $172.0K |
| Issuance of related party note (Note 10) | $792.9K |
No quarter-by-quarter statement was filed.
Corporate structure
MiNK Therapeutics, Inc. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of MiNK Therapeutics, Inc.
- GKCC, LLC Filed SC 13G on MiNK Therapeutics, Inc., latest May 22, 2024
- Garo H. Armen Filed SC 13D on MiNK Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2022)
- MiNK Therapeutics, Inc. New York, New York, United States
- AgenTus Therapeutics Limited Subsidiary · United Kingdom
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What MiNK Therapeutics, 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.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $1.0M11 Dec 31, 2025 | $1.3M11 Dec 31, 2024 | −20.3% |
| Accumulated depreciation | $612.2K11 Dec 31, 2025 | $524.6K11 Dec 31, 2024 | +16.7% |
| Property and equipment, net | $390.9K11 Dec 31, 2025 | $732.9K11 Dec 31, 2024 | −46.7% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $13.4M11 Dec 31, 2025 | $4.6M11 Dec 31, 2024 | +191.9% |
Properties, in its own words
We currently utilize a combined 3,500 square feet of Agenus’ facilities in Lexington, MA and New York, NY. The space supports our research, clinical, manufacturing and administrative functions. There is current capacity to expand our operations within existing Agenus facilities.
Item 2 of the 10-K filed Mar 31, 2026.6
Leadership
Who has led MiNK Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
- Chief executive officerJennifer Buell Jan 11, 2023 to now14
Board members and other officers (15)
- Principal Accounting OfficerAustin Charette Mar 23, 2026 to now15
- Principal Financial OfficerMelissa Orilall Apr 9, 2026 to now16
- TreasurerChristine M. Klaskin Oct 20, 2021 to Oct 20, 202117
- Chief Technology OfficerDijk Marcus Antonius Van Oct 20, 2021 to Jan 18, 202418
- OfficerJennifer Buell Oct 20, 2021 to Jan 25, 202219
- Board memberJohn Bradley Holcomb Dec 3, 2025 to now20
- Board memberRobert Peter Kadlec Dec 9, 2024 to now21
- Board memberBarbara Ryan Oct 20, 2021 to now22
- Board memberBrian Corvese Oct 20, 2021 to now23
- Board memberGaro H. Armen Oct 20, 2021 to May 26, 202324
- Board memberJennifer Buell Oct 20, 2021 to Oct 13, 202319
- Board memberJohn Baldoni Oct 20, 2021 to Sep 6, 202325
- Board memberPeter Behner Oct 20, 2021 to now26
- Board memberUlf Wiinberg Oct 20, 2021 to now27
- Board memberWalter Flamenbaum Md. Oct 20, 2021 to Oct 20, 202128
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- AgenTus Therapeutics Limited England and Wales5
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- AgenTus Therapeutics, Inc.Mar 17, 2021 to Mar 18, 20214
Timeline
- Aug 13, 20268-K Results of operations29
- Jun 23, 20268-K Shareholder vote30
- May 15, 20268-K Results of operations31
- Mar 31, 20268-K Results of operations32
- Mar 27, 20268-K Other events33
- Mar 19, 20268-K Executive or director change34
- Jan 2, 20268-K Executive or director change35
- Dec 8, 20258-K Results of operations36
- Sep 29, 20258-K Executive or director change37
- Aug 14, 20258-K Results of operations38
- Jul 15, 20258-K Entered a material agreement39
- Jul 14, 20258-K Other events40
- Jan 11, 2023New chief executive Jennifer Buell becomes CEO14
- Jul 15, 2017Founded MiNK Therapeutics, Inc. is founded2
Calendar
Coming up
- Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.65) a share, on Nov 14, 2025.41
When it reported results
- Aug 13, 2026Reported quarterly or annual results29
- May 15, 2026Reported quarterly or annual results31
- Mar 31, 2026Reported quarterly or annual results32
- Dec 8, 2025Reported quarterly or annual results36
- Aug 14, 2025Reported quarterly or annual results38
- May 15, 2025Reported quarterly or annual results42
- Mar 18, 2025Reported quarterly or annual results43
- Nov 14, 2024Reported quarterly or annual results44
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
254 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 42 major events, 145 insider forms, 6 large holders, 41 other. The latest 20:
- Oct 14, 20264 EDGAR
- Oct 13, 2026144 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Aug 13, 2026S-8 EDGAR
- Aug 13, 202610-Q EDGAR
- Aug 13, 20268-K EDGAR
- Jun 23, 20268-K EDGAR
- Jun 5, 20264 EDGAR
- Jun 2, 20264 EDGAR
- Jun 2, 20264 EDGAR
- Jun 2, 20264 EDGAR
- Jun 2, 20264 EDGAR
- Jun 2, 20264 EDGAR
- May 15, 202610-Q EDGAR
- May 15, 20268-K EDGAR
- Apr 30, 2026ARS EDGAR
The 254 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
22 open-market trades by officers, directors and large owners since October 2021: 16 buys and 6 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jun 4, 2026 | Ryan BarbaraDirector | Sale | 1,500 | $12.76 | $19.1K | Form 4 |
| Mar 10, 2026 | Ryan BarbaraDirector | Sale | 1,300 | $15.40 | $20.0K | Form 4 |
| Mar 9, 2026 | Ryan BarbaraDirector | Sale | 200 | $10.17 | $2.0K | Form 4 |
| Mar 2, 2026 | Ryan BarbaraDirector | Sale | 100 | $10.83 | $1.1K | Form 4 |
| Feb 27, 2026 | Ryan BarbaraDirector | Sale | 400 | $10.86 | $4.3K | Form 4 |
| Oct 16, 2023 | AGENUS INC10% owner | Buy | 429 | $1.10 | $472 | Form 4 |
| Oct 13, 2023 | AGENUS INC10% owner | Buy | 19,373 | $1.10 | $21.3K | Form 4 |
| Oct 12, 2023 | AGENUS INC10% owner | Buy | 3,173 | $1.10 | $3.5K | Form 4 |
| Oct 4, 2023 | AGENUS INC10% owner | Buy | 15,001 | $1.09 | $16.4K | Form 4 |
| Aug 29, 2023 | AGENUS INC10% owner | Buy | 29,678 | $1.52 | $45.1K | Form 4 |
| Aug 28, 2023 | AGENUS INC10% owner | Buy | 12,808 | $1.45 | $18.6K | Form 4 |
| Aug 24, 2023 | AGENUS INC10% owner | Buy | 170,244 | $1.54 | $262.2K | Form 4 |
| May 11, 2023 | AGENUS INC10% owner | Buy | 23,361 | $1.43 | $33.4K | Form 4 |
| May 10, 2023 | AGENUS INC10% owner | Buy | 22,065 | $1.51 | $33.3K | Form 4 |
| May 5, 2023 | ARMEN GARO HDirector | Sale | 100,000 | $0.95 | $95.0K | Form 4 |
| May 5, 2023 | AGENUS INC10% owner | Buy | 100,200 | $0.95 | $95.2K | Form 4 |
| May 4, 2023 | AGENUS INC10% owner | Buy | 21,473 | $1.22 | $26.2K | Form 4 |
| May 3, 2023 | AGENUS INC10% owner | Buy | 128,689 | $1.08 | $139.0K | Form 4 |
| May 2, 2023 | ARMEN GARO HDirector | Buy | 100,000 | $0.95 | $95.0K | Form 4 |
| Jul 19, 2022 | WIINBERG ULFDirector | Buy | 16,661 | $1.39 | $23.2K | Form 4 |
All 22 trades can be filtered by person here when JavaScript is on.
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.
- GKCC, LLCSC 13G, 1 filing May 22, 202445
- Garo H. ArmenSC 13D, 2 filings Feb 14, 2022 to Feb 14, 202446
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Jennifer S. BuellPh.D. | $448.0K | $2.1M47 | |
| 2025 | Christine M. Klaskin | $29.8K47 | ||
| 2024 | President and Chief Executive Officer | $448.0K | $1.1M47 | |
| 2024 | Consultant and Former Treasurer | $29.8K47 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 26. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How MiNK Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARMiNK Therapeutics, Inc.1
- CIK0001840229
- Employer ID (EIN)82-21420676
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company6
- Incorporated inDelaware6
- 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 address149 Fifth Avenue, Suite 500, New York, NY 100101
- Phone212-994-82501
- Shares outstanding5,103,002 as of Aug 11, 202613
- Public float$10.9M as of Jun 30, 20256
- AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; no auditor attestation of internal control over financial reporting6
- On EDGAR sinceJan 22, 20211
- Filings265 in all: 4 (125), 8-K (42), 10-Q (15), 3 (14), CORRESP (7), DEF 14A (6), 10-K (5), 4/A (5)1
All 31 form types
S-8 (5), UPLOAD (5), EFFECT (4), ARS (3), S-3 (3), 144 (2), 424B5 (2), DRS/A (2), DRSLTR (2), PRE 14A (2), SC 13D (2), SC 13D/A (2), SC 13G (2), 424B3 (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), DRS (1), FWP (1), S-1 (1), S-1/A (1), S-3/A (1)
- Latest filingsAnnual report (10-K) Mar 31, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Apr 30, 2026
Latest 8-K (8-K) Aug 13, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.00001 per share | INKT | Nasdaq |
From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).6
Risk factors and legal proceedings
The risks MiNK Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 72 risks under these headings, as written.6
- Risks Related to Our Financial Position and Need for Additional Capital
- Risks Related to Discovery, Development and Commercialization of Our Allogeneic iNKT Cells and Other Product Candidates
- Risks Related to Regulatory Review and Other Legal Compliance Matters
- Risks Related to Our Relationship with Agenus
- Risks Related to Our Relationships with Third Parties
- Risks Related to Our Intellectual Property
- Risks Related to Employee Matters, Managing Growth, Information Technology and Our Operations
- Risks Related to Ownership of Our Common Stock
- We have incurred losses since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
- We will need additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce, or eliminate our research and product development programs or future commercialization efforts.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates we may develop.
- Our short operating history as an independent company may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
The other 66 risks
- Our future ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements, and it is possible that such report on our financial statements may include such an explanation again in the future.
- Risks Related to Discovery, Development and Commercialization of Our Allogeneic iNKT Cells
- Our business is highly dependent on the success of our lead product candidate, agenT-797, which is our only product candidate in clinical development. We have a limited history of conducting clinical trials and may fail to develop agenT-797 successfully or be unable to obtain marketing approval for it.
- Utilizing allogeneic iNKT cells represents a novel approach to immunotherapy, and we must overcome significant challenges to develop, commercialize and manufacture our product candidates.
- Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and the results of prior clinical trials and studies involving our product candidates are not necessarily predictive of our future results. Our product candidates may not show favorable results in preclinical studies or clinical trials or receive marketing approval on a timely basis, if at all.
- Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
- If any of the product candidates we may develop, or the delivery modes we rely on to administer them, cause serious adverse events, undesirable side effects or unexpected characteristics, such events, side effects or characteristics could delay or prevent marketing approval of the product candidates, limit the commercial potential or result in significant negative consequences following any potential marketing approval.
- If we experience delays or difficulties in the enrollment of patients in our clinical trials for agenT-797 or any future trials, our receipt of necessary marketing approvals could be delayed or prevented.
- Interim, “topline” and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- We may develop our product in combination with other therapies, which exposes us to additional risks
- We may conduct clinical trials for our product candidates outside of the U.S. and the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business
- Even if any product candidates we may develop receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.
- If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.
- We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve marketing approval before us or develop adoptive cell therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.
- Even if we are able to commercialize any product candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain coverage and adequate reimbursement for or product candidates, if any and if approved, could limit our ability to market those products and decrease our ability to generate revenue.
- If we are required by the FDA to obtain clearance or approval of a companion diagnostic in connection with approval of any of our product candidates, and we do not obtain, or face delays in obtaining, FDA clearance or approval of such companion diagnostic, we will not be able to commercialize such product candidate and our ability to generate revenue will be materially impaired.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.
- Adoptive cell therapy treatments are novel, and any product candidates we develop may be complex and difficult to manufacture. We could experience delays in satisfying regulatory authorities or production problems that result in delays in our development or commercialization programs, limit the supply of our product candidates we may develop or otherwise harm our business.
- The marketing approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed.
- Because adoptive cell therapy is novel and the regulatory landscape that will govern any product candidates we may develop is uncertain and may change, we cannot predict the time and cost of obtaining marketing approval, if we receive it at all, for any product candidates we may develop.
- Failure to obtain marketing approval in foreign jurisdictions would prevent any product candidates we may develop from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
- Even if we receive marketing approval for any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
- Disruptions at the FDA and other government agencies caused by, funding shortages, staffing limitations, or policy changes could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified products from being developed, reviewed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
- Our relationships with healthcare providers, third-party payors and patients as well as our activities generally will be subject to a broad range of healthcare laws and regulations and any failure to comply with such laws and regulations could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Current and future healthcare reform and other legislation or regulation may increase the difficulty and cost for us and any collaborators to commercialize any product candidates we may develop and affect the prices we, or they, may obtain and may have a negative impact on our business and results of operations.
- We may not be able to obtain orphan drug exclusivity for one or more of our product candidates which we may develop, and even if we do, that exclusivity may not prevent the FDA from approving other competing products.
- Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
- Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading, or we may fail to satisfy certain arrangements with governmental authorities.
- If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
- Laws and regulations governing any of our international operations or those we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs.
- We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies and contractual obligations could adversely affect our business.
- We may experience difficulty in separating our resources from Agenus.
- Agenus owns a significant amount of our common stock and will be able to exert control over specific matters subject to stockholder approval.
- Agenus may sell or distribute a portion of the shares of our common stock it currently holds to its stockholders, which could impact our share price or volatility.
- Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Agenus.
- We rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing.
- We contract with third parties for the manufacture of GMP lentiviral vectors for our early phase programs. This reliance on third parties increases the risk that we will not have sufficient quantities of such materials, product candidates, or any product candidates that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.
- If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
- If we are unable to obtain and maintain patent and other intellectual property protection for any product candidates we develop and for our cell-based immunotherapies, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and therapies similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop, and our cell-based immunotherapies may be adversely affected.
- Our rights to develop and commercialize our cell-based immunotherapies and product candidates are subject, in part, to the terms and conditions of licenses granted to us by others, including Agenus.
- Our patent, patent applications and any future patents may not provide sufficient protection of our cell-based immunotherapies, our product candidates and our future product candidates or result in any competitive advantage.
- We have limited foreign intellectual property rights and may not be able to protect our intellectual property and proprietary rights throughout the world.
- If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
- We may not be successful in acquiring or in-licensing necessary rights to key technologies or any product candidates we may develop.
- Our existing collaboration arrangements and any that we may enter into in the future may not be successful and we may not realize the benefits of such relationships, which could adversely affect our ability to develop and commercialize our product candidates.
- The intellectual property landscape around cell-based immunotherapies is highly dynamic, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent, delay or otherwise interfere with our product discovery and development efforts.
- We may become involved in lawsuits to protect or enforce our present or future patents or the patents of our licensors, which could be expensive, time-consuming, and unsuccessful and could result in a finding that such patents are unenforceable or invalid.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Changes in patent law in the United States and in non-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our cell-based immunotherapies and product candidates.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- If we do not obtain PTE and data exclusivity for any product candidates we may develop, our business may be materially harmed.
- If we are unable to protect the confidentiality of our proprietary knowledge, our business and competitive position would be harmed.
- Third parties may assert that our employees, consultants or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets.
- 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.
- We currently have a limited number of employees, and our future success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel.
- We expect to expand our development, regulatory and future sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- Our internal computer systems, or those of our third-party vendors, collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
- We do not know whether a market for our common stock will be sustained or what the market price of our common stock will be, we may be delisted from the Nasdaq Capital Market if we are unable to comply with Nasdaq Listing Rules, and, as a result, it may be difficult for you to sell your shares of our common stock.
- If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our common stock, the price of our common stock could decline.
- Sales of substantial amounts of our common stock in the public market, or the perception that these sales may occur, could cause the market price of our common stock to decline.
- If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.
- We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
- Provisions in our amended and restated certificate of incorporation, our amended and restated by-laws and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
- Our amended and restated certificate of incorporation and amended and restated by-laws designate the state or federal courts within the State of Delaware as the exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- General Risk Factors
Legal proceedings
We are not currently a party to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources and other factors.
The opening of Item 3, Legal Proceedings.6
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1
- 2
- 3Yahoo FinanceINKT quote
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15
- 16
- 17SEC EDGARChristine M. Klaskin, Treasurer
- 18
- 19SEC EDGARJennifer Buell, Officer
- 20SEC EDGARJohn Bradley Holcomb, Board member
- 21SEC EDGARRobert Peter Kadlec, Board member
- 22SEC EDGARBarbara Ryan, Board member
- 23SEC EDGARBrian Corvese, Board member
- 24SEC EDGARGaro H. Armen, Board member
- 25SEC EDGARJohn Baldoni, Board member
- 26SEC EDGARPeter Behner, Board member
- 27SEC EDGARUlf Wiinberg, Board member
- 28SEC EDGARWalter Flamenbaum Md., Board member
- 29SEC EDGARResults of operations
- 30SEC EDGARShareholder vote
- 31SEC EDGARResults of operations
- 32SEC EDGARResults of operations
- 33SEC EDGAROther events
- 34SEC EDGARExecutive or director change
- 35SEC EDGARExecutive or director change
- 36SEC EDGARResults of operations
- 37SEC EDGARExecutive or director change
- 38SEC EDGARResults of operations
- 39SEC EDGAREntered a material agreement
- 40SEC EDGAROther events
- 41NasdaqNasdaq calendar
- 42
- 43
- 44
- 45
- 46
- 47